0A4F4F9BD490A749D5437F821CF06DF1
Opinion No. 22 - The Ethics Review of hESC FP7 Research Projects (2007)
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
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Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / criminal
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p.000127: to get the texts would be welcomed).
p.000127: In Poland there is no research on embryonic stem cells.
p.000127:
p.000127: Polish legal rules do not include distinct regulations for human embryonic stem cells research. There is also no legal
p.000127: definition for embryo stage of life.
p.000127: The fundamental legal act in Poland is the Constitution of the Republic of Poland
p.000127: (http://www.sejm.gov.pl/prawo/konst/angielski/kon1.htm), which was passed by the National Assembly on April 2nd, 1997.
p.000127: In accordance with Art.38 of this Law the Republic of Poland shall ensure the legal protection of the life of every
p.000127: human being Regulations referring to legal protection and conduct rules in the pre-birth stage of human life are
p.000127: included in the Act of January 7th, 1993 on Family Planning, Protection of Human Foetus and Admissible Conditions for
p.000127: an Abortion.
p.000127: In accordance with Art.1 of this Law, the right to life is protected, including also the prenatal stage, in the scope
p.000127: stipulated by the Law. The Law also includes regulations concerning the conceived child that is from the moment of
p.000127: conception through the embryo and foetal stages until birth.
p.000127: According to Art.157a of the Criminal Code any person except for child’s mother who commits any infringement to a
p.000127: conceived child, will be punished. The rule does not include a physician who undertakes medical action necessary to
p.000127: exclude danger- threatening mother’s or child’s health or life.
p.000127: What’s more, under the Act of December 5th, 1996 on Medical Profession’s, human embryos (conceived children) may not be
p.000127: used for therapeutic research (Art. 26 paragraph 1).
p.000127: Not directly refers to this matter the ruling of the Constitutional Court of the Republic of Poland from the 28th May
p.000127: 1997, which says: ‘A democratic state governed by the rule of law holds man and his most precious weal as a supreme
p.000127: value. By this weal, we understand life which in a democratic state governed by the rule of law must enjoy
p.000127: constitutional protection in each stage of its development’.
p.000127:
p.000127: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000127: As mentioned above, there is no legal definition for embryo stage of life.
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p.000127: 3 Is hESC research allowed and in what terms and conditions?
p.000127: In Poland, human embryo research is prohibited.
p.000127:
p.000127: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000127:
p.000127: NA
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p.000133: having not a legal personality.
p.000133:
p.000133: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000133: to get the texts would be welcomed).
p.000133: No specific regulations exist at present. There is an extensive governmental regulation in preparation, however, to
p.000133: deal with the ‘donation, procurement, testing and distribution of organs, tissues and cells, and processing,
p.000133: conservation and storage of tissues and cells’ (transposition of the requirements of the Dir. 2006/17/EC, ev. Dir.
p.000133: 2004/23/EC). It could tackle on some closely related issues, but probably not specifically on hESCs.
p.000133: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000133: N.A. (non-applicable)
p.000133: 3 Is hESC research allowed and in what terms and conditions?
p.000133: hESC research is not specifically prohibited by a law, however, according to the position the Slovak Republic (SR) has
p.000133: taken so far on the issue, it probably would not be allowed to take place in the country (as destroying of a human
p.000133: embryo is necessary to obtain the hESCs lines for research).
p.000133: The ‘non-therapeutic’ research on human embryo and fetus, as well as human cloning are prohibited both by the SR’s
p.000133: health law (law No. 576/2004 Coll. as later amended) and by SR’s Penal Code (law No. 300/2005 Coll.) – making both a
p.000133: criminal offence.
p.000133: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000133: N.A. (non-applicable)
p.000133: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000133: yes at what conditions?
p.000133: NO, it is prohibited as a criminal act (see 3, above).
p.000133:
p.000133: 6 Is the source of hESC used in research traceable and well documented?
p.000133: N.A. (non-applicable)
p.000133: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000133: N.A. (non-applicable)
p.000133:
p.000133: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000133: embryo donation for research, if so could you please describe them?
p.000133: N.A. (non-applicable)
p.000133:
p.000133: 9 Is financial inducement allowed? If so, in what terms?
p.000133:
p.000133: N.A. (non-applicable)
p.000133: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000133: N.A. (non-applicable)
p.000133:
p.000133: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000133: publications)?
p.000133: N.A. (non-applicable)
p.000133:
p.000133: 12 How is patenting of hESC lines regulated?
p.000133: N.A. (non-applicable)
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p.000134: 134
p.000134:
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p.000134: Regulatory frame applying to SLOVENIA
p.000134:
p.000134: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000134: having not a legal personality.
p.000134:
p.000134: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000134: to get the texts would be welcomed).
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Political / political affiliation
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p.000133:
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p.000134: 134
p.000134:
p.000134:
p.000134:
p.000134: Regulatory frame applying to SLOVENIA
p.000134:
p.000134: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000134: having not a legal personality.
p.000134:
p.000134: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000134: to get the texts would be welcomed).
p.000134: Explicit legal regulation on hESC does not exist. However, the Law on treatment of infertility and biomedically
p.000134: assisted fertilisation (Zakon o zdravljenju neplodnosti in postopkih oploditve z biomedicinsko pomocjo, /ZZNPOB/ 3307,
p.000134: Uradni list Republike Slovenije 70/2000, 8. 8. 2000, UL ONLINE) contains provisions that apply to research on embryos
p.000134: from IVF procedures and may apply to procurement of hESC.
p.000134: Web address (Ministry of Health): http://www.mz.gov.si
p.000134: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000134: Article 4: The embryo is created by fertilisation of the ovum. For the purposes of this Law, the early embryo is a
p.000134: zygote or an embryo that has developed outside the uterus for less than 14 days or until the appearance of the
p.000134: primitive streak.
p.000134:
p.000134:
p.000134: 3 Is hESC research allowed and in what terms and conditions?
p.000134: As said above, research on hESC is not specifically regulated.
p.000134:
p.000134: Slovenia is party to the Oviedo Convention and the protocol on prohibition of human cloning. Its Law on treatment of
p.000134: infertility and biomedically assisted fertilisation forbids the creation of human embryos for research, the production
p.000134: of cloned embryos and the use of in vitro fertilisation for any purpose other that birth of a child. Also prohibited is
p.000134: the use of parts of embryo for any purpose other than is explicitly allowed by law.
p.000134:
p.000134: However, the law allows research on surplus embryos from in vitro fertilisation procedures (and thus also procurement
p.000134: of hESC), if several conditions are fulfilled:
p.000134: Article 38 (unofficial translation)
p.000134: Scientific research on the gametes and early embryos (= in vitro embryos) is allowed exclusively for the purposes of
p.000134: (promoting knowledge on) protection and improvement of human health. It may be carried out on early embryos only if it
p.000134: cannot be done on animal embryos or otherwise with comparable efficiency. Early embryos may only be used for research
p.000134: after a written informed consent has been obtained for their parents who had undergone medically assisted reproduction.
p.000134: The research must be authorised by the National Commission for Assisted Reproduction and must be approved and
p.000134: supervised by the National Medical Ethics Committee (NMEC). Permission may be granted for embryos that, according to
p.000134: medical knowledge, are not suitable to be transferred into woman’s body or for storage, or would have to be left to
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p.000088: 88
p.000088: Annex IV — EU Member States’ regulatory framework for hESC research 90
p.000088: Appendix : Secretariat of the EGE 144
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p.000002: 2
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p.000002: SUMMARY
p.000002:
p.000002:
p.000002: The European Group on Ethics in Science and New Technologies (EGE) adopted Opinion No 22 on 20 June
p.000002: 2007. The opinion indicates the implementing measures (guidelines) to use during the ethics review of
p.000002: seventh framework programme for research and development (FP7) research projects on human embryonic stem cells
p.000002: (hESCs), as requested by the President of the European Commission, Mr Barroso (1), and in line with the
p.000002: adoption of the EU’s FP7.
p.000002:
p.000002: The EGE stressed that, as is the case in the European Union, there are divergent views within the
p.000002: group on the moral legitimacy of research on human embryos and hESCs, ranging from objection to research
p.000002: involving the destruction of human embryos (which makes the full respect of dignity of the human embryo impossible)
p.000002: to a position allowing hESC research under certain conditions or on a broader basis.
p.000002:
p.000002: The group, however, acknowledged the political decision taken as the starting point for its recommendations, but
p.000002: emphasised that the ethical dilemma regarding the moral status of the human embryo and its use in research still
p.000002: persists both within the EGE members and the EU. Therefore, the group did not elaborate ethical arguments on hESC
p.000002: research as such, but worked on recommendations for FP7 ethics review of hESC projects.
p.000002:
p.000002: The EGE recognised the need for promoting responsible research that is transparent, serves the public
p.000002: interest, respects Member State autonomy, preserves public trust, promotes international cooperation and
p.000002: requires the embedding of ethics within research practice. The group indicated that, in addition to the FP7
p.000002: ethics rules already adopted in co-decision, among others the following considerations should apply to hESCs funded by
p.000002: the EU:
p.000002:
p.000002: • FP7 hESC lines have to result from non-implanted IVF embryos;
p.000002: • if alternatives to hESCs with the same scientific potential as embryo- derived stem cells are found in the
p.000002: future, their use should be maximised;
p.000002:
p.000002:
p.000002: (1) Letter sent by European Commission President Barroso to the EGE on 22 November 2006: ‘I
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p.000010: the ethics review of human embryonic stem cell (hESC) projects funded under FP7;
p.000010:
p.000010: Having heard the rapporteurs A. Cambon-Thomsen, H. Haker, P. Martinho da Silva,
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p.000010: (29) http://www.ec.europa.eu/european_group_ethics/docs/avis16_en.pdf
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p.000011: 11
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p.000011: II. WHEREAS
p.000011:
p.000011: II.1. Preamble
p.000011: It is common knowledge that opinions about the ethical legitimacy of research on human embryos are sharply divided.
p.000011: The controversy is rooted in different ethical, philosophical, and/or religious viewpoints, each of which is
p.000011: acknowledged to be fully legitimate. In this respect, some claim that the divergences are ‘intrinsic’ and
p.000011: therefore irreconcilable, while others claim that common positions are achievable while respecting the pluralism of
p.000011: European societies, as practical solutions.
p.000011:
p.000011: The scope of these recommendations, however, is not to address the ethics of human embryonic stem cell research or
p.000011: research on human embryos. These recommendations relate to the political decision reached by the European
p.000011: institutions on the EU’s seventh framework research programme and is intended to contribute to the implementation
p.000011: of the mechanism established under the programme for an ethics review of EU-funded research activities
p.000011: involving the use of human embryonic stem cells.
p.000011:
p.000011: Because of the particular scope of these recommendations, it is important to identify the main
p.000011: requirements regarding the ethics of human embryonic stem cells that have been adopted in
p.000011: co-decision by the European institutions involved: the Council and the European Parliament. In
p.000011: addition, as the current EU framework programme follows on from the previous one, and since both
p.000011: implement the European research area (the policy strategy of the EU in research and development) and are linked to the
p.000011: economic strategy of the EU (the ‘Lisbon strategy’), the present document will refer to the previous
p.000011: EU framework programme and its implementation to date by the Commission services.
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p.000012: II.2. The sixth framework programme for research, technological development and demonstration:
p.000012: ‘Integrating and strengthening the European research area’ (2002–06) (FP6)
p.000012:
p.000012: On 30 September 2002, the Council adopted the specific programme implementing the sixth
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p.000031: (82) OJ L 213, 30.7.1998, pp. 13–21.
p.000031: (83) See COM(2005) 312
p.000031: (84) EGE Opinion No 16, ‘Ethical aspects involving the patenting of human stem cells’.
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p.000032: IV. RECOMMENDATIONS
p.000032:
p.000032: IV.1 Preamble
p.000032:
p.000032:
p.000032: These recommendations constitute the reply to the request from the President of the European
p.000032: Commission, Mr Barroso (85), after the adoption of the EU’s seventh framework programme for research and
p.000032: development (FP7), to elaborate an opinion on the implementing measures required during the ethics review of
p.000032: research projects on human embryonic stem cells (hESCs).
p.000032:
p.000032: As is the case in the European Union, there are divergent views within the European Group on Ethics
p.000032: (EGE) on the moral legitimacy of research on human embryos and hESCs, ranging from objection to research
p.000032: involving the destruction of human embryos (which makes the full respect of dignity of the human embryo impossible),
p.000032: to a position allowing hESC research under certain conditions or on a broader basis.
p.000032:
p.000032: The group acknowledges the political decision taken as the starting point for its recommendations, but emphasises that
p.000032: the ethical dilemma regarding the moral status of the human embryo and its use in research still persists. The EGE
p.000032: therefore stresses that the ethical differences of opinion concerning hESC research have not been resolved.
p.000032:
p.000032: However, these recommendations do not elaborate ethical arguments on hESC research as such; this is
p.000032: because this was not the task given to the group by the European Commission.
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p.000032: (85) Letter sent by Commission President Barroso to the EGE on 22 November 2006. ‘I would like to invite the
p.000032: European Group on Ethics to provide the Commission with an opinion on the implementing measures
p.000032: required during the ethics review of research projects on human embryonic stem cells that will assure
p.000032: that the ethical rules and requirements are fully met’.
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p.000033:
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p.000033: IV.2. Recommendations for the ethical review of research projects involving hESCs
p.000033:
p.000033: FP7 research projects involving the use of hESCs are subject to stringent rules for selection, are scrutinised at
...
p.000033: and to examine whether the ethics rules set out in FP7 are met.
p.000033:
p.000033: The ethics review panel is a transnational body composed of experts from different disciplines. The panel
p.000033: produces an ethical review report, which lists the different ethical issues, describes the way these issues
p.000033: were handled by applicants, and gives the recommendations of the panel.
p.000033:
p.000033: After having successfully passed both the scientific and ethics review, proposals for hESC projects are then handed
p.000033: over to a Regulatory Committee composed of EU Member State representatives, which decides upon the projects on a case-
p.000033: by-case basis.
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p.000033: (86) Seventh framework programme (Decision No 1982/2006/EC), Article 6(1): ‘All the research
p.000033: activities carried out under the Seventh Framework Programme shall be carried out in compliance with fundamental
p.000033: ethical principles.’; Rules for Participation, Article 10: ‘A proposal […] which contravenes fundamental ethical
p.000033: principles […] shall not be selected. Such a proposal may be excluded from the evaluation and selection
p.000033: procedures at any time.’
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p.000034:
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p.000034: In order to provide guidance to the members of the FP7 hESC ethics review panels who will be asked to
p.000034: review the research projects using hESC lines, and under the specific remit and conditions laid down by the political
p.000034: decision of the European Parliament and of the Council on FP7, and also by the specific request of the President of the
p.000034: European Commission, Mr J. M. Barroso (see above), the EGE elaborated the following guidelines and points to consider
p.000034: when conducting such ethics review of FP7 projects (87).
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p.000034: IV.2.1. General criteria
p.000034:
p.000034: The European Commission has stated that it ‘will support actions and initiatives that contribute to coordination
p.000034: and rationalisation of hESC research within a responsible ethical approach’ (88). In line with this statement,
p.000034: the EGE recognises the need to promote responsible research that is transparent, serves the public interest, respects
p.000034: Member States’ autonomy, preserves public trust, promotes international cooperation, and requires the embedding
p.000034: of ethics within research practice (89).
p.000034:
p.000034: Ethically responsible research involving human embryonic stem cells must comply with fundamental ethical
p.000034: principles and human rights in the European Union (90), from the procurement of stem cells (91) to clinical
p.000034: research based on hESCs.
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p.000034: (87) According to FP7 rules, evaluators sign a conflict of interest declaration and EC staff
p.000034: verify conflicts with each proposal they evaluate. Evaluation panels of ethics and scientific reviews are anonymous.
p.000034: (88) Declaration of the European Commission on 24 July 2006 during the meeting of the Council of Ministers
p.000034: regarding FP7. See OJ L 412, 30.12.2006.
p.000034: (89) For example, the Council of Europe Oviedo Convention (Article 2).
p.000034: (90) For details, see Section I of this opinion referring to the pertinent documents relevant to
p.000034: the context of medical research.
p.000034: (91) FP7 excludes the procurement of hESCs from Community funding (see paragraph II.2). See
p.000034: Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006
p.000034: concerning the seventh framework programme of the European Community for research, technological
p.000034: development and demonstration activities (2007–13), OJ L 412, 30.12.2006, pp. 1–
p.000034: 41.
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p.000035: The fundamental rights include: protection rights such as protection of human life, respect of its integrity,
p.000035: protection of health and freedom, political rights such as freedom from undue state intervention or participatory
p.000035: rights in political affairs, and positive rights such as basic social and economic rights insofar as these
p.000035: contribute to health and a threshold of development, resulting in health-related governance (92).
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p.000035: The balancing of these three groups of fundamental rights is by no means easy or pre-determined. Rather, it involves
p.000035: ongoing efforts to ensure their protection, granting and promotion of human dignity and human rights and, more
p.000035: concretely, it involves priority setting with respect to health-related research.
p.000035:
p.000035: General criteria for research incentives in specific areas incorporate this balancing. They can be
p.000035: summarised as follows:
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p.000035: • scientific necessity and high-ranking status of the research (93);
p.000035: • urgency (94);
p.000035: • social desirability;
p.000035: • primacy of the interest and welfare of the human being over the sole interest of society or science.
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p.000035: Social desirability is open to political and societal discourse on the goals and perspectives of the
p.000035: European Union in the 21st century, in particular the relation between economic growth and social goals, such as the
p.000035: promotion of healthcare standards and their sustainable application at national, international and global
p.000035: level.
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p.000035: (92) See the United Nations’ millennium goals, which the European Union has committed itself to
p.000035: achieving.
p.000035: (93) http://ec.europa.eu/research/fp7/index_en.cfm?pg=documents
p.000035: (94) http://www.who.int/rpc/en/HealthResearchinPolicyMaking.pdf
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p.000036: As far as hESC research is concerned, there is no consensus on its social acceptability in the European
p.000036: Union, and divergent views coexist. A debate on the best model (e.g. ‘minimal consensus’ or
p.000036: ‘subsidiarity’ model) to regulate hESC research at EU level is therefore taking place within and across several EU
p.000036: Member States.
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p.000036: Where morally sensitive means are to be used to achieve well-accepted goals — as in the case of human embryonic stem
p.000036: cells –— where not the goal of therapy- oriented research is questioned but the means to accomplish it, the EGE holds
p.000036: that additional criteria apply concerning the necessity of the research: (1) non- availability of validated
p.000036: alternatives, and (2) the non-redundancy of FP7 projects (95).
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p.000041: • once the registry is operational, after a necessary transitional period, the use of the hESC lines banked in
p.000041: the registry should be in line with the criteria
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p.000041: (102) Directive on the protection of personal data (95/46/EC).
p.000041: (103) Council of Europe Bioethics Conventions and additional protocols, Council of Europe Convention for the
p.000041: Protection of Individuals with regard to the Automatic Processing of Personal Data (No 108).
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p.000042: indicated in IV.2.3. The Commission should develop and actively maintain the necessary means to ensure this requirement
p.000042: is fulfilled;
p.000042: • applicants should use hESCs banked in the EU registry. The need to use other hESC lines in FP7
p.000042: proposals must therefore be justified on both scientific and ethical grounds;
p.000042: • the registry should prepare and publish (on its website) information on the hESCs banked and on
p.000042: the positive and negative results of the research performed with/on the hESC lines provided to the
p.000042: researchers. At the project’s conclusion, in addition to the scientific data, particularly health- related
p.000042: information, the publication of user-friendly information on hESC research, freely accessible to EU citizens, is
p.000042: also highly recommended. The portal should include interactive elements if possible.
p.000042:
p.000042: Researchers working in the field have a responsibility to inform the public about their work, but also to engage with
p.000042: the social, political and ethical debates. With regard to open questions such as how to balance different
p.000042: rights and how to prioritise conflicting interests, researchers should participate in public discourse and respect
p.000042: the democratic decision-making process with regard to common societal goals. Applicants should therefore commit
p.000042: time, money and activities to advance the dialogue of science and society in the field of human embryonic
p.000042: stem cell research. Applicants for hESC research under FP7 are therefore strongly encouraged to include the
p.000042: science and humanities dialogue, i.e. social, cultural/religious, philosophical and ethical reflection on hESC
p.000042: research, in their projects and to collaborate for this purpose with other disciplines from the humanities.
p.000042:
p.000042:
p.000042:
p.000042: IV.3. The need for further research and continuous public debate
p.000042:
p.000042: As the ethical conflicts concerning hESCs have not been resolved either academically or politically,
p.000042: the EGE recommends that, under FP7, funding should
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000043: 43
p.000043:
p.000043:
p.000043:
p.000043: be provided in order to foster further collaborative and multidisciplinary international research
p.000043: on the ethical implications of hESC research and the pertinent surrounding issues, as well as to encourage
p.000043: informed public debate.
p.000043: The EGE believes the following topics may be of particular immediate interest in such research and discourse:
p.000043: • the potentially conflicting goals of economic competitiveness and compliance with ethical standards;
...
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p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085: (1) Such as clinical trials, and research involving invasive techniques on persons (e.g. taking of tissue
p.000085: samples, examinations of the brain).
p.000085:
p.000085:
p.000085:
p.000085:
p.000086: 86
p.000086:
p.000086:
p.000086:
p.000086: ETHICAL ISSUES TABLE
p.000086:
p.000086:
p.000086: Informed consent
p.000086: • Does the proposal involve children?
p.000086: • Does the proposal involve patients or persons not able to give consent?
p.000086: • Does the proposal involve adult healthy volunteers?
p.000086:
p.000086:
p.000086:
p.000086: YES
p.000086:
p.000086:
p.000086:
p.000086:
p.000086: PAGE
p.000086:
p.000086: • Does the proposal involve human genetic material?
p.000086:
p.000086: • Does the proposal involve human biological samples?
p.000086: • Does the proposal involve human data collection?
p.000086:
p.000086: Research on human embryos/foetuses
p.000086: • Does the proposal involve human embryos?
p.000086: • Does the proposal involve human foetal tissue/cells?
p.000086:
p.000086: • Does the proposal involve human embryonic stem cells?
p.000086: Privacy
p.000086: • Does the proposal involve processing of genetic information or personal data (e.g. health, sexual lifestyle,
p.000086: ethnicity, political opinion, religious or philosophical conviction)?
p.000086: • Does the proposal involve tracking the location or observation of people?
p.000086: Research on animals
p.000086: • Does the proposal involve research on animals?
p.000086:
p.000086: • Are those animals transgenic small laboratory animals?
p.000086: • Are those animals transgenic farm animals?
p.000086: • Are those animals cloning farm animals?
p.000086: • Are those animals non-human primates?
p.000086: Research involving developing countries
p.000086: • Use of local resources (genetic, animal, plant, etc.)
p.000086:
p.000086: • Benefit to local community (capacity building, i.e. access to healthcare, education, etc.)
p.000086: Dual use
p.000086: • Research having potential military/terrorist application
p.000086:
p.000086: I CONFIRM THAT NONE OF THE ABOVE ISSUES APPLY TO MY PROPOSAL
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000087: 87
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087: ANNEX III
p.000087:
p.000087: LIST OF PROJECTS SUPPORTED WITHIN THE SIXTH FRAMEWORK PROGRAMME AND WITHIN THE HEALTH
p.000087: DIRECTORATE, INVOLVING HESCS
p.000087: 1. LYMPHANGIOGENOMICS: fundamental research to better understand the lymphatic vasculature with a view to
...
Health / Drug Usage
Searching for indicator drug:
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p.000021: URL_ID=1883&URL_DO=DO_TOPIC&URL_SECTION=201.html
p.000021: (54) http://www.bioethics.ac.uk/
p.000021: (55) http://www.careforeurope.org/
p.000021: (56) http://www.isscr.org/guidelines/
p.000021: (57) http://www.nuffieldbioethics.org/go/ourwork/stemcells/introduction
p.000021: (58) http://www.dfg.de/en/news/press_releases/2006/press_release_2006_60.html
p.000021: (59) UK HFEA, UK Department of Health, UK Stem Cell Initiative:
p.000021: http://www.hfea.gov.uk/cps/rde/xchg/SID-3F57D79B-370119F4/hfea/hs.xsl/295.html,
p.000021: http://www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/StemCell/fs/en,
p.000021: http://www.advisorybodies.doh.gov.uk/uksci/uksci-reportnov05.pdf
p.000021: (60) EMBO: http://www.vr.se/download/18.2aebc6b810f3c933b158000194/EMBO+document+nov+2006.pdf#
p.000021: search='stem+cell'
p.000021: (61) European Science Foundation: http://www.esf.org/publication/142/ESPB18.pdf
p.000021:
p.000021:
p.000021:
p.000021:
p.000022: 22
p.000022:
p.000022:
p.000022: development; procurements of gametes and somatic tissues for stem cell research; and the use of human stem
p.000022: cell lines (62).
p.000022:
p.000022:
p.000022: III.2. Research using human embryonic stem cells (hESCs)
p.000022:
p.000022:
p.000022: Human embryonic stem cells are used in a variety of research projects with different scientific goals.
p.000022: Some research protocols focus completely on hESCs, but sometimes they may use human embryonic and adult
p.000022: stem cells for comparative purposes or may use hESCs as a tool to obtain other scientific outcomes (for
p.000022: example, to make in vitro tests of a given experimental drug or a new chemical).
p.000022:
p.000022: The relevance and use of hESCs therefore varies considerably according to the expected scientific outcomes of the
p.000022: research trials. The scientific community is interested in investigating the basic physiology of stem cells, their
p.000022: potential and characteristics. One important aspect of such research is the comparative analysis of hESCs and
p.000022: other types of stem cells, such as umbilical-cord and adult tissue-specific stem cells, in order to address specific
p.000022: questions concerning the suitability of these types of cells. Stem cell research is also done to explore its potential
p.000022: use for regenerative medicine (degenerative diseases such as diabetes and Parkinson’s disease) and gene
p.000022: therapy (e.g. for cystic fibrosis and Huntington’s disease). At present, there are no indications that
p.000022: clinical trials will be carried out in the near future.
p.000022:
p.000022: In addition, researchers are exploring the potential use of hESCs in toxicological studies in order to replace
p.000022: animal models with in vitro models. Other uses of hESCs, with the exception of the ESTOOL project (see
p.000022: annex to this opinion), are in large multidisciplinary studies, such as those involving genomics and
p.000022:
p.000022:
p.000022: (62) http://www.isscr.org/guidelines/ISSCRhESCguidelines2006.pdf
p.000022:
p.000022:
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023:
p.000023:
p.000023: proteomics approaches, which focus on broader contexts with only a subset of experiments specifically dealing with
p.000023: hESCs.
...
p.000036:
p.000036:
p.000036: (95) However, repetitions are sometimes necessary to provide evidence of success; these are not
p.000036: redundant exercises in the sense used here.
p.000036:
p.000036:
p.000036:
p.000036:
p.000037: 37
p.000037:
p.000037:
p.000037:
p.000037: comparing hESCs with human stem cells derived from alternative sources.
p.000037:
p.000037: • Applicants must have documented the fact that, in accordance with the basic ethical principles of medical
p.000037: research, relevant research on animals and on cell lines of other origin (animal and human) has been adequately
p.000037: carried out before hESC research is performed.
p.000037:
p.000037: • Applicants must show that their research is aimed at future human health benefit or biomedical
p.000037: knowledge, and cannot be achieved by alternatives. This includes basic research using hESCs, which is
p.000037: allowed in FP7.
p.000037:
p.000037: • Applicants must have demonstrated that no alternatives can achieve the goals of the project. Although the
p.000037: group is aware of the importance of respecting animal welfare, it is concerned that respect for human dignity
p.000037: may not be maintained when hESCs are used in toxicity testing of industrial or other commercially produced
p.000037: chemicals not related to drugs, such as cosmetics, or for replacement of animal testing.
p.000037: Therefore, particular attention is to be drawn to this issue (see below, paragraph IV.3, point 2).
p.000037:
p.000037: • Applicants must provide extensive scientific justification when their projects involve toxicity drug
p.000037: testing; this justification should make clear what sort of additional information is expected from the use of hESCs as
p.000037: compared with the established tests.
p.000037:
p.000037: The scientific panel should ensure that researchers of hESC FP7 projects collaborate nationally and
p.000037: internationally in order to minimise the use of hESCs within FP7-funded projects and to achieve complementary
p.000037: synergy rather than competition.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000038: 38
p.000038:
p.000038:
p.000038:
p.000038: IV.2.2. Ethical criteria for research projects under FP6
p.000038: A few conditions have already been laid down under FP6 to ensure that ethical requirements are met, and these can be
p.000038: taken over under FP7.
p.000038:
p.000038: 1. Applicants must explicitly prove that the regulatory criteria are met for the given project and must
p.000038: indicate the relevant national legal and/or regulatory requirements of the country/countries where the
p.000038: research takes place, according to FP7, Article 6(3) (96). For further information, see Annex 1.
p.000038:
p.000038: 2. Applicants must provide information that the hESCs used in the given project result from non-implanted IVF embryos
p.000038: (see following paragraph on donors’ rights).
p.000038:
p.000038: 3. Applicants must provide information on the protection of personal data and privacy of the donors of
p.000038: embryos for the creation of stem cell lines.
p.000038:
p.000038: 4. Applicants must provide information on the conditions of donation of the embryos (e.g. no financial
p.000038: inducement, number of eggs retrieved, etc.). In order to guarantee the non-commercialisation of the human body
...
p.000087: million, 29 partners, 7 different countries (BE, DK, IL, ES, SE, CH, UK)
p.000087:
p.000087: 4. EUROSTEMCELL: comparison of the properties of adult, foetal and embryonic stem cells for the
p.000087: development of therapies including medicines in different set of diseases/disorders (skin, musculoskeletal,
p.000087: neurodegenerative diseases)/EUR 11.9 million, 14 partners, 7 different countries (UK, SE, FR, IT, DE, CH, DK)
p.000087:
p.000087: 5. HEART REPAIR: underlying principles of cardiac muscle cell formation for stem cell replacement therapies for
p.000087: heart failure and cardiac repair. Comparison of the potential of bone marrow derived stem cells and
p.000087: embryonic stem cells/EUR 11.4 million, 27 partners, 8 different countries (NL, DE, UK, IT, FR, ES, CH, SE)
p.000087: 6. OSTEOCORD: comparison of the properties of embryonic stem cells and umbilical cord blood stem
p.000087: cells in view of new applications and better characterisation of umbilical cord blood stem cells/EUR 2.5 million, 9
p.000087: partners, 5 different countries (UK, DK, DE, IL, PT)
p.000087: 7. THERCORD: development and preclinical testing of cord blood-derived cell therapy products, where
p.000087: comparative research on the potential of umbilical cord blood stem cells and embryonic stem
p.000087: cell is performed/EUR 1.8 million, 9 partners, 6 different countries (IT, UK, DE, NL, ES, IL)
p.000087:
p.000087:
p.000088: 88
p.000088:
p.000088:
p.000088:
p.000088: 8. VITROCELLOMICS: on reducing animal experimentation in preclinical predictive drug testing by human
p.000088: hepatic in vitro models derived from embryonic stem cells/EUR 2.9 million, 9 partners, 4 different
p.000088: countries (SE, DE, PT, IT)
p.000088: 9. ESTOOLS: better characterisation of 52 different existing human embryonic stem cell lines from all
p.000088: over the world to generate knowledge on the fundamental processes governing stem cell differentiation in view of
p.000088: biomedical discovery. This project will bring a major contribution to the various initiatives launched
p.000088: around the world on the issue of characterisation/EUR 12 million, 20 partners, 10 different
p.000088: countries (UK, CH, IL, FI, DE, IT, ES, CZ, SE, NL)
p.000088: 10. EUROHEAR: fundamental research on the development and function of the inner ear including
p.000088: genetics of hereditary hearing impairments/EUR 12.5 million, 26 partners, 12 different countries (FR,
p.000088: UK, IL, NL, DE, IT, ES, FI, SE, BE, HU, TN)
p.000088: 11. STEMS: preclinical evaluation of stem cell therapy in stroke/ EUR 2.4 million, 9 partners,
p.000088: 5 different countries (FR, SE, DK, DE, CZ)
p.000088:
p.000088: 12. STEMSTROKE: stem cell therapy for stroke. Outcome expected: first clinical protocol for
p.000088: application of stem cell therapy in stroke/EUR 2.5 million, 6 partners, 3 different countries (UK,
p.000088: SE, DE)
p.000088: 13. STEM-HD: using mutant hESC line (with the Huntington genetic defect) to understand Huntington’s disease and
p.000088: to perform drug screening/ EUR 2.5 million, 8 partners, 5 different countries (FR, IL, IT, UK, BE)
p.000088:
p.000088: 14. CARCINOGENOMICS: in vitro testing to assess genotoxic and carcinogenomic properties of
p.000088: chemical compounds/EUR 10.4 million, 20 partners, 12 different countries (NL, ES, BE, SE, IE, DK, UK, DE, IT, AT, CH,
p.000088: FR)
p.000088:
p.000088: 15. CRYSTAL: cryobanking of stem cells for human therapeutic applications/EUR 2.4 million, 8
p.000088: partners, 6 different countries (DE, NL, AT, CH, BE, FR)
p.000088:
p.000088: 16. SIROCCO: fundamental research on regulatory RNAs/EUR 11.8 million, 18 partners, 10 different countries (UK,
p.000088: HU, FR, CH, NL, DE, IT, DK, ES, IL)
p.000088: 17. INVITROHEART: in vitro testing for cardiotoxicity and drug development/EUR 2.7 million,
p.000088: 9 partners, 4 different countries (SE, DE, DK, BE)
p.000088:
p.000088: 18. NEUROCREEN: screening of neuro-therapeutic molecules/ EUR 2.6 million, 9 partners, 4
p.000088: different countries (UK, IT, DE, HU)
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000089: 89
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: ANNEX IV
p.000089:
p.000089:
p.000089:
p.000089: EU MEMBER STATES’ REGULATORY FRAMEWORK FOR HESC RESEARCH
p.000089:
p.000089:
p.000089:
p.000089: Information provided by EU-27 national ethics councils, updated May 2007
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
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p.000089:
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p.000089:
p.000089:
p.000089:
p.000089:
p.000090: 90
p.000090:
p.000090:
p.000090:
p.000090: Regulatory frame applying to AUSTRIA
p.000090:
p.000090:
p.000090: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000090: having not a legal personality.
p.000090:
p.000090:
p.000090: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000090: to get the texts would be welcomed).
p.000090: The hESC research (Untersuchung/Behandlung rather in the sense of medical examination and treatment) is limited to the
p.000090: field of reproductive medicine. It is therefore covered in the legislation applying to reproductive medicine
...
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p.000056:
p.000056: • la santé du donneur n'a pas été mise en danger par une stimulation ovarienne excessive;
p.000056: • pour les nouvelles lignées de CSEH, un consentement éclairé concernant le don pour la recherche d'un embryon
p.000056: initialement destiné à la reproduction est donné en connaissant la nature des recherches prévues (121),
p.000056: leurs implications (y compris commerciales) et dans le respect des conditions prévues par la loi au moment du
p.000056: don dans le pays où celui-ci a été effectué;
p.000056: • le donneur a été informé qu'il pourrait retirer son consentement jusqu'au stade de la création des
p.000056: cellules souches (122);
p.000056: • le traitement de l'infertilité et la recherche sont correctement séparés;
p.000056: • aucune incitation financière n'a été proposée à aucun moment pour donner des embryons pour la recherche,
p.000056: conformément à l'article 12 de la directive 2004/23/CE (123). Cependant, certains membres du GEE estiment acceptable la
p.000056: réduction des coûts de FIV.
p.000056:
p.000056: Si l'un ou plusieurs de ces critères ne peuvent être respectés en raison des conditions préalables dans
p.000056: lesquelles les lignées cellulaires ont été produites, les demandeurs doivent expliquer pourquoi. Le comité d'examen
p.000056: éthique doit alors statuer au cas par cas sur la manière de traiter cette question; pour les nouvelles
p.000056:
p.000056: expresse par le processus du SCRO (comité d'éthique compétent), aucun remboursement de dépenses directes ni
p.000056: rémunération financière d'aucune sorte ne peuvent être accordés pour le don d'embryons ou de gamètes produits au cours
p.000056: d'un traitement clinique et qui excèdent les besoins cliniques ou sont considérés de qualité insuffisante pour
p.000056: un usage clinique. Les chercheurs ne doivent pas demander à ce que les membres de l'équipe de traitement de la
p.000056: stérilité produisent plus d'embryons ou recueillent plus d'ovocytes que nécessaire pour garantir des chances optimales
p.000056: de succès reproductif. Les personnes qui choisissent de faire don de matériels stockés pour la recherche
p.000056: ne doivent pas être remboursées des frais de stockage correspondant à la période précédant la décision du
p.000056: don. Le remboursement des frais directs encourus par des donneurs à la suite du consentement peut être déterminé
p.000056: pendant le processus de surveillance de la recherche sur les cellules souches (SCRO)»].
p.000056: (121) Lignes directrices de l'ISSCR, 11.3-11.3.a (http://www.isscr.org/guidelines/).
p.000056: (122) Le consentement éclairé doit tenir compte du fait que les matériels seront utilisés afin de produire des
p.000056: cellules pour la recherche: «Le consentement du don de matériels pour la recherche doit être obtenu au moment de la
p.000056: proposition de cession de matériels à l'équipe de recherche. Ce n'est qu'après un examen rigoureux par un mécanisme ou
p.000056: organisme de surveillance de la recherche sur les cellules souches que l'autorisation peut être accordée d'utiliser des
p.000056: matériels pour lesquels il existe un consentement préalable dont le renouvellement s'avère extrêmement difficile»
p.000056: (ISSCR, http://www.isscr.org/guidelines/).
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000057: 57
p.000057:
p.000057:
p.000057:
p.000057: lignées de CSEH, les critères ci-dessus sont vivement recommandés (voir le point IV.2.4).
p.000057:
p.000057: Les chercheurs doivent présenter de façon anonyme toutes les données faisant référence aux donneurs. Le procédé
...
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p.000098: 98
p.000098:
p.000098:
p.000098:
p.000098: Regulatory frame applying to CZECH REPUBLIC
p.000098:
p.000098: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000098: having not a legal personality.
p.000098:
p.000098: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000098: to get the texts would be welcomed).
p.000098: Act on Human Embryonic Stem Cell Research (law no. 227/2006 Coll.) passed by the Czech Parliament on 26th of April
p.000098: 2006, in force since June 1 2006.
p.000098: Text available here: http://www.mvcr.cz/sbirka/2006/sb075-06.pdf (also attached)
p.000098:
p.000098: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000098: “Human embryo is a totopotent cell or a grouping of cells which are capable develop into human individuum’ (law no.
p.000098: 227/2006 Coll., § 2)
p.000098:
p.000098: 3 Is hESC research allowed and in what terms and conditions?
p.000098: Yes.
p.000098: Conditions: State licensing (given by the Ministry of Education, after approval of the Bioethics Committee of the
p.000098: Research and Development Council of the Czech Government and after positive appraisal of the Research and Development
p.000098: Council) Preconditions:
p.000098: a) Scientific criteria
p.000098:
p.000098: scientifically justifiable – new medical knowledge with applications for humans; scientific necessity (usage of in
p.000098: vitro models, animal cells or animals does not provide the necessary knowledge);
p.000098: no alternative research
p.000098: scientific quality of the research team
p.000098: b) Ethical criteria
p.000098:
p.000098: Research project is ethically acceptable (informed consent, donation…)
p.000098:
p.000098: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000098: Ministry of Education
p.000098:
p.000098: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000098: yes at what conditions?
p.000098:
p.000098: No. The Czech Republic ratified Oviedo Convention (2001).
p.000098: 6 Is the source of hESC used in research traceable and well documented?
p.000098: Yes.
p.000098: 7 What are the formal ethical and legal requirements for hESC research approval? Source of embryos:
p.000098: ‘surplus embryos’ from IVF (only from licensed IVF centres), no longer than 7 day of development, export of embryos
p.000098: prohibited
p.000098: Informed consent
p.000098: Donation (reimbursement of expenses possible)
p.000098:
p.000098: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000098: embryo donation for research, if so could you please describe them?
p.000098: Yes. Detailed description in § 9 Act no. 227/2006 Coll.
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000099: 99
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p.000084: embryonic stem cells and non-human primates are automatically submitted for ethical review.
p.000084:
p.000084:
p.000085: 85
p.000085:
p.000085:
p.000085:
p.000085: To ensure compliance with ethical principles, the Commission services will undertake ethics audit(s) of selected
p.000085: projects at its discretion. A website is being prepared aiming to provide clear, helpful information on ethical issues.
p.000085:
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p.000085:
p.000085: (1) Such as clinical trials, and research involving invasive techniques on persons (e.g. taking of tissue
p.000085: samples, examinations of the brain).
p.000085:
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p.000086: ETHICAL ISSUES TABLE
p.000086:
p.000086:
p.000086: Informed consent
p.000086: • Does the proposal involve children?
p.000086: • Does the proposal involve patients or persons not able to give consent?
p.000086: • Does the proposal involve adult healthy volunteers?
p.000086:
p.000086:
p.000086:
p.000086: YES
p.000086:
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p.000086: PAGE
p.000086:
p.000086: • Does the proposal involve human genetic material?
p.000086:
p.000086: • Does the proposal involve human biological samples?
p.000086: • Does the proposal involve human data collection?
p.000086:
p.000086: Research on human embryos/foetuses
p.000086: • Does the proposal involve human embryos?
p.000086: • Does the proposal involve human foetal tissue/cells?
p.000086:
p.000086: • Does the proposal involve human embryonic stem cells?
p.000086: Privacy
p.000086: • Does the proposal involve processing of genetic information or personal data (e.g. health, sexual lifestyle,
p.000086: ethnicity, political opinion, religious or philosophical conviction)?
p.000086: • Does the proposal involve tracking the location or observation of people?
p.000086: Research on animals
p.000086: • Does the proposal involve research on animals?
p.000086:
p.000086: • Are those animals transgenic small laboratory animals?
p.000086: • Are those animals transgenic farm animals?
p.000086: • Are those animals cloning farm animals?
p.000086: • Are those animals non-human primates?
p.000086: Research involving developing countries
p.000086: • Use of local resources (genetic, animal, plant, etc.)
p.000086:
...
Health / Motherhood/Family
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p.000126: No special regulations
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p.000127: 127
p.000127:
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p.000127:
p.000127: Regulatory frame applying to POLAND
p.000127:
p.000127: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000127: to get the texts would be welcomed).
p.000127: In Poland there is no research on embryonic stem cells.
p.000127:
p.000127: Polish legal rules do not include distinct regulations for human embryonic stem cells research. There is also no legal
p.000127: definition for embryo stage of life.
p.000127: The fundamental legal act in Poland is the Constitution of the Republic of Poland
p.000127: (http://www.sejm.gov.pl/prawo/konst/angielski/kon1.htm), which was passed by the National Assembly on April 2nd, 1997.
p.000127: In accordance with Art.38 of this Law the Republic of Poland shall ensure the legal protection of the life of every
p.000127: human being Regulations referring to legal protection and conduct rules in the pre-birth stage of human life are
p.000127: included in the Act of January 7th, 1993 on Family Planning, Protection of Human Foetus and Admissible Conditions for
p.000127: an Abortion.
p.000127: In accordance with Art.1 of this Law, the right to life is protected, including also the prenatal stage, in the scope
p.000127: stipulated by the Law. The Law also includes regulations concerning the conceived child that is from the moment of
p.000127: conception through the embryo and foetal stages until birth.
p.000127: According to Art.157a of the Criminal Code any person except for child’s mother who commits any infringement to a
p.000127: conceived child, will be punished. The rule does not include a physician who undertakes medical action necessary to
p.000127: exclude danger- threatening mother’s or child’s health or life.
p.000127: What’s more, under the Act of December 5th, 1996 on Medical Profession’s, human embryos (conceived children) may not be
p.000127: used for therapeutic research (Art. 26 paragraph 1).
p.000127: Not directly refers to this matter the ruling of the Constitutional Court of the Republic of Poland from the 28th May
p.000127: 1997, which says: ‘A democratic state governed by the rule of law holds man and his most precious weal as a supreme
p.000127: value. By this weal, we understand life which in a democratic state governed by the rule of law must enjoy
p.000127: constitutional protection in each stage of its development’.
p.000127:
...
Health / stem cells
Searching for indicator stem cells:
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p.000003:
p.000003: Printed in Italy
p.000003:
p.000003: Printed on white chlorine-free PaPer
p.000003:
p.000003:
p.000003: Contents
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: SUMMARY
p.000003: 3
p.000003: I. Having regard to
p.000005: 5
p.000005: II. Whereas
p.000012: 12
p.000012: II.1. Preamble
p.000012: 12
p.000012: II.2. The sixth framework programme 13
p.000012: II.3. Human embryonic stem cell (hESC) projects financed under FP6 15
p.000012: II.4. The ethics provisions applying to FP6-funded human embryonic
p.000012: stem cell projects 15
p.000012: II.4.1. FP6 ethics review 15
p.000012: II.4.2. Ethics provisions for FP6 hESC projects 17
p.000012: II.5. The seventh framework programme for research, technological
p.000012: development and demonstration (2007–13) (FP7) 18
p.000012: II.6. Ethics provisions under FP7: hESC research funded
p.000012: by the European Union 20
p.000012: III. Background for the ethical review of hESC projects 21
p.000012: III.1. Existing ethical guidelines: a brief historical overview 21
p.000012: III.2. Research using human embryonic stem cells (hESCs) 23
p.000012: III.3. Sources of human embryonic stem cells 24
p.000012: III.4. Derivation of new hESC lines 25
p.000012: III.5. Alternatives to hESC research 25
p.000012: III.6. European Registry of existing hESC lines 27
p.000012: III.7. EU Member States’ regulations on hESC research 28
p.000012: III.8. Commercialisation and patenting 32
p.000012:
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p.000001: 1
p.000001:
p.000001:
p.000001: IV. Recommendations 33
p.000001: French translation 47
p.000001: German translation 65
p.000001: IV.1. Preamble
p.000033: 33
p.000033: IV.2. Recommendations for the ethical review of research projects involving hESCs
p.000034: 34
p.000034: IV.2.1. General criteria 35
p.000034: IV.2.2. Ethical criteria for research projects under FP6 39
p.000034: IV.2.3. Additional criteria for FP7 40
p.000034: IV.2.3.1. Use of alternatives to hESCs 40
p.000034: IV.2.3.2. Donors’ rights 40
p.000034: IV.2.4. The need for continuous promotion of public governance and science–society dialogue
p.000042: 42
...
p.000002: persists both within the EGE members and the EU. Therefore, the group did not elaborate ethical arguments on hESC
p.000002: research as such, but worked on recommendations for FP7 ethics review of hESC projects.
p.000002:
p.000002: The EGE recognised the need for promoting responsible research that is transparent, serves the public
p.000002: interest, respects Member State autonomy, preserves public trust, promotes international cooperation and
p.000002: requires the embedding of ethics within research practice. The group indicated that, in addition to the FP7
p.000002: ethics rules already adopted in co-decision, among others the following considerations should apply to hESCs funded by
p.000002: the EU:
p.000002:
p.000002: • FP7 hESC lines have to result from non-implanted IVF embryos;
p.000002: • if alternatives to hESCs with the same scientific potential as embryo- derived stem cells are found in the
p.000002: future, their use should be maximised;
p.000002:
p.000002:
p.000002: (1) Letter sent by European Commission President Barroso to the EGE on 22 November 2006: ‘I
p.000002: would like to invite the European Group on Ethics to provide the Commission with an opinion on the implementing
p.000002: measures required during the ethics review of research projects on human embryonic stem cells that will
p.000002: assure that the ethical rules and requirements are fully met.’
p.000002:
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p.000003: 3
p.000003:
p.000003:
p.000003:
p.000003: • donors’ rights (in terms of health, informed consent, data protection and free donation) have to be
p.000003: protected and safeguarded.
p.000003:
p.000003: The EGE also stressed the following needs:
p.000003: • to maximise the use of hESCs banked in the European Registry on hESC research;
p.000003: • to take concrete actions to stimulate public debate on this research sector.
p.000003:
p.000003: In addition, the EGE expressed the view that the use of human embryos to generate stem cells should be minimised as
p.000003: much as possible in the EU and indicated a number of issues that would deserve interdisciplinary research and
p.000003: further discussion, such as, inter alia, the use of the human body for modern medicine, including
p.000003: commercialisation of products and procedures stemming from the use of human embryonic stem cells; the
p.000003: underlying anthropology of human embryonic stem cell research, especially in the light of hybrids and the chimera
p.000003: research connected to stem cell research; the correlation of human embryonic stem cell research and questions
p.000003: concerning regenerative medicine and health-related justice, including the issue of global justice; the relation
p.000003: between science and humanities and between science and society with respect to the development of new
p.000003: technologies.
p.000003:
p.000003: The EGE also indicated two topics that the group may address in the future:
p.000003: (1) the patenting of hESC-derived materials, and (2) the tension induced by a policy that encourages both free
p.000003: donation and commercial use of derivates from human substances.
p.000003:
p.000003: The recommendations were adopted by unanimity and issued to the Commission on 11 July 2007.
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p.000004: 4
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p.000004:
p.000004:
p.000004: RECOMMENDATIONS OF THE EUROPEAN GROUP ON ETHICS IN SCIENCE AND NEW TECHNOLOGIES
...
p.000007:
p.000007:
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p.000008: 8
p.000008:
p.000008:
p.000008: Having regard to the Charter of Fundamental Rights of the European Union of 28 September 2000, approved
p.000008: by the European Council in Biarritz on 14 October 2000 and proclaimed solemnly in Nice by the European
p.000008: Parliament, the Council and the Commission on 7 December 2000, and in particular Article 1 (human
p.000008: dignity), Article 3 (right to the integrity of the person) and Article 8 (protection of personal data) (17);
p.000008:
p.000008:
p.000008: Having regard to Council Decision 1513/2002/EC (18) of 27 June 2002 concerning the sixth framework
p.000008: programme of the European Community for research, technological development and demonstration
p.000008: activities (2002 — 2006), and in particular Article 3;
p.000008:
p.000008: Having regard to the programme adopted by the Council on 30 September 2002 in implementing the sixth
p.000008: framework programme for research, technological development and demonstration: ‘Integrating
p.000008: and strengthening the European research area’ (2002–06) (Decision 2002/834/EC) (19);
p.000008:
p.000008: Having regard to the report published by the Commission on 3 April 2003 (SEC(2003) 441) (20);
p.000008:
p.000008: Having regard to the decision of the European Commission on ‘Integrating and strengthening the European research
p.000008: area’ (2002–06) (Decision 2002/834/EC) (21) and the ‘procedural modalities for research activities involving
p.000008: banked or isolated human embryonic stem cells in culture to be funded under Council Decision 2002/834/EC’ (COM C(2003)
p.000008: 2952);
p.000008:
p.000008:
p.000008: (17) OJ C 364, 18.11.2000, pp. 1–22.
p.000008: (18) OJ L 138, 21.4.2004, pp. 7–11.
p.000008: (19) OJ L 294, 29.10.2002, pp. 1–43.
p.000008: (20) http://ec.europa.eu/research/press/2003/pdf/sec2003-441report_en.pdf
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009:
p.000009:
p.000009: Having regard to Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December
p.000009: 2006 concerning the seventh framework programme of the European Community for research,
p.000009: technological development and demonstration activities (2007–13);
p.000009:
p.000009: Having regard to Regulation (EC) No 1906/2006 (22) of the European Parliament and of the Council of 18
p.000009: December 2006 laying down the rules for the participation of undertakings, research centres and universities in actions
p.000009: under the seventh framework programme and for the dissemination of research results (2007–13);
p.000009:
p.000009: Having regard to Directive 2001/83/EC (23) and Regulation 726/2004/EC (24), currently being
p.000009: amended (25), on medicinal products for human use: advanced therapy medicinal products;
p.000009:
p.000009: Having regard to EGE Opinion No 11 ‘Ethical aspects of human tissue banking’ (26), published on 21 July
p.000009: 1998;
p.000009:
p.000009: Having regard to EGE Opinion No 12 ‘Ethical aspects of research involving the use of human embryo in
...
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p.000010: (29) http://www.ec.europa.eu/european_group_ethics/docs/avis16_en.pdf
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p.000011: 11
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p.000011:
p.000011: II. WHEREAS
p.000011:
p.000011: II.1. Preamble
p.000011: It is common knowledge that opinions about the ethical legitimacy of research on human embryos are sharply divided.
p.000011: The controversy is rooted in different ethical, philosophical, and/or religious viewpoints, each of which is
p.000011: acknowledged to be fully legitimate. In this respect, some claim that the divergences are ‘intrinsic’ and
p.000011: therefore irreconcilable, while others claim that common positions are achievable while respecting the pluralism of
p.000011: European societies, as practical solutions.
p.000011:
p.000011: The scope of these recommendations, however, is not to address the ethics of human embryonic stem cell research or
p.000011: research on human embryos. These recommendations relate to the political decision reached by the European
p.000011: institutions on the EU’s seventh framework research programme and is intended to contribute to the implementation
p.000011: of the mechanism established under the programme for an ethics review of EU-funded research activities
p.000011: involving the use of human embryonic stem cells.
p.000011:
p.000011: Because of the particular scope of these recommendations, it is important to identify the main
p.000011: requirements regarding the ethics of human embryonic stem cells that have been adopted in
p.000011: co-decision by the European institutions involved: the Council and the European Parliament. In
p.000011: addition, as the current EU framework programme follows on from the previous one, and since both
p.000011: implement the European research area (the policy strategy of the EU in research and development) and are linked to the
p.000011: economic strategy of the EU (the ‘Lisbon strategy’), the present document will refer to the previous
p.000011: EU framework programme and its implementation to date by the Commission services.
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p.000012:
p.000012:
p.000012: II.2. The sixth framework programme for research, technological development and demonstration:
p.000012: ‘Integrating and strengthening the European research area’ (2002–06) (FP6)
p.000012:
p.000012: On 30 September 2002, the Council adopted the specific programme implementing the sixth
p.000012: framework programme for research, technological development and demonstration: ‘Integrating and
p.000012: strengthening the European research area’ (2002–06) (Decision 2002/834/EC (30) — hereinafter referred to as
p.000012: ‘the specific programme’).
p.000012:
p.000012: The specific programme allowed the funding of research activities involving the use of human embryos and human
p.000012: embryonic stem cells except in three areas:
p.000012: — research activity aiming at human cloning for reproductive purposes (reproductive cloning);
p.000012:
p.000012: — research activity intended to modify the genetic heritage of human beings which could make such changes
p.000012: heritable (germline gene therapy) (31);
p.000012: — research activities intended to create human embryos solely for the purpose of research or for the purpose of stem
p.000012: cell procurement, including by means of somatic cell nuclear transfer (commonly referred to as therapeutic cloning).
p.000012: On adopting the programme, however, the Council indicated that ‘detailed implementing provisions concerning
p.000012: research activities involving the use of human embryos and human embryonic stem cells shall be
p.000012: established by 31 December 2003’. It asked the Commission to: (1) prepare these provisions; (2) prepare a working
p.000012: paper on the issue; and (3) organise an interinstitutional seminar on bioethics.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: (30) OJ L 294, 29.10.2002, p. 1.
p.000012: (31) Research into treatment of cancer of the gonads can be financed.
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p.000013: A moratorium was then implemented by the Commission and no hESC research has since been funded with the exception of
p.000013: proposals for projects that involved the use of already banked or isolated human embryonic stem cells.
p.000013: The Council asked the Commission to publish a staff report on scientific advances and needs and on
p.000013: the evolution of international and national legislation, regulations and ethical rules regarding research
p.000013: involving the use of human embryonic stem cells. The report was prepared by the Commission, published on 3
p.000013: April 2003 (SEC(2003) 441 (32)), and then transmitted to the European Parliament and the Council as
p.000013: a basis for discussion at an interinstitutional seminar on bioethics organised by the Commission (33).
p.000013: On 9 July 2003, the Commission then submitted to the Council a proposal for the modification of the specific
p.000013: programme (COM(2003) 390 (34)), on which the European Parliament had to express its opinion (35). The
p.000013: proposal applied specifically to Community funding of research activities involving the procurement of stem cells from
p.000013: human embryos created as a result of medically assisted in vitro fertilisation designed to induce pregnancy and no
p.000013: longer to be used for that purpose (non-implanted human embryos); and it was based on the principles
p.000013: established by the European Group on Ethics, in particular the fundamental ethical principles set out in
p.000013: Opinion No 15 ‘Ethical aspects of human stem cell research and use’ (36). This Commission proposal received a
p.000013: favourable opinion from the European Parliament but did not obtain a qualified majority at the Council of 3
p.000013: December 2003.
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: (32) http://europa.eu.int/comm/research/conferences/2003/bioethics/index_en.html
p.000013: (33) On 24 April 2003, the interinstitutional seminar on bioethics took place. The seminar addressed issues
p.000013: related to human embryonic stem cell research under the sixth framework programme for research and provided an
p.000013: opportunity for discussion and exchanging of views between experts (scientific, legal, and in ethics) and
p.000013: representatives of the European Parliament, the Council, the Commission, the Member States and the accession and
p.000013: candidate countries.
p.000013: (34) Proposal for a Council decision [COM(2003) 390] amending Decision 2002/834/EC on the specific
p.000013: programme for research, technological development and demonstration: ‘Integrating and
p.000013: strengthening the European research area’ (2002–06).
p.000013: (35) http://europa.eu.int/comm/research/conferences/2003/bioethics/index_en.html
p.000013: (36) http://europa.eu.int/comm/european_group_ethics/index_en.htm
p.000013:
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p.000014: 14
p.000014:
p.000014:
p.000014:
p.000014: In parallel, the ‘procedural modalities for research activities involving banked or isolated human embryonic stem
p.000014: cells in culture to be funded under Council Decision 2002/834/EC’ (37) were approved by the
p.000014: Regulatory Committee (comprising representatives of the Member States) on 25 June 2003 and by the Commission on 11
p.000014: November 2003.
p.000014:
p.000014: On 31 December 2003, the moratorium ended and the two legal texts on which the Commission based its research
p.000014: implementation were: (1) the specific programme implementing the sixth framework programme for
p.000014: research, technological development and demonstration, ‘Integrating and strengthening the European research area’
p.000014: (2002–06) (Decision 2002/834/EC) (38); and (2) the ‘procedural modalities for research activities involving banked
p.000014: or isolated human embryonic stem cells in culture’ (annexed to these recommendations).
p.000014:
p.000014: II.3. Human embryonic stem cell (hESC) projects financed under FP6
p.000014: In total, 18 hESC projects were financed under FP6 within the thematic priority ‘Life sciences, genomics and
p.000014: biotechnology for health’. These 18 projects accounted for less than 3 % of the total number of projects
p.000014: funded within this thematic priority under FP6. Most FP6 hESC projects also involved research into adult stem cells
p.000014: and/or foetal stem cells (comparative approach), but one of the 18 was entirely dedicated to human embryonic
p.000014: stem cell research (Estools). A detailed list of FP6 projects involving the use of hESCs is annexed to
p.000014: these recommendations.
p.000014:
p.000014: II.4. The ethics provisions applying to FP6-funded human embryonic stem cell projects
p.000014:
p.000014: II.4.1. FP6 ethics review
p.000014: In order to implement Article 6 of the framework programme and Article 15 of the rules for participation, the FP6
p.000014: evaluation procedure included a check of the ethical issues raised by the proposals. Following the
p.000014: scientific evaluation, an
p.000014:
p.000014: (37) C(2003) 2952.
p.000014: (38) OJ L 294, 29.10.2002, p. 1.
p.000014:
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p.000015: 15
p.000015:
p.000015:
p.000015:
p.000015: ethical review of the successful proposals involving sensitive ethical issues was carried out before the final
p.000015: selection by the Commission.
p.000015:
p.000015: The objective of the ethical review was to make sure that the European Union did not support research contrary to
p.000015: fundamental ethical principles and to examine whether the research complied with the rules relating to ethics
p.000015: set out in the decisions on the sixth framework programme and specific programmes.
p.000015:
p.000015: Breakdown of projects subjected to ethical review, by research area
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p.000018: 18
p.000018:
p.000018:
p.000018: implementation of the Lisbon strategy and benefited from a budget of EUR 53 billion for the time
p.000018: frame 2007–13 (43).
p.000018:
p.000018: The Commission proposal for FP7 was adopted on 6 April 2005. As for FP6, the proposal had a specific article (Article
p.000018: 6) stating that ‘All the research activities … shall be carried out in compliance with fundamental ethical
p.000018: principles’. The specific programme for FP7 was adopted by the Commission on 21 September 2005. The Commission
p.000018: proposal was then transmitted to the relevant institutions (the European Parliament and the Council) for their approval
p.000018: by co-decision.
p.000018:
p.000018: The Parliament adopted (first reading) the proposed programme on 15 June 2006 after a preceding vote and
p.000018: a request for amendments by the relevant Parliamentary commission (ITRE) on 30 May 2005. The Commission
p.000018: accepted Parliament’s request to have the ethics framework incorporated in the framework programme text, which required
p.000018: a co-decision by the European Parliament and the Council on this issue. This was not the case for FP6,
p.000018: where the ethical framework was included in the specific programme adopted by the Council alone.
p.000018:
p.000018: After intense discussions, the programme was adopted by the Council on 24 July 2006 (qualified majority). The Council
p.000018: agreement was based on a Commission declaration stating that ‘The European Commission will continue with the current
p.000018: practice and will not submit to the Regulatory Committee proposals for projects which include research activities which
p.000018: destroy human embryos, including for the procurement of stem cells. The exclusion of funding of this step of research
p.000018: will not prevent Community funding of subsequent steps involving human embryonic stem cells’.
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: (43) A detailed description of the interinstitutional adoption of the programme can be found at
p.000018: http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=en&DosId=192725
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p.000019:
p.000019:
p.000019: The programme, including the Commission declaration, was then approved at the European Parliament plenary
p.000019: session (second reading) on 30 November 2006 and adopted in co-decision on 18 December 2006.
p.000019:
p.000019:
p.000019:
p.000019: II.6. Ethics provisions under FP7: hESC research funded by the European Union
p.000019: The Council agreement made the eligibility of hESC research for EU funding subject to the same specific
p.000019: restrictions and conditions as with FP6.
p.000019:
p.000019: To ensure an optimal ethics review system, the President of the European Commission asked the EGE on
p.000019: November 2006 to issue an opinion on the ethics review of hESC projects funded under FP7:
p.000019:
p.000019: I would like to invite the European Group on Ethics to provide the Commission with an opinion on the implementing
p.000019: measures required during the ethics review of research projects on human embryonic stem cells that will
p.000019: assure that the ethical rules and requirements are fully met. Such an opinion would provide guidance (in
p.000019: relation to the values and principles to apply) for the Ethics Review within the frame of the Programme approved by the
p.000019: Council and the European Parliament. It would be important that this opinion is available for use when the first FP7
p.000019: projects involving human embryonic stem cells are evaluated (44).
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: (44) Letter by Commission President J. M. Barroso addressed to the EGE on 22 November 2006.
p.000019:
p.000019:
p.000019:
p.000019:
p.000020: 20
p.000020:
p.000020:
p.000020: III. BACKGROUND FOR THE ETHICAL REVIEW OF HESC PROJECTS
p.000020: III.1. Existing ethical guidelines: a brief historical overview
p.000020: In a fast-developing area such as stem cell research, ethical requirements are assuming increasing
p.000020: importance in project assessment. The process of research approval includes a review of projects by a panel of
p.000020: independent experts (both scientific and ethical).
p.000020:
p.000020: Up to the present, no clinical research making use of human embryonic stem cells has been carried out. In
p.000020: view of the long-term perspective of FP7, however, all ethical guidelines and regulations must be applied to FP7
p.000020: projects whenever they involve research on human subjects.
p.000020:
p.000020: Guidelines and regulations governing the participation of human subjects in biomedical research have been
p.000020: established at international level for many decades. These principles are laid down in internationally
p.000020: recognised research ethics guidelines and other instruments, including (to cite only the most
p.000020: important): the Nuremburg Code of 1947 (45), the Declaration of Helsinki of 1964 (46) (plus amendments), the
p.000020: Belmont Report of 1979 (47), the Convention for the Protection of Human Rights and Dignity of the Human Being with
p.000020: regard to the Application of Biology and Medicine of 1997 (the ‘Oviedo Convention’) (48) and the
p.000020: additional protocols to the convention (49), the Unesco Universal Declaration on the Human Genome
p.000020: and Human Rights (50) of 1997 and the International Declaration on Human Genetic Data (51) of 2003, the
p.000020: Council for International Organisations of Medical Sciences (CIOMS) International Ethical
p.000020:
p.000020: (45) http://www.ushmm.org/research/doctors/Nuremberg_Code.htm
p.000020: (46) http://www.wma.net/e/ethicsunit/helsinki.htm
p.000020: (47) http://ohsr.od.nih.gov/guidelines/belmont.html
p.000020: (48) http://conventions.coe.int/treaty/en/treaties/html/164.htm
p.000020: (49) http://conventions.coe.int/Treaty/EN/Treaties/Html/168.htm
p.000020: (50) http://portal.unesco.org/fr/ev.php-
...
p.000021: 2006 the International Society for Stem Cell Research (ISSCR) published specific guidelines on hESCs
p.000021: (Guidelines for the conduct of human embryonic stem cell research).
p.000021: The guidelines address the procurement, derivation, banking, distribution, and use of cells and tissues
p.000021: taken from pre-implantation stages of human
p.000021:
p.000021:
p.000021: (52) http://www.cioms.ch/
p.000021: (53) http://portal.unesco.org/shs/en/ev.php-
p.000021: URL_ID=1883&URL_DO=DO_TOPIC&URL_SECTION=201.html
p.000021: (54) http://www.bioethics.ac.uk/
p.000021: (55) http://www.careforeurope.org/
p.000021: (56) http://www.isscr.org/guidelines/
p.000021: (57) http://www.nuffieldbioethics.org/go/ourwork/stemcells/introduction
p.000021: (58) http://www.dfg.de/en/news/press_releases/2006/press_release_2006_60.html
p.000021: (59) UK HFEA, UK Department of Health, UK Stem Cell Initiative:
p.000021: http://www.hfea.gov.uk/cps/rde/xchg/SID-3F57D79B-370119F4/hfea/hs.xsl/295.html,
p.000021: http://www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/StemCell/fs/en,
p.000021: http://www.advisorybodies.doh.gov.uk/uksci/uksci-reportnov05.pdf
p.000021: (60) EMBO: http://www.vr.se/download/18.2aebc6b810f3c933b158000194/EMBO+document+nov+2006.pdf#
p.000021: search='stem+cell'
p.000021: (61) European Science Foundation: http://www.esf.org/publication/142/ESPB18.pdf
p.000021:
p.000021:
p.000021:
p.000021:
p.000022: 22
p.000022:
p.000022:
p.000022: development; procurements of gametes and somatic tissues for stem cell research; and the use of human stem
p.000022: cell lines (62).
p.000022:
p.000022:
p.000022: III.2. Research using human embryonic stem cells (hESCs)
p.000022:
p.000022:
p.000022: Human embryonic stem cells are used in a variety of research projects with different scientific goals.
p.000022: Some research protocols focus completely on hESCs, but sometimes they may use human embryonic and adult
p.000022: stem cells for comparative purposes or may use hESCs as a tool to obtain other scientific outcomes (for
p.000022: example, to make in vitro tests of a given experimental drug or a new chemical).
p.000022:
p.000022: The relevance and use of hESCs therefore varies considerably according to the expected scientific outcomes of the
p.000022: research trials. The scientific community is interested in investigating the basic physiology of stem cells, their
p.000022: potential and characteristics. One important aspect of such research is the comparative analysis of hESCs and
p.000022: other types of stem cells, such as umbilical-cord and adult tissue-specific stem cells, in order to address specific
p.000022: questions concerning the suitability of these types of cells. Stem cell research is also done to explore its potential
p.000022: use for regenerative medicine (degenerative diseases such as diabetes and Parkinson’s disease) and gene
p.000022: therapy (e.g. for cystic fibrosis and Huntington’s disease). At present, there are no indications that
p.000022: clinical trials will be carried out in the near future.
p.000022:
p.000022: In addition, researchers are exploring the potential use of hESCs in toxicological studies in order to replace
p.000022: animal models with in vitro models. Other uses of hESCs, with the exception of the ESTOOL project (see
p.000022: annex to this opinion), are in large multidisciplinary studies, such as those involving genomics and
p.000022:
p.000022:
p.000022: (62) http://www.isscr.org/guidelines/ISSCRhESCguidelines2006.pdf
p.000022:
p.000022:
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023:
p.000023:
p.000023: proteomics approaches, which focus on broader contexts with only a subset of experiments specifically dealing with
p.000023: hESCs.
p.000023:
p.000023: Examples of EU-funded projects that make different uses of hESCs:
p.000023:
p.000023:
p.000023: (1) EUROSTEMCELL: project aiming to compare adult, foetal, embryonic and tissue-specific stem cells (see
p.000023: http://www.eurostemcell.org/);
p.000023:
p.000023: (2) BETACELL THERAPY: project aiming to study the generation of insulin- producing pancreatic beta
p.000023: cells for the treatment of diabetes (see http://www.betacelltherapy.org);
p.000023:
p.000023: (3) CARCINOGENOMICS: project aiming to carry out in vitro testing to assess the genotoxic and carcinogenomic
p.000023: properties of chemical compounds (in silico models to evaluate the carcinogenic potential of a compound
p.000023: in vivo) (see http://www.ecopa.eu/doc/CarcinogenomicsPressRelease-201106.pdf).
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: III.3. Sources of human embryonic stem cells
p.000023: The most common source of tissue for human embryonic stem cell isolation is the inner cell mass (ICM) of
p.000023: embryos created using assisted reproduction technologies (ART), but not transferred to the woman’s uterus,
p.000023: either because the number of embryos exceeds the number allowed to be transferred under the law (usually two or
p.000023: three) or because of genetic defects detected by pre- implantation genetic diagnostics (PGD) (63). In the
p.000023: same way, embryos as a source of stem cells can be created solely for research purposes via in vitro
p.000023: fertilisation (IVF), but outside the ART context (64).
p.000023:
p.000023: Another source of human embryonic stem cells, which is allowed in only a few countries (65), is their creation by means
p.000023: of somatic nuclear cell transfer (SCNT), where a somatic cell is taken from an adult patient and its
p.000023: nucleus transferred
p.000023:
p.000023: (63) This practice is not permitted in all EU Member States.
p.000023: (64) This practice is not permitted in most EU Member States. See Table 1, p. 29.
p.000023: (65) In the EU, therapeutic cloning is allowed only in the following countries: Belgium, Spain, Sweden and the
p.000023: UK.
p.000023:
p.000023:
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000024:
p.000024:
p.000024: into a donated enucleated oocyte. Unlike hESCs derived from a donated IVF embryo, the resulting cell line
p.000024: using SCNT is genetically identical to the donor of the nucleus.
p.000024:
p.000024: Another possible way of creating stem cells by means of SCNT, but not leading to therapeutic cloning, is to create
p.000024: human/animal hybrids by mixing a human cell with an animal egg in order to obtain ‘humanised’ stem cells
p.000024: (66). There is currently debate on the ethics of human/animal hybrids in several EU and non- EU countries. The EC is
p.000024: at present financing a project on the ethical, legal and social implications of human/animal hybrids (67).
p.000024:
p.000024:
p.000024: III.4. Derivation of new hESC lines
p.000024:
p.000024: As indicated in Section II.2, the derivation of new totipotent cells or pluripotent stem cell lines from
p.000024: donated pre-implantation human embryos or embryonic cells, or via nuclear reprogramming, is not funded by the EU
p.000024: research programme. The derivation of new hESCs necessarily involves the procurement of biological material
p.000024: from human subjects, which then (when allowed) needs to be approved by institutional oversight bodies with
p.000024: specific responsibility for the protection of human subjects.
p.000024:
p.000024: III.5. Alternatives to hESC research
p.000024:
p.000024: As stated in Section II.2, the justification for the use of human embryonic stem cells under FP7 is to be
p.000024: assessed during the scientific evaluation of research proposals. EU projects can be funded only if no suitable
p.000024: alternatives to human embryonic stem cells can be found and the absolute necessity of using hESCs has been
p.000024: scientifically justified and evaluated. With regard to possible
p.000024:
p.000024: (66) Recently, British scientists have been seeking HFEA approval to create rabbit–human stem cells by using
p.000024: rabbits’ oocytes, in order to overcome the shortage of egg donors in the UK, in a collaboration between
p.000024: King’s College in London and Edinburgh University.
p.000024: (67) See www.chimbrids.org
p.000024:
p.000024:
p.000024:
p.000024:
p.000025: 25
p.000025:
p.000025:
p.000025:
p.000025: alternatives to hESCs, the first factor to consider is the possible use of adult human stem cells.
p.000025:
p.000025: Adult stem cells are multipotent stem cells, suitable for the treatment of human diseases such as leukaemia,
p.000025: lymphomas and other blood diseases. Such therapies rely on the very well-established practice
p.000025: of transplanting haematopoietic stem cells (blood-forming stem cells) present in bone marrow, placenta or
p.000025: umbilical cord blood cells. Other diseases that may be cured in the near future by using adult stem cells are, for
p.000025: example, diabetes and some forms of cancer (e.g. kidney), for which the clinical potential of adult stem cells looks
p.000025: very promising.
p.000025:
p.000025: Given the nature of embryonic stem cells and the moral dilemma regarding the destruction of human embryos to obtain
p.000025: embryonic stem cells, research has also been focusing on alternative sources of human embryonic stem cells,
p.000025: an endeavour which received criticisms, both scientific and ethical, as in the case of altered nuclear transfer (68),
p.000025: which was developed by scientists as a technological solution to the destruction of human embryos and
p.000025: the related ethical issues (69)(70), but implies an epigenetic alteration of the egg to preclude natural
p.000025: embryogenesis.
p.000025:
p.000025: Nevertheless, some recent promising research into alternatives to hESCs has been carried out, such as for:
p.000025: • pluripotent stem cells derived from ‘arrested’ embryos (71);
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: (68) Melton, D. A., Daley, G. D. and Jennings, C. G. ‘Altered nuclear transfer in stem-cell research — A flawed
p.000025: proposal’, The New England Journal of Medicine, Vol. 351: 2791–2792 (30 December 2004).
p.000025: (69) Solter, D. ‘Politically correct human embryonic stem cells?’, The New England Journal of
p.000025: Medicine, Vol. 353: 2321–2323 (1 December 2005).
p.000025: (70) Green, R. M. ‘Can we develop ethically universal embryonic stem-cell lines?’. Nature Reviews
p.000025: Genetics 8: 480–485 (2007).
p.000025: (71) Zhang, X. et al. ‘Derivation of human embryonic stem cells from developing and arrested
p.000025: embryos’, Stem Cells 24: 2660–76 (2006).
p.000025:
p.000025:
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026:
p.000026: • pluripotent stem cells via blastomere extraction from developing embryos (72);
p.000026: • pluripotent stem cells via somatic cell dedifferentiation (73);
p.000026: • human materials using cell fusion rather than genetic factors (74);
p.000026: • non-embryonal sources of ‘embryonic like’, multipotent human stem cells (from human umbilical cord blood (75) or
p.000026: from human amniotic fluid (76)).
p.000026:
p.000026: III.6. European Registry of existing hESC lines
p.000026:
p.000026: According to the available data, 81 different hESC lines have at present been established and are used in
p.000026: EU-funded projects. Since there is certain variability from cell line to cell line, the Commission has felt it
p.000026: important to: (1) gather in a centralised manner all information available on each single cell line
p.000026: for comparative purposes; and (2) render such information available at international level.
p.000026:
p.000026: The European Commission has therefore decided to establish and fund a European Registry for human
p.000026: embryonic stem cell lines (77) in order to help researchers to optimise the hESC resources available and
p.000026: avoid duplication of work and/or the creation of new cell lines where possible. This registry is expected to boost
p.000026: the coordination and rationalisation of human embryonic stem cell
p.000026:
p.000026:
p.000026: (72) Klimanskya, I. et al. ‘Human embryonic stem cell lines derived from single blastomeres’, Nature
p.000026: 444: 481–485 (2006).
p.000026: (73) Takahashi, K. and Yamanaka, S. ‘Induction of pluripotent stem cells from mouse embryonic and adult
p.000026: fibroblast cultures by defined factors’, Cell 126: 1–14 (2006).
p.000026: Wernig, M. et al. ‘In vitro reprogramming of fibroblasts into a pluripotent ES-cell-like state’,
p.000026: Nature, AOP doi:10.1038/nature05944 (2007).
p.000026: (74) Cowan, C. A. et al. ‘Nuclear reprogramming of somatic cells after fusion with human embryonic stem cells’,
p.000026: Science, 309: 1369–1373 (2005).
p.000026: (75) Zhao, Y. et al. ‘Identification of stem cells from human umbilical cord blood with embryonic and
p.000026: hematopoietic characteristics’, Experimental Cell Research, 312: 2454–2464 (2006).
p.000026: (76) De Coppi, P. et al. ‘Isolation of amniotic stem cell lines with potential for therapy’,
p.000026: Nature
p.000026: Biotechnology 25: 100–106 (2007).
p.000026: (77) The project will be funded for three years with grants for a total of EUR 1 million. The registry will be
p.000026: mainly coordinated by two institutions: the Centre of Regenerative Medicine (CRMB) in Barcelona, Spain, and the
p.000026: Berlin-Brandenburg Centre for Regenerative Therapies (BCRT) in Berlin, Germany.
p.000026:
p.000026:
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027:
p.000027: research in Europe. It will provide a platform to maximise reproducibility, comparability and
p.000027: transparency in the field (78).
p.000027:
p.000027: The main objective of this initiative is to provide comprehensive information about all human embryonic stem cell lines
p.000027: available in Europe. The information will be gathered together on a publicly accessible Internet site
p.000027: containing data on the cell lines (e.g. cell characteristics) and their use (e.g. research project outcomes,
p.000027: clinical trials, etc.). The registry will provide information on the sources of the stem cell lines and
p.000027: include comprehensive information on human embryonic stem cell lines obtained from ongoing and future EU-funded
p.000027: projects. The data will be regularly updated and made accessible to the public.
p.000027:
p.000027: A Steering Committee comprising representatives of the leading European public institutions involved in human
p.000027: embryonic stem cell research has also been established. The committee will be assisted by an Advisory Board,
p.000027: comprising 17 top scientists from Europe and outside Europe in the field of human embryonic stem cell research, and
p.000027: an independent Ethics Advisory Board to ensure compliance with ethical requirements and ethical guidance.
p.000027:
p.000027: III.7. EU Member States’ regulations on hESC research
p.000027: Among the 27 EU Member States (EU-27), several clusters of countries can be identified according to how they regulate
p.000027: hESC research. However, all countries apply at least some regulations and/or procedural rules to specific projects
p.000027: involving hESCs. Where hESC research is allowed, project proposals have to undergo strict evaluation criteria, both
p.000027: scientific and ethical, decided upon by the competent national bodies (79).
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027: (78) For more information see: www.cmrb.eu; www.cellnet.org;
p.000027: www.ec.europa.eu/research/fp6/index_en.cfm?p=1_stem_projects
p.000027: (79) See annex (pp. 52–102) for further details in single Member States.
p.000027:
p.000027:
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028:
p.000028:
p.000028: Permissive position
p.000028:
p.000028: A few EU Member States have specific legislation for hESC research, covering the procurement of stem cells and their
p.000028: use for research. In Belgium, Spain (80), Sweden and the UK, for example, embryo creation is allowed for research
p.000028: purposes.
p.000028:
p.000028: Permissive position with restrictions
p.000028:
p.000028: In other EU Member States such as the Czech Republic, Denmark, Greece, France, the Netherlands, Portugal and
p.000028: Finland (81), regulations allow the derivation of new hESCs from embryos created as a result of assisted
p.000028: reproduction technology (ART) and in vitro fertilisation to induce pregnancy, but only when they can no longer be used
p.000028: for that purpose.
p.000028:
p.000028: Restrictive position
p.000028: Germany and Italy have stricter hESC research regulations. Scientists in these countries cannot derive new
p.000028: hES cell lines, but can import them. In Germany, a new discussion has arisen as to whether the 2002 Stem Cell Act
p.000028: regulating the importation of hESC lines should be revised, but no legal proposal has been forthcoming by
p.000028: the date of these recommendations. Italian legislation covers artificial reproduction technology and the
p.000028: production of new hESCs (research involving the destruction of embryos is not allowed). Italy therefore has no
p.000028: legal provision as regards the use of imported hESCs or existing hESCs.
p.000028:
p.000028:
p.000028: No specific legislation or indirect legislation only
p.000028:
p.000028: In many Member States, hESC research still has no specific legislation (Bulgaria, Estonia, Ireland, Cyprus, Latvia,
p.000028: Luxembourg and Romania). Ireland, for instance,
p.000028:
p.000028:
p.000028: (80) A new law in Spain has just been voted for.
p.000028: (81) A new regulation is under way in Portugal.
p.000028:
p.000028:
p.000028:
p.000028:
...
p.000030: (d) Countries which voted against hESC research during Council decision for FP7.
p.000030: Country code key:
p.000030: AT: Austria DK: Denmark FR: France LU: Luxembourg PT: Portugal BE: Belgium
p.000030: EE: Estonia HU: Hungary LV: Latvia SE: Sweden CY: Cyprus
p.000030: EL: Greece IE: Ireland MT: Malta SI: Slovenia CZ: Czech Republic ES:
p.000030: Spain IT: Italy NL: Netherlands SK: Slovakia
p.000030: DE: Germany FI: Finland LT: Lithuania PL: Poland UK: United Kingdom
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000031: 31
p.000031:
p.000031:
p.000031:
p.000031: III.8. Commercialisation and patenting
p.000031:
p.000031: The directive on the legal protection of biotechnological inventions (98/44/EC) (82) regulates
p.000031: patentability of biological material, including hESCs. The debate on patenting hESCs is ongoing at both
p.000031: institutional (European Patent Office, the European Commission (83)) and academic level. At present, there is no EU
p.000031: consensus on the moral status of the embryo and its products and, reflecting this wide diversity of
p.000031: moral cultures, there are different policies for patenting among national patent offices. The European Group on
p.000031: Ethics (EGE) has evaluated the ethical aspects of patenting inventions involving human stem cells (84).
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: (82) OJ L 213, 30.7.1998, pp. 13–21.
p.000031: (83) See COM(2005) 312
p.000031: (84) EGE Opinion No 16, ‘Ethical aspects involving the patenting of human stem cells’.
p.000031:
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032:
p.000032:
p.000032:
p.000032: IV. RECOMMENDATIONS
p.000032:
p.000032: IV.1 Preamble
p.000032:
p.000032:
p.000032: These recommendations constitute the reply to the request from the President of the European
p.000032: Commission, Mr Barroso (85), after the adoption of the EU’s seventh framework programme for research and
p.000032: development (FP7), to elaborate an opinion on the implementing measures required during the ethics review of
p.000032: research projects on human embryonic stem cells (hESCs).
p.000032:
p.000032: As is the case in the European Union, there are divergent views within the European Group on Ethics
p.000032: (EGE) on the moral legitimacy of research on human embryos and hESCs, ranging from objection to research
p.000032: involving the destruction of human embryos (which makes the full respect of dignity of the human embryo impossible),
p.000032: to a position allowing hESC research under certain conditions or on a broader basis.
p.000032:
p.000032: The group acknowledges the political decision taken as the starting point for its recommendations, but emphasises that
p.000032: the ethical dilemma regarding the moral status of the human embryo and its use in research still persists. The EGE
p.000032: therefore stresses that the ethical differences of opinion concerning hESC research have not been resolved.
p.000032:
p.000032: However, these recommendations do not elaborate ethical arguments on hESC research as such; this is
p.000032: because this was not the task given to the group by the European Commission.
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: (85) Letter sent by Commission President Barroso to the EGE on 22 November 2006. ‘I would like to invite the
p.000032: European Group on Ethics to provide the Commission with an opinion on the implementing measures
p.000032: required during the ethics review of research projects on human embryonic stem cells that will assure
p.000032: that the ethical rules and requirements are fully met’.
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000033: 33
p.000033:
p.000033:
p.000033: IV.2. Recommendations for the ethical review of research projects involving hESCs
p.000033:
p.000033: FP7 research projects involving the use of hESCs are subject to stringent rules for selection, are scrutinised at
p.000033: both national and EU level, and undergo both scientific and ethical reviews.
p.000033:
p.000033: Under FP7, research proposals must include information about ethical aspects of the proposed research, explain in
p.000033: detail the project design, and show that the proposal meets the national legal and ethical requirements of the
p.000033: country where the research is performed.
p.000033:
p.000033: After successfully passing the scientific evaluation, the selected hESC proposals undergo a specific ethics review
p.000033: organised by the Commission on a case-by- case basis. The objective of the review is to ensure that
p.000033: the European Union does not support research that would not comply with fundamental ethical principles (86)
p.000033: and to examine whether the ethics rules set out in FP7 are met.
p.000033:
p.000033: The ethics review panel is a transnational body composed of experts from different disciplines. The panel
p.000033: produces an ethical review report, which lists the different ethical issues, describes the way these issues
p.000033: were handled by applicants, and gives the recommendations of the panel.
p.000033:
...
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000034: 34
p.000034:
p.000034:
p.000034: In order to provide guidance to the members of the FP7 hESC ethics review panels who will be asked to
p.000034: review the research projects using hESC lines, and under the specific remit and conditions laid down by the political
p.000034: decision of the European Parliament and of the Council on FP7, and also by the specific request of the President of the
p.000034: European Commission, Mr J. M. Barroso (see above), the EGE elaborated the following guidelines and points to consider
p.000034: when conducting such ethics review of FP7 projects (87).
p.000034:
p.000034:
p.000034: IV.2.1. General criteria
p.000034:
p.000034: The European Commission has stated that it ‘will support actions and initiatives that contribute to coordination
p.000034: and rationalisation of hESC research within a responsible ethical approach’ (88). In line with this statement,
p.000034: the EGE recognises the need to promote responsible research that is transparent, serves the public interest, respects
p.000034: Member States’ autonomy, preserves public trust, promotes international cooperation, and requires the embedding
p.000034: of ethics within research practice (89).
p.000034:
p.000034: Ethically responsible research involving human embryonic stem cells must comply with fundamental ethical
p.000034: principles and human rights in the European Union (90), from the procurement of stem cells (91) to clinical
p.000034: research based on hESCs.
p.000034:
p.000034:
p.000034:
p.000034: (87) According to FP7 rules, evaluators sign a conflict of interest declaration and EC staff
p.000034: verify conflicts with each proposal they evaluate. Evaluation panels of ethics and scientific reviews are anonymous.
p.000034: (88) Declaration of the European Commission on 24 July 2006 during the meeting of the Council of Ministers
p.000034: regarding FP7. See OJ L 412, 30.12.2006.
p.000034: (89) For example, the Council of Europe Oviedo Convention (Article 2).
p.000034: (90) For details, see Section I of this opinion referring to the pertinent documents relevant to
p.000034: the context of medical research.
p.000034: (91) FP7 excludes the procurement of hESCs from Community funding (see paragraph II.2). See
p.000034: Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006
p.000034: concerning the seventh framework programme of the European Community for research, technological
p.000034: development and demonstration activities (2007–13), OJ L 412, 30.12.2006, pp. 1–
p.000034: 41.
p.000034:
p.000034:
p.000034:
p.000034:
p.000035: 35
p.000035:
p.000035:
p.000035: The fundamental rights include: protection rights such as protection of human life, respect of its integrity,
p.000035: protection of health and freedom, political rights such as freedom from undue state intervention or participatory
...
p.000038: (see following paragraph on donors’ rights).
p.000038:
p.000038: 3. Applicants must provide information on the protection of personal data and privacy of the donors of
p.000038: embryos for the creation of stem cell lines.
p.000038:
p.000038: 4. Applicants must provide information on the conditions of donation of the embryos (e.g. no financial
p.000038: inducement, number of eggs retrieved, etc.). In order to guarantee the non-commercialisation of the human body
p.000038: and in line with Article 12 of Directive 2004/23/EC, the EGE holds the view that, in order to protect the freedom
p.000038: of donation, human embryo donation should not involve financial inducement, other than the reimbursement of costs
p.000038: incurred.
p.000038:
p.000038: In addition to these conditions, the EGE recommends that the ethics review panel should ensure that
p.000038: applicants provide information on the points listed below.
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038: (96) Article 6(3), http://cordis.europa.eu/fp7/ethics-ict_en.html
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000039: 39
p.000039:
p.000039:
p.000039:
p.000039: IV.2.3. Additional criteria for FP7
p.000039:
p.000039: IV.2.3.1. Use of alternatives to hESCs
p.000039: Should alternatives to hESCs with the same potential as embryo-derived stem cells be found in the
p.000039: future, the implications of such developments for both scientific and ethical aspects of the hESC-based research
p.000039: projects ought to be taken into account as soon as possible.
p.000039:
p.000039: IV.2.3.2. Donors’ rights
p.000039: The donation of human embryos for the production of hESCs for research purposes poses a moral dilemma. This
p.000039: arises from the fact that human embryos are not ‘neutral objects’. Informed consent should address explicitly
p.000039: this moral dilemma, leaving the decision to the donors.
p.000039:
p.000039: The protection rights of donors need particular attention, in a very concrete way, meaning that those countries
p.000039: allowing the procurement of hESCs must provide information on the procurement process for the stem cell lines
p.000039: used by the applicant. The information should state that the measures of this process are in accordance with the
p.000039: fundamental ethical principles and human rights in force in the European Union, national legislation applicable at the
p.000039: time of the donation in the country where the donation was carried out and other relevant EU
p.000039: regulations (97). Applicants must provide information from the institutes generating the stem
p.000039: cell lines that the following criteria have been met for the procurement of hESCs:
p.000039:
p.000039: • no pressure has been put on the donors at any stage (98);
p.000039:
p.000039: (97) See EC/2004/23.
p.000039: (98) See ISSCR guidelines (http://www.isscr.org/guidelines/, p. 9, ‘Procurement of materials: For
p.000039: donating embryos or gametes generated in the course of clinical treatment. Except when specifically
p.000039: authorized by the SCRO (relevant ethics board) process, no reimbursement of direct expenses or financial
p.000039: considerations of any kind may be provided for donating embryos or gametes that have been generated in the
p.000039: course of clinical treatment and are in excess of clinical
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000040: 40
p.000040:
p.000040:
p.000040: • the donor’s health has not been put at risk by excessive ovarian stimulation;
p.000040: • as far as new hESC lines are concerned, informed consent to the donation for research of an embryo, originally
p.000040: planned for reproduction, is given in knowledge of the kind of research intended (99), its implications
p.000040: (including commercial) and in respect of the conditions foreseen by law at the time of the donation in the country
p.000040: where the donation was carried out;
p.000040: • information was given that consent could be withdrawn up to the stage of the creation of stem cells (100);
p.000040: • infertility treatment and research was appropriately separated;
p.000040: • no financial incentives have been offered to donate embryos for research at any stage, in line with Article 12 of
p.000040: Directive 2004/23/EC (101). However, some members of the EGE hold the view that the reduction of IVF costs
p.000040: is acceptable.
p.000040:
p.000040: If any of these criteria cannot be met because of the former conditions in which cell lines were generated, the
p.000040: applicants must explain why. The ethics review board must then decide how to deal with this matter on a
p.000040: case-by-case basis; for new hESC lines the above criteria are strongly recommended (see following paragraph,
p.000040: IV.2.4).
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: need or deemed of insufficient quality for clinical use. Researchers may not request that members of the infertility
p.000040: treatment team generate more embryos or harvest more oocytes than necessary for the optimal chance of reproductive
p.000040: success. People who elect to donate stored materials for research should not be reimbursed for the costs
p.000040: of storage prior to the decision to donate. Reimbursement for direct expenses incurred by donors as a
p.000040: consequence of the consent process may be determined during the SCRO process.)
p.000040: (99) ISSCR guidelines, 11.3–11.3a (http://www.isscr.org/guidelines/).
p.000040: (100) Informed consent must take into account the fact that the materials will be used in the derivation of cells
...
p.000042: the democratic decision-making process with regard to common societal goals. Applicants should therefore commit
p.000042: time, money and activities to advance the dialogue of science and society in the field of human embryonic
p.000042: stem cell research. Applicants for hESC research under FP7 are therefore strongly encouraged to include the
p.000042: science and humanities dialogue, i.e. social, cultural/religious, philosophical and ethical reflection on hESC
p.000042: research, in their projects and to collaborate for this purpose with other disciplines from the humanities.
p.000042:
p.000042:
p.000042:
p.000042: IV.3. The need for further research and continuous public debate
p.000042:
p.000042: As the ethical conflicts concerning hESCs have not been resolved either academically or politically,
p.000042: the EGE recommends that, under FP7, funding should
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000043: 43
p.000043:
p.000043:
p.000043:
p.000043: be provided in order to foster further collaborative and multidisciplinary international research
p.000043: on the ethical implications of hESC research and the pertinent surrounding issues, as well as to encourage
p.000043: informed public debate.
p.000043: The EGE believes the following topics may be of particular immediate interest in such research and discourse:
p.000043: • the potentially conflicting goals of economic competitiveness and compliance with ethical standards;
p.000043: • the use of the human body for modern medicine, including commercialisation of products and procedures stemming
p.000043: from the use of human embryonic stem cells;
p.000043: • the underlying anthropology of human embryonic stem cell research, especially in the light of
p.000043: hybrids and the chimera research connected to stem cell research;
p.000043: • optimisation of clinical and therapeutic needs of patients suffering from the most common diseases
p.000043: addressed in hESC research on treatment and/or for specific diseases;
p.000043: • policy regarding numbers and production process of stem cell lines necessary in the case of
p.000043: successful therapies;
p.000043: • the correlation of human embryonic stem cell research and questions concerning regenerative
p.000043: medicine and health-related justice, including the issue of global justice;
p.000043: • the relation between science and humanities and between science and society with respect to the
p.000043: development of new technologies;
p.000043: • the ongoing efforts of scientific alternatives and their anthropological and ethical interpretations.
p.000043:
p.000043: The EGE also acknowledges that a number of issues will need further clarification,
p.000043: interdisciplinary research, thorough ethical evaluation and, if found necessary in the future, also
p.000043: appropriate legal action. At present, the EGE believes, the following issues require particular attention.
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000044: 44
p.000044:
p.000044:
p.000044: 1. The current provisions for patenting hESC-derived materials need to be addressed. Given new
p.000044: developments in research and taking into consideration the ongoing debate on the limits of
p.000044: patenting of biological materials, the EGE would like to deal with this issue at a later point in time
p.000044: (104).
p.000044:
p.000044: 2. The tension induced by a policy that encourages both free donation (105) and commercial use of derivates from human
p.000044: substances needs to be addressed.
p.000044:
p.000044: The EGE emphasises its view that the use of human embryos to generate stem cells should be minimised as much as
p.000044: possible. The EGE calls on the European Union to develop appropriate systems to minimise the use of human embryos to
p.000044: cases for which no alternatives exist.
p.000044:
p.000044: IV.4. Review of recommendations and communication with the Advisory Board of the European Registry on Human
p.000044: Embryonic Stem Cell Research
p.000044:
p.000044: The EGE would also welcome interaction with the Advisory Board of the European Registry on Human Embryonic
p.000044: Stem Cell Research, in particular with the registry’s Ethics Advisory Board, in order to address the ethical
p.000044: concerns regarding the procurement of stem cells and the storing of data in the light of the ongoing progress in this
p.000044: area.
p.000044:
p.000044: The concrete form and means of this collaboration should be specified and put into place, and should be
p.000044: appropriately supported and funded by the Commission.
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044: (104) The EGE has issued an opinion on ‘Ethical aspects of patenting inventions involving human stem cells’
p.000044: (http://www.ec.europa.eu/european_group_ethics/docs/avis16_en.pdf).
p.000044: (105) Article 12, Directive 2004/23/EC: ‘The EC encourages Member States to promote the voluntary
p.000044: and unpaid donation of tissue and cells’.
p.000044:
p.000044:
p.000044:
p.000044:
p.000045: 45
p.000045:
p.000045:
p.000045:
p.000045:
p.000045: IV. TRANSLATIONS OF THE RECOMMENDATIONS IN FRENCH AND GERMAN (106)
p.000045:
p.000045: IV.I. French translation
p.000045:
p.000045: RECOMMANDATIONS CONCERNANT L'EXAMEN ÉTHIQUE DES PROJETS DE RECHERCHE DU 7E PC DANS LE DOMAINE DES CSEH — Avis n° 22
p.000045:
p.000045: IV. RECOMMANDATIONS
p.000045: IV.1. Préambule
p.000045:
p.000045:
p.000045: Les présentes recommandations constituent la réponse à la demande du président de la Commission européenne, M.
p.000045: Barroso (107), après l'adoption du septième programme-cadre de l'Union européenne pour la recherche et le
p.000045: développement (7e PC), de formuler un avis sur les mesures d'exécution requises lors de l'examen éthique
p.000045: des projets de recherche sur les cellules souches embryonnaires humaines (CSEH).
p.000045:
p.000045: Tout comme au sein de l'Union européenne, il existe des vues divergentes au sein du Groupe européen d'éthique (GEE)
p.000045: quant à la légitimité morale de la recherche sur les embryons humains et les CSEH, qui vont du refus de la
p.000045: recherche comportant la destruction d'embryons humains (rendant impossible le respect total de la dignité de l'embryon
p.000045: humain) à une position permettant la recherche sur les CSEH sous certaines conditions ou sur une base plus
p.000045: générale.
p.000045:
...
p.000079: und gesellschaftlichen Entwicklungen zu überprüfen.
p.000079: Die Europäische Gruppe für Ethik in Naturwissenschaften und neuen Technologien150
p.000079:
p.000079: Der Vorsitzende: Göran Hermerén Die Mitglieder:
p.000079: Emmanuel Agius Diana Banati Anne Cambon-Thomsen
p.000079:
p.000079:
p.000079:
p.000079: Rafael Capurro Inez de Beaufort Jozef Glasa
p.000079:
p.000079:
p.000079:
p.000079: Hille Haker Julian Kinderlerer Krzysztof Marczewski
p.000079:
p.000079:
p.000079:
p.000079: Paula Martinho Da Silva Linda Nielsen
p.000079:
p.000079:
p.000079:
p.000079: Pere Puigdomenech-Rosell Günter Virt
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079: 150 Translation from the English original — only the English text is authentic — available at:
p.000079: http://ec.europa.eu/european_group_ethics/activities/docs/opinion_22_final_follow_up_en.pdf
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000080: 80
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080: ANNEXES
p.000080:
p.000080:
p.000080: ANNEX I
p.000080:
p.000080: THE SIXTH FRAMEWORK PROGRAMME
p.000080: The sixth framework programme covers Community activities in the field of research, technological development and
p.000080: demonstration (RTD) for the period 2002 to 2006
p.000080: PROCEDURAL MODALITIES FOR RESEARCH ACTIVITIES INVOLVING BANKED OR ISOLATED HUMAN EMBRYONIC STEM CELLS IN CULTURE TO BE
p.000080: FUNDED UNDER COUNCIL DECISION 2002/834/EC
p.000080:
p.000080: Introduction
p.000080:
p.000080: Pursuant to the Council decision adopting a specific programme for research, technological development and
p.000080: demonstration, ‘Integrating and strengthening the European research area’ (2002–06) (151), and in particular
p.000080: Article 6(3), the Commission has adopted procedural modalities to clarify the procedure which the
p.000080: Commission will follow when evaluating, selecting and supporting research projects involving the use of banked
p.000080: or isolated human embryonic stem cells in culture.
p.000080:
p.000080: Procedural modalities for research activities involving banked or isolated human embryonic stem cells in
p.000080: culture to be funded under Council Decision 2002/834/EC (152)
p.000080: When evaluating, and selecting proposals involving the use of banked or isolated human embryonic stem cells (hESCs)
p.000080: in culture and negotiating the related contracts, the Commission uses the following procedure:
p.000080:
p.000080: 1. Proposal: Proposers are requested to address, in the application form, the potential ethical aspects
p.000080: of the proposed research in terms of its objectives, methodology and the possible implications of the
p.000080: results. Pursuant to the decision on the work programme in the framework of the specific programme for research,
p.000080: technical development and demonstration on ‘Integrating and strengthening the European research
p.000080: area’ (153) (hereinafter the work programme), they should justify the research design, explain
p.000080: how ethical requirements will be fulfilled and indicate the relevant national legal and/or regulatory
p.000080: requirements of the country(ies) where the research takes place.
p.000080:
p.000080: (151) OJ L 294, 29.10.2002, p. 1.
p.000080: (152) C(2003) 2952 of 11.11.2003.
p.000080: (153) C(2002) 4789 of 9.12.2002.
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000082: 82
p.000082:
p.000082:
p.000082: 2. Evaluation: Proposals are evaluated in accordance with the procedure set out in the ‘Guidelines on proposal
p.000082: evaluation and selection procedures’ established by Decision C(2003) 883 (hereinafter the guidelines) by a panel of
...
p.000083:
p.000083:
p.000083:
p.000084: 84
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084: ANNEX II
p.000084:
p.000084: Ethical review procedures in FP7
p.000084:
p.000084: Ethical issues
p.000084: Describe any ethical issues that may arise in their proposal. In particular, you should explain the benefit and burden
p.000084: of their experiments and the effects it may have on the research subject.
p.000084:
p.000084: The following special issues should be taken into account.
p.000084:
p.000084: Informed consent: When describing issues relating to informed consent, it will be necessary to illustrate an
p.000084: appropriate level of ethical sensitivity, and consider issues of insurance, incidental findings and the
p.000084: consequences of leaving the study.
p.000084:
p.000084: Data protection issues: Avoid the unnecessary collection and use of personal data. Identify the source of the data,
p.000084: describing whether it is collected as part of the research or is previously collected data being used.
p.000084: Consider issues of informed consent for any data being used. Describe how the personal identity of the data is
p.000084: protected.
p.000084:
p.000084: Use of animals: Where animals are used in research, the application of the 3Rs (‘replace, reduce, refine’) must be
p.000084: convincingly addressed. Numbers of animals should be specified. Describe what happens to the animals after the research
p.000084: experiments.
p.000084: Human embryonic stem cells: Research proposals that will involve human embryonic stem cells (hESCs) will
p.000084: have to address all the following specific points:
p.000084: • the necessity to use hESCs in order to achieve the scientific objectives set forth in the
p.000084: proposal;
p.000084: • whether the applicants have taken into account the legislation, regulations, ethical rules and/or
p.000084: codes of conduct in place in the country(ies) where the research using hESCs is to take place, including the procedures
p.000084: for obtaining informed consent;
p.000084: • the source of the hESCs;
p.000084: • the measures taken to protect personal data, including genetic data, and privacy;
p.000084: • the nature of financial inducements, if any.
p.000084:
p.000084: Identify the countries where research will be undertaken and which ethical committees and regulatory
p.000084: organisations will need to be approached during the life of the project.
p.000084:
p.000084: Include the ethical issues table below. If you indicate YES to any issue, please identify the pages in the proposal
p.000084: where this ethical issue is described. Answering ‘YES’ to some of these boxes does not automatically lead to an ethical
p.000084: review. It enables the independent experts to decide if an ethical review is required. If you are sure that none of the
p.000084: issues apply to your proposal, simply tick the YES box in the last row.
p.000084:
p.000084: (No recommended length for section 4 — depends on the number of such issues involved.)
p.000084:
p.000084:
p.000084: Notes: Only in exceptional cases will additional information be sought for clarification, which means that
p.000084: any ethical review will be performed solely on the basis of the information available in the proposal (1). Projects
p.000084: raising specific ethical issues such as research intervention on human beings, research on human embryos and human
p.000084: embryonic stem cells and non-human primates are automatically submitted for ethical review.
p.000084:
p.000084:
p.000085: 85
p.000085:
p.000085:
p.000085:
p.000085: To ensure compliance with ethical principles, the Commission services will undertake ethics audit(s) of selected
p.000085: projects at its discretion. A website is being prepared aiming to provide clear, helpful information on ethical issues.
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085: (1) Such as clinical trials, and research involving invasive techniques on persons (e.g. taking of tissue
p.000085: samples, examinations of the brain).
p.000085:
p.000085:
p.000085:
p.000085:
p.000086: 86
p.000086:
p.000086:
p.000086:
p.000086: ETHICAL ISSUES TABLE
p.000086:
p.000086:
p.000086: Informed consent
p.000086: • Does the proposal involve children?
p.000086: • Does the proposal involve patients or persons not able to give consent?
p.000086: • Does the proposal involve adult healthy volunteers?
p.000086:
p.000086:
p.000086:
p.000086: YES
p.000086:
p.000086:
p.000086:
p.000086:
p.000086: PAGE
p.000086:
p.000086: • Does the proposal involve human genetic material?
p.000086:
p.000086: • Does the proposal involve human biological samples?
p.000086: • Does the proposal involve human data collection?
p.000086:
p.000086: Research on human embryos/foetuses
p.000086: • Does the proposal involve human embryos?
p.000086: • Does the proposal involve human foetal tissue/cells?
p.000086:
p.000086: • Does the proposal involve human embryonic stem cells?
p.000086: Privacy
p.000086: • Does the proposal involve processing of genetic information or personal data (e.g. health, sexual lifestyle,
p.000086: ethnicity, political opinion, religious or philosophical conviction)?
p.000086: • Does the proposal involve tracking the location or observation of people?
p.000086: Research on animals
p.000086: • Does the proposal involve research on animals?
p.000086:
p.000086: • Are those animals transgenic small laboratory animals?
p.000086: • Are those animals transgenic farm animals?
p.000086: • Are those animals cloning farm animals?
p.000086: • Are those animals non-human primates?
p.000086: Research involving developing countries
p.000086: • Use of local resources (genetic, animal, plant, etc.)
p.000086:
p.000086: • Benefit to local community (capacity building, i.e. access to healthcare, education, etc.)
p.000086: Dual use
p.000086: • Research having potential military/terrorist application
p.000086:
p.000086: I CONFIRM THAT NONE OF THE ABOVE ISSUES APPLY TO MY PROPOSAL
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000087: 87
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087: ANNEX III
p.000087:
p.000087: LIST OF PROJECTS SUPPORTED WITHIN THE SIXTH FRAMEWORK PROGRAMME AND WITHIN THE HEALTH
p.000087: DIRECTORATE, INVOLVING HESCS
p.000087: 1. LYMPHANGIOGENOMICS: fundamental research to better understand the lymphatic vasculature with a view to
p.000087: developing therapies to control the growth of lymphatic vessels (e.g. cancer, inflammatory diseases, for
p.000087: tissue ischæmia, lymphœdema)/EUR 9 million, 13 partners, 8 different countries (FI, FR, SE, AT, IT, CH, DE, BE)
p.000087:
p.000087: 2. REPROTECT: model to study reproductive toxicity by a combination of in vitro and sensor technologies/EUR 9.1
p.000087: million, 26 partners, 9 different countries (DE, NL, BE, IT, UK, FR, SE, BG, AT)
p.000087: 3. BETACELL THERAPY: treatment of diabetes: to generate insulin- producing beta cells/EUR 11.8
p.000087: million, 29 partners, 7 different countries (BE, DK, IL, ES, SE, CH, UK)
p.000087:
p.000087: 4. EUROSTEMCELL: comparison of the properties of adult, foetal and embryonic stem cells for the
p.000087: development of therapies including medicines in different set of diseases/disorders (skin, musculoskeletal,
p.000087: neurodegenerative diseases)/EUR 11.9 million, 14 partners, 7 different countries (UK, SE, FR, IT, DE, CH, DK)
p.000087:
p.000087: 5. HEART REPAIR: underlying principles of cardiac muscle cell formation for stem cell replacement therapies for
p.000087: heart failure and cardiac repair. Comparison of the potential of bone marrow derived stem cells and
p.000087: embryonic stem cells/EUR 11.4 million, 27 partners, 8 different countries (NL, DE, UK, IT, FR, ES, CH, SE)
p.000087: 6. OSTEOCORD: comparison of the properties of embryonic stem cells and umbilical cord blood stem
p.000087: cells in view of new applications and better characterisation of umbilical cord blood stem cells/EUR 2.5 million, 9
p.000087: partners, 5 different countries (UK, DK, DE, IL, PT)
p.000087: 7. THERCORD: development and preclinical testing of cord blood-derived cell therapy products, where
p.000087: comparative research on the potential of umbilical cord blood stem cells and embryonic stem
p.000087: cell is performed/EUR 1.8 million, 9 partners, 6 different countries (IT, UK, DE, NL, ES, IL)
p.000087:
p.000087:
p.000088: 88
p.000088:
p.000088:
p.000088:
p.000088: 8. VITROCELLOMICS: on reducing animal experimentation in preclinical predictive drug testing by human
p.000088: hepatic in vitro models derived from embryonic stem cells/EUR 2.9 million, 9 partners, 4 different
p.000088: countries (SE, DE, PT, IT)
p.000088: 9. ESTOOLS: better characterisation of 52 different existing human embryonic stem cell lines from all
p.000088: over the world to generate knowledge on the fundamental processes governing stem cell differentiation in view of
p.000088: biomedical discovery. This project will bring a major contribution to the various initiatives launched
p.000088: around the world on the issue of characterisation/EUR 12 million, 20 partners, 10 different
p.000088: countries (UK, CH, IL, FI, DE, IT, ES, CZ, SE, NL)
p.000088: 10. EUROHEAR: fundamental research on the development and function of the inner ear including
p.000088: genetics of hereditary hearing impairments/EUR 12.5 million, 26 partners, 12 different countries (FR,
p.000088: UK, IL, NL, DE, IT, ES, FI, SE, BE, HU, TN)
p.000088: 11. STEMS: preclinical evaluation of stem cell therapy in stroke/ EUR 2.4 million, 9 partners,
p.000088: 5 different countries (FR, SE, DK, DE, CZ)
p.000088:
...
p.000088: partners, 6 different countries (DE, NL, AT, CH, BE, FR)
p.000088:
p.000088: 16. SIROCCO: fundamental research on regulatory RNAs/EUR 11.8 million, 18 partners, 10 different countries (UK,
p.000088: HU, FR, CH, NL, DE, IT, DK, ES, IL)
p.000088: 17. INVITROHEART: in vitro testing for cardiotoxicity and drug development/EUR 2.7 million,
p.000088: 9 partners, 4 different countries (SE, DE, DK, BE)
p.000088:
p.000088: 18. NEUROCREEN: screening of neuro-therapeutic molecules/ EUR 2.6 million, 9 partners, 4
p.000088: different countries (UK, IT, DE, HU)
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000089: 89
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: ANNEX IV
p.000089:
p.000089:
p.000089:
p.000089: EU MEMBER STATES’ REGULATORY FRAMEWORK FOR HESC RESEARCH
p.000089:
p.000089:
p.000089:
p.000089: Information provided by EU-27 national ethics councils, updated May 2007
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000090: 90
p.000090:
p.000090:
p.000090:
p.000090: Regulatory frame applying to AUSTRIA
p.000090:
p.000090:
p.000090: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000090: having not a legal personality.
p.000090:
p.000090:
p.000090: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000090: to get the texts would be welcomed).
p.000090: The hESC research (Untersuchung/Behandlung rather in the sense of medical examination and treatment) is limited to the
p.000090: field of reproductive medicine. It is therefore covered in the legislation applying to reproductive medicine
p.000090: (Fortplanzungsmedizingesetz §9.(1); http://www.ris.bka.gv.at/bundesrecht/)
p.000090:
p.000090: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000090: No
p.000090:
p.000090: 3 Is hESC research allowed and in what terms and conditions?
p.000090: hESC research in the above mentioned sense is limited to the field of reproductive medicine; other research is not
p.000090: allowed;
p.000090:
p.000090: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000090: ---
p.000090:
p.000090: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000090: yes at what conditions?
p.000090: No
p.000090:
p.000090: 6 Is the source of hESC used in research traceable and well documented?
p.000090: ---
p.000090: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000090: ---
p.000090:
p.000090: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000090: embryo donation for research, if so could you please describe them?
p.000090: ---
p.000090:
p.000090: 9 Is financial inducement allowed? If so, in what terms?
p.000090:
p.000090: ---
p.000090:
p.000090: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000090: ---
p.000090:
p.000090: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000090: publications)?
p.000090:
p.000090:
p.000090: 12 How is patenting of hESC lines regulated?
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000091: 91
p.000091:
p.000091:
p.000091:
p.000091: Regulatory frame applying to BELGIUM
p.000091:
p.000091: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000091: having not a legal personality.
p.000091:
p.000091: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where to
p.000091: get the texts would be welcomed).
p.000091: There are several regulations applying on hESC research:
p.000091: 1: Law on organ transplantation 13/06/1986 (applicable on tissues, Published 14/02/1987) 2: Royal Decree on tissue
p.000091: banks of 15/04/1988 (Published 29/04/1988)
p.000091: 3: Embryo Law of 11/05/2003 (Published BS 28/05/2003)
p.000091:
p.000091:
p.000091: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000091: Yes: An embryo is a cell or a group of coherent cells that have the capacity to develop into a human being (see Embryo
p.000091: law, Art. 2, cited:)
p.000091: Loi du 11 mai 2003. Article 2. Pour l'application de la présente loi, on entend par:
p.000091: 1) «embryon»: la cellule ou l'ensemble organique de cellules susceptibles, en se développant, de donner un être
p.000091: humain
p.000091:
p.000091: 3 Is hESC research allowed and in what terms and conditions?
p.000091: Yes:
p.000091: At universities or in cooperation with universities, after consent of the local ethical commission and
p.000091: after positive advice (within 2 months) of the Federal Commission for medical and scientific research on embryos in
p.000091: vitro
p.000091: Loi du 11 mai 2003. Article 7, paragraphe 1. Toute recherche sur des embryons in vitro doit être soumise au préalable
p.000091: au comité local d'éthique de l'établissement universitaire concerné et à la Commission fédérale pour la recherche
p.000091: médicale et scientifique sur les embryons in vitro visée à l'article 9.
...
p.000091: assistée ou de génétique humaine agréé de l'établissement universitaire concerné ou de l'établissement qui a conclu une
p.000091: convention avec un établissement universitaire.
p.000091: La demande d'avis comporte une description détaillée de l'objectif, de la méthodologie et de la durée de la recherche.
p.000091: Elle indique spécialement si la recherche a lieu sur des embryons surnuméraires ou des embryons créés à des fins de
p.000091: recherche.
p.000091: Paragraphe 2. L'avis du comité local d'éthique est rendu dans un délai de deux mois suivant la demande d'avis.
p.000091: Si l'avis du comité local d'éthique est négatif, le projet de recherche est abandonné.
p.000091: Le chercheur et le chef de laboratoire portent à la connaissance de la Commission fédérale pour la recherche médicale
p.000091: et scientifique sur les embryons in vitro, visée à l'article 9, leur demande d'avis ainsi que l'avis positif du comité
p.000091: local d'éthique. Si, dans un délai de deux mois après cette transmission, la Commission n'a pas émis d'avis négatif à
p.000091: la majorité de ses membres, le projet de recherche est autorisé et peut être entamé. Toutes les décisions de la
p.000091: Commission fédérale pour la recherche médicale et scientifique sur les embryons in vitro sont motivées.
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000092: 92
p.000092:
p.000092:
p.000092:
p.000092: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000092:
p.000092: The Federal Commission for medical and scientific research on embryos in vitro
p.000092:
p.000092:
p.000092: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if yes
p.000092: at what conditions?
p.000092: Yes, but ONLY if the objective of this research project can’t be achieved by using supernumerary embryos and this still
p.000092: under the conditions complying with the embryo law.
p.000092: Loi du 11 mai 2003. Article 4, paragraphe 1. La constitution d'embryons in vitro à des fins de recherche est interdite,
p.000092: sauf si l'objectif de la recherche ne peut être atteint par la recherche sur les embryons surnuméraires et pour autant
p.000092: que les conditions de la présente loi soient remplies.
p.000092: 6 Is the source of hESC used in research traceable and well documented?
p.000092: Actually there is no mandatory traceability.
p.000092: In a short period of time, traceability will be assured by a new law dealing with storage and distribution of cells and
p.000092: tissues
p.000092: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000092: Cf question 4
p.000092: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in embryo
p.000092: donation for research, if so could you please describe them?
p.000092: Yes.
p.000092: Donors give their free and written consent for the use of their gametes for research purposes after being properly
p.000092: informed
p.000092: Loi du 11 mai 2003. Article 8. Les personnes concernées donnent leur consentement préalable libre, éclairé et consigné
p.000092: par écrit à l'utilisation des gamètes ou des embryons in vitro à des fins de recherche.
p.000092:
p.000092: 9 Is financial inducement allowed? If so, in what terms?
p.000092:
...
p.000093: 2) les modalités du respect des dispositions de la présente loi;
p.000093: 3) la demande et les avis rendus par le comité local d'éthique et la Commission conformément à l'article 7;
p.000093: 4) l'état d'avancement de la recherche.
p.000093:
p.000093: 12 How is patenting of hESC lines regulated?
p.000093: In Belgium, patenting of hESC is possible.
p.000093: Loi du 28 mars 1984 sur les brevets d'invention (Moniteur belge du 9.3.1985) modifiée par la loi du 9 mars 1995
p.000093: (Moniteur belge du 7.6.1995), la loi du 28 janvier 1997 (Moniteur belge du 4.4.1997), la loi du 26 juin 2000 (Moniteur
p.000093: belge du 29.7.2000) et la loi du 12 juin 2001 (Moniteur
p.000093: belge du 7.7.2001).
p.000093: Les droits (exploitation exclusive, intervention contre les contrefaçons) d’un titulaire d’un brevet d’invention sont
p.000093: limités dans le temps (maximum 20 ans) et limités au territoire belge. Pour bénéficier des mêmes droits dans d’autres
p.000093: pays, vous devez obtenir ces brevets d’invention dans ces pays aussi, par voie nationale, européenne ou internationale.
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000094: 94
p.000094:
p.000094:
p.000094:
p.000094: Regulatory frame applying to BULGARIA
p.000094:
p.000094: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000094: having not a legal personality.
p.000094:
p.000094: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000094: to get the texts would be welcomed).
p.000094:
p.000094: Healthcare Act /Chapter IV, Div. III – ‘Artificial Reproduction’/ In force from 01.01.2005 ./ SG N.70/2004., adopt.
p.000094: N.46/2005., N.76/2005., N.85/2005., N.88/ 2005., N.94/2005., N.103/2005., N.18/2006., N.30/2006., N.34/2006.,
p.000094: N.59/2006., N.71/2006., N.75/ 2006., N.81/2006., N.95/2006., N.102/ 2006./.
p.000094: Transplantation organ, tissue & cells Act In force from 01.01.2004 ./ SG N.83/2003., adopt..N88/2005.,N.71/2006./.;
p.000094: Ordinance N 37/28.09.2004 for the conditions and order for taking an embryos organs, tissue and somatic, amniotic and
p.000094: placenta cells for transplantation aims.
p.000094: / SG N.88/8.10.2004z.,adopt. SG N..89/ 12.10. 2004z./
p.000094:
p.000094: / the object of Ordinance regulation is only the ‘embryonic organs, tissue and cells’ after abortion — Art.1 and Art.4/
p.000094:
p.000094: Remark: To my opinion, the term ‘human embryonic stem sells’ have an wide and narrow understanding.. The ‘wide’ meaning
p.000094: comprises zygotes and life embryo as a source of stem cells.
p.000094: The narrow meaning comprises only life embryo as a source of stem cells.
p.000094: Therefore it will be useful to specify what meaning should be the right contents of the term ‘hESC’.
p.000094:
p.000094: Web address:
p.000094: www.bultransplant.bg ; www.mh.government.bg/iat.php;
p.000094: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000094: “Embryo’ is not defined explicitly.
p.000094: There is a definition of ‘embryonic organs, tissue and cells’ — Transplantation organ, tissue & cells Act, Additional
p.000094: provisions, &1, point.9.
p.000094:
p.000094: 3 Is hESC research allowed and in what terms and conditions?
p.000094: No.
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000095: 95
p.000095:
p.000095:
p.000095:
p.000095: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000095: see.point.3
p.000095:
p.000095: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000095: yes at what conditions? No.
p.000095: 6 Is the source of hESC used in research traceable and well documented?
p.000095: See point.5
p.000095: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000095: Healthcare Act — Art. 134 — ‘Gametes and zygotes, which are not used for the purpose of human creation, can be given to
p.000095: the research, academic and medicine entities in the country and outside, for the medicine, scientific and teaching
p.000095: purposes, after written inform consent of the donor, but concerning zygotes – the consent should be taken by the two
p.000095: donors, according to the Ordinance, issued by the Minister of healthcare.
p.000095:
p.000095: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000095: embryo donation for research, if so could you please describe them?
p.000095: See.point.7.
p.000095:
p.000095:
p.000095: 9 Is financial inducement allowed? If so, in what terms?
p.000095:
p.000095: No
p.000095:
p.000095: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000095: No
p.000095:
p.000095: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000095: publications)?
p.000095: N/A
p.000095: 12 How is patenting of hESC lines regulated?
p.000095: N/A
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000096: 96
p.000096:
p.000096:
p.000096:
p.000096: Regulatory frame applying to CYPRUS
p.000096:
p.000096: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000096: having not a legal personality.
p.000096:
p.000096: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000096: to get the texts would be welcomed).
p.000096: There is no specific law for hESC in the Republic of Cyprus.
p.000096: However, the Republic of Cyprus has ratified the ‘Convention for the Protection of Human Rights and Dignity
p.000096: of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine,
p.000096: Oviedo Convention’ with the Ratification Law N.31(III)/2001.
p.000096:
p.000096: Article 18 of the Convention and the Ratification Law, in relation to the research on embryos in vitro, states that:
p.000096: 1. Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo.
p.000096: 2. The creation of human embryos for research purposes is prohibited.
p.000096:
p.000096: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000096: No, it does not provide a definition of ‘embryo’.
p.000096:
p.000096: 3 Is hESC research allowed and in what terms and conditions?
p.000096: There is no law in the Republic of Cyprus allowing research on embryos in-vitro under any circumstances.
p.000096: The hESC research is not allowed in the Republic of Cyprus.
p.000096:
p.000096: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000096:
p.000096:
p.000096: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000096: yes at what conditions?
p.000096: The creation of embryos for research purposes is absolutely prohibited in the Republic of Cyprus in accordance with
p.000096: Article 18 (2) of the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the
p.000096: Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Oviedo Convention’. The Article 18 (2)
p.000096: of the Oviedo Convention states that ‘The creation of human embryos for research purposes is prohibited'. The
p.000096: Convention has been ratified by the Law 31 (III)/2001.
p.000096: 6 Is the source of hESC used in research traceable and well documented?
p.000096: The extraction of embryonic stem cells from embryos in-vitro is prohibited in accordance with Article 18 of the Oviedo
p.000096: Convention and Article 7 of its Ratification Law (No. 31 (III)/2001).
p.000096: 7 What are the formal ethical and legal requirements for hESC research approval? Having in mind all the
p.000096: above mentioned and in accordance with the information given in paragraphs 3, 5 and 6 above, research on embryonic stem
p.000096: cells is neither legally nor ethically approved by the legislation currently in force, in the Republic of Cyprus.
p.000096:
p.000096:
p.000096:
p.000096:
p.000097: 97
p.000097:
p.000097:
p.000097:
p.000097: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000097: embryo donation for research, if so could you please describe them?
p.000097: Not applicable
p.000097:
p.000097: 9 Is financial inducement allowed? If so, in what terms?
p.000097:
p.000097: Not applicable
p.000097: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000097:
p.000097: Not applicable
p.000097: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000097: publications)?
p.000097: Not applicable
p.000097: 12 How is patenting of hESC lines regulated?
p.000097: Not applicable
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
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p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000098: 98
p.000098:
p.000098:
p.000098:
p.000098: Regulatory frame applying to CZECH REPUBLIC
p.000098:
p.000098: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000098: having not a legal personality.
p.000098:
p.000098: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000098: to get the texts would be welcomed).
p.000098: Act on Human Embryonic Stem Cell Research (law no. 227/2006 Coll.) passed by the Czech Parliament on 26th of April
p.000098: 2006, in force since June 1 2006.
p.000098: Text available here: http://www.mvcr.cz/sbirka/2006/sb075-06.pdf (also attached)
p.000098:
p.000098: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000098: “Human embryo is a totopotent cell or a grouping of cells which are capable develop into human individuum’ (law no.
p.000098: 227/2006 Coll., § 2)
p.000098:
p.000098: 3 Is hESC research allowed and in what terms and conditions?
p.000098: Yes.
p.000098: Conditions: State licensing (given by the Ministry of Education, after approval of the Bioethics Committee of the
p.000098: Research and Development Council of the Czech Government and after positive appraisal of the Research and Development
p.000098: Council) Preconditions:
p.000098: a) Scientific criteria
p.000098:
p.000098: scientifically justifiable – new medical knowledge with applications for humans; scientific necessity (usage of in
p.000098: vitro models, animal cells or animals does not provide the necessary knowledge);
p.000098: no alternative research
p.000098: scientific quality of the research team
p.000098: b) Ethical criteria
p.000098:
p.000098: Research project is ethically acceptable (informed consent, donation…)
p.000098:
p.000098: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000098: Ministry of Education
p.000098:
p.000098: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000098: yes at what conditions?
p.000098:
p.000098: No. The Czech Republic ratified Oviedo Convention (2001).
p.000098: 6 Is the source of hESC used in research traceable and well documented?
p.000098: Yes.
p.000098: 7 What are the formal ethical and legal requirements for hESC research approval? Source of embryos:
p.000098: ‘surplus embryos’ from IVF (only from licensed IVF centres), no longer than 7 day of development, export of embryos
p.000098: prohibited
p.000098: Informed consent
p.000098: Donation (reimbursement of expenses possible)
p.000098:
p.000098: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000098: embryo donation for research, if so could you please describe them?
p.000098: Yes. Detailed description in § 9 Act no. 227/2006 Coll.
p.000098:
p.000098:
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p.000099: 9 Is financial inducement allowed? If so, in what terms?
p.000099:
p.000099: No.
p.000099: Only reimbursement of real expenses (to the IVF Centre)
p.000099: Reimbursement of real expenses related to the embryo donation (to the donor, payment and other compensation explicitly
p.000099: prohibited)
p.000099:
p.000099: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000099: Yes. The Act on Personal Data Protection applies.
p.000099:
p.000099: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000099: publications)?
p.000099: No
p.000099:
p.000099: 12 How is patenting of hESC lines regulated?
p.000099: No regulation.
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p.000100:
p.000100:
p.000100:
p.000100: Regulatory frame applying to DENMARK
p.000100:
p.000100: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000100: having not a legal personality.
p.000100:
p.000100: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000100: to get the texts would be welcomed).
p.000100: Yes www.retsinfo.dk
p.000100:
p.000100: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000100: No
p.000100:
p.000100: 3 Is hESC research allowed and in what terms and conditions?
p.000100: Research is allowed on human fertilized eggs meant for fertilisation of a woman under the conditions mentioned in
p.000100: Lovbekendtgørelse af lov om kunstig befrugtning i forbindelse med lægelig behandling, diagnostic og forskning LBK nr.
p.000100: 923 af 04//09/2006 chapter 7, paragraph 25-27
p.000100:
p.000100: Kapitel 7
p.000100: Forbud mod forskning og forsøg
p.000100:
p.000100: § 25. Biomedicinske forsøg på befrugtede menneskelige æg samt på kønsceller, der agtes anvendt til befrugtning, må kun
p.000100: foretages i følgende tilfælde:
p.000100: 1) Hvis de har til formål at forbedre in vitro-befrugtning eller lignende teknikker med henblik på at fremkalde en
p.000100: graviditet.
p.000100: 2) Hvis de har til formål at forbedre teknikker til genetisk undersøgelse af et befrugtet æg med henblik på at fastslå,
p.000100: om der foreligger en alvorlig arvelig sygdom eller en væsentlig kromosomabnormitet (præimplantationsdiagnostik).
p.000100: 3) Hvis forsøgene ved anvendelse af befrugtede æg og stamceller herfra har til formål at opnå ny viden, som vil kunne
p.000100: forbedre mulighederne for behandling af sygdomme hos mennesker.
p.000100: Stk. 2. Udtagning og befrugtning af æg med henblik på at gennemføre andre forsøg end de i stk. 1 nævnte er ikke
p.000100: tilladt.
p.000100:
p.000100: § 26. Befrugtede æg må kun holdes i live uden for en kvindes livmoder i 14 dage, fra befrugtningen er sket. Den tid,
p.000100: hvori de befrugtede menneskelige æg har været nedfrosset, medregnes ikke.
p.000100:
p.000100: § 27. Befrugtede menneskelige æg, der har været gjort til genstand for biomedicinsk forskning, herunder almindelig
p.000100: kvalitetssikrende forskning ved ægopsætning, må kun opsættes i en kvindes livmoder, hvis det befrugtede æg er genetisk
p.000100: uændret (umodificeret) og den forudgående forskning efter en faglig vurdering i øvrigt ikke må antages at have
p.000100: beskadiget ægget i dets videre udvikling.
p.000100: Stk. 2. Forskningsprojekter efter § 25 skal godkendes i det videnskabsetiske komitesystem, der forud for eventuel
p.000100: godkendelse vurderer, om projekterne har det tilladte formål.
p.000100:
p.000100: § 28. Følgende forsøg må ikke foretages:
p.000100: 1) Forsøg, der har til formål at muliggøre fremstilling af arvemæssigt identiske menneskelige individer.
p.000100: 2) Forsøg, der har til formål at muliggøre fremstilling af menneskelige individer ved sammensmeltning af genetisk
p.000100: forskellige fosteranlæg eller dele af fosteranlæg, før
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p.000101: de sætter sig fast i livmoderen.
p.000101: 3) Forsøg, der har til formål at muliggøre fremstilling af levende menneskelige individer, som er hybrider, med en
p.000101: arvemasse, hvori indgår bestanddele fra andre arter.
p.000101: 4) Forsøg, der har til formål at muliggøre udvikling af et menneskeligt individ i artsfremmed livmoder.
p.000101:
p.000101:
p.000101: 4 If yes, which body is in charge of the approval of hESC research (ethics review)? The Danish Committees
p.000101: on Biomedical Researchhttp://www.cvk.im.dk/cvk/site.aspx?p=23
p.000101:
p.000101: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000101: yes at what conditions?
p.000101: No
p.000101:
p.000101: 6 Is the source of hESC used in research traceable and well documented?
p.000101: Yes see provisions of Act on a Biomedical Research Ethics Committee System and the Processing of Biomedical Research
p.000101: Projects
p.000101: http://www.cvk.im.dk/cvk/site.aspx?p=150
p.000101:
p.000101: 7 What are the formal ethical and legal requirements for hESC research approval? See the Danish act on a
p.000101: Biomedical Research Ethics Committees System and the Processing of Biomedical Research Projects
p.000101:
p.000101: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000101: embryo donation for research, if so could you please describe them? See the Danish act on a Biomedical Research Ethics
p.000101: Committees System and the Processing of Biomedical Research Projects
p.000101:
p.000101:
p.000101:
p.000101: 9 Is financial inducement allowed? If so, in what terms? No
p.000101:
p.000101:
p.000101: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000101: Yes, see the Danish act on a Biomedical Research Ethics Committees System and the Processing of Biomedical Research
p.000101: Projects
p.000101:
p.000101:
p.000101: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000101: publications)?
p.000101: Yes, see the Danish act on a Biomedical Research Ethics Committees System and the Processing of Biomedical Research
p.000101: Projects
p.000101:
p.000101:
p.000101: 12 How is patenting of hESC lines regulated?
p.000101: See Danish Law on Patents Paragraph 1A
p.000101:
p.000101: § 1 a. Det menneskelige legeme på alle de forskellige stadier af dets opståen og udvikling og den blotte opdagelse af
p.000101: en del af det, herunder en sekvens eller delsekvens af et gen, kan ikke udgøre patenterbare opfindelser.
p.000101: Stk. 2. Uanset stk. 1 kan en del af det menneskelige legeme, der er isoleret herfra eller på anden måde fremstillet ved
p.000101: en teknisk fremgangsmåde, herunder en sekvens
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p.000102: eller delsekvens af et gen, udgøre en patenterbar opfindelse, selv om en sådan del i sin opbygning er identisk med
p.000102: opbygningen i en naturligt forekommende del.
p.000102:
p.000102: Unofficial translation of the paragraph:
p.000102: “The human body, at the various stages of its formation and development, and the simple discovery of one of its
p.000102: elements, including a sequence or partial sequence of a gene, cannot constitute patentable inventions.
p.000102: Subs. 2. Notwithstanding subsection 1 hereof, an element isolated from the human body or otherwise produced by means of
p.000102: a technical process, including a sequence or partial sequence of a gene, may constitute a patentable invention, even if
p.000102: the structure of that element is identical to that of a natural element.’
p.000102:
p.000102: In the Danish regulations, Article 5, subs. 3 of the EU directive on patenting of human stem cells has been set out in
p.000102: the statutory instrument on patents.
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p.000103:
p.000103: Regulatory frame applying to ESTONIA
p.000103:
p.000103:
p.000103: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000103: having not a legal personality.
p.000103:
p.000103: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000103: to get the texts would be welcomed).
p.000103: We have no special regulations of hESC research in Estonia and if needed we take into consideration relevant
p.000103: international documents..
p.000103:
p.000103: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000103: _
p.000103:
p.000103: 3 Is hESC research allowed and in what terms and conditions?
p.000103: The Estonian Council on Bioethics is on the position, that in principle hESC research is acceptable in Estonia.
p.000103:
p.000103: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000103: In needed cases the approval will be given by research ethics committees
p.000103:
p.000103: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000103: yes at what conditions?
p.000103: The creation of embryos for research purposes is not allowed by the Estonian law of artificial procreation and embryo
p.000103: protection
p.000103:
p.000103: 6 Is the source of hESC used in research traceable and well documented?
p.000103: We have no special system for this yet
p.000103: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000103: They are not fixed yet in Estonia
p.000103:
p.000103: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000103: embryo donation for research, if so could you please describe them?
p.000103: No regulations on it
p.000103:
p.000103: 9 Is financial inducement allowed? If so, in what terms?
p.000103:
p.000103: It is not regulated
p.000103:
p.000103: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000103: No
p.000103:
p.000103: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000103: publications)?
p.000103: No
p.000103:
p.000103: 12 How is patenting of hESC lines regulated?
p.000103: It is not regulated in Estonia
p.000103:
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p.000104:
p.000104:
p.000104:
p.000104: Regulatory frame applying to FINLAND
p.000104:
p.000104: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000104: having not a legal personality.
p.000104:
p.000104: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000104: to get the texts would be welcomed).
p.000104: Medical Research Act, 488/1999. www.finlex.fi
p.000104: Translation: see: http://www.finlex.fi/en/laki/kaannokset/1999/en19990488.pdf
p.000104: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000104: Yes. ‘embryo’ means a living group of cells resulting from fertilisation not implanted in a woman’s body
p.000104:
p.000104: 3 Is hESC research allowed and in what terms and conditions?
p.000104: It is allowed. Embryos shall be used for research only with a written informed consent from the donors of the gametes.
p.000104: Consent can be withdrawn in any time (Act on medical Research, section 12) Only supernumerary embryos shall be used for
p.000104: research. The production of embryos exclusively for the purpose of research is forbidden. (Act on Medical Research,
p.000104: section 13). When hESC lines have been produced, the law does not make any further provisions on the use of these
p.000104: cells. The production of hESC needs the favourable opinion of an ethics committee of a hospital district, and the
p.000104: research on embryos can be done only in the institutions that have got an authorisation from the National Authority of
p.000104: Medicolegal Affairs (TEO) The use of embryos for research is allowed only for 14 days after fertilisation
p.000104: 4 If yes, which body is in charge of the approval of hESC research (ethics review)? Ethics committees of
p.000104: hospital districts evaluate the research projects, although the research of cell lines is not specifically regulated in
p.000104: the Medical Research Act. The Ministry of Social Affairs and Health has established a working group on Biobanks that is
p.000104: working on the issue of biobanks including ethics evaluation of establishment of biobank and ethics evaluation of the
p.000104: research projects.
p.000104: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000104: yes at what conditions?
p.000104: Medical Research Act states that The production of embryos exclusively for the purpose of research shall be forbidden.
p.000104: However, the Act also determines the embryo as ‘the living group of cells resulting from fertilisation’. This can be
p.000104: interpreted so that cells produced by the somatic cell nuclear transfer are not considered as embryos.
p.000104: 6 Is the source of hESC used in research traceable and well documented?
p.000104: Anonymisation and coding as far as possible should be used in each project
p.000104: 7 What are the formal ethical and legal requirements for hESC research approval? We have formal ethical
p.000104: and legal requirements for embryo research stated in the Medical Research Act. Further requirements concerning hESC
p.000104: lines have not been established. The working group is working on this issue concerning research on biological sample
p.000104: collections.
p.000104: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000104: embryo donation for research, if so could you please describe them?
p.000104: Ethics committees approve information and consent forms before they can be used in the informed consent procedure
p.000104:
p.000104: 9 Is financial inducement allowed? If so, in what terms?
p.000104:
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p.000105: publications)?
p.000105: Not necessarily, only when they are published.
p.000105:
p.000105: 12 How is patenting of hESC lines regulated?
p.000105: We have Act on Patenting (550/1967, amendment 650/2000) that has implemented the EU Directive of biopatenting. It
p.000105: states that (Section 1a and b) human body or its part, whole or partial sequence of a gene or similar finding cannot be
p.000105: patented, but isolated or otherwise produced item, sequence or partial sequence of a single gene form an invention that
p.000105: can be patented, if provisions otherwise are fulfilled, although the structure of this item would be similar to natural
p.000105: item. However, section 1 b states that
p.000105: (3) uses of human embryos for industrial or commercial purposes cannot be patented See translation at:
p.000105: http://www.finlex.fi/en/laki/kaannokset/1967/en19670550.pdf
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p.000106: Regulatory frame applying to FRANCE
p.000106:
p.000106: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000106: having not a legal personality.
p.000106:
p.000106: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000106: to get the texts would be welcomed). www.agence-biomedecine.fr
p.000106: http://www.agence-biomedecine.fr/fr/experts/pegh-recherche.aspx
p.000106: Demande d'autorisation de protocoles d'étude et de recherche, d'importation ou de conservation
p.000106: Le décret n° 2006-121 du 6 février 2006 relatif aux recherches sur l'embryon et les cellules embryonnaires, précisant
p.000106: les conditions d'application de la loi du 6 août 2004, prévoit que le directeur général de l'Agence de la biomédecine
p.000106: notifie à l'établissement ou à l'organisme demandeur sa décision d'autorisation ou de refus d'autorisation dans les 4
p.000106: mois suivant la clôture de la période au cours de laquelle a été déposé le dossier complet.
p.000106: www.legifrance.gouv.fr
p.000106: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000106: The embryo in this law is :
p.000106: Obtained during an ART protocol and is no more subject to a parental (pregnancy) project
p.000106: Up to implantation stage
p.000106:
p.000106: 3 Is hESC research allowed and in what terms and conditions?
p.000106: Subjected to the obtention of a licence for
p.000106: -research project
p.000106: -importation
p.000106: -conservation/storage
p.000106:
p.000106: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000106: The agency of biomedicine www.agence-biomedecine.fr
p.000106:
p.000106: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000106: yes at what conditions?
p.000106: No
p.000106:
p.000106: 6 Is the source of hESC used in research traceable and well documented?
p.000106: It is a condition to fulfil in order to obtain a licence to be able to keep a local registry and tracks of cell
p.000106: culture;
p.000106: The agence de la biomedicine has also to keep a national hESC registry
p.000106: 7 What are the formal ethical and legal requirements for hESC research approval? The research project
p.000106: should benefit to the progress towards a potential therapeutic use of to progress on human embryo development and
p.000106: medicine.
p.000106: The team involved has to provide proof if feasibility of this research, and to documents the composition of the team,
p.000106: the lab rooms scheme, the traceability of the Es cell lines See décret n°2006-121 du 6 février 2006
p.000106:
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p.000107:
p.000107: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000107: embryo donation for research, if so could you please describe them?
p.000107: Yes
p.000107: The law does ask to document the origin of the cell line and to provide the consent form model : both parents should
p.000107: have signed for the use of the embryo for research,
p.000107:
p.000107: 9 Is financial inducement allowed? If so, in what terms?
p.000107:
p.000107: No
p.000107: The authority in charge of giving licences does not provide funds for research on those topics.
p.000107:
p.000107: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000107: Yes
p.000107:
p.000107: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000107: publications)?
p.000107: Yes, they are asked for every licence given, a yearly progress report is asked, and a final report.
p.000107:
p.000107: 12 How is patenting of hESC lines regulated?
p.000107: Not authorized
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p.000108:
p.000108: Regulatory frame applying to GERMANY
p.000108:
p.000108: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000108: having not a legal personality.
p.000108:
p.000108: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000108: to get the texts would be welcomed).
p.000108: 1) Act for the Protection of Embryos (Embryo Protection Act),
p.000108: Gesetz zum Schutz von Embryonen (Embryonenschutzgesetz – EschG)
p.000108: http://bundesrecht.juris.de/eschg/BJNR027460990.html,
p.000108:
p.000108: 2) Act ensuring protection of embryos in connection with the importation and utilisation of human embryonic stem cells
p.000108: (Stem Cell Act), Gesetz zur Sicherstellung des Embryonenschutzes im Zusammenhang mit Einfuhr und Verwendung
p.000108: menschlicher embryonaler Stammzellen (Stammzellgesetz – StZG)
p.000108: http://bundesrecht.juris.de/stzg/index.html
p.000108:
p.000108: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000108: For the purpose of the Embryo Protection Act, an embryo means a fertilised human egg capable of developing from the
p.000108: time of fusion of the nuclei, and further each totipotent cell removed from an embryo that is capable of dividing and
p.000108: developing into an individual human being if the necessary conditions prevail. (ESchG §8 (1)).
p.000108:
p.000108: For the Stem Cell Act embryo means any human totipotent cell which has the potential to divide and to develop into a
p.000108: human being if the necessary conditions prevail (StZG §3 (4)).
p.000108: 3 Is hESC research allowed and in what terms and conditions?
p.000108: According to the Embryo Protection Act the production of hESCs is forbidden. The Stem Cell Act ensures the protection
p.000108: of embryos in connection with the importation and utilisation of human embryonic stem cells. hESC research is only
p.000108: permitted using cell lines created before 1 January 2002 in the country of origin in accordance with relevant national
p.000108: legislation there and kept in culture or subsequently stored using cryopreservation methods. The embryos from which
p.000108: they were derived must have been produced by medically-assisted in vitro fertilisation in order to induce pregnancy and
p.000108: definitely no longer used for this purpose and no evidence that this was due to reasons inherent in the embryos
p.000108: themselves. No compensation or other benefit in money’s worth may have been granted or promised for the donation of
p.000108: embryos for the purpose of stem cell derivation.
p.000108: 4 If yes, which body is in charge of the approval of hESC research (ethics review)? The Central Ethics
p.000108: Committee for Stem Cell Research at the Robert Koch Institute (RKI) is in charge of the approval of applications to
p.000108: import hESCs.
p.000108:
p.000108: The RKI is the federal institution responsible for disease control and prevention and the central federal reference
p.000108: institution for applied and response-orientated research as well as for the Public Health Sector.
p.000108: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000108: yes at what conditions?
p.000108: The creation of embryos for research purposes is forbidden in Germany.
p.000108: 6 Is the source of hESC used in research traceable and well documented?
p.000108: Information on the requested NIH embryonic stem cell lines for the project is registered by the competent agency, the
p.000108: Robert Koch Institute, in a publicly accessible registry on their website
p.000108:
p.000108:
p.000108:
p.000108:
p.000109: 109
p.000109:
p.000109:
p.000109:
p.000109: (http://www.rki.de/cln_049/nn_207250/DE/Content/Gesund/Stammzellen/Register/reg- 20060725-IBMT.html).
p.000109: 7 What are the formal ethical and legal requirements for hESC research approval? The hESC research has to
p.000109: serve eminent research aims to generate scientific knowledge in basic research or to increase medical knowledge for the
p.000109: development of diagnostic, preventive or therapeutic methods to be applied to humans and according to the
p.000109: state-of-the-art of science and technology. Firstly the questions to be studied in the research project concerned must
p.000109: been clarified as far as possible through in vitro models using animal cells or through animal experiments and secondly
p.000109: the scientific knowledge to be obtained from the research project concerned cannot be expected to be gained by using
p.000109: cells other than embryonic stem cells.
p.000109:
p.000109: Any importation and any utilisation of embryonic stem cells has to be subject to approval by the stem cell ethics
p.000109: committee for stem cell research at the Robert Koch Institute. Applications for approval must be submitted in writing.
p.000109: In the documents accompanying the application, the applicant shall provide the following information in particular:
p.000109: 1. Name and official address of the person responsible for the research project concerned, 2. a description of the
p.000109: research project including scientific reasons showing that the research project meets the requirements described,3. a
p.000109: documentation concerning the embryonic stem cells to be imported or used showing that the requirements have been
p.000109: complied with equivalent evidence.
p.000109:
p.000109: The embryonic stem cells to be imported or used must be identical with those registered in a scientifically recognized,
p.000109: publicly accessible registry maintained by government agencies or agencies authorized by the government.
p.000109: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000109: embryo donation for research, if so could you please describe them?
p.000109: n/a
p.000109: 9 Is financial inducement allowed? If so, in what terms?
p.000109:
p.000109: For the stem cell lines to be imported no compensation or other benefit in money’s worth may have been granted for the
p.000109: donation of embryos for the purpose of stem cell derivation.
p.000109:
p.000109: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000109: Ad hoc data protection provisions are not mentioned in the Stem Cell Act.
p.000109:
p.000109: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000109: publications)?
p.000109: An obligation for publication is not mentioned in the Stem Cell Act.
p.000109:
p.000109: 12 How is patenting of hESC lines regulated?
p.000109: The Biotechnology Patenting Directive (98/44/EC) negotiated by the European Parliament and the European Council on 6
p.000109: July 1998 provides a uniform procedure for the patenting of biotechnological inventions in all EU Member States.
p.000109:
p.000109: In December 2004 Germany implemented the Biotechnology Patenting Directive and enacted the law 28 February 2005 (Gesetz
p.000109: zur Umsetzung der Richtlinie über den rechtlichen Schutz biotechnologischer Erfindungen (BioPatG), Act Implementing the
p.000109: Directive on the Legal Protection of Biotechnological Inventions in Germany).
p.000109: In December 2006 the German Federal Patent Court partially reversed their 1999 decision on Professor Oliver Brüstle’s
p.000109: patent, saying that anything made from human tissue cannot be patented.
p.000109:
p.000109:
p.000109:
p.000109:
p.000110: 110
p.000110:
p.000110:
p.000110:
p.000110: Regulatory frame applying to GREECE
p.000110:
p.000110: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000110: having not a legal personality.
p.000110:
p.000110: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where to get
p.000110: the texts would be welcomed).
p.000110:
p.000110: - Article 1459 c of the Civil Code (Act n. 3089/2002)
p.000110: - Article 11 par. 1 (e) of the Act n. 3305/2005 (“Application of M.A.R.)
p.000110: -
p.000110: - http://www.bioethics.gr/media/pdf/biolaw/human/law_3089_en.pdf?PHPSESSID=c730 cd74d93449cca3750bb51c50a228
p.000110:
p.000110:
p.000110:
p.000110: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000110:
p.000110: Yes, (article 3 of the Act n. 3305/2005, for the terms ‘zygote’ and ‘fertilized egg’
p.000110:
p.000110: ‘Zygote’: an ovum from its fertilisation until the merger of the two haploid nuclei
p.000110: “Fertilized egg’: an ovum after the penetration or initiation of sperm
p.000110:
p.000110:
p.000110: 3 Is hESC research allowed and in what terms and conditions?
p.000110: Yes.
p.000110: Under certain conditions:
p.000110: - Only on surplus embryos (up to the 14th day after fertilisation)
p.000110: - Prior written informed consent of the donors
p.000110: - Prior approval of the protocol (from the National Authority on M.A.R.)
p.000110: - Prior research on laboratory animals (if possible)
p.000110: - The research team should possess the necessary equipment and know-how
p.000110: - It is not allowed to implant the embryos that have been used
p.000110:
p.000110: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000110:
p.000110: The National Authority on Medically Assisted Reproduction (an independent regulatory agent, nominated by the
p.000110: Parliament)
p.000110:
p.000110:
p.000110: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if yes at
p.000110: what conditions?
p.000110:
p.000110: No
p.000110:
p.000110: 6 Is the source of hESC used in research traceable and well documented?
p.000110:
p.000110: Yes
p.000110:
p.000110:
p.000110:
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p.000111: 111
p.000111:
p.000111:
p.000111:
p.000111:
p.000111: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000111:
p.000111: See above (3)
p.000111:
p.000111: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in embryo
p.000111: donation for research, if so could you please describe them?
p.000111:
p.000111: See above (3)
p.000111:
p.000111: 9 Is financial inducement allowed? If so, in what terms?
p.000111:
p.000111: No (only compensation for justifiable expenses, medical services or undue damages is allowed)
p.000111:
p.000111: 1 Are ad hoc data protection provisions be defined for hESC research? 0
p.000111: No. The law on sensitive data protection (Act n. 2472/1997) is applicable, binding the research team.
p.000111: The Data Protection Authority is responsible for relevant controls.
p.000111:
p.000111:
p.000111: 1 Are data deriving from hESC projects necessarily provided, whether positive or
p.000111: 1 negative (in form of publications)?
p.000111:
p.000111: No
p.000111:
p.000111: 1 How is patenting of hESC lines regulated? 2
p.000111: By the presidential decree n. 321/2001 (on the Directive 98/44/EC)
p.000111:
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p.000112: 112
p.000112:
p.000112:
p.000112:
p.000112: Regulatory frame applying to HUNGARY
p.000112:
p.000112: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000112: to get the texts would be welcomed).
p.000112:
p.000112: The human embryonic stem cells research and use is regulated by law and five decrees.
p.000112: The 1997. CLIV. law about the health regulated the general conditions of the use and research of the human embryonic
p.000112: stem cells (180- 182 paragraphs.(
p.000112: The 2006 CXV. law about the health reform.
p.000112: The 21/1998. (VI.3.) MH decree contains the minimum conditions of the use of human embryonic stem cells ( 15/B
p.000112: attachment).
p.000112: The 22/1998. (VI.3.) MH decree contains the detailed regulation of the transplantation of different organs and tissues.
p.000112: The 31/1998. (VI.24.) MH decree regulated the ethical approval system of biomedical research.
p.000112: The 22/2002. (V.9.) MH decree regulated the ethical approval system of biomedical research.
p.000112: The 1/2007. (I.24.) MH decree regulated the ethical approval system of biomedical research.
p.000112:
p.000112: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000112:
p.000112: embryo is defined as every living human embryo following the completion of fertilisation until 12th week of pregnancy.
p.000112: The foetus is the human being developing within the uterus after the 12th week of pregnancy.
p.000112:
p.000112: 3 Is hESC research allowed and in what terms and conditions?
p.000112:
p.000112: Research on embryos can be carried out on the basis of an authorisation of the Hungarian Reproduction Commission.
p.000112: Embryos can only be used for research purposes and experiments can only be made on embryos for the research purposes
p.000112: that the Health Care Act fixes with regard to medical research.
p.000112:
p.000112: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000112:
p.000112: Hungarian Reproduction Commission
p.000112: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000112: yes at what conditions?
p.000112:
p.000112: Embryos cannot be created for research purposes, only embryos created in medically assisted human procreation
p.000112: procedures (MAP) can be used for research and experiments, either on the basis of the decision of those entitled to
p.000112: decide, or in case of damage of the embryo. If an embryo was donated for a MAP procedure, but not used within 10 years
p.000112: following the donation, the embryo can be used for research purposes.
p.000112:
p.000112: 6 Is the source of hESC used in research traceable and well documented?
p.000112:
p.000112: The source of the hESC is traceable and well documented in every cases.
p.000112:
p.000112: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000112:
p.000112: The formal ethical and legal requirements for hESC research approval are regulated in the 1/2007. (I.24.) MH decree.
p.000112: The decree accepted the EC recommendations.
p.000112:
p.000112: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000112: embryo donation for research, if so could you please describe them?
p.000113: 113
p.000113:
p.000113:
p.000113:
p.000113:
p.000113: There is no embryo donation for research.
p.000113:
p.000113: 9 Is financial inducement allowed? If so, in what terms?
p.000113:
p.000113:
p.000113:
p.000113: Financial inducement is not allowed.
p.000113:
p.000113: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000113:
p.000113: Data protection is according to EU regulations.
p.000113:
p.000113: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000113: publications)?
p.000113: It is not.
p.000113: 12 How is patenting of hESC lines regulated?
p.000113: Patenting of hESC lines is not regulated.
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p.000113:
p.000114: 114
p.000114:
p.000114:
p.000114:
p.000114: Regulatory frame applying to IRELAND
p.000114:
p.000114: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000114: having not a legal personality.
p.000114:
p.000114: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000114: to get the texts would be welcomed).
p.000114:
p.000114: Ireland currently has no specific legislation dealing with embryonic stem cell research and furthermore does not have a
p.000114: legislative basis for the practice of IVF and therefore has no legislation pertaining to use of embryos
p.000114: (supernumerary or otherwise) for research. The Medical Council’s Guide to Ethical Conduct and Behaviour
p.000114: 6th edition 2004 states that in relation to IVF ‘that any fertilised ovum must be used for normal
p.000114: implantation and must not be deliberately destroyed". They also state ‘the creation of new life forms for
p.000114: experimental purposes or the deliberate and intentional destruction of in-vitro human life already formed is
p.000114: professional misconduct". It should be noted that the Medical Council only regulate physicians and therefore scientists
p.000114: are not bound by the guide, e.g. it would appear that there is currently no legal impediment on importation or use of
p.000114: embryonic stem cells lines by scientists.
p.000114:
p.000114: Following a referendum some years ago, The Irish Constitution was amended and Article 40.3.3 of the
p.000114: Constitution acknowledges the right to life of the unborn. However, no legislation followed this amendment e.g.
p.000114: to articulate what is defined as ‘unborn’, would this include supernumerary embryos in storage etc.
p.000114: This Constitutional Amendment has been interpreted by some to mean that embryonic stem cell research would be
p.000114: prohibited by our constitution. A recent high court judgment (Nov 2006) found that three frozen embryos resulting
p.000114: from IVF are not ‘unborn" as defined under the Constitution. This judgment has been appealed to the Supreme
p.000114: Court.
p.000114: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000114: N/A
p.000114:
p.000114: 3 Is hESC research allowed and in what terms and conditions?
p.000114: There is no legislation prohibiting ESC research in Ireland. It would appear from the Recent High Court Judgement that
p.000114: ESC research is also not prohibited under the Irish Constitution. Further clarification will be forthcoming following a
p.000114: decision from the Supreme Court
p.000114:
p.000114: 4 If yes, which body is in charge of the approval of hESC research (ethics review)? Situation has not
p.000114: arisen to legal uncertainty in this area but it would come under research ethics committee review.
p.000114:
p.000114: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000114: yes at what conditions?
p.000114: No legislation/Regulation in this area.
p.000114:
p.000114: 6 Is the source of hESC used in research traceable and well documented?
p.000114: N/A
p.000114: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000114: N/A
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114:
p.000114:
p.000115: 115
p.000115:
p.000115:
p.000115:
p.000115: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000115: embryo donation for research, if so could you please describe them?
p.000115: N/A
p.000115:
p.000115: 9 Is financial inducement allowed? If so, in what terms?
p.000115:
p.000115: N/A
p.000115:
p.000115: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000115: N/A
p.000115:
p.000115: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000115: publications)?
p.000115: N/A
p.000115:
p.000115: 12 How is patenting of hESC lines regulated?
p.000115: N/A
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p.000116: 116
p.000116:
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p.000116:
p.000116: Regulatory frame applying to ITALY
p.000116:
p.000116:
p.000116: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000116: to get the texts would be welcomed). Italian discipline applying to human embryonic stem cells research consists in Law
p.000116: 19 February 2004, n. 40 (Law 40/2004), on medically assisted reproduction (“Norme in materia di procreazione
p.000116: medicalmente assistita’), published in Gazzetta Ufficiale n. 45, February 24, 2004.
p.000116:
p.000116: 2 Does the regulation provide a definition of 'embryo', if so which one? The law does not provide a
p.000116: definition of ‘embryo’. However, it aims to protect the rights of all the subjects involved in the medical assisted
p.000116: reproduction, included the conceived subject (see Art. 1, No 1, which specifies the scopes of the law).
p.000116:
p.000116: 3 Is hESC research allowed and in what terms and conditions?
p.000116: Art. 13, n. 1, of Law 40/2004 that has regards to the experimentation on human embryos (“Sperimentazione sugli embroni
p.000116: umani’) expressly prohibits any experimentation on human embryos.
p.000116:
p.000116: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000116: See answer No 3.
p.000116:
p.000116: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000116: yes at what conditions? Art. 13, n. 3 a), of Law 40/2004 expressly prohibits the creation of human embryos for research
p.000116: purposes or for experimentation.
p.000116:
p.000116: 6 Is the source of hESC used in research traceable and well documented?
p.000116: See answers No 3 and 5.
p.000116: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000116: See answers No 3 and 5.
p.000116:
p.000116: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000116: embryo donation for research, if so could you please describe them?
p.000116: The donation of embryos for research is not allowed by Italian law.
p.000116:
p.000116: 9 Is financial inducement allowed? If so, in what terms?
p.000116:
p.000116: See answer No 8.
p.000116:
p.000116: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000116: See answers No 3 and 5.
p.000116:
p.000116:
p.000116:
p.000116:
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p.000116:
p.000116:
p.000117: 117
p.000117:
p.000117:
p.000117:
p.000117: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000117: publications)?
p.000117: See answers No 3 and 5.
p.000117:
p.000117:
p.000117: 12 How is patenting of hESC lines regulated?
p.000117: See answers No 3, 5, 8.
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p.000118: 118
p.000118:
p.000118:
p.000118:
p.000118: Regulatory frame applying to LATVIA
p.000118:
p.000118: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000118: having not a legal personality.
p.000118:
p.000118: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000118: to get the texts would be welcomed).
p.000118:
p.000118: It is not regulated by legislation in Latvia
p.000118: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000118: No
p.000118:
p.000118: 3 Is hESC research allowed and in what terms and conditions?
p.000118: It is not prohibited by legislation
p.000118:
p.000118: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000118: Central Medical Ethics Committee
p.000118:
p.000118: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000118: yes at what conditions?
p.000118: It is prohibited by Latvian Reproductive Medicine Act;
p.000118: “The creation of human embryos for research purposes is prohibited.
p.000118:
p.000118:
p.000118: The human biological material or embryo shall not, as such, give rise to financial gain. ‘
p.000118:
p.000118:
p.000118: 6 Is the source of hESC used in research traceable and well documented?
p.000118: We have no experience
p.000118: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000118:
p.000118: It is not regulated by legislation
p.000118: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000118: embryo donation for research, if so could you please describe them?
p.000118:
p.000118: It is not regulated by legislation
p.000118: 9 Is financial inducement allowed? If so, in what terms?
p.000118:
p.000118: It is not regulated by legislation
p.000118:
p.000118: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000118: It is regulated for any research
p.000118: Law on Data Protection
p.000118: Personal data processing is permitted only if not prescribed otherwise by law, and at least one of the
p.000118: following conditions exist:
p.000118: 1) the data subject has given his or her consent;
p.000118:
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p.000119: 119
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...
p.000119: subject, exercise lawful interests of the system controller or of such third person as the personal data have been
p.000119: disclosed to.
p.000119:
p.000119:
p.000119:
p.000119: The processing of sensitive personal data is prohibited, except in cases where:
p.000119:
p.000119: 1) the data subject has given his or her written consent for the processing of his or her sensitive personal data;
p.000119: 2) special processing of personal data, without requesting the consent of the data subject, is provided for by
p.000119: regulatory enactments which regulate
p.000119:
p.000119: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000119: publications)?
p.000119: Yes, but it is not regulated by legislation.
p.000119:
p.000119:
p.000119: 12 How is patenting of hESC lines regulated?
p.000119: It is not regulated
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p.000120: 120
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p.000120: Regulatory frame applying to LITHUANIA
p.000120:
p.000120:
p.000120: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000120: having not a legal personality.
p.000120:
p.000120: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000120: to get the texts would be welcomed).
p.000120: As for today (16 March, 2007) embryonic stem cell research has not been specifically addressed in the law. However,
p.000120: Lithuanian Law on Ethics of Biomedical Research allows only observational studies on human embryo, all other research
p.000120: activities on human embryo are prohibited (Article 3, Paragraph 2;
p.000120: http://www3.lrs.lt/pls/inter2/dokpaieska.showdoc_l?p_id=148740)
p.000120: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000120: As for today (16 March, 2007) the regulation does not provide a definition of embryo
p.000120:
p.000120: 3 Is hESC research allowed and in what terms and conditions?
p.000120: hESC would not be allowed in the country because Lithuanian Law on Ethics of Biomedical Research allows only
p.000120: observational studies on human embryo, all other research activities on human embryo are prohibited.
p.000120:
p.000120: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000120: NA
p.000120:
p.000120: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000120: yes at what conditions?
p.000120: The creation of human embryos is prohibited by the law (Law on Ethics of Biomedical Research, Article 3, Paragraph 2)
p.000120:
p.000120: 6 Is the source of hESC used in research traceable and well documented?
p.000120: NA
p.000120: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000120: NA
p.000120:
p.000120: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000120: embryo donation for research, if so could you please describe them?
p.000120: NA
p.000120:
p.000120: 9 Is financial inducement allowed? If so, in what terms?
p.000120:
p.000120: NA
p.000120:
p.000120: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000120: NA
p.000120:
p.000120: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000120: publications)?
p.000120: NA
p.000120:
p.000120: 12 How is patenting of hESC lines regulated?
p.000120: NA
p.000120:
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p.000121: 121
p.000121:
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p.000121:
p.000121:
p.000121: Regulatory frame applying to GRAND-DUCHÉ DE LUXEMBOURG
p.000121: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000121: having not a legal personality.
p.000121:
p.000121: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000121: to get the texts would be welcomed).
p.000121: There is, at present, no legal or regulatory framework for human embryonic stem cells research in Luxembourg. However,
p.000121: a new law is under preparation:
p.000121:
p.000121: Projet de loi 5528/00 portant approbation:
p.000121: — de la convention pour la protection des droits de l’homme et de la dignité de l’être humain à l’égard des
p.000121: applications de la biologie et de la médecine: convention sur les droits de l’homme et la biomédecine, ouverte à la
p.000121: signature, à Oviedo, le 4 avril 1997;
p.000121: — du protocole additionnel à la convention pour la protection des droits de l’homme et de la dignité de l’être
p.000121: humain à l’égard des applications de la biologie et de la médecine, portant interdiction du clonage d’êtres humains,
p.000121: ouvert à la signature, à Paris, le 12 janvier 1998;
p.000121: — du protocole additionnel à la convention sur les droits de l’homme et la biomédecine relatif à la transplantation
p.000121: d’organes et de tissus d’origine humaine, ouvert à la signature, à Strasbourg, le 24janvier 2002;
p.000121: — du protocole additionnel à la convention sur les droits de l’homme et la biomédecine, relatif à la recherche
p.000121: biomédicale, ouvert à la signature, à Strasbourg, le 25 janvier 2005,
p.000121: et modifiant la loi du 25 novembre 1982 réglant le prélèvement de substances d’origine humaine.
p.000121:
p.000121: 2 Does the regulation provide a definition of ‘embryo’, if so which one?
p.000121: No definition of ‘embryo’ is provided in the draft law.
p.000121: 3 Is hESC research allowed and in what terms and conditions?
p.000121: No human embryonic stem cells research is being done in Luxembourg at this time.
p.000121: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000121: n/a
p.000121: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000121: yes at what conditions?
p.000121: n/a
p.000121: The draft law mentioned above doesn’t allow research on human embryos in vitro
p.000121: (article 6).
p.000121: 6 Is the source of hESC used in research traceable and well documented?
p.000121: n/a
p.000121: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000121: n/a
p.000121: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000121: embryo donation for research, if so could you please describe them?
p.000121: n/a
p.000121:
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p.000122: 122
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p.000122: 9 Is financial inducement allowed? If so, in what terms?
p.000122:
p.000122: n/a
p.000122: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000122: n/a
p.000122: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000122: publications)?
p.000122: n/a
p.000122: 12 How is patenting of hESC lines regulated?
p.000122: n/a
p.000122: However, ‘the use of human embryos for industrial and commercial purposes is not patentable.’
p.000122: («les utilisations d’embryons humains à des fins industrielles ou commerciales ne sont pas brevetables»), article 5,
p.000122: loi du 7 avril 2006 modifiant la loi modifiée du 20 juillet 1992 portant modification du régime des brevets
p.000122: d’invention.
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p.000123: 123
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p.000123:
p.000123: Regulatory frame applying to MALTA
p.000123:
p.000123: Currently there is no Embryonic Stem Cell or other embryonic regulation at all in Malta.
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p.000124: 124
p.000124:
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p.000124:
p.000124: Regulatory frame applying to NETHERLANDS
p.000124:
p.000124: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000124: having not a legal personality.
p.000124:
p.000124: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where to get
p.000124: the texts would be welcomed).
p.000124:
p.000124: The Dutch ‘Act containing rules relating to the use of human gametes and embryos’ (Embryos Act) came into force on
p.000124: September 1th 2002. A translation can be found at: http://www.minvws.nl/en/folders/ibe/2002/introduction-embryo-act.asp
p.000124: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000124: Embryos Act, Section 1:
p.000124: In this Act the following words shall have the following meanings: (….)
p.000124: c. embryo: a cell or a complex of cells with the capacity to develop into a human being; (…)
p.000124: This definition is criticised as being too narrow (excluding non-viable embryos). Cf:
p.000124: -Health Council of the Netherlands: Embryonic stem cells without moral pain? (2005). Translated report:
p.000124: http://www.gr.nl/pdf.php?ID=1270&p=1
p.000124: -Report of the recent evaluation of the Embryos Act (2006). Translated summary:
p.000124: http://www.zonmw.nl/fileadmin/cm/vraagsturing/documenten/Evaluatie_regelgeving/embryos_ act_en_sum.pdf
p.000124: 3 Is hESC research allowed and in what terms and conditions?
p.000124:
p.000124:
p.000124: hESC research is allowed. There are no special conditions for hESC research using existing stem cell lines. hESC
p.000124: involving the use of human embryos is subjected to the general conditions for research using human embryos set in the
p.000124: Embryos Act (including the moratorium regarding the creation of embryos for other purposes than pregnancy; cf sub
p.000124: question 5).
p.000124:
p.000124: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000124:
p.000124: Only hESC research involving the use of human embryos requires special approval. The Central Committee on Research
p.000124: Involving Human Subjects and Embryo Research (CCMO) is in charge of this. Website: www.ccmo.nl The head of the bureau
p.000124: of the national review committee (CCMO) is dr. Marcel Kenter; e-mail ccmo@ccmo.nl Tel +31 70 3406700.
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p.000125: 125
p.000125:
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p.000125:
p.000125: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if yes at
p.000125: what conditions?
p.000125:
p.000125: The Embryos Act prohibits the creation of embryos for purposes other than reproduction (section 24a). This also applies
p.000125: to ‘therapeutic cloning’ using human stem cells. However, the Act also contains the provision that this ban shall lapse
p.000125: on a date to be determined within five years after the coming into force of the Act (i.e. before September 2007), thus
p.000125: effectively turning the ban into a moratorium (section 33 sub 2). The Act already contains provisions for the handling
p.000125: of embryos created for purposes other than reproduction which would come into force after the lifting of the ban
p.000125: (sections 9 and 11). Section 11 limits the types of research for which embryos may then be created to 1) research which
p.000125: is reasonably likely to lead to new insights in the fields of infertility, 2) artificial reproduction techniques, 3)
p.000125: hereditary or congenital diseases or 4) transplant medicine.
p.000125:
p.000125: This complex construction was chosen in order to allow for making a reservation to Article 18 of the European
p.000125: Convention on Human Rights and Biomedicine (forbidding the creation of embryos for research purposes) when ratifying
p.000125: that Convention (as the Netherlands intends to do).
p.000125:
p.000125: The report of the recent evaluation of the Embryos Act (2006) has called for a swift end to the present moratorium on
p.000125: creating embryos for other purposes than pregnancy. Translated summary of report:
p.000125: http://www.zonmw.nl/fileadmin/cm/vraagsturing/documenten/Evaluatie_regelgeving/embryos_ act_en_sum.pdf
p.000125:
p.000125: However, the new government coalition formed early 2007 (Labour & two Christian Democrat parties) has announced its
p.000125: intention to maintain the current ban (possibly in the form of extending the moratorium for some further years). No
p.000125: formal decision about this has as yet been taken.
p.000125:
p.000125: 6 Is the source of hESC used in research traceable and well documented?
p.000125: No special regulations
p.000125:
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p.000125:
p.000126: 126
p.000126:
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p.000126:
p.000126: 9 Is financial inducement allowed? If so, in what terms?
p.000126:
p.000126:
p.000126: No, cf question 8: embryos may only be donated ‘without consideration’. The same holds for the donation of gametes. In
p.000126: practice, a remuneration of expenses is accepted.
p.000126: The report of the recent evaluation of the Embryos Act (2006) contains the recommendation to further debate the
p.000126: desirability/acceptability of a larger recompensation for women donating oocytes for research. Cf summary of report:
p.000126: http://www.zonmw.nl/fileadmin/cm/vraagsturing/documenten/Evaluatie_regelgeving/embryos_ act_en_sum.pdf
p.000126:
p.000126: 1 Are ad hoc data protection provisions be defined for hESC research? 0
p.000126: No special regulations
p.000126:
p.000126: 1 Are data deriving from hESC projects necessarily provided, whether positive or
p.000126: 1 negative (in form of publications)?
p.000126:
p.000126: No special regulations
p.000126:
p.000126: 1 How is patenting of hESC lines regulated? 2
p.000126: No special regulations
p.000126:
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p.000127: 127
p.000127:
p.000127:
p.000127:
p.000127: Regulatory frame applying to POLAND
p.000127:
p.000127: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000127: to get the texts would be welcomed).
p.000127: In Poland there is no research on embryonic stem cells.
p.000127:
p.000127: Polish legal rules do not include distinct regulations for human embryonic stem cells research. There is also no legal
p.000127: definition for embryo stage of life.
p.000127: The fundamental legal act in Poland is the Constitution of the Republic of Poland
p.000127: (http://www.sejm.gov.pl/prawo/konst/angielski/kon1.htm), which was passed by the National Assembly on April 2nd, 1997.
p.000127: In accordance with Art.38 of this Law the Republic of Poland shall ensure the legal protection of the life of every
p.000127: human being Regulations referring to legal protection and conduct rules in the pre-birth stage of human life are
p.000127: included in the Act of January 7th, 1993 on Family Planning, Protection of Human Foetus and Admissible Conditions for
p.000127: an Abortion.
p.000127: In accordance with Art.1 of this Law, the right to life is protected, including also the prenatal stage, in the scope
p.000127: stipulated by the Law. The Law also includes regulations concerning the conceived child that is from the moment of
p.000127: conception through the embryo and foetal stages until birth.
p.000127: According to Art.157a of the Criminal Code any person except for child’s mother who commits any infringement to a
p.000127: conceived child, will be punished. The rule does not include a physician who undertakes medical action necessary to
p.000127: exclude danger- threatening mother’s or child’s health or life.
p.000127: What’s more, under the Act of December 5th, 1996 on Medical Profession’s, human embryos (conceived children) may not be
p.000127: used for therapeutic research (Art. 26 paragraph 1).
p.000127: Not directly refers to this matter the ruling of the Constitutional Court of the Republic of Poland from the 28th May
p.000127: 1997, which says: ‘A democratic state governed by the rule of law holds man and his most precious weal as a supreme
p.000127: value. By this weal, we understand life which in a democratic state governed by the rule of law must enjoy
p.000127: constitutional protection in each stage of its development’.
p.000127:
p.000127: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000127: As mentioned above, there is no legal definition for embryo stage of life.
p.000127:
p.000127:
p.000127: 3 Is hESC research allowed and in what terms and conditions?
p.000127: In Poland, human embryo research is prohibited.
p.000127:
p.000127: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000127:
p.000127: NA
p.000127: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000127: yes at what conditions?
p.000127: Is not allowed.
p.000127:
p.000127: 6 Is the source of hESC used in research traceable and well documented?
p.000127: NA
p.000127: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000127: NA
p.000127:
p.000127:
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p.000128: 128
p.000128:
p.000128:
p.000128:
p.000128:
p.000128: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000128: embryo donation for research, if so could you please describe them?
p.000128: NA
p.000128:
p.000128: 9 Is financial inducement allowed? If so, in what terms?
p.000128:
p.000128:
p.000128: NA
p.000128: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000128: NA
p.000128:
p.000128: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000128: publications)?
p.000128:
p.000128:
p.000128: 12 How is patenting of hESC lines regulated?
p.000128: NA
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p.000129: 129
p.000129:
p.000129:
p.000129:
p.000129: Regulatory frame applying to PORTUGAL
p.000129:
p.000129: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000129: having not a legal personality.
p.000129:
p.000129: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000129: to get the texts would be welcomed).
p.000129: In Portugal, Law n. 32/2006, of the 26th of July, concerning Medically Assisted Reproduction, addresses hESC research.
p.000129: The text is available on http://www.dre.pt/pdfgratisa5/2006/07/14300.pdf (Portuguese version only)
p.000129: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000129: The Portuguese regulation doesn’t provide a definition of ‘embryo’.
p.000129: 3 Is hESC research allowed and in what terms and conditions?
p.000129: The article n. 9 of the law forbids the deliberate production of human embryos specifically for research purposes.
p.000129: However, scientific hESC research can be allowed provided it is reasonable to expect that the investigation project
p.000129: will benefit mankind. Research must aim:
p.000129: Prevention, diagnosis or therapy on embryos;
p.000129: Perfection of Medically Assisted Reproduction techniques;
p.000129: Creation of stem cell banks for transplantation programs or other therapeutic purposes.
p.000129: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000129: The law n. º 36/2006 created the National Council for Medically Assisted Reproduction, in charge of the approval of the
p.000129: investigation projects for hESC research.
p.000129: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000129: yes at what conditions?
p.000129: As mentioned above, the deliberate production of human embryos specifically for research purposes is forbidden.
p.000129: According to Arts. 9, 24 and 25, IVF techniques must ensure only the necessary number of embryos for the success of the
p.000129: IVF process.
p.000129: Only embryos whit particularly severe genetic anomalies with no conditions to be preserved or implanted, embryos not
p.000129: derived by fertilisation of a human oocyte by human sperm, or those created to enhance the success rate of IVF who
p.000129: became supernumerary and no longer a part of a parental project, can be used for research purposes.
p.000129: 6 Is the source of hESC used in research traceable and well documented?
p.000129: According to Art. 16, personal genetic and health data regarding medically assisted reproduction techniques is
p.000129: regulated by Law n.º 12/2005, of the 26th of January, concerning genetic and health personal information.
p.000129: The text is available on http://www.dre.pt/pdfgratisa5/2005/01/018A00.pdf (Portuguese version only)
p.000129: Further regulation on data documentation, storage and access is being prepared.
p.000129:
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p.000130: 130
p.000130:
p.000130:
p.000130:
p.000130:
p.000130: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000130: The regulation of the conditions under which the investigation projects will be evaluated is being prepared.
p.000130: However, in Art. 9º the actual law still requires that scientific hESC research is made for prevention, diagnosis or
...
p.000130:
p.000130: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000130: This regulation is being prepared.
p.000130: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000130: publications)?
p.000130: At this time, there is no knowledge of research involving human embryos being made in Portugal.
p.000130: The regulatory framework under which the investigation projects will be made is being prepared.
p.000130: 12 How is patenting of hESC lines regulated?
p.000130: By the Decree-Law n.º 36/2003, of the 5th of March, Portugal transposed the Directive 98/44/CE of the European
p.000130: Parliament and the Council of the 6th of July, regarding the legal protection of biotechnological inventions.
p.000130: Art. 53º of this decree-law states that the use of human embryos for industrial or commercial purposes, as well as the
p.000130: human body, in his various stages of development or by the mere discovery of one of his elements, aren’t patentable.
p.000130: The text is available on
p.000130: http://www.dre.pt/pdfgratisa5/2003/03/054A00.pdf (Portuguese version only)
p.000130:
p.000130:
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p.000130:
p.000131: 131
p.000131:
p.000131:
p.000131:
p.000131: Regulatory frame applying to ROMANIA
p.000131:
p.000131: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000131: having not a legal personality.
p.000131:
p.000131: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000131: to get the texts would be welcomed).
p.000131: In Romania there is no specific regulation applying to hESC.
p.000131: In the field of research on hESC the following general regulation could be applied:
p.000131: 1. Law 206/2004 regarding good conduct in scientific research, technological development and innovation, www.cdep.ro
p.000131: 2. Law 17/2001 regarding the ratification of Oviedo Convention, www.cdep.ro
p.000131: 3. Law 95/2006 regarding the reform in health care system, www.cdep.ro
p.000131: 4. The Code of Deontology for Physicians of the Romanian College of Physicians, www.cmr.ro
p.000131:
p.000131:
p.000131: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000131: No Romanian law provides a definition of ‘embryo’.
p.000131:
p.000131: 3 Is hESC research allowed and in what terms and conditions?
p.000131: There is no specific legal provision to forbid hESC research.
p.000131:
p.000131: 4 If yes, which body is in charge of the approval of hESC research (ethics review)? Ethics commissions
p.000131: organized according to law 206/2004 (art.12) must supervise the research projects in order to respect the protection of
p.000131: human being, including the protection of human embryos
p.000131:
p.000131: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000131: yes at what conditions?
p.000131: No
p.000131:
p.000131: 6 Is the source of hESC used in research traceable and well documented?
p.000131: No
p.000131: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000131: There are not specific formal ethical and legal requirements for hESC research approval
p.000131:
p.000131: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000131: embryo donation for research, if so could you please describe them?
p.000131: In such situations the general legislation mentioned in point 1 could be applied.
p.000131:
p.000131: 9 Is financial inducement allowed? If so, in what terms?
p.000131:
p.000131: The financial inducement is not allowed according to law 95/2006, title VI- organ and tissue donation must be purely
p.000131: altruistic
p.000131:
p.000131:
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p.000131:
p.000132: 132
p.000132:
p.000132:
p.000132:
p.000132:
p.000132: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000132: There are not specific provisions for ad hoc data protection in hESC research. There are general laws regarding
p.000132: personal data protection:
p.000132: 1. Law 667/2001, www.cdep.ro
p.000132:
p.000132: 2. Law 676/2001, www.cdep.ro
p.000132:
p.000132:
p.000132: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000132: publications)?
p.000132: I do not have such information
p.000132:
p.000132: 12 How is patenting of hESC lines regulated?
p.000132: I do not have certain information regarding this issue. I do not think that in Romania there are specific provisions
p.000132: regarding this issue
p.000132:
p.000132:
p.000132:
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p.000132:
p.000133: 133
p.000133:
p.000133:
p.000133:
p.000133: Regulatory frame applying to: SLOVAK REPUBLIC
p.000133:
p.000133: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000133: having not a legal personality.
p.000133:
p.000133: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000133: to get the texts would be welcomed).
p.000133: No specific regulations exist at present. There is an extensive governmental regulation in preparation, however, to
p.000133: deal with the ‘donation, procurement, testing and distribution of organs, tissues and cells, and processing,
p.000133: conservation and storage of tissues and cells’ (transposition of the requirements of the Dir. 2006/17/EC, ev. Dir.
p.000133: 2004/23/EC). It could tackle on some closely related issues, but probably not specifically on hESCs.
p.000133: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000133: N.A. (non-applicable)
p.000133: 3 Is hESC research allowed and in what terms and conditions?
p.000133: hESC research is not specifically prohibited by a law, however, according to the position the Slovak Republic (SR) has
p.000133: taken so far on the issue, it probably would not be allowed to take place in the country (as destroying of a human
p.000133: embryo is necessary to obtain the hESCs lines for research).
p.000133: The ‘non-therapeutic’ research on human embryo and fetus, as well as human cloning are prohibited both by the SR’s
p.000133: health law (law No. 576/2004 Coll. as later amended) and by SR’s Penal Code (law No. 300/2005 Coll.) – making both a
p.000133: criminal offence.
p.000133: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000133: N.A. (non-applicable)
p.000133: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000133: yes at what conditions?
p.000133: NO, it is prohibited as a criminal act (see 3, above).
p.000133:
p.000133: 6 Is the source of hESC used in research traceable and well documented?
p.000133: N.A. (non-applicable)
p.000133: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000133: N.A. (non-applicable)
p.000133:
p.000133: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000133: embryo donation for research, if so could you please describe them?
p.000133: N.A. (non-applicable)
p.000133:
p.000133: 9 Is financial inducement allowed? If so, in what terms?
p.000133:
p.000133: N.A. (non-applicable)
p.000133: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000133: N.A. (non-applicable)
p.000133:
p.000133: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000133: publications)?
p.000133: N.A. (non-applicable)
p.000133:
p.000133: 12 How is patenting of hESC lines regulated?
p.000133: N.A. (non-applicable)
p.000133:
p.000133:
p.000133:
p.000133:
p.000133:
p.000133:
p.000134: 134
p.000134:
p.000134:
p.000134:
p.000134: Regulatory frame applying to SLOVENIA
p.000134:
p.000134: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000134: having not a legal personality.
p.000134:
p.000134: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000134: to get the texts would be welcomed).
p.000134: Explicit legal regulation on hESC does not exist. However, the Law on treatment of infertility and biomedically
p.000134: assisted fertilisation (Zakon o zdravljenju neplodnosti in postopkih oploditve z biomedicinsko pomocjo, /ZZNPOB/ 3307,
p.000134: Uradni list Republike Slovenije 70/2000, 8. 8. 2000, UL ONLINE) contains provisions that apply to research on embryos
p.000134: from IVF procedures and may apply to procurement of hESC.
p.000134: Web address (Ministry of Health): http://www.mz.gov.si
p.000134: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000134: Article 4: The embryo is created by fertilisation of the ovum. For the purposes of this Law, the early embryo is a
p.000134: zygote or an embryo that has developed outside the uterus for less than 14 days or until the appearance of the
p.000134: primitive streak.
p.000134:
p.000134:
p.000134: 3 Is hESC research allowed and in what terms and conditions?
p.000134: As said above, research on hESC is not specifically regulated.
p.000134:
p.000134: Slovenia is party to the Oviedo Convention and the protocol on prohibition of human cloning. Its Law on treatment of
p.000134: infertility and biomedically assisted fertilisation forbids the creation of human embryos for research, the production
p.000134: of cloned embryos and the use of in vitro fertilisation for any purpose other that birth of a child. Also prohibited is
...
p.000134: cannot be done on animal embryos or otherwise with comparable efficiency. Early embryos may only be used for research
p.000134: after a written informed consent has been obtained for their parents who had undergone medically assisted reproduction.
p.000134: The research must be authorised by the National Commission for Assisted Reproduction and must be approved and
p.000134: supervised by the National Medical Ethics Committee (NMEC). Permission may be granted for embryos that, according to
p.000134: medical knowledge, are not suitable to be transferred into woman’s body or for storage, or would have to be left to
p.000134: perish according to the Article 35 of the Law (end of the maximum storage period). In research on embryos, current
p.000134: medical knowledge, experience, established practices and principles of general medical ethics must be taken into
p.000134: account.
p.000134:
p.000134:
p.000134:
p.000134:
p.000134:
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p.000134:
p.000134:
p.000135: 135
p.000135:
p.000135:
p.000135:
p.000135:
p.000135: 4 If yes, which body is in charge of the approval of hESC research (ethics review)? The National Medical
p.000135: Ethics Committee, after authorisation has been obtained from the National Commission for Assisted Reproduction.
p.000135:
p.000135: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000135: yes at what conditions?
p.000135: No.
p.000135:
p.000135: 6 Is the source of hESC used in research traceable and well documented?
p.000135: Traceability and full documentation of biological materials of human origin is legally required.
p.000135:
p.000135: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000135: Full compliance with the law (see answer to Q 3).
p.000135:
p.000135: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000135: embryo donation for research, if so could you please describe them?
p.000135: The regulatory framework (the Law on treatment of infertility and biomedically assisted fertilisation does not provide
p.000135: for any specific rules, except that written informed consent must be obtained from both partners.
p.000135: 9 Is financial inducement allowed? If so, in what terms?
p.000135:
p.000135: All financial inducement is strictly forbidden.
p.000135:
p.000135:
p.000135: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000135: This Q is slightly difficult to understand (syntactic error?). Until now, the National Medical Ethics
p.000135: Committee has received only one application for approval of a study on hESC derived from embryos and has approved
p.000135: harvesting hESC from nonviable embryos from in vitro fertilisation procedures.
p.000135: The usual rules of confidentiality and data protection apply.
p.000135: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000135: publications)?
p.000135: Yes. This is among the requirements of the NMEC.
p.000135:
p.000135: 12 How is patenting of hESC lines regulated?
p.000135: Specific regulation does not exist.
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
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p.000135:
p.000135:
p.000135:
p.000136: 136
p.000136:
p.000136:
p.000136:
p.000136: Regulatory frame applying to SPAIN
p.000136:
p.000136: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000136: having not a legal personality.
p.000136:
p.000136: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where to get
p.000136: the texts would be welcomed).
p.000136: Law 14/2006 about Human Assisted Reproduction Techniques (HARTAct):
p.000136: http://www.boe.es/boe/dias/2006/05/27/pdfs/A19947-19956.pdf
p.000136: http://www.boe.es/g/es/bases_datos/doc.php?coleccion=iberlex&id=2006/09292&txtlen=1000 Act of 2007, on Biomedical
p.000136: Research (BMRAct)
p.000136: (It has not been published in the State Official Journal) Other regulations:
p.000136: Research with spare frozen embryos after assisted reproduction techniques:
p.000136: http://www.isciii.es/htdocs/terapia/legislacion/Terapia_RD_2132_2004.pdf Organization of the National Bank of Stem Cell
p.000136: Lines: http://www.boe.es/boe/dias/2006/02/18/pdfs/A06637-06641.pdf
p.000136:
p.000136: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000136: Yes, it does.
p.000136: In the Spanish legislation there are two definitions, on the human pre-embryo and on the human embryo:
p.000136:
p.000136: a) Pre-embryo: the in vitro embryo as constituted by a group of cells derived of the continuous division of the
p.000136: fertilised oocyte until 14 days later (art. 1.2 of HARTAct and art. 3, s, BMRAct)
p.000136:
p.000136: b) Embryo: A step of embryonic development, which includes the time in what the fertilised oocyte is located in the
p.000136: uterus of a woman until the time of the beginning of the step of the formation of organs, it is to say, 56 days after
p.000136: fertilisation occurs, regardless the time during such development could be stopped (art. 3, l, BMRAct).
...
p.000137: the centre that have undertaken each of the processes of assisted reproduction that have generated pre-embryos or have
p.000137: intervened in the obtaining of oocytes.
p.000137: c) The written commitment to supply to the corresponding public authority the data that will permit to identify and
p.000137: know the storage of the cell lines that could be obtained as a consequence of the development of the research.
p.000137: d) The commitment of the free conveyance of line cells that could be obtained in the development of the research, for
p.000137: its use by other researchers.
p.000137: e) When using oocytes or pre-embryos, the indication and justification of its size, origin and the document of the
p.000137: informed consent signed by the donors or progenitors respectively.
p.000137:
p.000137: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000137:
p.000137: A) For researches related with the application and implementation of human assisted reproductive
p.000137: techniques: the National Commission on Assisted Human Reproduction (art. 15.1, d, HARTAct) ‘Comision de Garantías
p.000137: para la Donación y Utilización de Células y Tejidos Humanos’
p.000137:
p.000137: B) For researches related with the gain, implementation and use of hESC lines: the Commission for
p.000137: Establishing Guarantees in the donation and use of human cells and tissues (art. 35 BMRAct)
p.000137:
p.000137: In both cases the previous review by a local Research Ethics Committee is also needed.
p.000137: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if yes at
p.000137: what conditions?
p.000137: The new law explicitly prohibits the creation of pre-embryos and embryos for the exclusive use of research, although it
p.000137: permits the use of any other technique, including nuclear transfer, aimed to obtaining human embryonic stem cells for
p.000137: research or therapy (BMRAct): Article 33 Obtaining of embryonic cells
p.000137: 1. The creation of human pre-embryos and embryos solely for experimentation purposes shall be prohibited.
p.000137: 2. The use of any technique for obtaining human stem cells for therapeutic or research purposes shall be permitted,
p.000137: when it doesn’t entail the creation of a pre-embryo or embryo solely for this purpose, in the terms provided in this
p.000137: Law, including the activation of oocytes through nuclear transfer.
p.000137: A perceptive and favourable previous opinion by the Commission for Establishing
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000138: 138
p.000138:
p.000138:
p.000138:
p.000138: Guarantees in the donation and use of human cells and tissues is needed, as well as the authorisation of the Autonomous
p.000138: Community Authority.
p.000138:
p.000138: 6 Is the source of hESC used in research traceable and well documented?
p.000138: Yes, it is (art. 8 BMRAct).
p.000138:
p.000138: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000138: 1-Informed consents from the parents of all embryos used;
p.000138: 2-approval by the ethical committee of the institution or the autonomous community and
p.000138: 3-approval by the ad hoc ‘Comision de Garantías para la Donación y Utilización de Células y Tejidos Humanos’
p.000138: (See on this previous answer to question Nr 4).
p.000138: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in embryo
p.000138: donation for research, if so could you please describe them?
...
p.000138:
p.000138: Article 5 Protection of personal data and Confidentiality (general provisions on the use of human biological material).
p.000138:
p.000138: Article 53 Genetic analysis on pre-embryos, embryos and foetuses. The results of genetic analysis on per-embryonic,
p.000138: embryonic and foetal material shall be submitted to the principles of data protection and confidentiality established
p.000138: in this Act.
p.000138:
p.000138: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000138: publications)?
p.000138: Yes, they are, although it is not required to be provided in form of publications.
p.000138:
p.000138: 12 How is patenting of hESC lines regulated?
p.000138: In the same conditions as it is at the Directive 98/44/EC, on the legal protection of biological inventions.
p.000138: See the Act 11/1986 of 26 March, on Patent, as modified by Act 10/2002 of 29 April, transposing that Directive.
p.000138: Information provided by Prof. C.M. Romeo-Casabona (Universidad de Deusto, Bilbao) and Dr. Javier Arias (Institut de
p.000138: salud Carlos III, Madrid)
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000139: 139
p.000139:
p.000139:
p.000139:
p.000139: Regulatory frame applying to SWEDEN
p.000139:
p.000139: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000139: having not a legal personality.
p.000139:
p.000139: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000139: to get the texts would be welcomed).
p.000139: The Act (2006:351) on genetic integrity etc.. The Biobanks in Medical Care Act (2002:297)
p.000139: The Act (2003:460) on ethics review of research on humans http://www.epn.se/eng/start/index.aspx
p.000139: The Transplantation Act (1995:831)
p.000139: Guidelines issued by the Swedish Research Council
p.000139: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000139:
p.000139: The word used in Sweden is ‘fertilised egg’. There is a 14 day limit for its use.
p.000139: 3 Is hESC research allowed and under what terms and conditions?
p.000139: Yes. Approval by regional research ethics authority. Consent from both donors.
p.000139:
p.000139: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000139: see above
p.000139:
p.000139: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000139: yes under what conditions?
p.000139: same as 3
p.000139:
p.000139: 6 Is the source of hESC used in research traceable and well documented?
p.000139: Yes
p.000139: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000139: same as 3
p.000139:
p.000139: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000139: embryo donation for research, if so could you please describe them?
p.000139: Consent should be informed. Procedures are reviewed by the Regional Research Ethics Authority.
p.000139:
p.000139: 9 Is financial inducement allowed? If so, on what terms?
p.000139:
p.000139: No. Normally, only reimbursement of costs allowed
p.000139:
p.000139: 10 Are ad hoc data protection provisions defined for hESC research?
p.000139: The Patient Records Act and the Personal Data Act apply
p.000139:
p.000139: 11 Are data deriving from hESC projects necessarily (?) provided, whether positive or negative (in form of
p.000139: publications)?
p.000139: No different from other research
p.000139:
p.000139: 12 How is patenting of hESC lines regulated?
p.000139: Indirectly in the Transplantation Act
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000140: 140
p.000140:
p.000140:
p.000140:
p.000140: Regulatory frame applying to UNITED KINGDOM
p.000140:
p.000140: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000140: having not a legal personality.
p.000140:
p.000140: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000140: to get the texts would be welcomed).
p.000140: The use of embryos to derive hES cell lines is regulated by the Human Fertilisation and Embryology Authority (HFEA) in
p.000140: the UK (www.hfea.gov.uk).
p.000140: The UK Stem Cell Bank Steering Committee also issues guidelines on the use of hES cell lines in the UK
p.000140: (www.ukstemcellbank.org.uk)
p.000140:
p.000140: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000140: The Human Fertilisation and Embryology Act (HF&E Act) 1990 provides that ‘an embryo means a live human embryo where
p.000140: fertilisation is complete, and references to an embryo include an egg in the process of fertilisation, and, for this
p.000140: purpose, fertilisation is not complete until the appearance of a two cell zygote’.
p.000140:
p.000140: 3 Is hESC research allowed and in what terms and conditions?
p.000140: The HFEA regulates the use of embryos to derive hES cell lines. The use of hES cell lines in research is permitted in
p.000140: the UK but is not within the remit of the HFEA.
p.000140:
p.000140: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000140: The HFEA regulates the use of embryos to derive hES cell lines.
p.000140:
p.000140: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000140: yes at what conditions?
p.000140: Yes the creation of embryos for use in research, including the derivation of hES cell lines, is permitted in the UK. An
p.000140: explanation of how the HFEA licences research projects can be found on our website at www.hfea.gov.uk.
p.000140:
p.000140: 6 Is the source of hESC used in research traceable and well documented?
p.000140: Yes
p.000140: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000140: The use of embryos to derive hES cell lines requires a licence from the HFEA.
p.000140: The HFEA has set up a dedicated Research Licence Committee. Under section 9(5) of the 1990 Act, a Licence Committee is
p.000140: required to include at least 1 member who is not authorised to carry on or participate in any activity under the
p.000140: authority of a licence and would not be so authorised if outstanding applications were granted. In addition to this
p.000140: requirement, and in accordance with the recommendations of the Better Regulation Task Force, the Research Licence
p.000140: Committee has a lay chair and a lay majority.
p.000140:
p.000140: In considering whether to grant or renew a licence, the Committee will have access to the following documentation:
p.000140: • Application form signed by the Person Responsible and the Nominal Licensee
p.000140: • Curricula vitae of the principal personnel involved in the research
p.000140: • Approval of a properly constituted local research Ethics Committee,
p.000140: • Report of the inspection of the research centre
p.000140: • Comments from 2 peer reviewers
p.000140: • The centre’s licensing history
...
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p.000003: their contact details by sending a fax to (352) 29 29-42758.
p.000003:
p.000003:
p.000003:
p.000003: The European Group on Ethics in Science and New Technologies to the European Commission
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: Recommendations on the ethical review of hESC FP7 research projects
p.000003:
p.000003: Opinion No 22
p.000003: English original
p.000003: Translations in the EU-27 languages available at:
p.000003: http://ec.europa.eu/european_group_ethics/activities/docs/opinion_22_final_follow_up_en.pdf
p.000003:
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p.000003:
p.000003:
p.000003: 20 June 2007
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p.000003:
p.000003: Europe Direct is a service to help you find answers to your questions about the European Union
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p.000003: Freephone number (*):
p.000003: 00 800 6 7 8 9 10 11
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p.000003:
p.000003: More information on the European Union is available on the Internet (http://europa.eu). Cataloguing data can be found
p.000003: at the end of this publication.
p.000003: Luxembourg: Office for Official Publications of the European Communities, 2007 ISBN 978-92-79-07137-9
p.000003: © European Communities, 2007
p.000003: Reproduction is authorised provided the source is acknowledged.
p.000003:
p.000003: Printed in Italy
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p.000003:
p.000003:
p.000003: Contents
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: SUMMARY
p.000003: 3
p.000003: I. Having regard to
p.000005: 5
p.000005: II. Whereas
p.000012: 12
p.000012: II.1. Preamble
p.000012: 12
p.000012: II.2. The sixth framework programme 13
p.000012: II.3. Human embryonic stem cell (hESC) projects financed under FP6 15
p.000012: II.4. The ethics provisions applying to FP6-funded human embryonic
p.000012: stem cell projects 15
p.000012: II.4.1. FP6 ethics review 15
p.000012: II.4.2. Ethics provisions for FP6 hESC projects 17
p.000012: II.5. The seventh framework programme for research, technological
p.000012: development and demonstration (2007–13) (FP7) 18
...
p.000040: (99) ISSCR guidelines, 11.3–11.3a (http://www.isscr.org/guidelines/).
p.000040: (100) Informed consent must take into account the fact that the materials will be used in the derivation of cells
p.000040: for research: ‘Consent for donation of materials for research should be obtained at the time of proposed transfer of
p.000040: materials to the research team. Only after a rigorous review by a SCRO mechanism or body can permission be granted to
p.000040: use materials for which prior consent exists but for which re-consent is prohibitively difficult.’ (ISSCR,
p.000040: http://www.isscr.org/guidelines/).
p.000040: (101) Article 12, Directive 2004/23/EC: ‘Member States shall endeavour to ensure voluntary and unpaid donations
p.000040: of tissues and cells’.
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000041: 41
p.000041:
p.000041:
p.000041: Researchers must present all the data referred to donors in an anonymous way. The process used to encode the data
p.000041: must be explained and referenced according to relevant provisions (102)(103).
p.000041:
p.000041: IV.2.4. The need for continuous promotion of public governance and science–society dialogue
p.000041:
p.000041: Apart from consent and respect of donors’ rights, hESC research needs appropriate measures to be
p.000041: put in place to promote the public governance and science–society dialogue with regard to its aims, achievements
p.000041: and failures. Adequate means should be established for public access to relevant and comprehensible
p.000041: information on FP7 hESC research to ensure these goals are being continuously fostered and achieved.
p.000041:
p.000041: As the Council has stated, the Commission is supporting the creation of a European Registry for human
p.000041: embryonic stem cell lines. This registry is intended to allow the monitoring of existing hESCs in Europe and to help
p.000041: maximise their use by avoiding unnecessary derivations of new hESC lines.
p.000041:
p.000041: In due time, the registry should ask applicants to provide relevant data on hESCs. The registry will
p.000041: store the data according to scientific and ethical standards to be defined by its newly established Scientific
p.000041: and Ethics Advisory Boards.
p.000041:
p.000041: With regard to the use of the hESC lines banked in the registry, the EGE recommends:
p.000041: • once the registry is operational, after a necessary transitional period, the use of the hESC lines banked in
p.000041: the registry should be in line with the criteria
p.000041:
p.000041: (102) Directive on the protection of personal data (95/46/EC).
p.000041: (103) Council of Europe Bioethics Conventions and additional protocols, Council of Europe Convention for the
p.000041: Protection of Individuals with regard to the Automatic Processing of Personal Data (No 108).
p.000041:
p.000041:
p.000041:
p.000041:
p.000042: 42
p.000042:
p.000042:
p.000042:
p.000042: indicated in IV.2.3. The Commission should develop and actively maintain the necessary means to ensure this requirement
p.000042: is fulfilled;
...
p.000129: Perfection of Medically Assisted Reproduction techniques;
p.000129: Creation of stem cell banks for transplantation programs or other therapeutic purposes.
p.000129: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000129: The law n. º 36/2006 created the National Council for Medically Assisted Reproduction, in charge of the approval of the
p.000129: investigation projects for hESC research.
p.000129: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000129: yes at what conditions?
p.000129: As mentioned above, the deliberate production of human embryos specifically for research purposes is forbidden.
p.000129: According to Arts. 9, 24 and 25, IVF techniques must ensure only the necessary number of embryos for the success of the
p.000129: IVF process.
p.000129: Only embryos whit particularly severe genetic anomalies with no conditions to be preserved or implanted, embryos not
p.000129: derived by fertilisation of a human oocyte by human sperm, or those created to enhance the success rate of IVF who
p.000129: became supernumerary and no longer a part of a parental project, can be used for research purposes.
p.000129: 6 Is the source of hESC used in research traceable and well documented?
p.000129: According to Art. 16, personal genetic and health data regarding medically assisted reproduction techniques is
p.000129: regulated by Law n.º 12/2005, of the 26th of January, concerning genetic and health personal information.
p.000129: The text is available on http://www.dre.pt/pdfgratisa5/2005/01/018A00.pdf (Portuguese version only)
p.000129: Further regulation on data documentation, storage and access is being prepared.
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
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p.000130:
p.000130:
p.000130:
p.000130:
p.000130: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000130: The regulation of the conditions under which the investigation projects will be evaluated is being prepared.
p.000130: However, in Art. 9º the actual law still requires that scientific hESC research is made for prevention, diagnosis or
p.000130: therapy on embryos, for the perfection of Medically Assisted Reproduction techniques or for the creation of stem cell
p.000130: banks for transplantation programs or other therapeutic purposes.
p.000130: Additionally, research can be allowed provided it is reasonable to expect that the investigation project will benefit
p.000130: mankind.
p.000130: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000130: embryo donation for research, if so could you please describe them?
p.000130: According to the present law, the use of supernumerary embryos or of embryos with particularly severe genetic anomalies
p.000130: entails previous informed consent from donors. This consent must also be express, free and conscientious.
p.000130: It is expected that the regulation to further to the law establishes further requirements for consent.
p.000130: 9 Is financial inducement allowed? If so, in what terms?
p.000130:
...
p.000140: the UK but is not within the remit of the HFEA.
p.000140:
p.000140: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000140: The HFEA regulates the use of embryos to derive hES cell lines.
p.000140:
p.000140: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000140: yes at what conditions?
p.000140: Yes the creation of embryos for use in research, including the derivation of hES cell lines, is permitted in the UK. An
p.000140: explanation of how the HFEA licences research projects can be found on our website at www.hfea.gov.uk.
p.000140:
p.000140: 6 Is the source of hESC used in research traceable and well documented?
p.000140: Yes
p.000140: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000140: The use of embryos to derive hES cell lines requires a licence from the HFEA.
p.000140: The HFEA has set up a dedicated Research Licence Committee. Under section 9(5) of the 1990 Act, a Licence Committee is
p.000140: required to include at least 1 member who is not authorised to carry on or participate in any activity under the
p.000140: authority of a licence and would not be so authorised if outstanding applications were granted. In addition to this
p.000140: requirement, and in accordance with the recommendations of the Better Regulation Task Force, the Research Licence
p.000140: Committee has a lay chair and a lay majority.
p.000140:
p.000140: In considering whether to grant or renew a licence, the Committee will have access to the following documentation:
p.000140: • Application form signed by the Person Responsible and the Nominal Licensee
p.000140: • Curricula vitae of the principal personnel involved in the research
p.000140: • Approval of a properly constituted local research Ethics Committee,
p.000140: • Report of the inspection of the research centre
p.000140: • Comments from 2 peer reviewers
p.000140: • The centre’s licensing history
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000141: 141
p.000141:
p.000141:
p.000141:
p.000141: • Copies of relevant publications
p.000141: • Patient Information and Consent Forms
p.000141:
p.000141: Before considering whether it is appropriate to grant or renew a licence the Research Licence Committee has to be
p.000141: satisfied that activities proposed in the licence application are necessary or desirable for one or more of the
p.000141: purposes set out in Schedule 2 to the HF&E Act 1990 (as amended by the Research Purposes Regulations 2001). In
p.000141: addition, the Research Licence Committee has to be satisfied that any proposed use of embryos is necessary for the
p.000141: purposes of the research.
p.000141:
p.000141: In addition the Research Licence Committee has to be satisfied that the character, qualifications and experience of the
p.000141: Person Responsible are such as are required to supervise the activities that s/he will discharge their duties under
p.000141: section 17 of the HF&E Act 1990 and that the premises where the research is to be carried out are suitable for the
p.000141: activities.
p.000141:
p.000141: To aid the Licence Committee in its consideration of research applications a decision making tool (the Decision Tree)
...
Social / Child
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p.000127: 127
p.000127:
p.000127:
p.000127:
p.000127: Regulatory frame applying to POLAND
p.000127:
p.000127: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000127: to get the texts would be welcomed).
p.000127: In Poland there is no research on embryonic stem cells.
p.000127:
p.000127: Polish legal rules do not include distinct regulations for human embryonic stem cells research. There is also no legal
p.000127: definition for embryo stage of life.
p.000127: The fundamental legal act in Poland is the Constitution of the Republic of Poland
p.000127: (http://www.sejm.gov.pl/prawo/konst/angielski/kon1.htm), which was passed by the National Assembly on April 2nd, 1997.
p.000127: In accordance with Art.38 of this Law the Republic of Poland shall ensure the legal protection of the life of every
p.000127: human being Regulations referring to legal protection and conduct rules in the pre-birth stage of human life are
p.000127: included in the Act of January 7th, 1993 on Family Planning, Protection of Human Foetus and Admissible Conditions for
p.000127: an Abortion.
p.000127: In accordance with Art.1 of this Law, the right to life is protected, including also the prenatal stage, in the scope
p.000127: stipulated by the Law. The Law also includes regulations concerning the conceived child that is from the moment of
p.000127: conception through the embryo and foetal stages until birth.
p.000127: According to Art.157a of the Criminal Code any person except for child’s mother who commits any infringement to a
p.000127: conceived child, will be punished. The rule does not include a physician who undertakes medical action necessary to
p.000127: exclude danger- threatening mother’s or child’s health or life.
p.000127: What’s more, under the Act of December 5th, 1996 on Medical Profession’s, human embryos (conceived children) may not be
p.000127: used for therapeutic research (Art. 26 paragraph 1).
p.000127: Not directly refers to this matter the ruling of the Constitutional Court of the Republic of Poland from the 28th May
p.000127: 1997, which says: ‘A democratic state governed by the rule of law holds man and his most precious weal as a supreme
p.000127: value. By this weal, we understand life which in a democratic state governed by the rule of law must enjoy
p.000127: constitutional protection in each stage of its development’.
p.000127:
p.000127: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000127: As mentioned above, there is no legal definition for embryo stage of life.
p.000127:
p.000127:
p.000127: 3 Is hESC research allowed and in what terms and conditions?
p.000127: In Poland, human embryo research is prohibited.
p.000127:
p.000127: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000127:
p.000127: NA
p.000127: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000127: yes at what conditions?
p.000127: Is not allowed.
p.000127:
p.000127: 6 Is the source of hESC used in research traceable and well documented?
p.000127: NA
...
p.000134: to get the texts would be welcomed).
p.000134: Explicit legal regulation on hESC does not exist. However, the Law on treatment of infertility and biomedically
p.000134: assisted fertilisation (Zakon o zdravljenju neplodnosti in postopkih oploditve z biomedicinsko pomocjo, /ZZNPOB/ 3307,
p.000134: Uradni list Republike Slovenije 70/2000, 8. 8. 2000, UL ONLINE) contains provisions that apply to research on embryos
p.000134: from IVF procedures and may apply to procurement of hESC.
p.000134: Web address (Ministry of Health): http://www.mz.gov.si
p.000134: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000134: Article 4: The embryo is created by fertilisation of the ovum. For the purposes of this Law, the early embryo is a
p.000134: zygote or an embryo that has developed outside the uterus for less than 14 days or until the appearance of the
p.000134: primitive streak.
p.000134:
p.000134:
p.000134: 3 Is hESC research allowed and in what terms and conditions?
p.000134: As said above, research on hESC is not specifically regulated.
p.000134:
p.000134: Slovenia is party to the Oviedo Convention and the protocol on prohibition of human cloning. Its Law on treatment of
p.000134: infertility and biomedically assisted fertilisation forbids the creation of human embryos for research, the production
p.000134: of cloned embryos and the use of in vitro fertilisation for any purpose other that birth of a child. Also prohibited is
p.000134: the use of parts of embryo for any purpose other than is explicitly allowed by law.
p.000134:
p.000134: However, the law allows research on surplus embryos from in vitro fertilisation procedures (and thus also procurement
p.000134: of hESC), if several conditions are fulfilled:
p.000134: Article 38 (unofficial translation)
p.000134: Scientific research on the gametes and early embryos (= in vitro embryos) is allowed exclusively for the purposes of
p.000134: (promoting knowledge on) protection and improvement of human health. It may be carried out on early embryos only if it
p.000134: cannot be done on animal embryos or otherwise with comparable efficiency. Early embryos may only be used for research
p.000134: after a written informed consent has been obtained for their parents who had undergone medically assisted reproduction.
p.000134: The research must be authorised by the National Commission for Assisted Reproduction and must be approved and
p.000134: supervised by the National Medical Ethics Committee (NMEC). Permission may be granted for embryos that, according to
p.000134: medical knowledge, are not suitable to be transferred into woman’s body or for storage, or would have to be left to
p.000134: perish according to the Article 35 of the Law (end of the maximum storage period). In research on embryos, current
p.000134: medical knowledge, experience, established practices and principles of general medical ethics must be taken into
p.000134: account.
p.000134:
p.000134:
p.000134:
p.000134:
p.000134:
p.000134:
p.000134:
p.000134:
...
Searching for indicator children:
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p.000084: any ethical review will be performed solely on the basis of the information available in the proposal (1). Projects
p.000084: raising specific ethical issues such as research intervention on human beings, research on human embryos and human
p.000084: embryonic stem cells and non-human primates are automatically submitted for ethical review.
p.000084:
p.000084:
p.000085: 85
p.000085:
p.000085:
p.000085:
p.000085: To ensure compliance with ethical principles, the Commission services will undertake ethics audit(s) of selected
p.000085: projects at its discretion. A website is being prepared aiming to provide clear, helpful information on ethical issues.
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
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p.000085:
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p.000085:
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p.000085:
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p.000085:
p.000085:
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p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
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p.000085:
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p.000085:
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p.000085:
p.000085:
p.000085: (1) Such as clinical trials, and research involving invasive techniques on persons (e.g. taking of tissue
p.000085: samples, examinations of the brain).
p.000085:
p.000085:
p.000085:
p.000085:
p.000086: 86
p.000086:
p.000086:
p.000086:
p.000086: ETHICAL ISSUES TABLE
p.000086:
p.000086:
p.000086: Informed consent
p.000086: • Does the proposal involve children?
p.000086: • Does the proposal involve patients or persons not able to give consent?
p.000086: • Does the proposal involve adult healthy volunteers?
p.000086:
p.000086:
p.000086:
p.000086: YES
p.000086:
p.000086:
p.000086:
p.000086:
p.000086: PAGE
p.000086:
p.000086: • Does the proposal involve human genetic material?
p.000086:
p.000086: • Does the proposal involve human biological samples?
p.000086: • Does the proposal involve human data collection?
p.000086:
p.000086: Research on human embryos/foetuses
p.000086: • Does the proposal involve human embryos?
p.000086: • Does the proposal involve human foetal tissue/cells?
p.000086:
p.000086: • Does the proposal involve human embryonic stem cells?
p.000086: Privacy
p.000086: • Does the proposal involve processing of genetic information or personal data (e.g. health, sexual lifestyle,
p.000086: ethnicity, political opinion, religious or philosophical conviction)?
p.000086: • Does the proposal involve tracking the location or observation of people?
p.000086: Research on animals
p.000086: • Does the proposal involve research on animals?
p.000086:
p.000086: • Are those animals transgenic small laboratory animals?
p.000086: • Are those animals transgenic farm animals?
p.000086: • Are those animals cloning farm animals?
p.000086: • Are those animals non-human primates?
...
p.000127: human being Regulations referring to legal protection and conduct rules in the pre-birth stage of human life are
p.000127: included in the Act of January 7th, 1993 on Family Planning, Protection of Human Foetus and Admissible Conditions for
p.000127: an Abortion.
p.000127: In accordance with Art.1 of this Law, the right to life is protected, including also the prenatal stage, in the scope
p.000127: stipulated by the Law. The Law also includes regulations concerning the conceived child that is from the moment of
p.000127: conception through the embryo and foetal stages until birth.
p.000127: According to Art.157a of the Criminal Code any person except for child’s mother who commits any infringement to a
p.000127: conceived child, will be punished. The rule does not include a physician who undertakes medical action necessary to
p.000127: exclude danger- threatening mother’s or child’s health or life.
p.000127: What’s more, under the Act of December 5th, 1996 on Medical Profession’s, human embryos (conceived children) may not be
p.000127: used for therapeutic research (Art. 26 paragraph 1).
p.000127: Not directly refers to this matter the ruling of the Constitutional Court of the Republic of Poland from the 28th May
p.000127: 1997, which says: ‘A democratic state governed by the rule of law holds man and his most precious weal as a supreme
p.000127: value. By this weal, we understand life which in a democratic state governed by the rule of law must enjoy
p.000127: constitutional protection in each stage of its development’.
p.000127:
p.000127: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000127: As mentioned above, there is no legal definition for embryo stage of life.
p.000127:
p.000127:
p.000127: 3 Is hESC research allowed and in what terms and conditions?
p.000127: In Poland, human embryo research is prohibited.
p.000127:
p.000127: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000127:
p.000127: NA
p.000127: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000127: yes at what conditions?
p.000127: Is not allowed.
p.000127:
p.000127: 6 Is the source of hESC used in research traceable and well documented?
p.000127: NA
p.000127: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000127: NA
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000128: 128
p.000128:
p.000128:
p.000128:
p.000128:
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Social / Ethnicity
Searching for indicator ethnicity:
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p.000085:
p.000085:
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p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085: (1) Such as clinical trials, and research involving invasive techniques on persons (e.g. taking of tissue
p.000085: samples, examinations of the brain).
p.000085:
p.000085:
p.000085:
p.000085:
p.000086: 86
p.000086:
p.000086:
p.000086:
p.000086: ETHICAL ISSUES TABLE
p.000086:
p.000086:
p.000086: Informed consent
p.000086: • Does the proposal involve children?
p.000086: • Does the proposal involve patients or persons not able to give consent?
p.000086: • Does the proposal involve adult healthy volunteers?
p.000086:
p.000086:
p.000086:
p.000086: YES
p.000086:
p.000086:
p.000086:
p.000086:
p.000086: PAGE
p.000086:
p.000086: • Does the proposal involve human genetic material?
p.000086:
p.000086: • Does the proposal involve human biological samples?
p.000086: • Does the proposal involve human data collection?
p.000086:
p.000086: Research on human embryos/foetuses
p.000086: • Does the proposal involve human embryos?
p.000086: • Does the proposal involve human foetal tissue/cells?
p.000086:
p.000086: • Does the proposal involve human embryonic stem cells?
p.000086: Privacy
p.000086: • Does the proposal involve processing of genetic information or personal data (e.g. health, sexual lifestyle,
p.000086: ethnicity, political opinion, religious or philosophical conviction)?
p.000086: • Does the proposal involve tracking the location or observation of people?
p.000086: Research on animals
p.000086: • Does the proposal involve research on animals?
p.000086:
p.000086: • Are those animals transgenic small laboratory animals?
p.000086: • Are those animals transgenic farm animals?
p.000086: • Are those animals cloning farm animals?
p.000086: • Are those animals non-human primates?
p.000086: Research involving developing countries
p.000086: • Use of local resources (genetic, animal, plant, etc.)
p.000086:
p.000086: • Benefit to local community (capacity building, i.e. access to healthcare, education, etc.)
p.000086: Dual use
p.000086: • Research having potential military/terrorist application
p.000086:
p.000086: I CONFIRM THAT NONE OF THE ABOVE ISSUES APPLY TO MY PROPOSAL
p.000086:
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p.000087: ANNEX III
p.000087:
p.000087: LIST OF PROJECTS SUPPORTED WITHIN THE SIXTH FRAMEWORK PROGRAMME AND WITHIN THE HEALTH
p.000087: DIRECTORATE, INVOLVING HESCS
p.000087: 1. LYMPHANGIOGENOMICS: fundamental research to better understand the lymphatic vasculature with a view to
...
Social / Fetus/Neonate
Searching for indicator fetus:
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p.000133: Regulatory frame applying to: SLOVAK REPUBLIC
p.000133:
p.000133: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000133: having not a legal personality.
p.000133:
p.000133: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000133: to get the texts would be welcomed).
p.000133: No specific regulations exist at present. There is an extensive governmental regulation in preparation, however, to
p.000133: deal with the ‘donation, procurement, testing and distribution of organs, tissues and cells, and processing,
p.000133: conservation and storage of tissues and cells’ (transposition of the requirements of the Dir. 2006/17/EC, ev. Dir.
p.000133: 2004/23/EC). It could tackle on some closely related issues, but probably not specifically on hESCs.
p.000133: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000133: N.A. (non-applicable)
p.000133: 3 Is hESC research allowed and in what terms and conditions?
p.000133: hESC research is not specifically prohibited by a law, however, according to the position the Slovak Republic (SR) has
p.000133: taken so far on the issue, it probably would not be allowed to take place in the country (as destroying of a human
p.000133: embryo is necessary to obtain the hESCs lines for research).
p.000133: The ‘non-therapeutic’ research on human embryo and fetus, as well as human cloning are prohibited both by the SR’s
p.000133: health law (law No. 576/2004 Coll. as later amended) and by SR’s Penal Code (law No. 300/2005 Coll.) – making both a
p.000133: criminal offence.
p.000133: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000133: N.A. (non-applicable)
p.000133: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000133: yes at what conditions?
p.000133: NO, it is prohibited as a criminal act (see 3, above).
p.000133:
p.000133: 6 Is the source of hESC used in research traceable and well documented?
p.000133: N.A. (non-applicable)
p.000133: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000133: N.A. (non-applicable)
p.000133:
p.000133: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000133: embryo donation for research, if so could you please describe them?
p.000133: N.A. (non-applicable)
p.000133:
p.000133: 9 Is financial inducement allowed? If so, in what terms?
p.000133:
p.000133: N.A. (non-applicable)
p.000133: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000133: N.A. (non-applicable)
p.000133:
p.000133: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000133: publications)?
...
Searching for indicator foetus:
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p.000111:
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p.000112: 112
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p.000112:
p.000112:
p.000112: Regulatory frame applying to HUNGARY
p.000112:
p.000112: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000112: to get the texts would be welcomed).
p.000112:
p.000112: The human embryonic stem cells research and use is regulated by law and five decrees.
p.000112: The 1997. CLIV. law about the health regulated the general conditions of the use and research of the human embryonic
p.000112: stem cells (180- 182 paragraphs.(
p.000112: The 2006 CXV. law about the health reform.
p.000112: The 21/1998. (VI.3.) MH decree contains the minimum conditions of the use of human embryonic stem cells ( 15/B
p.000112: attachment).
p.000112: The 22/1998. (VI.3.) MH decree contains the detailed regulation of the transplantation of different organs and tissues.
p.000112: The 31/1998. (VI.24.) MH decree regulated the ethical approval system of biomedical research.
p.000112: The 22/2002. (V.9.) MH decree regulated the ethical approval system of biomedical research.
p.000112: The 1/2007. (I.24.) MH decree regulated the ethical approval system of biomedical research.
p.000112:
p.000112: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000112:
p.000112: embryo is defined as every living human embryo following the completion of fertilisation until 12th week of pregnancy.
p.000112: The foetus is the human being developing within the uterus after the 12th week of pregnancy.
p.000112:
p.000112: 3 Is hESC research allowed and in what terms and conditions?
p.000112:
p.000112: Research on embryos can be carried out on the basis of an authorisation of the Hungarian Reproduction Commission.
p.000112: Embryos can only be used for research purposes and experiments can only be made on embryos for the research purposes
p.000112: that the Health Care Act fixes with regard to medical research.
p.000112:
p.000112: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000112:
p.000112: Hungarian Reproduction Commission
p.000112: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000112: yes at what conditions?
p.000112:
p.000112: Embryos cannot be created for research purposes, only embryos created in medically assisted human procreation
p.000112: procedures (MAP) can be used for research and experiments, either on the basis of the decision of those entitled to
p.000112: decide, or in case of damage of the embryo. If an embryo was donated for a MAP procedure, but not used within 10 years
p.000112: following the donation, the embryo can be used for research purposes.
p.000112:
p.000112: 6 Is the source of hESC used in research traceable and well documented?
p.000112:
p.000112: The source of the hESC is traceable and well documented in every cases.
p.000112:
...
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p.000127: 127
p.000127:
p.000127:
p.000127:
p.000127: Regulatory frame applying to POLAND
p.000127:
p.000127: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000127: to get the texts would be welcomed).
p.000127: In Poland there is no research on embryonic stem cells.
p.000127:
p.000127: Polish legal rules do not include distinct regulations for human embryonic stem cells research. There is also no legal
p.000127: definition for embryo stage of life.
p.000127: The fundamental legal act in Poland is the Constitution of the Republic of Poland
p.000127: (http://www.sejm.gov.pl/prawo/konst/angielski/kon1.htm), which was passed by the National Assembly on April 2nd, 1997.
p.000127: In accordance with Art.38 of this Law the Republic of Poland shall ensure the legal protection of the life of every
p.000127: human being Regulations referring to legal protection and conduct rules in the pre-birth stage of human life are
p.000127: included in the Act of January 7th, 1993 on Family Planning, Protection of Human Foetus and Admissible Conditions for
p.000127: an Abortion.
p.000127: In accordance with Art.1 of this Law, the right to life is protected, including also the prenatal stage, in the scope
p.000127: stipulated by the Law. The Law also includes regulations concerning the conceived child that is from the moment of
p.000127: conception through the embryo and foetal stages until birth.
p.000127: According to Art.157a of the Criminal Code any person except for child’s mother who commits any infringement to a
p.000127: conceived child, will be punished. The rule does not include a physician who undertakes medical action necessary to
p.000127: exclude danger- threatening mother’s or child’s health or life.
p.000127: What’s more, under the Act of December 5th, 1996 on Medical Profession’s, human embryos (conceived children) may not be
p.000127: used for therapeutic research (Art. 26 paragraph 1).
p.000127: Not directly refers to this matter the ruling of the Constitutional Court of the Republic of Poland from the 28th May
p.000127: 1997, which says: ‘A democratic state governed by the rule of law holds man and his most precious weal as a supreme
p.000127: value. By this weal, we understand life which in a democratic state governed by the rule of law must enjoy
p.000127: constitutional protection in each stage of its development’.
p.000127:
...
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p.000085: projects at its discretion. A website is being prepared aiming to provide clear, helpful information on ethical issues.
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p.000085: (1) Such as clinical trials, and research involving invasive techniques on persons (e.g. taking of tissue
p.000085: samples, examinations of the brain).
p.000085:
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p.000086: 86
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p.000086:
p.000086: ETHICAL ISSUES TABLE
p.000086:
p.000086:
p.000086: Informed consent
p.000086: • Does the proposal involve children?
p.000086: • Does the proposal involve patients or persons not able to give consent?
p.000086: • Does the proposal involve adult healthy volunteers?
p.000086:
p.000086:
p.000086:
p.000086: YES
p.000086:
p.000086:
p.000086:
p.000086:
p.000086: PAGE
p.000086:
p.000086: • Does the proposal involve human genetic material?
p.000086:
p.000086: • Does the proposal involve human biological samples?
p.000086: • Does the proposal involve human data collection?
p.000086:
p.000086: Research on human embryos/foetuses
p.000086: • Does the proposal involve human embryos?
p.000086: • Does the proposal involve human foetal tissue/cells?
p.000086:
p.000086: • Does the proposal involve human embryonic stem cells?
p.000086: Privacy
p.000086: • Does the proposal involve processing of genetic information or personal data (e.g. health, sexual lifestyle,
p.000086: ethnicity, political opinion, religious or philosophical conviction)?
p.000086: • Does the proposal involve tracking the location or observation of people?
p.000086: Research on animals
p.000086: • Does the proposal involve research on animals?
p.000086:
p.000086: • Are those animals transgenic small laboratory animals?
p.000086: • Are those animals transgenic farm animals?
p.000086: • Are those animals cloning farm animals?
p.000086: • Are those animals non-human primates?
p.000086: Research involving developing countries
p.000086: • Use of local resources (genetic, animal, plant, etc.)
p.000086:
p.000086: • Benefit to local community (capacity building, i.e. access to healthcare, education, etc.)
p.000086: Dual use
p.000086: • Research having potential military/terrorist application
p.000086:
p.000086: I CONFIRM THAT NONE OF THE ABOVE ISSUES APPLY TO MY PROPOSAL
p.000086:
p.000086:
p.000086:
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p.000138: 2-approval by the ethical committee of the institution or the autonomous community and
p.000138: 3-approval by the ad hoc ‘Comision de Garantías para la Donación y Utilización de Células y Tejidos Humanos’
p.000138: (See on this previous answer to question Nr 4).
p.000138: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in embryo
p.000138: donation for research, if so could you please describe them?
p.000138: Yes. If embryos are going to be used for a research project, parents must sign an informed consent specific for that
p.000138: project. The informed consent form includes the name of the research project, a short summary of the main research
p.000138: objectives, the name of the IP and a disclosure of any financial interest (Art. 15.1, a of HARTAct).
p.000138:
p.000138:
p.000138: 9 Is financial inducement allowed? If so, in what terms?
p.000138:
p.000138: No, it is not.
p.000138: (See art. 7 BMRAct and art. 15.1, a of HARTAct).
p.000138: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000138: Yes, they are. (arts. 5 and 53 of BMRAct):
p.000138:
p.000138: Article 5 Protection of personal data and Confidentiality (general provisions on the use of human biological material).
p.000138:
p.000138: Article 53 Genetic analysis on pre-embryos, embryos and foetuses. The results of genetic analysis on per-embryonic,
p.000138: embryonic and foetal material shall be submitted to the principles of data protection and confidentiality established
p.000138: in this Act.
p.000138:
p.000138: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000138: publications)?
p.000138: Yes, they are, although it is not required to be provided in form of publications.
p.000138:
p.000138: 12 How is patenting of hESC lines regulated?
p.000138: In the same conditions as it is at the Directive 98/44/EC, on the legal protection of biological inventions.
p.000138: See the Act 11/1986 of 26 March, on Patent, as modified by Act 10/2002 of 29 April, transposing that Directive.
p.000138: Information provided by Prof. C.M. Romeo-Casabona (Universidad de Deusto, Bilbao) and Dr. Javier Arias (Institut de
p.000138: salud Carlos III, Madrid)
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000139: 139
p.000139:
p.000139:
p.000139:
p.000139: Regulatory frame applying to SWEDEN
p.000139:
p.000139: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000139: having not a legal personality.
p.000139:
p.000139: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000139: to get the texts would be welcomed).
p.000139: The Act (2006:351) on genetic integrity etc.. The Biobanks in Medical Care Act (2002:297)
p.000139: The Act (2003:460) on ethics review of research on humans http://www.epn.se/eng/start/index.aspx
...
Social / Marital Status
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p.000025: (69) Solter, D. ‘Politically correct human embryonic stem cells?’, The New England Journal of
p.000025: Medicine, Vol. 353: 2321–2323 (1 December 2005).
p.000025: (70) Green, R. M. ‘Can we develop ethically universal embryonic stem-cell lines?’. Nature Reviews
p.000025: Genetics 8: 480–485 (2007).
p.000025: (71) Zhang, X. et al. ‘Derivation of human embryonic stem cells from developing and arrested
p.000025: embryos’, Stem Cells 24: 2660–76 (2006).
p.000025:
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p.000026: 26
p.000026:
p.000026:
p.000026: • pluripotent stem cells via blastomere extraction from developing embryos (72);
p.000026: • pluripotent stem cells via somatic cell dedifferentiation (73);
p.000026: • human materials using cell fusion rather than genetic factors (74);
p.000026: • non-embryonal sources of ‘embryonic like’, multipotent human stem cells (from human umbilical cord blood (75) or
p.000026: from human amniotic fluid (76)).
p.000026:
p.000026: III.6. European Registry of existing hESC lines
p.000026:
p.000026: According to the available data, 81 different hESC lines have at present been established and are used in
p.000026: EU-funded projects. Since there is certain variability from cell line to cell line, the Commission has felt it
p.000026: important to: (1) gather in a centralised manner all information available on each single cell line
p.000026: for comparative purposes; and (2) render such information available at international level.
p.000026:
p.000026: The European Commission has therefore decided to establish and fund a European Registry for human
p.000026: embryonic stem cell lines (77) in order to help researchers to optimise the hESC resources available and
p.000026: avoid duplication of work and/or the creation of new cell lines where possible. This registry is expected to boost
p.000026: the coordination and rationalisation of human embryonic stem cell
p.000026:
p.000026:
p.000026: (72) Klimanskya, I. et al. ‘Human embryonic stem cell lines derived from single blastomeres’, Nature
p.000026: 444: 481–485 (2006).
p.000026: (73) Takahashi, K. and Yamanaka, S. ‘Induction of pluripotent stem cells from mouse embryonic and adult
p.000026: fibroblast cultures by defined factors’, Cell 126: 1–14 (2006).
p.000026: Wernig, M. et al. ‘In vitro reprogramming of fibroblasts into a pluripotent ES-cell-like state’,
p.000026: Nature, AOP doi:10.1038/nature05944 (2007).
p.000026: (74) Cowan, C. A. et al. ‘Nuclear reprogramming of somatic cells after fusion with human embryonic stem cells’,
p.000026: Science, 309: 1369–1373 (2005).
p.000026: (75) Zhao, Y. et al. ‘Identification of stem cells from human umbilical cord blood with embryonic and
p.000026: hematopoietic characteristics’, Experimental Cell Research, 312: 2454–2464 (2006).
p.000026: (76) De Coppi, P. et al. ‘Isolation of amniotic stem cell lines with potential for therapy’,
p.000026: Nature
p.000026: Biotechnology 25: 100–106 (2007).
p.000026: (77) The project will be funded for three years with grants for a total of EUR 1 million. The registry will be
p.000026: mainly coordinated by two institutions: the Centre of Regenerative Medicine (CRMB) in Barcelona, Spain, and the
p.000026: Berlin-Brandenburg Centre for Regenerative Therapies (BCRT) in Berlin, Germany.
p.000026:
p.000026:
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027:
p.000027: research in Europe. It will provide a platform to maximise reproducibility, comparability and
p.000027: transparency in the field (78).
p.000027:
p.000027: The main objective of this initiative is to provide comprehensive information about all human embryonic stem cell lines
...
p.000027: containing data on the cell lines (e.g. cell characteristics) and their use (e.g. research project outcomes,
p.000027: clinical trials, etc.). The registry will provide information on the sources of the stem cell lines and
p.000027: include comprehensive information on human embryonic stem cell lines obtained from ongoing and future EU-funded
p.000027: projects. The data will be regularly updated and made accessible to the public.
p.000027:
p.000027: A Steering Committee comprising representatives of the leading European public institutions involved in human
p.000027: embryonic stem cell research has also been established. The committee will be assisted by an Advisory Board,
p.000027: comprising 17 top scientists from Europe and outside Europe in the field of human embryonic stem cell research, and
p.000027: an independent Ethics Advisory Board to ensure compliance with ethical requirements and ethical guidance.
p.000027:
p.000027: III.7. EU Member States’ regulations on hESC research
p.000027: Among the 27 EU Member States (EU-27), several clusters of countries can be identified according to how they regulate
p.000027: hESC research. However, all countries apply at least some regulations and/or procedural rules to specific projects
p.000027: involving hESCs. Where hESC research is allowed, project proposals have to undergo strict evaluation criteria, both
p.000027: scientific and ethical, decided upon by the competent national bodies (79).
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027: (78) For more information see: www.cmrb.eu; www.cellnet.org;
p.000027: www.ec.europa.eu/research/fp6/index_en.cfm?p=1_stem_projects
p.000027: (79) See annex (pp. 52–102) for further details in single Member States.
p.000027:
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p.000028: 28
p.000028:
p.000028:
p.000028:
p.000028: Permissive position
p.000028:
p.000028: A few EU Member States have specific legislation for hESC research, covering the procurement of stem cells and their
p.000028: use for research. In Belgium, Spain (80), Sweden and the UK, for example, embryo creation is allowed for research
p.000028: purposes.
p.000028:
p.000028: Permissive position with restrictions
p.000028:
p.000028: In other EU Member States such as the Czech Republic, Denmark, Greece, France, the Netherlands, Portugal and
p.000028: Finland (81), regulations allow the derivation of new hESCs from embryos created as a result of assisted
p.000028: reproduction technology (ART) and in vitro fertilisation to induce pregnancy, but only when they can no longer be used
p.000028: for that purpose.
p.000028:
p.000028: Restrictive position
p.000028: Germany and Italy have stricter hESC research regulations. Scientists in these countries cannot derive new
p.000028: hES cell lines, but can import them. In Germany, a new discussion has arisen as to whether the 2002 Stem Cell Act
p.000028: regulating the importation of hESC lines should be revised, but no legal proposal has been forthcoming by
p.000028: the date of these recommendations. Italian legislation covers artificial reproduction technology and the
p.000028: production of new hESCs (research involving the destruction of embryos is not allowed). Italy therefore has no
p.000028: legal provision as regards the use of imported hESCs or existing hESCs.
p.000028:
p.000028:
p.000028: No specific legislation or indirect legislation only
p.000028:
...
p.000104: Ethics committees approve information and consent forms before they can be used in the informed consent procedure
p.000104:
p.000104: 9 Is financial inducement allowed? If so, in what terms?
p.000104:
p.000104:
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p.000104:
p.000105: 105
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p.000105:
p.000105: No; donation must be voluntary. Only compensation of the expenses and harms (healthy donors) is allowed according to
p.000105: Decree 1390/2006. There are not such expenses or harm related to hESC while embryos that could be donated for research
p.000105: are surplus embryos.
p.000105:
p.000105: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000105: No, regular data protection provisions similar to medical research in general are applied to hESC research.
p.000105:
p.000105: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000105: publications)?
p.000105: Not necessarily, only when they are published.
p.000105:
p.000105: 12 How is patenting of hESC lines regulated?
p.000105: We have Act on Patenting (550/1967, amendment 650/2000) that has implemented the EU Directive of biopatenting. It
p.000105: states that (Section 1a and b) human body or its part, whole or partial sequence of a gene or similar finding cannot be
p.000105: patented, but isolated or otherwise produced item, sequence or partial sequence of a single gene form an invention that
p.000105: can be patented, if provisions otherwise are fulfilled, although the structure of this item would be similar to natural
p.000105: item. However, section 1 b states that
p.000105: (3) uses of human embryos for industrial or commercial purposes cannot be patented See translation at:
p.000105: http://www.finlex.fi/en/laki/kaannokset/1967/en19670550.pdf
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p.000106: Regulatory frame applying to FRANCE
p.000106:
p.000106: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000106: having not a legal personality.
p.000106:
p.000106: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000106: to get the texts would be welcomed). www.agence-biomedecine.fr
p.000106: http://www.agence-biomedecine.fr/fr/experts/pegh-recherche.aspx
p.000106: Demande d'autorisation de protocoles d'étude et de recherche, d'importation ou de conservation
p.000106: Le décret n° 2006-121 du 6 février 2006 relatif aux recherches sur l'embryon et les cellules embryonnaires, précisant
p.000106: les conditions d'application de la loi du 6 août 2004, prévoit que le directeur général de l'Agence de la biomédecine
p.000106: notifie à l'établissement ou à l'organisme demandeur sa décision d'autorisation ou de refus d'autorisation dans les 4
...
p.000136: Lines: http://www.boe.es/boe/dias/2006/02/18/pdfs/A06637-06641.pdf
p.000136:
p.000136: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000136: Yes, it does.
p.000136: In the Spanish legislation there are two definitions, on the human pre-embryo and on the human embryo:
p.000136:
p.000136: a) Pre-embryo: the in vitro embryo as constituted by a group of cells derived of the continuous division of the
p.000136: fertilised oocyte until 14 days later (art. 1.2 of HARTAct and art. 3, s, BMRAct)
p.000136:
p.000136: b) Embryo: A step of embryonic development, which includes the time in what the fertilised oocyte is located in the
p.000136: uterus of a woman until the time of the beginning of the step of the formation of organs, it is to say, 56 days after
p.000136: fertilisation occurs, regardless the time during such development could be stopped (art. 3, l, BMRAct).
p.000136:
p.000136:
p.000136: 3 Is hESC research allowed and in what terms and conditions?
p.000136: Yes, this type of research is allowed but only under case by case scrutiny. The research project has to fulfil, by the
p.000136: research group, the ethical guarantees requested.
p.000136: A) From surplus pre-embryos HARTAct):
p.000136: Article 15. Using pre-embryos for research purposes.
p.000136:
p.000136: a) Informed consent of the couple or of the single woman.
p.000136: b) The pre-embryo shall not be developed in vitro more than 14 days, regardless the time it could be cryo-preserved
p.000136: c) Research shall be performed in authorised centres
p.000136: d) Research will be done on the basis of a research project authorised by the competent authority, previous the
p.000136: perceptive and favourable Commission (see down).
p.000136:
p.000136:
p.000136: B) From cloned pre-embryos (BMRAct):
p.000136: Article 34 Guarantees and requisites for research
p.000136: 1. Research or experimentation with surplus oocytes and pre-embryos from the application of assisted
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000137: 137
p.000137:
p.000137:
p.000137:
p.000137: reproduction techniques, or from their biological structures, with the aim to obtain, develop and use embryonic stem
p.000137: cell lines or with other purposes not associated with the development and application of assisted reproduction
p.000137: techniques, shall be undertaken in accordance with the conditions established in Law 14/2006, of 26 May, and comply
p.000137: with the following requisites:
p.000137: a) That the research abides by the applicable ethical principles and legal regulations, especially in that provided
p.000137: in this Law and its development of rules and guidelines in law, and that it follows the principles
p.000137: of relevance, feasibility and suitability, specifically of the main researcher, of the research
p.000137: team and of the facilities of the centre that shall undertake the research.
p.000137:
p.000137: b) That it is based on a research project authorised by the relevant State or autonomous authorities,
...
Social / Religion
Searching for indicator conviction:
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p.000085: samples, examinations of the brain).
p.000085:
p.000085:
p.000085:
p.000085:
p.000086: 86
p.000086:
p.000086:
p.000086:
p.000086: ETHICAL ISSUES TABLE
p.000086:
p.000086:
p.000086: Informed consent
p.000086: • Does the proposal involve children?
p.000086: • Does the proposal involve patients or persons not able to give consent?
p.000086: • Does the proposal involve adult healthy volunteers?
p.000086:
p.000086:
p.000086:
p.000086: YES
p.000086:
p.000086:
p.000086:
p.000086:
p.000086: PAGE
p.000086:
p.000086: • Does the proposal involve human genetic material?
p.000086:
p.000086: • Does the proposal involve human biological samples?
p.000086: • Does the proposal involve human data collection?
p.000086:
p.000086: Research on human embryos/foetuses
p.000086: • Does the proposal involve human embryos?
p.000086: • Does the proposal involve human foetal tissue/cells?
p.000086:
p.000086: • Does the proposal involve human embryonic stem cells?
p.000086: Privacy
p.000086: • Does the proposal involve processing of genetic information or personal data (e.g. health, sexual lifestyle,
p.000086: ethnicity, political opinion, religious or philosophical conviction)?
p.000086: • Does the proposal involve tracking the location or observation of people?
p.000086: Research on animals
p.000086: • Does the proposal involve research on animals?
p.000086:
p.000086: • Are those animals transgenic small laboratory animals?
p.000086: • Are those animals transgenic farm animals?
p.000086: • Are those animals cloning farm animals?
p.000086: • Are those animals non-human primates?
p.000086: Research involving developing countries
p.000086: • Use of local resources (genetic, animal, plant, etc.)
p.000086:
p.000086: • Benefit to local community (capacity building, i.e. access to healthcare, education, etc.)
p.000086: Dual use
p.000086: • Research having potential military/terrorist application
p.000086:
p.000086: I CONFIRM THAT NONE OF THE ABOVE ISSUES APPLY TO MY PROPOSAL
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000087: 87
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087: ANNEX III
p.000087:
p.000087: LIST OF PROJECTS SUPPORTED WITHIN THE SIXTH FRAMEWORK PROGRAMME AND WITHIN THE HEALTH
p.000087: DIRECTORATE, INVOLVING HESCS
p.000087: 1. LYMPHANGIOGENOMICS: fundamental research to better understand the lymphatic vasculature with a view to
p.000087: developing therapies to control the growth of lymphatic vessels (e.g. cancer, inflammatory diseases, for
...
Searching for indicator religious:
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p.000009: (27) http://www.ec.europa.eu/european_group_ethics/docs/avis12_en.pdf
p.000009: (28) http://www.ec.europa.eu/european_group_ethics/docs/avis15_en.pdf
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010:
p.000010:
p.000010: Having regard to EGE Opinion No 16 ‘Ethical aspects of patenting inventions involving human stem cells’
p.000010: (29), published on 14 November 2002;
p.000010:
p.000010: Having regard the request of November 2006 from the President of the EU Commission to the EGE to issue an opinion on
p.000010: the ethics review of human embryonic stem cell (hESC) projects funded under FP7;
p.000010:
p.000010: Having heard the rapporteurs A. Cambon-Thomsen, H. Haker, P. Martinho da Silva,
p.000010:
p.000010:
p.000010:
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p.000010:
p.000010:
p.000010: (29) http://www.ec.europa.eu/european_group_ethics/docs/avis16_en.pdf
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011:
p.000011:
p.000011: II. WHEREAS
p.000011:
p.000011: II.1. Preamble
p.000011: It is common knowledge that opinions about the ethical legitimacy of research on human embryos are sharply divided.
p.000011: The controversy is rooted in different ethical, philosophical, and/or religious viewpoints, each of which is
p.000011: acknowledged to be fully legitimate. In this respect, some claim that the divergences are ‘intrinsic’ and
p.000011: therefore irreconcilable, while others claim that common positions are achievable while respecting the pluralism of
p.000011: European societies, as practical solutions.
p.000011:
p.000011: The scope of these recommendations, however, is not to address the ethics of human embryonic stem cell research or
p.000011: research on human embryos. These recommendations relate to the political decision reached by the European
p.000011: institutions on the EU’s seventh framework research programme and is intended to contribute to the implementation
p.000011: of the mechanism established under the programme for an ethics review of EU-funded research activities
p.000011: involving the use of human embryonic stem cells.
p.000011:
p.000011: Because of the particular scope of these recommendations, it is important to identify the main
p.000011: requirements regarding the ethics of human embryonic stem cells that have been adopted in
p.000011: co-decision by the European institutions involved: the Council and the European Parliament. In
p.000011: addition, as the current EU framework programme follows on from the previous one, and since both
p.000011: implement the European research area (the policy strategy of the EU in research and development) and are linked to the
...
p.000042: is fulfilled;
p.000042: • applicants should use hESCs banked in the EU registry. The need to use other hESC lines in FP7
p.000042: proposals must therefore be justified on both scientific and ethical grounds;
p.000042: • the registry should prepare and publish (on its website) information on the hESCs banked and on
p.000042: the positive and negative results of the research performed with/on the hESC lines provided to the
p.000042: researchers. At the project’s conclusion, in addition to the scientific data, particularly health- related
p.000042: information, the publication of user-friendly information on hESC research, freely accessible to EU citizens, is
p.000042: also highly recommended. The portal should include interactive elements if possible.
p.000042:
p.000042: Researchers working in the field have a responsibility to inform the public about their work, but also to engage with
p.000042: the social, political and ethical debates. With regard to open questions such as how to balance different
p.000042: rights and how to prioritise conflicting interests, researchers should participate in public discourse and respect
p.000042: the democratic decision-making process with regard to common societal goals. Applicants should therefore commit
p.000042: time, money and activities to advance the dialogue of science and society in the field of human embryonic
p.000042: stem cell research. Applicants for hESC research under FP7 are therefore strongly encouraged to include the
p.000042: science and humanities dialogue, i.e. social, cultural/religious, philosophical and ethical reflection on hESC
p.000042: research, in their projects and to collaborate for this purpose with other disciplines from the humanities.
p.000042:
p.000042:
p.000042:
p.000042: IV.3. The need for further research and continuous public debate
p.000042:
p.000042: As the ethical conflicts concerning hESCs have not been resolved either academically or politically,
p.000042: the EGE recommends that, under FP7, funding should
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000043: 43
p.000043:
p.000043:
p.000043:
p.000043: be provided in order to foster further collaborative and multidisciplinary international research
p.000043: on the ethical implications of hESC research and the pertinent surrounding issues, as well as to encourage
p.000043: informed public debate.
p.000043: The EGE believes the following topics may be of particular immediate interest in such research and discourse:
p.000043: • the potentially conflicting goals of economic competitiveness and compliance with ethical standards;
p.000043: • the use of the human body for modern medicine, including commercialisation of products and procedures stemming
p.000043: from the use of human embryonic stem cells;
p.000043: • the underlying anthropology of human embryonic stem cell research, especially in the light of
p.000043: hybrids and the chimera research connected to stem cell research;
p.000043: • optimisation of clinical and therapeutic needs of patients suffering from the most common diseases
p.000043: addressed in hESC research on treatment and/or for specific diseases;
p.000043: • policy regarding numbers and production process of stem cell lines necessary in the case of
p.000043: successful therapies;
...
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085: (1) Such as clinical trials, and research involving invasive techniques on persons (e.g. taking of tissue
p.000085: samples, examinations of the brain).
p.000085:
p.000085:
p.000085:
p.000085:
p.000086: 86
p.000086:
p.000086:
p.000086:
p.000086: ETHICAL ISSUES TABLE
p.000086:
p.000086:
p.000086: Informed consent
p.000086: • Does the proposal involve children?
p.000086: • Does the proposal involve patients or persons not able to give consent?
p.000086: • Does the proposal involve adult healthy volunteers?
p.000086:
p.000086:
p.000086:
p.000086: YES
p.000086:
p.000086:
p.000086:
p.000086:
p.000086: PAGE
p.000086:
p.000086: • Does the proposal involve human genetic material?
p.000086:
p.000086: • Does the proposal involve human biological samples?
p.000086: • Does the proposal involve human data collection?
p.000086:
p.000086: Research on human embryos/foetuses
p.000086: • Does the proposal involve human embryos?
p.000086: • Does the proposal involve human foetal tissue/cells?
p.000086:
p.000086: • Does the proposal involve human embryonic stem cells?
p.000086: Privacy
p.000086: • Does the proposal involve processing of genetic information or personal data (e.g. health, sexual lifestyle,
p.000086: ethnicity, political opinion, religious or philosophical conviction)?
p.000086: • Does the proposal involve tracking the location or observation of people?
p.000086: Research on animals
p.000086: • Does the proposal involve research on animals?
p.000086:
p.000086: • Are those animals transgenic small laboratory animals?
p.000086: • Are those animals transgenic farm animals?
p.000086: • Are those animals cloning farm animals?
p.000086: • Are those animals non-human primates?
p.000086: Research involving developing countries
p.000086: • Use of local resources (genetic, animal, plant, etc.)
p.000086:
p.000086: • Benefit to local community (capacity building, i.e. access to healthcare, education, etc.)
p.000086: Dual use
p.000086: • Research having potential military/terrorist application
p.000086:
p.000086: I CONFIRM THAT NONE OF THE ABOVE ISSUES APPLY TO MY PROPOSAL
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000087: 87
p.000087:
p.000087:
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p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087: ANNEX III
p.000087:
p.000087: LIST OF PROJECTS SUPPORTED WITHIN THE SIXTH FRAMEWORK PROGRAMME AND WITHIN THE HEALTH
p.000087: DIRECTORATE, INVOLVING HESCS
p.000087: 1. LYMPHANGIOGENOMICS: fundamental research to better understand the lymphatic vasculature with a view to
...
Social / Soldier
Searching for indicator military:
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p.000086: • Does the proposal involve human data collection?
p.000086:
p.000086: Research on human embryos/foetuses
p.000086: • Does the proposal involve human embryos?
p.000086: • Does the proposal involve human foetal tissue/cells?
p.000086:
p.000086: • Does the proposal involve human embryonic stem cells?
p.000086: Privacy
p.000086: • Does the proposal involve processing of genetic information or personal data (e.g. health, sexual lifestyle,
p.000086: ethnicity, political opinion, religious or philosophical conviction)?
p.000086: • Does the proposal involve tracking the location or observation of people?
p.000086: Research on animals
p.000086: • Does the proposal involve research on animals?
p.000086:
p.000086: • Are those animals transgenic small laboratory animals?
p.000086: • Are those animals transgenic farm animals?
p.000086: • Are those animals cloning farm animals?
p.000086: • Are those animals non-human primates?
p.000086: Research involving developing countries
p.000086: • Use of local resources (genetic, animal, plant, etc.)
p.000086:
p.000086: • Benefit to local community (capacity building, i.e. access to healthcare, education, etc.)
p.000086: Dual use
p.000086: • Research having potential military/terrorist application
p.000086:
p.000086: I CONFIRM THAT NONE OF THE ABOVE ISSUES APPLY TO MY PROPOSAL
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000087: 87
p.000087:
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p.000087:
p.000087:
p.000087:
p.000087:
p.000087: ANNEX III
p.000087:
p.000087: LIST OF PROJECTS SUPPORTED WITHIN THE SIXTH FRAMEWORK PROGRAMME AND WITHIN THE HEALTH
p.000087: DIRECTORATE, INVOLVING HESCS
p.000087: 1. LYMPHANGIOGENOMICS: fundamental research to better understand the lymphatic vasculature with a view to
p.000087: developing therapies to control the growth of lymphatic vessels (e.g. cancer, inflammatory diseases, for
p.000087: tissue ischæmia, lymphœdema)/EUR 9 million, 13 partners, 8 different countries (FI, FR, SE, AT, IT, CH, DE, BE)
p.000087:
p.000087: 2. REPROTECT: model to study reproductive toxicity by a combination of in vitro and sensor technologies/EUR 9.1
p.000087: million, 26 partners, 9 different countries (DE, NL, BE, IT, UK, FR, SE, BG, AT)
p.000087: 3. BETACELL THERAPY: treatment of diabetes: to generate insulin- producing beta cells/EUR 11.8
p.000087: million, 29 partners, 7 different countries (BE, DK, IL, ES, SE, CH, UK)
p.000087:
p.000087: 4. EUROSTEMCELL: comparison of the properties of adult, foetal and embryonic stem cells for the
p.000087: development of therapies including medicines in different set of diseases/disorders (skin, musculoskeletal,
p.000087: neurodegenerative diseases)/EUR 11.9 million, 14 partners, 7 different countries (UK, SE, FR, IT, DE, CH, DK)
p.000087:
p.000087: 5. HEART REPAIR: underlying principles of cardiac muscle cell formation for stem cell replacement therapies for
...
Social / Trade Union Membership
Searching for indicator union:
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p.000003:
p.000003:
p.000003:
p.000003:
p.000003: How to obtain EU publications
p.000003:
p.000003: Our priced publications are available from EU Bookshop (http://bookshop.europa. eu), where you can place an order with
p.000003: the sales agent of your choice.
p.000003:
p.000003: The Publications Office has a worldwide network of sales agents. You can obtain
p.000003: their contact details by sending a fax to (352) 29 29-42758.
p.000003:
p.000003:
p.000003:
p.000003: The European Group on Ethics in Science and New Technologies to the European Commission
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: Recommendations on the ethical review of hESC FP7 research projects
p.000003:
p.000003: Opinion No 22
p.000003: English original
p.000003: Translations in the EU-27 languages available at:
p.000003: http://ec.europa.eu/european_group_ethics/activities/docs/opinion_22_final_follow_up_en.pdf
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p.000003:
p.000003: 20 June 2007
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p.000003:
p.000003:
p.000003:
p.000003: Europe Direct is a service to help you find answers to your questions about the European Union
p.000003:
p.000003: Freephone number (*):
p.000003: 00 800 6 7 8 9 10 11
p.000003: (*) Certain mobile telephone operators do not allow access to 00 800 numbers or these calls may be billed.
p.000003:
p.000003:
p.000003: More information on the European Union is available on the Internet (http://europa.eu). Cataloguing data can be found
p.000003: at the end of this publication.
p.000003: Luxembourg: Office for Official Publications of the European Communities, 2007 ISBN 978-92-79-07137-9
p.000003: © European Communities, 2007
p.000003: Reproduction is authorised provided the source is acknowledged.
p.000003:
p.000003: Printed in Italy
p.000003:
p.000003: Printed on white chlorine-free PaPer
p.000003:
p.000003:
p.000003: Contents
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: SUMMARY
p.000003: 3
p.000003: I. Having regard to
p.000005: 5
p.000005: II. Whereas
p.000012: 12
p.000012: II.1. Preamble
p.000012: 12
p.000012: II.2. The sixth framework programme 13
p.000012: II.3. Human embryonic stem cell (hESC) projects financed under FP6 15
p.000012: II.4. The ethics provisions applying to FP6-funded human embryonic
p.000012: stem cell projects 15
p.000012: II.4.1. FP6 ethics review 15
p.000012: II.4.2. Ethics provisions for FP6 hESC projects 17
p.000012: II.5. The seventh framework programme for research, technological
p.000012: development and demonstration (2007–13) (FP7) 18
p.000012: II.6. Ethics provisions under FP7: hESC research funded
p.000012: by the European Union 20
p.000012: III. Background for the ethical review of hESC projects 21
p.000012: III.1. Existing ethical guidelines: a brief historical overview 21
p.000012: III.2. Research using human embryonic stem cells (hESCs) 23
p.000012: III.3. Sources of human embryonic stem cells 24
p.000012: III.4. Derivation of new hESC lines 25
p.000012: III.5. Alternatives to hESC research 25
p.000012: III.6. European Registry of existing hESC lines 27
p.000012: III.7. EU Member States’ regulations on hESC research 28
p.000012: III.8. Commercialisation and patenting 32
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000001: 1
p.000001:
p.000001:
p.000001: IV. Recommendations 33
p.000001: French translation 47
p.000001: German translation 65
p.000001: IV.1. Preamble
p.000033: 33
p.000033: IV.2. Recommendations for the ethical review of research projects involving hESCs
p.000034: 34
p.000034: IV.2.1. General criteria 35
...
p.000042:
p.000042:
p.000042:
p.000042: Annexes
p.000081: 81
p.000081: Annex I — The sixth framework programme 85
p.000081: Annex II — Ethical review procedures in FP7 85
p.000081: Ethical issues table 87
p.000081: Annex III — List of projects supported within the sixth framework
p.000081: programme and within the Health and Consumer Protection DG, involving hESCs
p.000088: 88
p.000088: Annex IV — EU Member States’ regulatory framework for hESC research 90
p.000088: Appendix : Secretariat of the EGE 144
p.000088:
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p.000002: 2
p.000002:
p.000002: SUMMARY
p.000002:
p.000002:
p.000002: The European Group on Ethics in Science and New Technologies (EGE) adopted Opinion No 22 on 20 June
p.000002: 2007. The opinion indicates the implementing measures (guidelines) to use during the ethics review of
p.000002: seventh framework programme for research and development (FP7) research projects on human embryonic stem cells
p.000002: (hESCs), as requested by the President of the European Commission, Mr Barroso (1), and in line with the
p.000002: adoption of the EU’s FP7.
p.000002:
p.000002: The EGE stressed that, as is the case in the European Union, there are divergent views within the
p.000002: group on the moral legitimacy of research on human embryos and hESCs, ranging from objection to research
p.000002: involving the destruction of human embryos (which makes the full respect of dignity of the human embryo impossible)
p.000002: to a position allowing hESC research under certain conditions or on a broader basis.
p.000002:
p.000002: The group, however, acknowledged the political decision taken as the starting point for its recommendations, but
p.000002: emphasised that the ethical dilemma regarding the moral status of the human embryo and its use in research still
p.000002: persists both within the EGE members and the EU. Therefore, the group did not elaborate ethical arguments on hESC
p.000002: research as such, but worked on recommendations for FP7 ethics review of hESC projects.
p.000002:
p.000002: The EGE recognised the need for promoting responsible research that is transparent, serves the public
p.000002: interest, respects Member State autonomy, preserves public trust, promotes international cooperation and
p.000002: requires the embedding of ethics within research practice. The group indicated that, in addition to the FP7
p.000002: ethics rules already adopted in co-decision, among others the following considerations should apply to hESCs funded by
p.000002: the EU:
p.000002:
p.000002: • FP7 hESC lines have to result from non-implanted IVF embryos;
...
p.000003: between science and humanities and between science and society with respect to the development of new
p.000003: technologies.
p.000003:
p.000003: The EGE also indicated two topics that the group may address in the future:
p.000003: (1) the patenting of hESC-derived materials, and (2) the tension induced by a policy that encourages both free
p.000003: donation and commercial use of derivates from human substances.
p.000003:
p.000003: The recommendations were adopted by unanimity and issued to the Commission on 11 July 2007.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004:
p.000004:
p.000004: RECOMMENDATIONS OF THE EUROPEAN GROUP ON ETHICS IN SCIENCE AND NEW TECHNOLOGIES
p.000004: TO THE EUROPEAN COMMISSION
p.000004:
p.000004:
p.000004: No 22 Original in English 20 JUNE 2007
p.000004: *********************************************************************************************** ETHICAL REVIEW OF HESC
p.000004: FP7 PROJECTS
p.000004: Reference: Request by President Barroso
p.000004: Rapporteurs: A. Cambon-Thomsen, H. Haker, P. Martinho da Silva
p.000004: ********************************************************************************************** THE EUROPEAN GROUP ON
p.000004: ETHICS IN SCIENCE AND NEW TECHNOLOGIES (EGE),
p.000004:
p.000004: I. HAVING REGARD TO
p.000004: Having regard to the Treaty on European Union as amended by the Treaty of Amsterdam, and in particular Article 6
p.000004: (formerly Article F) of the common provisions, concerning respect for fundamental rights, Article 152 (formerly
p.000004: Article 129) of the EC Treaty on public health, and in particular paragraph 4(a) referring to substances of human
p.000004: origin, and Articles 163–
p.000004: 173 (formerly Articles 130F–130P) on research and technological development;
p.000004:
p.000004: Having regard to Recommendation (79)5 of the Committee of Ministers of the Council of Europe to Member
p.000004: States concerning international exchange and transportation of human substances, adopted on 14 March 1979 (2);
p.000004:
p.000004: Having regard to the resolutions of the European Parliament namely the resolution on the ethical and legal problems of
p.000004: genetic engineering, and on artificial insemination in vivo and in vitro, both of 16 March 1989;
p.000004:
p.000004: (2) http://www.coe.int/t/e/social_cohesion/health/recommendations/Rec(79)5.pdf
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005:
p.000005: Having regard to Recommendation R(94)1 of the Committee of Ministers of the Council of Europe on human tissue
p.000005: banks adopted on 14 March 1994 (3);
p.000005:
p.000005: Having regard to Directive 95/46/EC (4) of the European Parliament and of the Council of the European Union of 24
p.000005: October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement
p.000005: of such data;
p.000005:
p.000005: Having regard to the Council of Europe Convention on Human Rights and Biomedicine signed on 4 April 1997 in
p.000005: Oviedo (5), and the additional protocols to the convention;
p.000005:
p.000005: Having regards to Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro
p.000005: diagnostic medical devices (6);
p.000005:
p.000005: Having regard to Commission Decision 2002/364/EC (7) on common technical specifications for in vitro diagnostic medical
p.000005: devices;
p.000005:
p.000005: Having regard to the Convention on the Grant of European Patents (European Patent Convention) of 5 October
p.000005: 1973 (text as amended by the act revising Article 63 EPC of 17 December 1991 and by decisions of the Administrative
p.000005: Council of the European Patent Organisation of 21 December 1978, 13 December 1994, 20 October 1995, 5
p.000005: December 1996,
p.000005: 10 December 1998 and 27 October 2005 and comprising the provisionally
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: (3) http://www.coe.int/T/E/Social_Cohesion/Health/Recommendations/Rec(1994)01.asp (4) OJ L 281,
p.000005: 23.11.1995, pp. 31–50.
p.000005: (5) http://conventions.coe.int/treaty/en/treaties/html/164.htm (6) OJ L 331, 7.12.1998, pp. 1–37.
p.000005: (7) OJ L 131, 16.5.2002, pp. 17–30.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006:
p.000006: applicable provisions of the act revising the EPC of 29 November 2000) (8);
...
p.000007: Personal Data adopted by the Council of Europe on 1 January 1981 (15);
p.000007:
p.000007: Having regard to the United Nations Declaration on Human Cloning adopted by the UN General Assembly on 8 March
p.000007: 2005;
p.000007:
p.000007: Having regard to the common position of the Council of Ministers of 23 March 1998 and the second
p.000007: reading of the European Parliament of 17 June 1998 concerning the fifth framework programme;
p.000007:
p.000007: Having regard to Council Directive 98/44/EC (16) of 6 July 1998 on the legal protection of
p.000007: biotechnological inventions, and in particular Article 6 concerning ordre public and morality;
p.000007:
p.000007: Having regard to the decision of the European Parliament and of the Council of 22 December 1998 adopting the
p.000007: fifth framework programme of the European Community for research, technological development and demonstration
p.000007: activities (1998–2002), and in particular Article 7 concerning compliance with fundamental ethical
p.000007: principles;
p.000007:
p.000007: Having regard to the Council decision of 25 January 1999 concerning the specific programme for research,
p.000007: development and demonstration activities on ‘Quality of life and management of living resources’, and in
p.000007: particular the ethical requirements in footnote (1) of Annex II;
p.000007:
p.000007:
p.000007:
p.000007: (15) http://conventions.coe.int/Treaty/en/Treaties/Html/108.htm (16) OJ L 213, 6.7.1998, pp. 13–21.
p.000007:
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008:
p.000008: Having regard to the Charter of Fundamental Rights of the European Union of 28 September 2000, approved
p.000008: by the European Council in Biarritz on 14 October 2000 and proclaimed solemnly in Nice by the European
p.000008: Parliament, the Council and the Commission on 7 December 2000, and in particular Article 1 (human
p.000008: dignity), Article 3 (right to the integrity of the person) and Article 8 (protection of personal data) (17);
p.000008:
p.000008:
p.000008: Having regard to Council Decision 1513/2002/EC (18) of 27 June 2002 concerning the sixth framework
p.000008: programme of the European Community for research, technological development and demonstration
p.000008: activities (2002 — 2006), and in particular Article 3;
p.000008:
p.000008: Having regard to the programme adopted by the Council on 30 September 2002 in implementing the sixth
p.000008: framework programme for research, technological development and demonstration: ‘Integrating
p.000008: and strengthening the European research area’ (2002–06) (Decision 2002/834/EC) (19);
p.000008:
p.000008: Having regard to the report published by the Commission on 3 April 2003 (SEC(2003) 441) (20);
p.000008:
p.000008: Having regard to the decision of the European Commission on ‘Integrating and strengthening the European research
p.000008: area’ (2002–06) (Decision 2002/834/EC) (21) and the ‘procedural modalities for research activities involving
p.000008: banked or isolated human embryonic stem cells in culture to be funded under Council Decision 2002/834/EC’ (COM C(2003)
p.000008: 2952);
p.000008:
p.000008:
p.000008: (17) OJ C 364, 18.11.2000, pp. 1–22.
p.000008: (18) OJ L 138, 21.4.2004, pp. 7–11.
p.000008: (19) OJ L 294, 29.10.2002, pp. 1–43.
...
p.000014: In total, 18 hESC projects were financed under FP6 within the thematic priority ‘Life sciences, genomics and
p.000014: biotechnology for health’. These 18 projects accounted for less than 3 % of the total number of projects
p.000014: funded within this thematic priority under FP6. Most FP6 hESC projects also involved research into adult stem cells
p.000014: and/or foetal stem cells (comparative approach), but one of the 18 was entirely dedicated to human embryonic
p.000014: stem cell research (Estools). A detailed list of FP6 projects involving the use of hESCs is annexed to
p.000014: these recommendations.
p.000014:
p.000014: II.4. The ethics provisions applying to FP6-funded human embryonic stem cell projects
p.000014:
p.000014: II.4.1. FP6 ethics review
p.000014: In order to implement Article 6 of the framework programme and Article 15 of the rules for participation, the FP6
p.000014: evaluation procedure included a check of the ethical issues raised by the proposals. Following the
p.000014: scientific evaluation, an
p.000014:
p.000014: (37) C(2003) 2952.
p.000014: (38) OJ L 294, 29.10.2002, p. 1.
p.000014:
p.000014:
p.000014:
p.000014:
p.000015: 15
p.000015:
p.000015:
p.000015:
p.000015: ethical review of the successful proposals involving sensitive ethical issues was carried out before the final
p.000015: selection by the Commission.
p.000015:
p.000015: The objective of the ethical review was to make sure that the European Union did not support research contrary to
p.000015: fundamental ethical principles and to examine whether the research complied with the rules relating to ethics
p.000015: set out in the decisions on the sixth framework programme and specific programmes.
p.000015:
p.000015: Breakdown of projects subjected to ethical review, by research area
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: The ethical review was carried out by external experts with the expertise needed for an ethical assessment of the
p.000015: proposals (interdisciplinary approach). The experts were different each time and were selected by the Commission on
p.000015: the basis of expertise, geographical balance and gender balance.
p.000015:
p.000015: The total number of FP6 proposals that underwent an ethical review was 885 (11 % of FP6 research
p.000015: projects), whereby 18 involved human embryonic stem cell research (around 2 % of the total number of ethically
p.000015: reviewed proposals).
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016:
p.000016:
p.000016: The graph below shows the numbers of FP6 projects subjected to ethical review.
p.000016:
p.000016: FP6 Proposals undergoing Ethical Reviews
p.000016:
p.000016:
p.000450: 450
p.000450:
p.000450:
p.000400: 400
p.000400:
p.000400:
p.000350: 350
p.000350:
p.000350:
p.000300: 300
p.000300:
p.000300:
p.000300:
p.000250: 250
p.000250:
p.000250:
p.000200: 200
p.000200:
p.000200: Other
p.000200: hESC Proposals
p.000200:
p.000200:
...
p.000018: a co-decision by the European Parliament and the Council on this issue. This was not the case for FP6,
p.000018: where the ethical framework was included in the specific programme adopted by the Council alone.
p.000018:
p.000018: After intense discussions, the programme was adopted by the Council on 24 July 2006 (qualified majority). The Council
p.000018: agreement was based on a Commission declaration stating that ‘The European Commission will continue with the current
p.000018: practice and will not submit to the Regulatory Committee proposals for projects which include research activities which
p.000018: destroy human embryos, including for the procurement of stem cells. The exclusion of funding of this step of research
p.000018: will not prevent Community funding of subsequent steps involving human embryonic stem cells’.
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: (43) A detailed description of the interinstitutional adoption of the programme can be found at
p.000018: http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=en&DosId=192725
p.000018:
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019:
p.000019:
p.000019: The programme, including the Commission declaration, was then approved at the European Parliament plenary
p.000019: session (second reading) on 30 November 2006 and adopted in co-decision on 18 December 2006.
p.000019:
p.000019:
p.000019:
p.000019: II.6. Ethics provisions under FP7: hESC research funded by the European Union
p.000019: The Council agreement made the eligibility of hESC research for EU funding subject to the same specific
p.000019: restrictions and conditions as with FP6.
p.000019:
p.000019: To ensure an optimal ethics review system, the President of the European Commission asked the EGE on
p.000019: November 2006 to issue an opinion on the ethics review of hESC projects funded under FP7:
p.000019:
p.000019: I would like to invite the European Group on Ethics to provide the Commission with an opinion on the implementing
p.000019: measures required during the ethics review of research projects on human embryonic stem cells that will
p.000019: assure that the ethical rules and requirements are fully met. Such an opinion would provide guidance (in
p.000019: relation to the values and principles to apply) for the Ethics Review within the frame of the Programme approved by the
p.000019: Council and the European Parliament. It would be important that this opinion is available for use when the first FP7
p.000019: projects involving human embryonic stem cells are evaluated (44).
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
...
p.000031: moral cultures, there are different policies for patenting among national patent offices. The European Group on
p.000031: Ethics (EGE) has evaluated the ethical aspects of patenting inventions involving human stem cells (84).
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: (82) OJ L 213, 30.7.1998, pp. 13–21.
p.000031: (83) See COM(2005) 312
p.000031: (84) EGE Opinion No 16, ‘Ethical aspects involving the patenting of human stem cells’.
p.000031:
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032:
p.000032:
p.000032:
p.000032: IV. RECOMMENDATIONS
p.000032:
p.000032: IV.1 Preamble
p.000032:
p.000032:
p.000032: These recommendations constitute the reply to the request from the President of the European
p.000032: Commission, Mr Barroso (85), after the adoption of the EU’s seventh framework programme for research and
p.000032: development (FP7), to elaborate an opinion on the implementing measures required during the ethics review of
p.000032: research projects on human embryonic stem cells (hESCs).
p.000032:
p.000032: As is the case in the European Union, there are divergent views within the European Group on Ethics
p.000032: (EGE) on the moral legitimacy of research on human embryos and hESCs, ranging from objection to research
p.000032: involving the destruction of human embryos (which makes the full respect of dignity of the human embryo impossible),
p.000032: to a position allowing hESC research under certain conditions or on a broader basis.
p.000032:
p.000032: The group acknowledges the political decision taken as the starting point for its recommendations, but emphasises that
p.000032: the ethical dilemma regarding the moral status of the human embryo and its use in research still persists. The EGE
p.000032: therefore stresses that the ethical differences of opinion concerning hESC research have not been resolved.
p.000032:
p.000032: However, these recommendations do not elaborate ethical arguments on hESC research as such; this is
p.000032: because this was not the task given to the group by the European Commission.
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: (85) Letter sent by Commission President Barroso to the EGE on 22 November 2006. ‘I would like to invite the
p.000032: European Group on Ethics to provide the Commission with an opinion on the implementing measures
p.000032: required during the ethics review of research projects on human embryonic stem cells that will assure
p.000032: that the ethical rules and requirements are fully met’.
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000033: 33
p.000033:
p.000033:
p.000033: IV.2. Recommendations for the ethical review of research projects involving hESCs
p.000033:
p.000033: FP7 research projects involving the use of hESCs are subject to stringent rules for selection, are scrutinised at
p.000033: both national and EU level, and undergo both scientific and ethical reviews.
p.000033:
p.000033: Under FP7, research proposals must include information about ethical aspects of the proposed research, explain in
p.000033: detail the project design, and show that the proposal meets the national legal and ethical requirements of the
p.000033: country where the research is performed.
p.000033:
p.000033: After successfully passing the scientific evaluation, the selected hESC proposals undergo a specific ethics review
p.000033: organised by the Commission on a case-by- case basis. The objective of the review is to ensure that
p.000033: the European Union does not support research that would not comply with fundamental ethical principles (86)
p.000033: and to examine whether the ethics rules set out in FP7 are met.
p.000033:
p.000033: The ethics review panel is a transnational body composed of experts from different disciplines. The panel
p.000033: produces an ethical review report, which lists the different ethical issues, describes the way these issues
p.000033: were handled by applicants, and gives the recommendations of the panel.
p.000033:
p.000033: After having successfully passed both the scientific and ethics review, proposals for hESC projects are then handed
p.000033: over to a Regulatory Committee composed of EU Member State representatives, which decides upon the projects on a case-
p.000033: by-case basis.
p.000033:
p.000033:
p.000033: (86) Seventh framework programme (Decision No 1982/2006/EC), Article 6(1): ‘All the research
p.000033: activities carried out under the Seventh Framework Programme shall be carried out in compliance with fundamental
p.000033: ethical principles.’; Rules for Participation, Article 10: ‘A proposal […] which contravenes fundamental ethical
p.000033: principles […] shall not be selected. Such a proposal may be excluded from the evaluation and selection
p.000033: procedures at any time.’
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000034: 34
p.000034:
p.000034:
p.000034: In order to provide guidance to the members of the FP7 hESC ethics review panels who will be asked to
p.000034: review the research projects using hESC lines, and under the specific remit and conditions laid down by the political
p.000034: decision of the European Parliament and of the Council on FP7, and also by the specific request of the President of the
p.000034: European Commission, Mr J. M. Barroso (see above), the EGE elaborated the following guidelines and points to consider
p.000034: when conducting such ethics review of FP7 projects (87).
p.000034:
p.000034:
p.000034: IV.2.1. General criteria
p.000034:
p.000034: The European Commission has stated that it ‘will support actions and initiatives that contribute to coordination
p.000034: and rationalisation of hESC research within a responsible ethical approach’ (88). In line with this statement,
p.000034: the EGE recognises the need to promote responsible research that is transparent, serves the public interest, respects
p.000034: Member States’ autonomy, preserves public trust, promotes international cooperation, and requires the embedding
p.000034: of ethics within research practice (89).
p.000034:
p.000034: Ethically responsible research involving human embryonic stem cells must comply with fundamental ethical
p.000034: principles and human rights in the European Union (90), from the procurement of stem cells (91) to clinical
p.000034: research based on hESCs.
p.000034:
p.000034:
p.000034:
p.000034: (87) According to FP7 rules, evaluators sign a conflict of interest declaration and EC staff
p.000034: verify conflicts with each proposal they evaluate. Evaluation panels of ethics and scientific reviews are anonymous.
p.000034: (88) Declaration of the European Commission on 24 July 2006 during the meeting of the Council of Ministers
p.000034: regarding FP7. See OJ L 412, 30.12.2006.
p.000034: (89) For example, the Council of Europe Oviedo Convention (Article 2).
p.000034: (90) For details, see Section I of this opinion referring to the pertinent documents relevant to
p.000034: the context of medical research.
p.000034: (91) FP7 excludes the procurement of hESCs from Community funding (see paragraph II.2). See
p.000034: Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006
p.000034: concerning the seventh framework programme of the European Community for research, technological
p.000034: development and demonstration activities (2007–13), OJ L 412, 30.12.2006, pp. 1–
p.000034: 41.
p.000034:
p.000034:
p.000034:
p.000034:
p.000035: 35
p.000035:
p.000035:
p.000035: The fundamental rights include: protection rights such as protection of human life, respect of its integrity,
p.000035: protection of health and freedom, political rights such as freedom from undue state intervention or participatory
p.000035: rights in political affairs, and positive rights such as basic social and economic rights insofar as these
p.000035: contribute to health and a threshold of development, resulting in health-related governance (92).
p.000035:
p.000035: The balancing of these three groups of fundamental rights is by no means easy or pre-determined. Rather, it involves
p.000035: ongoing efforts to ensure their protection, granting and promotion of human dignity and human rights and, more
p.000035: concretely, it involves priority setting with respect to health-related research.
p.000035:
p.000035: General criteria for research incentives in specific areas incorporate this balancing. They can be
p.000035: summarised as follows:
p.000035:
p.000035: • scientific necessity and high-ranking status of the research (93);
p.000035: • urgency (94);
p.000035: • social desirability;
p.000035: • primacy of the interest and welfare of the human being over the sole interest of society or science.
p.000035:
p.000035: Social desirability is open to political and societal discourse on the goals and perspectives of the
p.000035: European Union in the 21st century, in particular the relation between economic growth and social goals, such as the
p.000035: promotion of healthcare standards and their sustainable application at national, international and global
p.000035: level.
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: (92) See the United Nations’ millennium goals, which the European Union has committed itself to
p.000035: achieving.
p.000035: (93) http://ec.europa.eu/research/fp7/index_en.cfm?pg=documents
p.000035: (94) http://www.who.int/rpc/en/HealthResearchinPolicyMaking.pdf
p.000035:
p.000035:
p.000035:
p.000035:
p.000036: 36
p.000036:
p.000036:
p.000036:
p.000036: As far as hESC research is concerned, there is no consensus on its social acceptability in the European
p.000036: Union, and divergent views coexist. A debate on the best model (e.g. ‘minimal consensus’ or
p.000036: ‘subsidiarity’ model) to regulate hESC research at EU level is therefore taking place within and across several EU
p.000036: Member States.
p.000036:
p.000036: Where morally sensitive means are to be used to achieve well-accepted goals — as in the case of human embryonic stem
p.000036: cells –— where not the goal of therapy- oriented research is questioned but the means to accomplish it, the EGE holds
p.000036: that additional criteria apply concerning the necessity of the research: (1) non- availability of validated
p.000036: alternatives, and (2) the non-redundancy of FP7 projects (95).
p.000036:
p.000036: However, all the above criteria, which constitute the key scientific evaluation criteria, need to be assessed
p.000036: from an ethical perspective during the ethics review process. It is clear that the ethics review cannot and
p.000036: should not duplicate the scientific evaluation, which remains the main assessment of the scientific quality of the
p.000036: project proposals. Nevertheless, the two reviews are complementary. As far as FP7 hESC projects are concerned, the
p.000036: Commission should ensure that the scientific evaluation report is available to the ethics review panel and that there
p.000036: is effective communication between the two panels if needed.
p.000036:
p.000036: To ensure the complementarity of the two reviews, the scientific review report should address at least the
p.000036: points below.
p.000036:
...
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038: (96) Article 6(3), http://cordis.europa.eu/fp7/ethics-ict_en.html
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000039: 39
p.000039:
p.000039:
p.000039:
p.000039: IV.2.3. Additional criteria for FP7
p.000039:
p.000039: IV.2.3.1. Use of alternatives to hESCs
p.000039: Should alternatives to hESCs with the same potential as embryo-derived stem cells be found in the
p.000039: future, the implications of such developments for both scientific and ethical aspects of the hESC-based research
p.000039: projects ought to be taken into account as soon as possible.
p.000039:
p.000039: IV.2.3.2. Donors’ rights
p.000039: The donation of human embryos for the production of hESCs for research purposes poses a moral dilemma. This
p.000039: arises from the fact that human embryos are not ‘neutral objects’. Informed consent should address explicitly
p.000039: this moral dilemma, leaving the decision to the donors.
p.000039:
p.000039: The protection rights of donors need particular attention, in a very concrete way, meaning that those countries
p.000039: allowing the procurement of hESCs must provide information on the procurement process for the stem cell lines
p.000039: used by the applicant. The information should state that the measures of this process are in accordance with the
p.000039: fundamental ethical principles and human rights in force in the European Union, national legislation applicable at the
p.000039: time of the donation in the country where the donation was carried out and other relevant EU
p.000039: regulations (97). Applicants must provide information from the institutes generating the stem
p.000039: cell lines that the following criteria have been met for the procurement of hESCs:
p.000039:
p.000039: • no pressure has been put on the donors at any stage (98);
p.000039:
p.000039: (97) See EC/2004/23.
p.000039: (98) See ISSCR guidelines (http://www.isscr.org/guidelines/, p. 9, ‘Procurement of materials: For
p.000039: donating embryos or gametes generated in the course of clinical treatment. Except when specifically
p.000039: authorized by the SCRO (relevant ethics board) process, no reimbursement of direct expenses or financial
p.000039: considerations of any kind may be provided for donating embryos or gametes that have been generated in the
p.000039: course of clinical treatment and are in excess of clinical
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000040: 40
p.000040:
p.000040:
p.000040: • the donor’s health has not been put at risk by excessive ovarian stimulation;
p.000040: • as far as new hESC lines are concerned, informed consent to the donation for research of an embryo, originally
p.000040: planned for reproduction, is given in knowledge of the kind of research intended (99), its implications
p.000040: (including commercial) and in respect of the conditions foreseen by law at the time of the donation in the country
p.000040: where the donation was carried out;
...
p.000043: medicine and health-related justice, including the issue of global justice;
p.000043: • the relation between science and humanities and between science and society with respect to the
p.000043: development of new technologies;
p.000043: • the ongoing efforts of scientific alternatives and their anthropological and ethical interpretations.
p.000043:
p.000043: The EGE also acknowledges that a number of issues will need further clarification,
p.000043: interdisciplinary research, thorough ethical evaluation and, if found necessary in the future, also
p.000043: appropriate legal action. At present, the EGE believes, the following issues require particular attention.
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000044: 44
p.000044:
p.000044:
p.000044: 1. The current provisions for patenting hESC-derived materials need to be addressed. Given new
p.000044: developments in research and taking into consideration the ongoing debate on the limits of
p.000044: patenting of biological materials, the EGE would like to deal with this issue at a later point in time
p.000044: (104).
p.000044:
p.000044: 2. The tension induced by a policy that encourages both free donation (105) and commercial use of derivates from human
p.000044: substances needs to be addressed.
p.000044:
p.000044: The EGE emphasises its view that the use of human embryos to generate stem cells should be minimised as much as
p.000044: possible. The EGE calls on the European Union to develop appropriate systems to minimise the use of human embryos to
p.000044: cases for which no alternatives exist.
p.000044:
p.000044: IV.4. Review of recommendations and communication with the Advisory Board of the European Registry on Human
p.000044: Embryonic Stem Cell Research
p.000044:
p.000044: The EGE would also welcome interaction with the Advisory Board of the European Registry on Human Embryonic
p.000044: Stem Cell Research, in particular with the registry’s Ethics Advisory Board, in order to address the ethical
p.000044: concerns regarding the procurement of stem cells and the storing of data in the light of the ongoing progress in this
p.000044: area.
p.000044:
p.000044: The concrete form and means of this collaboration should be specified and put into place, and should be
p.000044: appropriately supported and funded by the Commission.
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044: (104) The EGE has issued an opinion on ‘Ethical aspects of patenting inventions involving human stem cells’
p.000044: (http://www.ec.europa.eu/european_group_ethics/docs/avis16_en.pdf).
p.000044: (105) Article 12, Directive 2004/23/EC: ‘The EC encourages Member States to promote the voluntary
p.000044: and unpaid donation of tissue and cells’.
p.000044:
p.000044:
p.000044:
p.000044:
p.000045: 45
p.000045:
p.000045:
p.000045:
p.000045:
p.000045: IV. TRANSLATIONS OF THE RECOMMENDATIONS IN FRENCH AND GERMAN (106)
p.000045:
p.000045: IV.I. French translation
p.000045:
p.000045: RECOMMANDATIONS CONCERNANT L'EXAMEN ÉTHIQUE DES PROJETS DE RECHERCHE DU 7E PC DANS LE DOMAINE DES CSEH — Avis n° 22
p.000045:
p.000045: IV. RECOMMANDATIONS
p.000045: IV.1. Préambule
p.000045:
p.000045:
p.000045: Les présentes recommandations constituent la réponse à la demande du président de la Commission européenne, M.
p.000045: Barroso (107), après l'adoption du septième programme-cadre de l'Union européenne pour la recherche et le
p.000045: développement (7e PC), de formuler un avis sur les mesures d'exécution requises lors de l'examen éthique
p.000045: des projets de recherche sur les cellules souches embryonnaires humaines (CSEH).
p.000045:
p.000045: Tout comme au sein de l'Union européenne, il existe des vues divergentes au sein du Groupe européen d'éthique (GEE)
p.000045: quant à la légitimité morale de la recherche sur les embryons humains et les CSEH, qui vont du refus de la
p.000045: recherche comportant la destruction d'embryons humains (rendant impossible le respect total de la dignité de l'embryon
p.000045: humain) à une position permettant la recherche sur les CSEH sous certaines conditions ou sur une base plus
p.000045: générale.
p.000045:
p.000045: Le groupe prend acte de la décision politique servant de point de départ à ses recommandations, mais souligne que le
p.000045: dilemme éthique subsiste à propos du statut moral de l'embryon humain et de son utilisation dans le cadre de la
p.000045: recherche. Le GEE insiste donc sur le fait que les divergences de vues d'ordre éthique relatives à la
p.000045: recherche sur les CSEH n'ont pas été résolues.
p.000045:
p.000045: Cependant, ces recommandations ne formulent pas d'arguments éthiques sur la recherche sur les CSEH en tant que telle,
p.000045: car telle n'était pas la mission confiée au Groupe par la Commission européenne.
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000047: 47
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
...
p.000047: européenne: «Je souhaiterais inviter le Groupe européen d'éthique à remettre à la Commission un avis sur les mesures
p.000047: d'exécution requises lors de l'examen éthique des projets de recherche sur les cellules souches embryonnaires humaines
p.000047: pour assurer le respect intégral des règles et exigences éthiques».
p.000047: (107) Translations from the English original — only the English text is authentic. Translations in the EU-27
p.000047: languages are available at:
p.000047: http://ec.europa.eu/european_group_ethics/activities/docs/opinion_22_final_follow_up_en.pdf, or upon request to the EGE
p.000047: Secretariat mailbox (bepa-ethics-group@ec.europa.eu)
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000048: 48
p.000048:
p.000048:
p.000048: IV.2. Recommandations pour l'examen éthique des projets de recherche impliquant des CSEH
p.000048:
p.000048: Les projets de recherche du 7e PC comportant l'utilisation de CSEH sont soumis à des règles de sélection
p.000048: rigoureuses, sont contrôlés aux niveaux national et communautaire, et font l'objet d'examens scientifiques et
p.000048: éthiques.
p.000048:
p.000048: Dans le cadre du 7e PC, les propositions de recherche doivent comprendre des informations sur les aspects éthiques
p.000048: de la recherche proposée, expliquer en détail la conception du projet et démontrer que la proposition
p.000048: répond aux exigences juridiques et éthiques du pays dans lequel la recherche est menée.
p.000048:
p.000048: Après avoir passé avec succès l'étape de l'évaluation scientifique, les propositions CSEH retenues
p.000048: subissent un examen éthique spécifique organisé par la Commission au cas par cas. L'objectif de cet examen est de
p.000048: garantir que l'Union européenne ne soutient pas des recherches qui ne seraient pas conformes aux
p.000048: principes éthiques fondamentaux (108) et de contrôler si les règles d'éthique définies dans le 7e PC sont respectées.
p.000048:
p.000048: Le comité d'examen éthique est un organisme transnational composé d'experts de différentes disciplines. Le comité
p.000048: produit un rapport d'examen éthique, qui énumère les différentes questions éthiques, décrit la manière dont ces
p.000048: questions ont été traitées par les demandeurs et énonce les recommandations du comité.
p.000048:
p.000048: Après avoir passé avec succès l'examen scientifique et éthique, les propositions de projets CSEH sont ensuite
p.000048: transmises à un comité de réglementation composé de représentants des États membres de l'UE, qui statue sur les
p.000048: projets au cas par cas.
p.000048:
p.000048: (108) Septième programme-cadre (décision n° 1982/2006/CE), article 6, paragraphe 1: «Toutes les actions
p.000048: de recherche menées au titre du septième programme-cadre sont réalisées dans le respect des principes éthiques
p.000048: fondamentaux.»; règles de participation, article 10: «une proposition […] allant à l’encontre des principes
p.000048: éthiques fondamentaux […] n’est pas sélectionnée. Une telle proposition peut être exclue à tout moment des
p.000048: procédures d’évaluation et de sélection.»
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000049: 49
p.000049:
p.000049:
p.000049: Afin de fournir des lignes directrices aux membres des comités d'examen éthique du 7e PC en matière de CSEH, qui
p.000049: seront invités à examiner les projets de recherche utilisant des lignées de CSEH, et dans le cadre du
p.000049: mandat et des conditions spécifiques établis par la décision politique du Parlement européen et du Conseil relative
p.000049: au 7e PC, ainsi que par la demande spécifique du président de la Commission européenne, M. J. M. Barroso (voir
p.000049: ci-dessus), le GEE a élaboré les lignes directrices et points suivants à prendre en compte lors de
p.000049: l'examen éthique de projets dans le cadre du 7e PC (109).
p.000049:
p.000049:
p.000049: IV.2.1. Critères généraux
p.000049:
p.000049: La Commission européenne a déclaré qu'elle «soutiendra les actions et initiatives qui contribuent à
p.000049: coordonner et rationaliser les activités de recherche sur les cellules souches embryonnaires humaines selon
p.000049: une approche déontologique responsable» (110). En conformité avec cette déclaration, le GEE reconnaît la
p.000049: nécessité de promouvoir une recherche responsable et transparente, qui sert l'intérêt public,
p.000049: respecte l'autonomie des États membres, préserve la confiance du public, encourage la coopération internationale et
p.000049: exige l'adoption d'une démarche déontologique dans les activités de recherche (111).
p.000049:
p.000049: La recherche sur les cellules souches embryonnaires humaines, menée selon une approche déontologique
p.000049: responsable, doit être conforme aux principes éthiques fondamentaux et aux droits de l'homme dans l'Union
p.000049: européenne (112),
p.000049:
p.000049:
p.000049:
p.000049:
p.000049: (109) Selon les règles du 7e PC, les évaluateurs signent une déclaration d'absence de conflit d'intérêts, et le
p.000049: personnel de la Commission européenne vérifie les conflits avec chacune des propositions qu'ils évaluent. Les comités
p.000049: d'évaluation des examens éthiques et scientifiques sont anonymes.
p.000049: (110) Déclaration de la Commission européenne du 24 juillet 2006, lors de la réunion du Conseil
p.000049: de ministres, à propos du 7e PC. Voir JO L 412 du 30.12.2006, p. 43.
p.000049: (111) Par exemple la convention d'Oviedo du Conseil de l'Europe (article 2).
p.000049: (112) Pour plus de détails, voir la section I du présent avis relative aux documents pertinents
p.000049: dans le cadre de la recherche médicale.
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000050: 50
p.000050:
p.000050:
p.000050:
p.000050: depuis la fourniture des cellules souches (113) jusqu'aux activités de recherche cliniques portant sur les
p.000050: CSEH.
p.000050:
p.000050: Les droits fondamentaux comprennent: les droits de protection tels que la protection de la vie humaine, le
p.000050: respect de son intégrité, la protection de la santé et de la liberté, les droits politiques tels que l'absence
p.000050: d'intervention injustifiée de l'État ou les droits participatifs dans le domaine politique, ainsi que les
p.000050: droits positifs tels que les droits sociaux et économiques de base dans la mesure où ils contribuent à la santé et
p.000050: à un seuil de développement, avec pour résultat une gouvernance de la santé (114).
p.000050:
p.000050: L'équilibre entre ces trois catégories de droits fondamentaux n'est nullement facile ni prédéterminé, mais
p.000050: implique des efforts continus pour assurer leur protection, la reconnaissance et la promotion de la dignité
p.000050: humaine et des droits de l'homme et, plus concrètement, implique de définir des priorités en matière de recherche
p.000050: médicale.
p.000050:
p.000050: Les critères généraux des éléments d'incitation de la recherche dans des domaines spécifiques intègrent cet
p.000050: équilibre. Ils peuvent être récapitulés comme suit:
p.000050:
p.000050: • la nécessité scientifique et le haut statut de la recherche (115),
p.000050: • l'urgence (116) et
p.000050: • la désirabilité sociale,
p.000050: • la primauté de l'intérêt et du bien-être de l'être humain sur l'intérêt exclusif de la société ou de la science.
p.000050:
p.000050: (113) Le 7e PC exclut l'approvisionnement en CSEH du financement communautaire (voir
p.000050: paragraphe II.2). Voir décision n° 1982/2006/CE du Parlement européen et du Conseil du 18 décembre
p.000050: 2006 relative au septième programme-cadre de la Communauté européenne pour des actions de recherche, de développement
p.000050: technologique et de démonstration (2007-2013), JO L 412 du 30.12.2006, p. 1-41.
p.000050: (114) Cf. les objectifs du millénaire des Nations Unies, que l'Union européenne s'est engagée à réaliser.
p.000050: (115) http://ec.europa.eu/research/7PC/index_en.cfm?pg=documents.
p.000050: (116) http://www.who.int/rpc/en/HealthResearchinPolicyMaking.pdf.
p.000050:
p.000050:
p.000050:
p.000050:
p.000051: 51
p.000051:
p.000051:
p.000051:
p.000051: La désirabilité sociale donne lieu à un discours politique et sociétal sur les objectifs et perspectives de
p.000051: l'Union européenne au XXIe siècle, en particulier sur la relation entre la croissance économique et les
p.000051: objectifs sociaux, tels que la promotion des normes de santé et leur application durable aux niveaux national,
p.000051: international et mondial.
p.000051:
p.000051: En ce qui concerne la recherche sur les CSEH, il n'y a aucun consensus sur son acceptabilité sociale au sein de
p.000051: l'Union européenne, et des vues divergentes coexistent. Un débat sur le meilleur modèle (par exemple un
p.000051: «consensus minimal» ou la «subsidiarité») pour réglementer la recherche sur les CSEH au niveau de l'UE a donc
p.000051: lieu dans plusieurs États membres de l'UE.
p.000051:
p.000051: Lorsque des moyens sensibles sur le plan éthique doivent être utilisés pour atteindre des objectifs
p.000051: unanimement acceptés — comme dans le cas des cellules souches embryonnaires humaines —, lorsque la finalité de la
p.000051: recherche thérapeutique n'est pas remise en cause mais les moyens d'y parvenir, le GEE soutient que des critères
p.000051: additionnels s'appliquent en ce qui concerne la nécessité de la recherche: 1) la non-disponibilité
p.000051: d'alternatives validées et 2) la non-redondance des projets du 7e PC (117).
p.000051:
p.000051: Cependant, tous les critères indiqués ci-dessus, qui constituent les principaux critères d'évaluation
p.000051: scientifique, doivent être évalués d'un point de vue éthique au cours du processus d'examen éthique. Il est
p.000051: clair que l'examen éthique ne peut pas et ne doit pas faire double emploi avec l'évaluation
p.000051: scientifique, qui demeure la principale évaluation de la qualité scientifique des propositions de projets.
p.000051: Néanmoins, les deux examens sont complémentaires. En ce qui concerne les projets CSEH du 7e PC,
p.000051: la Commission doit veiller à ce que le
p.000051:
p.000051:
p.000051:
p.000051: (117) Des répétitions sont cependant parfois nécessaires pour apporter la preuve de la réussite; il
p.000051: ne s'agit pas d'exercices redondants au sens où on l'entend ici.
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000052: 52
p.000052:
p.000052:
p.000052:
...
p.000054:
p.000054:
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p.000054:
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p.000054:
p.000054:
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p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
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p.000054:
p.000054:
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p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000055: 55
p.000055:
p.000055:
p.000055: IV.2.3. Critères additionnels pour le 7e PC
p.000055:
p.000055: IV.2.3.1. Utilisation de solutions alternatives aux CSEH
p.000055: En cas de découverte future de solutions alternatives aux CSEH présentant le même potentiel que les
p.000055: cellules souches embryonnaires, il conviendra de prendre en compte au plus vite les implications de ces
p.000055: avancées, pour les aspects tant scientifiques qu'éthiques des projets de recherche basés sur les CSEH.
p.000055:
p.000055: IV.2.3.2. Droits des donneurs
p.000055: Le don d'embryons humains pour la production de CSEH à des fins de recherche pose un dilemme moral, qui résulte du fait
p.000055: que les embryons humains ne sont pas des «objets neutres». Ce dilemme moral doit faire l'objet d'un consentement
p.000055: éclairé explicite, laissant la décision aux donneurs.
p.000055: Les droits de protection des donneurs requièrent une attention particulière, sous une forme très concrète,
p.000055: ce qui signifie que les pays autorisant l'approvisionnement en CSEH doivent fournir des informations
p.000055: sur le processus d'obtention des lignées de cellules souches utilisées par le demandeur. Ces informations
p.000055: doivent préciser que les mesures de ce processus sont conformes aux principes éthiques fondamentaux et aux droits de
p.000055: l'homme en vigueur dans l'Union européenne, à la législation nationale applicable au moment du don dans le pays où
p.000055: le don est effectué et aux autres règlements communautaires applicables (119). Les demandeurs doivent
p.000055: fournir des informations en provenance des instituts produisant les lignées de cellules souches
p.000055: selon lesquelles les critères énoncés ci-après ont été respectés lors de l'obtention de CSEH:
p.000055:
p.000055: • aucune pression n'a été exercée à aucun moment sur les donneurs (120);
p.000055:
p.000055: (119) Voir la directive 2004/23/CE.
p.000055: (120) Voir les lignes directrices de l'ISSCR (société internationale de recherche sur les cellules souches)
p.000055: [http://www.isscr.org/guidelines/, p. 9, «Approvisionnement en matériels: pour les dons d'embryons
p.000055: ou de gamètes produits au cours d'un traitement clinique. Sauf en cas d'autorisation
p.000055:
p.000055:
p.000055:
p.000055:
p.000056: 56
p.000056:
p.000056:
p.000056: • la santé du donneur n'a pas été mise en danger par une stimulation ovarienne excessive;
p.000056: • pour les nouvelles lignées de CSEH, un consentement éclairé concernant le don pour la recherche d'un embryon
p.000056: initialement destiné à la reproduction est donné en connaissant la nature des recherches prévues (121),
p.000056: leurs implications (y compris commerciales) et dans le respect des conditions prévues par la loi au moment du
p.000056: don dans le pays où celui-ci a été effectué;
p.000056: • le donneur a été informé qu'il pourrait retirer son consentement jusqu'au stade de la création des
p.000056: cellules souches (122);
p.000056: • le traitement de l'infertilité et la recherche sont correctement séparés;
...
p.000060: • la relation entre la science et les sciences humaines et entre la science et la société en ce qui concerne le
p.000060: développement de nouvelles technologies;
p.000060: • les efforts continus des solutions alternatives scientifiques et leurs interprétations
p.000060: anthropologiques et éthiques.
p.000060:
p.000060: Le GEE reconnaît également qu'un certain nombre de questions devront faire l'objet de précisions
p.000060: supplémentaires, d'une recherche interdisciplinaire, d'une évaluation éthique complète et également, si cela
p.000060: s'avère nécessaire dans le futur, d'une action en justice appropriée. Le GEE estime actuellement que les
p.000060: questions suivantes exigent une attention particulière:
p.000060:
p.000060: • les dispositions courantes de brevetabilité des matériels issus de CSEH doivent être abordées.
p.000060: Étant donné les nouvelles avancées de la recherche et compte tenu du débat en cours sur
p.000060: les limites de brevetabilité des matériels biologiques, le GEE voudrait traiter cette question
p.000060: ultérieurement (126);
p.000060:
p.000060: • la tension induite par une politique qui encourage à la fois le don gratuit (127) et l'utilisation
p.000060: commerciale de dérivés de substances humaines doit être abordée.
p.000060:
p.000060: Le GEE souligne avec insistance le fait que l'utilisation d'embryons humains pour produire des cellules souches
p.000060: doit être limitée au minimum possible. Le GEE invite l'Union européenne à développer des systèmes
p.000060: appropriés pour limiter
p.000060:
p.000060:
p.000060:
p.000060: (126) Le GEE a émis un avis sur les aspects éthiques de la brevetabilité des inventions impliquant des cellules
p.000060: souches humaines, http://www.ec.europa.eu/european_group_ethics/docs/avis16_fr.pdf.
p.000060: (127) Article 12 de la directive 2004/23/CE: «Les États membres s'efforcent de garantir les dons
p.000060: volontaires et non rémunérés de tissus et cellules.»
p.000060:
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p.000061: 61
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p.000061:
p.000061:
p.000061: l'utilisation d'embryons humains aux cas pour lesquels il n'existe aucune solution de rechange.
p.000061:
p.000061: IV.4. Examen des recommandations et communication avec le comité consultatif du registre européen des lignées de
p.000061: cellules souches embryonnaires humaines
p.000061: Le GEE serait également favorable à une interaction avec le comité consultatif du registre européen des lignées de
p.000061: cellules souches embryonnaires humaines, en particulier avec le comité consultatif du registre en matière
p.000061: d'éthique, afin d'aborder les questions éthiques relatives à l'obtention de cellules souches et au stockage des
p.000061: données à la lumière des progrès continus dans ce domaine.
p.000061: La forme et les moyens concrets de cette collaboration devraient être précisés et mis en place, et devraient être
p.000061: convenablement soutenus et financés par la Commission.
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p.000062:
p.000062: Membres:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Emmanuel Agius Diana Banati Anne Cambon-Thomsen
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Rafael Capurro Inez de Beaufort Jozef Glasa
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Hille Haker Julian Kinderlerer Krzysztof Marczewski
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Paula Martinho Da Silva Linda Nielsen
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Pere Puigdomenech-Rosell Günter Virt
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p.000063: 63
p.000063:
p.000063:
p.000063: IV.I. GERMAN TRANSLATION128
p.000063:
p.000063: DEUTSCHE ÜBERSETZUNG DER : EMPFEHLUNGEN ZUR ETHISCHEN PRÜFUNG VON FP7- FORSCHUNGSPROJEKTEN MIT HUMANEN EMBRYONALEN
p.000063: STAMMZELLEN - STELLUNGNAHME NR. 22 -
p.000063: IV. EMPFEHLUNGEN
p.000063: IV.1 Einleitung
p.000063:
p.000063:
p.000063: Nach Verabschiedung des Siebten Rahmenprogramms für Forschung und Entwicklung (FP7) forderte der Präsident der
p.000063: Europäischen Kommission, Herr Barroso129, die Gruppe auf, eine Stellungnahme zu den
p.000063: Durchführungsmaßnahmen auszuarbeiten, die bei der ethischen Prüfung von Forschungsprojekten mit humanen embryonalen
p.000063: Stammzellen (hES-Zellen) erforderlich sind. Die vorliegenden Empfehlungen sind das Ergebnis dieser Arbeit.
p.000063:
p.000063: Wie in der Europäischen Union generell, so gehen auch innerhalb der EGE die Ansichten über die moralische
p.000063: Legitimität der Forschung an humanen Embryonen und humanen embryonalen Stammzellen auseinander; sie
p.000063: reichen von der Ablehnung der verbrauchenden Embryonenforschung (da diese es unmöglich macht, die Würde des
p.000063: menschlichen Embryos zu wahren) bis zur Position, die Forschung mit hES-Zellen unter bestimmten
p.000063: Bedingungen oder auf breiterer Basis zu erlauben.
p.000063:
p.000063: Die Gruppe erkennt den politischen Beschluss als Ausgangspunkt dieser Empfehlungen an, betont aber
p.000063: gleichzeitig, dass das ethische Dilemma hinsichtlich des Status des humanen Embryos und seiner Verwendung
p.000063: für Forschungszwecke nach wie vor besteht. Die EGE unterstreicht daher, dass die Meinungsunterschiede in ethischen
p.000063: Fragen im Zusammenhang mit der Forschung an humanen embryonalen Stammzellen nicht ausgeräumt wurden.
p.000063:
p.000063: In diesen Empfehlungen werden jedoch keine ethischen Argumente über die Forschung an humanen embryonalen Stammzellen
p.000063: als solche erarbeitet, da dies nicht dem von der Europäischen Kommission der Gruppe erteilten Auftrag
p.000063: entsprach.
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p.000064: 129 Schreiben des Präsidenten der Europäischen Kommission, Herrn Barroso, an die EGE vom
p.000064: 22.11.2006. „Ich möchte die Europäische Ethikgruppe auffordern, für die Kommission eine Stellungnahme über
p.000064: die Durchführung von Maßnahmen auszuarbeiten, die für die ethische Prüfung von Forschungsprojekten mit humanen
p.000064: embryonalen Stammzellen erforderlich sind, um sicherzustellen, dass die ethischen Regeln und Anforderungen vollständig
p.000064: eingehalten werden.“
p.000064:
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p.000065: 65
p.000065:
p.000065:
p.000065: IV.2 Empfehlungen zur ethischen Prüfung von Forschungsprojekten mit hES-Zellen
p.000065:
p.000065: FP7-Forschungsprojekte, in denen hES-Zellen verwendet werden, unterliegen bei der Auswahl strengen Regeln,
p.000065: werden sowohl auf nationaler wie auf EU- Ebene überwacht und durchlaufen sowohl wissenschaftliche als auch
p.000065: ethische Prüfungen.
p.000065:
p.000065: Forschungsanträge im Rahmen des FP7 müssen Informationen über ethische Aspekte der vorgeschlagenen Arbeit
p.000065: enthalten; die Projektgestaltung ist detailliert zu erläutern und es ist nachzuweisen, dass der Antrag den
p.000065: rechtlichen und ethischen Anforderungen des Landes entspricht, in denen die Forschung durchgeführt
p.000065: wird.
p.000065:
p.000065: Nachdem die Forschungsvorhaben die wissenschaftliche Prüfung erfolgreich durchlaufen haben, werden die
p.000065: Forschungsprojekte mit hES-Zellen einer speziellen von der Kommission organisierten ethischen
p.000065: Einzelfallprüfung unterzogen. Das Ziel dieser Prüfung ist es sicherzustellen, dass die Europäische Union keine
p.000065: Forschung unterstützt, die mit grundlegenden ethischen Prinzipien unvereinbar ist130, und es soll überprüft
p.000065: werden, ob die im FP7 festgelegten ethischen Regeln eingehalten werden.
p.000065:
p.000065: Dem transnational zusammengesetzten Gremium gehören Experten unterschiedlicher Disziplinen an.
p.000065: Es erarbeitet einen Bericht, in dem die verschiedenen ethischen Fragen aufgeführt werden und
p.000065: beschrieben wird, wie die Antragsteller mit ihnen umgehen; außerdem enthält der Bericht die
p.000065: Empfehlungen des Gremiums.
p.000065:
p.000065:
p.000065: 130 Siebtes Rahmenprogramm (Beschluss Nr. 1982/2006/EG), Artikel 6 Absatz 1: „Bei allen
p.000065: Forschungsmaßnahmen innerhalb des Siebten Rahmenprogramms werden die ethischen Grundprinzipien
p.000065: beachtet.“ Regeln für die Beteiligung, Artikel 14 Absatz 2: „Ein Vorschlag, der im Widerspruch zu grundlegenden
p.000065: ethischen Prinzipien steht […], wird nicht ausgewählt. Ein
p.000065:
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p.000066: 66
p.000066:
p.000066: Vorschläge für hES-Zellforschungen werden, sobald sie die wissenschaftliche und die ethische Prüfung
p.000066: durchlaufen haben, einem Regelungsausschuss vorgelegt, der aus Vertretern der EU-Mitgliedstaaten
p.000066: besteht und auf Einzelfallbasis über die Projekte entscheidet.
p.000066:
p.000066: Für die Mitglieder der Gremien, die im Rahmen des FP7 die ethische Prüfung von Forschungsprojekten mit
p.000066: hES-Zelllinien vornehmen sollen, hat die EGE entsprechend dem konkreten Mandat und den Bedingungen, die im
p.000066: politischen Beschluss des Europäischen Parlaments und des Rates über das FP7 festgelegt sind, sowie auf die
...
p.000066: beitragen, dass Forschungsarbeiten mit humanen embryonalen Stammzellen auf ethisch vertretbare Art und Weise
p.000066: koordiniert und rationalisiert werden können“132. Übereinstimmend mit dieser Erklärung ist auch die EGE der Ansicht,
p.000066: dass nur ethisch vertretbare Forschung gefördert werden kann, die transparent ist, dem öffentlichen Interesse
p.000066: dient, die Autonomie der Mitgliedstaaten respektiert, das Vertrauen der Öffentlichkeit wahrt,
p.000066: die internationale Zusammenarbeit fördert und die ethischen Fragen in der Forschungspraxis
p.000066: verankert133.
p.000066:
p.000066: solcher Vorschlag kann jederzeit von den Bewertungs-, Auswahl- und Gewährungsverfahren ausgeschlossen werden.“
p.000066: 131 Nach den Regeln für die Beteiligung am FP7 unterzeichnen die Bewerter eine Erklärung zum
p.000066: Interessenkonflikt, und die Kommissionsdienststelle überprüft bei jedem Vorschlag, den sie bewertet, ob
p.000066: ein Interessenkonflikt besteht. Die Evaluationsgremien der ethischen und wissenschaftlichen Bewertungen
p.000066: sind anonym.
p.000066: 132 Erklärung der Europäischen Kommission vom 24. Juli 2006 während der Ministerratstagung über das FP7.
p.000066: Siehe ABl. L 412/43 vom 30. Dezember 2006.
p.000066: 133 Siehe beispielsweise das Übereinkommen von Oviedo des Europarats (Artikel 2).
p.000066:
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p.000067: 67
p.000067:
p.000067:
p.000067: Ethisch vertretbare Forschung mit humanen embryonalen Stammzellen muss von der Beschaffung der Stammzellen134
p.000067: bis zu der auf hES-Zellen basierenden klinischen Forschung den grundlegenden ethischen Prinzipien
p.000067: und Menschenrechten der Europäischen Union entsprechen135.
p.000067:
p.000067: Zu den Grundrechten gehören: Schutzrechte, etwa das Recht auf Leben und auf körperliche Unversehrtheit und der
p.000067: Schutz von Gesundheit und Freiheit, politische Rechte, etwa das Recht auf Schutz vor ungerechtfertigtem
p.000067: Eingreifen des Staates oder das Recht auf politische Betätigung, und positive Rechte, etwa grundlegende soziale und
p.000067: wirtschaftliche Rechte, soweit sie zur Gesundheit und zum Erreichen einer Entwicklungsschwelle beitragen und
p.000067: die Einführung gesundheitsbezogener Steuerungsmechanismen erfordern.136
p.000067:
p.000067: Der Ausgleich zwischen diesen drei Gruppen von Grundrechten ist keineswegs leicht herzustellen oder gar
p.000067: vorgegeben. Eher ist es so, dass laufend Bemühungen erforderlich sind, um ihren Schutz
p.000067: sicherzustellen und die Menschenwürde und die Menschenrechte zu gewährleisten und zu fördern. Konkret
p.000067: bedeutet dies im Zusammenhang mit gesundheitsrelevanter Forschung auch, Prioritäten zu setzen.
p.000067:
p.000067: Die allgemeinen Kriterien, nach denen Forschungsförderung betrieben wird, beinhalten eine solche
p.000067: Prioritätensetzung. Diese Kriterien lassen sich folgendermaßen zusammenfassen:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067: 134 Die Gewinnung humaner embryonaler Stammzellen wird laut FP7 nicht mit Gemeinschaftsmitteln finanziert
p.000067: (siehe Abschnitt II.2). Siehe Beschluss Nr. 1982/2006/EG des Europäischen Parlaments und des Rates vom 18. Dezember
p.000067: 2006 über das Siebte Rahmenprogramm der Europäischen Gemeinschaft für Forschung, technologische Entwicklung
p.000067: und Demonstration (2007 bis 2013), ABl. L 412 vom 30. Dezember 2006, S.1-41.
p.000067: 135 Einzelheiten siehe Abschnitt I dieser Stellungnahme über die relevanten Dokumente im Kontext der
p.000067: medizinischen Forschung.
p.000067: 136 Siehe die Millenniumsziele der Vereinten Nationen, zu deren Realisierung sich die Europäische Union
p.000067: verpflichtet hat.
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p.000068: 68
p.000068:
p.000068:
p.000068: • wissenschaftliche Notwendigkeit und hoher Rang der Forschung137,
p.000068: • Dringlichkeit138 und
p.000068: • gesellschaftliche Erwünschtheit,
p.000068: • Vorrang der Interessen und des Wohlbefindens des einzelnen Menschen vor rein gesellschaftlichen oder
p.000068: wissenschaftlichen Interessen.
p.000068:
p.000068: Die gesellschaftliche Erwünschtheit von Fördermaßnahmen wird im Rahmen des politischen und gesellschaftlichen
p.000068: Diskurses über Ziele und Perspektiven der Europäischen Union im 21. Jahrhundert diskutiert; dabei geht es
p.000068: auch um die Beziehung zwischen Wirtschaftswachstum und sozialen Zielen, etwa der Förderung von
p.000068: Gesundheitsstandards und ihrer nachhaltigen Anwendung auf nationaler, internationaler und globaler Ebene.
p.000068:
p.000068: Was die hES-Zellforschung betrifft, gibt es in der Europäischen Union keinen Konsens über ihre
p.000068: gesellschaftliche Akzeptabilität, divergente Meinungen stehen nebeneinander. Deshalb werden derzeit in mehreren
p.000068: EU-Mitgliedstaaten und auch über ihre Grenzen hinweg verschiedene Modelle (z. B. das
p.000068: „Minimalkonsens-Modell“ oder das „Subsidiaritäts-Modell“) zur Regulierung der hES-Zellforschung auf EU-Ebene
p.000068: diskutiert.
p.000068:
p.000068: Wo moralisch sensible Mittel eingesetzt werden, um allgemein akzeptierte Ziele zu erreichen – wie im Falle der humanen
p.000068: embryonalen Stammzellen –, wo also nicht das Ziel therapieorientierter Forschung hinterfragt wird, sondern die
p.000068: „Mittel“, mit deren Hilfe es erreicht werden soll, gelten nach Ansicht der EGE zusätzliche Kriterien hinsichtlich
p.000068: der Notwendigkeit der Forschung: 1) das Fehlen validierter Alternativen und 2) die Nichtredundanz von
p.000068: FP7-Projekten139.
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p.000068: 137 http://ec.europa.eu/research/fp7/index_en.cfm?pg=documents.
p.000068: 138 http://www.who.int/rpc/en/HealthResearchinPolicyMaking.pdf.
p.000068: 139 Wiederholungen sind allerdings zuweilen notwendig, um den Erfolgsnachweis zu erbringen; diese werden
p.000068: nicht im obigen Sinne als redundant angesehen.
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p.000069:
p.000069:
p.000069: Diese zentralen wissenschaftlichen Bewertungskriterien müssen jedoch im Rahmen der ethischen
p.000069: Prüfung aus ethischer Sicht bewertet werden. Selbstverständlich kann und soll die ethische Prüfung
p.000069: nicht eine Wiederholung der wissenschaftlichen Prüfung sein, die nach wie vor für die Beurteilung der
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p.000071: sicherstellen, dass die Antragsteller Angaben zu den nachstehend aufgeführten Punkten machen.
p.000071:
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p.000071: 140 Artikel 6 Absatz 3, http://cordis.europa.eu/fp7/ethics-ict_en.html.
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p.000072:
p.000072: IV.2.3 ZUSÄTZLICHE KRITERIEN FÜR DAS FP7
p.000072:
p.000072: IV.2.3.1 Verwendung von Alternativen zu hES-Zellen
p.000072: Falls in Zukunft Alternativen zu hES-Zellen gefunden werden, die das gleiche Potenzial aufweisen wie die aus
p.000072: Embryonen gewonnenen Stammzellen, sollten die Folgen dieser Entwicklungen für die wissenschaftlichen und
p.000072: ethischen Aspekte der auf hES-Zellen basierenden Forschungsprojekte so bald wie möglich
p.000072: Berücksichtigung finden.
p.000072:
p.000072: IV.2.3.2 Rechte der Spendenden
p.000072: Die Spende von Humanembryonen zur Gewinnung von hES-Zellen für Forschungszwecke wirft ein moralisches
p.000072: Dilemma auf. Dies ergibt sich aus der Tatsache, dass Humanembryonen keine „neutralen Objekte“ sind. Im Rahmen
p.000072: der informierten Einwilligung sollte dieses moralische Dilemma ausdrücklich angesprochen werden und die
p.000072: Entscheidung den Spendenden überlassen bleiben.
p.000072: Den Schutzrechten der Spendenden muss besondere Aufmerksamkeit gelten, was konkret bedeutet, dass diejenigen
p.000072: Länder, die die Beschaffung von hES- Zellen erlauben, Angaben über das vom Antragsteller angewandte Verfahren zur
p.000072: Beschaffung vorlegen müssen. Die Informationen müssen Aussagen darüber enthalten, dass die entsprechenden
p.000072: Maßnahmen den in der Europäischen Union geltenden grundlegenden ethischen Prinzipien und Menschenrechten, den zum
p.000072: Zeitpunkt der Spende im Land, in dem die Spende erfolgt, geltenden einzelstaatlichen
p.000072: Rechtsvorschriften und anderen einschlägigen EU-Regelungen entsprechen141. Die Antragsteller müssen Angaben der
p.000072: Institutionen vorlegen, in denen die Stammzelllinien gewonnen wurden, aus denen hervorgeht, dass bei der
p.000072: Gewinnung der hES-Zellen folgende Kriterien eingehalten wurden:
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p.000072: 141 Siehe Richtlinie 2004/23/EG.
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p.000073: 73
p.000073:
p.000073:
p.000073: • Die Spendenden wurden in keiner Phase unter Druck gesetzt142.
p.000073: • Die Gesundheit der Spenderin wurde nicht durch ovarielle Überstimulation gefährdet.
p.000073: • Soweit neue hES-Zelllinien betroffen sind, erfolgte die informierte Einwilligung zur Spende eines ursprünglich für
p.000073: die Reproduktion vorgesehenen Embryos zu Forschungszwecken in Kenntnis der Art der geplanten Forschung143 und ihrer
p.000073: (auch kommerziellen) Implikationen sowie in Übereinstimmung mit den zum Zeitpunkt der Spende in dem Land, in
p.000073: dem die Spende durchgeführt wurde, geltenden Bedingungen.
p.000073: • Die Spendenden wurden informiert, dass sie bis zur Phase der Gewinnung von Stammzellen ihre Einwilligung
p.000073: zurückziehen können.144
p.000073: • Unfruchtbarkeitsbehandlung und Forschung wurden in angemessener Weise voneinander getrennt.
p.000073: • Für die Spende von Embryonen zu Forschungszwecken wurden gemäß Artikel 12 der Richtlinie 2004/23/EG in
p.000073: keiner Phase finanzielle Anreize
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p.000077: • die Beziehungen zwischen Natur- und Geisteswissenschaften sowie zwischen Wissenschaft und
p.000077: Gesellschaft im Zusammenhang mit der Entwicklung neuer Technologien;
p.000077: • die laufenden Bemühungen um wissenschaftliche Alternativen zur Forschung an hES-Zellen und deren anthropologische
p.000077: und ethische Interpretation.
p.000077:
p.000077: Die EGE bekräftigt, dass für zahlreiche Fragen noch weitere Klärung, interdisziplinäre Forschung,
p.000077: gründliche ethische Bewertung und, falls künftig als notwendig erachtet, auch angemessene rechtliche Schritte
p.000077: erforderlich sind. Momentan erfordern nach Ansicht der EGE folgende Fragen besondere Beachtung:
p.000077:
p.000077: 1. Die derzeitigen Bestimmungen für die Patentierung von aus hES-Zellen gewonnenem Material müssen
p.000077: angegangen werden. Angesichts der neuesten Entwicklungen in der Forschung und unter Berücksichtigung der
p.000077: laufenden Debatte über die Grenzen der Patentierung biologischen
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p.000078: 78
p.000078:
p.000078:
p.000078: Materials möchte sich die EGE mit dieser Frage zu einem späteren Zeitpunkt befassen148.
p.000078:
p.000078: 2. Die durch eine sowohl die freiwillige Spende149 als auch die kommerzielle Verwendung von Derivaten humaner
p.000078: Substanzen fördernde Politik verursachte Spannung muss behandelt werden.
p.000078:
p.000078: Die EGE unterstreicht, dass ihrer Auffassung nach die Verwendung humaner Embryonen zur Erzeugung von
p.000078: Stammzellen so weit wie möglich reduziert werden sollte. Die EGE ruft die Europäische Union auf, geeignete
p.000078: Systeme zu entwickeln, um die Verwendung humaner Embryonen auf Fälle zu reduzieren, in denen es keine Alternative
p.000078: gibt.
p.000078:
p.000078: IV.4 Prüfung der Empfehlungen und Kommunikation mit dem Beirat des Europäischen Registers für humane
p.000078: embryonale Stammzelllinien
p.000078: Die EGE würde einen intensiven Austausch mit dem Beirat des Europäischen Registers für humane embryonale
p.000078: Stammzelllinien begrüßen, insbesondere mit dem Ethik-Beirat des Registers. Das Ziel wäre es, die ethischen
p.000078: Bedenken hinsichtlich der Beschaffung von Stammzellen und der Speicherung von Daten im Lichte der laufenden
p.000078: Fortschritte in diesem Bereich gemeinsam behandeln zu können.
p.000078: Die konkrete Art und Weise dieser Zusammenarbeit sollte spezifiziert und etabliert werden, und sie sollte
p.000078: von der Kommission entsprechend unterstützt und finanziert werden.
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078: 148 Die EGE hat eine Stellungnahme über „Ethische Aspekte der Patentierung von Erfindungen unter Nutzung
p.000078: humaner Stammzellen“ herausgegeben, http://www.ec.europa.eu/european_group_ethics/docs/avis16_en.pdf
p.000078: 149 Artikel 12 der Richtlinie 2004/23/EG: „Die Mitgliedstaaten streben danach, freiwillige und
p.000078: unentgeltliche Spenden von Geweben und Zellen sicherzustellen.“.
p.000078:
p.000078:
p.000078:
p.000078:
p.000079: 79
p.000079:
p.000079:
p.000079:
p.000079: IV.4.1 Prüfungsbedarf
p.000079:
p.000079: Die EGE schlägt vor, die beschlossenen ethischen Leitlinien im Lichte der wissenschaftlichen, rechtlichen
p.000079: und gesellschaftlichen Entwicklungen zu überprüfen.
p.000079: Die Europäische Gruppe für Ethik in Naturwissenschaften und neuen Technologien150
p.000079:
...
Social / Women
Searching for indicator women:
(return to top)
p.000125: donation for research, if so could you please describe them?
p.000125:
p.000125: Yes. As specified in section 8.2 of the Embryos Act, embryos may be made available only by means of a written donation
p.000125: and without consideration, and only after the persons concerned (which may also include a gamete donor), have been
p.000125: informed by the person storing the embryos regarding the nature and the purpose thereof. Where a difference of opinion
p.000125: arises between the parties concerned, the embryos shall not be made available. Any of the persons concerned may revoke
p.000125: his/her decision at any time before the embryos have been used, without giving reasons.
p.000125: In the report of the recent evaluation of the Embryos Act (2006), it is pointed out that the Act does not provide
p.000125: sufficient guidance as to the required specificity of the information to be given about the nature of the research. Cf
p.000125: summary of report: http://www.zonmw.nl/fileadmin/cm/vraagsturing/documenten/Evaluatie_regelgeving/embryos_
p.000125: act_en_sum.pdf
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000126: 126
p.000126:
p.000126:
p.000126:
p.000126: 9 Is financial inducement allowed? If so, in what terms?
p.000126:
p.000126:
p.000126: No, cf question 8: embryos may only be donated ‘without consideration’. The same holds for the donation of gametes. In
p.000126: practice, a remuneration of expenses is accepted.
p.000126: The report of the recent evaluation of the Embryos Act (2006) contains the recommendation to further debate the
p.000126: desirability/acceptability of a larger recompensation for women donating oocytes for research. Cf summary of report:
p.000126: http://www.zonmw.nl/fileadmin/cm/vraagsturing/documenten/Evaluatie_regelgeving/embryos_ act_en_sum.pdf
p.000126:
p.000126: 1 Are ad hoc data protection provisions be defined for hESC research? 0
p.000126: No special regulations
p.000126:
p.000126: 1 Are data deriving from hESC projects necessarily provided, whether positive or
p.000126: 1 negative (in form of publications)?
p.000126:
p.000126: No special regulations
p.000126:
p.000126: 1 How is patenting of hESC lines regulated? 2
p.000126: No special regulations
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
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p.000126:
p.000126:
p.000126:
p.000127: 127
p.000127:
p.000127:
p.000127:
p.000127: Regulatory frame applying to POLAND
p.000127:
p.000127: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000127: to get the texts would be welcomed).
p.000127: In Poland there is no research on embryonic stem cells.
p.000127:
p.000127: Polish legal rules do not include distinct regulations for human embryonic stem cells research. There is also no legal
p.000127: definition for embryo stage of life.
...
p.000141:
p.000141: Yes
p.000141: Should conditions be put on licence
p.000141:
p.000141:
p.000141: Decision on whether to grant licence
p.000141:
p.000141: No - Reject
p.000141: Is each activity necessary or
p.000141: forms?
p.000141: Yes
p.000141: Satisfied
p.000141:
p.000141: No - Reject
p.000141: desirable for one of the specified purposed purposes
p.000141: Yes
p.000141: that use of embryos is necessary?
p.000141:
p.000141:
p.000141:
p.000141: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000141: embryo donation for research, if so could you please describe them?
p.000141: The HFEA, as part of the licensing procedure, see and must approve the patient information and consent forms used in
p.000141: obtaining consent from patient donating gametes and/or embryos in licensed research projects. These documents must also
p.000141: be approved by a local research ethics committee.
p.000141: Furthermore, all research centres are inspected, by the HFEA, annually and as part of this process, the HFEA examines
p.000141: the process used by the centre in obtaining the
p.000141:
p.000141:
p.000141:
p.000141:
p.000141:
p.000142: 142
p.000142:
p.000142:
p.000142:
p.000142: consent of patients whose gametes and/or embryos are used in licensed research.
p.000142:
p.000142: 9 Is financial inducement allowed? If so, in what terms?
p.000142:
p.000142: Women will not be paid for donating their eggs. Researchers will have to follow the same system as donation for
p.000142: treatment.
p.000142: Non patient donors can only claim back the expenses that they have actually incurred
p.000142: i.e. in money or money’s worth, a donor may be given reasonable, demonstrable expenses which she has incurred, within
p.000142: the UK, in connection with the donation. Donors may be compensated for loss of earnings (but not for other costs or
p.000142: inconveniences) up to a daily maximum of £55.19 but with an overall limit of £250 (or the equivalent in local currency)
p.000142: for each cycle of egg donation.
p.000142:
p.000142: Patient participating in egg sharing schemes will be permitted to receive treatment services in exchange for sharing a
p.000142: proportion of the eggs collected.
p.000142:
p.000142:
p.000142: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000142: This is not within the remit of the HFEA
p.000142:
p.000142:
p.000142: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000142: publications)?
p.000142: This is not within the remit of the HFEA
p.000142:
p.000142: 12 How is patenting of hESC lines regulated?
p.000142: This is not within the remit of the HFEA
p.000142:
p.000142:
p.000142: When clinical experiments are carried out, the Ethics Review Board must broaden its review to cover research ethics
p.000142: questions and consider patients’ protective rights as laid down in the general medical ethics principles and
...
Social / access to healthcare
Searching for indicator access to healthcare:
(return to top)
p.000086:
p.000086: YES
p.000086:
p.000086:
p.000086:
p.000086:
p.000086: PAGE
p.000086:
p.000086: • Does the proposal involve human genetic material?
p.000086:
p.000086: • Does the proposal involve human biological samples?
p.000086: • Does the proposal involve human data collection?
p.000086:
p.000086: Research on human embryos/foetuses
p.000086: • Does the proposal involve human embryos?
p.000086: • Does the proposal involve human foetal tissue/cells?
p.000086:
p.000086: • Does the proposal involve human embryonic stem cells?
p.000086: Privacy
p.000086: • Does the proposal involve processing of genetic information or personal data (e.g. health, sexual lifestyle,
p.000086: ethnicity, political opinion, religious or philosophical conviction)?
p.000086: • Does the proposal involve tracking the location or observation of people?
p.000086: Research on animals
p.000086: • Does the proposal involve research on animals?
p.000086:
p.000086: • Are those animals transgenic small laboratory animals?
p.000086: • Are those animals transgenic farm animals?
p.000086: • Are those animals cloning farm animals?
p.000086: • Are those animals non-human primates?
p.000086: Research involving developing countries
p.000086: • Use of local resources (genetic, animal, plant, etc.)
p.000086:
p.000086: • Benefit to local community (capacity building, i.e. access to healthcare, education, etc.)
p.000086: Dual use
p.000086: • Research having potential military/terrorist application
p.000086:
p.000086: I CONFIRM THAT NONE OF THE ABOVE ISSUES APPLY TO MY PROPOSAL
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000087: 87
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087: ANNEX III
p.000087:
p.000087: LIST OF PROJECTS SUPPORTED WITHIN THE SIXTH FRAMEWORK PROGRAMME AND WITHIN THE HEALTH
p.000087: DIRECTORATE, INVOLVING HESCS
p.000087: 1. LYMPHANGIOGENOMICS: fundamental research to better understand the lymphatic vasculature with a view to
p.000087: developing therapies to control the growth of lymphatic vessels (e.g. cancer, inflammatory diseases, for
p.000087: tissue ischæmia, lymphœdema)/EUR 9 million, 13 partners, 8 different countries (FI, FR, SE, AT, IT, CH, DE, BE)
p.000087:
p.000087: 2. REPROTECT: model to study reproductive toxicity by a combination of in vitro and sensor technologies/EUR 9.1
p.000087: million, 26 partners, 9 different countries (DE, NL, BE, IT, UK, FR, SE, BG, AT)
p.000087: 3. BETACELL THERAPY: treatment of diabetes: to generate insulin- producing beta cells/EUR 11.8
p.000087: million, 29 partners, 7 different countries (BE, DK, IL, ES, SE, CH, UK)
p.000087:
p.000087: 4. EUROSTEMCELL: comparison of the properties of adult, foetal and embryonic stem cells for the
p.000087: development of therapies including medicines in different set of diseases/disorders (skin, musculoskeletal,
...
Social / education
Searching for indicator education:
(return to top)
p.000086: PAGE
p.000086:
p.000086: • Does the proposal involve human genetic material?
p.000086:
p.000086: • Does the proposal involve human biological samples?
p.000086: • Does the proposal involve human data collection?
p.000086:
p.000086: Research on human embryos/foetuses
p.000086: • Does the proposal involve human embryos?
p.000086: • Does the proposal involve human foetal tissue/cells?
p.000086:
p.000086: • Does the proposal involve human embryonic stem cells?
p.000086: Privacy
p.000086: • Does the proposal involve processing of genetic information or personal data (e.g. health, sexual lifestyle,
p.000086: ethnicity, political opinion, religious or philosophical conviction)?
p.000086: • Does the proposal involve tracking the location or observation of people?
p.000086: Research on animals
p.000086: • Does the proposal involve research on animals?
p.000086:
p.000086: • Are those animals transgenic small laboratory animals?
p.000086: • Are those animals transgenic farm animals?
p.000086: • Are those animals cloning farm animals?
p.000086: • Are those animals non-human primates?
p.000086: Research involving developing countries
p.000086: • Use of local resources (genetic, animal, plant, etc.)
p.000086:
p.000086: • Benefit to local community (capacity building, i.e. access to healthcare, education, etc.)
p.000086: Dual use
p.000086: • Research having potential military/terrorist application
p.000086:
p.000086: I CONFIRM THAT NONE OF THE ABOVE ISSUES APPLY TO MY PROPOSAL
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000087: 87
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087: ANNEX III
p.000087:
p.000087: LIST OF PROJECTS SUPPORTED WITHIN THE SIXTH FRAMEWORK PROGRAMME AND WITHIN THE HEALTH
p.000087: DIRECTORATE, INVOLVING HESCS
p.000087: 1. LYMPHANGIOGENOMICS: fundamental research to better understand the lymphatic vasculature with a view to
p.000087: developing therapies to control the growth of lymphatic vessels (e.g. cancer, inflammatory diseases, for
p.000087: tissue ischæmia, lymphœdema)/EUR 9 million, 13 partners, 8 different countries (FI, FR, SE, AT, IT, CH, DE, BE)
p.000087:
p.000087: 2. REPROTECT: model to study reproductive toxicity by a combination of in vitro and sensor technologies/EUR 9.1
p.000087: million, 26 partners, 9 different countries (DE, NL, BE, IT, UK, FR, SE, BG, AT)
p.000087: 3. BETACELL THERAPY: treatment of diabetes: to generate insulin- producing beta cells/EUR 11.8
p.000087: million, 29 partners, 7 different countries (BE, DK, IL, ES, SE, CH, UK)
p.000087:
p.000087: 4. EUROSTEMCELL: comparison of the properties of adult, foetal and embryonic stem cells for the
p.000087: development of therapies including medicines in different set of diseases/disorders (skin, musculoskeletal,
p.000087: neurodegenerative diseases)/EUR 11.9 million, 14 partners, 7 different countries (UK, SE, FR, IT, DE, CH, DK)
...
p.000097: Not applicable
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
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p.000097:
p.000097:
p.000097:
p.000097:
p.000098: 98
p.000098:
p.000098:
p.000098:
p.000098: Regulatory frame applying to CZECH REPUBLIC
p.000098:
p.000098: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000098: having not a legal personality.
p.000098:
p.000098: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000098: to get the texts would be welcomed).
p.000098: Act on Human Embryonic Stem Cell Research (law no. 227/2006 Coll.) passed by the Czech Parliament on 26th of April
p.000098: 2006, in force since June 1 2006.
p.000098: Text available here: http://www.mvcr.cz/sbirka/2006/sb075-06.pdf (also attached)
p.000098:
p.000098: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000098: “Human embryo is a totopotent cell or a grouping of cells which are capable develop into human individuum’ (law no.
p.000098: 227/2006 Coll., § 2)
p.000098:
p.000098: 3 Is hESC research allowed and in what terms and conditions?
p.000098: Yes.
p.000098: Conditions: State licensing (given by the Ministry of Education, after approval of the Bioethics Committee of the
p.000098: Research and Development Council of the Czech Government and after positive appraisal of the Research and Development
p.000098: Council) Preconditions:
p.000098: a) Scientific criteria
p.000098:
p.000098: scientifically justifiable – new medical knowledge with applications for humans; scientific necessity (usage of in
p.000098: vitro models, animal cells or animals does not provide the necessary knowledge);
p.000098: no alternative research
p.000098: scientific quality of the research team
p.000098: b) Ethical criteria
p.000098:
p.000098: Research project is ethically acceptable (informed consent, donation…)
p.000098:
p.000098: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000098: Ministry of Education
p.000098:
p.000098: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000098: yes at what conditions?
p.000098:
p.000098: No. The Czech Republic ratified Oviedo Convention (2001).
p.000098: 6 Is the source of hESC used in research traceable and well documented?
p.000098: Yes.
p.000098: 7 What are the formal ethical and legal requirements for hESC research approval? Source of embryos:
p.000098: ‘surplus embryos’ from IVF (only from licensed IVF centres), no longer than 7 day of development, export of embryos
p.000098: prohibited
p.000098: Informed consent
p.000098: Donation (reimbursement of expenses possible)
p.000098:
p.000098: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000098: embryo donation for research, if so could you please describe them?
p.000098: Yes. Detailed description in § 9 Act no. 227/2006 Coll.
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000099: 99
p.000099:
p.000099:
p.000099:
p.000099: 9 Is financial inducement allowed? If so, in what terms?
p.000099:
p.000099: No.
p.000099: Only reimbursement of real expenses (to the IVF Centre)
p.000099: Reimbursement of real expenses related to the embryo donation (to the donor, payment and other compensation explicitly
p.000099: prohibited)
p.000099:
p.000099: 10 Are ad hoc data protection provisions be defined for hESC research?
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.000081: Ethical issues table 87
p.000081: Annex III — List of projects supported within the sixth framework
p.000081: programme and within the Health and Consumer Protection DG, involving hESCs
p.000088: 88
p.000088: Annex IV — EU Member States’ regulatory framework for hESC research 90
p.000088: Appendix : Secretariat of the EGE 144
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000002: 2
p.000002:
p.000002: SUMMARY
p.000002:
p.000002:
p.000002: The European Group on Ethics in Science and New Technologies (EGE) adopted Opinion No 22 on 20 June
p.000002: 2007. The opinion indicates the implementing measures (guidelines) to use during the ethics review of
p.000002: seventh framework programme for research and development (FP7) research projects on human embryonic stem cells
p.000002: (hESCs), as requested by the President of the European Commission, Mr Barroso (1), and in line with the
p.000002: adoption of the EU’s FP7.
p.000002:
p.000002: The EGE stressed that, as is the case in the European Union, there are divergent views within the
p.000002: group on the moral legitimacy of research on human embryos and hESCs, ranging from objection to research
p.000002: involving the destruction of human embryos (which makes the full respect of dignity of the human embryo impossible)
p.000002: to a position allowing hESC research under certain conditions or on a broader basis.
p.000002:
p.000002: The group, however, acknowledged the political decision taken as the starting point for its recommendations, but
p.000002: emphasised that the ethical dilemma regarding the moral status of the human embryo and its use in research still
p.000002: persists both within the EGE members and the EU. Therefore, the group did not elaborate ethical arguments on hESC
p.000002: research as such, but worked on recommendations for FP7 ethics review of hESC projects.
p.000002:
p.000002: The EGE recognised the need for promoting responsible research that is transparent, serves the public
p.000002: interest, respects Member State autonomy, preserves public trust, promotes international cooperation and
p.000002: requires the embedding of ethics within research practice. The group indicated that, in addition to the FP7
p.000002: ethics rules already adopted in co-decision, among others the following considerations should apply to hESCs funded by
p.000002: the EU:
p.000002:
p.000002: • FP7 hESC lines have to result from non-implanted IVF embryos;
p.000002: • if alternatives to hESCs with the same scientific potential as embryo- derived stem cells are found in the
p.000002: future, their use should be maximised;
p.000002:
p.000002:
p.000002: (1) Letter sent by European Commission President Barroso to the EGE on 22 November 2006: ‘I
p.000002: would like to invite the European Group on Ethics to provide the Commission with an opinion on the implementing
p.000002: measures required during the ethics review of research projects on human embryonic stem cells that will
p.000002: assure that the ethical rules and requirements are fully met.’
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003:
p.000003:
p.000003: • donors’ rights (in terms of health, informed consent, data protection and free donation) have to be
p.000003: protected and safeguarded.
p.000003:
p.000003: The EGE also stressed the following needs:
p.000003: • to maximise the use of hESCs banked in the European Registry on hESC research;
p.000003: • to take concrete actions to stimulate public debate on this research sector.
p.000003:
p.000003: In addition, the EGE expressed the view that the use of human embryos to generate stem cells should be minimised as
p.000003: much as possible in the EU and indicated a number of issues that would deserve interdisciplinary research and
p.000003: further discussion, such as, inter alia, the use of the human body for modern medicine, including
...
p.000008: 2952);
p.000008:
p.000008:
p.000008: (17) OJ C 364, 18.11.2000, pp. 1–22.
p.000008: (18) OJ L 138, 21.4.2004, pp. 7–11.
p.000008: (19) OJ L 294, 29.10.2002, pp. 1–43.
p.000008: (20) http://ec.europa.eu/research/press/2003/pdf/sec2003-441report_en.pdf
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009:
p.000009:
p.000009: Having regard to Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December
p.000009: 2006 concerning the seventh framework programme of the European Community for research,
p.000009: technological development and demonstration activities (2007–13);
p.000009:
p.000009: Having regard to Regulation (EC) No 1906/2006 (22) of the European Parliament and of the Council of 18
p.000009: December 2006 laying down the rules for the participation of undertakings, research centres and universities in actions
p.000009: under the seventh framework programme and for the dissemination of research results (2007–13);
p.000009:
p.000009: Having regard to Directive 2001/83/EC (23) and Regulation 726/2004/EC (24), currently being
p.000009: amended (25), on medicinal products for human use: advanced therapy medicinal products;
p.000009:
p.000009: Having regard to EGE Opinion No 11 ‘Ethical aspects of human tissue banking’ (26), published on 21 July
p.000009: 1998;
p.000009:
p.000009: Having regard to EGE Opinion No 12 ‘Ethical aspects of research involving the use of human embryo in
p.000009: the context of the fifth framework programme’ (27), published on 23 November 1998;
p.000009:
p.000009: Having regard to EGE Opinion No 15 ‘Ethical aspects of human stem cell research and use’ (28), published on 14 November
p.000009: 2000;
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: (22) OJ L 391, 18.12.2006, pp. 1–18.
p.000009: (23) OJ L 311, 28.11.2001, pp. 67–128.
p.000009: (24) OJ L 136, 30.4.2004, pp. 1–33.
p.000009: (25) http://www.europarl.europa.eu/oeil/FindByProcnum.do?lang=2&procnum=COD/2005/0227
p.000009: (26) http://www.ec.europa.eu/european_group_ethics/docs/avis11_en.pdf
p.000009: (27) http://www.ec.europa.eu/european_group_ethics/docs/avis12_en.pdf
p.000009: (28) http://www.ec.europa.eu/european_group_ethics/docs/avis15_en.pdf
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010:
p.000010:
p.000010: Having regard to EGE Opinion No 16 ‘Ethical aspects of patenting inventions involving human stem cells’
p.000010: (29), published on 14 November 2002;
p.000010:
p.000010: Having regard the request of November 2006 from the President of the EU Commission to the EGE to issue an opinion on
p.000010: the ethics review of human embryonic stem cell (hESC) projects funded under FP7;
p.000010:
p.000010: Having heard the rapporteurs A. Cambon-Thomsen, H. Haker, P. Martinho da Silva,
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
...
p.000023: in vivo) (see http://www.ecopa.eu/doc/CarcinogenomicsPressRelease-201106.pdf).
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: III.3. Sources of human embryonic stem cells
p.000023: The most common source of tissue for human embryonic stem cell isolation is the inner cell mass (ICM) of
p.000023: embryos created using assisted reproduction technologies (ART), but not transferred to the woman’s uterus,
p.000023: either because the number of embryos exceeds the number allowed to be transferred under the law (usually two or
p.000023: three) or because of genetic defects detected by pre- implantation genetic diagnostics (PGD) (63). In the
p.000023: same way, embryos as a source of stem cells can be created solely for research purposes via in vitro
p.000023: fertilisation (IVF), but outside the ART context (64).
p.000023:
p.000023: Another source of human embryonic stem cells, which is allowed in only a few countries (65), is their creation by means
p.000023: of somatic nuclear cell transfer (SCNT), where a somatic cell is taken from an adult patient and its
p.000023: nucleus transferred
p.000023:
p.000023: (63) This practice is not permitted in all EU Member States.
p.000023: (64) This practice is not permitted in most EU Member States. See Table 1, p. 29.
p.000023: (65) In the EU, therapeutic cloning is allowed only in the following countries: Belgium, Spain, Sweden and the
p.000023: UK.
p.000023:
p.000023:
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000024:
p.000024:
p.000024: into a donated enucleated oocyte. Unlike hESCs derived from a donated IVF embryo, the resulting cell line
p.000024: using SCNT is genetically identical to the donor of the nucleus.
p.000024:
p.000024: Another possible way of creating stem cells by means of SCNT, but not leading to therapeutic cloning, is to create
p.000024: human/animal hybrids by mixing a human cell with an animal egg in order to obtain ‘humanised’ stem cells
p.000024: (66). There is currently debate on the ethics of human/animal hybrids in several EU and non- EU countries. The EC is
p.000024: at present financing a project on the ethical, legal and social implications of human/animal hybrids (67).
p.000024:
p.000024:
p.000024: III.4. Derivation of new hESC lines
p.000024:
p.000024: As indicated in Section II.2, the derivation of new totipotent cells or pluripotent stem cell lines from
p.000024: donated pre-implantation human embryos or embryonic cells, or via nuclear reprogramming, is not funded by the EU
p.000024: research programme. The derivation of new hESCs necessarily involves the procurement of biological material
p.000024: from human subjects, which then (when allowed) needs to be approved by institutional oversight bodies with
p.000024: specific responsibility for the protection of human subjects.
p.000024:
p.000024: III.5. Alternatives to hESC research
p.000024:
p.000024: As stated in Section II.2, the justification for the use of human embryonic stem cells under FP7 is to be
p.000024: assessed during the scientific evaluation of research proposals. EU projects can be funded only if no suitable
...
p.000027:
p.000027: A Steering Committee comprising representatives of the leading European public institutions involved in human
p.000027: embryonic stem cell research has also been established. The committee will be assisted by an Advisory Board,
p.000027: comprising 17 top scientists from Europe and outside Europe in the field of human embryonic stem cell research, and
p.000027: an independent Ethics Advisory Board to ensure compliance with ethical requirements and ethical guidance.
p.000027:
p.000027: III.7. EU Member States’ regulations on hESC research
p.000027: Among the 27 EU Member States (EU-27), several clusters of countries can be identified according to how they regulate
p.000027: hESC research. However, all countries apply at least some regulations and/or procedural rules to specific projects
p.000027: involving hESCs. Where hESC research is allowed, project proposals have to undergo strict evaluation criteria, both
p.000027: scientific and ethical, decided upon by the competent national bodies (79).
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027: (78) For more information see: www.cmrb.eu; www.cellnet.org;
p.000027: www.ec.europa.eu/research/fp6/index_en.cfm?p=1_stem_projects
p.000027: (79) See annex (pp. 52–102) for further details in single Member States.
p.000027:
p.000027:
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028:
p.000028:
p.000028: Permissive position
p.000028:
p.000028: A few EU Member States have specific legislation for hESC research, covering the procurement of stem cells and their
p.000028: use for research. In Belgium, Spain (80), Sweden and the UK, for example, embryo creation is allowed for research
p.000028: purposes.
p.000028:
p.000028: Permissive position with restrictions
p.000028:
p.000028: In other EU Member States such as the Czech Republic, Denmark, Greece, France, the Netherlands, Portugal and
p.000028: Finland (81), regulations allow the derivation of new hESCs from embryos created as a result of assisted
p.000028: reproduction technology (ART) and in vitro fertilisation to induce pregnancy, but only when they can no longer be used
p.000028: for that purpose.
p.000028:
p.000028: Restrictive position
p.000028: Germany and Italy have stricter hESC research regulations. Scientists in these countries cannot derive new
p.000028: hES cell lines, but can import them. In Germany, a new discussion has arisen as to whether the 2002 Stem Cell Act
p.000028: regulating the importation of hESC lines should be revised, but no legal proposal has been forthcoming by
p.000028: the date of these recommendations. Italian legislation covers artificial reproduction technology and the
p.000028: production of new hESCs (research involving the destruction of embryos is not allowed). Italy therefore has no
p.000028: legal provision as regards the use of imported hESCs or existing hESCs.
p.000028:
p.000028:
p.000028: No specific legislation or indirect legislation only
p.000028:
p.000028: In many Member States, hESC research still has no specific legislation (Bulgaria, Estonia, Ireland, Cyprus, Latvia,
p.000028: Luxembourg and Romania). Ireland, for instance,
p.000028:
p.000028:
p.000028: (80) A new law in Spain has just been voted for.
p.000028: (81) A new regulation is under way in Portugal.
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000029: 29
p.000029:
p.000029:
p.000029:
p.000029: currently has no specific legislation dealing with embryonic stem cell research and furthermore does not have
p.000029: a legislative basis for the practice of IVF.
p.000029:
p.000029: Some other EU Member States have no ‘specific’ regulation on hESC research, but explicitly indicated that they are
p.000029: against it (Lithuania, Malta, Austria, Poland and Slovakia) by voting against hESC research during the
p.000029: Council decision for FP7.
p.000029:
p.000029: Lastly, in some countries hESC is at present regulated only by indirect legislation for embryo research (Hungary,
p.000029: Slovenia), but without specific reference to hESCs. The table below summarises the current regulatory systems
p.000029: in the EU-27, but specific information on the position of each Member State can be found in the annex
p.000029: to these recommendations (regulatory issues).
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000030: 30
p.000030:
p.000030:
p.000030:
p.000030: Table 1. Regulations in EU Member States regarding hESC research (updated June 2007)
p.000030:
p.000030:
p.000030:
p.000030: Allowing procurement of hESCs from supernumerary embryos by law
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: AT
p.000030: BE X
p.000030: BG CY
p.000030: CZ X
p.000030: DE
p.000030: DK X
p.000030: EE
p.000030: EL X
p.000030: ES X
p.000030: FI X
p.000030: FR X
p.000030: HU IE IT LT LU LV MT
p.000030: NL X
p.000030: PL
p.000030: PT X
p.000030: RO
p.000030: SE X
p.000030: SI SK
p.000030: UK X
p.000030:
p.000030: Specific legislation for embryo research including supernumerary embryos but without specific reference to hESCs
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: X
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: X
p.000030:
p.000030: Prohibiting procurement of hESCs from human embryos but allowing importation of hESC lines
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: X (a)
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: X (b)
p.000030:
p.000030: No specific regulation on hESC
p.000030: research
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: X (d)
p.000030:
p.000030: X X
p.000030:
p.000030:
p.000030:
p.000030: X
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: X X (d)
p.000030: X X
p.000030: X (d)
p.000030:
p.000030: X (d) X
p.000030:
p.000030: X (d)
p.000030:
p.000030: Allowing creation of human embryos for procurement of hESCs by law
p.000030:
p.000030:
p.000030:
p.000030: X
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: X (c)
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: X
p.000030:
p.000030:
p.000030: X
p.000030:
p.000030: Countries which signed and ratified the Oviedo Convention of 4.4.1997 (against the creation of human embryos for
p.000030: research purposes)
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: X X X
p.000030:
p.000030: X X X X
p.000030:
p.000030:
p.000030: X
p.000030:
p.000030:
p.000030: X
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: X X
p.000030:
p.000030: X X
p.000030: (a) Germany has a law and hESC lines have to be derived before 1 January 2002.
p.000030: (b) Italy has no law regarding importation.
p.000030: (c) Spain allows techniques such as SCNT to obtain hESCs.
p.000030: (d) Countries which voted against hESC research during Council decision for FP7.
p.000030: Country code key:
p.000030: AT: Austria DK: Denmark FR: France LU: Luxembourg PT: Portugal BE: Belgium
p.000030: EE: Estonia HU: Hungary LV: Latvia SE: Sweden CY: Cyprus
p.000030: EL: Greece IE: Ireland MT: Malta SI: Slovenia CZ: Czech Republic ES:
p.000030: Spain IT: Italy NL: Netherlands SK: Slovakia
p.000030: DE: Germany FI: Finland LT: Lithuania PL: Poland UK: United Kingdom
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000031: 31
p.000031:
p.000031:
p.000031:
p.000031: III.8. Commercialisation and patenting
p.000031:
p.000031: The directive on the legal protection of biotechnological inventions (98/44/EC) (82) regulates
p.000031: patentability of biological material, including hESCs. The debate on patenting hESCs is ongoing at both
p.000031: institutional (European Patent Office, the European Commission (83)) and academic level. At present, there is no EU
p.000031: consensus on the moral status of the embryo and its products and, reflecting this wide diversity of
p.000031: moral cultures, there are different policies for patenting among national patent offices. The European Group on
p.000031: Ethics (EGE) has evaluated the ethical aspects of patenting inventions involving human stem cells (84).
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: (82) OJ L 213, 30.7.1998, pp. 13–21.
p.000031: (83) See COM(2005) 312
p.000031: (84) EGE Opinion No 16, ‘Ethical aspects involving the patenting of human stem cells’.
p.000031:
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032:
p.000032:
p.000032:
p.000032: IV. RECOMMENDATIONS
p.000032:
p.000032: IV.1 Preamble
p.000032:
p.000032:
p.000032: These recommendations constitute the reply to the request from the President of the European
p.000032: Commission, Mr Barroso (85), after the adoption of the EU’s seventh framework programme for research and
p.000032: development (FP7), to elaborate an opinion on the implementing measures required during the ethics review of
p.000032: research projects on human embryonic stem cells (hESCs).
p.000032:
p.000032: As is the case in the European Union, there are divergent views within the European Group on Ethics
p.000032: (EGE) on the moral legitimacy of research on human embryos and hESCs, ranging from objection to research
p.000032: involving the destruction of human embryos (which makes the full respect of dignity of the human embryo impossible),
p.000032: to a position allowing hESC research under certain conditions or on a broader basis.
p.000032:
p.000032: The group acknowledges the political decision taken as the starting point for its recommendations, but emphasises that
p.000032: the ethical dilemma regarding the moral status of the human embryo and its use in research still persists. The EGE
p.000032: therefore stresses that the ethical differences of opinion concerning hESC research have not been resolved.
p.000032:
p.000032: However, these recommendations do not elaborate ethical arguments on hESC research as such; this is
p.000032: because this was not the task given to the group by the European Commission.
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: (85) Letter sent by Commission President Barroso to the EGE on 22 November 2006. ‘I would like to invite the
p.000032: European Group on Ethics to provide the Commission with an opinion on the implementing measures
p.000032: required during the ethics review of research projects on human embryonic stem cells that will assure
p.000032: that the ethical rules and requirements are fully met’.
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000033: 33
p.000033:
p.000033:
p.000033: IV.2. Recommendations for the ethical review of research projects involving hESCs
p.000033:
p.000033: FP7 research projects involving the use of hESCs are subject to stringent rules for selection, are scrutinised at
p.000033: both national and EU level, and undergo both scientific and ethical reviews.
p.000033:
p.000033: Under FP7, research proposals must include information about ethical aspects of the proposed research, explain in
...
p.000037: internationally in order to minimise the use of hESCs within FP7-funded projects and to achieve complementary
p.000037: synergy rather than competition.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000038: 38
p.000038:
p.000038:
p.000038:
p.000038: IV.2.2. Ethical criteria for research projects under FP6
p.000038: A few conditions have already been laid down under FP6 to ensure that ethical requirements are met, and these can be
p.000038: taken over under FP7.
p.000038:
p.000038: 1. Applicants must explicitly prove that the regulatory criteria are met for the given project and must
p.000038: indicate the relevant national legal and/or regulatory requirements of the country/countries where the
p.000038: research takes place, according to FP7, Article 6(3) (96). For further information, see Annex 1.
p.000038:
p.000038: 2. Applicants must provide information that the hESCs used in the given project result from non-implanted IVF embryos
p.000038: (see following paragraph on donors’ rights).
p.000038:
p.000038: 3. Applicants must provide information on the protection of personal data and privacy of the donors of
p.000038: embryos for the creation of stem cell lines.
p.000038:
p.000038: 4. Applicants must provide information on the conditions of donation of the embryos (e.g. no financial
p.000038: inducement, number of eggs retrieved, etc.). In order to guarantee the non-commercialisation of the human body
p.000038: and in line with Article 12 of Directive 2004/23/EC, the EGE holds the view that, in order to protect the freedom
p.000038: of donation, human embryo donation should not involve financial inducement, other than the reimbursement of costs
p.000038: incurred.
p.000038:
p.000038: In addition to these conditions, the EGE recommends that the ethics review panel should ensure that
p.000038: applicants provide information on the points listed below.
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038: (96) Article 6(3), http://cordis.europa.eu/fp7/ethics-ict_en.html
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000039: 39
p.000039:
p.000039:
p.000039:
p.000039: IV.2.3. Additional criteria for FP7
p.000039:
p.000039: IV.2.3.1. Use of alternatives to hESCs
p.000039: Should alternatives to hESCs with the same potential as embryo-derived stem cells be found in the
p.000039: future, the implications of such developments for both scientific and ethical aspects of the hESC-based research
p.000039: projects ought to be taken into account as soon as possible.
p.000039:
p.000039: IV.2.3.2. Donors’ rights
p.000039: The donation of human embryos for the production of hESCs for research purposes poses a moral dilemma. This
p.000039: arises from the fact that human embryos are not ‘neutral objects’. Informed consent should address explicitly
p.000039: this moral dilemma, leaving the decision to the donors.
p.000039:
p.000039: The protection rights of donors need particular attention, in a very concrete way, meaning that those countries
p.000039: allowing the procurement of hESCs must provide information on the procurement process for the stem cell lines
p.000039: used by the applicant. The information should state that the measures of this process are in accordance with the
p.000039: fundamental ethical principles and human rights in force in the European Union, national legislation applicable at the
p.000039: time of the donation in the country where the donation was carried out and other relevant EU
p.000039: regulations (97). Applicants must provide information from the institutes generating the stem
p.000039: cell lines that the following criteria have been met for the procurement of hESCs:
p.000039:
p.000039: • no pressure has been put on the donors at any stage (98);
p.000039:
p.000039: (97) See EC/2004/23.
p.000039: (98) See ISSCR guidelines (http://www.isscr.org/guidelines/, p. 9, ‘Procurement of materials: For
p.000039: donating embryos or gametes generated in the course of clinical treatment. Except when specifically
p.000039: authorized by the SCRO (relevant ethics board) process, no reimbursement of direct expenses or financial
p.000039: considerations of any kind may be provided for donating embryos or gametes that have been generated in the
p.000039: course of clinical treatment and are in excess of clinical
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000040: 40
p.000040:
p.000040:
p.000040: • the donor’s health has not been put at risk by excessive ovarian stimulation;
p.000040: • as far as new hESC lines are concerned, informed consent to the donation for research of an embryo, originally
p.000040: planned for reproduction, is given in knowledge of the kind of research intended (99), its implications
p.000040: (including commercial) and in respect of the conditions foreseen by law at the time of the donation in the country
p.000040: where the donation was carried out;
p.000040: • information was given that consent could be withdrawn up to the stage of the creation of stem cells (100);
p.000040: • infertility treatment and research was appropriately separated;
p.000040: • no financial incentives have been offered to donate embryos for research at any stage, in line with Article 12 of
p.000040: Directive 2004/23/EC (101). However, some members of the EGE hold the view that the reduction of IVF costs
p.000040: is acceptable.
p.000040:
p.000040: If any of these criteria cannot be met because of the former conditions in which cell lines were generated, the
p.000040: applicants must explain why. The ethics review board must then decide how to deal with this matter on a
p.000040: case-by-case basis; for new hESC lines the above criteria are strongly recommended (see following paragraph,
p.000040: IV.2.4).
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: need or deemed of insufficient quality for clinical use. Researchers may not request that members of the infertility
p.000040: treatment team generate more embryos or harvest more oocytes than necessary for the optimal chance of reproductive
p.000040: success. People who elect to donate stored materials for research should not be reimbursed for the costs
...
p.000088: different countries (UK, IT, DE, HU)
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000089: 89
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: ANNEX IV
p.000089:
p.000089:
p.000089:
p.000089: EU MEMBER STATES’ REGULATORY FRAMEWORK FOR HESC RESEARCH
p.000089:
p.000089:
p.000089:
p.000089: Information provided by EU-27 national ethics councils, updated May 2007
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
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p.000090: 90
p.000090:
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p.000090:
p.000090: Regulatory frame applying to AUSTRIA
p.000090:
p.000090:
p.000090: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000090: having not a legal personality.
p.000090:
p.000090:
p.000090: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000090: to get the texts would be welcomed).
p.000090: The hESC research (Untersuchung/Behandlung rather in the sense of medical examination and treatment) is limited to the
p.000090: field of reproductive medicine. It is therefore covered in the legislation applying to reproductive medicine
p.000090: (Fortplanzungsmedizingesetz §9.(1); http://www.ris.bka.gv.at/bundesrecht/)
p.000090:
p.000090: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000090: No
p.000090:
p.000090: 3 Is hESC research allowed and in what terms and conditions?
p.000090: hESC research in the above mentioned sense is limited to the field of reproductive medicine; other research is not
p.000090: allowed;
p.000090:
p.000090: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000090: ---
p.000090:
p.000090: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000090: yes at what conditions?
p.000090: No
p.000090:
p.000090: 6 Is the source of hESC used in research traceable and well documented?
p.000090: ---
p.000090: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000090: ---
p.000090:
p.000090: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000090: embryo donation for research, if so could you please describe them?
p.000090: ---
p.000090:
p.000090: 9 Is financial inducement allowed? If so, in what terms?
p.000090:
p.000090: ---
p.000090:
p.000090: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000090: ---
p.000090:
p.000090: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000090: publications)?
p.000090:
p.000090:
p.000090: 12 How is patenting of hESC lines regulated?
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000091: 91
p.000091:
p.000091:
p.000091:
p.000091: Regulatory frame applying to BELGIUM
p.000091:
p.000091: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000091: having not a legal personality.
p.000091:
p.000091: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where to
p.000091: get the texts would be welcomed).
p.000091: There are several regulations applying on hESC research:
p.000091: 1: Law on organ transplantation 13/06/1986 (applicable on tissues, Published 14/02/1987) 2: Royal Decree on tissue
p.000091: banks of 15/04/1988 (Published 29/04/1988)
p.000091: 3: Embryo Law of 11/05/2003 (Published BS 28/05/2003)
p.000091:
p.000091:
p.000091: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000091: Yes: An embryo is a cell or a group of coherent cells that have the capacity to develop into a human being (see Embryo
p.000091: law, Art. 2, cited:)
p.000091: Loi du 11 mai 2003. Article 2. Pour l'application de la présente loi, on entend par:
p.000091: 1) «embryon»: la cellule ou l'ensemble organique de cellules susceptibles, en se développant, de donner un être
p.000091: humain
p.000091:
p.000091: 3 Is hESC research allowed and in what terms and conditions?
p.000091: Yes:
p.000091: At universities or in cooperation with universities, after consent of the local ethical commission and
p.000091: after positive advice (within 2 months) of the Federal Commission for medical and scientific research on embryos in
p.000091: vitro
p.000091: Loi du 11 mai 2003. Article 7, paragraphe 1. Toute recherche sur des embryons in vitro doit être soumise au préalable
p.000091: au comité local d'éthique de l'établissement universitaire concerné et à la Commission fédérale pour la recherche
p.000091: médicale et scientifique sur les embryons in vitro visée à l'article 9.
p.000091: La demande d'avis est introduite conjointement par le chercheur et le chef du laboratoire de procréation médicalement
p.000091: assistée ou de génétique humaine agréé de l'établissement universitaire concerné ou de l'établissement qui a conclu une
p.000091: convention avec un établissement universitaire.
p.000091: La demande d'avis comporte une description détaillée de l'objectif, de la méthodologie et de la durée de la recherche.
p.000091: Elle indique spécialement si la recherche a lieu sur des embryons surnuméraires ou des embryons créés à des fins de
p.000091: recherche.
p.000091: Paragraphe 2. L'avis du comité local d'éthique est rendu dans un délai de deux mois suivant la demande d'avis.
p.000091: Si l'avis du comité local d'éthique est négatif, le projet de recherche est abandonné.
p.000091: Le chercheur et le chef de laboratoire portent à la connaissance de la Commission fédérale pour la recherche médicale
p.000091: et scientifique sur les embryons in vitro, visée à l'article 9, leur demande d'avis ainsi que l'avis positif du comité
p.000091: local d'éthique. Si, dans un délai de deux mois après cette transmission, la Commission n'a pas émis d'avis négatif à
p.000091: la majorité de ses membres, le projet de recherche est autorisé et peut être entamé. Toutes les décisions de la
p.000091: Commission fédérale pour la recherche médicale et scientifique sur les embryons in vitro sont motivées.
p.000091:
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p.000091:
p.000092: 92
p.000092:
p.000092:
p.000092:
p.000092: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000092:
p.000092: The Federal Commission for medical and scientific research on embryos in vitro
p.000092:
p.000092:
p.000092: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if yes
p.000092: at what conditions?
p.000092: Yes, but ONLY if the objective of this research project can’t be achieved by using supernumerary embryos and this still
p.000092: under the conditions complying with the embryo law.
p.000092: Loi du 11 mai 2003. Article 4, paragraphe 1. La constitution d'embryons in vitro à des fins de recherche est interdite,
p.000092: sauf si l'objectif de la recherche ne peut être atteint par la recherche sur les embryons surnuméraires et pour autant
p.000092: que les conditions de la présente loi soient remplies.
p.000092: 6 Is the source of hESC used in research traceable and well documented?
p.000092: Actually there is no mandatory traceability.
p.000092: In a short period of time, traceability will be assured by a new law dealing with storage and distribution of cells and
p.000092: tissues
p.000092: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000092: Cf question 4
p.000092: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in embryo
p.000092: donation for research, if so could you please describe them?
p.000092: Yes.
p.000092: Donors give their free and written consent for the use of their gametes for research purposes after being properly
p.000092: informed
p.000092: Loi du 11 mai 2003. Article 8. Les personnes concernées donnent leur consentement préalable libre, éclairé et consigné
p.000092: par écrit à l'utilisation des gamètes ou des embryons in vitro à des fins de recherche.
p.000092:
p.000092: 9 Is financial inducement allowed? If so, in what terms?
p.000092:
p.000092: Yes, for research No, for donation
p.000092: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000092: Anonymity is guaranteed for the donors of gametes and/or embryos (Medical confidentiality and the law on rights of
p.000092: patients)
p.000092:
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p.000093: 93
p.000093:
p.000093:
p.000093:
p.000093:
p.000093: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000093: publications)?
p.000093: The Federal Commission for medical and scientific research on embryos in vitro can control the laboratories where
p.000093: research on embryos in vitro is ongoing. (Art 10)
p.000093: Every year, the researchers have to procure to the Federal Commission a progress report on their research on embryos
p.000093: (Art 11)
p.000093: Loi du 11 mai 2003. Article 10, paragraphe 2. […] Elle peut à tout moment visiter les laboratoires dans lesquels se
...
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p.000094: 94
p.000094:
p.000094:
p.000094:
p.000094: Regulatory frame applying to BULGARIA
p.000094:
p.000094: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000094: having not a legal personality.
p.000094:
p.000094: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000094: to get the texts would be welcomed).
p.000094:
p.000094: Healthcare Act /Chapter IV, Div. III – ‘Artificial Reproduction’/ In force from 01.01.2005 ./ SG N.70/2004., adopt.
p.000094: N.46/2005., N.76/2005., N.85/2005., N.88/ 2005., N.94/2005., N.103/2005., N.18/2006., N.30/2006., N.34/2006.,
p.000094: N.59/2006., N.71/2006., N.75/ 2006., N.81/2006., N.95/2006., N.102/ 2006./.
p.000094: Transplantation organ, tissue & cells Act In force from 01.01.2004 ./ SG N.83/2003., adopt..N88/2005.,N.71/2006./.;
p.000094: Ordinance N 37/28.09.2004 for the conditions and order for taking an embryos organs, tissue and somatic, amniotic and
p.000094: placenta cells for transplantation aims.
p.000094: / SG N.88/8.10.2004z.,adopt. SG N..89/ 12.10. 2004z./
p.000094:
p.000094: / the object of Ordinance regulation is only the ‘embryonic organs, tissue and cells’ after abortion — Art.1 and Art.4/
p.000094:
p.000094: Remark: To my opinion, the term ‘human embryonic stem sells’ have an wide and narrow understanding.. The ‘wide’ meaning
p.000094: comprises zygotes and life embryo as a source of stem cells.
p.000094: The narrow meaning comprises only life embryo as a source of stem cells.
p.000094: Therefore it will be useful to specify what meaning should be the right contents of the term ‘hESC’.
p.000094:
p.000094: Web address:
p.000094: www.bultransplant.bg ; www.mh.government.bg/iat.php;
p.000094: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000094: “Embryo’ is not defined explicitly.
p.000094: There is a definition of ‘embryonic organs, tissue and cells’ — Transplantation organ, tissue & cells Act, Additional
p.000094: provisions, &1, point.9.
p.000094:
p.000094: 3 Is hESC research allowed and in what terms and conditions?
p.000094: No.
p.000094:
p.000094:
p.000094:
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p.000095: 95
p.000095:
p.000095:
p.000095:
p.000095: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000095: see.point.3
p.000095:
p.000095: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000095: yes at what conditions? No.
p.000095: 6 Is the source of hESC used in research traceable and well documented?
p.000095: See point.5
p.000095: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000095: Healthcare Act — Art. 134 — ‘Gametes and zygotes, which are not used for the purpose of human creation, can be given to
p.000095: the research, academic and medicine entities in the country and outside, for the medicine, scientific and teaching
p.000095: purposes, after written inform consent of the donor, but concerning zygotes – the consent should be taken by the two
p.000095: donors, according to the Ordinance, issued by the Minister of healthcare.
p.000095:
p.000095: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000095: embryo donation for research, if so could you please describe them?
p.000095: See.point.7.
p.000095:
p.000095:
p.000095: 9 Is financial inducement allowed? If so, in what terms?
p.000095:
p.000095: No
p.000095:
p.000095: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000095: No
p.000095:
p.000095: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000095: publications)?
p.000095: N/A
p.000095: 12 How is patenting of hESC lines regulated?
p.000095: N/A
p.000095:
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p.000096: 96
p.000096:
p.000096:
p.000096:
p.000096: Regulatory frame applying to CYPRUS
p.000096:
p.000096: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000096: having not a legal personality.
p.000096:
p.000096: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000096: to get the texts would be welcomed).
p.000096: There is no specific law for hESC in the Republic of Cyprus.
p.000096: However, the Republic of Cyprus has ratified the ‘Convention for the Protection of Human Rights and Dignity
p.000096: of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine,
p.000096: Oviedo Convention’ with the Ratification Law N.31(III)/2001.
p.000096:
p.000096: Article 18 of the Convention and the Ratification Law, in relation to the research on embryos in vitro, states that:
p.000096: 1. Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo.
p.000096: 2. The creation of human embryos for research purposes is prohibited.
p.000096:
p.000096: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000096: No, it does not provide a definition of ‘embryo’.
p.000096:
p.000096: 3 Is hESC research allowed and in what terms and conditions?
p.000096: There is no law in the Republic of Cyprus allowing research on embryos in-vitro under any circumstances.
p.000096: The hESC research is not allowed in the Republic of Cyprus.
p.000096:
p.000096: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000096:
p.000096:
p.000096: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000096: yes at what conditions?
p.000096: The creation of embryos for research purposes is absolutely prohibited in the Republic of Cyprus in accordance with
p.000096: Article 18 (2) of the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the
p.000096: Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Oviedo Convention’. The Article 18 (2)
p.000096: of the Oviedo Convention states that ‘The creation of human embryos for research purposes is prohibited'. The
p.000096: Convention has been ratified by the Law 31 (III)/2001.
p.000096: 6 Is the source of hESC used in research traceable and well documented?
p.000096: The extraction of embryonic stem cells from embryos in-vitro is prohibited in accordance with Article 18 of the Oviedo
p.000096: Convention and Article 7 of its Ratification Law (No. 31 (III)/2001).
p.000096: 7 What are the formal ethical and legal requirements for hESC research approval? Having in mind all the
p.000096: above mentioned and in accordance with the information given in paragraphs 3, 5 and 6 above, research on embryonic stem
p.000096: cells is neither legally nor ethically approved by the legislation currently in force, in the Republic of Cyprus.
p.000096:
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p.000096:
p.000097: 97
p.000097:
p.000097:
p.000097:
p.000097: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000097: embryo donation for research, if so could you please describe them?
p.000097: Not applicable
p.000097:
p.000097: 9 Is financial inducement allowed? If so, in what terms?
p.000097:
p.000097: Not applicable
p.000097: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000097:
p.000097: Not applicable
p.000097: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000097: publications)?
p.000097: Not applicable
p.000097: 12 How is patenting of hESC lines regulated?
p.000097: Not applicable
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p.000098: 98
p.000098:
p.000098:
p.000098:
p.000098: Regulatory frame applying to CZECH REPUBLIC
p.000098:
p.000098: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000098: having not a legal personality.
p.000098:
p.000098: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000098: to get the texts would be welcomed).
p.000098: Act on Human Embryonic Stem Cell Research (law no. 227/2006 Coll.) passed by the Czech Parliament on 26th of April
p.000098: 2006, in force since June 1 2006.
p.000098: Text available here: http://www.mvcr.cz/sbirka/2006/sb075-06.pdf (also attached)
p.000098:
p.000098: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000098: “Human embryo is a totopotent cell or a grouping of cells which are capable develop into human individuum’ (law no.
p.000098: 227/2006 Coll., § 2)
p.000098:
p.000098: 3 Is hESC research allowed and in what terms and conditions?
p.000098: Yes.
p.000098: Conditions: State licensing (given by the Ministry of Education, after approval of the Bioethics Committee of the
p.000098: Research and Development Council of the Czech Government and after positive appraisal of the Research and Development
p.000098: Council) Preconditions:
p.000098: a) Scientific criteria
p.000098:
p.000098: scientifically justifiable – new medical knowledge with applications for humans; scientific necessity (usage of in
p.000098: vitro models, animal cells or animals does not provide the necessary knowledge);
p.000098: no alternative research
p.000098: scientific quality of the research team
p.000098: b) Ethical criteria
p.000098:
p.000098: Research project is ethically acceptable (informed consent, donation…)
p.000098:
p.000098: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000098: Ministry of Education
p.000098:
p.000098: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000098: yes at what conditions?
p.000098:
p.000098: No. The Czech Republic ratified Oviedo Convention (2001).
p.000098: 6 Is the source of hESC used in research traceable and well documented?
p.000098: Yes.
p.000098: 7 What are the formal ethical and legal requirements for hESC research approval? Source of embryos:
p.000098: ‘surplus embryos’ from IVF (only from licensed IVF centres), no longer than 7 day of development, export of embryos
p.000098: prohibited
p.000098: Informed consent
p.000098: Donation (reimbursement of expenses possible)
p.000098:
p.000098: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000098: embryo donation for research, if so could you please describe them?
p.000098: Yes. Detailed description in § 9 Act no. 227/2006 Coll.
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000099: 99
p.000099:
p.000099:
p.000099:
p.000099: 9 Is financial inducement allowed? If so, in what terms?
p.000099:
p.000099: No.
p.000099: Only reimbursement of real expenses (to the IVF Centre)
p.000099: Reimbursement of real expenses related to the embryo donation (to the donor, payment and other compensation explicitly
p.000099: prohibited)
p.000099:
p.000099: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000099: Yes. The Act on Personal Data Protection applies.
p.000099:
p.000099: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000099: publications)?
p.000099: No
p.000099:
p.000099: 12 How is patenting of hESC lines regulated?
p.000099: No regulation.
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p.000100: 100
p.000100:
p.000100:
p.000100:
p.000100: Regulatory frame applying to DENMARK
p.000100:
p.000100: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000100: having not a legal personality.
p.000100:
p.000100: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000100: to get the texts would be welcomed).
p.000100: Yes www.retsinfo.dk
p.000100:
p.000100: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000100: No
p.000100:
p.000100: 3 Is hESC research allowed and in what terms and conditions?
p.000100: Research is allowed on human fertilized eggs meant for fertilisation of a woman under the conditions mentioned in
p.000100: Lovbekendtgørelse af lov om kunstig befrugtning i forbindelse med lægelig behandling, diagnostic og forskning LBK nr.
p.000100: 923 af 04//09/2006 chapter 7, paragraph 25-27
p.000100:
p.000100: Kapitel 7
p.000100: Forbud mod forskning og forsøg
p.000100:
p.000100: § 25. Biomedicinske forsøg på befrugtede menneskelige æg samt på kønsceller, der agtes anvendt til befrugtning, må kun
p.000100: foretages i følgende tilfælde:
p.000100: 1) Hvis de har til formål at forbedre in vitro-befrugtning eller lignende teknikker med henblik på at fremkalde en
p.000100: graviditet.
p.000100: 2) Hvis de har til formål at forbedre teknikker til genetisk undersøgelse af et befrugtet æg med henblik på at fastslå,
p.000100: om der foreligger en alvorlig arvelig sygdom eller en væsentlig kromosomabnormitet (præimplantationsdiagnostik).
p.000100: 3) Hvis forsøgene ved anvendelse af befrugtede æg og stamceller herfra har til formål at opnå ny viden, som vil kunne
p.000100: forbedre mulighederne for behandling af sygdomme hos mennesker.
p.000100: Stk. 2. Udtagning og befrugtning af æg med henblik på at gennemføre andre forsøg end de i stk. 1 nævnte er ikke
p.000100: tilladt.
p.000100:
p.000100: § 26. Befrugtede æg må kun holdes i live uden for en kvindes livmoder i 14 dage, fra befrugtningen er sket. Den tid,
p.000100: hvori de befrugtede menneskelige æg har været nedfrosset, medregnes ikke.
p.000100:
p.000100: § 27. Befrugtede menneskelige æg, der har været gjort til genstand for biomedicinsk forskning, herunder almindelig
p.000100: kvalitetssikrende forskning ved ægopsætning, må kun opsættes i en kvindes livmoder, hvis det befrugtede æg er genetisk
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p.000101: de sætter sig fast i livmoderen.
p.000101: 3) Forsøg, der har til formål at muliggøre fremstilling af levende menneskelige individer, som er hybrider, med en
p.000101: arvemasse, hvori indgår bestanddele fra andre arter.
p.000101: 4) Forsøg, der har til formål at muliggøre udvikling af et menneskeligt individ i artsfremmed livmoder.
p.000101:
p.000101:
p.000101: 4 If yes, which body is in charge of the approval of hESC research (ethics review)? The Danish Committees
p.000101: on Biomedical Researchhttp://www.cvk.im.dk/cvk/site.aspx?p=23
p.000101:
p.000101: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000101: yes at what conditions?
p.000101: No
p.000101:
p.000101: 6 Is the source of hESC used in research traceable and well documented?
p.000101: Yes see provisions of Act on a Biomedical Research Ethics Committee System and the Processing of Biomedical Research
p.000101: Projects
p.000101: http://www.cvk.im.dk/cvk/site.aspx?p=150
p.000101:
p.000101: 7 What are the formal ethical and legal requirements for hESC research approval? See the Danish act on a
p.000101: Biomedical Research Ethics Committees System and the Processing of Biomedical Research Projects
p.000101:
p.000101: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000101: embryo donation for research, if so could you please describe them? See the Danish act on a Biomedical Research Ethics
p.000101: Committees System and the Processing of Biomedical Research Projects
p.000101:
p.000101:
p.000101:
p.000101: 9 Is financial inducement allowed? If so, in what terms? No
p.000101:
p.000101:
p.000101: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000101: Yes, see the Danish act on a Biomedical Research Ethics Committees System and the Processing of Biomedical Research
p.000101: Projects
p.000101:
p.000101:
p.000101: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000101: publications)?
p.000101: Yes, see the Danish act on a Biomedical Research Ethics Committees System and the Processing of Biomedical Research
p.000101: Projects
p.000101:
p.000101:
p.000101: 12 How is patenting of hESC lines regulated?
p.000101: See Danish Law on Patents Paragraph 1A
p.000101:
p.000101: § 1 a. Det menneskelige legeme på alle de forskellige stadier af dets opståen og udvikling og den blotte opdagelse af
p.000101: en del af det, herunder en sekvens eller delsekvens af et gen, kan ikke udgøre patenterbare opfindelser.
p.000101: Stk. 2. Uanset stk. 1 kan en del af det menneskelige legeme, der er isoleret herfra eller på anden måde fremstillet ved
p.000101: en teknisk fremgangsmåde, herunder en sekvens
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p.000102: eller delsekvens af et gen, udgøre en patenterbar opfindelse, selv om en sådan del i sin opbygning er identisk med
...
p.000102: Subs. 2. Notwithstanding subsection 1 hereof, an element isolated from the human body or otherwise produced by means of
p.000102: a technical process, including a sequence or partial sequence of a gene, may constitute a patentable invention, even if
p.000102: the structure of that element is identical to that of a natural element.’
p.000102:
p.000102: In the Danish regulations, Article 5, subs. 3 of the EU directive on patenting of human stem cells has been set out in
p.000102: the statutory instrument on patents.
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p.000103:
p.000103: Regulatory frame applying to ESTONIA
p.000103:
p.000103:
p.000103: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000103: having not a legal personality.
p.000103:
p.000103: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000103: to get the texts would be welcomed).
p.000103: We have no special regulations of hESC research in Estonia and if needed we take into consideration relevant
p.000103: international documents..
p.000103:
p.000103: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000103: _
p.000103:
p.000103: 3 Is hESC research allowed and in what terms and conditions?
p.000103: The Estonian Council on Bioethics is on the position, that in principle hESC research is acceptable in Estonia.
p.000103:
p.000103: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000103: In needed cases the approval will be given by research ethics committees
p.000103:
p.000103: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000103: yes at what conditions?
p.000103: The creation of embryos for research purposes is not allowed by the Estonian law of artificial procreation and embryo
p.000103: protection
p.000103:
p.000103: 6 Is the source of hESC used in research traceable and well documented?
p.000103: We have no special system for this yet
p.000103: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000103: They are not fixed yet in Estonia
p.000103:
p.000103: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000103: embryo donation for research, if so could you please describe them?
p.000103: No regulations on it
p.000103:
p.000103: 9 Is financial inducement allowed? If so, in what terms?
p.000103:
p.000103: It is not regulated
p.000103:
p.000103: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000103: No
p.000103:
p.000103: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000103: publications)?
p.000103: No
p.000103:
p.000103: 12 How is patenting of hESC lines regulated?
p.000103: It is not regulated in Estonia
p.000103:
p.000103:
p.000103:
p.000103:
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p.000104: 104
p.000104:
p.000104:
p.000104:
p.000104: Regulatory frame applying to FINLAND
p.000104:
p.000104: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000104: having not a legal personality.
p.000104:
p.000104: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000104: to get the texts would be welcomed).
p.000104: Medical Research Act, 488/1999. www.finlex.fi
p.000104: Translation: see: http://www.finlex.fi/en/laki/kaannokset/1999/en19990488.pdf
p.000104: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000104: Yes. ‘embryo’ means a living group of cells resulting from fertilisation not implanted in a woman’s body
p.000104:
p.000104: 3 Is hESC research allowed and in what terms and conditions?
p.000104: It is allowed. Embryos shall be used for research only with a written informed consent from the donors of the gametes.
p.000104: Consent can be withdrawn in any time (Act on medical Research, section 12) Only supernumerary embryos shall be used for
p.000104: research. The production of embryos exclusively for the purpose of research is forbidden. (Act on Medical Research,
p.000104: section 13). When hESC lines have been produced, the law does not make any further provisions on the use of these
p.000104: cells. The production of hESC needs the favourable opinion of an ethics committee of a hospital district, and the
p.000104: research on embryos can be done only in the institutions that have got an authorisation from the National Authority of
p.000104: Medicolegal Affairs (TEO) The use of embryos for research is allowed only for 14 days after fertilisation
p.000104: 4 If yes, which body is in charge of the approval of hESC research (ethics review)? Ethics committees of
p.000104: hospital districts evaluate the research projects, although the research of cell lines is not specifically regulated in
p.000104: the Medical Research Act. The Ministry of Social Affairs and Health has established a working group on Biobanks that is
p.000104: working on the issue of biobanks including ethics evaluation of establishment of biobank and ethics evaluation of the
p.000104: research projects.
p.000104: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000104: yes at what conditions?
p.000104: Medical Research Act states that The production of embryos exclusively for the purpose of research shall be forbidden.
p.000104: However, the Act also determines the embryo as ‘the living group of cells resulting from fertilisation’. This can be
p.000104: interpreted so that cells produced by the somatic cell nuclear transfer are not considered as embryos.
p.000104: 6 Is the source of hESC used in research traceable and well documented?
p.000104: Anonymisation and coding as far as possible should be used in each project
p.000104: 7 What are the formal ethical and legal requirements for hESC research approval? We have formal ethical
p.000104: and legal requirements for embryo research stated in the Medical Research Act. Further requirements concerning hESC
p.000104: lines have not been established. The working group is working on this issue concerning research on biological sample
p.000104: collections.
p.000104: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000104: embryo donation for research, if so could you please describe them?
p.000104: Ethics committees approve information and consent forms before they can be used in the informed consent procedure
p.000104:
p.000104: 9 Is financial inducement allowed? If so, in what terms?
p.000104:
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p.000105: 105
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p.000105: No; donation must be voluntary. Only compensation of the expenses and harms (healthy donors) is allowed according to
p.000105: Decree 1390/2006. There are not such expenses or harm related to hESC while embryos that could be donated for research
p.000105: are surplus embryos.
p.000105:
p.000105: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000105: No, regular data protection provisions similar to medical research in general are applied to hESC research.
p.000105:
p.000105: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000105: publications)?
p.000105: Not necessarily, only when they are published.
p.000105:
p.000105: 12 How is patenting of hESC lines regulated?
p.000105: We have Act on Patenting (550/1967, amendment 650/2000) that has implemented the EU Directive of biopatenting. It
p.000105: states that (Section 1a and b) human body or its part, whole or partial sequence of a gene or similar finding cannot be
...
p.000105: http://www.finlex.fi/en/laki/kaannokset/1967/en19670550.pdf
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p.000106: 106
p.000106:
p.000106:
p.000106:
p.000106: Regulatory frame applying to FRANCE
p.000106:
p.000106: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000106: having not a legal personality.
p.000106:
p.000106: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000106: to get the texts would be welcomed). www.agence-biomedecine.fr
p.000106: http://www.agence-biomedecine.fr/fr/experts/pegh-recherche.aspx
p.000106: Demande d'autorisation de protocoles d'étude et de recherche, d'importation ou de conservation
p.000106: Le décret n° 2006-121 du 6 février 2006 relatif aux recherches sur l'embryon et les cellules embryonnaires, précisant
p.000106: les conditions d'application de la loi du 6 août 2004, prévoit que le directeur général de l'Agence de la biomédecine
p.000106: notifie à l'établissement ou à l'organisme demandeur sa décision d'autorisation ou de refus d'autorisation dans les 4
p.000106: mois suivant la clôture de la période au cours de laquelle a été déposé le dossier complet.
p.000106: www.legifrance.gouv.fr
p.000106: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000106: The embryo in this law is :
p.000106: Obtained during an ART protocol and is no more subject to a parental (pregnancy) project
p.000106: Up to implantation stage
p.000106:
p.000106: 3 Is hESC research allowed and in what terms and conditions?
p.000106: Subjected to the obtention of a licence for
p.000106: -research project
p.000106: -importation
p.000106: -conservation/storage
p.000106:
p.000106: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000106: The agency of biomedicine www.agence-biomedecine.fr
p.000106:
p.000106: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000106: yes at what conditions?
p.000106: No
p.000106:
p.000106: 6 Is the source of hESC used in research traceable and well documented?
p.000106: It is a condition to fulfil in order to obtain a licence to be able to keep a local registry and tracks of cell
p.000106: culture;
p.000106: The agence de la biomedicine has also to keep a national hESC registry
p.000106: 7 What are the formal ethical and legal requirements for hESC research approval? The research project
p.000106: should benefit to the progress towards a potential therapeutic use of to progress on human embryo development and
p.000106: medicine.
p.000106: The team involved has to provide proof if feasibility of this research, and to documents the composition of the team,
p.000106: the lab rooms scheme, the traceability of the Es cell lines See décret n°2006-121 du 6 février 2006
p.000106:
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p.000107: 107
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p.000107:
p.000107: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000107: embryo donation for research, if so could you please describe them?
p.000107: Yes
p.000107: The law does ask to document the origin of the cell line and to provide the consent form model : both parents should
p.000107: have signed for the use of the embryo for research,
p.000107:
p.000107: 9 Is financial inducement allowed? If so, in what terms?
p.000107:
p.000107: No
p.000107: The authority in charge of giving licences does not provide funds for research on those topics.
p.000107:
p.000107: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000107: Yes
p.000107:
p.000107: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000107: publications)?
p.000107: Yes, they are asked for every licence given, a yearly progress report is asked, and a final report.
p.000107:
p.000107: 12 How is patenting of hESC lines regulated?
p.000107: Not authorized
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p.000108: 108
p.000108:
p.000108:
p.000108:
p.000108: Regulatory frame applying to GERMANY
p.000108:
p.000108: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000108: having not a legal personality.
p.000108:
p.000108: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000108: to get the texts would be welcomed).
p.000108: 1) Act for the Protection of Embryos (Embryo Protection Act),
p.000108: Gesetz zum Schutz von Embryonen (Embryonenschutzgesetz – EschG)
p.000108: http://bundesrecht.juris.de/eschg/BJNR027460990.html,
p.000108:
p.000108: 2) Act ensuring protection of embryos in connection with the importation and utilisation of human embryonic stem cells
p.000108: (Stem Cell Act), Gesetz zur Sicherstellung des Embryonenschutzes im Zusammenhang mit Einfuhr und Verwendung
p.000108: menschlicher embryonaler Stammzellen (Stammzellgesetz – StZG)
p.000108: http://bundesrecht.juris.de/stzg/index.html
p.000108:
p.000108: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000108: For the purpose of the Embryo Protection Act, an embryo means a fertilised human egg capable of developing from the
p.000108: time of fusion of the nuclei, and further each totipotent cell removed from an embryo that is capable of dividing and
p.000108: developing into an individual human being if the necessary conditions prevail. (ESchG §8 (1)).
p.000108:
p.000108: For the Stem Cell Act embryo means any human totipotent cell which has the potential to divide and to develop into a
p.000108: human being if the necessary conditions prevail (StZG §3 (4)).
p.000108: 3 Is hESC research allowed and in what terms and conditions?
p.000108: According to the Embryo Protection Act the production of hESCs is forbidden. The Stem Cell Act ensures the protection
p.000108: of embryos in connection with the importation and utilisation of human embryonic stem cells. hESC research is only
p.000108: permitted using cell lines created before 1 January 2002 in the country of origin in accordance with relevant national
p.000108: legislation there and kept in culture or subsequently stored using cryopreservation methods. The embryos from which
p.000108: they were derived must have been produced by medically-assisted in vitro fertilisation in order to induce pregnancy and
p.000108: definitely no longer used for this purpose and no evidence that this was due to reasons inherent in the embryos
p.000108: themselves. No compensation or other benefit in money’s worth may have been granted or promised for the donation of
p.000108: embryos for the purpose of stem cell derivation.
p.000108: 4 If yes, which body is in charge of the approval of hESC research (ethics review)? The Central Ethics
p.000108: Committee for Stem Cell Research at the Robert Koch Institute (RKI) is in charge of the approval of applications to
p.000108: import hESCs.
p.000108:
p.000108: The RKI is the federal institution responsible for disease control and prevention and the central federal reference
p.000108: institution for applied and response-orientated research as well as for the Public Health Sector.
p.000108: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000108: yes at what conditions?
...
p.000109: been clarified as far as possible through in vitro models using animal cells or through animal experiments and secondly
p.000109: the scientific knowledge to be obtained from the research project concerned cannot be expected to be gained by using
p.000109: cells other than embryonic stem cells.
p.000109:
p.000109: Any importation and any utilisation of embryonic stem cells has to be subject to approval by the stem cell ethics
p.000109: committee for stem cell research at the Robert Koch Institute. Applications for approval must be submitted in writing.
p.000109: In the documents accompanying the application, the applicant shall provide the following information in particular:
p.000109: 1. Name and official address of the person responsible for the research project concerned, 2. a description of the
p.000109: research project including scientific reasons showing that the research project meets the requirements described,3. a
p.000109: documentation concerning the embryonic stem cells to be imported or used showing that the requirements have been
p.000109: complied with equivalent evidence.
p.000109:
p.000109: The embryonic stem cells to be imported or used must be identical with those registered in a scientifically recognized,
p.000109: publicly accessible registry maintained by government agencies or agencies authorized by the government.
p.000109: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000109: embryo donation for research, if so could you please describe them?
p.000109: n/a
p.000109: 9 Is financial inducement allowed? If so, in what terms?
p.000109:
p.000109: For the stem cell lines to be imported no compensation or other benefit in money’s worth may have been granted for the
p.000109: donation of embryos for the purpose of stem cell derivation.
p.000109:
p.000109: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000109: Ad hoc data protection provisions are not mentioned in the Stem Cell Act.
p.000109:
p.000109: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000109: publications)?
p.000109: An obligation for publication is not mentioned in the Stem Cell Act.
p.000109:
p.000109: 12 How is patenting of hESC lines regulated?
p.000109: The Biotechnology Patenting Directive (98/44/EC) negotiated by the European Parliament and the European Council on 6
p.000109: July 1998 provides a uniform procedure for the patenting of biotechnological inventions in all EU Member States.
p.000109:
p.000109: In December 2004 Germany implemented the Biotechnology Patenting Directive and enacted the law 28 February 2005 (Gesetz
p.000109: zur Umsetzung der Richtlinie über den rechtlichen Schutz biotechnologischer Erfindungen (BioPatG), Act Implementing the
p.000109: Directive on the Legal Protection of Biotechnological Inventions in Germany).
p.000109: In December 2006 the German Federal Patent Court partially reversed their 1999 decision on Professor Oliver Brüstle’s
p.000109: patent, saying that anything made from human tissue cannot be patented.
p.000109:
p.000109:
p.000109:
p.000109:
p.000110: 110
p.000110:
p.000110:
p.000110:
p.000110: Regulatory frame applying to GREECE
p.000110:
p.000110: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000110: having not a legal personality.
p.000110:
p.000110: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where to get
p.000110: the texts would be welcomed).
p.000110:
p.000110: - Article 1459 c of the Civil Code (Act n. 3089/2002)
p.000110: - Article 11 par. 1 (e) of the Act n. 3305/2005 (“Application of M.A.R.)
p.000110: -
p.000110: - http://www.bioethics.gr/media/pdf/biolaw/human/law_3089_en.pdf?PHPSESSID=c730 cd74d93449cca3750bb51c50a228
p.000110:
p.000110:
p.000110:
p.000110: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000110:
p.000110: Yes, (article 3 of the Act n. 3305/2005, for the terms ‘zygote’ and ‘fertilized egg’
p.000110:
p.000110: ‘Zygote’: an ovum from its fertilisation until the merger of the two haploid nuclei
p.000110: “Fertilized egg’: an ovum after the penetration or initiation of sperm
p.000110:
p.000110:
p.000110: 3 Is hESC research allowed and in what terms and conditions?
p.000110: Yes.
p.000110: Under certain conditions:
p.000110: - Only on surplus embryos (up to the 14th day after fertilisation)
p.000110: - Prior written informed consent of the donors
p.000110: - Prior approval of the protocol (from the National Authority on M.A.R.)
p.000110: - Prior research on laboratory animals (if possible)
p.000110: - The research team should possess the necessary equipment and know-how
p.000110: - It is not allowed to implant the embryos that have been used
p.000110:
p.000110: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000110:
p.000110: The National Authority on Medically Assisted Reproduction (an independent regulatory agent, nominated by the
p.000110: Parliament)
p.000110:
p.000110:
p.000110: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if yes at
p.000110: what conditions?
p.000110:
p.000110: No
p.000110:
p.000110: 6 Is the source of hESC used in research traceable and well documented?
p.000110:
p.000110: Yes
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000111: 111
p.000111:
p.000111:
p.000111:
p.000111:
p.000111: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000111:
p.000111: See above (3)
p.000111:
p.000111: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in embryo
p.000111: donation for research, if so could you please describe them?
p.000111:
p.000111: See above (3)
p.000111:
p.000111: 9 Is financial inducement allowed? If so, in what terms?
p.000111:
p.000111: No (only compensation for justifiable expenses, medical services or undue damages is allowed)
p.000111:
p.000111: 1 Are ad hoc data protection provisions be defined for hESC research? 0
p.000111: No. The law on sensitive data protection (Act n. 2472/1997) is applicable, binding the research team.
p.000111: The Data Protection Authority is responsible for relevant controls.
p.000111:
p.000111:
p.000111: 1 Are data deriving from hESC projects necessarily provided, whether positive or
p.000111: 1 negative (in form of publications)?
p.000111:
p.000111: No
p.000111:
p.000111: 1 How is patenting of hESC lines regulated? 2
p.000111: By the presidential decree n. 321/2001 (on the Directive 98/44/EC)
p.000111:
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p.000111:
p.000112: 112
p.000112:
p.000112:
p.000112:
p.000112: Regulatory frame applying to HUNGARY
p.000112:
p.000112: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000112: to get the texts would be welcomed).
p.000112:
p.000112: The human embryonic stem cells research and use is regulated by law and five decrees.
p.000112: The 1997. CLIV. law about the health regulated the general conditions of the use and research of the human embryonic
p.000112: stem cells (180- 182 paragraphs.(
p.000112: The 2006 CXV. law about the health reform.
p.000112: The 21/1998. (VI.3.) MH decree contains the minimum conditions of the use of human embryonic stem cells ( 15/B
p.000112: attachment).
p.000112: The 22/1998. (VI.3.) MH decree contains the detailed regulation of the transplantation of different organs and tissues.
p.000112: The 31/1998. (VI.24.) MH decree regulated the ethical approval system of biomedical research.
p.000112: The 22/2002. (V.9.) MH decree regulated the ethical approval system of biomedical research.
p.000112: The 1/2007. (I.24.) MH decree regulated the ethical approval system of biomedical research.
p.000112:
p.000112: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000112:
p.000112: embryo is defined as every living human embryo following the completion of fertilisation until 12th week of pregnancy.
p.000112: The foetus is the human being developing within the uterus after the 12th week of pregnancy.
p.000112:
p.000112: 3 Is hESC research allowed and in what terms and conditions?
p.000112:
p.000112: Research on embryos can be carried out on the basis of an authorisation of the Hungarian Reproduction Commission.
p.000112: Embryos can only be used for research purposes and experiments can only be made on embryos for the research purposes
p.000112: that the Health Care Act fixes with regard to medical research.
p.000112:
p.000112: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000112:
p.000112: Hungarian Reproduction Commission
p.000112: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000112: yes at what conditions?
p.000112:
p.000112: Embryos cannot be created for research purposes, only embryos created in medically assisted human procreation
p.000112: procedures (MAP) can be used for research and experiments, either on the basis of the decision of those entitled to
p.000112: decide, or in case of damage of the embryo. If an embryo was donated for a MAP procedure, but not used within 10 years
p.000112: following the donation, the embryo can be used for research purposes.
p.000112:
p.000112: 6 Is the source of hESC used in research traceable and well documented?
p.000112:
p.000112: The source of the hESC is traceable and well documented in every cases.
p.000112:
p.000112: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000112:
p.000112: The formal ethical and legal requirements for hESC research approval are regulated in the 1/2007. (I.24.) MH decree.
p.000112: The decree accepted the EC recommendations.
p.000112:
p.000112: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000112: embryo donation for research, if so could you please describe them?
p.000113: 113
p.000113:
p.000113:
p.000113:
p.000113:
p.000113: There is no embryo donation for research.
p.000113:
p.000113: 9 Is financial inducement allowed? If so, in what terms?
p.000113:
p.000113:
p.000113:
p.000113: Financial inducement is not allowed.
p.000113:
p.000113: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000113:
p.000113: Data protection is according to EU regulations.
p.000113:
p.000113: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000113: publications)?
p.000113: It is not.
p.000113: 12 How is patenting of hESC lines regulated?
p.000113: Patenting of hESC lines is not regulated.
p.000113:
p.000113:
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p.000113:
p.000114: 114
p.000114:
p.000114:
p.000114:
p.000114: Regulatory frame applying to IRELAND
p.000114:
p.000114: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000114: having not a legal personality.
p.000114:
p.000114: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000114: to get the texts would be welcomed).
p.000114:
p.000114: Ireland currently has no specific legislation dealing with embryonic stem cell research and furthermore does not have a
p.000114: legislative basis for the practice of IVF and therefore has no legislation pertaining to use of embryos
p.000114: (supernumerary or otherwise) for research. The Medical Council’s Guide to Ethical Conduct and Behaviour
p.000114: 6th edition 2004 states that in relation to IVF ‘that any fertilised ovum must be used for normal
p.000114: implantation and must not be deliberately destroyed". They also state ‘the creation of new life forms for
p.000114: experimental purposes or the deliberate and intentional destruction of in-vitro human life already formed is
p.000114: professional misconduct". It should be noted that the Medical Council only regulate physicians and therefore scientists
p.000114: are not bound by the guide, e.g. it would appear that there is currently no legal impediment on importation or use of
p.000114: embryonic stem cells lines by scientists.
p.000114:
p.000114: Following a referendum some years ago, The Irish Constitution was amended and Article 40.3.3 of the
p.000114: Constitution acknowledges the right to life of the unborn. However, no legislation followed this amendment e.g.
p.000114: to articulate what is defined as ‘unborn’, would this include supernumerary embryos in storage etc.
p.000114: This Constitutional Amendment has been interpreted by some to mean that embryonic stem cell research would be
p.000114: prohibited by our constitution. A recent high court judgment (Nov 2006) found that three frozen embryos resulting
p.000114: from IVF are not ‘unborn" as defined under the Constitution. This judgment has been appealed to the Supreme
p.000114: Court.
p.000114: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000114: N/A
p.000114:
p.000114: 3 Is hESC research allowed and in what terms and conditions?
p.000114: There is no legislation prohibiting ESC research in Ireland. It would appear from the Recent High Court Judgement that
p.000114: ESC research is also not prohibited under the Irish Constitution. Further clarification will be forthcoming following a
p.000114: decision from the Supreme Court
p.000114:
p.000114: 4 If yes, which body is in charge of the approval of hESC research (ethics review)? Situation has not
p.000114: arisen to legal uncertainty in this area but it would come under research ethics committee review.
p.000114:
p.000114: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000114: yes at what conditions?
p.000114: No legislation/Regulation in this area.
p.000114:
p.000114: 6 Is the source of hESC used in research traceable and well documented?
p.000114: N/A
p.000114: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000114: N/A
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000115: 115
p.000115:
p.000115:
p.000115:
p.000115: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000115: embryo donation for research, if so could you please describe them?
p.000115: N/A
p.000115:
p.000115: 9 Is financial inducement allowed? If so, in what terms?
p.000115:
p.000115: N/A
p.000115:
p.000115: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000115: N/A
p.000115:
p.000115: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000115: publications)?
p.000115: N/A
p.000115:
p.000115: 12 How is patenting of hESC lines regulated?
p.000115: N/A
p.000115:
p.000115:
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p.000115:
p.000116: 116
p.000116:
p.000116:
p.000116:
p.000116: Regulatory frame applying to ITALY
p.000116:
p.000116:
p.000116: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000116: to get the texts would be welcomed). Italian discipline applying to human embryonic stem cells research consists in Law
p.000116: 19 February 2004, n. 40 (Law 40/2004), on medically assisted reproduction (“Norme in materia di procreazione
p.000116: medicalmente assistita’), published in Gazzetta Ufficiale n. 45, February 24, 2004.
p.000116:
p.000116: 2 Does the regulation provide a definition of 'embryo', if so which one? The law does not provide a
p.000116: definition of ‘embryo’. However, it aims to protect the rights of all the subjects involved in the medical assisted
p.000116: reproduction, included the conceived subject (see Art. 1, No 1, which specifies the scopes of the law).
p.000116:
p.000116: 3 Is hESC research allowed and in what terms and conditions?
p.000116: Art. 13, n. 1, of Law 40/2004 that has regards to the experimentation on human embryos (“Sperimentazione sugli embroni
p.000116: umani’) expressly prohibits any experimentation on human embryos.
p.000116:
p.000116: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000116: See answer No 3.
p.000116:
p.000116: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000116: yes at what conditions? Art. 13, n. 3 a), of Law 40/2004 expressly prohibits the creation of human embryos for research
p.000116: purposes or for experimentation.
p.000116:
p.000116: 6 Is the source of hESC used in research traceable and well documented?
p.000116: See answers No 3 and 5.
p.000116: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000116: See answers No 3 and 5.
p.000116:
p.000116: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000116: embryo donation for research, if so could you please describe them?
p.000116: The donation of embryos for research is not allowed by Italian law.
p.000116:
p.000116: 9 Is financial inducement allowed? If so, in what terms?
p.000116:
p.000116: See answer No 8.
p.000116:
p.000116: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000116: See answers No 3 and 5.
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000116:
p.000117: 117
p.000117:
p.000117:
p.000117:
p.000117: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000117: publications)?
p.000117: See answers No 3 and 5.
p.000117:
p.000117:
p.000117: 12 How is patenting of hESC lines regulated?
p.000117: See answers No 3, 5, 8.
p.000117:
p.000117:
p.000117:
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p.000117:
p.000118: 118
p.000118:
p.000118:
p.000118:
p.000118: Regulatory frame applying to LATVIA
p.000118:
p.000118: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000118: having not a legal personality.
p.000118:
p.000118: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000118: to get the texts would be welcomed).
p.000118:
p.000118: It is not regulated by legislation in Latvia
p.000118: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000118: No
p.000118:
p.000118: 3 Is hESC research allowed and in what terms and conditions?
p.000118: It is not prohibited by legislation
p.000118:
p.000118: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000118: Central Medical Ethics Committee
p.000118:
p.000118: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000118: yes at what conditions?
p.000118: It is prohibited by Latvian Reproductive Medicine Act;
p.000118: “The creation of human embryos for research purposes is prohibited.
p.000118:
p.000118:
p.000118: The human biological material or embryo shall not, as such, give rise to financial gain. ‘
p.000118:
p.000118:
p.000118: 6 Is the source of hESC used in research traceable and well documented?
p.000118: We have no experience
p.000118: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000118:
p.000118: It is not regulated by legislation
p.000118: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000118: embryo donation for research, if so could you please describe them?
p.000118:
p.000118: It is not regulated by legislation
p.000118: 9 Is financial inducement allowed? If so, in what terms?
p.000118:
p.000118: It is not regulated by legislation
p.000118:
p.000118: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000118: It is regulated for any research
p.000118: Law on Data Protection
p.000118: Personal data processing is permitted only if not prescribed otherwise by law, and at least one of the
p.000118: following conditions exist:
p.000118: 1) the data subject has given his or her consent;
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000119: 119
p.000119:
p.000119:
p.000119:
p.000119: 2) the personal data processing results from contractual obligations of the data subject;
p.000119:
p.000119: 3) the data processing is necessary to a system controller for the performance of his or her lawful obligations;
p.000119: 4) the data processing is necessary to protect vitally important interests of the data subject, including
p.000119: life and health;
p.000119: 5) the data processing is necessary in order to ensure that the public interest is complied with, or
p.000119: to fulfil functions of public authority for whose performance the personal data have been transferred to
p.000119: a system controller or transmitted to a third person; and
p.000119: 6) the data processing is necessary in order to, complying with the fundamental human rights and freedoms of the data
...
p.000119: 2) special processing of personal data, without requesting the consent of the data subject, is provided for by
p.000119: regulatory enactments which regulate
p.000119:
p.000119: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000119: publications)?
p.000119: Yes, but it is not regulated by legislation.
p.000119:
p.000119:
p.000119: 12 How is patenting of hESC lines regulated?
p.000119: It is not regulated
p.000119:
p.000119:
p.000119:
p.000119:
p.000119:
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p.000119:
p.000120: 120
p.000120:
p.000120:
p.000120:
p.000120: Regulatory frame applying to LITHUANIA
p.000120:
p.000120:
p.000120: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000120: having not a legal personality.
p.000120:
p.000120: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000120: to get the texts would be welcomed).
p.000120: As for today (16 March, 2007) embryonic stem cell research has not been specifically addressed in the law. However,
p.000120: Lithuanian Law on Ethics of Biomedical Research allows only observational studies on human embryo, all other research
p.000120: activities on human embryo are prohibited (Article 3, Paragraph 2;
p.000120: http://www3.lrs.lt/pls/inter2/dokpaieska.showdoc_l?p_id=148740)
p.000120: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000120: As for today (16 March, 2007) the regulation does not provide a definition of embryo
p.000120:
p.000120: 3 Is hESC research allowed and in what terms and conditions?
p.000120: hESC would not be allowed in the country because Lithuanian Law on Ethics of Biomedical Research allows only
p.000120: observational studies on human embryo, all other research activities on human embryo are prohibited.
p.000120:
p.000120: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000120: NA
p.000120:
p.000120: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000120: yes at what conditions?
p.000120: The creation of human embryos is prohibited by the law (Law on Ethics of Biomedical Research, Article 3, Paragraph 2)
p.000120:
p.000120: 6 Is the source of hESC used in research traceable and well documented?
p.000120: NA
p.000120: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000120: NA
p.000120:
p.000120: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000120: embryo donation for research, if so could you please describe them?
p.000120: NA
p.000120:
p.000120: 9 Is financial inducement allowed? If so, in what terms?
p.000120:
p.000120: NA
p.000120:
p.000120: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000120: NA
p.000120:
p.000120: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000120: publications)?
p.000120: NA
p.000120:
p.000120: 12 How is patenting of hESC lines regulated?
p.000120: NA
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000121: 121
p.000121:
p.000121:
p.000121:
p.000121:
p.000121: Regulatory frame applying to GRAND-DUCHÉ DE LUXEMBOURG
p.000121: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000121: having not a legal personality.
p.000121:
p.000121: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000121: to get the texts would be welcomed).
p.000121: There is, at present, no legal or regulatory framework for human embryonic stem cells research in Luxembourg. However,
p.000121: a new law is under preparation:
p.000121:
p.000121: Projet de loi 5528/00 portant approbation:
p.000121: — de la convention pour la protection des droits de l’homme et de la dignité de l’être humain à l’égard des
p.000121: applications de la biologie et de la médecine: convention sur les droits de l’homme et la biomédecine, ouverte à la
p.000121: signature, à Oviedo, le 4 avril 1997;
p.000121: — du protocole additionnel à la convention pour la protection des droits de l’homme et de la dignité de l’être
p.000121: humain à l’égard des applications de la biologie et de la médecine, portant interdiction du clonage d’êtres humains,
p.000121: ouvert à la signature, à Paris, le 12 janvier 1998;
p.000121: — du protocole additionnel à la convention sur les droits de l’homme et la biomédecine relatif à la transplantation
p.000121: d’organes et de tissus d’origine humaine, ouvert à la signature, à Strasbourg, le 24janvier 2002;
p.000121: — du protocole additionnel à la convention sur les droits de l’homme et la biomédecine, relatif à la recherche
p.000121: biomédicale, ouvert à la signature, à Strasbourg, le 25 janvier 2005,
p.000121: et modifiant la loi du 25 novembre 1982 réglant le prélèvement de substances d’origine humaine.
p.000121:
p.000121: 2 Does the regulation provide a definition of ‘embryo’, if so which one?
p.000121: No definition of ‘embryo’ is provided in the draft law.
p.000121: 3 Is hESC research allowed and in what terms and conditions?
p.000121: No human embryonic stem cells research is being done in Luxembourg at this time.
p.000121: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000121: n/a
p.000121: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000121: yes at what conditions?
p.000121: n/a
p.000121: The draft law mentioned above doesn’t allow research on human embryos in vitro
p.000121: (article 6).
p.000121: 6 Is the source of hESC used in research traceable and well documented?
p.000121: n/a
p.000121: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000121: n/a
p.000121: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000121: embryo donation for research, if so could you please describe them?
p.000121: n/a
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p.000122: 122
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p.000122: 9 Is financial inducement allowed? If so, in what terms?
p.000122:
p.000122: n/a
p.000122: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000122: n/a
p.000122: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000122: publications)?
p.000122: n/a
p.000122: 12 How is patenting of hESC lines regulated?
p.000122: n/a
p.000122: However, ‘the use of human embryos for industrial and commercial purposes is not patentable.’
p.000122: («les utilisations d’embryons humains à des fins industrielles ou commerciales ne sont pas brevetables»), article 5,
p.000122: loi du 7 avril 2006 modifiant la loi modifiée du 20 juillet 1992 portant modification du régime des brevets
p.000122: d’invention.
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p.000123: 123
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p.000123: Regulatory frame applying to MALTA
p.000123:
p.000123: Currently there is no Embryonic Stem Cell or other embryonic regulation at all in Malta.
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p.000124: 124
p.000124:
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p.000124: Regulatory frame applying to NETHERLANDS
p.000124:
p.000124: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000124: having not a legal personality.
p.000124:
p.000124: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where to get
p.000124: the texts would be welcomed).
p.000124:
p.000124: The Dutch ‘Act containing rules relating to the use of human gametes and embryos’ (Embryos Act) came into force on
p.000124: September 1th 2002. A translation can be found at: http://www.minvws.nl/en/folders/ibe/2002/introduction-embryo-act.asp
p.000124: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000124: Embryos Act, Section 1:
p.000124: In this Act the following words shall have the following meanings: (….)
p.000124: c. embryo: a cell or a complex of cells with the capacity to develop into a human being; (…)
p.000124: This definition is criticised as being too narrow (excluding non-viable embryos). Cf:
p.000124: -Health Council of the Netherlands: Embryonic stem cells without moral pain? (2005). Translated report:
p.000124: http://www.gr.nl/pdf.php?ID=1270&p=1
p.000124: -Report of the recent evaluation of the Embryos Act (2006). Translated summary:
p.000124: http://www.zonmw.nl/fileadmin/cm/vraagsturing/documenten/Evaluatie_regelgeving/embryos_ act_en_sum.pdf
p.000124: 3 Is hESC research allowed and in what terms and conditions?
p.000124:
p.000124:
p.000124: hESC research is allowed. There are no special conditions for hESC research using existing stem cell lines. hESC
p.000124: involving the use of human embryos is subjected to the general conditions for research using human embryos set in the
p.000124: Embryos Act (including the moratorium regarding the creation of embryos for other purposes than pregnancy; cf sub
p.000124: question 5).
p.000124:
p.000124: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000124:
p.000124: Only hESC research involving the use of human embryos requires special approval. The Central Committee on Research
p.000124: Involving Human Subjects and Embryo Research (CCMO) is in charge of this. Website: www.ccmo.nl The head of the bureau
p.000124: of the national review committee (CCMO) is dr. Marcel Kenter; e-mail ccmo@ccmo.nl Tel +31 70 3406700.
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p.000125: 125
p.000125:
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p.000125:
p.000125: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if yes at
p.000125: what conditions?
p.000125:
p.000125: The Embryos Act prohibits the creation of embryos for purposes other than reproduction (section 24a). This also applies
p.000125: to ‘therapeutic cloning’ using human stem cells. However, the Act also contains the provision that this ban shall lapse
p.000125: on a date to be determined within five years after the coming into force of the Act (i.e. before September 2007), thus
p.000125: effectively turning the ban into a moratorium (section 33 sub 2). The Act already contains provisions for the handling
p.000125: of embryos created for purposes other than reproduction which would come into force after the lifting of the ban
p.000125: (sections 9 and 11). Section 11 limits the types of research for which embryos may then be created to 1) research which
p.000125: is reasonably likely to lead to new insights in the fields of infertility, 2) artificial reproduction techniques, 3)
p.000125: hereditary or congenital diseases or 4) transplant medicine.
p.000125:
p.000125: This complex construction was chosen in order to allow for making a reservation to Article 18 of the European
p.000125: Convention on Human Rights and Biomedicine (forbidding the creation of embryos for research purposes) when ratifying
p.000125: that Convention (as the Netherlands intends to do).
p.000125:
p.000125: The report of the recent evaluation of the Embryos Act (2006) has called for a swift end to the present moratorium on
p.000125: creating embryos for other purposes than pregnancy. Translated summary of report:
p.000125: http://www.zonmw.nl/fileadmin/cm/vraagsturing/documenten/Evaluatie_regelgeving/embryos_ act_en_sum.pdf
p.000125:
p.000125: However, the new government coalition formed early 2007 (Labour & two Christian Democrat parties) has announced its
p.000125: intention to maintain the current ban (possibly in the form of extending the moratorium for some further years). No
p.000125: formal decision about this has as yet been taken.
p.000125:
p.000125: 6 Is the source of hESC used in research traceable and well documented?
p.000125: No special regulations
p.000125:
p.000125: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000125:
p.000125: Cf questions 4 and 8
p.000125:
p.000125: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in embryo
p.000125: donation for research, if so could you please describe them?
p.000125:
p.000125: Yes. As specified in section 8.2 of the Embryos Act, embryos may be made available only by means of a written donation
p.000125: and without consideration, and only after the persons concerned (which may also include a gamete donor), have been
p.000125: informed by the person storing the embryos regarding the nature and the purpose thereof. Where a difference of opinion
p.000125: arises between the parties concerned, the embryos shall not be made available. Any of the persons concerned may revoke
p.000125: his/her decision at any time before the embryos have been used, without giving reasons.
p.000125: In the report of the recent evaluation of the Embryos Act (2006), it is pointed out that the Act does not provide
p.000125: sufficient guidance as to the required specificity of the information to be given about the nature of the research. Cf
p.000125: summary of report: http://www.zonmw.nl/fileadmin/cm/vraagsturing/documenten/Evaluatie_regelgeving/embryos_
p.000125: act_en_sum.pdf
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p.000126: 126
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p.000126: 9 Is financial inducement allowed? If so, in what terms?
p.000126:
p.000126:
p.000126: No, cf question 8: embryos may only be donated ‘without consideration’. The same holds for the donation of gametes. In
p.000126: practice, a remuneration of expenses is accepted.
p.000126: The report of the recent evaluation of the Embryos Act (2006) contains the recommendation to further debate the
p.000126: desirability/acceptability of a larger recompensation for women donating oocytes for research. Cf summary of report:
p.000126: http://www.zonmw.nl/fileadmin/cm/vraagsturing/documenten/Evaluatie_regelgeving/embryos_ act_en_sum.pdf
p.000126:
p.000126: 1 Are ad hoc data protection provisions be defined for hESC research? 0
p.000126: No special regulations
p.000126:
p.000126: 1 Are data deriving from hESC projects necessarily provided, whether positive or
p.000126: 1 negative (in form of publications)?
p.000126:
p.000126: No special regulations
p.000126:
p.000126: 1 How is patenting of hESC lines regulated? 2
p.000126: No special regulations
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p.000127: 127
p.000127:
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p.000127: Regulatory frame applying to POLAND
p.000127:
p.000127: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000127: to get the texts would be welcomed).
p.000127: In Poland there is no research on embryonic stem cells.
p.000127:
p.000127: Polish legal rules do not include distinct regulations for human embryonic stem cells research. There is also no legal
p.000127: definition for embryo stage of life.
p.000127: The fundamental legal act in Poland is the Constitution of the Republic of Poland
p.000127: (http://www.sejm.gov.pl/prawo/konst/angielski/kon1.htm), which was passed by the National Assembly on April 2nd, 1997.
p.000127: In accordance with Art.38 of this Law the Republic of Poland shall ensure the legal protection of the life of every
p.000127: human being Regulations referring to legal protection and conduct rules in the pre-birth stage of human life are
p.000127: included in the Act of January 7th, 1993 on Family Planning, Protection of Human Foetus and Admissible Conditions for
p.000127: an Abortion.
p.000127: In accordance with Art.1 of this Law, the right to life is protected, including also the prenatal stage, in the scope
p.000127: stipulated by the Law. The Law also includes regulations concerning the conceived child that is from the moment of
p.000127: conception through the embryo and foetal stages until birth.
p.000127: According to Art.157a of the Criminal Code any person except for child’s mother who commits any infringement to a
p.000127: conceived child, will be punished. The rule does not include a physician who undertakes medical action necessary to
p.000127: exclude danger- threatening mother’s or child’s health or life.
p.000127: What’s more, under the Act of December 5th, 1996 on Medical Profession’s, human embryos (conceived children) may not be
p.000127: used for therapeutic research (Art. 26 paragraph 1).
p.000127: Not directly refers to this matter the ruling of the Constitutional Court of the Republic of Poland from the 28th May
p.000127: 1997, which says: ‘A democratic state governed by the rule of law holds man and his most precious weal as a supreme
p.000127: value. By this weal, we understand life which in a democratic state governed by the rule of law must enjoy
p.000127: constitutional protection in each stage of its development’.
p.000127:
p.000127: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000127: As mentioned above, there is no legal definition for embryo stage of life.
p.000127:
p.000127:
p.000127: 3 Is hESC research allowed and in what terms and conditions?
p.000127: In Poland, human embryo research is prohibited.
p.000127:
p.000127: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000127:
p.000127: NA
p.000127: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000127: yes at what conditions?
p.000127: Is not allowed.
p.000127:
p.000127: 6 Is the source of hESC used in research traceable and well documented?
p.000127: NA
p.000127: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000127: NA
p.000127:
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p.000128: 128
p.000128:
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p.000128:
p.000128: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000128: embryo donation for research, if so could you please describe them?
p.000128: NA
p.000128:
p.000128: 9 Is financial inducement allowed? If so, in what terms?
p.000128:
p.000128:
p.000128: NA
p.000128: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000128: NA
p.000128:
p.000128: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000128: publications)?
p.000128:
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p.000128: 12 How is patenting of hESC lines regulated?
p.000128: NA
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p.000129: 129
p.000129:
p.000129:
p.000129:
p.000129: Regulatory frame applying to PORTUGAL
p.000129:
p.000129: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000129: having not a legal personality.
p.000129:
p.000129: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000129: to get the texts would be welcomed).
p.000129: In Portugal, Law n. 32/2006, of the 26th of July, concerning Medically Assisted Reproduction, addresses hESC research.
p.000129: The text is available on http://www.dre.pt/pdfgratisa5/2006/07/14300.pdf (Portuguese version only)
p.000129: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000129: The Portuguese regulation doesn’t provide a definition of ‘embryo’.
p.000129: 3 Is hESC research allowed and in what terms and conditions?
p.000129: The article n. 9 of the law forbids the deliberate production of human embryos specifically for research purposes.
p.000129: However, scientific hESC research can be allowed provided it is reasonable to expect that the investigation project
p.000129: will benefit mankind. Research must aim:
p.000129: Prevention, diagnosis or therapy on embryos;
p.000129: Perfection of Medically Assisted Reproduction techniques;
p.000129: Creation of stem cell banks for transplantation programs or other therapeutic purposes.
p.000129: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000129: The law n. º 36/2006 created the National Council for Medically Assisted Reproduction, in charge of the approval of the
p.000129: investigation projects for hESC research.
p.000129: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000129: yes at what conditions?
p.000129: As mentioned above, the deliberate production of human embryos specifically for research purposes is forbidden.
p.000129: According to Arts. 9, 24 and 25, IVF techniques must ensure only the necessary number of embryos for the success of the
p.000129: IVF process.
p.000129: Only embryos whit particularly severe genetic anomalies with no conditions to be preserved or implanted, embryos not
p.000129: derived by fertilisation of a human oocyte by human sperm, or those created to enhance the success rate of IVF who
p.000129: became supernumerary and no longer a part of a parental project, can be used for research purposes.
p.000129: 6 Is the source of hESC used in research traceable and well documented?
p.000129: According to Art. 16, personal genetic and health data regarding medically assisted reproduction techniques is
p.000129: regulated by Law n.º 12/2005, of the 26th of January, concerning genetic and health personal information.
p.000129: The text is available on http://www.dre.pt/pdfgratisa5/2005/01/018A00.pdf (Portuguese version only)
p.000129: Further regulation on data documentation, storage and access is being prepared.
p.000129:
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p.000130: 130
p.000130:
p.000130:
p.000130:
p.000130:
p.000130: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000130: The regulation of the conditions under which the investigation projects will be evaluated is being prepared.
p.000130: However, in Art. 9º the actual law still requires that scientific hESC research is made for prevention, diagnosis or
p.000130: therapy on embryos, for the perfection of Medically Assisted Reproduction techniques or for the creation of stem cell
p.000130: banks for transplantation programs or other therapeutic purposes.
p.000130: Additionally, research can be allowed provided it is reasonable to expect that the investigation project will benefit
p.000130: mankind.
p.000130: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000130: embryo donation for research, if so could you please describe them?
p.000130: According to the present law, the use of supernumerary embryos or of embryos with particularly severe genetic anomalies
p.000130: entails previous informed consent from donors. This consent must also be express, free and conscientious.
p.000130: It is expected that the regulation to further to the law establishes further requirements for consent.
p.000130: 9 Is financial inducement allowed? If so, in what terms?
p.000130:
p.000130: Art. 18 states that the purchase or sell of embryos or any other biological material obtained from the use of Medically
p.000130: Assisted Reproduction techniques is forbidden.
p.000130:
p.000130: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000130: This regulation is being prepared.
p.000130: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000130: publications)?
p.000130: At this time, there is no knowledge of research involving human embryos being made in Portugal.
p.000130: The regulatory framework under which the investigation projects will be made is being prepared.
p.000130: 12 How is patenting of hESC lines regulated?
p.000130: By the Decree-Law n.º 36/2003, of the 5th of March, Portugal transposed the Directive 98/44/CE of the European
p.000130: Parliament and the Council of the 6th of July, regarding the legal protection of biotechnological inventions.
p.000130: Art. 53º of this decree-law states that the use of human embryos for industrial or commercial purposes, as well as the
p.000130: human body, in his various stages of development or by the mere discovery of one of his elements, aren’t patentable.
p.000130: The text is available on
p.000130: http://www.dre.pt/pdfgratisa5/2003/03/054A00.pdf (Portuguese version only)
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p.000131: 131
p.000131:
p.000131:
p.000131:
p.000131: Regulatory frame applying to ROMANIA
p.000131:
p.000131: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000131: having not a legal personality.
p.000131:
p.000131: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000131: to get the texts would be welcomed).
p.000131: In Romania there is no specific regulation applying to hESC.
p.000131: In the field of research on hESC the following general regulation could be applied:
p.000131: 1. Law 206/2004 regarding good conduct in scientific research, technological development and innovation, www.cdep.ro
p.000131: 2. Law 17/2001 regarding the ratification of Oviedo Convention, www.cdep.ro
p.000131: 3. Law 95/2006 regarding the reform in health care system, www.cdep.ro
p.000131: 4. The Code of Deontology for Physicians of the Romanian College of Physicians, www.cmr.ro
p.000131:
p.000131:
p.000131: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000131: No Romanian law provides a definition of ‘embryo’.
p.000131:
p.000131: 3 Is hESC research allowed and in what terms and conditions?
p.000131: There is no specific legal provision to forbid hESC research.
p.000131:
p.000131: 4 If yes, which body is in charge of the approval of hESC research (ethics review)? Ethics commissions
p.000131: organized according to law 206/2004 (art.12) must supervise the research projects in order to respect the protection of
p.000131: human being, including the protection of human embryos
p.000131:
p.000131: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000131: yes at what conditions?
p.000131: No
p.000131:
p.000131: 6 Is the source of hESC used in research traceable and well documented?
p.000131: No
p.000131: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000131: There are not specific formal ethical and legal requirements for hESC research approval
p.000131:
p.000131: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000131: embryo donation for research, if so could you please describe them?
p.000131: In such situations the general legislation mentioned in point 1 could be applied.
p.000131:
p.000131: 9 Is financial inducement allowed? If so, in what terms?
p.000131:
p.000131: The financial inducement is not allowed according to law 95/2006, title VI- organ and tissue donation must be purely
p.000131: altruistic
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p.000132: 132
p.000132:
p.000132:
p.000132:
p.000132:
p.000132: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000132: There are not specific provisions for ad hoc data protection in hESC research. There are general laws regarding
p.000132: personal data protection:
p.000132: 1. Law 667/2001, www.cdep.ro
p.000132:
p.000132: 2. Law 676/2001, www.cdep.ro
p.000132:
p.000132:
p.000132: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000132: publications)?
p.000132: I do not have such information
p.000132:
p.000132: 12 How is patenting of hESC lines regulated?
p.000132: I do not have certain information regarding this issue. I do not think that in Romania there are specific provisions
p.000132: regarding this issue
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p.000133: 133
p.000133:
p.000133:
p.000133:
p.000133: Regulatory frame applying to: SLOVAK REPUBLIC
p.000133:
p.000133: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000133: having not a legal personality.
p.000133:
p.000133: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000133: to get the texts would be welcomed).
p.000133: No specific regulations exist at present. There is an extensive governmental regulation in preparation, however, to
p.000133: deal with the ‘donation, procurement, testing and distribution of organs, tissues and cells, and processing,
p.000133: conservation and storage of tissues and cells’ (transposition of the requirements of the Dir. 2006/17/EC, ev. Dir.
p.000133: 2004/23/EC). It could tackle on some closely related issues, but probably not specifically on hESCs.
p.000133: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000133: N.A. (non-applicable)
p.000133: 3 Is hESC research allowed and in what terms and conditions?
p.000133: hESC research is not specifically prohibited by a law, however, according to the position the Slovak Republic (SR) has
p.000133: taken so far on the issue, it probably would not be allowed to take place in the country (as destroying of a human
p.000133: embryo is necessary to obtain the hESCs lines for research).
p.000133: The ‘non-therapeutic’ research on human embryo and fetus, as well as human cloning are prohibited both by the SR’s
p.000133: health law (law No. 576/2004 Coll. as later amended) and by SR’s Penal Code (law No. 300/2005 Coll.) – making both a
p.000133: criminal offence.
p.000133: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000133: N.A. (non-applicable)
p.000133: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000133: yes at what conditions?
p.000133: NO, it is prohibited as a criminal act (see 3, above).
p.000133:
p.000133: 6 Is the source of hESC used in research traceable and well documented?
p.000133: N.A. (non-applicable)
p.000133: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000133: N.A. (non-applicable)
p.000133:
p.000133: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000133: embryo donation for research, if so could you please describe them?
p.000133: N.A. (non-applicable)
p.000133:
p.000133: 9 Is financial inducement allowed? If so, in what terms?
p.000133:
p.000133: N.A. (non-applicable)
p.000133: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000133: N.A. (non-applicable)
p.000133:
p.000133: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000133: publications)?
p.000133: N.A. (non-applicable)
p.000133:
p.000133: 12 How is patenting of hESC lines regulated?
p.000133: N.A. (non-applicable)
p.000133:
p.000133:
p.000133:
p.000133:
p.000133:
p.000133:
p.000134: 134
p.000134:
p.000134:
p.000134:
p.000134: Regulatory frame applying to SLOVENIA
p.000134:
p.000134: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000134: having not a legal personality.
p.000134:
p.000134: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000134: to get the texts would be welcomed).
p.000134: Explicit legal regulation on hESC does not exist. However, the Law on treatment of infertility and biomedically
p.000134: assisted fertilisation (Zakon o zdravljenju neplodnosti in postopkih oploditve z biomedicinsko pomocjo, /ZZNPOB/ 3307,
p.000134: Uradni list Republike Slovenije 70/2000, 8. 8. 2000, UL ONLINE) contains provisions that apply to research on embryos
p.000134: from IVF procedures and may apply to procurement of hESC.
p.000134: Web address (Ministry of Health): http://www.mz.gov.si
p.000134: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000134: Article 4: The embryo is created by fertilisation of the ovum. For the purposes of this Law, the early embryo is a
p.000134: zygote or an embryo that has developed outside the uterus for less than 14 days or until the appearance of the
p.000134: primitive streak.
p.000134:
p.000134:
p.000134: 3 Is hESC research allowed and in what terms and conditions?
p.000134: As said above, research on hESC is not specifically regulated.
p.000134:
p.000134: Slovenia is party to the Oviedo Convention and the protocol on prohibition of human cloning. Its Law on treatment of
p.000134: infertility and biomedically assisted fertilisation forbids the creation of human embryos for research, the production
p.000134: of cloned embryos and the use of in vitro fertilisation for any purpose other that birth of a child. Also prohibited is
p.000134: the use of parts of embryo for any purpose other than is explicitly allowed by law.
p.000134:
p.000134: However, the law allows research on surplus embryos from in vitro fertilisation procedures (and thus also procurement
p.000134: of hESC), if several conditions are fulfilled:
p.000134: Article 38 (unofficial translation)
p.000134: Scientific research on the gametes and early embryos (= in vitro embryos) is allowed exclusively for the purposes of
p.000134: (promoting knowledge on) protection and improvement of human health. It may be carried out on early embryos only if it
p.000134: cannot be done on animal embryos or otherwise with comparable efficiency. Early embryos may only be used for research
p.000134: after a written informed consent has been obtained for their parents who had undergone medically assisted reproduction.
p.000134: The research must be authorised by the National Commission for Assisted Reproduction and must be approved and
p.000134: supervised by the National Medical Ethics Committee (NMEC). Permission may be granted for embryos that, according to
p.000134: medical knowledge, are not suitable to be transferred into woman’s body or for storage, or would have to be left to
p.000134: perish according to the Article 35 of the Law (end of the maximum storage period). In research on embryos, current
p.000134: medical knowledge, experience, established practices and principles of general medical ethics must be taken into
p.000134: account.
p.000134:
p.000134:
p.000134:
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p.000134:
p.000135: 135
p.000135:
p.000135:
p.000135:
p.000135:
p.000135: 4 If yes, which body is in charge of the approval of hESC research (ethics review)? The National Medical
p.000135: Ethics Committee, after authorisation has been obtained from the National Commission for Assisted Reproduction.
p.000135:
p.000135: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000135: yes at what conditions?
p.000135: No.
p.000135:
p.000135: 6 Is the source of hESC used in research traceable and well documented?
p.000135: Traceability and full documentation of biological materials of human origin is legally required.
p.000135:
p.000135: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000135: Full compliance with the law (see answer to Q 3).
p.000135:
p.000135: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000135: embryo donation for research, if so could you please describe them?
p.000135: The regulatory framework (the Law on treatment of infertility and biomedically assisted fertilisation does not provide
p.000135: for any specific rules, except that written informed consent must be obtained from both partners.
p.000135: 9 Is financial inducement allowed? If so, in what terms?
p.000135:
p.000135: All financial inducement is strictly forbidden.
p.000135:
p.000135:
p.000135: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000135: This Q is slightly difficult to understand (syntactic error?). Until now, the National Medical Ethics
p.000135: Committee has received only one application for approval of a study on hESC derived from embryos and has approved
p.000135: harvesting hESC from nonviable embryos from in vitro fertilisation procedures.
p.000135: The usual rules of confidentiality and data protection apply.
p.000135: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000135: publications)?
p.000135: Yes. This is among the requirements of the NMEC.
p.000135:
p.000135: 12 How is patenting of hESC lines regulated?
p.000135: Specific regulation does not exist.
p.000135:
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p.000136: 136
p.000136:
p.000136:
p.000136:
p.000136: Regulatory frame applying to SPAIN
p.000136:
p.000136: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000136: having not a legal personality.
p.000136:
p.000136: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where to get
p.000136: the texts would be welcomed).
p.000136: Law 14/2006 about Human Assisted Reproduction Techniques (HARTAct):
p.000136: http://www.boe.es/boe/dias/2006/05/27/pdfs/A19947-19956.pdf
p.000136: http://www.boe.es/g/es/bases_datos/doc.php?coleccion=iberlex&id=2006/09292&txtlen=1000 Act of 2007, on Biomedical
p.000136: Research (BMRAct)
p.000136: (It has not been published in the State Official Journal) Other regulations:
p.000136: Research with spare frozen embryos after assisted reproduction techniques:
p.000136: http://www.isciii.es/htdocs/terapia/legislacion/Terapia_RD_2132_2004.pdf Organization of the National Bank of Stem Cell
p.000136: Lines: http://www.boe.es/boe/dias/2006/02/18/pdfs/A06637-06641.pdf
p.000136:
p.000136: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000136: Yes, it does.
p.000136: In the Spanish legislation there are two definitions, on the human pre-embryo and on the human embryo:
p.000136:
p.000136: a) Pre-embryo: the in vitro embryo as constituted by a group of cells derived of the continuous division of the
p.000136: fertilised oocyte until 14 days later (art. 1.2 of HARTAct and art. 3, s, BMRAct)
p.000136:
p.000136: b) Embryo: A step of embryonic development, which includes the time in what the fertilised oocyte is located in the
p.000136: uterus of a woman until the time of the beginning of the step of the formation of organs, it is to say, 56 days after
p.000136: fertilisation occurs, regardless the time during such development could be stopped (art. 3, l, BMRAct).
p.000136:
p.000136:
p.000136: 3 Is hESC research allowed and in what terms and conditions?
p.000136: Yes, this type of research is allowed but only under case by case scrutiny. The research project has to fulfil, by the
p.000136: research group, the ethical guarantees requested.
p.000136: A) From surplus pre-embryos HARTAct):
p.000136: Article 15. Using pre-embryos for research purposes.
p.000136:
p.000136: a) Informed consent of the couple or of the single woman.
p.000136: b) The pre-embryo shall not be developed in vitro more than 14 days, regardless the time it could be cryo-preserved
p.000136: c) Research shall be performed in authorised centres
p.000136: d) Research will be done on the basis of a research project authorised by the competent authority, previous the
p.000136: perceptive and favourable Commission (see down).
p.000136:
p.000136:
p.000136: B) From cloned pre-embryos (BMRAct):
p.000136: Article 34 Guarantees and requisites for research
p.000136: 1. Research or experimentation with surplus oocytes and pre-embryos from the application of assisted
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000137: 137
p.000137:
p.000137:
p.000137:
p.000137: reproduction techniques, or from their biological structures, with the aim to obtain, develop and use embryonic stem
p.000137: cell lines or with other purposes not associated with the development and application of assisted reproduction
p.000137: techniques, shall be undertaken in accordance with the conditions established in Law 14/2006, of 26 May, and comply
p.000137: with the following requisites:
p.000137: a) That the research abides by the applicable ethical principles and legal regulations, especially in that provided
p.000137: in this Law and its development of rules and guidelines in law, and that it follows the principles
p.000137: of relevance, feasibility and suitability, specifically of the main researcher, of the research
p.000137: team and of the facilities of the centre that shall undertake the research.
p.000137:
p.000137: b) That it is based on a research project authorised by the relevant State or autonomous authorities,
p.000137: after a favourable report by the Commission for establishing guarantees in the donation and use of human
...
p.000137:
p.000137: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000137:
p.000137: A) For researches related with the application and implementation of human assisted reproductive
p.000137: techniques: the National Commission on Assisted Human Reproduction (art. 15.1, d, HARTAct) ‘Comision de Garantías
p.000137: para la Donación y Utilización de Células y Tejidos Humanos’
p.000137:
p.000137: B) For researches related with the gain, implementation and use of hESC lines: the Commission for
p.000137: Establishing Guarantees in the donation and use of human cells and tissues (art. 35 BMRAct)
p.000137:
p.000137: In both cases the previous review by a local Research Ethics Committee is also needed.
p.000137: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if yes at
p.000137: what conditions?
p.000137: The new law explicitly prohibits the creation of pre-embryos and embryos for the exclusive use of research, although it
p.000137: permits the use of any other technique, including nuclear transfer, aimed to obtaining human embryonic stem cells for
p.000137: research or therapy (BMRAct): Article 33 Obtaining of embryonic cells
p.000137: 1. The creation of human pre-embryos and embryos solely for experimentation purposes shall be prohibited.
p.000137: 2. The use of any technique for obtaining human stem cells for therapeutic or research purposes shall be permitted,
p.000137: when it doesn’t entail the creation of a pre-embryo or embryo solely for this purpose, in the terms provided in this
p.000137: Law, including the activation of oocytes through nuclear transfer.
p.000137: A perceptive and favourable previous opinion by the Commission for Establishing
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000138: 138
p.000138:
p.000138:
p.000138:
p.000138: Guarantees in the donation and use of human cells and tissues is needed, as well as the authorisation of the Autonomous
p.000138: Community Authority.
p.000138:
p.000138: 6 Is the source of hESC used in research traceable and well documented?
p.000138: Yes, it is (art. 8 BMRAct).
p.000138:
p.000138: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000138: 1-Informed consents from the parents of all embryos used;
p.000138: 2-approval by the ethical committee of the institution or the autonomous community and
p.000138: 3-approval by the ad hoc ‘Comision de Garantías para la Donación y Utilización de Células y Tejidos Humanos’
p.000138: (See on this previous answer to question Nr 4).
p.000138: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in embryo
p.000138: donation for research, if so could you please describe them?
p.000138: Yes. If embryos are going to be used for a research project, parents must sign an informed consent specific for that
p.000138: project. The informed consent form includes the name of the research project, a short summary of the main research
p.000138: objectives, the name of the IP and a disclosure of any financial interest (Art. 15.1, a of HARTAct).
p.000138:
p.000138:
p.000138: 9 Is financial inducement allowed? If so, in what terms?
p.000138:
p.000138: No, it is not.
p.000138: (See art. 7 BMRAct and art. 15.1, a of HARTAct).
p.000138: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000138: Yes, they are. (arts. 5 and 53 of BMRAct):
p.000138:
p.000138: Article 5 Protection of personal data and Confidentiality (general provisions on the use of human biological material).
p.000138:
p.000138: Article 53 Genetic analysis on pre-embryos, embryos and foetuses. The results of genetic analysis on per-embryonic,
p.000138: embryonic and foetal material shall be submitted to the principles of data protection and confidentiality established
p.000138: in this Act.
p.000138:
p.000138: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000138: publications)?
p.000138: Yes, they are, although it is not required to be provided in form of publications.
p.000138:
p.000138: 12 How is patenting of hESC lines regulated?
p.000138: In the same conditions as it is at the Directive 98/44/EC, on the legal protection of biological inventions.
p.000138: See the Act 11/1986 of 26 March, on Patent, as modified by Act 10/2002 of 29 April, transposing that Directive.
p.000138: Information provided by Prof. C.M. Romeo-Casabona (Universidad de Deusto, Bilbao) and Dr. Javier Arias (Institut de
p.000138: salud Carlos III, Madrid)
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000139: 139
p.000139:
p.000139:
p.000139:
p.000139: Regulatory frame applying to SWEDEN
p.000139:
p.000139: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000139: having not a legal personality.
p.000139:
p.000139: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000139: to get the texts would be welcomed).
p.000139: The Act (2006:351) on genetic integrity etc.. The Biobanks in Medical Care Act (2002:297)
p.000139: The Act (2003:460) on ethics review of research on humans http://www.epn.se/eng/start/index.aspx
p.000139: The Transplantation Act (1995:831)
p.000139: Guidelines issued by the Swedish Research Council
p.000139: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000139:
p.000139: The word used in Sweden is ‘fertilised egg’. There is a 14 day limit for its use.
p.000139: 3 Is hESC research allowed and under what terms and conditions?
p.000139: Yes. Approval by regional research ethics authority. Consent from both donors.
p.000139:
p.000139: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000139: see above
p.000139:
p.000139: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000139: yes under what conditions?
p.000139: same as 3
p.000139:
p.000139: 6 Is the source of hESC used in research traceable and well documented?
p.000139: Yes
p.000139: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000139: same as 3
p.000139:
p.000139: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000139: embryo donation for research, if so could you please describe them?
p.000139: Consent should be informed. Procedures are reviewed by the Regional Research Ethics Authority.
p.000139:
p.000139: 9 Is financial inducement allowed? If so, on what terms?
p.000139:
p.000139: No. Normally, only reimbursement of costs allowed
p.000139:
p.000139: 10 Are ad hoc data protection provisions defined for hESC research?
p.000139: The Patient Records Act and the Personal Data Act apply
p.000139:
p.000139: 11 Are data deriving from hESC projects necessarily (?) provided, whether positive or negative (in form of
p.000139: publications)?
p.000139: No different from other research
p.000139:
p.000139: 12 How is patenting of hESC lines regulated?
p.000139: Indirectly in the Transplantation Act
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000140: 140
p.000140:
p.000140:
p.000140:
p.000140: Regulatory frame applying to UNITED KINGDOM
p.000140:
p.000140: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000140: having not a legal personality.
p.000140:
p.000140: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000140: to get the texts would be welcomed).
p.000140: The use of embryos to derive hES cell lines is regulated by the Human Fertilisation and Embryology Authority (HFEA) in
p.000140: the UK (www.hfea.gov.uk).
p.000140: The UK Stem Cell Bank Steering Committee also issues guidelines on the use of hES cell lines in the UK
p.000140: (www.ukstemcellbank.org.uk)
p.000140:
p.000140: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000140: The Human Fertilisation and Embryology Act (HF&E Act) 1990 provides that ‘an embryo means a live human embryo where
p.000140: fertilisation is complete, and references to an embryo include an egg in the process of fertilisation, and, for this
p.000140: purpose, fertilisation is not complete until the appearance of a two cell zygote’.
p.000140:
p.000140: 3 Is hESC research allowed and in what terms and conditions?
p.000140: The HFEA regulates the use of embryos to derive hES cell lines. The use of hES cell lines in research is permitted in
p.000140: the UK but is not within the remit of the HFEA.
p.000140:
p.000140: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000140: The HFEA regulates the use of embryos to derive hES cell lines.
p.000140:
p.000140: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000140: yes at what conditions?
p.000140: Yes the creation of embryos for use in research, including the derivation of hES cell lines, is permitted in the UK. An
p.000140: explanation of how the HFEA licences research projects can be found on our website at www.hfea.gov.uk.
p.000140:
p.000140: 6 Is the source of hESC used in research traceable and well documented?
p.000140: Yes
p.000140: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000140: The use of embryos to derive hES cell lines requires a licence from the HFEA.
p.000140: The HFEA has set up a dedicated Research Licence Committee. Under section 9(5) of the 1990 Act, a Licence Committee is
p.000140: required to include at least 1 member who is not authorised to carry on or participate in any activity under the
p.000140: authority of a licence and would not be so authorised if outstanding applications were granted. In addition to this
...
p.000141: section 17 of the HF&E Act 1990 and that the premises where the research is to be carried out are suitable for the
p.000141: activities.
p.000141:
p.000141: To aid the Licence Committee in its consideration of research applications a decision making tool (the Decision Tree)
p.000141: which was formulated on the basis of legal advice and includes the statutory criteria that the Committee is required to
p.000141: consider.
p.000141:
p.000141: If the Licence Committee decides to grant or renew a licence, the Licence Committee will consider whether any
p.000141: conditions should be specified in the licence.
p.000141: Decision Tree for Research Applications
p.000141:
p.000141:
p.000141:
p.000141:
p.000141:
p.000141:
p.000141:
p.000141:
p.000141: Yes - Reject
p.000141:
p.000141: Identify activities
p.000141:
p.000141:
p.000141:
p.000141: Are any activities prohibited under
p.000141: HFE Act?
p.000141: No
p.000141:
p.000141: No - Reject
p.000141:
p.000141:
p.000141:
p.000141: No - Reject
p.000141: Is it appropriate to grant a Licence?
p.000141: Yes Satisfied
p.000141: with patient information and consent
p.000141:
p.000141: Yes
p.000141: Should conditions be put on licence
p.000141:
p.000141:
p.000141: Decision on whether to grant licence
p.000141:
p.000141: No - Reject
p.000141: Is each activity necessary or
p.000141: forms?
p.000141: Yes
p.000141: Satisfied
p.000141:
p.000141: No - Reject
p.000141: desirable for one of the specified purposed purposes
p.000141: Yes
p.000141: that use of embryos is necessary?
p.000141:
p.000141:
p.000141:
p.000141: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000141: embryo donation for research, if so could you please describe them?
p.000141: The HFEA, as part of the licensing procedure, see and must approve the patient information and consent forms used in
p.000141: obtaining consent from patient donating gametes and/or embryos in licensed research projects. These documents must also
p.000141: be approved by a local research ethics committee.
p.000141: Furthermore, all research centres are inspected, by the HFEA, annually and as part of this process, the HFEA examines
p.000141: the process used by the centre in obtaining the
p.000141:
p.000141:
p.000141:
p.000141:
p.000141:
p.000142: 142
p.000142:
p.000142:
p.000142:
p.000142: consent of patients whose gametes and/or embryos are used in licensed research.
p.000142:
p.000142: 9 Is financial inducement allowed? If so, in what terms?
p.000142:
p.000142: Women will not be paid for donating their eggs. Researchers will have to follow the same system as donation for
p.000142: treatment.
p.000142: Non patient donors can only claim back the expenses that they have actually incurred
p.000142: i.e. in money or money’s worth, a donor may be given reasonable, demonstrable expenses which she has incurred, within
p.000142: the UK, in connection with the donation. Donors may be compensated for loss of earnings (but not for other costs or
p.000142: inconveniences) up to a daily maximum of £55.19 but with an overall limit of £250 (or the equivalent in local currency)
p.000142: for each cycle of egg donation.
p.000142:
...
Social / gender
Searching for indicator gender:
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p.000014: In order to implement Article 6 of the framework programme and Article 15 of the rules for participation, the FP6
p.000014: evaluation procedure included a check of the ethical issues raised by the proposals. Following the
p.000014: scientific evaluation, an
p.000014:
p.000014: (37) C(2003) 2952.
p.000014: (38) OJ L 294, 29.10.2002, p. 1.
p.000014:
p.000014:
p.000014:
p.000014:
p.000015: 15
p.000015:
p.000015:
p.000015:
p.000015: ethical review of the successful proposals involving sensitive ethical issues was carried out before the final
p.000015: selection by the Commission.
p.000015:
p.000015: The objective of the ethical review was to make sure that the European Union did not support research contrary to
p.000015: fundamental ethical principles and to examine whether the research complied with the rules relating to ethics
p.000015: set out in the decisions on the sixth framework programme and specific programmes.
p.000015:
p.000015: Breakdown of projects subjected to ethical review, by research area
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: The ethical review was carried out by external experts with the expertise needed for an ethical assessment of the
p.000015: proposals (interdisciplinary approach). The experts were different each time and were selected by the Commission on
p.000015: the basis of expertise, geographical balance and gender balance.
p.000015:
p.000015: The total number of FP6 proposals that underwent an ethical review was 885 (11 % of FP6 research
p.000015: projects), whereby 18 involved human embryonic stem cell research (around 2 % of the total number of ethically
p.000015: reviewed proposals).
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016:
p.000016:
p.000016: The graph below shows the numbers of FP6 projects subjected to ethical review.
p.000016:
p.000016: FP6 Proposals undergoing Ethical Reviews
p.000016:
p.000016:
p.000450: 450
p.000450:
p.000450:
p.000400: 400
p.000400:
p.000400:
p.000350: 350
p.000350:
p.000350:
p.000300: 300
p.000300:
p.000300:
p.000300:
p.000250: 250
p.000250:
p.000250:
p.000200: 200
p.000200:
p.000200: Other
p.000200: hESC Proposals
p.000200:
p.000200:
p.000150: 150
p.000150:
p.000150:
p.000100: 100
p.000100:
p.000100:
p.000050: 50
p.000050:
p.000050:
p.000000: 0
p.000000: 1 2
p.000000: 3 4
p.000000: FP6 Years (2003-2006)
p.000000:
p.000000: II.4.2. Ethics provisions for FP6 hESC projects
p.000000: For human embryonic stem cell projects funded under FP6, the following provisions applied.
p.000000: (a) During the scientific evaluation, independent experts assessed the need to use hESCs to achieve the scientific
p.000000: objectives set forth in the proposal (39).
p.000000: (b) An ethical review was organised by the Commission with independent experts on a case-by-case basis. It was based on
p.000000: the ethical rules embodied in the European Charter of Fundamental Rights and in the different national, EU
...
Social / parents
Searching for indicator parents:
(return to top)
p.000106: The agency of biomedicine www.agence-biomedecine.fr
p.000106:
p.000106: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000106: yes at what conditions?
p.000106: No
p.000106:
p.000106: 6 Is the source of hESC used in research traceable and well documented?
p.000106: It is a condition to fulfil in order to obtain a licence to be able to keep a local registry and tracks of cell
p.000106: culture;
p.000106: The agence de la biomedicine has also to keep a national hESC registry
p.000106: 7 What are the formal ethical and legal requirements for hESC research approval? The research project
p.000106: should benefit to the progress towards a potential therapeutic use of to progress on human embryo development and
p.000106: medicine.
p.000106: The team involved has to provide proof if feasibility of this research, and to documents the composition of the team,
p.000106: the lab rooms scheme, the traceability of the Es cell lines See décret n°2006-121 du 6 février 2006
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000107: 107
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000107: embryo donation for research, if so could you please describe them?
p.000107: Yes
p.000107: The law does ask to document the origin of the cell line and to provide the consent form model : both parents should
p.000107: have signed for the use of the embryo for research,
p.000107:
p.000107: 9 Is financial inducement allowed? If so, in what terms?
p.000107:
p.000107: No
p.000107: The authority in charge of giving licences does not provide funds for research on those topics.
p.000107:
p.000107: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000107: Yes
p.000107:
p.000107: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000107: publications)?
p.000107: Yes, they are asked for every licence given, a yearly progress report is asked, and a final report.
p.000107:
p.000107: 12 How is patenting of hESC lines regulated?
p.000107: Not authorized
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000108: 108
p.000108:
p.000108:
p.000108:
p.000108: Regulatory frame applying to GERMANY
p.000108:
p.000108: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000108: having not a legal personality.
p.000108:
p.000108: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000108: to get the texts would be welcomed).
...
p.000134: zygote or an embryo that has developed outside the uterus for less than 14 days or until the appearance of the
p.000134: primitive streak.
p.000134:
p.000134:
p.000134: 3 Is hESC research allowed and in what terms and conditions?
p.000134: As said above, research on hESC is not specifically regulated.
p.000134:
p.000134: Slovenia is party to the Oviedo Convention and the protocol on prohibition of human cloning. Its Law on treatment of
p.000134: infertility and biomedically assisted fertilisation forbids the creation of human embryos for research, the production
p.000134: of cloned embryos and the use of in vitro fertilisation for any purpose other that birth of a child. Also prohibited is
p.000134: the use of parts of embryo for any purpose other than is explicitly allowed by law.
p.000134:
p.000134: However, the law allows research on surplus embryos from in vitro fertilisation procedures (and thus also procurement
p.000134: of hESC), if several conditions are fulfilled:
p.000134: Article 38 (unofficial translation)
p.000134: Scientific research on the gametes and early embryos (= in vitro embryos) is allowed exclusively for the purposes of
p.000134: (promoting knowledge on) protection and improvement of human health. It may be carried out on early embryos only if it
p.000134: cannot be done on animal embryos or otherwise with comparable efficiency. Early embryos may only be used for research
p.000134: after a written informed consent has been obtained for their parents who had undergone medically assisted reproduction.
p.000134: The research must be authorised by the National Commission for Assisted Reproduction and must be approved and
p.000134: supervised by the National Medical Ethics Committee (NMEC). Permission may be granted for embryos that, according to
p.000134: medical knowledge, are not suitable to be transferred into woman’s body or for storage, or would have to be left to
p.000134: perish according to the Article 35 of the Law (end of the maximum storage period). In research on embryos, current
p.000134: medical knowledge, experience, established practices and principles of general medical ethics must be taken into
p.000134: account.
p.000134:
p.000134:
p.000134:
p.000134:
p.000134:
p.000134:
p.000134:
p.000134:
p.000134:
p.000134:
p.000134:
p.000134:
p.000134:
p.000135: 135
p.000135:
p.000135:
p.000135:
p.000135:
p.000135: 4 If yes, which body is in charge of the approval of hESC research (ethics review)? The National Medical
p.000135: Ethics Committee, after authorisation has been obtained from the National Commission for Assisted Reproduction.
p.000135:
p.000135: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000135: yes at what conditions?
p.000135: No.
p.000135:
p.000135: 6 Is the source of hESC used in research traceable and well documented?
p.000135: Traceability and full documentation of biological materials of human origin is legally required.
p.000135:
...
p.000137: what conditions?
p.000137: The new law explicitly prohibits the creation of pre-embryos and embryos for the exclusive use of research, although it
p.000137: permits the use of any other technique, including nuclear transfer, aimed to obtaining human embryonic stem cells for
p.000137: research or therapy (BMRAct): Article 33 Obtaining of embryonic cells
p.000137: 1. The creation of human pre-embryos and embryos solely for experimentation purposes shall be prohibited.
p.000137: 2. The use of any technique for obtaining human stem cells for therapeutic or research purposes shall be permitted,
p.000137: when it doesn’t entail the creation of a pre-embryo or embryo solely for this purpose, in the terms provided in this
p.000137: Law, including the activation of oocytes through nuclear transfer.
p.000137: A perceptive and favourable previous opinion by the Commission for Establishing
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000138: 138
p.000138:
p.000138:
p.000138:
p.000138: Guarantees in the donation and use of human cells and tissues is needed, as well as the authorisation of the Autonomous
p.000138: Community Authority.
p.000138:
p.000138: 6 Is the source of hESC used in research traceable and well documented?
p.000138: Yes, it is (art. 8 BMRAct).
p.000138:
p.000138: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000138: 1-Informed consents from the parents of all embryos used;
p.000138: 2-approval by the ethical committee of the institution or the autonomous community and
p.000138: 3-approval by the ad hoc ‘Comision de Garantías para la Donación y Utilización de Células y Tejidos Humanos’
p.000138: (See on this previous answer to question Nr 4).
p.000138: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in embryo
p.000138: donation for research, if so could you please describe them?
p.000138: Yes. If embryos are going to be used for a research project, parents must sign an informed consent specific for that
p.000138: project. The informed consent form includes the name of the research project, a short summary of the main research
p.000138: objectives, the name of the IP and a disclosure of any financial interest (Art. 15.1, a of HARTAct).
p.000138:
p.000138:
p.000138: 9 Is financial inducement allowed? If so, in what terms?
p.000138:
p.000138: No, it is not.
p.000138: (See art. 7 BMRAct and art. 15.1, a of HARTAct).
p.000138: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000138: Yes, they are. (arts. 5 and 53 of BMRAct):
p.000138:
p.000138: Article 5 Protection of personal data and Confidentiality (general provisions on the use of human biological material).
p.000138:
p.000138: Article 53 Genetic analysis on pre-embryos, embryos and foetuses. The results of genetic analysis on per-embryonic,
p.000138: embryonic and foetal material shall be submitted to the principles of data protection and confidentiality established
p.000138: in this Act.
p.000138:
p.000138: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000138: publications)?
p.000138: Yes, they are, although it is not required to be provided in form of publications.
p.000138:
p.000138: 12 How is patenting of hESC lines regulated?
p.000138: In the same conditions as it is at the Directive 98/44/EC, on the legal protection of biological inventions.
...
Social / philosophical differences/differences of opinion
Searching for indicator difference of opinion:
(return to top)
p.000125: Convention on Human Rights and Biomedicine (forbidding the creation of embryos for research purposes) when ratifying
p.000125: that Convention (as the Netherlands intends to do).
p.000125:
p.000125: The report of the recent evaluation of the Embryos Act (2006) has called for a swift end to the present moratorium on
p.000125: creating embryos for other purposes than pregnancy. Translated summary of report:
p.000125: http://www.zonmw.nl/fileadmin/cm/vraagsturing/documenten/Evaluatie_regelgeving/embryos_ act_en_sum.pdf
p.000125:
p.000125: However, the new government coalition formed early 2007 (Labour & two Christian Democrat parties) has announced its
p.000125: intention to maintain the current ban (possibly in the form of extending the moratorium for some further years). No
p.000125: formal decision about this has as yet been taken.
p.000125:
p.000125: 6 Is the source of hESC used in research traceable and well documented?
p.000125: No special regulations
p.000125:
p.000125: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000125:
p.000125: Cf questions 4 and 8
p.000125:
p.000125: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in embryo
p.000125: donation for research, if so could you please describe them?
p.000125:
p.000125: Yes. As specified in section 8.2 of the Embryos Act, embryos may be made available only by means of a written donation
p.000125: and without consideration, and only after the persons concerned (which may also include a gamete donor), have been
p.000125: informed by the person storing the embryos regarding the nature and the purpose thereof. Where a difference of opinion
p.000125: arises between the parties concerned, the embryos shall not be made available. Any of the persons concerned may revoke
p.000125: his/her decision at any time before the embryos have been used, without giving reasons.
p.000125: In the report of the recent evaluation of the Embryos Act (2006), it is pointed out that the Act does not provide
p.000125: sufficient guidance as to the required specificity of the information to be given about the nature of the research. Cf
p.000125: summary of report: http://www.zonmw.nl/fileadmin/cm/vraagsturing/documenten/Evaluatie_regelgeving/embryos_
p.000125: act_en_sum.pdf
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000126: 126
p.000126:
p.000126:
p.000126:
p.000126: 9 Is financial inducement allowed? If so, in what terms?
p.000126:
p.000126:
p.000126: No, cf question 8: embryos may only be donated ‘without consideration’. The same holds for the donation of gametes. In
p.000126: practice, a remuneration of expenses is accepted.
p.000126: The report of the recent evaluation of the Embryos Act (2006) contains the recommendation to further debate the
p.000126: desirability/acceptability of a larger recompensation for women donating oocytes for research. Cf summary of report:
p.000126: http://www.zonmw.nl/fileadmin/cm/vraagsturing/documenten/Evaluatie_regelgeving/embryos_ act_en_sum.pdf
p.000126:
p.000126: 1 Are ad hoc data protection provisions be defined for hESC research? 0
p.000126: No special regulations
p.000126:
p.000126: 1 Are data deriving from hESC projects necessarily provided, whether positive or
p.000126: 1 negative (in form of publications)?
p.000126:
p.000126: No special regulations
p.000126:
p.000126: 1 How is patenting of hESC lines regulated? 2
...
Searching for indicator opinion:
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p.000003:
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p.000003:
p.000003:
p.000003:
p.000003: Recommendations on
p.000003: the ethical review of hESC FP7 research projects
p.000003: 20 June 2007
p.000003: 234-2-322 2
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p.000003:
p.000003: ISBN 978-92-79-07137-9
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p.000003: How to obtain EU publications
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p.000003: Our priced publications are available from EU Bookshop (http://bookshop.europa. eu), where you can place an order with
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p.000003: their contact details by sending a fax to (352) 29 29-42758.
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p.000003: The European Group on Ethics in Science and New Technologies to the European Commission
p.000003:
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p.000003:
p.000003:
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p.000003: Recommendations on the ethical review of hESC FP7 research projects
p.000003:
p.000003: Opinion No 22
p.000003: English original
p.000003: Translations in the EU-27 languages available at:
p.000003: http://ec.europa.eu/european_group_ethics/activities/docs/opinion_22_final_follow_up_en.pdf
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p.000003: 20 June 2007
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p.000003: Europe Direct is a service to help you find answers to your questions about the European Union
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p.000003: More information on the European Union is available on the Internet (http://europa.eu). Cataloguing data can be found
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p.000003: Luxembourg: Office for Official Publications of the European Communities, 2007 ISBN 978-92-79-07137-9
p.000003: © European Communities, 2007
p.000003: Reproduction is authorised provided the source is acknowledged.
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p.000003: Printed in Italy
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p.000003: Contents
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: SUMMARY
...
p.000034: IV.2.3.2. Donors’ rights 40
p.000034: IV.2.4. The need for continuous promotion of public governance and science–society dialogue
p.000042: 42
p.000042: IV.3. The need for further research and continuous public debate 43
p.000042: IV.4. Review of recommendations and communication with the Advisory Board of the European Human Embryonic Stem Cell
p.000042: Research Registry 45
p.000042: IV.4.1. The need for review 46
p.000042:
p.000042:
p.000042:
p.000042: Annexes
p.000081: 81
p.000081: Annex I — The sixth framework programme 85
p.000081: Annex II — Ethical review procedures in FP7 85
p.000081: Ethical issues table 87
p.000081: Annex III — List of projects supported within the sixth framework
p.000081: programme and within the Health and Consumer Protection DG, involving hESCs
p.000088: 88
p.000088: Annex IV — EU Member States’ regulatory framework for hESC research 90
p.000088: Appendix : Secretariat of the EGE 144
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000002: 2
p.000002:
p.000002: SUMMARY
p.000002:
p.000002:
p.000002: The European Group on Ethics in Science and New Technologies (EGE) adopted Opinion No 22 on 20 June
p.000002: 2007. The opinion indicates the implementing measures (guidelines) to use during the ethics review of
p.000002: seventh framework programme for research and development (FP7) research projects on human embryonic stem cells
p.000002: (hESCs), as requested by the President of the European Commission, Mr Barroso (1), and in line with the
p.000002: adoption of the EU’s FP7.
p.000002:
p.000002: The EGE stressed that, as is the case in the European Union, there are divergent views within the
p.000002: group on the moral legitimacy of research on human embryos and hESCs, ranging from objection to research
p.000002: involving the destruction of human embryos (which makes the full respect of dignity of the human embryo impossible)
p.000002: to a position allowing hESC research under certain conditions or on a broader basis.
p.000002:
p.000002: The group, however, acknowledged the political decision taken as the starting point for its recommendations, but
p.000002: emphasised that the ethical dilemma regarding the moral status of the human embryo and its use in research still
p.000002: persists both within the EGE members and the EU. Therefore, the group did not elaborate ethical arguments on hESC
p.000002: research as such, but worked on recommendations for FP7 ethics review of hESC projects.
p.000002:
p.000002: The EGE recognised the need for promoting responsible research that is transparent, serves the public
p.000002: interest, respects Member State autonomy, preserves public trust, promotes international cooperation and
p.000002: requires the embedding of ethics within research practice. The group indicated that, in addition to the FP7
p.000002: ethics rules already adopted in co-decision, among others the following considerations should apply to hESCs funded by
p.000002: the EU:
p.000002:
p.000002: • FP7 hESC lines have to result from non-implanted IVF embryos;
p.000002: • if alternatives to hESCs with the same scientific potential as embryo- derived stem cells are found in the
p.000002: future, their use should be maximised;
p.000002:
p.000002:
p.000002: (1) Letter sent by European Commission President Barroso to the EGE on 22 November 2006: ‘I
p.000002: would like to invite the European Group on Ethics to provide the Commission with an opinion on the implementing
p.000002: measures required during the ethics review of research projects on human embryonic stem cells that will
p.000002: assure that the ethical rules and requirements are fully met.’
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003:
p.000003:
p.000003: • donors’ rights (in terms of health, informed consent, data protection and free donation) have to be
p.000003: protected and safeguarded.
p.000003:
p.000003: The EGE also stressed the following needs:
p.000003: • to maximise the use of hESCs banked in the European Registry on hESC research;
p.000003: • to take concrete actions to stimulate public debate on this research sector.
p.000003:
p.000003: In addition, the EGE expressed the view that the use of human embryos to generate stem cells should be minimised as
p.000003: much as possible in the EU and indicated a number of issues that would deserve interdisciplinary research and
p.000003: further discussion, such as, inter alia, the use of the human body for modern medicine, including
p.000003: commercialisation of products and procedures stemming from the use of human embryonic stem cells; the
p.000003: underlying anthropology of human embryonic stem cell research, especially in the light of hybrids and the chimera
p.000003: research connected to stem cell research; the correlation of human embryonic stem cell research and questions
...
p.000008:
p.000008: Having regard to the decision of the European Commission on ‘Integrating and strengthening the European research
p.000008: area’ (2002–06) (Decision 2002/834/EC) (21) and the ‘procedural modalities for research activities involving
p.000008: banked or isolated human embryonic stem cells in culture to be funded under Council Decision 2002/834/EC’ (COM C(2003)
p.000008: 2952);
p.000008:
p.000008:
p.000008: (17) OJ C 364, 18.11.2000, pp. 1–22.
p.000008: (18) OJ L 138, 21.4.2004, pp. 7–11.
p.000008: (19) OJ L 294, 29.10.2002, pp. 1–43.
p.000008: (20) http://ec.europa.eu/research/press/2003/pdf/sec2003-441report_en.pdf
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009:
p.000009:
p.000009: Having regard to Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December
p.000009: 2006 concerning the seventh framework programme of the European Community for research,
p.000009: technological development and demonstration activities (2007–13);
p.000009:
p.000009: Having regard to Regulation (EC) No 1906/2006 (22) of the European Parliament and of the Council of 18
p.000009: December 2006 laying down the rules for the participation of undertakings, research centres and universities in actions
p.000009: under the seventh framework programme and for the dissemination of research results (2007–13);
p.000009:
p.000009: Having regard to Directive 2001/83/EC (23) and Regulation 726/2004/EC (24), currently being
p.000009: amended (25), on medicinal products for human use: advanced therapy medicinal products;
p.000009:
p.000009: Having regard to EGE Opinion No 11 ‘Ethical aspects of human tissue banking’ (26), published on 21 July
p.000009: 1998;
p.000009:
p.000009: Having regard to EGE Opinion No 12 ‘Ethical aspects of research involving the use of human embryo in
p.000009: the context of the fifth framework programme’ (27), published on 23 November 1998;
p.000009:
p.000009: Having regard to EGE Opinion No 15 ‘Ethical aspects of human stem cell research and use’ (28), published on 14 November
p.000009: 2000;
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: (22) OJ L 391, 18.12.2006, pp. 1–18.
p.000009: (23) OJ L 311, 28.11.2001, pp. 67–128.
p.000009: (24) OJ L 136, 30.4.2004, pp. 1–33.
p.000009: (25) http://www.europarl.europa.eu/oeil/FindByProcnum.do?lang=2&procnum=COD/2005/0227
p.000009: (26) http://www.ec.europa.eu/european_group_ethics/docs/avis11_en.pdf
p.000009: (27) http://www.ec.europa.eu/european_group_ethics/docs/avis12_en.pdf
p.000009: (28) http://www.ec.europa.eu/european_group_ethics/docs/avis15_en.pdf
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010:
p.000010:
p.000010: Having regard to EGE Opinion No 16 ‘Ethical aspects of patenting inventions involving human stem cells’
p.000010: (29), published on 14 November 2002;
p.000010:
p.000010: Having regard the request of November 2006 from the President of the EU Commission to the EGE to issue an opinion on
p.000010: the ethics review of human embryonic stem cell (hESC) projects funded under FP7;
p.000010:
p.000010: Having heard the rapporteurs A. Cambon-Thomsen, H. Haker, P. Martinho da Silva,
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: (29) http://www.ec.europa.eu/european_group_ethics/docs/avis16_en.pdf
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011:
p.000011:
p.000011: II. WHEREAS
p.000011:
p.000011: II.1. Preamble
p.000011: It is common knowledge that opinions about the ethical legitimacy of research on human embryos are sharply divided.
p.000011: The controversy is rooted in different ethical, philosophical, and/or religious viewpoints, each of which is
p.000011: acknowledged to be fully legitimate. In this respect, some claim that the divergences are ‘intrinsic’ and
p.000011: therefore irreconcilable, while others claim that common positions are achievable while respecting the pluralism of
p.000011: European societies, as practical solutions.
p.000011:
p.000011: The scope of these recommendations, however, is not to address the ethics of human embryonic stem cell research or
p.000011: research on human embryos. These recommendations relate to the political decision reached by the European
...
p.000012: research activities involving the use of human embryos and human embryonic stem cells shall be
p.000012: established by 31 December 2003’. It asked the Commission to: (1) prepare these provisions; (2) prepare a working
p.000012: paper on the issue; and (3) organise an interinstitutional seminar on bioethics.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: (30) OJ L 294, 29.10.2002, p. 1.
p.000012: (31) Research into treatment of cancer of the gonads can be financed.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013:
p.000013:
p.000013: A moratorium was then implemented by the Commission and no hESC research has since been funded with the exception of
p.000013: proposals for projects that involved the use of already banked or isolated human embryonic stem cells.
p.000013: The Council asked the Commission to publish a staff report on scientific advances and needs and on
p.000013: the evolution of international and national legislation, regulations and ethical rules regarding research
p.000013: involving the use of human embryonic stem cells. The report was prepared by the Commission, published on 3
p.000013: April 2003 (SEC(2003) 441 (32)), and then transmitted to the European Parliament and the Council as
p.000013: a basis for discussion at an interinstitutional seminar on bioethics organised by the Commission (33).
p.000013: On 9 July 2003, the Commission then submitted to the Council a proposal for the modification of the specific
p.000013: programme (COM(2003) 390 (34)), on which the European Parliament had to express its opinion (35). The
p.000013: proposal applied specifically to Community funding of research activities involving the procurement of stem cells from
p.000013: human embryos created as a result of medically assisted in vitro fertilisation designed to induce pregnancy and no
p.000013: longer to be used for that purpose (non-implanted human embryos); and it was based on the principles
p.000013: established by the European Group on Ethics, in particular the fundamental ethical principles set out in
p.000013: Opinion No 15 ‘Ethical aspects of human stem cell research and use’ (36). This Commission proposal received a
p.000013: favourable opinion from the European Parliament but did not obtain a qualified majority at the Council of 3
p.000013: December 2003.
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: (32) http://europa.eu.int/comm/research/conferences/2003/bioethics/index_en.html
p.000013: (33) On 24 April 2003, the interinstitutional seminar on bioethics took place. The seminar addressed issues
p.000013: related to human embryonic stem cell research under the sixth framework programme for research and provided an
p.000013: opportunity for discussion and exchanging of views between experts (scientific, legal, and in ethics) and
p.000013: representatives of the European Parliament, the Council, the Commission, the Member States and the accession and
p.000013: candidate countries.
p.000013: (34) Proposal for a Council decision [COM(2003) 390] amending Decision 2002/834/EC on the specific
p.000013: programme for research, technological development and demonstration: ‘Integrating and
p.000013: strengthening the European research area’ (2002–06).
p.000013: (35) http://europa.eu.int/comm/research/conferences/2003/bioethics/index_en.html
p.000013: (36) http://europa.eu.int/comm/european_group_ethics/index_en.htm
p.000013:
p.000013:
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014:
p.000014:
p.000014: In parallel, the ‘procedural modalities for research activities involving banked or isolated human embryonic stem
p.000014: cells in culture to be funded under Council Decision 2002/834/EC’ (37) were approved by the
p.000014: Regulatory Committee (comprising representatives of the Member States) on 25 June 2003 and by the Commission on 11
p.000014: November 2003.
p.000014:
...
p.000000: the ethical rules embodied in the European Charter of Fundamental Rights and in the different national, EU
p.000000: and international regulations or conventions, also taking into account the opinions of the European Group
p.000000: on Ethics (40). In particular, four different criteria were assessed:
p.000000:
p.000000: • whether the applicants took into account the legislation, regulations, ethical rules and/or codes of
p.000000: conduct in place in the country where the
p.000000:
p.000000:
p.000000:
p.000000: (39) The type of stem cells to be used is chosen by the scientists in view of the objectives of
p.000000: the proposal, which should relate to fundamental research questions or medical applications. Then,
p.000000: independent experts evaluate the proposal to assess the appropriateness of the approach chosen by the scientists.
p.000000: (40) Council Decision 2002/834/EC, OJ L 294, 29.10.2002; see pp. 7–8 for details.
p.000000:
p.000000:
p.000000:
p.000000:
p.000017: 17
p.000017:
p.000017:
p.000017: research using banked or isolated hESCs in culture was to take place, including the procedures for obtaining
p.000017: informed consent (41);
p.000017: • the source of the banked or isolated hESCs in culture;
p.000017:
p.000017: • the measures taken to protect personal data, including genetic data, and privacy;
p.000017:
p.000017: • the nature of financial inducements, if any.
p.000017:
p.000017:
p.000017: (c) A positive opinion from a regulatory committee comprising Member State representatives was required.
p.000017: (d) Finally, the Commission checked that the participants in research projects had received the approval of
p.000017: the relevant national or local ethics committees prior to the start of research activities.
p.000017: All these conditions were cumulative.
p.000017:
p.000017:
p.000017: In conclusion, each hESC research proposal supported under FP6 was assessed by at least two independent ethical
p.000017: reviews: one at national level (in the country where the research was to be carried out) (42) and one at EU level.
p.000017:
p.000017:
p.000017: II.5. The seventh framework programme for research, technological development and demonstration (2007–13)
p.000017: (FP7)
p.000017: As with FP6, ethics and hESCs played a major role in the interinstitutional debate on the seventh framework
p.000017: programme; this was intended to contribute to the
p.000017:
p.000017:
p.000017:
p.000017: (41) The EU has never required a uniform regulatory system for all fields of science and technology. The
p.000017: Treaty itself guarantees the autonomy of the Member States. As a consequence, diverse regulatory
p.000017: frameworks coexist (e.g. for research on non-human primates, nuclear research, security and prevention of
p.000017: terrorism, bio-banking, etc.). The principle of subsidiarity is respected in full, assuming respect of fundamental
p.000017: ethical principles.
p.000017: (42) If the research raising ethical issues is performed in more than one country (i.e. n countries), this
...
p.000018: agreement was based on a Commission declaration stating that ‘The European Commission will continue with the current
p.000018: practice and will not submit to the Regulatory Committee proposals for projects which include research activities which
p.000018: destroy human embryos, including for the procurement of stem cells. The exclusion of funding of this step of research
p.000018: will not prevent Community funding of subsequent steps involving human embryonic stem cells’.
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: (43) A detailed description of the interinstitutional adoption of the programme can be found at
p.000018: http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=en&DosId=192725
p.000018:
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019:
p.000019:
p.000019: The programme, including the Commission declaration, was then approved at the European Parliament plenary
p.000019: session (second reading) on 30 November 2006 and adopted in co-decision on 18 December 2006.
p.000019:
p.000019:
p.000019:
p.000019: II.6. Ethics provisions under FP7: hESC research funded by the European Union
p.000019: The Council agreement made the eligibility of hESC research for EU funding subject to the same specific
p.000019: restrictions and conditions as with FP6.
p.000019:
p.000019: To ensure an optimal ethics review system, the President of the European Commission asked the EGE on
p.000019: November 2006 to issue an opinion on the ethics review of hESC projects funded under FP7:
p.000019:
p.000019: I would like to invite the European Group on Ethics to provide the Commission with an opinion on the implementing
p.000019: measures required during the ethics review of research projects on human embryonic stem cells that will
p.000019: assure that the ethical rules and requirements are fully met. Such an opinion would provide guidance (in
p.000019: relation to the values and principles to apply) for the Ethics Review within the frame of the Programme approved by the
p.000019: Council and the European Parliament. It would be important that this opinion is available for use when the first FP7
p.000019: projects involving human embryonic stem cells are evaluated (44).
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: (44) Letter by Commission President J. M. Barroso addressed to the EGE on 22 November 2006.
p.000019:
p.000019:
p.000019:
p.000019:
p.000020: 20
p.000020:
p.000020:
p.000020: III. BACKGROUND FOR THE ETHICAL REVIEW OF HESC PROJECTS
p.000020: III.1. Existing ethical guidelines: a brief historical overview
p.000020: In a fast-developing area such as stem cell research, ethical requirements are assuming increasing
p.000020: importance in project assessment. The process of research approval includes a review of projects by a panel of
p.000020: independent experts (both scientific and ethical).
p.000020:
p.000020: Up to the present, no clinical research making use of human embryonic stem cells has been carried out. In
p.000020: view of the long-term perspective of FP7, however, all ethical guidelines and regulations must be applied to FP7
p.000020: projects whenever they involve research on human subjects.
p.000020:
p.000020: Guidelines and regulations governing the participation of human subjects in biomedical research have been
p.000020: established at international level for many decades. These principles are laid down in internationally
p.000020: recognised research ethics guidelines and other instruments, including (to cite only the most
...
p.000022: Some research protocols focus completely on hESCs, but sometimes they may use human embryonic and adult
p.000022: stem cells for comparative purposes or may use hESCs as a tool to obtain other scientific outcomes (for
p.000022: example, to make in vitro tests of a given experimental drug or a new chemical).
p.000022:
p.000022: The relevance and use of hESCs therefore varies considerably according to the expected scientific outcomes of the
p.000022: research trials. The scientific community is interested in investigating the basic physiology of stem cells, their
p.000022: potential and characteristics. One important aspect of such research is the comparative analysis of hESCs and
p.000022: other types of stem cells, such as umbilical-cord and adult tissue-specific stem cells, in order to address specific
p.000022: questions concerning the suitability of these types of cells. Stem cell research is also done to explore its potential
p.000022: use for regenerative medicine (degenerative diseases such as diabetes and Parkinson’s disease) and gene
p.000022: therapy (e.g. for cystic fibrosis and Huntington’s disease). At present, there are no indications that
p.000022: clinical trials will be carried out in the near future.
p.000022:
p.000022: In addition, researchers are exploring the potential use of hESCs in toxicological studies in order to replace
p.000022: animal models with in vitro models. Other uses of hESCs, with the exception of the ESTOOL project (see
p.000022: annex to this opinion), are in large multidisciplinary studies, such as those involving genomics and
p.000022:
p.000022:
p.000022: (62) http://www.isscr.org/guidelines/ISSCRhESCguidelines2006.pdf
p.000022:
p.000022:
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023:
p.000023:
p.000023: proteomics approaches, which focus on broader contexts with only a subset of experiments specifically dealing with
p.000023: hESCs.
p.000023:
p.000023: Examples of EU-funded projects that make different uses of hESCs:
p.000023:
p.000023:
p.000023: (1) EUROSTEMCELL: project aiming to compare adult, foetal, embryonic and tissue-specific stem cells (see
p.000023: http://www.eurostemcell.org/);
p.000023:
p.000023: (2) BETACELL THERAPY: project aiming to study the generation of insulin- producing pancreatic beta
p.000023: cells for the treatment of diabetes (see http://www.betacelltherapy.org);
p.000023:
p.000023: (3) CARCINOGENOMICS: project aiming to carry out in vitro testing to assess the genotoxic and carcinogenomic
p.000023: properties of chemical compounds (in silico models to evaluate the carcinogenic potential of a compound
p.000023: in vivo) (see http://www.ecopa.eu/doc/CarcinogenomicsPressRelease-201106.pdf).
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: III.3. Sources of human embryonic stem cells
p.000023: The most common source of tissue for human embryonic stem cell isolation is the inner cell mass (ICM) of
p.000023: embryos created using assisted reproduction technologies (ART), but not transferred to the woman’s uterus,
p.000023: either because the number of embryos exceeds the number allowed to be transferred under the law (usually two or
...
p.000030: DE: Germany FI: Finland LT: Lithuania PL: Poland UK: United Kingdom
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000031: 31
p.000031:
p.000031:
p.000031:
p.000031: III.8. Commercialisation and patenting
p.000031:
p.000031: The directive on the legal protection of biotechnological inventions (98/44/EC) (82) regulates
p.000031: patentability of biological material, including hESCs. The debate on patenting hESCs is ongoing at both
p.000031: institutional (European Patent Office, the European Commission (83)) and academic level. At present, there is no EU
p.000031: consensus on the moral status of the embryo and its products and, reflecting this wide diversity of
p.000031: moral cultures, there are different policies for patenting among national patent offices. The European Group on
p.000031: Ethics (EGE) has evaluated the ethical aspects of patenting inventions involving human stem cells (84).
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: (82) OJ L 213, 30.7.1998, pp. 13–21.
p.000031: (83) See COM(2005) 312
p.000031: (84) EGE Opinion No 16, ‘Ethical aspects involving the patenting of human stem cells’.
p.000031:
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032:
p.000032:
p.000032:
p.000032: IV. RECOMMENDATIONS
p.000032:
p.000032: IV.1 Preamble
p.000032:
p.000032:
p.000032: These recommendations constitute the reply to the request from the President of the European
p.000032: Commission, Mr Barroso (85), after the adoption of the EU’s seventh framework programme for research and
p.000032: development (FP7), to elaborate an opinion on the implementing measures required during the ethics review of
p.000032: research projects on human embryonic stem cells (hESCs).
p.000032:
p.000032: As is the case in the European Union, there are divergent views within the European Group on Ethics
p.000032: (EGE) on the moral legitimacy of research on human embryos and hESCs, ranging from objection to research
p.000032: involving the destruction of human embryos (which makes the full respect of dignity of the human embryo impossible),
p.000032: to a position allowing hESC research under certain conditions or on a broader basis.
p.000032:
p.000032: The group acknowledges the political decision taken as the starting point for its recommendations, but emphasises that
p.000032: the ethical dilemma regarding the moral status of the human embryo and its use in research still persists. The EGE
p.000032: therefore stresses that the ethical differences of opinion concerning hESC research have not been resolved.
p.000032:
p.000032: However, these recommendations do not elaborate ethical arguments on hESC research as such; this is
p.000032: because this was not the task given to the group by the European Commission.
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: (85) Letter sent by Commission President Barroso to the EGE on 22 November 2006. ‘I would like to invite the
p.000032: European Group on Ethics to provide the Commission with an opinion on the implementing measures
p.000032: required during the ethics review of research projects on human embryonic stem cells that will assure
p.000032: that the ethical rules and requirements are fully met’.
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000033: 33
p.000033:
p.000033:
p.000033: IV.2. Recommendations for the ethical review of research projects involving hESCs
p.000033:
p.000033: FP7 research projects involving the use of hESCs are subject to stringent rules for selection, are scrutinised at
p.000033: both national and EU level, and undergo both scientific and ethical reviews.
p.000033:
p.000033: Under FP7, research proposals must include information about ethical aspects of the proposed research, explain in
p.000033: detail the project design, and show that the proposal meets the national legal and ethical requirements of the
p.000033: country where the research is performed.
p.000033:
p.000033: After successfully passing the scientific evaluation, the selected hESC proposals undergo a specific ethics review
p.000033: organised by the Commission on a case-by- case basis. The objective of the review is to ensure that
p.000033: the European Union does not support research that would not comply with fundamental ethical principles (86)
p.000033: and to examine whether the ethics rules set out in FP7 are met.
p.000033:
p.000033: The ethics review panel is a transnational body composed of experts from different disciplines. The panel
...
p.000034:
p.000034:
p.000034: IV.2.1. General criteria
p.000034:
p.000034: The European Commission has stated that it ‘will support actions and initiatives that contribute to coordination
p.000034: and rationalisation of hESC research within a responsible ethical approach’ (88). In line with this statement,
p.000034: the EGE recognises the need to promote responsible research that is transparent, serves the public interest, respects
p.000034: Member States’ autonomy, preserves public trust, promotes international cooperation, and requires the embedding
p.000034: of ethics within research practice (89).
p.000034:
p.000034: Ethically responsible research involving human embryonic stem cells must comply with fundamental ethical
p.000034: principles and human rights in the European Union (90), from the procurement of stem cells (91) to clinical
p.000034: research based on hESCs.
p.000034:
p.000034:
p.000034:
p.000034: (87) According to FP7 rules, evaluators sign a conflict of interest declaration and EC staff
p.000034: verify conflicts with each proposal they evaluate. Evaluation panels of ethics and scientific reviews are anonymous.
p.000034: (88) Declaration of the European Commission on 24 July 2006 during the meeting of the Council of Ministers
p.000034: regarding FP7. See OJ L 412, 30.12.2006.
p.000034: (89) For example, the Council of Europe Oviedo Convention (Article 2).
p.000034: (90) For details, see Section I of this opinion referring to the pertinent documents relevant to
p.000034: the context of medical research.
p.000034: (91) FP7 excludes the procurement of hESCs from Community funding (see paragraph II.2). See
p.000034: Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006
p.000034: concerning the seventh framework programme of the European Community for research, technological
p.000034: development and demonstration activities (2007–13), OJ L 412, 30.12.2006, pp. 1–
p.000034: 41.
p.000034:
p.000034:
p.000034:
p.000034:
p.000035: 35
p.000035:
p.000035:
p.000035: The fundamental rights include: protection rights such as protection of human life, respect of its integrity,
p.000035: protection of health and freedom, political rights such as freedom from undue state intervention or participatory
p.000035: rights in political affairs, and positive rights such as basic social and economic rights insofar as these
p.000035: contribute to health and a threshold of development, resulting in health-related governance (92).
p.000035:
p.000035: The balancing of these three groups of fundamental rights is by no means easy or pre-determined. Rather, it involves
p.000035: ongoing efforts to ensure their protection, granting and promotion of human dignity and human rights and, more
p.000035: concretely, it involves priority setting with respect to health-related research.
p.000035:
...
p.000044: patenting of biological materials, the EGE would like to deal with this issue at a later point in time
p.000044: (104).
p.000044:
p.000044: 2. The tension induced by a policy that encourages both free donation (105) and commercial use of derivates from human
p.000044: substances needs to be addressed.
p.000044:
p.000044: The EGE emphasises its view that the use of human embryos to generate stem cells should be minimised as much as
p.000044: possible. The EGE calls on the European Union to develop appropriate systems to minimise the use of human embryos to
p.000044: cases for which no alternatives exist.
p.000044:
p.000044: IV.4. Review of recommendations and communication with the Advisory Board of the European Registry on Human
p.000044: Embryonic Stem Cell Research
p.000044:
p.000044: The EGE would also welcome interaction with the Advisory Board of the European Registry on Human Embryonic
p.000044: Stem Cell Research, in particular with the registry’s Ethics Advisory Board, in order to address the ethical
p.000044: concerns regarding the procurement of stem cells and the storing of data in the light of the ongoing progress in this
p.000044: area.
p.000044:
p.000044: The concrete form and means of this collaboration should be specified and put into place, and should be
p.000044: appropriately supported and funded by the Commission.
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044: (104) The EGE has issued an opinion on ‘Ethical aspects of patenting inventions involving human stem cells’
p.000044: (http://www.ec.europa.eu/european_group_ethics/docs/avis16_en.pdf).
p.000044: (105) Article 12, Directive 2004/23/EC: ‘The EC encourages Member States to promote the voluntary
p.000044: and unpaid donation of tissue and cells’.
p.000044:
p.000044:
p.000044:
p.000044:
p.000045: 45
p.000045:
p.000045:
p.000045:
p.000045:
p.000045: IV. TRANSLATIONS OF THE RECOMMENDATIONS IN FRENCH AND GERMAN (106)
p.000045:
p.000045: IV.I. French translation
p.000045:
p.000045: RECOMMANDATIONS CONCERNANT L'EXAMEN ÉTHIQUE DES PROJETS DE RECHERCHE DU 7E PC DANS LE DOMAINE DES CSEH — Avis n° 22
p.000045:
p.000045: IV. RECOMMANDATIONS
p.000045: IV.1. Préambule
p.000045:
p.000045:
p.000045: Les présentes recommandations constituent la réponse à la demande du président de la Commission européenne, M.
p.000045: Barroso (107), après l'adoption du septième programme-cadre de l'Union européenne pour la recherche et le
p.000045: développement (7e PC), de formuler un avis sur les mesures d'exécution requises lors de l'examen éthique
p.000045: des projets de recherche sur les cellules souches embryonnaires humaines (CSEH).
p.000045:
p.000045: Tout comme au sein de l'Union européenne, il existe des vues divergentes au sein du Groupe européen d'éthique (GEE)
p.000045: quant à la légitimité morale de la recherche sur les embryons humains et les CSEH, qui vont du refus de la
p.000045: recherche comportant la destruction d'embryons humains (rendant impossible le respect total de la dignité de l'embryon
...
p.000082: guidelines and the common evaluation criteria for evaluating proposals set out in Annex B to the work programme.
p.000082:
p.000082: In the course of that review, the ethical review panel examines whether the proposal complies with the
p.000082: rules relating to ethics set out in Decision No 1513/2002/EC (154) and Decision 2002/834/EC.
p.000082:
p.000082: In addition, that panel assesses:
p.000082: (a) whether the proposers have taken into account the legislation, regulations, ethical rules and/or
p.000082: codes of conduct in place in the country(ies) where the research using banked or isolated hESC in culture is to
p.000082: take place, including the procedures for obtaining informed consent;
p.000082:
p.000082: (b) the source of the banked or isolated hESCs in culture;
p.000082:
p.000082: (c) the measures taken to protect personal data, including genetic data, and privacy;
p.000082:
p.000082: (d) the nature of financial inducements, if any.
p.000082: When preparing the ethical review, the Commission may request that the proposers provide additional
p.000082: information on the way the ethical issues raised by the project will be handled.
p.000082:
p.000082: 4. National approvals and opinions of competent ethics committee: The Commission ascertains that the
p.000082: participants have received appropriate approval from the national authority and/or a favourable opinion from the
p.000082: competent ethics committee before the signature of the contract, or before the banked or isolated hESCs in culture are
p.000082: to be used in the project.
p.000082:
p.000082: 5. Negotiation: During the negotiation of the contract, account is taken of the results of the ethical
p.000082: review. The result of the ethical review is reflected in the
p.000082:
p.000082: (154) OJ L 231, 29.8.2002, p. 1.
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000083: 83
p.000083:
p.000083:
p.000083:
p.000083: technical annex of the contract. Where the approval of the national authority and/or a favourable opinion
p.000083: from a local ethical committee is/are not obtained before the start of the contract, the contract includes a
p.000083: special clause requiring that the relevant authorisation or opinion be obtained before the start of the
p.000083: corresponding research.
p.000083:
p.000083: 6. Selection: In accordance with Article 6(3) of Decision 2002/834/EC any proposal involving the use of
p.000083: human embryonic stem cells is submitted for an opinion to the Programme Committee established by Article
p.000083: 7(1) of Decision 2002/834/EC.
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
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p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000084: 84
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084: ANNEX II
p.000084:
p.000084: Ethical review procedures in FP7
p.000084:
p.000084: Ethical issues
p.000084: Describe any ethical issues that may arise in their proposal. In particular, you should explain the benefit and burden
p.000084: of their experiments and the effects it may have on the research subject.
p.000084:
p.000084: The following special issues should be taken into account.
p.000084:
p.000084: Informed consent: When describing issues relating to informed consent, it will be necessary to illustrate an
p.000084: appropriate level of ethical sensitivity, and consider issues of insurance, incidental findings and the
p.000084: consequences of leaving the study.
p.000084:
p.000084: Data protection issues: Avoid the unnecessary collection and use of personal data. Identify the source of the data,
p.000084: describing whether it is collected as part of the research or is previously collected data being used.
...
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085: (1) Such as clinical trials, and research involving invasive techniques on persons (e.g. taking of tissue
p.000085: samples, examinations of the brain).
p.000085:
p.000085:
p.000085:
p.000085:
p.000086: 86
p.000086:
p.000086:
p.000086:
p.000086: ETHICAL ISSUES TABLE
p.000086:
p.000086:
p.000086: Informed consent
p.000086: • Does the proposal involve children?
p.000086: • Does the proposal involve patients or persons not able to give consent?
p.000086: • Does the proposal involve adult healthy volunteers?
p.000086:
p.000086:
p.000086:
p.000086: YES
p.000086:
p.000086:
p.000086:
p.000086:
p.000086: PAGE
p.000086:
p.000086: • Does the proposal involve human genetic material?
p.000086:
p.000086: • Does the proposal involve human biological samples?
p.000086: • Does the proposal involve human data collection?
p.000086:
p.000086: Research on human embryos/foetuses
p.000086: • Does the proposal involve human embryos?
p.000086: • Does the proposal involve human foetal tissue/cells?
p.000086:
p.000086: • Does the proposal involve human embryonic stem cells?
p.000086: Privacy
p.000086: • Does the proposal involve processing of genetic information or personal data (e.g. health, sexual lifestyle,
p.000086: ethnicity, political opinion, religious or philosophical conviction)?
p.000086: • Does the proposal involve tracking the location or observation of people?
p.000086: Research on animals
p.000086: • Does the proposal involve research on animals?
p.000086:
p.000086: • Are those animals transgenic small laboratory animals?
p.000086: • Are those animals transgenic farm animals?
p.000086: • Are those animals cloning farm animals?
p.000086: • Are those animals non-human primates?
p.000086: Research involving developing countries
p.000086: • Use of local resources (genetic, animal, plant, etc.)
p.000086:
p.000086: • Benefit to local community (capacity building, i.e. access to healthcare, education, etc.)
p.000086: Dual use
p.000086: • Research having potential military/terrorist application
p.000086:
p.000086: I CONFIRM THAT NONE OF THE ABOVE ISSUES APPLY TO MY PROPOSAL
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000087: 87
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087: ANNEX III
p.000087:
p.000087: LIST OF PROJECTS SUPPORTED WITHIN THE SIXTH FRAMEWORK PROGRAMME AND WITHIN THE HEALTH
p.000087: DIRECTORATE, INVOLVING HESCS
p.000087: 1. LYMPHANGIOGENOMICS: fundamental research to better understand the lymphatic vasculature with a view to
...
p.000093: pays, vous devez obtenir ces brevets d’invention dans ces pays aussi, par voie nationale, européenne ou internationale.
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000094: 94
p.000094:
p.000094:
p.000094:
p.000094: Regulatory frame applying to BULGARIA
p.000094:
p.000094: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000094: having not a legal personality.
p.000094:
p.000094: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000094: to get the texts would be welcomed).
p.000094:
p.000094: Healthcare Act /Chapter IV, Div. III – ‘Artificial Reproduction’/ In force from 01.01.2005 ./ SG N.70/2004., adopt.
p.000094: N.46/2005., N.76/2005., N.85/2005., N.88/ 2005., N.94/2005., N.103/2005., N.18/2006., N.30/2006., N.34/2006.,
p.000094: N.59/2006., N.71/2006., N.75/ 2006., N.81/2006., N.95/2006., N.102/ 2006./.
p.000094: Transplantation organ, tissue & cells Act In force from 01.01.2004 ./ SG N.83/2003., adopt..N88/2005.,N.71/2006./.;
p.000094: Ordinance N 37/28.09.2004 for the conditions and order for taking an embryos organs, tissue and somatic, amniotic and
p.000094: placenta cells for transplantation aims.
p.000094: / SG N.88/8.10.2004z.,adopt. SG N..89/ 12.10. 2004z./
p.000094:
p.000094: / the object of Ordinance regulation is only the ‘embryonic organs, tissue and cells’ after abortion — Art.1 and Art.4/
p.000094:
p.000094: Remark: To my opinion, the term ‘human embryonic stem sells’ have an wide and narrow understanding.. The ‘wide’ meaning
p.000094: comprises zygotes and life embryo as a source of stem cells.
p.000094: The narrow meaning comprises only life embryo as a source of stem cells.
p.000094: Therefore it will be useful to specify what meaning should be the right contents of the term ‘hESC’.
p.000094:
p.000094: Web address:
p.000094: www.bultransplant.bg ; www.mh.government.bg/iat.php;
p.000094: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000094: “Embryo’ is not defined explicitly.
p.000094: There is a definition of ‘embryonic organs, tissue and cells’ — Transplantation organ, tissue & cells Act, Additional
p.000094: provisions, &1, point.9.
p.000094:
p.000094: 3 Is hESC research allowed and in what terms and conditions?
p.000094: No.
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000095: 95
p.000095:
p.000095:
p.000095:
p.000095: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000095: see.point.3
p.000095:
p.000095: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000095: yes at what conditions? No.
p.000095: 6 Is the source of hESC used in research traceable and well documented?
p.000095: See point.5
...
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000104: 104
p.000104:
p.000104:
p.000104:
p.000104: Regulatory frame applying to FINLAND
p.000104:
p.000104: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000104: having not a legal personality.
p.000104:
p.000104: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000104: to get the texts would be welcomed).
p.000104: Medical Research Act, 488/1999. www.finlex.fi
p.000104: Translation: see: http://www.finlex.fi/en/laki/kaannokset/1999/en19990488.pdf
p.000104: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000104: Yes. ‘embryo’ means a living group of cells resulting from fertilisation not implanted in a woman’s body
p.000104:
p.000104: 3 Is hESC research allowed and in what terms and conditions?
p.000104: It is allowed. Embryos shall be used for research only with a written informed consent from the donors of the gametes.
p.000104: Consent can be withdrawn in any time (Act on medical Research, section 12) Only supernumerary embryos shall be used for
p.000104: research. The production of embryos exclusively for the purpose of research is forbidden. (Act on Medical Research,
p.000104: section 13). When hESC lines have been produced, the law does not make any further provisions on the use of these
p.000104: cells. The production of hESC needs the favourable opinion of an ethics committee of a hospital district, and the
p.000104: research on embryos can be done only in the institutions that have got an authorisation from the National Authority of
p.000104: Medicolegal Affairs (TEO) The use of embryos for research is allowed only for 14 days after fertilisation
p.000104: 4 If yes, which body is in charge of the approval of hESC research (ethics review)? Ethics committees of
p.000104: hospital districts evaluate the research projects, although the research of cell lines is not specifically regulated in
p.000104: the Medical Research Act. The Ministry of Social Affairs and Health has established a working group on Biobanks that is
p.000104: working on the issue of biobanks including ethics evaluation of establishment of biobank and ethics evaluation of the
p.000104: research projects.
p.000104: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000104: yes at what conditions?
p.000104: Medical Research Act states that The production of embryos exclusively for the purpose of research shall be forbidden.
p.000104: However, the Act also determines the embryo as ‘the living group of cells resulting from fertilisation’. This can be
p.000104: interpreted so that cells produced by the somatic cell nuclear transfer are not considered as embryos.
p.000104: 6 Is the source of hESC used in research traceable and well documented?
...
p.000137: techniques: the National Commission on Assisted Human Reproduction (art. 15.1, d, HARTAct) ‘Comision de Garantías
p.000137: para la Donación y Utilización de Células y Tejidos Humanos’
p.000137:
p.000137: B) For researches related with the gain, implementation and use of hESC lines: the Commission for
p.000137: Establishing Guarantees in the donation and use of human cells and tissues (art. 35 BMRAct)
p.000137:
p.000137: In both cases the previous review by a local Research Ethics Committee is also needed.
p.000137: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if yes at
p.000137: what conditions?
p.000137: The new law explicitly prohibits the creation of pre-embryos and embryos for the exclusive use of research, although it
p.000137: permits the use of any other technique, including nuclear transfer, aimed to obtaining human embryonic stem cells for
p.000137: research or therapy (BMRAct): Article 33 Obtaining of embryonic cells
p.000137: 1. The creation of human pre-embryos and embryos solely for experimentation purposes shall be prohibited.
p.000137: 2. The use of any technique for obtaining human stem cells for therapeutic or research purposes shall be permitted,
p.000137: when it doesn’t entail the creation of a pre-embryo or embryo solely for this purpose, in the terms provided in this
p.000137: Law, including the activation of oocytes through nuclear transfer.
p.000137: A perceptive and favourable previous opinion by the Commission for Establishing
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000138: 138
p.000138:
p.000138:
p.000138:
p.000138: Guarantees in the donation and use of human cells and tissues is needed, as well as the authorisation of the Autonomous
p.000138: Community Authority.
p.000138:
p.000138: 6 Is the source of hESC used in research traceable and well documented?
p.000138: Yes, it is (art. 8 BMRAct).
p.000138:
p.000138: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000138: 1-Informed consents from the parents of all embryos used;
p.000138: 2-approval by the ethical committee of the institution or the autonomous community and
p.000138: 3-approval by the ad hoc ‘Comision de Garantías para la Donación y Utilización de Células y Tejidos Humanos’
p.000138: (See on this previous answer to question Nr 4).
p.000138: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in embryo
p.000138: donation for research, if so could you please describe them?
p.000138: Yes. If embryos are going to be used for a research project, parents must sign an informed consent specific for that
p.000138: project. The informed consent form includes the name of the research project, a short summary of the main research
p.000138: objectives, the name of the IP and a disclosure of any financial interest (Art. 15.1, a of HARTAct).
p.000138:
p.000138:
p.000138: 9 Is financial inducement allowed? If so, in what terms?
...
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: APPENDIX: SECRETARIAT OF THE EGE
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: Secretariat of the European Group on Ethics
p.000143:
p.000143:
p.000143:
p.000143: Dr Maurizio Salvi, PhD Head of the EGE Secretariat
p.000143: Member of the European Bureau of Policy Advisors (BEPA)
p.000143:
p.000143: Tel. (32-2) 299 11 79
p.000143: Fax (32-2) 299 45 65
p.000143: E-mail: maurizio.salvi@ec.europa.eu
p.000143:
p.000143:
p.000143: Ms Alessandra Ferrari
p.000143:
p.000143: Tel. (32-2) 295 43 29
p.000143: Fax (32-2) 299 45 65
p.000143: E-mail: alessandra.ferrari@ec.europa.eu
p.000143:
p.000143:
p.000143:
p.000143: Ms Joëlle Bezzan
p.000143:
p.000143: Tel. (32-2) 296 19 48
p.000143: Fax (32-2) 299 45 65
p.000143: E-mail: joelle.bezzan@ec.europa.eu
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: Secretariat e-mail address
p.000143: bepa-group-ethics@ec.europa.eu
p.000143:
p.000143: Postal address
p.000143: European Commission
p.000143: Secretariat of the European Group on Ethics in Science and New Technologies BERL 8/143
p.000143: B–1049 Brussels
p.000143:
p.000143: Office European Commission Berlaymont Building
p.000143: Rue de la Loi 200 B–1049 Brussels
p.000143:
p.000143: Website
p.000143: http://europa.eu.int/comm/european_group_ethics
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000147: 147
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147: European Commission
p.000147:
p.000147: Recommendations on the ethical review of hESC FP7 research projects — Opinion No 22
p.000147:
p.000147: Luxembourg: Office for Official Publications of the European Communities 2008 — ii, 147 pp. — 21 x 29.7 cm
p.000147: ISBN 978-92-79-07137-9
p.000147:
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.000002: seventh framework programme for research and development (FP7) research projects on human embryonic stem cells
p.000002: (hESCs), as requested by the President of the European Commission, Mr Barroso (1), and in line with the
p.000002: adoption of the EU’s FP7.
p.000002:
p.000002: The EGE stressed that, as is the case in the European Union, there are divergent views within the
p.000002: group on the moral legitimacy of research on human embryos and hESCs, ranging from objection to research
p.000002: involving the destruction of human embryos (which makes the full respect of dignity of the human embryo impossible)
p.000002: to a position allowing hESC research under certain conditions or on a broader basis.
p.000002:
p.000002: The group, however, acknowledged the political decision taken as the starting point for its recommendations, but
p.000002: emphasised that the ethical dilemma regarding the moral status of the human embryo and its use in research still
p.000002: persists both within the EGE members and the EU. Therefore, the group did not elaborate ethical arguments on hESC
p.000002: research as such, but worked on recommendations for FP7 ethics review of hESC projects.
p.000002:
p.000002: The EGE recognised the need for promoting responsible research that is transparent, serves the public
p.000002: interest, respects Member State autonomy, preserves public trust, promotes international cooperation and
p.000002: requires the embedding of ethics within research practice. The group indicated that, in addition to the FP7
p.000002: ethics rules already adopted in co-decision, among others the following considerations should apply to hESCs funded by
p.000002: the EU:
p.000002:
p.000002: • FP7 hESC lines have to result from non-implanted IVF embryos;
p.000002: • if alternatives to hESCs with the same scientific potential as embryo- derived stem cells are found in the
p.000002: future, their use should be maximised;
p.000002:
p.000002:
p.000002: (1) Letter sent by European Commission President Barroso to the EGE on 22 November 2006: ‘I
p.000002: would like to invite the European Group on Ethics to provide the Commission with an opinion on the implementing
p.000002: measures required during the ethics review of research projects on human embryonic stem cells that will
p.000002: assure that the ethical rules and requirements are fully met.’
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003:
p.000003:
p.000003: • donors’ rights (in terms of health, informed consent, data protection and free donation) have to be
p.000003: protected and safeguarded.
p.000003:
...
p.000017: informed consent (41);
p.000017: • the source of the banked or isolated hESCs in culture;
p.000017:
p.000017: • the measures taken to protect personal data, including genetic data, and privacy;
p.000017:
p.000017: • the nature of financial inducements, if any.
p.000017:
p.000017:
p.000017: (c) A positive opinion from a regulatory committee comprising Member State representatives was required.
p.000017: (d) Finally, the Commission checked that the participants in research projects had received the approval of
p.000017: the relevant national or local ethics committees prior to the start of research activities.
p.000017: All these conditions were cumulative.
p.000017:
p.000017:
p.000017: In conclusion, each hESC research proposal supported under FP6 was assessed by at least two independent ethical
p.000017: reviews: one at national level (in the country where the research was to be carried out) (42) and one at EU level.
p.000017:
p.000017:
p.000017: II.5. The seventh framework programme for research, technological development and demonstration (2007–13)
p.000017: (FP7)
p.000017: As with FP6, ethics and hESCs played a major role in the interinstitutional debate on the seventh framework
p.000017: programme; this was intended to contribute to the
p.000017:
p.000017:
p.000017:
p.000017: (41) The EU has never required a uniform regulatory system for all fields of science and technology. The
p.000017: Treaty itself guarantees the autonomy of the Member States. As a consequence, diverse regulatory
p.000017: frameworks coexist (e.g. for research on non-human primates, nuclear research, security and prevention of
p.000017: terrorism, bio-banking, etc.). The principle of subsidiarity is respected in full, assuming respect of fundamental
p.000017: ethical principles.
p.000017: (42) If the research raising ethical issues is performed in more than one country (i.e. n countries), this
p.000017: implies that more than two ethical reviews will be performed (i.e. in fact n + 1 ethical reviews).
p.000017:
p.000017:
p.000017:
p.000017:
p.000018: 18
p.000018:
p.000018:
p.000018: implementation of the Lisbon strategy and benefited from a budget of EUR 53 billion for the time
p.000018: frame 2007–13 (43).
p.000018:
p.000018: The Commission proposal for FP7 was adopted on 6 April 2005. As for FP6, the proposal had a specific article (Article
p.000018: 6) stating that ‘All the research activities … shall be carried out in compliance with fundamental ethical
p.000018: principles’. The specific programme for FP7 was adopted by the Commission on 21 September 2005. The Commission
p.000018: proposal was then transmitted to the relevant institutions (the European Parliament and the Council) for their approval
p.000018: by co-decision.
p.000018:
p.000018: The Parliament adopted (first reading) the proposed programme on 15 June 2006 after a preceding vote and
p.000018: a request for amendments by the relevant Parliamentary commission (ITRE) on 30 May 2005. The Commission
p.000018: accepted Parliament’s request to have the ethics framework incorporated in the framework programme text, which required
p.000018: a co-decision by the European Parliament and the Council on this issue. This was not the case for FP6,
...
p.000033:
p.000033:
p.000033: (86) Seventh framework programme (Decision No 1982/2006/EC), Article 6(1): ‘All the research
p.000033: activities carried out under the Seventh Framework Programme shall be carried out in compliance with fundamental
p.000033: ethical principles.’; Rules for Participation, Article 10: ‘A proposal […] which contravenes fundamental ethical
p.000033: principles […] shall not be selected. Such a proposal may be excluded from the evaluation and selection
p.000033: procedures at any time.’
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000034: 34
p.000034:
p.000034:
p.000034: In order to provide guidance to the members of the FP7 hESC ethics review panels who will be asked to
p.000034: review the research projects using hESC lines, and under the specific remit and conditions laid down by the political
p.000034: decision of the European Parliament and of the Council on FP7, and also by the specific request of the President of the
p.000034: European Commission, Mr J. M. Barroso (see above), the EGE elaborated the following guidelines and points to consider
p.000034: when conducting such ethics review of FP7 projects (87).
p.000034:
p.000034:
p.000034: IV.2.1. General criteria
p.000034:
p.000034: The European Commission has stated that it ‘will support actions and initiatives that contribute to coordination
p.000034: and rationalisation of hESC research within a responsible ethical approach’ (88). In line with this statement,
p.000034: the EGE recognises the need to promote responsible research that is transparent, serves the public interest, respects
p.000034: Member States’ autonomy, preserves public trust, promotes international cooperation, and requires the embedding
p.000034: of ethics within research practice (89).
p.000034:
p.000034: Ethically responsible research involving human embryonic stem cells must comply with fundamental ethical
p.000034: principles and human rights in the European Union (90), from the procurement of stem cells (91) to clinical
p.000034: research based on hESCs.
p.000034:
p.000034:
p.000034:
p.000034: (87) According to FP7 rules, evaluators sign a conflict of interest declaration and EC staff
p.000034: verify conflicts with each proposal they evaluate. Evaluation panels of ethics and scientific reviews are anonymous.
p.000034: (88) Declaration of the European Commission on 24 July 2006 during the meeting of the Council of Ministers
p.000034: regarding FP7. See OJ L 412, 30.12.2006.
p.000034: (89) For example, the Council of Europe Oviedo Convention (Article 2).
p.000034: (90) For details, see Section I of this opinion referring to the pertinent documents relevant to
p.000034: the context of medical research.
p.000034: (91) FP7 excludes the procurement of hESCs from Community funding (see paragraph II.2). See
p.000034: Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006
p.000034: concerning the seventh framework programme of the European Community for research, technological
p.000034: development and demonstration activities (2007–13), OJ L 412, 30.12.2006, pp. 1–
p.000034: 41.
p.000034:
p.000034:
p.000034:
p.000034:
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General/Other / Relationship to Authority
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p.000082: guidelines
p.000082:
p.000082: 3. Ethical review: The ethical review is conducted in accordance with the procedure set out in the
p.000082: guidelines and the common evaluation criteria for evaluating proposals set out in Annex B to the work programme.
p.000082:
p.000082: In the course of that review, the ethical review panel examines whether the proposal complies with the
p.000082: rules relating to ethics set out in Decision No 1513/2002/EC (154) and Decision 2002/834/EC.
p.000082:
p.000082: In addition, that panel assesses:
p.000082: (a) whether the proposers have taken into account the legislation, regulations, ethical rules and/or
p.000082: codes of conduct in place in the country(ies) where the research using banked or isolated hESC in culture is to
p.000082: take place, including the procedures for obtaining informed consent;
p.000082:
p.000082: (b) the source of the banked or isolated hESCs in culture;
p.000082:
p.000082: (c) the measures taken to protect personal data, including genetic data, and privacy;
p.000082:
p.000082: (d) the nature of financial inducements, if any.
p.000082: When preparing the ethical review, the Commission may request that the proposers provide additional
p.000082: information on the way the ethical issues raised by the project will be handled.
p.000082:
p.000082: 4. National approvals and opinions of competent ethics committee: The Commission ascertains that the
p.000082: participants have received appropriate approval from the national authority and/or a favourable opinion from the
p.000082: competent ethics committee before the signature of the contract, or before the banked or isolated hESCs in culture are
p.000082: to be used in the project.
p.000082:
p.000082: 5. Negotiation: During the negotiation of the contract, account is taken of the results of the ethical
p.000082: review. The result of the ethical review is reflected in the
p.000082:
p.000082: (154) OJ L 231, 29.8.2002, p. 1.
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p.000083:
p.000083: technical annex of the contract. Where the approval of the national authority and/or a favourable opinion
p.000083: from a local ethical committee is/are not obtained before the start of the contract, the contract includes a
p.000083: special clause requiring that the relevant authorisation or opinion be obtained before the start of the
p.000083: corresponding research.
p.000083:
p.000083: 6. Selection: In accordance with Article 6(3) of Decision 2002/834/EC any proposal involving the use of
p.000083: human embryonic stem cells is submitted for an opinion to the Programme Committee established by Article
p.000083: 7(1) of Decision 2002/834/EC.
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p.000084:
p.000084: ANNEX II
p.000084:
p.000084: Ethical review procedures in FP7
p.000084:
p.000084: Ethical issues
p.000084: Describe any ethical issues that may arise in their proposal. In particular, you should explain the benefit and burden
p.000084: of their experiments and the effects it may have on the research subject.
p.000084:
p.000084: The following special issues should be taken into account.
p.000084:
...
p.000104: having not a legal personality.
p.000104:
p.000104: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000104: to get the texts would be welcomed).
p.000104: Medical Research Act, 488/1999. www.finlex.fi
p.000104: Translation: see: http://www.finlex.fi/en/laki/kaannokset/1999/en19990488.pdf
p.000104: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000104: Yes. ‘embryo’ means a living group of cells resulting from fertilisation not implanted in a woman’s body
p.000104:
p.000104: 3 Is hESC research allowed and in what terms and conditions?
p.000104: It is allowed. Embryos shall be used for research only with a written informed consent from the donors of the gametes.
p.000104: Consent can be withdrawn in any time (Act on medical Research, section 12) Only supernumerary embryos shall be used for
p.000104: research. The production of embryos exclusively for the purpose of research is forbidden. (Act on Medical Research,
p.000104: section 13). When hESC lines have been produced, the law does not make any further provisions on the use of these
p.000104: cells. The production of hESC needs the favourable opinion of an ethics committee of a hospital district, and the
p.000104: research on embryos can be done only in the institutions that have got an authorisation from the National Authority of
p.000104: Medicolegal Affairs (TEO) The use of embryos for research is allowed only for 14 days after fertilisation
p.000104: 4 If yes, which body is in charge of the approval of hESC research (ethics review)? Ethics committees of
p.000104: hospital districts evaluate the research projects, although the research of cell lines is not specifically regulated in
p.000104: the Medical Research Act. The Ministry of Social Affairs and Health has established a working group on Biobanks that is
p.000104: working on the issue of biobanks including ethics evaluation of establishment of biobank and ethics evaluation of the
p.000104: research projects.
p.000104: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000104: yes at what conditions?
p.000104: Medical Research Act states that The production of embryos exclusively for the purpose of research shall be forbidden.
p.000104: However, the Act also determines the embryo as ‘the living group of cells resulting from fertilisation’. This can be
p.000104: interpreted so that cells produced by the somatic cell nuclear transfer are not considered as embryos.
p.000104: 6 Is the source of hESC used in research traceable and well documented?
p.000104: Anonymisation and coding as far as possible should be used in each project
p.000104: 7 What are the formal ethical and legal requirements for hESC research approval? We have formal ethical
...
p.000106:
p.000106: 6 Is the source of hESC used in research traceable and well documented?
p.000106: It is a condition to fulfil in order to obtain a licence to be able to keep a local registry and tracks of cell
p.000106: culture;
p.000106: The agence de la biomedicine has also to keep a national hESC registry
p.000106: 7 What are the formal ethical and legal requirements for hESC research approval? The research project
p.000106: should benefit to the progress towards a potential therapeutic use of to progress on human embryo development and
p.000106: medicine.
p.000106: The team involved has to provide proof if feasibility of this research, and to documents the composition of the team,
p.000106: the lab rooms scheme, the traceability of the Es cell lines See décret n°2006-121 du 6 février 2006
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
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p.000106:
p.000107: 107
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000107: embryo donation for research, if so could you please describe them?
p.000107: Yes
p.000107: The law does ask to document the origin of the cell line and to provide the consent form model : both parents should
p.000107: have signed for the use of the embryo for research,
p.000107:
p.000107: 9 Is financial inducement allowed? If so, in what terms?
p.000107:
p.000107: No
p.000107: The authority in charge of giving licences does not provide funds for research on those topics.
p.000107:
p.000107: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000107: Yes
p.000107:
p.000107: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000107: publications)?
p.000107: Yes, they are asked for every licence given, a yearly progress report is asked, and a final report.
p.000107:
p.000107: 12 How is patenting of hESC lines regulated?
p.000107: Not authorized
p.000107:
p.000107:
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p.000108: 108
p.000108:
p.000108:
p.000108:
p.000108: Regulatory frame applying to GERMANY
p.000108:
p.000108: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000108: having not a legal personality.
p.000108:
p.000108: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000108: to get the texts would be welcomed).
p.000108: 1) Act for the Protection of Embryos (Embryo Protection Act),
p.000108: Gesetz zum Schutz von Embryonen (Embryonenschutzgesetz – EschG)
p.000108: http://bundesrecht.juris.de/eschg/BJNR027460990.html,
...
p.000109: patent, saying that anything made from human tissue cannot be patented.
p.000109:
p.000109:
p.000109:
p.000109:
p.000110: 110
p.000110:
p.000110:
p.000110:
p.000110: Regulatory frame applying to GREECE
p.000110:
p.000110: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000110: having not a legal personality.
p.000110:
p.000110: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where to get
p.000110: the texts would be welcomed).
p.000110:
p.000110: - Article 1459 c of the Civil Code (Act n. 3089/2002)
p.000110: - Article 11 par. 1 (e) of the Act n. 3305/2005 (“Application of M.A.R.)
p.000110: -
p.000110: - http://www.bioethics.gr/media/pdf/biolaw/human/law_3089_en.pdf?PHPSESSID=c730 cd74d93449cca3750bb51c50a228
p.000110:
p.000110:
p.000110:
p.000110: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000110:
p.000110: Yes, (article 3 of the Act n. 3305/2005, for the terms ‘zygote’ and ‘fertilized egg’
p.000110:
p.000110: ‘Zygote’: an ovum from its fertilisation until the merger of the two haploid nuclei
p.000110: “Fertilized egg’: an ovum after the penetration or initiation of sperm
p.000110:
p.000110:
p.000110: 3 Is hESC research allowed and in what terms and conditions?
p.000110: Yes.
p.000110: Under certain conditions:
p.000110: - Only on surplus embryos (up to the 14th day after fertilisation)
p.000110: - Prior written informed consent of the donors
p.000110: - Prior approval of the protocol (from the National Authority on M.A.R.)
p.000110: - Prior research on laboratory animals (if possible)
p.000110: - The research team should possess the necessary equipment and know-how
p.000110: - It is not allowed to implant the embryos that have been used
p.000110:
p.000110: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000110:
p.000110: The National Authority on Medically Assisted Reproduction (an independent regulatory agent, nominated by the
p.000110: Parliament)
p.000110:
p.000110:
p.000110: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if yes at
p.000110: what conditions?
p.000110:
p.000110: No
p.000110:
p.000110: 6 Is the source of hESC used in research traceable and well documented?
p.000110:
p.000110: Yes
p.000110:
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p.000111: 111
p.000111:
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p.000111:
p.000111:
p.000111: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000111:
p.000111: See above (3)
p.000111:
p.000111: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in embryo
p.000111: donation for research, if so could you please describe them?
p.000111:
p.000111: See above (3)
p.000111:
p.000111: 9 Is financial inducement allowed? If so, in what terms?
p.000111:
p.000111: No (only compensation for justifiable expenses, medical services or undue damages is allowed)
p.000111:
p.000111: 1 Are ad hoc data protection provisions be defined for hESC research? 0
p.000111: No. The law on sensitive data protection (Act n. 2472/1997) is applicable, binding the research team.
p.000111: The Data Protection Authority is responsible for relevant controls.
p.000111:
p.000111:
p.000111: 1 Are data deriving from hESC projects necessarily provided, whether positive or
p.000111: 1 negative (in form of publications)?
p.000111:
p.000111: No
p.000111:
p.000111: 1 How is patenting of hESC lines regulated? 2
p.000111: By the presidential decree n. 321/2001 (on the Directive 98/44/EC)
p.000111:
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p.000112:
p.000112:
p.000112:
p.000112: Regulatory frame applying to HUNGARY
p.000112:
p.000112: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000112: to get the texts would be welcomed).
p.000112:
p.000112: The human embryonic stem cells research and use is regulated by law and five decrees.
p.000112: The 1997. CLIV. law about the health regulated the general conditions of the use and research of the human embryonic
p.000112: stem cells (180- 182 paragraphs.(
p.000112: The 2006 CXV. law about the health reform.
p.000112: The 21/1998. (VI.3.) MH decree contains the minimum conditions of the use of human embryonic stem cells ( 15/B
p.000112: attachment).
p.000112: The 22/1998. (VI.3.) MH decree contains the detailed regulation of the transplantation of different organs and tissues.
p.000112: The 31/1998. (VI.24.) MH decree regulated the ethical approval system of biomedical research.
...
p.000118:
p.000118: It is not regulated by legislation
p.000118: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000118: embryo donation for research, if so could you please describe them?
p.000118:
p.000118: It is not regulated by legislation
p.000118: 9 Is financial inducement allowed? If so, in what terms?
p.000118:
p.000118: It is not regulated by legislation
p.000118:
p.000118: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000118: It is regulated for any research
p.000118: Law on Data Protection
p.000118: Personal data processing is permitted only if not prescribed otherwise by law, and at least one of the
p.000118: following conditions exist:
p.000118: 1) the data subject has given his or her consent;
p.000118:
p.000118:
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p.000119: 119
p.000119:
p.000119:
p.000119:
p.000119: 2) the personal data processing results from contractual obligations of the data subject;
p.000119:
p.000119: 3) the data processing is necessary to a system controller for the performance of his or her lawful obligations;
p.000119: 4) the data processing is necessary to protect vitally important interests of the data subject, including
p.000119: life and health;
p.000119: 5) the data processing is necessary in order to ensure that the public interest is complied with, or
p.000119: to fulfil functions of public authority for whose performance the personal data have been transferred to
p.000119: a system controller or transmitted to a third person; and
p.000119: 6) the data processing is necessary in order to, complying with the fundamental human rights and freedoms of the data
p.000119: subject, exercise lawful interests of the system controller or of such third person as the personal data have been
p.000119: disclosed to.
p.000119:
p.000119:
p.000119:
p.000119: The processing of sensitive personal data is prohibited, except in cases where:
p.000119:
p.000119: 1) the data subject has given his or her written consent for the processing of his or her sensitive personal data;
p.000119: 2) special processing of personal data, without requesting the consent of the data subject, is provided for by
p.000119: regulatory enactments which regulate
p.000119:
p.000119: 11 Are data deriving from hESC projects necessarily provided, whether positive or negative (in form of
p.000119: publications)?
p.000119: Yes, but it is not regulated by legislation.
p.000119:
p.000119:
p.000119: 12 How is patenting of hESC lines regulated?
p.000119: It is not regulated
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p.000120: Regulatory frame applying to LITHUANIA
p.000120:
p.000120:
...
p.000136:
p.000136: a) Pre-embryo: the in vitro embryo as constituted by a group of cells derived of the continuous division of the
p.000136: fertilised oocyte until 14 days later (art. 1.2 of HARTAct and art. 3, s, BMRAct)
p.000136:
p.000136: b) Embryo: A step of embryonic development, which includes the time in what the fertilised oocyte is located in the
p.000136: uterus of a woman until the time of the beginning of the step of the formation of organs, it is to say, 56 days after
p.000136: fertilisation occurs, regardless the time during such development could be stopped (art. 3, l, BMRAct).
p.000136:
p.000136:
p.000136: 3 Is hESC research allowed and in what terms and conditions?
p.000136: Yes, this type of research is allowed but only under case by case scrutiny. The research project has to fulfil, by the
p.000136: research group, the ethical guarantees requested.
p.000136: A) From surplus pre-embryos HARTAct):
p.000136: Article 15. Using pre-embryos for research purposes.
p.000136:
p.000136: a) Informed consent of the couple or of the single woman.
p.000136: b) The pre-embryo shall not be developed in vitro more than 14 days, regardless the time it could be cryo-preserved
p.000136: c) Research shall be performed in authorised centres
p.000136: d) Research will be done on the basis of a research project authorised by the competent authority, previous the
p.000136: perceptive and favourable Commission (see down).
p.000136:
p.000136:
p.000136: B) From cloned pre-embryos (BMRAct):
p.000136: Article 34 Guarantees and requisites for research
p.000136: 1. Research or experimentation with surplus oocytes and pre-embryos from the application of assisted
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000137: 137
p.000137:
p.000137:
p.000137:
p.000137: reproduction techniques, or from their biological structures, with the aim to obtain, develop and use embryonic stem
p.000137: cell lines or with other purposes not associated with the development and application of assisted reproduction
p.000137: techniques, shall be undertaken in accordance with the conditions established in Law 14/2006, of 26 May, and comply
p.000137: with the following requisites:
p.000137: a) That the research abides by the applicable ethical principles and legal regulations, especially in that provided
p.000137: in this Law and its development of rules and guidelines in law, and that it follows the principles
p.000137: of relevance, feasibility and suitability, specifically of the main researcher, of the research
p.000137: team and of the facilities of the centre that shall undertake the research.
p.000137:
p.000137: b) That it is based on a research project authorised by the relevant State or autonomous authorities,
p.000137: after a favourable report by the Commission for establishing guarantees in the donation and use of human
p.000137: cells and tissues, in the event that the project deals with matters provided in article 35.
p.000137:
p.000137: 2. The authorisation of the research projects shall be conditioned on the project including at least the following
p.000137: elements:
p.000137: a) The authorisation by the management of the centre that shall undertake the research, as well as the favourable
p.000137: report of the corresponding Research Ethics Committee.
p.000137: b) The notification of the common relations and interests, of any nature or the absence of such, between the team and
p.000137: the centre that have undertaken each of the processes of assisted reproduction that have generated pre-embryos or have
p.000137: intervened in the obtaining of oocytes.
p.000137: c) The written commitment to supply to the corresponding public authority the data that will permit to identify and
p.000137: know the storage of the cell lines that could be obtained as a consequence of the development of the research.
p.000137: d) The commitment of the free conveyance of line cells that could be obtained in the development of the research, for
p.000137: its use by other researchers.
p.000137: e) When using oocytes or pre-embryos, the indication and justification of its size, origin and the document of the
p.000137: informed consent signed by the donors or progenitors respectively.
p.000137:
p.000137: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000137:
p.000137: A) For researches related with the application and implementation of human assisted reproductive
p.000137: techniques: the National Commission on Assisted Human Reproduction (art. 15.1, d, HARTAct) ‘Comision de Garantías
p.000137: para la Donación y Utilización de Células y Tejidos Humanos’
p.000137:
p.000137: B) For researches related with the gain, implementation and use of hESC lines: the Commission for
p.000137: Establishing Guarantees in the donation and use of human cells and tissues (art. 35 BMRAct)
p.000137:
p.000137: In both cases the previous review by a local Research Ethics Committee is also needed.
p.000137: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if yes at
p.000137: what conditions?
p.000137: The new law explicitly prohibits the creation of pre-embryos and embryos for the exclusive use of research, although it
p.000137: permits the use of any other technique, including nuclear transfer, aimed to obtaining human embryonic stem cells for
p.000137: research or therapy (BMRAct): Article 33 Obtaining of embryonic cells
p.000137: 1. The creation of human pre-embryos and embryos solely for experimentation purposes shall be prohibited.
p.000137: 2. The use of any technique for obtaining human stem cells for therapeutic or research purposes shall be permitted,
p.000137: when it doesn’t entail the creation of a pre-embryo or embryo solely for this purpose, in the terms provided in this
p.000137: Law, including the activation of oocytes through nuclear transfer.
p.000137: A perceptive and favourable previous opinion by the Commission for Establishing
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000138: 138
p.000138:
p.000138:
p.000138:
p.000138: Guarantees in the donation and use of human cells and tissues is needed, as well as the authorisation of the Autonomous
p.000138: Community Authority.
p.000138:
p.000138: 6 Is the source of hESC used in research traceable and well documented?
p.000138: Yes, it is (art. 8 BMRAct).
p.000138:
p.000138: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000138: 1-Informed consents from the parents of all embryos used;
p.000138: 2-approval by the ethical committee of the institution or the autonomous community and
p.000138: 3-approval by the ad hoc ‘Comision de Garantías para la Donación y Utilización de Células y Tejidos Humanos’
p.000138: (See on this previous answer to question Nr 4).
p.000138: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in embryo
p.000138: donation for research, if so could you please describe them?
p.000138: Yes. If embryos are going to be used for a research project, parents must sign an informed consent specific for that
p.000138: project. The informed consent form includes the name of the research project, a short summary of the main research
p.000138: objectives, the name of the IP and a disclosure of any financial interest (Art. 15.1, a of HARTAct).
p.000138:
p.000138:
p.000138: 9 Is financial inducement allowed? If so, in what terms?
p.000138:
p.000138: No, it is not.
p.000138: (See art. 7 BMRAct and art. 15.1, a of HARTAct).
p.000138: 10 Are ad hoc data protection provisions be defined for hESC research?
p.000138: Yes, they are. (arts. 5 and 53 of BMRAct):
p.000138:
...
p.000138: See the Act 11/1986 of 26 March, on Patent, as modified by Act 10/2002 of 29 April, transposing that Directive.
p.000138: Information provided by Prof. C.M. Romeo-Casabona (Universidad de Deusto, Bilbao) and Dr. Javier Arias (Institut de
p.000138: salud Carlos III, Madrid)
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000139: 139
p.000139:
p.000139:
p.000139:
p.000139: Regulatory frame applying to SWEDEN
p.000139:
p.000139: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000139: having not a legal personality.
p.000139:
p.000139: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000139: to get the texts would be welcomed).
p.000139: The Act (2006:351) on genetic integrity etc.. The Biobanks in Medical Care Act (2002:297)
p.000139: The Act (2003:460) on ethics review of research on humans http://www.epn.se/eng/start/index.aspx
p.000139: The Transplantation Act (1995:831)
p.000139: Guidelines issued by the Swedish Research Council
p.000139: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000139:
p.000139: The word used in Sweden is ‘fertilised egg’. There is a 14 day limit for its use.
p.000139: 3 Is hESC research allowed and under what terms and conditions?
p.000139: Yes. Approval by regional research ethics authority. Consent from both donors.
p.000139:
p.000139: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000139: see above
p.000139:
p.000139: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000139: yes under what conditions?
p.000139: same as 3
p.000139:
p.000139: 6 Is the source of hESC used in research traceable and well documented?
p.000139: Yes
p.000139: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000139: same as 3
p.000139:
p.000139: 8 Does the relevant regulatory frame foresee informed consent procedures from individuals involved in
p.000139: embryo donation for research, if so could you please describe them?
p.000139: Consent should be informed. Procedures are reviewed by the Regional Research Ethics Authority.
p.000139:
p.000139: 9 Is financial inducement allowed? If so, on what terms?
p.000139:
p.000139: No. Normally, only reimbursement of costs allowed
p.000139:
p.000139: 10 Are ad hoc data protection provisions defined for hESC research?
p.000139: The Patient Records Act and the Personal Data Act apply
p.000139:
p.000139: 11 Are data deriving from hESC projects necessarily (?) provided, whether positive or negative (in form of
p.000139: publications)?
p.000139: No different from other research
p.000139:
p.000139: 12 How is patenting of hESC lines regulated?
p.000139: Indirectly in the Transplantation Act
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000140: 140
p.000140:
p.000140:
p.000140:
p.000140: Regulatory frame applying to UNITED KINGDOM
p.000140:
p.000140: Please the information here provided should concern current regulatory requirements and not other reference documents
p.000140: having not a legal personality.
p.000140:
p.000140: 1 Please list existing regulation applying to human embryonic stem cells (hESC) research (web address where
p.000140: to get the texts would be welcomed).
p.000140: The use of embryos to derive hES cell lines is regulated by the Human Fertilisation and Embryology Authority (HFEA) in
p.000140: the UK (www.hfea.gov.uk).
p.000140: The UK Stem Cell Bank Steering Committee also issues guidelines on the use of hES cell lines in the UK
p.000140: (www.ukstemcellbank.org.uk)
p.000140:
p.000140: 2 Does the regulation provide a definition of 'embryo', if so which one?
p.000140: The Human Fertilisation and Embryology Act (HF&E Act) 1990 provides that ‘an embryo means a live human embryo where
p.000140: fertilisation is complete, and references to an embryo include an egg in the process of fertilisation, and, for this
p.000140: purpose, fertilisation is not complete until the appearance of a two cell zygote’.
p.000140:
p.000140: 3 Is hESC research allowed and in what terms and conditions?
p.000140: The HFEA regulates the use of embryos to derive hES cell lines. The use of hES cell lines in research is permitted in
p.000140: the UK but is not within the remit of the HFEA.
p.000140:
p.000140: 4 If yes, which body is in charge of the approval of hESC research (ethics review)?
p.000140: The HFEA regulates the use of embryos to derive hES cell lines.
p.000140:
p.000140: 5 Is the creation of embryos for research purposes, or stem cells procurement, allowed in your country, if
p.000140: yes at what conditions?
p.000140: Yes the creation of embryos for use in research, including the derivation of hES cell lines, is permitted in the UK. An
p.000140: explanation of how the HFEA licences research projects can be found on our website at www.hfea.gov.uk.
p.000140:
p.000140: 6 Is the source of hESC used in research traceable and well documented?
p.000140: Yes
p.000140: 7 What are the formal ethical and legal requirements for hESC research approval?
p.000140: The use of embryos to derive hES cell lines requires a licence from the HFEA.
p.000140: The HFEA has set up a dedicated Research Licence Committee. Under section 9(5) of the 1990 Act, a Licence Committee is
p.000140: required to include at least 1 member who is not authorised to carry on or participate in any activity under the
p.000140: authority of a licence and would not be so authorised if outstanding applications were granted. In addition to this
p.000140: requirement, and in accordance with the recommendations of the Better Regulation Task Force, the Research Licence
p.000140: Committee has a lay chair and a lay majority.
p.000140:
p.000140: In considering whether to grant or renew a licence, the Committee will have access to the following documentation:
p.000140: • Application form signed by the Person Responsible and the Nominal Licensee
p.000140: • Curricula vitae of the principal personnel involved in the research
p.000140: • Approval of a properly constituted local research Ethics Committee,
p.000140: • Report of the inspection of the research centre
p.000140: • Comments from 2 peer reviewers
p.000140: • The centre’s licensing history
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000141: 141
p.000141:
p.000141:
p.000141:
p.000141: • Copies of relevant publications
p.000141: • Patient Information and Consent Forms
p.000141:
p.000141: Before considering whether it is appropriate to grant or renew a licence the Research Licence Committee has to be
p.000141: satisfied that activities proposed in the licence application are necessary or desirable for one or more of the
p.000141: purposes set out in Schedule 2 to the HF&E Act 1990 (as amended by the Research Purposes Regulations 2001). In
p.000141: addition, the Research Licence Committee has to be satisfied that any proposed use of embryos is necessary for the
p.000141: purposes of the research.
p.000141:
...
Orphaned Trigger Words
p.000005: of such data;
p.000005:
p.000005: Having regard to the Council of Europe Convention on Human Rights and Biomedicine signed on 4 April 1997 in
p.000005: Oviedo (5), and the additional protocols to the convention;
p.000005:
p.000005: Having regards to Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro
p.000005: diagnostic medical devices (6);
p.000005:
p.000005: Having regard to Commission Decision 2002/364/EC (7) on common technical specifications for in vitro diagnostic medical
p.000005: devices;
p.000005:
p.000005: Having regard to the Convention on the Grant of European Patents (European Patent Convention) of 5 October
p.000005: 1973 (text as amended by the act revising Article 63 EPC of 17 December 1991 and by decisions of the Administrative
p.000005: Council of the European Patent Organisation of 21 December 1978, 13 December 1994, 20 October 1995, 5
p.000005: December 1996,
p.000005: 10 December 1998 and 27 October 2005 and comprising the provisionally
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: (3) http://www.coe.int/T/E/Social_Cohesion/Health/Recommendations/Rec(1994)01.asp (4) OJ L 281,
p.000005: 23.11.1995, pp. 31–50.
p.000005: (5) http://conventions.coe.int/treaty/en/treaties/html/164.htm (6) OJ L 331, 7.12.1998, pp. 1–37.
p.000005: (7) OJ L 131, 16.5.2002, pp. 17–30.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006:
p.000006: applicable provisions of the act revising the EPC of 29 November 2000) (8);
p.000006: Having regard to Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the
p.000006: processing of personal data and the protection of privacy in the electronic communications sector (9);
p.000006:
p.000006: Having regard to Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the
p.000006: approximation of the laws, regulations and administrative provisions of the Member States relating to
p.000006: the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
p.000006: (10), as amended in 2003 (Directive 2003/94/EC) (11) and 2005 (Directive 2005/28/EC);
p.000006:
p.000006: Having regard to Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on
p.000006: the legal protection of biotechnological inventions (12);
p.000006:
p.000006: Having regard to Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the
p.000006: protection of individuals with regard to the processing of personal data and on the free movement of such
p.000006: data (13);
p.000006:
p.000006: Having regard to the Universal Declaration on the Human Genome and the Rights of Man adopted by Unesco
p.000006: on 11 November 1997 (14), the Declaration on Human Genetic Data adopted by Unesco on 16 October
p.000006:
p.000006:
p.000006: (8) http://www.european-patent-office.org/legal/epc/e/ma1.html (9) OJ L 201, 31.7.2002, pp. 37–47.
p.000006: (10) OJ L 121, 1.5.2001, pp. 34–44.
p.000006: (11) OJ L 261, 14.10.2003, pp. 22–26.
p.000006: (12) OJ L 213, 30.7.1998, pp. 13–21.
p.000006: (13) OJ L 281, 23.11.1995, pp. 31–50.
p.000006: (14) http://portal.unesco.org/shs/en/ev.php- URL_ID=2228&URL_DO=DO_TOPIC&URL_SECTION=201.html
p.000006:
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007:
p.000007:
p.000007: 2003 and the Universal Declaration on Bioethics and Human Rights adopted by Unesco on 19 October 2005;
p.000007:
p.000007: Having regard to the Convention for the Protection of Individuals with regard to Automatic Processing of
p.000007: Personal Data adopted by the Council of Europe on 1 January 1981 (15);
p.000007:
p.000007: Having regard to the United Nations Declaration on Human Cloning adopted by the UN General Assembly on 8 March
p.000007: 2005;
p.000007:
p.000007: Having regard to the common position of the Council of Ministers of 23 March 1998 and the second
p.000007: reading of the European Parliament of 17 June 1998 concerning the fifth framework programme;
p.000007:
p.000007: Having regard to Council Directive 98/44/EC (16) of 6 July 1998 on the legal protection of
p.000007: biotechnological inventions, and in particular Article 6 concerning ordre public and morality;
p.000007:
p.000007: Having regard to the decision of the European Parliament and of the Council of 22 December 1998 adopting the
p.000007: fifth framework programme of the European Community for research, technological development and demonstration
p.000007: activities (1998–2002), and in particular Article 7 concerning compliance with fundamental ethical
p.000007: principles;
p.000007:
p.000007: Having regard to the Council decision of 25 January 1999 concerning the specific programme for research,
p.000007: development and demonstration activities on ‘Quality of life and management of living resources’, and in
p.000007: particular the ethical requirements in footnote (1) of Annex II;
p.000007:
p.000007:
p.000007:
p.000007: (15) http://conventions.coe.int/Treaty/en/Treaties/Html/108.htm (16) OJ L 213, 6.7.1998, pp. 13–21.
p.000007:
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008:
...
p.000020: regard to the Application of Biology and Medicine of 1997 (the ‘Oviedo Convention’) (48) and the
p.000020: additional protocols to the convention (49), the Unesco Universal Declaration on the Human Genome
p.000020: and Human Rights (50) of 1997 and the International Declaration on Human Genetic Data (51) of 2003, the
p.000020: Council for International Organisations of Medical Sciences (CIOMS) International Ethical
p.000020:
p.000020: (45) http://www.ushmm.org/research/doctors/Nuremberg_Code.htm
p.000020: (46) http://www.wma.net/e/ethicsunit/helsinki.htm
p.000020: (47) http://ohsr.od.nih.gov/guidelines/belmont.html
p.000020: (48) http://conventions.coe.int/treaty/en/treaties/html/164.htm
p.000020: (49) http://conventions.coe.int/Treaty/EN/Treaties/Html/168.htm
p.000020: (50) http://portal.unesco.org/fr/ev.php-
p.000020: URL_ID=13177&URL_DO=DO_TOPIC&URL_SECTION=201.html
p.000020: (51) http://portal.unesco.org/en/ev.php- URL_ID=17720&URL_DO=DO_TOPIC&URL_SECTION=201.html
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000021: 21
p.000021:
p.000021:
p.000021: Guidelines for Biomedical Research Involving Human Subjects of 2002 (52), and the Unesco Universal Declaration on
p.000021: Bioethics and Human Rights of 2005 (53).
p.000021: Over the last few years, several international bodies have been established across the world, which give
p.000021: information and guidance in the process of research proposal preparation, application, and definition of standards,
p.000021: both scientific and ethically sound.
p.000021: As noted before, the volume of documents addressing the ethics of hESCs is vast and diverse. Additional
p.000021: information on relevant initiatives in this area may be found, for example, on the following websites: the
p.000021: BioCentre for Bioethics and Public Policy (CBPP) (54), CARE for Europe (55), the International Society for
p.000021: Stem Cell Research (56), and the Nuffield Council on Bioethics (57), along with those of various
p.000021: national institutions (58)(59) and international organisations (60)(61).
p.000021: In addition to the abovementioned ethics guidelines produced by relevant international organisations, in
p.000021: 2006 the International Society for Stem Cell Research (ISSCR) published specific guidelines on hESCs
p.000021: (Guidelines for the conduct of human embryonic stem cell research).
p.000021: The guidelines address the procurement, derivation, banking, distribution, and use of cells and tissues
p.000021: taken from pre-implantation stages of human
p.000021:
p.000021:
p.000021: (52) http://www.cioms.ch/
p.000021: (53) http://portal.unesco.org/shs/en/ev.php-
p.000021: URL_ID=1883&URL_DO=DO_TOPIC&URL_SECTION=201.html
p.000021: (54) http://www.bioethics.ac.uk/
p.000021: (55) http://www.careforeurope.org/
p.000021: (56) http://www.isscr.org/guidelines/
p.000021: (57) http://www.nuffieldbioethics.org/go/ourwork/stemcells/introduction
p.000021: (58) http://www.dfg.de/en/news/press_releases/2006/press_release_2006_60.html
p.000021: (59) UK HFEA, UK Department of Health, UK Stem Cell Initiative:
p.000021: http://www.hfea.gov.uk/cps/rde/xchg/SID-3F57D79B-370119F4/hfea/hs.xsl/295.html,
p.000021: http://www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/StemCell/fs/en,
...
p.000053: cosmétiques, ou en remplacement d'essais sur les animaux. Il convient par conséquent de porter une attention
p.000053: particulière à cette question (voir ci-après le point IV.3.2);
p.000053:
p.000053: • les demandeurs doivent fournir une justification scientifique complète lorsque leurs projets
p.000053: comportent des essais de toxicité de médicaments; cette justification devra établir clairement
p.000053: le type d'informations additionnelles que l'on peut attendre de l'utilisation de CSEH par rapport aux
p.000053: essais établis.
p.000053:
p.000053: Le comité scientifique doit veiller à ce que les chercheurs participant à des projets CSEH du 7e PC
p.000053: collaborent sur le plan national et international afin de limiter au minimum l'utilisation de CSEH dans le
p.000053: cadre de projets financés par le 7e PC et pour mettre en place une synergie de complémentarité plutôt qu'une
p.000053: situation de compétition.
p.000053:
p.000053: IV.2.2. Critères éthiques des projets de recherche dans le cadre du 6e PC Certaines conditions ont déjà été définies
p.000053: dans le cadre du 6e PC pour assurer le respect des exigences éthiques, et celles-ci peuvent être reprises au
p.000053: titre du 7e PC:
p.000053:
p.000053: • les demandeurs doivent prouver de façon explicite que le projet en question répond aux critères
p.000053: réglementaires et doivent indiquer les exigences juridiques et/ou réglementaires applicables du/des pays où la
p.000053: recherche a lieu, conformément à l'article 6, paragraphe 3 (118), du 7e PC. Pour de plus amples informations, voir
p.000053: l'annexe 1;
p.000053:
p.000053:
p.000053:
p.000053: (118) Article 6, paragraphe 3, http://cordis.europa.eu/7PC/ethics-ict_en.html
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000054: 54
p.000054:
p.000054:
p.000054: • les demandeurs doivent indiquer que les CSEH utilisées dans le cadre du projet sont issues d'embryons de
p.000054: FIV non implantés (voir paragraphe suivant sur les droits des donneurs);
p.000054: • les demandeurs doivent fournir des informations sur la protection des données personnelles et de l'anonymat
p.000054: des donneurs d'embryons pour la production de lignées de cellules souches;
p.000054: • les demandeurs doivent fournir des informations sur les conditions de don des embryons (par exemple: aucune
p.000054: incitation financière, nombre d'ovules prélevés, etc.). Afin de garantir la non-commercialisation du corps humain et
p.000054: en accord avec l'article 12 de la directive 2004/23/CE, le GEE estime que pour protéger la liberté de don, le don
p.000054: d'embryons humains ne doit pas comporter d'incitation financière autre que le remboursement des frais
p.000054: encourus.
p.000054:
p.000054: Outre ces conditions, le GEE recommande que le comité d'examen éthique veille à ce que les demandeurs fournissent des
p.000054: informations sur les points énumérés ci-après.
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000055: 55
p.000055:
p.000055:
p.000055: IV.2.3. Critères additionnels pour le 7e PC
p.000055:
p.000055: IV.2.3.1. Utilisation de solutions alternatives aux CSEH
p.000055: En cas de découverte future de solutions alternatives aux CSEH présentant le même potentiel que les
p.000055: cellules souches embryonnaires, il conviendra de prendre en compte au plus vite les implications de ces
p.000055: avancées, pour les aspects tant scientifiques qu'éthiques des projets de recherche basés sur les CSEH.
p.000055:
p.000055: IV.2.3.2. Droits des donneurs
p.000055: Le don d'embryons humains pour la production de CSEH à des fins de recherche pose un dilemme moral, qui résulte du fait
...
p.000057: utilisé pour coder les données doit être expliqué et référencé selon les dispositions applicables (124) (125).
p.000057:
p.000057: IV.2.4. Nécessité d'encourager en permanence la gouvernance publique et le dialogue science-société
p.000057:
p.000057: Indépendamment du consentement et du respect des droits des donneurs, la recherche sur les CSEH nécessite la
p.000057: mise en place de mesures pour favoriser la gouvernance publique et le dialogue science-société en ce qui
p.000057: concerne ses objectifs, réussites et échecs. Des moyens suffisants doivent être établis pour permettre
p.000057: l'accès du public à des informations pertinentes et compréhensibles sur la recherche sur les CSEH dans
p.000057: le cadre du 7e PC, afin de promouvoir et d'atteindre en permanence ces objectifs.
p.000057: Comme l'a indiqué le Conseil de ministres, la Commission soutient la création d'un registre européen
p.000057: des lignées de cellules souches embryonnaires humaines. Ce registre permettra une surveillance des CSEH
p.000057: existant en Europe et favorisera leur utilisation optimale en évitant d'inutiles dérivations de nouvelles lignées de
p.000057: CSEH.
p.000057: Le moment venu, le registre invitera les demandeurs à fournir des données appropriées sur les CSEH. Le
p.000057: registre stockera les données selon des normes scientifiques et éthiques à définir par ses comités consultatifs
p.000057: scientifiques et éthiques récemment formés.
p.000057:
p.000057: (123) Article 12 de la directive 2004/23/CE: «Les États membres s'efforcent de garantir les dons
p.000057: volontaires et non rémunérés de tissus et cellules.»
p.000057: (124) Directive 95/46/CE du Parlement européen et du Conseil du 24 octobre 1995 relative à la
p.000057: protection des personnes physiques à l'égard du traitement des données à caractère personnel et à la libre circulation
p.000057: de ces données.
p.000057: (125) Conventions de bioéthique du Conseil de l'Europe et protocoles additionnels, convention du
p.000057: Conseil de l'Europe pour la protection des personnes à l'égard du traitement automatisé des données à
p.000057: caractère personnel (n° 108).
p.000057:
p.000057:
p.000057:
p.000057:
p.000058: 58
p.000058:
p.000058:
p.000058:
p.000058:
p.000058: En ce qui concerne l'utilisation des lignées de CSEH stockées dans le registre, le GEE formule les recommandations
p.000058: suivantes:
p.000058: • une fois le registre opérationnel, après une période de transition nécessaire, l'utilisation des lignées de
p.000058: CSEH stockées dans le registre devra être conforme aux critères énoncés au point IV.2.3. La
p.000058: Commission devra développer et maintenir activement les moyens nécessaires pour assurer le respect de cette exigence;
p.000058: • les demandeurs devront utiliser des CSEH stockées dans le registre communautaire. La
p.000058: nécessité d'utiliser d'autres lignées de CSEH dans les propositions du 7e PC devra par conséquent
p.000058: être justifiée sur le plan scientifique et éthique;
p.000058: • le registre devra préparer et publier (sur son site internet) des informations sur les CSEH stockées en
p.000058: banque et sur les résultats positifs et négatifs des recherches effectuées sur les lignées de CSEH fournies aux
p.000058: chercheurs. En fin de projet, en plus des données scientifiques, en particulier des informations
p.000058: relatives à la santé, il est également fortement recommandé de publier des informations conviviales et librement
p.000058: accessibles aux citoyens de l'UE sur les activités de recherche en matière de CSEH. Le portail devra si possible
p.000058: intégrer des éléments interactifs.
p.000058:
p.000058: Il incombe aux chercheurs opérant sur le terrain d'informer le public de leurs travaux, mais également de
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| access to healthcare | access to healthcare |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| child | Child |
| children | Child |
| conviction | Religion |
| criminal | criminal |
| difference of opinion | philosophical differences/differences of opinion |
| drug | Drug Usage |
| education | education |
| embryo | embryo |
| ethnicity | Ethnicity |
| family | Motherhood/Family |
| fetus | Fetus/Neonate |
| foetus | Fetus/Neonate |
| foetuses | Fetus/Neonate |
| gender | gender |
| healthy volunteers | Healthy People |
| military | Soldier |
| opinion | philosophical differences/differences of opinion |
| parents | parents |
| party | political affiliation |
| political | political affiliation |
| religious | Religion |
| single | Marital Status |
| stem cells | stem cells |
| union | Trade Union Membership |
| usage | Drug Usage |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| conviction | ['religious'] |
| difference of opinion | ['opinion'] |
| drug | ['usage'] |
| fetus | ['foetus', 'foetuses'] |
| foetus | ['fetus', 'foetuses'] |
| foetuses | ['fetus', 'foetus'] |
| opinion | ['differenceXofXopinion'] |
| party | ['political'] |
| political | ['party'] |
| religious | ['conviction'] |
| usage | ['drug'] |
Trigger Words
capacity
consent
cultural
developing
ethics
harm
justice
protect
protection
risk
sensitive
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input