GAZETTE OFFICIAL GAZETTE OF RS Official Gazette of the Republic of Slovenia Cancellation of documents  TABLE OF CONTENTS  42. Act ratifying the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the use of biology and medicine (Convention on Human Rights in Biomedicine) and the Additional Protocol on the Prohibition of Human Cloning to the Protection of Human Rights and the Dignity of the Human Being in Relation to the Use of Biology and Medicine (MVCPB), page 277. On the basis of the second indent of the first paragraph of Article 107 and the first paragraph of Article 91 of the Constitution of the Republic of Slovenia, I issue DECREE ON THE DECLARATION OF THE LAW ON RATIFICATION OF THE CONVENTION ON THE PROTECTION OF HUMAN RIGHTS AND DIGNITY OF HUMAN BEING IN CONNECTION WITH THE USE OF BIOLOGY AND MEDICINE (CONVENTION ON HUMAN RIGHTS IN CONNECTION WITH BIOMEDICINE) AND THE ADDITIONAL PROTOCOL PROHIBITING THE CLONING OF HUMAN BEINGS TO THE CONVENTION ON THE PROTECTION OF OF HUMAN RIGHTS AND THE DIGNITY OF HUMAN BEING IN CONNECTION WITH THE USE OF BIOLOGY AND MEDICINE (MVCPB) I hereby promulgate the Ratification Act of the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Use of Biology and Medicine (Convention on Human Rights in concerning biomedicine) and the Additional Protocol prohibiting the cloning of human beings to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the use of biology and Medicine (MVCPB), adopted by the National Assembly of the Republic of Slovenia at its session on 24 September 1998. No. 001-22-90 / 98 Ljubljana, 2 October 1998 The President Of the Republic of Slovenia Milan Kucan l. r. THE LAW RATIFICATION OF THE CONVENTION ON THE PROTECTION OF HUMAN RIGHTS AND THE DIGNITY OF HUMAN BEING IN CONNECTION WITH USE OF BIOLOGY AND MEDICINE (CONVENTION ON HUMAN RIGHTS RELATING TO BIOMEDICINE) AND ADDITIONAL PROTOCOL PROHIBITING THE CLONING OF HUMAN BEINGS TO THE CONVENTION ON THE PROTECTION OF HUMAN RIGHTS AND DIGNITY OF HUMAN BEING IN CONNECTION WITH THE USE OF BIOLOGY AND MEDICINE (MVCPB) Article 1 The Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the use of biology and medicine (Convention on Human Rights concluded in Oviedo (Asturias) on 4 April 1997 and the Additional Protocol prohibiting the cloning of human beings to the Convention for the Protection of Human Rights and Dignity of Human Beings concerning the Application of Biology and Medicine, done at Paris on 12 January 1998. Article 2 The Convention and the Additional Protocol shall read in the English original and in the Slovenian translation: CONVENTION FOR THE PROTECTION OF HUMAN RIGHTS AND DIGNITY OF THE HUMAN BEING WITH REGARD TO THE APPLICATION OF BIOLOGY AND MEDICINE: CONVENTION ON HUMAN RIGHTS AND BIOMEDICINE Oviedo, 4. IV. 1997 Preamble The Member States of the Council of Europe, the other States and the European Community signatories hereto, Bearing in mind the Universal Declaration of Human Rights proclaimed by the General Assembly of the United Nations on 10 December 1948; Bearing in mind the Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950; Bearing in mind the European Social Charter of 18 October 1961; Bearing in mind the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights of 16 December 1966; Bearing in mind the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data of 28 January 1981; Bearing also in mind the Convention on the Rights of the Child of 20 November 1989; Considering that the aim of the Council of Europe is the achievement of a greater unity between its members and that one of the methods by which that aim is to be pursued is the maintenance and further realization of human rights and fundamental freedoms; Conscious of the accelerating developments in biology and medicine; Convinced of the need to respect the human being both as an individual and as a member of the human species and recognizing the importance of ensuring the dignity of the human being; Conscious that the misuse of biology and medicine may lead to acts endangering human dignity; Affirming that progress in biology and medicine should be used for the benefit of present and future generations; Stressing the need for international co-operation so that all humanity may enjoy the benefits of biology and medicine; Recognising the importance of promoting a public debate on the questions posed by the application of biology and medicine and the responses to be given thereto; Wishing to remind all members of society of their rights and responsibilities; Taking account of the work of the Parliamentary Assembly in this field, including Recommendation 1160 (1991) on the preparation of a Convention on bioethics; Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to the application of biology and medicine; Have agreed as follows: Chapter I - General provisions Article 1 - Purpose and object Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine. Each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention. Article 2 - Primacy of the human being The interests and welfare of the human being shall prevail over the sole interest of society or science. Article 3 - Equitable access to health care Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality. Article 4 - Professional standards Any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards. Chapter II - Consent Article 5 - General rule An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it. This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks. The person concerned may freely withdraw consent at any time. Article 6 - Protection of persons not able to consent 1. Subject to Articles 17 and 20 below, an intervention may only be carried out on a person who does not have the capacity to consent, for his or her direct benefit. 2. Where, according to law, a minor does not have the capacity to consent to an intervention, the intervention may only be carried out with the authorization of his or her representative or an authority or a person or body provided for by law. The opinion of the minor shall be taken into consideration as an increasingly determining factor in proportion to his or her age and degree of maturity. 3. Where, according to law, an adult does not have the capacity to consent to an intervention because of a mental disability, a disease or for similar reasons, the intervention may only be carried out with the authorization of his or her representative or an authority or a person or body provided for by law. The individual concerned shall as far as possible take part in the authorization procedure. 4. The representative, the authority, the person or the body mentioned in paragraphs 2 and 3 above shall be given, under the same conditions, the information referred to in Article 5. 5. The authorization referred to in paragraphs 2 and 3 above may be withdrawn at any time in the best interests of the person concerned. Article 7 - Protection of persons who have mental disorder Subject to protective conditions prescribed by law, including supervisory, control and appeal procedures, a person who has a mental disorder of a serious nature may be subjected, without his or her consent, to an intervention aimed at treating his or her mental disorder only where, without such treatment, serious harm is likely to result to his or her health. Article 8 - Emergency situation When because of an emergency situation the appropriate consent cannot be obtained, any medically necessary intervention may be carried out immediately for the bene fi t of the health of the individual concerned. Article 9 - Previously expressed wishes The previously expressed wishes relating to a medical intervention by a patient who is not, at the time of the intervention, in a state to express his or her wishes shall be taken into account. Chapter III - Private life and right to information Article 10 - Private life and right to information 1. Everyone has the right to respect for private life in relation to information about his or her health. 2. Everyone is entitled to know any information collected about his or her health. However, the wishes of individuals not to be so informed shall be observed. 3. In exceptional cases, restrictions may be placed by law on the exercise of the rights contained in paragraph 2 in the interests of the patient. Chapter IV - Human genome Article 11 - Non-discrimination Any form of discrimination against a person on grounds of his or her genetic heritage is prohibited. Article 12 - Predictive genetic tests Tests which are predictive of genetic diseases or which serve either to identify the subject as a carrier of a gene responsible for a disease or to detect a genetic predisposition or susceptibility to a disease may be performed only for health purposes or for scientific research linked to health purposes, and subject to appropriate genetic counseling. Article 13 - Interventions on the human genome An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants. Article 14 - Non-selection of sex The use of techniques of medically assisted procreation shall not be allowed for the purpose of choosing a future child’s sex, except where serious hereditary sex-related disease is to be avoided. Chapter V - Scientific research Article 15 - General rule Scienti fi c research in the fi eld of biology and medicine shall be carried out freely, subject to the provisions of this Convention and the other legal provisions ensuring the protection of the human being. Article 16 - Protection of persons undergoing research Research on a person may only be undertaken if all the following conditions are met: i) there is no alternative of comparable effectiveness to research on humans, ii) the risks which may be incurred by that person are not disproportionate to the potential benefits of the research, iii) the research project has been approved by the competent body after independent examination of its scienti mer c merit, including assessment of the importance of the aim of the research, and multidisciplinary review of its ethical acceptability, iv) the persons undergoing research have been informed of their rights and the safeguards prescribed by law for their protection, c) the necessary consent as provided for under Article 5 has been given expressly, specifically and is documented. Such consent may be freely withdrawn at any time. Article 17 - Protection of persons not able to consent to research 1. Research on a person without the capacity to consent as stipulated in Article 5 may be undertaken only if all the following conditions are met: i) the conditions laid down in Article 16, sub-paragraphs i to iv, are fulfilled; ii) the results of the research have the potential to produce real and direct benefit to his or her health; iii) research of comparable effectiveness cannot be carried out on individuals capable of giving consent; iv) the necessary authorization provided for under Article 6 has been given specifically and in writing, and c) the person concerned does not object. 2. Exceptionally and under the protective conditions prescribed by law, where the research has not the potential to produce results of direct bene fi t to the health of the person concerned, such research may be authorized subject to the conditions laid down in paragraph 1, sub-paragraphs i, iii, iv and v above, and to the following additional conditions: i) the research has the aim of contributing, through signi fi cant improvement in the scienti fi c understanding of the individual’s condition, disease or disorder, to the ultimate attainment of results capable of conferring bene fi t to the person concerned or to other persons in the same age category or a ffl icted with the same disease or disorder or having the same condition. ii) the research entails only minimal risk and minimal burden for the individual concerned. Article 18 - Research on embryos in vitro 1. Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2. The creation of human embryos for research purposes is prohibited. Chapter VI - Organ and tissue removal from living donors for transplantation purposes Article 19 - General rule 1. Removal of organs or tissue from a living person for transplantation purposes may be carried out solely for the therapeutic bene fi t of the recipient and where there is no suitable organ or tissue available from a deceased person and no other alternative therapeutic method of comparable effectiveness. 2. The necessary consent as provided for under Article 5 must have been given expressly and specifically either in written form or before an official body. Article 20 - Protection of persons not able to consent to organ removal 1. No organ or tissue removal may be carried out on a person who does not have the capacity to consent under Article 5. 2. Exceptionally and under the protective conditions prescribed by law, the removal of regenerative tissue from a person who does not have the capacity to consent may be authorized provided the following conditions are met: i) there is no compatible donor available who has the capacity to consent, (ii) the recipient is a brother or sister of the donor, iii) the donation must have the potential to be life-saving for the recipient, (iv) the authorization provided for under paragraphs 2 and 3 of Article 6 has been given speci fi cally and in writing, in accordance with the law and with the approval of the competent body, c) the potential donor concerned does not object. Chapter VII - Prohibition of financial gain and disposal of a part of the human body Article 21 - Prohibition of financial gain The human body and its parts shall not, as such, give rise to financial gain. Article 22 - Disposal of a removed part of the human body When in the course of an intervention any part of a human body is removed, it may be stored and used for a purpose other than that for which it was removed, only if this is done in conformity with appropriate information and consent procedures. Chapter VIII - Infringements of the provisions of the Convention Article 23 - Infringement of the rights or principles The Parties shall provide appropriate judicial protection to prevent or to put a stop to an unlawful infringement of the rights and principles set forth in this Convention at short notice. Article 24 - Compensation for undue damage The person who has suffered undue damage resulting from an intervention is entitled to fair compensation according to the conditions and procedures prescribed by law. Article 25 - Sanctions The Parties shall provide for appropriate sanctions to be applied in the event of infringement of the provisions contained in this Convention. Chapter IX - Relation between this Convention and other provisions Article 26 - Restrictions on the exercise of rights 1. No restrictions shall be placed on the exercise of the rights and protective provisions contained in this Convention other than such as are prescribed by law and are necessary in a democratic society in the interest of public safety, for the prevention of crime, for the protection of public health or for the protection of the rights and freedoms of others. 2. The restrictions contemplated in the preceding paragraph may not be placed on Articles 11, 13, 14, 16, 17, 19, 20 and 21. Article 27 - Wider protection None of the provisions of this Convention shall be interpreted as limiting or otherwise a ff ecting the possibility for a Party to grant a wider measure of protection with regard to the application of biology and medicine than is stipulated in this Convention. Chapter X - Public debate Article 28 - Public debate Parties to this Convention shall see to it that the fundamental questions raised by the developments of biology and medicine are the subject of appropriate public discussion in the light, in particular, of relevant medical, social, economic, ethical and legal implications, and that their possible application is made the subject of appropriate consultation. Chapter XI - Interpretation and follow-up of the Convention Article 29 - Interpretation of the Convention The European Court of Human Rights may give, without direct reference to any speci fi c proceedings pending in a court, advisory opinions on legal questions concerning the interpretation of the present Convention at the request of: - the Government of a Party, after having informed the other Parties, - the Committee set up by Article 32, with membership restricted to the Representatives of the Parties to this Convention, by a decision adopted by a two-third majority of votes cast. Article 30 - Reports on the application of the Convention On receipt of a request from the Secretary General of the Council of Europe any Party shall furnish an explanation of the manner in which its internal law ensures the e ff ective implementation of any of the provisions of the Convention. Chapter XII - Protocols Article 31 - Protocols Protocols may be concluded in pursuance of Article 32, with a view to developing, in specific fields, the principles contained in this Convention. The Protocols shall be open for signature by Signatories of the Convention. They shall be subject to ratification, acceptance or approval. A signatory may not ratify, accept or approve Protocols without previously or simultaneously ratifying accepting or approving the Convention. Chapter XIII - Amendments to the Convention Article 32 - Amendments to the Convention 1. The tasks assigned to the Committee in the present article and in Article 29 shall be carried out by the Steering Committee on Bioethics (CDBI), or by any other committee. designated to do so by the Committee of Ministers. 2. Without prejudice to the speci fi c provisions of Article 29, each member State of the Council of Europe, as well as each Party to the present Convention which is not a member of the Council of Europe, may be represented and have one vote in the Committee when the Committee carries out the tasks assigned to it by the present Convention. 3. Any State referred to in Article 33 or invited to accede to the Convention in accordance with the provisions of Article 34 which is not Party to this Convention may be represented on the Committee by an observer. If the European Community is not a Party it may be represented on the Committee by an observer. 4. In order to monitor scienti fi c developments, the present Convention shall be examined within the Committee no later than fi ve years from its entry into force and thereafter at such intervals as the Committee may determine. 5. Any proposal for an amendment to this Convention, and any proposal for a Protocol or for an amendment to a Protocol, presented by a Party, the Committee or the Committee of Ministers shall be communicated to the Secretary General of the Council of Europe and forwarded by him to the member States of the Council of Europe, to the European Community, to any Signatory, to any Party, to any State invited to sign this Convention in accordance with the provisions of Article 33 and to any State invited to accede to it in in accordance with the provisions of Article 34. 6. The Committee shall examine the proposal not earlier than two months after it has been forwarded by the Secretary-General in accordance with paragraph 5. submit the text adopted by a two-thirds majority of the votes cast to the Committee of Ministers for approval. After its approval, this text shall be forwarded to the Parties for ratification, acceptance or approval. 7. Any amendment shall enter into force, in respect of those Parties which have accepted it, on the first day of the month following the expiration of a period of one month after the date on which five Parties, including at least four member States of the Council of Europe, have informed the Secretary General that they have accepted it. In respect of any Party which subsequently accepts it, the amendment shall enter into force on the fi rst day of the month following the expiration of a period of one month after the date on which that Party has informed the Secretary General of its acceptance. Chapter XIV - Final clauses Article 33 - Signature, ratification and entry into force 1. This Convention shall be open for signature by the member States of the Council of Europe, the non-member States which have participated in its elaboration and by the European Community. 2. This Convention is subject to ratification, acceptance or approval. Instruments of ratification, acceptance or approval shall be deposited with the Secretary General of the Council of Europe. 3. This Convention shall enter into force on the day rst day of the month following the expiration of a period of three months after the date on which fi ve States, including at least four member States of the Council of Europe, have expressed their consent to be bound by the Convention in accordance with the provisions of paragraph 2 of the present article. 4. In respect of any Signatory which subsequently expresses its consent to be bound by it, the Convention shall enter into force on the day rst day of the month following the expiration of a period of three months after the date of the deposit of its instrument of ratification, acceptance or approval. Article 34 - Non-member States 1. After the entry into force of this Convention, the Committee of Ministers of the Council of Europe may, after consultation of the Parties, invite any non-member State of the The Council of Europe to accede to this Convention by a decision taken by the majority provided for in Article 20, sub-paragraph d, of the Statute of the Council of Europe, and by the unanimous vote of the representatives of the Contracting States entitled to sit on the Committee of Ministers. 2. In respect of any acceding State, the Convention shall enter into force on the fi rst day of the month following the expiration of a period of three months after the date of deposit of the instrument of accession with the Secretary General of the Council of Europe. Article 35 - Territories 1. Any Signatory may, at the time of signature or when depositing its instrument of ratification, acceptance or approval, specify the territory or territories to which this Convention shall apply. Any other State may formulate the same declaration when depositing its instrument of accession. 2. Any Party may, at any later date, by a declaration addressed to the Secretary General of the Council of Europe, extend the application of this Convention to any other territory speci fi ed in the declaration and for whose international relations it is responsible or on whose behalf it is authorized to give undertakings. In respect of such territory the Convention shall enter into force on the first day of the month following the expiration of a period of three months after the date of receipt of such declaration by the Secretary-General. 3. Any declaration made under the two preceding paragraphs may, in respect of any territory speci fi ed in such declaration, be withdrawn by a noti fi cation addressed to the Secretary General. The withdrawal shall become e ff ective on the day rst day of the month following the expiration of a period of three months after the date of receipt of such noti fi cation by the Secretary General. Article 36 - Reservations 1. Any State and the European Community may, when signing this Convention or when depositing the instrument of ratification, acceptance, approval or accession, make a reservation in respect of any particular provision of the Convention to the extent that any law then in force in its territory is not in conformity with the provision. Reservations of a general character shall not be permitted under this article. 2. Any reservation made under this article shall contain a brief statement of the relevant law. 3. Any Party which extends the application of this Convention to a territory mentioned in the declaration referred to in Article 35, paragraph 2, may, in respect of the territory concerned, make a reservation in accordance with the provisions of the preceding paragraphs. 4. Any Party which has made the reservation mentioned in this Article may withdraw it by means of a declaration addressed to the Secretary General of the Council of Europe. The withdrawal shall become effective on the first day of the month following the expiration of a period of one month after the date of its receipt by the Secretary General. Article 37 - Denunciation 1. Any Party may at any time denounce this Convention by means of a notification addressed to the Secretary General of the Council of Europe. 2. Such denunciation shall become effective on the first day of the month following the expiration of a period of three months after the date of receipt of the notification by the Secretary General. Article 38 - Notifications The Secretary General of the Council of Europe shall notify the member States of the Council, the European Community, any Signatory, any Party and any other State which has been invited to accede to this Convention of: a) any signature; b) the deposit of any instrument of ratification, acceptance, approval or accession; c) any date of entry into force of this Convention in accordance with Articles 33 or 34; d) any amendment or Protocol adopted in accordance with Article 32, and the date on which such an amendment or Protocol enters into force; (e) any declaration made under the provisions of Article 35; f) any reservation and withdrawal of reservation made in pursuance of the provisions of Article 36; g) any other act, notification or communication relating to this Convention. In witness whereof the undersigned, being duly authorized thereto, have signed this Convention. Done at Oviedo (Asturias), this 4th day of April 1997, in English and French, both texts being equally authentic, in a single copy which shall be deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe shall transmit certi copies ed copies to each member State of the Council of Europe, to the European Community, to the non-member States which have participated in the elaboration of this Convention, and to any State invited to accede to this Convention. ADDITIONAL PROTOCOL to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings Paris, 12. January 1998 The member States of the Council of Europe, the other States and the European Community Signatories to this Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, Noting scientific developments in the field of mammal cloning, particularly through embryo splitting and nuclear transfer; Mindful of the progress that some cloning techniques themselves may bring to scientific knowledge and its medical application; Considering that the cloning of human beings may become a technical possibility; Having noted that embryo splitting may occur naturally and sometimes result in the birth of genetically identical twins; Considering, however, that the instrumentalization of human beings through the deliberate creation of genetically identical human beings is contrary to human dignity and thus constitutes a misuse of biology and medicine; Considering also the serious difficulties of a medical, psychological and social nature that such a deliberate biomedical practice might imply for all the individuals involved; Considering the purpose of the Convention on Human Rights and Biomedicine, in particular the principle mentioned in Article 1 aiming to protect the dignity and identity of all human beings, Have agreed as follows: Article 1 1 Any intervention seeking to create a human being genetically identical to another human being, whether living or dead, is prohibited. 2 For the purpose of this article, the term human being “genetically identical” to another human being means a human being sharing with another the same nuclear gene set. Article 2 No derogation from the provisions of this Protocol shall be made under Article 26, paragraph 1, of the Convention. Article 3 As between the Parties, the provisions of Articles 1 and 2 of this Protocol shall be regarded as additional articles to the Convention and all the provisions of the Convention shall apply accordingly. Article 4 This Protocol shall be open for signature by Signatories to the Convention. It is subject to ratification, acceptance or approval. A Signatory may not ratify, accept or approve this Protocol unless it has previously or simultaneously rati fi ed, accepted or approved the Convention. Instruments of ratification, acceptance or approval shall be deposited with the Secretary General of the Council of Europe. Article 5 1 This Protocol shall enter into force on the fi rst day of the month following the expiration of a period of three months after the date on which fi ve States, including at least four member States of the Council of Europe, have expressed their consent to be bound by the Protocol in accordance with the provisions of Article 4. 2 In respect of any Signatory which subsequently expresses its consent to be bound by it, the Protocol shall enter into force on the fi rst day of the month following the expiration of a period of three months after the date of the deposit of the instrument of ratification, acceptance or approval. Article 6 1 After the entry into force of this Protocol, any State which has acceded to the Convention may also accede to this Protocol. 2 Accession shall be e ff ected by the deposit with the Secretary General of the Council of Europe of an instrument of accession which shall take e ff ect on the fi rst day of the month following the expiration of a period of three months after the date of its deposit. Article 7 1 Any Party may at any time denounce this Protocol by means of a notification addressed to the Secretary General of the Council of Europe. 2 Such denunciation shall become e ff ective on the following rst day of the month following the expiration of a period of three months after the date of receipt of such noti fi cation by the Secretary General. Article 8 The Secretary General of the Council of Europe shall notify the member States of the Council of Europe, the European Community, any Signatory, any Party and any other State which has been invited to accede to the Convention of: a) any signature; b) the deposit of any instrument of ratification, acceptance, approval or accession; c) any date of entry into force of this Protocol in accordance with Articles 5 and 6; d) any other act, notification or communication relating to this Protocol. In witness whereof the undersigned, being duly authorized thereto, have signed this Protocol. Done at Paris, this twelfth day of January 1998, in English and in French, both texts being equally authentic, in a single copy which shall be deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe shall transmit certi fi ed copies to each member State of the Council of Europe, to the non-member States which have participated in the elaboration of this Protocol, to any State invited to accede to the Convention and to the European Community. CONVENTION ON THE PROTECTION OF HUMAN RIGHTS AND THE DIGNITY OF HUMAN BEING IN CONNECTION WITH THE USE OF BIOLOGY AND MEDICINE: CONVENTION ON HUMAN RIGHTS RELATING TO BIOMEDICINE Oviedo, 4. IV. 1997 Preamble The member States of the Council of Europe, the other States and the European Community, signatory hereto, have agreed Having regard to the Universal Declaration of Human Rights, proclaimed by the United Nations General Assembly on 10 December 1948; Having regard to the Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950; Having regard to the European Social Charter of 18 October 1961; Having regard to the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights of 16 December 1966; Having regard to the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data of 28 January 1981; also having regard to the Convention on the Rights of the Child of 20 November 1989; Considering that the aim of the Council of Europe is to establish a closer link between its members and that one of the ways to achieve this objective is to maintain and continue to pursue human rights and fundamental freedoms; whereas they are aware of the accelerating development in biology and medicine; Convinced of the need to respect man as an individual and as a member of the human race, and recognizing the importance of ensuring the dignity of the human being; whereas they are aware that the inappropriate use of biology and medicine could lead to acts that would endanger human dignity; whereas they argue that advances in biology and medicine must be used for the benefit of present and future generations; whereas they emphasize the need for international cooperation so that all humanity can benefit from biology and medicine; Whereas they are aware of the importance of stimulating public debate on the questions raised in connection with the use of biology and medicine and on the answers to be given to them; Desiring to remind all members of society of their rights and responsibilities; having regard to the work of the Parliamentary Assembly in this area, including Recommendation no. 1160 (1991) on the preparation of a convention on bioethics; Determined to take the necessary measures with regard to the application of biology and medicine to protect human dignity and the fundamental rights and freedoms of the individual, Have agreed as follows: Chapter I - General provisions Article 1 - purpose and subject The Contracting Parties to this Convention shall protect the dignity and identity of all human beings and shall guarantee to everyone, without discrimination, respect for their mental and physical integrity, and other rights and fundamental freedoms relating to the use of biology and medicine. Each Contracting Party shall adopt in its internal legislation the measures necessary to implement the provisions of this Convention. Article 2 - the primacy of the human being The benefits and concerns of man must outweigh the exclusive benefits of society or science. Article 3 - equitable access to health care The Parties shall, taking into account medical needs and available resources, take appropriate measures to ensure equitable access to health care within their jurisdiction. protection of adequate quality. Article 4 - professional norms Every medical procedure, including research, must be performed in accordance with professional duties and norms. II. chapter - consent Article 5 - general rule A medical procedure may be performed only after the person concerned has been informed of it and has voluntarily consented to it. This person should be instructed in advance about the purpose and nature of the intervention as well as its consequences and risks. The person concerned may freely withdraw the consent at any time. Article 6 - protection of persons who are unable to consent 1. Subject to Articles 17 and 20, an intervention may be carried out on a person who is unable to consent only for his or her direct benefit. 2. Where a minor is not legally able to consent to the intervention, the intervention may be carried out only with the permission of his or her representative or institution or person or body, as provided for in by law. The opinion of a minor is considered to be an increasingly decisive factor in proportion to his or her age and level of maturity. 3. Where an adult is unable by law to consent to the intervention due to mental incapacity, illness or similar reasons, the intervention may be carried out only with the permission of his or her representative or institution or person or body as provided by law. The individual concerned must be involved as far as possible in the authorization process. 4. The representative, institution, person or body referred to in paragraphs 2 and 3 of this Article shall be instructed under the same conditions as referred to in Article 5. 5. The authorization provided for in paragraphs 2 and 3 of this Article may be revoked at any time for the benefit of the person concerned. Article 7 - protection of persons with mental disorders A person with a severe mental disorder may, without his or her consent, be treated for the purpose of treating the disorder only if failure to treat him or her is likely to cause significant harm. her health; in doing so, the protective conditions prescribed by law, including procedures for supervision, control and appeal, must be observed. Article 8 - emergencies Where, due to an emergency, it is not possible to obtain adequate consent, any medically necessary intervention may be carried out immediately for the benefit of the health of the individual concerned. Article 9 - previously expressed wishes The wishes previously expressed by the patient regarding the medical procedure, who are not able to express their will at the time of the procedure, are taken into account. III. chapter - privacy and the right to information Article 10 - Privacy and the right to information 1. Everyone has the right to respect for his or her privacy when it comes to his or her health. 2. Everyone has the right to know of any information obtained concerning his health. However, the individual's wish not to be told this information must also be respected. 3. Exceptionally, the exercise of the rights referred to in paragraph 2 of this Article may be legally restricted for the benefit of the patient. IV. chapter - the human genome Article 11 - non-discrimination Any form of neglect of an individual on the basis of his genetic heritage is prohibited. Article 12 - predictive genetic testing Investigations that may predict hereditary diseases or make it possible to determine the carrier of the gene responsible for the disease or to detect a genetic predisposition or susceptibility to the disease may be performed only for medical purposes or for scientific research for medical purposes and only with appropriate genetic counseling. Article 13 - Interventions on the human genome An operation aimed at altering the human genome may only be performed for preventive, diagnostic or therapeutic purposes, and only if its purpose is not to introduce any changes in the genome of the offspring. Article 14 - Prohibition of gender selection Medical assisted reproduction methods should not be used to select the sex of the unborn child, unless this is intended to avoid severe sex-related inherited diseases. Chapter V - Scientific Research Article 15 - general rule Scientific research in the field of biology and medicine is free subject to the provisions of this Convention and other legal provisions ensuring the protection of man. Article 16 - protection of persons on whom research is carried out Studies in humans may only be performed if all of the following conditions are met: i) that human research cannot be replaced by another, similarly successful study, ii) that the risks to which the person may be exposed are not disproportionate to the potential benefits of the research, iii) that the research design has been approved by the competent authority after having independently examined its scientific value, considered the relevance of the research objective and assessed in the light of several different disciplines its ethical acceptability, iv) that the person on whom the research is to be conducted is aware of his or her rights and guarantees provided by law for his or her protection, v) that the consent provided for in Article 5 has been given explicitly, specifically for that purpose and is documented. This consent may be freely revoked at any time. Article 17 - protection of persons who are not able to consent to the research 1. A survey of a person who is unable to consent in accordance with Article 5 may be carried out only if all of the following conditions are met: i) that the conditions set out in subparagraphs i) to iv) of Article 16 are met, ii) that the results of the research can be expected to have real and immediate benefits for its health, iii) that comparably successful research cannot be performed on persons who are able to consent, iv) that the authorization provided for in Article 6 has been granted specifically for that purpose and in writing; and v) that the person concerned does not object. 2. Exceptionally and under the protective conditions prescribed by law, research may be permitted from the results of which no direct benefit to the health of the person concerned if the conditions set out in subparagraphs i), iii), iv) and v) of the first paragraph of this Article and the following additional conditions are met: i) that the aim of research, through a significantly better scientific understanding of an individual's condition, disease or disorder, is to contribute to findings that may ultimately benefit the person concerns whether other persons of the same age group or persons who have the same disease or disorder or are in the same condition, ii) that the research represents a minimum hazard and a minimum burden for the person concerned. Article 18 - In vitro embryo research 1. Where the law allows research on embryos outside the mother's body (in vitro), it must provide adequate protection for the embryo. 2. The creation of human embryos for research purposes is prohibited. VI. Chapter - removal of organs and living tissues from donors for transplantation Article 19 - general rule 1. Organs or tissues may be removed from a living donor for transplantation only for the treatment of the recipient and where no suitable organ or tissue of the deceased person or any another possible treatment that would be comparatively successful. 2. The necessary consent provided for in Article 5 must be given explicitly and specifically for that purpose, either in writing or before an official body. Article 20 - protection of persons who are not able to consent to the removal of an organ 1. An organ or tissue may not be seized from a person who is unable to consent in accordance with Article 5. 2. Exceptionally and under the protective conditions prescribed by law, the removal of renewable tissue may be permitted to a person who is unable to consent if the following conditions are met: i) that no biologically suitable donor is available who is able to consent, ii) that the recipient is the donor's brother or sister, iii) that it is a donation that can save the life of the recipient, iv) that the permit provided for in paragraphs 2 and 3 of Articles 6 has been given specifically for this purpose and in writing in accordance with the law and with the approval of the competent authority; and v) that the potential donor does not object. VII. chapter - the prohibition of obtaining material gain and disposing of parts of the human body Article 21 - Prohibition of obtaining material gain The human body and its parts must not in themselves be subject to the acquisition of material gain. Article 22 - Disposal of the deprived part of the human body Where a part of the human body has been removed in an operation, it may be stored and used for a purpose other than that taken only if it is done in accordance with the relevant teaching and assent procedures. VIII. Chapter - violation of the provisions of the Convention Article 23 - violation of rights or principles The Parties shall provide adequate judicial protection for the immediate prevention or cessation of unlawful violations of the rights and principles set forth in this Convention. Article 24 - compensation for unjustified damage A person who has suffered unjustified damage as a result of the intervention is entitled to fair compensation under the conditions and in the manner prescribed by law. Article 25 - sanctions The Contracting Parties shall provide for appropriate sanctions to be applied in the event of a violation of the provisions of this Convention. IX. Chapter - the relationship between this Convention and other regulations Article 26 - Restrictions on the exercise of rights 1. The exercise of the rights and safeguard provisions contained in this Convention may be limited only by such limitations as are prescribed by law and are in a democratic society. necessary for public safety, the prevention of crime, the protection of human health or the protection of the rights and freedoms of others. 2. The restrictions referred to in the preceding paragraph of this Article may not be applied to Articles 11, 13, 14, 16, 17, 19, 20 and 21. Article 27 - broader protection Nothing in the Convention shall be construed to limit or otherwise affect the ability of a Party to provide wider protection with respect to the use of biology and medicine as prescribed by this Convention. Chapter X - Public Debate Article 28 - public debate The Parties to the Convention shall ensure an appropriate public debate on the fundamental issues arising from the developments in biology and medicine, in particular from the medical, social, economic, ethical and legal aspects and also for appropriate consultation on their possible use. XI. Chapter - Interpretation and monitoring of the implementation of the Convention Article 29 - Interpretation of the Convention The European Court of Human Rights may - without direct reference to a specific case pending before any court - give advisory opinions on legal questions relating to the interpretation of the Convention, at the request of: - the Government of a Contracting Party, after giving notice to the other Contracting Party, - a committee established under Article 32, composed only of representatives of the Parties to the Convention, on the basis of a decision taken by a two-thirds majority of the votes cast. Article 30 - Reports on the implementation of the Convention Each Party shall, at the request of the Secretary General of the Council of Europe, explain how its national legislation ensures the effective implementation of any provision of conventions. XII. chapter - protocols Article 31 - protocols In accordance with the provisions of Article 32, protocols may be adopted with the aim of developing in individual areas the principles contained in the Convention. The protocols will be available for signature by the signatories to the Convention. They need to be ratified, accepted or approved. A Party shall not ratify, accept or approve protocols unless it has previously or simultaneously ratify, adopt or approve conventions. XIII. Chapter - Amendments to the Convention Article 32 - Amendments to the Convention 1. The tasks assigned to the "Committee" under this Article and under Article 29 shall be carried out by the Bioethics Steering Committee (CDBI) or any other committee designated by the Committee of Ministers. 2. Subject to the special provisions of Article 29, any member State of the Council of Europe, as well as any Contracting Party to the Convention which is not a member of the Council of Europe, may have its representative and one vote in the committee if that committee carries out the tasks entrusted to it by the Convention. 3. Any State referred to in Article 33 or any State which has been invited to accede to the Convention in accordance with the provisions of Article 34 and which is not a Party to the Convention may be represented on the Committee. observer. If the European Community is not a Contracting Party, it may be represented on the committee by an observer. 4. In order to follow developments in science, the Committee shall reassess the relevance of the Convention no later than five years after its entry into force, and thereafter at such intervals as the Committee may determine. 5. Any proposal to amend the Convention as well as any proposal for a protocol or to amend a protocol submitted by a Party, a committee or a Committee of Ministers shall be communicated the Secretary General of the Council of Europe, who shall forward it to the member States of the Council of Europe, to the European Community, to any signatory, to any Contracting Party, to any State invited to the signing of the Convention in accordance with the provisions of Article 33, and any State invited to accede to the Convention in accordance with the provisions of Article 34. 6. The Committee shall consider the proposal at least two months after receiving it from the Secretary-General in accordance with paragraph 5 of this article. The committee shall submit the text adopted by a two-thirds majority of the votes cast, for approval by the Committee of Ministers. After its approval, the text shall be communicated to the Parties for ratification, acceptance or approval. 7. For those Contracting Parties which have accepted the amendment, it shall enter into force on the first day of the month following the expiration of a period of one month after the date on which five Contracting Parties, of which at least four member States of the Council of Europe, informed the Secretary General that they had accepted it. For each Contracting Party which subsequently accepts the amendment, it shall enter into force on the first day of the month following the expiration of a period of one month after the date of its notification to the Contracting Party. Secretary-General to adopt it. XIV. Chapter - Final Provisions Article 33 - Signature, ratification and entry into force 1. This Convention shall be open for signature by the member States of the Council of Europe, the non-member States which have participated in its elaboration and the European Community. 2. The Convention is subject to ratification, acceptance or approval. Instruments of ratification, acceptance or approval shall be deposited with the Secretary General of the Council of Europe. 3. The Convention shall enter into force on the first day of the month following the expiration of a period of three months after the date on which five States, at least four of which are members of the Council of Europe, have agreed to the Convention shall be binding in accordance with the provisions of paragraph 2 of this Article. 4. For each signatory which subsequently agrees to be bound by this Convention, this Convention shall enter into force on the first day of the month following the expiration of a period of three months after the date of deposit of its instrument of deposit. ratification, acceptance or approval. Article 34 - Non-member countries 1. After the entry into force of the Convention, the Committee of Ministers of the Council of Europe may, after consulting the Contracting Parties, invite any non-member State of the Council of Europe to accede to this Convention. Convention, on the basis of a decision taken by a majority provided for in article 20, paragraph d), of the Statute of the Council of Europe, and by a unanimous decision of the representatives of the Contracting States the right to be represented on the Committee of Ministers. 2. For each State which accedes to the Convention, it shall enter into force on the first day of the month following the expiration of a period of three months after the date of deposit of the instrument of accession with the Secretary-General. Council of Europe. Article 35 - territories of application 1. Any Party may, at the time of signature or when depositing its instrument of ratification, acceptance or approval, specify the territory or territories to which this Convention shall apply. Each another country may make the same declaration when depositing its instrument of accession. 2. Any Party may, at any later date, by a declaration addressed to the Secretary General of the Council of Europe, extend the application of this Convention to any other territory specified in the Convention. in a statement and for whose international relations it is responsible or on whose behalf it is authorized to assume obligations. For such territory, the Convention shall enter into force on the first day of that month it shall expire three months after the date on which the Secretary-General has received such declaration. 3. Any declaration made under the two preceding paragraphs may, in respect of any territory specified in such declaration, be withdrawn by a notification addressed to the Secretary General. Withdrawal begins shall take effect on the first day of the month following the expiration of a period of three months after the date of receipt of such notification by the Secretary General. Article 36 - reservations 1. Any State and the European Community may, at the time of signature or when depositing its instrument of ratification, acceptance, approval or accession, enter a reservation in respect of any provision of the Convention in so far as any law in force in its territory at that time is incompatible with this provision. General reservations are not permitted under this article. 2. Any reservation made in accordance with this article shall contain a brief excerpt of the relevant law. 3. Any Contracting Party which extends the application of the Convention to the territory referred to in the declaration referred to in article 35, paragraph 2, may enter a reservation in respect of that territory in accordance with the provisions of the preceding paragraphs. paragraphs. 4. Any Party which has made a reservation in accordance with this article may withdraw it by means of a declaration addressed to the Secretary General of the Council of Europe. The withdrawal shall take effect on the first day the month following the expiration of a period of one month after the date of receipt of such declaration by the Secretary General. Article 37 - termination 1. Any Party may, at any time, denounce this Convention by means of a notification addressed to the Secretary General of the Council of Europe. 2. Such denunciation shall become effective on the first day of the month following the expiration of a period of three months after the date of receipt of the notification by the Secretary General. Article 38 - notifications The Secretary General of the Council of Europe shall notify the member States of the Council, the European Community, any signatory, any Contracting Party and any other State invited to acceding to the Convention on: a) any signature, b) the deposit of any instrument of ratification, acceptance, approval or accession, c any date of entry into force of this Convention in accordance with Article 33 or 34, d any amendment or protocol adopted in accordance with article 32 and the date of entry into force of that amendment or protocol, e any declaration made in pursuance of the provisions of Article 35; f) any reservation made and the reservation lifted pursuant to the provisions of Article 36, g) any other act, notification or communication relating to this Convention. In witness whereof the undersigned, being duly authorized thereto, have signed this Convention. Done at Oviedo (Asturias) on 4 April 1997 in English and in French, both texts being equally authentic, in a single copy which shall be deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe shall transmit certified copies to each member State of the Council of Europe, to the European Community, to the non-member States which have participated in the elaboration of the Convention and to each a country invited to accede to this Convention. ADDITIONAL PROTOCOL on the prohibition of the cloning of human beings into the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to use of biology and medicine Paris, January 12, 1998 The member States of the Council of Europe, the other States and the European Community, signatories to this Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being concerning the use of biology and medicine, Observe scientific developments in the field of mammalian cloning, in particular through embryo fission and nuclear transfer, Recognizing the progress that certain cloning techniques may in themselves contribute to scientific knowledge and its application in medicine, take into account that human cloning may become technically possible, have found that embryo cleavage can occur naturally and sometimes results in the birth of genetically identical twins, take into account, however, that the exploitation of human beings by deliberately creating genetically identical humans is contrary to human dignity and therefore constitutes an abuse of biology and medicine, also take into account the serious medical, psychological and social problems that such deliberate biomedical practices could cause to all individuals concerned, take into account the purpose of the Convention on Human Rights with regard to biomedicine, in particular the principle set out in Article 1, which aims to protect the dignity and identity of all human beings, and Have agreed as follows: Article 1 1. Any intervention aimed at creating a human being who is genetically identical to another human being, living or dead, is prohibited. 2. For the purposes of this Article, the term human being, "genetically identical" to another human being, means that they both have the same nuclear genome. Article 2 Restrictions on the provisions of this Protocol in accordance with article 26, paragraph 1, of the Convention are not permitted. Article 3 The Contracting Parties shall take into account the provisions of Articles 1 and 2 of this Protocol as additional articles to the Convention and therefore all the provisions of the Convention shall apply. Article 4 The Protocol shall be open for signature by the States Parties to the Convention. It needs to be ratified, accepted or approved. A Party may not ratify, accept or approve this Protocol, unless earlier or has not simultaneously ratified, accepted or approved the Convention. Instruments of ratification, acceptance or approval shall be deposited with the Secretary General of the Council of Europe. Article 5 1. This Protocol shall enter into force on the first day of the month following the expiration of a period of three months after the date on which five States, at least four of which are members of the Council of Europe, have agreed to shall be bound by this Protocol in accordance with the provisions of Article 4. 2. For each signatory which subsequently agrees to be bound by this Protocol, this Protocol shall enter into force on the first day of the month following the expiration of a period of three months after the date of deposit of the instrument of ratification. acceptance or approval. Article 6 1. After the entry into force of this Protocol, any State which has acceded to the Convention may also accede to this Protocol. 2. Accession shall be effected by the deposit of an instrument of accession with the Secretary General of the Council of Europe, which shall enter into force on the first day of the month following the expiration of a period of three months after that date. depositing such a document. Article 7 1. Any Party may, at any time, denounce this Protocol by means of a notification addressed to the Secretary General of the Council of Europe. 2. Such denunciation shall become effective on the first day of the month following the expiration of a period of three months after the date of receipt of such notification by the Secretary General. Article 8 The Secretary General of the Council of Europe shall notify the member States of the Council of Europe, the European Community, any signatory, any Contracting Party and any other State which has been invited to accede to the Convention on: a) any signature, b) the deposit of any instrument of ratification, acceptance, approval or accession, c any date of entry into force of this Protocol in accordance with Articles 5 and 6, d) any other act, notification or communication relating to this Protocol. In witness whereof the undersigned, being duly authorized thereto, have signed this Protocol. Done at Paris, this 12th day of January 1998, in English and in French, both texts being equally authentic, in a single copy which shall be deposited in the archives of the Council of Europe. General the Secretary of the Council of Europe shall transmit certified copies to each member State of the Council of Europe, to the non-member States which have participated in the elaboration of this Protocol and to any State invited, to accede to the Convention, and the European Community. Article 3 The Ministry of Health is responsible for the implementation of the Convention and the Additional Protocol. Article 4 This Act shall enter into force on the day following its publication in the Official Gazette of the Republic of Slovenia - International Treaties. No. 500-01 / 98-8 / 1 Ljubljana, 24 September 1998 The President Of the National Assembly Of the Republic of Slovenia Janez Podobnik, Ph.D. med. l. r.  TABLE OF CONTENTS TOP Stay informed about all our news, promotions and events. 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