Convention for the Protection of Human Rights and Human Dignity
beings regarding the application of biology and medicine in connection
transplants of organs and tissues of human origin
Newspaper - International Treaties ", No. XX / 03, XX / 06)
CROATIAN PARLIAMENT
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Pursuant to Article 88 of the Constitution of the Republic of Croatia, I hereby
DECISION
ON DECLARING THE LAW
FUNDAMENTAL DISTRIBUTION
APPROVAL OF THE CONVENTION ON PROTECTION
A - ORGANIZATION I
THE ORGANIZATION OF RH HUMAN RIGHTS AND Dignity
B - JUDICIAL HUMAN BEING IN APPLICATION
C - OWNERSHIP LAW
RELATIONS, FAMILY LAW
BIOLOGY AND MEDICINE: CONVENTIONS ON
D - LABOR AND SOCIAL HUMAN RIGHTS AND BIOMEDICINE,
RIGHT
ADDITIONAL PROTOCOL WITH
E - CONVERT,
PRIVATIZATION, TRADE CONVENTION ON HUMAN PROTECTION
SOCIETIES
F - ECONOMIC
HUMAN RIGHTS AND DIGNITIES
ACTIVITIES OF BEING IN APPLICATION OF BIOLOGY I
G - PUBLIC FINANCING
THE NEED FOR CLONING PROHIBITION MEDICINE
H - CONTROL AND RECORD OF HUMAN BEINGS AND ADDITIONAL
BUSINESS
I - BANKING AND MONETARY
PROTOCOLS TO THE CONVENTION ON PROTECTION
HUMAN RIGHTS AND DIGNITY SYSTEM
J - INSURANCE
THE HUMAN BEING IN APPLICATION
K - EDUCATION, SCIENCE,
CULTURE, SPORT OF BIOLOGY AND MEDICINE, RELATED
X - REGULATIONS ON TAKING OVER THE BODY AND TISSUE TREATMENTS
REGULATIONS FROM FIG. I J.
OTHER COURT PRACTICE
HUMAN ORIGIN
DECISIONS AND JUDGMENTS
Of the EUROPEAN COURT OF JUSTICE I hereby declare the Law on Ratification of the Convention for the Protection of Human Rights i
HUMAN RIGHTS The dignity of the human being with respect to the application of biology and medicine: The Convention on the
Human Rights and Biomedicine, Additional Protocol to the Convention on Protection
human rights and the dignity of the human being with respect to the application of biology and
medicine on the prohibition of cloning of human beings and the Additional Protocol to the Convention on
the protection of human rights and the dignity of the human being with respect to the application of biology and
medicine, regarding the transplantation of organs and tissues of human origin, which he brought
Croatian Parliament at its session of 14 July 2003
No: 01-081-03-2606 / 2
Zagreb, 16 July 2003
The President
Of the Republic of Croatia
Stjepan Mesic, v. r.
LAW
APPROVAL OF THE CONVENTION
PROTECTION OF HUMAN RIGHTS AND
Dignities of the human being in
APPLICATION OF BIOLOGY I
MEDICINE: HUMAN CONVENTIONS
RIGHTS AND BIOMEDICINE,
ADDITIONAL PROTOCOL WITH
CONVENTION ON THE PROTECTION OF HUMANS
HUMAN RIGHTS AND DIGNITIES
BEING IN VIEW OF APPLIED BIOLOGY I
CLONING PROHIBITION MEDICINE
HUMAN BEINGS
AND THE ADDITIONAL PROTOCOL WITH
CONVENTION ON THE PROTECTION OF HUMANS
HUMAN RIGHTS AND DIGNITIES
BEING IN VIEW OF APPLIED BIOLOGY I
MEDICINE RELATING TO TRANSFERS
BODIES AND TISSUES OF HUMAN ORIGIN
Article 1
The Convention for the Protection of Human Rights and Dignity of the Human Being is hereby approved
on the application of biology and medicine: the Convention on Human Rights and
biomedicine, done at Oviedo, 4 April 1997, in the English version and
French, which entered into force on 1 December 1999.
The Additional Protocol to the Convention for the Protection of Human Rights and
the dignity of the human being with respect to the application of biology and prohibition medicine
cloning human beings, done at Paris, 12 January 1998, in the original at
English and French, effective March 1, 2001.
The Additional Protocol to the Convention for the Protection of Human Rights and
the dignity of the human being with respect to the application of biology and medicine in connection
transplantation of organs and tissues of human origin, done at Strasbourg, 24.
January 2002, in the English and French languages.
Article 2
The text of the Convention and the additional protocols referred to in Article 1 of this Law, in the original
in English, and translated into Croatian reads:
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
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
United Nations General Assembly 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 it
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
the aim is to be pursued with 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 securing the
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 issues
possession 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 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
The Parties to this Convention shall protect the dignity and identity of all human beings
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 the necessary measures to give effect to its internal law
the provisions of this Convention.
Article 2.
PRIMACY OF THE HUMAN BEING
The interests and welfare of the human being will 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
compliance 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 should be given appropriate information beforehand as to the purpose
and the nature of the intervention as well as 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 should be taken into account 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 mental disability, a disease or for similar reasons, the
intervention may only be carried out with the authorization of his or her
a representative or an authority or a person or body provided for by law.
The individual concerned shall be as far as possible to take part in the authorization
procedures.
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 A 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 directed at
treating his or her mental disorder only where, without such treatment, serious
harm is likely to result in his or her health.
Article 8.
EMERGENCY SITUATION
When due to an emergency the appropriate consent cannot be
obtained, 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 previously expressed wishes related to medical intervention by a patient
who is not, at the time of intervention, in a state to express his or her wishes
will 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 invited to know any information collected about his or her health.
However, the wishes of individuals are not to be informed should 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 the grounds of his or her genetic
heritage is prohibited.
Article 12.
PREDICTIVE GENETIC TESTS
Tests that are predictive of genetic diseases or which serve either to identify
the subject as a carrier of a gene responsible for a disease or for detecting a genetic
predisposition or susceptibility to a disease may be performed solely for health
purposes or for scientific research related 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 purpose is not to
introduce any modification in the genome of any descendants.
Article 14.
NON-SELECTION OF SEX
The use of medically assisted procreation techniques should not be allowed for
the purpose of choosing a future child's sex, except where serious hereditary
sex-related illness is to be avoided.
Chapter V.
SCIENTIFIC RESEARCH
Article 15.
GENERAL RULE
Scientific research in the field of biology and medicine should be carried out freely,
subject to the provisions of this Convention and 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 of the following conditions are
met:
i. there are no alternatives to comparable effectiveness to research on humans,
ii. the risks that may be incurred by that person are not disproportionate to the
the potential benefits of research,
iii. the research project has been approved by the competent body after
independent examination of its scientific merit, including assessment of the
the importance of the purpose of research, and the multidisciplinary review of its ethical
acceptability,
iv. Persons undergoing research have been informed of their rights and rights
safeguards prescribed by law for their protection,
v. 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 of 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 benefits
to his or her health,
iii. research on 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
v. the person concerned does not object.
2. Exceptionally and under the protective conditions prescribed by law, where
The research has no potential to produce direct benefit results
the health of the person concerned, such research may be an 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. research has the goal of contributing, through significant improvement in
the scientific understanding of the individual condition, disease or disorder, to
the ultimate attainment of results capable of conferring benefit to the person
concerned or to other persons in the same age category or afflicted with the
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 WITRO
1. Where law permits 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.
AUTHORITY 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 benefit 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 a written form or before an official body.
Article 20.
PROTECTION OF PERSONS NOT ABLE TO CONSENT TO AUTHORITY
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
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
were given specifically and in writing, in accordance with the law and with the
approval of the competent body,
v. 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 should 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 violation of 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
a violation of the provisions contained in this Convention.
Chapter IX.
RELATION BETWEEN THIS CONVENTION AND OTHER PROVISIONS
Article 26.
RESTRICTIONS ON THE EXERCISE OF THE RIGHTS
1. No restrictions shall be placed on the exercise of the rights and protective
provisions contained in this Convention
law and are necessary in a democratic society in the interest of public safety, for
the prevention of crime, the protection of public health or 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 affecting the possibility of 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
The Parties to this Convention shall see to it that the fundamental questions are 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
specific proceedings pending in a court, advisory opinions on legal issues
regarding 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-thirds 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
The party shall furnish an explanation of the manner in which its internal law provides
the effective implementation of any of the provisions of the Convention.
Chapter XII.
PROTOCOLS
Article 31.
PROTOCOLS
Protocols may be concluded in pursuit 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 the 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 specific 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
Article 34. which is not a Party to this
Convention may be represented on the Committee by an observer. If the
The European Community is not a party it may be represented on the Committee by
an observer.
4. In order to monitor scientific developments, the present Convention shall be
examined within the Committee no later than five 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 amendment to a Protocol presented by a Party, the
The Committee of Ministers shall be communicated to the Committee
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
with the provisions of Article 34.
6. The Committee shall examine the proposal not earlier than two months after it
has been advanced by the Secretary General in accordance with paragraph 5.
The Committee shall submit the text adopted by a two-thirds majority
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 they have
accepted it, on the first day of the month following the expiration of a period of
one month after the date on which the five Parties, including at least four members
States of the Council of Europe, have informed the Secretary General that they
have accepted it.
In respect of any Party which accepts it, the amendment 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 the 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 Member States
The Council of Europe, the non-member States which have their membership
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 first day of the month following
the expiration of a period of three months after the date on which five 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 expresses its consent to be
bound by it, 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 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
The Council of Europe may invite any non-member, after consultation of the Parties
The State of the Council of Europe accedes to this Convention by a decision taken
by the majority provided for in Article 20, 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
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 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 specified in the declaration and for whose international law
relations it is responsible or whose name it is authorized to give
undertakings. In respect of such territories, 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 specified in such declaration, be withdrawn by a notification
addressed to the Secretary General. The withdrawal will 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 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
compliance with the provision. Reservations of a general character shall not be
allowed 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 provisions.
4. Any Party that has made the reservation mentioned in this article may
withdrawal by means of a declaration addressed to the Secretary General
Council of Europe. The withdrawal will 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 the 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 Article 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
the provisions of Article 36,
Mr Rücker 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 to 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 of the Council of State
Europe, to the European Community, to the non-member States which have
involved in the elaboration of this Convention, and any State invited to it
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
The member States of the Council of Europe, the other States and the European
Community Signatories to this Additional Protocol to the Convention
Protection of Human Rights and the Dignity of the Human Being with regard to the
Application of Biology and Medicine,
Noting scientific developments in the field of mammalian cloning, particularly
through embryo splitting and nuclear transfer,
Mindful of the progress that some cloning techniques themselves may bring to it
scientific knowledge and its medical application,
Considering that cloning of human beings may become 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 referred to in Article 1 aimed at protecting 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 provided as additional articles to the Convention and all the provisions of the
The Convention shall apply accordingly.
Article 4.
This Protocol shall be open for signature by the 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 been previously or 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 following
expiration of a period of three months after the date on which five 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 expresses its consent to be
bound by it, the 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 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
The Convention may also accede to this Protocol.
2. The Accession shall be effected by the deposit with the Secretary General
The Council of Europe of an instrument of accession which shall take effect on the
the first 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 deny this Protocol by means of 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 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 to be deposited in the
Council of Europe archives. The Secretary General of the Council of
Europe shall transmit certified copies to each member of the Council of State
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.
ADDITIONAL PROTOCOL TO THE CONVENTION ON HUMAN RIGHTS AND
BIOMEDICINE CONCERNING TRANSPLANTATION OF ORGANS AND
TISSUES OF HUMAN ORIGIN
PREAMBLE
The member States of the Council of Europe, the other States and the European
Community signatories to this Additional Protocol to the Convention
Protection of Human Rights and the Dignity of the Human Being with regard to the
Application of Biology and Medicine (hereinafter referred to as “Convention on
Human Rights and Biomedicine ”),
Considering that the aim of the Council of Europe is the achievement of greater
unity between its members and that one of the methods by which this aim is
pursued is the maintenance and further realization of human rights and
fundamental freedoms,
Considering that the aim of the Convention on Human Rights and Biomedicine,
as defined in Article 1, is to 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,
Considering that progress in medical science, in particular in the field of organ
and tissue transplantation, contributing to saving lives or greatly improving theirs
quality,
Considering that transplantation of organs and tissues is an established part of
the health services offered to the population,
Considering that, in view of the shortage of organs and tissues, appropriate
action should be taken to increase organ and tissue donation, in particular by
informing the public of the importance of organ and tissue transplantation and by
promoting European co-operation in this field,
Considering moreover the ethical, psychological and socio-cultural problems
inherent in the transplantation of organs and tissues,
Considering that the misuse of organ and tissue transplantation may lead to acts
endangering human life, well being or dignity,
Considering that organ and tissue transplantation should take place under
conditions protecting the rights and freedoms of donors, potential donors and
recipients of organs and tissues and that institutions must be instrumental in
ensuring such conditions,
Recognizing that, in facilitating the transplantation of organs and tissues in the
interest of patients in Europe, there is a need to protect individual rights and
freedoms and to prevent the commercialization of parts of the human body
involved in organ and tissue procurement, exchange and distribution activities,
Taking into account previous work of the Committee of Ministers and the
Parliamentary Assembly of the Council of Europe in this field,
Resolving to take such measures as necessary to safeguard human dignity
and the rights and fundamental freedoms of the individual with regard to the organ
and tissue transplantation,
Have agreed as follows:
Chapter I.
OBJECT AND SCOPE
Article 1.
OBJECT
The Parties to this Protocol shall protect the dignity and identity of everyone and
guarantee, without discrimination, respect for his or her integrity and other rights
and fundamental freedoms with regard to transplantation of organs and tissues
of human origin.
Article 2.
SCOPE AND DEFINITIONS
1. This Protocol applies to the transplantation of organs and tissues of human
origin carried out for therapeutic purposes.
2. The provisions of this Protocol applicable to tissues shall also apply to cells,
including haematopoietic stem cells.
3. The Protocol does not apply:
a. to reproductive organs and tissue,
b. to embryonic or foetal organs and tissues,
c. to blood and blood derivatives.
4. For the purposes of this Protocol:
- the term "transplantation" covers the complete process of removal of an
organ or tissue from one person and implantation of that organ or tissue into
another person, including all procedures for preparation, preservation and
storage,
- subject to the provisions of Article 20, the term "removal" refers to removal for
the purposes of implantation.
Chapter II.
GENERAL PROVISIONS
Article 3.
TRANSPLANTATION SYSTEM
Parties shall ensure that a system exists to provide equitable access to
transplantation services for patients.
Subject to the provisions of Chapter III, organs and, where appropriate, tissues
shall be allocated only to patients on an official waiting list, in conformity
with transparent, objective and duly justified rules according to medical criteria.
The persons or bodies responsible for the allocation decision shall be
designated within this framework.
In the case of an international body exchange arrangements, the procedures must
also ensure justified, effective distribution across participating countries in a
a principle that takes into account the solidarity principle within each country.
The transplantation system will ensure the collection and recording of the
information required to ensure traceability of organs and tissues.
Article 4.
PROFESSIONAL STANDARDS
Any intervention in the field of organ or tissue transplantation must be carried out
out in compliance with relevant professional obligations and standards.
Article 5.
INFORMATION FOR THE RECIPIENT
The recipient and, where appropriate, the person or body providing authorization
for the implantation should be given beforehand appropriate information as to the
purpose and nature of implantation, its consequences and risks, as well as
on the alternatives to the intervention.
Article 6.
HEALTH AND SAFETY
All professionals involved in organ or tissue transplantation should take all
reasonable measures to minimize the risks of transmission of any disease to the
recipient and to avoid any action that might affect the suitability of an organ or
Tissue for implantation.
Article 7.
MEDICAL FOLLOW-UP
Appropriate medical follow-ups will be offered to living donors and recipients
after transplantation.
Article 8.
INFORMATION FOR HEALTH PROFESSIONALS AND THE PUBLIC
Parties shall provide information for health professionals and for the public in
general on the need for organs and tissues. They will also provide information
on the conditions relating to the removal and implantation of organs and tissues,
including matters concerning consent or authorization, in particular with regard to
removal from deceased persons.
Chapter III.
AUTHORITY AND TISSUE REMOVAL FROM LIVING PERSONS
Article 9.
GENERAL RULE
Removal of organs or tissue from a living person may be carried out solely for
the therapeutic benefit of the recipient and where there is no suitable organ or
tissue available from a deceased person and no other therapeutic alternative
method of comparable effectiveness.
Article 10.
POTENTIAL AUTHORITY DONORS
Organ removal from a living donor may be carried out for the benefit of a
recipient with whom the donor has a close personal relationship as defined by
law, or, in the absence of such a relationship, only under the conditions defined by
law and with the approval of an appropriately independent body.
Article 11.
EVALUATION OF RISKS FOR THE DONOR
Before organ or tissue removal, appropriate medical investigations and
interventions will be carried out to evaluate and reduce physical and
psychological risks to the health of the donor. The removal may not be carried
out if there is a serious risk to the life or health of the donor.
Article 12.
INFORMATION FOR THE DONOR
The donor and, where appropriate, the person or body providing authorization
According to Article 14, paragraph 2, this Protocol shall be given beforehand
appropriate information as to the purpose and nature of the removal as well as
on its consequences and risks.
They will also be informed of the rights and safeguards prescribed by law
for the protection of the donor. In particular, they will be informed of the right to
have access to independent advice on such risks by a health professional
having appropriate experience and who is not involved in the organ or tissue
removal or subsequent transplantation procedures.
Article 13.
CONSENT OF THE LIVING DONOR
Subjects to Articles 14 and 15 of this Protocol, an organ or tissue may be
removed from a living donor only after the person concerned has been given free,
informed and specific consent to it either in written form or before an official
body.
The person concerned may freely withdraw consent at any time.
Article 14.
Protection of persons not able to consent to organ or tissue removal
1. No organ or tissue removal may be carried out on a person who does not
have the capacity to consent under Article 13 of this Protocol.
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
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 has the potential to be life-saving for the recipient,
iv. the authorization of his or her representative or an authority or a person or
body provided for by law has been given specifically and in writing and with the
approval of the competent body,
v. The potential donor concerned does not object.
Article 15.
CELL REMOVAL FROM A LIVING DONOR
The law may provide that the provisions of Article 14, paragraph 2, indents ii and
iii, shall not apply to cells insofar as it is established that their removal only
implies minimum risk and minimum burden for the donor.
Chapter IV.
AUTHORITY AND TISSUE REMOVAL FROM DECEASED PERSONS
Article 16.
DEATH CERTIFICATION
Organs or tissues will not be removed from the body of a deceased person
unless that person is certified dead in accordance with the law.
The doctors certifying the death of a person should not be the same doctors who
participate directly in the removal of organs or tissues from the deceased person, or
subsequent transplantation procedures, or having responsibilities for the care of
potential organ or tissue recipients.
Article 17.
CONSENT AND AUTHORISATION
Organs or tissues will not be removed from the body of a deceased person
unless consent or authorization required by law has been obtained.
The removal will not be carried out if the deceased person had an objected to it.
Article 18.
RESPECT FOR THE HUMAN BODY
During removal the human body must be treated with respect and all reasonable
measures will be taken to restore the appearance of the corpse.
Article 19.
PROMOTION OF DONATION
The Parties shall take all appropriate measures to promote the donation of organs
and tissues.
Chapter V.
IMPLANTATION OF AN ORGAN OR TISSUE REMOVED FOR A PURPOSE
OTHER THAN DONATION FOR IMPLANTATION
Article 20.
IMPLANTATION OF AN ORGAN OR TISSUE REMOVED FOR A PURPOSE
OTHER THAN DONATION FOR IMPLANTATION
1. When an organ or tissue is removed from a person for a purpose other than
donation for implantation, it may only be implanted if the consequences and
possible risks have been explained to that person and his or her informed
consent, or appropriate authorization in the case of a person not able to
consent has been obtained.
2. All the provisions of this Protocol shall apply to the situations referred to in
paragraph 1, except for those in Chapter III. and IV.
Chapter VI.
PROHIBITION OF FINANCIAL GAIN
Article 21.
PROHIBITION OF FINANCIAL GAIN
1. The human body and its parts should not, as such, give rise to financial gain or
comparable advantage.
The aforementioned provision will not prevent payments which do not
represents a financial gain or a comparable advantage, in particular:
- compensation of living donors for loss of earnings and any other justifiable
expenses caused by the removal or by the related medical examinations,
- payment of a justifiable fee for legitimate medical or related technical services
rendered in connection with transplantation,
- compensation in case of undue damage resulting from the removal of organs
or tissues from living persons.
2. Advertising the need for, or availability of, organs or tissues, with a view to
offering or seeking financial gain or comparable advantage will be prohibited.
Article 22.
AUTHORITY AND TISSUE TRAFFICKING PROHIBITION
Organ and tissue trafficking should be prohibited.
Chapter VII.
CONFIDENTIALITY
Article 23.
CONFIDENTIALITY
1. All personal data relating to the person from whom organs or tissues have
have been removed and those related to the recipient should be considered to be
confidential. Such data may only be collected, processed and communicated
according to the rules regarding professional confidentiality and personal data
protection.
2. The provisions of paragraph 1 shall be interpreted without prejudice to the latter
provisions making possible, subject to appropriate safeguards, the collection,
processing and communication of the necessary information about the person
from which organs or tissues have been removed or the recipient (s) of organs
and tissues in so far as this is required for medical purposes, including
traceability, as provided for in Article 3 of this Protocol.
Chapter VIII.
INFRINGEMENTS OF THE PROVISIONS OF THE PROTOCOL
Article 24.
INFRINGEMENTS OF RIGHTS OR PRINCIPLES
The Parties shall provide appropriate judicial protection to prevent or stop a stop
an unlawful violation of the rights and principles set forth in this Protocol at
short notice.
Article 25.
COMPENSATION FOR UNDUE DAMAGE
The person who has suffered undue damage resulting from transplantation
procedures are entitled to fair compensation according to the conditions and
procedures prescribed by law.
Article 26.
SANCTIONS
The Parties shall provide for appropriate sanctions to be applied in the event of
a violation of the provisions contained in this Protocol.
Chapter IX.
CO-OPERATION BETWEEN PARTIES
Article 27.
CO-OPERATION BETWEEN PARTIES
Parties shall take appropriate measures to ensure that there is efficient co-
operation between them on organ and tissue transplantation, inter alia through
information exchange.
In particular, they will take appropriate measures to promote the rapid
and safe transportation of organs and tissues to and from their territory.
Chapter X.
BETWEEN THIS PROTOCOL RELATION AND THE CONVENTION, AND RE-
EXAMINATION OF THE PROTOCOL
Article 28.
RELATION BETWEEN THIS PROTOCOL AND THE CONVENTION
As between the Parties, the provisions of Articles 1 to 27 of this Protocol shall
be cited as additional articles on the Convention on Human Rights and
Biomedicine, and all provisions of that Convention shall apply accordingly.
Article 29.
RE-EXAMINATION OF THE PROTOCOL
In order to monitor scientific developments, the present Protocol shall be
examined within the Committee referred to in Article 32 of the Convention on
Human Rights and Biomedicine no later than five years from the entry into force
of this Protocol and thereafter at such intervals as the Committee may
determine.
Chapter XI.
FINAL CLAUSES
Article 30.
SIGNATURE AND RATIFICATION
This Protocol shall be open for signature by the 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 been previously or 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 31.
ENTRY INTO FORCE
1. This Protocol shall enter into force on the first day of the month following the following
expiration of a period of three months after the date on which five 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 30.
2. In respect of any Signatory which expresses its consent to be
bound by it, the 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 the deposit
of the instrument of ratification, acceptance or approval.
Article 32.
ACCESSION
1. After the entry into force of this Protocol, any State which has acceded to the
The Convention may also accede to this Protocol.
2. The Accession shall be effected by the deposit with the Secretary General
The Council of Europe of an instrument of accession which shall take effect on the
the first day of the month following the expiration of a period of three months after
the date of its deposit.
Article 33.
DENUNCIATION
1. Any Party may at any time deny this Protocol by means of 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 34.
NOTIFICATION
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 Article 31.
and 32.,
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 Strasbourg, this 24th day of January 2002, in English and in French,
both texts being equally authentic, in a single copy to 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 of the Council of State
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 PROTECTION
HUMAN RIGHTS AND
Dignity of the human
IT WILL BE IN VIEW OF APPLICATION
BIOLOGY AND MEDICINE:
THE HUMAN CONVENTION
RIGHTS AND BIOMEDICINE
PREAMBLE
Council of Europe member states, other countries and the European Community, which are
signatories to this Convention,
Bearing in mind the Universal Declaration of Human Rights, promulgated by the Universal Declaration of Human Rights
United Nations Assembly on December 10, 1948,
Bearing in mind the Convention for the Protection of Human Rights and Fundamental Freedoms of
November 1950,
Having regard to the European Social Charter of 18 October 1961,
Bearing in mind the International Covenant on Civil and Political Rights i
International Covenant on Economic, Social and Cultural Rights of 16 November
December 1966,
Bearing in mind the Convention on the Protection of Individuals with regard to Automatic Processing
personal data as of January 28, 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 achieve greater unity among its members
and that one of the ways to achieve this goal is to preserve and further achieve it
human rights and fundamental freedoms,
Aware of the rapid evolution of biology and medicine,
Convinced of the need to respect the human being as an individual and as a member
of the human species, and recognizing the importance of ensuring the dignity of the human being,
Aware that the misuse of biology and medicine can lead to an act that
endanger human dignity,
Affirming that advances in biology and medicine should be used for good
present and future generations,
Emphasizing the need for international cooperation so that the whole
humanity can enjoy the benefits of biology and medicine,
Recognizing the importance of promoting public debate on the issues it raises
the application of biology and medicine and the answers that should be given to them,
Desiring to remind all members of society of their rights and obligations,
Having regard to the work of the Parliamentary Assembly in this field, including
Recommendation 1160 (1991) on the preparation of the Convention on Bioethics,
Deciding to take such measures as may be necessary to protect the human
the dignity and fundamental rights and freedoms of the individual with regard to the application of biology and
medicine,
They agreed as follows:
Chapter I.
GENERAL PROVISIONS
Article 1
PURPOSE AND SUBJECT MATTER
The Parties to this Convention protect the dignity and identity of all human beings and guarantee it
everyone, without discrimination, respect for their integrity and other rights and
fundamental freedoms regarding the application of biology and medicine.
Each Party shall take the necessary implementing measures in its internal law
the provisions of this Convention.
Article 2
PRIMATE HUMAN BEING
The interests and well-being of the human being take precedence over the self-interest of society or
science.
Article 3
RIGHT TO ACCESS TO HEALTH CARE
The parties, taking into account the health needs and the resources available, take action
appropriate measures to ensure equitable treatment within the area of ​​their competence
access to health care of appropriate quality.
Article 4
PROFESSIONAL STANDARDS
Any intervention in the field of health, including research, must be carried out at
in accordance with relevant professional obligations and standards.
II. Chapter
CONNECTION
Article 5
GENERAL RULE
A health-related procedure can only be performed after the person is on
The procedure concerned informed him and gave his free consent to it.
This person is previously provided with relevant information about the purpose and nature of the procedure
as well as its consequences and risks.
The person concerned is free to withdraw his or her consent at any time.
Article 6
PROTECTION OF PERSONS WHO ARE NOT ABLE TO GIVE ACCEPT
1. Subject to the conditions laid down in Articles 17 and 20, the intervention on a person who is incapable of giving
consent can only be exercised for its direct benefit.
2. If, by law, a minor is incapable of consenting to the intervention,
the intervention can only be carried out with the approval of its representative or authority, or
persons or bodies prescribed by law.
The opinion of a minor is taken into account as an increasingly important factor in
the proportion of her or his age and the degree of maturity.
3. If, by law, the adult is not capable of consenting to the procedure
due to mental disability, illness or similar reasons, the intervention can be performed
only with the approval of her representative or authority, or person or other person
bodies provided by law.
The person concerned shall, as far as possible, participate in the authorization process.
4. To the representative, authority, person or other body referred to in paragraphs 2 and 2 above
3. the information referred to in Article 5 is provided under the same conditions.
5. The approval referred to in paragraphs 2 and 3 above may be withdrawn at any time at
the best interests of the person concerned.
Article 7
PROTECTION OF MENTAL DISORDERS
In accordance with the protective conditions prescribed by law, including supervisory,
control and appeal procedures, a person with a mental disorder of a serious nature
may, without her consent, undergo surgery to treat her
mental disorder only if, without such treatment, it would probably have occurred
severe damage to her health.
Article 8
URGENT SITUATION
If due to an emergency, proper consent cannot be obtained, any
a medically necessary procedure can be carried out immediately in favor of the health of the person concerned
individual.
Article 9
PREVIOUSLY WISHED
The previously expressed wishes regarding the patient's medical intervention will be taken into account
who at the time of the procedure is unable to express his wishes.
III. Chapter
PRIVATE LIFE AND RIGHT TO INFORMATION
Article 10
PRIVATE LIFE AND RIGHT TO INFORMATION
1. Everyone has the right to respect for his private life as regards his information
health.
2. Everyone is empowered to know any information they may have about their health.
However, the wishes of individuals not to be informed will be respected.
3. In exceptional cases, use restrictions may be imposed by law
rights contained in paragraph 2 in the interest of the patient.
IV. Chapter
THE HUMAN GENOM
Article 11
NON-DISCRIMINATION
Any form of discrimination against a person on the basis of his or her genetic character is forbidden
inheritance.
Article 12
GENETIC TEST PREVIEWS
Tests that predict genetic diseases or serve to identify subjects as
the carrier of a gene responsible for the disease or for detecting a genetic predisposition or
susceptibility to the disease can only be done for health purposes or for work
scientific research related to health purposes and related
genetic counseling.
Article 13
WORK ON THE HUMAN GENOMA
Human genome-wide intervention can only be undertaken for
preventive, diagnostic or therapeutic purposes, and only if its purpose is not to introduce it
any alteration in the genome of any offspring.
Article 14
GENDER SELECTION
The use of medically assisted procreation procedures for the purpose is not permitted
choosing the sex of the future child, except to avoid serious hereditary illness
related to gender.
Chapter V.
SCIENTIFIC RESEARCH
Article 15
GENERAL RULE
Scientific research regarding the application of biology and medicine is being done
freely subject to the provisions of this Convention and other legal provisions
which ensure the protection of the human being.
Article 16
PROTECTION OF THE RESEARCHERS
Research on a person can only be undertaken if all of the following are completed
conditions:
i. there is no alternative of comparable effectiveness to human research,
ii. the risks to which that person is exposed are not disproportionate to the potential benefits of
research,
iii. the research project was approved by the competent authority after independent testing
its scientific values, including the importance of the research objective and
multidisciplinary evaluation of its ethical acceptability,
iv. that the persons subjected to the survey are informed of their rights and guarantees
prescribed by law for their protection,
v. that the requisite consent provided for in Article 5 has been obtained expressly and specifically, and
that it is documented. Such consent may be freely withdrawn at any time.
Article 17
PROTECTION OF DISABLED PERSONS
RESEARCH
1. Research on a person who does not have the ability to consent as is
provided for in Article 5 can only be taken on condition that all are fulfilled
the following conditions:
i. the conditions set out in Article 16 (i) to (iv) are fulfilled,
ii. research results have the ability to produce a real and direct benefit to
her health,
iii. comparative effectiveness research cannot be conducted on individuals who
are able to consent,
iv. the necessary approval provided for in Article 6 has been given specifically and in writing
form, these
v. the person concerned has no objection.
2. Exceptionally and under the protective conditions prescribed by law, when there is no research
the ability to produce results of direct benefit to the health of the person concerned,
such research may be approved under the conditions set out in paragraph 1,
subparagraph i., iii., iv. and v., and subject to the following additional conditions:
i. the research aims to contribute through a much better scientific understanding
states of illness or disorder of the individual and contribute to the final achievement
results that may be of benefit to the person concerned or to other persons of the same age group
or other persons affected by the same disease or disorder or
are in the same condition,
ii. research entails only minimal risk and minimal burden
for the individual concerned.
Article 18
RESEARCH ON JUMP AND VITRO
1. When law permits research on embryos in vitro, it must provide i
adequate embryo protection.
2. It is forbidden to create human embryos for research purposes.
VI. Chapter
TAKING BODIES AND TISSUES FROM LIVE DONORS FOR PURPOSE
TRANSFERS
Article 19
GENERAL RULE
1. The taking of an organ or tissue from a living donor for the purpose of transplantation shall be carried out
solely for the purpose of treating the recipient and when there is no appropriate organ or tissue
deceased persons, and there is no other, approximately equal treatment method.
2. The consent required under Article 5 must be given explicitly and clearly, at
in writing.
Article 20
PROTECTION OF DISABLED PERSONS
BODY AND Tissue Transplantation
1. No organ or tissue can be taken from a person who is not
capable of giving consent under Article 5.
2. Exceptionally and under the conditions prescribed by law, taking regenerative tissue with
A person who is incapable of giving consent can be approved after they have been filled
the following conditions:
i. no compatible provider capable of consent is available,
ii. the recipient is the brother or sister of the donor,
iii. the gift must have the purpose of saving the life of the recipient,
iv. the approval provided for in Article 6, paragraphs 2 and 3, shall be given clearly and in writing
in accordance with the law,
v. the potential donor does not object.
VII. Chapter
PROHIBITION OF MONEY PROFITS AND DISPOSAL OF HUMAN PART
BODIES
Article 21
MONEY PROFIT PROHIBITION
The human body and its parts must not, as such, be a source of monetary gain.
Article 22
DISPOSAL OF THE TAKEN PART OF THE HUMAN BODY
When a part of the human body is taken during an operation, it can
store and use for a purpose different from that for which it was taken only when it is
act in accordance with the appropriate information and consent procedure.
VIII. Chapter
VIOLATIONS OF THE CONVENTION
Article 23
VIOLATION OF RIGHTS OR PRINCIPLES
The parties are required to provide adequate judicial protection in the short term in order
prevent or stop unlawful infringement of the rights and principles set out in this
Convention.
Article 24
EXTRAORDINARY DAMAGES
A person who has suffered excessive damage resulting from an operation is entitled
to just compensation under the terms and procedures prescribed by law.
Article 25
PUNISHMENTS
The parties are required to prescribe the appropriate sanctions to be applied in the case
violations of the provisions of this Convention.
IX. Chapter
CONNECTION BETWEEN THIS CONVENTION AND OTHER PROVISIONS
Article 26
LIMITATIONS ON USE OF RIGHTS
1. There shall be no restriction on the exercise of the rights and safeguards contained in
to this Convention except those prescribed by law and which are necessary in a democratic manner
society for the sake of public safety, crime prevention, public protection
or to protect the rights and freedoms of others.
2. The restrictions provided for in the preceding paragraph may not apply to an article
11, 13, 14, 16, 17, 19, 20 and 21
Article 27
WIDER PROTECTION
None of the provisions of this Convention shall be construed as limiting or limiting
otherwise it affects the possibility that the party recognizes broader protection in relation to
applying biology and medicine than provided for in this Convention.
Chapter X
PUBLIC DISCUSSION
Article 28
PUBLIC DISCUSSION
The Parties to this Convention must ensure that the essential questions arising from the
the development of biology and medicine are subject to appropriate public debate,
especially in the light of relevant medical, social, economic, ethical and
legal implications, and making their possible application subject
appropriate consultation.
XI. Chapter
INTERPRETATION AND MONITORING OF THE CONVENTION
Article 29
INTERPRETATION OF THE CONVENTION
The European Court of Human Rights can give, without directly referring to any
special proceedings pending in court, advisory opinion on legal
questions concerning the interpretation of this Convention upon request:
- the governments of a party, after being notified to the other parties,
- a committee set up under Article 32, with membership limited to
representatives of the Parties to the Convention, on the basis of a decision to be taken
by a two-thirds majority of the votes cast.
Article 30
CONVENTION APPLICATION REPORTS
Upon receipt of a request from the Secretary General of the Council of Europe, each Party shall be bound
provide an explanation of how its internal law provides real
application of any provision of the Convention.
XII. Chapter
PROTOCOLS
Article 31
PROTOCOLS
Protocols may be concluded, in accordance with Article 32, for the purpose of elaboration on particulars
areas, the principles enshrined in this Convention.
The Protocols are open for signature by the signatories to the Convention. They are submissive
ratification, acceptance or approval. A signatory may not ratify, accept or
approve protocols without first or simultaneously ratifying, accepting or
approval of the Convention.
XIII. Chapter
AMENDMENTS TO THE CONVENTION
Article 32
AMENDMENTS TO THE CONVENTION
1. The tasks assigned to the Committee referred to in this Article and Article 29 shall be carried out by the Administrative Board
the Bioethics Committee (CDBI), or any other committee designated by the Committee of Ministers.
2. Without prejudice to the specific provisions of Article 29, each Member State
The Council of Europe, as well as any Party to this Convention which is not a member of the Council
Europe, may be represented and have one vote in the Committee, when the Committee is in office
the tasks assigned to it by this 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 a party to the Convention,
may be represented on the Board by an observer. If the European Community is not a party,
it may be represented by an observer on the Committee.
4. For the purpose of monitoring scientific development, this Convention should be reviewed
The Committee shall, not later than five years after its entry into force, and thereafter
at intervals determined by himself.
5. Any proposal for an amendment to the Convention and any proposal for a protocol or amendment
protocols submitted by a Party, the Committee or the Committee of Ministers shall be communicated to the Chief
the Secretary of the Council of Europe, the European Community, each signatory, each party,
to any State called upon to sign this Convention in accordance with the provisions
Article 33 and any State called upon to accede to it in accordance with the provisions
Article 34
6. The Committee shall examine the proposal at the earliest two months after its adoption by the Secretary-General
submitted in accordance with Rule 5. The Committee shall submit the text adopted by a two-thirds majority
by a majority of votes cast to the Committee of Ministers for approval. Once approved, this
it shall forward the text to the Parties for ratification, acceptance or approval.
7. Any amendment, in respect of the parties that have accepted the amendment, shall take effect
the force on the first day of that month following the expiration of the month
days after the date when five parties, including at least four States
Council of Europe members, informed the Secretary-General that they had accepted it.
For parties that subsequently accept them, the amendments will take effect on the first day
of the month following the expiration of a month after the date on which
that Party informed the Secretary-General of its acceptance.
XIV. CHAPTER
FINAL PROVISIONS
Article 33
SIGNATURE, RATIFICATION AND ENTRY INTO FORCE
1. The Convention is open for signature by the member States of the Council of Europe,
non-member countries which participated in its elaboration and European
community.
2. The Convention shall be 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 its expiration
a three-month period following the date when five States, including at least
four member states of the Council of Europe stated that they agreed to be bound by the Convention
in accordance with the provisions of paragraph 2 of this Article.
4. For any signatory which subsequently agrees to be bound by the Convention, it
shall take effect on the first day of the month following the expiration of a quarterly period
the period after the date of deposit of the instrument of ratification, acceptance or approval.
Article 34
NON - MEMBER STATES
1. After the entry into force of the Convention, the Committee of Ministers of the Council of Europe may,
after consulting the parties, invite any non-member country
The Council of Europe to accede to this Convention on the basis of a decision taken by the majority
provided for in Article 20 (d) of the Statue of the Council of Europe and unanimously
by the vote of the representatives of the Contracting States who are authorized to sit at
Committee of Ministers.
2. For a State which accedes to the Convention, it shall enter into force on the first day of that Convention
of the month following the expiration of a period of three months after the date
the deposit of an instrument of accession with the Secretary General of the Council of Europe.
Article 35
TERRITORIES
1. Each Signatory may, at the time of signature or when depositing its instrument of o
ratification, acceptance or approval, specify the territory or territories to which it will be subject
to apply the Convention. Any other State may make the same statement on occasion
depositing his instrument of accession.
2. Each Party may subsequently at any time, by a declaration addressed to it
To the Secretary General of the Council of Europe, extend the application of the Convention to any other
the territory specified in the statement for whose international relations it is responsible or in whose
name authorized to commit. In respect of such territory the Convention shall
shall take effect on the first day of the month following the expiration of a period of three months
months after the date of receipt of such declaration by the Secretary-General.
3. Any statement made under the two preceding paragraphs may, in respect of
withdraw any terrorium referred to in such statement by means of a notice addressed to the Chief
to the secretary. The withdrawal shall take effect on the first day of the month following the expiration of that month
a period of three months after the date of receipt of such by the Secretary General
notice.
Article 36
RESERVES
1. Any State and the European Community may, at the time of signature of the Convention or
to deposit a reservation on ratification, acceptance, approval or accession,
with respect to a particular provision of the Convention, to the extent that a law is in force at
its territory does not comply with that provision. Based on this article no
reserves of a general nature are permitted.
2. Each reservation made under this article shall contain a brief
a statement of the relevant law.
3. Any Party extending the application of the Convention to the territory specified in the declaration
under Article 35 (2), may reserve a reservation in respect of that territory
in accordance with the provisions of the preceding paragraphs.
4. Any party which has made the reservation mentioned in this article may
withdraw with a statement addressed to the Secretary General of the Council of Europe. Withdrawal begins at
the strength of the first day of the month following the expiration of a month
after the date of receipt by the Secretary-General of the withdrawal statement.
Article 37
CANCELLATION
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 cancellation shall take effect on the first day of the month following
the expiry of a period of three months after the date of receipt of such by the Secretary General
notice.
Article 38
NOTICE
The Secretary General of the Council of Europe shall inform the member States of the Council of Europe
community, every signatory, every party and every other state that is
invited to accede to the Convention on:
a) any signature,
b) the deposit of an instrument of ratification, acceptance, approval or accession,
c any date of entry into force of the Convention in accordance with Article 33 or
34.,
d) any amendment or protocol adopted in accordance with Article 32 and the date when
such amendment or protocol shall enter into force,
e any statement made under the provisions of Article 35;
f) any reservation and withdrawal of a reservation made in accordance with the provisions of Article 36;
g) any other act, notification or communication relating to the Convention.
In witness whereof, the undersigned, being duly authorized thereto, have signed this one
Convention.
Done at Oviedo (Asturias) on 4 April 1997, in English and French
language, in which both texts are equally authentic, in one copy which will
be deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe shall deliver
certified transcripts of each Member State of the Council of Europe, the European Community,
to the non-member States which have participated in the elaboration of this Convention and to each
a State invited to accede to this Convention.
ADDITIONAL PROTOCOL TO THE CONVENTION
ON THE PROTECTION OF HUMAN RIGHTS
AND THE DIGNITIES OF THE HUMAN BEING
IN VIEW OF APPLIED BIOLOGY
AND MEDICINES FOR THE PROHIBITION OF CLONING
HUMAN BEINGS
Council of Europe member states, other states and the European Community, signatories
of this Additional Protocol to the Convention for the Protection of Human Rights and Dignity
the human being with respect to the application of biology and medicine,
They are making scientific advances in the field of mammalian cloning, especially through partitioning
embryo and nucleus transfer,
Aware that the advancement of some cloning techniques can be scientific
cognition and its application in medicine,
Considering that cloning of human beings can become technically possible,
Keeping in mind that division of the embryo can occur naturally, and sometimes
result in the birth of genetically identical twins,
Considering, however, that the use of human beings in deliberate creation is genetic
of identical beings is contrary to human dignity and thus constitutes abuse
biology and medicine,
Considering the same serious medical, psychological and social difficulties
of nature, such deliberate biomedical practices may be for everyone involved
individuals,
Considering the purpose of the Convention on Human Rights and Biomedicine, in particular
the principle set out in Article 1 aimed at protecting the dignity and identity of all
human beings,
They agreed as follows:
Article 1
1. Any procedure intended to create a human being genetically is prohibited
identical to another human being, whether alive or dead.
2. For the purposes of applying this Article, the term human being "genetically identical"
to another human being means a human being who shares the same set of genes with another
cell nuclei.
Article 2
No restriction on the application of this Protocol shall be permitted under Article 26, paragraph
Of the Convention.
Article 3
The Parties consider the provisions of Articles 1 and 2 of this Protocol additional articles
Of the Convention, and all the provisions of the Convention shall apply accordingly.
Article 4
This Protocol shall be open for signature by the signatories to the Convention. The same is subject
ratification, acceptance or approval. A signatory may not ratify, accept or
to approve this Protocol if it has not, at the same time or at the same time ratified, accepted or
approved the Convention. Instruments of ratification, acceptance or approval shall be deposited with the Code
Secretary General of the Council of Europe.
Article 5
1. The Protocol shall enter into force on the first day of the month following its expiration
a three-month period following the date when five States, including at least
four member states of the Council of Europe stated that they agreed to be bound by the Protocol
in accordance with the provisions of Article 4.
2. For any signatory subsequently agreeing to be bound by the Protocol, he
shall enter into force on the first day of the month following the expiration of a quarterly period
the period 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 acceding State
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
The Council of Europe, which will enter into force on the first day of the month following
at the end of the three-month period from the date of deposit.
Article 7
1. Any Party may, at any time, denounce this Protocol by notification
addressed to the Secretary General of the Council of Europe.
2. Such cancellation 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 by the Secretary General
notice.
Article 8
The Secretary General of the Council of Europe shall inform the member States of the Council of Europe
community, every signatory, every party and every other state that is
invited to accede to the Convention on:
a) any signature,
b) the deposit of an instrument of ratification, acceptance, approval or accession,
c any date of entry into force of the Protocol in accordance with Articles 5 and 6;
d any other act of notification or communication relating to the Protocol.
In witness whereof, the undersigned, being duly authorized thereto, have signed this one
Protocol.
Done at Paris, 12 January 1998, in English and in French, at
to which both texts are equally authentic in one copy to be
deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe shall deliver
certified transcripts to each member state of the Council of Europe, to non-member countries
Member States which have participated in the elaboration of this Protocol, to any State which is
invited to accede to the Convention and to the European Community.
ADDITIONAL PROTOCOL TO THE CONVENTION ON THE PROTECTION OF HUMAN RIGHTS AND
HUMAN BEING DIGNITIES IN APPLICATION OF BIOLOGY AND
MEDICINES RELATING TO THE TRANSMISSION OF BODIES AND TISSUES
ORIGIN
PREAMBLE
Council of Europe member states, other countries and the European Community
of this Additional Protocol to the Convention for the Protection of Human Rights and Dignity
of the human being with respect to the application of biology and medicine (hereinafter referred to as
"The Convention on Human Rights and Biomedicine"),
Considering that the aim of the Council of Europe is to achieve greater unity between the Member States and that
is one of the ways in which this goal is achieved, maintained and further pursued
human rights and fundamental freedoms,
Considering that the goal of the Convention on Human Rights and Biomedicine is as it is
defined in Article 1, to protect the dignity of all human beings and to guarantee everyone,
without discrimination, respect for their integrity and other rights and
fundamental freedoms regarding the application of biology and medicine,
Considering that advances in medical science and especially in the field
organ and tissue transplants, contributes to life-saving or significant improvement
their qualities,
Considering that the taking and transplanting of organs and tissues is an established part
health services offered to the population,
Considering that, due to lack of available organs and tissues, it is necessary to take action
appropriate measures to maximize organ and tissue donation, in particular
by reporting to the public the importance of organ and tissue transplantation and by
promoting European cooperation in this field,
Considering that, furthermore, ethical, psychological and sociocultural issues are narrow
associated with organ and tissue transplants,
Believing abuse of the process of taking and transplanting organs and tissues
can endanger human life, health or dignity,
Considering that the taking and transplantation of organs and tissues should be carried out under
conditions that protect the rights and freedoms of donors, potential donors and recipients
organs and tissues, and that institutions must be an instrument to ensure such conditions,
Recognizing the need to protect individual rights and freedoms, and
preventing the commercialization of parts of the human body involved in supply,
exchange and allocation of organs and tissues, to facilitate the taking and
organ and tissue transplants in the interest of patients in Europe,
Taking into account the previous work of the Committee of Ministers and the Parliamentary Assembly
The Council of Europe in this field,
Deciding to take such measures as are necessary to preserve the human
the dignity and rights and fundamental freedoms of the individual with regard to taking and
organ and tissue transplantation,
They agreed as follows:
Chapter I.
SUBJECT MATTER AND SCOPE
Article 1
SCOPE
The Parties to this Protocol shall protect the dignity and identity of each individual and
guarantee, without discrimination, respect for his or her integrity and others
rights and fundamental freedoms regarding the taking and transplantation of organs and tissues
of human origin.
Article 2
SCOPE AND DEFINITIONS
1. This Protocol shall apply to cases of organ harvesting and transplantation and
tissues of human origin that have been carried out for the purpose of treatment.
2. The provisions of this Protocol relating to tissues shall also apply to
cells, including hematopoietic stem cells.
3. The Protocol shall not apply to:
a. organs and tissues for reproduction,
b. organs and tissues of the embryo or fetus,
c. blood and blood derivatives.
4. For the purposes of the Protocol
- the term "transplantation" covers the whole process of taking an organ or tissue
from one person and transplanting that organ or tissue to another person, including everyone
preparation, preservation and storage procedures,
- the term "taking" refers to taking for the purpose of transplantation.
II. Chapter
GENERAL PROVISIONS
Article 3
SYSTEM OF TAKING AND TRANSITION OF HUMAN BODIES IN
PURPOSE OF TREATMENT
The parties guarantee that there is a system that gives patients fair access
services.
In accordance with the provisions of Chapter III, organs and, where appropriate, organs and tissues
will only be assigned to patients on the official waiting list, in accordance with
transparent, objective and generally accepted medical criteria. Inside
these criteria will designate the persons or bodies responsible for the award decision.
In the case of an agreement on the international exchange of organs, the procedures must also
ensure justified, efficient allocation in principle by participating States
solidarity within each state.
Organ and tissue collection and transplantation systems ensure collection and recording
data required for traceability of organs and tissues.
Article 4
PROFESSIONAL STANDARDS
Any organ and tissue transplant procedure must be performed in accordance with
appropriate professional obligations and standards.
Article 5
NOTICE TO THE RECIPIENTS
The recipient and, where appropriate, the person or body authorizing the transplant
will be informed in advance of the purpose and nature of the transplant,
consequences and risks as well as alternatives to the intervention.
Article 6
HEALTH AND SAFETY
All experts involved in the process of taking and transplanting an organ or tissue
take all reasonable measures to reduce the risk of transmission of any disease
the recipient and avoid any action that might affect the eligibility of the organ
or transplant tissues.
Article 7
HEALTH MONITORING
After organ harvesting and transplanting, to living donors and recipients,
adequate health monitoring is ensured.
Article 8
NOTICE TO HEALTH WORKERS AND THE PUBLIC
The parties inform health professionals and the public about the need for organs and
tissues. It will also give notice of conditions for organ harvesting and transplantation
and tissues, including issues related to consent, especially with respect to
organ harvesting from a deceased person.
III. Chapter
TAKING BODIES AND TISSUES FROM LIVING PERSONS
Article 9
GENERAL RULES
Taking organs or tissues from a living donor is for purely purposes
treatment of the recipient and when there is no appropriate organ or tissue of the deceased person,
and there is no other, approximately equal, treatment method.
Article 10
POTENTIAL AUTHORITY GIFTS
Organ harvesting from a living donor can be done for the benefit of the recipient s
by which the donor is in a close emotional relationship, as defined by law, or, at
lack of such connection, only under the conditions laid down by law and with
the approval of the appropriate independent body.
Article 11
RISK ASSESSMENT FOR DONOR
Before taking an organ or tissue, appropriate medical examinations and tests are performed
interventions to assess and reduce physical and psychological health risks
of the donor. Taking will not be carried out if there is a serious risk to life or
donor health.
Article 12
NOTICE TO THE DONORS
The donor and, where justified, the person or body empowering the
Article 14, paragraph 2, of this Protocol, shall receive an appropriate advance
information on the purpose and nature of the intake and the consequences and risks.
They will also be informed of the rights prescribed by law for the purpose
donor protection. In particular, they will be informed of the right to impartial advice for
possible risks by a healthcare professional who has appropriate experience and
which does not participate in the subsequent process of organ and tissue removal and transplantation.
Article 13
CONSTITUTION OF A LIVING GIFT
According to Articles 14 and 15 of this Protocol, an organ or tissue may be taken alive
of the donor, provided that the person concerned is informed and is in favor
the procedure gave free consent in writing.
The donor is free to withdraw his or her consent at any time.
Article 14
PROTECTION OF PERSONS WHO ARE NOT ABLE TO GIVE ACCEPT
1. It is not allowed to take organs or tissues from a person who is unable to give
consent under Article 13 of this Protocol.
2. Exceptionally and under the conditions prescribed by law, the taking may be authorized
regenerative tissue from a person who is incapable of giving consent after they have
the following conditions are met:
(i) there is no compatible donor available to consent,
(ii) the recipient is the brother or sister of the donor,
(iii) the gift must have the purpose of saving the life of the recipient;
(iv) the approval of his or her legal representative or competent authority
provided for by law is given clearly and in writing,
(v) the potential donor does not object.
Article 15
TAKING STATIONS FROM A LIVING GIFT
The law may provide that the provisions of Article 14, paragraph 2, point (ii) of that point
(iii) not apply to cells if their uptake is found to include
only minimal risk and minimal burden on the donor.
IV. Chapter
TAKING BODIES AND Tissues From A Deceased Person
Article 16
CERTIFICATE OF DEATH
Organs and tissues will not be taken from the body of a deceased person unless that person is
officially declared dead in accordance with the law.
Doctors who issue a death certificate may not be the same participating physicians
in the taking of organs or tissues from a deceased person or who are responsible for the care of
potential organ or tissue recipients.
Article 17
CONNECTION
Organs or tissues will not be taken from the body of a deceased person unless obtained
consent in accordance with the law.
The taking is not carried out if the deceased person objected.
Article 18
DIGNITY OF THE HUMAN BODY
When taking organs and tissues from a deceased person, it is necessary to treat them
due respect and take all measures to ensure that the appearance of the deceased person remains
unchanged.
Article 19
PROMOTION OF BODIES AND TISSUE GIFTS
The Parties shall take all appropriate measures to promote the gift
organs and tissues.
Chapter V.
TRANSFER OF BODIES OR TISSUES TAKEN FOR ANOTHER PURPOSE, NOT WORKING
TRANSFERS
Article 20
TRANSFER OF BODIES OR TISSUES TAKEN INTO ANOTHER PURPOSE
DON'T MAKE GIFTS FOR TRANSFER
1. When an organ or tissue is taken from a person for another reason than it does not work
gifts for the purpose of transplantation can only be transplanted if the consequences are i
the possible risks explained to that person and, if informed, the person
gave free consent.
2. All the provisions of this Protocol shall apply to the situations referred to in paragraph 1 of this Protocol
articles other than those in Chapter III. and IV.
VI. Chapter
MONEY PROFIT PROHIBITION
Article 21
MONEY PROFIT PROHIBITION
1. The human body and its parts must not, as such, be a source of money or the like
to get.
The preceding paragraph shall not prevent payments which do not represent monetary gain or
comparable benefit, in particular:
- compensation to living donors for lost profits or any other
justified costs caused by taking or related to necessary
health checks,
- payment of justified fees for necessary health or similar technical servants
provided in connection with the transplant,
- compensation in the event of excessive damage resulting from the taking of an organ or
tissues from a living donor.
2. It is prohibited to advertise the needs or availability of a target organ or tissue
offering or seeking monetary or similar profit.
Article 22
PROHIBITION OF TRADING OR TISSUES
Organ and tissue trafficking is prohibited.
VII. Chapter
CONFIDENTIALITY
Article 23
CONFIDENTIALITY
1. All personal data relating to the donor and recipient person shall be considered
confidential. Such data may only be collected, processed and communicated
according to regulations regarding professional confidentiality and personal protection
data.
2. The provision of paragraph 1 shall be interpreted without bias with respect to the provisions which
allow, with the application of appropriate safeguards, to collect, process and
communication of necessary notifications of organ or tissue donors or recipients
if necessary for health purposes, including monitoring, how
is provided for in Article 3 of this Protocol.
VIII. Chapter
INFRINGEMENT OF PROTOCOL PROVISIONS
Article 24
VIOLATIONS OF RIGHTS OR PRINCIPLES
The parties are required to provide adequate judicial protection in the short term in order
prevent or stop unlawful infringement of the rights and principles set out in this
Protocol.
Article 25
EXTRAORDINARY DAMAGES
A person who has suffered excessive damage resulting from the taking and
the transplant is entitled to fair compensation under the terms and procedures
prescribed by law.
Article 26
PUNISHMENTS
The parties are required to prescribe the appropriate penalties to be applied in the case
violations of the provisions of this Protocol.
IX. Chapter
COOPERATION OF THE PARTIES
Article 27
COOPERATION OF THE PARTIES
The Parties shall take appropriate measures to ensure that they are effective
mutual cooperation in transplantation of organs and tissues, inter alia through
exchange of information.
They will, in particular, take appropriate measures to facilitate rapid and safe operation
transport of organs and tissues from or to their territory.
Chapter X
RELATIONSHIP OF PROTOCOLS AND CONVENTIONS AND REVIEW OF PROTOCOLS
Article 28
RELATIONSHIP OF PROTOCOL AND CONVENTION
The Parties shall consider the provisions of Articles 1 to 27 of this Protocol additional
Articles of the Convention on Human Rights and Biomedicine and all provisions
Conventions should be applied accordingly.
Article 29
REVIEW OF THE PROTOCOL
In order to monitor scientific developments, this Protocol will be reviewed by
by the Committee referred to in Article 32 of the Convention on Human Rights and Biomedicine
at the latest five years after the entry into force of the Protocol, and thereafter at
at intervals determined by himself.
XI. Chapter
FINAL PROVISIONS
Article 30
SIGNATURE AND RATIFICATION
This Protocol shall be open for signature by States signatory to the Convention. He
subject to ratification, acceptance or approval. A State Party may not ratify,
to accept or approve the Protocol, if it has not been ratified before or at the same time,
accepted or approved the Convention. Instruments of ratification, acceptance or approval
deposited with the Secretary General of the Council of Europe.
Article 31
ENTRY INTO FORCE
1. This Protocol shall enter into force on the first day of the month following its expiration
a three-month period after the date when five states, including at least
four member states of the Council of Europe, declaring that they agree to be bound by this
Protocol in accordance with the provisions of Article 30.
2. For any signatory which subsequently agrees to be bound by this Protocol,
it shall take effect after the expiry of a period of three months after deposit
instruments of ratification, acceptance or approval.
Article 32
ACCESS
1. After the entry into force of this Protocol, any acceding State
It may also accede to the Protocol.
2. Accession shall be effected by the deposit of an instrument of accession with the Secretary-General
The Council of Europe, which will enter into force on the first day of the month following
three months after the date of deposit of the document.
Article 33
CANCELLATION
1. Any Party may, at any time, denounce this Protocol by notification
addressed to the Secretary General of the Council of Europe.
2. Such cancellation shall take effect on the first day of the month following
the expiry of a period of three months after the date of receipt of such by the Secretary General
notice.
Article 34
NOTICE
The Secretary General of the Council of Europe shall notify the member States of the Council of Europe, the European Council
the Community, each State Party, each Party and any State which is
invited to accede to the Convention, on:
a. every signing,
b. the deposit of an instrument of ratification, acceptance, approval or accession,
c. any date of entry into force of this Protocol in accordance with Article 31 and
32.,
d. any other act, notification or communication relating to this Protocol.
In witness whereof, the undersigned, being duly authorized thereto, have signed this one
Protocol.
Done at Strassbourg, 24 January 2002, in English and French
language, in which both texts are equally authentic, in one copy which will
be deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe shall deliver
certified copies to each member state of the Council of Europe, non-member countries
who have participated in the drafting of this Protocol and any State called upon to do so
accession to this Protocol and to the European Community.
Article 3
In accordance with Article 36 of the Convention for the Protection of Human Rights and Human Dignity
beings in the application of biology and medicine: the Convention on Human Rights and
biomedicine, the Republic of Croatia places the following reservation on the conditions prescribed
Article 20 (2), subparagraph ii. Conventions:
The Republic of Croatia excludes the application of the restriction contained in Article 20.
paragraph 2, subparagraph ii of the Convention, which exceptionally allows removal
regenerative tissue from a person who is incapable of giving consent only if there is none
at the disposal of a compatible donor able to consent, and the recipient
is the donor brother or sister. The specified restriction is not allowed
the removal of regenerative tissue (bone marrow) from a minor in favor
parents. Such a restriction is not in accordance with the applicable Law of the Republic
Of Croatia - Law on Conditions for Taking and Transplanting Parts of the Human Body
(Official Gazette 53/91), which permits the transplantation of regenerative tissue
from a minor for the benefit of the parent. The Republic of Croatia is thus protecting the vital
the interests of the minor donor because it saves the life of his parent who
is necessary.
The Republic of Croatia shall apply Article 20 (2) (ii)
Conventions, in the way that the recipient is: the donor’s parent, brother or sister.
Article 4
Ministries and other state bodies are responsible for the implementation of this Law
the administration of the Republic of Croatia, within the scope of which certain rights are exercised
provided for in the Convention and the additional protocols.
Article 5
On the date of the entry into force of this Act, the Convention and the additional protocols referred to in
Article 1 of this Law for the Republic of Croatia are not in force, and so will the data
of their entry into force subsequently, in accordance with the provisions of Article 30.
paragraph 3 of the Law on Conclusion and Execution of International Treaties.
Article 6
This Law shall enter into force on the eighth day after its publication in the Official Gazette
newspaper «.
Class: 018-05 / 03-01 / 06
Zagreb, 14 July 2003
CROATIAN PARLIAMENT
The President
Of the Croatian Parliament
Zlatko Tomcic, v. r.