Key Benefits:
President of the Republic,
On the report of the Prime Minister and the Minister for Foreign Affairs,
Considering the Constitution, in particular articles 52 to 55;
Vu la Act No. 2011-814 of 7 July 2011 on bioethics, including article 1;
Vu le Decree No. 53-192 of 14 March 1953 amended on the ratification and publication of international commitments undertaken by France,
Decrete:
The Convention for the Protection of Human Rights and Human Dignity in the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, signed in Oviedo on 4 April 1997, will be published in the Official Journal of the French Republic.
The Prime Minister and the Minister for Foreign Affairs are responsible for the execution of this Order, which will be published in the Official Journal of the French Republic.
C O N V E N T I O N
FOR THE PROTECTION OF THE RIGHTS OF THE HOMME AND DIGNITY OF THE BEHUM WITH THE IMPLEMENTATION OF BIOLOGY AND MEDECINE: CONVENTION ON HUMAN RIGHTS AND BIOMEDECINE
Preamble
Member States of the Council of Europe, other States and the European Community signatories to this Convention,
Considering the Universal Declaration of Human Rights, proclaimed by the United Nations General Assembly on 10 December 1948;
Considering the Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950;
Considering the European Social Charter of 18 October 1961;
Considering the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights of 16 December 1966;
Considering the Convention for the Protection of Persons with regard to the automated processing of personal data of 28 January 1981;
Considering also the Convention on the Rights of the Child of 20 November 1989;
Considering that the purpose of the Council of Europe is to achieve a closer union between its members, and that one of the means to achieve this goal is to safeguard and develop human rights and fundamental freedoms;
Aware of the rapid developments in biology and medicine;
Convinced of the need to respect both human beings and their membership in the human species and recognizing the importance of ensuring their dignity;
Aware of the actions that could endanger human dignity through the improper use of biology and medicine;
Affirming that progress in biology and medicine must be used for the benefit of present and future generations;
Emphasizing the need for international cooperation to ensure that all humankind enjoys the contribution of biology and medicine;
Acknowledging the importance of promoting a public debate on the issues posed by the application of biology and medicine, and the answers to it;
Desirous of reminding each member of the social body of his rights and responsibilities;
Taking into consideration the work of the Parliamentary Assembly in this area, including Recommendation 1160 (1991) on the development of a bioethics convention;
Determined to take, in the field of applications of biology and medicine, measures to guarantee the dignity of the human being and the fundamental human rights and freedoms,
The following agreed:
Article 1
Purpose and finality
The Parties to this Convention shall protect the human being in his or her dignity and identity and shall guarantee to everyone, without discrimination, respect for his or her integrity and other fundamental rights and freedoms with regard to the applications of biology and medicine.
Each Party shall take the necessary measures in its domestic law to give effect to the provisions of this Convention.
Article 2
Primity of the human being
The interest and good of the human being must prevail over the sole interest of society or science.
Article 3
Equitable access to health care
Parties shall take appropriate measures, taking into account health needs and available resources, to ensure, in their jurisdiction, equitable access to appropriate quality health care.
Article 4
Occupational obligations
and rules of conduct
Any intervention in the field of health, including research, must be carried out in accordance with professional standards and obligations, as well as applicable rules of conduct in this case.
Article 5
General rule
An intervention in the field of health can only be made after the person concerned has given his or her free and informed consent.
This person is previously provided with adequate information on the purpose and nature of the intervention and its consequences and risks.
The data subject may, at any time, freely withdraw consent.
Article 6
Protection of persons
not having the capacity to consent
1. Subject to sections 17 and 20, an intervention may be made on a person who is not able to consent only for his or her direct benefit.
2. Where, according to the law, a minor does not have the capacity to consent to an intervention, the intervention may not be carried out without the authorization of his or her representative, authority or body designated by law.
The opinion of the minor is taken into account as an increasingly important factor, depending on the age and maturity of the minor.
3. Where, according to the law, a major does not, because of a mental disability, illness or for a similar reason, have the capacity to consent to an intervention, the intervention may not be carried out without the authorization of its representative, authority or person or body designated by law.
The person concerned must, to the extent possible, be associated with the authorization procedure.
4. The representative, authority, person or proceeding referred to in paragraphs 2 and 3 shall receive, under the same conditions, information referred to in section 5.
5. The authorization referred to in paragraphs 2 and 3 may, at any time, be withdrawn in the interest of the person concerned.
Article 7
Protection of persons
suffering from a mental disorder
A person who suffers from a serious mental disorder may not be subjected, without his or her consent, to an intervention intended to treat this disorder only when the absence of such treatment may be seriously detrimental to his or her health and subject to the conditions of protection provided by law including monitoring and control procedures and remedies.
Article 8
Emergency situations
Where, 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 person concerned.
Article 9
Previously expressed wishes
Previously expressed wishes about a medical intervention by a patient who, at the time of the intervention, is not in a position to express their will will be taken into account.
Article 10
Privacy and the right to information
1. Everyone has the right to respect his or her privacy with respect to health information.
2. Everyone has the right to know any information collected about his or her health. However, a person's desire not to be informed must be respected.
3. In exceptional circumstances, the law may provide, in the patient's interest, restrictions on the exercise of the rights referred to in paragraph 2.
Article 11
Non-discrimination
Any form of discrimination against a person because of his or her genetic heritage is prohibited.
Article 12
Predictive genetic tests
Predictive tests of genetic diseases may not be carried out or may be used to identify the subject as a gene responsible for a disease or to detect genetic predisposition or susceptibility to a disease for medical or medical purposes, and subject to appropriate genetic advice.
Article 13
Interventions on the human genome
An intervention intended to modify the human genome can only be undertaken for preventive, diagnostic or therapeutic reasons and only if it is not intended to introduce a modification in the genome of the progeny.
Article 14
Non-selection of sex
The use of reproductive medical assistance techniques is not allowed to choose the sex of the unborn child, except for the purpose of avoiding a serious inherited disease related to sex.
Article 15
General rule
Scientific research in the field of biology and medicine is carried out freely, subject to the provisions of this Convention and other legal provisions that ensure the protection of the human being.
Article 16
Protection of people lending to research
No research may be undertaken on a person unless the following conditions are met:
i. There is no alternative method for research on human beings, of comparable efficacy;
ii. the risks that may be incurred by the person are not disproportionate to the potential benefits of the research;
iii. the research project was approved by the competent authority, after an independent review of its scientific relevance, including an assessment of the importance of the research objective, as well as a multidisciplinary review of its ethical acceptability;
iv. the person seeking research is informed of his or her rights and the guarantees provided for by law for his or her protection;
v. the consent referred to in Article 5 has been expressly given, specifically and is documented in writing. This consent may, at any time, be freely withdrawn.
Article 17
Protection of people who do not have
the ability to consent to research
1. A search may not be undertaken on a person who does not, in accordance with section 5, have the capacity to consent to it only if the following conditions are met:
i. the conditions set out in article 16, paragraphs i to iv, are met;
ii. the expected results of the research have a real and direct benefit to its health;
iii. research cannot be carried out with comparable efficiency on subjects capable of consenting to it;
iv. the authorization provided for in Article 6 was given specifically and in writing; and
v. the person does not object to a refusal.
2. On an exceptional basis and under the conditions of protection provided for by law, a research whose intended results do not have a direct benefit to the health of the person may be authorized if the conditions set out in paragraphs 1 (i), (iii), (iv) and (v) above and the following additional conditions are met:
i. the purpose of the research is to contribute, by a significant improvement in the scientific knowledge of the state of the person, his or her illness or disorder, to the attainment, in term, of results allowing a benefit to the person concerned or to other persons in the same age category or suffering from the same disease or disorder or having the same characteristics;
ii. research only presents a minimum risk and a minimum stress to the person.
Article 18
Research on embryos in vitro
1. When research on in vitro embryos is permitted by law, it ensures adequate protection of the embryo.
2. The constitution of human embryos for research purposes is prohibited.
Article 19
General rule
1. The removal of organs or tissue for transplantation can only be done on a living donor in the recipient's therapeutic interest and where there is no appropriate organ or tissue of a deceased person or alternative therapeutic method of comparable effectiveness.
2. The consent referred to in Article 5 must have been expressly and specifically given, either in writing or before an official proceeding.
Rule 20
Protection of people who do not have the capacity
consent to organ sampling
1. No organ or tissue sampling may be performed on a person who does not have the capacity to consent in accordance with section 5.
2. In exceptional circumstances and in the conditions of protection provided by law, the removal of regenerable tissue from a person who has no capacity to consent may be authorized if the following conditions are met:
i. a compatible donor with the ability to consent is not available;
ii. the receiver is a brother or sister of the donor;
iii. the gift must be of a nature to preserve the life of the recipient;
iv. the authorization provided for in paragraphs 2 and 3 of Article 6 has been given specifically and in writing, according to the law and in agreement with the competent body;
v. the potential donor does not object to a refusal.
Article 21
Prohibition of profit
The human body and its parts should not be, as such, a source of profit.
Article 22
Use of part of the collected human body
When a portion of the human body has been taken during an intervention, it may not be retained and used for any purpose other than that for which it was taken only in accordance with the appropriate information and consent procedures.
Article 23
Rights or principles
The Parties shall provide appropriate legal protection in order to prevent or terminate, at short notice, an unlawful infringement of the rights and principles recognized in this Convention.
Article 24
Repair of unjustified damage
A person who has suffered an unjustified injury resulting from an intervention shall be entitled to a fair remedy under the conditions and conditions laid down by law.
Rule 25
Sanctions
The Parties shall provide appropriate sanctions in cases of breach of the provisions of this Convention.
Rule 26
Restrictions on the exercise of rights
1. The exercise of rights and the provisions of protection contained in this Convention shall not be subject to any other restrictions other than those which, as provided by law, constitute necessary measures, in a democratic society, to public safety, to the prevention of criminal offences, to the protection of public health or to the protection of the rights and freedoms of others.
2. The restrictions referred to in the preceding paragraph may not be applied to sections 11, 13, 14, 16, 17, 19, 20 and 21.
Rule 27
Extended protection
None of the provisions of this Convention shall be construed as limiting or impairing the ability of each Party to provide greater protection in respect of applications of biology and medicine than that provided for in this Convention.
Rule 28
Public debate
The Parties to this Convention shall ensure that the fundamental questions posed by developments in biology and medicine are the subject of appropriate public debate in the light, in particular, of the relevant medical, social, economic, ethical and legal implications, and that their possible applications are subject to appropriate consultations.
Rule 29
Interpretation of the Convention
The European Court of Human Rights may give, in addition to any specific dispute before a court, advisory opinions on legal issues concerning the interpretation of this Convention at the request of:
- the Government of a Party, after having informed the other Parties;
the Committee established by article 32, in its limited membership to the Representatives of the Parties to this Convention, by a two-thirds majority of the votes cast.
Rule 30
Reports on the implementation of the Convention
Any Party shall, upon request of the Secretary-General of the Council of Europe, provide the necessary explanations on how its domestic law ensures the effective implementation of all provisions of this Convention.
Rule 31
Protocols
Protocols may be developed in accordance with the provisions of Article 32 with a view to developing, in specific areas, the principles contained in this Convention.
The protocols are open for signature by signatories to the Convention. They will be subject to ratification, acceptance or approval. A signatory may not ratify, accept or approve the protocols without having previously or simultaneously ratified, accepted or approved the Convention.
Rule 32
Amendments to the Convention
1. The tasks assigned to the "Committee" in this section and in section 29 are performed by the Steering Committee for Bioethics (CDBI), or by any other committee designated for this purpose by the Committee of Ministers.
2. Without prejudice to the specific provisions of Article 29, any Member State of the Council of Europe and any Party to this Convention that is not a member of the Council of Europe may be represented in the Committee when the Committee performs the tasks entrusted by this Convention and shall have a vote thereon.
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 this Convention, may designate an observer to the Committee. If the European Community is not a Party, it may designate an observer to the Committee.
4. In order to take into account scientific developments, this Convention will be reviewed within the committee within a maximum of five years after it comes into force, and thereafter at intervals that the committee may determine.
5. Any proposal to amend this Convention and any proposal for a protocol or amendment to a protocol, submitted by a Party, by the Committee or the Committee of Ministers, shall be communicated to the Secretary General of the Council of Europe and transmitted by his care to the States members 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 to this Convention.
6. The Committee shall consider the proposal no later than two months after it has been transmitted by the Secretary General in accordance with paragraph 5. The Committee shall submit the text adopted by a two-thirds majority of the votes cast for approval by the Committee of Ministers. After its approval, this text is communicated to Parties for ratification, acceptance or approval.
7. Any amendment shall enter into force, with respect to the Parties that have accepted it, on the first day of the month following the expiration of one month after the date on which five Parties, including at least four Member States of the Council of Europe, have informed the Secretary General that they have accepted it.
For any Party that has subsequently accepted 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 said Party has informed the Secretary General of its acceptance.
Rule 33
Signature, ratification and entry into force
1. This Convention is open for signature by the Member States of the Council of Europe, the non-member States that participated in its preparation and the European Community.
2. This Convention shall be subject to ratification, acceptance or approval. Instruments of ratification, acceptance or approval will 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 the preceding paragraph.
4. For any Signatories who subsequently express their consent to be bound by the Convention, the Agreement shall enter into force on the first day of the month following the expiration of a period of three months after the date of deposit of its instrument of ratification, acceptance or approval.
Rule 34
States not members
1. After the entry into force of this Convention, the Committee of Ministers of the Council of Europe may, after consultation with the Parties, invite any non-member State of the Council of Europe to accede to this Convention by a majority decision provided for in Article 20, paragraph (d), of the Statute of the Council of Europe and unanimously by the representatives of the Contracting States entitled to sit on the Committee of Ministers.
2. For any Member State, 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 the instrument of accession to the Secretary General of the Council of Europe.
Rule 35
Territorial application
1. Any Signatories may, at the time of signature or at the time of deposit of their instrument of ratification, acceptance or approval, designate the territory or territories to which this Convention applies. Any other State may make the same declaration at the time of deposit of its instrument of accession.
2. Any Party may, at any time thereafter, by a declaration addressed to the Secretary General of the Council of Europe, extend the application of this Convention to any other territory designated in the declaration and to which it provides international relations or for which it is authorized to provide. The Convention shall enter into force in respect of that territory on the first day of the month following the expiration of a period of three months after the date of receipt of the declaration by the Secretary-General.
3. Any declaration made under the preceding two paragraphs may be withdrawn, with respect to any territory designated in that declaration, by notification addressed to the Secretary-General. The withdrawal 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 the notification by the Secretary General.
Rule 36
Reservations
1. Any State and the European Community may, at the time of signing this Convention or the deposit of the instrument of ratification, acceptance, approval or accession, make a reservation with respect to a particular provision of the Convention, to the extent that a law then in force on its territory is not in conformity with that provision. General reservations are not permitted under this article.
2. Any reservation made under this section shall contain a brief statement of the relevant law.
3. Any Party extending the application of this Convention to a territory designated by a declaration under paragraph 2 of Article 35 may, for the territory concerned, make a reservation in accordance with the provisions of the preceding paragraphs.
4. Any Party that has made the reservation referred to in this article may withdraw it by means of a statement addressed to the Secretary General of the Council of Europe. The withdrawal shall take effect on the first day of the month following the expiration of one month after the date of receipt by the Secretary General.
Rule 37
Denunciation
1. Any Party may, at any time, denounce this Convention by sending a notification to the Secretary General of the Council of Europe.
2. The denunciation 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 the notification by the Secretary General.
Rule 38
Notifications
The Secretary General of the Council of Europe shall notify the States members of the Council, the European Community, any Signatories, any Party and any other State that has been invited to accede to this Convention:
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 its Articles 33 or 34;
d. any amendment or protocol adopted in accordance with Article 32, and the date on which that 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 accordance with the provisions of Article 36;
g. any other act, notification or communication relating to this Convention.
In faith, the undersigned, duly authorized to do so, have signed this Convention.
Done at Oviedo (Asturias), on 4 April 1997, in French and English, both texts being equally authentic, in a single copy which will be deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe shall transmit certified copies thereof to each Member State of the Council of Europe, to the European Community, to the non-member States that have participated in the elaboration of this Convention, and to any State invited to accede to this Convention.
Done on 5 July 2012.
François Hollande
By the President of the Republic:
The Prime Minister,
Jean-Marc Ayrault
Minister of Foreign Affairs,
Laurent Fabius
