CouncilEurope

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

(ETS No. 164)

Open for signature by the member States of the Council of Europe, the non-member States which have participated in its elaboration and by the European Union, in Oviedo, on 4 April 1997.

Entry into force : 1 December 1999.

Summary of the treaty

The Convention is the first legally-binding international text designed to preserve human dignity, rights and freedoms, through a series of principles and prohibitions against the misuse of biological and medical advances.

The Convention's starting point is that the interests of human beings must come before the interests of science or society. It lays down a series of principles and prohibitions concerning bioethics, medical research, consent, rights to private life and information, organ transplantation, public debate etc.

It bans all forms of discrimination based on the grounds of a person's genetic make-up and allows the carrying out of predictive genetic tests only for medical purposes. The treaty allows genetic engineering only for preventive, diagnostic or therapeutic reasons and only where it does not aim to change the genetic make-up of a person's descendants. It prohibits the use of techniques of medically assisted procreation to help choose the sex of a child, except where it would avoid a serious hereditary condition.

The Convention sets out rules related to medical research by including detailed and precise conditions, especially for people who cannot give their consent. It prohibits the creation of human embryos for research purposes and requires an adequate protection of embryos where countries allow in-vitro research.

The Convention states the principle according to which a person has to give the necessary consent for treatment expressly, in advance, except in emergencies, and that such consent may be freely withdrawn at any time. The treatment of persons unable to give their consent, such as children and people with mental illnesses, may be carried out only if it could produce real and direct benefit to his or her health,

The Convention stipulates that all patients have a right to be informed about their health, including the results of predictive genetic tests. The Convention recognises also the patient's right not to know.

The Convention prohibits the removal of organs and other tissues which cannot be regenerated from people not able to give consent. The only exception is, under certain conditions, for regenerative tissue (especially bone marrow) between siblings.

The Convention recognises the importance of promoting a public debate and consultation on these questions. The only restrictions are those prescribed by law and which are necessary in a democratic society in the interest of public safety, for the prevention of crime, for the protection of public health or for the protection of the rights and freedoms of others.

Additional Protocols are foreseen to clarify, strengthen and supplement the overall Convention.

The Steering Committee on Bioethics (CDBI), or any other committee designated by the Committee of Ministers or the Parties may request the European Court of Human Rights to give advisory opinions on legal questions concerning the interpretation of the Convention.