Council of Europe adopts protocol on genetic testing for health purposes

Abstract

A new Additional Protocol to the Convention on Human Rights and Biomedicine On 7 May 2008, the first international legally binding instrument concerning genetic testing for health purposes was adopted by the Committee of Ministers of the Council of Europe. (The Council of Europe, set up in 1949, is an intergovernmental organization with a pan-European vocation that aims at fostering a closer cooperation between its 47 Member States (which include the 27 EU members) for the protection of human rights and the promotion of democracy. Since the beginning of the 1980s, this organization has been active in the field of bioethics. A substantial legal corpus has been developed laying down fundamental principles. The reference instrument is the Convention on Human Rights and Biomedicine (ETS no. 164, 1997).) The sequencing of the human genome and the development of new technologies make human genetics a very dynamic sector. The very rapid progress in this field has prompted the Council of Europe to focus on the ethical and legal issues raised by applications of genetics, in particular genetic testing, and to draw up legal standards to protect fundamental human rights with regard to these applications. Protection and guarantees in the fields of biology and medicine, including human genetics, are provided by the Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Applications of Biology and Medicine (Convention on Human Rights and Biomedicine). (Convention on Human Rights and Biomedicine (Oviedo Convention) (ETS no. 164)). This Council of Europe convention was opened for signature on 4 April 1997 and has been signed by most European states. It sets out fundamental principles applicable to routine medicine and those that apply to new technology in the area of human biology and medicine. It also serves as a reference instrument for the European Union and for other international organizations, such as UNESCO and WHO. The Convention sets out a number of principles with regard to genetics (Articles 11–14), particularly genetic testing and interventions on the human genome. To develop and supplement the principles set forth in the Convention, the Council of Europe Steering Committee on Bioethics (CDBI) elaborated a new Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes. This Protocol was adopted by the Committee of Ministers of the 47 Member States of the Council of Europe on 7 May 2008 and opened for signature on 28 November 2008.