Human Genetics

The sequencing of the human genome and the development of new technologies such as DNA chips make human genetics a highly dynamic sector. The very rapid developments in this area have prompted the Council of Europe to focus on the ethical and legal issues raised by applications of genetics and to draw up legal instruments to protect fundamental human rights with respect to these applications.

The Convention on Human Rights and Biomedicine (Oviedo Convention) contains some specific provisions relating to genetics (Articles 11 to 14), particularly predictive genetic tests and interventions on the human genome.

Later, it was agreed to develop and complement the principles of the Oviedo Convention in an additional Protocol.

The Additional Protocol concerning Genetic Testing for Health Purposes was adopted on 7 May 2008. This Protocol applies to tests, which are carried out for health purposes, involving analysis of biological samples of human origin and aiming specifically to identify the genetic characteristics of a person which are inherited or acquired during early prenatal development ("genetic tests").

The Protocol sets down principles relating inter alia to the quality of genetic services, prior information and consent and genetic counselling. It lays down general rules on the conduct of genetic tests, and, for the first time at international level, deals with the directly accessible genetic tests for which a commercial offer could develop in future. It specifies the conditions in which tests may be carried out on persons not able to consent. Also covered are the protection of private life and the right to information collected through genetic testing. Finally, the Protocol touches on genetic screening.

Following the adoption of the additional Protocol, and to contribute to facilitating its implementation, a Leaflet on Genetic TEsts for Health Purposes has bee prepared. The Leaflet aims at providing general objective information on genetic tests, including their nature and the potential implications of their results. The leaflet has so far been translated into 27 languages with the support of the European Society of Human Genetics and Eurogentest.

The DH-BIO then agreed to adress the application of genetics outside the medical field starting in the field of insurance.

A Seminar on Predictivity, Genetic TEsts and Insurance was held on 3-4 December 2007. Following that, the Committee on Bioethics (DH-BIO) prepared and published for consultation a Document on Predictivity, Genetic TEsting and Insurance. During its meeting on 26-28 November 2013, the DH-BIO agredd to prepare a non-legally binding instrument in the form of a Recommendation of the Commitee of Ministers to the governments of the member States.

Background document on preimplantation and prenatel genetic testing

This background paper, elaborated by the Secretariat of the CDBI comes within the realm of the reflection on ethical issues raised by teh application of genetics. The document aims at contributing to this reflection by providing information on clinical practice, trends and technological developments concerning PGD/PND (Part I) as well as relevant legal framework in force in the Council of Europe members States (Part II).

Part II of the document is regularly updated.