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 contains some principles relating to genetics (Articles 11 to 14), particularly genetic tests and interventions on the human genome. The draft Protocol, which will extend the protection of individuals in this area, will consist of two main parts: one relating to medical applications of genetics and the other to non-medical applications.

It is envisaged that the Protocol will deal with the issues of individual genetic tests, screening programmes, gene therapy and genetics research. In connection with this, the fundamental issues of consent and the quality of genetic services will be addressed. The part of the Protocol relating to non-medical applications of genetics will deal in particular with the use of genetic tests in connection with employment and insurance.

Progress of Work

The Working Party responsible for preparing the draft Protocol on Human Genetics held its first meeting in September 1997. Before beginning to prepare the legal instrument, it organised a hearing of genetics experts in April 1998 and a hearing of European organisations of patients affected by genetic diseases in June 1998.

The Working Party first focused on the applications of genetics for health purposes. The result of its work was made public in February 2003 as a working document, for comments. In October 2004, the CDBI agreed to focus the Protocol on genetic testing. In May 2006, the CDBI decided to split the Protocol and to bring out separate instruments dealing with genetic testing for health purposes, for employment and for insurance purposes.

The Protocol was approved by the CDBI at its 32nd meeting (4-8 June 2007). The draft Protocol was submitted to the Parliamentary Assembly for consultation by the Committee of Ministers prior to final adoption. The Protocol was adopted by the Committee of Ministers on 7 May 2008 and opened for signature on 27 November 2008. Work on the genetic testing for non-medical purposes has now started. The Group of Specialists is now considering genetic testing in the field of insurance.

Background document on preimplantation and prenatal genetic testing

This background paper, elaborated by the Secretariat of the CDBI comes within the realm of the reflection on ethical issues raised by the application of genetics. A first step in this work has been completed with the adoption on 7 May 2008 of the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes. 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 will be updated regularly.