The sequencing of the human genome and the development of new technologies such as DNA chips make human genetics and genomics 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) and its Additional Protocol concerning Genetic Testing for Health Purposes. Oviedo Convention contains specific provisions relating to genetics (Articles 11 to 14), particularly predictive genetic tests and interventions on the human genome.

The principles laid down in these provisions were developed and complemented in the Additional Protocol concerning Genetic Testing for Health Purposes 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 does not cover genetic tests carried out on the human embryo or foetus (see background document on preimplantation and prenatal genetic testing) and genetic tests for research purposes.