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.


Back Statement on Genome Editing Technologies

Council of Europe supports new genome editing technologies, but within certain limits
Statement on Genome Editing Technologies

The DH-BIO adopted a Statement on Genome Editing Technologies during it's 8th meeting in Strasbourg on 2 December 2015.

The scientific community is abuzz with discussion of the new technologies to modify genes such as CrisprCas9. “There is strong support for better understanding of causes of diseases and future treatment through new technologies, however the application of genome editing to human gametes or embryos raises many ethical, social and safety issues, particularly modification which could be passed on to future generations,” said the Council of Europe Committee on bioethics DH-BIO in a statement.

The committee stressed  the Oviedo Convention as the only international legally binding treaty addressing human rights in the biomedical field. The article 13 in the convention limits the purposes of any intervention on the human genome, including in the field of research, to prevention, diagnosis or therapy. In addition, it prohibits any gene modification of embryos that would be passed on to future generations.

The Committee on Bioethics agreed, as part of its mandate, to examine the ethical and legal challenges raised by the emerging genome editing technologies.

  • Interview of Mark Bale, Chair of the Committee on Bioethics [en] :
Strasbourg 2/12/2015
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