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.
Additional Protocol concerning Genetic Testing for Health Purposes
The Convention on Human Rights and Biomedicine (Oviedo Convention) and its Additional Protocol concerning Genetic Testing for Health Purposes
The Convention on Human Rights and Biomedicine (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.
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.
Predictivity, Genetic Testing and Insurance: Adoption of a Recommendation
Following the adoption of the Additional Protocol, the DH-BIO then agreed to address the applications of genetics outside the medical field starting in the field of insurance.
It's on 26 October 2016 that the Recommendation CM/Rec(2016)8 on the processing of personal health-related data for insurance purposes, including data resulting from genetic tests was adopted by the Committee of Ministers.
The Council of Europe calls upon the Governments of its Member States to ensure non-discrimination, including on grounds of genetic characteristics, and the protection of private life in the framework of insurance contracts covering risks related to health, age or death. “People’s health and genetic data are highly sensitive and must be properly protected. Governments have duty to ensure nobody is discriminated on the grounds of his or her genetic characteristics. Genetic tests for insurance purposes should therefore be banned,” said Secretary General Jagland. “Our recommendations show the way how to better protect the rights of insured people in an increasingly international market,” he added. The new Recommendation adopted today sets out essential principles aimed at protecting the rights of persons whose personal data are processed for insurance purposes. It takes into account insurance companies’ legitimate interest in assessing the level of risk presented by the insured person. The recommended measures include strict safeguards for the collection and processing of health-related personal data, based on the insured person’s consent, as well as the prohibition of requiring genetic tests for insurance purposes. As a first international legal instrument in this field, the Recommendation notably aims at preventing any processing of health-related data which would not be justified and would not comply with the criteria of relevance and validity. The text also underlines the necessity of facilitating access to insurance, under affordable conditions, to persons presenting an increased health risk, and the importance of promoting fair and objective settlement of disputes between insured persons and insurers.
Leaflet on Genetic Tests for Health Purposes: general information on genetic testing for the general public
Following the adoption of the Additional Protocol, and to contribute to facilitating its implementation, a Leaflet on Genetic Tests for Health Purposes has been 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 29 languages with the support of the European Society of Human Genetics and Eurogentest.
Background document on preimplantation and prenatal genetic testing
This background paper, elaborated by the Secretariat comes within the realm of the reflection on ethical issues raised by the 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.
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...
Watch video of the PACE debate "Manufacturing a New Human Species?" Mark Bale, Chair of the Committee on Bioethics (DH-BIO) participated in the debate on the use of genome editing technology (CRISPR-Cas9). The debate was organised by PACE on 30 September 2015 from 14.00 to 15.30. Interview of...