Council of Europe

BIOETHICS AT THE COUNCIL OF EUROPE

Biological and medical research and developments in technology have produced spectacular advances in the health field. However, these advances raise ethical issues that affect the individual and protection of the individual�s rights and dignity (genetics, medically assisted procreation, prenatal diagnosis, stem cell research etc). A brochure on Bioethics at the Council of Europe informs about the activities of the Council of Europe in the field of bioethics.

The Committee on Bioethics

One of the objectives of the Council of Europe is to protect the individual�s dignity and fundamental rights with regard to the applications of biology and medicine. To that end, the Committee on Bioethics (DH-BIO), formerly Steering Committee on Bioethics (CDBI), was set up to address ethical and legal challenges raised by developments in the biomedical field. Following the adoption of the Convention on Human Rights and Biomedicine (Oviedo Convention), the Committee on Bioethics is assigned the task to conduct regular re-examinations foreseen in the Convention and its Additional Protocols and to develop further its principles, as appropriate. In addition, under the supervision of the Steering Committee for Human Rights (CDDH), the Committee on Bioethics is conducting intergovernmental work on the protection of human rights in the field of biomedicine assigned to it by the Committee of Ministers.

The Committee on Bioethics is an intergovernmental body which meets twice a year, consisting of delegations of the 47 Member States with expertise in the various aspects of bioethics. The Parliamentary Assembly, the Consultative Committee of the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (T-PD), the Committee (Partial Agreement) on Transplantation of Organs and Tissues (CD-P-TO) and the Committee (Partial agreement) on Blood Transfusion (CD-P-TS) and other bodies of the Council of Europe engaged in related work, the European Union, Observer States and international organisations active in the field of bioethics may send representatives to take part in the discussions. In order to obtain information, the Committee on Bioethics may request the service of external consultants or scientific experts and organise conferences and symposia.

The Committee on Bioethics is assisted by a permanent secretariat, the Bioethics Unit, resorting under the Directorate General Human Rights and Rule of Law of the Council of Europe.

Legal instruments

The Committee on Bioethics has adopted a substantial set of legal instruments which serve as a reference point at the international level. The Convention on Human Rights and Biomedicine is the first international legally binding instrument in the field of bioethics. It provides a framework for the protection of human rights and human dignity by establishing fundamental principles applicable to health care, medical research, transplantation and genomics. These principles are intended to be developed in greater detail in additional protocols on specific biomedical topics. As of today, four additional protocols have been adopted, respectively on the Prohibition of Cloning Human Beings, on Transplantation of Organs and Tissues of Human Origin, on Biomedical Research and on Genetic Testing for Health Purposes. Apart from these binding instruments, the Committee on Bioethics also adopted a number of Recommendations and issued several reports and white papers.

Current work

Genetic Testing for Health Purposes

Following the adoption on 7 May 2008 of the Additional Protocol concerning Genetic Testing for Health Purposes, a Leaflet on Genetic Tests for Health Purposes has been produced, aiming 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.

Trafficking in Human Organs, Tissues and Cells

Following the joint Council of Europe/United Nations Study on trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs, the Committee on Bioethics contributed to the elaboration of a draft Convention against Trafficking in Human Organs, prepared by the Committee of Experts on Trafficking in Human Organs, Tissues and Cells (PC-TO) under the authority of the European Committee on Crime Problems (CDPC).

End of Life

Following the Symposium on the decision-making process regarding medical treatment in end-of-life situations, held on 30 November-1 December 2010, the Committee on Bioethics launched a Guide on the decision-making process regarding medical treatment in end-of-life situations.

Predictivity, Genetic Tests and Insurance

Following the Seminar on Predictivity, Genetic Tests and Insurance, held on 3-4 December 2007 and taking into account the results of the public consultation carried out in April 2012, the Committee on Bioethics held a preliminary exchange of views and examinded in particular the scope of the Recommendation on the use for insurance purposes of personal health-related information, in particular information of a genetic and predictive nature.

Biobanks

The Committee on Bioethics is currently re-examining Rec(2006)4 on Research on Biological Materials of Human Origin. Following the closure of the public consultation, the replies have been compiled in one document and will be taken into consideration when finalising the revision of the Recommendation.

Mental disorders

The Committee on Bioethics is in the preliminary stages of elaborating an Additional Protocol on the protection of the dignity and fundamental rights of persons with mental disorders with regard to involuntary treatment and placement.

Emerging technologies

As a basis for possible future activities, the Committee on Bioethics will be looking into the ethical and legal challenges raised by developments in emerging technologies, particularly neurosciences and nanotechnology. To this end, expert studies will be conducted addressing both the scientific and technical aspects and their implications for human rights.

Public consultations

Biobanks

Cover letter
Working document
Compilaton of replies

Public consultation on the working document presenting a draft revised Recommendation was launched in March 2014 with the deadline on 15 August 2014 within the context of re-examination of Recommendation (2006) 4 of the Committee of Ministers on research on biological materials of human origin.

The purpose of this consultation was to elicit comments, in particular from the sectors directly concerned (such as researchers, relevant bodies or institutions, patient organisations and biobank managers).

Following the closure of the public consultation, the replies have been compiled in one document and will be taken into consideration when finalising the revision of the Recommendation.

Prenatal Sex Selection

A questionnaire on prenatal sex selection has been distributed among Member States. An analysis of the replies was carried with a view to the possible preparation of guidelines. The DH-BIO also examined the conclusions of the Bureau that had been prepared taking into account the proposals from delegations, in response to the decision of the Committee of Ministers and the subsequent mandate of the CDDH regarding prenatal sex selection. These conclusions were communicated to the CDDH at its meeting on 24-27 June 2014, (see page 4 of the abridged report).