Ministers’ Deputies
Notes on the Agenda
CM/Notes/799/10.4 (restricted) 7 June 2002
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799 Meeting, 13 June 2002
10 Legal questions
10.4 Protection of the human genome by the Council of Europe -
Parliamentary Assembly Recommendation 1512 (2001)
Reference documents
REC_1512(2001)
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Action The Deputies are invited to resume consideration of this item, with a view to examining the draft reply to Parliamentary Assembly Recommendation 1512 (2001), as set out below and drawn up at the informal meeting of 5 June 2002, with a view to its adoption. |
Context
The Parliamentary Assembly adopted Recommendation 1512 (2001), on protection of the human genome by the Council of Europe, on 25 April 2001. The Ministers’ Deputies brought it to the attention of the governments of the member States at their 752nd meeting (16 May 2001), and adopted two sets of ad hoc terms of reference instructing the Steering Committee on Bioethics (CDBI) and the European Health Committee (CDSP) to prepare opinions on Recommendation 1512.
The two opinions were presented to the Ministers’ Deputies at their 785th meeting (26 and 27 February 2002), under agenda items 10.3 and 6.1 respectively.
The Ministers’ Deputies, having taken note of these opinions, held some preliminary discussions on the draft reply at their 793rd meeting (18 April 2002), when some amendments were proposed. One delegation further indicated that it would submit a set of amendments to the draft reply at a later stage.
The Deputies resumed consideration of this item at their 794th meeting (30 April 2002), on the basis of a revised draft reply, setting out also the additional amendments presented. At that meeting they entrusted jointly the Chairs of their Rapporteur Groups GR-J and GR-SOC, with the mission of consulting the delegations interested with a view to finalising a draft reply to be submitted to them at a forthcoming meeting, for adoption.
The Chairs of GR-J and GR-SOC held an informal meeting on the question on 5 June 2002, with the participation of some experts from capitals. At that meeting, delegations agreed on the draft reply to Recommendation 1512 (2001), as it appears below. The Deputies are invited to consider this draft with a view to its adoption.
Concerning the Recommendation
In its Recommendation the Assembly refers to the almost unlimited possibilities of the Human Genome project in terms of prevention, diagnosis and therapy.
It emphasises that in view of the enormous ethical and economic implications of the project, its guiding principle must be the protection of human dignity.
The Assembly stresses the importance of sharing the scientific information obtained, which is a common human heritage, while subjecting its use to ethical principles. It proposes establishing a Euroforum on human genetics to study these questions, possibly on a worldwide level.
Accordingly, the Assembly recommends that the Committee of Ministers:
- invite every Council of Europe member state concerned to set up a national authority having the task of monitoring the compliance of research on the human genome with universally recognised ethical and moral principles;
- set up, in the context of the Council of Europe, a body or authority to fulfil on a permanent basis the task of monitoring the development of the Human Genome project research process, ensuring respect for ethical principles in the context of research on the human genome, assessing the effects of such research also regarding health risks, and giving thorough consideration to all the ethical aspects of the project, and consider in this context the role of the Steering Committee on Bioethics (CDBI);
- ensure that this body for monitoring research on the human genome will keep the public and health professionals duly informed;
- make sure that consultation of this European authority is mandatory when conventions are drafted on this subject by the Council of Europe and codes of ethics produced, and that it has free access to important information on genetics and is able to carry out its own inspections of public and private European research institutes;
- ask member states to sign, ratify and implement the Convention on Human Rights and Biomedicine;
- ask all Council of Europe member States to strive to change the basis of patent law in international fora, as far as the ownership of human tissue and genes is concerned, into law pertaining to the common heritage of mankind.
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Financing assured: YES |
DRAFT DECISION
799th meeting – 13 June 2002
Item 10.4
Protection of the human genome by the Council of Europe -
Parliamentary Assembly Recommendation 1512 (2001)
Decision
The Deputies adopted the following reply to Parliamentary Assembly Recommendation 1512 (2001) on protection of the human genome by the Council of Europe:
“1. The Committee of Ministers has given careful consideration to Parliamentary Assembly Recommendation 1512 (2001) on protection of the human genome by the Council of Europe.
2. Like the Assembly, the Committee of Ministers considers that the Human Genome international research project holds the promise of considerable improvements in the quality of life, while at the same time raising numerous ethical issues. It shares the Assembly’s conviction that the protection of human dignity must be the guiding principle of the Human Genome project. Indeed, the major advances reported every day in the biomedical sciences call for an ethical and legal framework to guarantee that people’s individual rights are respected. The Committee of Ministers notes in particular the Parliamentary Assembly’s concern not only at the magnitude of the ethical implications of research on the human genome, but also at the questions raised by the divulgation and use of the information thus obtained.
3. For a long time now, the Committee of Ministers, through its specialised steering committees, has followed the major debates concerning medical advances and their consequences. In its Recommendation the Assembly refers in particular to the questions raised by genetic testing. This question was addressed back in 1992, when the Committee of Ministers adopted a Recommendation to the member States on genetic testing and screening for health purposes (R (92) 3). Moreover, in this context, the Committee of Ministers refers to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine which contains fundamental principles also applicable to this matter.
4. The Committee of Ministers agrees that insight into, and understanding of, the mechanism of human genetics will be beneficial for diagnosis and treatment of many known diseases. It might also open up new possibilities for “predictive medicine”, improving the prospects of preventing illnesses in whose development individual genetic predisposition is also involved.
5. With regard to predictive genetic testing, the Committee of Ministers recognises the potential value of taking into account the precautionary principle. Predictive tests often carry a degree of uncertainty about whether the condition will develop, when it will develop and how severe it will be. The value of predictive testing indeed depends, for example, on the nature of the disease for which testing is being carried out, how effective treatment is and the cost and efficacy of screening and surveillance measures. No genetic screening should be introduced within health care systems without preventive health benefit, availability of treatment methods or other options for the individual, like adaptation of life style and pre-conceptual choices.
6. The Committee of Ministers acknowledges that it could be useful to draw up guidelines for national decision-making on the introduction of testing and screening programmes from the perspective of health benefit: equity of access, evidence based and best practices. The Committee of Ministers will take this into account in its future work programme.
7. The Committee of Ministers recognises the importance of public debate on the implications of genetic tests in health care from a range of perspectives, including those concerning the potential contribution to the health and well-being of the individual.
8. Concerning the Parliamentary Assembly’s recommendation that all the Council of Europe’s member States set up a national authority having the express task of monitoring, informing and advising on the compliance of research on the human genome with universally recognised ethical and moral principles of respect for life and human dignity, the Committee of Ministers agrees with the necessity of advising on research in genetics but recalls that this function is carried out in the member States for individual research projects by research ethics committees. A number of member States also have national-level committees, either specifically addressing genetics or with a broader mandate, monitoring, informing and advising on the human genome and genetic research.
9. The Committee of Ministers takes due note of the Parliamentary Assembly’s invitation to set up at the European level, and more specifically in the context of the Council of Europe, a body or authority to fulfil on a permanent basis the task of monitoring the development of the Human Genome Project research process, ensuring respect for ethical principles in the context of research on the human genome and giving thorough consideration to all the ethical aspects of the project. The Committee of Ministers further takes into account the recommendation that such a body familiarise the public with new possibilities for progress in genetics and serve also to promote campaigns to inform and educate the public, in particular the health professions.
10. The Committee of Ministers notes the existence of a wide range of internationally working bodies and considers it highly advisable to cooperate with these bodies to further at the European and worldwide level their common goals, including in the framework of the United Nations. However, it emphasises the need to avoid any duplication of existing activities and considers that the creation of a Euroforum in this field could duplicate efforts carried out at the European – notably within its specialised committees - and, in some cases, at the national level. It is necessary to ensure the widest possible involvement by citizens in sharing knowledge about the human genome, and in participating in discussions about the beneficial effects and risks associated with it.
11. The Committee of Ministers attaches great importance to the signature, ratification and implementation of the Convention on Human Rights and Biomedicine by as many member States as possible, and assures the Assembly that it is working towards that goal.
12. The work done by the Council of Europe contributes to the harmonious development of medical progress, in keeping with the major principles of Europe’s democratic societies. The Committee of Ministers assures the Assembly that it is carefully following the progress made, concerned as it is to adapt the framework and orientations of its future action accordingly.”