COUNCIL DECISION of 29 June 1990 adopting a specific research and technological development programme in the field of health: human genome analysis (1990 to 1991) (90/395/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and in particular Article 130q (2) thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas Article 130k of the Treaty provides that the framework programme is to be implemented through specific programmes developed within each activity;
Whereas, by its Decision 87/516/Euratom, EEC (4), as amended by Decision 88/193/EEC, Euratom (5), the Council adopted a framework programme for Community activities in the field of research and technological development (1987 to 1991), which defined activities to be undertaken in the field of health;
Whereas that Decision provides that Community action is justified where research contributes, inter alia, to the strengthening of the economic and social cohesion of the Community and to the promotion of its overall harmonious development, while being consistent with the pursuit of scientific and technical excellence;
Whereas two successive pluriannual programmes of research and training of the European Economic Community in the field of biotechnologies (6), the second of which is still in progress, have shown the possibility and usefulness of Community action promoting the utilization of modern biology for scientific, medical and industrial purposes;
Whereas the framework programme provides, under the heading 'Health' in the 'Quality of Life' section, for the
initiation of new activities relating to the development of knowledge of the human genome;
Whereas, following the adoption of a third Community Framework Programme for activities in the field of research and technological development (1990 to 1994), it is necessary to continue the implementation of the second Framework Programme (1987 to 1991) by means of specific programmes for which the latter makes provision;
Whereas a specific programme to study the human genome is therefore necessary and, in particular, it is necessary to:
- develop and disseminate the basic technologies concerning the study of the human genome, with the intention of improving knowledge of matters of medical importance,
- increase the resolution of the human genetic map and improve the physical map by the creation of ordered clone libraries, as a basis for locating genes of medical importance on chromosomes and for a better general understanding of gene function, and
- organize networks and coordination, on a European and international scale, of researchers from all disciplines working in this field;
Whereas achievement of the abovementioned goals requires the undertaking at Community level of action aimed at:
- filling some existing gaps in scientific and technological knowledge, and
- encouraging cooperation between European research establishments with a view to furthering the development of existing technologies, while promoting all research sectors capable of generating new lines of research;
Whereas, simultaneously, measures must be taken to promote cooperation between the Community programme and similar ones developed in third countries or by international organizations;
Whereas the right to a genetic identity forms part of the integrity and the dignity of an individual and this principle is recognized in the constitutions and laws of Member States and in the Community legal system as forming part of the fundamental rights for which respect is ensured;
Whereas the results which can be achieved from human genome research require the development of an integrated
approach, taking into account the medical, ethical, social and legal aspects of the possible applications of such results and the need to avoid any improper use thereof;
Whereas the development of an integrated approach was proposed by the European Parliament in its resolution of 16 March 1989 (7);
Whereas there are good grounds for guaranteeing the right of an individual to have an informed choice as to whether or not he should receive information concerning his genetic characteristics;
Whereas, in the absence of clear standards and provisions concerning possible developments in the field of genome analysis, there may be a risk, on the one hand, that attempts will be made to intervene in the human genome in order to make the modifications so obtained hereditary and, on the other, that genetic analyses will be carried out for monitoring purposes, which may have a profound effect on social life; whereas there are, accordingly, good grounds for taking the necessary steps to preclude unacceptable developments, particularly in terms of predictive medicine;
Whereas, furthermore, it is necessary to examine in detail, during the course of the programme, the prenormative aspects arising from human genome analysis by establishing a reliable scientific data set which could provide a basis for political authorities to establish sound, clear and responsible rules;
Whereas the Scientific and Technical Research Committee (Crest) has been consulted,
HAS ADOPTED THIS DECISION:
Article 1
A specific research and technological development programme for the European Economic Community in the field of human genome analysis, as defined in Annex II, is hereby adopted for a period of two years commencing on 29 June 1990.
Article 2
1. The funds estimated as necessary for the execution of the programme amount to ECU 14 million, including expenditure on a staff of two.
2. An indicative allocation of funds is set out in Annex I.
Article 3
Detailed rules for the implementation of the programme and the rates of the Community's financial participation are set out in Annex II.
Article 4
1. The Commission shall send the European Parliament and the Council an annual report on the progress of the programme.
2. In the second year of implementation of the programme, the Commission shall review it and send the results of its review to the European Parliament and the Council; the report shall be accompanied, where necessary, by proposals for amendment or extension of the programme.
3. An evaluation of the results achieved shall be carried out by independent experts and published in the form of a communication to the European Parliament and the Council.
4. The abovementioned reports shall be established having regard to the objectives and evaluation criteria set out in Annex II and in accordance with Article 2 (2) of Decision 87/516/Euratom, EEC.
Article 5
The Commission shall be responsible for the execution of the programme. It shall be assisted by a committee of an advisory nature, hereinafter referred to as 'the Committee', composed of the representatives of the Member States and chaired by the representative of the Commission.
Article 6
1. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote.
2. The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes.
3. The Commission shall take the utmost account of the opinion delivered by the committee. It shall inform the committee of the manner in which its opinion has been taken into account.
Article 7
The procedure laid down in Article 6 shall apply in particular to:
- the contents of the calls for proposals,
- the assessment of the proposed projects and the estimated amount of the Community's contribution to them,
- departures from the general rules governing Community participation set out in Annex II,
- the participation in any project by third-country organizations and enterprises referred to in Article 8 (2),
- any adjustment to the indicative allocation of resources set out in Annex I,
- the measures to be undertaken to evaluate the programme,
- the arrangements for the dissemination, protection and exploitation of the results of research carried out under the programme.
Article 8
1. The Commission is authorized, in accordance with Article 130n of the Treaty, to negotiate agreements with third countries and international organizations, particularly with third countries participating in European Cooperation in the field of Scientific and Technical Research (COST) and with States which have concluded framework agreements for
scientific and technical cooperation with the Community, with a view to associating them with the programme.
2. Where framework agreements for scientific and technical cooperation between third countries and the European Communities have been concluded, organizations and enterprises established in those countries may, on the basis of the criterion of mutual benefit, become partners in a project undertaken within this programme.
3. No contracting party based outside the Community and participating as a partner in a project undertaken under the programme may benefit from Community financing for this programme. Such contracting party shall contribute to the general administrative costs.
Article 9
This Decision is addressed to the Member States.
Done at Luxembourg, 29 June 1990.