COUNCIL DECISION of 9 September 1991 adopting a specific research and technological development programme in the field of biomedicine and health (1990 to 1994) (91/505/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, by Decision 90/221/Euratom, EEC (4), the Council adopted a third framework programme for Community activities in the field of research and technological development (1990 to 1994), specifying, inter alia, the activities to be pursued for contributing to the development of Europe's potential for understanding and using the properties and structures of living matter; whereas this Decision should be taken in the light of the grounds set out in the preamble to that Decision;
Whereas Article 130k of the Treaty stipulates that the framework programme shall be implemented through specific programmes developed within each activity;
Whereas basic research in the field of biomedicine and health must be encouraged throughout the Community;
Whereas, in addition to the specific programme concerning human resources and mobility, it might be necessary to encourage the training of research workers in the context of this programme;
Whereas matters relating to biomedical ethics should be studied, with particular reference to the 'recommendations guiding physicians in biomedical research involving human subjects' adopted by the 18th World Medical Assembly in Helsinki in June 1964 and subsequently amended in Tokyo in 1975, Venice in 1983 and Hong Kong in 1989;
Whereas, pursuant to Article 4 and Annex I of Decision 90/221/Euratom, EEC, the amount deemed necessary for the whole framework programme includes an amount of ECU 57 million for the centralized dissemination and exploitation of results, to be divided up in proportion to the amount envisaged for each specific programme;
Whereas Decision 90/221/Euratom, EEC provides that a particular aim of Community research must be to strengthen the scientific and technological basis of European industry and to encourage it to become more competitive at international level; whereas it also 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 the programme in the field of biomedicine and health should contribute to the achievement of these objectives;
Whereas small and medium-sized enterprises (SMEs) should be involved to the maximum extent possible in this programme; whereas account should be taken of their special requirements without prejudice to the scientific and technical quality of the programme;
Whereas it is necessary, as Annex II to Decision 90/221/Euratom, EEC provides, to contribute to improving the efficacy of medical and health research and development in the Member States, in particular by better coordination of the Member States' research and development activities and application of the results through Community cooperation and a pooling of resources;
Whereas, in the context of this programme, an assessment should be made of economic and social impact as well as of any technological risks;
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 Community in the field of biomedicine and health, hereinafter referred to as 'the programme', as defined in Annex I, is hereby adopted for the period 9 September 1991 to 31 December 1994.
Article 2
1. The funds estimated as necessary for the execution of the programme amount to ECU 131,67 million, including expenditure on staff and administration amounting to ECU 13 million.
2. An indicative breakdown of funds is set out in Annex II.
3. Should the Council take a decision in implementation of Article 1 (4) of Decision 90/221/Euratom, EEC, this Decision shall be adapted accordingly.
Article 3
Detailed rules for the implementation of the programme, including the amount of the Community's financial contribution, are set out in Annex III.
Article 4
1. In the second year of implementation of the programme, the Commission shall review it and send a report on the results of its review to the European Parliament and the Council; the report shall be accompanied, where necessary, by proposals for amendment of the programme.
2. At the end of the programme, an evaluation of the results achieved shall be conducted for the Commission by a group of independent experts. This group's report, together with any comments by the Commission, shall be submitted to the European Parliament and the Council.
3. The reports referred to in paragraphs 1 and 2 shall be established having regard to the objectives set out in Annex I to this Decision and in accordance with Article 2 (4) of Decision 90/221/Euratom, EEC.
Article 5
1. The Commission shall be responsible for the implementation of the programme.
2. Contracts concluded by the Commission shall govern the rights and obligations of each party, in particular the arrangements for the dissemination, protection and exploitation of research results, in accordance with the provisions adopted pursuant to the second paragraph of Article 130k of the Treaty.
3. A work programme shall be drawn up in accordance with the objectives set out in Annex I and updated where necessary. It shall set out the detailed objectives and types of projects to be undertaken, and the financial arrangements to be made for them. The Commission shall make calls for proposals for projects on the basis of the work programme.
Article 6
The Commission shall be assisted by a Committee of an advisory nature composed of representatives of the Member States and chaired by the representative of the Commission.
The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft, within a time limit which the chairman may lay down according to the urgency of the matter to be dealt with, taking a vote thereon should the need arise.
The opinion shall be entered in the minutes; moreover, each Member State shall have the right to request that its position be recorded in the said minutes.
The Commission shall take the greatest account of the opinion delivered by the Committee. It shall inform the Committee of the way in which it took the said opinion into account.
Article 7
1. The procedure laid down in Article 6 shall apply in particular to:
- the preparation and updating of the work programme referred to in Article 5 (3),
- the contents of the calls for proposals,
- the assessment of the research projects and concerted action provided for in Annex III and the estimated amount of the Community's contribution to them where this amount exceeds ECU 0,1 million per year,
- departures from the general rules set out in Annex III,
- the participation in any project by non-Community organizations, bodies and enterprises referred to in Article 8,
- any adaptation of the indicative breakdown of the amount set out in Annex II,
- the measures to be undertaken to evaluate the programme,
- arrangements for the dissemination, protection and exploitation of the results of research carried out under the programme.
2. Where, pursuant to the third indent of paragraph 1, the amount of the Community contribution is less than, or equal to ECU 0,1 million per year, the Commission shall inform the Committee of the research projects and of the outcome of their assessment.
The Commission shall also inform the Committee of the implementation of the accompanying measures referred to in Annex III.
Article 8
1. The Commission is hereby authorized to negotiate, in accordance with Article 130n of the Treaty, international agreements with third countries which are members of COST, particularly the member countries of EFTA and the countries of Central and Eastern Europe, with a view to associating them with the whole programme or a part of it and, as regards Area 3, with other third countries and international organizations with a view to associating them with the whole programme.
2. Bodies and enterprises established in non-Community European States may, on the basis of the criterion of mutual benefit, be allowed to become partners in a project undertaken within the programme. For projects in Area 3 of Annex I, this option may be extended to bodies and enterprises from other non-Community countries engaged in research in the area.
No contracting partner 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 partner shall contribute to the general administrative costs.
Article 9
This Decision is addressed to the Member States. Done at Brussels, 9 September 1991.