COUNCIL DECISION of 26 March 1992 adopting a specific research and technological development programme in the field of biotechnology (1990 to 1994) (92/218/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 its 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 Decision 90/221/Euratom/EEC;
Whereas Article 130k of the Treaty stipulates that the framework programme is to be implemented through specific programmes developed within each activity;
Whereas research and technological development in this field should be linked to various relevant Community policies and objectives;
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 action of dissemination and exploitation of results, to be divided up in proportion to the amount envisaged for each of the actions;
Whereas, in the context of this programme, an assessment should be made of the economic and social impact as well as of any technological risks;
Whereas basic research in the field of biotechnology must be encouraged throughout the Community;
Whereas, in addition to the specific programme concerning human resources and mobility, it is necessary to encourage the training of research workers in the context of this programme;
Whereas biological research, in particular that which uses the methods of recombinant DNA, is often subject to national laws with which the contractors must comply;
Whereas on 23 April 1990 the Council adopted Directive 90/219/EEC on the contained use of genetically modified micro-organisms (5) and Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms (6);
Whereas the positive development of biotechnology could be enhanced by concerted actions;
Whereas actions should be undertaken to ensure that the necessary consideration is given to the ethical and social effects of these projects, and their applications in agriculture, industry, health care and the environment; whereas such actions will ensure that information is made available to the public concerning the content of the programme;
Whereas the results which may be achieved by genetic research make it necessary to adopt an integrated approach which takes account of the scientific, safety, ethical and legal aspects of possible applications and of the need to ensure that the results are not used in an improper manner or subject to misrepresentation;
Whereas the Commission has announced its intention to examine further the ethical implications of biotechnology using the appropriate advisory structure;
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 biotechnology is looked upon as contributing to the achievement of these objectives;
Whereas small and medium-sized enterprises (SME) 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 research in biotechnology may lead to improvements in agriculture and industrial efficiency and viability, in the preservation of the environment and health, and in quality products for the consumer;
Whereas, in accordance with Article 130g of the Treaty, the Community's activities aimed at strengthening the scientific and technological basis of European industry and encouraging it to become more competitive include promoting cooperation on research and technological development with third countries and international organizations; whereas such cooperation may prove particularly beneficial for the development of this programme;
Whereas it is necessary, as Annex II to Decision 90/221/Euratom, EEC provides, to reinforce biological knowledge as the common and integrated foundation needed for applications in agriculture, industry, nutrition and the environment;
Whereas the Scientific and Technical Research Committee (Crest) has been consulted,
HAS ADOPTED THIS DECISION:
Article 1
A specific research and technological development programme in the field of biotechnology, as defined in Annex I, is hereby adopted for a period commencing on 26 March 1992 and ending on 31 December 1994.
Article 2
1. The funds estimated as necessary for the execution of the programme referred to in Article 1 amount to ECU 162,36 million, including expenditure on staff and administration amounting to ECU 7 million.
2. An indicative allocation of funds is set out in Annex II.
3. Should the Council take a decision pursuant to 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 and the amount of the Community's financial contribution are set out in Annex III.
Article 4
1. In the second year of the implementation of the programme, the Commission shall review it and send a report on the results of its review to the European Parliament, the Council and the Economic and Social Committee; 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. The group's report, together with the Commission's comments, shall be submitted to the European Parliament, the Council and the Economic and Social Committee.
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 subparagraph of Article 130k of the Treaty.
3. A work programme shall be drawn up in accordance with the aims 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 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 within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority provided for in Article 148 (2) of the Treaty as regards adoption of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
The Commission shall adopt the measures envisaged when they are in accordance with the opinion of the committee.
When the measures envisaged are not in accordance with the committee's opinion, or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If, on the expiry of a period of three months from referral of the matter to the Council, the latter has not acted, the proposed measures shall be adopted by the Commission.
Article 7
1. The procedure laid down in Article 6 shall apply 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 projects and concerted actions provided for in Annex III and the estimated amount of the Community's contribution to them where this amount exceeds ECU 0,3 million,
- departures from the general rules set out in Annex III,
- the participation in any project by non-Community organizations 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 0,3 million, the Commission shall inform the committee of the projects and concerted actions 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, in particular the member countries of EFTA and the countries of central and eastern Europe, with a view to associating them with all, or part, of the programme.
2. When framework agreements for scientific and technical cooperation have been concluded between the Community and European non-Member States, bodies and enterprises established in those countries may, in accordance with the procedures laid down in
Article 6
and 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 established in other third countries as well as to international organizations engaged in research in this area.
No contracting body 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 bodies shall contribute to the general administrative costs.
Article 9
This Decision is addressed to the Member States.
Done at Brussels, 26 March 1992.