COUNCIL DECISION of 15 December 1994 adopting a specific programme of research and technological development, including demonstration, in the field of biotechnology (1994 to 1998) (94/912/EC)
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 130 i (4) thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas by Decision No 1110/94 EC (4), the European Parliament and the Council adopted a fourth framework programme for Community activities in the field of research, technological development and demonstration (RTD) for the period 1994 to 1998 specifying inter alia the activities to be carried out in the field of biotechnology; whereas this Decision takes account of the grounds set out in the preamble to that Decision;
Whereas Article 130i (3) of the Treaty stipulates that the framework programme shall be implemented through specific programmes developed within each activity under the framework programme and that each specific programme shall define the detailed rules for its implementation, fix its duration and provide for the means deemed necessary;
Whereas the amount deemed necessary for carrying out this programme is ECU 522 million; whereas the appropriations for each financial year shall be laid down by the budgetary authority, subject to the availability of resources within the financial perspectives and the conditions set out in Article 1 (3) of Decision No 1110/94/EC;
Whereas research in biotechnology may lead to improvements in agricultural and industrial efficiency and viability, to more protection of the environment and health and a better quality of consumer products;
Whereas agriculture should benefit from biotechnology spin-offs to maintain its productivity levels, whilst preferring technical solutions in order to diversify products, reduce environmental impacts, and favour partnerships with European enterprises;
Whereas this programme may make a significant contribution to the stimulation of sustainable growth, to the strengthening of competitiveness and to the development of employment in the Community, as indicated in the White Paper on 'Growth, competitiveness and employment';
Whereas the content of the fourth framework programme for Community RTD activities was established in accordance with the subsidiarity principle; whereas this specific programme specifies the content of the activities to be carried out in accordance with this principle in the field of biotechnology;
Whereas Decision No 1110/94/EC lays down that a Community action is justified if, inter alia, research contributes to the strengthening of the economic and social cohesion of the Community and the promotion of its overall harmonious development, while being consistent with the pursuit of scientific and technical quality; whereas this programme is intended to help meet these objectives;
Whereas the Community should only support RTD activities of high quality; whereas the implementation of this programme should be directed towards strategic and, where possible, measurable aims with a view to facilitating coordination with programmes in the Member States and evaluation of the present programme;
Whereas basic research in biotechnology must be encouraged throughout the Community because it provides a source of innovation offering a large range of scientific opportunities to meet the real needs of society;
Whereas the rules for the participation of undertakings, research centres (including the Joint Research Centre (JRC)) and universities and the rules governing the dissemination of research results specified in the measures provided for in Article 130j of the Treaty apply to this specific programme;
Whereas provision should be made for measures to encourage the involvement of small and medium-sized enterprises (SMEs) in this programme, in particular through technology stimulation measures;
Whereas the Commission's efforts to simplify and accelerate the application and selection procedures and make them more transparent must be continued in order to promote the implementation of the programme and to facilitate the action which undertakings, particularly SMEs, research centres and universities have to undertake in order to participate in a Community RTD activity;
Whereas this programme will help to strengthen synergy between the RTD activities carried out in the field of biotechnology by research centres, universities and enterprises, in particular SMEs, in the Member States and between these and the corresponding Community RTD activities;
Whereas the nature of the activities to be undertaken in this programme requires close cooperation and coordination with activities undertaken under other specific research programmes; whereas such coordination and cooperation should achieve synergies especially in the fields of biomedicine and health, and agriculture and fisheries;
Whereas it may be appropriate to engage in international cooperation activities with international organizations and third countries for the purpose of implementing this programme;
Whereas this programme should also comprise support activities and activities for the dissemination and exploitation of RTD results, in particular towards SMEs, notably those in the Member States or regions which participate least in the programme (close coordination with Activity 3 of the framework programme being necessary to achieve synergies), and activities to stimulate the mobility and training of researchers within this programme to the extent necessary for proper implementation of the programme;
Whereas ex ante and ex post assessments should be made of possible socio-economic and ecological consequences and of any technological and biological risks and of the social desirability of the activities undertaken in this programme;
Whereas, in view of the rapid progress being made in biotechnology, the programme should also contribute to the development of ethical guidelines for the promotion of biotechnological research;
Whereas any projects aimed at modifying germ cells or any stage in the development of the human embryo must be excluded from the research funded by this programme;
Whereas progress with this programme should be continuously and systematically monitored with a view to adapting it, where appropriate, to scientific and technological developments in this area; whereas in due course there should be an independent evaluation of progress with the programme so as to provide all the background information needed in order to determine the objectives of the fifth RTD framework programme; whereas at the end of this programme there should be a final evaluation of the results obtained compared with the objectives set out in this Decision;
Whereas on 23 April 1990 the Council aodpted Directive 90/219/EEC on the contained use of gentically modified micro-organisms (5) and Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms (6); and whereas research financed by the Community must follow all the legislative provisons of the biotechnology regulatory framework concerning the protection of human health and the environment, the protection of workers exposed to biological agents at work, and the protection of animals used for experimental purposes or for other scientific purposes, current at the time of the programme's application;
Whereas this programme should set up a scientific basis to guide the formulation and technical adaptation of biotechnology regulations;
Whereas, to achieve this, there must be an informed public in society which, by making the content, goals and methods of biotechnology transparent, takes part in a competent manner in the discussion on issues as to the desirability of this programme;
Whereas activities undertaken within this programme will take account of common principles such as those embodied in international treaties for the protection of fundamental human rights and of the draft Bioethics Convention of the Council of Europe, once it is adopted;
Whereas the JRC may participate in indirect actions covered by this programme;
Whereas the Scientific and Technical Research Committee (Crest) has been consulted,
HAS ADOPTED THIS DECISION:
Article 1
A specific programme of research and technological development, including demonstration, in the field of biotechnology, as set out in Annex I, is hereby adopted for the period from the date of adoption of this Decision to 31 December 1998.
Article 2
1. The amount deemed necessary for carrying out the programme is ECU 552 million, including a maximum of 7,5 % for staff and administrative expenditure.
2. An indicative breakdown of this amount is given in Annex II.
3. The budgetary authority shall lay down the appropriations for each financial year, subject to the availability of resources within the financial perspectives and in accordance with the conditions set out in Article 1 (3) of Decision No 1110/94/EC, taking into account the principles of sound management referred to in Article 2 of the Financial Regulation applicable to the general budget of the European Communities.
Article 3
1. The general rules for the Community's financial contribution are laid down in Annex IV to Decision No 1110/94/EC.
2. The rules for the participation of undertakings, research centres and universities and for the dissemination of results are specified in the measures envisaged under Article 130j of the Treaty.
3. Annex III sets out the specific rules for implementing this programme, supplementary to those referred to in paragraphs 1 and 2.
Article 4
1. In order to help ensure, inter alia, the cost-effective implementation of this programme, the Commission shall continually and systematically monitor, with appropriate assistance from independent, external experts, progress within the programme in relation to the objectives set out in Annex I, as amplified in the work programme. It shall in particular examine whether the objectives, priorities and financial resources are still appropriate to the changing situation. It shall, if necessary, in the light of the results of this monitoring process, submit proposals to adapt or supplement this programme.
2. In order to contribute towards the evaluation of Community activities, as required by Article 4 (2) of Decision No 1110/94/EC and in compliance with the timetable laid down in that paragraph, the Commission shall have an external assessment conducted by independent qualified experts of the activities carried out within the areas covered by this programme and their management during the five years preceding this assessment.
3. At the end of this programme, the Commission shall have an independent final evaluation carried out of the results achieved compared with the objectives set out in Annex III to Decision No 1110/94/EC and Annex I to this Decision. The final evaluation report shall be forwarded to the European Parliament, the Council and the Economic and Social Committee.
Article 5
1. A work programme shall be drawn up by the Commission in accordance with the objectives set out in Annex I and the indicative financial breakdown set out in Annex II, and shall be updated where appropriate. It shall set out in detail:
- the scientific and technological objectives and research tasks,
- the implementation schedule, including dates for calls for proposals,
- the proposed financial and managerial arrangements, including specific modalities for implementing technology stimulation measures for SMEs and other measures, including preparatory, accompanying and support measures,
- arrangements for coordination with other RTD activities carried out in this area, in particular under other specific programmes, and, where appropriate, for ensuring improved interaction with activities carried out in other frameworks, such as Eureka and COST,
- arrangements for the dissemination, protection and exploitation of the results of RTD activities carried out under the programme.
2. The Commission shall issue calls for proposals for projects on the basis of the work programme.
Article 6
1. The Commission shall be responsible for the implementation of the programme.
2. In the cases provided for in Article 7 (1), the Commission shall be assisted by a committee composed of representatives of the Member States and chaired by the representative of the Commission.
3. 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. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case 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.
4. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.
5. If the measures envisaged are not in accordance with the opinion of the committee, 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.
6. If, on the expiry of a period of three months from referral of the matter to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.
Article 7
1. The procedure laid down in Article 6 (2) to 6 (6) shall apply to:
- the preparation and updating of the work programme referred to in Article 5 (1),
- the content of the calls for proposals, and establishment of criteria and mechanisms for project approval and selection,
- the assessment of the RTD activities proposed for Community funding and the estimated amount of the Community contribution for each activity where this is equal to or more than ECU 0,5 million,
- any adjustment to the indicative breakdown of the amount as set out in Annex II,
- specific modalities for the financial participation of the Community in the different activities envisaged,
- the measures and terms of reference for programme evaluation,
- any departure from the rules set out in Annex III,
- participation in any project by legal entities from third countries and international organizations.
2. Where, pursuant to the third indent of paragraph 1, the amount of the Community contribution is less than ECU 0,5 million, the Commission shall inform the committee of the activities and of the outcome of their assessment.
3. The Commission shall regularly inform the committee of progress with the implementation of the programme as a whole.
Article 8
Participation in the area of prenormative research, biodiversity and social acceptance may be open on a project-by-project basis, without financial support from the Community, to legal entities established in third countries, where such participation contributes effectively to the implementation of the programme taking into account the principle of mutual benefit.
Article 9
This Decision is addressed to the Member States.
Done at Brussels, 15 December 1994.