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Specific research, technological development and demonstration programme in the field of biotechnology, 1994-1998

The specific programme forms part of the First Activity under the Fourth Framework Programme.

BIOTECH II is established to sustain the advances made in the biotechnology sector under the Third Framework programme. It comes on stream at a time when biotechnology is passing from the realm of future promise into the realm of present reality for scientists, industry and policy makers. This development presents new opportunities to European concerns which must be seized.

The various activities address the weaknesses inhibiting the European biotechnology sector from realizing its full potential, which were identified by the Commission's White Paper on Growth, Competitiveness and Employment (COM(93) 700).

Particular measures will focus on ensuring the continued development and growth of European economic sectors which depend heavily on biotechnology (pharmaceuticals, chemicals, agriculture and food). This will be achieved by the creation of a favourable environment consisting of a strong and innovative scientific base; a highly skilled and trained work force; effective technology transfers from the science base to industry; the validation of scientific principles to underpin a unified market of biotechnology-derived products; and, the harmonious application of bioprocesses as beneficial alternatives to promote the environment, human health and welfare.

The activities are carried out under three headings:
- Objectives requiring concentrated means;
- Objectives addressed by concertation;
- Objectives treated by horizontal activities.

This approach provides a cohesive framework where the key information and know-how derived from research activities can be used to conceive and test new technological options. The approach also creates the integrative effort necessary for putting living cells safely to work, for improving the European contribution to international genome projects and, for overcoming the distinctions between neurobiology, endocrinology and immunology (until the principles of cell and molecular interactions are unravelled).

Research actions cover a broad spectrum of scientific opportunities in order to facilitate the translation of biotechnology advances into industrial and social benefits across a diverse range of fields. Such benefits could include improvements in agricultural and industrial efficiency and viability, greater environmental and health protection and better quality consumer products. Close collaboration between the Biotechnology programme and other related activities covered by the Framework Programme is therefore a key element.

In particular, the specific programmes covering Agriculture and Fisheries and Biomedical and Health shall promote the application of biotechnology know-how within their respective domains, enabling the transformation of research results into the provision of goods and services (e.g. genetic design of crops and animal health control). Where appropriate, coordination with other specific programmes, such as Information Technologies, Measurement and Testing, Environment and Targeted Socio-economic Research, is also envisaged.

At the international level, collaboration with the Human Frontier Science Programme will be strengthened, as will the links with certain EUREKA projects.

Research attempting to modify the genetic constitution of human beings by alteration of germ cells and the development of the process referred to as "cloning" will not be carried out under this specific programme. Wherever possible, experimentation and testing on animals should be replaced by in vitro or other methods.
To seize a broad spectrum of scientific opportunities arising from the accelerating progress of molecular and cellar biology and, to concentrate the joint effort in biotechnology where the value-added of cooperation can readily be translated into industrial and social benefits.
Three types of action:

- Objectives requiring concentrated means:
. Cell factories (analysis of the productivity of living cells and how industry can learn from cellular processes in order to design and operate safe, specific and sustainable bioprocesses);
. Genome analysis (analysis and sequencing of model genomes, including the human genome, and the development of appropriate technologies and infrastructures);
. Plant and animal biotechnology (development of plant molecular and cellular biology including protein engineering, and plant and animal physiology, notably with agricultural and agro-industrial applications in mind);
. Cell Communications in neurosciences (multidisciplinary studies combining genetic engineering with cellular biology, molecular biology and pharmacology);
- Objectives mainly addressed by concertation:
. Immunology and transdisease vaccinology (prevention or control of major human and animal pathologies and the organization of European-wide research on transdisease vaccinology);
. Structural biology (discovery and refinement of new biological entities through the study of the three-dimensional structure of biomolecules);
. Pre-normative research, biodiversity and social acceptance (toxicological/pharmacological in vitro tests, biosafety evaluation of biotechnology-derived products, and the development of processes solving environmental problems);
. Infrastructures (development of bioinformatics, information infrastructures and resource centres to support wider-scale research at both the Community and Member State level);

- Objectives treated by means of horizontal activities:
. Demonstration activities in biotechnology (assistance to European concerns in overcoming the specific socio-economic difficulties in exploiting the results of biotechnological research, so as to facilitate the adoption of new biotechnologies by potential users);
. Ethical, social and legal aspects (consideration of all relevant socio-political and bioethical positions, taking into account cultural differences and existing national policies);
. Public perception (measures to improve public awareness of biotechnology, such as workshops, conferences and reports);
. Socio-economic impacts (incorporation of advanced biotechnological research tools into existing production practices).
The Commission is responsible for implementing the programme, assisted by a committee consisting of representatives of the Member States and chaired by a representative of the Commission. The Commission has drawn up an initial work programme, detailing the scientific and technological objectives of the action, the stages in the programme's implementation and the proposed financial arrangements. Calls for proposals for RTD projects will be issued by the Commission on the basis of this work programme.

The indicative breakdown of the programme budget is as follows: Cell factories ECU 121.5 million; Genome analysis ECU 88 million; Plant and animal biotechnology ECU 133 million; Cell communication ECU 33 million; Immunology, transdisease vaccinology ECU 39 million; Structural biology ECU 55 million; Prenormative research, biodiversity, social acceptance ECU 52.5 million; and Infrastructures ECU 30 million.

These figures include an allocation of up to 7% for horizontal training activities, up to 6% for horizontal demonstration actions and up to 3% for horizontal activities on ethical, social and legal aspects and on public perception and socio-economic impact studies. A maximum of 7.5% may be spent on staff and administration costs whilst a sum of ECU 5 million is earmarked for the dissemination and utilization of results. This activity will be closely coordinated with the specific dissemination and exploitation programme of the Third Activity of the Fourth Framework Programme. Activities are directed for the benefit of SMEs in particular, notably those located in the less developed areas of the Community or in regions which have the lowest participation in the programme.

The budget allocated to the programme may be increased in 1996, in accordance with the provisions of the decision establishing the Fourth Framework Programme.

The programme will be mainly implemented through shared-cost activities, concerted actions and preparatory, accompanying and support measures. Community support for shared-cost activities will not exceed 50% of the costs of the RTD project. Concerted actions may qualify for a contribution of up to 100% of the concertation costs whilst, in principle, the costs of direct actions are fully financed by the Community. Specific measures, such as actions to encourage standardization and measures to set up general service tools for research centres, universities and firms, may qualify for a contribution of up to 100% of total costs.

The Commission is authorized to negotiate cooperation agreements with European third countries with a view to their partial or full involvement in the programme. The JRC may participate in the indirect activities of the programme.

The Commission will continuously review the implementation of the programme to ensure that its objectives, priorities and financial resources remain appropriate. On the basis of this review process it shall, where appropriate, submit proposals to adapt or supplement the programme. In addition, regular assessments of the activities covered by the specific programme will be conducted by independent experts who, upon completion of the programme, will carry out a final evaluation of the results achieved. A report of this final evaluation will be sent to the Council, the European Parliament and the Economic and Social Committee.