CELEX: 51988PC0806
Language: en
Date: 1989-01-03
Title: PROPOSAL FOR A COUNCIL DECISION ADOPTING A SPECIFIC RESEARCH AND TECHNOLOGICAL DEVELOPMENT PROGRAMME IN THE FIELD OF BIOTECHNOLOGY ( 1990-94 ); BRIDGE: BIOTECHNOLOGY RESEARCH FOR INNOVATION, DEVELOPMENT AND GROWTH IN EUROPE ( 1990-94 )

20. 3. 89                               Official Journal of the European Communities                               No C 70/1
                                                               II
                                                      (Preparatory Acts)
                                                  COMMISSION
               Proposal for a Council Decision adopting a specific research and technological development
               programme in the field of biotechnology (1990 to 1994) — Biotechnology research for innovation,
                                        development and growth in Europe (BRIDGE)
                                                COM(88) 806 final — SYN 182
                                     (Submitted by the Commission on 5 January 1989)
                                                         (89/C 70/01)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                           — the continuous evaluation of the strategic significance of
                                                                       new developments in biotechnology and promotion of
Having regard to the Treaty establishing the European                  the essential coherence between the different areas of
Economic Community, and in particular Article 130Q (2)                 Community policy concerned with biotechnology;
thereof,
                                                                   Whereas the multiannual research and training programme
                                                                   for the European Economic Community in the field of
Having regard to the proposal from the Commission,                 biomolecular engineering (2) and the ongoing multiannual
                                                                   research action programme for the European Economic
In cooperation with the European Parliament,                       Community in the field of biotechnology (1985 to 1989) (3)
                                                                    (4) have clearly demonstrated the utility of Community
                                                                   actions in biotechnology and the need for their expansion;
Having regard to the opinion of the Economic and Social
Committee,
                                                                   Whereas the participation of European non-Member States
                                                                   wholly or partially with projects in this programme is
Whereas Article 130K of the Treaty stipulates that the             desirable;
framework programme shall be implemented through
specific programmes developed within each activity;
                                                                   Whereas it is desirable to involve small and medium-sized
                                                                   enterprises to the maximum extent possible in the
Whereas, by its Decision 87/516/Euratom/EEC 0), the                biotechnology research and development programme;
Council has adopted a framework programme of Com-
munity research and technological development (1987 to             Whereas the implementation of research and training
1991), providing inter alia for activities ensuring the            actions in the COST framework is an essential element to
exploitation and optimum use of biological resources;              complement R&D projects in the field of biotechnology;
Whereas, for the selection of Community actions, the               Whereas the Scientific and Technical Committee (Crest)
framework programme sets out criteria among which is               has been consulted,
that of contributing to the strengthening of economic and
social cohesion of the Community consistent with the
pursuit of scientific and technical quality;                       HAS ADOPTED THIS DECISION:
Whereas the activities provided for in the framework
programme include, in particular:                                                                Article 1
                                                                   A specific research and technological development pro-
— the establishment of Community R&D for contributing              gramme for the European Economic Community in the
    a transnational dimension to national efforts and for          field of biotechnology, as defined in the Annex, is hereby
    facilitating technology transfer towards industry and          adopted for a period of five years, from 1 January 1990.
    agriculture in the areas of infrastructures, basic
    biotechnology and risk analysis,
                                                                   (2) OJ No L 375, 20. 12. 1981, p. 1.
                                                                   (3) OJ N o L 83, 2 3 . 3 . 1985, p. 1.
(!) OJ No L 302, 24. 10. 1987, p. 1.                               (4) OJ No L 206, 30. 7. 1988, p. 38.
 ---pagebreak--- No C 70/2                                 Official Journal of the European Communities                                      20. 3. 89
                            Article 2.                                  composed of the representatives of the Member States and
                                                                        chaired by the representative of the Commission.
The amount deemed necessary for the execution of the
programme is 100 million ECU, including expenditure on a
                                                                                                   Article 6
staff of 30.
                                                                        The Commission shall submit to the Committee a draft of
                            Article 3                                   the measures to be taken. The Committee shall deliver its
                                                                        opinion within a time limit which the Chairman may lay
Detailed rules for the implementation of the programme                  down according to the urgency of the matter, if necessary
and the rate of the Community's financial participation are             by taking a vote.
set out in the Annex.
                                                                        The opinion shall be recorded in the minutes of the
The contracts entered into by the Commission shall                      Committee; in addition, each Member State shall have the
regulate the rights and obligations of each party, in                   right to have its position recorded in the minutes.
particular the methods of disseminating, protecting and
exploiting the research results.                                        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
                            Article 4                                   taken into account.
In the third year of implementation of the programme, the
Commission shall review it and shall report to the Council                                         Article 7
and to the European Parliament on the results thereof,
                                                                        The Commission is hereby authorized to negotiate, in
together, if necessary, with any proposals for modification
                                                                        accordance with Article 130N of the Treaty, agreements
or prolongation.
                                                                        with non-member States and international organisations,
An evaluation of the results achieved shall be conducted by             in particular with those countries participating in European
the Commission, which shall report thereon to the Council               cooperation in the field of scientific and technological
and the Parliament.                                                     research (COST), and those having concluded framework
                                                                        agreements in scientific and technical cooperation with the
The abovementioned reports shall be established having                  Community with a view to associating them wholly or
regard to the objectives set out in the Annex to this Decision          partly in concerted actions within this programme.
and in conformity with the provisions of Article 2(2) of
Decision 87/516/Euratom/EEC.                                            Where framework agreements for scientific and technical
                                                                        cooperation between non-member States and the European
                                                                        Communities have been concluded, organisations and
                            Article '5
                                                                        enterprises established in those countries may participate in
The Commission shall be responsible for implementing the                a project undertaken within this programme.
programme.
                                                                                                  Article 8
The Commission shall be assisted by a Committee of an
advisory nature, hereinafter referred to as 'the Committee',            This Decision is addressed to the Member States.
                                                       TECHNICAL         ANNEX
                                              ACTION I: RESEARCH AND TRAINING
                                                              CONTENT
                     Information infrastructure
              1.1.   Culture collections
                     Development of a communication system for easy and rapid access to the most important service culture
                     collections within the Community; to be achieved through support to:
                     — a Promotion Centre for Culture Collections, specifically designed for providing to European users
                         (distribution of catalogues, patent regulations, printed and visual material, etc.) adequate
                         information on expertise and services available in different European Culture Collections; and
 ---pagebreak--- 20. 3. 89                            Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                  No C 70/3
               — a Centralized European Data Bank, primarily on micro-organisms and subsequently extended to
                   other biotic materials (animal and plant cells, viruses, plasmids, etc.). The first phase towards this
                   objective to involve the harmonisation of formats and data in the main service culture collections of
                    the European Community.
          1.2. Processing and analysis of bio(techno)logical       data
               — applications of information technology (specialised software and equipment) such as required for
                   the implementation of the activities in protein engineering and gene sequencing (see also 2.1 and 2.3
                    below); and
               — updating and design of knowledge bases for storing and classifying bio(techno)logical data such as
                   sequences, genetic maps, protein and biopolymer structures, risk assessment data; and
               — exploitation of existing or newly developed information technology for rapid access to European
                   knowledge bases and closed sequencing networks via an electronic network including electronic
                   input, on-line catalogues, electronic ordering, etc.
          2.   Enabling technologies
          2.1. Protein design!molecular     modelling
               — multi-disciplinary approaches including genetic engineering and advanced structural methods
                   aiming at improving the properties (such as stability, pH optimum, substrate specificity, etc.) of
                   interesting proteins and their complexes (including glycoproteins); and
               — development of methods to understand and predict structure/function relationships of proteins,
                   such as those involved in folding, stability, crystallisation, including theoretical methods for
                   simulation of these properties, and their interactions with other related molecules.
          2.2.   Biotransformation
               — development of biological reactions using new strains of cells or novel enzymes for synthesis of key
                   intermediates needed for the production of high added value substances (particular attention to be
                   given to the bioconversion of agricultural surpluses) and for converting pollutants to innocuous
                   compounds; and
               — research addressing the problem of genetic and physiological stability of the free or immobilised
                   genetically modified microbes or cells under biotransformation conditions; and
               — research addressing the problem of enzymatic activity under extreme environments (organic
                   solvents, pHs, temperatures, immobilisation); and
               — development of methods for the isolation and purification of biotransformation products (up- and
                   downstream processing); and
               — development of specialised software and mathematical modelling for the control and analysis of
                   biotechnological processes.
          2.3. Gene mapping, genome sequencing, novel cloning             methods
               — sequencing the genome of yeast (Saccharomyces cerevisiae) or parts therof and of Bacillus subtilis;
                   and
               — development of molecular genetic techniques to identify new meaningful plant genes, using the
                   Arabidopsis genome as a resource; characterisation of the identified genes; and
               — development of advanced sequencing procedures and technology (see 1.2) and integration of these
                   procedures and technology in the sequencing projects.
          3.   Cellular biology
          3.1. Physiology and molecular genetics of industrial         micro-organisms
               — gene stability and expression, post-translational processes, genetic and metabolic regulation of
                  overproduction, transport and secretion. These studies, adapted in each case to the current state of
                   the art, will concentrate on some industrially interesting micro-organisms such as the genera lactic
 ---pagebreak--- No C 70/4                            Official Journal of the European Communities                                         20. 3. 89
                   acid bacteria, Streptomyces, Pseudomonas, Bacillus, Clostridium, Corynebacterium, and including
                   the larger groups of lactic acid bacteria, extremophiles, yeasts and filamentous fungi.
          3.2. Basic biology of plants and associated organisms
               — core processes for sexual breeding: mechanisms of flower initiation and evocation; differentiation of
                   sex cells; molecular bases of gamete recognition and selection systems; and
               — fundamentals of plant cell regeneration: genetics and molecular biology of somatic and zygotic
                   embryoge,nesis; perception and transduction of growth-promoting signals; and
               — molecular interfaces of plants and associated organisms: molecular bases of host-range and
                   virulence; characterisation of plant defence reactions; development of genetic techniques for
                   pathogenic fungi or mycorrhizae; regulation from plant/microbial signals of the expression of
                   microbial/plant genes; structural and functional identification of genes involved in N2-fixing
                   symbioses; and
               — physiological attributes of crops: storage processes; stress physiology; nitrogen use efficiency.
          3.3. Biotechnology of animal cells
               — animal cell engineering and culture technology leading to new or improved productions of important
                   substances for industrial and zootechnical purposes; and
               — animal genetics: mapping and sequencing of important genes; methods of gene transfer; gene
                   expression and regulation; and
               — animal husbandry: improved immunity through genetically engineered vaccines of second
                   generation.
          4.   Pre-normative Research
               Pre-normative Research in biotechnology places itself at both ends of the research-development-
               exploitation chain.
          4.1. Safety assessments associated with the release of genetically engineered organisms
               — monitoring and control techniques: sampling and probes for engineered organisms and introduced
                   segments of DNA; methods and instrumentation for high resolution automated microbial
                   identification and the establishment of adequate data bases; creation of a bank of specific probes and
                   chemical signatures for a large number of specific micro-organisms; eradication methods; and
               — assessment techniques: biological containment; gene stability and gene transfer; development of
                   microcosms and simulating methods for impact analysis; and
               — acquisition of fundamental knowledge on gene behaviour (horizontal transfer between species,
                   rearrangement of introduced genes in the host organism) and on the survival and adaptation of
                   released organisms, in particular soil bacteria, and including modification of host range and tissue
                   range for engineered viruses; and
               — novel constructions: biologically contained organisms; suicide vectors or constructions which can
                   not develop outside the host organism; engineered organisms which can be destroyed in the
                   environment by known and specific techniques.
          4.2. In vitro evaluation of the toxicity and pharmacological activity of molecules
               — development of cellular and multicellular systems as surrogates for in vivo tissues and organs; and
               — research addressing the problems of preparation, storage maintenance and growth of human cell
                   cultures; and
               — development of cell lines in which functional properties are better preserved.
                                                        IMPLEMENTATION
               Training actions shall be implemented through training contracts and courses for any of the themes
               defined above. The cost of these actions shall be borne by the Community.
 ---pagebreak--- 20. 3. 89                      Official Journal of the European Communities                                          No C 70/5
          Research actions are to be implemented through cost-shared research contracts for each of the themes
          defined above. The Community financial contribution shall not normally exceed 50 % of total
          allowable projects costs. Alternatively, in respect of universities and similar institutes of higher
          education, the Community financial contribution shall normally be 100 % of the marginal costs.
          Two types of transnational research projects are foreseen:
          — N projects, for the integration in adapted Community structures (European Laboratories Without
              Walls: ELWW) of research efforts in areas where the main bottlenecks result from gaps in basic
              knowledge. The contribution of the Community in such projects shall not exceed ECU 400 000 per
              year per project, and
          — T projects, for the removal, through a significant investment of skills and resources, of important
              bottlenecks resulting from structural and scale constraints; the contribution of the Community in
              such projects may vary from one to three million ECU per year per project.
                                     Cost activities (category II) associated to Action I
                                                         CONTENT
          — Marine primary biomass
          — In vitro-cuhmes     for the purification and propagation of plants
          — Methods for early detection and identification of plant diseases
          — Vesicular-arbuscular (VA) mycorrhizae
          — Development of vaccines against coccidiosis.
                                                    IMPLEMENTATION
          Implementation shall take place through the organisation of meetings, consultation of experts,
          publications, exchange of research workers between laboratories, and coordination contracts.
                                              ACTION II: CONCERTATION
                                                         CONTENT
          In conjunction with the relevant Commission services and the Member States, the following tasks will be
          executed:
          — monitoring developments in biotechnology, particularly in the field of R&D, assessing their
              implications, and hence informing services of the Commission and interested public authorities
              having related responsibilities,
          — identifying possible ways in which the contextual conditions for the beneficial development of
              biotechnology in Europe may be improved, and the effectiveness and coherence of Member State and
              Community biotechnology programmes and related policies enhanced; including those involving
              international collaboration,
          — disseminating knowledge and helping to increase public awareness and understanding of the nature,
              potential, and possible risks associated with biotechnology,
          — identifying the need for, and helping to promote greater activity in the biotechnology small firm
              sector in the Community.
                                                    IMPLEMENTATION
          The action will continue to develop the work (begun under BAP) of ad hoc collaboration between
          groups and individuals with interests and capabilities in the life sciences and biotechnology, so creating
          networks, as informal and flexible as possible, adapted to the needs of encouraging coordination
          through the exchange of information between the participants, and assisting the broader diffusion of
          information required by the above tasks.
          Specifically, the work will involve in-house analysis, the setting-up and the exploitation of an organised
          information base, and missions. It will also include as necessary the commissioning of study reports, the
          organisation of workshops and meetings, and support for the production of reports and diffusion of
          information.