CELEX: 51984PC0230
Language: en
Date: 1984-04-26
Title: PROPOSAL FOR A COUNCIL DECISION ADOPTING A MULTIANNUAL RESEARCH ACTION PROGRAMME OF THE EUROPEAN ECONOMIC COMMUNITY IN THE FIELD OF BIOTECHNOLOGY ( 1985-1989 )

9. 7. 84                             Official Journal of the European Communities                         NoC 182/7
               Proposal for a Council Decision adopting a multiannual research action programme of
                   the European Economic Community in the field of biotechnology (1985 to 1989)
                                                     COM(84) 230 final
                              (Submitted by the Commission to the Council on 11 May 1984)
                                                       (84/C 182/05)
THE COUNCIL OF THE EUROPEAN                                      Whereas the Commission submitted to the Council
COMMUNITIES,                                                     on 13 June 1983 a communication (4) on the role of
                                                                the Community in biotechnology;
 Having regard to the Treaty establishing the Euro-
 pean Economic Community, and in particular
 Article 235 thereof,
                                                                 Whereas the Commission submitted to the Council
                                                                 on 29 September 1983 a communication (5) on bio-
 Having regard to the proposal from the Commis-                  technology in the Community;
sion,
Having regard to the opinion of the European                     Whereas a Community research action programme
Parliament,                                                      is necessary for the development of biotechnology
                                                                 in the Community and, particularly for:
Having regard to the opinion of the Economic and
Social Committee,                                               — the establishment of new methods for the syn-
                                                                      thesis of compounds with high added value,
Whereas Article 2 of the Treaty assigns to the Com-             — more efficient land use through the design of
munity inter alia the task of promoting throughout                    new crops which can provide important feed-
the Community a harmonious development of                             stocks for the European industries,
economic activities, a continuous and balanced
expansion and an accelerated raising of the stan-               — acceptability of the products of modern biotech-
dard of living;                                                       nology through the use of new testing methods
                                                                      which render possible a more efficient and less
                                                                      costly evaluation of toxicity and biological
Whereas, in its resolution of 14 January 1974 on an                   activity,
initial outline programme of the European Commu-
nities in the field of science and technology ('), the          — new approaches in the detection, prevention
Council stated that the whole range of available                      and treatment of costly diseases,
ways and means should be used as appropriate,
including concerted action projects and that when-              — protection of health and environment against
ever it proves desirable that third countries, parti-                 risks which may be associated to new develop-
cularly European ones, should be associated in                        ments in modern biotechnology;
these projects, steps should be taken to make this
possible;
                                                                Whereas the achievement of the objectives men-
Whereas, in its resolution of 25 July 1983 on the first         tioned above requires that actions be implemented
framework programme for Community research,                     at Community level which lead to:
development and demonstration activities (2), the
Council has approved the development of biotech-                — the establishment of a supportive infrastructure
nology as part of the objective 'promoting industrial                for biotechnology research in the Community,
competitiveness';
                                                                — the elimination, through research and through
                                                                      training, of bottlenecks which prevent the
Whereas the ongoing multiannual research and                          exploitation by industry and agriculture of the
training programme for the European Economic                          materials and methods originating from modern
Community in the field of biomolecular engineer-                      biology,
ing (3) has clearly underlined the possibility and util-
ity of a Community action for the exploitation of               — the experimental assessment of biohazards pos-
modern biology in agriculture and industry;                           sibly associated with applications in agriculture
                                                                      and industry of biomolecular engineering;
(')
 2
     OJNoC7, 29. 1. 1974, p. 6.
()    OJ NoC 208, 4. 8. 1983.                                   (4)   COM(83) 328 final.
(3)  OJ No L 375, 20. 12. 1981, p. 1.                           (5)   COM(83) 672 final/2 and Annex.
 ---pagebreak---  N o C 182/8                      Official Journal of the European Communities                                9. 7. 84
 Whereas it is necessary to monitor developments in                                   Article 4
 biotechnology, with a view to assess their strategic
 significance for Europe, and to promote effective           The Commission shall be responsible for the execu-
 concertation between the Community and its Mem-             tion of the programme with regard to the contract
 ber States in matters affecting the development of          research and shall be responsible for the coordina-
 biotechnology;                                              tion with regard to concerted actions.
 Whereas the Treaty has not provided the necessary           The detailed implementation of the programme,
 specific powers;                                            particularly concerning the breakdown of the work
                                                             between contract research and concerted actions, is
 Whereas account should be taken of the opinion of           set out in the Annex.
the Scientific and Technical Research Committee
(CREST) on the Commission proposal,
                                                                                      Article 5
HAS DECIDED AS FOLLOWS:                                      The Commission will be assisted in the tasks listed
                                                             in Article 4 by the Management and Consultative
                                                             Committee (CGC) created by Council Deci-
                                                             sion . . . (').
                        Article 1
 1. A research action programme for the European                                     Article 6
Community in the field of biotechnology is hereby
adopted in the form set out in the Annex for a five-
                                                            With regard to the concerted actions in accordance
year period starting on 1 January 1985.
                                                            with a procedure to be laid down by the Commis-
                                                            sion, after consulting the CGC the participating
2. The programme includes work carried out as               Member States and the Community shall regularly
contract research, training and concerted action.           exchange all useful information concerning the exe-
                                                            cution of the research covered by such activities.
The work will be carried out by means of shared
cost contracts to be placed with appropriate indus-         The participating Member States shall provide the
trial organizations, research laboratories or univers-      Commission with all information relevant for coor-
ity institutes or combinations of them.                     dination purposes. They shall also endeavour to
                                                            provide the Commission with information on simi-
The concerted actions consist of the coordination at        lar research planned or carried out by bodies which
Community level of research activities which are            are not under their authority.
part of existing research programmes in the Member
States and, where applicable, of the Community.             Any information shall be treated as confidential if
                                                            so requested by the Member State which provides it.
                        Article 2
                                                                                     Article 7
The appropriations necessary for the execution of
the programme are estimated at 88 520 000 ECU,               1. In accordance with Article 228 of the Treaty, the
including expenditure related to a staff of 26.             Community may conclude Agreements with non-
                                                            Member States participating in European Coopera-
                                                            tion in the field of Scientific and Technical research
                                                            (COST) with a view to ensuring cooperation
                        Article 3                           between the Community concerted action projects
                                                            referred to in the Annex and the relevant pro-
The Commission will report to the Council and the           grammes of such States.
European Parliament at the end of the third year of
the programme and will propose, where appropriate,          2. The Commission is hereby authorized to nego-
any amendments necessary. These amendments may              tiate the Agreements referred to in paragraph 1.
lead to a revision of the programme in the course of
the fourth year in accordance with the appropriate          (')   Draft Council Decision COM(83) 143 final (OJ No C
procedures.                                                       113,27.4. 1983).
 ---pagebreak--- 9. 7. 84                              Official Journal of the European Communities                                 No C 182/9
                                                             ANNEX
                                RESEARCH ACTION PROGRAMME BIOTECHNOLOGY
                                               (1 January 1985 to 31 December 1989)
                                                            ACTION I
                                                  RESEARCH AND TRAINING
         Sub-programme I: contextual measures for R & D in biotechnology
         Content
         Measures to upgrade the quality and capabilities of facilities, resources and support services
         underpinning biotechnology research, particularly by the enhancement of existing activities in
         the Member States, but not excluding the development of new activities and collaboration in
         wider international activities where essential.
         Measures to enhance access to these facilities, and encourage their use, in research, teaching,
         agriculture, industry and health care.
         —       Bio-informatics:
                — data-capture techniques (particularly advanced instrumentation and measurement,
                       automated reading),
                — data banks,
                — computer modelling of biological structures and systems,
                — sophisticated computer software for the human interface with computerized facilities
                        relating to the life sciences and biotechnology.
         — Collections of biotic materials:
                — organized collections of animal and plant cells, hybridomas, micro-organisms, their
                        viruses, and all other forms of biotic material of potential use and relevance to biotech-
                        nology,
                — development of information and communication techniques for enhancing the quality
                        and usefulness of such collections,
                 — development of techniques for the identification, characterization, conservation and
                        resuscitation of the materials held in such collections.
          Implementation
          Through cost-shared contracts with appropriate institutions, with provision as necessary for work-
          shops and meetings.
          F i n a n c i a l means
          Estimated at 11 110 000 ECU including expenditure for a staff of four.
          Sub-programme 2: basic biotechnology                                                             '
          Content
          Pre-competitive research and research through training in areas of basic biotechnology where
          technical and scientific bottlenecks prevent the applications of modern genetic and biochemical
          methods to agriculture and industry.
 ---pagebreak--- No C 182/10                        Official Journal of the European Communities                                  9. 7. 84
           — Enzyme engineering:
               — development and evaluation of bio-reactors (and particularly those which are multien-
                     zymatic, multiphasic or co-factor requiring) for industrial applications, depollution and
                     detoxification ('),
               — modifications of enzyme properties, protein design, synthesis of artificial enzymes and
                     development of new methods (including, for example, filtration, centrifugation and
                     reverse osmosis) for large-scale and highly selective separation of proteins and other
                     substances with industrial or agricultural value.
           — Genetic engineering:
               — improvement of soil- micro-organisms (particularly Rhizobium, bacteria of the rhizo-
                     sphere of graminaceae, mycorhiza) and of cultivated plants important for European agri-
                     culture ('),
               — exploitation of plant products (particularly ligno-cellulose) ('),
               — applications to animal husbandry (particularly the production of vaccines and hor-
                     mones (') and gene transfer in animals).
           — Physiology and genetics of species important to industry and to agriculture:
               — study of poorly understood basic functions in micro-organisms (particularly chemo-
                     autotrophs, methanotrophs, mycorhiza) which appear to be promising for future indus-
                     trial use,
               — analysis of factors governing the yield and stability of micro-organisms during industrial
                     exploitation or in relation to symbiotic relationships with higher plants,
               — identification of factors and mechanisms governing important properties in cultivated
                     plants (particularly in Triticum, Vicia, Brassica).
           — Technology of cells and tissues cultured in vitro:
                — analysis of factors governing yield and stability during continuous cultivation or in
                     mixed populations,
                — control of the differentiation of plant cells and of their regeneration in entire plants ('),
               — methodology of animal cell cultures (in particular for the production of monoclonal
                     antibodies)
                — development of micro-analytical methods for the identification and quantification of
                     biologically important molecules,
               — study of cell biology applied to the prevention, detection and treatment of a few
                     selected diseases which are particularly important from a socio-economic point of view.
           — Screening methods for the evaluation of the toxicological effects and of the biological activ-
                ity of molecules:
                the tests (essentially in vitro and non-invasive in vivo) to be developed should contribute to a
                better understanding of structure-function relationships and to the uniformization of screen-
                ing procedures throughout the Community.
          — Assessment of risks:
               development of new methods for detecting contamination and for the assessment of possible
               risks associated with applications in industry (particularly during downstream processing)
               and agriculture of biomolecular engineering (').
           Implementation
          Through cost-shared research contracts, training contracts, short-term training grants, courses,
           consultations of national experts, organization of study-group meetings, participation in seminars
           and symposia, and publications.
          (')  Continuation from 1 April 1986 to 31 December 1989 of a project presently implemented in
               the framework of the biomolecular engineering programme (April 1982 to March 1986).
 ---pagebreak--- 9. 7. 84                           Official Journal of the European Communities                               No C 182/11
         F i n a n c i a l means
         The appropriations necessary for the implementation of the sub-programme are estimated at
         69 000 000 ECU, including expenditure for a staff of 14 (>).
                                 COST activities associated to the programme as category II
         Content
         — aquatic primary biomass (marine macroalgae),
         — plant in vitro culture.
         Implementation
         Through the organization of meetings, consultation of experts, publications, exchange of research
         workers between laboratories, coordination contracts.
         F i n a n c i a l means
         The appropriations estimated necessary for the implementation of these activities are estimated at
         1 500 000 ECU.
            Involvement in the activities of the 'Technology, growth and employment' working group created at
                                               the Versailles summit of 1982 (2)
         Content
          Coordination and concertation in basic biology
         — area 1: data banks,
          — area 2: collections of biotic materials.
          Implementation
          Through the organization of meetings, consultations of experts, publications.
          F i n a n c i a l means
          The appropriations estimated as necessary for the implementation of these activities are esti-
          mated at 500 000 ECU.
                                                         ACTION II
                                                      CONCERTATION
          Content
          A concertation activity will be implemented with the objectives of improving standards and capa-
          bilities in the life sciences, and enhancing the strategic effectiveness with which these are applied
          to the social and economic objectives of the Community and its Member States.
          (')    Includes the staff of five of the ongoing biomolecular engineering programme (April 1982 to
           2
                 March 1986) who will be assigned to the sub-programme on 1 April 1986.
          ( ) Technology, growth, employment: report to the seven Heads of State and Governments and
                 to the representatives of the European Communities. Coll. Rapports Officiels, January 1983.
 ---pagebreak--- N o C 182/12                         Official Journal of the European Communities                                9. 7. 84
           In conjunction with the relevant services in the Community and the Member States, the follow-
           ing tasks will be executed:
           — monitoring the strategic implications of developments elsewhere in the world for biotechnol-
                  ogy-based industry in Europe,
           — working with the services of the Community, Member States and other interested parties to
                  identify ways in which the contextual conditions of operation for biotechnology in the Com-
                  munity may be further improved, to promote its development in all useful applications, and
                 the supporting scientific capabilities,
           — responding to the needs for research and information in support of the specific actions of
                  other services of the Commission,
           — identifying opportunities for enhancing through concertation and cooperation the effective-
                  ness of biotechnology-related programmes in the Member States, and promoting collabora-
                 tive initiatives in biotechnology with and between industry and universities,
           — consideration of how the safe and sustainable exploitation of the renewable natural resource
                  systems in Europe may be enhanced by the application of biotechnology,
           — promoting in cooperation with developing countries and relevant institutions the pursuit of
                 the same task (see preceding paragraph) within their respective regions,
           — monitoring and assessing developments in biotechnology bearing on safety and other
                  aspects of the 'social dimensions',
           — disseminating knowledge and increasing public awareness of the nature and potential of
                 biotechnology and the life sciences, to raise the quality of public debate,
           — establishing an ad hoc system of collaboration between groups and individuals with inter-
                 ests and capabilities in the life sciences and biotechnology; so creating networks, as informal
                  and flexible as possible, adapted to the particular problems under study: the networks to
                  have the triple function of providing an active input into the programme, encouraging coor-
                  dination through the exchange of information between the participants, and assisting the
                  broader diffussion of information envisaged in the preceding task.
           Implementation
           Essentially through in-house work, the setting-up and the exploitation of an organized informa-
           tion base and through missions, but will include as necessary the commissioning of study reports,
           the organization of workshops and meetings, support for the production of reports and diffusion
           of information.
           F i n a n c i a l means
           Estimated at 6 410 000 ECU including expenditure for a staff of eight.