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) (presented by the Commission)

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 ---pagebreak---   COMMISSION OF THE EUROPEAN COMMUNITIES
                                              COM(88 ) 806 final - SYN 182
                                              Brussels , 3 January 1989
:
                                  Proposai 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 )
                                                    B (,
                          ( presented by the Commission)n)
                                                            n A -
                                                                      , -.A h j
                                                                              // /
                                                               PO eo
 ---pagebreak---                                   СОМКАкЛ
Over the past ten years , the basic scientific successes of bio¬
technology have been brought closer to applications for a wide range
of social and economic purposes , principally in health care and in
agriculture . Throughout the world , new biotechnology products are now
being brought to market , their benefits reaching patients , farmers and
consumers . In the United States , public expenditure on biotechnology
research amounts to $ 2.7 bn per year ( L ) motivated by a clear percep ¬
tion in scientific , economic and political circles of its importance
to the future competitiveness of US exports .
Within the EEC , action in biotechnology is one of the lines of the
framework programme for Community activities in the field of research
and technological development ( 2 ); the stated purpose being :
           "To master the properties of living cells and to secure
            their exploitation , in the interests of consumers , by both
            industry and agriculture".
Past and current Community actions have aimed at strengthening the
scientific base of     Europe 's biotechnology ,  and hence  inter alia
improving its international competitiveness . Through the Biomolecular
Engineering Programme ( 1982-86 ) and the ongoing Biotechnology Action
Programme ( 1985-89 ), the Community is stimulating a network for
training and for transnational collaborative research in European
Laboratories Without Walls ( ELWW ). Through collaboration with Member
States , through other Community programmes and through a range of
concertation activities including impact assessments , the Commission
seeks to encourage the effective application of the fruits of bio¬
technology to the social and economic objectives of the Community and
Its Member States . These objectives include not only competitiveness ,
but the improvement of health and environment , and the promotion of
scientific and industrial collaboration with developing countries .
Objectives of the proposed programme
The present proposal for a successor programme to BAP is in line with
the above developments . Entitled BRIDGE ( Biotechnology Research for
Innovation , Development and Growth in Europe ), it is planned for
1990-94 , with a total budget of 100 Mio ECU .
The objectives of BRIDGE have been defined on the basis of past
achievements in BEP and BAP and through recommendations received from
a panel of Independent Experts , the European Parliament , industrial
organisations and the CGC Biotechnology .
BRIDGE is subdivided , as was BAP , JLnta two actions :
Action I for Research and Training , and Action II for accompanying
actions grouped under the term "Concertation". Ninety per cent of the
total budget will be devoted to Action I and 10% to Action II .
                                      Ü
                                                                          S
 ---pagebreak--- The main Casks of Action T will be Co develop cooperative basic
researcn and training throogU research adapted to the long term needs
of the Community . This Implies , for the removal of bottlenecks result¬
ing from gaps in basic knowledge , the reinforcement of existing
networks of ELWWs and their extension to new areas considered of high
significance for the Community . Alternatively , larger targeted pro¬
jects will be Implemented , when necessary , for removing bottlenecks
originating from scale or structural constraints . A very substantial
effort Is foreseen In the area of pre-normative research and , in
particular , with regard to the assessment of risks possibly associated
to the release of genetically engineered microorganisms . The research
and training programme is subdivided into four sectors :
                     - Information infrastructures
                     – enabllng technologies
                     - cellular blology
                    – pre-normative research
Action II "Concertation" will cover a range of monitoring . Information
and collaborative activities to provide and facilitate the effective
application of biotechnology to the social and economic objectives of
the Community and of the Member States .
 ( 1 ) U.S. Congressional Office .of Technology Assessment , "U.S.
       Investment in Biotechnology", April 1988 .
 (2 ) Council Decision of 28 September 1987 , 87/ 516 : OJ L 302/ 1–23 ,
       24.10.1987 .
                                       iii
                                                                         *
 ---pagebreak---                                                1
                              TABLE OF CONTENT
SUMMARY                                                         I
TABLE OF CONTENT                                                TLv
EXPLANATORY MEMORANDUM  . ...                                     I
         Action I :  RESEARCH AND TRAINING                        3
                 1.  Basis of the present proposal                3
                 2.  Objectives and orientations of BRIDGE        8
                 3.  Implémentation schemes                      10
                 4.  Management principles                       10
         Action II : CONCERTATION                                13
                 1.  Origin and aims                             13
                 2.  Current activities and achievements         14
                 3.  Opinions , évaluation and recommendations   15
                 4.  Objectives and priorities for concertation  16
                 5.  Implémentation                              16
PROPOSAL FOR A COUNCIL DECISION                                   1
Annexes : TECHNICAL ANNEX                                         7
          EVALUATION CRITERIA                                    18
          COMPETITIVENESS AND EMPLOYMENT IMPACT STATEMENT        22
          FINANCIAL STATEMENT                                    25
                                       Iv
                                                                    S
 ---pagebreak--- EXPLANATORY   MEMORANDUM
            1
 ---pagebreak---                         ACTION I : RESEARCH AND TRAINING
l . BASIS OF THE PRESENT PROPOSAL
   The argumentation for a continuation of Community R&D efforts in
   biotechnology and the choice of the main orientations in the proposed
   programme are based upon :
             – the assessment , by the Commission services and by indepen¬
   dent experts , of past and ongoing R&D Community programmes in bio-
   molecular engineering and biotechnology
      *                             _                                  %
             - recommendations for future activities , as expressed by
   Commission and national experts , the European Parliament , a panel of
   Independent experts-;–Industrial bodies and– the national delegations
   of the CGC " Biotechnology".
1.1 . Assessment of past and ongoing Community programmes
      The first R&D Community activity in biotechnology was BEP ( Bio-
      molecular Engineering Programme ) with a budget of 15 Mio ECU ,
      which supported between April 1982 and March 1986 91 training
      contracts and 103 cost-shared research contracts with public and
      private laboratories in the Community . The second R&D programme in
      biotechnology is BAP ( Biotechnology Action Programme ) which covers
      the period 1985 - 1989 with a budget of 75 Mio ECU . The research
      activities of BAP are being executed , for the time being , in 90
      transnational projects by groups of laboratories which agreed to
      join their efforts and to work together .
      Detailed information on the implementation and achievements . of
      these two programmes have been published by the Commission ser¬
      vices ( 1 , 2 , 3 ).
      BEP has been submitted to evaluation procedures carried out at
      three different levels : research contractors ( 1 ), CGC " Bio­
      technology" ( 4 ), Panel of Independent Experts nominated by the
      Commission .
(1)   Biomolecular Engineering in the European Community : achievements
      of the research programme ( 1982-1986 ), edited by E. Magnien ,
      Martlnus Nljhoff Publishers for the Commission of the European
      Communities , EUR 10658 EN , 1986 .
(2 ) European Laboratories Without Walls :           focused pre-competitlve
      research .     R. van der Meer ,   E. Magnien –'and  D. de Nettancourt :
      Trends in biotechnology ( 1987 ) 4:277 .
(3)   BIOTECHNOLOGY ACTION PROGRAMME . Progress report 1987 ( 2 volumes ).
       Ed. :  E. Magnien . Commission of the European Comminitles ,
      EUR 11138 EN , Luxemburg , 1987 . The 1988 issue will be published in
      January 1989 .
(4)   COM(86 ) 27 2 final     "Communication   from  the  Commission  to  the
      Council concerning the review of the multiannual research pro ¬
      gramme for the EEC in the field of biotechnology", 21 May 1986 .
                                       - 3 -
 ---pagebreak---         BAP was assessed by the same Panel of Independent Experts who
        evaluated BEP ( I ).
        Every one ot these evaluations underlined         the usefulness or
        Community R&D in biotechnology .
        With regard to BEP , the CCC biotechnology considered that "its
        most convincing result is undoubtedly the creation of a climate
        favourable to transnational cooperation , the effects of which fall
        beyond the hopes expressed when the programme was launched".
        Commenting on both BEP and BAP , the Evaluation Panel of Indepen¬
        dent Experts stated that "... a major achievement of the research
        programmes , and one that is important for the future , has been to
        break down national frontiers between laboratories . We commend the
        Commission’s initiative in linking groups into European Labora¬
        tories Without Walls , a useful concept that could be applied in
        other domains . We were Impressed by the way some contractors , who
        had initially been sceptical- about transnational cooperation , -were
        now enthusiastic".
        The Evaluation Panel concluded that the training activities in BEP
        and BAP had been successful and that the research programmes led
        to a number of substantial scientific achievements testifying for
        their high quality . The panel noted that "highly significant
        technical breakthroughs" ( 2 ) had been achieved by the programme
        particularly in sectors such as the genetics of plants and of
        industrial microorganisms . In sectors where such breakthroughs
        were not reached , the Panel considered that either the goals and
        bottlenecks had been insufficiently defined or that a critical
        mass of researchers had not been assembled .
1.2 . Recommendations for future activities
l , 0 -!. Recommendations of the Evaluation . Panel   –-
          The panel concluded its report ( 1 ) by a number of recommen¬
           dations which , as far as the. ,research activities' of BRIDGE are
           concerned , call for "science-led" projects and " large scale"
           projects .
           The panel considered that the following large scale projects are
           of particular importance :
           " – To sequence the yeast genome completely .
             – To develop detailed molecular genetic maps for one plant and
               one animal species of economic importance to Europe .
( 1 ) Evaluation of the Biomolecular Engineering              Programme ,   BEP
       ( 1982-1986 ) and the Biotechnology Action             Programme ,   BAP
       ( 1985-1989 ). Research Evaluation Report n° 32 – EUR 11833 EN / l .
( 2 ) It is of course on the basis of such breakthroughs , ultimate
       consequence of the catalytic effects of transnational cooperation ,
       that the programmes need to be judged . The complete list of
       scientific and technical achievements , which cannot be reproduced
       here , are to be found in the final report of BEP and in the last
       two annual reports of BAP ( l.c .).
                                      - 4 -
 ---pagebreak---           - To undertake a focused programme in protein engineering so as
            to understand and modify in a multi-disciplinary manner the
            structure and biological and / or physical properties of a few
            proteins .
          - To elucidate the control of gene stability , transcription ,
            post-transcriptional    and    post-translational       processing ,
            protein over-production , and secretion in one major industrial
            microorganism through genetic manipulation , biochemistry and
            cell physiology .
          - To apply recent progress in molecular biology to the physio ¬
            logy and improvement of major European crops , including gene
            transfer to , and cell regeneration of , cereals .
          - To establish a complete interconnection and cataloguing system
            for the major culture collections in all Member States with
            on-line access , for a fee , by all research workers . A pilot
            scheme , involving the current BAP contractors , should achieve
            these objectives by 1991 .
         - To continue to develop appropriate methodology for an assess¬
            ment of the safety and ecological consequences of the release
            of genetically modified organisms , especially bacteria and
            viruses , in order to develop guidelines for best practice in
            the production and use of such organisms ."
1.2.2 . Resolution of the European Parliament on biotechnology in Europe
         and the need for an integrated policy ( 1 )
          In this resolution , which goes beyond the limits of R&D in bio¬
         technology , and upon which the Commission reported on
         30 October 1987 ( 2 ), the European Parliament acknowledged the
         " considerable success . of BEP . in stimulating transnational
         cooperation between European laboratories and the training of
         young scientists as well as coordinating research activities ".
         The resolution noted , however , that BEP only had a limited
         budget and concentrated mainly on research connected with
         agriculture and the food processing industry , and specified the
         priorities and essential features for future Community pro ¬
         grammes in biotechnology . Among many specifications which , in
         certain cases , concerned other programmes of the Community
          (medical research , cooperation with the third world countries ,
         AIM . ..), the European Parliament underlined the necessity to
         give priority in future to projects studying the problems posed
         by the intentional release of genetically engineered micro ¬
         organisms in the environment .
( 1 ) O.J. of the European Communities , 16 February 1987 , n° C 76 / 25 .
( 2 ) Half-yearly report on actions taken on Parliament 's own initiative
      resolutions ( January to June 1987 ), SP(87 ) 2461 / 2 , 30 October 1987 ,
      Commission of the European Communities .
                                     - 5 -
 ---pagebreak--- 1.2.3. The polnc of view of Industrial organisations
       Xhe organisations which expressed opinions are listed in
       Table I , together with the titles of their reports .
       IRDAC ,   the  industrial   research   and  development   advisory
       committee of the CEC , delivered the most detailed opinion on the
       content of BRIDGE . Many of its recommendations are in line with
       the programme proposed by the Commission . In particular , it was
       through a request of IRDAC W.P.5 "Biotechnology" that the
       research activities implemented      in the framework of BAP on
       " second generation bioreactors" are not suggested to continue
       within BRIDGE . On the other hand , their recommendations to rank
       as top priorities protein engineering , or plant and microbial
       biotechnology (with increased emphasis on physiology and
       metabolism), have been taken up entirely .
       The first recommendations submitted by EBCG with regard to
       safety evaluation (detection methods , micro-ecosystems , biologi¬
       cal containment , survival and speed of dispersal) have been
       Integrated in the present proposal . Similarly , the various
       areas , including safety evaluation , which EBCG considered as
       priorities in its position paper " the approach of the
       biotechnology industry to BRIDGE" are parts of the present
       proposal . The CEEIC report on bio-informatics in Europe goes
       beyond , in ambition and in scope , the activities restricted in
       BRIDGE to the information needs of three sectors : protein
       design , genome sequencing , data banks and information networks .
       Other programmes have been defined , such as AIM (Advanced
       Informatics for Medicine ), which will also contribute to the
       main objectives outlined by CEFIC .
       The "Green Industry Biotechnology Platform" and a group of 16
       yeast related industries provided opinions which were restricted
       to the interest of defined industrial, brancher .. The correspon¬
       dence between their expectations and the provisions made by
       BRIDGE in the various sectors which they covered is extensive .
                                   - 6 -
                                                                          λθ
 ---pagebreak---  Table 1 : References to opinions expressed by Industrial organisations
  Industrial R&D Advisory Committee of the European Communities ( IRDAC )
     "Opinion on future R&D programmes In the field of biotechnology",
     December 1987 .
  European Biotechnology Co-ordination Group * ( EBCG )
     " Safety Evaluation Through Risk Assessment in Biotechnology", March 1987 .
     "The Approach of the Biotechnology Industry to BRIDGE", November 1987 .
  European Council of Chemical Manufacturers Federation (CEFIC )
     " Bio-informatlcs in Europe - An industry position paper", March 1987 .
  Green Industry Biotechnology Platform (GIB1P )
     " Final opinion of GIB1P on the BRIDGE programme", April 1988 .
  Consultation of yeast Industries
     In " Sequencing the yeast genome , a detailed assessment", June 1988 .
* The members of EBCG are CEFIC , CIAA (Confederation of Food and Drink Indus¬
  tries of EEC ), EFPIA ( European Federation of Pharmaceutical Industries'
  Associations ), GIFAP ( International Group of National Associations of
  Agrochemical Manufacturers ) and AMFEP ( Association of Microbial Food F^zyme
  Producers ).
    1.2.4 . Opinion of the CGC " Biotechnology"
            The present proposal was prepared with the constant help and
            feed-back of the CGC "Biotechnology" and , in particular , through
            the guidance of 10 specific ad hoc groups , each created by the
            CGC , for reviewing a specific sector or subsector of BRIDGE and
            making recommendations . At its meeting of 17 November 1988 , the
            CGC reviewed an earlier version of the document and examined , at
            the same time , draft suggestions for amendments prepared by
            subgroups of IRDAC W.P. for biotechnology . The CGC thereafter ~
            formulated final recommendations which are taken into account in
            the present proposal .
                                       - 7
 ---pagebreak--- 2. OBJECTIVES AND ORIENTATIONS OF BRIDCE
    It is considereu , on tne basis of tlu- assessment*-, and recommen¬
    dations
    be :
               outlined above, that the objectives of the programme should
                – to foster transnational research and to promote its
    catalytic effects , for accelerating the production of biological
    data , materials and methods ' necessary for the safe and rational
    exploitation of useful organisms ;
                – to place such data , materials and methods at the disposal
   of    industry
    exploitation ;
                  , agriculture and research centres and to encourage their
                – to ensure that Information generated under the programme
    is available for current discussions on the social acceptability of
   modem biotechnology ;
                ~ to establish , through normative research , the scientific
   basis necessary for the establishment of guidelines to regulate new
   and economically important production methods (including , in partic¬
   ular , those which are based upon the use of genetic engineering);
                – to take advantage of the scientific competences dispersed
    throughout the Community for contributing , via training and scien¬
    tific mobility , to the requirements of biotechnology operators in
   qualified scientific staff and in multidisciplinary combinations of
   expertise .
   Two approaches will be followed for the development of the pro¬
    gramme .
2.1 . Removal of bottlenecks resulting from gaps in basic knowledge
        In most areas of biotechnology , there is clearly a need fot
        embarking on exploratory research ventures , particularly when
        Insufficient basic knowledge of organismal biology has been
        reducing the scope for applying molecular methods . The primary
        requirement in this prevalent situation is to increase the multl-
        disciplinarity of research by fostering temporary combinations of
        skills . The uncertainty of the outcome recommends a reasonable
        dosage of efforts and of supporting funds but its Importance
        justifies an active partnership with industries , either for an
        active collaboration of efforts or for the exploitation of data ,
        methods and materials originating from the research. Finally , the
        difficulty and complexity of the work calls for the catalytic
        mobilisation of competences throughout the entire Community.
        All these requirements can best be satisfied through the creation
     -- of European Laboratories Without Walls (ELWWs ) similar to those
        which have been successfully promoted in the framework of BAP . The
        scientific content for cooperative projects foreseeen for imple¬
        mentation by networks of ELWWs is outlined in annex to the pro¬
        posal for a Council decision under the four headings - information
        infrastructure ,  enabling    technologies ,  cellular biology and
        normative research .
                                      - 8 -
                                                                             \ъ
 ---pagebreak--- 2 . 2 , Removal of bottlenecks resulting from structural or scale con-
        stralncs
        In several Instances , the bottleneck to the exploitation of modern
        biology results from structural or scale constraints which could
        be overcome through a significant investment of skills and re¬
        sources during a       specific   period .   Community   projects for the
        removal of such bottlenecks will , in many instances , represent the
        logical extension of activities initiated by European Laboratories
        Without Walls ; they must , in all cases , clearly form part of the
        sectors outlined in annex to the proposal for a Council decision
        and are to be defined , at the time the call for proposals is
        prepared ,   in    close   cooperation     with   the   relevant  advisory
        committee .   " Sequencing of    the yeast genome ", " High resolution
        automated microbial identification" and " Molecular identification
        of new plant       genes "  are  examples ,    among  several others , of
        subjects which could be addressed in this way .
2.3 . Training
        It is proposed , on the basis of recent analyses ( 1 , 2 , 3 ) and of
        several consultations of experts and expert committees , to con¬
        tinue in BRIDGE the activities which have been shown , through BEP
        and BAP , to answer an essential need of the Community for scien¬
        tists trained in the complex areas of biotechnology .
        Training in BRIDGE will therefore involve :
                - the establishment of training contracts for junior and
        senior scientists with duration periods ranging from 6 to 24
        months . The scientific scope for these " training through research"
        activities will cover each of the specific areas outlined in annex
        to the proposal for a Council decision .
                - the organisation , as in BAP , of courses and summer
        schools in all areas of research where obvious training needs are
        identified during the implementation of the programme .
( 1 ) W. Dostal , Fast series n° 22 "New technology and development in
        employment ", EUR 11386 EN , 1988 .
( 2 ) D.J. Bennett "Manpower , Education and Training in Biotechnology"
        A.A.B.B. , London , 1988 .
( 3)    A. Dollacker , M. Olast ,     E. Magnien "The advertised demand for
        qualified staff in biotechnology-related fields : a statistical
        approach", DG XII , 1986 ( draft report ).
                                         - 9 -
                                                                                   \3
 ---pagebreak--- 3. IMPLEMENTATION SCHEMES
3.1 . Cooperative networks proleics ("H" projects )
      These projects , such as defined above In 2.I. , will be based on
      the BAP model with a contribution of the Comnunlty ranging from
      200.000 - 400.000 ECU/year x project . Applications for support
      will be requested to provide a very dear matrix of the tasks
      suggested for each of the laboratories presenting the proposal .
      Only closely Integrated projects , obviously leading to the forma¬
      tion of an active European Laboratory Without Walls , will be
      considered for funding .
      When necessary , the Commission services will also organise trans¬
      national activities (visits , meetings , exchanges of information)
      between laboratories of high scientific level not involved In the
      Implementation of science-led projects . It is expected that these
      laboratories , after a year or two of collaborations stimulated by -
      small financial contributions will be ready , at the time BRIDCE is
      revised , to submit new transnational proposals for science-led
      projects .
3.2 . Larger targeted projects ("T" projects )
      Support of the Commission to "T" projects , such as defined above
      in 2.2 ., may vary from 1 to 3 Mio ECU per year and per project .
      The manner in which the work is distributed and research funds are
      allocated to each participating laboratory will be specific to
      each project . Sequencing of the yeast genome , one of the
      "T" projects proposed above by the Commission , represents a case
      where Community funds are going to be allocated to very many
      laboratories working in one single project .
3.3 . Training
      Training activities will be pursued on the BAP model . For training
      through research , it is planned to attribute a number of training
      contracts to junior and senior scientists corresponding to an
      average of 160 man/year . Benchfees will be attributed to the host-
      laboratories .
4 . MANAGEMENT PRINCIPLES
4.1 . Consultation of the advisory committee
      Preparation of tender documents for research and training activ¬
      ities , assessment of proposals and selection of trainees , evalua¬
      tion of results and diffusion of information on the programme will
      be made by the Commission in consultation with the relevant
      advisory committee .
4.2 . Setting up of target-linked monitoring units
      Owing to the complexity and the wide diversity of scientific
      subjects that are encompassed in the definition of modern bio¬
       technology , much specialised expertise appears required for the
                                      10 -
 ---pagebreak---       proper management of all programme areas . Target-linked monitoring
      units should be established in association with each "T" project
      and , if needed , with certain groups of " N " projects . Each monitor ¬
      ing unit could be constituted , with the scientific officer ct tu :.
      Commission , through a list of experts from the Commission and from
      advisory committees . Each monitoring unit should follow the
      progress of relevant projects towards specific goals of the
      corresponding part of the programme , and assist the Commission in
      various assessment and steering tasks . It should meet at least
      once a year , to analyse annual progress within the corresponding
      programme areas , and to report to the relevant advisory committee .
      These monitoring units could constitute one of the elements of a
      decentralised management system established progressively in the
      framework of the programme .
4.3 . Criteria for selection of research projects
      The selection of proposals will be carried out with the help of
      the advisory committee . The following criteria will be applied :
              - the technical competence of the proposer
              - the scientific interest of the . proposal , its originality ,
      its relevance to the scope of the programme and its feasibility
      ( including ultimate economic feasibility )
              - the likely contribution of the proposed research to
      safety , to the harmonisation of norms and to the economic strength
      and competitiveness of the European Communities
              - the intensity of transnational collaboration ( proposals
      not   originating   from  at   least  two    laboratories   located  in
      different Member States will not be considered for funding )
              - the involvement of industry , through direct participa¬
      tion , co-financing , supply of materials , access to infrastruc¬
      tures , expression of Interest for exploitation of research
      results ...
              - when applicable , the assessment of risks possibly associ¬
      ated to the research proposed (each . contractant will have to
      adhere most strictly to the rules and recommendations issued on
      the matter in the Member State where the laboratory is located ).
                                       11 -
                                                                               IS
 ---pagebreak--- 4.4 . Relationships and cooperation with oth e r Comiranlty or Internation¬
      al K&D programmes
      " BRIDGE contributes to the Implementation of the subdivision "4.1 .
      Biotechnology" of the Community Framework Programme for research
      and technological development . It Is complemented by current and
      future specific programmes foreseeen under the subdivision "4.2 .
      Agro–industrial technologies" and "4.3 . Competitiveness of agri¬
      culture and management of agricultural resources ". The ties
      between BRIDGE and these actions are very narrow , particularly
      with regard to ECLAIR and FLAIR which lie directly downstream of
      the programme .
      Other relationships between BRIDGE and existing or future R&D
      Community activities are to be found In some of the areas covered
      by the programme " Environment", in the foreseen action for "Predi¬
      ctive Medicine", the "Science" plan , the programme "Science and
      Technique for Development ", in ESPRIT ( in particular area II . 2
      "knowledge engineering") and in the demonstration projects for- the
      Energy Sector .
      In all these cases , close coordination will be assured to exploit
      natural complementarities between programmes and to avoid any
      unnecessary duplication .
      The generic and pre-competitive technological work envisaged for
      BRIDGE should , in the medium to long term range , create opportun¬
      ities for Eureka projects with commercial alms .
      The present links with the European Federation of Biotechnology
      ( participation of Commission staff to meetings of the Science
      Advisory and Executive EFB Committees , attendance of EFB represen¬
      tatives to CEC workshops , support , as in June 1987 . to th■a -.- or¬
      ganisation of the European Congress on Biotechnology          wlijL tz
      maintained and intensified .
                                      12 -
 ---pagebreak---                             ACTION II : CONCERTATION
 1 . ORIGIN AND AIMS
     Throughout the world , national administrations have recognised de
      facto that the interdisciplinary and multi-sectoral character of
     biotechnology demands            inter-agency coordination           for policy
     coherence . Recognising this , the Commission in 1984 established an
     inter-service Biotechnology Steering Committee , and supporting
     structures and activities ; charged with implementing the range of
     priority actions for biotechnology defined in its previous
     communication to Council ( 1 ), leading to the preparation of
     Commission initiatives ,           such as the recent proposals for
     biotechnology regulation ( 2 ).
     In March 1985 , the Council Decision ( 3 ) establishing the Bio¬
     technology Action Programme provided a mandate for a concertation
     action involving the Member States . The Council mandate defined the
     objectives :
          " improving standards and capabilities 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 ".
     A list of supporting tasks was itemised , which can be summarised as :
     - worldwide     monitoring and        information    gathering ;   analysis   and
        evaluation ; storage ; and selective diffusion ;
     - coordination and promotion of collaboration                 in   policy   areas
        affecting or affected by biotechnology ,
          (i)    - across the services of the Commission
          ( ii ) - between Commission and Member States ,
     - scope for more specific initiatives on key biotechnology-related
        topics such as agriculture and environment , Third World develop¬
        ment , safety , public information , academic-industrial collabora¬
        tion , and social dimensions .
     Across all these areas , emphasis was placed on acting in conjunction
     with relevant services in the Community and the Member States , and
     through ad hoc , informal and flexible networks .
(1)     COM(83 ) 672    final / 2 ,     " Biotechnology     in    the      Community ",
        4 October 1983 .
(2)     E.g . COM(86 ) 573 final , "A community Framework for the Regulation
        of Biotechnology ", Communication from the Commission to the
        Council , 4 November 1986 ; COM(88 ) 160 final , " Proposal for a
        Council Directive on the contained use of genetically modified
        microorganisms " and " Proposal for a Council Directive on the
        deliberate release to the environment of genetically modified
        organisms ", 4 May 1988 ; and COM(88 ) 165 final , " Proposal for a
        Council   Directive  on     the   Protection of    Workers    from   the Risks
        related to Exposure to Biological Agents at Work", 5 April 1988 .
(3)    O.J. L 83 of 25 Marc h 1985 .
                                                        «
                                                                                        Vi
                                                                                           !
 ---pagebreak---  2 . CURRENT ACTTVTTTES AND ACHTEVEMENTS
     Numerous activities have been initiated under these mandates , to
     provide a service of strategic awareness , analysis , recommendations
     for action , and supporting actions . Concertation is a service
     activity , to enable all Commission services , Member State agencies ,
     or other actors involved in biotechnology to perform better or to
     coordinate better their actions . The following are examples of
     activities
     role :
                  in which the concertation action has played a significant
      (i)    - a documentation centre , now containing some 25.000
                policy–relevant papers on biotechnology , is used increas–
                ingly by Commission and Member State colleagues , their
                advisers , consultants , researchers , and Parliamentary aids .
                Plans are in preparation to upgrade it , in particular to
                facilitate access and diffusion . Thousands of requests are
               met each year for information , advice and documentation ;
               current activities are increasingly constrained by manpower
               and space limits .
     (ii) - ad hoc studies and workshops have led to actions on
               recommendations
     - the "BICEPS'* planning exercise (Bio-Informatics : Collaborative
        European Programmes and Strategy ( 1 ); provided foundations for
        reinforcing bio-informatics in BAP and BRIDGE , and for the AIM
        programme (Advanced Informatics in Medicine );
     - various studies , consultative meetings , a Commission discussion
        paper (2 ) and a call for expressions of Interest prepared the
        proposal for the ECLAIR and FLAIR programmes ( 3 , 4 );
     - studies arising from the work of the Task Force for Biotechnology
        Information have led to concrete recommendations , well-supported
        by industry , for a European biotechnology information policy ( 5 );
(1)     BICEPS summary report available , and 15 supporting study or work¬
        shop reports .
(2 )   COM(86 ) 221 / 2 , Discussion Paper , " Biotechnology in the Comnunity :
        Stimulating Agro-Industrial Development", 15 April 1986 .
(3)    COM(87) 667 , Proposal for a Council Decision to adopt a first
       multi–annual programme ( 1988–1993 ) for biotechnology–based agro¬
       industrial research and technological development " ECLAIR ( Eur¬
       opean Collaborative Linkage of Agriculture and Industry through
       Research ), 18 December 1987 .
(4 )   COM(88 ) 351 , Proposal for a Council Decision to adopt a multi¬
       annual research and development programme In food science and
       technology ( 1989 to mid– 1993 ) FLAIR ( Food–Linked Agro-Industrial
       Research ), 24 June 1988 .
(5 )   "The Role of Information Technology and Services in the Future .
       Competitiveness of Europe 's Bio–industries " , report prepared for
       the Commission , January 1988 , by ASFRA consultants .
 ---pagebreak---       ( ill ) - secretariat of interservice groups such as the
                 Biotechnology Steering Committee , BRIC , and Bio-RDD .
     These and other activities are pursued in implementation of the
     multi-service strategy defined in 1983 .
3 . OPINIONS , EVALUATION AND RECOMMENDATIONS
     The above initiatives , both in the general aim of strategic coher¬
     ence and the specific examples cited , are in accordance with the
     recommendations of IRDAC ( 1 ). The EVALUATION PANEL ( 2 ) recommended
     that
     "The concertatlon activity should also be expanded in line with the
     general growth of the biotechnology research programme , to about 10%
     of the total budget of BRIDGE"; and
     " should concentrate on four major tasks , of which the last is new :
     (i)      The coordination of the Commission 's approach to bio¬
              technology , including the dissemination of information in¬
              ternally , and the formulation of proposals for future initia¬
              tives .
     ( ii )   The concertatlon of biotechnology activities of Member States .
     ( iii ) The provision of information on the advantages , limitations
              and safety of biotechnology to politicians , scientists and the
              general public in the Community and in Associated States under
              the Lome Convention .
     ( iv )   Activities designed to promote the formation and growth of
              small and medium-sized biotechnology firms ."
     These recommendations are generally acceptable to the Commission ,
     and in the proposals for the future of the concertatlon action , the
     objectives , tasks and resource requirements have taken these recom¬
     mendations       into   account .  Current  tasks have   been  reviewed and
     focussed more closely towards the above priorities ; in line also
     with the recommendations of the CGC ( Biotechnology ).
( 1 ) IRDAC , Industrial R&D Advisory Committee of the Commission of         the
       European Communities , " Opinion on future R&D programmes in          the
       field of biotechnology ", December 1987 .
( 2 ) " Evaluation of the Biomolecular Engineering Programme ,               BEP
       ( 1982-1986 )     and    the    Biotechnology   Action    Programme , BAP
       ( 1985-1989 )", expert panel , Summer 1988 .
                                             15
 ---pagebreak---  4 . OBJECTIVES AND PRIORITIES FOR CONCERTATION
      The objectives for concertatlon originally defined by the March 1985
      Council Decision ( see §1 above ) remain pertinent , but their effec¬
      tive pursuit through specific actions and tasks will be updated to
      take account of :
      ((i1 )) - worldwide developments in biotechnology over the last few
                years - for example , the Increased importance of worldwide
                electronic networking , databanks , and related information
                infrastructure ; the rapidly growing competitive challenge
                from newly industrialising countries ;
      (Ü
      (Hi>    ~ the recent and likely future evolution of Community and
                Member State policies related to or Influenced by bio¬
                technology - for example , the launching of the agro¬
                industrial programmes ECLAIR and FLAIR will diminish the
                need for the concertatlon action to promote new activities
                in this area .
     The implementation of the supporting tasks (see § L ) will thus be
     modified , taking into account the recommendations of the Evaluation
     Panel , IRDAC , the programme management committee , and other needs
     Identified via the networks (industrial , scientific , public interest
     etc .). In particular , collaboration will be reinforced with those
     responsible for biotechnology-related matters in Member State
     administrations and agencies .
5 . IMPLEMENTATION
     Implementation of the concertatlon action will be through in-house
    work , in collaboration with Commission services , Member States and
    other Interested bodies ; based on the continued development and more
    effective exploitation of the monitoring , information base , informa¬
     tion diffusion and analysis activities ; the commissioning of study
    reports , the organisation of workshops and meetings , and support for
    "Task Force " activities around the aims outlined above .
    Although some staff increase are seen as essential to cope with the
    growing volume of biotechnology activities , maximum use will be made
    of external services , and of collaborative activities with bio ¬
    technology-related units in Member State administrations and public
    agencies . The secondment of Member State staff over periods
    typically of 1 to 3 years will be particularly encouraged , in order
    to reinforce links with Member State actions in biotechnology .
                                    *     *
                                       i  -
 ---pagebreak--- PROPOSAL FOR A COUNCIL DECISION
                1
                                Ъ\
 ---pagebreak---                        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
THE COUNCIL OF THE EUROPEAN COMMUNITIES ,
Having regard to the Treaty establishing the European Economic Commu¬
nity , and in particular Article 130 Q ( 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 Article 130 k of the Treaty stipulates that the framework
programme shall be Implemented through specific programmes developed
within each activity ;
Whereas by its Decision          87 / 516 /Euratom/ EEC ( 4 ),
The Council has adopted a framework programme of Community
research and technological development ( 1987-1991 ), providing inter
alia for activities ensuring the exploitation and optimum use of
biological resources ;
( 1 ) OJ No C
( 2 ) OJ No C
( 3 ) OJ No C
(4 ) OJ No L 302 , 24.10.1987 , p. 1
                                       - 2 -
                                                                         1Л
 ---pagebreak--- Whereas , for the selection of Community actions , the framework pro ¬
gramme sets out criteria among which is that of contributing to the
strengthening of economic and social cohesion of the Commu/ii ty .
consistent with the pursuit of scientific and technical quality ;
Whereas the activities provided for in the framework programme include , in
particular :
               - the establishment of Community R&D for contributing a
transnational     dimension   to   national   efforts  and   for  facilitating
                                                                         %
technology transfer towards industry and agriculture in the areas of
infrastructures , basic biotechnology and risk analysis
               - the continuous evaluation of the strategic significance
of new developments in biotechnology and promotion of the essential
coherence between the different areas of Community policy concerned
with biotechnology ;
Whereas     the multiannual research and        training   programme  for  the
European Economic Community in the field of biomolecular engineering (5)
and the ongoing multiannual research action programme for the
European Economic Community in the field of biotechnology ( 1985-89 ) ( 6 , 7 )
have clearly demonstrated the utility of Community actions in
biotechnology and the need for their expansion ;
Whereas the participation of European non-Member States wholly or
partially with projects in this programme is desirable ;
Whereas it is desirable to involve small         and medium-sized enterprises
to the maximum extent possible in the biotechnology research and
development programme ;
 ( 5 ) OJ No L 375 , 20.12.1981 . p . I
( 6 ) OJ No L 83 , 23.3.1985 . p . 1
 ( 7 ) OJ No L 206 , 30.7.1988 , p . 38
                                        - 3 -
                                                                                II
 ---pagebreak---   Whereas the implementation of research and training actions in the
 COST framework is an essential element to complement R&D projects in
 the field of biotechnology ;
 Whereas the Scientific and Technical Committee (CREST) has been
 consulted .
 HAS ADOPTED THIS DECISION :
                                Article 1
 A specific research and technological development programme for the
 European Economic Community in the field of biotechnology , as defined
 in the annex, is hereby adopted for a period of five years , from
 1 January 1990 .
                                Article 2
The amount deemed necessary for the execution of the programme is
 100 million ECU , including expenditure on a staff of 30 .
                                Article 3
Detailed rules for the implementation of the programme and the rate of
the Community 's financial participation are set out in the Annex .
The contracts entered into by the Commission shall regulate the rights
and obligations of each party , in particular the methods of dissem¬
inating , protecting and exploiting the research results .
                                   - 4 -
 ---pagebreak---                                Article 4
 In the third year of implementation of the programme , the
Commission shall review it and shall report to the
Council and to the European Parliament on the results thereof , to ¬
gether , if necessary , with any proposals for modification or prolon¬
gation .
An evaluation of the results achieved shall be conducted by the Commis ¬
sion , which shall report thereon to the Council and the Parliament .
The abovement i oned reports shall be established having regard to the
objectives set out in the Annex to this Decision and in conformity
with the provisions of Article 2(2 ) of Decision 87 / 51 6 / Euratom / EEC .
                               Article 5
The Commission shall be responsible for implementing the programme .
The Commission shall be assisted by a committee of an advisory nature ,
hereinafter referred to as " the Committee", composed of the
representatives of the Member States and chaired by the representative
of the Commission .
                               Article 6
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 urgency of the
matter , if necessary by taking a vote .
The opinion shall be recorded in the minutes of the Committee ; in
addition , each Member State shall have the right to have its position
recorded in the minutes .
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 taken into account .
 ---pagebreak---                                Article 7
The Commission is hereby authorised to negotiate , in accordance with
Article 130 n of the Treaty , agreements with non-member States and
international  organisations ,   in  particular   with  those  countries
participating in European cooperation in the field of scientific and
technological research (COST ), and those having concluded framework
agreements in scientific and technical cooperation with the Community
with a view to associating them wholly or partly in concerted actions
within this programme .
Where framework agreements for scientific and technical cooperation
between non-member States and the European Communities have been
concluded , organisations and enterprises established in those
countries may participate in a project undertaken within this
programme .
                               Article 8
This Decision is addressed to the Member States .
Dc ii£ at                                      For the Cpuncil
                                              The President
 ---pagebreak---                   KlUibCHNULOGY RESEARCH FOR INNOVATION ,
                      DEVELOPMENT AND GROWTH IN EUROPE
                           ( BRIDGE : 1990 - 1994 )
                                TECHNICAL ANNEX
 ACTION 1 : RESEARCH AND TRAINING
CONTENT
1 . Information infrastructure
l.l . 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 ,
         ...) adequate Information on expertise and services available
         in different European Culture Collections ; and
      – a Centralised European Data Banl&i^-primarlly on microorganism
         and subsequently extended to other biotic materials (animal and
         plant cells , viruses , plasmids ...). The first phase towards
         this objective to involve the harmonisation of formats and data
         in the main service culture collections of the European Commu­
         nity .
                                       - 7 -
                                                                               ït
 ---pagebreak--- 1.2 . Ptoccjoing auu ana. .e& ox oiof techno'Moglcal 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 classi¬
        fying bio (techno) logical data such as sequences , genetic maps ,
        protein and biopolymer structures , risk assessment data; and
      – exploitation of existing or newly developed information techno–
        logy for rapid access to European knowledge bases and closed
        sequencing networks via an electronic network including elec¬
        tronic input , on-line catalogues , electronic ordering , etc .
2 . Enabling technologies
2.1 . Protein design/molecular modelling
      - inulti-disclplinary approaches including genetic engineering and
        advanced structural methods aiming at Improving the properties
        (such as stability , pH optimum , substrate specificity , ...) 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 inter¬
        actions with other related molecules .
                                    - 8 -
 ---pagebreak--- 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 map ping , 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 Arab ldop sis 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 .
 ---pagebreak--- 3 . Cellular biology
3.1 . Physiology and molecular genetics of industrial microorganisms
        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 microorganisms such as the genera lactic 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 ; molecu¬
        lar bases of gamete recognition and selection systems ; and
      - fundamentals of plant cell regeneration : genetics and molecu¬
        lar biology of somatic and zygotic embryogenesis ; perception
        and transduction of growth-promoting signals ; and
        molecular interfaces of plants and associated organi-ius :
        molecular bases of host-range and virulence ; characterisation
        of plant defence reactions ; development of genetic techniques
        for pathogenic fungi or mycorrhizae ; regulation from
        plant/microblal signals of the expression of microblal/plant
        genes ; structural and functional identification of genes
        involved in N2-fixing symb loses ; and
      - physiological attributes of crops : storage processes ; stress
        physiology; nitrogen use efficiency.
 ---pagebreak--- 3.3 . Biotechnology of animal cells
      - animal cell engineering and culture technology icidi..g to new
        or improved productions of important substances for industrial
        and zootechnlcal 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 . Safe ty as sessments associated wit h the rele ase of geneticall y
      engine ered 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
                                       11
                                                                            51
 ---pagebreak---       – acquisition of fundamental knowledge on gene behaviour
        ( lic' Izontal transfer between species , rearrangement o£
        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 molécules
      - 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 .
Research actions to be implemented through cost-shared research
contracts for each of the themes defined above . The Community finan¬
cial contribution shall not normally exceed 50Z of total allowable
projects costs . Alternatively , in respect of universities and similar
institutes of higher education , the Comminity financial contribution
shall normally be 100Z of the marginal costs .       ..
                                     12 -
 ---pagebreak--- Two types of transnational research projects are foreseen :
        - N projects , for the integration in adapted Community struc¬
tures ( European Laboratories Without Walls : ELWW) of research efforts
in areas where the main bottlenecks result from gaps in basic know¬
ledge . The contribution of the Community in such projects shall not
exceed 400.000 ECU / 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 1 to 3 Mio ECU / year per project .
                                       13 -
 ---pagebreak---    COST ACTIVITIES (CATEGORY II ) ASSOCIATED TO ACTION I
  CONTENT
       - Marine primary biomass
       - In vitro–cultures for the purification and propagation of
         plants
       - Methods for early detection and identification of plant
         diseases
       - Vesicular-arbuscular (VA) mycorrhizae
       - Development of vaccines against coccidlosls .
  IMPLEMENTATION
  Implementation shall take place through the organisation of meetings ,
  consultation of experts , publications , exchange , of research workers
  between laboratories , coordination contracts .
i
                                       14 -
                                                                     .    I
 ---pagebreak---     ACTION   II : CONCERTATION
 CONTENT
  In conjunction with the         relevant Commission    services   and    the Member
 States , the following tasks will be executed :
 (i)     monitoring developments in biotechnology ,           particularly in the
         field of R i D ,      assessing their implications , and hence informing
         services    of   the   Commission   and   interested   public   authorities
         having related responsiblities ;
 ( ii )  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 ;
 ( iii ) disseminating knowledge and helping to increase public awareness
         and understanding of the nature , potential , and possible risks
         associated with biotechnology ;
( iv )   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
                                          15
 ---pagebreak--- 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 .
                                16 -
 ---pagebreak--- INDICATIVE DISTRIBUTION OF EXPENDITURES
                                           Mio ECU
   ACTION I      ( Research and Training )
                - Contract research
                             N proj ects     38.5
                             T projects      38.5
                - Training activities        10.0
                - Cost activities              3.0
   ACTION II     (Concertation )              10.0
                                            Ιυύ.υ
                                      17
 ---pagebreak---                             EVALUATION CRITERIA
The Commission 's Communication to the Council concerning a
Community Plan of Action relating to the evaluation of Community
research and development activities for the years 1987 to 1991
( COM ( 86 ) 660 final ) states that the objectives and milestones of
each research programme have to be set out in a testable form .
The objectives and milestones of the programme are set out below .
Action - I : ^research and training
1.    The long term objective is to contribute to the exploitation
      and the optimum use of            biological resources       in the
      Community , thus improving the research capabilities and
      infrastructures necessary for           the    competitiveness      of
      European agriculture and biotechnology industry , and for the
      protection of the environment .        This aim is to be pursued
      through the removal of scientific and technical bottlenecks
      resulting either from gaps in knowledge or from scale and
      structural constraints . Research projects will be executed
      in the interactive way , making full use of integration
      between disciplines , bringing needs and opportunities in
      different Member States together ,           combining     different
      expertises from basic and applied fields .
2.    The primary short term objectives are , therefore , to elicit
      proposals for research and for training activities on a
      scale commensurate with the Community resources proposed
      and , thereafter , to implement          these    activities     (" N "
      projects , " T " projects , training , and cooperation with third
      countries )      in    such    a   way    that    multidisciplinary
      transnational cooperation and           scientific     mobility are
      vigorously promoted . These objectives shall be testable in
      1992-93 .
3.    Particular objectives , testable in 1995 , to            be attained
      through " N " projects include the following :
      3.1 . constitution of networks for transnational cooperation
             in each of the four areas ( information infrastructure ;
             enabling technologies ; cellular biology ; pre-normative
             research ) of the programme ;
      3.2 . transnational cooperation as demonstrated through the
             analysis of scientific publications ( each specific
             network or ELWW to produce at least one paper either
             with transnational authorship or with acknoledgment of
             materials /methods supplied by other contract partners );
      3.3 . hight     quality     of   scientific      achievements ,     as
             demonstrated through       consultations     of    scientific
             experts and through analysis of citation records of
             scientific articles summarizing the results of the
             research ; and
                                - 19 -
 ---pagebreak--- 3.4 . expression of industrial interest as underlined , at
      least in 20      % of     the projects ,     by industrial
      involvement during the implementation phase or , outside
      the BRIDGE legal   framework , at   the time of exploiting
      the results of the research .
Particular objectives ,      to be       attained through the
constitution and implementation of " T " projects include the
following :
4.1 . Setting out a description , in terms of research efforts
      and expected benefits , of specific targets such as the
      sequencing of     the yeast     genome , high resolution
      automated   microbical    identif ication    or   molecular
      identification of new plant genes ;
4.2 . accomplishment , two years after initiation of a T
      project , of progress towards the specified targets
      ( namely through having made the right provisions and
      commitments securing      that    scientific    goals     are
      attainable by the time the programme is completed );
      and
4.3 . significant contributions indicating that the specified
      targets have     been reached and that the specific
      interest of industry , agriculture or environmental
      control has been met .
For   the    training  programme ,   the   aim    is  to    provide
fellowships in research laboratories of a high scientific
level for approximately 2 years for junior scientists , and
1-2 years for senior scientists . Particular objectives are
the following :
5.1 . accomplishment of a marketing effort in all Community
      Member States ;
5.2 . return of most fellows , after their training period , to
      any other Community Member State , if not their own
      country of origin , to work in biotechnology ; and
5.3 . organisation of training courses , summer schools and
      workshops , with support from the programme , and
      including participants from industry whenever possible .
The above criteria can be     partially tested    in 1993 ,   but a
further examination should be made in 1998 .
 ---pagebreak--- Action II z concertation
The evaluation    of the   concertation action will consider whether
the programme has in fact implemented the tasks specified in the
Council    Decision ,    and     whether   their   implementation has
effectively contributed to the stated objectives . More specific
evaluation criteria are as follows :
1.   Concertation     with   Member   States : the concertation action
     should have assisted those responsible for biotechnology in
     Member States administrations ,
     1.1 . to   be     aware     of current and planned *Commission
           initiatives in areas relevant to biotechnology ;
     1.2 . to be aware of biotechnology activities        and plans in
           other Member States ;
     1.3 . consequently , to have taken into account , in their
           national plans        or   initiatives for biotechnology ,
           activities at Community level or in other Member
           States .
2.   Impact on the conditions for biotechnology       in Europe  : the
     concertation action should be examined to       establish whether
     and to what extent it has contributed to improving the
     contextual conditions in Europe for the safe development and
     beneficial application of biotechnology ; with particular
     reference to international competitiveness ; to the formation
     and growth of small companies and to the climate of public
     opinion about biotechnology .
3.   Impact on the development of international collaboration in
     biotechnology , particularly        in the field of R&D , and
     including developing countries .
                              21
 ---pagebreak--- COMPETITIVENESS AND EMPLOYMENT
       IMPACT STATEMENT
               - 22 -
 ---pagebreak---                   COMPETITIVENESS AND EMPLOYMENT IMPACT STATEMENT
1 . Reasons for promoting the proposal
     The main reason for the proposed research and technological
     development programme Is to contribute , In the medium to long-term ,
     to   the     promotion   of  Industrial   competitiveness ,  agricultural
     innovations and economic growth in the Community .
     The contributions are to be made through research , training and
     concertatlon efforts specifically designed for removing bottlenecks
     to creativity and to applications which result from gaps din know¬
     ledge or from scale and structural constraints .
     In the absence of such a programme , the rate of adoption by Euro¬
     pean industry and agriculture of the new technologies which are
     regularly emerging from modern biology will be significantly
     s lowe r .
2 . Features of the businesses involved
     The sectors potentially involved in or influenced by biotechnology
     produce 40Z of output in a modern economy ( see FAST occasional
     paper n“ 1 ). In the long-term , agriculture , the suppliers of
     biological Inputs to agriculture and the industries exploiting the
     outputs of agriculture are directly involved by the proposal .
     In the short to medium-term , however ,       the businesses immediately
     concerned by the results of the programmes will be those which are
     central to plant and animal breeding (particularly in the seed
     production and vaccine production areas ) and , to a lower extent , to
     industrial microbiology . The major effort foreseen by the programme
     for " enabling technologies'* (particularly protein design and genome
     sequencing ), should      contribute  rapidly , to  innovations   in  bio ¬
     informatics and m instrumentation .
3 . Obligations which the programme imposes on business
     They are the same obligations which are imposed to all laboratories
     participating in the programme , namely :
                - conformity of the proposed research to the technical annex
                  of the programme
                - cost-sharing (normally 50Z )
                - transnational coopération
                - availability to on-site visits from Commission staff
                - participation to workshops and to meetings of contractors
                  organised by the Commission
                - yearly reports of activities and results .
4 . Provisions in respect of SMEs
   • While no formal provisions in respect of SMEs have been proposed in
     the research action , they would be foreseen as major beneficiaries
     of this proposal . Often unable to undertake complex long-term
     research on their own , such firms are dependent on the results of
     publicly funded research and development .               However ,   their
                                          23 -
                                                                                 43
 ---pagebreak---      participation in a project shall be favourably considered in the
     selection of proposals .
     Dissemination of Information about the research results shall ue
     given particular priority . Special emphasis shall be placed on the
     availability of this information to SMEs .
     The conditions of participation , modelled on those of the BRITE
     programme , offer to SMEs the advantage that all participants in a
     BRIDGE project shall be treated on an equal basis .
     Within the concertation action , specific priority will be devoted
     to promoting conditions favouring the formation and growth of
     biotechnology-based SMEs ; in collaboration with the SME Task Force
     and other Interested services .
5 . Llkely effect on :
    a ) the competitiveness of business
    As BRIDGE is aimed at pre-competitlve development there is no
     immediate effect of the programme on the competitiveness of busi¬
    ness . However, some short-term to medium effects and many long-term
    effects can be expected – see point 1 .
    b ) on employment
    The effects of the programme on employment are difficult to esti¬
    mate . However , greater international competitiveness of European
    biotechnology may contribute to reduce long-term decline in agri¬
    culture and should bring about favourable consequences for employ¬
    ment in several industrial branches , particularly in firms with
    growth opportunities in specialist high-value -market niches .
6 . Consultations of relevant representative organisations
    The programme has been prepared on the basis of recommehdatlons
    received from the European Parliament , independent experts , indus¬
    trial organisations , the national delegations of the CGC Bio¬
    technology and 10 ad-hoc working parties established by the CGC
    Biotechnology .
    The list of industrial organisations consulted during the prepara¬
    tory phase of the programme is provided in Table 1 of the attached
    memorandum. It includes , in particular , the Working Party on
    Biotechnology of the Industrial Research and Development Advisory
    Committee of the European Communities (IRDAC) and the European
    Biotechnology Co-ordination Group ( EBCG) which comprises the
    European Council of Chemical Manufacturers Federation (CEFIC ), the
    Confederation of Food and Drink Industries of EEC (CIAA ), the
    European Federation of Pharmaceutical Industries' Associations
    ( EFPIAj ,  the  International Group of National Associations of
    Agrochemical Manufacturers (GIFAP ) and the Association of Microbial
    Food Enzyme Producers (AMFEP ).
                                      x
                                  • X   X
                                    - 24 -
 ---pagebreak--- FINANCIAL   STATEMENT
          25 -
 ---pagebreak---                            FINANCIAL STATEMENT
 1 . Budget Heading
 - . ( 1990 )
    7341 ( 1989 , Biotechnology Programme )
- Framework Programme 1987-1991 Action Line : 4.1
BRIDGE
 ( Biotechnology Research for Innovation , Development and Growth in
Europe ) :    a   specific  research   and technological   development
programme in the field of Biotechnology .
2 . Legal Base
Article 130q-2 , Council decision
3 . Description of action and objective
The global objective is to promote       the exploitation  and optimum
use of biological resources through the         removal of bottlenecks
resulting from gaps in knowledge or from        scale and structural
constraints .
The main task of BRIDGE will      be to   harness fundamental research
to the expectations of European industry and agriculture . This
implies the reinforcement of existing networks of ELWWs and their
extension to new areas considered of high Community significance .
A very substantial effort is foreseen in the area of pre-
normative research and , in particular , with regard to the
assessment of risks possibly associated to the release of
genetically engineered microorganisms .
The programme is subdivided , as was BAP , in two actions :
Action I for research and training       activities  under  four main
headings :
- information infrastructure
- enabling technologies
- cellular biology
- pre-normative research
                                - 26 -
 ---pagebreak--- Action II        is a specific concertation activity to monitor
possibilities ,     needs    and    consequences     of    biotechnology
developments in the Community and throughout the world .
4 . Justification of the action
The action finds its justification in the fact that the sectors
involved or influenced by biotechnology produce 40 % of total
output in a modern economy . The proposed activities in research
training , monitoring and concertation should , in particular ,
contribute in the long run to the reduction of trade deficits .
They should also lead to the establishment of new methods for the
evaluation of bio-safety and to the harmonious development of
policies and regulations which govern the promotion of modern
biotechnology in the Community .
The assessment       of past Community activities and intensive
consultations have demonstrated the utility of joint Community
efforts in biotechnology R & D and widespread interest for a
continution and expansion of these efforts .
5 . Financial incidence of action on expenditures
( Ni 11 ion ECUs )
( including costs    for staff   and expenses   for administrative and
technical management )
5.1 . Total cost over the whole of the expected duration :
        From the Budget of the Communities         :    100.000
        From other sectors at the national level :       70.820
                                            Total  :    170.820
                                    - 27 -
 ---pagebreak--- 5.2 . Schedule of Commitment Appropriations and Payments - BRIDGE
5.2.1 . Action I : Research and Training
     С0ЧЯ1И1Е815
           *
                            1550       mi          mz         m3       m<      m3     m;               loiei
     ? £3S0RHEl(incl .     1.300      1.360       1.300     l.í(0     1.(30                           7.(50
     tissions
     consel tints )
     SPEHftT IRC
     EiPEKOimfs             . 800     1.000       1.100    •1.100     1.Z00                           3 . ZOO
     COKTRftCIS           30 . ZOO   18.700      17.3S0      3.300    1.(00                          77.150
      TOTAL               33.300     21 . 200    20.010      (. 0(0    (.( 30                    . . 10.000
      PAYjtFSTS
                              mo        1151        mz         1553      155 (  1553  155 (               TOTAL
      PERSO SISELt incl .   1.300      1.500       1.5(0      1.(40     1.(50               -
                                                                                                        7.(50
       tissions »0
      consa 1 ti nts
                                              *-
       OPERATIC
                                                                                              ■■
       £XP£K0ITUR£S            . 800   1.000       1.100      1.100     1.200                            3 . ZOO
       COR TRAC I S         7.2(0     18 . ZZO    20.000     17.705     8.783  (. 0(8 1.135            77.150
       TOTAL                 1.3(0    20.720      22 . ((0   20 . ((5  11.(33  4.0(8  1.135            50.000
                                                        - 28 -
 ---pagebreak--- 5.2.2 . Action II : Concertation Action ( I )
   cosimtm
                      \m          mi        1332       1333       1331      1335      ! 33 (        ( oiti
   PEOSOSREKUcl .      . 7-0      . 300     . 350     1.010      1.030                             (.( 00
   lissions 11)4               -
   cmvlWntsi
    OFEîftlliC
    txruaimes          . 350       . 3(0     . 370      . 300      . 330                            1.350
    C03120C15           .( SO      . 700     . 750      . 100      .( 50                            3.550
     τοιοι            1.710       1.3(0     2.070      2.130      2.070                            10.000
     rmeiiis
                         isso       1331      1332       1333        1334 *  1335       133 (          TOTAL
      Ftasomuioci .       . 11 !     . 300     . 350    1.010      1.030                              (.(00
      tissions Má
      consolants
      OPEÎSUKC
      iXFEROUOaES          . 353     . 3(0     . 370      . 330       . 330                           1.850
      COKlRftCIS           . 520      . 700     . 750      . 300      .(50    . 130                   3.550
       101 AL            1.530      1.3(0     2.070      2.130       2.070     . 130      . 000      10.000
  (1)        It   should         be       noted       that          the     Concertation Action is not
  comparable to regular "research" actions , but comprises a number
  of activities ( as specified in the Technical Annex ) which are
  demanding of staff time s Toe administration of- small studies ,
  information                 management ,                   response             to .... external       demands ,
  organisation of                     frequent               workshops , .meetings , conferences ,
  networking and other “concertation " activities .
                                                              - 29
 ---pagebreak--- 5.3 . Method of calculation
a ) Expenditure by contract
     This expenditure      covers the     Community financial contribution
      to  :
      - pre-competitive research       and   development    work implemented
      through cost-shared     contracts     concluded   with   research   and
      industrial groups established and        active   in   Europe ( average
      Community financial contribution - about 50 % of total costs )
      - studies , analytical work , training /mobility grants ( 1 )
b ) Operational expenditure ( 1 )
      Administrative costs      ( management committee     and working party
      meetings ,    document       distribution     or   dissemination     of
      techniques , use of data processing and telecommunications
      facilities ); and supporting coordination activities .
c ) Personnel costs
      The minimum requirements for the             implementation of this
      programme have been estimated on the         basis of a management
       staff of  :
                            - 16 officiais - category A
                            - 4 officiais - category 3
                            - 10 officiais - category C
                   Total :    30 officiais
       - A staff of   :
                            - 12 officiais - category A
                            - 4 officiais - category B
                            - 6 officiais - category C
       is already in place ( Biotechnology Action Programme 1985 -
       1989 ).
  ( 1 ) Including    provisions for 5 COST actions , category 2 , Support
  to COST actions       is distributed over “contracts " and “operational
 expenditure " and amount to a total of 3 MioEcus .
                                        - 30 -
                                                                              ςο
 ---pagebreak---            An additional staff of    :
                       - 4 officials – category A
                       - ' 4 officials – category C.
         is requested for the period 1990-1994 .
         - Personnel costs have been    calculated on   the following
         bases ( see P.D.B.   1989 )
                           A = 93.000 ECUS
                           B = 58.000 ECUS
                           C = 37.000 ECUS
         - The cost of the new staff has been     calculated at  50 %
         in the enrolment year .
         - In the following years ,- 4 % inflation has been provided
         for .
         - The total staff of the programme ( 30 officials ) will be
         deployed as follows :
                      Action I , Research and Training :
                        - 11 officiais - category A
                        - 2 officiais - category B
                        - o officiais - category <_
                      Action II , Concertation Action :
                        -   5 officiais - category A
                        -   2 officiais - category B
                        -   5 officiais - category C
    - The personnel costs include provisions for missions and
    consultants .
6 . Financing of expenditure
The appropriations required to cover the Community’s contribution
to this project are to be entered in the Community’s future
budgets .
 ---pagebreak--- 7 . .Type of Control
     Administrative control by the Director General for Financial
     Control as regards budget implementation .
     Scientific Control :
     . Advisory Committee
     . Officials of the Commission
     . Audit by the Court of Auditors in accordance with provisions
        of the Treaty .
     The programme will be evaluated in accordance with the
     " Community plan of action relating to the evaluation of
     Community research and development activities for the years
     1987 to 1991 " ( COM ( 86 ) 660 final ). See Evaluation Criteria in
     annex .
                                       - 32 -