title: Proposta de DECISÃO DO CONSELHO que adopta um programa específico de investigação e desenvolvimento tecnológico no domínio da biotecnologia (1990-1994) "B R I D G E" Biotechnology Research for Innovation, Development and Growth in Europe (Investigação Biotecnológica para a Inovação, Desenvolvimento e Crescimento na Europa) (Apresentada pela Comissão)

text:
ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (88) 806
Vol. 1988/0267
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 ---pagebreak---         COMISSÃO DAS COMUNIDADES EUROPEIAS
                                              COM(88 ) 806 final - SYN 182
                                              Bruxelas , 3 de Janeiro de 1989
                                Proposta de
                            DECISÃO DO CONSELHO
            que adopta um programa especifico de investigação
               e desenvolvimento tecnológico no domínio da
                         biotecnologia ( 1990-1994 )
                               "B R I D G E "
Biotechnology Research for Innovation , Development and Growth in Europe
    ( Investigação Biotecnológica para a Inovação , Desenvolvimento e
                           Crescimento na Europa )
                      ( Apresentada pela Comissão )
 ---pagebreak---                                   SUMMARY
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 , fanners and
consumers . In the United States , public expenditure on biotechnology
research amounts to $ 2.7 bn per year ( 1 ) 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 Blomolecular
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 fat 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 , into 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 .
                                                                         2
 ---pagebreak--- The main casks of Action I will be         Co develop cooperative basic
research and training through 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-normàtlve research
Action II " Concertatlon" 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
                                                                          H
 ---pagebreak---                                        INDICE
SUMARIO
ÍNDICE                                                      iv
MEMORANDO EXPLICATIVO                                          1
       Acção I       INVESTIGAÇÃO E FORMAÇÃO                   3
             1.     Fundamentos da presente proposta           3
             2.     Objectivos e orientação do BRIDGE         8
             3.     Esquemas de execução                     10
             4.     Princípios de gestão                     10
      Acção II      CONCERTAÇÃO                              13
             1.     Origem e objectivos                      13
             2.     Acções e resultados actuais              14
             3.     Pareceres , avaliações e recomendações   15
             4.     Objectivos e prioridades de concertação  16
             5.     Execução                                 16
PROPOSTA DE DECISÃO DO CONSELHO                                1
ANEXO TÉCNICO                                                 6
CRITÉRIOS DE AVALIAÇÃO                                       18
FICHA DE IMPACTO SOBRE A COMPETITIVIDADE E 0 EMPREGO         22
FICHA FINANCEIRA                                             25
                                         iv
                                                                 S
 ---pagebreak---                      BIOTECHNOLOGY RESEARCH FOR INNOVATION
                        DEVELOPMENT AND GROWTH IN EUROPE
                                 ( BRIDGE 1990-1994 )
                              EXPLANATORY MEMORANDUM
The importance of modern biology for agriculture , industry , human
health and environmental protection , and - the need for strong Community
foundations in biotechnology R&D have been outlined in several
communications and proposals of the Commission ( 1 , 2,3 , 4 ).
It was on the basis of the arguments presented on such occasions that
the first two Community programmes in biotechnology ( BEP : Biomolecular
Engineering Programme , 1982-1986 ; BAP : Biotechnology Action Programme ,
1985-1989 ) were established and adopted by Council ( 5 , 6 ).
In the Community Framework Programme of Research and Technical Develop ¬
ment ( 7 ) which Council adopted in 1987 , the Commission underlined once
more the decisive role of Biotechnology for the development of the
Community and announced its intention to launch in 1990 a third Bio¬
technology Programme ( Biotechnology Research for Innovation , Develop ¬
ment and Growth in Europe : BRIDGE ) for the evolution and expansion of
the concertation , research and training activities implemented in BAP .
BRIDGE is to consist of two distinct but related actions :
                - research and training
                - concertation .
( 1 ) COM(83 ) 328 " Biotechnology : the Community 's role", 8 June 1983
( 2 ) C0M(83 ) 672 "Biotechnology in the Community", 4 October 1983
( 3) COM(84 ) 230 "Proposal for a Council decision adopting a multiannual
      research action programme of the EEC in the field of Biotechnology
      ( 1985-1989 )", 26 April 1984
( 4 ) COM ( 86 ) 272 final " Communication from the Commission to the Council
      concerning the review of the multiannual research programme for the
      EEC in the field of biotechnology ( 1985-1989 )", 21 May 1986
( 5 ) O.J. n° L375 of 30 December 1981
( 6 ) O.J. n 8 L83 of 25 March 1985
( 7 ) O.J. n° L302 of 24 October 1987
                                         - 2 -
 ---pagebreak---                          ACTION I : RESEARCH AND TRAINING
1 . 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".
i.l . 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 ) Bionolecular Engineering in the European Community : achievements
       of the research programme ( 1982–1986 ), edited by E. Magnlen ,
       Martinus Nijhoff Publishers for the Commission of the European
       Communities , EUR 10658 EN , 1986 .
(2) European Laboratories Without Walls : focused pre-competitive
       research . R. van der Meer , E. Magnlen       and  D. de Nettancourt :
       Trends in biotechnology ( 1987)4:277 .
(3) BIOTECHNOLOGY ACTION PROGRAMME. Progress report 1987 ( 2 volumes ).
       Ed. : E. Magnlen . Commission of the European Communities ,
       EUR 11138 EN , Luxemburg , 1987 . The 1988 issue will be published in
       January 1989 .                                                     .
(4) C0M(86) 272 final "Communication from the Commission to the
       Council concerning the review of the ">ultiannual research pro¬
       gramme for the EEC in the field of biotechnology , 21 May 1986 .
 ---pagebreak---         BAP was assessed by Che same Panel of Independent Experts who
        evaluated BEP ( 1 ).
        Every one of these evaluations       underlined  the  usefulness    of
        Community R&D In biotechnology .
        With regard to BEP , the CGC 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 conxnend 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
 1.2:1 . 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 / 1 .
( 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 .).
 ---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 biotechnololy 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 Comnunity 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 -                                      \o
 ---pagebreak--- 1.2.3 . The point of view of industrial organisations
        The organisations which expressed opinions are            listed  in
        Table 1 , 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 CEFIC 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 ATM (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 branches . The correspon¬
        dence between their expectations and the provisions made by
        BRIDGE in the various sectors which they covered is extensive .
                                    - 6 -                                    U
 ---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-informatics in Europe - An industry position paper", March 1987 .
  Green Industry Biotechnology Platform ( GIBiP )
     "Final opinion of GIBiP 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 Enzyme
  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 .
 ---pagebreak--- 2 . OBJECTIVES AND ORIENTATIONS OF BRIDGE
    It Is considered ,   on the basis of    the assessments and recommen¬
    dations outlined above , that the objectives of the programme should
    be :
              - 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 , agriculture and research centres and to encourage their
    exploitation ;
              - to ensure that information generated under the programme
    is available for current discussions on the social acceptability of
    modern 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 for
      embarking on exploratory research ventures , particularly when
      insufficient basic knowledge of organlsmal biology has been
      reducing the scope for applying molecular methods . The primary
      requirement in this prevalent situation is to increase the multi -
      dlsciplinarity 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 .
 ---pagebreak--- 2.2 . Removal of bottlenecks resulting from structural or scale con
       straints
       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
 ---pagebreak--- 3 . IMPLEMENTATION SCHEMES
3.1 . Cooperative networks projects ("N " projects )
      These projects , such as defined above in 2.1 ., will be 1>ased on
      the BAP model with a contribution of the Community ranging from
      200.000 - 400.000 ECU/ year x project . Applications for support
      will be requested to provide a very clear 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 BRIDGE 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 jionitoring 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
 ---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 of the
      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                                      VC
 ---pagebreak--- 4.4 . Relationships and cooperation with other Community or Internation
      al R&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 programme 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 aims .
      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 the or¬
      ganisation of the European Congress on Biotechnology ...) will be
      maintained and intensified .
                                      12                                    \1
 ---pagebreak---                           ACTION TI : CONCERTATION
1 . ORIGTN AND À1MS
    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 ( 11 , 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 C0M(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 March 1985 .
                                           13 -
 ---pagebreak--- 2 . CURRENT ACTIVITIES AND ACHIEVEMENTS
     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 in which the concertation action has played a significant
     role :
     (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 Community :
        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 )    C0M(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 .
                                          14                                     \H
 ---pagebreak---       ( Hi } - secretariat of interservice groups such as the
                 Biotechnology Steering Committee , BRTC , 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 concertation 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 concertation 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 concertation 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 ).
( I ) 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 concertation 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 :
    (i)    - 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 ;
    ( ii ) -  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 concertation action to promote new activities
              in this area .
    The implementation of the supporting tasks ( see § 1 ) 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 concertation 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 .
                                      *
                                   •k    k
                                      16 -
 ---pagebreak--- PROPOSTA DE DECISÃO DO CONSELHO ---pagebreak---                                             1
                           PROPOSTA DE DECISÃO DO CONSELHO
                       QUE ADOPTA UM PROGRAMA ESPECIFICO DE
                    INVESTIGAÇÃO E DESENVOLVIMENTO TECNOLÓGICO
                     NO DOM lN IO DA BIOTECNOLOGIA ( 1990-1994 )
                                     "B R I D G E "
  Rlotechnology Research for Innovatlon , Revelopment and firowth In Rurope
        ( Investigação Blotecno lógica para a Inovação , Desenvolvimento e
                                Crescimento na Europa )
 0 CONSELHO DAS COMUNIDADES EUROPEIAS ,
Tendo em conta o Tratado que Institui a Comunidade Económica Europeia e ,
nomeadamente , o no 2 do seu artigo 130O-Q ,
Tendo em conta a proposta da Comissão ^ 1 ),
Em cooperação com o Parlamento Europeu ^ 2 ),
Tendo em conta o parecer do Comité Económico e Social ( 3 ),
Considerando que o artigo 130O-K do Tratado determina que a execução do
programa-quadro será           feita por melo de programas                  específicos
desenvolvidos no âmbito de cada acção ;
 Considerando        que ,    pela    sua     Decisão   87 / 51 6 / Eu r a t om / C E E ( 4 ),
ó Conselho         adoptou        um       programa-quadro de Investigação e de
desenvolvimento tecnológico na Comunidade ( 1987/ 1991 ), o qual prevê ,
 Inter alia , acções que garantam a exploração e a valorização dos recursos
biológicos ;
( 1 ) JO no c
( 2 ) JO no C
( 3 ) JO no C
( 4 ) JO no L 302 de 24.10.87 , p. 1 .
                                                                                Ί3
 ---pagebreak---                                              2
Considerando que o programa-quadro estabelece cr I tér los de selecção de
acções comunitárias , um dos quais é o de contribuírem para o
fortalecimento da coesio económica e social da Comunidade , sendo
 Igualmente compatíveis com os objectlvos de qualidade cientifica e
técnica ;
Considerando que as acções previstas pelo programa-quadro                   Incluem ,
nomeadamente :
-    o estabelecimento de l&D comunitários para contribuir com uma dimensão
     transnacional           para os  esforços   nacionais  e    para  facilitar   a
     transferência de tecnologias para a Indústria e a agricultura nos
     domínios das Infra-estruturas , da biotecnologia de base e da análise
     de r I scos ;
                                                                   %
- a avaliação continua do significado estratégico de progressos recentes
     no domínio da biotecnologia e a promoção da Imprescindível coerência
     entre as diferentes áreas da política comunitária relacionadas com a
     biotecnologia ;
Considerando que o programa pl uri anual de Investigação e formação para a
Comunidade          Económica      Europeia   no   domínio    da         engenharia
blomoleculart 5 ) e o programa plurlanual de acção de investigação para a
Comunidade         Econoómlca      Europeia    no   domínio    da     biotecnologia
( 1985-1989 ) ( 6 ) t ( 7 ) ^ actualmente em curso , demonstraram claramente a
utilidade de acções comunitárias no domínio da biotecnologia , bem como a
necessidade do seu alargamento ;
Considerando que é desejável a participação de Estados europeus não
membros com projectos na totalidade ou em parte deste programa ;
Considerando que é desejável envolver o mals possível as pequenas e
médias empresas no programa de Investigação e desenvolvimento no domínio
da biotecnologia ;
( 5 ) JO no L 375 de 20.12.1981 , p. 1 .
( 6 ) JO no L 83 de 23.03.1985 , p. 1 .
( 7 ) JO no L 206 de 30.07.1988 . p.38 .
 ---pagebreak--- Considerando que a execução de acções de         Investigação e formação no
quadro do COST é um complemento essencial dos projectos de l&D no domínio
da biotecnologia -,
Considerando que o Comité da Investigação Cientifica e Técnica ( CREST )
 foi consultado ,
DECIDE :
                                  Artigo 1o
É adoptado por um período de cinco anos , com Inicio em 1 de Janeiro de
1990 , um programa especifico de           Investigação e desenvolvimento
tecnológico    para   a  Comunidade   Económica   Europeia   no domínio  da
biotecnologia , tal como definido em anexo .
                                  Artigo 20
0 montante considerado necessário para a execução do programa é de 100
milhões de ecus ,   Incluindo as despesas relativas a um efectlvo de 30
agentes .
                                  Artigo 30
São estatuídas no Anexo regras pormenorizadas para a execução do programa ,
bem como o grau de participação financeira da Comunidade . Os contratos
celebrados pela Comissão regularão os direitos e obrigações de cada uma
das partes , em especial os métodos de divulgação , protecção e exploração
dos resultados da Investigação .
                                  Artigo 4o
Durante o seu terceiro ano de execução ,        a Comissão empreenderá uma
análise do programa , cujos resultados comunicará ao Conselho e ao
Parlamento Europeu Juntamente com , se necessário , propostas de alteração
ou de prolongamento .
 ---pagebreak---                                     - 4 -
A avaliação dos resultados alcançados será efectuada pela Comissão ,
 que a transmitirá ao Conselho e ao Parlamento .
Os relatórios acima referidos serão elaborados tendo em conta os
object Ivos definidos no Anexo da presente decisão e em conformidade com o
disposto no       n2 2 do artigo 2o da Decisão 87/516/Euratom , CEE .
                                  Artigo 5o
A Comissão é responsável pela execução do programa .
A Comissão será assistida por um comité de natureza consultiva , a seguir
denominado " Comité ", composto por representantes dos Estados-membros e
presidido pelo representante da Comissão .
                                                          *
                                  Art Igo 6o
A Comissão apresentará ao Comité um projecto das medidas a adoptar . 0
Comité emitirá o seu parecer num prazo que o presidente pode fixar em
função da urgência da questão em causa , sobmetendo-a se necessário a
votação .
0 parecer será lavrado nas actas do Comité ;      além disso , cada Estado-
membro pode exigir que a sua opinião seja registada em acta .
A Comissão tomará em devida conta o parecer emitido pelo Comité , e
Informá - lo-á do modo como teve em conta o seu parecer .
                                  Art igo 7o
Nos termos do artigo 130O-N do Tratado , a Comissão está autorizada a
negociar acordos com Estados terceiros e organizações Internacionais , em
especial com os países que participam na Cooperação Europeia em matéria
de investigação cientifica e técnica ( COST ) e aqueles que tenham
celebrado com a Comunidade acordos-quadro de cooperação cientifica e
técnica , com vista a assoe lá- los total ou parclalmente a acções
concertadas no âmbito deste programa .
 ---pagebreak---                                   - 5 -
Sempre que os acordos-quadro de cooperação cientifica e técnica tiverem
sido concluídos entre Estados não-membros e as Comunidades Europeias , as
organizações e as empresas estabelecidas nesses países podem  participar
num projecto realizado no âmbito deste programa .
                                Art Igo 80
São destinatários da presente decisão os Estados-membros .
Fe i to em                                 Pelo Consel ho
                                           O Presidente
 ---pagebreak---                                           - β -
                   INVESTIGAÇÃO B IOTECNOLÓGICA PARA. A INOVAÇÃO ,
                     DESENVOLVIMENTO E CRESCIMENTO NA EUROPA
                                 ( BRIDGE : 1990-1994 )
                                      ANEXO TÉCNICO
   ACÇÃO I : INVESTIGAÇÃO E FORMAÇÃO
CONTEÚDO
1 . Infra-estruturas de informação
1.1 .  Coleccoes de culturas
       Desenvolvimento de um sistema de comunicação que permita um acesso
       fácil e rápido aos serviços de colecções de culturas mals
       Importantes da Comunidade ;        a concretizar mediante o apoio a :
       - um Centro de Promoção das Colecções de Culturas , especif icamente
           concebido para proporcionar aos utentes europeus ( distribuição
         . de catálogos , regulamentos sobre patentes , materiais Impressos e
           meios visuais , etc .) Informação adequada quanto à competência e
           serviços em Colecções de Culturas Europeias ; e
       -   um Banco de Dados Centralizado Europeu abrangendo sobretudo
           m I croorgan I smos , e que será póster lormente alargado a outros
           materiais biótlcos ( células animais e vegetais , vírus ,
           plasmfdeos , etc .). A primeira fase da concretização deste
           objectivo deverá envolver a harmonização de formatos e de dados
           nos principais serviços de colecções de culturas da Comunidade
           Europeia .
 ---pagebreak---                                          - 7 -
1.2 .  Processamento e aná lises da dados blo(tecno ) lóolcos
       - Aplicações das         tecnologias da      Informação   ( suportes    lógicos
           (" software ")   e   equipamentos   especializados )     nos   domínios  da
          engenharia de proteínas e da determinação da sequência de genes
          ( ver Igualmente os pontos 2.1 e 2.3 a seguir );
       -  Actuallzação e concepção de bases de conhecimentos destinados ao
          armazenamento e classificação de dados blo(tecno ) lógicos tais
          como sequências , mapas genéticos , estruturas de proteínas e de
          blopo II meros e dados relativos à análise de riscos ;
       -  Exploração das tecnologias da                informação existentes ou
          recentemente desenvolvidas , para o rápido acesso a bases de
                                                                  %
          conhecimentos europeias e a redes fechadas de determinação de
          sequências através de uma rede electrónlca que Inclua sinais de
          entrada      electrónicos ,      catálogos     em    linha ,      encomendas
          electrónlcas , etc .
2 . Tecnologias de base
2.1 .  Concepção de protelnas/model Izacão molecular
       -  Abordagens mui t Idisc ip I inares , que Incluam a engenharia genética
          e    métodos    estruturais     avançados   destinados     a   melhorar   as
          propriedades      ( tais   como   a   estabilidade ,   o    pH   óptimo ,  a
          especificidade para o substrato , etc .) de proteínas e de seus
          complexos com Interesse ( Incluindo as gl Icoprotelnas ) ;
       -  Desenvolvimento de métodos que permitam explicar e prever as
          relações estrutura / função das proteínas , tais como as envolvidas
          na sua configuração tridimensional , na sua estabilidade , na sua
          cristalização , Incluindo métodos teóricos de simulação destas
          propriedades , e suas Interacções com outras moléculas afins ;
 ---pagebreak---                                        - 8 -
2.2 .  BlotransformacSo
      - Desenvolvimento de reacções biológicas que empreguem estirpes de
          células ou enzimas novos na síntese de compostos Intermediários
          multo Importantes na produção de substâncias com elevado valor
          acrescentado     ( deverá    ser   prestada    especial    atenção      á
          bloconversão    de    excedentes   agrícolas )   e  na   conversão     de
          poluentes em compostos Inócuos ;
      -    Investigação sobre a questão da estabilidade genética e
          fisiológica de micróbios ou células geneticamente modificados ,
           livres ou Imobilizados , em situações de biotransformação ;
      -    Investigação sobre a questão da actlvldade enzlmática em
                                                               «
          condições ambientais extremas ( solventes orgânicos , pH ,
          temperaturas , Imobilização );
      -   Desenvolvimento     de  métodos   de   Isolamento  e   purificação     de
          produtos de biotransformação ( processamento a montante e a
           Jusante ).
      -   Desenvolvimento de suportes lógicos (" software ") especializados
          e de modelização matemática destinados ao controlo e análise de
          processos blotecno lógicos .
2.3 . Elaboração_de_mapas_genéticos ._determinação_da_sequência_de
      aenomas . novos métodos de c lonaaem
      - Determinação da totalidade ou de partes da sequência do genoma
          da levedura ( Saccharomyces cerevlslae ) e do Bacl I lus subtl I I s :
      -   Desenvolvimento de técnicas de genética molecular para
          Identificação de novos genes vegetais com Interesse , através de
          recurso ao genoma de Arabldopsls : caracterização dos genes
          Identificados ;
      -   Desenvolvimento     de   processos   e    tecnologias   avançados      de
          determinação da sequência de genomas ( ver 1.2 ) e Integração
          destes processos e tecnologias nos projectos de determinação da
          sequéncia de genomas .
 ---pagebreak---                                       - 9 -
3 . Bloloala celular
3.1 .  Fisiología a genética molecular de mlcroroanlsmos Industriáis
       -  estabilidade e expressão genéticas , processos pós-tr adução ,
          controlo genético 9 metabólico da hlperprodução , transporte e
          secreção . Estes estudos , cada qual adaptado ao estado actual
          dos conhecimentos , Incidirão sobre alguns microrganismos com
          Interesse Industrial , como os géneros de bactérias de ácido
          láctico ,  Streptomyces ,  Baclllus   da   Pseudomonas ,   Clostrldlum ,
          Corynebacter lum e Incluindo o grupo maior de bactérias de ácido
          láctico , extremophl les , leveduras e fungos filamentosos .
3.2 .  Noções   biológicas  de  base   relativas   a  vegetais   e  a  organismos
       associados
       -  Processos fundamentais na reprodução sexuada : mecanismos de
          desencadeamento e de evocação da floração ; diferenciação de
          células sexuais ; bases moleculares de sistemas de Identificação
          e selecção dos gâmetas ;
       -  Aspectos fundamentais da regeneração de células vegetais :
          genética e biologia molecular da embrlogénese somática e
          zl gótica ; detecção e transdução de sinais de Indução do
          crescimento ;
          Interfaces    moleculares    das   plantas    e  organismos     a  elas
          associados : bases moleculares da diversidade de hospedeiros e da
          virulência ; caracterização das reacções de defesa das plantas ;
          desenvolvimento de técnicas genéticas para fungos ou mycorchizae
          patogénlcos ; controlo , através de sinais planta / micróbio , da
          expressão      de    genes     microbianos/ vegeta Is ; Identificação
          estrutural e funcional de genes responsáveis por simbioses com
          fixação de N2 ;
       -  caracter Ist Icas   fisiológicas    das    culturas :    processos   de
          armazenamento ; fisiologia do stress ; eficiência da utilização do
          azoto .
 ---pagebreak---                                     - 10 -
3.3 .  Biotecnologia da células anlmala
       - Engenharia e tecnologia de cultura de células animais que
          permitam    a  produção  nova   ou    aperfeiçoada   de  substâncias
           Importantes para fins industriais e zootéonlcos ;
       - Genética animal : elaboração de mapas e determinação da sequâncla
          de genes Importantes ; métodos de transferência de genes ;
          expressão e controlo genéticos ;
       - Criação de animais : imunoest I mui ação , por Intermédio de vacinas
          de segunda geração obtidas pela aplicação da engenharia
          genética .
4 . Investloac ão oré-normat I va
    Na biotecnologia , a Investigação pré-normatlva Insere-se em ambos os
    extremos da cadela invest Igação-desenvolvlmen to-exploração .
4.1 .  Avaliação    dos  riscos   Inerentes   à    libertação   de  organismos
       geneticamente modificados
       - Técnicas de monitorização e controlo :       amostragem e marcadores
          dos   organismos  manipulados   e   dos   segmentos   de  ADN  neles
          Introduzidos ; métodos e Instrumentos destinados à Identificação
          microbiana automática com elevada resolução e à criação de bases
          de dados apropriadas ; criação de um banco de marcadores e de
          Identificadores químicos específicos para um grande número de
          microrganismos Individuais ; métodos de erradicação ;
       - Técnicas de avaliação : contenção biológica ; estabilidade e
          transferência de genes ; desenvolvimento de microcosmos e de
          métodos de simulação para análises de Impacto ;
                                                                               1,1
 ---pagebreak---                                         11
      -  Aquisição de conhecimentos fundamentais sobre o comportamento
         dos genes ( transferência horizontal entre espécies , rearranjo
         dos   genes    Introduzidos   no organismo     hospedeiro )  e  sobre   a
         sobrevivência     e   a   adaptação   de   organismos   libertados ,   em
         especial    as bactérias do solo .      Incluindo , no caso dos vírus
         manipulados , a alteração do leque de hospedeiros e de tecidos
         que lhes são sensíveis ;
      -  novos    modelos :     organismos    biologicamente     auto-l Iml tados ;
         vectores suicidas ou modelos que não possam desenvolver -se fora
         do organismo hospedeiro ; organismos artificiais que possam ser
         destruídos no ambiente por         técnicas especificas que são do
         conhecimento geral .
4.2 . Avaliação   In   vltro  da   toxicidade   e  da  accão  farmacológica    das
      moléculas
         Desenvolvimento de sistemas celulares e pluricelulares capazes
         de substituir tecidos e órgãos vivos ;
         Investigação relativa às questões da preparação , armazenamento ,
         manutenção e crescimento de culturas de células humanas ;
         Desenvolvimento de linhagens celulares em que haja uma melhor
         preservação das propriedades funcionais .
 ---pagebreak---                                         12 -
EXECUÇÃO
                                 \
Deverão ser empreendidas acções de formação através de contratos e cursos
de formação relativos a cada um dos temas acima referidos . A Comunidade
custeará estas acções .
Deverão ser empreendidas acções de Investigação através de contratos de
Investigação a custos repartidos relativos a cada um dos temas acima
referidos . A contribuição financeira da Comunidade não deve normalmente
exceder    50%    dos    custos    totais   admissíveis dos    projectos .  Em
contrapartida , re lat I vamente às universidades e a outros Institutos de
ensino superior , a contribuição financeira da Comunidade elevar-se-á
normal mente a 100% dos custos marginais .
                                                            «
Estão previstos dois tipos de projectos de Investigação transnacional :
   -   projectos N ,   destinados a     Integrar em estruturas   comunitárias
       adaptadas ( European Laboratories Without Walls : ELWW - Laboratórios
       Europeus Sem Paredes ) acções de Investigação em áreas em que os
       principais estrangulamentos decorram de lacunas nos conhecimentos
       básicos . A contribuição da Comunidade em        tais   projectos   não
       excederá 200-400000 ecus / ano por projecto ;
   -   projectos T ,  destinados a suprimir estrangulamentos      importantes
       resultantes de limitações estruturais e de escala , através - do
       Investimento significativo em termos de capacidades técnicas e de
       recursos . A contribuição da Comunidade em tais projectos oscilará
       entre 1 e 3 milhões de ecus/ano por projecto .
                                                                               14
 ---pagebreak---    ACTIVIDADES COST ( CATEGORIA II ) ASSOCIADAS A ACÇÃO I
CONTEÚDO
    -  Blomassa marinha primária
    - Culturas In vltro destinadas à purificação e propagação de végétais
    - Métodos de despi stagem e de diagnóstico precoce de doenças de
       vegetais
    -  Mycorrhlzae veslculo-arbusculares ( VA )
    -  Desenvol vlmento de vaclnas contra a coccldlose
EX ECUÇÃO
A execução processar -se-á através da organização de reuniões , de
consultas de peritos , de publicações , do intercâmbio de Investigadores
entre laboratórios e de contratos de coordenação .
 ---pagebreak---                                        14 -
   ACÇÂO II : CONCERTApXo
CONTEÚDO
Serão executadas as seguintes tarefas , em colaboração com os serviços
competentes da Comissão :
A acção de concertação será executada tendo por objectlvo a melhoria das
normas e das capacidades das ciências da vida e o aumento da eficácia
                                                            »
estratégica com que são aplicadas aos objectivos sociais e económicos da
Comunidade e dos seus Estados-membros .
Serão executadas as seguintes tarefas :
(I)     monitorização     dos   progressos   registados    no   domínio     da
        biotecnologia , especlalmente no domínio da l&D , avaliação das suas
         Implicações e subsequente Informação dos serviços da Comissão e das
        autoridades públicas com responsabilidades afins ;
( II )   Identificação de meios exequíveis que permitam aperfeiçoar ainda
        ma Is as condições necessárias ao desenvolvimento benéfico da
        biotecnologia na Europa , e aumentar a eficácia e a coerência dos
        programas blotecno lógicos dos Estados-membros e da Comunidade , e
        das políticas com eles relacionadas , Incluindo as políticas que
        envolvem a cooperação cientifica e técnica Internacionais ,
        nomeadamente com os Estados Associados ao abrigo da Convenção de
        Lomé ;
( III ) divulgação dos conhecimentos e contribuição para o aumento da
        sensibilização e da compreensão da opinião pública quanto à
        natureza , potencial e eventuais riscos Inerentes á biotecnologia ;
 ---pagebreak---                                          15 -
( IV )   Identificação da necessidade de uma maior actlvldade no sector das
        pequenas empresas de biotecnologia da Comunidade e contribuição á
        sua promoção .
EXECUÇÃO
Esta acção dará continuidade ao trabalho ( iniciado sob a égide do BAP ) de
colaboração ad hoc entre grupos e pessoas Isoladas com Interesses e
competências nos domínios das ciências da vida e da biotecnologia , de
modo a que sejam criadas redes , tão Informais e flexíveis quanto
possível ,     adaptadas   às  necessidades   das tarefas acima  mencionadas ;
fornecendo deste modo uma Inter acção com o programa , Incentivando a
coordenação através da troca de Informações entre os participantes e
contribuindo para uma maior difusão da Informação de que as tarefas acima
refer I das carecem .
Espec I f I camente , o trabalho consistirá na análise Interna , na criação e
exploração de uma base organizada de Informações e em missões . Se
necessário . Incluirá , também a encomenda de relatórios sobre estudos , a
organização de reuniões de trabalho e de encontros , o apoio à elaboração
de relatórios e a difusão de Informações .
 ---pagebreak---                                   - 16 -
  REPARTIÇÃO INDICATIVA DAS DESPESAS
                                         M I I hoes de Ecus
ACÇÃO I ( Investigação e Formação)
         - Investigação por contrato
                projectos N                          38,5
                                                   »
                projectos T                          38,5
         - Acções de formação                        10,0
         - Acgoes COST                                3,0
ACÇÃO II (Concertação)                               10,0
 ---pagebreak--- CRITÉRIOS DE AVALIAÇÃO ---pagebreak---                                         18 -
                              CRITÉRIOS DE AVALIAÇfo
A Comunicação da Comissão ao Conselho relativa a um Plano de Acção
Comunitário respeitante à avaliação das actlvldades comunitárias de
 Investigação e desenvolvimento para os anos 1987 a 1991 ( C0M(86 ) 660
final ), afirma que os objectlvos e marcos de cada um dos programas de
 Investigação devem ser definidos de forma a que possam ser verificados .
Expõem-se de seguida os objectlvos e marcos do programa .
Accão I ; I nvestigação e formação
1 . 0 objectlvo a longo prazo desta acção é o de contribuir para a
    exploração e a utilização óptima dos recursos biológicos na
    Comunidade ,   melhorando assim as capacidades e      Infra-est ruturas de
     Investigação necessárias para a competitividade da agricultura e da
     Indústria da biotecnologia da Europa e para a protecção do ambiente .
    Este objectlvo deve ser prosseguido através da remoção de
    estrangulamentos científicos e técnicos resultantes quer de lacunas de
    conhecimentos quer de constrangimentos de escala e estruturais . Os
    projectos de Investigação serão executados de modo Interactlvo ,
    utilizando totalmente a integração entre disciplinas , reunindo as
    necessidades     e   oportunidades   nos   diferentes  Estados-membros   e
    combinando diferentes capacidades técnicas provenientes de domínios de
    base e ap I Içados .
2 . Os principais objectlvos a curto prazo são , portanto , os de fazer
    aparecer propostas de actlvldades de Investigação e de formação numa
    escala proporcional aos recursos comunitários propostos e , em seguida ,
    executar essas actlvldades ( projectos " N ", projectos " T ", formação e
    cooperação com países terceiros ), por forma a que haja um forte
    Incentivo da cooperação mult Idlsclpl Inar transnac lona I e da mobilidade
    cientifica .   Estes objectlvos devem ser verificáveis em 1992-93 .
3 . Alguns dos objectlvos específicos a atingir através de projectos " N ",
    susceptlvels de serem testados em 1995 , são os seguintes :
    3.1 .  Criação de redes de cooperação transnac lona I nas quatro áreas do
           programa ( Infra-estruturas de Informação ; tecnologias de base ;
           biologia celular ; Investigação pré-normatlva );
 ---pagebreak---                                          19 -
    3.2 . Cooperação transnac lona I , comprovada através da análise de
          publicações cientificas ( cada rede ou ELWW especifico deverá
          produzir    pelo    menos   um   artigo    que  envolva     uma    autoria
           transnac lona I ou que reconheça a utilização de mater lals /métodos
          fornecidos por outros parceiros no contrato );
    3.3 . Resultados científicos de elevado nível , comprovados através de
          consultas de peritos científicos e da análise do               Indlce das
          citações de artigos científicos que apresentem            um resumo dos
          resultados das Investigações ; e
    3.4 . Manifestação de Interesse por parte da Indústria , comprovado em
          pelo menos 20% dos projectos pelo envolvimento da Indústria na
          fase de execução , ou . Já fora do quadro legal do BRIOGE , na
          exploração dos resultados das Investigações .
4 . Alguns dos objectivos específicos a atingir através da criação e
    execução de projectos " T " são os seguintes :
    4.1 . Proceder à descrição de       objectivos específicos em termos das
          acções de Investigação e      dos benefícios previstos , tais como a
          determinação da sequência     do genoma da levedura , a identificação
          microbiana automática de       elevada resolução ou a Identificação
          molecular de novos genes de vegetais ;
    4.2 . Dois anos após o Inicio de cada projecto T , concretização de
          progressos rumo aos objectivos especificados ( nomeadamente por
          se terem tomado as disposições e os compromissos adequados que
          garantam que os objectivos científicos do programa sejam
          concretizáveis na altura em que seja completado );
    4.3 . Contribuições significativas , que comprovem terem sido atingidos
          os   objectivos     especificados     e   satisfeitos    os     Interesses
          específicos     da   Indústria ,   da   agricultura   ou    do    controlo
          ambiental .
 ---pagebreak--- 5 . 0 objectlvo do programa da formação é o de proporcionar bolsas de
    estudo em laboratórios de Investigação de elevado nível cientifico a
    cientistas Juniores , durante um período de cerca de 2 anos , e
    seniores , durante 1 a 2 anos . Os objectlvos específicos Incluem os
    seguintes :
    5.1 . Concretização de uma acção de "marketing " em todos os Estados-
           membros da Comunidade ;
    5.2 . Após o período de formação , regresso da maior parte dos
          bolseiros a qualquer outro Estado-membro da Comunidade , caso não
          retornem ao seu próprio pais de origem , para trabalharem em
          biotecnologia ;
    5.3 . Organização de cursos de formação , cursos de verão e reuniões de
          trabalho , que contem com o apoio do programa e envolvam sempre
          que possível participantes provenientes da Indústria .
Os critérios acima expostos poderão ser parclalmente testados em 1993 ,
embora em 1998 devam ser sujeitos a uma nova análise .
 ---pagebreak---                                            21
AccSo I I : concert acSo
A avaliação da acção de concertação considerará se o programa executou de
facto as tarefas especificadas na Decisão do Conselho e se a sua execução
contribuiu realmente para a concretização dos objectlvos formulados .
Critérios mals específicos de avaliação são os seguintes :
1 . Concertação com os Estados-membros : a acção de concertação deveria ter
    assistido os responsáveis pela biotecnologia nas administrações dos
    Estados-membros a :
    1.1 .  terem    conhecimento     de   Iniciativas   actuals  e  planeadas   da
          Comissão em áreas de Interesse no âmbito da biotecnologia ;
    1.2 .  terem conhecimento de acções e planos de outros Estados-membros
          no domtnlo da biotecnologia ;
    1.3 .  terem ,   por conseguinte ,    tido em consideração acções a nível
          comunitário     ou   noutros    Estados-membros    nos seus   planos  ou
           Iniciativas nacionais no domínio da biotecnologia .
2 . Impacto no contexto em que a biotecnologia europeia se Insere : a acção
    de concertação deveria ser analisada para se determinar se , e em que
    medida , contribuiu para a melhoria das condições contextuais na Europa
    para o desenvolvimento seguro e a aplicação útil da biotecnologia , com
    especial     destaque  para    a    competitividade   Internacional ,  para  a
    formação e o crescimento de pequenas empresas e para o ambiente da
    opinião pública em matéria de biotecnologia .
3 . Impacto no desenvolvimento da cooperação Internacional no domínio da
    biotecnologia , espec I a Imente na área da l&D , que abranja os países em
    desenvo I v imento .
                                                                                kl
 ---pagebreak--- COMPETITIVENESS AND EMPLOYMENT
       IMPACT STATEMENT
 ---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 in 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
    slower .
2 . Features of the businesses involved
    The sectors potentially involved in or Influenced by biotechnology
    produce 40% 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 in 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 50% )
             - 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 ofSMEs
    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 -
 ---pagebreak---     participation In a project shall be favourably considered in the
    selection of proposals .
    Dissemination of information about the research results shall be
    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 . Likely effect on :
    a ) the competitlveness of business
    As BRIDGE is aimed at pre-competltlve 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 recommendations
    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 Comnunitles (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
    ( EFPIA ), the International Group of National Associations of
    Agrochemical Manufacturers (GIFAP ) and the Association of Microbial
    Food Enzyme Producers (AMFEP).
                                      x
                                    X   X
                                    - 24 -                                U-C
 ---pagebreak--- FINANCIAL      STATEMENT
          - 25           ЧЧ
 ---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
 ( Killion 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 -
                                                                       ЧЧ
 ---pagebreak---   5.2 . Schedule of Commitment Appropriations and Payments - BU1DGE
  5.2.1 - Action I : Research and Training
I      ШЯ1ШК15
                             1110       mi       m2       mi       mi     1115    mt           10 ! AL
       PERSOKXElliod .      1.300     1.S00     1.540    1.440    1.450                       7.450
        ItSSiODS ift4
       consul tints )
        9PCHA11KC
        EXPEXOITORES          . 000    1.000    1.100    '1.108   1.200                       5.200
        COXIRACIS          36.200     10.700   17.350     3.300   1.400                      77.150
         101 AL            30.300     21.200   20.010     4.040    4.450                 . . 10.000
         PAYXEXIS
                                mo        mi       m2       1113     1114   1115   1114          10IAL
          PERSQXREllincl .    1.300     1.500     1.540    1.440    1.450                       7.450
          tissions and
          consul tints
          0PERA1IXC
          EXPEK01 10RES         . 000    1.000    1.100     1.100   1.200                        5.200
          COXIRACIS            7.2 «   10.220    20.000   17.705    0.701  4.040   1.135       77.150
           101 AL              1.340    20.720   22.440    20.445  11.433   4.040  1.135        10.000
                                                      - 28 -
                                                                                ^0
 ---pagebreak--- 5.2.2 . Action 11              : Concertation Action ( 1 )
   corjimm
                       mo         mt         1552       1553       1554      1555       1554          I01AI
   fílSOHRÍUiocl .     . 7:0      . 100      . 550     1.010      1.030                              4.400
   lissi ORS ind
   cnnsnl tants )
   CPtSftl lite
   Lxpcnoimts           . iso      . 1(0      . 170      . 380      . 350                            1.850
   CQM2AC1S             . ISO      . 700      . 750      . 800      . 450                             3.550
    I OUI              1.71C      1.540      2.070      2.150      2.070                             10.000
     PftYKfKTS
                          mo         mi         1552       1553       1554 '   1555       1554          TOTAL
     PLBSOHKEKincl .      . no       . 500      . 550    1.010      1.030                              4.400
     s lisions ind
     consultants
      OPEBAIIKC
      EXPEKOIIOBES         ■ 3S3      . 140      . 370      . 380      . 350                            1.850
      COHIBAOS             . 520      . 700      . 750      . 800      . 450    . 130                   3.550
       101 AL             1.580      i.540      2.070      2.150      2.070      . 130     . 000       10.000
  (1)        It    should        be        noted       that          the      Concertation Action is
  comparable to regular " research ** actions , but comprises a number
  of activities ( as specified in the Technical Annex ) which are
  demanding of staff time x Tor 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 oi'iici.ais    t.ateg • _ 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 -
 ---pagebreak--- f
          - 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
                         - i of f 1'' iair.. – CaL - jUl";- •. .
                        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 .
                                       - 31
 ---pagebreak--- 7 . .Type of Control
-    Administrative control by tne 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 -