CELEX: 51986PC0549
Language: en
Date: 1986-11-11
Title: PROPOSAL FOR A COUNCIL REGULATION RELATING TO A RESEARCH AND DEVELOPMENT COORDINATION PROGRAMME OF THE EUROPEAN ECONOMIC COMMUNITY IN THE FIELD OF MEDICAL AND HEALTH RESEARCH ( 1987-1989 )

26. 2. 87                                      Official Journal of the European Communities                                No C 50/59
               Proposal for a Council Regulation relating to a research and development coordination programme of
                           the European Economic Community in the field of medical and health research
                                                               (1987 to 1989)
                                                             COM(86) 549 final
                                    (Submitted by the Commission to the Council on 29 October 1986)
                                                                (87/C 50/02)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                                  Whereas the Member States intend, in accordance with
                                                                          the rules and procedures applicable to their national
Having regard to the Treaty establishing the European                     programmes, to carry out all or part of the research indicated
Economic Community, and in particular Article 235                         in Annex I, and are prepared to integrate such research
thereof,                                                                  into a process of coordination at Community level until
                                                                          31 December 1989;
Having regard to the proposal from the Commission,
                                                                          Whereas the cost of the research indicated in Annex I,
                                                                          performed in the Member States, is estimated at more than
Having regard to the opinion of the European Parliament,                  1 000 million ECU;
Having regard to the opinion of the Economic and Social
                                                                          Whereas in its resolution of 25 July 1983 the Council
Committee,
                                                                          adopted a first framework programme for Community
                                                                          research, development and demonstration activities (7);
Whereas Article 2 of the Treaty assigns to the Community
the task inter alia of promoting throughout the Community
                                                                          Whereas Community research in the field of medical and
a harmonious development of economic activities, a
                                                                          health research has contributed effectively to the aim of
continuous and balanced expansion and an accelerated                      improving safety and protecting health within the objective
raising of the standard of living;                                        of improving living and working conditions;
Whereas, by Decision 78/167/EEC (*), as amended by
                                                                          Whereas the European Council in Milan on 28 and 29 June
Decision 81/21/EEC ( 2 ), and Decisions 78/168/EEC (3)
                                                                           1985 emphasized the value of launching a European action
and 78/169/EEC ( 4 ), the Council has adopted three
                                                                          programme against cancer;
concerted projects as a first programme in the field of medical
and public health research;
                                                                          Whereas, pursuant to the conclusions of further European
                                             5
Whereas, by Decision 80/344/EEC ( ), the Council adopted                  Councils, the respective research part dealt with by this
a second research programme in the field of medical and                    Regulation would constitute the contribution of medical
public health research;                                                   research and development towards such programme of
                                                                           action;
Whereas, by Decision 82/616/EEC ( 6 ), the Council adopted
 a third and sectoral research programme in the field of                  Whereas AIDS (acquired immune deficiency syndrome) is a
medical and public health research;                                        rapidly increasing transmissible disease of the greatest
                                                                           concern to the public health authorities of the Member
                                                                           States; whereas the European Parliament in its resolution of
Whereas the fourth research and development programme,                     13 March 1986 (8) called on the Commission to give priority
 dealt with by this Regulation, appears necessary to attain in             to research into AIDS in the new medical research
 the course of the operation of the common market the                      programme for the period 1987 to 1989;
 objectives of the Community as regards the harmonious
 development of economic activities, a continuous and
 balanced expansion and an accelerated raising of the                      Whereas the representatives of the Governments of the
 standard of living, account being taken in particular of                  Member States, meeting within the Council, stated in their
 potential economic and industrial development within the                  resolution of 29 May 1986 on AIDS that research efforts in
 fields covered by the research areas;                                     the Community and coordination of such efforts are
                                                                           therefore of special importance ( 9 ); whereas the respective
 (») OJ No  L 52, 23. 2 , 1 9 7 8 , p. 20.
                                                                           research part dealt with by this Regulation would meet either
 (2) OJ  No L 43, 13. 2. 1981, p. 12.                                      demand;
 (3) OJ  No L 52, 23. 2. 1978, p. 4.
 (4) OJ  No L 52, 23. 2. 1978, p. 20.                                      (7) OJ No C 208, 4, 8. 1983, p. 1.
 (5) OJ  No L 78, 25. 3. 1980, p. 24.                                      (8) OJ No C 88, 14. 4. 1986, p. 83.
 (6) OJ  No L 248, 24. 8. 1982, p. 12.                                     (9) OJ No C 148, 23. 7. 1986, p. 2 1 .
 ---pagebreak---  No C 50/60                                Official Journal of the European Communities                                     26. 2. 87
 Whereas the Community is empowered to conclude                        and Health, hereinafter designated 'the committee', which
 agreements with non-member States in the fields covered by            replaces the Advisory Committee for Management and
 this Regulation; whereas it may prove advisable to associate          Coordination 'Research in Medicine and Health' instituted
 the non-member States participating in European                       by Council Decision 84/338/Euratom, ECSC, EEC (7).
 cooperation in the field of scientific and technical research
 (COST) wholly or partly with the programme covered by this
                                                                       The committee shall be composed of Member State
 Regulation; whereas by Decisions 82/178/EEC ('),
                                                                       representatives responsible for science and technology in the
 83/224/EEC( 2 ),          83/225/EEC (3),   85/150/EEC (4),
                                                                       area of medical and health research, and in particular for the
 86/71/EEC( 5 ) and 86/233/EEC (6) the Council has
                                                                       coordination of national contributions to the programme,
 concluded or amended such agreements on concerted
                                                                      with a maximum of two per Member State.
 projects in the field of medical and public health research;
 Whereas the Treaty has not provided the necessary                     The members of the committee may be assisted by experts or
 powers;                                                               advisers according to the nature of the problems to be dealt
                                                                      with.
 Whereas the Scientific and Technical Research Committee
 (CREST) has delivered its opinion,
                                                                      The committee shall establish its rules of procedure.
 HAS ADOPTED THIS REGULATION:                                         The committee may be assisted             by 'concerted action
                                                                      committees' (COMAC) composed             of experts designated
                                                                      by the competent authorities of the     Member States. It may
                              Article 1                               also be assisted by working parties      entrusted with specific
                                                                      tasks.
 A research and development coordination programme of the
 European Economic Community in the field of medical and              The Commission shall ensure the secretariat of the
 health research is hereby adopted for a period of three years        committee.
 commencing on 1 January 1987.
The programme shall be carried out by means of the                    2.     The committee shall debate on opinion requests
concerted action method.                                              formulated by the Commission. The latter, when asking for
                                                                      the opinion of the committee may set a deadline for the
 The programme shall consist in coordination at Community             opinion to be given. The discussions of the committee shall
level, within the research areas described in Annex I, of those       not be concluded by a vote. However, each member of the
activities which form part of the research programmes of the          committee may require his opinion to be registered in the
Member States.                                                        minutes.
                              Article 2
                                                                                                 Article 5
The Commission shall ensure the implementation of the
coordination programme.
                                                                      Implementation and coordination of the national
                                                                      contributions to the programme shall be carried out by the
                                                                      national bodies in the list given for guidance in Annex III.
                              Article 3
The funds estimated as necessary for the Community
contribution to the coordination amount to 37 million ECU,
which includes expenditure on a staff of 12.                                                     Article 6
The internal and indicative allocation of these funds is set out      In accordance with a procedure to be laid down by the
in Annex II.                                                          Commission, after having consulted the committee, the
                                                                      participating Member States and the Commission shall
                                                                      regularly exchange all useful information concerning the
                              Article 4                               execution of the research covered by this Regulation. The
                                                                      participating Member States shall provide the Commission
1.     In the execution of its tasks, the Commission shall be         with all information relevant for coordination purposes.
assisted by an Advisory Committee for Research in Medicine            They shall also endeavour to provide the Commission with
                                                                      information on similar research planned or carried out by
(») O J N o L 8 3 , 29. 3. 1982, p. 1.                                bodies which are not under their authority. Any information
(2) OJ No L 126, 13. 5. 1983, p. 1.                                   shall be treated as confidential if so required by the Member
(3) OJ No L 126, 13. 5. 1983, p. 7.
(4) OJ No L 58, 26. 2. 1985, p. 26.                                   State which provides it.
(5) OJ No L 75, 20. 3. 1986, p. 31.
(6) OJ No L 158, 13. 6. 1986, p. 58.                                  (7) OJ No L 177, 4. 7. 1984, p. 25.
 ---pagebreak--- 2 6 . 2. 87                                     Official Journal of the European Communities                                     No C 50/61
O n completion of the p r o g r a m m e , the Commission, in                                             Article  8
agreement with the committee, shall send to the M e m b e r
States and the E u r o p e a n Parliament a summary report on the           The a m o u n t s which have been authorized in the
implementation and results of the p r o g r a m m e , particularly          corresponding items of the 1 9 8 2 , 1 9 8 3 , 1 9 8 4 , 1985 and
so that the results obtained may be accessible as rapidly as                1986 budgets and which, on 1 J a n u a r y 1 9 8 7 , have been
possible to the enterprises, institutions and other parties                 committed but not yet settled, shall be used in implementing
concerned, especially in the social area.                                   this Regulation.
                                Article   7                                                              Article  9
In accordance with Article 228 of the Treaty, the Community                 This Regulation shall enter into force on 1 January 1 9 8 7 .
may conclude agreements with the non-member States
participating in E u r o p e a n cooperation in the field of
scientific and technical research (COST) with a view to                     This Regulation shall be binding in its entirety and directly
associating them wholly or partly with this p r o g r a m m e .             applicable in all M e m b e r States.
                                                                     ANNEX I
                                                   SCIENTIFIC AND TECHNICAL CONTENT
                                                      (Coordination programme 1987 to 1989)
              The coordination programme, for which the expenditure commitments are estimated at 37 million ECU,
              comprises the following two sub-programmes:
                                              SUB-PROGRAMME I: MAJOR HEALTH PROBLEMS
              Target 1.1: Cancer
              Area     1.1.1:   Cancer research training scheme
              Area     1.1.2:   Clinical treatment research
              Area     1.1.3:   Epidemiological research
              Area     1.1.4:   Early detection and diagnosis
              Area     1.1.5:   Drug development
              Area     1.1.6:   Experimental (fundamental) research
              Target 1.2: AIDS
              Area 1.2.1: Disease control and prevention
              Area 1.2.2: Viro-immunological research
              Area 1.2.3: Clinical research
              Target 1.3: Age-related health problems
              Area 1.3.1: Reproduction
              Area 1.3.2: Ageing and diseases
              Area 1.3.3: Disabilities
              Target 1.4: Environment and life-style-related health problems
              Area     1.4.1:   Breakdown in human adaptation
              Area     1.4.2:   Nutrition
              Area     1.4.3:   Consumption of illicit drugs
              Area     1.4.4:   Infections
 ---pagebreak--- No C 50/62                               Official Journal of the European Communities                                           26. 2. 87
                                           SUB-PROGRAMME II: HEALTH RESOURCES
           Target II. 1: Medical technology development
           Area II. 1.1 Diagnostic methods and monitoring
           Area II. 1.2 Treatment and rehabilitation
           Area II. 1.3 Technical and clinical evaluation
           Target II.2: Health services research
           AreaH.2.1     Research on prevention
           Area II.2.2   Research on care delivery systems
           Area H.2.3    Research on health care organization
           Area II.2.4   Health technology assessment
                                                              ANNEX II
                                      INDICATIVE INTERNAL DISTRIBUTION OF FUNDS
                                                            (1987 to 1989)
                                       SUB-PROGRAMME I: MAJOR HEALTH PROBLEMS
                                                                                                        Million
                 Ta, 6 «                                       Title
                                                                                                         ECU
                                                                                                                        %
           Target I.l            Cancer                                                                 11,05          30
           Target 1.2            AIDS                                                                    5,45          15
           Target 1.3            Age-related health problems                                             5,65          15
           Target 1.4            Environment and life-style-related health problems                      3,35            9
                                           SUB-PROGRAMME II: HEALTH RESOURCES
                                                                                                        Million
                 T„m                                           Title
                                                                                                         ECU
                                                                                                                        %
           Target II. 1          Medical technology development                                          6,95          19
           Target II.2           Health services research                                                4,55          12
                                                                                            Total       37,00         100
                                                              ANNEX III
                    IMPLEMENTATION AND COORDINATION OF THE NATIONAL CONTRIBUTIONS
                                                      TO THE PROGRAMME
           The authorities of the participating Member States, listed below for guidance, will endeavour to ensure the
           implementation of the national contributions to the respective research areas indicated in Annex I, as well as their
           coordination at national level:
           Belgium:                      Ministere de la sante publique et de la famille, Bruxelles
                                         Service de programmation de la politique scientifique, Bruxelles
           Denmark:                      Statens laegevidenskabelige Forskningsrad, Kobenhavn
 ---pagebreak--- 26. 2. 87                     Official Journal of the European Communities
          France:             INSERM — Institut national de la sante et de la recherche medicale, Paris
                              Ministere des affaires sociales et de la solidarite nationale, Paris
          Federal Republic of Bundesminister fur Forschung und Technologie, Bonn
          Germany:            Bundesminister fur Jugend, Familie und Gesundheit, Bonn
                              Bundesminister fur Arbeit und Sozialordnung, Bonn
          Greece:             Ministry of Energy, Research and Technology, Athens
                              Ministry of Health, Welfare and Social Security, Athens
          Ireland:            Medical Research Council of Ireland, Dublin
                              Department of Health, Dublin
          Italy:              CNR — Consiglio nazionale della ricerca, Roma
                              Istituto superiore di sanita, Roma
          Luxembourg:         Ministere de la sante, Luxembourg
          Netherlands:        Ministry of Welfare, Health and Culture, Leidschendam
                              TNO/MEDIGON: Stichting voor Medisch Onderzoek en
                              Gezondheidsonderzoek
          Portugal:           National Institute of Health, Lisbon
          Spain:              Ministerio de Sanidad y Consumo, Madrid
                              CSIC — Consejo Superior de Investigaciones Cientificas, Madrid
          United Kingdom:     MRC — Medical Research Council, London
                              DHSS — Department of Health and Social Security, London