Source: EURLEX
Language: en
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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,

Having regard to the Treaty establishing the European
Economic Community, and in particular Article 235
thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament,

Having regard to the opinion of the Economic and Social
Committee,

Whereas Article 2 of the Treaty assigns to the Community
the task _inter alia_ of promoting throughout the Community
a harmonious development of economic activities, a
continuous and balanced expansion and an accelerated
raising of the standard of living;

Whereas, by Decision 78/167/EEC (*), as amended by
Decision 81/21/EEC ( [2] ), and Decisions 78/168/EEC ( [3] )
and 78/169/EEC ( [4] ), the Council has adopted three
concerted projects as a first programme in the field of medical
and public health research;

Whereas, by Decision 80/344/EEC ( [5] ), the Council adopted
a second research programme in the field of medical and
public health research;

Whereas, by Decision 82/616/EEC ( [6] ), the Council adopted
a third and sectoral research programme in the field of
medical and public health research;

Whereas the fourth research and development programme,
dealt with by this Regulation, appears necessary to attain in
the course of the operation of the common market the
objectives of the Community as regards the harmonious
development of economic activities, a continuous and
balanced expansion and an accelerated raising of the
standard of living, account being taken in particular of
potential economic and industrial development within the
fields covered by the research areas;

(») OJ No L 52, 23. 2,1978, p. 20.
( [2] ) OJ No L 43, 13. 2. 1981, p. 12.
( [3] ) OJ No L 52, 23. 2. 1978, p. 4.
( [4] ) OJ No L 52, 23. 2. 1978, p. 20.
( [5] ) OJ No L 78, 25. 3. 1980, p. 24.
( [6] ) OJ No L 248, 24. 8. 1982, p. 12.

Whereas the Member States intend, in accordance with
the rules and procedures applicable to their national
programmes, to carry out all or part of the research indicated
in Annex I, and are prepared to integrate such research
into a process of coordination at Community level until
31 December 1989;

Whereas the cost of the research indicated in Annex I,
performed in the Member States, is estimated at more than
1 000 million ECU;

Whereas in its resolution of 25 July 1983 the Council
adopted a first framework programme for Community
research, development and demonstration activities ( [7] );

Whereas Community research in the field of medical and
health research has contributed effectively to the aim of
improving safety and protecting health within the objective
of improving living and working conditions;

Whereas the European Council in Milan on 28 and 29 June
1985 emphasized the value of launching a European action
programme against cancer;

Whereas, pursuant to the conclusions of further European
Councils, the respective research part dealt with by this
Regulation would constitute the contribution of medical
research and development towards such programme of
action;

Whereas AIDS (acquired immune deficiency syndrome) is a
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
13 March 1986 ( [8] ) called on the Commission to give priority
to research into AIDS in the new medical research

programme for the period 1987 to 1989;

Whereas the representatives of the Governments of the
Member States, meeting within the Council, stated in their
resolution of 29 May 1986 on AIDS that research efforts in
the Community and coordination of such efforts are
therefore of special importance ( [9] ); whereas the respective
research part dealt with by this Regulation would meet either
demand;

( [7] ) OJ No C 208, 4, 8. 1983, p. 1.
( [8] ) OJ No C 88, 14. 4. 1986, p. 83.
( [9] ) OJ No C 148, 23. 7. 1986, p. 21.

No C 50/60 Official Journal of the European Communities 26. 2. 87

Whereas the Community is empowered to conclude
agreements with non-member States in the fields covered by
this Regulation; whereas it may prove advisable to associate
the non-member States participating in European
cooperation in the field of scientific and technical research
(COST) wholly or partly with the programme covered by this
Regulation; whereas by Decisions 82/178/EEC ('),
83/224/EEC( [2] ), 83/225/EEC ( [3] ), 85/150/EEC ( [4] ),
86/71/EEC( [5] ) and 86/233/EEC _(_ _[6]_ _)_ the Council has
concluded or amended such agreements on concerted
projects in the field of medical and public health research;

Whereas the Treaty has not provided the necessary

powers;

Whereas the Scientific and Technical Research Committee

(CREST) has delivered its opinion,

HAS ADOPTED THIS REGULATION:

_Article 1_

A research and development coordination programme of the
European Economic Community in the field of medical and
health research is hereby adopted for a period of three years
commencing on 1 January 1987.

The programme shall be carried out by means of the
concerted action method.

The programme shall consist in coordination at Community
level, within the research areas described in Annex I, of those
activities which form part of the research programmes of the
Member States.

_Article 2_

The Commission shall ensure the implementation of the
coordination programme.

_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.

The internal and indicative allocation of these funds is set out

in Annex II.

_Article 4_

1. In the execution of its tasks, the Commission shall be
assisted by an Advisory Committee for Research in Medicine

(») OJNoL83, 29. 3. 1982, p. 1.
( [2] ) OJ No L 126, 13. 5. 1983, p. 1.
( [3] ) OJ No L 126, 13. 5. 1983, p. 7.
( [4] ) OJ No L 58, 26. 2. 1985, p. 26.
( [5] ) OJ No L 75, 20. 3. 1986, p. 31.
( [6] ) OJ No L 158, 13. 6. 1986, p. 58.

and Health, hereinafter designated 'the committee', which
replaces the Advisory Committee for Management and
Coordination 'Research in Medicine and Health' instituted
by Council Decision 84/338/Euratom, ECSC, EEC ( [7] ).

The committee shall be composed of Member State
representatives responsible for science and technology in the
area of medical and health research, and in particular for the
coordination of national contributions to the programme,
with a maximum of two per Member State.

The members of the committee may be assisted by experts or
advisers according to the nature of the problems to be dealt
with.

The committee shall establish its rules of procedure.

The committee may be assisted by 'concerted action
committees' (COMAC) composed of experts designated
by the competent authorities of the Member States. It may
also be assisted by working parties entrusted with specific
tasks.

The Commission shall ensure the secretariat of the

committee.

2. The committee shall debate on opinion requests
formulated by the Commission. The latter, when asking for
the opinion of the committee may set a deadline for the
opinion to be given. The discussions of the committee shall
not be concluded by a vote. However, each member of the
committee may require his opinion to be registered in the
minutes.

_Article 5_

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 6_

In accordance with a procedure to be laid down by the
Commission, after having consulted the committee, the
participating Member States and the Commission shall
regularly exchange all useful information concerning the
execution of the research covered by this Regulation. The
participating Member States shall provide the Commission
with all information relevant for coordination purposes.
They shall also endeavour to provide the Commission with
information on similar research planned or carried out by
bodies which are not under their authority. Any information
shall be treated as confidential if so required by the Member
State which provides it.

( [7] ) OJ No L 177, 4. 7. 1984, p. 25.

26. 2. 87 Official Journal of the European Communities No C 5 0 / 6 1

On completion of the programme, the Commission, in
agreement with the committee, shall send to the Member
States and the European Parliament a summary report on the
implementation and results of the programme, particularly
so that the results obtained may be accessible as rapidly as
possible to the enterprises, institutions and other parties
concerned, especially in the social area.

_Article 7_

In accordance with Article 228 of the Treaty, the Community
may conclude agreements with the non-member States
participating in European cooperation in the field of
scientific and technical research (COST) with a view to

associating them wholly or partly with this programme.

_Article 8_

The amounts which have been authorized in the

corresponding items of the 1982, 1983, 1984, 1985 and
1986 budgets and which, on 1 January 1987, have been
committed but not yet settled, shall be used in implementing
this Regulation.

_Article 9_

This Regulation shall enter into force on 1 January 1987.

This Regulation shall be binding in its entirety and directly
applicable in all Member 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

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

Area II. 1.2

Area II. 1.3

Diagnostic methods and monitoring
Treatment and rehabilitation

Technical and clinical evaluation

Target II.2: Health services research

AreaH.2.1

Area II.2.2

Area H.2.3

Area II.2.4

Ta, 6 «

Target I.l

Target 1.2

Target 1.3

Target 1.4

_T„_ _m_

Target II. 1

Target II.2

Research on prevention
Research on care delivery systems
Research on health care organization
Health technology assessment

_ANNEX II_

INDICATIVE INTERNAL DISTRIBUTION OF FUNDS

(1987 to 1989)

SUB-PROGRAMME I: MAJOR HEALTH PROBLEMS

Title

Cancer

AIDS

Age-related health problems

Environment and life-style-related health problems

SUB-PROGRAMME II: HEALTH RESOURCES

Title

Medical technology development

Health services research

Total

_ANNEX III_

Million

ECU

11,05

5,45

5,65

3,35

Million

ECU

6,95

4,55

37,00

%

30

15

15

9

%

19

12

100

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:

Denmark:

Ministere de la sante publique et de la famille, Bruxelles
Service de programmation de la politique scientifique, Bruxelles

Statens laegevidenskabelige Forskningsrad, Kobenhavn

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