CELEX: 51990PC0162
Language: en
Date: 1990-05-28
Title: PROPOSAL FOR A COUNCIL DECISION ADOPTING A SPECIFIC RESEARCH AND TECHNOLOGICAL DEVELOPMENT PROGRAMME IN THE FIELD OF BIOMEDICINE AND HEALTH ( 1990-1994 )

16. 7. 90                               Official Journal of the European Communities                                     No C 174/65
             4. The choice of projects shall be carried out according to the following order of priority, the first method
                being the rule, the second the exception.
                The participants in the projects shall be selected on the basis of the ordinary procedure of calls for
                proposals referred to in Article 6 (3) and published in the Official Journal of the European Communities.
                The Commission may also accept proposals according to an exceptional procedure and under the
                conditions mentioned below, when they make a particularly promising and significant contribution as
                regards the originality of the theme proposed, the novelty of the scientific and technical approach and
                the methodology of execution, also taking into account the particular nature of the proposers.
                A favourable technical evaluation of such proposals shall not by itself be a sufficient justification for
                accepting a project; this exceptional procedure may only apply after verification that the nature of the
                project, as defined above, does not justify the use of the normal procedure for calls for proposals.
                The exceptional procedure must be completed before the ordinary procedure in such a way that the
                available amount for the Community's financial participation in projects retained by the ordinary
                procedure can be determined precisely. The closing date for the exceptional procedure shall be published
                each year in the Official Journal of the European Communities.
                The amount of the financial participation of the Community for all the projects retained by the exceptional
                procedure will be decided each year, in relation to the projects selected according to particularly strict
                criteria of excellence. In any case, this amount may not exceed 15%; it may be revised each year in the
                light of experience.
                The Commission shall draw up a vade mecum setting out all the rules applicable to this exceptional
                procedure in order to guarantee full transparency.
             5. The projects must involve at least two mutually independent partners established in different Member
                States.
             6. The Commission may encourage the participants to form a European Economic Interest Grouping (EEIG)
                or make other arrangements for carrying out projects, such as those on a large scale, permitting
                decentralized management adapted to the specific requirements of the project.
             7. The knowledge acquired during the course of the projects shall be disseminated on the one hand within
                the specific programme and on the other and by means of a centralized activity, pursuant to the Decision
                referred to in the third subparagraph of Article 4 of Decision 90/221 /Euratom, EEC.
             Proposal for a Council Decision adopting a specific programme of research and technological
                             development in the field of biomedicine and health (1990 to 1994)
                                                  COM(90) 162 final — SYN 267
                                         (Submitted by the Commission on 3 May 1990)
                                                            (90/C 174/10)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                                 Whereas, by Decision 90/221/Euratom, EEC(*), the
                                                                         Council adopted a third framework programme for
Having regard to the Treaty establishing the European                   Community activities in the field of research and tech-
Economic Community, and in particular Article 130q                      nological development (1990 to 1994), specifying inter
(2) thereof,                                                            alia the activities to be pursued for contributing to the
                                                                        development of the European potential for understand-
Having regard to the proposal from the Commission,                      ing and expoiting the properties and structures of living
                                                                        matter; whereas this decision should be taken in the
In cooperation with the European Parliament,                            light of the grounds set out in the preamble to that
                                                                        Decision;
Having regard to the opinion of the Economic and
Social Committee,                                                       (') OJ No L 117, 8. 5. 1990, p. 28.
 ---pagebreak---  No C 174/66                         Official Journal of the European Communities                               16. 7. 90
 Whereas Article 130k of the Treaty stipulates that the         the Treaty, if they contribute to the achievement of the
 framework programme is to be implemented through               programme's objectives, in accordance with the option
 specific programmes developed within each activity;            made available by Article 2 (2) of Decision 90/221/
                                                                Euratom, EEC;
 Whereas an estimate should be made of the amount of
 Community financial resources needed to carry out this        Whereas, in accordance with Article 130g of the Treaty,
 specific programme; whereas the definitive amounts             the Community's activities aimed at strengthening the
 will be fixed by the budgetary authority in line with         scientific and technological basis of European industry
 the financial perspectives covering the period 1988 to        and encouraging it to become more competitive include
  1992 included in the Interinstitutional Agreement of         promoting cooperation on research and technological
 29 June 1988 (*) and with any future financial perspec-       development with third countries and international
 tives covering the period 1993 to 1994;                       organizations; whereas such cooperation may prove
                                                               particularly beneficial for the development of this pro-
                                                               gramme;
 Whereas, pursuant to Article 4 of and Annex I to
 Decision 90/221/Euratom, EEC, the amount deemed
 necessary for the whole framework programme includes          Whereas it is necessary, as Annex II to Decision 90/
 an amount of ECU 57 million for the centralized dis-          221/Euratom, EEC provides to contribute to improving
 semination and exploitation of results, to be divided up      the efficacy of medical and health research and develop-
 in proportion to the amount envisaged for each activity;      ment in the Member States, in particular by better
 whereas in view of the importance of this specific            coordination of the Member States' research and devel-
 programme within the 'Life sciences and technologies'         opment activities and application of the results through
 action the estimate of the financial resources needed by      Community cooperation and a pooling of resources;
 this programme is to be reduced by ECU 1 300 000,
 which amount is to be allocated to the centralized
                                                               Whereas the Scientific and Technical Research Com-
 activities, in order to comply with the second sentence
                                                               mittee (Crest) has been consulted,
 of Article 130p (2) of the Treaty;
 Whereas this programme must be implemented by the
 Commission; whereas, to help accomplish this, the             HAS ADOPTED THIS DECISION.
 Member States are bound, pursuant to Article 5 of the
 Treaty, to facilitate the achievement of its tasks, where
 necessary, notably within a committee;                                                 Article 1
Whereas this programme must be implemented essen-              A specific research and technological development pro-
tially by the selection of research and development            gramme for the European Economic Community in the
projects to enable them to benefit from Community              field of biomedicine and health, as defined in Annex I,
participation; whereas the Commission should encour-           is hereby adopted for a period of five years as from
age the submission of such projects by the usual means          1 January 1990.
of publishing calls for proposals in the Official Journal
of the European Communities; whereas a special pro-
cedure should also be devised so as to maintain a degree                                Article 2
of flexibility enabling the Commission, in the face of
the continuous evolution and gradual acceleration of           1. The Community funds estimated as necessary for
technological progress, also to take into consideration        the execution of the programme under this Decision
spontaneous proposals consistent with the objectives of        amount to ECU 133 million. Of this amount ECU
the programme;                                                 1 330 000 is drawn for the centralized dissemination
                                                               and exploitation of results. The amount thus reduced
                                                               to ECU 131 670 000 includes staff costs which may not
Whereas the projects to be carried out under the pro-          exceed 4 %. An indicative breakdown of expenditure is
gramme must be selected with special attention to the          set out in Annex II.
principle of economic and social cohesion in the Com-
munity, the transnational nature of the projects and
the support to be given to small and medium-sized              2. Should the Council take a decision in implemen-
enterprises;                                                   tation of Article 1 (4) of Decision 90/221/Euratom,
                                                               EEC, this decision shall be adapted to take account of
                                                               the abovementioned Decision.
Whereas it is only in the light of experience gathered
in the course of this programme that the Commission
will be able to propose and the Council to adopt sup-          3. The budgetary authority shall decide on the appro-
plementary programmes by having recourse to the                priations available for each financial year.
means provided for in Articles 1301, 130m or 130o of
                                                                                        Article 3
                                                               Rules for the implementation of the programme are set
(•) OJ No L 185, 15. 7. 1988, p. 33.                           out in Annex III.
 ---pagebreak---  16. 7. 90                          Official Journal of the European Communities                           No C 174/67
                        Article 4                               2. The Commission shall adopt the measures envis-
                                                                aged where they are in accordance with the Commit-
 The rate of the Community financial contribution shall         tee's opinion.
 be laid down in accordance with Annex IV to Decision
 90/221/Euratom, EEC.
                                                                3. If the measures envisaged are not in accordance with
                                                                the Committee's opinion, or if no opinion is delivered,
                                                                the Commission shall forthwith submit to the Council
                        Article 5                               a proposal relating to the measures to be taken. The
                                                                Council shall act by a qualified majority.
 1. During 1992 the Commission shall review the pro-
 gramme and address a report on the results of the
 review to the Council and the European Parliament,
 together with proposals for any necessary changes.            4. If the Council has not acted within one month of
                                                                submission of the proposal, the proposed measures
                                                                shall be adopted by the Commission.
 2. At the end of the programme the Commission shall
 assess the results obtained. It shall address a report
thereon to the Council and the European Parliament.
                                                                                          Article 8
3. The reports shall be drawn up having regard to the
objectives set out in Annex I to this Decision and              1. The procedure laid down in Article 7 shall apply
in accordance with Article 2 (4) of Decision 90/221/            to:
Euratom, EEC.                                                  — the preparation and updating of the work pro-
                                                                     grammes referred to in Article 6 (3),
                                                               — evaluation of the projects referred to in point 2 of
                        Article 6                                    Annex III, as well as the estimated amount of the
                                                                     Community's financial contribution when these
1. The Commission shall be responsible for the                       projects are submitted through the ordinary
execution of the programme. It shall be assisted by a                procedure referred to in point 4 of Annex III
committee, hereinafter referred to as 'the Committee',               and the abovementioned amount is more than
composed of representatives of the Member States and                 ECU 5 million,
chaired by a representative of the Commission.
                                                               — evaluation of all projects submitted through the
                                                                     exceptional procedure referred to in point 4 of
2. The contracts concluded by the Commission shall                   Annex III, as well as the estimated amount of the
govern the rights and obligations of each party, includ-             Community's financial contribution,
ing the procedures for disseminating, protecting and
exploiting the research results, in accordance with the        — measures for evaluating the programme.
arrangements adopted pursuant to the second para^
graph of Article 130k of the Treaty.
                                                               2. The Commission may consult the Committee on
3. A work programme for each year shall be drawn               any matter falling within the scope of the programme.
up and updated where necessary. It shall set out the
detailed objectives and types of projects to be under-
taken, and the financial arrangements to be made for          3. The Commission shall inform the Committee with
them. The Commission shall make calls for proposals            regard to:
for projects on the basis of the annual work pro-
grammes.                                                      — the progress of the programme,
                                                              — planned calls for proposals, referred to in Article 6 (3),
                                                              — projects, referred to in point 2 of Annex III, submit-
                        Article 7                                   ted through the ordinary procedure, for which the
                                                                    Community contribution is less than ECU 5 million,
1. In the cases envisaged in Article 8 (1), the Com-                and the results of their evaluation,
mission representative shall submit to the Committee a        — accompanying measures, referred to in point 2 of
draft of the measures to be taken. The Committee shall              Annex III,
deliver its opinion on the draft within a time limit
which the chairman may set according to the urgency of        — concerted actions, referred to in point 2 of Annex III.
the matter. The opinion shall be delivered by qualified
majority as provided for in Article 148 (2) of the Treaty
in the case of decisions which the Council is required
to adopt on a proposal from the Commission. The                                          Article 9
votes of the Member States' representatives within the
Committee shall be weighted in the manner set out in          In implementing this programme, supplementary pro-
that Article. The chairman shall not vote.                    grammes within the meaning of Article 1301, partici-
 ---pagebreak--- N o C 174/68                            Official Journal of the European Communities                                        16. 7. 90
pation within the meaning of Article 130m and joint                     cerned, the Commission shall be authorized to nego-
undertakings or any other structures within the mean-                   tiate, in accordance with Article 130n of the Treaty,
ing of Article 130o of the Treaty may also be decided                   international agreements laying down the terms of such
on as the need arises.                                                  cooperation.
                                                                        Decisions on the conclusion of such agreements shall
                                                                        be adopted in accordance with the procedure referred
                           Article 10                                   to in Article 130q (2) of the Treaty.
Where cooperation with third countries and inter-
national organizations aiming at achieving the objec-                                             Article 11
tives of this programme requires legal undertakings
between the Community and the third parties con-                        This Decision is addressed to the Member States.
                                                               ANNEX I
                                         Scientific and technical objectives and content
            This specific programme fully reflects the approach embodied in the third Framework Programme in terms
            of the scientific and technical goals and the underlying aims which it pursues.
            Paragraph 4C of Annex II to the Framework Programme forms an integral part of the present specific
            programme.
            Close coordination will be maintained with other relevant research programmes, including 'Life sciences and
            technologies for developing countries', 'Telematics systems — health care', and 'Medical research' under the
            European Coal and Steel Community Treaty.
           The principle of subsidiarity will be applied to the maximum, through encouraging the harmonization of
            approaches and methodologies used in different national programmes. The projects themselves will have a
           European dimension arising from their polycentric execution based on research networks. Harmonized
            methods, specified in the relevant protocols, will ensure that the data resulting from the projects carried out
            throughout the Community can be statistically analysed and coherently exploited anywhere in the Community.
           Prenormative research will be developed whenever needed for serving patients' needs and for the completion
           of the internal market.
           The following presents an analytical description of the content of the programme, based on and taking
            account of the above elements.
            Area 1: Harmonization of methodologies and protocols in epidemiological, biological and clinical research
           The essential features of this area are outlined below: testing of drugs will be conducted through the
           development of networks, enabling both the collection of clinical and epidemiological data and the monitoring
           and surveillance of prescriptions and of adverse drug reactions.
           Screening for risk factors will be covered, especially in the context of occupational health. Examples of risk
           factors at work include shiftwork, new technology in the office and occupational health risks in health care
           workers. Safety in laboratories is of particular importance. Related topics include audit in occupational
           health and ethical problems.
           In biomedical technology, research will be directed towards the development of new coherent diagnostic
           procedures, such as medical imaging techniques. In the biomedical engineering area, the aim is to restore
           function as completely as possible to the handicapped, particularly by developing new biomaterials for use
           in prostheses, tissue replacements and artificial organs. Methods of monitoring the effects of treatment, and
           consequent restoration of function, will also be developed.
           Harmonization of protocols and approaches as regards the management of health services will be emphasized.
 ---pagebreak--- 16. 7. 90                               Official Journal of the European Communities                                      No C 174/69
            Area 2: Applications to diseases of great socioeconomic impact
            Five economically and socially significant disease groupings will be considered, as described below:
            AIDS
            The research will take into account the activities already developed by the Community and will be spread
            over five sectors.
            The disease prevention sector will concentrate on specific epidemiological projects, studies of primary and
            secondary prevention, assessment of preventive strategies, behavioural research and forecasting, using inter
            alia centres or facilities with unique characteristics.
            The fundamental research sector will concentrate on AIDS viruses, host response, pathogenesis and animal
            studies.
            The clinical research sector will concentrate on clinical trials, clinical manifestations, support of clinical
            centres and support of national coordination, e.g. by establishing a network of clinical AIDS reference centres
            and other relevant groups. This immediately sensitive part of the programme will be given a special priority.
            Prenormative research will be included, with development of new drugs being emphasized.
            The development of a European vaccine against AIDS (EVA) will be actively pursued. Its objective is the
            promotion of collaborative research by the provision of high-quality reagents for investigations of the immune
            response to lentiviruses and the induction of protective immunity. A centralized laboratory facility will be
            provided, and arrangements will be made for industrial and academic laboratories to produce to agreed
            specifications required amounts of antigens, sera, cells and other materials; the centralized facility will be
            responsible for assaying the materials, together with^their adequate storage and distribution.
            Testing methods for antiviral drugs in AIDS management (ADAM), the most recent domain of research, will
            be developed. Primary screening capacity will be increased by introducing additional primary screening
            methods; further research will be undertaken on the mode of action of promising compounds, and consider-
            ation may be given to ways of scaling up their production.
            Cancer
           Research will concentrate on improved methodologies involving differing combinations of surgery, radio-
           therapy, chemotherapy and immunotherapy, and their subsequent harmonization. Local approaches involving
           surgery and radiotherapy will be studied vis-a-vis improved methods of removing all visible tumour tissue,
           aiming to leave a minimal tumour burden with resulting maximization of the effects of new systemic
           treatments as they become available. More effective methods of local control, as well as of systemic treatments,
           will be developed in order to achieve rapid improvement in overall survival. Selectivity of radiotherapy will
           be further improved, e.g. using light ion therapy and boron neutron capture therapy (BNCT), aiming at an
           improved survival rate.
           Epidemiology and fundamental research on genomic and phenotypic changes in cancer cells (invasion and
           metastasis) and immune surveillance will be extended. Priority support activities will include the improvement
           of European tumour cell and tissue bank resources, and the development of the scientific basis for common
           guidelines for anti-cancer drug screening.
           Cardiovascular disease
           The various forms of heart and circulatory disease will be studied, focusing on research where coherent
           broadly-based clinical surveys are most useful; this includes correlation between life style, nutrition, and the
           incidence and development of cardiovascular disturbances, the effects of prophylactic and therapeutic
           measures, the development of new regimens for the treatment and the testing of drugs.
          Mental illness and neurological disorders, and mental handicap
          A comparative analysis of aetio-pathogenetic factors and conditions relative to the incidence of mental illness
          in widely different psycho-social environments will be carried out in order to obtain an insight into the
          responsible mechanisms. Systems for the handling and treatment of patients will be compared in order to
 ---pagebreak--- No C 174/70                          Official Journal of the European Communities                                          16. 7. 90
          identify the most effective. A coherent, multidisciplinary approach to the study of central nervous system
          malfunctioning common to mental illness and neurological disorders will be pursued. Multiple sclerosis and
          Parkinson's disease are examples.
          A comparative study of the handling of the mentally handicapped and of their rehabilitation will be carried
          out. The approach will be broad and comprehensive, ranging from the molecular to the socioeconomic
          aspects.
          Ageing, and age-related health problems and disabilities
           Comparative research on perinatal and paediatric illness and on the effectiveness of prophylactic and
          therapeutic measures will be carried out.
          A concerted approach to the study of ageing, with emphasis on the clinical aspects, will be pursued in order
          to identify, on a large-scale factual basis, essential elements in the maintenance of the quality of life in the
          aged, in preventing or delaying the functional decline of the individual, and in reducing costs to society.
          Special attention will be given to the effects of the environment on health, especially on people in the more
          vulnerable ages; this will be pursued in close liaison with research on environmental protection.
          Area 3: Human genome analysis
          This research will be developed towards the completion and the integration of the genetic and physical maps.
          In addition, the study of the genetic basis for biological functions will be pursued, as well as the setting-up
          of a consortium to sequence a portion of the genome of major biological interest (e.g. the portion coding for
          the human lymphocyte antigen system).
          Emphasis will be placed on medical applications which contribute to the well-being of patients: in particular,
          on understanding the genetic component of multifactorial conditions such as Alzheimer's disease, and on
          developing methods intended to improve therapies. Links will be maintained with appropriate international
          organizations or forums (e.g. HUGO, the human genome organization), as well as with research actions in
          non-member states using similar or complementary approaches. The Community programme is characterized
          by its emphasis on gene mapping and on the use of information resulting from the analysis of other species'
          genomes.
          Particular attention and caution will be given to the ethical, social and legal aspects of this work, especially
          to those which may be linked to possible misuses of research findings. No research modifying, or seeking to
          modify, the genetic constitution of human beings by alteration of germ cells or of any stage of embryo
          development which may make these alterations hereditary will be carried out under this programme.
                                                             ANNEX 11
                            Indicative breakdown of expenditures for the period 1990 to 1994
                                                                                                                      (%)
          Area 1: Harmonization of methodologies and protocols in epidemiological, biological and
                   clinical research                                                                                20-25
          Area 2: Applications to diseases of great socioeconomic impact                                            45-50
          Area 3: Human genome analysis                                                                             30-35
          The breakdown between different areas does not exclude the possibility that projects could cover several
          areas.
 ---pagebreak--- r^.B.^                                   Co^n^ic^i]ourn^lo^heEu^oroc^nCon^n^unine^                                                           ^o^i^B^i
                             ^nd^cnv^ie^^^^eB^^noB^Bde^plo^nono^^he^e^^s
       1. The Commission shall implement the programme o n t h e basis of the scientific andtechnical content
          described in Anneal.
       ^. The rules for implementing the programme, referred to in Article 3, comprise research and technological
          development projects, accompanying measures and concerted actions.
          The projects shall be the subject of shared^cost research and technological development contracts.
          The accompanying measures consist of applying the means to ensure proper technical execution, managed
          ment and evaluation of the programme, as well as adequate dissemination and accessibility of the results,
          and coordination, training and consciousnessraising of the participants in the programme.
          The concerted actions are those defined in the financial regulations
       3. The participants in the projects must be natural or legal persons established in the Community^ such as
          universities, research organisations and industrial firms, including small and mediumsi^ed enterprises,
          or associations thereof, in particular European economic interest groupings ^ ^ C s ^ .
          natural or legal persons established in countries which have concluded agreements with the Community
          foreseeing scientific and technical research, may,based on the criterion of mutual advantage, tal^e part
          in the projects undertaken in the content of this programme. The contracting parties under such
          arrangements shall not benefit from Community funding. They shall contribute to thegeneral administrate
          ive costs.
       4. The choice of projects shall be carried out according to the following order of prionty,the first method
          being the rule, the second the exception.
          The participants i n t h e projects shall be selected o n t h e basis of the ordinary procedure o f c a l l s f o r
          proposals referred to in AiTicle^^^ and published in the C ^ ^ ^ ^ o ^ r ^ ^ ^ o ^ r ^ ^ r o ^ ^ ^ C o ^ ^ ^ ^ ^ ^
          The Commission may also accept proposals according to an exceptional procedure and under the
          conditions mentioned below, when they mal^eaparticularly promising and significant contribution as
          regards the originality of the theme proposed, the novelty of the scientific and technical approach and
          the methodology of execution, also taking into account the particular nature of the proposers.
          ^favourable technical evaluation of such proposals shall not by itself beasufficient justification for
          acceptingaproject^ this exceptional procedure may only apply after verification that the nature of the
          project, as defined above, does not justify the use of the normal procedure for calls for proposals.
          Thee^ceptional proceduremustbe completed before the ordinary procedurem such a way that the
          available amount for the Commumtys financial participation in projects retained by the ordinary
          procedure can be determined precisely. The closing date for the exceptional procedure shall be published
          each year in the O O ^ ^ ^ o ^ r ^ ^ o ^ r ^ ^ r o ^ ^ ^ C o ^ ^ ^ ^ ^ ^
          The amount ofthe financial participation oftheCommunity for all the projects retained by thee^ceptional
          procedure will be decided eachyear, in relation to the projects selected according to particularly strict
          criteria of e^cellence.ln any case, this amount may not exceed t ^ m ^ t n a y be revised each year in the
          light of experience
          T h e C o m m i s s i o n s h a l l d r a w u p a v a d e m e c u m s e t t i n g o u t a l l the rules applicableto this exceptional
          procedure in order to guarantee full transparency.
       ^. The projectsmust involve at least two mutually independent partners established in different Member
          states.
       ^. The Commission may encourage the participants to formar^uropean economic interest C r o u p i n g ^ t C ^
          or mal^e other arrangements for carrying out projects, such as those on a large scale, permitting
          decentralized management adapted to the specific requirements of the project.
       ^  The knowledge acquired during the course of the projects shall be disseminated on the one hand within
          the specific programme and on the other and by means ofacentrali^edactivity,pursuant to the Oecision
          referred to in the third subparagraph of A r t i c l e 4 o f O e c i s i o n ^ 0 B ^ t ^ u r a t o m , ^ C .