CELEX: 51990PC0676
Language: en
Date: 1990-12-14
Title: AMENDED PROPOSAL FOR A COUNCIL DECISION ADOPTING A SPECIFIC RESEARCH AND TECHNOLOGICAL DEVELOPMENT PROGRAMME IN THE FIELD OF BIOMEDICINE AND HEALTH ( 1990-1994 )

No C 11/10                            Official Journal of the European Communities                                  17. 1. 91
                                                             II
                                                      (Preparatory Acts)
                                                COMMISSION
               Amended proposal for a Council Decision adopting a specific research and technological devel-
                        opment programme in the field of biomedicine and health (1990 to 1994) (')
                                              COM(90) 676 final — SYN 267
               (Submitted by the Commission pursuant to Article 149(3) of the EEC Treaty on 14 December
                                                            1990)
                                                        (91/C 11/04)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                          amounts will be fixed by the budgetary authority in line
                                                                  with the financial perspectives covering the period 1988
                                                                  to 1992 included in the interinstitutional Agreement of
                                                                  29 June 1988 (J) and with any future financial
Having regard to the Treaty establishing the European
                                                                  perspectives covering the period 1993 to 1994;
Economic Community, and in particular Article 130q (2)
thereof,
                                                                  Whereas fundamental research must be specifically
                                                                  encouraged Community-wide in each of the strategic
Having regard to the proposal from the Commission,
                                                                  research sectors of the framework programme;
In cooperation with the European Parliament,
                                                                  Whereas, in addition to the specific programme on
                                                                  human capital and mobility, training of researchers in
                                                                  each of the strategic research sectors of the framework
Having regard to the opinion of the Economic and                  programme must be ensured;
Social Committee,
                                                                  Whereas the social and human impact of the programme
Whereas, by its Decision 90/221/Euratom, EEC (2), the             must be assessed by an independent panel and tech-
Council adopted a third framework programme for                   nology and risk assessment be undertaken, particularly in
Community activities in the field of research and techno-         the field of bioethics;
logical development (1990 to 1994), specifying inter alia
the activities to be pursued for contributing to the devel-
opment of the European potential for understanding and
exploiting the properties and structures of living matter;        Whereas, pursuant to Article 4 and Annex I of Decision
whereas this Decision should be taken in the light of the         90/221/Euratom, EEC, the funds estimated as necessary
grounds set out in the preamble to that Decision;                 for the whole of the framework programme include an
                                                                  amount of ECU 57 million for the centralized dissemi-
                                                                  nation and exploitation of results, to be divided up in
                                                                  proportion to the amount envisaged for each activity;
Whereas Article 130k of the Treaty stipulates that the            whereas in view of the importance of this specific
framework programme shall be implemented through                  programme within the 'Life Sciences and Technologies'
specific programmes developed within each activity;               action the estimate of the financial resources needed by
                                                                  this programme is to be reduced by ECU 1,33 million,
                                                                  which amount is to be allocated to the said centralized
                                                                  activities, in order to comply with the second sentence of
Whereas an estimate should be made of the amount of               Article 130p (2) of the Treaty;
Community financial resources needed to carry out
this specific programme; whereas the definitive
O OJ No C 174, 16. 7. 1990, p. 65.
(2) OJ No L 117, 8. 5. 1990, p. 28.                               O OJ No L 185, 15. 7. 1988, p. 33.
 ---pagebreak---  17. 1.91                                Official Journal of the European Communities                             N o C 11/11
Whereas this programme must be implemented by the                  Whereas it is necessary, as Annex II to Decision
Commission; whereas to help accomplish this, the                    90/221/Euratom, EEC, provides, to contribute to
Member States are bound, pursuant to Article 5 of the              improving the efficacy of medical and health research
Treaty, to facilitate the achievement of its tasks where            and development in the Member States, in particular by
necessary, notably within a committee;                             better coordination of the Member States' research and
                                                                   development activities and application of the results
                                                                   through Community cooperation and a pooling of
                                                                   resources;
Whereas this programme must be implemented essen-
tially by the selection of research and development
projects to enable them to benefit from Community
participation; whereas the Commission should encourage             Whereas the Scientific and Technical              Research
the submission of such projects by the usual means of              Committee (Crest) has been consulted,
publishing calls for proposals in the Official Journal of the
European        Communities;    whereas      an    exceptional
procedure should also be devised so as to come into
effect between calls for proposals to maintain a degree of         HAS ADOPTED THIS DECISION:
flexibility enabling the Commission, in the face of the
continuous evolution and gradual acceleration of techno-
logical progress, also to take into consideration spon-
taneous proposals consistent with the objectives of the                                     Article 1
programme;                                                         A specific research and technological development
                                                                   programme for the European Economic Community in
                                                                   the field of biomedicine and health, as defined in Annex
Whereas support for the international competitiveness of           I, is hereby adopted for the period from the date of
European industry, through Community research and                  publication of this Decision in the Official Journal of the
technological development programmes, is linked with               European Communities to 31 December 1994.
the Community's external relations policy based on the
principle of 'the global equilibrium of opportunities', and
that it is also in the light of this policy that participation
                                                                                            Article 2
of European companies owned by citizens of
non-Community countries must be considered;                        1.    The Community funds estimated as necessary for
                                                                   the execution of the programme under this Decision
                                                                   amount to ECU 133 million. From these funds, an
                                                                   amount of ECU 1,33 million is drawn for the centralized
Whereas the projects to be carried out under the                   action of dissemination and exploitation of results. The
programme must be selected with special attention to the           amount thus reduced to ECU 131,67 million includes
principle of economic and social cohesion in the                   staff costs which may not exceed 4 %. An indicative
Community, to the transnational nature of the projects             breakdown of expenditure is set out in Annex II.
and to the support to be given to small and
medium-sized enterprises;
                                                                   2.    Should the Council take a decision in implemen-
                                                                   tation of Article 1 (4) of Decision 90/221/Euratom,
Whereas it is only in the light of experience gathered in          EEC, this Decision shall be adapted to take account of
the course of development of this programme that the               the abovementioned decision.
Commission will be able to propose and the Council to
adopt supplementary programmes by having recourse to
the means provided for in Articles 1301, 130m or 130o of
the Treaty, if they contribute to the achievement of the           3.    The budgetary authority shall decide on the appro-
programme's objectives, in accordance with the option              priations available for each financial year.
made       available by Article        2 (2)    of   Decision
90/221/Euratom, EEC;
                                                                                            Article 3
Whereas, in accordance with Article 130g of the Treaty,            Rules for the implementation of the programme are set
the Community's activities aimed at strengthening the              out in Annex III.
scientific and technological basis of European industry
and encouraging it to become more competitive include
promoting cooperation on research and technological
                                                                                            Article 4
development with third countries and international
organizations; whereas such cooperation may prove                  The rate of the Community financial contribution shall
particularly beneficial to the development of this                 be laid down in accordance with Annex IV to Decision
programme;                                                         90/221/Euratom, EEC.
 ---pagebreak--- N o C 11/12                           Official Journal of the European Communities                                  17. 1.91
                         Article 5                              2.    The Commission shall adopt the measures
                                                                envisaged where they are in accordance with the
1.    During 1992 the Commission shall review the               committee's opinion.
programme and address a report on the results of the
review to the Council and the European Parliament,
together with proposals for any necessary changes.
                                                                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
2.    At the end of the programme, the Commission shall         Council a proposal relating to measures to be taken. The
assess the results obtained. It shall address a report          Council shall act by a qualified majority.
thereon to the Council and the European Parliament.
                                                                4.    If the Council has not acted within one month of
3.    The reports shall be drawn up having regard to the        submission of the proposal, the proposed measures shall
objectives set out in Annex I to this Decision and              be adopted by the Commission.
in accordance with Article 2 (4) of               Decision
90/221/Euratom, EEC. These reports shall assess the
coherence of the programme's measurable implemen-                                         Article 8
tation with the six major concerns set out in Annex II to
Council Decision 90/221/Euratom, EEC.                            1.   The procedure laid down in Article 7 shall apply
                                                                to:
                         Article 6                              — preparation and updating of the work programmes
                                                                    referred to in Article 6 (3),
1.    The Commission shall be responsible for the
execution of the programme. It shall be assisted by a
committee, hereinafter referred to as 'the committee',          — evaluation of the projects, referred to in point 2 of
composed of representatives of the Member States and                Annex III, as well as the estimated amount of the
chaired by a representative of the Commission.                      Community's financial contribution, when these
                                                                    projects are submitted through the ordinary
                                                                    procedure referred to in point 4 of Annex III and the
2.    The contracts concluded by the Commission shall               abovementioned amount is more than ECU 5 million,
govern the rights and obligations of each party,
including the procedures for disseminating, protecting          — evaluation of all projects submitted through the
and exploiting the research results, in accordance with             exceptional procedure referred to in point 4 of Annex
the arrangements adopted pursuant to the second                     III, as well as the estimated amount of the
paragraph of Article 130k of the Treaty and, where                  Community's financial contribution,
appropriate, procedures for training and evaluation.
                                                                — measures for evaluating the programme.
3.    A work programme shall be drawn up at the start
of the programme and shall be regularly revised. It shall
set out the detailed objectives and types of projects to be     2.    The Commission may consult the Committee on
undertaken, and the financial arrangements to be made           any matter falling within the scope of the programme.
for them. The Commission shall make calls for proposals
for projects on the basis of the work programmes.
                                                                3    The Commission shall inform the Committee with
                                                                regard to:
                         Article 7
                                                                — the progress of the programme,
1.    In the cases envisaged in Article 8 (1), the
Commission representative shall submit to the committee
a draft of the measures to be taken. The committee shall        — planned calls for proposals, referred to in Article
deliver its opinion on the draft within a time limit which          6 (3),
the chairman may set according to the urgency of the
matter. The opinion shall be delivered by qualified
                                                                — projects, referred to in point 2 of Annex III,
majority as provided for in Article 148 (2) of the Treaty
                                                                    submitted through the ordinary procedure, for which
for the adoption of decisions which the Council is called
                                                                    the Community contribution is less than ECU
upon to make on a proposal from the Commission.
                                                                    5 million, and the results of their evaluation,
"When voting takes place in the committee, the votes of
the representatives of the Member States shall be
weighted as specified in the abovementioned Article. The        — accompanying measures, referred to in point 2 of
chairman shall not take part in the voting.                         Annex III,
 ---pagebreak---  17. 1.91                                Official Journal of the European Communities                                    N o C 11/13
— concerted actions, referred to in point 2 of Annex HI.               Priority will be given to cooperation with EFTA
                                                                       countries and European countries not members of the
                                                                       European Community, in accordance, where appro-
                           Article 9                                   priate, with the guidelines drawn up between the Council
                                                                       and the European Parliament during the conciliation
In implementing this programme,                  supplementary         procedure on the third framework programme.
programmes within the meaning of Article 1301, partici-
pation within the meaning of Article 130m and joint
                                                                       The negotiations for such international agreements may
undertakings or any other structures within the meaning
                                                                       only be initiated with third countries who are already
of Article 130o of the Treaty may also be decided on as
                                                                       signatories of an agreement with the Community which
the need arises.
                                                                       explicitly cites research and technological development
                                                                       or scientific progress as one of the objectives of
                                                                       cooperation.
                          Article 10
Where cooperation with third countries and international               Decisions on the conclusion of such international
organizations aiming at achieving the objectives of this               agreements shall be adopted in accordance with the
programme requires legal undertakings between the                      procedure referred to in Article 130q (2) of the Treaty.
Community and the third parties concerned, the
Commission shall be authorized to negotiate, in
                                                                                                 Article 11
accordance with Article 130n of the Treaty, international
agreements laying down the terms of such cooperation.                  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 of the framework programme forms an integral part of the present specific
             programme.
             Close coordination will be maintained with other relevant research programmes, including 'Biotechnology',
             'Life Sciences and Technologies for Developing Countries', 'Telematics Systems — Health Care', 'Medical
             Research' under the European Coal and Steel Community Treaty, and also the 'Europe against Cancer'
             programme.
             The principle of subsidiarity will be applied to the maximum. Harmonization of approaches and methodo-
             logies used in different national programmes will be encouraged. The projects within the programme will
             have a European dimension based on research networks. Their main criteria will be quality and
             additionality. Strengthening of networks, particularly by the establishment of 'European Laboratories
             Without Walls', will aim at the development of specific and competitive subject areas. Mobility of research
             workers between participating laboratories will be encouraged, including for short periods of time.
             Harmonized methods, specific to the relevant protocols, will ensure that the data resulting from the
             projects carried out throughout the Community can be analysed and exploited anywhere in the
             Community. Coordination with national activities will ensure effective use of resources.
            The fundamental role of basic research in underpinning the work of the programme is recognized. Prenor-
             mative research will be developed whenever needed for the completion of the internal market, in respect of
             serving patients' needs.
 ---pagebreak--- N o C 11/14                              Official J o u r n a l of t h e E u r o p e a n C o m m u n i t i e s                     17. 1.91
            The following presents an analytical description of the content of the programme, based on and taking
            account of the above elements.
            Area 1: Development of coordinated research on prevention, care and health systems
            This area covers the harmonization of methodologies and protocols in epidemiological, biological, clinical
            and technological research. The key targets will be:
            Precompetitive drug-testing and research into the monitoring and surveillance of drug-prescribing
            practices, patient compliance and the incidence of adverse drug reactions will be carried out, based on
            clinical and epidemiological data collected through coordinated networks, and with a view to an improved
            harmonization of norms, parameters and guidelines.
            Risk factors relating to occupational health, including dangerous            substances and biological agents, will be
            studied with the aim of their identification, and of risk prevention         and of early detection of disease. Among
            the subject fields will be information methods for workers about             safety and cost-effective management of
            screening systems. Research related to the genetic screening of              workers for apparent predispositions to
            occupational diseases and workplace hazards, and which implies               those workers' participation, will not be
            conducted without their consent.
            Enhancement and application of biomedical technology to medical and health care will be directed towards
            the development of coherent systems and procedures for diagnosis, therapy, prevention, care and rehabili-
            tation. Coordination of basic research (modelling) in biomedical technology will be aimed at fundamental
            insight into failing human functions and on the characteristics of biomaterials. Applied technological
            research will be aimed at artificial systems to restore failing human functions and alleviate handicaps as
            completely as possible.
            Lastly, support must be given in these different fields to multicentre studies between countries to facilitate
            the granting of patents, epidemiological studies and authorizations for the marketing of new medicinal
            products.
            Harmonization of protocols and approaches in health services will be emphasized, particularly with Europe
            1992 in view. Research will be carried out into the financing of health care, the management of the health
            care workforce, and health care systems. The methodology of research into prevention, therapy and reha-
            bilitation will also be studied.
            Area 2: Major health problems and diseases of great socio-economic impact
            Major health problems and economically and socially significant disease groupings will be considered, in
            particular the following:
            AIDS
            The research will take into account the activities already developed by the Community and will be spread
            over five main sectors:
           — disease prevention — concentrating on specific epidemiological projects, studies of primary and
                secondary prevention, assessment of preventive strategies, behavioural research and forecasting,
 ---pagebreak--- 17. 1.91                              Official Journal of the European Communities                                    N o C 11/15
         — fundamental research — concentrating on AIDS viruses, host response, pathogenesis and experimental
             mode}s,
         — clinical research — concentrating on clinical trials, clinical manifestations, support of clinical centres
             and national coordination,
         — the development of a 'European Vaccine against AIDS' (EVA) will be actively pursued. A centralized
             facility will work in collaboration with industrial and academic laboratories to produce antigens, sera,
             cells and other materials,
         — testing methods of 'Antiviral Drugs in AIDS Management' (ADAM) will be developed. Primary
             screening capacity will be increased by introducing additional primary screening methods.
         In this specific area collaboration with other European Community actions, including the specific
         programme on 'Life Sciences and Technologies for Developing Countries', will receive particular attention.
         Cancer
         Epidemiology and fundamental research on genomic and phenotypic changes in cancer cells (invasion and
         metastasis) and immune surveillance will be extended. Particular attention will be paid to research into
         oncogenes and antioncogenes. 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.
         Research will concentrate on improved methodologies involving differing combinations of surgery,
         radiotherapy, chemotherapy and immunotherapy, and their subsequent harmonization with associated local
         and general approaches.
         Research will also be carried out on the links between environmental factors and the incidence of cancer,
         with the aim of developing preventive approaches, in coordination with the research programme on the
         environment.
         In conjunction with the 'Europe against Cancer' programme, particular attention will be paid to research in
         the area of paediatric oncology.
         Cardiovascular disease
         The various forms of heart and circulatory disease will be studied, focusing on research where coherent
         broadly-based clinical and epidemiological surveys are most useful; this will include correlation between
         genetic factors, lifestyle, nutrition, and the incidence and development of cardiovascular disturbances, the
         effects of prophylactic and therapeutic measures, the development of new regimens for treatment including
         non-invasive methods of diagnosis, and the testing of drugs.
         Mental illness and neurological disease
         Multidisciplinary approaches to the study of aetiological factors and predisposing conditions will be
         developed in a range of psychosocial environments. The aim of such studies will be to improve under-
         standing of the causes of mental illness and also the evolution from pathology to disability and social
         disadvantage, and to develop new methods of prevention and care.
         A global approach to the study of central nervous system malfunctioning common to pathological and
         physiopathological conditions will be pursued, to improve understanding of aetiopathogenic mechanisms.
 ---pagebreak--- N o C 11/16                              Official Journal of the European Communities                                        17. 1.91
            Specific studies will be carried out in the areas of enzymology, neuroendocrinology and genetics.
            Particular attention will also be paid to the part played by mental processes in the development of diseases
            such as cancer, AIDS or cardiovascular disorders.
            Ageing, age-related health problems and handicaps
            Research on perinatal illnesses (including the study of the social and economic impact of prenatal
            diagnosis) and paediatric illnesses and on the effectiveness of prophylactic and therapeutic measures will be
            carried out.
            The overall target for research in the field of ageing will be directed towards prevention of and coping
            with dependency. A concerted approach to the study of ageing will be pursued in order to identify 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. Emphasis will be placed on longitudinal studies
            on ageing in different cultural settings, and on specific pathologies relating to ageing such as senile
            dementia, osteoporosis and disorders of the immune system. Special attention will be given to the effects of
            the environment on health, especially on people in the more vulnerable age groups; this will be pursued in
            close liaison with research on environmental protection.
            Studies will be carried out on methods of improving organ transplants.
            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 coordinating mechanism 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 wellbeing of patients: in coordi-
            nation with other elements of the research programme in biomedicine and health, to ensure that the
            advances in the understanding of genetics are used to enhance human health; in particular, on under-
            standing 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. It is therefore
            important that the research programme in biomedicine and health should link closely with relevant acti-
            vities elsewhere in the framework programme.
            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.
            However, the results of this research must enable the genetic data of the donors required for transplants to
            be established at any time.
 ---pagebreak--- 17. 1.91                              Official Journal of the European Communities                                 N o C 11/17
         Area 4: Research on Biomedical ethics
         Studies will deal with:
         — the compilation of current legislation on bioethics and current projects,
         — the organization of meetings of experts in the field of bioethics with a view to drawing up Community
             positions,
         — the evaluation of the social impact of the programme, as well as any technological risks which may be
             associated with it,
         — the assessment of the bioethical aspects of the various research programmes in the framework
             programme of Community activities and research.
         Preparatory studies will be undertaken with a view to the setting up of a European ethical observatory in
         conjunction with the European institutions and organizations.
                                                            ANNEX II
                                           Indicative breakdown of expenditures
         for the period 1990 to 1994
                                                                                                            (in %)
         Area 1:        Development of coordinated research on prevention, care and
                        health systems                                                                      20-25
         Area 2:        Major health problems and diseases of great socio-economic
                        impact, with AIDS receiving 50 °/o of the sum for Area 2                            55-60
         Area 3:        Human genome analysis                                                               20-25
         Area 4:        Research on Biomedical ethics: 5 % of the total for Areas 1, 2
                        and 3.
         The breakdown between different areas does not exclude the possibility that projects could cover several
         areas.
         1. An amount equivalent to 10 % of the total shall be used for projects encouraging fundamental research,
            which should be clearly identified.
         2. An amount equivalent to 5 % of the total shall be devoted to projects encouraging the training of
            researchers in the field covered by this specific programme.
 ---pagebreak--- N o C 11/18                              Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s              17. 1. 91
                                                                  ANNEX      III
            Rules for implementing t h e p r o g r a m m e a n d activities for dissemination a n d exploitation of the
                                                                    results
            1. The Commission shall implement the programme on the basis of the scientific and technical content
               described in Annex I.
            2. The rules for implementing the programme, referred to in Article 3, comprise research and techno-
               logical 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,
               management and evaluation of the programme, as well as adequate dissemination and accessibility of
               the results, and coordination, training and consciousness-raising of the participants in the programme.
               The concerted actions are those defined in Article 92 of the Financial Regulation.
            3. The participants in the projects must be natural or legal persons established in the Community, such as
               universities, research organizations and industrial firms, including small and medium-sized enterprises,
               or associations thereof, in particular European Economic Interest Groupings (EEIGs).
               Natural or legal persons established in countries which have concluded cooperation agreements on
               scientific and technical research with the Community may, on the principle of mutual benefit, participate
               in the projects undertaken in the framework of this programme. Such contracting parties will not benefit
               from Community financing under the framework programme. They will contribute to the general
               administrative costs.
            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 (4) and published in the Official Journal of the European Communities.
               Where other criteria of scientific excellence are satisfied, and in accordance with the guidelines agreed
               between Council and the European Parliament, in the case of a number of project proposals of equal
               scientific value, preference shall be given:
                (i) to project proposals whose implementation involves project participants in less-developed regions
                    and/or regions in industrial decline as defined by Articles 8 and 9 of Council Regulation EEC
                    N o 2052/88;
               (ii) to project proposals involving small and medium-sized entreprises or an association of such enter-
                    prises.
               The Commission shall determine in each case whether the management of the programme, or parts
               thereof, can be undertaken by organizations or institutions outside the Commission, without delegation
               of its decision-taking powers.
               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.
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              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 shall come into effect after the first call for proposals and 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.
              When it submits the preliminary draft budget the Commission shall inform the budgetary authority
              whether the appropriations approved in the budget of the previous year have also financed projects
              retained by the exceptional procedure and the amounts allocated. Should these projects cover several
              programmes, it shall state the type of committee which assisted it.
              The amount of the financial participation of the Community for all the projects retained by the excep-
              tional 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 10 %; 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 hand by means of a centralized activity, pursuant to the
              decision referred to in the third paragraph of Article 4 in Decision 90/221 /Euratom, EEC.
           Proposal for a Council Decision concerning the conclusion of the amendment to the Montreal
           Protocol on substances that deplete the ozone layer as adopted in June 1990 in London by the
                                                      Parties to the Protocol
                                                        COM(90) 589 final
                                     (Submitted by the Commission on 20 December 1990)
                                                            (91/C 11/05)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                               Having regard       to   the   opinion    of  the   European
                                                                       Parliament,
Having regard to the Treaty establishing the European                  Having regard to the opinion            of the Social    and
Economic Community, and in particular Article 130s                     Economic Committee,
thereof,
                                                                      Whereas the Community together with all of its Member
                                                                       States signed the Vienna Convention for the protection
Having regard to the proposal from the Commission,                     of the ozone layer;