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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,

Having regard to the Treaty establishing the European
Economic Community, and in particular Article 130q
(2) thereof,

Having regard to the proposal from the Commission,

In cooperation with the European Parliament,

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

Whereas, by Decision 90/221/Euratom, EEC(*), the
Council adopted a third framework programme for
Community activities in the field of research and technological development (1990 to 1994), specifying _inter_
_alia_ the activities to be pursued for contributing to the
development of the European potential for understanding and expoiting the properties and structures of living
matter; whereas this decision should be taken in the
light of the grounds set out in the preamble to that
Decision;

(') OJ No L 117, 8. 5. 1990, p. 28.

No C 174/66 Official Journal of the European Communities 16. 7. 90

Whereas Article 130k of the Treaty stipulates that the
framework programme is to be implemented through
specific programmes developed within each activity;

Whereas an estimate should be made of the amount of
Community financial resources needed to carry out this
specific programme; whereas the definitive 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 (*) and with any future financial perspectives covering the period 1993 to 1994;

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
an amount of ECU 57 million for the centralized dissemination and exploitation of results, to be divided up
in proportion to the amount envisaged for each activity;
whereas in view of the importance of this specific
programme within the 'Life sciences and technologies'
action the estimate of the financial resources needed by
this programme is to be reduced by ECU 1 300 000,
which amount is to be allocated to the centralized
activities, in order to comply with the second sentence
of Article 130p (2) of the Treaty;

Whereas this programme must be implemented by the
Commission; whereas, to help accomplish this, the
Member States are bound, pursuant to Article 5 of the
Treaty, to facilitate the achievement of its tasks, where
necessary, notably within a committee;

Whereas this programme must be implemented essentially by the selection of research and development
projects to enable them to benefit from Community
participation; whereas the Commission should encourage the submission of such projects by the usual means
of publishing calls for proposals in the _Official Journal_
_of the European Communities;_ whereas a special procedure should also be devised so as to maintain a degree
of flexibility enabling the Commission, in the face of
the continuous evolution and gradual acceleration of
technological progress, also to take into consideration
spontaneous proposals consistent with the objectives of
the programme;

Whereas the projects to be carried out under the programme must be selected with special attention to the
principle of economic and social cohesion in the Community, the transnational nature of the projects and
the support to be given to small and medium-sized
enterprises;

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 supplementary programmes by having recourse to the
means provided for in Articles 1301, 130m or 130o of

(•) OJ No L 185, 15. 7. 1988, p. 33.

the Treaty, if they contribute to the achievement of the
programme's objectives, in accordance with the option
made available by Article 2 (2) of Decision 90/221/
Euratom, EEC;

Whereas, in accordance with Article 130g of the Treaty,
the Community's activities aimed at strengthening the
scientific and technological basis of European industry
and encouraging it to become more competitive include
promoting cooperation on research and technological
development with third countries and international
organizations; whereas such cooperation may prove
particularly beneficial for the development of this pro
gramme;

Whereas it is necessary, as Annex II to Decision 90/
221/Euratom, EEC provides to contribute to improving
the efficacy of medical and health research and development in the Member States, in particular by better
coordination of the Member States' research and development activities and application of the results through
Community cooperation and a pooling of resources;

Whereas the Scientific and Technical Research Committee (Crest) has been consulted,

HAS ADOPTED THIS DECISION.

_Article 1_

A specific research and technological development programme for the European Economic Community in the
field of biomedicine and health, as defined in Annex I,
is hereby adopted for a period of five years as from
1 January 1990.

_Article 2_

1. The Community funds estimated as necessary for
the execution of the programme under this Decision
amount to ECU 133 million. Of this amount ECU
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
exceed 4 %. An indicative breakdown of expenditure is
set out in Annex II.

2. Should the Council take a decision in implementation of Article 1 (4) of Decision 90/221/Euratom,
EEC, this decision shall be adapted to take account of
the abovementioned Decision.

3. The budgetary authority shall decide on the appropriations available for each financial year.

_Article 3_

Rules for the implementation of the programme are set
out in Annex III.

16. 7. 90 Official Journal of the European Communities No C 174/67

_Article 4_

The rate of the Community financial contribution shall
be laid down in accordance with Annex IV to Decision
90/221/Euratom, EEC.

_Article_ 5

1. During 1992 the Commission shall review the 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.

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.

3. The reports shall be drawn up having regard to the
objectives set out in Annex I to this Decision and
in accordance with Article 2 (4) of Decision 90/221/
Euratom, EEC.

_Article 6_

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',
composed of representatives of the Member States and
chaired by a representative of the Commission.

2. The contracts concluded by the Commission shall
govern the rights and obligations of each party, including the procedures for disseminating, protecting and
exploiting the research results, in accordance with the
arrangements adopted pursuant to the second para^
graph of Article 130k of the Treaty.

3. A work programme for each year shall be drawn
up and updated where necessary. It shall set out the
detailed objectives and types of projects to be undertaken, and the financial arrangements to be made for
them. The Commission shall make calls for proposals
for projects on the basis of the annual work pro
grammes.

_Article 7_

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
deliver its opinion on the draft within a time limit
which the chairman may set according to the urgency of
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
votes of the Member States' representatives within the
Committee shall be weighted in the manner set out in
that Article. The chairman shall not vote.

2. The Commission shall adopt the measures envisaged where they are in accordance with the Committee's opinion.

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
a proposal relating to the measures to be taken. The
Council shall act by a qualified majority.

4. If the Council has not acted within one month of
submission of the proposal, the proposed measures
shall be adopted by the Commission.

_Article 8_

1. The procedure laid down in Article 7 shall apply
to:

— the preparation and updating of the work programmes referred to in Article 6 (3),

— evaluation of the projects referred to in point 2 of
Annex III, as well as the estimated amount of the
Community's financial contribution when these
projects are submitted through the ordinary
procedure referred to in point 4 of Annex III
and the abovementioned amount is more than
ECU 5 million,

— evaluation of all projects submitted through the
exceptional procedure referred to in point 4 of
Annex III, as well as the estimated amount of the
Community's financial contribution,

— measures for evaluating the programme.

2. The Commission may consult the Committee on
any matter falling within the scope of the programme.

3. The Commission shall inform the Committee with
regard to:

— the progress of the programme,

— planned calls for proposals, referred to in Article 6 (3),

— projects, referred to in point 2 of Annex III, submitted through the ordinary procedure, for which the
Community contribution is less than ECU 5 million,
and the results of their evaluation,

— accompanying measures, referred to in point 2 of
Annex III,

— concerted actions, referred to in point 2 of Annex III.

_Article 9_

In implementing this programme, supplementary programmes within the meaning of Article 1301, partici

No C 174/68 Official Journal of the European Communities 16. 7. 90

pation within the meaning of Article 130m and joint
undertakings or any other structures within the meaning of Article 130o of the Treaty may also be decided
on as the need arises.

_Article 10_

Where cooperation with third countries and international organizations aiming at achieving the objectives of this programme requires legal undertakings
between the Community and the third parties con

cerned, the Commission shall be authorized to negotiate, in accordance with Article 130n of the Treaty,
international agreements laying down the terms of such
cooperation.

Decisions on the conclusion of such agreements shall
be adopted in accordance with the procedure referred
to in Article 130q (2) of the Treaty.

_Article 11_

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.

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 consideration may be given to ways of scaling up their production.

_Cancer_

Research will concentrate on improved methodologies involving differing combinations of surgery, radiotherapy, 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

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.

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 onthe 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 inthe projects shall be selected onthe basis of the ordinary procedure ofcallsfor
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

TheCommissionshalldrawupavademecumsettingoutall 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 Crouping^tC^
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 Article4ofOecision^0B^t^uratom,^C.