CELEX: 51981PC0517
Language: en
Date: 1981-09-21
Title: Proposal for a Council Decision adopting a sectoral research and development programme of the European Economic Community in the field of medical and public health research - concerted action - (1982 - 1986) (submitted to the Council by the Commission)

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 ---pagebreak---      COMMISSION OF THE EUROPEAN COMMUNITIES
                                                        COM(81)517 final.
                                                        Brussels - 21 September 1981
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                               Proposal for a Council Decision
            adopting a sectoral research and development programme of the
            European Economic Community in the field of medical and public
                                       health research
                                    - concerted action -
                                        ( 1982 - 1986 )
                       ( submitted to the Council by the Commission )
C0M(81 ) 517 final .
 ---pagebreak---                                  - 1 -
                           TABLE OF CONTENTS
                                                 page
A. Summary                                         2
                       ι
B. Introduction                                    4
C. Objectives , justification and orientations     8
D. Programme content                              12
   Subprogramme    1     :  Health problems
   Subprogramme    2     :  Health Resources
   Subprogramme    3     :  Personal environment
E. Programme implementation                      19
F. Operational and management structure          20
G. Ways and means                                26
   ANNEX     I » :   Draft Decision
   ANNEX    II   :   Financial Data
 ---pagebreak---                                      - 2 -
A. SUMMARY
   The present proposal deals with a new sectoral research and development
   programme ( 1982 - 1986 ) of the EEC in the field of medical and public
   health research , to be carried out by means of the concerted action method .
   It aims at increasing the efficiency of the relevant R S D efforts in the
   Member States through the mobilization of the available research potential
   of parts of national programmes and its gradual coordination at Community
   level .
   Particular attention is devoted to the potential economic and industrial
   development within the fields covered by the research actions of this
   programme , in conformity with Article 235 of the Treaty establishing the
   European Economic Community and in accordance with the objectives and
   means of action described in Article 2 of the Treaty .
   This proposal constitutes a step towards the sectoral grouping of Community
   research actions in the field of medical and public health research and'
   towards the rationalization of structures and procedures for the " prepara­
   tion , examination and implementation of Community R&D programmes ".
   The programme proposal , by presenting a coherent scheme of Community con­
   certed research , provides for the continuation of the first medical research
   programme ( 1978 - 1981 ) and the integration of the second one ( 1980 - 1984 )
   as well as for new activities in critical areas of common interest . It is
   subdivided into three subprogrammes :
                 Subprogramme   1  :  Health problems
                 Subprogramme   2  :  Health resources
                 Subprogramme   3  :  Personal environment ( diet and drugs ).
   Each one is further detailed in research areas grouping several projects .
   Overall programme implementation will be ensured by one " General Concerted
   Action Committee " assisted in its tasks by four " Concerted Action Committees "
   with defined scientific-technical competences , each responsible for the
   optimal execution of several projects entrusted to it .
 ---pagebreak---                                   - 3 -
The Member States intend,accordmg to the rules and procedures applicable
to their national programmes , to carry out the research work estimated to
involve global financial contributions of about 300 million ECU over the
programme period of 5 years ( 1982 - 86 ).
The Commission is responsible for the coordination of the national research
contributions to the programme at Community level . The appropriations ne­
cessary to finance the Community contribution to such coordination are
evaluated to be in the order of 20 million ECU for the duration of the pro­
gramme . This figure includes staff expenditures for a total of 10 officials
(4 of them were already allocated to the 2nd medical research programme ).
Interested non-Member States participating in European Cooperation in the
field of Scientific and Technical Research ( COST ) will be invited to asso­
ciate wholly or partly with this programme .
In order to ensure continuity , the programme is foreseen to start on
1 January 1982 .
                                               *
                   ι
 ---pagebreak---                                              - 4 -
B. INTRODUCTION
   The Counci L Deci sions of 13 February 1978 , adopting three concerted actions
   as a f i rst Community research programme in the field of medical and public
   health research , gave a new dimension to the task of the Commission , namely
   to extend its efforts of " gradually coordinating national research acti­
   vities " to a further area of increasing importance for the Community .
   The first programme was followed by the Council Decision of 18 March 1980
                     (4)
   ( 80 / 344 / EEC       ), adopting a second medical research programme consisting
   of four multiannual concerted actions .
   The latter Decision was of crucial importance to the Commission since it
   confirmed the option taken by the Council , and furthermore settled the
   institutional problem of using under certain conditions the Article 235
   of the EEC Treaty for undertaking medical and public health research .
   The following concerted actions are presently implemented :
                                                      (1 , 5) )
   1 . Registration of congenital abnormalities
                             (2)                                1st programme
   2 . Cellular ageing
                                                                (1 .1 . 1978 - 31 . 12.1981 )
                                         (3)
   3 . Extracorporeal oxygenation
   4 . Detection of tendency to thrombosis
                                                                                  (4)
   5 . Hearing impairment                                       2nd programme
                                                                (1 . 6.1980 - 31 . 5.1984 )
   6 . Perinatal monitoring
   7 . Quantitative electrocardiography
   (1 )    OJ   No L  52 , 23.2.78 , p. 20
   (2)     0J   No L  52 , 23.2.78 , p. 24
   (3)     OJ   No L  52 , 23.2.78 , p. 28
   (4)     OJ   No L  78 , 25.3.80 , p. 24
   (5)     OJ   No L  43 , 14.2.81 , p. 12
 ---pagebreak---                                       - 5 -
The concerted action method for initiating Community activities in the
medical and public health field in a number of well defined topics has
been preferred at the time of their proposal .
Two main reasons led to this choice , namely the existing dicrepancies
between national research policies and strategies , as stated at an earlier
confrontation exercise ( CREST / 22 / 76 ), as well as the existence of many
scattered and relatively small research teams at national level . The va­
lidity of this choice has been proven and at present more than 400 national
projects are coordinated by the ongoing seven EC actions . The number of
institutes wishing to join this venture is in fact steadily increasing .
The close collaboration evolved over ten years between the Committee on
Medical and Public Health Research CRM / CREST and the Commission has faci­
litated considerably this coordination .
The achievements in coordination and the recognized scientific and technical
enhancement of results of the actions of the first programme confirm the :
- remarkably improved efficiency of national efforts in the respective
   f i elds ,
- favourable cost / benefit ratio of the Community funds spent for co­
   ordination purposes , and
- strengthened confidence and interest of the Member States in this form
   of Community action for its contribution to economic returns in the bio­
   medical and industrial fields .
CRM , assisted by its Specialized Working Groups , also advised the Commission
to promote a wide range of exploratory activities in the form of studies ,
seminars , workshops etc .   Thus , a coherent scheme has been set up , where
3 broad subprogrammes have been defined . Each of them is divided in research
areas where the ongoing concerted actions and a number of new projects are
integrated .
Considering the above , the Commission advised by CRM prepared its present
proposal for a sectoral R&D programme of the EC in the field of medical
and public health research .
 ---pagebreak--- This proposal provides for the following specific requirements :
- continuation of the concerted actions of the first programme enabling
   their extension and / or expansion , as already foreseen at the time of
   their proposal ( C0M(77 ) 282 final );
- integration of the concerted actions of the second programme considering
   their present state of evolution and plans for extension and continuation
    ( C0MC78 ) 377 final );
- implementation of new actions in critical fields of common interest ;
- support of centralized coordination facilities , whenever required .
The proposal presents a coherent scheme of Community actions as shown in
tables I - III . It constitutes a step towards the sectoral grouping of
Community medical research actions of the Member States conducted under
the EEC Treaty , and the rationalization of structures and procedures for
the " preparation , examination and implementation of Community R&D pro­
grammes " in conformity with the Council conclusions of 20 December 1979 .
Relevant activities in progress in other countries as well as those of
appropriate international organizations such as WHO , OECD , Council of
Europe , European Medical Research Councils of the European Science
Foundation , etc . were taken into consideration when preparing the project
proposals .
The conclusions of the meetings of the Ministers of Public Health ( 13.12.1977
and 16.11.1978 ) have also been considered .
In the implementation of the present programme , close coordination is en­
visaged wi th other research programmes of the EC which include or are related
to medical and / or public health research components . At present these include
- parts of the research programme of the EC in the field of reference
                                                            (1)
   materials and methods ( Community Bureau of Reference )      related
   to the production of standards for materials which are of biomedical
   interest ;
(1 )    0J No L 258 , 13.10.79 , p. 32
 ---pagebreak---                                        - 7 -
                                                                           (2)
- the sectoral R&D programme of the EEC in the field of environment            ,
   in particular for the part relating to man-environment interaction ;
- the plan of action of the EEC in the field of scientific and technical
  information and documentation ^ for its part concerning "Biomedical
   Information ";               '
- the research and training programme of the EAEC in the field of biology -
                                                           (4)
  health protection ( Radiation Protection Programme )         in its medical
  and public health aspects ;
                                                ( 5-8 )
- the current four ECSC research programmes             related to occupational
  health ;
- the action programme of the European Communities on safety and health
  at work
         i. ( 9 )
– Finally , important areas of "this proposal ,    namely areas 1.1 .
  (Pre-, peri-, and postnatal care ) and 1.2 . ( Ageing, Disabled
  and Handicapped) can "be seen in the perspective of the
  International Year of Disabled Persons and of the opinions
  of the European Parliament and the Economic and Social Committee
  pertaining to it .
(2)   OJ No L 101 , 11.4.81 , p. 1
(3)   OJ No L 311 , 4.11.78 , p. 1
(4)   OJ No L     78 , 25.3.80 , p. 19
(5)   OJ No C     10 , 14.1.77 , p. 2
(6)   OJ No C 159 ,     5.7.78 , p. 2
(7)   OJ No C 161 ,     1.7.80 , p. 4
(8)   OJ No C
(9)   OJ No C 165 , 11.7.78 , p. 1
 ---pagebreak--- OBJECTIVES , JUSTIFICATION AND ORIENTATIONS
The diseases of modern society with their incidence on industrial deve­
lopment and the steadily mounting costs of health care are among the most
important economic problems confronting all Member States .
National efforts to solve them are in progress . Thus , within the Community ,
there exists a considerable potential for scientific research and in­
dustrial development . If mobilized within the frame of a coherent Commu­
nity medical research programme it would allow the realization of evident
scientific progress , giving adequate and more effective information .
1 . Obi ecti ves
    The main objectives of European cooperation in the sector of medical
    and public health research are prevention , early detection of disease
    and rehabilitation . More specifically they aim at the following ,
    namely to :
    a ) optimize the capacity and economic efficiency of health care
        efforts by initiating or implementing common actions in defined
        fields considered as critically relevant to the solution of major
        health problems and their incidence on occupational health ;
    b ) improve efficiency of ongoing national R&D through the encoura­
        gement of concerted actions thus making a better use of the avai­
        lable research potential ;
    c ) promote through coordinated efforts an active interaction of the
        National Research Agencies , of the Health Authorities and of the
        Biomedical Industries , leading to an accelerated raising of the
        social and economic welfare of the Community ;
    d ) gradually coordinate , at Community level , the national research
        programmes in the fields of common interest . The implementation
        of the research work is the remit of competent research organi­
        zations of the Member States ;
 ---pagebreak---                                          - 9 -
     e ) provide a systematic template for medical and public health research
         in the Community R&D policy by bringing under it an increasing
         proportion of national research activities in this sector .
2 . Just2f2çat2on
     The legal basis for this programme is Article 235 of the Treaty esta­
     blishing the European Economic Community and the Council Decision of
                                    (1 )
     18 March 1980 ( 80 / 344 / CEE       ) adopting the second medical research
     programme .
     On this basis , and in line with the conclusions of the 619th meeting
     of the Council on 20 December 1979 ( doc . 4230 / 80 / RECH . 1 ), the
     Commission prepared the present proposal for a new " sectoral " R&D
     programme in which an attempt is made to group several ongoing and
     new research actions pertaining to the field of medical and public
     health research .
     Although this research field is not mentioned among the areas of fore­
     most priority , the Commission proposes to devote to it a certain pro­
     portion of its R&D efforts , in conformity with the Council conclusion
     " not to exclude a priori other areas where a Community contribution
     could be of particular value for the Community " ( see : C0M(80 ) 412
     final ) .
     Similarly , this programme proposal corresponds to the Resolution of the
     European Parliament embodying its opinion on both earlier programmes ,
     in which " the Commission is expected , in accordance with the tradi­
     tionally universal nature of medical knowledge , to continue to promote
     such research at European level and to ensure that it is coordinated
     and , where possible , integrated with similar research being carried out
     in other parts of the world ".
                                                            (2)
     Moreover , the Council Decision of 9 April 1981            on the conclusion
     of the Agreement between the EEC and the Swiss Confederation on a con­
     certed action , should be considered as a beginning of associating non
     Member States , participating in COST , wholly or partly with this pro­
     gramme .
(1 )    J0 No L  78 , 25.3.80 , p. 24
(2)     JO No L 113 , 25.4.81 , p. 44
 ---pagebreak---                                      - 10 -
3 . Orientations
    Current national programmes in the field of medical and public health
    research are predominantly oriented to disease-related targets such
    as : cardiovascular disorders , mental illnesses , congenital abnorma­
     lities , geriatric diseases , etc . Here , progress derives largely from
    individual efforts and dissemination of information is assured by
    scientific societies . Development as well as coordination at national
     level is mainly or partially done by making available purpose-linked
    public research funds . The Commission in line with the advise of CRM
    does not feel that additional coordination efforts along these targets
    are considered opportune or necessary at Community level .
    In compliance with its mandate and on advice of the CRM , the Commission
    proposes to orient its sectoral R&D programme towards more compre­
    hensive targets of common interest .
    The present R&D programme proposal will allow for more effective re­
    search through collaboration and coordination at EC level making use
    of a multidisciplinary research potential beyond the possibilities of
    any single country . It focuses on the following three key areas , herein­
    after referred to as subprogrammes , relating to :
    1 .  Health Problems
    2.   Health Resources
    3.   Personal environment ( Diet and Drugs ).
    The first R&D subprogramme is essentially oriented to the solution of
    those health problems involving the critical phases of human life , namely ■
    birth and old age , to the effects of the life-style related stress of the
    industrial environment and the ability to cope with it , and to the impro­
    vement of rehabilitation of the disabled and handicapped .
    It would thus promote the identification of ways and means likely to
    maximize the results of scientific and technological progress , and
    to minimize the negative economic and social consequences related to
    inappropriate intervention in these areas .
 ---pagebreak---                                - 11 -
The second R 8 D subprogramme is oriented to the improvement and appro­
priate use of those health resources required to ensure optimization of
the cost-effectiveness ratio in the health care field . Particular atten­
tion is given to coordination of efforts to develop health services re­
search , improve health technology and promote upgrading and qualifica-
                           «
tion of human resources .
The third R&D subprogramme focuses on the need for a better under­
standing of the effects on the individual 's health resulting from its
diet and the intake of pharmaceuticals , as part of its personal envi­
ronment .
                                      X
                             *                *
                    I
 ---pagebreak--- PROGRAMME    CONTENT
                                I.   HEALTH PROBLEMS
This subprogramme covers research aimed at establishing the biological ,
physiological , technological , epidemiological and organizational data
required for improving the medical intervention at birth , during develop­
ment and in old age , as well as the effective prevention , better handling
and reduced dependence of unfitness , be it the consequence of congenital
or acquired handicaps . Results from these investigations are expected to
have an important fall-out for the European biomedical and pharmaceutical
industries .
The subprogramme also includes studies on the quantification of risk po­
tential and adaptive responses to psychological and social stresses , of
particular importance to the area of occupational health .
Part of the research included in this subprogramme is already coordinated
in ongoing " Concerted Actions " of the 1st and 2nd medical and public
health research programmes . It is proposed to continue these actions .
Area   1   :   Pre - i,_ger2- z _ and_gost-nat a l_care
- Technological development and assessment for perinatal monitoring pro­
  cedures with emphasis on non-invasive techniques . Particular attention
  will be given to their reliability , to the relevance of information ob­
  tained , to mother distress and risks , as well as to foetal loss .
- Research in laboratories equipped to carry out chromosome analysis will
  endeavour to solve technical problems needed to reach partially automated
  measurements . Simultaneous parallel biochemical and genetical studies
  are envisaged .
- The determination of inborn metabolic errors through a    uniform methodic
  approach to different screening programmes aims at defining the criteria
  for monitoring their incidence and prevalence in the Member States , at
  diagnosis and at development of treatment .
  Particular attention will be given to treatable errors , and the project
  will include studies on cystic fibrosis , hemoglobinopathies and hyper-
  l ipoproteinemi a .
 ---pagebreak---                                      - 13 -
- The congenital anomalies registry in progress will be complemented by
  investigations on intrauterine diagnosis and studies on early foetal
  loss , death in early childhood and foetal growth disturbances .
- Current practices in Member States regarding care delivery systems , and
  in particular the application of technical devices and procedures to
  perinatal medicine , including cost / effectiveness evaluat ions,wi 1 1 be
  examined .
Area    2  :  Aqei^2 r _cH sabled_and_handi cagged
- The continuation and further development of the concerted action on
  cellular ageing wi 11 involve studies at organ , cellular and sub-cellular
  level . It is proposed to include also further investigations of the im­
  mune response during ageing including studies contributing to the under­
  standing of arthritic diseases , and of ageing of the brain and senile
  dementia . The problem of premature , as opposed to normal , ageing will
  be considered .
- Ageing of the lens and hearing impairment form the crux of the action
  on sensorial impairment partly covered by ongoing concerted actions .
  The development of adequate aids to vision and hearing deterioration or
  loss due to a metabolic or occupational origin will be considered .
  Biomaterial compatibility studies , closely associated with technological
  developments , will form the basis of this research .
- The continuation and development of the concerted action on detection of
  thrombosis and prevention of its resulting disabi lities are expected to
  lead to a better understanding of the pathogenesis of thrombosis as well
  as to the availability of adequate tests which will aid in the prevention .
                          i
  early diagnosis and treatment of the disease .
- Evaluation and identification of specific needs as regards aids for disa-
  b led will be undertaken to define coordinated activities leading to techni­
  cal , developments .
- The pattern    of care for the chronic or long term patient with several
  functional disabilities , and for the impaired elderly will be examined
  in a study on care delivery systems . Relevant epidemiological aspects will
  be taken into account .
 ---pagebreak---                                       - 14 -
 Area   3   :  Breakdgwn_in_ada[3tat ion
- The determination of measurable parameters which could indicate first
   a posteriori but also a priori the tendency or initiation of breakdown
   in adaptation or the form it may take if no counter-measure is introduced ,
   forms this complex mult idi sciplinary programme . It is envisaged to
   developed it into parallel projects strictly coordinated between them­
   selves .   Particular attention will be given to high risk groups in the
    working population .
- Studies on quantification of parameters aim at the simultaneous evaluation
   of already measurable hormonal parameters as well as psychological and
   sociological ones . The improvement and standardization of methods for mea­
   suring possible biological markers of the adaptive process are part of
   these studies . The interaction of various disciplines closely associated
   with studies in the following projects form the basis of the whole
   area .
- Coordination of the ongoing uncorrelated efforts in several Member States
   to investigate the performance decrement of workers under various envi­
   ronmental conditions so as to avoid accident proneness is envisaged ,
   using the multidisciplinary approach mentioned above .
- Application of the same multidisciplinary approach to the field of cardio­
   vascular diseases with particular reference to hypertension and ischaemic
   heart diseases is here envisaged . Studies will be integrated with results
   from other projects and involve the evaluation of psychosocial and neuro­
   endocrine factors in selected groups of subclinical and clinically esta­
   blished patients combined with appropriate monitoring of the relevant
   physiological variables .
- The model indicated above will be applied to correlate gastro-intestinal
   di seases with the results of psychobiologi cal and psychosocial measure­
   ments . Subjects with borderline gastro-intestinal complaints and esta­
   blished cases will be studied .
- A further particular study of increasing importance for health and safety
  at work is envisaged in order to assess the relevant problems of drug abuse .
   Effects of alcohol abuse as well as the mechanisms involved in the proneness
  to it , of tobacco or products associated with its consumption , as well as of
  potential opiate intake on the central nervous system and the general meta­
  bolism, will be examined in biological and epidemiological studies .
 ---pagebreak---                              II . HEALTH RESOURCES
This subprogramme comprises 3 main areas of research : the 1st one aims at
assessing health services research concerned with the development of health
services particularly in relation to changes in social , demographic , envi­
ronmental and occupational conditions . Correct and problem-oriented development
of health technologies including the transfer of new knowledge and methods from
basic hard and soft sciences into medical technologies , as well as the assess­
ment and testing of medical equipment form the 2nd area in this subprogramme .
Important impacts on the European biomedical industries can be foreseen .
The 3rd area deals with qualitative improvement of medical research scientists
in fields in which knowledge and technology are progressing rapidly and where
highly skilled researchers are critically needed .
Area _ 1  :  He ait h_sery2çes_research
Health services research has to develop generally acceptable scientific methods
to investigate efficiency of different health systems , effectiveness of various
medical procedures and technologies , and to analyse problems of planning , orga­
nization , management , evaluation and acceptability of health services in their
relationship to social and environmental circumstances , in order to ensure opti­
mal health of the working population in a cost-efficient way .
Variations in organization and structure of health services research in the
Member States as well as special research requirements and difficulties entail
a still poor development of research in this area .
The proposed research therefore aims , in a first phase , at the development on
Community scale of a common methodology including strategies for comparative
evaluation studies which involve evaluation of process ( efficiency ) and assess­
ment of outcomes versus the originally stated objectives ( effectiveness ).
In a second phase , four interrelated topics are selected for elaboration :
- Coordination of health services research      :  following evaluation of the
  present state of the art of health services research in the Member States ,
  of its problems and of its organisation and structure , this topic will aim
  at the coordination of ongoing national efforts in order to develop at
  Community level an efficient research in this area .
- Assessment of health status     :  the development of health indicators is a
  basic tool in occupational health , in determining the need for early care
  in specific population groups and in identifying risk factors .
 ---pagebreak---                                        - 16 -
- Research on prevention    :  the change in emphasis from medication to health
  promotion has increased the demand for further knowledge about health risk
  factors , influence of the working environment on health , as well as the use
  of medical services , sick leave , accidents at work and drug consumption ;
  relevant national activities will be assessed in order to elaborate a con­
  certed approach .
- Community versus hospital care      : this research topic aims at assessing the
  feasibility and potential importance of community care to the population in
  its home and occupational environment , in comparison with hospitalization
  and by considering in particular technological progress in monitoring and
  drug delivery , as well as development of new drugs .
Area   2   : Health Technology
- A continuation and development of the ongoing concerted action on extracor­
  poreal oxygenation will consider advanced technological developments for
  the replacement of body functions . Developments foresee further research on
  oxygenator design and performance as well as parallel studies into alterna­
  tive methods of oxygenation including enzyme binding to membrane and re­
  search on biomaterials .
- The concerted action on common standards in electrocardiography will be con­
  tinued in a broader context of quantitative functional assessment to include
  the standardization and improvement of diagnostic criteria . The same approach
  will be used for computerized analysis of other diagnostic functional para­
  meters .
- The monitoring of developments in the field of imaging techniques , both
  in vivo and in vitro is of great interest and will be carried out in a spe­
  cific project . Pilot studies to define common multipurpose packages for
  image elaboration may be initiated .
- Criteria for better exploitation of the possibility of ambulatory monitoring
  of physiological variables of great diagnostic importance will be defined .
  Its application to rehabilitation , therapeutic needs , drug use and occupa­
  tional health will be examined .
- The development of clinical and technical evaluation of new medical devices
  and procedures , including cost / eff i ciency aspects i s the scope of this action .
  It will include a comparative evaluation of medical equipment in technical
  and user trials undertaken by a panel of clinicians , scientists from the par­
  ticipating centers in liaison with health authorities .
 ---pagebreak---                                     - 17 -
Area   3   :
This area shall deal with methodological research on ways and means for pro­
viding industry as well as public and private institutes with highly qualified
research scientists in need-areas such as toxicology , occupational health ,
advanced health technology , 'clinical investigation , health services management
and epidemiology .
The projects aim first at the evaluation of present and future needs , confron­
tation of national measures taken , identification of suitable upgrading faci­
lities , and subsequently at the development of coordinated procedures . Assess­
ment of their efficiency through test cases in toxicology , advanced health
technology and clinical investigation is envisaged .
                     III . PERSONAL ENVIRONMENT    ( Diet and Drugs )
A nutritional research programme will aim at ascertaining the diet component
involved in the occurrence of diseases such as arterial hypertension and di­
gestive tract diseases . It incorporates development and implementation of
specific methodologies for the study of food and the detection of individual
predisposition to the relevant diseases . Research based on multicenter studies
will aim at assessing by post-marketing clinical trials of adequate scale the
efficacy of specific drugs as well as at developing a drug surveillance project .
Area _ 1   : Nutrjtjon
- The importance of dietary factors in the promotion of hypertension will be
   investigated to identify adequate measures of preventing their effects .
  This project includes biological and epidemiological aspects so as to de­
  fine the prevalence in each Member State . and the environmental causes of
  the disease . These studies will have a relevant impact on the European
  food industry at production and marketing level .
Area   2   : Pharmaceuticals
Adequate post-marketing drug surveillance and multicenter controlled clinical
trials require studies on very large populations for the short - and long-time
evaluation of both new and old pharmaceuticals . Ongoing activities in the
Member States are scattered , unrelated to each other and therefore of minor
effectiveness . By regrouping and coordination , thus by making better and more
 ---pagebreak---                                        - 18 -
effective use of existing and potential resources , joint medical research con­
ducted at Community level would give a greater and more consistent support
to the pharmaceutical industry , contribute to drug development , and ensure a
quicker warning system .
- It is proposed to stimulate and coordinate post-marketing clinical trials
  to test the efficacy or some specific effects of pharmaceuticals . Such
  controlled trials of adequate scale aim at appropriate collection , storage
  and dissemination of information on new developments and on the efficacy
  of old and new drugs .
- In order to improve existing mechanisms for identifying adverse effects
  of drugs which because of low incidence or late occurrence have escaped
  premarketing testing , it is proposed to develop a post-marketing drug
  survei I lance oroject . It would promote exchange and early dissemination
  of information and would attempt to supplement existing methods by dif­
  ferent approaches i.e. case control surveillance and record linkage drug
  surveillance .
 ---pagebreak---                                      - 19 -
E. PROGRAMME IMPLEMENTATION
   The basis for optimal implementation of the proposed R&D programme is
   the sharing of its inherent responsibilities between the Member States
   and the Commission :
   - The Member States endeavour to carry out , according to the rules and proce-
      cedures applicable to their national programmes , the execution of the
      research as described in the foregoing chapter D , and are prepared to
      integrate such research into a process of coordination at Community
      level over the programme period .
   - The Commission is responsible for such coordination of the national con­
      tributions to the programme as well as for the management of the Community
      budget allocated to it ( see chapter G ) .
   Implementation is carried out as a concerted action programme relating to
   well defined research fields chosen for European collaboration , and in­
   cluding the actions of the 1st and 2nd medical programme .
   The national contributions to this programme and their coordination at na­
   tional level , as well as the selection of national experts for their scien­
   tific management , will be part of the responsibilities of the concerned
   authorities in the Member States . These authorities are indicated in
   Appendix 3 of the proposed Council Decision .
   An active participation of all Member States in each single project is not
   mandatory e.g. in the case of absence of a national programme in a parti-
                        ι
   cular research line .
   Following the Council Decision , third countries involved in European co­
   operation in the field of Scientific and Technical Research ( COST ) will
   be invited to participate to all or parts of this programme .
   A reexamination of the programme is foreseen at the end of the third year
   which may lead to a revision in the course of the fourth year as well as
   in the preparation of a proposal for a possible new programme intended
   to constitute a follow-up to the present one .
 ---pagebreak---                                     - 20 -
F. OPERATIONAL AND MANAGEMENT STRUCTURE
   An adequate operational and management structure is indispensable in order
   to   :
   - ensure maximum efficacy in both programme implementation and coordination ,
   - meet the requests stressed by the Council in its Resolution of 1974 and
      its Conclusions of 1979 ,
   - achieve the objectives of this programme ( given in chapter C.1 .),
   - maximize economy and profits of the allocated budget while ensuring all
      the specific requests to achieve the research goals of the programme
      ( see page 6 ) .
   The rationalization of structures and the simplification of procedures
   aimed at in the present attempt of grouping R&D actions in the sector
   of medical and public health research , should also allow a greater flexi­
   bility in programme implementation and management .
        Three subprogrammes are forming the overall R S D programme ; their ope­
        rational structure is shown in the following Tables I - III .
        Each subprogramme is divided into 3 research areas which group scienti­
        fically related projects .
        Some projects will of course have to go through an organizational pre­
        paratory phase before active coordination can start .
        The following steps will have to be taken for each project :
       - the setting up of its own operational structure including a technical
          steering committee ,
        - the identification of the contributing national institutes ,
        - the appointment of a project leader , and
        - the conclusions of contracts making available the funds needed for
          coordination purposes .
 ---pagebreak---                                    - 21 -
                                                           TABLE I
                    SUBPROGRAMME   I   :  HEALIH_Ç|OBU|MS
                        Research Areas and Projects
Area 1.1 . Pre-, peri -, and postnatal care
           Project    1.1.1 . Perinatal Monitoring
                      1.1.2 . Chromosome Analysis
                      1.1.3 . Inborn Metabolic Errors
                      1.1.4 . Congenital Anomalies
                      1.1.5 . Care Delivery Systems
Area 1.2 . Ageing , Disabled and Handicapped
           Project    1.2.1 . Cellular Ageing and Diseases
                      1.2.2 . Sensonal Impairment
                      1.2.3 . Thrombosis and Disabilities
                      1.2.4 . Aids to the Disabled
                      1.2.5 . Care Delivery Systems
Area 1.3 . Breakdown in Adaptation
           Project    1.3.1 . Quantification of Parameters
                      1.3.2 . Performance Decrement
                      1.3.3 . Cardiovascular Diseases
                      1.3.4 . Gastro-intestinal Diseases
                      1.3.5 . Drug Abuse
 ---pagebreak---                                          - 22 -
                                                                      TABLE II
                    SUBPROGRAMME        II   :  H|^XH_|||Qy|£ES
                           Research Areas and Projects
Area II . 1 . Health Services        Research
              Project   II.1.1 .       Coordination of Health Services Research
                        11 . 1.2 .    Health Status Assessment
                        11 . 1.3 .     Research on Prevention
                        11 . 1.4 .    Community vs. Hospital Care
Area II . 2 . Health Technology
              Project   II . 2.1 .    Replacement of Body Functions
                                      and Biomaterial Research
                        11 . 2 . 2 .  Quantitative Functional Assessment
                        11 . 2 . 3 .  Imaging Techniques
                        11 . 2 . 4 .  Ambulatory Monitoring
                        11 . 2 . 5 .  Clinical and Technical Evaluation
Area II . 3 . Human Resources
              Project   II . 3.1 .    Upgrading in Toxicology
                        II . 3 . 2 .                Health Service Management
                        II . 3 . 3 .             "  Occupational Health
                        II . 3 . 4 .                Advanced Technology
                        II . 3 . 5 .                Epidemiology
                        II . 3 . 6 .       "     "  Clini cal Investigation
 ---pagebreak---                                           - 23 -
                                                                  TABLE III
                  SUBPROGRAMME        III   :  E|ESQ^L_|^IRQ^|^I
                               •               ( Diet and Drugs )
                         Research Areas and Projects
Area III . 1 . Nutrition
               Project III.1.1 .       Diet , Hypertension and
                                       Digestive Tract Diseases
Area III . 2 . Pharmaceuticals
               Project III . 2.1 .     Clinical Trials
                        III . 2 . 2 .  Drug Surveillance
 ---pagebreak--- On the basis of the experience gained from the ongoing concerted actions
and following a critical examination of the most rational management
structure for the optimal implementation of this multidisciplinary R&D
programme , the Commission , in agreement with CRM , proposes the setting
up of the following Committees :
a ) One " General Concerted Action Commi ttee ", hereinafter referred to as
    the " General Committee ", ensures the best possible implementation of
    the overall programme . For this purpose it is composed of representa­
    tives of the Member States responsible for science and technology in
    the field of medical and public health research .
    At national level , its representatives take care of the integration
    of those parts of their research activities , which correspond with
    this programme , into a process of coordination at Community level ,
    while the Commission ensures the coordination of the national contri­
    butions to the programme .
    The General Comrmttee    :
    - advices the Commission on the allocation of Community funds needed
       for : coordinating purposes , supporting centralized facilities ,
      meeting urgent needs in critical areas , and undertaking exploratory
      activities in view of the preparation of future programmes ;
    - coordinates within the programme the activation , duration and possibly
      early termination of the projects forming the research areas of this
       programme , on advise of the respective COMAC 's ( see under b ) assisting
       it in its scientific-technical management tasks , and according to
       emerging needs or results of periodical evaluations ;
    - indicates guidelines to the COMAC 's .
b ) Four " Concerted Action Committees ", hereinafter referred to as " COMAC 's *
    ensure the scientific-technical management of those projects entrusted
    to each COMAC , in conformity with its respective competence , by the
    General Committee .
 ---pagebreak---                              - 25 -
    For this function , each COMAC is oriented towards one of the following
    research domains  :
    1.  Epidemiology , statistics and clinical trials .
    2.  Bioengineering , technology evaluation , transfer and standar­
        dization .
    3.  Applied biology , physiology and biochemistry .
    4.  Health services research .
Its members will be chosen among national experts in such a way that
all appropriate competences needed are made available by complementing
one another ; they will be appointed by their responsible national
authorities .
Each COMAC , in particular :
- evaluates the results of the projects entrusted to it , draws conclu­
  sions as regards their application and reports its opinions and re­
  commendations to the General Committee ;
- keeps abreast of ongoing relevant research and technical development
  likely to affect the execution of the projects ;
- suggests guidelines to the project leaders .
 ---pagebreak---                                         - 26 -
G. WAYS AND MEANS
   1 . Research funding
       The financial volume of the national research contributions to this
       research and development programme is estimated at 300 mi I lion ECU
       over the programme period , which corresponds to about 12% of the
       aggregate funding of medical and public health research in the Member
                (*)
       States
   2 . Coordination costs
       The cost of coordination , charged to the Community budget , is estima­
       ted at 20 mi I lion ECU for the duration of the programme .
       These costs include administrative and technical expenditures , and ex­
       penditure for staff subdivided as follows :
       a)   Administration                   1.40   million ECU
       b)   Technical    ( contracts )      15.30      "
       c)   Staff                            3.30
                                            20.00
       a ) Administrative expenditures are used mainly for organizing the meetings
           of the 5 Concerted Action Committees , as well as for convocation of
           experts , publication , missions , etc .
       b ) Technical expenditures are spent :
           - for ' cont racts with project leaders in order to ensure scientific
              coordination ( organization of meetings of technical steering
              committee and of workshops , exchange of personnel , dissemination
              of information , administrative help , etc .).
   (*)    Doc . CREST No 1245 / 79
 ---pagebreak---                                 - 27 -
   - for support needed by centralized facilities , whenever its proper
     functioning requires substantial and / or additional funding , such
     as : need of computer including programming/ production and exchange
     of costly material , breeding or maintenance of certain animals ,
     data evaluation of clinical trials , preparation of reference soft­
     ware , etc .
   - for support of national experts in order to perform exploratory
     activities by means of studies , workshops or seminars needed
     either to complement ongoing actions or to prepare new ones .
   - for support of national or private institutes in order to make
     possible a rapid intervention in the case of an unexpected but
     urgent need of recognized importance .
   Their distributions among the subprogrammes are as follows :
                   Subprogramme   I    :  41 - 49 %
                                 II    :  36 - 44 %
                                111    :  13 - 17 %
c) Staff expenditures
   Staff requested for executing the coordination of the programme at
   Community level is 10 officials , i.e. 6 additional staff .
   At present , 4 officials (2 A and 2 C ) are allocated to the 2nd Medical
   research programme .
   The 6 additional staff (3 A , 1 B and 2 C ) are requested in view of
   the competence necessary to cope with the new research areas pro­
   posed , to ensure the secretariats of the General Committee and its
   four COMAC 's , and to carry out the coordination tasks .
 ---pagebreak---                                     ANNEX   I
                        Proposal for a Council Decision
       adopting a sectoral research and development programme of the European
       Economic Community in the field of medical and public health research
                                - concerted action -
                                    ( 1982 - 1986 )
THE COUNCIL OF THE EUROPEAN COMMUNITIES ,
Having regard to the Treaty establishing the European Economic Community ,
and in particular Article 235 thereof .
Having regard to the proposal from the Commission ,
Having regard to the opinion of the European Parliament ,
Having regard to the opinion of the Economic and Social Committee ,
Whereas,pursuant to Article 2 of the Treaty , the Community has been assigned
the task of promoting throughout the Community a harmonious development of
economic activities , a continuous and balanced expansion and an accelerated
raising of the standard of living ;
Whereas by Decision 78/ 167/ EEC ,^ amended by Decision 81 / 21 / EEC
and Decisions 78/ 168/ EEC^and 78/ 169 / EEC ^ , the Council has adopted three
concerted projects as a first research programme in the field of medical and
public health research ;
Whereas by Decision 80/344 / EEC ^ the Council has adopted a second research
programme in the field of medical and public health research , consisting of
four multiannual concerted projects ;
(1 )  OJ No L 52 , 23.2.1978 , p. 20 .
(2)   OJ No L 43 , 13.2.1981 , p. 12 .
(3)   OJ No L 52 , 23.2.1978 , p. 24 .
(4)   OJ No L 52 , 23.2.1978 , p. 28 .
(5)   OJ No L 78 , 25.3.1980 , p. 24 .
 ---pagebreak---                                       - 2 -
Whereas in its resolution of 14 January 1974 on an initial outline programme
of the European Communities in the field of science and technology ^ the
Council stressed that an appropriate approach should be adopted towards the
whole range of available ways and means , including concerted action / and
that whenever it proves necessary or desirable that non-Member States , par­
ticularly European ones , should be associated in these projects , steps should
be taken to make this possible ;
Whereas , in its resolution of 14 January 1974 ^ relating in particular to
the coordination of national policies in the field of science and technology ,
the Council entrusted the Community institutions with the task of gradually
ensuring such coordination , aided by the Scientific and Technical Research
Committee ( CREST );
Whereas the sectoral R&D programme dealt with by this Decision appears ne­
cessary to attain in the course of the operation of the common market the
objectives of the Community as regards the harmonious development of economic
activities , a continuous and balanced expansion and an accelerated raising
of the standard of living , account being taken in particular of potential
economic and industrial development within the fields covered by the research
areas ;
Whereas the Treaty does not provided the specific powers of action required
for these ends ;
Whereas the Member States intend , in accordance with the rules and procedures appli
cable to their national programmes , to carry out the research indicated in
Annex 1 , and are prepared to integrate such research into a process of co­
ordination at Community level until 31 December 1986 ;
Whereas the cost of such research , as indicated in the aforesaid Annex 1 , per­
formed in the Member States is evaluated at about 300 million ECU ;
( 6)   OJ No C 7 , 29.1.1974 , p. 6
( 7 ). OJ No C 7 , 29.1 . 1974 , p. 2
 ---pagebreak---                                         - 3 -
Whereas in its conclusions of 20 December 1979 , the Council invited the
Commission to submit proposals    aimed at the rationalization of structures
for the preparation , examination and implementation of Community research
and development programmes ; whereas a grouping of concerted actions in the
field of medical and public health research would constitute a first con­
tribution towards meeting these objectives ;
Whereas the Community is empowered to conclude Agreements with non-Member
States in the fields covered by this Decision ; whereas it may prove advi­
sable to associate the non-Member States participating in European Coope­
ration in the field of Scientific and Technical Research ( COST ) wholly or
partly with the programme covered by this Decision , in accordance with the
conclusions approved by the Council on 18 July 1978 in connection with
such cooperation ; whereas , on the one hand , procedural conditions should
be determined so as to lead to a rapid conclusion of such Agreements , and
on the other hand , negotiations should be opened with the non-Member States ,
as soon as this Decision is adopted ;
Whereas the Council has concluded such Agreement between the EEC and the
                                                (8)
Swiss Confederation on a concerted project          ;
Whereas the Scientific and Technical Research Committee ( CREST ) has given
its opinion on the Commission proposal ;
HAS DECIDED AS FOLLOWS    :
                                   Article    1
A concerted research and development programme of the European Economic
Community in the field of medical and public health research is hereby
adopted for a period of five years commencing on 1 January 1982 .
(8)  0J  No L 113 , 25.4.1981 , p. 44 .
 ---pagebreak---                                      - L -
The programme shall consist in coordination at Community level , wi thin the
 research areas described in Annex 1 , of those activities which form part of
the research programmes of the Member States .
                                   Article  2
                                i
The Commission shall be responsible for such coordination .
                                   Article  3
The appropriations necessary to finance the Community contribution to the
coordination , the amount of which is estimated at 20 million ECU , including
the expenditure relating to a staff of ten officials , shall be entered in
the budget of the European Communities . These figures are given merely by
way of indication .
The indicative internal distribution of funds is shown in Annex 2 .
In the light of experience gained during the implementation of the programme ,
and provided the opinion of the Scientific and Technical Research Committee
( CREST ) and of the committee referred to in Article 5 a ) is secured beforehand ,
the Commission is authorized to transfer funds from one to another subpro-
gramme , provided that such transfers do not result in an increase or a re­
duction of more than 10 % in the original appropriation for each subprogramme
envi saged .
                                   Article  4
The programme shall be reexamined at the end of the third year ; this reexami-
nation may lead to a revision of the programme in the course of the fourth
year following the appropriate procedures , and after the Committee referred
to in Article 5 a ) has- been consulted . The European Parliament shall be in­
formed of the results of the reexamination .
                                   Article  5
To facilitate the execution of the programme ,
a)   one General Concerted Action Committee , hereinafter referred to as the
     General Committee , and
 ---pagebreak---                                        - 5 -
b)    four Concerted Action Committees assisting the General Committee in its
     management tasks /
shall be established .
The terms of reference and the composition of these Committees are defined
in Annex 3 .
The Commission shall be assisted in its coordinating action by project leaders
appointed by the Commission , after having consulted the General Committee .
 Each Committee shall draw up its rules of internal procedure . Its secretariat
 ? hall be provided by the Commission .
Implementation and coordination of the national contribution to the programme
shall be carried out by the bodies listed in Annex A.
                                  Article 6
In accordance with a procedure to be laid down by the Commission after having con­
sulted the General Committee referred to in Article 5 a ), the participating
Member States and the Commission shall regularly exchange all useful informa­
tion concerning the execution of the research covered by such activities .
The participating Member States shall provide the Commission with all infor­
mation relevant for coordination purposes .      They shall also endeavour to pro­
vide the Commission with information on similar research planned or carried
out by bodies which are not under their authority . Any information shall be
treated as confidential if so requested by the Member State which provides it .
At the completion of the programme , the Commission , in agreement with the
General Committee , shall send to the Member States and the European Parliament
a summary report on the implementation and results of the programme particu­
larly so that the results obtained may be accessible as completely and rapidly
as possible to the enterprises , institutions and other parties particularly
concerned at the social level . The Commission shall publish this report six
months after the latter has been sent to the Member States , unless a Member
State objects . In the latter case , the report shall be distributed only to
those institutions and enterprises that request it and whose research or pro­
duction activities justify access to the results of research arising from the
programme . The Commission shall make the necessary arrangements for the report
to remain confidential and not to be divulged to third parties .
 ---pagebreak---                                     Article  7
1 . In accordance with Article 228 of the Treaty , the Community may conclude
Agreements with the non-Member States participating in European Cooperation
in the field of Scientific and Technical Research ( COST ) with a view to asso­
ciating them wholly or partly with this programme .
2 . The Commission is hereby authorized to negotiate the Agreements referred
to in paragraph 1 .
                                    Article  8
Decision 80 / 344 / EEC is hereby repealed with effect on 1 January 1982 .
                                         Done at
                                         For the Council
                                         The President
 ---pagebreak---                                                                      Annex    1
                         SCIENTIFIC AND TECHNICAL CONTENT
                           ( Concerted Action Programme )
The aim of this concerted European collaboration in the sector of medical and
public health research is :
- to increase the efficiency of relevant R&D efforts in the Member States
    through the mobilization of the available research potential of parts of
    national programmes and its gradual coordination at Community level ;
- to improve the scientific and technical knowledge in the R&D areas ,
    selected for their importance to all Member States taking a particular
    account of potential economic and industrial development within the
    projects forming them , and
- to provide for the continuation of the 3 concerted projects of the first
    medical research programme ( 1978-1981 ), the integration of the*4 ones of
    the second programme ( 1980-1984 ) as well as for new projects of common
    i nterest .
                         SUB-PROGRAMME     I :   HEALTH PROBLEMS
 Research area       1 :  Pre-^jDeri - and gostnatal care
•>- Continuation of the ongoing project relating to perinatal monitoring           ,
    with emphasis on technological development and assessment of devices and
    procedures for non-invasive monitoring , and extension to prevention of
    mother 's distress and risk as well as of foetal loss .
- Improvement of techniques needed for ( partially ) automated chromosome analysis
    as well as biochemical and genetical studies to increase possibilities of its
    appli cation .
- Screening of inborn metabolic diseases , including cystic fibrosis , hemo­
    globinopathies and hyperlipoproteinaemia , by        standardization or improvement
    of existing methodologies and developing new ones , as well as studies on early
    detection and treatment .
- Continuation of the project relating to the registration of congenital abnor­
    malities ^ with extension to improvement of intrauterine diagnosis and studii
    on early foetal loss , death in early childhood and foetal growth disturbances .
 (1 )   for programme description see :      O.J. NP L 78 , 25.3.80, p. 24 .
 (2)     "         "          "       "  :   O.J. No . L 52 , 23.2.78 , p . 20 .
 ---pagebreak---                                                 - 8 -
  - Examination of current practices regarding care delivery systems , and in
     particular the application of technical devices and procedures to perinatal
     medicine , including cost / ef fectiveness evaluations .
  Research area      2    :  A2gin2z_ Di sabled_and_Handi cagged
                                       »
                                                                   \   (2)
  - Continuation of the project relating to cellular ageing                  with extension
     of its immunological subproject to the understanding of arthritic diseases
     and of its subproject concerning organs to studies of the brain and senile
     dementia .
                                                                           (1 )
  - Continuation of the project relating to hearing impairment                  and of the
                                                                                       (2)
     subproject on ageing of the crystalline lens of the foregoing project                 ;
     development of adequate aids for visual and auditory sensorial impairment
     including biomaterial compatibility studies .
  - Continuation of the ongoing project relating to the detection of tendency
                       (1 )
     to thrombosis          with extension to population studies following development
     of suitable methodology .
  - Evaluation of selected aids for the disabled , identification of specific
     needs and their technological development .
  - Examination of care pattern for the chronic patient with several functional
     disabilities and for the impaired elderly including epidemiological aspects .
  ^ Ë2ÊËI£!ü_êEÊË    ^    :  Breakdown in_adagtat ion
> - Evaluation , improvement , standardization and / or development of quantitative
     measurements of hormonal , psychological and sociological parameters involved
     in the adaptive process .
  - Investigation of performance decrement in workers under various environmental
     conditions using the above mentioned methodology .
  - Comparative studies , through monitoring the relevant physiological variables ,
     in selected groups suffering from cardiovascular symptoms with particular re­
     ference to hypertension and ischaemic heart diseases .
  - Comparative studies , through determination of the relevant psychobiologi cal and
     psychosocial parameters , in selected groups suffering from gastro-intestinal
     di seases .
  (1)    for programme description see :          O.J. No L 78 , 25.3.80 , p. 24 .
   (2)    "        "             "        "   :   O.J. No L 52 , 23.2.78 , p . 24 .
 ---pagebreak---                                         - 9 -
- Biological and epidemiological studies in workers on the effects of alcohol
   abuse and the mechanisms involved in the proneness to it , of tobacco or pro­
   ducts associated with its consumption , as well as of potential opiate intake
   on the central nervous system and the general metabolism .
                         SUB-PROGRAMME    II   :   HEALTH RESOURCES
                    1 •:   HeaL^th_services_research
- Assessment of the present state of the art of health services research in
   the Member States following development of a common methodology for compa­
   rative evaluation , and elaboration of joint projects .
- Development of health indicators and subsequent assessment of the health
   status of the working population        in the Community .
- Studies of health risk factors , influence of the working environment on
   health , as well as the use of medical services , sick leave , accidents at
   work and drug consumption ; evaluation of relevant national activities and
   elaboration of a concerted approach towards prevention .
- Assessment of the feasibility , by considering in particular relevant techno­
   logical progress , and potential importance of community care to the popula­
   tion in its home and occupational environment , in comparison with hospita­
    lization .
B£searçh_area     2   :   Healt h_Teçhno_log ^
                     .....                                                  .   (2)
- Continuation of the project relating to extracorporeal oxygenation                with
   extension to advanced technological developments for the replacement of
   further body functions including research on biomaterials .
- Continuation of the ongoing project relating to common standards in quanti-
                                    1 )
   tative electrocardiography           with extension to standardization and im­
   provement of diagnostic criteria ; the same approach will be used for com­
   puterized analysis of other diagnostic functional parameters .
- In vivo et in vitro development of imaging techniques following pilot studies
   to define common multipurpose packages for application .
- Development of devices and procedures for ambulatory monitoring of physiolo­
   gical variables of great diagnostic importance to rehabilitation , therapeutic
   needs , drug use and occupational health .
(1 )    for programme description see :        O.J. No L 78 , 25.3.80 , p. 24
(2)     for programme description see :        O.J. No L 52 , 23.2.78 , p. 28 .
 ---pagebreak---                                      - 10 -
- Clinical and technical evaluation of new medical devices and procedures ,
  including cost / efficiency aspects , through coordination of existing faci­
  lities for both comparative technical testing and user trials , considering
  in particular : ultrasonic tissue characterization , accelerated bone frac­
  ture healing , blood flow measurements , automated cell identification and
                                t
  medical telemetry .
Research area _3    :
- Methodological research on ways and means for providing industry as well
  as public and private institutes with highly qualified research scientists
  in need-areas such as toxicology , occupational health , advanced health
  technology , clinical investigation , health services management and epide­
  miology .
- Evaluation of present and future needs , confrontation of national measures
  taken and identification of suitable upgrading facilities ; subsequently
  development of coordinated procedures and assessment of their efficiency
  through test cases in toxicology , advanced health technology and clinical
  investigation .
                       SUB-PROGRAMME  III   : PERSONAL ENVIRONMENT
                                              ( Diet and Drugs )
Research area   1   :   Nutrition
- Development and improvement of specific methodologies for the study of
  food and the detection of individual predisposition to arterial hyperten­
  sion and digestive tiract diseases ; biological and / or epidemiological
  studies on their prevalence and on the environmental factors involved , as
  well as on preventive measures .
                2   :   Pharmaceuticals
- Controlled post-marketing clinical trials of large scale through mobilisa­
  tion and coordination of existing facilities ; appropriate collection , sto­
  rage and dissemination of information on the efficacy or some specific
  effects of selected old and new pharmaceuticals .
 ---pagebreak---                                        - 11 -
- Development of a post-marketing drug surveillance project of large scale
  through the coordination of existing facilities in the Member States ;
  collection , storage and early dissemination of information on adverse
  drug effects of low incidence or late occurrence , including case control
  surveillance and record linkage drug surveillance .
                                                           Annex  2
                 INDICATIVE INTERNAL DISTRIBUTION OF FUNDS
                              ( 1982 - 1986 )
     Subprogramme        I                    45 %
     Subprogramme       II                    40 %
     Subprograrnme     III                    15 %
 ---pagebreak---                                                               Annex  3
Implementation and coordination of the nat ional contributions to the programme
The following authorities of the participating Member States will endeavour to
ensure the implementation of the national contributions to the research areas
of the three subprogrammes indicated in Annex 1 , as well as their coordination
at national  level  :
Belgi um                FRSM - Fonds de la recherche scientifique médicale ,
                        Bruxel les
                        FGW0 - Fonds voor Geneeskundig Wetenschappelijk
                        Onderzoek , Brussel
Denmark                 Statens Laegevidenskabelige Forskningsrad , København
France                  INSERM - Institut national de la santé et de la
                        recherche médicale , Paris
Germany                 Bundesminister für Forschung und Technologie , Bonn
                        Bundesminister für Jugend , Familie und Gesundheit ,
                        Bonn
                        Bundesminister für Arbeit und Sozialordnung , Bonn
Greece                  Ipiresia Epistimoni kis Erevnis ke Techno loghias ,
                        Athens
                        Simvoulion Iatrikon Erevnon , Athens
Ireland                 Medical Research Council of Ireland , Dublin
                        Medico-Social Research Board , Dublin
Italy                   CNR - Consiglio nazionale della ricerca , Roma and
                        Istituto superiore di sanità , Roma
Luxembourg              Ministère de la santé , Luxembourg
Netherlands             Hoofdgroep Gezondheidsonderzoek TNO , Den Haag
United Kingdom          MRC - Medical Research Council , London and
                        DHSS - Department of Health and Social Security ,
                        London
 ---pagebreak---                                           - 13 -
                                                                   Annex  4
. TERMS OF REFERENCE AND COMPOSITION OF THE COMMITTEE
   I . General    Concerted Action Committee
   1 . The General Committee shall    :
        - contribute to the best possible implementation of the programme by
          giving its opinion to all of its aspects ;
        - endeavour to integrate those parts of national research activities
          covered by this programme into a process of coordination at Community
          level ;
        - within the programme as defined in Annex 1 of the present Decision ,
          coordinate the activation , duration and possibly early termination of
          the projects forming the research areas of this programme , according
          to emerging needs or results of periodical evaluations ;
        - indicate guidelines to the Concerted Action Committees ;
        - advise the Commission on the allocation of funds for coordination
          purposes , supporting centralized facilities , meeting urgent needs
          in critical areas , and undertaking eploratory activities in view
          of the preparation of future programmes .
   2 . The General Committee 's reports and opinions shall be forwarded to the
        Commission and to the Member States participating in the programme *
        The Commission shall forward these opinions to CREST .
   3' . The General Committee shall be composed of representatives of the Member
        States responsible for science and technology in the field of medical and
        public health research and , in particular , for coordinating the national
        contributions to the programme .
 II . Concerted Action Committee
 1 .    Each Committee shall     :
        - assist the General Committee in its management tasks by ensuring the
          scientific and technical execution of all those projects allocated to
          it in accordance with its competence ;
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    - evaluate the results and draw conclusions as regards their application ;
    - be responsible for the exchange of information referred to in the first
      paragraph of article 6 ;
    - keep abreast of national research being done in the field of the projects ,
      and more especially of sc-ientific and technical development likely to
      affect their execution ;
    - suggest guidelines to the project leaders .
2 . The Committee 's reports and opinions shall be forwarded to the General
    Committee and to the Commission .
3 . The Committee shall be composed of experts nominated by the competent
    authorities of the Member States and the project leaders .
 ---pagebreak---                                                                 ANNEX II
                              FINANCIAL RECORD
1 . RELEVANT BUDGET HEADING
2 . TITLE OF THE BUDGETARY HEADING : Sectoral R&D programme in "the field
    of Medical and Public Health Research - Concerted Action
3 . LEGAL BASIS :
    - Implementation of Article 235 of the Treaty establishing the EEC
    - Decision of the Council of
4 . DESCRIPTION . OBJECTIVE AND JUSTIFICATION OF THE PROGRAMME :
4.1 . Description
      The present proposal deals with a new sectoral research and
      development programme of the EEC in the field of medical and
      public health research , to be carried out by means of the
      concerted action method .
      It is subdivided into three subprogrammes :
      - Subprogramme 1 : Health problems
      - Subprogramme 2 : Health resources
      – Subprogramme 3 : Personal environment ( diet and drugs ).
      Each subprogramme is further detailed in research areas grouping
      several projects .
4.2 . Objective
      It aims at increasing the efficiency of the relevant R&D efforts
      in the Member States through the mobilization of the available
      research potential of parts of national programmes and its gradual
      coordination at Community level .
4.3 . Justification
      This proposal constitutes a step towards the sectoral grouping of
      Community research actions in medical and public health research
      and towards the rationalization of structures and procedures for the
      implementation of Community R&D programmes .
      The programme proposal , by presenting a coherent scheme of Community
      concerted research , provides for the continuation of the first medical
      research programme ( 1978 ~ 1981 )     "the integration of the second
      one ( 198O - 1984 ) as well as for new activities in critical areas of
      common interest .
 ---pagebreak---  5 . FINANCIAL IMPLICATIONS IN RESPECT OF INTERVENTION APPROPRIATIONS
     ( including expenditure on staff and administrative and technical
     expenditure )
 5.1 . Total cost for the expected duration:                       320 Mio
                                                                       Mio ECU
                                                                            ECU
 5.2 . Proportion financed from :
        - the Community budget      «
                                                                    20 Mio ECU*
        - national budgets                                         300 Mio ECU
 5.3 . Multi-annual timetable
 5.3.1 . Appropriations for commitment           ( in Mio ECU)
  Type of               1982     1983    1984       1985    1986       TOTAL
   expenditure
   Staff                0.54     0.61    0.66       O . 72  0.77        3.3
   Administration       0.26     0.32    0.26       O . 29  O . 27      1.4
   Contracts            2.0      4.0     5.0        3.3     1.0        15.3
  TOTAL                 2.8      4.93    5.92       4.31    2.04       20.0*
 5.3.2 . Appropriations for payment          ( in Mio ECU)
   Type of              1982     1983    1984       1985    1986       1987     TOTAL
   expenditure
   Staff                0.54     0.61    0.66       O . 72  0.77                 3.3
   Admi ni st rat i on  0.26     0.32    0.26       O . 29  0.27                 1.4
   Contracts            1.0      3.0     4.5        4.2     2.1        0.5      15.3
   TOTAL                1.8      3.93    5.42       5.21    3.14       0.5      20.0*
  5.4 . Method of calculation
  5.4.1 Staff expenditure
         Requirements have been calculated on the basis of a staff complement
         of 10       persons ( including the staff complement of 2 category A
         and 2 category C officials allocated to the 2nd medical research
         programme ), i.e. :
 * Since Decision 80/344/ EEC will be repealed with effect from 1 January 1982 ,
      the amounts which are authorized under the relevant heading in the 1980 and
      1981 budget and which , as at 1 January 1982 , have not yet been committed or
      have been committed but not yet paid may be used for the execution of the
      present programme .
be For 1982 , the staff complement requested in the budget is as follows :
     4 category A , 1 category B , 3 category C.
 ---pagebreak---                                       - 3 -
         - 5 category A officials
         - 1 category B official
         - 4 category C officials .
         Apart from the actual staff complement , the calculations also take
         account of the rates of salary increases of Commission staff used
         to estimate the appropriations entered in the 1982 "budget ; the
         estimated overall increases for subsequent years are "based on the
         rate of change in the general Community price index used in drawing
         up the triennial estimates , i.e. 8,6 % per annum .
5.4*2 . Administrative anchor technical expenditure
         This expenditure specifically oovers the cost of the organization
         of meetings (5 committees of 30 - 40 members meeting 4 times 2 days ),
         convocation of experts and that of missions . It has "been estimated
         on the basis of average requirements .
5.4.3 . Expenditure on_contracts_
         This expenditure covers the financial contribution of the Community
         to the coordination essentially carried out under contracts to be
         concluded with the project leaders ( for organization of : meetings
         of technical steering committee , seminars , workshops , exchange of
         personnel , disseminations of information , scientific and administrative
         help , etc .), with institutes ensuring costly centralized services to
         all Member States ( for computer including programming , production of
         exchange of material , breeding and maintainance of certain animals ,
         data evaluation of clinical trials , preparation of reference soft­
         ware , etc .), with national experts ( for exploratory activities in
         form of studies , etc .) and with national or private institutes
         ( for rapid intervention in the case of an unexpected but urgent
         need etc .).
 6 . FINANCIAL IMPLICATIONS IN RESPECT OF APPROPRIATIONS FOR STAFF AND
     CURRENT ADMINISTRATIVE EXPENDITURE :
     ( see point 5 above )
 7 . FINANCING OF EXPENDITURE
     Appropriations to be entered under future budgets
 8 . IMPLICATIONS IN RESPECT OF REVENUE
     – Community taxes on officials' salaries
     - Officials' contribution to the pension scheme .
 9 . TYPE OF MONITORING TO BE APPLIED
     - Administrative checks by the DG for Financial Control with regard
        to the implementation of the budget and to ensure that the
        expenditure has been incurred in a regular and proper manner
        plus checks carried out by the Contracts Service of DG XII .
     – Scientific checks : General Concerted Action Committee assisted by
                             4 Concerted Action Committees .