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COM(81)517
Vol.1981/0155

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COMMISSION OFTHE EUROPEAN COMMUNITIES
COM(81)517 final .
Brussels -21September 1981
/Filu>M
V .»v*A V
Proposal for aCouncil Decision
adopting asectoral research anddevelopment programme ofthe
European Economic Community inthe field ofmedical andpublic
health research
-concerted action -
(1982 -1986 )
(submitted tothe Council bytheCommission )
C0M(81 )517 final .

-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

-2-
A. SUMMARY
Thepresent proposal deals with anewsectoral research and development
programme (1982 -1986 )ofthe EEC inthefield ofmedical andpublic
health research ,tobecarried out bymeans ofthe concerted action method .
Itaims atincreasing theefficiency ofthe relevant RSDefforts inthe
Member States through themobilization ofthe available research potential
ofparts ofnational programmes anditsgradual coordination atCommunity
level .
Particular attention isdevoted tothe potential economic and industrial
development within the fields covered bythe research actions ofthis
programme ,inconformity with Article 235 ofthe Treaty establishing the
European Economic Community and inaccordance with the objectives and
means ofaction described inArticle 2ofthe Treaty .
This proposal constitutes astep towards the sectoral grouping ofCommunity
research actions inthefield ofmedical and public health research and'
towards the rationalization ofstructures and procedures for the "prepara­
tion ,examination and implementation ofCommunity R&D programmes ".
The programme proposal ,bypresenting acoherent scheme ofCommunity con­
certed research ,provides for the continuation ofthefirst medical research
programme (1978 -1981 )and the integration ofthe second one (1980 -1984 )
aswell asfor new activities incritical areas of common interest .Itis
subdivided into three subprogrammes :
Subprogramme 1 :Health problems
Subprogramme 2 :Health resources
Subprogramme 3 :Personal environment (diet and drugs ).
Each one isfurther detailed inresearch areas grouping several projects .
Overall programme implementation will beensured byone "General Concerted
Action Committee "assisted initstasks byfour "Concerted Action Committees "
with defined scientific-technical competences ,each responsible for the
optimal execution ofseveral projects entrusted toit.

-3-
The Member States intend,accordmg tothe rules and procedures applicable
totheir national programmes ,tocarry out the research work estimated to
involve global financial contributions ofabout 300 million ECU over the
programme period of 5years (1982 -86).
The Commission isresponsible for the coordination ofthe national research
contributions tothe programme atCommunity level .The appropriations ne­
cessary tofinance the Community contribution tosuch coordination are
evaluated tobeinthe order of20million ECU for the duration ofthe pro­
gramme .This figure includes staff expenditures for atotal of10officials
(4ofthem were already allocated tothe 2nd medical research programme ).
Interested non-Member States participating inEuropean Cooperation inthe
field ofScientific and Technical Research (COST )will beinvited toasso­
ciate wholly orpartly with this programme .
Inorder toensure continuity ,the programme isforeseen tostart on
1January 1982 .
 
 *
ι

-4-
B. INTRODUCTION
The Counci LDeci sions of13February 1978 ,adopting three concerted actions
asafirst Community research programme inthefield ofmedical and public
health research ,gave anew dimension tothe task ofthe Commission ,namely
toextend itsefforts of"gradually coordinating national research acti­
vities "toafurther area ofincreasing importance for the Community .
Thefirst programme was followed bythe Council Decision of18March 1980
(4)(80/344/EEC ),adopting asecond medical research programme consisting
offour multiannual concerted actions .
The latter Decision was ofcrucial importance tothe Commission since it
confirmed the option taken bythe Council ,and furthermore settled the
institutional problem ofusing under certain conditions the Article 235
ofthe EEC Treaty for undertaking medical and public health research .
The following concerted actions are presently implemented :
(1,5))1.Registration ofcongenital abnormalities
(2)2.Cellular ageing
3.Extracorporeal oxygenation(3)1st programme
(1.1.1978 -31.12.1981 )
4.Detection oftendency tothrombosis
5.Hearing impairment
6.Perinatal monitoring
7.Quantitative electrocardiography(4)2nd programme
(1.6.1980 -31.5.1984 )
(1) OJ No L52,
(2)0J No L52,
(3) OJ No L52,
(4) OJ No L78,
(5) OJ No L43,23.2.78 ,p.20
23.2.78 ,p.24
23.2.78 ,p.28
25.3.80 ,p.24
14.2.81 ,p.12

-5-
Theconcertedactionmethodforinitiating Communityactivities inthe
medicalandpublichealthfieldinanumberofwelldefinedtopicshas
beenpreferredatthetimeoftheirproposal.
Twomainreasonsledtothischoice,namelytheexistingdicrepancies
betweennationalresearchpoliciesandstrategies,asstatedatanearlier
confrontation exercise (CREST/22/76),aswellastheexistenceofmany
scattered andrelatively smallresearchteamsatnationallevel.Theva­
lidityofthischoicehasbeenprovenandatpresentmorethan400national
projectsarecoordinated bytheongoingsevenECactions.Thenumberof
institutes wishingtojointhisventureisinfactsteadilyincreasing .
Theclosecollaboration evolvedovertenyearsbetweentheCommittee on
MedicalandPublicHealthResearch CRM/CRESTandtheCommission hasfaci­
litatedconsiderably thiscoordination .
Theachievements incoordination andtherecognizedscientific andtechnical
enhancement ofresultsoftheactionsofthefirstprogrammeconfirmthe:
-remarkably improvedefficiency ofnationaleffortsintherespective
fields,
-favourable cost/benefitratiooftheCommunityfundsspentforco­
ordination purposes,and
-strengthened confidence andinterestoftheMemberStatesinthisform
ofCommunityactionforitscontribution toeconomicreturnsinthebio­
medicalandindustrial fields.
CRM,assistedbyitsSpecialized WorkingGroups,alsoadvisedtheCommission
topromoteawiderangeofexploratory activities intheformofstudies,
seminars,workshopsetc.Thus,acoherentschemehasbeensetup,where
3broadsubprogrammes havebeendefined.Eachofthemisdividedinresearch
areaswheretheongoingconcertedactionsandanumberofnewprojectsare
integrated .
Considering theabove,theCommission advisedbyCRMprepareditspresent
proposalforasectoralR&DprogrammeoftheECinthefieldofmedical
andpublichealthresearch.

Thisproposalprovidesforthefollowingspecificrequirements :
-continuation oftheconcertedactionsofthefirstprogrammeenabling
theirextension and/orexpansion,asalreadyforeseenatthetimeof
theirproposal (C0M(77)282final);
-integration oftheconcertedactionsofthesecondprogrammeconsidering
theirpresentstateofevolution andplansforextension andcontinuation
(C0MC78)377final);
-implementation ofnewactionsincriticalfieldsofcommoninterest;
-supportofcentralized coordination facilities,wheneverrequired.
Theproposalpresents acoherentschemeofCommunityactionsasshownin
tablesI-III.Itconstitutes asteptowardsthesectoralgroupingof
CommunitymedicalresearchactionsoftheMemberStatesconductedunder
theEECTreaty,andtherationalization ofstructures andproceduresfor
the"preparation,examination andimplementation ofCommunityR&Dpro­
grammes"inconformity withtheCouncilconclusions of20December1979.
Relevantactivitiesinprogressinothercountries aswellasthoseof
appropriate international organizations suchasWHO,OECD,Councilof
Europe,EuropeanMedicalResearchCouncilsoftheEuropeanScience
Foundation,etc.weretakenintoconsideration whenpreparingtheproject
proposals .
Theconclusions ofthemeetingsoftheMinistersofPublicHealth(13.12.1977
and16.11.1978 )havealsobeenconsidered .
Intheimplementation ofthepresentprogramme,closecoordination isen­
visagedwithotherresearchprogrammes oftheECwhichincludeorarerelated
tomedicaland/orpublichealthresearchcomponents .Atpresenttheseinclude
-partsoftheresearchprogrammeoftheECinthefieldofreference
(1)materials andmethods(CommunityBureauofReference )related
totheproductionofstandardsformaterialswhichareofbiomedical
interest;
(1)0JNoL258,13.10.79,p.32

-7-
(2)-thesectoral R&D programme ofthe EEC inthefield ofenvironment ,
inparticular for thepart relating toman-environment interaction ;
-the plan ofaction ofthe EEC inthe field ofscientific and technical
information anddocumentation ^foritspart concerning "Biomedical
Information "; '
-the research andtraining programme ofthe EAEC inthefield ofbiology -
(4)health protection (Radiation Protection Programme ) inits medical
and public health aspects ;
(5-8 )-the current four ECSC research programmes related tooccupational
health ;
-the action programme ofthe European Communities onsafety and health
i.(9)atwork
–Finally ,important areas of "this proposal ,namely areas 1.1.
(Pre-,peri-,andpostnatal care )and1.2.(Ageing ,Disabled
andHandicapped )can "beseen intheperspective ofthe
International Year ofDisabled Persons and ofthe opinions
ofthe European Parliament and the Economic and Social Committee
pertaining toit.
(2)OJNo L101,11.4.81 ,p. 1
(3)OJNo L311,4.11.78 ,p. 1
(4)OJNo L78,25.3.80 ,p.19
(5)OJNo C10,14.1.77 ,p.2
(6)OJNo C159,5.7.78 ,p.2
(7)OJNo C161,1.7.80 ,p.4
(8) OJ No C
(9)OJNo C165,11.7.78 ,p. 1

OBJECTIVES ,JUSTIFICATION AND ORIENTATIONS
The diseases ofmodern society with their incidence onindustrial deve­
lopment and thesteadily mounting costs ofhealth care are among the most
important economic problems confronting all Member States .
National efforts tosolve them are inprogress .Thus ,within the Community ,
there exists aconsiderable potential forscientific research and in­
dustrial development .Ifmobilized within the frame ofacoherent Commu­
nity medical research programme itwould allow the realization ofevident
scientific progress ,giving adequate and more effective information .
1.Obiecti ves
The main objectives ofEuropean cooperation inthe sector ofmedical
and public health research are prevention ,early detection ofdisease
andrehabilitation .More specifically they aim atthe following ,
namely to :
a)optimize the capacity and economic efficiency ofhealth care
efforts byinitiating orimplementing common actions indefined
fields considered ascritically relevant tothe solution ofmajor
health problems andtheir incidence onoccupational health ;
b)improve efficiency ofongoing national R&D through the encoura­
gement ofconcerted actions thus making abetter use ofthe avai­
lable research potential ;
c)promote through coordinated efforts anactive interaction ofthe
National Research Agencies ,ofthe Health Authorities and ofthe
Biomedical Industries ,leading toanaccelerated raising ofthe
social and economic welfare ofthe Community ;
d)gradually coordinate ,atCommunity level ,the national research
programmes inthefields ofcommon interest .The implementation
ofthe research work isthe remit ofcompetent research organi­
zations ofthe Member States ;

-9-
e)provide asystematic template for medical and public health research
inthe Community R&D policy bybringing under itanincreasing
proportion ofnational research activities inthis sector .
2.Just2f2çat2on
The legal basis forthis programme isArticle 235 ofthe Treaty esta­
blishing the European Economic Community and the Council Decision of
(1)18March 1980 (80/344/CEE )adopting the second medical research
programme .
Onthis basis ,and inline with the conclusions ofthe 619th meeting
ofthe Council on20December 1979 (doc .4230 /80/RECH .1),the
Commission prepared the present proposal for anew "sectoral "R&D
programme inwhich anattempt ismade togroup several ongoing and
new research actions pertaining tothe field ofmedical and public
health research .
Although this research field isnot mentioned among the areas offore­
most priority ,the Commission proposes todevote toitacertain pro­
portion ofits R&D efforts ,inconformity with the Council conclusion
"not toexclude apriori other areas where aCommunity contribution
could beofparticular value for the Community "(see :C0M(80 )412
final ).
Similarly ,this programme proposal corresponds tothe Resolution ofthe
European Parliament embodying its opinion onboth earlier programmes ,
inwhich "the Commission isexpected ,inaccordance with thetradi­
tionally universal nature ofmedical knowledge ,tocontinue topromote
such research atEuropean level and toensure that itiscoordinated
and,where possible ,integrated with similar research being carried out
inother parts ofthe world ".
(2)Moreover ,the Council Decision of9April 1981 onthe conclusion
ofthe Agreement between the EEC and the Swiss Confederation onacon­
certed action ,should beconsidered asabeginning ofassociating non
Member States ,participating inCOST,wholly orpartly with this pro­
gramme .
(1)J0No L78,25.3.80 ,p.24
(2)JONo L113,25.4.81 ,p.44

-10-
3.Orientations
Current national programmes inthefield ofmedical and public health
research are predominantly oriented todisease-related targets such
as :cardiovascular disorders ,mental illnesses ,congenital abnorma­
lities ,geriatric diseases ,etc.Here,progress derives largely from
individual efforts anddissemination ofinformation isassured by
scientific societies .Development aswell ascoordination atnational
level ismainly orpartially done bymaking available purpose-linked
public research funds .The Commission inline with the advise of CRM
does not feel that additional coordination efforts along these targets
are considered opportune ornecessary atCommunity level .
Incompliance with its mandate and onadvice ofthe CRM,the Commission
proposes toorient its sectoral R&D programme towards more compre­
hensive targets ofcommon interest .
The present R&D programme proposal will allow for more effective re­
search through collaboration and coordination at EClevel making use
ofamultidisciplinary research potential beyond thepossibilities of
any single country .Itfocuses onthe following three key areas ,herein­
after referred toassubprogrammes ,relating to :
1.Health Problems
2.Health Resources
3.Personal environment (Diet and Drugs ).
Thefirst R&D subprogramme isessentially oriented tothe solution of
those health problems involving thecritical phases ofhuman life,namely ■
birth andold age,totheeffects ofthelife-style related stress ofthe
industrial environment and theability tocope with it,andtothe impro­
vement ofrehabilitation ofthe disabled and handicapped .
Itwould thus promote the identification ofways and means likely to
maximize the results ofscientific and technological progress ,and
tominimize the negative economic and social consequences related to
inappropriate intervention inthese areas .

-11-
The second R8Dsubprogramme isoriented tothe improvement and appro­
priate use ofthose health resources required toensure optimization of
the cost-effectiveness ratio inthe health care field .Particular atten­
tion isgiven tocoordination ofefforts todevelop health services re­
search ,improve health technology and promote upgrading andqualifica -
«
tion ofhuman resources .
The third R&D subprogramme focuses onthe need for abetter under­
standing ofthe effects onthe individual 'shealth resulting from its
diet and the intake ofpharmaceuticals ,aspart ofits personal envi­
ronment .
X
* *
I

PROGRAMME CONTENT
I. HEALTH PROBLEMS
This subprogramme covers research aimed atestablishing thebiological ,
physiological ,technological ,epidemiological and organizational data
required for improving the medical intervention atbirth ,during develop­
ment and inold age,aswell astheeffective prevention ,better handling
and reduced dependence ofunfitness ,beitthe consequence ofcongenital
oracquired handicaps .Results from these investigations are expected to
have animportant fall-out for the European biomedical and pharmaceutical
industries .
The subprogramme also includes studies onthe quantification ofrisk po­
tential and adaptive responses topsychological and social stresses ,of
particular importance tothe area ofoccupational health .
Part ofthe research included inthis subprogramme isalready coordinated
inongoing "Concerted Actions "ofthe 1st and 2nd medical and public
health research programmes .Itisproposed tocontinue these actions .
Area 1 :Pre-i,_ger2-z_and_gost-nat al_care
-Technological development and assessment forperinatal monitoring pro­
cedures with emphasis onnon-invasive techniques .Particular attention
will begiven totheir reliability ,tothe relevance ofinformation ob­
tained ,tomother distress and risks ,aswell astofoetal loss .
-Research inlaboratories equipped tocarry out chromosome analysis will
endeavour tosolve technical problems needed toreach partially automated
measurements .Simultaneous parallel biochemical and genetical studies
are envisaged .
-The determination ofinborn metabolic errors through auniform methodic
approach todifferent screening programmes aims atdefining thecriteria
for monitoring their incidence and prevalence inthe Member States ,at
diagnosis and atdevelopment oftreatment .
Particular attention will begiven totreatable errors ,and theproject
will include studies oncystic fibrosis ,hemoglobinopathies and hyper -
lipoproteinemi a.

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-The congenital anomalies registry inprogress will becomplemented by
investigations onintrauterine diagnosis andstudies onearly foetal
loss,death inearly childhood andfoetal growth disturbances .
-Current practices inMember States regarding care delivery systems ,and
inparticular theapplication oftechnical devices andprocedures to
perinatal medicine ,including cost/effectiveness evaluat ions,wi 11be
examined .
Area 2 :Aqei^2 r_cHsabled_and_handi cagged
-The continuation and further development ofthe concerted action on
cellular ageing wi11involve studies atorgan ,cellular andsub-cellular
level .Itisproposed toinclude also further investigations ofthe im­
mune response during ageing including studies contributing tothe under­
standing ofarthritic diseases ,and ofageing ofthe brain and senile
dementia .The problem ofpremature ,asopposed tonormal ,ageing will
beconsidered .
-Ageing ofthe lens and hearing impairment form the crux ofthe action
onsensorial impairment partly covered byongoing concerted actions .
The development ofadequate aids tovision and hearing deterioration or
loss due toametabolic oroccupational origin will beconsidered .
Biomaterial compatibility studies ,closely associated with technological
developments ,will form thebasis ofthis research .
-The continuation and development ofthe concerted action ondetection of
thrombosis andprevention ofitsresulting disabi lities areexpected to
lead toabetter understanding ofthe pathogenesis ofthrombosis aswell
astotheavailability ofadequate tests which will aid inthe prevention .
i
early diagnosis and treatment ofthe disease .
-Evaluation and identification ofspecific needs asregards aids for disa-
bledwill beundertaken todefine coordinated activities leading totechni­
cal ,developments .
-The pattern ofcare for the chronic orlong term patient with several
functional disabilities ,and for the impaired elderly will beexamined
inastudy oncare delivery systems .Relevant epidemiological aspects will
betaken into account .

-14-
Area 3 :Breakdgwn_in_ada[3tat ion
-The determination ofmeasurable parameters which could indicate first
aposteriori but also apriori the tendency orinitiation ofbreakdown
inadaptation orthe form itmay take ifnocounter-measure isintroduced ,
forms this complex mult idisciplinary programme .Itisenvisaged to
developed itinto parallel projects strictly coordinated between them­
selves .Particular attention will begiven tohigh risk groups inthe
working population .
-Studies onquantification ofparameters aim atthe simultaneous evaluation
ofalready measurable hormonal parameters aswell aspsychological and
sociological ones .The improvement and standardization ofmethods for mea­
suring possible biological markers ofthe adaptive process arepart of
these studies .The interaction ofvarious disciplines closely associated
with studies inthe following projects form the basis ofthe whole
area .
-Coordination ofthe ongoing uncorrelated efforts inseveral Member States
toinvestigate the performance decrement ofworkers under various envi­
ronmental conditions soastoavoid accident proneness isenvisaged ,
using themultidisciplinary approach mentioned above .
-Application ofthe same multidisciplinary approach tothe field ofcardio­
vascular diseases with particular reference tohypertension and ischaemic
heart diseases ishere envisaged .Studies will beintegrated with results
from other projects and involve the evaluation ofpsychosocial and neuro­
endocrine factors inselected groups ofsubclinical and clinically esta­
blished patients combined with appropriate monitoring ofthe relevant
physiological variables .
-The model indicated above will beapplied tocorrelate gastro-intestinal
diseases with the results ofpsychobiologi cal and psychosocial measure­
ments .Subjects with borderline gastro-intestinal complaints and esta­
blished cases will bestudied .
-Afurther particular study ofincreasing importance forhealth andsafety
atwork isenvisaged inorder toassess therelevant problems ofdrug abuse .
Effects ofalcohol abuse aswell asthe mechanisms involved inthe proneness
toit,oftobacco orproducts associated with itsconsumption ,aswell asof
potential opiate intake onthecentral nervous system andthegeneral meta­
bolism ,will beexamined inbiological andepidemiological studies .

II. HEALTH RESOURCES
This subprogramme comprises 3main areas ofresearch :the 1st one aims at
assessing health services research concerned with the development ofhealth
services particularly inrelation tochanges insocial ,demographic ,envi­
ronmental and occupational conditions .Correct and problem-oriented development
ofhealth technologies including thetransfer ofnew knowledge andmethods from
basic hard and soft sciences into medical technologies ,aswell asthe assess­
ment andtesting ofmedical equipment form the 2nd area inthis subprogramme .
Important impacts onthe European biomedical industries can beforeseen .
The 3rd area deals with qualitative improvement ofmedical research scientists
infields inwhich knowledge and technology are progressing rapidly and where
highly skilled researchers arecritically needed .
Area _1 :Heaith_sery2çes_research
Health services research has todevelop generally acceptable scientific methods
toinvestigate efficiency ofdifferent health systems ,effectiveness ofvarious
medical procedures and technologies ,and toanalyse problems ofplanning ,orga­
nization ,management ,evaluation andacceptability ofhealth services intheir
relationship tosocial and environmental circumstances ,inorder toensure opti­
mal health ofthe working population inacost-efficient way .
Variations inorganization and structure ofhealth services research inthe
Member States aswell asspecial research requirements anddifficulties entail
astill poor development ofresearch inthis area .
The proposed research therefore aims ,inafirst phase ,atthe development on
Community scale ofacommon methodology including strategies for comparative
evaluation studies which involve evaluation ofprocess (efficiency )and assess­
ment ofoutcomes versus theoriginally stated objectives (effectiveness ).
Inasecond phase ,four interrelated topics are selected for elaboration :
-Coordination ofhealth services research :following evaluation ofthe
present state oftheart ofhealth services research inthe Member States ,
ofits problems and ofitsorganisation and structure ,this topic will aim
atthe coordination ofongoing national efforts inorder todevelop at
Community level anefficient research inthis area .
-Assessment ofhealth status :the development ofhealth indicators isa
basic tool inoccupational health ,indetermining the need forearly care
inspecific population groups and inidentifying risk factors .

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-Research onprevention :the change inemphasis from medication tohealth
promotion has increased the demand forfurther knowledge about health risk
factors ,influence ofthe working environment onhealth ,aswell asthe use
ofmedical services ,sick leave ,accidents atwork and drug consumption ;
relevant national activities will beassessed inorder toelaborate acon­
certed approach .
-Community versus hospital care :this research topic aims atassessing the
feasibility andpotential importance ofcommunity care tothe population in
its home and occupational environment ,incomparison with hospitalization
and byconsidering inparticular technological progress inmonitoring and
drug delivery ,aswell asdevelopment ofnew drugs .
Area 2 :Health Technology
-Acontinuation and development ofthe ongoing concerted action onextracor­
poreal oxygenation will consider advanced technological developments for
the replacement ofbody functions .Developments foresee further research on
oxygenator design and performance aswell asparallel studies into alterna­
tive methods ofoxygenation including enzyme binding tomembrane and re­
search onbiomaterials .
-The concerted action on common standards inelectrocardiography will becon­
tinued inabroader context ofquantitative functional assessment toinclude
the standardization and improvement ofdiagnostic criteria .The same approach
will beused for computerized analysis ofother diagnostic functional para­
meters .
-The monitoring ofdevelopments inthe field ofimaging techniques ,both
invivo and invitro isofgreat interest and will becarried out inaspe­
cific project .Pilot studies todefine common multipurpose packages for
image elaboration may beinitiated .
-Criteria forbetter exploitation ofthepossibility ofambulatory monitoring
ofphysiological variables ofgreat diagnostic importance will bedefined .
Its application torehabilitation ,therapeutic needs ,drug use and occupa­
tional health will beexamined .
-The development ofclinical andtechnical evaluation ofnew medical devices
andprocedures ,including cost/efficiency aspects isthescope ofthis action .
Itwill include acomparative evaluation ofmedical equipment intechnical
and user trials undertaken byapanel ofclinicians ,scientists from the par­
ticipating centers inliaison with health authorities .

-17-
Area 3 :
This area shall deal with methodological research onways and means for pro­
viding industry aswell aspublic andprivate institutes with highly qualified
research scientists inneed-areas such astoxicology ,occupational health ,
advanced health technology ,'clinical investigation ,health services management
and epidemiology .
Theprojects aimfirst atthe evaluation ofpresent and future needs ,confron­
tation ofnational measures taken ,identification ofsuitable upgrading faci­
lities ,and subsequently atthe development ofcoordinated procedures .Assess­
ment oftheir efficiency through test cases intoxicology ,advanced health
technology andclinical investigation isenvisaged .
III.PERSONAL ENVIRONMENT (Diet and Drugs )
Anutritional research programme will aim atascertaining the diet component
involved inthe occurrence ofdiseases such asarterial hypertension and di­
gestive tract diseases .Itincorporates development and implementation of
specific methodologies for the study offood and the detection ofindividual
predisposition tothe relevant diseases .Research based onmulticenter studies
will aim atassessing bypost-marketing clinical trials ofadequate scale the
efficacy ofspecific drugs aswell asatdeveloping adrug surveillance project .
Area _1 :Nutrjtjon
-The importance ofdietary factors inthe promotion ofhypertension will be
investigated toidentify adequate measures ofpreventing their effects .
This project includes biological and epidemiological aspects soastode­
fine the prevalence ineach Member State .and the environmental causes of
the disease .These studies will have arelevant impact onthe European
food industry atproduction and marketing level .
Area 2 :Pharmaceuticals
Adequate post-marketing drug surveillance and multicenter controlled clinical
trials require studies onvery large populations for the short -and long-time
evaluation ofboth new and old pharmaceuticals .Ongoing activities inthe
Member States are scattered ,unrelated toeach other and therefore ofminor
effectiveness .Byregrouping and coordination ,thus bymaking better and more

-18-
effective use ofexisting and potential resources ,joint medical research con­
ducted atCommunity level would give agreater and more consistent support
tothe pharmaceutical industry ,contribute todrug development ,and ensure a
quicker warning system .
-Itisproposed tostimulate and coordinate post-marketing clinical trials
totest the efficacy orsome specific effects ofpharmaceuticals .Such
controlled trials ofadequate scale aim atappropriate collection ,storage
and dissemination ofinformation onnew developments and onthe efficacy
ofold and new drugs .
-Inorder toimprove existing mechanisms for identifying adverse effects
ofdrugs which because oflow incidence orlate occurrence have escaped
premarketing testing ,itisproposed todevelop apost-marketing drug
survei Ilance oroject .Itwould promote exchange and early dissemination
ofinformation and would attempt tosupplement existing methods bydif­
ferent approaches i.e. case control surveillance and record linkage drug
surveillance .

-19-
E. PROGRAMME IMPLEMENTATION
The basis for optimal implementation ofthe proposed R&D programme is
the sharing ofits inherent responsibilities between the Member States
and the Commission :
-The Member States endeavour tocarry out,according tothe rules andproce -
cedures applicable totheir national programmes ,the execution ofthe
research asdescribed inthe foregoing chapter D,and are prepared to
integrate such research into aprocess ofcoordination atCommunity
level over the programme period .
-The Commission isresponsible for such coordination ofthe national con­
tributions tothe programme aswell asfor the management ofthe Community
budget allocated toit (see chapter G).
Implementation iscarried out asaconcerted action programme relating to
well defined research fields chosen for European collaboration ,and in­
cluding the actions ofthe 1st and 2nd medical programme .
The national contributions tothis programme and their coordination atna­
tional level ,aswell asthe selection ofnational experts fortheir scien­
tific management ,will bepart ofthe responsibilities ofthe concerned
authorities inthe Member States .These authorities are indicated in
Appendix 3ofthe proposed Council Decision .
Anactive participation ofall Member States ineach single project isnot
mandatory e.g. inthe case ofabsence ofanational programme inaparti-
ι
cular research line .
Following the Council Decision ,third countries involved inEuropean co­
operation inthe field ofScientific and Technical Research (COST )will
beinvited toparticipate toall orparts ofthis programme .
Areexamination ofthe programme isforeseen atthe end ofthethird year
which may lead toarevision inthe course ofthe fourth year aswell as
inthepreparation ofaproposal for apossible new programme intended
toconstitute afollow-up tothe present one.

-20-
F.OPERATIONAL ANDMANAGEMENT STRUCTURE
Anadequateoperational andmanagementstructureisindispensable inorder
to:
-ensuremaximumefficacyinbothprogrammeimplementation andcoordination ,
-meettherequestsstressedbytheCouncilinitsResolution of1974and
itsConclusions of1979,
-achievetheobjectives ofthisprogramme (giveninchapterC.1.),
-maximizeeconomyandprofitsoftheallocatedbudgetwhileensuringall
thespecificrequeststoachievetheresearchgoalsoftheprogramme
(seepage6).
Therationalization ofstructures andthesimplification ofprocedures
aimedatinthepresentattemptofgroupingR&Dactionsinthesector
ofmedicalandpublichealthresearch,shouldalsoallowagreaterflexi­
bilityinprogrammeimplementation andmanagement .
Threesubprogrammes areformingtheoverall RSDprogramme;theirope­
rationalstructureisshowninthefollowingTablesI-III.
Eachsubprogramme isdividedinto3researchareaswhichgroupscienti­
ficallyrelatedprojects.
Someprojectswillofcoursehavetogothroughanorganizational pre­
paratoryphasebeforeactivecoordination canstart.
Thefollowingstepswillhavetobetakenforeachproject:
-thesettingupofitsownoperational structureincluding atechnical
steeringcommittee,
-theidentification ofthecontributing nationalinstitutes,
-theappointment ofaprojectleader,and
-theconclusions ofcontractsmakingavailablethefundsneededfor
coordination purposes.

-21-
TABLEI
SUBPROGRAMME I:HEALIH_Ç|OBU|MS
ResearchAreasandProjects
Area1.1.Pre-,peri-,andpostnatal care
Project1.1.1.PerinatalMonitoring
1.1.2.Chromosome Analysis
1.1.3.InbornMetabolic Errors
1.1.4.Congenital Anomalies
1.1.5.CareDeliverySystems
Area1.2.Ageing,DisabledandHandicapped
Project1.2.1.CellularAgeingandDiseases
1.2.2.Sensonal Impairment
1.2.3.Thrombosis andDisabilities
1.2.4.AidstotheDisabled
1.2.5.CareDeliverySystems
Area1.3.BreakdowninAdaptation
Project1.3.1.Quantification ofParameters
1.3.2.Performance Decrement
1.3.3.Cardiovascular Diseases
1.3.4.Gastro-intestinal Diseases
1.3.5.DrugAbuse

-22-
TABLE II
SUBPROGRAMME II :H|^XH_|||Qy|£ES
Research Areas and Projects
Area II.1.Health Services Research
Project II.1.1 .Coordination ofHealth Services Research
11.1.2 .Health Status Assessment
11.1.3 .Research onPrevention
11.1.4.Community vs. Hospital Care
Area II.2.Health Technology
Project II.2.1 .Replacement ofBody 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 inToxicology
II.3.2. Health Service Management
II.3.3. "Occupational Health
II.3.4. Advanced Technology
II.3.5. Epidemiology
II.3.6. " "Clini calInvestigation

-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

Onthe basis ofthe experience gained from the ongoing concerted actions
and following acritical examination ofthe most rational management
structure for the optimal implementation ofthis multidisciplinary R&D
programme ,the Commission ,inagreement with CRM,proposes thesetting
upofthe following Committees :
a)One "General Concerted Action Commi ttee ",hereinafter referred toas
the "General Committee ",ensures the best possible implementation of
the overall programme .Forthis purpose itiscomposed ofrepresenta­
tives ofthe Member States responsible for science and technology in
the field ofmedical and public health research .
Atnational level ,its representatives take care ofthe integration
ofthose parts oftheir research activities ,which correspond with
this programme ,into aprocess ofcoordination atCommunity level ,
while the Commission ensures the coordination ofthe national contri­
butions tothe programme .
The General Comrmttee :
-advices the Commission onthe allocation ofCommunity funds needed
for :coordinating purposes ,supporting centralized facilities ,
meeting urgent needs incritical areas ,and undertaking exploratory
activities inview ofthe preparation offuture programmes ;
-coordinates within the programme theactivation ,duration andpossibly
early termination oftheprojects forming the research areas ofthis
programme ,onadvise oftherespective COMAC 's(seeunder b)assisting
itinitsscientific-technical management tasks ,and according to
emerging needs orresults ofperiodical evaluations ;
-indicates guidelines tothe COMAC 's.
b)Four "Concerted Action Committees ",hereinafter referred toas"COMAC 's*
ensure thescientific-technical management ofthose projects entrusted
toeach COMAC ,inconformity with itsrespective competence ,bythe
General Committee .

-25-
Forthis function ,each COMAC isoriented towards one ofthe 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 bechosen among national experts insuch awaythat
all appropriate competences needed are made available bycomplementing
one another ;they will beappointed bytheir responsible national
authorities .
Each COMAC ,inparticular :
-evaluates the results ofthe projects entrusted toit,draws conclu­
sions asregards their application and reports its opinions and re­
commendations tothe General Committee ;
-keeps abreast ofongoing relevant research and technical development
likely toaffect the execution ofthe projects ;
-suggests guidelines totheproject leaders .

-26-
G. WAYS AND MEANS
1.Research funding
The financial volume ofthe national research contributions tothis
research and development programme isestimated at300 miIlion ECU
over the programme period ,which corresponds toabout 12% ofthe
aggregate funding ofmedical and public health research inthe Member
(*)States
2.Coordination costs
The cost ofcoordination ,charged tothe Community budget ,isestima­
ted at20miIlion ECU for the duration ofthe programme .
These costs include administrative and technical expenditures ,and ex­
penditure forstaff subdivided asfollows :
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
ofthe 5Concerted Action Committees ,aswell asfor convocation of
experts ,publication ,missions ,etc .
b)Technical expenditures are spent :
-for 'contracts with project leaders inorder toensure scientific
coordination (organization ofmeetings oftechnical steering
committee andofworkshops ,exchange ofpersonnel ,dissemination
ofinformation ,administrative help,etc.).
(*) Doc .CREST No1245 /79

-27-
-for support needed bycentralized facilities ,whenever its proper
functioning requires substantial and/oradditional funding ,such
as:need ofcomputer including programming /production andexchange
ofcostly material ,breeding ormaintenance ofcertain animals ,
data evaluation ofclinical trials ,preparation ofreference soft­
ware ,etc .
-for support ofnational experts inorder toperform exploratory
activities bymeans ofstudies ,workshops orseminars needed
either tocomplement ongoing actions ortoprepare new ones .
-for support ofnational orprivate institutes inorder tomake
possible arapid intervention inthe case ofanunexpected but
urgent need ofrecognized importance .
Their distributions among the subprogrammes are asfollows :
Subprogramme I : 41-49 %
II : 36-44 %
111 : 13-17 %
c)Staff expenditures
Staff requested for executing the coordination ofthe programme at
Community level is10officials ,i.e. 6additional staff .
Atpresent ,4officials (2 Aand 2C)are allocated tothe 2nd Medical
research programme .
The 6additional staff (3 A,1Band 2C)are requested inview of
the competence necessary tocope with the new research areas pro­
posed ,toensure the secretariats ofthe General Committee and its
four COMAC 's,and tocarry out the coordination tasks .

ANNEX I
Proposal for aCouncil Decision
adopting asectoral research and development programme ofthe European
Economic Community inthe field ofmedical and public health research
-concerted action -
(1982 -1986 )
THE COUNCIL OFTHE EUROPEAN COMMUNITIES ,
Having regard tothe Treaty establishing the European Economic Community ,
and inparticular Article 235 thereof .
Having regard tothe proposal from the Commission ,
Having regard tothe opinion ofthe European Parliament ,
Having regard tothe opinion ofthe Economic and Social Committee ,
Whereas,pursuant toArticle 2ofthe Treaty ,the Community has been assigned
the task ofpromoting throughout the Community aharmonious development of
economic activities ,acontinuous and balanced expansion and anaccelerated
raising ofthe standard ofliving ;
Whereas byDecision 78/167/EEC,^ amended byDecision 81/21/EEC
andDecisions 78/168/EEC^and 78/169/EEC^,theCouncil hasadopted three
concerted projects asafirst research programme inthefield ofmedical and
public health research ;
Whereas byDecision 80/344/EEC^theCouncil hasadopted asecond research
programme inthefield ofmedical and public health research ,consisting of
four multiannual concerted projects ;
(1)OJ No L52,23.2.1978 ,p.20.
(2)OJ No L43,13.2.1981 ,p.12.
(3)OJ No L52,23.2.1978 ,p.24.
(4)OJ No L52,23.2.1978 ,p.28.
(5)OJ No L78,25.3.1980 ,p.24.

-2-
Whereas initsresolution of14January 1974 onaninitial outline programme
oftheEuropean Communities inthefield ofscience andtechnology ^the
Council stressed that anappropriate approach should beadopted towards the
whole range ofavailable ways and means ,including concerted action /and
that whenever itproves necessary ordesirable that non-Member States ,par­
ticularly European ones ,should beassociated inthese projects ,steps should
betaken tomake this possible ;
Whereas ,initsresolution of14January 1974^relating inparticular to
the coordination ofnational policies inthefield ofscience and technology ,
the Council entrusted the Community institutions with the task ofgradually
ensuring such coordination ,aided bythe Scientific and Technical Research
Committee (CREST );
Whereas the sectoral R&D programme dealt with bythis Decision appears ne­
cessary toattain inthe course ofthe operation ofthe common market the
objectives ofthe Community asregards the harmonious development ofeconomic
activities ,acontinuous and balanced expansion and anaccelerated raising
ofthe standard ofliving ,account being taken inparticular ofpotential
economic and industrial development within thefields covered bythe research
areas ;
Whereas the Treaty does not provided the specific powers ofaction required
for these ends ;
Whereas the Member States intend ,inaccordance with therules andprocedures appli
cable totheir national programmes ,tocarry out the research indicated in
Annex 1,and are prepared tointegrate such research into aprocess ofco­
ordination atCommunity level until 31December 1986 ;
Whereas the cost ofsuch research ,asindicated inthe aforesaid Annex 1,per­
formed inthe Member States isevaluated atabout 300 million ECU;
(6)OJNo C7,29.1.1974 ,p.6
(7).OJNo C7,29.1 .1974 ,p.2

-3-
Whereas inits conclusions of20December 1979 ,the Council invited the
Commission tosubmit proposals aimed atthe rationalization ofstructures
for the preparation ,examination and implementation ofCommunity research
and development programmes ;whereas agrouping ofconcerted actions inthe
field ofmedical and public health research would constitute afirst con­
tribution towards meeting these objectives ;
Whereas the Community isempowered toconclude Agreements with non-Member
States inthefields covered bythis Decision ;whereas itmay prove advi­
sable toassociate the non-Member States participating inEuropean Coope­
ration inthefield ofScientific and Technical Research (COST )wholly or
partly with the programme covered bythis Decision ,inaccordance with the
conclusions approved bythe Council on18July 1978 inconnection with
such cooperation ;whereas ,onthe one hand ,procedural conditions should
bedetermined soastolead toarapid conclusion ofsuch Agreements ,and
onthe other hand ,negotiations should beopened with the non-Member States ,
assoon asthis Decision isadopted ;
Whereas the Council has concluded such Agreement between the EEC and the
(8)Swiss Confederation onaconcerted project ;
Whereas the Scientific and Technical Research Committee (CREST )has given
its opinion onthe Commission proposal ;
HAS DECIDED AS FOLLOWS :
Article 1
Aconcerted research and development programme ofthe European Economic
Community inthefield ofmedical andpublic health research ishereby
adopted for aperiod offive years commencing on 1January 1982 .
(8)0J No L113,25.4.1981 ,p.44.

-L-
The programme shall consist incoordination atCommunity level ,within the
research areas described inAnnex 1,ofthose activities which form part of
the research programmes ofthe Member States .
Article 2
i
The Commission shall beresponsible for such coordination .
Article 3
The appropriations necessary tofinance the Community contribution tothe
coordination ,the amount ofwhich isestimated at20million ECU,including
the expenditure relating toastaff oftenofficials ,shall beentered in
the budget ofthe European Communities .These figures are given merely by
way ofindication .
The indicative internal distribution offunds isshown inAnnex 2.
Inthe light ofexperience gained during the implementation ofthe programme ,
and provided the opinion ofthe Scientific and Technical Research Committee
(CREST )and ofthe committee referred toinArticle 5a)issecured beforehand ,
the Commission isauthorized totransfer funds from one toanother subpro -
gramme ,provided that such transfers donot result inanincrease orare­
duction ofmore than 10 %intheoriginal appropriation for each subprogramme
envi saged .
Article 4
The programme shall bereexamined atthe end ofthe third year ;this reexami -
nation may lead toarevision ofthe programme inthe course ofthe fourth
year following the appropriate procedures ,andafter the Committee referred
toinArticle 5a)has-been consulted .The European Parliament shall bein­
formed ofthe results ofthe reexamination .
Article 5
Tofacilitate the execution ofthe programme ,
a)one General Concerted Action Committee ,hereinafter referred toasthe
General Committee ,and

-5-
b)four Concerted Action Committees assisting the General Committee inits
management tasks /
shall beestablished .
The terms ofreference and the composition ofthese Committees are defined
inAnnex 3.
The Commission shall beassisted inits coordinating action byproject leaders
appointed bythe Commission ,after having consulted the General Committee .
Each Committee shall draw upits rules ofinternal procedure .Itssecretariat
?hall beprovided bythe Commission .
Implementation andcoordination ofthenational contribution totheprogramme
shall becarried out bythe bodies listed inAnnex A.
Article 6
Inaccordance with aprocedure tobelaid down bythe Commission after having con­
sulted theGeneral Committee referred toinArticle 5a),theparticipating
Member States and the Commission shall regularly exchange all useful informa­
tion concerning the execution ofthe research covered bysuch activities .
Theparticipating Member States shall provide the Commission with all infor­
mation relevant for coordination purposes .They shall also endeavour topro­
vide the Commission with information onsimilar research planned orcarried
out bybodies which are not under their authority .Any information shall be
treated asconfidential ifsorequested bythe Member State which provides it.
Atthe completion ofthe programme ,the Commission ,inagreement with the
General Committee ,shall send tothe Member States and the European Parliament
asummary report onthe implementation and results ofthe programme particu­
larly sothat the results obtained may beaccessible ascompletely and rapidly
aspossible totheenterprises ,institutions andother parties particularly
concerned atthe social level .The Commission shall publish this report six
months after thelatter has been sent tothe Member States ,unless aMember
State objects .Inthelatter case,the report shall bedistributed only to
those institutions and enterprises that request itand whose research orpro­
duction activities justify access tothe results ofresearch arising from the
programme .The Commission shall make the necessary arrangements for the report
toremain confidential and not tobedivulged tothird parties .

Article 7
1.Inaccordance with Article 228 ofthe Treaty ,the Community may conclude
Agreements with the non-Member States participating inEuropean Cooperation
inthe field ofScientific and Technical Research (COST )with aview toasso­
ciating them wholly orpartly with this programme .
2.The Commission ishereby authorized tonegotiate the Agreements referred
toinparagraph 1.
Article 8
Decision 80/344/EECishereby repealed with effect on 1January 1982 .
Done at
For the Council
The President

Annex 1
SCIENTIFIC AND TECHNICAL CONTENT
(Concerted Action Programme )
The aim ofthis concerted European collaboration inthe sector ofmedical and
public health research is :
-toincrease the efficiency ofrelevant R&D efforts inthe Member States
through the mobilization ofthe available research potential ofparts of
national programmes andits gradual coordination atCommunity level ;
-toimprove thescientific and technical knowledge inthe R&D areas ,
selected fortheir importance toall Member States taking aparticular
account ofpotential economic and industrial development within the
projects forming them ,and
-toprovide for the continuation ofthe 3concerted projects ofthefirst
medical research programme (1978-1981 ),theintegration ofthe*4 ones of
the second programme (1980-1984 )aswell asfor new projects ofcommon
interest .
SUB-PROGRAMME I : HEALTH PROBLEMS
Research area 1 :Pre-^jDeri -andgostnatal care
•>-Continuation ofthe ongoing project relating toperinatal monitoring ,
with emphasis ontechnological development and assessment ofdevices and
procedures for non-invasive monitoring ,and extension toprevention of
mother 'sdistress and risk aswell asoffoetal loss .
-Improvement oftechniques needed for (partially )automated chromosome analysis
aswell asbiochemical andgenetical studies toincrease possibilities ofits
appli cation .
-Screening ofinborn metabolic diseases ,including cystic fibrosis ,hemo­
globinopathies and hyperlipoproteinaemia ,by standardization orimprovement
ofexisting methodologies and developing new ones ,aswell asstudies onearly
detection and treatment .
-Continuation oftheproject relating tothe registration ofcongenital abnor­
malities ^with extension toimprovement ofintrauterine diagnosis andstudii
onearly foetal loss,death inearly childhood andfoetal growth disturbances .
(1)for programme description see :O.J. NP L78,25.3.80 ,p.24.
(2) " " " ":O.J. No.L52,23.2.78 ,p.20.

-8-
-Examination ofcurrent practices regarding care delivery systems ,and in
particular theapplication oftechnical devices andprocedures toperinatal
medicine ,including cost /effectiveness evaluations .
Research area 2 : A2gin2 z_Disabled_and_Handi cagged
»
\ (2)-Continuation oftheproject relating tocellular ageing with extension
ofits immunological subproject tothe understanding ofarthritic diseases
and ofitssubproject concerning organs tostudies ofthe brain and senile
dementia .
(1)-Continuation oftheproject relating tohearing impairment and ofthe
(2)subproject onageing ofthe crystalline lens ofthe foregoing project ;
development ofadequate aids for visual and auditory sensorial impairment
including biomaterial compatibility studies .
-Continuation ofthe ongoing project relating tothe detection oftendency
(1)tothrombosis with extension topopulation studies following development
ofsuitable methodology .
-Evaluation ofselected aids for the disabled ,identification ofspecific
needs andtheir technological development .
-Examination ofcare pattern forthe chronic patient with several functional
disabilities andfortheimpaired elderly including epidemiological aspects .
^Ë2ÊËI£!ü_êEÊË ^ :Breakdown in_adagtat ion
>-Evaluation ,improvement ,standardization and/ordevelopment ofquantitative
measurements ofhormonal ,psychological and sociological parameters involved
inthe adaptive process .
-Investigation ofperformance decrement inworkers under various environmental
conditions using the above mentioned methodology .
-Comparative studies ,through monitoring the relevant physiological variables ,
inselected groups suffering from cardiovascular symptoms with particular re­
ference tohypertension and ischaemic heart diseases .
-Comparative studies ,through determination ofthe relevant psychobiologi caland
psychosocial parameters ,inselected groups suffering from gastro-intestinal
diseases .
(1)for programme description see :O.J. NoL78,25.3.80 ,p.24.
(2) " " " " :O.J. NoL52,23.2.78 ,p.24.

-9-
-Biological andepidemiological studiesinworkersontheeffectsofalcohol
abuseandthemechanismsinvolvedinthepronenesstoit,oftobaccoorpro­
ductsassociatedwithitsconsumption,aswellasofpotentialopiateintake
onthecentralnervoussystemandthegeneralmetabolism .
SUB-PROGRAMME II:HEALTHRESOURCES
1•:HeaL^th_services_research
-Assessment ofthepresentstateoftheartofhealthservicesresearchin
theMemberStatesfollowingdevelopment ofacommonmethodology forcompa­
rativeevaluation,andelaboration ofjointprojects.
-Development ofhealthindicators andsubsequent assessment ofthehealth
statusoftheworkingpopulation intheCommunity.
-Studiesofhealthriskfactors,influenceoftheworkingenvironment on
health,aswellastheuseofmedicalservices,sickleave,accidentsat
workanddrugconsumption ;evaluation ofrelevantnationalactivities and
elaboration ofaconcertedapproachtowardsprevention .
-Assessment ofthefeasibility ,byconsidering inparticular relevanttechno­
logicalprogress,andpotentialimportanceofcommunitycaretothepopula­
tioninitshomeandoccupational environment ,incomparison withhospita­
lization.
B£searçh_area 2:Health_Teçhno_log ^..... .(2)-Continuation oftheprojectrelatingtoextracorporeal oxygenation with
extensiontoadvancedtechnological developments forthereplacement of
furtherbodyfunctionsincludingresearchonbiomaterials .
-Continuation oftheongoingprojectrelatingtocommonstandardsinquanti-
1)tativeelectrocardiography withextensiontostandardization andim­
provementofdiagnosticcriteria;thesameapproachwillbeusedforcom­
puterizedanalysisofotherdiagnosticfunctional parameters .
-Invivoetinvitrodevelopment ofimagingtechniquesfollowingpilotstudies
todefinecommonmultipurpose packagesforapplication .
-Development ofdevicesandproceduresforambulatorymonitoringofphysiolo­
gicalvariablesofgreatdiagnostic importancetorehabilitation ,therapeutic
needs,druguseandoccupational health.
(1)forprogrammedescription see:O.J.NoL78,25.3.80,p.24
(2)forprogrammedescription see:O.J.NoL52,23.2.78,p.28.

-10-
-Clinical and technical evaluation ofnew medical devices and procedures ,
including cost /efficiency aspects ,through coordination ofexisting faci­
lities for both comparative technical testing and user trials ,considering
inparticular :ultrasonic tissue characterization ,accelerated bone frac­
ture healing ,blood flow measurements ,automated cell identification and
t
medical telemetry .
Research area _3 :
-Methodological research onways and means for providing industry aswell
aspublic and private institutes with highly qualified research scientists
inneed-areas such astoxicology ,occupational health ,advanced health
technology ,clinical investigation ,health services management and epide­
miology .
-Evaluation ofpresent and future needs ,confrontation ofnational measures
taken and identification ofsuitable upgrading facilities ;subsequently
development ofcoordinated procedures and assessment oftheir efficiency
through test cases intoxicology ,advanced health technology and clinical
investigation .
SUB-PROGRAMME III : PERSONAL ENVIRONMENT
(Diet and Drugs )
Research area 1 :Nutrition
-Development and improvement ofspecific methodologies for the study of
food and the detection ofindividual predisposition toarterial hyperten­
sion anddigestive tiract diseases ;biological and/orepidemiological
studies ontheir prevalence and onthe environmental factors involved ,as
well asonpreventive measures .
2 :Pharmaceuticals
-Controlled post-marketing clinical trials oflarge scale through mobilisa­
tion and coordination ofexisting facilities ;appropriate collection ,sto­
rage and dissemination ofinformation onthe efficacy orsome specific
effects ofselected old and new pharmaceuticals .

-11-
-Development ofapost-marketing drug surveillance project oflarge scale
through the coordination ofexisting facilities inthe Member States ;
collection ,storage and early dissemination ofinformation onadverse
drug effects oflow incidence orlate 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 %

Implementation and coordination ofthe nationalAnnex 3
contributions tothe programme
The following authorities oftheparticipating Member States will endeavour to
ensure the implementation ofthe national contributions tothe research areas
ofthe three subprogrammes indicated inAnnex 1,aswell astheir coordination
atnational level :
Belgi um
Denmark
France
Germany
Greece
Ireland
Italy
Luxembourg
Netherlands
United KingdomFRSM -Fonds delarecherche scientifique médicale ,
Bruxel les
FGW0 -Fonds voor Geneeskundig Wetenschappelijk
Onderzoek ,Brussel
Statens Laegevidenskabelige Forskningsrad ,København
INSERM -Institut national delasanté etdela
recherche médicale ,Paris
Bundesminister für Forschung und Technologie ,Bonn
Bundesminister für Jugend ,Familie und Gesundheit ,
Bonn
Bundesminister für Arbeit und Sozialordnung ,Bonn
Ipiresia Epistimoni kis Erevnis keTechno loghias ,
Athens
Simvoulion Iatrikon Erevnon ,Athens
Medical Research Council ofIreland ,Dublin
Medico-Social Research Board ,Dublin
CNR-Consiglio nazionale della ricerca ,Roma and
Istituto superiore disanità ,Roma
Ministère delasanté ,Luxembourg
Hoofdgroep Gezondheidsonderzoek TNO,Den Haag
MRC -Medical Research Council ,London and
DHSS -Department ofHealth and Social Security ,
London

-13-
Annex 4
.TERMS OF REFERENCE AND COMPOSITION OF THE COMMITTEE
I.General Concerted Action Committee
1.The General Committee shall :
-contribute tothebest possible implementation ofthe programme by
giving its opinion toall ofits aspects ;
-endeavour tointegrate those parts ofnational research activities
covered bythis programme into aprocess ofcoordination atCommunity
level ;
-within the programme asdefined inAnnex 1ofthe present Decision ,
coordinate theactivation ,duration and possibly early termination of
the projects forming the research areas ofthis programme ,according
toemerging needs orresults ofperiodical evaluations ;
-indicate guidelines tothe Concerted Action Committees ;
-advise the Commission onthe allocation offunds for coordination
purposes ,supporting centralized facilities ,meeting urgent needs
incritical areas ,and undertaking eploratory activities inview
ofthe preparation offuture programmes .
2.The General Committee 'sreports and opinions shall beforwarded tothe
Commission and tothe Member States participating inthe programme *
The Commission shall forward these opinions to CREST .
3'.The General Committee shall becomposed ofrepresentatives ofthe Member
States responsible for science and technology inthefield ofmedical and
public health research and,inparticular ,forcoordinating thenational
contributions tothe programme .
II.Concerted Action Committee
1.Each Committee shall :
-assist the General Committee inits management tasks byensuring the
scientific and technical execution ofall those projects allocated to
itinaccordance with its competence ;

-14-
-evaluate the results and draw conclusions asregards their application ;
-beresponsible for the exchange ofinformation referred tointhefirst
paragraph ofarticle 6;
-keep abreast ofnational research being done inthefield oftheprojects ,
and more especially ofsc-ientific and technical development likely to
affect their execution ;
-suggest guidelines tothe project leaders .
2.The Committee 'sreports and opinions shall beforwarded tothe General
Committee and tothe Commission .
3.The Committee shall becomposed ofexperts nominated bythe competent
authorities ofthe Member States and the project leaders .

ANNEX II
FINANCIAL RECORD
1.RELEV ANT BUDGET HEADING
2.TITLE OFTHE BUDGETARY HEADING :Sectoral R&D programme in "thefield
ofMedical and Public Health Research -Concerted Action
3.LEGAL BASIS :
-Implementation ofArticle 235 oftheTreaty establishing the EEC
-Decision ofthe Council of
4.DESCRIPTION .OBJECTIVE AND JUSTIFICATION OFTHE PROGRAMME :
4.1.Description
The present proposal deals with anew sectoral research and
development programme ofthe EEC inthefield ofmedical and
public health research ,tobecarried out bymeans ofthe
concerted action method .
Itissubdivided into three subprogrammes :
-Subprogramme 1:Health problems
-Subprogramme 2:Health resources
–Subprogramme 3:Personal environment (diet and drugs ).
Each subprogramme isfurther detailed inresearch areas grouping
several projects .
4.2.Objective
Itaims atincreasing the efficiency ofthe relevant R&Defforts
inthe Member States through the mobilization ofthe available
research potential ofparts ofnational programmes andits gradual
coordination atCommunity level .
4.3.Justification
This proposal constitutes astep towards the sectoral grouping of
Community research actions inmedical andpublic health research
and towards therationalization ofstructures and procedures for the
implementation ofCommunity R&D programmes .
The programme proposal ,bypresenting acoherent scheme ofCommunity
concerted research ,provides forthecontinuation ofthefirst medical
research programme (1978 ~1981 ) "the integration ofthe second
one (198O -1984 )aswell asfor newactivities incritical areas of
common interest .

5.FINANCIAL IMPLICATIONS INRESPECT OFINTERVENTION APPROPRIATIONS
(including expenditure onstaff andadministrative andtechnical
expenditure )
5.1.Total cost forthe expected duration : 320 Mio ECU
5.2.Proportion financed from :
-theCommunity budget 20Mio ECU*
«
-national budgets 300
5.3.Multi-annual timetable
5.3.1 .Appropriations for commitment (inMio ECU)
Type of
expenditure1982 1983 1984 1985 1986 TOTAL
Staff
Administration
Contracts0.54
0.26
2.00.61
0.32
4.00.66
0.26
5.0O.72
O.29
3.30.77
O.27
1.03.3
1.4
15.3
TOTAL 2.8 4.93 5.92 4.31 2.04 20.0*
5.3.2 .Appropriations forpayment (inMio ECU)
Type of
expenditure1982 1983 1984 1985 1986 1987 TOTAL
Staff
Admi nistration
Contracts0.54
0.26
1.00.61
0.32
3.00.66
0.26
4.5O.72
O.29
4.20.77
0.27
2.1 0.53.3
1.4
15.3
TOTAL 1.8 3.93 5.42 5.21 3.14 0.5 20.0*
5.4.Method ofcalculation
5.4.1 Staff expenditure
Requirements have been calculated onthebasis ofastaff complement
of10 persons (including thestaff complement of2category A
and 2category Cofficials allocated tothe 2nd medical research
programme ),i.e. :
*Since Decision 80/344/EECwill berepealed with effect from 1January 1982 ,
the amounts which areauthorized under therelevant heading inthe 1980 and
1981 budget and which ,asat1January 1982 ,have notyet been committed or
have been committed but not yetpaid may beused for the execution ofthe
present programme .
be For 1982 ,thestaff complement requested inthe budget isasfollows :
4category A,1category B,3category C.Mio ECU
Mio ECU*
Mio ECU

-3-
-5category Aofficials
-1category Bofficial
-4category Cofficials .
Apart from the actual staff complement ,the calculations also take
account oftherates ofsalary increases ofCommission staff used
toestimate theappropriations entered inthe 1982 "budget ;the
estimated overall increases for subsequent years are "based onthe
rate ofchange inthe general Community price index used indrawing
upthetriennial estimates ,i.e. 8,6 %per annum .
5.4*2 .Administrative anchor technical expenditure
This expenditure specifically oovers the cost ofthe organization
ofmeetings (5committees of30-40members meeting 4times 2days),
convocation ofexperts and that ofmissions .Ithas "been estimated
onthe basis ofaverage requirements .
5.4.3 .Expenditure on_contracts _
This expenditure covers thefinancial contribution ofthe Community
tothe coordination essentially carried out under contracts tobe
concluded with theproject leaders (fororganization of:meetings
oftechnical steering committee ,seminars ,workshops ,exchange of
personnel ,disseminations ofinformation ,scientific and administrative
help ,etc.),with institutes ensuring costly centralized services to
all Member States (for computer including programming ,production of
exchange ofmaterial ,breeding and maintainance ofcertain animals ,
data evaluation ofclinical trials ,preparation ofreference soft­
ware ,etc.),with national experts (forexploratory activities in
form ofstudies ,etc.)andwith national orprivate institutes
(forrapid intervention inthecase ofanunexpected buturgent
need etc.).
6.FINANCIAL IMPLICATIONS IN RESPECT OFAPPROPRIATIONS FOR STAFF AND
CURRENT ADMINISTRATIVE EXPENDITURE :
(seepoint 5above )
7.FINANCING OF EXPENDITURE
Appropriations tobeentered under future budgets
8.IMPLICATIONS INRESPECT OF REVENUE
–Community taxes onofficials' salaries
-Officials' contribution tothe pension scheme .
9.TYPE OFMONITORING TOBEAPPLIED
-Administrative checks bythe DGforFinancial Control with regard
tothe implementation ofthe budget andtoensure that the
expenditure has been incurred inaregular andproper manner
plus checks carried out bytheContracts Service ofDGXII.
–Scientific checks :General Concerted Action Committee assisted by
4Concerted Action Committees .