ARCHIVESHISTORIQUES
DELACOMMISSION
COLLECTION RELIEEDES
DOCUMENTS "COM"
COM(77)282
Vol.1977/0095

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COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(77)282final.
Brussels.21June1977.
FIRSTPROGRAMME OPRESEARCH ACTIONS
inthesectorof
MEDICALANDPUBLICHEALTHRESEARCH
PROPOSAL FORACOUNCILDECISION
adoptingaconcertedactioninthefieldof
Registration ofCongenitalAbnormalities
(MedicalandPublicHealthResearch)
PROPOSALFORACOUNCILDECISION
A
adoptingaconcertedactioninthefieldof
CellularAgeingandDecreasedFunctionalCapacityofOrgans/
/ \^Ul!,■v\(MedicalandPublicHealthResearch),A
.
■
i-:
PROPOSAL FORACOUÏEILDECISION
adoptingaconcertedactioninthefieldof
Extracorporeal Oxygenation
(MedicalandPublicHealthResearch)
(submittedtotheCouncilbytheCommission)
CQK(77)282final.

-1-
FIRST PROGRAMME OF RESEARCH ACTIONS
inthe sector of
MEDICAL AND PUBLIC HEALTH RESEARCH
TABLE OF CONTENTS
Page
I. Introduction ...... 2
II. Elaboration and choice ofthe actions 3
III. Short description andcharactetistics ofthe actions . 4
IV. Implementation ofthefirst action programme 6
V. Financial volume .. 7
VI. Prospectives 7
-Multiannual concerted action <3years )inthefield of
"Registration ofCongenital Abnormalities "
including PROPOSAL FOR ACOUNCIL DECISION A.1-A.11
-Multiannual concerted action (4years )inthefield of
"Cellular Ageing and Decreased Functional .Capacity of
Organs "
including PROPOSAL FOR ACOUNCIL DECISION B.1-8.13
-Multiannual concerted action (4years )inthefield of
"Extracorooreal Oxygenation "
including PROPOSAL FOR ACOUNCIL DECISION C.1-C.12
'\

FIRST PROGRAMME OF RESEARCH ACTIONS
inthe' sector of
MEDICAL AND PUBLIC HEALTH RESEARCH
INTRODUCTION
According to,theCouncil 'sResolution ofJanuary 1974 ontheco-ordination of
national policies andthedefinition ofprojects ofinterest tothe Community
inthefield ofscience and technology ,the Committee onMedical andPublic
Health Research (CRM),set upbythe PREST group onJune 1972,became
responsible toCREST inorder toassist it,and inturn the Community
Institutions ,inperforming their tasks .
Incompliance with its mandate ,CRM,assisted bythree Specialized andthree
AdHoc Working Groups ,executed itsexplorative tasks according tothe time­
table appearing inthe Annex oftheResolution andcovering the 1974-1976
period ,and reported toCREST (Doc.CREST /21and 22/1976 )inparticular on
the conclusions drawn from the experience gained during this first phase .
The conclusions ofrelevance tothis proposal for aFirst Programme ofResearch
Actions are the followings :
(a)The main objectives ofEuropean co-operation inthe medical field should
beintheprevention ,intheearly detection ofdisease and inrehabili­
tation .
(b)Implementation ofcommon actions should beperformed byorinassociation
with the research organizations ofthe Member States .
(c)Following important criteria should beapplied tothe choice ofcommon
actions andtothe selection ofpriorities :
-thetopic should beofimportance tothe Community asawhole ;
-thetopic should have practical importance inparticular from the
social and economic point ofview ;
-onscientific grounds :either theproject should need tobeimplemented
jointly oratleast could becarried out much more effectively onan
conisranity basis than separately ineach Member State ;
-theproject should beexpected togive clear and reasonably early
results .
(d)Co-ordination ofnational policies should encourage coherence ofmethods
ofworking ofthenational research organizations ,thus laying the
foundations for aneffective scientific community .
(e)Itisshown that inrespect toco-ordination ofmedical andpublic health
research policies within the Community there isacommon pattern .of
organization inall Member States ,butwithin this pattern there are wide
differences ofdetail .Mainly both facts ,namely that the machinery within
thenational research organizations and theexisting scientific policies

XII/269/77
oftheseorganizations arewidelydiffering,andthatresearchinthe
medicalfieldislargelycarriedoutassmallprojects,putconstraints
onpolicymaking.Variationsinwaysofcategorizing workanddefining
priorities rr*ketheestablishment ofgeneralcommonpolicypriorities
difficultatthistime.However,comparisonandco-operation inrespect
ofresearchpv.'iciesisconsideredpossibleforspecificfieldsof
researchdirectedtooneofafewcloselyrelatedpracticalobjectives.
CRESTinturnacceptedtheseconclusions (Doc.CREST/27/1976),gaveafevourabl
opiniononcriteriaforchoosingtopicsandselectingpriorities,considered
CRM'sexplorative workasanextremelyvaluablebasistoenterimmediately a
secondworkingphasewhichwouldconsistintheelaboration,beforetheend
of1976,ofafirstprogrammeofresearchactions,andinvitedtheCommission
tosubmittotheCouncilacorresponding proposalfordecisions.
II*ELABORATION ANDCHOICEOFTHEACTIONS
«<1
Severalpreliminarystudiesforpossiblecommonactionhavebeenperformed
byCRM'sWorkingGroupsafteridentification ofspecificfieldsofcommon
interest,accordingtotheirtermsofreference.Theprocedureappliedto
suchanelaborationrequiressurvyingvariousfieldsofinterestfromthe
followingpointsofview:
-stateofknowledgeandcriticalaspectsofthefieldinrelationtothe
presentstatusofmedicalandpublichealthproblems;
-identification ofthemostsignificant problemswithparticularreference
tothedevelopment ofprevention,earlydiagnosisandrehabilitation ;
-evaluationoftheneedsforthemostefficienthandlingoftheabove-
mentionedproblems,fromthepointofviewofresearchand/ortraining
requirements .
Onthebackgroundofthesestudies,CRMhassuggestedascomponentsofthe
FirstProgrammeofResearchActionsthreesubjectswhicharerelatedtothe
particularfieldsof:
(A)Registration ofCongenitalAbnormalities
(B)CellularAgeingandDecreasedFunctionalCapacityofOrgans
(C)Extracorporeal Oxygenation
OnthebasisoftheopinionsofCRMandCREST,theCommissionthenprepared
theproposalforaCouncilDecisionadoptingthreemultiannual concerted
actionsintheabove-mentioned fieldsofMedicalandPublicHealthResearch.
Thechoicewasperformedbyapplyingtheapprovedcriteria,byconsidering
thefeasibilityofagradualco-ordination (bothmentionedunderI),andby
takingintoaccounttherelevantactivitiesofappropriateInternational
Organizations suchasWHO',OECD,CouncilofEurope,EuropeanMedicalResearch -
Councils,EuropeanScienceFoundation,etc.

-3bis- XII/269/77
Thereareobviouslymanyotherresearchthemesasimportantasthosewhich
wereretainednow,whichcanbetakenintoconsideration intheframeof
aCommunityprogrammeinmedicalresearch.Thepreparative workcarried
outbythespecialized workinggroupsofCRMledtothepresentation to
CRMof5projects.Amongthem,andnexttothe3projectspresentedin
thisdocument,were:thrombosis,andhumanfactorsinroadtraffic
accidents.DuringitsmeetingofJune30,1976,CRMrequestedfurther
information onthesetwosubjects.Theywillbereexaminedtogetherwith
aseriesofnewprojectsinJune1977.Astothe3projectspresented
hereafter,theywereretainedasbeinginconformitywiththeCommunity
objectives andinterestsaccordingtothecriteriadescribedonpages2
and3ofthisnote.ChapterIII(p.4and5)outlinesforeachofthemthe
motivationforCommunityapproach.
Thus,the3abovementionedthemesmustbeconsideredasthefirstelements
ofamorecomprehensive programmeofwhichotherelementsarepresently
beingstudied,andwhichwillbethesubjectoffutureproposals.

-4- XII/269/77
III.SHORT DESCRIPTION AND CHARACTERISTICS OFTHE ACTIONS
(A)Multiannual Concerted Action (3years )inthefield of
"Registratio nofCongenital Abnormalities "
Objective :Registration ofcongenital malformations andofInherited
biochemical and chromosome abnormalities aswell ssoftwins andmultiple
pregnancies inselected areas ofthe Community inorder tomonitor incidence
and prevalence ofcongenital abnormalities andtoallow early institution
ofremedial measures . ;
Harmonization ofexisting national registers andstandardization ofre­
gistration procedures . j
Gradual co-ordination oftheresearch covered bytheconcerted action . -J
Motivation :Congenital abnormalities have become amajor cause ofstill-j
birth ,infant death and childhood disablement .Still ,the number ofcases j
ofcongenital abnormalities occurring inany one area aswell asinasingle |
country isinsufficient for aneffective study atnational level alone ;
therefore ,only aCommunity effort can ensure statistically valid results . !
Ontheother hand,co-ordination will begreatly facilitated bythelimited ;
number ofexisting national registers . '
Starting phase :Establishment ofanappropriate network ofnational
registers with theinitial participation of14regional services from all I
the Member States . -jAfter the Council 'sDecision non-Member States involved inEuropean co- . !
operation inthefield ofscientific andtechnical research (COST )will be
invited toparticipate .
Continuation :Submission ofapossible newaction proposal induetime.
Related activities :First centralized exercise toco-ordinate thenational
policies forresearch onCongenital Abnormalities byanew AdHocWorking
Group of CRM.
Actual elaboration ofaresearch programme inthefield of"Prenatal and
Perinatal screening ofinborn metabolic diseases and chromosome abnormalities
(B)Multiannual Concerted Action <4years )inthefield of
"Cellular Ageing and Decreased Functional Capacity ofOrgans "
Objective :Oriented research oncellular ageing asthebasis fordecreased
functional capacity oforgans inorder tounderstand theresulting phy- ■'
siological ageing processes occurring atthelevel ofthe whole individual ;
study ofthe mechanisms underlying theage-related functional decline in
particular oftheliver ,ofthe immune system andofthelens . ]
Gradual co-ordination oftheresearch covered bytheconcerted action . j
Motivation :There isaclear need toenhance multidisciplinary collaboratioi
andexchange ofexperience andknowledge inanincreasingly important area of
research related tothehealth status ofelder persons ,which isamajor socio
medical problem inEurope .This area hasnever received theattention itde­
serves andinteraction attheexecutive scientific level hastoberegarded
asnot being sufficiently developed .

-5- XII/269/77
Anattempt should bemade toinitiate agradual co-ordination ofavary larga
snddiversified research domain ,where numerous small projects arecarried
out byrelative small research te-^rns from various scientific disciplines ,by
starting from afew ,butwell defined fundamental research topics .
Starting phase :Collaboration between more than 70scientists from about
20institutes ofthe Member States .
After the Council 'sDecision non-Member States involved inEuropean co­
operation inthefield ofscientific andtechnical research (COST )will be
invited toparticipate .
Continuat ion :Aproposal for alargely extended programme inthis field
will very probably benecessary inalater stage inorder tomeet the numerous
research andco-ordinat ionrequirements ,which areinherent but uncovered by
this programme .
(C)Multiannual Concerted Action (4years )inthefield of
"Extracorporeal Oxygenation "
Objective :Collaborative research onimprovement ofpresent extracorporeal
oxygenator principles aswell asondevelopment ofalternative ones,including
methods for continuous monitoring and dynamic compensation ofthepatients
deficiencies ,inorder toobtain thepossibility ofaclinically satisfactory
long-term treatment ;aparticular effort isdirected towards technologies
which diminish the damage tothe blood and atthe same time increase the
efficiency ofgas exchange .
Co-ordination ofthe research covered bythe concerted action .
Motivation :Presently available oxygenators work satisfactorily forperiods
upto5-10hours .Longer working period are needed .Since individual countries
each tackle separately only some ofthe inherent problems and since none of
these national efforts islikely toensure adequate and reasonably early results ,
the chances ofsuccess can besignificantly improved byanintegration ofall
related activities ongoing inthe Member States into acommon action .
Starting phase :Collaboration between more than 100scientists from about
20institutes ofthe Member States .
After the Council 'sDecision Non-Member States involved inEuropean co­
operation inthefield ofscientific andtechnical research (COST )will be
invited toparticipate .
Continuation :Adecision tocontinue this action will rsainly depend or.
theresults obtained from research execution andco-ordination during thefirst three years .

-6- XII/269/77
IV.IMPLEMENTATION OFTHEFIQSTACTIONPROGRAMME
ThefirstprogrammeofresearchactionsinthesectorofMedicalandPublic
HealthResearch,,whichwillbeimplemented bycarryingoutitsthreemulti-
annualconcertedactions,willbeofconsiderable interest,becauseofits
socialandeconomicimportance,toallMemberStates,eventothosenot
involvedinaparticularlineofresearchorlackingtherequiredfacilities
toparticipateactivelyinaparticular way.
AftertheCouncil'sDecisionnon-MemberStatesinvolvedinEuropeanco­
operationinthefieldofscientific andtechnicalresearch(COST)willbe
invitedtoparticipate ineachsingleconcertedaction.
Inprinciple,thecompetentnationalauthorities areresponsible forthe
executionofthenationalcontributions toeachactionwithintheframework
oftheircommitments andarepreparedtointegratetheresearch,coveredby
eachconcertedaction,intoaprocessofco-ordination atCommunitylevel
overtherespectiveperiodsoftime.
ι
ForeachsingleactionaConcertedActionCommitteeisestablished inwhich
theMemberStatesarerepresented byonedelegateandonealternative.The
termsofreferencearelaiddownintherespective AnnexBtotheDraft
CouncilDecision.
Provisionwillbemadeforanadequaterepresentation ofthepossibly
participating ncn-iv'.emberStatesoneachcommittee. '
Thecompetences oftheCommitteeforMedicalandPublicHealthResearch
coveralsotheimplementation ofeachsinjleaction;thisCommitteeisin
particulardulyqualifiedforgivingtotheresearchitsproperplacewithin
thesectorialpolicyoftheEurooeanCommunities aswellasforensuringits
success. |
Theco-ordination ofeachsingLeactionwillbecarriedoutunderthe !
responsibility oftheCommission,assistedbyaProjectLeadertobe !
appointedbytheCommissioninagreementwiththerespectiveConcerted I
ActionCommittees. - 'i
»
V

XII/269/77
FINANCIAL VOLUME
Theestimated financial volume ofthe researcn tobecarnea out bythe
Member States within the framework ofeach action are asfollows :
Concerted action A :"Registration ofCongenital Abnormalities "
0.85 m.u.a .for a3-year period with the active
participation ofalltheMember States .
Concerted action 3 :"Cellular Ageing andDecreased Functional Capacity
ofOrgans "
4.0 m.u.a .for a4-year period with theactive
participation ofBelgium ,Denmark ,
France ,Germany ,Ireland ,Italy ,
TheNetherlands and United Kingdom .
Concerted action C :"Extracorporeal Oxygenation "
4.1 m.u.a .for a4-year period with theactive
participation ofBelgium ,Denmark ,
France ,Germany ,Ireland ,Italy ,
TheNetherlands and United Kingdom .
These figures arebased onestimates ascommunicated bythe competent
national authorities .
The costs ofco-ordination ,oncharge oftheCommunity budget ,areestimated
at :
Concerted action A
Concerted action B
Concerted action C330,000 u.a .for a3-year period
400,000 u.a .for a4-year period
360,000 u.a .for a4-year period
PROSPECTIVES
Thepresent proposal must beseen asoearmg onthe first elements ofthe
Community Medical Research Programme .They will begradually complemented
byother action proposals ,allofwhich will have tomeet the criteria laid
down forCommunity action .Sub-groups arepresently carrying outpreparatory
work ,which will bescreened byCRM atalater stage .
Itisexpected that aproposal forasecond programme will "beready forpre3entat
tothe Council in1978 .

-Α.1- XII/269/77
MULTIANNUAL CONCERTED ACTION
inthe field of
"REGISTRATION OFCONGENITAL ABNORMALITIES "
(3years )
TABLE OF CONTENTS
I. Introduction A.2
II. Motivation A.2
III. Specific aims . A.3
 
IV. Content A.4
V. Structure A.4
VI. Duration A.5
VII.Implementation A.5
VIII .Financial volume A.ó
ANNEX I
PROPOSAL FOR ACOUNCIL DECISION adopting aconcerted action
inthefield of"Registration ofCongenital Abnormalities "
(Medical and Public Health Research ) A.7
Annex AtoANNEX I A.10
Annex BtoANNEX I A.11

-Α.2~ XII/269/77
CONCERTED ACTION
inthe field of
"REGISTRATION OFCONGENITAL ABNORMALITIES "
(Medical and Public Health Research )
INTRODUCTION
Incompliance with itsmandate ,theCommittee onMedical andPublic Health
Research (CRM),assisted byitsSpecialized Workinq Group :Epidemiological ,
Statistics andClinical Trials ,hasrecommended asaproject ofinterest tothe
Community ajoint action inthefield of"Registration ofcongenital Abnor­
malities "andadvised theCommission inelaborating this proposal for amulti -
annual concerted action .
Inaccordance with this opinion theCommission has "chosen this specific research
field :
-onthebasis ofanextensive review ,sponsored byCRM andtheCommission ,
recording theongoing activities intheMember States ;
-byconsidering the agreed objectives ofEuropean co-operation inthe
medical andpublic health domain ,and ... ..
-byapplying theapproved criteria fortheselection ofresearch priorities .
Therelevant activities ongoing innon-Member States ,particularly inEuropean
countries ,aswell asthose ofappropriate International Organizations have
been taken into account .
Theoverall aim oftheproposed action istoset upineach participating "
Member States (where possible forthewhole country ,where notpossible in
aregion with adefined birth population )aregister ofallcongenital ab­
normalities observed atbirth (orduring aperiod after birth tobedefined )
inthetotal birth population (including still-births ),either bymaking use
ofexisting registers ofbycreating newones .
Particular attention isdrawn onthe fact that the information available from
such registers will also beofparticular importance forthe implementation
ofspecific topics relevant tothe "Biology andHealth Protection Programme "
(1976-1980 )andtothe "Environmental Research Programme (1976-1980 ),both
ongoing Indirect Actions ofthe Commission .
Asmodality ofresearch execution preference isgiven toa"Concerted Action ".
MOTIVATION
Inthecountries ofthe European Community ,asaresult ofanincreasing
control ofother major conditions inchildhood ,congenital abnormalities
have become aleading cause ofstill-birth ,infant death andchildhood
disablement .Meanwhile they represent amajor birth problem because they are
common ,they cause agreat amount ofsuffering andtheir care creates a
considerable financial burden tothesociety .

-Α.3- XII/269/77
Betterknowledgeofthefactorsresponsibleforcongenitalabnormalities can
leadtothepreventionofsomeandgreatlyreducethenumberofothersbecause
theseabnormalities oftenresultfromenvironmental factorswithintheuterus
aswellasfromgeneticfactors:forexampledrugortoxicsubstancestaken
bythemother,orcertaininfectionsduringpregnancy.Whilesomeofthese
factorshavebeenidentified,thereisaneedforanearlywarningsystemto
recognizechangingpatternsofcongenitalabnormalities duetofactorsnotyet
identified.
Varioussystemsforrecordingare,astheperformedreviewshows,existingin
theMemberStatesbut,unfortunately,usefulinformation regardingcongenital
abnormalities restsatpresentverylimitedforfollowingreasons:
-systematicinformationdiffersinitscompleteness fromonecountryto
anotherduetolegalandfiscaldifferences insetting-uprecordsandin
runningregisters;
-thenumberofcasesoccurringinanyoneareaaswellasinasinglecountry
isinsufficient foraneffectivestudyatnationallevelalone;
-therecordeddataareofvarioustypesbecausethediagnosticcriteria
appliedvarytoagreatextent.
Theestablishment ofaregisterandanappropriate networkisthereforene­
cessarytom^keonastandardized basisstatistically validstudiesfeasible.
III.SPECIFICAIMS
Theproposedregisterandtheappropriate networkhavethefollowingspecific
aims:
(1)Tomonitorincidenceandprevalenceofcongenitalabnormalities (conge­
nitalmalformations andinheritedabnormalities )indifferentpopulation
groupsandtofollowfluctuations oftrendswithtime.
(2)Toassembleasufficientnumberofspecificabnormalities forretrospective
studiesoftheeffectsofsuspectedenvironmental factors.
(3)Tosetupgroupsforprospectivestudiesontheeffectiveness ofcare,
thecostandthepsychological effectsofabnormalities inordertoassist
ingeneticcounselling.
(4)Toidentifytwinswithorwithoutabnormalities andtoidentifythemas
faraspossibleintomonozyqotic anddizygotictwins;abnormalities with
chromosomalpatternsandwithgeneticdeterminants canthenbestudied.
Finally,itshouldbestressedthatanimportantconsequencewillbetoraise
thelevelofexistingcongenitalabnormalities registerstoa"European
standard"mainlyby:
-thestandardization ofdiagnosticcriteriaandofrecordingprocedures
toallowcomparability ;
-thedissemination ofinformation;
Λ
~theexchangeofexperienceandknowledge;
-theexchangeofpersonnel,and
**thetrainingofskilledpersonnel.

-Α.4- XII/269/77
IV.CONTENT
Theactioninvolvessettingupanotification systemtocollectdataaboiit
anycongenitaldefectobservedbythepersoninattendanceatthebirth
(doctorormidwife)foreverybirth(liveorstillborn)inthecountry(or
inoneofitsdefinedregions).Areportofanyobserveddefecthowever
trivialwouldbeaskedfor,butinitiallythestudydatawouldbeanalysed
foronlythosemalformations whichareimmediately obviousandforwhich
thedatawouldlikelybereasonably complete.
Screeningnewbornchildrenforbiochemicalabnormalities iscarriedoutin
themostEuropeancountriesbutthedatacollectedarenotcentralised,they
remainusuallyinthelaboratories andhospitalswherethechildrenwere
examined.Laboratories inEuropeancountriesbegintoexchangeinformation
aboutthesescreeningproceduresbutthereisanurgentneedforcentra­
lisationofinformation topermitmuchneededepidemiological studiestobe
setup.
Methodological studieswillbecarriedoutinordertoimprovecompleteness
aridrepresentativeness ofascertainment ,procedures andofdiagnostic con­
sistency,aswellastospeedupreportingproceduresformonitoringneeds
inordertoallowearlyinstitution ofremedialmeasuresonthepartof
healthauthorities .
Initiallytheprogrammewillnottrytoencompassallcongenitalabnormalities .
Preliminary studiessuggestthatthelistingofabnormalities reportableto
theregistersshouldberestricted andincludetheanomaliesofth:-central
nervoussystem(anencephaly,spinabifidaetc...),Down'ssyndroire,gross
anomaliesofthelimbs,multipleabnormalities ,phenylketonuria andceliac
disease.Twinsandmultiplepregnancieswillalsoberegistered.Thepro­
grammewillbeexpandedoncetheinitialaimsoffosteringreportingsystems
andupgradingthestandardsofexistingsystemswillbeachieved.
Thestructureoftheconcertedactionisbasedonanextensivereviewofthe
existingsystemsforrecordingbirthsandcongenitalabnormalities inthe
■countriesoftheECaswellasinanumberofneighbouring countrieswith
similartechnicalproblems.
Fromthesesystemsaselectionofregionalregistersorserviceshasbeen
madewithregardtotheircompetences,facilitiesandwillingness ofcollabo­
ration.
Thus,theproposednetworkofregisterswillinitiallybeestablished onthe
collaboration betweenthefollowingexistingregionalregistersoftheMember
States:
BELGIUM :BruggeV.STRUCTURE
Hainaut
DENMARK Odense
FRANCE Paris
GERMANY Hessen
IRELAND Dublin
Galway

-Α.5- XII/269/77
ITALY Milano
Roma
LUXEMBOURG Luxembourg •
NETHERLANDS Leidschendam
UNITED KINGDOM Belfast
Glasgow
Liverpool
Since certain countries outside ofthe ECbuilt upahigh level ofexpertise
inthe running ofcorresponding registers end thus conactively contribute
tothe success ofthis endeavour ,anamendment fortheparticipation ofnon-
Member countries involved inEuropean co-operation inthefield ofscientific
and technical research (COST )inthis action isforeseen after the Council 's
Decision .
VI.DURATION
Aduration of3years isproposed forthis concerted action .
Duetothe complexity ofthe problem tobetackled ,this period should be
considered asaninitial phase .Continuation isforeseen bythe submission
ofanewproposal indue time .
VII.IMPLEMENTATION
The concerted action istobeimplemented with theparticipation ofall Member
States .
After the Council 'sDecision non-Member States involved inEuropean co­
operation inthefield ofscientific andtechnical research (COST )will be
invited toparticipate .
Inprinciple ,the competent national authorities areresponsible forthe
execution ofthenational contributions tothis action and are prepared to
integrate theresearch ,covered bythis concerted action ,into aprocess of
v co-ordination atCommunity level over aperiod of3years .
AConcerted Action Committee isestablished inwhich the Member States are
each represented byonedelegate andonealternative who may beassisted by
experts .
Provision will bemade for anadequate representation oftheparticipating
non-Member States onthe Concerted Action Committee .
The competences ofthe Committee onMedical andPublic Health Research cover
also theimplementation ofthis action ;this Committee isinparticular duly
qualified forgiving tothis research itsproper place within thesectorial
policy ofthe European Communities aswell asforensuring itssuccess .
TheConcerted Action Committee 1sthebody inwhich theexchange ofinformatior
between theMember States ,CRMandtheCommission isstaged .TheCommission anc
the Committee will beassisted byaProject Leader .
V

-Α.6 XII/269/77
®.®yond this ^theterms ofreference ofthis Conimlttee areessentially :
-toassist intheco-ordination ofthenational research projects executed
inthis field andtoadvise theexecuting laboratories ;
-toadvise governments andtheCommission with' regard toresearch needs in
this field ;
-toevaluate the results ofresearch and todraw conclusions with regard
totheir applications ;
-topromote exchange ofexperience between thescientists involved by
organizing symposia ,etc ....;
-topromote thedissemination ofknowledge .
FINANCIAL VOLUME
Thefinancial volume ofthe research inthis field toboexecuted bythe
participating registers orservices ofalltheMember States isestimated
at0.85 m.u.a .for a3-year period .
This figure isbased onestimates ,ascommunicated bythecompetent national
authorities .
Thecosts ofco-ordination ,oncharge oftheCommunity budget ,areestimated
at330,000 u.a .forthe 3-year period .

\
-Α.7-
ANNEX I
PROPOSAL FOR ACOUNCIL DECISION
adopting aconcerted action inthefield of
Registration ofCongenital Abnormalities
(Medical and Public Health Research )
THECOUNCIL OFTHEEUROPEAN COMMUNITIES ,
 
Having regard totheTreaty estaolishing theEuropean Economic Community /
and inparticular Article 235thereof ;
Having regard totheproposal oftheCommission ;
Having regard totheopinion ofthe European Parliament ;
Whereas byvirtue ofArticle 2oftheTreaty ,theCommunity hasbeen assigned
the task ofpromoting throughout theCommunity aharmonious development of
economic activities ,acontinuous andbalanced expansion and anaccelerated
raising ofthestandard ofliving ;
Whereas theCouncil stressed initsResolution of14January 1974 onan
initial outline programme ofthe European Communities inthefield ofscience
andtechnology that anappropriate approach should beadopted towards the
whole range ofavailable ways andmeans ,including concerted action andthat
whenever itproves desirable that third countries ,particularly European ones ,
should beassociated inthese projects ,steps should betaken tomake this
possible ; '■ .
Whereas on14January 1974 ,the Council entrusted theCommunity Institutions
aided bytheScientific andTechnical Research Committee (CREST )with the
task ofensuring thegradual co-ordination ofnational policies inthefield
ofscience andtechnology ;
Whereas aconcerted Community research action inthefield ofregistration
ofcongenital abnormalities islikely tocontribute effectively tothe
achievement oftheabove-mentioned aims ;
Whereas theMember States intend ,aspart oftherules andprocedures appli­
cable totheir national programmes ,tocarry outtheresearch described in
Annex A,andareprepared tointegrate such research into aprocess ofco­
ordination atCommunity level over aperiod ofthree years ;
Whereas thecarrying outofsuch research asdescribed inAnnex Awill require
afinancial contribution ofabout 0.85 MUA from theMember States ;
Whereas theTreaty hasnotprovided thenecessary powers forthis purpose ;
V

Α.8- XII/269/77
ANNEXI
WhereastheScientific andTechnicalResearchCommittee(CREST)hasgiven
itsopinionwithregardtotheCommissionproposal;
HASDECIDED:
Article 1
TheCommunityshallimplementforaperiodof3yearsaconcerted
actioninthefieldofRegistration ofCongenitalAbnormalities .
Thisactionshallconsistintheco-ordination atCommunitylevelof
researchwhichisdescribedinAnnexAandwhichformspartoftheresearch
programmeoftheMemberStates.
Article2
TheCommissionshallboresponsible forsuchco-ordination .
Article3
Themaximumfinancialcontribution bytheCommunitytosuchco-ordination
actionisestimatedat330,000UA,theunitofaccountbeingdefinedaccordingtonancialregulationinforce.
Article4
Tofacilitatethecarryingoutoftheaction,aconcertedactionCommittee
onthe"Registration ofCongenitalAbnormalities",hereinafterreferredtoas
"theCommittee",isherebyestablished.
Aprojectleader:shallbeappointedbytheCommissionwitntheCommittee,s
agreement.HeassistsinparticulartheCommissioninitsco-ordinating action.
Thetermsofreferenceandthecomposition ofthisCommitteearedefined
inAnnexB.
TheCommitteeshalldrawupitsrulesofprocedure.Itssecretariatwill
beprovidedbytheCommission.
Article5
(a)InaccordancewithaproceduretobeadoptedbytheCommissionin
agreementwiththeCommittee,theparticipating Statesshallexchangere­
gularlyallusefulinformationconcerningtheexecutionoftheresearch
coveredbytheconcertedactionandforwardtotheCommissionallinfor­
mationusefulforco-ordination .Theyshallalsoendeavourtoprovidethe
Commissionwithinformation insimilarresearchplannedorcarriedoutby
bodiesforwhichtheyarenotresponsible.Thisinformationshallbe
treatedasconfidentialifrequestedbytheMemberStatewhichprovidesit.
(b)TheCommissionshallprepareyearlyprogressreportsonthebasisof
theinformationsupplied,andshallforwardthemtotheMemberStates.
(c)Attheendoftheco-ordination period,theCommissioninagreement
withtheCommitteeshallforwardtotheMemberStatesandtotheEuropean
Parliament ageneralreportontheexecutionandresultsoftheco­
ordinationaction.TheCommissionshallpublishthisreportsixmonths
afterithasbeenforwarded,unlessaMemberStateobjects.Inthiscase

-Α.9- XII/269/77
ANNEX I
thereport shall bedistributed ,attheir request ,solely totheinstitu­
tions andundertakings ofwhich the research orproduction activities are
justifying access tothe knowledge resulting from the performance ofthe
research covered bythe Community concerted action .The Commission mr.y
make provision tha >the report remains confidential andisnot passed to
third parties .
Article 6
Inaccordance with theprovisions laid down inArticle 228ofthe
Treaty establishing the EEC,the Community may conclude agreements with
other States involved inEuropean Co-operation inthefield ofScientific
andTechnical Research (COST )with aview toextending the co-ordination
which isthe subject ofthis Decision toresearch undertaken inthese
States .
The Commission ishereby authorized toopen negotiations for the
conclusion ofagreements ofthetype referred inthepreceding paragraph .
Article 7
This Decision shall come into force onthe1st January ,1978 .
Done at on
For the Council
The President
}

Α.10 XII/269/77
Annex Ato ANNEX I
ANNEX ATOTHE PROPOSED COUNCIL DECISION
adopting aconcerted action inthefield of
Reqistration ofConqenitnL Abnormalities
(Hedical and Public Health Research )
The research will becarried outwith the purpose ofacquiring scientific and
technical knowledge inthis field ,selected forits importance atCommunity
level .
The research isexpected tocover thefollowing topics :
(1)Registration ofcongenital malformations aswell asofinherited bio­
• chemical and chromosome abnormalities inselected regions ofthe
Community .Initially ,the recorded abnormalities will include the
anomalies ofthe nervous system (anencephaly ,spina bifida ,etc.
.Down'ssyndrome ,gross anomalies ofthe limbs ,multiple abnormalities ,
' phenylketonuria andceliac disease .
i?.
(2)Registration oftwins andmultiple pregnancies inselected regions of
the Community .
(3)Relevant methodological studies inorder toobtain anoptimal co-ordination
ofboth existing national registers andregistration procedures .
i The co-ordination will include thefollowing regional registers ofthe Member
States
BELGIUM
LUXEMBOURG
NETHERLANDS
United KingdomGERMANYDENMARK
ITALYIRELANDFRANCEBrugge and Hairiaut
Odense
Paris
Hessen
Dublin end Galway
Milano and Roma
Luxembourg
Leidschendam
Belfast ,Glasgow andLiverpool
These countries will contribute research under alt three tooics mentioned
above .
ι

Α.11 XII/269/77
Annex Bto ANNEX I
ANNEX BTOTHE PROPOSED COUNCIL DECISION
adopting aconcerted action inthefield of
Registration ofCongenital Abnormalities
(Medical and Public Health Research )
l£H2S-2Í-££Í£C®Q£§_2Q^_£2!!!!22£Í£Í2Q_2Í_Í.Di.£2D£££££íí.§£ÍÍ2Q_£2!!3'3ÍÍS£I
"I§2Í§£ü¿£Í2Q_2Í_£2GíI£ ni*a^Abno rmalities"
1. The Committee shall :
1.1.Contribute tothe optimum execution ofthe programme bygiving its
opinion onallofits aspects ;
1.2.Evaluate theresults and draw conclusions asregards totheir
application ;
1.3.Ensure the exchange ofinformation referred tpinArticle 5(a);
1.4.Keep abreast ofnational research being done inthefields covered
bythe concerted action .,and more especially ofscientific and
technical developments likely toaffect the carrying outofthe
action ;
1.5.Indicate theorientations totheproject leader .
2. The Committee 'sreports andopinions shall betransmitted tothe
Commission andtotheparticipating States .The Commission shall forward
these opinions tothe CREST .
3. The Committee shall becomposed ofon£representative and one
alternative responsible forco-ordinating thenational contributions
tothe programme /andtheproject leader .Each member may beaccompanied
byexperts .
\

XII/269/77
MULTIANNUAL CONCERTED ACTION
inthe field of
"CELLULAR AGEING AND DECREASED FUNCTIONAL CAPACITY OF03G<U 'S"
(4years )
TABLE OFCONTENTS
Pane
I. Introduction 8.2
II. Motivation ....... ......... B.2
III . Content andtopics B.3
IV. Structure D.5
V. Durât icn ..... B.6
VI.Implementation B.6
VII .Financial volume B.7
ANNEX I
PROPOSAL FOR ACOUNCIL DECISION adopting aconcerted action
inthefield of"Cellular Ageing andDecreased Functional
Capacity ofOrgans
<Mc-dical and Public Health Research ) B.8
Annex AtoANNEX I B.11
Annex BtoANNEX I B.13

-Β.2- XII/269/77
CONCERTED ACTION
inthefieldof
"CELLULARAGEINGANDDECREASED FUNCTIONAL CAPACITY OFORGA'.'S"
(MedicalandPublicHealthResearch)
I.INTRODUCTION
Incompliancewithitsmandate,theCommitteeonMedicalandPublicHealth
Research(CRM),assistedbyitsSpecialized WorkingGroup:Researchinthe
fieldofMedicalBiology,hasrecommendedasaprojectofinteresttothe.Commun
thejointimplementation ofresearchinthefieldof"Cellularageingand
decreasedfunctionalcapacityoforgans"andadvisedtheCommissioninelabo­
ratingacorresponding proposalforamultiannual concertedaction.
InaccordancewiththisopiniontheCommissionhaschosenthisspecificresearch
field:
-onthebasisoftheexploratory workcarriedoutbytheSpecialized
WorkingGroup;
-byconsidering theagreedobjectivesofEuropeanco-operation inthe
medicalandpublichealthdomain;
-byapplyingtheapprovedcriteriafortheselectionofresearch
priorities,and
-havingregardtotheconclusionselaborated bytheEuropeanexperts
inthisspecificfieldduringaworkshop,heldon12-14February1976
underthesponsorship ofCRMandtheCommission,,whereaccordingtothe
presentstateoftheartthemostsignificantresearchproblemswere
identified,andwheretheneedsforthemostefficienthandlingofthe
problem,fromthepointofviewcfresearchandtrainingrequirements,
wereevaluated.
Therelevantactivitiesongoinginnon-MemberStates,particularly inEuropean
countries,aswellasthoseofappropriateInternational Organizations have
beentakenintoaccount.
Asmodalityofresearchexecutionpreferenceisgiventoa"Conc®rtedAction".
II.MOTIVATION
Thehealthstatusofelderpersonsandproblemsconnectedtoitareofmajor \
socio-medicaIconcernsinceatleast11%ofthepopulationintheEuropean j
Communityisolderthan65yearsofage.Socialandmedicaladvanceswill jcontinuetochangetheage-structure ofthepopulationandincreasethepro- .
portionofelderpersonsinit.Alsobirthratemayplayanadditionalrole j
infuture;thusitcanbeexpectedthatthesechangesinsizeandstructure jofthepopulationwillhaveagreatimpactofhealth,healthcareand.health
researchintheEC. j

Β.3- XII/269/77
Biologicalageingprocessesarethecauseforthegradualchangeofayoung
individualintoanoldoneandtheycontributetothedevelopment ofmany
diseasesintheelderlypopulation.Inthe11%quotedabove,between80and
90%sufferfromoneormorechronicdisease.Thus,increasingsumshaveto
beyearlyallocatedbythesingleMemberStatesforthehealthcareofelderly
persons.
Nevertheless,researchinthedomainofGERONTOLOGY,coveringthebiological,
psychological andsocialaspectsofageing,hasneverreceivedalltheatten­
tionitdeserves.AlthoughresearchiscarryingoutintheMemberStateson
thevariousaspectsofthiscomplexproblemandseveralscientificcentres
havereachedahighlevelofspecialknowledgeandexpertise,thescientific
developments inthisareahavenotkeptupneitherwiththeneedsofour
societynortherequirements.ofourscientific community.
Therefore,asarealisticapproachinordertotackleabasicpartofthe
problemconnectedwiththephysiologyofageinginamoreefficientway,and
toachieveclearandreasonablyearlyresults,ajointEuropeanresearch
effortwasdeemednecessary.
Sincechangesatthecellularlevelareprobablyresponsible formostofthe
physiological ageingprocessesoccurringattheorganLevelandatthelevel
ofthewholeindividual,theemphasiswasplacedoncellularageingasthe
basisfordecreasedfunctionalcapacityoforgans.
Threerepresentative topics,eachwithitsownspecificapproachtothe
problemofthecellularbasisofageing,allcloselyrelatedtothephysiology
ofelderlypeople,wereselectedforinitialaction.Thesewere:
A.Cellularbasisofliverageing
B.Theimmuneresponseduringageing
C.Ageingofthelens
CONTENTANDTOPICS
A.Cellularbasisofliverageing
Manymammalianorgans,includingtheliver,showadecreaseinfunctional
capacitywithage.Duetothecomplexmannerinwhichorgansfunction,it
isverydifficulttodifferentiate betweencellularandextracellular
causesfortheimpairmentinfunction.Furthermore,itisimpossibleto
makeadetailedinterpretation oftheageingofanorganintheabsence
ofquantitative information onthepropertiesofthevariouscellclasses
withintheorganinquestion.
Thecellularbasisoftheageingprocesshasbeenstudiedinorgans,
tissuesandcellorganelles,inparticularintheliver/thefunctionsof
whichdeclinewithage.Abetterunderstanding ofthemechanismunder­
lyingthisfunctionaldeclinewillbeachievedbyimprovingthemethods
ofanalyzingseparatelythedifferentcelltypesoftheliverandbyre­
constituting invitrotherelationships whichexistbetweenparenchymal
cellsandKupfferandendothelialcells,inordertodeterminetheir
respectiveimportance.Theanalysisofthevariouscelltypeswillinclude
thecomparisonofalterations inbioenergetic andotherbiochemical cha­
racteristics ofmithochondria andintheregulationoflysosomalenzyme
activities.

Β.4- XII/269/77
Tho immune response during ageing
Thedisciplines ofimmunology andgerontology impinge upon each other in
several ways .
The immune systerr provides aconvenient model fortheinvestigation of
ageing processes -"Janimmense a-nount ofbackground information is
available .The system can bestudied byawide variety ofwell-established
quantitative techniques aridisknown toundergo progressive age-associated
changes .Longitudinal studies arepracticable inboth animals and,toa
more limited extent ,inman.
Theexisting patterns of,and immediate potential for,collaboration in
immunogerontology are perhaps less highly evolved partly duetothe
broadness ofthesubject andthediversity oftopics currently understudy .
Such diversity isasource ofstrength ,provided that good contact can be
maintained and developed among theinterested laboratories .Inthe immediate
future ,exchanges oftechniques andmaterial among several laboratories are
planned .Inaslightly longer term,itisenvisaged that more extensive
collaboration will develop incertain areas ,particularly intheapplication
tomanofinvestigational systems developed inanimals .
Ageing ofthe lens
The lens grows during the whole lifespan ,increasing inweight and volume .
Itisthe organ with the highest protein content ;about 35% ofits wet
weight consists almost completely oforgan specific proteins which ,through
aspecial arrangement ,are responsible foritstransparency .
Ageing leads to2different effects representing adecreased functional
capacity ,which have been well-known toophthalmologists forcenturies :
a)around the 4th decade ,the human lens looses theability ofaccomodation ,
which means that the capacity for changing the lens shape toenable lens
focusing atdifferent distances becomes weaker ,
and
b)each ageing person develops morphological lens changes .However ,itis
remarkable that only insome patients dothese circumscribed opacities
progress tomature cataracts ,the time ofoccurrence warying widely .
The proposed co-operative research onageing ofthe lens should provide
more complete information onthedifferent age-induced mechanisms loading
towell-differentiates types ofsenile cataracts .From experimental
cataract research ,there isevidence that certain models provide transpa­
rency changes which aresimilar tothose observed inthe ageing human .
This study hastobeperfected inorder toperform future investigations
with suitable animal models .Itisnecessary togain better knowledge on
the age-related disturbances andmodifications which could influence the
process ofcell division anddifferentiation for the synthesis ofcrystallin
and capsular material .
Inepithelial andterminally differentiated lens cells ,the machinery for
protein synthesis hastobemaintained .This implies astabilization of
mRNA,the molecular mechanisms ofwhich have not yet been completely elu­
cidated .Proteins once synthesized undergo age-induced changes byaggrega­
tion,insolubi lisation andposttranslational modifications ofprimary
structure .Theunderlying mechanisms ofsuch changes must befurther in­
vestigated inorder tobetter understand howthey effect thefunctional
capacity ofthe lens .Discoveries inthe mechanisms ofageing inthe lens
will probably beapplicable tothe mechanisms inmost oftheother tissues
notreadily available for research purposes .

-Β.5- XII/269/77
Finallyinadditiontotheseresearchtopics,theconcertedactionhastp
includethefollowingpossibilities andtechnicalfacilities,respectively :
-shorttermexchangeofresearchworkersbetweencollaborating laboratori' >
inordertotraininspecialmethodsortoperformspecialinvestigations
onthespotusingavailableexperimental material;
-aninformationcentretoadviceonavailability ofmaterial(animals,organs
andtissues)whichisscarceandexpensive.Thiswouldnotonlyleadtocon­
siderablesavingsbyavoidingwaste,butalsopermitanoptimalutilization
ofoldanimals,whicharedifficulttoobtain;
-.aoneyearplenarymeetingatwhichaninterdisciplinary viewoftherelated
researchandresultsaswellasfuturetrendsandplansmaybeobtainedby
allparticipants .Thisgeneralmeetingwouldalsopermittheestablishment
ofstandardization inmaterialsandmethodsused;
-twiceyearlyinterlaboratoryexchangeofideas,methodsandresultsbyvisits
ofscientistswithineachsub-group.Thesein-depthdiscussions shouldbe
donebyrotationofthemeetingplacestoallowabetterknowledgeofthe
facilities,methodsandresearchofeachteam,and
-aprojectleader.
STRUCTURE
Sincethenationalauthorities areresponsiblefortheexecutionoftheir
respectivecontributions tothisconcertedaction,severalMemberStateshave
designatedtheircompetentmedicalresearchorganizations asactivepartici­
pants,whileotherMemberStatesdesignateddirectlytheparticipating insti­
tutes,whichwerechosenwithregardLotheircompetences,facilities and
willingnessforcollaboration .
BELGIUM
-F.N.R.M.FondsNationaldelaRechercheMédicale,Bruxelles
DENMARK .
-DanishMedicalResearchCouncil,Copenhagen
t
FRANCE­
-INSERMInstitutNationaldelaSantéetdelaRechercheMédicale,
Paris
GERMANY
D1-InstitutfürExperimentelle Ophthalmologie derUniversität Bonn
AbteilungBiochemiedesAuges,Bonn-Venusberg
D2-Max-Planck-InstitutfürImmunbiologie,Freiburg-Zähringen
IRELAND
-MedicalResearchCouncilofIreland,Dublin
ITALY ' '
-C.N.R.ConsiglioNazionaledellaRicerca,Roma ■

-3.6 - XII /269/77
NETHERLANDS
NL1 -Laboratorium voor Biochemie Universiteir vanNijmegen ,Nijmegen
NL2 -Institute forExperimental GërontoLcgy TNO,Rijswijk
NL3 -Centraal Laboratorium Bloed Transfus-iedienst ,Amsterdam
unII§2_!<ING£0M
-M.R.C. Medical Research Council ,London
V. DURATI0N
Aduration of4years isproposed forthis concerted action .
VI.IMPLEMENTATION
The concerted action istobeimplemented with theagreement ofallMember
States .
After theCouncil 'sDecision non-Member States involved inEuropean co­
operation inthe field ofscientific andtechnical research (COST )will be
invited toparticipate .
Inprinciple ,the competent national authorities areresponsible forthe
execution ofthenational contributions tothis action and areprepared to
integrate the research ,covered bythis concerted action ,into aprocess of
co-ordination atCommunity level over aperiod of4years .
AConcerted Action Committee isestablished inwhich the Member States are
each represented byone delegate andone alternative ,who may beassisted by
experts .
Provision will bemade for anadequate representation oftheparticipating
non-Member States onthe Concerted Action Committee .
The competences .ofthe Committee onMedical and Public Health Research cover
also the implementation ofthis action ;this Committee isinparticular duly
qualified forgiving tothis research itsproper place within the sectorial
policy ofthe European Communities aswell asforensuring itssuccess .
TheConcerted Metier ;Committee isthebody inwhich theexchange ofinformation
i-wt -.,een theMember States ,CRMandtheCommission isstaged .The Commission and
theCommittee will beassisted byaProject Leader .
Beyond this ,theterms ofreference ofthis Committee areessentially :
-toassist intheco-ordination ofthenational research projects executed
inthis field andtoadvise theexecuting laboratories ;
-toadvise governments andtheCommission with regard toresearch needs in
this field ;
-toevaluate the results ofresearch and todraw conclusions with regard
totheir applications ;
-topromote exchange ofexperience between thescientists involved by
organizing symposia ,etc ....;
~topromote thedissemination ofknowledge .

XII/269/77
VII.FINANCIAL VOLUME
Thefinancialvolumeoftheresearchinthisfieldtobeexecutedbythe
MemberStatesisestimatedat4,0m.u.a.fora4-yearperiod.
Thisfigureisbasedonestimates,ascommunicated bythecompetentnational
authorities .
TheinventoryoftheresearchprojectsindicatesthatBelgium,Denmark,France,
Germany,Ireland,Italy,TheNetherlands andUnitedKingdomwouldcontribute
researchunderthethreetopicsofthisconcertedresearchaction.
Thecostofco-ordination ,onchargeoftheCommunitybudget,isestimated
at400,000u.a.forthe4-yearperiod.

-Β.8-
ANNEXI
PROPOSAL FORACOUNCILDECISION
adopting3concertedactioninthefieldcf
CellularAgeingandDecreasedFunctionalCapacityofOrgans
(MedicalandPublicHealthResearch)
THECOUNCILOFTHEEUROPEANCOMMUNITIES,
HavingregardtotheTreatyestablishing theEuropeanEconomicCommunity,
andinparticularArticle235thereof;
HavingregardtotheproposaloftheCommission;
HavingregardtotheopinionoftheEuropeanParliament;
WhereasbyvirtueofArticle2oftheTreaty,theCommunityhasbeenassigned
thetaskofpromotingthroughout the-'Communityaharmoniousdevelopment of
economicactivities,acontinuousandbalancedexpansionandanaccelerated
reisingofthestandardofliving;
WhereastheCouncilstressedinitsResolutionof14January1974onan
initialoutlineprogrammeoftheEuropeanCommunities inthefieldofscience
andtechnologythatanappropriate approachshouldbeadoptedtowardsthe
wholerangeofavailablewaysandmeans,includingconcertedactionandthat
wheneveritproves,desirablethatthirdcountries,particularly Europeanones,
shouldbeassociatedintheseprojects,stepsshouldbetakentomakethis
possible;
Whereason14January1974,theCouncilentrustedtheCommunityInstitutions
aidedbytheScientific andTechnicalResearchCommittee (CREST)withthe
taskofensuringthegradualco-ordination ofnationalpoliciesinthefield
ofscienceandtechnology;
WhereasaconcertedCommunityresearchactioninthefieldofcellularageing
anddecreasedfunctionalcapacityoforgansislikelytocontributeeffectively
totheachievement oftheabove-mentioned aims;
WhereastheMemberStatesintend,aspartoftherulesandproceduresappli­
cabletotheirnationalprogrammes *tocarryouttheresearchdescribedin
AnnexA,andarepreparedtointegratesuchresearchintoaprocessofco­
ordinationatCommunityleveloveraperiodoffouryears;
WhereasthecarryingoutofsuchresearchasdescribedinAnnexAwillrequire
afinancialcontribution ofabout4,0MUAfromtheMemberStates;
WhereastheTreatyhasnotprovidedthenecessarypowersforthispurpose;

-Β.9 XII/269/77
AnnexI
WhereastheScientific andTechnicalResearchCommittee (CREST)hasgiven
itsopinionwithregardtotheCommissionproposal;
••
HASDECIDED:
Article 1
TheCommunityshallimplementforaperiodof4yearsaconcerted
actioninthefieldofCellularAgeingandDecreasedFunctionalCapacityof
Organs.
Thisactionshallconsistintheco-ordination atCommunitylevelof
researchwhichisdescribedinAnnexAandwhichformspartoftheresearch
programmesoftheMemberStates.
Article2
TheCommissionshallberesponsibleforsuchco-ordination .
Article3
Themaximumfinancialcontribution bytheCommunitytosuchco-ordination
actionisestimatedat400,000UA,theunitofaccountbeingdefinedaccordingtothi
financialregulationinforce.
Article4
Tofacilitatethecarryingoutoftheaction,aconcertedactionCommittee
onthe"CellularAgeing"hereinafterreferredtoas"theCommittee",is
herebyestablished.AprojectleadershallbeappointedbytheCommissionwith
theCommittee'sagreement.HeassistsinparticulartheCommissioninitsco­
ordinatingaction.
ThetermsofreferenceandtheconpositionofthisCommitteearedefined
inAnnexB.
TheCommitteeshalldrawupitsrulesofprocedure.Itssecretariatwill
beprovidedbytheCommission.
Article5
<a)InaccordancewithaproceduretobeadoptedbytheCommissionin
agreementwiththeCommittee,theparticipating Statesshallexchangere­
gularlyallusefulinformationconcerningtheexecutionoftheresearch
coveredbytheconcertedactionandforwardtotheCommissionallinfor­
mationusefulforco-ordination.Theyshallalsoendeavourtoprovidethe
Commissionwithinformation onsimilarresearchplannedorcarriedoutby
bodiesforwhichtheyarenotresponsible .,ThisinformationshallbetreatedasconfidentialifrequestedbytheMemberStatewhichprovidesit.
(b)TheCommissionshallprepareyearlyprogressreportsonthebasisof
theinformationsupplied,andshallforwardthemtotheMemberStates.
<c)Attheendoftheco-ordination period,theCommissioninagreement
withtheCommitte ;eshallforwardtotheMemberStatesandtotheEuropean
Parliamentageneralreportonthoexecutionandresultsoftheco­
ordinationaction.TheCommissionshallpublishthisreportsixmonths
afterithasbeenforwarded,unlessaMemberStateobjects.Inthiscase

-Β.10- XII/269/77
Annex I
-» –––.
the report shall bedistributed ,attheir request ,solely totheinstitu­
tions andundertakings ofwhich the research orproduction activities are
justifying access tothe knowledge resulting from the performance ofthe
research covered bythe Community concerted action .The Commission mry
mak?provision that the report remains confidential andisnot passed to
third parties .
Article 6
1. Inaccordance with theprovision laid down inArticle 228ofthe
Treaty establishing the EEC,the Community may conclude agreements with
other States involved inEuropean Cc-operation inthefield ofScientific
andTechnical Research (COST )with aview toextending theco-ordination
which isthe subject ofthis Decision toresearch undertaken inthese
States .
2. The Commission ishereby authorized toopen negotiations forthe
conclusion ofagreements ofthe type referred inthe oreceding paragraph .
Article 7
This Decision shall come into force onthe1stJanuary ,1978.
Done at on
For the Council
The President

-Β.11- XII/269/77
Annex Ato ANNEX I
ANNEX ATOTHE P80P0SED COUNCIL DECISION
adopting aconcerted action inth?field of
Cellular Ageing and Decreased Functional Capacity ofOrgans
(Medical and Public Health Research )
The research will becarried out wich thepurpose ofacquiring scientific and
technical knowledge inthis field ,selected foritsimportance atCommunity
level .
The research isexpected tocover thefollowing topics :
(1)Cellular basis ofliver ageing :biophysical andbiochemical studies
atorgan ,cellular andsubcellular level oftheprogressive ,cge-
associated functional alterations ,including comparative studies in
other cell types .
(2)The immune response during ageing :oriented studies inboth animals
and,toalimited extent ,inmanofthe age-induced changes inthe
immune system with emphasis onimmunodeficiencies andpossibilities
oftherapy .
(3)Ageing ofthe Ions :physiological ,-morphological and biochemical
studies inhuman and animal tissues ofthe age-related functional
alterations leading tosenile cataracts .
The co-ordination will include thefollowing competent medical research
organizations respectively participating institutes ofthe Member States :
BELGIUM
-F.N.M.R. Fonds National delaRecherche Médicale ,Bruxelles
DENMARK
-Danish Medical Research Council ,Copenhagen
FRANCE
-INSERM Institut National delaSanté etdelaRecherche Médicale ,
Paris
GERMANY
-Institut für Experimentelle Ophtalmologie derUniversität Bonn
Abteilung Biochemie des Auges ,Bonn-Venusberg
-Max-Planck -Institut für Immunbiologie ,Freiburg-Zähringen
IRELAND
-Medical Research Council ofIreland ,Dublin
ITALY
-C.N.R. Consiglio Nazionale della Ricerca ,Roma

-8.12- XII/269/77
AnnexAtoANNEXI
NETHERLANDS
-Laboratorium "voorBiochemie-Universiteit vanNijmegen,Nijmegen
-InstituteforExperimental Gerontology TNO,Rijswik
-CentraalLaboratorium BloedTransfusiedienst ,Amsterdam
-M.R.C.MedicalResearchCouncil,London
Thesecountrieswillcontributeresearchunderthethreetopicsmentioned
above.
;

-B.13 - XII/269/77
Annex Bto ANNEX I
AMNEX 'dTOTHE -ROPOSED COUNCIL DECISION
adontin :-)acrncerted action inthefield of
Cellular Ageing and Decreased Functional Capacity ofOrgans
(Medical and Public Health Research )
Terffis_£f_reíerençG_ind_çori£2£ÍÍÍ2Q_2Í_Ab2_£2Q£e£ted_açtÍ2Q-.Çommitte2
"Cellular_Ageinn
1. The Committee shall :
1.1.Contribute tothe optimum execution ofthe programme bygiving
itsopinion onallofits aspects ;
1.2.Evaluate theresults and draw conclusions asregards totheir
application ;
1.3.Ensure the exchange ofinformation referred toinArticle 5(a);
1.4.Keep abreast ofnational research being done inthefields covered
bythe concerted action ,and more esecially ofscientific and
technical developments likely toaffect the carrying outofthe
action .
1.5.Indicate theorientations totheproject leader .
2. The Committee 'sreports andopinions shall betransmitted tothe
Commission andtotheparticipating States .The Commission shall forward
these opinions tothe CREST .
3. The Committee shall becomposed ofone representative and onealter­
native responsible forco-ordination thenational contributions tothe
programme ,andtheproject leaser ,Each member may beaccompanied •
byexperts .

-C.1- XII/269/77
MULTIAMNUAL CONCERTED ACTION
inthefieldof
"EXTRACORPOREAL OXYGENATION "
(4years)
TABLEOFCONTENTS
Paqe
I.Introduction C.2
II.Motivation C.2
III.Objectives C.4
IV.Structure C.4
V.Duraticn C.5
VI.Implementation ...... C.5
VII.Financialvolume C.6
ANNEXI
PROPOSALFOSACOUNCILDECISION'adontingaconcertedaction
inthefieldof"Extracorporeal Oxygenation"
(MedicalandPublicHealthResearch) C.7
AnnexAtoANNEXI C.10
AnnexBtoANNEXI .C.12
V

-C.2 - XII /269/77
CONCERTED ACTION
inthe field of
"EXTRACORPOREAL OXYGENATION "
(Medical end Public Health Research )
INTRODUCTION
Incompliance with itsmandate ,the Committee onMedical andPublic Health
Research (CRM),assisted byitsSpecialized Working Group :Research inthe
field ofBiomedical Engineering ,hasrecommended asaproject ofinterest tothe
Community thejoint implementation ofresearch inthefield of"Extracorporeal
Oxygenation "andadvised theCommission inelaborating acorresponding pro­
posal for amultiannual concerted action .
Inaccordance with this opinion theCommission haschosen this specific research
field :
-onthebasis oftheexplorative work carried outbytheSpecialized
Working Group ;
-byconsidering theagreed objectives ofEuropean co-operation inthe
medical andpublic health domain ;
-byapplying theapproved criteria fortheselection ofresearch
priorities ,and
-having regard to.theconclusions elaborated bytheEuropean exports
inthis specific "»■»•»Idduring aworkshop ,held on15-20 June 1975 in
Copenhagen under thtsponsorship ofCRMandtheCommission ,where
according tothepreset state oftheartthemost significant problems
related tothis field o:-research were identified .
Therelevant activities ongoing non-Member States ,particularly inEuropean
countries ,have been taken into «-'-'f>unt.
Execution intheform ofa"Concerted ;**.ion"wasdeemed important ifthe -
research problems were tobecarried on -;-■£eiciently .Because none ofthe
national efforts alone islikely toensure v.--.quate andreasonably early
results ,thechances ofsuccess canbesign ^ev...ntly improved bytheir in­
tegration into aconcerted acti-on .
r
MOTIVATION
Treatment with oxygenators hasinthepast twodecades >\>-iiybeen focused
onshort term usetoprovide cardiopulmonary support durv\surgical cor­
rections and replacements .
Forthis purpose thepresently available oxygenator types havt pr->ve clinically
satisfactory forperiods upto5-10 hours .
Thecategories ofillnesses treated bysuch surgery arevalvular functional
defects andcongenital malformations .However ,these diseases constitute
only apart ofthecardio-pulmonary disorders which could potentially be
treated better iflong term extracorporeal oxygenation were possible .

-C.3 • XÏI/269/77
Forexample ,cardiac failure duetoacute myocardial infarction istoday the
most frequent cause ofphysical disability intheproductive agegroups ,from
which relatively high direct andindirect costs tooursociety arearising .
Recent advances ir>coronary surgery provide apossibility ofrecovering the
full function oftht ;schaemic myocardial tissue .Here ,theremarkable ca­
pability ofrapid revac.' xMlarisation ofthemyocardium canbeutilized by
attempting arelief ofx-.-.heart through cardiopulmonary support during this
period .Also thetreatment t;reversible reduction orlossoflung function
will require theuseofextracorporeal oxygenation butforperiods longer
than aweek .
With itsdemand forlong term use\foxygenators what seemed earlier appa­
rently negligible problems have grown •->become limiting factors forthe
success ofthetreatment .Furthermore ,vpatients inquestion areinvariably
very illandundergo apoor functioning o?their regulatory systems which are
outofcontrol .Cardiopulmonary failure is .vsquently associated with anuria ,
coagulopathies andoften further complicated r.yinfections .Thevictims are
thus unable towithstand further shifts intheir ohysiologi calparameters .
Consequently ,success oftreatment depends onacloie dynamic adjustment of
theperformance according totheneeds ofthepatient .Inclinical terms this
implies attempts notonly tocontrol theconventional blood gasandelectrolyte
parameters aswell astheoxygen consumption ,butalso tomaintain asufficiem
blood flow through atleast thevital organs andtosustain thenutrition of
theorganism .
From asurvey ofthepresent state oftheartconcerning oxygenator research
thefollowing main conclusions canbedrawn :
–Substitution ofmembrane oxygenators forthose simply using direct gas-to -
blood interface ,e.g. inform ofgasbubbles ,mayimprove possibilities
forextracorporeal clinical oxygenation from hours toweeks duration .
Thefirst generation ofsuch membrane oxygenators confirms this view .
Though improvement offlow geometry already haslead toartincrease in
thegastransfer rate ,thepresently available oxygenators aswell as
those ofthenear future will represent only atemporary solution dueto
theserious physical andbiological limitations inherent inpresent membran
materials .
–Available systems aredesigned andused attheir peak capacity andthe
problem ofcontrolled adaptation ofgasexchange capacity totheneeds of
thepatient remains unsolved .
–Thecurrently available membrane materials areatbest biologically inert ,
andthese arenotable toprevent blood trauma andthrombotic deposits
which inturn leads toprogressive deterioration ofoxygenation efficiency
andtoanenhancement ofbleeding tendency inthetreated patient .
Inview ofthemultitude ofproblems tobesolved ,atdifferent levels ,a
joint multidisciplinary research effort will "bemore likely toovercome the
difficulties involved .
Furthermore ,since individual countries each tackle separately only some of
these problems andsince none ofthese national research efforts alone is
likely toensure aconcerted attack ontheoverall problem ,anintegration of
allrelated activities ,ongoing intheMember countries ,into aConcerted
Action "islikely toincrease thechances ofsolving theproblem .

C.4- XII/269/77
III.OBJECTIVES
Thefollowingthreerepresentativeobjectives,allofthornfeasibleandofferinggoodprospectsofsuccess,werechosenforthisjointEuropean
researcheffort:
1)Continuousimprovementinperformanceofpresentoxygenatorprinciples
withrespecttothelimitationssotbydiffusionresistanceandblood
trauma.
a)Clinical-applicabilityofintroductionofacontrolledsecondary
flow(bloodnixing)intopresentoxygenatorprinciples.
b)Studiesoftheeffectsofbloodflowandshearstressontheaggre­
gationandadhesionofplatelets,oftheinteractionof^redcells
andplatelets,andofpharmacologic methodsofintervention.
2)Continuousdevelopmentofalternativeoxygenationprinciplesandtesting
fortheirclinicalapplicability . __
•Here,researchisaiminginparticularatfurtherdevelopmentandjoint
evaluationoftheprinciplesof:
a)Hyperbaricoxygenation .
b)Physico-chemical releaseofoxygen(from2®2'troughmembranes
containingcatalaticactivity.
C)Liquidoxygenationbyusinginertliquids<fluorocarhons )fordirect
gastransfertotheblood.
3)Developmentofmethodsforcontinuouscontrolanddynamic _compensation
ofthepatientrespiratory,circulatoryandmetabolicdeficiencies.
a)Dynamiccontrolsystems,basedonoxygenconsumptionandcarbon
dioxideproductioninthepatient,fortheregulationofthegas
transferrateinoxygenators .
b)RegulationofbloodelectrolytesandpHintheperfusedpatient.
Inadditiontotheseresearchobjectives,,theprogrammeshouldforesee:
-aoneyearlyplenarymeetingatwhichaninterdisciplinary viewoftherelatedresearchandresultsaswellasfuturetrendsandplansmaybe
obtainedbyallparticipants,
-interlaboratorymeetingsandexchangeofpersonnelforshortperiodstofamiliarizewithmethodsandequipmentoractuallycarryoutexperiments
onthespotinclosecollaboration withthehostscientists,
-aprojectleader.
£V.STRUCTURE
Sincethenationalauthoritiesareresponsiblefortheexecutionoftheir
respectivecontributionstothisconcertedaction,severalMemberStates
havedssionatedtheircompetentsnedicalresearchorganizations asactiveparticipants,whileotherMemberStatesdesignateddirectlytheparticipatinginstitutes,whichwerechosenwithregardtotheircompetences,faculties
andwillingnessforcollaboration .

-c.s XII/269/77
BELGIUM
-F.N.R.M.FondsNationaldelaRechercheMédicale/Bruxelles
DENHARK
-DanishMedicalResearchCouncil,Copenhagen
FRANCE
-INSERMInstitutNationaldelaSantéetdelaRechercheMédicale,
Paris
GERMANY
01-GermanHearthCentre,Munich
D2-Dept.ofPhysiology,TechnicalUniversity,Aachen
D3-MPI,System-Physiologie ,Dortmund
D4-Dept.ofPhysiology,UniversityofMainz
IRELAND
-MedicalResearchCouncilofIreland,Dublin
ITALY
-C.N.R.ConsiglioNazionaledellaRicerca,Roma
NETHERLANDS
NL1-UniversityofGroningen
NL2-EindhovenUniversityofTechnology
NL3-Dept.pfPhysiology,UniversityofNijmegen
NL4-Dept.ofappl.PhysiologyandCryobioLogy,CentralRedCrossBlood
Transfusion Service,Amsterdam
y^II£!L!<INGD0M
-M.R.C.MedicalResearchCouncil,London
V.DURATI0N
Adurationof4yearsisproposedforthisconcertedaction.
VI.IMPLEMENTATION
Theconcertedactionistobeimplemented withtheagreementofallMember
States.
AftertheCouncil'sDecisionnon-MemberStatesinvolvedinEuropeanco­
operationinthefieldofscientificandtechnicalresearch(COST)willbe
invitedtoparticipate . v
Inprinciple,thecompetentnationalauthoritiesareresponsibleforthe
executionofthenationalcontributions tothisactionandarepreparedto
integratetheresearch,coveredbythisconcertedaction,intoaprocessof
co-ordination atCommunityleveloveraperiodof4years.
V

C.6- XII/269/77
AConcerted Action Committee isestablished inwhich the Member States are
each represented byone delegate and onealternative who may beassisted by
experts . .... ...
Provision will bemade for anadequate representation oftheparticipating
non-Member States onthe Concerted Action Committee .
The competences ofthe Committee onMedical and Public Health Research cover
also the implementation ofthis action ;this Committee isinparticular duly
qualified forgiving tothis research itsproper place within thesectorial
policy ofthe European Communities aswell asforensuring its success .
The Concerted Action Committee isthe body inwhich the exchange ofinformation
between the Member States ,CRM and the Commission isstaged .The Commission and
the Committee will beassisted byaProject Leader .
Beyond this,the terms ofreference ofthis Committee areessentially :
-toassist intheco-ordination ofthenational research projects executed
'inthis field andtoadvise theexecuting laboratories ;
-toadvise governments andthe Commission with regard toresearch needs in
this field ;
-toevaluate theresults ofresearch andtodraw conclusions with regard
totheir applications ;
-topromote exchange ofexperience between thescientists involved by
organizing symposia ,etc....;
-topromote thedissemination ofknowledge .
FINANCIAL VOLUME
Thefinancial volume ofthe research inthis field tobeexecuted bythe
Member States isestimated at4,1 m.u.a .for a4-year period .
This figure isbased onestimates ,ascommunicated bythe competent national
authorities .
The inventory ofthe research projects indicates that Belgium ,Denmark ,France ,
Germany ,Ireland ,Italy ,The Netherlands and United Kingdom would contribute
research under thethree topics ofthis concerted research action .
The cost ofco-ordination ,oncharge of ,the Community budget ,isestimated
at360,000 u.a.forthe 4-year period .

ANNEXI
PROFOS.AL FORACOUNCILDECISION
adoptingaconcertedactioninthefieldof
Extracorporeal Oxygenation
(MedicalandPublicHealthResearch)
THECOUNCILOFTHEEUROPEANCOMMUNITIES,
HavingregardtotheTreatyestablishing theEuropeanEconomicCommunity,
andinparticularArticle235thereof;
HavingregardtotheproposaloftheCommission;
HavingregardtotheopinionoftheEuropeanParliament;
WhereasbyvirtueofArticle2oftheTreaty,theCommunityhasbeenassigned
thetaskofpromotingthroughouttheCommunityaharmoniousdevelopment of
economicactivities,acontinuousandbalancedexpansionandanaccelerated
raisingofthestandardofliving;
WhereastheCouncilstressedinitsResolutionof14January1974onan
initialoutlineprogrammeoftheEuropeanCommunitiesinthefieldofscience
andtechnologythatanappropriate approachshouldbeadoptedtowardsthe
wholerangeofavailablewaysandmeans,includingconcertedactionandthat.
wheneveritprovesdesirablethatthirdcountries,particularly Europeanones,
shouldbeassociatedintheseprojects,stepsshouldbetakentomakethis'
possible;
Whereason14January1974,theCouncilentrustedtheCommunityInstitutions
aidedbytheScientificandTechnicalResearchCommittee(CREST)withthe
taskofensuringthegradualco-ordination ofnationalpoliciesinthefield
ofscienceandtechnology;
WhereasaconcertedCommunityresearchactioninthefieldofextracorporeal
oxygenationislikelytocontributeeffectivelytotheachievementofthe
above-mentioned aims;
WhereastheMemberStatesintend,aspartoftherulesandproceduresappli­
cabletotheirnationalprogrammes,tocarryouttheresearchdescribedin
AnnexA,andarepreparedtointegratesuchresearchintoaprocessofco­
ordinationatCommunityleveloveraperiodoffouryears;
WhereasthecarryingoutofsuchresearchasdescribedinAnnexAwillrequire
afinancialcontribution ofabout4,1MUAfromtheMemberStates;
WhereastheTreatyhasnotprovidedthenecessarypowersforthispurpose;

-C.8
ANNEXI
WhereastheScientifcandTechnicalResearchCommittee(CREST)hasgivenits
opinionwithregardtotheCommissionproposal.;
HASDECIDED:
Article 1
TheCommunityshallimplementforaperiodof4yearsaconcertedaction
inthefieldofExtracorporeal Oxygenation.
Thisactionshallconsistintheco-ordination atCommunitylevelof
researchwhichisdescribedinAnnexAandwhichformspartoftheresearch
programmesoftheMemberStates.
Article2
TheCommissionshallberesponsible forsuchco-ordination .
Article3
Themaximumfinancialcontribution bytheCommunitytosuchcc-ordination
actionisestimatedat360,000UA,theunitofaccountbeingdefinedaccordingtoth
financialregulationinforce.
Article4
Tofacilitatethecarryingoutoftheaction,aconcertedactionCommittee
onthe"Extracorporeal Oxygenation",hereinafterreferredtoas"theCommittee",
isherebyestablished .AprojectleadershallbdappointedbytheCommissionwith
theCommittee'sagreement.HeassistsinparticulartheCommissioninitsco­
ordinatingaction.
Thetermsofreferenceandthecomposition ofthisCommitteearedefined
inAnnexB.
TheCommitteeshalldrawupitsrulesofprocedure.Itssecretariatwill
beprovidedbytheCommission.
Article5
(a)InaccordancewithaproceduretobeadoptedbytheCommissionin
agreementwiththeCommittee,theparticipating Statesshallexchangere­
gularlyallusefulinformation concerningtheexecutionoftheresearch
coveredbytheconcertedactionandforwardtotheCommissionallinformation
usefulforco-ordination .TheyshallalsoendeavourtoprovidetheCommission
withinformation onsimilarresearchplannedorcarriedoutbybodiesforwhich
theyarenotresponsible.Thisinformationshallbetreatedasconfidential
ifrequestedbytheMemberStatewhichprovidesit.
(b)TheCommissionshallprepareyearlyprogressreportsonthebasis
oftheinformationsupplied,andshallforwardthemtotheMemberStates.
(c)Attheendoftheco-ordination period,theCommissioninagreement
withtheCommitteeshallforwardtotheMemberStatesandtotheEuropean
Parliament ageneralreportontheexecutionandresultsoftheco-ordination
action.TheCommissionshallpublishthisreportsixmonthsafterithasbeen
forwarded,unlessaMemberStateobjects.Inthiscasethereportshallbe

-C.9- XII/269/77
ANNEXI
distributed,attheirrequest,,solelytotheinstitutions andundertakings
cfwhichtheresearchorproductionactivitiesarejustifyingaccessto
knowledgeresultingfromtheperformance oftheresearchcoveredbythe
Communityconcertedaction.TheCommission maymakeprovisionthatthe
reoortremainsconfidential andisnotpassedtothirdparties.
Article6
InaccordancewiththeprovisionslaiddowninArticle228ofthe
Treatyestablishing theEEC,theCommunitymayconcludeagreementswith
otherStatesinvolvedinEuropeanCo-operation inthefield.ofScientific
andTechnicalResearch(COST)withaviewtoextendingtheco-ordination
whichisthesubjectofthisDecisiontoresearchundertakeninthose
States.
TheCommissionisherebyauthorizedtoopennegotiations forthe
conclusionofagreementsofthetypereferredtoinprecedingparagraph.
Artiele.7
ThisDecisionshallcomeintoforceonthe1stJanuary-1978.
Doneat on
*•f•
FortheCouncil"
ThePresident

-C-10- XII/269/77
Annex Ato ANNEX I
ANNEX ATOTHE PROPOSED COUNCIL DECISION
adopting aconcerted action inthefield of
Extracorporeal Oxygenation
(Medical and Public Health Research )
The research will becarried outwith thepurpose ofacquiring scientific and
technical knowledge inthis field ,selected forits importance atCommunity
level .
The research isexpected tocover thefollowing topics :
(1)Continuous improvemeht inperformance ofpresent oxygenator principles
with respect tothelimitations set bydiffusion resistance andblood
trauma :
a)Clinical applicability ofintroduction ofacontrolled secondary
flow (blood mixing )into present oxygenator principles .
b)Studies oftheeffects ofblood flow shear stress onthe aggre­
gation and adhesion ofplatelets ,oftheinteraction ofredcells
andplatelets ,andofpharmacologic methods ofintervention .
(2)Continuous development ofalternative oxygenation principles andtesting
fortheir clinical applicability .
Here ,research isaiming inparticular atfurther development andjoint
evaluation oftheprinciple of:
a)Hyperbaric oxygenation .
b)Physico-chemical release ofoxygen (from H^O-)through membranescontaining catalatic activity .
c)Liquid oxygenation byusing inert liquids (fluorocarbons )fordirect
gastransfer tothe blood .
(3)Development ofmethods for continuous control and dynamic compensation
ofthepatients respiratory ,circulatory andmetabolic deficiencies .
a)Dynamic control system ,based onoxygen consumption and carbon
dioxide production inthepatient ,fortheregulation ofthe gas
transfer rate inoxygenators .
b)Regulation ofblood electrolytes and pHinthe perfused patient .
Theco-ordination will include thefollowing competent medical research
organizations respectively participating institutes ofthe Member States :
BELGIUM
-F.N.M.R. Fonds National delaRecherche Médicale ,Bruxelles
DENMARK
-Danish Medical Research Council ,Copenhagen

-C.11 - XII/269/77
Annex AtoANNEX I
FRANCE
-INSERM Institut National delaSanté etdelaRecherche Médicale ,
Paris
GERMANY ...
-German Heart Center ,Munich ■
-Dept .ofPhysiology ,Technical University ,Aachen
-MPI,System-Physiology ,Dortmund
-Dept .ofPhysiology ,University ofMainz
IRELAND
-Medical Research Council ofIreland ,Dublin
ITALY
-C.N.R. Consiglio Nazionale della Ricerca ,Roma
NETHERLANDS / '
-Umversity ofGroningen
-Eindhoven University ofTechnology
-Dept .ofPhysiology ,University ofNijmegen
-Dept .ofAppl .Physiology andCryobiology ,Central Red Cross
Blood Transfusion Services ,Amsterdam ! ?
yNIIED_KINGDOM
-M.R.C. Medical Research Council ,London
These -countries will contribute research under thethree topics mentioned
above .

-C.12 XII/269/77
Annex Bto ANNEX I
ANNEX BTO THE PROPOSED COUNCIL DECISION
adopting aconcerted action inthefield of
Extrscorneal Oxygenation
(Medical and Public Health Research )
Terms ofreference andcomposit ion ofthe.concerted _action^Committeg
1. The Committee shall
1.1.Contribute tothe optimum execution ofthe programme bygiving
itsopinion onallofits aspects ;
1.2.Evaluate theresults and draw conclusions asregards totheir
application ;
1.3.Ensure the exchange ofinformation referred toinArticle 5(a);
1.4.Keep abreast ofnational research being done inthefields
covered bythe concerted action ,and more especially of
scientific andtechnical developments likely toaffect the
carrying out ofthe action .
1.5.Indicate theorientations totheproject leader .
The Committee 'sreports andopinions shall betransmitted tothe
Commission andtotheparticipating States .The Commission shall forward
these opinions tothe CREST .
3. The Committee shall becomposed ofone representative and one
alternative responsible forco-ordinating thenational contributions
tothe programme ,andtheproject leader .Each member may be
accompanied byexperts .