ARCHIVESHISTORIQUES
DELACOMMISSION
COLLECTION RELIEEDES
DOCUMENTS "COM"
COM(79)204
Vol.1979/0088

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COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(79)204 final
Brussels,19April1979
DRAFTCOUNCILDECISION
ontheconclusionoftheAgreementonaconcerted
actionprojectinthefieldofregistration of
congenitalabnormalities (medicalandpublic
healthresearch)
(submittedtotheCouncilbytheCommission )
C0M(79)204finali)/'\
\
.•V\
•9*ï
Cov

CODIFICATION FROMTH^COICaGSIOTT TOTHECOUNCIL
:>unject:AgreementbetweentheESCandGreeceonaconcertedaction
projectinthefieldoftheregistration ofcongenitalabnor­
malities(nodicalandpublichealthresearch)
Aprogramofresearch(concertedactionproject)ontheregistration of
cor.goni.tala'onorira.iitie3 (medicalandpublichealthresearch)wasadopted
bytheCouncilon13February1978
Article6ofthatDecisionprovidesthattheCommunitymayconcludeagree­
ment:;withotherStatesinvolvedinEuropeancooperation inthefieldof
scientificandtechnicalresearch(COST)withaviewtoextendingthecoor­
dinationwhichisthesubjectofthatDecisiontoresearchundertakenin
thoceStates.TheCommission hasbeenauthorized underthetermsofthat
provisiontoenterintonegotiations forthepurposestated.
On6October197°,Greeceexpressedthewishtoparticipateintheconcer­
tedactionprojectconcerned.Negociations withtheHellenicRepublic
haveledtoadraftagreementwhichissetoutinanannextotheattached
draftCouncildecision.
Thisagreementprovidesthat:
-theofficialresponsibleforcoordinating thenationalcontribution from
GreecetotheconcertedactionprogrammeshallbeamemberoftheConcer­
tedActionCommitteeontheRegistration ofCongenitalAbnormalities
-thefinancialcontribution madetothecoordination costsbyGreece
shallbe22000EUAfortheperiodreferredtoinArticle1oftheAgree­
ment•
TheCommissionrequeststheCounciltoadoptthedraftdecisiononthecon­
clusionoftheagreementrelatingtoaconcertedactionprojectinthefieldof
theregistration ofcongenitalabnormalities (medicalandpublichealthre­
search).
*J.O.L52,Pe20oí23,2,78»

DRAFTCOUNCILDECISION ONTHE
CONCLUSION OPTHEAGREEMENT ON
ACONCERTED ACTIONPROJECT' 1IN
THEFIELDOPREGISTRATION OP
CONGENITALABNORMALITIES (ME­
DICALANDPUBLICHEALTHRE­
SEARCH)
TheCounciloftheEuropeanCommunities,
havingregardtotheTreatyestablishing theEuropeanEconomicCommunity,
havingregardtoCouncilDecision78/167/EECof13February1978adopting
aEuropeanEconomicCommunityconcertedactionprojectinthefieldof
registration ofcongenitalabnormalities (medicalandpublichealthresearch)
andinparticularArticle6(l)thereof,
havingregardtothedraftdecisionsubmittedbytheCommission,
whereas,pursuanttoArticle6(2)ofDecision78/167/EEC,theCommission
hasnegotiatedanAgreementwiththeRepublioofGreecewithaviewtoex­
tendingthecoordination whichisthesubjectoftheabovementioned decision
toresearchundertakeninthatState,
whereasthatAgreementshouldbeapproved,
HASDECIDEDASFOLLOWS:
Article1
TheAgreementbetweentheCommunityandtheRepublicofGreeceonaconcerted
actionprojectinthefieldofregistration ofcongenitalabnormalities (me­
dicalandpublichealthresearch)isherebyapprovedonbehalfoftheCommu­
nity.
ThetextoftheagreementisannexedtothisDecision*
t1'OJN°L52/20of23.2.78

-2-
Article2
ThePreui&enfcoftheCouncilisherebyauthorizedtodesignatethepersons
empoweredtosigntheagreementinorderto"bindtheCoramnity#
Doneat Date
FortheCouncil,
thePresident

-3-
AGREEMENT BETWEEN THECOMMUNITY ANDTHEREPUBLIC OFGREECE
ONACONCERTED ACTIONPROJECTINTHEFIELDOFREGISTRATION
OFCONGENITAL ABNORMALITIES (MEDICAL ANDPUBLICHEALTHRESEARCH)
TheEuropeanEconomicCommunity,hereinafter referredtoasthe
Community",andtheRepublicofGreece,hereinafter referredtoas
the"participating non-memberstate",
WhereasaEuropeanconcertedresearchprojectinthefieldofregistration
ofcongenitalabnormalities islikelytocontributeeffectively tothe
optimalhealthoftheindividual andofsociety;
Whereas,byitsDecisionof13February1978,theCouncilofthe
EuropeanCommunities adoptedaCommunityconcertedprojectinthefield
ofregistration ofcongenitalabnormalities (medicalandpublichealth
research);
WhereastheMemberStatesoftheCommunity andtheparticipating non-member
state,hereinafter referredtoas"theStates",undertakeresearchin
thefieldlistedinAnnexAandconsiderthatcoordination ofthisresearch
willbeofmutualbenefit;
Whereastheimplementation oftheresearchcoveredbytheconcerted
actionprojectwillrequireafinancialcontribution ofapproximately
900000EuropeanunitsofaccountfromtheStates
HAVEAGREEDASFOLLOWS:
Article 1
TheCommunityandtheparticipating non-memberState,hereinafterreferred
toasthe"contractingparties",shallparticipateforaperiodextending
until31December1980inaconcertedactionprojectinthefieldof
registrationofcongenitalabnormalities (medicalandpublichealth
research).
ThisprojectshallconsistincoordinatingtheCommunityconcertedaction
programmeandthecorresponding programmeoftheparticipating non-member
State.TheprogrammescoveredbythisAgreementarelistedinAnnexA.
TheStatesshallremainresponsiblefortheresearchexecutedbytheir
nationalinstitutions orbodies.
Article2
TheCommissionoftheEuropeanCommunities,hereinafterreferredtoas
the"Commission",shallberesponsibleforthecoordination .
ItshallbeassistedinthistaskbyaProjectLeader.

Article 3
Inorder tofacilitate theexecution oftheproject ,theConcerted Action
Conmittee ontheRegistration ofCongenital Abnormalities ,hereinafter re­
ferred toas"theCommittee ",setupbytheDecision oftheCouncil ofthe
European Communities of13June 1978 »shall beextended toinclude thepar­
ticipating non-member State *
TheSecretariat oftheCommittee shall beprovided bythe Commission#
Theterms ofreference andthecomposition oftheCommittee shall beas
set out .inAnnex B.
Article 4
Themaximum financial contribution bythecontracting parties tothe coor­
dination costs shall "be:
-330000European units ofaccount from theCommunity forathree year
period beginning on1J-anuary 1978
-22000European units ofaccount from theparticipating non-member State
fortheperiod referred tointhefirst paragraph ofArticle 1#
TheEuropean unit ofacoount shall beasdefined inthefinancial
regulation inforce applicable totheGeneral Budget oftheEuropean •
Communities and inthefinancial provisions adopted pursuant -thereto .
Therules governing thefinancing oftheAgreement aresetoutinAnnex C.
Article 5
Theotates shall ,inaccordance with aprocedure laid down bytheCommission
inagreement with theCommittee ,exchange regularly allrelevant information
concerning theexecution oftheresearch covered bytheproject ,supplying
theCommission with allinformation ofuseinensuring coordination# They
shall also endeavour toprovide theCommission with information onresearch
inthefield inquestion planned orcarried outby "bodies ncisubject to
their authority# This information shall betreated asconfidential ifthe
State which provides issorequests#

-5-
2)TheCommission shall prepare yearly progress reports onthe "basis ofthe
information supplied andshall forward them totheStates#
3)Attheendoftheperiod ofconcerted action ,theCommission shall
forward totheStates areport onitsexecution andtheresults obtained .
This report shall "bepublished "bytheCommission sixmonths after ithas
been forwarded ,unless aState object s#Inthat case ,thereport shall be
regarded a3confidential andshall beforwarded ,onrequest ,solely tothe
institutions andundertakings whose research orproduction activities jus­
tify access totheresults oftheresearch covered bytheconcerted action
project .
Article 6
1)Each ofthecontracting parties shall ,after signing this agreement ,notify
theSecretary-General oftheCouncil oftheEuropean Communities assoon as
possible ofthecompletion oftheprocedures necessary under itsinternal
provisions fortheimplementation ofthis Agreement#
2)This Agreement shall enter into foroe onthefirst dayofthemonth follo­
wing that inwhich thesecond ofthecontracting parties forwards this no-
tification#
Theparticipating non-member State maytake part inthework oftheCommittee ,
without voting rights ,foraperiod ofnine months after thesignature of
this Agreement#
3)Foraperiod ofsixmonths following itsentry into force ,this Agreement
shall beopen foraccession byotha ?European States which took part inthe
Ilininterial Conference held inBrussels on22and23November 1971 •Th®
instruments ofaccession shall bedeposited with theSecretary-General
oftheCouncil oftheEuropean Communities#
AState which accedes tothis Agreement shall become acontracting party
within themeaning ofArticle 1onthedate ofdeposit oftheinstrument
ofaccession# Itshall contribute tothecoordination costs under thecon­
ditions laid down inArticle 4concerning theparticipating non-Member
State .

4;TheSecretary-General oftheCounciloftheEuropeanCommunitiesshall
notifyeachofthecontractingpartiesofthedepositofthenotifications
providedforinparagraph1,ofthedateofentryintoforceofthisAgree­
mentandofthedepositoftheinstruments ofaccessionprovidedforinpa­
ragraph3»
Article7
ThisAgreement,drawnupinasingleoriginalintheDanish,Dutch,English,
French,GermanandItalianlanguages,eachtexrt"beingequallyauthentic,
shallbedepositedinthearchivesoftheGeneralSecretariat oftheCouncil
oftheEuropeanCommunities,whichshalltransmitacertifiedcopytoeach
ofthecontractingparties.
Doneat date:
*<·τ

FortheEuropeanEconomicCommunity
FortheGovernmentoftheRepublioofGreece

AnnexA
Programmes coveredbytheAgreement
!•Registration ofcongenitalmalformations aswellasofinheritedbio­
chemicalandchromosomeabnormalities inselectedregionsofthecon­
tractingparties*Registration willprogressively extendtoabnorma­
litiesofthenervoussystem(anencephaly,spinabifida,etc.),Down's
syndrome,grossabnormalities ofthelimbs,multipleabnormalities ,phe­
nylketonuria andcoeliacdisease*
2.Registration oftwinsandmultiplepregnanciesinselectedregionsof
thecontractingparties*
3»Relevantmethodological studiestoobtainoptimumcoordination ofexis­
tingnationalregisterandregistration procedures.
Thecoordination willincludethefollowingregionalregistersofthe
States:
Belgium BrugesandHainaut
Denmark Odense
Prance Paris
FederalRepublicofGermanyHessen
Ireland I>ublinandGalway
Italy FlorenceandRome
Luxembourg Luxembourg
Netherlands Leidschendam
UnitedKingdom Belfast,GlasgowandLiverpool
Greece Athens
TheseStateswillcontributeresearohunderthethreetopicsmentioned
above.

AnnexB
TER15OPREFERENCE AI1DCOMPOSITION OFTHECONCERTED
ACTIONCOHTITTEE PITTHEREGISTRATION OPCONGENITAL
ABNORMALITIES
1*TheCommitteeshall;
1*1contributetotheoptimumexecutionoftheprojectbygiving
itsopiniononallaspeotsofitsexecution;
1*2evaluatetheresultsanddrawconclusions astotheirappli­
cation;
1.3.ensuretheexchangeofinformationreferredtoinArticle5
oftheAgreement;
1.4Keepabreastofnationalresearchbeingdoneinthefields
coveredbytheconcertedprojeotandmoreespeciallyofscien­
tificandtechnicaldevelopments likelytoaffeottheexecu­
tionoftheproject;
1*5*suggestguidelinestotheprojectleader#
2*TheCommittee *sreportsandopinionsshallbeforwardedtothe
Commission andtotheStates*TheCommissionshallforwardthese
opinionstotheCREST.
3.TheCommitteeshallbecomposedofpersonsresponsibleforcoor­
dinatingthenationalcontributions totheprogrammetandthe
projectleader*Eaohdelegatemaybeaccompanied byexperts*1.2
1*3.
2.
3.

AnnexC
Financingrules
I.TheseprovisionslaydownthefinancingrulesreferredtoinArticle4
oftheAgreementrelatingtoaconcertedactionprojectinthefield
ofregistrationofcongenitalabnormalities (medicalandpublichealth
research)
II.Atthebeginningofeachfinancialyear,acallforfundsshall "be
issuedbytheCommissiontotheparticipating non-memberState.Such
callsforfundsshallexpressthecontribution ofthenon-memberState
inquestionbothinEuropeanunitsofaccountandinthecurrencyofthe
non-memberState,thevalueoftheEuropeanunitofaccountbeingasdefined
.intheFinancialRegulationapplicabletotheGeneralBudgetofthe
EuropeanCommunities anddetermined onthedateofthecallforfunds.
Theparticipating non-memberStateshallpayitscontribution tothe
Agreementatthebeginningofeachyear,andby31Marchatthelatest.
Thetotalcontribution shallamounttoamaximumof22000European
unitsofaccount.
Onanysumunpaidbythatdate,interestshallbechargedatarateequal
tothehighestdiscountrateintheStatesinforceontheduedate.
Thisrateshallbeincreasedby0.25ofapointpermonthofthepayment
beingoverdue.Theratethusincreasedshallapplytotheentireperiod
ofoverduepayment.
III.Thefundsaccruingfromthecontribution oftheparticipating non-member
Stateshallbecreditedtothisconcertedactionprojectbybeingentered
inthestatementofrevenueofthebudgetoftheCommissionasreceipts
withinthemeaningofthesecondsubparagraph ofArticle90(4)ofthe
FinancialRegulationof21December1977applicabletotheGeneralBudget
oftheEuropeanCommunities.
IV.Theprovisionaltimetableforthecoordination costsref®rr<jltoin
Article4oftheAgreementissetoutintheAnnex.

V.TheFinancialRegulationinforceapplicabletotheGeneralBudget
oftheEuropeanCommunitiesshallapplytothemanagementoftheappro­
priations;furthermore ,theCommissionshallensurethatsuchappro­
priationaremanagedinconformitywiththerulesoftheimplementa­
tionoftheBudget.
VI.Attheendofeachfinancialyear,astatementofappropriations for
thisprojectshallbepreparedandtransmittedtotheparticipating
non-memberStateforinformation..

PROVISIONAL TIMETABLE FORTIE COORBINATION OFTHE
CONCERTED ACTION PROJECT ONREGISTRATION OPCOI.'CSNITAL ABNORMALITIES (inEUA) toANKEX C
Budget Item 3371 Iapleaentation ofconcerted action projects *1
inHJA
X«Initial estimate ofoverall re-
quiremcnts (figures appearing in
tba timetable ofcommitments and
inthecorrespondence table shown
shown inAnnex IItothe Commis­
sion budget ).1978 1979 1980 TOTAL
AC AP AC AP AC AP AC AP «0 AP
110.000j
110.0002.000
13.000
95.0002.000
13.000
95.000)110.000 )110.0001
i
II
)330.000i
|330.000-Staff
-Administrative operating
expenditure
-Contracts
TOTAL (tobecovered byappro­
priations under Item 3371 )110.000 110.000 110.000110.000110.000 110.000 330.000330.000Ι
2.Revised estimate ofexpenditure
taking into account additional
requirements !arising from the
accession ofparticipating non-
member State
II
2.000
13.000 +
5.000
95.000+
6.0002.000
13.000 +
5.000
95.000+
6.000)110.000 *
)11.000!110.00CM11.000
;) I}
t
330.000-1
22.0001K330.CCO +
(22.000-Staff
-Administrative operating
c;';.".nditure
•Contracts
110.000+
11.000110.000 + I
11.000 I110.000 +
11.000110.0004
11.000330.000J
22.OCO,
330.C00+!
22.000
3*Difference between Ieind II
tobecovered bycontributions
from participating non-member
States11.000 11.0C0 11.000 11.000 22.000i
22.000
i !-