CELEX: 51979PC0204
Language: en
Date: 1979-04-19
Title: DRAFT COUNCIL DECISION on the conclusion of the Agreement on a concerted action project in the field of registration of congenital abnormalities (medical and public health research) (submitted to the Council by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (79) 204
Vol. 1979/0088
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                             COM(79)204 final
                                             Brussels , 19 April 1979
                           DRAFT COUNCIL DECISION
             on the conclusion of the Agreement on a concerted
             action project in the field of registration of
             congenital abnormalities ( medical and public
                             health research )
              ( submitted to the Council by the Commission )
C0M(79 ) 204 finali )/ ' \
                                  \
                                .•V  \
                                    • 9* ï
                                    Cov
 ---pagebreak---               CODIFICATION FROM TH^ COICaGSIOTT TO THE COUNCIL
 :> un ject :  Agreement between the ESC and Greece on a concerted action
               project in the field of the registration of congenital abnor­
               malities ( nodical and public health research )
A program of research ( concerted action project ) on the registration of
cor.goni.tal a'onorira.iitie3 ( medical and public health research ) was adopted
by the Council on 13 February 1978
Article 6 of that Decision provides that the Community may conclude agree­
ment :; with other States involved in European cooperation in the field of
scientific and technical research ( COST ) with a view to extending the coor­
dination which is the subject of that Decision to research undertaken in
thoce States .      The Commission has been authorized under the terms of that
provision to enter into negotiations for the purpose stated .
On 6 October 197° , Greece expressed the wish to participate in the concer­
ted action project concerned . Negociations with the Hellenic Republic
have led to a draft agreement which is set out in an annex to the attached
draft Council decision .
This agreement provides that :
-     the official responsible for coordinating the national contribution from
      Greece to the concerted action programme shall be a member of the Concer­
      ted Action Committee on the Registration of Congenital Abnormalities
-     the financial contribution made to the coordination costs by Greece
      shall be 22 000 EUA for the period referred to in Article 1 of the Agree­
      ment •
The Commission requests the Council to adopt the draft decision on the con­
clusion of the agreement relating to a concerted action project in the field of
the registration of congenital abnormalities (medical and public health re­
search ).
* J.O.        L 52 , Pe 20 oí 23,2,78»
 ---pagebreak---                     DRAFT COUNCIL DECISION ON THE
                    CONCLUSION OP THE AGREEMENT ON
                    A CONCERTED ACTION PROJECT'1 IN
                    THE FIELD OP REGISTRATION OP
                    CONGENITAL ABNORMALITIES (ME ­
                    DICAL AND PUBLIC HEALTH RE­
                    SEARCH)
The Council of the European Communities ,
having regard to the Treaty establishing the European Economic Community ,
having regard to Council Decision 78/167/EEC of 13 February 1978 adopting
a European Economic Community concerted action project in the field of
registration of congenital abnormalities (medical and public health research )
and in particular Article 6 ( l ) thereof ,
having regard to the draft decision submitted by the Commission ,
whereas , pursuant to Article 6 ( 2 ) of Decision 78/167/EEC , the Commission
has negotiated an Agreement with the Republio of Greece with a view to ex­
tending the coordination which is the subject of the abovementioned decision
to research undertaken in that State ,
whereas that Agreement should be approved ,
HAS DECIDED AS FOLLOWS :
                              Article 1
The Agreement between the Community and the Republic of Greece on a concerted
action project in the field of registration of congenital abnormalities (me­
dical and public health research ) is hereby approved on behalf of the Commu­
nity.
The text of the agreement is annexed to this Decision*
t1 ' OJ N° L 52/20 of 23.2.78
 ---pagebreak---                                  - 2 -
                              Article 2
The Preui&enfc of the Council is hereby authorized to designate the persons
empowered to sign the agreement in order to "bind the Coramnity#
Done at                               Date
                                          For the Council ,
                                          the President
 ---pagebreak---                                     - 3 -
        AGREEMENT BETWEEN THE COMMUNITY AND THE REPUBLIC OF GREECE
        ON A CONCERTED ACTION PROJECT IN THE FIELD OF REGISTRATION
        OF CONGENITAL ABNORMALITIES ( MEDICAL AND PUBLIC HEALTH RESEARCH )
The European Economic Community, hereinafter referred to as      the
Community", and the Republic of Greece , hereinafter referred to as
the " participating non-member state",
Whereas a European concerted research project in the field of registration
of congenital abnormalities is likely to contribute effectively to the
optimal health of the individual and of society ;
Whereas , by its Decision of 13 February 1978 , the Council of the
European Communities adopted a Community concerted project in the field
of registration of congenital abnormalities ( medical and public health
research );
Whereas the Member States of the Community and the participating non-member
state , hereinafter referred to as " the States ", undertake research in
the field listed in Annex A and consider that coordination of this research
will be of mutual benefit ;
Whereas the implementation of the research covered by the concerted
action project will require a financial contribution of approximately
900 000 European units of account from the States
HAVE AGREED AS FOLLOWS :
                               Article 1
 The Community and the participating non-member State , hereinafter referred
 to as the " contracting parties", shall participate for a period extending
 until 31 December 1980 in a concerted action project in the field of
 registration of congenital abnormalities ( medical and public health
 research ).
 This project shall consist in coordinating the Community concerted action
 programme and the corresponding programme of the participating non-member
 State .   The programmes covered by this Agreement are listed in Annex A.
 The States shall remain responsible for the research executed by their
  national institutions or bodies .
                               Article 2
  The Commission of the European Communities , hereinafter referred to as
  the " Commission", shall be responsible for the coordination .
  It shall be assisted in this task by a Project Leader .
 ---pagebreak---                                Article 3
In order to facilitate the execution of the project , the Concerted Action
Conmittee on the Registration of Congenital Abnormalities , hereinafter re­
ferred to as "the Committee", set up by the Decision of the Council of the
European Communities of 13 June 1978» shall be extended to include the par­
ticipating non-member State *
The Secretariat of the Committee shall be provided by the Commission#
The terms of reference and the composition of the Committee shall be as
set out . in Annex B.
                               Article 4
The maximum financial contribution by the contracting parties to the coor­
dination costs shall "be :
- 330 000 European units of account from the Community for a three year
   period beginning on 1 J-anuary 1978
- 22 000 European units of account from the participating non-member State
   for the period referred to in the first paragraph of Article 1#
The European unit of acoount shall be as defined in the financial
regulation in force applicable to the General Budget of the European •
Communities and in the financial provisions adopted pursuant - thereto .
The rules governing the financing of the Agreement are set out in Annex C.
                               Article 5
The otates shall , in accordance with a procedure laid down by the Commission
in agreement with the Committee , exchange regularly all relevant information
concerning the execution of the research covered by the project , supplying
the Commission with all information of use in ensuring coordination# They
shall also endeavour to provide the Commission with information on research
in the field in question planned or carried out by "bodies nc i subject to
their authority# This information shall be treated as confidential if the
State which provides is so requests#
 ---pagebreak---                                       - 5 -
2 ) The Commission shall prepare yearly progress reports on the "basis of the
    information supplied and shall forward them to the States#
3 ) At the end of the period of concerted action, the Commission shall
     forward to the States a report on its execution and the results obtained .
    This report shall "be published "by the Commission six months after it has
    been forwarded , unless a State object s# In that case , the report shall be
    regarded a3 confidential and shall be forwarded , on request , solely to the
    institutions and undertakings whose research or production activities jus­
    tify access to the results of the research covered by the concerted action
    project .
                                  Article 6
1 ) Each of the contracting parties shall , after signing this agreement , notify
    the Secretary-General of the Council of the European Communities as soon as
    possible of the completion of the procedures necessary under its internal
    provisions for the implementation of this Agreement#
2 ) This Agreement shall enter into foroe on the first day of the month follo­
    wing that in which the second of the contracting parties forwards this no-
    tification#
    The participating non-member State may take part in the work of the Committee ,
    without voting rights , for a period of nine months after the signature of
    this Agreement#
3 ) For a period of six months following its entry into force , this Agreement
    shall be open for accession by   otha? European States which took part in the
    Ilininterial Conference held in Brussels on 22 and 23 November 1971 • Th®
    instruments of accession shall  be deposited with the Secretary-General
    of the Council of the European   Communities#
    A State which accedes to this Agreement shall become a contracting party
    within the meaning of Article 1 on the date of deposit of the instrument
    of accession# It shall contribute to the coordination costs under the con­
    ditions laid down in Article 4 concerning the participating non-Member
    State .
 ---pagebreak--- 4 ; The Secretary-General of the Council of the European Communities shall
    notify each of the contracting parties of the deposit of the notifications
    provided for in paragraph 1 , of the date of entry into force of this Agree­
    ment and of the deposit of the instruments of accession provided for in pa­
    ragraph 3»
                                  Article 7
    This Agreement , drawn up in a single original in the Danish , Dutch , English ,
    French , German and Italian languages , each texrt "being equally authentic ,
    shall be deposited in the archives of the General Secretariat of the Council
    of the European Communities , which shall transmit a certified copy to each
    of the contracting parties .
    Done at                                date :
                                                                                   <· τ
                                                                          *
 ---pagebreak--- For the European Economic Community
For the Government of the Republio of Greece
 ---pagebreak---                                                              Annex A
                     Programmes covered by the Agreement
!•   Registration of congenital malformations as well as of inherited bio­
      chemical and chromosome abnormalities in selected regions of the con­
     tracting parties *    Registration will progressively extend to abnorma­
     lities of the nervous system (anencephaly, spina bifida , etc .), Down 's
     syndrome , gross abnormalities of the limbs , multiple abnormalities , phe­
     nylketonuria and coeliac disease *
2.   Registration of twins and multiple pregnancies in selected regions of
     the contracting parties *
3»   Relevant methodological studies to obtain optimum coordination of exis­
     ting national register and registration procedures .
 The coordination will include the following regional registers of the
 States :
          Belgium                         Bruges and Hainaut
          Denmark                         Odense
          Prance                          Paris
          Federal Republic of Germany     Hessen
          Ireland                         I>ublin and Galway
          Italy                           Florence and Rome
          Luxembourg                      Luxembourg
          Netherlands                     Leidschendam
          United Kingdom                  Belfast , Glasgow and Liverpool
          Greece                          Athens
 These States will contribute researoh under the three topics mentioned
 above .
 ---pagebreak---                                                              Annex B
           TER15 OP REFERENCE AI1D COMPOSITION OF THE CONCERTED
           ACTION COHTITTEE PIT   THE REGISTRATION OP CONGENITAL
                               ABNORMALITIES
1*         The Committee shall ;
     1*1   contribute to the optimum execution of the project by giving
           its opinion on all aspeots of its execution ;
     1.2
     1*2   evaluate the results and draw conclusions as to their appli­
           cation ;
     1.3 .
     1*3   ensure the exchange of information referred to in Article 5
           of the Agreement ;
     1.4   Keep abreast of national research being done in the fields
           covered by the concerted projeot and more especially of scien­
           tific and technical developments likely to affeot the execu­
           tion of the project ;
     1*5 * suggest guidelines to the project leader#
2 .*       The Committee * s reports and opinions shall be forwarded to the
           Commission and to the States *    The Commission shall forward these
           opinions to the CREST.
3.         The Committee shall be composed of persons responsible for coor­
           dinating the national contributions to the programme t and the
           project leader *   Eaoh delegate may be accompanied by experts *
 ---pagebreak---                                                            Annex C
                             Financing rules
   I. These provisions lay down the financing rules referred to in Article 4
      of the Agreement relating to a concerted action project in the field
      of registration of congenital abnormalities ( medical and public health
      research)
 II . At the beginning of each financial year , a call for funds shall "be
      issued by the Commission to the participating non-member State . Such
      calls for funds shall express the contribution of the non-member State
      in question both in European units of account and in the currency of the
      non-member State , the value of the European unit of account being as defined
         . in the Financial Regulation applicable to the General Budget of the
      European Communities and determined on the date of the call for funds .
      The participating non-member State shall pay its contribution to the
      Agreement at the beginning of each year , and by 31 March at the latest .
      The total contribution shall amount to a maximum of 22 000 European
      units of account .
      On any sum unpaid by that date , interest shall be charged at a rate equal
      to the highest discount rate in the States in force on the due date .
      This rate shall be increased by 0.25 of a point per month of the payment
      being overdue .  The rate thus increased shall apply to the entire period
      of overdue payment .
III . The funds accruing from the contribution of the participating non-member
      State shall be credited to this concerted action project by being entered
      in the statement of revenue of the budget of the Commission as receipts
      within the meaning of the second subparagraph of Article 90(4 ) of the
      Financial Regulation of 21 December 1977 applicable to the General Budget
      of the European Communities .
 IV . The provisional timetable for the coordination costs ref®rr<jl to in
      Article 4 of the Agreement is set out in the Annex.
 ---pagebreak---  V.  The Financial Regulation in force applicable to the General Budget
     of the European Communities shall apply to the management of the appro­
     priations ; furthermore , the Commission shall ensure that such appro­
     priation are managed in conformity with the    rules of the implementa­
     tion of the Budget .
VI . At the end of each financial year , a statement of appropriations for
     this project shall be prepared and transmitted to the participating
     non-member State for information . .
 ---pagebreak---                       PROVISIONAL TIMETABLE FOR TIE COORBINATION OF THE
                      CONCERTED ACTION PROJECT ON REGISTRATION OP COI.'CSNITAL ABNORMALITIES ( in EUA)                to ANKEX C
                                            Budget Item 3371  Iapleaentation of concerted action projects*1
                                                                                                                                in HJA
                                                . 1978                  1979                  1980                              TOTAL
                                             AC         AP         AC          AP         AC          AP      AC   AP       «0            AP
X « Initial estimate of overall re-
    quiremcnts (figures appearing in
    tba timetable of commitments and
     in the correspondence table shown                        j
    shown in Annex II to the Commis­
    sion budget )
                                                                                                                             I
    - Staff
    - Administrative operating
                                                                   2.000       2.000                                     1
                                                                                                                        i)            i
       expenditure
    - Contracts
                                            110.000   110.000     13.000
                                                                  95.000
                                                                              13.000 ) 110.000
                                                                              95.000
                                                                                                   ) 110.000            I
                                                                                                                           330.000
                                                                                                                                      | 330.000
 TOTAL ( to be covered by appro­            110.000   110.000    110.000     110.000    110.000      110.000               330.000      330.000 Ι
 priations under Item 3371 )
                                                                          I
2 . Re vised estimate of expenditure
    taking into account additional
    requirements! arising from the
    accession of participating non-                                                                                          }
    member State                                                                                                             t
    - Staff
    - Administrative operating
       c;';.".nditure
    • Contracts
                                          I
                                                                  2.000
                                                                 13.000+
                                                                  5.000
                                                                 95.000+
                                                                  6.000
                                                                              2.000
                                                                             13.000+
                                                                              5.000 )
                                                                             95.000+ )
                                                                              6.000
                                                                                        110.000*
                                                                                         11.000
                                                                                                   ! 1 0.0 CM
                                                                                                  ;)
                                                                                                      11.000
                                                                                                                 I
                                                                                                                           330.000-1K
                                                                                                                            22.0001(
                                                                                                                                        330.CCO+
                                                                                                                                         22.000
                                                                                                                                                  ,
                                                                110.000+    110.000 + I 110.000 +    110.0004              330.000J 330.C00+ !
                                                                 11.000      11.000 I    11.000       11.000                22 .OCO      22.000
3* Difference between I eind II                                                                                                     i
    to be covered by contributions                                11.000      11 . 0C0  11.000        11.000                22.000      22.000
    from participating non-member
    States
                                                                                                                                    i        !  -