CELEX: 51983PC0032
Language: en
Date: 1983-02-01
Title: Draft for a COUNCIL DECISION on the conclusion of an agreement between the European Economic Community and the Swiss Confederation amending the agreement on a concerted action project in the field of registration of congenital abnormalities (Medical Research and Public Health) (submitted to the Council by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (83) 032
Vol. 1983/0013
 ---pagebreak--- Disclaimer
Conformément au règlement (CEE, Euratom) n° 354/83 du Conseil du 1er février 1983
concernant l'ouverture au public des archives historiques de la Communauté économique
européenne et de la Communauté européenne de l'énergie atomique (JO L 43 du 15.2.1983,
p. 1), tel que modifié par le règlement (CE, Euratom) n° 1700/2003 du 22 septembre 2003
(JO L 243 du 27.9.2003, p. 1), ce dossier est ouvert au public. Le cas échéant, les documents
classifiés présents dans ce dossier ont été déclassifiés conformément à l'article 5 dudit
règlement.
In accordance with Council Regulation (EEC, Euratom) No 354/83 of 1 February 1983
concerning the opening to the public of the historical archives of the European Economic
Community and the European Atomic Energy Community (OJ L 43, 15.2.1983, p. 1), as
amended by Regulation (EC, Euratom) No 1700/2003 of 22 September 2003 (OJ L 243,
27.9.2003, p. 1), this file is open to the public. Where necessary, classified documents in this
file have been declassified in conformity with Article 5 of the aforementioned regulation.
In Übereinstimmung mit der Verordnung (EWG, Euratom) Nr. 354/83 des Rates vom 1.
Februar 1983 über die Freigabe der historischen Archive der Europäischen
Wirtschaftsgemeinschaft und der Europäischen Atomgemeinschaft (ABI. L 43 vom 15.2.1983,
S. 1), geändert durch die Verordnung (EG, Euratom) Nr. 1700/2003 vom 22. September 2003
(ABI. L 243 vom 27.9.2003, S. 1), ist diese Datei der Öffentlichkeit zugänglich. Soweit
erforderlich, wurden die Verschlusssachen in dieser Datei in Übereinstimmung mit Artikel 5
der genannten Verordnung freigegeben.
 ---pagebreak---  COMMISSION OF THE E U R O P E A N COMMUNITIES
                                                                                 COM(83) 32           final
                                                                                 Brussels,        1 F e b r u a r y 1983
                                                          Draft      for     a
                                                       COUNCIL DECISION
         on t h e       c o n c l u s i o n of     an a g r e e m e n t      between the        E u r o p e a n E c o n o m i c Community
         and t h e        Swiss       C o n f e d e r a t i o n a m e n d i n g t h e a g r e e m e n t on a c o n c e r t e d    action
         project          i n the       field      of     registration          of   congenital           abnormalities          (Medical
         R e s e a r c h and P u b l i c         Health)
                            (submitted          to    the      C o u n c i l by t h e C o m m i s s i o n )
COM(83) 32    final
 ---pagebreak---                           COMMUNICATION FROM THE COMMISSION TO THE COUNCIL
SUBJECT : P r o p o s a l f o r             a C o u n c i l d e c i s i o n on t h e             c o n c l u s i o n of    an  agreement
                 between the              EEC and t h e            S w i s s C o n f e d e r a t i o n amending the             Agreement
                 on a c o n c e r t e d - a c t i o n          project          i n the       field     of     registration        of
                  congenital             abnormalities.
A concerted-action                   project          in the       field        of    registration             of     congenital     abnor­
malities        (medical           r e s e a r c h and p u b l i c          health)          was a d o p t e d by t h e       Council
on 13 F e b r u a r y 1 9 7 8           (1).
An A g r e e m e n t    between the               E u r o p e a n E c o n o m i c Community and t h e H e l l e n i c                Republic
extending         the     coordination                which      is     the      subject        of   the      relevant       Decision   to
corresponding              research undertaken                      in that          S t a t e was c o n c l u d e d by t h e       Council
on 24 J u l y 1979 ( 2 ) ,               was s i g n e d by t h e              two p a r t i e s     on 14 December 1979 and
entered        into force             on 1 A u g u s t         1980.
On 1 A u g u s t       1980, the           Swiss Confederation acceded to                                 the above         mentioned
 Agreement         in    accordance with A r t i c l e                    6 (3)         thereof.
 T h i s Agreement           e x p i r e d on 31 December 1 9 8 1 .
 By i t s    D e c i s i o n 82/616/EEC                (3)    of     17 A u g u s t      1982, the          C o u n c i l adopted a
 sectoral        r e s e a r c h and d e v e l o p m e n t          programme            in the       field        of   medical    and
 public      health        research -              concerted action                  (1982 t o        1986),        including      the
 continuation            of    the      concerted-action                   project          relating        to     the   registration     of
 congenital           abnormalities.
 Since the         Contracting              P a r t i e s , namely              the    Community           (the     Hellenic     Republic
 is     no l o n g e r   a contracting                 party,        h a v i n g b e e n a member o f               the    Community
 s i n c e 1 J a n u a r y 1981)            and t h e        S w i s s C o n f e d e r a t i o n , h a v e a common i n t e r e s t        in
  continuing         their        cooperation              i n the       field       of      registration            of   congenital
 abnormalities,               it     is desirable that                   the      above m e n t i o n e d Agreement             be
  renewed f o r         the period             f r o m 1 J a n u a r y 1982 t o 31 December 1 9 8 6 .
  As p r o v i d e d    for      in Article            7 (2)       of    D e c i s i o n 82/616/EEC, the                  Commission has
  negotiated          the     s a i d renewal             with the          S w i s s C o n f e d e r a t i o n . The       negotiations
  have     led to       the      following            results         :
  (1)                          0J          N° L 52 o f           23 F e b r u a r y 1 9 7 8 , p .           20
  (2)                          0J        N° L 205 o f            13 A u g u s t       1 9 7 9 , p.     27
   (3)                         0J          N° L 2 4 8 o f           24 A u g u s t       1982, p.         12
 ---pagebreak---                                                  - 2 -
- the Agreement             r e l a t i n g t o t h e c o n c e r t e d - a c t i o n p r o j e c t i n t h e f i e l d of
    r e g i s t r a t i o n of c o n g e n i t a l a b n o r m a l i t i e s w i l l c o n s e q u e n t l y be amended.
- t h e f i n a n c i a l c o n t r i b u t i o n o f t h e P a r t i e s t o t h e Agreement w i l l             be
                          - 600 000 ECU by t h e Community
                          -  55 000 ECU by t h e Swiss                     Confederation.
The Commission r e q u e s t s             t h e C o u n c i l t o adopt t h e d r a f t d e c i s i o n annexed           hereto.
 ---pagebreak---                                      DRAFT        FOR A COUNCIL DECISION
                  THE CONCLUSION OF AN AGREEMENT BETWEEN THE EUROPEAN
                      ECONOMIC COMMUNITY AND THE SWISS CONFEDERATION
                  AMENDING THE AGREEMENT ON A CONCERTED ACTION PROJECT
              IN THE FIELD OF REGISTRATION OF CONGENITAL ABNORMALITIES
                              (MEDICAL RESEARCH AND PUBLIC HEALTH)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having r e g a r d t o the T r e a t y e s t a b l i s h i n g t h e European Economic Community,
Having r e g a r d t o C o u n c i l D e c i s i o n 82/616/EEC o f 17 August 1982 a d o p t i n g a
s e c t o r a l r e s e a r c h and development programme o f the European Economic
 Community i n t h e f i e l d o f m e d i c a l and p u b l i c h e a l t h r e s e a r c h - c o n c e r t e d
                                 1
 a c t i o n - (1982 t o 9 8 6 ) ( 1 ) , and .in p a r t i c u l a r A r t i c l e 7(1) t h e r e o f ,
Having r e g a r d t o C o u n c i l D e c i s i o n 79/696/EEC o f 24 J u l y 1979 on t h e c o n c l u s i o n
o f t h e Agreement between t h e European Economic Community and t h e H e l l e n i c
R e p u b l i c on a c o n c e r t e d - a c t i o n p r o j e c t i n t h e f i e l d o f r e g i s t r a t i o n of
c o n g e n i t a l a b n o r m a l i t i e s ( m e d i c a l and p u b l i c h e a l t h r e s e a r c h ) ( 2 ) ,
Having r e g a r d t o t h e d r a f t d e c i s i o n s u b m i t t e d by t h e Commission,
Whereas on 1 August 1980 t h e Swiss C o n f e d e r a t i o n acceded t o t h e Agreement on
a c o n c e r t e d - a c t i o n p r o j e c t i n the f i e l d of r e g i s t r a t i o n of c o n g e n i t a l
a b n o r m a l i t i e s ( m e d i c a l r e s e a r c h and p u b l i c h e a l t h ) ;
Whereas, i n accordance w i t h A r t i c l e 7 (2) o f D e c i s i o n 82/616/EEC, t h e
Commission has n e g o t i a t e d an Agreement w i t h t h e Swiss C o n f e d e r a t i o n                       amending
the       above mentioned Agreement;
Whereas i t i s n e c e s s a r y t o approve t h a t Agreement,
HAS DECIDED AS FOLLOWS :
              (1)      OJ        N° L 2 4 8 ,             24.   8.   1982, p. 12
              (1)      OJ          N° L 2 0 5 ,           13.   8.     1979, p. 27
 ---pagebreak---                                                   -   2    -
                                      Article 1
The Agreement amending t h e Agreement on a c o n c e r t e d - a c t i o n p r o j e c t i n t h e
f i e l d o f c o n g e n i t a l a b n o r m a l i t i e s i s hereby approved on b e h a l f of t h e
Community.
The t e x t of t h e Agreement i s annexed t o t h i s D e c i s i o n .
                                      Article 2
The P r e s i d e n t o f the C o u n c i l i s hereby a u t h o r i z e d t o d e s i g n a t e t h e persons
empowered t o s i g n the Agreement i n o r d e r t o bind the Community.
Done at B r u s s e l s ,
                                                                       For t h e C o u n c i I
                                                                        The P r e s i d e n t
 ---pagebreak---                           DRAFT AGREEMENT BETWEEN THE EUROPEAN ECONOMIC
                          COMMUNITY AND THE SWISS CONFEDERATION AMENDING
                          THE AGREEMENT ON A CONCERTED ACTION PROJECT IN
                                THE FIELD OF REGISTRATION OF CONGENITAL
                                                        ABNORMALITIES
THE EUROPEAN ECONOMIC                       COMMUNITY,
and
THE SWISS CONFEDERATION, h e r e i n a f t e r r e f e r r e d t o as " t h e c o n t r a c t i n g p a r t i e s "
Whereas on 1 August 1980 t h e Swiss C o n f e d e r a t i o n acceded t o t h e Agreement on
a concerted-action                    p r o j e c t i n t h e f i e l d of r e g i s t r a t i o n o f c o n g e n i t a l
a b n o r m a l i t i e s , h e r e i n a f t e r r e f e r r e d t o as " t h e Agreement", signed                 by t h e
European Economic Community and t h e H e l l e n i c R e p u b l i c                           on 14 December 1979;
Whereas t h i s Agreement                     e x p i r e d on 31 December 1981;
Whereas, by i t s D e c i s i o n                 o f 17 August 1982, t h e C o u n c i l o f t h e European
Communities adopted a s e c t o r a l r e s e a r c h                   and development programme i n t h e
f i e l d o f m e d i c a l and p u b l i c h e a l t h          research   - c o n c e r t e d a c t i o n (1982 t o
1 9 8 6 ) , which i n c l u d e d t h e c o n t i n u a t i o n        of the project           relating to registration
of c o n g e n i t a l        abnormalities;
Whereas i t i s i n t h e common i n t e r e s t o f t h e c o n t r a c t i n g p a r t i e s t o c o n t i n u e
the      research          c o v e r e d by t h e Agreement;
Whereas t h e renewal o f t h e above mentioned Agreement                                     necessitates           supple­
mentary f i n a n c i a l c o n t r i b u t i o n s by t h e c o n t r a c t i n g p a r t i e s ,
HAVE AGREED AS FOLLOWS :
 ---pagebreak---                                                           - 2      -
                                                      ARTICLE 1
The   Agreement s h a l l           be    renewed f o r the p e r i o d from 1 January                                 1982     to
31  December           1986.
                                                      ARTICLE          2
The  p r o v i s i o n s of the         Agreement are                h e r e b y amended as               follows        :
1) The      following text shall                    be    added t o Annex A                    :
    "2    b i s . Improvement of                intra-uterine diagnosis                           and     s t u d i e s on    early    foetal
    loss, death            in early childhood                    and      foetal        growth         disturbances".
2) A n n e x B s h a l l      be    r e p l a c e d by       Annex A t o t h i s               Agreement.
3) A r t i c l e   3 shall        be    r e p l a c e d by t h e          following text                :
                                                    "Article            3
In order        to f a c i l i t a t e    the      execution           of the p r o j e c t , the               General       Committee
and   the Concerted             A c t i o n C o m m i t t e e f o r t h a t p r o j e c t , s e t up                  by   the   decision
of the      Council of the              European Communities dated                               17   August        1982,     shall    be
enlarged        to include the              Swiss       Confederation                 f o r the purposes of a l l a c t i ­
vities      arising        from the         concerted-action                    project covered                 by    this     agreement.
The   terms of         reference          of these           enlarged           Committees are                set out       i n Annex     A.
The   s e c r e t a r i a t s services f o r the                 enlarged           Committees s h a l l              be   provided     by
the    Commission.".
4)  In A r t i c l e     5 ( 1 ) , the        word "Committee" s h a l l                      be    r e p l a c e d by     the   words
    "enlarged          General         Committee".
5)  Paragraph          2 of A r t i c l e       5 shall          be     deleted.
6)  Paragraph          3 of A r t i c l e        5 shall         be    r e p l a c e d by t h e         f o l l o w i n g paragraph       :
    "On     completion          of the p r o j e c t , the                Commission, i n agreement with                           the
    enlarged         General        Committee, shall                   send         to the         States       a summary         report
    on t h e      implementation              and      r e s u l t s of the p r o j e c t p a r t i c u l a r l y             so   that
    the     results obtained                may      be    a c c e s s i b l e as        r a p i d l y as p o s s i b l e t o      the
    enterprises, institutions                          and     other        p a r t i e s concerned,               especially in
    the     social         areas.".
7)  I n A n n e x C,       paragraph           III shall           be     r e p l a c e d by t h e        f o l l o w i n g paragraph       :
 ---pagebreak---                                                   - 3 -
      "The      funds p a i d by the Swiss C o n f e d e r a t i o n               s h a l L be c r e d i t e d t o      the
      concerted-action               p r o j e c t as budget r e c e i p t s a l l o c a t e d t o a chapter
      i n the statement of revenue of the budget of the European Communities
      (Commission s e c t i o n ) " .
8) The        Appendix t o Annex C s h a l l be r e p l a c e d by Annex B t o t h i s Agreement.
                                                   ARTICLE 3
The     estimated           financial        c o n t r i b u t i o n by the c o n t r a c t i n g p a r t i e s t o       the
c o o r d i n a t i o n c o s t s f o r the p e r i o d 1 January 1982                    - 31      December 1986          s h a l l be :
                             - 600     000      ECU    from the European Economic Community
                             -     55 000       ECU    from the Swiss             Confederation.
The     ECU     s h a l l be t h a t d e f i n e d       i n the F i n a n c i a l R e g u l a t i o n   i n force applicable
t o the g e n e r a l        budget of the European Communities and                                 i n the   financial
p r o v i s i o n s adopted pursuant t o t h a t                     Regulation.
                                                   ARTICLE 4
The     p r o j e c t s h a l l be e v a l u a t e d       before     the end of the t h i r d y e a r . In the                     light
of t h i s e v a l u a t i o n the Commission may,                      a f t e r c o n s u l t i n g the e n l a r g e d    General
Committee, submit a p r o p o s a l                    f o r r e v i s i o n of the p r o j e c t i n accordance w i t h
the a p p r o p r i a t e       procedures.
                                                   ARTICLE 5
1. T h i s Agreement s h a l l e n t e r i n t o f o r c e on 1 January                              1982.
2. I t s h a l l a p p l y , on the one                  hand, t o the t e r r i t o r i e s i n which the                  Treaty
      e s t a b l i s h i n g the European Economic Community i s a p p l i e d                               under the
      conditions            l a i d down i n t h a t T r e a t y        and,     on the o t h e r , t o the           territory
      of the Swiss                Confederation.
 ---pagebreak---                                                   - 4  -
                                          ARTICLE 6
T h i s Agreement, drawn up i n a s i n g l e o r i g i n a l                  i n the D a n i s h , D u t c h , E n g l i s h ,
F r e n c h , German, Greek and I t a l i a n             l a n g u a g e s , each t e x t b e i n g equally
a u t h e n t i c , s h a l l be d e p o s i t e d  i n t h e a r c h i v e s of the G e n e r a l S e c r e t a r i a t of
the C o u n c i l of the European Communities, which s h a l l t r a n s m i t a c e r t i f i e d
copy t o each of t h e c o n t r a c t i n g p a r t i e s .
 ---pagebreak---                                                                                                            ANNEX A
                              TERMS OF REFERENCE OF THE ENLARGED COMMITTEES
                              I.    Enlarged        G e n e r a l Concerted A c t i o n Committee
1 . The G e n e r a l Committee s h a l l :
    - c o n t r i b u t e t o t h e best p o s s i b l e i m p l e m e n t a t i o n of t h e programme by g i v i n g i t s
        o p i n i o n on a l l i t s a s p e c t s ;
    - endeavour t o i n t e g r a t e those p a r t s o f n a t i o n a l r e s e a r c h a c t i v i t i e s covered by
        t h i s Agreement i n t o a p r o c e s s o f c o o r d i n a t i o n between the c o n t r a c t i n g p a r t i e s ;
    - c o o r d i n a t e , w i t h i n the programme as d e f i n e d i n Annex A t o the Agreement, the
        a c t i v i t i e s , d u r a t i o n and, p o s s i b l y , e a r l y t e r m i n a t i o n of the p r o j e c t s forming
        the r e s e a r c h a r e a s of t h i s programme, a c c o r d i n g t o emerging needs or r e s u l t s
        of p e r i o d i c a l e v a l u a t i o n s ;
    - i n d i c a t e g u i d e l i n e s t o the enlarged                Concerted A c t i o n Committee ;
    - a d v i s e the Commission on a l l o c a t i o n of funds f o r c o o r d i n a t i o n p u r p o s e s ,
        s u p p o r t i n g c e n t r a l i s e d f a c i l i t i e s , meeting urgent needs i n c r i t i c a l a r e a s ,
        and u n d e r t a k i n g e x p l o r a t o r y a c t i v i t i e s i n view t o t h e p r e p a r a t i o n of f u t u r e
        programmes.
2. The r e p o r t s and o p i n i o n s o f the e n l a r g e d G e n e r a l Committee s h a l l be forwarded
    t o the c o n t r a c t i n g p a r t i e s . The Commission s h a l l f o r w a r d t h e s e o p i n i o n s t o
    CREST.
                            I I . Enlarged        C o n c e r t e d A c t i o n Committee
1 . The Committee s h a l l :
    - a s s i s t t h e e n l a r g e d General Committee i n i t s management t a s k s by e n s u r i n g
        the s c i e n t i f i c and t e c h n i c a l e x e c u t i o n o f a l l those p r o j e c t s a l l o c a t e d t o
        i t i n a c c o r d a n c e w i t h i t s competence ;
    - evaluate             t h e r e s u l t s and draw c o n c l u s i o n s as regards t h e i r a p p l i c a t i o n ;
    - be r e s p o n s i b l e f o r the exchange of i n f o r m a t i o n r e f e r r e d t o i n the f i r s t
        sub-paragraph of A r t i c l e 5 ;
    - keep a b r e a s t of n a t i o n a l r e s e a r c h being done i n the f i e l d of t h e p r o j e c t s
        and, more e s p e c i a l l y of s c i e n t i f i c and t e c h n i c a l developments L i k e l y t o
        affect their execution;
    - suggest g u i d e l i n e s t o the P r o j e c t L e a d e r s .
2. The Committee's r e p o r t s and o p i n i o n s s h a l l be forwarded t o the e n l a r g e d
    G e n e r a l Committee and t o t h e Commission.
3. The p r o j e c t l e a d e r s s h a l l a t t e n d t h e meetings o f the Committee but s h a l l
    not have the r i g h t t o v o t e .
 ---pagebreak---                                                          "REGISTRATION OF CONGENITAL ABNORMALITIES"
                                                               Budget item 7367         "Medical   Research"
                                                                             PROJECT : 1.1.4.
                                                                                                                                              (in ECU)
                                                                                       1982                 1983 to 1986                TOTAL
                                                                                                         Annual      Annua I
                                                                             Commitments  Payments                  Payments  [fcrnmitments  Payments
                                                                                                      Commitments
  I.Initial           e s t i m a t e of overall requirements
    ( f i g u r e s appearing i n the t i m e t a b l e of committ­
    ments and payments and in t h e table o f e q u i v a ­
    lence shown i n Annex I I t o t h e Commission
    budget) :
   - Staff
    -Administrative o p e r a t i n g e x p e n d i t u r e                    20.000      20.000       20.000      20.000     100.000      100.000
    - Contracts                                                               100.000     100.000      100.000     100.000     500.000      500.000
    T o t a l ( t o be covered by a p p r o p r i a t i o n s en­             120.000     120.000      120.000     120.000     600.000      600.000
                 t e r e d under Item 7367)
 II.Revised estimate of expenditure taking into
      account a d d i t i o n a l requirements a r i s i n g from
      the accession of the Swiss Confederation :
      - Staff                                                                    —           —            —           —           —            —
      - A d m i n i s t r a t i v e operating expenditure                       20.000 +    20.000 +     20.000 +     20.000 + 100.000 +    100.000 +
                                                                                 5.000       5.000         5.000       5.000     25.000       25.000
                                                                               100.000 +   100.000 +    100.000 +    100.000 + 500.000 +     500.000 +
      - Contracts                                                                                          6.000       6.000     30.000       30.000
                                                                                 6.000       6.000
                                                                               120.000 +   120.000 +    120.000 +    120.000 + 600.000 +     600.000 +
 New      total                                                                 11.000      11.000       11.000       11.000     55.000       55.000
III.Difference between I . and I I . t o be covered
                                                                                11.000      11.000        11.000      11.000     55.000       55.000
       by c o n t r i b u t i o n s from the Swiss C o n f e d e r a t i o n
 IV. T o t a l e x p e n d i t u r e 1979-1981                                   —           —             —            —       352.000      352.000