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COM (83) 032 
 
 
 
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l. 1983/0 013 
  
 
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COMMISSION  OF THE EUROPEAN  COMMUNITIES 
COM(83)  32  final 
Brussels,  1 February  1983 
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) 
COM(83)  32  final 

COMMUNICATION  FROM  THE  COMMISSION  TO THE  COUNCIL 
SUBJECT  : Proposal for a Council decision on the conclusion of an agreement 
between the EEC and the  Swiss  Confederation amending the Agreement 
on a concerted-action project in the field of registration of 
congenital abnormalities. 
A concerted-action project in the field of registration of congenital abnor­
malities (medical research and public health) was adopted by the Council 
on 13 February  1978 (1). 
An Agreement between the European Economic Community and the Hellenic Republic 
extending the coordination which is the subject of the relevant Decision to 
corresponding research undertaken in  that  State was concluded by the Council 
on 24 July  1979 (2),  was signed by the two parties on  14 December  1979  and 
entered  into  force on  1 August  1980. 
On 1 August  1980,  the  Swiss  Confederation acceded to the above mentioned 
Agreement in accordance  with  Article  6 (3)  thereof. 
This  Agreement expired on  31 December  1981. 
By its Decision  82/616/EEC  (3)  of  17  August  1982,  the Council adopted a 
sectoral research and development programme in the field of medical and 
public health research  - concerted action  (1982  to 1986),  including the 
continuation of the concerted-action project relating to the registration of 
congenital abnormalities. 
Since  the Contracting Parties, namely the Community (the Hellenic Republic 
is no longer a contracting party, having been a member of the Community 
since  1 January  1981)  and the  Swiss  Confederation, have a common interest in 
continuing their cooperation in the field of registration of congenital 
abnormalities, it is desirable  that  the above mentioned Agreement be 
renewed for the period  from  1 January  1982  to 31  December  1986. 
As provided for in Article  7 (2)  of Decision  82/616/EEC,  the Commission has 
negotiated the said renewal  with  the  Swiss  Confederation. The negotiations 
have led to the following results  : 
(1) 
(2) 
(3) 0J 
0J 
0J N° L  52 of 23  February  1978,  p. 20 
N° L  205  of 13  August  1979,  p. 27 
N° L  248  of 24  August  1982,  p. 12 

- 2 -
- the Agreement  relating  to the  concerted-action project  in the  field of 
registration  of congenital abnormalities  will consequently  be amended. 
- the financial  contribution  of the  Parties  to the Agreement  will be 
- 600 000 ECU by the Community 
- 55 000 ECU by the  Swiss Confederation. 
The Commission  requests  the Council  to adopt the  draft decision  annexed  hereto. 

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 regard to the  Treaty establishing  the European Economic  Community, 
Having regard to Council Decision  82/616/EEC  of 17 August 1982 adopting  a 
sectoral  research  and development  programme  of the  European Economic 
Community  in the  field of medical and public health research  - concerted 
action - (1982 to  1986)(1),  and .in particular  Article  7(1) thereof, 
Having regard to Council Decision  79/696/EEC  of 24 July 1979 on the  conclusion 
of the Agreement between  the European Economic  Community  and the  Hellenic 
Republic  on a concerted-action project  in the  field of registration  of 
congenital  abnormalities (medical  and public health research)  (2), 
Having regard to the  draft decision submitted  by the  Commission, 
Whereas on 1 August 1980 the  Swiss Confederation  acceded  to the  Agreement  on 
a concerted-action project  in the  field of registration  of congenital 
abnormalities  (medical research  and public health); 
Whereas,  in accordance  with Article  7 (2) of  Decision  82/616/EEC,  the 
Commission  has negotiated  an Agreement  with the Swiss Confederation  amending 
the above mentioned Agreement; 
Whereas it is  necessary  to approve  that Agreement, 
HAS DECIDED AS  FOLLOWS  : 
(1) OJ N° L 248, 24. 8. 1982, p. 12 
(1) OJ N° L 205, 13. 8. 1979, p. 27 

- 2 -
Article 1 
The Agreement amending the Agreement on a  concerted-action project  in the 
field of congenital abnormalities  is hereby approved  on behalf of the 
Community. 
The text of the Agreement is annexed to  this Decision. 
Article 2 
The President  of the  Council  is hereby authorized  to designate  the persons 
empowered  to sign the Agreement in  order to bind the Community. 
Done at Brussels, 
For the CounciI 
The President 

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,  hereinafter referred  to as "the  contracting parties" 
Whereas on 1 August 1980 the Swiss Confederation  acceded  to the  Agreement  on 
a concerted-action project  in the  field of registration  of congenital 
abnormalities, hereinafter referred  to as "the  Agreement",  signed by the 
European Economic  Community  and the  Hellenic Republic  on 14 December  1979; 
Whereas  this Agreement  expired  on 31 December  1981; 
Whereas,  by its Decision  of 17 August 1982, the Council of the  European 
Communities adopted  a sectoral research  and development  programme  in the 
field of medical and public health research  - concerted  action (1982 to 
1986), which included  the continuation  of the  project relating  to registration 
of congenital abnormalities; 
Whereas it is in the common  interest  of the  contracting parties  to continue 
the research  covered  by the  Agreement; 
Whereas the renewal of the  above mentioned Agreement  necessitates  supple­
mentary  financial  contributions  by the  contracting parties, 
HAVE AGREED AS FOLLOWS  : 

- 2 -
ARTICLE  1 
The Agreement  shall  be renewed  for the period  from 1 January  1982 to 
31 December  1986. 
ARTICLE  2 
The provisions of the  Agreement  are hereby  amended  as follows  : 
1) The following text  shall  be added  to Annex  A : 
"2 bis. Improvement  of intra-uteri ne diagnosis and studies on early  foetal 
loss, death in early childhood and  foetal  growth  disturbances". 
2) Annex B shall  be replaced by  Annex  A to this Agreement. 
3) Article  3 shall  be replaced by the following text  : 
"Article  3 
In order to  facilitate  the execution of the project, the General  Committee 
and the Concerted Action  Committee  for that project, set up by the decision 
of the Council of the  European  Communities  dated  17 August  1982,  shall  be 
enlarged to include the Swiss Confederation for the  purposes  of all  acti­
vities  arising  from the concerted-action project covered by  this agreement. 
The terms  of reference of these enlarged  Committees  are set out in  Annex  A. 
The secretariats services for the enlarged  Committees  shall  be provided by 
the Commission.". 
4) In Article  5 (1),  the word "Committee"  shall  be replaced by the  words 
"enlarged General  Committee". 
5) Paragraph  2 of Article  5 shall  be deleted. 
6) Paragraph  3 of Article  5 shall  be replaced by the following paragraph  : 
"On completion of the project, the  Commission,  in agreement  with the 
enlarged General  Committee,  shall send to the States a  summary  report 
on the implementation and results of the project  particularly  so that 
the results obtained may be accessible as rapidly as possible to the 
enterprises,  institutions  and other parties concerned, especially in 
the social  areas.". 
7) In Annex  C, paragraph III  shall be replaced by the following paragraph  : 

- 3 -
"The funds  paid by the  Swiss Confederation shalL be credited to the 
concerted-action project as  budget  receipts allocated to a  chapter 
in the statement  of revenue  of the budget  of the European  Communities 
(Commission  section)". 
8) The Appendix  to Annex C shall be replaced by  Annex B to this Agreement. 
ARTICLE  3 
The estimated  financial  contribution by the contracting parties to the 
coordination costs for the period 1  January  1982 - 31  December  1986 shall be : 
- 600 000 ECU  from the European  Economic  Community 
- 55 000 ECU  from the Swiss Confederation. 
The ECU  shall be that defined in the Financial Regulation in force applicable 
to the general  budget  of the European  Communities  and in the  financial 
provisions  adopted  pursuant  to that Regulation. 
ARTICLE  4 
The project  shall be evaluated before the end of the  third year. In the  light 
of this evaluation the  Commission  may, after consulting the enlarged  General 
Committee,  submit  a proposal for revision of the project in  accordance  with 
the appropriate  procedures. 
ARTICLE  5 
1. This Agreement  shall enter into force on 1  January  1982. 
2. It shall apply, on the one  hand,  to the  territories  in which the Treaty 
establishing  the European  Economic  Community  is applied  under  the 
conditions  laid down in that Treaty and, on the other, to the  territory 
of the Swiss Confederation. 

- 4 -
ARTICLE  6 
This Agreement,  drawn up in a  single  original  in the Danish, Dutch,  English, 
French, German,  Greek and  Italian  languages, each  text 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. 

ANNEX A 
TERMS OF REFERENCE  OF THE ENLARGED  COMMITTEES 
I. Enlarged  General  Concerted  Action Committee 
1. The General  Committee  shall : 
- contribute  to the  best possible  implementation  of the programme  by giving  its 
opinion on all its aspects ; 
- endeavour to  integrate  those parts of national research  activities  covered  by 
this Agreement  into a process  of coordination  between the  contracting parties  ; 
- coordinate, within  the programme  as defined  in Annex A to the Agreement, the 
activities,  duration  and, possibly, early termination  of the  projects forming 
the research  areas of this programme,  according  to emerging needs or  results 
of periodical evaluations; 
- indicate guidelines  to the  enlarged  Concerted  Action  Committee ; 
- advise the Commission on  allocation  of funds for coordination  purposes, 
supporting centralised  facilities,  meeting  urgent needs in  critical  areas, 
and undertaking exploratory  activities  in view to the  preparation  of future 
programmes. 
2. The reports  and opinions  of the  enlarged  General  Committee  shall be forwarded 
to the contracting parties.  The Commission  shall forward  these opinions  to 
CREST. 
II. Enlarged  Concerted  Action Committee 
1. The Committee  shall : 
- assist the enlarged  General  Committee in  its management  tasks by ensuring 
the scientific  and technical execution  of all those projects allocated  to 
it in accordance  with its competence ; 
- evaluate  the results  and draw conclusions  as regards  their application; 
- be responsible  for the exchange of  information referred  to in the  first 
sub-paragraph  of Article  5; 
- keep abreast  of national research being  done in the  field of the  projects 
and, more especially  of scientific  and technical  developments  Likely to 
affect their execution; 
- suggest  guidelines  to the  Project  Leaders. 
2. The Committee's  reports  and opinions  shall be forwarded  to the  enlarged 
General Committee and to the Commission. 
3. The project leaders  shall attend the meetings of the Committee but  shall 
not have the  right to vote. 

"REGISTRATION  OF CONGENITAL  ABNORMALITIES" 
Budget item 7367 "Medical Research" 
PROJECT : 1.1.4. 
(in ECU) 
1982 1983 to 1986 TOTAL 
Commitments Payments Annual 
Commitments Annua I 
Payments [fcrnmitments Payments 
I.Initial  estimate  of overall requirements 
(figures  appearing  in the  timetable  of committ­
ments and payments and in the  table of equiva­
lence shown in Annex II to the  Commission 
budget) : 
- Staff 
-Administrative  operating expenditure 
- Contracts 
Total (to be  covered  by appropriations  en­
tered under Item 7367) 20.000 
100.000 20.000 
100.000 20.000 
100.000 20.000 
100.000 100.000 
500.000 100.000 
500.000 I.Initial  estimate  of overall requirements 
(figures  appearing  in the  timetable  of committ­
ments and payments and in the  table of equiva­
lence shown in Annex II to the  Commission 
budget) : 
- Staff 
-Administrative  operating expenditure 
- Contracts 
Total (to be  covered  by appropriations  en­
tered under Item 7367) 120.000 120.000 120.000 120.000 600.000 600.000 
II.Revised  estimate  of expenditure  taking into 
account additional  requirements  arising  from 
the accession  of the Swiss Confederation  : 
- Staff — — — — — — 
- Administrative 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 
- Contracts 100.000 + 100.000 + 100.000 + 100.000 + 500.000 + 500.000 + - Contracts 6.000 6.000 6.000 6.000 30.000 30.000 
New total New total 120.000 + 
11.000 120.000 + 
11.000 120.000 + 
11.000 120.000 + 
11.000 600.000 + 
55.000 600.000 + 
55.000 
III.Difference  between  I. and  II. to be covered 
by contributions from  the Swiss Confederation 11.000 11.000 11.000 11.000 55.000 55.000 
IV. Total expenditure  1979-1981 — — — — 352.000 352.000