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AGREEMENT

BETWEEN THE EUROPEAN ECONOMIC COMMUNITY AND THE SWISS CONFEDERATION ON A CONCERTED ACTION PROJECT IN THE FIELD OF THE DETECTION OF THE TENDENCY TO THROMBOSIS

THE EUROPEAN ECONOMIC COMMUNITY ,

OF THE ONE PART ,

AND

THE SWISS CONFEDERATION ,

OF THE OTHER PART ,

WHEREAS A EUROPEAN CONCERTED RESEARCH ACTION PROJECT IN THE FIELD OF THE DETECTION OF THE TENDENCY TO THROMBOSIS IS LIKELY TO CONTRIBUTE EFFECTIVELY TO ENSURING AN OPTIMUM LEVEL OF HEALTH IN INDIVIDUALS AND IN SOCIETY ;

WHEREAS , BY ITS DECISION OF 18 MARCH 1980 , THE COUNCIL OF THE EUROPEAN COMMUNITIES ADOPTED A SECOND RESEARCH PROGRAMME IN THE FIELD OF MEDICAL AND PUBLIC HEALTH RESEARCH CONSISTING OF FOUR MULTIANNUAL CONCERTED PROJECTS , ONE OF WHICH RELATES TO THE DETECTION OF THE TENDENCY TO THROMBOSIS ;

WHEREAS THE MEMBER STATES OF THE COMMUNITY AND THE SWISS CONFEDERATION , HEREINAFTER REFERRED TO AS " THE STATES " , INTEND , SUBJECT TO THE RULES AND PROCEDURES APPLICABLE TO THEIR NATIONAL PROGRAMMES , TO CARRY OUT THE RESEARCH DESCRIBED IN ANNEX I AND ARE PREPARED TO INTEGRATE SUCH RESEARCH INTO A PROCESS OF COORDINATION WHICH THEY CONSIDER WILL BE OF MUTUAL BENEFIT ;

WHEREAS THE EXECUTION OF THE RESEARCH COVERED BY THE CONCERTED ACTION PROJECT WILL REQUIRE A FINANCIAL CONTRIBUTION OF APPROXIMATELY 10 MILLION ECU FROM THE STATES ,

HAVE DECIDED TO CONCLUDE THIS AGREEMENT AND TO THIS END HAVE DESIGNATED AS THEIR PLENIPOTENTIARIES :

THE COUNCIL OF THE EUROPEAN COMMUNITIES

AND

THE SWISS CONFEDERATION :

WHO HAVE AGREED AS FOLLOWS :

ARTICLE 1

THE COMMUNITY AND THE SWISS CONFEDERATION , HEREINAFTER REFERRED TO AS " THE CONTRACTING PARTIES " , SHALL PARTICIPATE FOR A PERIOD EXTENDING UNTIL 31 MAY 1984 IN A CONCERTED ACTION PROJECT IN THE FIELD OF THE DETECTION OF THE TENDENCY TO THROMBOSIS .

THIS PROJECT SHALL CONSIST OF COORDINATING THE COMMUNITY CONCERTED ACTION PROGRAMME WITH THE CORRESPONDING PROGRAMME OF SWITZERLAND . THE PROGRAMMES COVERED BY THIS AGREEMENT ARE LISTED IN ANNEX I .

THE STATES SHALL REMAIN ENTIRELY RESPONSIBLE FOR THE RESEARCH EXECUTED OR COORDINATED BY THEIR NATIONAL INSTITUTIONS OR BODIES , LISTED IN ANNEX I .

ARTICLE 2

THE COMMISSION OF THE EUROPEAN COMMUNITIES SHALL BE RESPONSIBLE FOR THE COORDINATION .

IT SHALL BE ASSISTED IN THIS TASK BY THE PROJECT LEADER .

ARTICLE 3

IN ORDER TO FACILITATE THE EXECUTION OF THE PROJECT , THE CONCERTED ACTION COMMITTEE ON THE DETECTION OF THE TENDENCY TO THROMBOSIS , HEREINAFTER REFERRED TO AS " THE COMMITTEE " , SET UP BY THE DECISION OF 18 MARCH 1980 , SHALL BE ENLARGED TO INCLUDE THE SWISS CONFEDERATION .

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 II .

ARTICLE 4

THE MAXIMUM FINANCIAL CONTRIBUTION BY THE CONTRACTING PARTIES TO THE COORDINATION COSTS SHALL BE :

- 616 000 ECU FROM THE COMMUNITY FOR A FOUR-YEAR PERIOD BEGINNING ON 1 JUNE 1980 ,

- 38 000 ECU FROM THE SWISS CONFEDERATION FOR THE PERIOD REFERRED TO IN THE FIRST PARAGRAPH OF ARTICLE 1 .

THE ECU IS THAT DEFINED IN THE FINANCIAL REGULATION APPLICABLE TO THE GENERAL BUDGET OF THE EUROPEAN COMMUNITIES AND BY THE FINANCIAL PROVISIONS ADOPTED PURSUANT TO THAT REGULATION .

THE RULES GOVERNING THE FINANCING OF THE AGREEMENT ARE SET OUT IN ANNEX III .

ARTICLE 5

IN ACCORDANCE WITH THE PROCEDURE LAID DOWN BY THE COMMISSION IN AGREEMENT WITH THE COMMITTEE , THE STATES SHALL EXCHANGE REGULARLY ALL RELEVANT INFORMATION CONCERNING THE EXECUTION OF THE RESEARCH COVERED BY THE CONCERTED ACTION PROJECT AND SHALL FORWARD TO THE COMMISSION ALL INFORMATION WHICH MAY BE USEFUL FOR COORDINATION PURPOSES . THEY SHALL ALSO ENDEAVOUR TO PROVIDE THE COMMISSION WITH INFORMATION ON RESEARCH IN THE FIELD IN QUESTION PLANNED OR CARRIED OUT BY BODIES FOR WHICH THEY ARE NOT RESPONSIBLE . ANY INFORMATION SHALL BE TREATED AS CONFIDENTIAL IF THE STATE WHICH PROVIDES IT SO REQUESTS .

THE COMMISSION SHALL PREPARE YEARLY PROGRESS REPORTS ON THE BASIS OF THE INFORMATION SUPPLIED AND SHALL FORWARD THEM TO THE STATES .

AT THE END OF THE PERIOD OF THE CONCERTED ACTION PROJECT , THE COMMISSION , IN AGREEMENT WITH THE COMMITTEE , SHALL FORWARD TO THE STATES A GENERAL REPORT ON THE EXECUTION AND THE RESULTS OF THE PROJECT OBTAINED , IN PARTICULAR SO THAT THE RESULTS OBTAINED ARE MADE ACCESSIBLE AS COMPLETELY AND RAPIDLY AS POSSIBLE TO UNDERTAKINGS , INSTITUTIONS AND OTHER PARTIES CONCERNED , IN PARTICULAR ON THE SOCIAL LEVEL . THIS REPORT SHALL BE PUBLISHED BY THE COMMISSION SIX MONTHS AFTER IT HAS BEEN FORWARDED TO THE STATES , UNLESS A STATE OBJECTS . IN THE LATTER CASE , THE REPORT SHALL BE DISTRIBUTED , AT THEIR REQUEST , SOLELY TO THE INSTITUTIONS AND UNDERTAKINGS WHOSE RESEARCH AND PRODUCTION ACTIVITIES JUSTIFY ACCESS TO THE RESULTS OF THE RESEARCH COVERED BY THE PROJECT .

ARTICLE 6

1 . AS SOON AS POSSIBLE AFTER SIGNING THIS AGREEMENT , EACH OF THE CONTRACTING PARTIES SHALL NOTIFY THE SECRETARY-GENERAL OF THE COUNCIL OF THE EUROPEAN COMMUNITIES OF THE COMPLETION OF THE PROCEDURES NECESSARY UNDER ITS INTERNAL PROVISIONS FOR THE IMPLEMENTATION OF THIS AGREEMENT .

2 . THIS AGREEMENT SHALL ENTER INTO FORCE ON THE DAY ON WHICH THE SECOND OF THE CONTRACTING PARTIES FORWARDS THE NOTIFICATION REFERRED TO IN THE FIRST PARAGRAPH .

PRIOR TO ENTRY INTO FORCE OF THIS AGREEMENT AND FOR A MAXIMUM PERIOD OF NINE MONTHS AFTER IT IS SIGNED , THE SWISS CONFEDERATION MAY TAKE PART WITHOUT VOTING RIGHTS IN THE WORK OF THE COMMITTEE .

3 . FOR A PERIOD OF SIX MONTHS FOLLOWING ITS ENTRY INTO FORCE , THIS AGREEMENT SHALL BE OPEN FOR ACCESSION BY OTHER EUROPEAN STATES WHICH TOOK PART IN THE MINISTERIAL CONFERENCE HELD IN BRUSSELS ON 22 AND 23 NOVEMBER 1971 . THE INSTRUMENTS OF ACCESSION SHALL BE DEPOSITED WITH THE GENERAL SECRETARIAT 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 ON WHICH THE INSTRUMENT OF ACCESSION IS DEPOSITED . IT SHALL CONTRIBUTE TO THE COORDINATION COSTS UNDER THE CONDITIONS LAID DOWN IN ARTICLE 4 CONCERNING THE SWISS CONFEDERATION .

4 . THE SECRETARY-GENERAL OF THE COUNCIL OF THE EUROPEAN COMMUNITIES SHALL INFORM EACH OF THE CONTRACTING PARTIES OF THE LODGING OF THE NOTIFICATIONS REFERRED TO IN PARAGRAPH 1 , OF THE DATE OF ENTRY INTO FORCE OF THIS AGREEMENT AND OF THE DEPOSIT OF THE INSTRUMENTS OF ACCESSION REFERRED TO IN PARAGRAPH 3 .

ARTICLE 7

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 I

PROGRAMMES COVERED BY THE AGREEMENT

A . PROJECT RELATING TO THE DETECTION OF THE TENDENCY TO THROMBOSIS

THE RESEARCH WILL BE CARRIED OUT WITH THE PURPOSE OF ACQUIRING SCIENTIFIC AND TECHNICAL KNOWLEDGE IN THIS FIELD , SELECTED FOR ITS IMPORTANCE AT COMMUNITY LEVEL .

THE RESEARCH IS EXPECTED TO COVER THE FOLLOWING TOPICS :

1 . DETECTION OF ACTIVATED CLOTTING FACTORS AND THEIR REACTION PRODUCTS ;

2 . QUANTITATIVE ANALYSIS OF THE INHIBITORS OF THE CLOTTING SYSTEM ;

3 . STUDIES OF THE ACTIVE AND INHIBITORY COMPONENTS OF THE FIBRINOLYTIC SYSTEM ;

4 . STUDIES OF BLOOD PLATELETS ;

5 . PILOT STUDIES IN WELL-DEFINED POPULATIONS FOLLOWING STANDARDIZATION OF MATERIALS AND METHODOLOGY .

BELGIUM , DENMARK , GERMANY , GREECE , FRANCE , IRELAND , ITALY , THE NETHERLANDS , THE UNITED KINGDOM AND SWITZERLAND WILL CONTRIBUTE RESEARCH UNDER THE TOPICS MENTIONED ABOVE .

B . IMPLEMENTATION AND COORDINATION OF THE NATIONAL CONTRIBUTIONS TO THE PROJECT

THE FOLLOWING AUTHORITIES CARRYING OUT MEDICAL RESEARCH IN THE STATES WILL ENSURE THE IMPLEMENTATION OF THE NATIONAL CONTRIBUTIONS TO THE PROJECT AND THEIR COORDINATION AT NATIONAL LEVEL .

BELGIUM :

( FRSM ) FONDS DE LA RECHERCHE SCIENTIFIQUE MEDICALE , BRUXELLES

( FGWO ) FONDS VOOR GENEESKUNDIG WETENSCHAPPELIJK ONDERZOEK , BRUSSEL

DENMARK :

STATENS COEGEVIDENSKABELIGE FORSKNINGSRAAD , KOEBHAVN

GERMANY :

ZENTRUM FUER INNERE MEDIZIN DER UNIVERSITAET GIESSEN

DEPARTMENT FUER INNERE MEDIZIN DER UNIVERSITAET ULM

GREECE :

!***

FRANCE :

( INSERM ) INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE , PARIS

IRELAND :

MEDICAL RESEARCH COUNCIL OF IRELAND , DUBLIN

ITALY :

( CNR ) CONSIGLIO NAZIONALE DELLA RICERCA , ROMA , AND ISTITUTO SUPERIORE DI SANITA , ROMA

NETHERLANDS :

GEZONDHEITSORGANISATIE TNO AND STICHTING MEDISCH WETENSCHAPPELIJK ONDERZOEK FUNGO , DEN HAAG

UNITED KINGDOM :

( MRC ) MEDICAL RESEARCH COUNCIL , LONDON

SWITZERLAND :

THEODOR KOCHER INSTITUT , UNIVERSITAET BERN

ANNEX II

TERMS OF REFERENCE AND COMPOSITION OF THE COMMITTEE

1 . THE COMMITTEE SHALL :

1.1 . CONTRIBUTE TO THE OPTIMUM EXECUTION OF THE PROJECT BY GIVING ITS OPINION ON ALL OF ITS ASPECTS ;

1.2 . EVALUATE THE RESULTS AND DRAW CONCLUSIONS AS REGARDS THEIR APPLICATION ;

1.3 . BE RESPONSIBLE FOR THE EXCHANGE OF INFORMATION REFERRED TO IN THE FIRST PARAGRAPH OF ARTICLE 5 ;

1.4 . KEEP ABREAST OF NATIONAL RESEARCH BEING DONE IN THE FIELDS COVERED BY THE PROJECT , AND MORE ESPECIALLY OF SCIENTIFIC AND TECHNICAL DEVELOPMENTS LIKELY TO AFFECT THE EXECUTION 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 CREST .

3 . THE COMMITTEE SHALL BE COMPOSED OF PERSONS RESPONSIBLE FOR COORDINATING THE NATIONAL CONTRIBUTIONS TO THE PROJECT LEADER . EACH MEMBER MAY BE ACCOMPANIED BY EXPERTS .

ANNEX III

FINANCING RULES

ARTICLE 1

THESE PROVISIONS LAY DOWN THE FINANCING RULES REFERRED TO IN ARTICLE 4 OF THE AGREEMENT .

ARTICLE 2

AT THE BEGINNING OF EACH FINANCIAL YEAR , THE COMMISSION SHALL SEND TO THE SWISS CONFEDERATION A CALL FOR FUNDS CORRESPONDING TO ITS SHARE OF THE ANNUAL COORDINATION COSTS UNDER THE AGREEMENT , CALCULATED IN PROPORTION TO THE MAXIMUM AMOUNTS LAID DOWN IN ARTICLE 4 OF THE AGREEMENT .

THIS CONTRIBUTION SHALL BE EXPRESSED BOTH IN ECU AND IN THE CURRENCY OF THE STATE CONCERNED , THE VALUE OF THE ECU BEING THAT 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 TOTAL CONTRIBUTIONS SHALL COVER THE TRAVEL AND SUBSISTENCE COSTS OF THE DELEGATES TO THE COMMITTEE , IN ADDITION TO THE COORDINATION COSTS PROPER .

THE SWISS CONFEDERATION SHALL PAY ITS ANNUAL CONTRIBUTION TO THE COORDINATION COSTS UNDER THE AGREEMENT AT THE BEGINNING OF EACH YEAR AND BY 31 MARCH AT THE LATEST . ANY DELAY IN PAYMENT SHALL GIVE RISE TO THE PAYMENT OF INTEREST BY THE SWISS CONFEDERATION AT A RATE EQUAL TO THE HIGHEST DISCOUNT RATE OBTAINING IN THE STATES ON THE DUE DATE . THE RATE SHALL BE INCREASED BY 0,25 OF A PERCENTAGE POINT FOR EACH MONTH OF DELAY . THIS INCREASED RATE SHALL BE APPLIED TO THE ENTIRE PERIOD OF DELAY . HOWEVER , THIS INTEREST SHALL BE RECOVERABLE ONLY IF PAYMENT IS MADE MORE THAN THREE MONTHS AFTER THE COMMISSION HAS SENT A CALL FOR FUNDS .

ARTICLE 3

THE FUNDS PAID BY THE SWISS CONFEDERATION SHALL BE CREDITED TO THE PROJECT AS BUDGET RECEIPTS ALLOCATED TO A HEADING IN THE STATEMENT OF REVENUE OF THE BUDGET OF THE COMMISSION .

ARTICLE 4

THE PROVISIONAL TIMETABLE FOR THE COORDINATION COSTS REFERRED TO IN ARTICLE 4 OF THE AGREEMENT IS ANNEXED HERETO .

ARTICLE 5

THE FINANCIAL REGULATION IN FORCE APPLICABLE TO THE GENERAL BUDGET OF THE EUROPEAN COMMUNITIES SHALL APPLY TO THE MANAGEMENT OF THE APPROPRIATIONS .

ARTICLE 6

AT THE END OF EACH FINANCIAL YEAR , A STATEMENT OF APPROPRIATIONS FOR THE PROJECT SHALL BE PREPARED AND TRANSMITTED TO THE SWISS CONFEDERATION FOR INFORMATION .

ANNEX TO ANNEX III : SEE O.J .