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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 )

THE EUROPEAN ECONOMIC COMMUNITY ,

AND

THE HELLENIC REPUBLIC ,

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

WHEREAS , BY ITS DECISION OF 13 FEBRUARY 1978 , THE COUNCIL OF THE EUROPEAN COMMUNITIES ADOPTED A COMMUNITY CONCERTED ACTION PROJECT IN THE FIELD OF REGISTRATION OF CONGENITAL ABNORMALITIES ( MEDICAL AND PUBLIC HEALTH RESEARCH ) ;

WHEREAS THE MEMBER STATES OF THE COMMUNITY AND THE HELLENIC REPUBLIC , 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 A AND ARE PREPARED TO INTEGRATE SUCH RESEARCH INTO A PROCESS OF COORDINATION WHICH THEY CONSIDER 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 HELLENIC REPUBLIC , 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 WITH THE CORRESPONDING PROGRAMME OF THE HELLENIC REPUBLIC . THE PROGRAMMES COVERED BY THIS AGREEMENT ARE LISTED IN ANNEX A .

THE STATES SHALL REMAIN ENTIRELY RESPONSIBLE FOR THE RESEARCH EXECUTED BY THEIR NATIONAL INSTITUTIONS OR BODIES .

ARTICLE 2

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

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

ARTICLE 3

IN ORDER TO FACILITATE THE EXECUTION OF THE PROJECT , THE CONCERTED ACTION COMMITTEE ON THE REGISTRATION OF CONGENITAL ABNORMALITIES , HEREINAFTER REFERRED TO AS " THE COMMITTEE " , SET UP BY THE DECISION OF THE COUNCIL OF THE EUROPEAN COMMUNITIES OF 13 FEBRUARY 1978 , SHALL BE ENLARGED TO INCLUDE THE HELLENIC REPUBLIC .

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 COORDINATION COSTS SHALL BE :

- 330 000 EUROPEAN UNITS OF ACCOUNT FROM THE COMMUNITY FOR A THREE-YEAR PERIOD BEGINNING ON 1 JANUARY 1978 ,

- 22 000 EUROPEAN UNITS OF ACCOUNT FROM THE HELLENIC REPUBLIC FOR THE PERIOD REFERRED TO IN THE FIRST PARAGRAPH OF ARTICLE 1 .

THE EUROPEAN UNIT OF ACCOUNT SHALL BE THAT DEFINED IN THE FINANCIAL REGULATION APPLICABLE TO THE GENERAL BUDGET OF THE EUROPEAN COMMUNITIES AND IN THE FINANCIAL PROVISIONS ADOPTED PURSUANT TO THAT REGULATION .

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

ARTICLE 5

1 . 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 WILL ASSIST COORDINATION . THEY SHALL ALSO ENDEAVOUR TO PROVIDE THE COMMISSION WITH INFORMATION ON RESEARCH IN THE FIELD IN QUESTION PLANNED OR CARRIED OUT BY BODIES NOT SUBJECT TO THEIR AUTHORITY . ANY INFORMATION SHALL BE TREATED AS CONFIDENTIAL IF THE STATE WHICH PROVIDES IT SO REQUESTS .

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 THE CONCERTED ACTION PROJECT , THE COMMISSION SHALL FORWARD TO THE STATES A GENERAL REPORT ON ITS EXECUTION AND ON THE RESULTS OBTAINED . THIS REPORT SHALL BE PUBLISHED BY THE COMMISSION SIX MONTHS AFTER FORWARDING , UNLESS A STATE OBJECTS . IN THAT CASE , THE REPORT SHALL BE REGARDED AS CONFIDENTIAL AND , WITH THE AGREEMENT OF THE COMMITTEE , SHALL BE FORWARDED SOLELY TO THE INSTITUTIONS AND UNDERTAKINGS WHICH SO REQUEST AND THE RESEARCH OR PRODUCTION ACTIVITIES OF WHICH JUSTIFY ACCESS TO THE RESULTS OF THE RESEARCH COVERED BY THE CONCERTED ACTION 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 FIRST DAY OF THE MONTH FOLLOWING THAT IN WHICH THE SECOND OF THE CONTRACTING PARTIES FORWARDS THIS NOTIFICATION .

PRIOR TO THE ENTRY INTO FORCE OF THIS AGREEMENT AND FOR A MAXIMUM PERIOD OF NINE MONTHS AFTER IT IS SIGNED , THE HELLENIC REPUBLIC 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 HELLENIC REPUBLIC .

4 . THE SECRETARY-GENERAL OF THE COUNCIL OF THE EUROPEAN COMMUNITIES SHALL NOTIFY 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 A

PROGRAMMES COVERED BY THE AGREEMENT

1 . REGISTRATION OF CONGENITAL MALFORMATIONS AS WELL AS OF INHERITED BIOCHEMICAL AND CHROMOSOME ABNORMALITIES IN SELECTED REGIONS OF THE CONTRACTING PARTIES . REGISTRATION WILL PROGRESSIVELY EXTEND TO ABNORMALITIES OF THE NERVOUS SYSTEM ( ANENCEPHALY , SPINA BIFIDA , ETC ) , DOWN'S SYNDROME , GROSS ABNORMALITIES OF THE LIMBS , MULTIPLE ABNORMALITIES , PHENYLKETONURIA AND COELIAC DISEASE .

2 . REGISTRATION OF TWIN AND MULTIPLE PREGNANCIES IN SELECTED REGIONS OF THE CONTRACTING PARTIES .

3 . RELEVANT METHODOLOGICAL STUDIES TO OBTAIN OPTIMUM COORDINATION OF EXISTING NATIONAL REGISTERS AND REGISTRATION PROCEDURES .

THE COORDINATION WILL INCLUDE THE FOLLOWING REGIONAL REGISTERS IN THE STATES :

BELGIUM*BRUGES AND HAINAUT*

DENMARK*ODENSE*

FRANCE*PARIS*

GERMANY*HESSEN*

GREECE*ATHENS*

IRELAND*DUBLIN AND GALWAY*

ITALY*FLORENCE AND ROME*

LUXEMBOURG*LUXEMBOURG*

NETHERLANDS*LEIDSCHENDAM*

UNITED KINGDOM*BELFAST , GLASGOW AND LIVERPOOL*

THESE STATES WILL CONTRIBUTE RESEARCH UNDER THE THREE TOPICS MENTIONED ABOVE .

ANNEX B

TERMS OF REFERENCE AND COMPOSITION OF THE CONCERTED ACTION COMMITTEE ON THE REGISTRATION OF CONGENITAL ABNORMALITIES

1 . THE COMMITTEE SHALL :

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

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

1.3 . BE RESPONSIBLE FOR THE EXCHANGE OF INFORMATION REFERRED TO IN ARTICLE 5 ( 1 ) OF THE AGREEMENT ;

1.4 . KEEP ABREAST OF NATIONAL RESEARCH BEING DONE IN THE FIELDS COVERED BY THE CONCERTED 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 PROGRAMME , AND THE PROJECT LEADER . EACH MEMBER MAY BE ACCOMPANIED BY EXPERTS .

ANNEX C

FINANCING RULES

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

II . AT THE BEGINNING OF EACH FINANCIAL YEAR , A CALL FOR FUNDS SHALL BE ISSUED BY THE COMMISSION TO THE HELLENIC REPUBLIC . SUCH CALLS FOR FUNDS SHALL EXPRESS THE CONTRIBUTION OF THE LATTER BOTH IN EUROPEAN UNITS OF ACCOUNT AND IN THE CURRENCY OF THAT STATE , THE VALUTE 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 HELLENIC REPUBLIC 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 TO THE HELLENIC REPUBLIC 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 HELLENIC REPUBLIC SHALL BE CREDITED TO THE 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 APPLICABLE TO THE GENERAL BUDGET OF THE EUROPEAN COMMUNITIES .

IV . THE PROVISIONAL TIMETABLE FOR THE COORDINATION COSTS REFERRED TO IN ARTICLE 4 OF THE AGREEMENT IS SET OUT IN THE TABLE BELOW .

V . THE FINANCIAL REGULATION APPLICABLE TO THE GENERAL BUDGET OF THE EUROPEAN COMMUNITIES SHALL APPLY TO THE MANAGEMENT OF THE APPROPRIATIONS ; FURTHERMORE , THE COMMISSION SHALL ENSURE THAT SUCH APPROPRIATIONS ARE MANAGED IN CONFORMITY WITH THE RULES FOR THE IMPLEMENTATION OF THE BUDGET .

VI . AT THE END OF EACH FINANCIAL YEAR , A STATEMENT OF APPROPRIATIONS FOR THE CONCERTED ACTION PROJECT SHALL BE PREPARED AND TRANSMITTED TO THE HELLENIC REPUBLIC FOR INFORMATION .

PROVISIONAL TIMETABLE FOR THE COORDINATION COSTS OF THE CONCERTED ACTION PROJECT ON REGISTRATION OF CONGENITAL ABNORMALITIES

BUDGET ITEM 3371 " IMPLEMENTATION OF CONCERTED ACTION PROJECTS "

* ( EUA ) *

*1978*1979*1980**TOTAL*

*COMMITMENTS*PAYMENTS*COMMITMENTS*PAYMENTS*COMMITMENTS* PAYMENTS*COMMITMENTS*PAYMENTS*COMMITMENTS*PAYMENTS*

I . INITIAL ESTIMATE OF OVERALL REQUIREMENTS ( FIGURES APPEARING IN THE TIMETABLE OF COMMITMENTS AND PAYMENTS , AND IN THE TABLE OF EQUIVALENCE SHOWN IN ANNEX II TO THE COMMISSION BUDGET ) ***********

- STAFF*110 000*110 000*2 000*2 000*110 000*110 000*** 330 000*330 000*

- ADMINISTRATIVE OPERATING EXPENDITURE*110 000*110 000* 13 000*13 000*110 000*110 000***330 000*330 000*

- CONTRACTS*110 000*110 000*95 000*95 000*110 000* 110 000***330 000*330 000*

TOTAL ( TO BE COVERED BY APPROPRIATIONS UNDER ITEM 3371 ) *110 000*110 000*110 000*110 000*110 000*110 000*** 330 000*330 000*

II . REVISED ESTIMATE OF EXPENDITURE TAKING INTO ACCOUNT ADDITIONAL REQUIREMENTS ARISING FROM THE ACCESSION OF THE HELLENIC REPUBLIC***********

- STAFF***2 000*2 000*110 000 + 11 000*110 000 + 11 000***330 000 + 22 000*330 000 + 22 000*

- ADMINISTRATIVE OPERATING EXPENDITURE***13 000 + 5 000*13 000 + 5 000*110 000 + 11 000*110 000 + 11 000***330 000 + 22 000*330 000 + 22 000*

- CONTRACTS***95 000 + 6 000*95 000 + 6 000*110 000 + 11 000*110 000 + 11 000***330 000 + 22 000*330 000 + 22 000*

NEW TOTAL***110 000 + 11 000*110 000 + 11 000*110 000 + 11 000*110 000 + 11 000***330 000 + 22 000*330 000 + 22 000*

III . DIFFERENCE BETWEEN I AND II TO BE COVERED BY CONTRIBUTIONS FROM THE HELLENIC REPUBLIC***11 000*11 000*11 000*11 000***22 000*22 000