61982J0145

MEASURES ADOPTED BY INSTITUTIONS - DIRECTIVES - IMPLEMENTATION BY THE MEMBER STATES

( EEC TREATY , THIRD PARAGRAPH OF ART . 189 )

MERE ADMINISTRATIVE PRACTICES , WHICH BY THEIR NATURE MAY BE ALTERED AT THE WHIM OF THE AUTHORITIES AND LACK THE APPROPRIATE PUBLICITY , CANNOT BE REGARDED AS A VALID FULFILMENT OF THE OBLIGATION IMPOSED BY ARTICLE 189 OF THE TREATY ON MEMBER STATES TO WHICH THE DIRECTIVES ARE ADDRESSED .

IN CASE 145/82

COMMISSION OF THE EUROPEAN COMMUNITIES , REPRESENTED BY MICHEL VAN ACKERE , ACTING AS AGENT , ASSISTED BY EUGENIO DE MARCH , BOTH MEMBERS OF ITS LEGAL DEPARTMENT , WITH AN ADDRESS FOR SERVICE IN LUXEMBOURG AT THE OFFICE OF ORESTE MONTALTO , JEAN MONNET BUILDING , KIRCHBERG ,

APPLICANT ,

V

ITALIAN REPUBLIC , REPRESENTED BY ARNALDO SQUILLANTE , PRESIDENT OF SECTION OF THE STATE COUNCIL , HEAD OF THE DEPARTMENT FOR CONTENTIOUS DIPLOMATIC AFFAIRS , ACTING AS AGENT , ASSISTED BY PIER GIORGIO FERRI , AVVOCATO DELLO STATO , WITH AN ADDRESS FOR SERVICE IN LUXEMBOURG AT THE ITALIAN EMBASSY ,

DEFENDANT ,

APPLICATION FOR A DECLARATION THAT BY FAILING TO ADOPT WITHIN THE PRESCRIBED PERIODS THE MEASURES NEEDED TO IMPLEMENT DIRECTIVES NOS 65/65/EEC , 75/318/EEC AND 75/319/EEC ON THE APPROXIMATION OF PROVISIONS LAID DOWN BY LAW , REGULATION OR ADMINISTRATIVE ACTION RELATING TO PROPRIETARY MEDICINAL PRODUCTS , THE ITALIAN REPUBLIC HAS FAILED TO FULFIL ITS OBLIGATIONS UNDER THE EEC TREATY ,

1 BY APPLICATION LODGED AT THE COURT REGISTRY ON 11 MAY 1982 THE COMMISSION OF THE EUROPEAN COMMUNITIES BROUGHT AN ACTION BEFORE THE COURT UNDER ARTICLE 169 OF THE EEC TREATY FOR A DECLARATION THAT BY FAILING TO ADOPT WITHIN THE PRESCRIBED PERIODS THE PROVISIONS NEEDED TO COMPLY WITH COUNCIL DIRECTIVES NOS 65/65/EEC , 75/318/EEC AND 75/319/EEC ON THE APPROXIMATION OF PROVISIONS LAID DOWN BY LAW , REGULATION OR ADMINISTRATIVE ACTION RELATING TO PROPRIETARY MEDICINAL PRODUCTS , THE ITALIAN REPUBLIC HAS FAILED TO FULFIL ITS OBLIGATIONS UNDER ARTICLE 189 OF THE EEC TREATY .

2 THE PURPOSE OF COUNCIL DIRECTIVE NO 65/65 OF 26 JANUARY 1965 ON THE APPROXIMATION OF PROVISIONS LAID DOWN BY LAW , REGULATION OR ADMINISTRATIVE ACTION RELATING TO PROPRIETARY MEDICINAL PRODUCTS ( OFFICIAL JOURNAL , ENGLISH SPECIAL EDITION 1965-1966 , P . 20 ) IS TO ELIMINATE THE DISPARITIES IN THIS SECTOR LIABLE TO HAVE THE GREATEST EFFECT ON THE FUNCTIONING OF THE COMMON MARKET . TO THAT END IT LAYS DOWN PROVISIONS ON AUTHORIZATION TO PLACE PROPRIETARY MEDICINAL PRODUCTS ON THE MARKET , THE SUSPENSION AND REVOCATION OF SUCH AUTHORIZATION AND ON THE LABELLING OF PROPRIETARY MEDICINAL PRODUCTS .

3 COUNCIL DIRECTIVE NO 75/318 OF 20 MAY 1975 ON THE APPROXIMATION OF THE LAWS OF MEMBER STATES RELATING TO ANALYTICAL , PHARMACO-TOXICOLOGICAL AND CLINICAL STANDARDS AND PROTOCOLS IN RESPECT OF THE TESTING OF PROPRIETARY MEDICINAL PRODUCTS ( OFFICIAL JOURNAL 1975 , L 147 , P . 1 ) CONTINUES THE APPROXIMATION INITIATED BY DIRECTIVE NO 65/65 BY LAYING DOWN UNIFORM RULES FOR CARRYING OUT TESTS AND TRIALS , COMPILING DOSSIERS AND EXAMINING APPLICATIONS FOR MARKETING AUTHORIZATION . THOSE UNIFORM RULES ARE SET OUT IN A DETAILED ANNEX TO THE DIRECTIVE , ARTICLE 2 OF WHICH REQUIRES MEMBER STATES TO TAKE ALL APPROPRIATE MEASURES TO ENSURE THAT THE COMPETENT AUTHORITIES EXAMINE THE PARTICULARS AND DOCUMENTS SUBMITTED IN SUPPORT OF APPLICATIONS FOR MARKETING AUTHORIZATION IN ACCORDANCE WITH THE CRITERIA LAID DOWN IN THAT ANNEX .

4 COUNCIL DIRECTIVE NO 75/319 OF 20 MAY 1975 , THE SECOND DIRECTIVE ON THE APPROXIMATION OF PROVISIONS LAID DOWN BY LAW , REGULATION OR ADMINISTRATIVE ACTION RELATING TO PROPRIETARY MEDICINAL PRODUCTS ( OFFICIAL JOURNAL 1975 , L 147 , P . 13 ) CONCERNS IN PARTICULAR THE PROCEDURES TO BE FOLLOWED BY THE COMPETENT AUTHORITIES OF THE MEMBER STATES WHEN EXAMINING APPLICATIONS FOR MARKETING AUTHORIZATION . TO ASSIST IN THE ADOPTION OF A COMMON ATTITUDE IN THIS REGARD THE DIRECTIVE SETS UP A COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS CONSISTING OF REPRESENTATIVES OF THE MEMBER STATES AND OF THE COMMISSION .

5 THE PERIODS WITHIN WHICH THE MEMBER STATES WERE TO BRING INTO FORCE THE PROVISIONS NEEDED TO COMPLY WITH THE THREE DIRECTIVES EXPIRED ON 31 DECEMBER 1966 FOR DIRECTIVE NO 65/65 AND ON 22 NOVEMBER 1976 FOR DIRECTIVES NOS 75/318 AND 75/319 .

6 IT IS COMMON GROUND THAT IN ITALY A DRAFT LAW IMPLEMENTING THE THREE DIRECTIVES AND APPROVED BY THE SENATE IN 1978 WAS UNABLE TO COMPLETE THE PARLIAMENTARY PROCEDURE OWING TO THE PREMATURE DISSOLUTION OF THE CHAMBERS . THE ITALIAN GOVERNMENT MAINTAINS THAT THE DRAWING UP OF A NEW DRAFT LAW REQUIRES TIME AS IT IS NECESSARY TO BRING IT UP TO DATE AS REGARDS ITS TECHNICAL ASPECTS .

7 THE ITALIAN GOVERNMENT CONTENDS , HOWEVER , THAT THE DIRECTIVES IN QUESTION HAVE BY AND LARGE BEEN IMPLEMENTED BY ADMINISTRATIVE PROVISIONS . IT REFERS IN THIS REGARD TO THE MINISTERIAL ORDER OF 18 DECEMBER 1979 LAYING DOWN A PROCEDURE FOR THE GENERAL REVIEW OF PROPRIETARY MEDICINAL PRODUCTS ( GAZZETTA UFFICIALE DELLA REPUBBLICA ITALIANA NO 351 OF 28 DECEMBER 1979 ) AND TO A NUMBER OF CIRCULARS ISSUED BY THE MINISTRY OF PUBLIC HEALTH , COPIES OF WHICH IT HAS PROVIDED FOR THE COURT .

8 ALTHOUGH THE RECITALS IN THE PREAMBLE TO THE MINISTERIAL ORDER OF 1979 EVINCE THE INTENTION OF THE ITALIAN AUTHORITIES TO ADAPT THE PROCEDURE FOR GRANTING MARKETING AUTHORIZATION TO THE REQUIREMENTS OF THE THREE DIRECTIVES , THAT FACT IS NOT SUFFICIENT TO REMEDY THE ALLEGED FAILURE . FIRST , THE MINISTERIAL ORDER WAS ADOPTED AFTER THE PERIOD PRESCRIBED FOR THE IMPLEMENTATION OF THE DIRECTIVES HAD EXPIRED . SECONDLY , THE ORDER IS CONCERNED ONLY WITH THE CONTINUED REGISTRATION OF PROPRIETARY MEDICINAL PRODUCTS ALREADY REGISTERED BEFORE 1 JANUARY 1975 .

9 AS TO THE CIRCULARS RELIED UPON BY THE ITALIAN GOVERNMENT , THEY COVER THE PROCEDURE TO BE FOLLOWED FOR AUTHORIZING THE MARKETING OF PROPRIETARY MEDICINAL PRODUCTS . THEY DO NOT GOVERN EITHER THE SUSPENSION OR REVOCATION OF SUCH AUTHORIZATIONS , THE LABELLING OF PROPRIETARY MEDICINAL PRODUCTS OR THE RULES APPLYING TO PRODUCTS IMPORTED FROM NON-MEMBER COUNTRIES .

10 IT SHOULD BE ADDED IN THIS RESPECT THAT , AS THE COURT HAS ALREADY STRESSED ON OTHER OCCASIONS , IN PARTICULAR IN ITS JUDGMENT OF 6 MAY 1980 IN CASE 102/79 COMMISSION V BELGIUM ( 1980 ) ECR 1473 , MERE ADMINISTRATIVE PRACTICES , WHICH BY THEIR NATURE MAY BE ALTERED AT THE WHIM OF THE AUTHORITIES AND LACK THE APPROPRIATE PUBLICITY CANNOT BE REGARDED AS A VALID FULFILMENT OF THE OBLIGATION IMPOSED BY ARTICLE 189 OF THE TREATY ON MEMBER STATES TO WHICH THE DIRECTIVES ARE ADDRESSED .

11 IT FOLLOWS FROM ALL THE CONSIDERATIONS SET OUT ABOVE THAT THE ITALIAN GOVERNMENT ' S ARGUMENT TO THE EFFECT THAT IT IS A MATTER FOR THE MEMBER STATES TO WHICH A DIRECTIVE IS ADDRESSED TO DETERMINE THE METHODS TO IMPLEMENT THE DIRECTIVE IS , THOUGH CORRECT , NEVERTHELESS IRRELEVANT IN THE PRESENT CASE . INDEED , APART FROM THE FACT THAT IT WAS BASED AT LEAST IN PART ON MERE ADMINISTRATIVE PRACTICE , THE IMPLEMENTATION OF THE THREE DIRECTIVES IN ISSUE UPON WHICH THE ITALIAN GOVERNMENT RELIES , CAME TOO LATE AND WAS INCOMPLETE .

12 IN THESE CIRCUMSTANCES IT MUST THEREFORE BE DECLARED THAT BY FAILING TO ADOPT WITHIN THE PRESCRIBED PERIODS THE PROVISIONS NEEDED TO ENSURE THE IMPLEMENTATION OF COUNCIL DIRECTIVES NOS 65/65/EEC , 75/318/EEC AND 75/319/EEC , THE ITALIAN REPUBLIC HAS FAILED TO FULFIL ITS OBLIGATIONS UNDER ARTICLE 189 OF THE TREATY .

COSTS

13 UNDER ARTICLE 69 ( 2 ) OF THE RULES OF PROCEDURE THE UNSUCCESSFUL PARTY IS TO BE ORDERED TO PAY THE COSTS IF THEY HAVE BEEN ASKED FOR IN THE SUCCESSFUL PARTY ' S PLEADING . SINCE THE DEFENDANT HAS FAILED IN ITS SUBMISSIONS , IT MUST BE ORDERED TO PAY THE COSTS .

ON THOSE GROUNDS ,

THE COURT

HEREBY :

1 . DECLARES THAT , BY FAILING TO ADOPT WITHIN THE PRESCRIBED PERIODS THE PROVISIONS NEEDED TO ENSURE THE IMPLEMENTATION OF COUNCIL DIRECTIVES NOS 65/65/EEC OF 26 JANUARY 1965 AND 75/318/EEC AND 75/319 / EEC OF 20 MAY 1975 ON THE APPROXIMATION OF PROVISIONS LAID DOWN BY LAW , REGULATION OR ADMINISTRATIVE ACTION RELATING TO PROPRIETARY MEDICINAL PRODUCTS , THE ITALIAN REPUBLIC HAS FAILED TO FULFIL ITS OBLIGATIONS UNDER ARTICLE 189 OF THE TREATY ;

2.ORDERS THE DEFENDANT TO PAY THE COSTS .