Avis juridique important

61982J0301

European Court reports 1984 Page 00251

Summary

1 . MEASURES ADOPTED BY THE INSTITUTIONS - DIRECTIVES - DIRECT EFFECT - CONDITIONS ( COUNCIL DIRECTIVE 65/65 , ART . 21 )

Parties

IN CASE 301/82 REFERENCE TO THE COURT UNDER ARTICLE 177 OF THE EEC TREATY BY THE CONSEIL D ' ETAT ( STATE COUNCIL ) OF BELGIUM FOR A PRELIMINARY RULING IN THE PROCEEDINGS PENDING BEFORE THAT COURT BETWEEN SA CLIN-MIDY AND OTHERS AND THE BELGIAN STATE

Subject of the case

ON THE INTERPRETATION OF COUNCIL DIRECTIVE 65/65/EEC CONCERNING PROPRIETARY MEDICINAL PRODUCTS ,

Grounds

1 BY A JUDGMENT OF 22 OCTOBER 1982 , WHICH WAS RECEIVED AT THE COURT ON 3 DECEMBER 1982 , THE BELGIAN CONSEIL D ' ETAT ( STATE COUNCIL ) REFERRED TO THE COURT FOR A PRELIMINARY RULING UNDER ARTICLE 177 OF THE EEC TREATY SEVERAL QUESTIONS ON THE INTERPRETATION OF COUNCIL DIRECTIVE 65/65/EEC 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 ), IN ORDER TO ENABLE IT TO ASSESS THE CONFORMITY WITH THAT DIRECTIVE OF A MINISTERIAL ORDER OF 10 FEBRUARY 1976 WHICH PROVIDES FOR A PRICE FREEZE ON PROPRIETARY MEDICINAL PRODUCTS AND FIXES THE MAXIMUM PROFIT MARGINS OF WHOLESALERS , DISPENSING CHEMISTS AND HOSPITAL ESTABLISHMENTS IN RESPECT OF THOSE PRODUCTS .

2 THOSE QUESTIONS AROSE IN THE COURSE OF AN ACTION BEFORE THE CONSEIL D ' ETAT IN WHICH 14 PHARMACEUTICAL COMPANIES , INCLUDING SA CLIN-MIDY , SOUGHT A DECLARATION THAT THE ABOVE-MENTIONED MINISTERIAL ORDER WAS VOID . IN SUPPORT OF THEIR CLAIM THE PLAINTIFFS SUBMITTED THAT THE CONTESTED RULES WERE CONTRARY TO COMMUNITY LAW , IN PARTICULAR DIRECTIVE 65/65 . THE NATIONAL COURT THEREFORE REFERRED THE FOLLOWING QUESTIONS TO THE COURT OF JUSTICE : ' ' 1 . DOES COUNCIL DIRECTIVE 65/65/EEC OF 26 JANUARY 1965 ON THE APPROXIMATION OF PROVISIONS LAID DOWN BY LAW , REGULATION OR ADMINISTRATIVE ACTION RELATING TO PROPRIETARY MEDICINAL PRODUCTS HAVE DIRECT EFFECT IN RELATIONS BETWEEN MEMBER STATES AND THOSE SUBJECT TO THEIR JURISDICTION AND MAY THE LATTER PLEAD A BREACH THEREOF BEFORE A NATIONAL COURT?

FIRST QUESTION

3 BY THIS QUESTION THE NATIONAL COURT ASKS IN SUBSTANCE WHETHER DIRECTIVE 65/65 HAS DIRECT EFFECT IN THE NATIONAL LEGAL ORDER OF THE MEMBER STATES AND WHETHER INDIVIDUALS MAY THEREFORE RELY UPON IT BEFORE A NATIONAL COURT .

4 THAT QUESTION WOULD ARISE IN PARTICULAR IF A MEMBER STATE WERE TO REFUSE AUTHORIZATION TO MARKET A PRODUCT ON GROUNDS OTHER THAN THOSE PROVIDED FOR IN THE DIRECTIVE , SUCH AS THE DESIRE TO ENSURE COMPLIANCE WITH ITS LEGISLATION ON PRICES . IN THAT REGARD , IT MUST BE NOTED THAT THE PROVISIONS OF THE DIRECTIVE LAYING DOWN THE CONDITIONS FOR THE GRANT , SUSPENSION OR REVOCATION OF AN AUTHORIZATION TO MARKET , IN PARTICULAR ARTICLE 21 , ARE UNCONDITIONAL AND SUFFICIENTLY PRECISE FOR THEM TO BE RELIED UPON BEFORE A NATIONAL COURT BY THE PERSONS CONCERNED IN ORDER TO CHALLENGE ANY NATIONAL PROVISION LAID DOWN BY LAW , REGULATION OR ADMINISTRATIVE ACTION WHICH IS INCOMPATIBLE WITH THE DIRECTIVE .

SECOND QUESTION

5 ACCORDING TO THE PREAMBLE TO THE DIRECTIVE , THE PRIMARY PURPOSE OF ANY RULES CONCERNING THE PRODUCTION AND DISTRIBUTION OF PROPRIETARY MEDICINAL PRODUCTS MUST BE TO SAFEGUARD PUBLIC HEALTH . THE APPROXIMATION OF NATIONAL PROVISIONS ADOPTED FOR THAT PURPOSE , WHICH THE DIRECTIVE SEEKS TO ACHIEVE , IS INTENDED TO ELIMINATE THE EXISTING DISPARITIES IN SO FAR AS THEY HINDER TRADE IN PROPRIETARY MEDICINAL PRODUCTS . HOWEVER , THE DIRECTIVE IS ONLY THE FIRST STAGE OF HARMONIZATION AND IT DEALS CHIEFLY WITH THE DISPARITIES WHICH HAVE THE GREATEST EFFECT ON THE FUNCTIONING OF THE COMMON MARKET . FOR THAT PURPOSE IT LAYS DOWN COMMON CONDITIONS FOR THE GRANT , SUSPENSION AND REVOCATION OF AUTHORIZATION TO PLACE PROPRIETARY MEDICINAL PRODUCTS ON THE MARKET AND MAKES COMMON RULES GOVERNING THE LABELLING OF THE PRODUCTS CONCERNED .

6 IT IS THEREFORE CLEAR THAT THE DIRECTIVE SEEKS TO APPROXIMATE PROVISIONS LAID DOWN BY LAW , REGULATION OR ADMINISTRATIVE ACTION IN MEMBER STATES RELATING TO PROPRIETARY MEDICINAL PRODUCTS ONLY IN SO FAR AS SUCH PROVISIONS ARE CONNECTED WITH PUBLIC HEALTH . IT DOES NOT CONTAIN ANY PROVISION AIMED AT LIMITING THE POWER OF THE MEMBER STATES TO REGULATE THE PRICES OF THOSE PRODUCTS . IN THE ABSENCE OF ANY PROVISION TO THAT EFFECT , SUCH A LIMITATION CANNOT BE INFERRED .

7 CONSEQUENTLY , THE ANSWER TO THE SECOND QUESTION MUST BE THAT COUNCIL DIRECTIVE 65/65/EEC OF 26 JANUARY 1965 ON THE APPROXIMATION OF PROVISIONS LAID DOWN BY LAW , REGULATION OR ADMINISTRATIVE ACTION RELATING TO PROPRIETARY MEDICINAL PRODUCTS MUST BE INTERPRETED AS CONCERNING SOLELY NATIONAL PROVISIONS WHICH ARE INTENDED TO PROTECT PUBLIC HEALTH .

THIRD QUESTION

8 THE CONSEIL D ' ETAT ASKS IN SUBSTANCE WHETHER ARTICLE 21 OF DIRECTIVE 65/65 MUST BE INTERPRETED AS PREVENTING MEMBER STATES FROM REFUSING , SUSPENDING OR REVOKING AN AUTHORIZATION TO MARKET A PROPRIETARY MEDICINAL PRODUCT ON THE GROUND THAT RULES ON PRICES HAVE NOT BEEN COMPLIED WITH .

9 IN THAT REGARD , IT SHOULD BE STRESSED THAT THE WORDS ' ' AUTHORIZATION TO MARKET ' ' IN THE DIRECTIVE RELATE SOLELY TO AN AUTHORIZATION CONCERNED WITH THE PROTECTION OF PUBLIC HEALTH AND THAT THE EXISTENCE OF SUCH AN AUTHORIZATION DOES NOT IMPLY THAT THE OTHER REQUIREMENTS WHICH A PRODUCT MUST MEET IN ORDER TO BE LAWFULLY MARKETED ARE SATISFIED .

10 ARTICLE 21 OF THE DIRECTIVE PROVIDES THAT AUTHORIZATION MAY NOT BE REFUSED , SUSPENDED OR REVOKED EXCEPT ON THE GROUNDS SET OUT IN THE DIRECTIVE . IT IS CLEAR FROM ARTICLES 3 TO 10 OF THE DIRECTIVE , WHICH DEAL WITH THE GRANTING OF AUTHORIZATION , AND FROM ARTICLES 11 AND 12 , WHICH DEAL WITH THE SUSPENSION AND REVOCATION OF AUTHORIZATION , THAT THE COUNCIL INTENDED TO RESTRICT THE GROUNDS FOR THE REFUSAL , SUSPENSION OR REVOCATION OF AUTHORIZATION TO MARKET PROPRIETARY MEDICINAL PRODUCTS SOLELY TO THE CONSIDERATIONS OF PUBLIC HEALTH EXPRESSLY MENTIONED IN THE DIRECTIVE .

11 THE ANSWER TO THE THIRD QUESTION SHOULD THEREFORE BE THAT ARTICLE 21 OF THE DIRECTIVE MUST BE INTERPRETED AS MEANING THAT AUTHORIZATION TO MARKET A PROPRIETARY MEDICINAL PRODUCT MAY NOT BE REFUSED , SUSPENDED OR REVOKED SAVE ON THE GROUND OF THE PROTECTION OF PUBLIC HEALTH AS REFERRED TO BY THE DIRECTIVE .

12 THAT DOES NOT PREVENT MEMBER STATES WHICH INTRODUCE A PRICE CONTROL SYSTEM FOR PROPRIETARY MEDICINAL PRODUCTS FROM ENSURING THAT IT IS COMPLIED WITH BY MEANS WHICH ARE APPROPRIATE TO THAT SYSTEM AND COMPATIBLE WITH THE TREATY , IN PARTICULAR ARTICLE 30 THEREOF .

Decision on costs

COSTS

13 THE COSTS INCURRED BY THE KINGDOM OF BELGIUM , THE ITALIAN GOVERNMENT AND THE COMMISSION OF THE EUROPEAN COMMUNITIES , WHICH HAVE SUBMITTED OBSERVATIONS TO THE COURT , ARE NOT RECOVERABLE . AS THESE PROCEEDINGS ARE , IN SO FAR AS THE PARTIES TO THE MAIN PROCEEDINGS ARE CONCERNED , IN THE NATURE OF A STEP IN THE ACTION BEFORE THE NATIONAL COURT , COSTS ARE A MATTER FOR THAT COURT .

Operative part

ON THOSE GROUNDS , THE COURT ( THIRD CHAMBER ), IN ANSWER TO THE QUESTIONS SUBMITTED TO IT BY THE BELGIAN CONSEIL D ' ETAT BY JUDGMENT OF 22 OCTOBER 1982 , HEREBY RULES :

1 . COUNCIL DIRECTIVE 65/65/EEC OF 26 JANUARY 1965 ON THE APPROXIMATION OF PROVISIONS LAID DOWN BY LAW , REGULATION OR ADMINISTRATIVE ACTION RELATING TO PROPRIETARY MEDICINAL PRODUCTS MUST BE INTERPRETED AS CONCERNING SOLELY NATIONAL PROVISIONS WHICH ARE INTENDED TO PROTECT PUBLIC HEALTH .