61982J0301

1 . MEASURES ADOPTED BY THE INSTITUTIONS - DIRECTIVES - DIRECT EFFECT - CONDITIONS

( COUNCIL DIRECTIVE 65/65 , ART . 21 )

2.APPROXIMATION OF LAWS - PROPRIETARY MEDICINAL PRODUCTS - DIRECTIVE 65/65 - PURPOSE - PROTECTION OF PUBLIC HEALTH - REGULATION OF PRICES - EXCLUDED

( COUNCIL DIRECTIVE 65/65 )

3.APPROXIMATION OF LAWS - PROPRIETARY MEDICINAL PRODUCTS - AUTHORIZATION TO MARKET - REFUSAL , SUSPENSION OR REVOCATION OF AUTHORIZATION - GROUNDS - PROTECTION OF PUBLIC HEALTH

( COUNCIL DIRECTIVE 65/65 , ART . 21 )

1 . THE PROVISIONS OF DIRECTIVE 65/65 LAYING DOWN THE CONDITIONS FOR THE GRANT , SUSPENSION OR REVOCATION OF AUTHORIZATION TO MARKET , PROPRIETARY MEDICINAL PRODUCTS , 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 .

2 . DIRECTIVE 65/65 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 .

3 . ARTICLE 21 OF DIRECTIVE 65/65 MUST BE INTERPRETED AS MEANING THAT THE AUTHORIZATION TO MARKET A PROPRIETARY MEDICINAL PRODUCT MAY BE REFUSED , SUSPENDED OR REVOKED ONLY ON THE GROUND OF THE PROTECTION OF PUBLIC HEALTH REFERRED TO BY THE DIRECTIVE .

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

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

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?

2.IS DIRECTIVE 65/65 OF 26 JANUARY 1965 CONCERNED SOLELY WITH THE APPROXIMATION OF PROVISIONS WHICH ARE INTENDED TO PROTECT PUBLIC HEALTH OR IS IT ALSO CONCERNED WITH THE APPROXIMATION OF OTHER PROVISIONS RELATING TO PROPRIETARY MEDICINAL PRODUCTS , IN PARTICULAR THOSE WHICH ARE ENACTED FOR THE PURPOSE OF CONTROLLING PRICES?

3.SHOULD ARTICLE 21 OF DIRECTIVE 65/65 BE INTERPRETED AS MEANING THAT AN AUTHORIZATION TO MARKET A PROPRIETARY MEDICINAL PRODUCT MAY BE REFUSED , SUSPENDED OR REVOKED ON THE GROUND THAT RULES ON PRICES HAVE NOT BEEN COMPLIED WITH?

' '

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 .

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 .

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 .

2.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 IN THE DIRECTIVE .