Criminal proceedings against Leendert van Bennekom.
Date: 1983-11-30
14 DIRECTIVE 65/65 IS DESIGNED TO ELIMINATE - AT LEAST IN PART - OBSTACLES TO TRADE IN PROPRIETARY MEDICINAL PRODUCTS WITHIN THE COMMUNITY WHILST AT THE SAME TIME ATTAINING THE ESSENTIAL OBJECTIVE OF SAFEGUARDING PUBLIC HEALTH . AS A RESULT OF SUCH HARMONIZATION RECOURSE TO ARTICLE 36 OF THE EEC TREATY MUST GRADUALLY BECOME UNNECESSARY .
17 IN ORDER TO ANSWER THIS QUESTION , IT SHOULD BE OBSERVED THAT THE DIRECTIVE , BY BASING ITSELF , IN THE FIRST COMMUNITY DEFINITION OF A MEDICINAL PRODUCT , ON THE CRITERION OF THE PRODUCT ' S ' ' PRESENTATION ' ' , IS DESIGNED TO COVER NOT ONLY MEDICINAL PRODUCTS HAVING A GENUINE THERAPEUTIC OR MEDICAL EFFECT BUT ALSO THOSE WHICH ARE NOT SUFFICIENTLY EFFECTIVE OR WHICH DO NOT HAVE THE EFFECT WHICH CONSUMERS WOULD BE ENTITLED TO EXPECT IN VIEW OF THEIR PRESENTATION .     THE DIRECTIVE THEREBY SEEKS TO PRESERVE CONSUMERS NOT ONLY FROM HARMFUL OR TOXIC MEDICINAL PRODUCTS AS SUCH BUT ALSO FROM A VARIETY OF PRODUCTS USED INSTEAD OF THE PROPER REMEDIES . FOR THAT REASON , THE CONCEPT OF THE ' ' PRESENTATION ' '  OF A PRODUCT MUST BE BROADLY CONSTRUED .
18 IT IS THEREFORE NECESSARY TO TAKE THE VIEW THAT A PRODUCT IS ' ' PRESENTED FOR TREATING OR PREVENTING DISEASE ' '  WITHIN THE MEANING OF DIRECTIVE 65/65 NOT ONLY WHEN IT IS EXPRESSLY ' ' INDICATED ' '  OR ' ' RECOMMENDED ' '  AS SUCH , POSSIBLY BY MEANS OF LABELS , LEAFLETS OR ORAL REPRESENTATION , BUT ALSO WHENEVER ANY AVERAGELY WILL-INFORMED CONSUMER GAINS THE IMPRESSION , WHICH , PROVIDED IT IS DEFINITE , MAY EVEN RESULT FROM IMPLICATION , THAT THE PRODUCT IN QUESTION SHOULD , REGARD BEING HAD TO ITS PRESENTATION , HAVE AN EFFECT SUCH AS IS DESCRIBED BY THE FIRST PART OF THE COMMUNITY DEFINITION .
19 IN PARTICULAR , THE EXTERNAL FORM GIVEN TO THE PRODUCT IN QUESTION - SUCH AS THAT OF A TABLET , PILL OR CAPSULE - MAY IN THIS CONNECTION SERVE AS STRONG EVIDENCE OF THE SELLER ' S OR MANUFACTURER ' S INTENTION TO MARKET THAT PRODUCT AS A MEDICINAL PRODUCT . SUCH EVIDENCE CANNOT , HOWEVER , BE THE SOLE OR CONCLUSIVE EVIDENCE , SINCE OTHERWISE CERTAIN FOOD PRODUCTS WHICH ARE TRADITIONALLY PRESENTED IN A SIMILAR FORM TO PHARMACEUTICAL PRODUCTS WOULD ALSO BE COVERED .
22 IT IS APPARENT IN THIS CONNECTION THAT A SUBSTANCE WHICH IS ENDOWED WITH PROPERTIES ' ' FOR TREATING OR PREVENTING DISEASE IN HUMAN BEINGS OR ANIMALS ' '  WITHIN THE MEANING OF THE FIRST PART OF THE COMMUNITY DEFINITION , BUT WHICH IS NOT ' ' PRESENTED ' '  AS SUCH , FALLS IN PRINCIPLE WITHIN THE SCOPE OF THE SECOND PART OF THE COMMUNITY DEFINITION OF A MEDICINAL PRODUCT .
26 INASMUCH AS VITAMINS ARE USUALLY DEFINED AS SUBSTANCES WHICH , IN MINUTE QUANTITIES , FORM AN ESSENTIAL PART OF THE DAILY DIET AND ARE INDISPENSABLE FOR THE PROPER FUNCTIONING OF THE BODY , THEY MAY NOT , AS A GENERAL RULE , BE REGARDED AS MEDICINAL PRODUCTS WHEN THEY ARE CONSUMED IN SMALL QUANTITIES .
27 SIMILARLY , IT IS A FACT THAT VITAMIN OR MULTI-VITAMIN PREPARATIONS ARE SOMETIMES USED , GENERALLY IN LARGE DOSES , FOR THERAPEUTIC PURPOSES IN COMBATING CERTAIN DISEASES OTHER THAN THOSE OF WHICH THE MORBID CAUSE IS A VITAMIN DEFICIENCY . IN SUCH CASES , IT IS BEYOND DISPUTE THAT THE VITAMIN PREPARATIONS CONSTITUTE MEDICINAL PRODUCTS .
29 THE ANSWER TO BE GIVEN TO THE NATIONAL COURT SHOULD THEREFORE BE THAT THE CLASSIFICATION OF A VITAMIN AS A MEDICINAL PRODUCT WITHIN THE MEANING OF THE SECOND PART OF THE DEFINITION IN DIRECTIVE 65/65 MUST BE CARRIED OUT CASE BY CASE , HAVING REGARD TO THE PHARMACOLOGICAL PROPERTIES OF EACH SUCH VITAMIN TO THE EXTENT TO WHICH THEY HAVE BEEN ESTABLISHED IN THE PRESENT STATE OF SCIENTIFIC KNOWLEDGE .

FOURTH , FIFTH AND SIXTH QUESTIONS
35 IT IS ONLY WHEN COMMUNITY DIRECTIVES , IN PURSUANCE OF ARTICLE 100 OF THE TREATY , MAKE PROVISION FOR THE FULL HARMONIZATION OF ALL THE MEASURES NEEDED TO ENSURE THE PROTECTION OF HUMAN AND ANIMAL LIFE AND INSTITUTE COMMUNITY PROCEDURES TO MONITOR COMPLIANCE THEREWITH THAT RECOURSE TO ARTICLE 36 CEASES TO BE JUSTIFIED . IT IS , HOWEVER NOT IN DISPUTE THAT SUCH IS NOT THE CASE WITH THE DIRECTIVES DEALING WITH PHARMACEUTICAL PRODUCTS . IT IS THEREFORE NECESSARY TO CONSIDER WHETHER MEASURES WHICH RESTRICT THE MARKETING OF VITAMINS MAY BE JUSTIFIED BY ARTICLE 36 OF THE TREATY .
36 AS THE COURT HAS HAD OCCASION TO AFFIRM IN ITS JUDGMENT OF 14 JULY 1983 ( OFFICIER VAN JUSTITIE V SANDOZ , CASE 174/82 , ( 1983 ) ECR 2445 ), THE EXCESSIVE CONSUMPTION OF VITAMINS OVER A PROLONGED PERIOD MAY HAVE HARMFUL EFFECTS , THE EXTENT OF WHICH VARIES ACCORDING TO THE TYPE OF VITAMIN , THERE BEING GENERALLY A GREATER RISK WITH VITAMINS SOLUBLE IN FAT THAN WITH THOSE SOLUBLE IN WATER . IT IS FURTHER APPARENT THAT IT IS PRINCIPALLY IN HIGH CONCENTRATIONS THAT     VITAMINS CONSTITUTE A SERIOUS RISK TO HEALTH . ACCORDING TO THE OBSERVATIONS SUBMITTED TO THE COURT , HOWEVER , SCIENTIFIC RESEARCH DOES NOT APPEAR TO BE SUFFICIENTLY ADVANCED TO BE ABLE TO DETERMINE WITH CERTAINTY THE CRITICAL QUANTITIES AND THE PRECISE EFFECTS .
37 IN A CONSISTENT LINE OF DECISION THE COURT HAS STATED THAT , IN SO FAR AS UNCERTAINTIES PERSIST IN THE PRESENT STATE OF SCIENTIFIC RESEARCH , IT IS FOR THE MEMBER STATES , IN THE ABSENCE OF HARMONIZATION , TO DECIDE WHAT DEGREE OF PROTECTION OF HEALTH AND LIFE OF HUMANS THEY INTEND TO ENSURE , HAVING REGARD HOWEVER TO THE REQUIREMENTS OF THE FREE MOVEMENT OF GOODS WITHIN THE COMMUNITY .
39 NEVERTHELESS , THE PRINCIPLE OF PROPORTIONALITY WHICH UNDERLIES THE LAST SENTENCE OF ARTICLE 36 OF THE TREATY REQUIRES THAT THE POWER OF THE MEMBER STATES TO PROHIBIT IMPORTS OF THE PRODUCTS IN QUESTION FROM OTHER MEMBER STATES SHOULD BE RESTRICTED TO WHAT IS NECESSARY TO ATTAIN THE LEGITIMATE AIM OF PROTECTING HEALTH . ACCORDINGLY , NATIONAL RULES IMPOSING SUCH RESTRICTIONS ARE JUSTIFIED ONLY IF AUTHORIZATIONS FOR MARKETING ARE GRANTED WHEN THEY ARE COMPATIBLE WITH THE REQUIREMENTS OF HEALTH PROTECTION .
40 IN THIS CONNECTION IT IS FOR THE NATIONAL AUTHORITIES TO DEMONSTRATE IN EACH CASE THAT THEIR RULES ARE NECESSARY TO GIVE EFFECTIVE PROTECTION TO THE INTERESTS REFERRED TO IN ARTICLE 36 OF THE TREATY AND , IN PARTICULAR , TO SHOW THAT THE MARKETING OF THE PRODUCT IN QUESTION CREATES A SERIOUS RISK TO PUBLIC HEALTH .