Evolution recente de la jurisprudence en matiere de definition du medicament
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Abstract EN:
Over the last twenty years, the definition of a drug (article l. 511 of the public health code) has been the subject of wide-ranging legal controversy. An analysis of the many decisions handed down by the internal courts reflects the opposition, on the one hand, of those who support a broad approach to the text, as protector of public health, and on the other hand, of those who would like a narrower interpretation, allowing the free sale of products classified as "borderline" : vitamins, antiseptics, etc. It was inevitable that the debate would be brought to the court of justice of the european community. At one of its early rulings handed down in 1983, the above body favored the protection of public health. But this decision, in the opinion of the writer, presented flaws which allowed the letter rather than the spirit to be interpreted to an even greater extent. In france, the main tribunals found themselves split between the two approaches to article l. 511. I. E. The broad or the narrow interpretation. A study of the various rulins handed down in 1991 shows how the community body was lead to pronouncing even more clearly in favor of a broad concept of what constitutes a drug. However, the debate has now moved to the area of civil liberties : article l. 511, on the basis of which proceedings can be brought for the illegal exercise of pharmacy, could appear too ague to allow the principle of the legality of crimes and penalties to be respected. The european court of human rights will shortly rule on the relevance of this criticism. Its decision could have a tremendous effect on the choices open to public health in the future.
Abstract FR:
Ces vingt dernieres annees, la definition du medicament (article l. 511 du code de la sante publique) a fait l'objet d'une vaste controverse juridique. L'analyse des nombreuses decisions rendues par les juridictions internes met en evidence l'opposition, d'une part des tenants d'une approche extensive du texte, protectrice de la sante, d'autre part des partisans d'une lecture plus restrictive permettant la vente libre de produits qualifies de "frontieres" : vitamines, antiseptiques. . . Le debat ne pouvait manquer d'etre porte devant la cour de justice des communautes europeennes. Dans un premier arret rendu en 1983, celle-ci a entendu privilegier la protection de la sante publique. Mais cette decision presentait, selon l'auteur, des failles qui permirent a certains d'en respecter davantage la lettre que l'esprit. En france, les juridictions du fond se trouverent ainsi partagees entre les deux approches de l'article l. 511 : extensive ou restrictive. L'etude de plusieurs arrets rendus en 1991 montre comment le juge communautaire fut donc conduit a se prononcer encore plus nettement pour une conception extensive du medicament. Cependant le debat se deplace aujourd'hui sur le terrain des libertes publiques : l'article l. 511, sur la base duquel peuvent etre engagees des poursuites pour exercice illegal de la pharmacie, pourrait apparaitre trop imprecis pour respecter le principe de la legalite des delits et des peines. La cour europeenne des droits de l'homme doit prochainement se prononcer sur la pertinence de cette critique. Sa decision pourrait etre lourde de consequences pour les futurs choix de sante publique.