Le médicament en droit communautaire
Institution:
Paris 2Disciplines:
Directors:
Abstract EN:
European law concerning pharmaceuticals follows a double aim: to protect public health and to promote free movement of goods. The harmonization related to european community regulations surrounding pharmaceuticals and community politics provided by the european community treaty are building, step by step, a true single market for pharmaceuticals. The single market for pharmaceuticals, i. E. A high technology and quality market, presumes the existence of an integrated economic space where laws concerning these particular products have, anywhere on this space, an uniform and unitary character with the same executive force, and where pharmaceuticals may circulate without any impediment, from a single point to another, as well as in a national market. This ultimate target, for legal, political and financial reasons, can only be executed, stage by stage, concerning harmonization of specific national regulations for pharmaceuticals as well as those related to the pharmaceuticals market (free movement of goods, competition, environment,. . . ). The european union will have in any event to overcome obstacles to the harmonization concerning prices of pharmaceuticals as well as reimbursement by national health systems.
Abstract FR:
Le droit communautaire du medicament poursuit un double objectif : la protection de la sante publique et la libre circulation du medicament. L'harmonisation relative au statut du medicament et les politiques communautaires consacrees par les dispositions du traite instituant la communaute europeenne edifient, peu a peu, un veritable marche unique du medicament. Le marche unique du medicament, marche de haute qualite et de haute technologie, suppose l'existence d'un espace economique homogene ou la reglementation relative a ce produit a, en tous points de cet espace, un caractere uniforme et unitaire, beneficiant de la meme force executive, et au sein duquel le medicament circule sans entrave, d'un point a un autre, dans des conditions analogues a celles d'un marche interieur. La realisation de cet objectif ultime, pour des motifs juridiques, politiques et financiers, ne peut s'effectuer que par etapes graduees, tant en ce qui concerne l'harmonisation des reglementations nationales relatives au statut du medicament, que celles concernant le marche du medicament. L'union europeenne devra toutefois surmonter les obstacles a l'harmonisation relative a la fixation des prix des medicaments et des conditions de leur remboursement par les organismes nationaux d'assurance maladie.