La responsabilite du fait des produits defectueux imputable aux producteurs de medicaments
Institution:
Paris 11Disciplines:
Directors:
Abstract EN:
In the past decades, consumers's safety has become a right that society has the obligation to defend from a powerful and inovative industry. This right has seemed even more important when the consumer is a sick person because research in the pharmaceutical industry develops molecules that are always more efficient and, therefore, potentially more and more dangerous. This is why the right to safety has become political, illustrating in a very exceptional way a general tendency to fall indemnification of damages suffered. To france, where case law and law have constantly improved the protection of victims of defective products, the idea of a general safety obligation, the scope of which we have determined, has finally been accepted. A step further was taken with the european directive of july 25, 1985 which increases the manufacturer's liability. At a time where france must transpose this directive into its legal system, although it should have been done ten years ago, our purpose has been to study, on the one hand, the impact of this directive on french law with respect to the medicine field and, on the second hand, the terms and conditions of setting up a system of objective liability. Because it results from a compromise, the directive provides alternatives, specially regarding the indemnification of the risk of -- the drawbacks of which we had foreseen. We have tried to prove that the provisions of the directive were less inovating with respect to french law than it was said at first. Besides, we believe that the directive does not achieve its goals set : the harmonisation will maintain various systems with various degrees of severeness which may lead to disputable indemnification. However, acknowledging the necessity to set up a system of objective liability, specially with respect to medicine, we have confirmed the interest of a collective garantee which will hopefully be extended to cover medical hazard in general.
Abstract FR:
Dans les dernieres decennies, la securite du consommateur a tendu a devenir un veritable droit que la societe a le devoir de defendre, face a une industrie innovatrice et puissante. Et lorsque le consommateur est un malade, ce droit est apparu plus imperieux encore, en relation avec une industrie du medicament dont la recherche conduit a des molecules toujours plus performantes, et, partant, potentiellement plus dangereuses. La, le droit a la securite a revetu une dimension politique, prefigurant peut-etre de facon exemplaire une aspiration generale a une indemnisation quasiment absolue des dommages. En france, ou la jurisprudence, puis la loi, ont constamment ameliore la protection de la victime d'un produit defectueux, la notion a fini par etre acceptee d'une obligation generale de securite dont nous avons dessine l'etendue. Mais la directive europeenne du 25 juillet 1985 marquait une etape de plus en instaurant une responsabilite aggravee des producteurs. En un moment ou, avec 10 annees de retard, la france va devoir transposer ses dispositions dans le droit interne, notre propos a ete, en nous attachant au secteur du medicament, d'etudier, d'une part, l'impact de la directive sur le droit francais et, d'autre part, les conditions d'instauration d'un regime de responsabilite objective. Fruit d'une logique de compromis, la directive ouvre des options, notamment quant a l'indemnisation du risque de developpement dont nous avons envisage les inconvenients. Nous nous sommes attachee a montrer que les dispositions de la directive apparaissent moins novatrices par rapport au droit francais que d'aucuns ont voulu le dire. Par ailleurs, nous croyons qu'elles repondent mal aux objectifs fixes : l'harmonisation desiree laissera subsister des regimes de severite inegale, et peut conduire a une indemnisation contestable. Reconnaissant cependant la necessite de mettre en oeuvre une responsabilite objective, specialement en ce qui concerne le produit-medicament, nous avons montre l'interet d'un systeme de garantie collective, si possible elargi de facon a couvrir l'alea therapeutique en son ensemble.