Liability for pharmaceutical products: a difficult attempt at harmonisation.
On the 25 July 1985, the European Community adopted a Directive on liability for defective products. Doctors are very affected by this law because an injured person will possibly be able to take action against them. This directive had several aims: to harmonise member states' legislation concerning the legal protection of victims and to subject producers to the same framework of liability and competition rules. However, this directive currently remains relatively ineffective. Several reasons can be put forward to explain this failure. First, by leaving it open to member states to decide whether to opt for one or more derogations, the Directive has made it easier for different interpretations to emerge. Secondly, several ideas proposed by the Directive have not been defined. As a result, the different legal terminology used in different states makes the interpretation of these concepts more difficult. Our paper concludes that the Directive was soundly based. However, Member States must enquire about the solutions adopted in neighbouring countries, and the ECJ (European Court of Justice) should try to impress on states the importance of a community vision. Without an adequate level of convergence, the differences between national laws will encourage 'forum shopping' on the part of a claimant and the situation will become more difficult for prescribers.
Rougé-Maillart
Clotilde
C
Department of Legal Medicine, Medical University of Angers, France.
Jousset
Nathalie
N
Penneau
Michel
M
D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000592:standards; D005062:European Union; D006801:Humans; D007880:Legislation, Drug; D016365:Liability, Legal; D004364:Pharmaceutical Preparations / Q000592:standards*; D011786:Quality Control
D004364:Pharmaceutical Preparations