[Strict liability and development risk exemption in the pharmaceutical sector].
The law adopted on May 19th 1998 for the transposition of the 1985 directive has introduced in French law a strict liability applicable to all products, and in particular the health products. These new provisions, that are added to the existing rules of contractual and non contractual liability law, state that the manufacturer and suppliers can be liable if harm is caused by a defective product. This law provides for the exemption of liability for "development risks" in some cases. This means that the manufacturer has the possibility to prove that the state of scientific and technical knowledge at the time when he put the product on the market was not such as to enable the existence of the defect to be discovered. However, this exemption does not apply to products from the human body. A product is considered as defective when it does not provide "the safety which a person is entitled to expect". This implies that the presentation of a product, and particularly of its sides effects, is going to become more and more important. This new law, which is compatible with the current jurisprudence, will lead to the modification of some attitudes, not only from the pharmaceutical industry, but also from the Health Authorities and in particular the Medicine Agency.
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Secrétaire Général du Syndicat National de l'Industrie Pharmaceutique, 88, rue de la Faisanderie, F75116 Paris.
D004341:Drug Evaluation; D004345:Drug Industry / Q000331:legislation & jurisprudence* / Q000592:standards; D005602:France; D006801:Humans; D016365:Liability, Legal; D004364:Pharmaceutical Preparations / Q000592:standards*; D018570:Risk Assessment
D004364:Pharmaceutical Preparations