Compensation for Damage Caused by Defective Drugs: European Private Law between Safety Requirements and Free-Market Values

Abstract: Within the European Union, the success of private law harmonisation is based upon the fragile balance between legal integration and protection of national traditions. In this respect, a transversal analysis of the obligation of safety established by the Directive 374/85/CEE shows that harmonisation sometimes prevails over the potential protections granted to the victims of a damage caused by defective products. On the one hand, this reduction arises from the balance between objective and subjective criteria used in evaluating the defect as defined in the harmonised text. On the other hand, it results from problems of coordination between national laws and EC law remedies. This latter difficulty is illustrated by the 25 April 2002 European Court of Justice decisions on the French experience. The paradigmatic example of the pharmaceutical sector is a clear illustration of these tensions, since it heightens free‐market values at the same time as seeking to ensure compensation for breach of health and safety of consumers.