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

Date01 January 2004
Published date01 January 2004
DOIhttp://doi.org/10.1111/j.1468-0386.2004.00204.x
Compensation for Damage Caused
by Defective Drugs: European Private Law
between Safety Requirements and Free-
Market Values
Marie-Eve Arbour*
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 Direc-
tive 374/85/CEE shows that harmonisation sometimes prevails over the potential protec-
tions 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 diffi-
culty 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.
I Introduction
The interaction between civil liability and the free market is a particularly rich theme
to examine when it comes to compensation for damage resulting from technological
risks.1More specifically, in the pharmaceutical sector, rules governing civil liability
reflect the challenges Community and national law-makers face when balancing
European Law Journal, Vol.10, No. 1, January 2004, pp. 87–101.
© Blackwell Publishing Ltd. 2004, 9600 Garsington Road, Oxford OX4 2DQ, UK
and 350 Main Street, Malden, MA 02148, USA
*LL. M., Laval University, Québec, and PhD student at Scuola Superiore Sant’Anna di Pisa, Italy.
1On this topic, see Y. Lambert-Faivre, Droit du dommage corporel, Systèmes d’indemnisation,4th edn
(Dalloz, 2000) at 782; J.Huet, Le paradoxe des médicaments et les risques de développement, (Dalloz, 1987),
at 73; H. Teff, ‘Products Liability in the Pharmaceutical Industry at Common Law’, (1974) 20 Revue de
droit de Mc Gill,102; G. G. Howells, ‘The Relationship Between Product Liability and Product Safety—
Understanding a Necessary Element in European Product Liability Through a Comparison with the U.S.
Position’, (2000) 39 Washburn Law Journal 305.

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