Pharmaceutical Products: The Relationship between Regulatory Approval and the Existence of a Defect
![handle is hein.kluwer/eblr0018 and id is 1279 raw text is: Pharmaceutical Products: The Relationship between
Regulatory Approval and the Existence of a Defect
MARK MILDRED*
The questions whether and to what extent the fact of regulatory approval of a
pharmaceutical product may or should influence a court's decision whether that
product is defective for the purpose of the Product Liability Directive have become
topical in Europe.' In the third five-yearly report of the European Commission on
the application of the PL Directive the Commission included in the list of areas
where close and regular monitoring should take place the defence of regulatory
compliance.2
The text notes that some stakeholders, and in particular representatives of the
pharmaceutical industry, have argued strongly for the introduction of a defence of
regulatory compliance, which would apply to a product whose safety was closely
regulated, provided that the product complied fully with the applicable regula-
tions. No view is expressed on the merits of those arguments or on the legisla-
tive means by which any such change to the PL Directive might be implemented.
The PL Directive is one of maximum harmonisation so that amendment of it rather
than passing national legislation to supplement or extend the ambit of liability or
exculpation would be required.'
This article attempts to explore the legal context in which these arguments are
expressed, to note parallels with the current controversy in the United States in
relation to Federal pre-emption of failure to warn claims and to examine whether
such a defence would maintain the fair apportionment of risk between producers
and consumers that the PL Directive sets out to achieve.4
* Nottingham Trent University.
Directive 85/374/EEC on the approximation of the laws, regulations and administrative provisions
of the member states concerning liability for defective products (the PL Directive).
2 COM(2006) 496 final, 14 September 2006 at page 11.
Case 183-00 Sanchez v Medicina Asturiana SA [2002] ECR 1-3901. Article 13 of the PL Direc-
tive provides that special liability schemes predating notification of the Directive are unaffected. Sub-
sequent national schemes imposing a special liability would, however, offend Article 13.
Recital 2 of the Directive.
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Copyright 2007 by Kluwer Law International. All rights reserved
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Pharmaceutical Products: The Relationship between Regulatory Approval and the Existence of a Defect
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