Introduction

This chapter attempts to address and to link two major issues of European law in respect of medicinal products, one in the product liability arena and the other in the intellectual property arena. First, the role of the development risk defence of the UK Consumer Protection Act 1987, Part I, which implemented the EC Product Liability Directive, is discussed. Examination is made of the implications of the decision of the Court of Justice of the European Communities (ECJ) concerning the UK's alleged failure to implement the Directive, in particular in respect of the development risk defence. Secondly, the chapter discusses the potential role of intellectual property rights in addressing the difficulty of increased injury costs as a result of the Product Liability Directive. A review is made of the Regulation establishing the so-called ‘Supplementary Protection Certificate’ (SPC), which was designed to address the problem of patent life erosion caused by the increased testing and authorisation requirements of new medicinal products. The possibility is then discussed of increasing patent restoration or marketing exclusivity in order to redress the adverse impact of product liability litigation on drug innovation. It is hoped that the interlinking of both product liability and intellectual property issues in this way will promote a greater understanding of the role of intellectual property rights as a potential tool in addressing the problem of increased injury costs in product liability litigation.

The nature of the development risk defence

One of the most controversial elements of the Product Liability Directive (the Directive) and its implementing Statute in the UK, the Consumer Protection Act 1987 (the Act), has been the development risk defence (the defence).