Parallel trade in pharmaceutical products within the EEA: From first to final marketing. - Balancing the need to protect and promote public health and safety with the EC treaty objective of establishing a common market

Abstract

This thesis provides a thorough clarification of the rules governing parallel trade in pharmaceutical products within the EEA; from first to final marketing. More specifically, the thesis provides an analysis of the application of EC competition law (Articles 81 and 82 EC Treaty), the free movement of goods provisions (Articles 28-30 EC Treaty), Community measures, and Member State laws to parallel import-restrictive measures. The EC Treaty and Community measures must, in conjunction with Member State laws, facilitate the establishment of an internal market without compromising public health and safety. For example, the application of Articles 81 and 82 EC Treaty to parallel import-restrictive measures must take into consideration the need to promote public health and safety by acknowledging the pharmaceutical industry’s reliance on future investments in 'research and development' (R&D). Similarly, the application of Articles 28-30 EC Treaty to repackaging of pharmaceutical products must take into consideration the need to protect public health and safety. The importance of balancing the pro-integration objective with the public health and safety objective is particularly evident in relation to the application of the EC Treaty to Member State laws governing the pharmaceutical market-specific and potentially parallel import-restrictive requirement of marketing authorisations. Parallel trade is, nevertheless, a statistically safe practice, and considered essential to market integration by encouraging intra-brand competition and widening customer choice. Parallel trade is also believed to generate savings to national health authorities, and ultimately patients and taxpayers. The thesis therefore concludes with a set of recommendations aimed at strengthening the protection and promotion of public health and safety without having an unduly negative impact on the establishment of an internal market.