Competition of Agencies in European Pharmaceutical Law – Does It Exist, Is It Desirable and How to Handle It?

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Abstract

When we look at competition and markets at the international level we are used to investigating regulation of Business to Business (B2B), Business to Consumer (B2C) and Consumer to Consumer (C2C) relationships. In international economic law, in addition, questions focus on the regulatory framework that is applicable for cross-border transactions or how to create markets through regulation. Rarely has international law been investigated from a Business to Agency (B2A) or even Agency to Agency (A2A) perspective. In recent years, the “mushrooming” of agencies at European level triggers the importance of looking more closely into the relationship of the agencies towards each other. Is there a struggle over competences and regulatory objects and would such competition lead to desirable outcomes? In this paper I will first draft the divergent underlying concepts of agency competition in Europe and the USA. I will show that due to the historical development of administrative law in Europe and the USA, the perception of the desirability of agency competition differs (II.). I will then discuss with reference to pharmaceutical law whether these different perceptions of agency competition are reflected in European law. Indeed, EU law and regulation likewise tends to avoid competition. Agency competition, thanks to rather clear competences and governance procedures, agency competition remains being the exception in European pharmaceutical regulation. However, structural differences and failures remain. (III). Finally, I will conclude these findings and hint at the limits of the desired process for further coherence. I will conclude that although a move towards even more convergence in European risk regulation is desirable, it does have its limits set by the principle of conferral in Art. 5 (1, 2) EU read in conjunction with the areas of shared competence and the one to support, coordinate and supplement (IV.).
Original languageEnglish
Pages (from-to)227-238
JournalEuropean Journal of Risk Regulation
Volume1
Issue number3
DOIs
Publication statusPublished - 2013

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