Expertise Embedded in International Communities: The Case of EU Pharmaceutical Regulation

Characterised by a highly-technical and globalised sector, the deployment and governing of expertise has a crucial role in regulation of pharmaceutical products. Over the past few decades, the domain has been marked by a remarkable development of the authority of the EU. The European Medicines Agency, with its organisational structure connecting experts from member state authorities, has often been regarded as a “model” of successful development of a networked agency. Despite its significance, however, how the agency uses expertise has met scant attention. The paper examines how the development of expertise in EU pharmaceutical regulation has been embedded in international communities of experts. In so doing, it aims at offering an empirical investigation on the use of expertise by a networked regulator, which is seen as a backbone on which EU regulation rests both normatively and empirically.