Implications for Political and Judicial Accountability
Edited by Miroslava Scholten and Michiel Luchtman
Chapter 6: Complex procedures as hurdle to accountability: verticalization of pharmaceutical enforcement
The legislative framework of pharmaceuticals regulation in the internal market is foremost defined at EU level, while enforcement powers are predominantly shared in the sense that the EU enforcement authority relies on the national authorities. However, a parallel enforcement power has been created with the Penalties Regulation allowing for EU level sanctions. Moreover, the Urgent Union Procedure shows characteristics of subordinate enforcement. This enforcement structure leads to challenges to accountability, mainly resulting from the complexity of the composite procedures which have been put in place. This chapter examines the enforcement role of the European Medicines Agency and examines the accountability mechanisms applicable at the European level. In addition, it offers insights into the national enforcement means in Belgium as well as Germany and the corresponding accountability mechanisms.
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