Law Enforcement by EU Authorities
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Law Enforcement by EU Authorities

Implications for Political and Judicial Accountability

Edited by Miroslava Scholten and Michiel Luchtman

EU law and governance have faced a new development – the proliferation of EU enforcement authorities, which have grown in number over the last 15 years. These entities, either acting alone or together with national enforcement authorities, have been investigating and sanctioning private actors on their compliance with EU law. Law Enforcement by EU Authorities investigates whether the system of control (in terms of both judicial and political accountability) has evolved to support the new system of law enforcement in the EU.
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Chapter 6: Complex procedures as hurdle to accountability: verticalization of pharmaceutical enforcement

Merijn Chamon and Sabrina Wirtz


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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