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.
Merijn Chamon and Sabrina Wirtz
Antonia Corini, Bernd van der Meulen, Floris Kets, Giuseppa Ottimofiore and Florentin Blanc
National competences to enforce EU food law are heavily regulated through the Official Controls Regulation. Information on food safety issues is shared among competent authorities through the Rapid Alert System for Food and Feed (RASFF). National performance is supervised by Directorate-F of DG SANTE; EU supervision though indirect enforcement by nature may directly affect businesses as is shown in the Bowland case. Also RASFF alerts that are traceable to individual businesses may heavily affect these businesses. The EU holds direct enforcement competences with regard to third countries and in case of emergencies including failing enforcement at Member State level. Due to the interlinkedness of competences, judicial accountability regarding RASFF alerts and Directorate-F supervision is lacking both at national level and at EU level. Also political accountability seems to fall short both at national and at EU level.
Alex Brenninkmeijer and Emma van Gelder
In recent years there has been an increasing development of direct enforcement powers shifting from the national to the EU level. Accountability issues arise as the control over this enforcement appears to remain separate between national and European supervisory authorities. As the guardian of EU finances, the European Court of Auditors (ECA) audits the reliability of the accounts, the regularity and legality of the underlying transactions and the sound financial management of the European Enforcement Authorities (EEAs). In this chapter the ECA is analysed as an accountability forum in holding EEAs to account discussing its two distinct features: the auditor of the EU Budget and an information tool for the political branch. In relation to the first function the audit task and the encountered accountability issues are discussed. In relation to the latter function the extent to which the ECA can strengthen political accountability is analysed.
Federica Cacciatore and Mariolina Eliantonio
The management of the Common Fisheries Policy (CFP) has been one of the earliest concerns of the EU. While establishing a decentralised system with most responsibilities falling within the competence of Member States’ authorities, the EU also felt the need to create a dedicated agency, the European Fisheries Control Agency (EFCA), endowed with mostly coordinating and some enforcement powers. This chapter seeks to examine the shared enforcement mechanisms between EFCA and the NCAs in the CFP and assess whether they are supported by adequate accountability mechanisms. In order to do so, we examine the relationship between EFCA and two selected MS, Italy and the UK. The chapter shows that there exist two shared enforcement mechanisms, one concerning the formulation and development of the general inspection policies, another referring to the cooperation between EFCA, which has the power to carry out inspections on EU vessels in international waters, and the NCAs, which are in charge of the sanctioning phase. Such mechanisms show some gaps of judicial accountability, which however could be considered as compensated for through a complete system of political accountability.
Edited by Miroslava Scholten and Michiel Luchtman
Florentin Blanc and Giuseppa Ottimofiore
The chapter considers legal and actual accountability of EEAs, looking at the interplay between how mandates are defined, accountability exercised, and which outcomes can be assessed. It analyses if and how formulation of mandates and performance measurement can affect practices, accountability, and results for the public. The hypotheses investigated are: (1) Accountability is meaningful when it reflects regulatory outcomes in terms of public welfare. Mandates and performance indicators should be consistent with the primary goal of EEAs. (2) Accountability is not a mere mechanism, but substantive content in terms of mandate, goals and indicators being assessed. (3) The formulation and measurement of mandates, goals and indicators have effects on EEAs’ performance, operations, methods, use of resources and results. Performance management needs to be linked to accountability, to ensure that EEAs are held accountable for the way they carry out their mandate and not only for the implementation of procedures.
The overall picture of the institutional design shows that the EPPO will be fully dependent on the delegates in the national legal regimes for conducting the investigation. Because of the transnational character of many important fraud cases this means that the EPPO will have to apply EU law and different settings of national provisions. This shared enforcement with the delegates under national law this will result in a complex patchwork in which the legal consequences of its actions and the applicable procedural safeguards for suspects, victims and third parties will be quite unclear.
Implications for Political and Judicial Accountability
Edited by Miroslava Scholten and Michiel Luchtman
Katalin Cseres and Annalies Outhuijse
EU competition law is enforced parallel by the EU Commission and 28 national competition authorities (NCAs) in a multi-level governance system composed of EU and national procedural laws. Regulation 1/2003 established the European Competition Network (ECN) in order to coordinate parallel proceedings between the Commission and the NCAs. This chapter analyses the shared enforcement of EU competition law from the perspective of political and judicial accountability. The chapter focuses on the accountability of the Commission, the NCAs and the ECN in their role of/as main actors of the shared enforcement. Two jurisdictions are used to illustrate the role and powers of the NCAs: the Netherlands and Hungary. After analysis of the powers and roles of the three respective actors (the Commission, the NCAs and the ECN) of parallel enforcement, section 3 examines judicial and political accountability and section 4 concludes.
Rob Widdershoven and Paul Craig
This chapter discusses the judicial accountability of enforcement actions in which European Enforcement Authorities (EEAs) are involved, in the light of the fundamental European standards of the CFR and ECHR. In this respect three general weaknesses are highlighted. First, the framework of some EEAs facilitates the possibility of forum shopping by the authorities to the national legal order with the most far-reaching competences and the lowest procedural guarantees. Second, most regulatory EEA frameworks neglect essential procedural safeguards applicable to EEA investigations, such as the principle of legal professional privilege, the right not to incriminate oneself, and the ex-ante judicial authorisation of on-the-spot inspections. Third, in several areas it is uncertain whether individuals enjoy effective access to a court against EEA investigations. Most weaknesses should be addressed by the European legislator; some may be solved by the national courts.