Pharmaceuticals are globally traded products and often the manufacturing takes place far away from the point of sale. The manufacturing process is regulated though global standards, as well as European and national law. How can such a multi-level level framework be enforced? This paper will examine the cooperative procedures that lie at the heart of the EU’s enforcement regime though inspections. Next to mapping the applicable procedures and cooperative inspection models, it will analyze if the composite nature of this enforcement strategy leads to problems of accountability.
Ever growing policy sectors of the EU are managed through a system of composite administration. This does not only apply to regulatory tasks, but also to enforcement powers, and with inspection powers therein. This is the case with some highly relevant policy sectors, such as the European Banking Union, fisheries, food law, competition, financial markets, antifraud provisions and aviation safety. These can either be directly conducted by the EU, where the Commission inspects by itself, or through various forms of cooperation with MS. Focusing on the cases where inspections are conducted in a mixed fashion – that is, where agencies and the ECB are involved together with national authorities – our aim is twofold: first, we try to highlight the different patterns of cooperation emerging between the different administrative levels involved in the inspection tasks; second, we try to investigate what kind of political and judicial accountability mechanisms apply to each model.
Frontex’s operations can affect fundamental right and should thus be subject to efficient control. The paper aims at analyzing whether sufficient legal (or administrative) remedies are in place to protect individuals harmed by an operation coordinated by the agency. The paper will first shed the light on the actions coordinated by Frontex, illustrating in this way the composite nature of the decision-making procedures and operations, and the opacity thereof. In a second part, the paper will analyze the legal implications of Frontex’s operations from a national, European and international perspective, so as to determine whether these jurisdictions can offer adequate judicial protection to harmed individuals. As an alternative solution, possibilities of administrative review will be developed. The case-study of ‘hotspots’ in Greece and in Italy will be studied so as to test the hypothesis developed before in an even-more complex environment with more actors involved.
The governance of the humanitarian dimension of migration is one of the most salient challenges for the EU and for European integration as a process. One core aspect of migration today rests on externalization policies, which aim at creating transnational governance structures geared at sharing the administration of the preventive containment of migration flows directed to Europe. These externalization policies feature predominantly the actorness of executive organs; they take place with informal acts, instead of formal legal instruments; they materialize more and more in practices of shared administration enabled by new technological and communication infrastructures. Informality of instruments and the operational dimension challenge traditional accountability mechanisms. Which is the most appropriate forum for ensuring accountability for the actions described above? The article defines different situations and scenarios and also sketches out different liability frameworks.
The initial implementation design of EU’s asylum policy, reflective of the theory of executive federalism, foresaw that national authorities were to conduct asylum processing. This design shifted and patterns of joint implementation surfaced. Joint implementation broadly refers to staff and experts deployed by the European Asylum Support Office (EASO), an EU agency, working alongside national administrators, including on asylum processing. I scrutinize these patterns and the resulting accountability challenge, drawing from legal analysis, political science theories, and administrative practice. EASO is subject to a mosaic of accountability processes. Two main pitfalls emerge: the balance between accountability and independence; and accessibility for the individual. Against this backdrop, I focus on extra-judicial accountability through the European Ombudsman which, combined with the envisaged internal “individual complaints mechanism”, could help ensure applicants’ procedural rights.
An increasing number of EU institutions and agencies conduct administrative inspections, having a direct impact on fundamental rights, such as the inviolability of the home. This is the case of the European Anti-Fraud Office (OLAF), of the European Central Bank (ECB), of the European Securities and Markets Authority (ESMA), of the European Aviation Safety Agency (EASA), of the European Fisheries Control Agency (EFCA), of the Directorate on Health and food audits (Directorate-F).
Does control on these powers meet supranational standards of protection of fundamental rights? The paper argues that, given the variety of inspections powers, different variables have to be taken into account, depending on whom is the direct subject of the inspection – if a national authority or a private entity – and on the type of inspection proceeding. As a result, also the models of judicial control vary and different reforms are needed.