The past decade has witnessed a proliferation of regulatory agencies at both the national and the EU level. This coherent and clearly structured book is the first of its kind to analyse in equal measure, and interdependently, both national regulatory authorities and European agencies. It brings together a select group of highly esteemed contributors - authorities in their fields - to provide a systematic and over-arching view of regulation in the EU. Unlike many of the previous attempts to shed light on this increasingly opaque and complex co-existence of regulatory systems, this book takes a genuinely multi-disciplinary approach with integrated perspectives from law, politics and economics.

This book examines a largely unexplored dimension of the European agencies, namely their role in EU external relations and on the international plane. International cooperation has become a salient feature of EU agencies triggering important legal questions regarding the scope and limits of their international dimension, the nature and effects of their international cooperation instruments, their status within the EU and on the global level, and leading potentially to tensions between EU law and international law. This book fills the existing knowledge gap by scrutinizing the international cooperation legal framework and practice of EU agencies, including their mandate, tasks and instruments, together with their legal status as actors with a global dimension. It sets out a general legal-analytical framework which combines legal parameters from EU and international law to assess EU agencies as global actors, and examines in detail three case studies on carefully selected agencies to shed light on the complexities of EU agencies’ daily international cooperation.

This insightful book analyzes the evolution of the operational tasks and cooperation of the European Border and Coast Guard Agency (FRONTEX), the European Asylum Support Office (EASO) and the European Union Agency for Law Enforcement Cooperation (EUROPOL). Exploring the recent expansion of the legal mandates of these decentralized EU agencies and the activities they undertake in practice, David Fernández-Rojo offers a critical assessment of the EU migration agencies.

European agencies have been created at a rapid pace in recent years in a multitude of highly pertinent and sensitive fields ranging from pharmaceuticals and aviation safety to chemicals or financial supervision. This agency phenomenon shows no signs of relenting, and the trend in recent years is towards the delegation of ever-broader powers. These bodies, meant to operate at arm's length from political control, have real power and their opinions and decisions can have a direct impact on individuals, regulators, and member states. Given the powers wielded by the agencies, who is responsible for holding these non-majoritarian actors to account? Is the growing concern surrounding agency accountability 'much ado about nothing' or are we faced with the threat of a powerful and unaccountable bureaucracy? These are precisely the questions that this book seeks to answer. It thus addresses one of the most relevant topics in current European governance: the accountability of European agencies. Scholars have increasingly called attention to the risk of placing too much power in the hands of such agencies, which operate at arm's length from traditional controls and cannot easily be held accountable for their actions. Although this is a major issue of concern, systematic empirical research into the topic is lacking. This book addresses empirically whether, and if so on what counts, agency accountability is problematic. It examines how the accountability system of European agencies operates at both the de jure as well as the de facto level, through an examination of legal provisions, relevant case law as well as policy documents and extensive interview material. Reflecting on these findings, the book also offers important theoretical insights for our understanding and study of accountability in a complex regulatory regime such as the EU context. The book follows a multi-disciplinary approach and is at the cutting edge of law and public administration.

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.

These changes, together with the general advance in the study of regulation, undoubtedly demand a re-evaluation of the theory of regulation, its methodologies and scope of application. This book is a perceptive investigation of recent evolutions in the manner and extent of governance through regulation. Scholars and students of comparative politics, public policy, regulation theory, institutional economics and political sociology will find it to be essential reading. It will also prove a valuable source of reference for those working or dealing with regulatory authorities and for business managers in private industries and services operating under a regulatory framework.

Combining an empirical analysis of the evolution of EU food regulation with a theoretical study of selected mechanisms used in governing food, this book provides a critical outlook on the capacity of the regulatory system to accommodate increased post-enlargement diversity of socio-economic concerns.

This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy. Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union's reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.

The rapid development of information technology has exacerbated the need for robust personal data protection, the right to which is safeguarded by both European Union (EU) and Council of Europe (CoE) instruments. Safeguarding this important right entails new and significant challenges as technological advances expand the frontiers of areas such as surveillance, communication interception and data storage. This handbook is designed to familiarise legal practitioners not specialised in data protection with this emerging area of the law. It provides an overview of the EU’s and the CoE’s applicable legal frameworks. It also explains key case law, summarising major rulings of both the Court of Justice of the European Union and the European Court of Human Rights. In addition, it presents hypothetical scenarios that serve as practical illustrations of the diverse issues encountered in this ever-evolving field.