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European Regulatory Agencies in EU Decision-Making

European Regulatory Agencies in EU Decision-Making
Author: Christoph Ossege
Publisher: Springer
Total Pages: 173
Release: 2016-01-06
Genre: Political Science
ISBN: 1137517905

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European Regulatory Agencies (ERAs) have become increasingly important features in EU decision-making. They aim to provide expert advice independent of political or economic considerations. This book explains whether and under what conditions ERAs comply with this scientific mandate. Expanding on rational institutionalism, Ossege provides novel insights into the behaviour of ERAs, their autonomy from 'undue' external influence, and their impact on EU policy-making. The empirical comparison of three major ERAs - the European Medicines Agency, the European Food Safety Authority, and the European Chemicals Agency - not only shows that agencies capitalise on their expertise and rule-making competences to protect their autonomy. Rather, in making strategic use of their expertise, the ERAs also guard their autonomy in areas of high political salience, though their policy influence in these areas is partially circumscribed. Based on these insights, European Regulatory Agencies in EU Decision-Making locates its subject in the wider system of European Governance and considers the perennial question of how to reconcile the need for expert advice with democratic decision-making.


Regulation Through Agencies in the EU

Regulation Through Agencies in the EU
Author: Damien Geradin
Publisher: Edward Elgar Publishing
Total Pages: 304
Release: 2005-01-01
Genre: Business & Economics
ISBN: 9781781950234

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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.


Agency Governance in the EU

Agency Governance in the EU
Author: Berthold Rittberger
Publisher: Routledge
Total Pages: 167
Release: 2013-09-13
Genre: Political Science
ISBN: 1135750246

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The rapid proliferation of EU agencies represents one of the most significant changes to the EU’s organisational set-up in past decades. At the same time, this development has significantly affected regulatory policy-making in the EU. This volume assembles the most renowned scholars in the field to address the key themes and challenges that agency governance in the EU poses to effective and legitimate policy-making. The first theme addresses the causes and dynamics of the creation and design of regulatory bodies in EU governance, focusing not only on EU agencies but also on alternatives to the agency format, such as regulatory networks. Second, once agencies are established, the book goes on to explore the consequences and trajectories of agency governance. How effective and autonomous are EU agencies? How does EU agency governance transform existing patterns of executive governance in the EU? Third, the book addresses the design of EU agencies as independent, non-majoritarian institutions poses pressing questions with a view to their legitimacy and accountability. The volume appeals to scholars and practitioners interested in the development and transformation of executive governance in the EU. This book was published as a special issue of the Journal of European Public Policy.


The Political Accountability of EU and US Independent Regulatory Agencies

The Political Accountability of EU and US Independent Regulatory Agencies
Author: Miroslava Scholten
Publisher: Martinus Nijhoff Publishers
Total Pages: 507
Release: 2015-01-27
Genre: Law
ISBN: 9004262997

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The Political Accountability of EU and US Independent Regulatory Agencies is an in-depth investigation on the law and practices of the political accountability arrangements of the 35 EU and 16 US independent agencies. The comparative analysis demonstrates similarities between the political accountability arsenals and challenges to political oversight in the EU and the US. The greatest differences are revealed in the organization of the political accountability of independent agencies, i.e., ‘excessive diversity in the EU vs. uniformity in the US’, and the design of accountability obligations. Based on comparative insights, the book concludes with three recommendations on how the EU agencies’ political accountability could be adjusted in the ongoing reform on agencies’ creation and operation.


Foundations of EU Food Law and Policy

Foundations of EU Food Law and Policy
Author: Alberto Alemanno
Publisher: Routledge
Total Pages: 414
Release: 2016-04-15
Genre: Law
ISBN: 1317133684

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This volume presents the viewpoints of academics, food lawyers, industry and consumer representatives as well as those of EU policymakers on the first ten years of activity of one of the most prominent European agencies. Its broader purpose, however, is to discuss the future role played by EFSA within the rapidly-evolving area of EU food law and policy. By revisiting and discussing the milestones in the history of EFSA, the collection provides forward-looking views of food leaders and practitioners on the future scientific and regulatory challenges facing the European Union. In particular, by presenting a critical assessment of the agency’s activities within its different areas of work, the book offers readers a set of innovative tools for evaluating policy recommendations and better equips experts and the public to address pressing regulatory issues in this emotive area of law and policy. Despite its celebratory mood, the book’s focus is more about the future than the past of EU food law and policy. Each chapter discusses how EFSA’s role has evolved and identifies what it should have done differently while presenting an overall assessment of how the agency has discharged its mandate.


EU Regulatory Decision Making and the Role of the United States

EU Regulatory Decision Making and the Role of the United States
Author: Oliver Ziegler
Publisher: Springer Science & Business Media
Total Pages: 270
Release: 2012-09-05
Genre: Political Science
ISBN: 3658000546

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Oliver Ziegler raises the question of what role economic interests of the United States play in the regulatory decision making process of the European Union. Critics often assume that U. S. dominance in the world economy, fueled by a powerful business elite, has significantly affected EU regulations at the expense of environmental and consumer protection standards. The author falsifies this proposition. He shows, first, that the EU often adopts regulations against the explicit opposition of the U. S. thereby ignoring the principles of transatlantic regulatory cooperation. Second, he demonstrates that business interests in the EU are usually not homogenous and often come second to environmental and consumer concerns. In addition, the author shows the increasing role of the European Parliament in EU regulatory decison making.


The Interplay of Global Standards and EU Pharmaceutical Regulation

The Interplay of Global Standards and EU Pharmaceutical Regulation
Author: Sabrina Röttger-Wirtz
Publisher: Bloomsbury Publishing
Total Pages: 288
Release: 2021-08-26
Genre: Law
ISBN: 1509943013

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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.


European Union

European Union
Author: Jeremy Richardson
Publisher: Routledge
Total Pages: 902
Release: 2015-02-23
Genre: Political Science
ISBN: 1317563832

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A key textbook for undergraduate and postgraduate students of contemporary European politics, European Union: Power and policy-making 4th edition offers a comprehensive and accessible analysis of the European Union policy process. Intended to advance understanding of the EU as a now mature and ongoing policy system, this book addresses the central issues relating to the distribution of power and influence in the European Union including: Theoretical perspectives The roles of key institutions in the processing of policy problems Different channels of representation The EU as a policy-making state Written by a distinguished group of international scholars, this new edition will also appeal to the worldwide community of researchers on the EU. New to this edition: New chapters on The Politics of Multispeed Europe, The Distribution of Power Among Institutions, EU Agencies, Covert Integration in the European Union, and Political Representation and Democracy in the EU. New authors and theoretical approaches on many topics such as differentiated integration, opt-outs and multi-speed integration, negotiation and coalition building, the interplay of judicial and legislative policy-making, power distribution, agency behaviour, integration by subterfuge, the democratic deficit fully updated data and content throughout Jeremy Richardson is joined by a co-editor, Professor Sonia Mazey, for the fourth expanded edition of this highly regarded textbook on the EU. Jeremy Richardson is an Emeritus Fellow at Nuffield College, Oxford, UK, and Adjunct Professor at the National Centre for Research on Europe, University of Canterbury, New Zealand. He is also Founder and Co-editor of the Journal of European Public Policy Sonia Mazey is a Professor and Pro-Vice-Chancellor of the College of Business and Law, University of Canterbury, New Zealand and formally a Fellow of Keble College, Oxford, UK


EU Pharmaceutical Regulation

EU Pharmaceutical Regulation
Author: Govin Permanand
Publisher: Manchester University Press
Total Pages: 272
Release: 2006-09-05
Genre: Medical
ISBN: 9780719072727

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This book provides an analysis of European Union pharmaceutical regulation from a policy-making perspective. The focus is on how the often conflicting agendas of the pharmaceutical industry, the EU member states, the European Commission, and consumer interests are reconciled within the context of regulatory outcomes having to serve public health, healthcare and industrial policy needs within the single market. In providing a unique perspective on how and why EU pharmaceutical policy is made, the book will be of interest to academics, students and policy-practitioners interested in EU policy-making, regulation and public policy analysis.