Risk Regulation in the Single Market: The Governance of Pharmaceuticals and Foodstuffs in the European Union PDF
Preview Risk Regulation in the Single Market: The Governance of Pharmaceuticals and Foodstuffs in the European Union
Palgrave Studies in European Union Politics Edited by: Michelle Egan, American University USA, Neill Nugent, Manchester Metropolitan University, UK, William Paterson, University of Birmingham, UK Editorial Board: Christopher Hill, Cambridge, UK, Simon Hix, London School of Economics, UK, Mark Pollack, Temple University, USA, Kalypso Nicolaidis, Oxford UK, Morten Egeberg, University of Oslo, Norway, Amy Verdun, University of Victoria, Canada, Claudio M. Radaelli, University of Exeter, UK, Frank Schimmelfennig, Swiss Federal Institute of Technology, Switzerland Following on the sustained success of the acclaimed European Union Series, which essentially publishes research-based textbooks, Pa/grave Studies in European Union Politics publishes cutting edge research-driven monographs. The remit of the series is broadly defined, both in terms of subject and academic discipline. 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Meyer, Ingo Linsenmann and Wolfgang Wessels (editors) ECONOMIC GOVERNMENT OF THE EU A Balance Sheet of New Modes of Policy Coordination Philomena Murray (editor) EUROPE AND ASIA Regions in Flux Daniel Naurin and Helen Wallace (editors) UNVEILING THE COUNCIL OF THE EUROPEAN UNION Games Governments Play in Brussels Frank Schimmelfennig, Stefan Engert and Heiko Knobel INTERNATIONAL SOCIALIZATION IN EUROPE European Organizations, Political Conditionality and Democratic Change Justus Schonlau DRAFTING THE EU CHARTER Angelos Sepos THE EUROPEANIZATION OF CYPRUS Polity, Policies and Politics Marc Weller, Denika Blacklock and Katherine Nobbs (editors) THE PROTECTION OF THE MINORITIES IN THE WIDER EUROPE Palgrave Studies in European Union Politics Series Standing Order ISBN 978-1-4039-9511-7 (hardback) and ISBN 978-1-4039-9512-4 (paperback) You can receive future titles in this series as they are published by placing a standing order. Please contact your bookseller or, in case of difficulty, write to us at the address below with your name and address, the title of the series and one of the ISBNs quoted above. Customer Services Department, Macmillan Distribution Ltd, Houndmills, Basingstoke, Hampshire RG21 6XS, England Risk Regulation in the Single Market The Governance of Pharmaceuticals and Foodstuffs in the European Union Sebastian Krapohl Assistant Professor of International Relations, Otto-Friedrich-University of Bamberg, Germany palgrave macmillan © Sebastian Krapohl 2008 Softcover reprint of the hardcover 1st edition 2008 978-0-230-53765-1 All rights reserved. No reproduction, copy or transmission of this publication may be made without written permission. No portion of this publication may be reproduced, copied or transmitted save with written permission or in accordance with the provisions of the Copyright, Designs and Patents Act 1988, or under the terms of any licence permitting limited copying issued by the Copyright Licensing Agency, Saffron House, 6-10 Kirby Street,London EC1N 8TS. Any person who does any unauthorized act in relation to this publication may be liable to criminal prosecution and civil claims for damages. The author has asserted his right to be identified as the author of this work in accordance with the Copyright, Designs and Patents Act 1988. First published 2008 by PALGRAVE MACMILLAN Palgrave Macmillan in the UK is an imprint of Macmillan Publishers Limited, registered in England, company number 785998, of Houndmills, Basingstoke, Hampshire RG21 6XS. Palgrave Macmillan in the US is a division of St Martin's Press LLC, 175 Fifth Avenue, New York, NY 10010. Palgrave Macmillan is the global academic imprint of the above companies and has companies and representatives throughout the world. Palgrave® and Macmillan® are registered trademarks in the United States, the United Kingdom, Europe and other countries. ISBN 978-1-349-35936-3 ISBN 978-0-230-58404-4 (eBook) DOI 10.1057/9780230584044 This book is printed on paper suitable for recycling and made from fully managed and sustained forest sources. Logging, pulping and manufacturing processes are expected to conform to the environmental regulations of the country of origin. A catalogue record for this book is available from the British Library. A catalog record for this book is available from the Library of Congress. 10987654 321 17 16 15 14 13 12 11 10 09 08 Transferred to Digital Printing 2011 For Sarah and Laura may they always have safe food and medicine Contents List of Figures and Tables ix Preface x List of Abbreviations xiii 1 Introduction: The Need for a Systematic Analysis of ' Supranational Risk Regulation 1 Part I An Institutionalist Approach to Supranational Risk Regulation 2 Functional Pressure and Path-Dependencies: The Emergence and Development of Supranational Regulatory Regimes 17 3 Efficiency and Legitimacy: The Evaluation of Supranational Regulatory Regimes 33 Part II The Authorisation of Pharmaceuticals in the EU 4 From National Crises to a Strong Supranational Regime: The Development of Pharmaceutical Authorisation in Europe 61 5 A Strong Regulatory Network: The Evaluation of the European Regulatory Regime for Pharmaceuticals 86 Part III The Regulation of Foodstuffs in the EU 6 From an Early Single Market to a Crisis of Consumer Confidence: The Development of Foodstuff Regulation in Europe 121 7 A Weak Supranational Agency: The Evaluation of the European Regulatory Regime for Foodstuffs 151 vii viii Contents Part IV Conclusion 8 A Comparison of Pharmaceutical and Foodstuff Regulation in Europe 183 Notes 195 Bibliography 208 Index 221 Figures and Tables Figure 2.1 Product regulation in the Single Market 19 Figure 2.2 Path-dependencies of supranational regulatory regimes 28 Figure 5.1 Multi-state and concertation procedures 88 Figure 5.2 Centralised authorisation procedure 92 Figure 5.3 Mutual recognition and decentralised authorisation procedures 103 Figure 7.1 The committee system in the foodstuff sector 153 Figure 7.2 Regulatory policy-making in the foodstuff sector after 2002 159 Figure 7.3 Authorisation of genetically modified food 165 Table 5.1 Evaluation of the two authorisation procedures in 2000 101 Table 5.2 Activities within the comitology procedure from 1995 to 2001 102 Table 5.3 Activities within the mutual recognition procedure from 1995 to 2000 106 ix
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