Risk Regulation in the Single Market: The Governance of Pharmaceuticals and Foodstuffs in the European Union

232 Pages·2008·24.349 MB·English

by  Sebastian Krapohl (auth.)

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. All topics of significance concerning the nature and operation of the
European Union potentially fall within the scope of the series. The series is
multidisCiplinary to reflect the growing importance of the EU as a political,
economic and social phenomenon. We will welcome submissions from the areas of
political studies, international relations, political economy, public and social policy,
economics, law and sociology.
Submissions should be sent to Amy Lankester-Owen, Politics Publisher,
'a.lankester- [email protected]'.
Titles include:
Ian Bache and Andrew Jordan (editors)
THE EUROPEANIZATION OF BRITISH POLITICS
Richard Balme and Brian Bridges (editors)
EUROPE-ASIA RELATIONS
Building Multilateralisms
Derek Beach and Colette Mazzucelli (editors)
LEADERSHIP IN THE BIG BANGS OF EUROPEAN INTEGRATION
Milena Buchs
NEW GOVERNANCE IN EUROPEAN SOCIAL POLICY
The Open Method of Coordination
Dario Castiglione, Justus Schbnlau, Chris Longman, Emanuela Lombardo, Nieves
Perez-Solorzano Borragan and Mirim Aziz
CONSTITUTIONAL POLITICS IN THE EUROPEAN UNION
The Convention Moment and its Aftermath
Morten Egeberg (editor)
MULTILEVEL UNION ADMINISTRATION
The Transformation of Executive Politics in Europe
Kevin Featherstone and Dimitris Papadimitriou
THE LIMITS OF EUROPEANIZATION
Reform Capacity and Policy Conflict in Greece
Stefan GanzIe and Allen G. Sens (editors)
THE CHANGING POLITICS OF EUROPEAN SECURITY
Europe Alone?
Isabelle Garzon
REFORMING THE COMMON AGRICULTURAL POLICY
History of a Paradigm Change
Heather Grabbe
THE EU'S TRANSFORMATIVE POWER
Katie Verlin Laatikainen and Karen E. Smith (editors)
THE EUROPEAN UNION AND THE UNITED NATIONS
Intersecting MultiIateralisms
Esra LaGro and Knud ErikJ0Igensen (editors)
TURKEY AND THE EUROPEAN UNION
Prospects for a Difficult Encounter
Paul G.Lewis and Zdenka Mansfeldova (editors)
THE EUROPEAN UNION AND PARTY POLITICS IN CENTRAL AND EASTERN EUROPE
Ingo Linsenmann, Christoph O. Meyer and Wolfgang T. Wessels (editors)
ECONOMIC GOVERNMENT OF THE EU
A Balance Sheet of New Modes of Policy Coordination
Hartmut Mayer and Henri Vogt (editors)
A RESPONSIBLE EUROPE?
Ethical Foundations of EU External Affairs
Lauren M. McLaren
IDENTITY, INTERESTS AND ATTITUDES TO EUROPEAN INTEGRATION
Christoph O. 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