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RU: Regulating Pharmaceuticals in Europe: Striving for Efficiency, Equity and Quality Regulating pharm… new 22/4/04 9:12 am Page 1 Regulating pharmaceuticals in Europe: striving for efficiency, equity and quality European Observatory on Health Care Systems Series "This thoughtful and comprehensive book represents the best work I have seen on the current situation concerning medication policies in Regulating pharmaceuticals the EU. It is not just that this is a very up-to-date compendium of facts…the book is also strong on analysis of those facts." Jerry Avorn, Harvard Medical School "A valuable and timely contribution to understanding the many debates about regulating industry, medicines and prescribing across Europe." Sir Alisdair Breckenridge, Chairman of the Medicines and Healthcare Products Regulatory Agency, United Kingdom Regulating pharmaceuticals The rising cost of pharmaceutical expenditures in many European countries is of concern to governments required to make effective use of health care budgets. Taking a broad perspective that encompasses institutional, political and supranational aspects of pharmaceutical in in Europe: striving for regulation, this book examines approaches used to manage pharmaceutical expenditure across Europe and what impact these Europe strategies have had on the efficiency, quality, equity and cost of pharmaceutical care. efficiency, equity and quality Regulating Pharmaceuticals in Europe is an important book for students of health policy, regulation and management, and for health managers and policy makers. Edited by Mossialos/Mrazek/Walley by Edited The editors Elias Mossialos is Brian Abel-Smith Professor of Health Policy at the London School of Economics and Political Science and a Research Director of the European Observatory on Health Systems and Policies. Monique Mrazek is a Health Economist for the World Bank (Europe and Central Asia region) and formerly a Research Officer in Health Economics at the European Observatory on Health Systems and Policies at the London School of Economics and Political Science. Tom Walley is Professor of Clinical Pharmacology at the University of Liverpool and Director of the UK National Health Technology Assessment Programme. The contributors Edited by Julia Abelson, Christa Altenstetter, Vittorio Bertele‘, Christine Bond, Marcel L. Bouvy, Colin Bradley, Steve Chapman, Anna Dixon, Michael Elias Mossialos Drummond, Pierre Durieux, Edzard Ernst, Armin Fidler, Eric Fortess, Richard Frank, Silvio Garattini, Leigh Hancher, Ebba Holme Hansen, Steve Hudson, Kees de Jonchere, Panos Kanavos, Sjoerd Kooiker, Jean- Monique Mrazek Marc Leder, Graham Lewis, Donald W. Light, Alistair McGuire, Elias Mossialos, Monique Mrazek, Maria Pia Orru, Govin Permanand, Guenka Petrova, Munir Pirmohamed, Dennis Ross-Degnan, Frans Tom Walley Rutten, Steven Soummerai, David Taylor, Sarah Thomson, Tom Walley. 5 ISBN 0-335-21465-7 www.openup.co.uk 9 780335 214655 European Observatory on Health Systems and Policies Series The European Observatory on Health Systems and Policies is an interna- tional project that builds on the commitment of all its partners to improving health care systems: • World Health Organization Regional Office for Europe • Government of Belgium • Government of Finland • Government of Greece • Government of Norway • Government of Spain • Government of Sweden • European Investment Bank • Open Society Institute • World Bank • London School of Economics and Political Science • London School of Hygiene & Tropical Medicine Series Editors Josep Figueras is Head of the Secretariat and Research Director of the European Observatory on Health Systems and Policies and Head of the European Centre for Health Policy, World Health Organization Regional Office for Europe. Martin McKee is Research Director of the European Observatory on Health Systems and Policies and Professor of European Public Health at the London School of Hygiene & Tropical Medicine as well as a co-director of the School’s European Centre on Health of Societies in Transition. Elias Mossialos is Research Director of the European Observatory on Health Systems and Policies, Brian Abel-Smith Professor of Health Policy, Department of Social Policy, London School of Economics and Political Science and Co-Director of LSE Health and Social Care. Richard B. Saltman is Research Director of the European Observatory on Health Systems and Policies and Professor of Health Policy and Management at the Rollins School of Public Health, Emory University in Atlanta, Georgia. The series The volumes in this series focus on key issues for health policy making in Europe. Each study explores the conceptual background, outcomes and lessons learned about the development of more equitable, more efficient and more effective health systems in Europe. With this focus, the series seeks to contribute to the evolution of a more evidence- based approach to policy formulation in the health sector. These studies will be important to all those involved in formulating or evaluating national health care policies and, in particular, will be of use to health policy makers and advisers, who are under increasing pressure to rationalize the structure and funding of their health systems. Academics and students in the field of health policy will also find this series valuable in seeking to understand better the complex choices that confront the health systems of Europe. The Observatory supports and promotes evidence-based health policy-making through comprehensive and rigorous analysis of the dynamics of health care systems in Europe. European Observatory on Health Systems and Policies Series Series Editors: Josep Figueras, Martin McKee, Elias Mossialos and Richard B. Saltman Published titles Funding health care: options for Europe Elias Mossialos, Anna Dixon, Josep Figueras, Joe Kutzin (eds) Health care in central Asia Martin McKee, Judith Healy and Jane Falkingham (eds) Health policy and European Union enlargement Martin McKee, Laura MacLehose and Ellen Nolte (eds) Hospitals in a changing Europe Martin McKee and Judith Healy (eds) Regulating entrepreneurial behaviour in European health care systems Richard B. Saltman, Reinhard Busse and Elias Mossialos (eds) Regulating pharmaceuticals in Europe: striving for efficiency, equity and quality Elias Mossialos, Monique Mrazek and Tom Walley (eds) Forthcoming titles Effective purchasing for health gain Josep Figueras, Ray Robinson and Elke Jakubowski (eds) Mental Health Policy and Practice across Europe Martin Knapp, David McDaid, Elias Mossialos and Graham Thornicroft (eds) Social health insurance systems in western Europe Richard B. Saltman, Reinhard Busse and Josep Figueras (eds) European Observatory on Health Systems and Policies Series Edited by Josep Figueras, Martin McKee, Elias Mossialos and Richard B. Saltman Regulating pharmaceuticals in Europe: striving for efficiency, equity and quality Edited by Elias Mossialos Monique Mrazek Tom Walley Open University Press Open University Press McGraw-Hill Education McGraw-Hill House Shoppenhangers Road Maidenhead Berkshire England SL6 2QL email: [email protected] world wide web: www.openup.co.uk First published 2004 Copyright © World Health Organization on behalf of the European Observatory on Health Systems and Policies 2004 This study was produced in collaboration with the Health Technology and Pharmaceuticals programme, World Health Organization Regional Office for Europe. The views expressed in this publication are those of the editiors and contributors and do not necessarily represent the decisions or the stated policy of the participating organizations of the European Observatory on Health Systems and Policies. All rights reserved. Except for the quotation of short passages for the purpose of criticism and review, no part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior written permission of the publisher or a licence from the Copyright Licensing Agency Limited. Details of such licences (for reprographic reproduction) may be obtained from the Copyright Licensing Agency Ltd of 90 Tottenham Court Road, London, W1T 4LP. A catalogue record of this book is available from the British Library ISBN 0 335 21465 7(pb) 0 335 21466 5 (hb) Library of Congress Cataloging-in-Publication Data CIP data applied for Typeset by RefineCatch Limited, Bungay, Suffolk Printed in Great Britain by MPG Books Ltd, Bodmin, Cornwall Contents List of boxes, figures and tables viii List of contributors xi Series editors’ introduction xiv Foreword xvi Preface xviii Acknowledgements xx one Regulating pharmaceuticals in Europe: an overview 1 Elias Mossialos, Tom Walley and Monique Mrazek two The politics of pharmaceuticals in the European Union 38 Govin Permanand and Christa Altenstetter three The European Community dimension: coordinating divergence 55 Leigh Hancher four The role of the EMEA in regulating pharmaceutical products 80 Silvio Garattini and Vittorio Bertele’ five Measuring, monitoring and evaluating policy outcomes in the pharmaceutical sector 97 Panos Kanavos, Dennis Ross-Degnan, Eric Fortess, Julia Abelson and Stephen Soumerai vi Regulating pharmaceuticals in Europe six Regulating pharmaceutical prices in the European Union 114 Monique Mrazek and Elias Mossialos seven Reimbursement of pharmaceuticals in the European Union 130 Alistair McGuire, Michael Drummond and Frans Rutten eight Good prescribing practice 144 Steve Chapman, Pierre Durieux and Tom Walley nine Patients and their medicines 158 Colin Bradley, Ebba Holme
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