Pharmaceutical Reform

Marc J. Roberts

Description

This book applies an established analytical framework for health sector reform (Getting Health Reform Right, Oxford, 2004) to the performance problems of the pharmaceutical sector. The book is divided into three sections. The first section presents the basic ideas for analysis. It begins by insisting that reform start with a clear understanding of the performance deficiencies of the current system. Like all priority setting in the public sector, this 'definition of the problem' involves both ethical choices and political processes. Early chapters explain the foundations of these ideas and apply them to the pharmaceutical sector. The relationship of ultimate outcomes (like health status or risk protection) to classic health systems concepts like efficiency, access and quality is also explored. The last chapter in the first part is devoted to 'diagnosis'-explaining how to move from the definition of a problem to an understanding of how the functioning of the system produces the undesirable outcomes in question.
The second part of the book devotes one chapter to each of five 'control knobs': finance, payment, organization, regulation and persuasion. These are sets of potential interventions that governments can use to improve pharmaceutical sector performance. Each chapter presents basic concepts and discusses examples of reform options. Throughout we provide 'conditional guidance'-avoiding the approach of a 'one size fits all' model of 'best practices' in these five arenas for reform. Instead we stress the need for local knowledge of political systems, administrative capacities, community values and market conditions in order to design pharmaceutical sector policies appropriate to a country's particular circumstances.
The last part of the book is a set of teaching cases. Each is preceded by questions and is followed by a brief note on the lessons to be learned. The goal is to help readers develop the skills they need to deal effectively with pharmaceutical sector reform problems in their own countries.

Sujets

• Drug trade
• Health

Informations

• Publié par: world-bank-publications
• Publié le: 21 septembre 2011
• Nombre de lectures: 54
• EAN13: 9780821387719
• Langue: English
• Poids de l'ouvrage: 1 Mo

Extrait

Interactive textbook at
http://www.worldbank.org/pdt
Pharmaceutical
Reform
A Guide to Improving Performance and Equity
Marc J. Roberts and
Michael R. ReichPharmaceutical
ReformPharmaceutical Reform is available as
an interactive textbook at http://www
.worldbank.org/pdt. The electronic version
allows communities of practice and colleagues
working in sectors and regions, as well as
students and teachers, to share notes and
related materials for an enhanced, multimedia
learning and knowledge-exchange experience.Pharmaceutical
Reform
A Guide to Improving Performance and Equity
Marc J. Roberts and Michael R. Reich
THE WORLD BANK
Washington, D.C.© 2011 The International Bank for Reconstruction and Development / The World Bank
1818 H Street NW
Washington DC 20433
Telephone: [phone]
Internet: www.worldbank.org
All rights reserved
1 2 3 4 :: 14 13 12 11

This volume is a product of the staf of the International Bank for Reconstruction and
Development / The World Bank. The fi ndings, interpretations, and conclusions
expressed in this volume do not necessarily refl ect the views of the Executive Directors
of The World Bank or the governments they represent.
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ISBN 978-0-8213-8760-3
eISBN 978-0-8213-8771-9
DOI 10.1596/978-0-8213-8760-3
Library of Congress Cataloging-in-Publication Data
Roberts, Marc J.
Pharmaceutical reform : a guide to improving performance and equity / by Marc J.
Roberts and Michael R. Reich.
p. ; cm.
Includes bibliographical references and index.
ISBN 978-0-8213-8760-3 — ISBN 978-0-8213-8771-9 (eISBN)
1. Pharmaceutical policy. 2. Pharmaceutical industry. 3. Health care reform.
I. Reich, Michael, 1950- II. World Bank. III. Title.
[DNLM: 1. Drug Industry—organization & administration. 2. Health Care Reform—
organization & administration. 3. Pharmaceutical Preparations. QV 736]
RA401.A1R63 2011
615.1—dc22
2011012020CONTENTS
Foreword xi
Prefacexiii
Acknowledgments xix
Chapter 1. Introduction 1
Why Care about Pharmaceutical Policy? 1
What Is Pharmaceutical Policy? 5
What the Book Seeks to Accomplish 7
References 9
Chapter 2. Using the Flagship Framework to Reform
Pharmaceutical Policy 11
How to Begin the Process of Reform 11
Ultimate Performance Goals 13
The Role of Cost in Setting Reform Goals 17
The Role of Politics and Ethics in Identifying Problems and
Choosing Reform Priorities 20
The Reform Cycle 22
The Control Knobs 24
Government Failures and Market Failures 26
Summary on the Flagship Framework 32
References 33
Chapter 3. Introduction to the Pharmaceutical Sector 35
The World Pharmaceutical Market 35
Consolidation of Research and Development Companies 42
Pharmaceutical Pricing 44
The Role of National Policy 47
Summary on the Pharmaceutical Sector 50
References 51
vChapter 4. Ethics and Priority Setting in
Pharmaceutical Reform 53
Commonly Identifi ed Pharmaceutical Sector Problems 55
Relating Identifi ed Problems to Performance Goals 56
Relating Performance Goals to Ethical Perspectives: Utilitarianism 58
Relating Performance Goals to Ethical Perspectives: Liberalism 61
Relating Performance Goals to Ethical Perspectives:
Communitarianism 63
The Flagship Framework and Economic Development Goals 66
The International Dimension of Pharmaceutical Policy 67
The Importance of Fair Process 69
Summary on Ethics (and Some Suggestions) 70
Case Studies for Chapter 4 (Ethics) 71
References 72
Chapter 5. Diagnosing Performance Problems and
Developing a Policy Response 75
A Simple Pharmaceutical Example to Illustrate the Method 77
The Intermediate Performance Goals and Their Role in the
Diagnostic Process 79
Using the Intermediate Performance Measures 82
A Systems Approach to Process Improvement 84
Developing Policy Responses 85
Summary on Diagnosis 87
References 88
Chapter 6. Managing the Politics of Pharmaceutical
Policy Reform 89
The Role of Politics in Pharmaceutical Policy Making 89
Stakeholder Analysis and Political Context 91
Moving to Strategy Development 93
The Politics of Pharmaceutical Policy Reform—Some Examples 96
Summary on Politics 98
Case Study on Politics 98
References 98
Chapter 7. Financing the Pharmaceutical Sector 101
Pharmaceutical Financing and Health Sector Financing 102
Judging the Distributional Impact of Financing Options 103
Pharmaceutical Financing Choices 115
Summary on Financing 118
Case Study on Financing and Payment 119
References 119
vi ContentsChapter 8. Paying for Pharmaceuticals 121
Pharmaceutical Payment Reform and Health Sector Reform 122
Pharmaceutical Payment and Corruption 123
Procurement 124
Wholesale Payments 129
Payments by End Users 133
Summary on Payment 139
Case Studies on Financing and Payment 140
References 140
Chapter 9. Organizing the Public Sector to Improve
Pharmaceutical Performance 143
Pharmaceutical Sector Performance: The Six Keys 144
Autonomy, Corporatization, and Marketization 149
Contracting In and Contracting Out 151
Decentralization 152
Social Franchising 154
Using the New Public Sector Management 156
Essential Medicines Lists 157
The Potential Contribution of Process Improvement 158
The Challenges of Change 160
Summary on Organization 161
Case Studies on Organization 162
References 162
Chapter 10. Improving Pharmaceutical Sector Performance
through Regulation 165
The Conditions for Successful Regulation 167
Regulating Product Quality 170
Regulating Use 176
Regulation Directed at Controlling Prices 178
Summary on Regulation 179
Case Studies on Regulation 180
References 180
Chapter 11. Using Persuasion to Infl uence
Pharmaceutical Use 181
Elements of Human Decision Making 181
Using Persuasion: The Lessons of Social Marketing 184
Changing Behavior in the Pharmaceutical Sector 187
Summary on Persuasion 192
Case Studies on Persuasion 193
References 193
Contents viiChapter 12. Conclusions 195
Thinking about Pharmaceutical Systems 195
Steps in the Process 196
Final Thoughts 198
Case Study A. Defi ning an Essential Medicines List
in Sudamerica 201
Case Study B. Registering Misoprostol in Sri Lanka 211
Case Study C. Disentangling Prescribing and Dispensing
in the Republic of Korea 225
Case Study D. Last Mile Logistics for Essential Drugs:
The Case of Zambia 235
Case Study E. Drug Procurement in East Africania 247
Case Study F. Converting Basic Drug Shops to
Accredited Drug Dispensing Outlets in Tanzania 255
Case Study G. Counterfeit Medicines in Nigeria 267
Case Study H. Changing the Use of Antibiotics in Peru 279
Case Study I. Preparing for Microbicide Introduction
in South Africa 289
Case Study J. Drug Coverage in Ghana’s National
Health Insurance Scheme 301
Index. 321
Figures
1.1 The Pharmaceutical System 5
2.1 The Flagship Framework for Health System Performance 16
2.2 Cost-Performance Trade-Offs 17
2.3 The Reform Cycle 22
3.1 Growth Forecasts for Global Pharmaceutical Sales by Region 36
3.2 Distribution of Population and Total Pharmaceutical
Expenditure by Country Income Level, 2005–06 37
3.3 Medicines in Countries’ International Trade, Exports
minus Imports, 2009 38
3.4 Evolution of the Pharmaceutical Sector in Countries
of Different Income Levels 40
4.1 The Relationship of Pharmaceutical Sector Problems
to Ultimate Performance Goals 57
5.1 Pharmaceutical Performance Diagnostic Tree 77
5.2 Schematic Overview of the Determinants of System
Performance 83
viii Contents