Official PDF , 240 pages

240 Pages·2010·2.44 MB·English

by  World Bank Group

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Andreas Seiter
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APAPP_i-xxii.qxd 5/21/10 11:45 AM Page i
A Practical Approach to
Pharmaceutical Policy
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A Practical Approach to
Pharmaceutical Policy
Andreas Seiter
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© 2010 The International Bank for Reconstruction and Development / The World Bank
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Washington DC 20433
Telephone:[phone]
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E-mail:[email protected]
All rights reserved
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This volume is a product of the staff of the International Bank for Reconstruction and Development/
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ISBN:978-0-8213-8386-5
eISBN:978-0-8213-8387-2
DOI:10.1596/978-0-8213-8386-5
Library of Congress Cataloging-in-Publication Data
Seiter,Andreas.
A practical approach to pharmaceutical policy / Andreas Seiter.
p.;cm.— (Directions in development)
Includes bibliographical references and index.
ISBN 978-0-8213-8386-5 (alk.paper)
I.Pharmaceutical policy. I.World Bank. II.Title. III.Series: Directions in development
(Washington,D.C.)
[DNLM:1.Drug Industry—organization & administration.2.Developed Countries.3.Government
Regulation.4.Health Plan Implementation.5.Health Policy—economics.QV 736 S462p 2010]
RA401.A1S45 2010
362.17'82—dc22
2010015420
Cover photo:istockphoto.com
Cover design:Naylor Design,Washington,D.C.
APAPP_i-xxii.qxd 5/21/10 11:45 AM Page v
Contents
Foreword xi
Preface xiii
Acknowledgments xv
About the Author xvii
Abbreviations xix
Chapter 1 Pharmaceutical Policy Goals 1
Pharmaceutical Policy Framework 3
Parameters for Monitoring the Effect and
Progress of Pharmaceutical Reforms 6
References 10
Chapter 2 Introducing the Stakeholders 11
Multinational Research-Based Companies 13
Multinational Generics Companies 18
National Generics Companies 21
Brokers 22
Procurement Agents 23
Importers and Agents 24
Wholesalers 25
Central Medical Stores 26
vv
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vi Contents
Retail Pharmacists and Drug Sellers 27
Prescribers 28
Consumers 29
Public Policy Makers:Legislative and Executive 30
Regulatory and Executive Agencies 31
Expert Commissions and Advisers 32
Civil Society Organizations 32
International Agencies and Donors 33
Public Purchasers 35
Payers 35
Pharmaceutical Benefit Managers 36
Consultants 36
Notes 37
References 38
Chapter 3 Patterns of Dysfunction 39
Inadequate Regulation of Core Pharmaceutical
Sector Functions 41
Lack or Misuse of Funds 44
Ineffective or Inefficient Procurement 45
Dysfunctional Supply Chains 48
Corruption,Abuse of Public Funds,and
Unethical Business Practices 51
Inadequate Incentives for Providers and
Policy Makers 53
Medicine Prices Perceived as Too High 59
Conflicts between Innovation and Cost
Containment 66
Conflicts between Industrial Policy and
Public Health Objectives 71
Irrational or Inappropriate Use of Drugs 73
A Tool to Assess the Sector and Diagnose
Dysfunctions 75
Notes 77
References 78
Chapter 4 Key Elements of a Successful Pharmaceutical
Policy 81
Ensuring Access to Safe and Effective Drugs
through Well-Designed Supply Chains 82
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Contents vii
Using Purchasing Power to Get Value for Money 93
Managing the Decision Process on Formulary
Inclusion 97
Creating Adequate Information Systems 104
Ensuring Rational and Cost-Effective Use of
Medicines 107
Securing Adequate Financing and Payment
Mechanism for Pharmaceuticals 110
Reconciling Health Policy and Industrial Policy
in the Pharmaceutical Sector 113
Ensuring Good Governance of the Sector 117
Notes 120
References 121
Chapter 5 Policy Packages to Achieve Strategic
Long-Term Goals 123
Essential Medicines Policy 124
Generic Drugs Policy 126
Innovation-Friendly Drugs Policy 127
Combining Several Policy Models within
One Country 128
Notes 129
Reference 129
Chapter 6 Factors Influencing Policy Implementation 131
Stakeholder Assessment and Involvement 132
Strategies to Neutralize Political Opposition 135
Note 137
Reference 137
Chapter 7 Pharmaceutical Policy Illustrated in Country
Examples 139
Ghana:National Health Insurance as a
“Game Changer” 139
Lithuania:Dealing with the Effects of the
Financial Crisis 143
China:Improving Social Protection for the
Rural Poor 145
Russian Federation:Affordability and Access
to Essential Drugs 146
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viii Contents
Liberia:Building Up after Conflict 147
Notes 149
References 149
Chapter 8 Pharmaceutical Policy Outlook 151
Regulatory Framework 151
Drug Prices 153
Financing and Management of Drug Benefits 154
Effect on Markets and Industry 155
General Trend:Convergence toward Models
That Work 158
References 159
Appendix A A Tool to Assess the Pharmaceutical Sector
in a Given Country 161
Appendix B Customized Version of the Assessment Tool
(Appendix A) for Use in an Assessment of the
Pharmaceutical Sector in Turkey 167
Part 1:Quantitative Data 169
Part 2:Descriptive Section 171
Appendix C Assessment Tool for Government Procurement
Agencies in the Health Sector in India 175
Index 207
Boxes
1.1 Example of Target Setting in a Project Aimed at
Improving Access to Medicines in a Low-Income Country 8
2.1 A Tragedy in Panama,Caused by a Toxic Ingredient
in Cough Syrup 21
3.1 Major Cost Drivers for Ensuring Drug Availability
in Health Centers in Lesotho 50
3.2 Fraudulent Abuse of Health Insurance Funds in Germany 53
3.3 Example of Price Regulation in Practice 62
3.4 NICE:Example of an Institution Set Up to Manage
the Conflict between Innovation and Cost Containment
in Health Care 69
3.5 Access to Medicines and the TRIPs Agreement in Brazil 70
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Contents ix
4.1 Scope and Purpose of a Framework Contract 90
4.2 Creating a Secure Supply Chain in Liberia 93
4.3 Hypothetical Example of the Use of Purchasing Power
to Ensure Availability of Low-Price Drugs to Patients
with Health Insurance 95
4.4 Hypothetical Example of a Low-Cost Assessment
Process for New Drugs 101
4.5 Sample Format for Ranking Drug X for Treatment of
Acute Ischemic Stroke within the First 60 Minutes 103
6.1 Example of a Multistakeholder Process to Address
Controversial Policy Positions 134
Figures
1.1 Emergence of Core Pharmaceutical Policy Objectives
by Income Level 2
1.2 Hierarchy of Laws,Regulations,and Implementing
Agencies in the Pharmaceutical Sector 5
2.1 Evolution of the Pharmaceutical Sector in Countries
of Different Income Levels 13
3.1 Example of a Pharmaceutical Procurement Cycle 46
3.2 Incentives Influencing a Physician’s Prescribing Behavior 54
3.3 Components of the Retail Drug Price 60
4.1 Example of an Integrated Pharmaceutical Supply Chain 84
4.2 Example of a Public Sector Supply System 87
4.3 Collection of Prescribing and Drug Use Information at
the Pharmacy Level 105
5.1 Three Levels of Pharmaceutical Policy 124
5.2 Standard Elements of an Essential Medicines Policy 125
5.3 Standard Elements of a Generic Drugs Policy 126
5.4 Standard Elements of an Innovation-Friendly
Drugs Policy 128
6.1 Model Process to Secure Acceptance for a Difficult
Reform Project 136
7.1 Increase in Turnover of Revolving Drug Funds after
Introduction of NHIS in Ghana 141
Tables
2.1 Top-10 Pharmaceutical Companies by Sales,2008 16
3.1 Links between Enforcement of Drug Regulation and
Access to Medicines 43