A Practical Approach to Pharmaceutical Policy

by World Bank

Overview

Pharmaceuticals are an essential component of health care. But for many people in low- and middle-income countries, access to the medicines they need to prevent or treat severe illnesses is limited. Typical problems are lack of availability, costs that exceed the individual’s purchasing power or lack of competent “agents” – health workers that are well trained to give the correct advice on which medicines to take. Pharmaceutical policy is the part of health policy that aims at addressing these problems and increasing access to safe, effective and affordable medicines for all patients. There are many obstacles against achieving these goals. Such obstacles can arise from financial interests on the side of suppliers and health care providers, who may benefit from charging higher prices and issuing more prescriptions than might be justified from a clinical and economic viewpoint. Or from rogue suppliers trying to introduce low quality or counterfeit drugs into markets with less effective regulation. Also, corruption and ineffective bureaucracies sometimes interfere with well intended programs to offer access to essential medicines for the poor. This book offers policy makers a hands-on approach, tested in the World Bank’s field work in many countries, for assessing the pharmaceutical sector, recognizing typical “patterns of dysfunction” and developing strategies to quickly deal with the most urgent problems while at the same time building a platform for sustainable long term policy. It offers examples from a variety of low- and middle income countries and provides practical assessment tools for policy makers. The book ends with the author’s outlook on future developments in this complex policy field.

Product Details

ISBN-13:	9780821383865
Publisher:	World Bank Publications
Publication date:	06/17/2010
Series:	Directions in Development
Pages:	238
Product dimensions:	5.90(w) x 8.90(h) x 0.60(d)

Table of 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

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

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

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