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.
Author(s): Marc J. Roberts, Michael R. Reich
Edition: 1
Publisher: The World Bank
Year: 2011
Language: English
Pages: 332
City: Washington, DC
Contents
Foreword
Preface
Acknowledgments
Chapter 1. Introduction
Why Care about Pharmaceutical Policy?
What Is Pharmaceutical Policy?
What the Book Seeks to Accomplish
References
Chapter 2. Using the Flagship Framework to Reform Pharmaceutical Policy
How to Begin the Process of Reform
Ultimate Performance Goals
The Role of Cost in Setting Reform Goals
The Role of Politics and Ethics in Identifying Problems and Choosing Reform Priorities
The Reform Cycle
The Control Knobs
Government Failures and Market Failures
Summary on the Flagship Framework
References
Chapter 3. Introduction to the Pharmaceutical Sector
The World Pharmaceutical Market
Consolidation of Research and Development Companies
Pharmaceutical Pricing
The Role of National Policy
Summary on the Pharmaceutical Sector
References
Chapter 4. Ethics and Priority Setting in Pharmaceutical Reform
Commonly Identified Pharmaceutical Sector Problems
Relating Identified Problems to Performance Goals
Relating Performance Goals to Ethical Perspectives: Utilitarianism
Relating Performance Goals to Ethical Perspectives: Liberalism
Relating Performance Goals to Ethical Perspectives: Communitarianism
The Flagship Framework and Economic Development Goals
The International Dimension of Pharmaceutical Policy
The Importance of Fair Process
Summary on Ethics (and Some Suggestions)
Case Studies for Chapter 4 (Ethics)
References
Chapter 5. Diagnosing Performance Problems and Developing a Policy Response
A Simple Pharmaceutical Example to Illustrate the Method
The Intermediate Performance Goals and Their Role in the Diagnostic Process
Using the Intermediate Performance Measures
A Systems Approach to Process Improvement
Developing Policy Responses
Summary on Diagnosis
References
Chapter 6. Managing the Politics of Pharmaceutical Policy Reform
The Role of Politics in Pharmaceutical Policy Making
Stakeholder Analysis and Political Context
Moving to Strategy Development
The Politics of Pharmaceutical Policy Reform—Some Examples
Summary on Politics
Case Study on Politics
References
Chapter 7. Financing the Pharmaceutical Sector
Pharmaceutical Financing and Health Sector Financing
Judging the Distributional Impact of Financing Options
Pharmaceutical Financing Choices
Summary on Financing
Case Study on Financing and Payment
References
Chapter 8. Paying for Pharmaceuticals
Pharmaceutical Payment Reform and Health Sector Reform
Pharmaceutical Payment and Corruption
Procurement
Wholesale Payments
Payments by End Users
Summary on Payment
Case Studies on Financing and Payment
References
Chapter 9. Organizing the Public Sector to Improve Pharmaceutical Performance
Pharmaceutical Sector Performance: The Six Keys
Autonomy, Corporatization, and Marketization
Contracting In and Contracting Out
Decentralization
Social Franchising
Using the New Public Sector Management
Essential Medicines Lists
The Potential Contribution of Process Improvement
The Challenges of Change
Summary on Organization
Case Studies on Organization
References
Chapter 10. Improving Pharmaceutical Sector Performance through Regulation
The Conditions for Successful Regulation
Regulating Product Quality
Regulating Use
Regulation Directed at Controlling Prices
Summary on Regulation
Case Studies on Regulation
References
Chapter 11. Using Persuasion to Influence Pharmaceutical Use
Elements of Human Decision Making
Using Persuasion: The Lessons of Social Marketing
Changing Behavior in the Pharmaceutical Sector
Summary on Persuasion
Case Studies on Persuasion
References
Chapter 12. Conclusions
Thinking about Pharmaceutical Systems
Steps in the Process
Final Thoughts
Case Study A. Defining an Essential Medicines List in Sudamerica
Case Study B. Registering Misoprostol in Sri Lanka
Case Study C. Disentangling Prescribing and Dispensing in the Republic of Korea
Case Study D. Last Mile Logistics for Essential Drugs: The Case of Zambia
Case Study E. Drug Procurement in East Africania
Case Study F. Converting Basic Drug Shops to Accredited Drug Dispensing Outlets in Tanzania
Case Study G. Counterfeit Medicines in Nigeria
Case Study H. Changing the Use of Antibiotics in Peru
Case Study I. Preparing for Microbicide Introduction in South Africa
Case Study J. Drug Coverage in Ghana’s National Health Insurance Scheme
Index
Figures
1.1 The Pharmaceutical System
2.1 The Flagship Framework for Health System Performance
2.2 Cost-Performance Trade-Offs
2.3 The Reform Cycle
3.1 Growth Forecasts for Global Pharmaceutical Sales by Region
3.2 Distribution of Population and Total Pharmaceutical Expenditure by Country Income Level, 2005–06
3.3 Medicines in Countries’ International Trade, Exports minus Imports, 2009
3.4 Evolution of the Pharmaceutical Sector in Countries of Different Income Levels
4.1 The Relationship of Pharmaceutical Sector Problems to Ultimate Performance Goals
5.1 Pharmaceutical Performance Diagnostic Tree
5.2 Schematic Overview of the Determinants of System Performance
5.3 The Effect of Alternative Quality Improvement Strategies: The “Rotten Apple” View
5.4 The Effect of Alternative Quality Improvement Strategies: The Systems View
7.1 National Health Insurance Coverage for Countries by Region
7.2 Commodity Logistics System in Kenya
8.1 Private Sector Patient Prices for Selected Medicines in Pakistan Compared to International Reference Prices
9.1 The Six Keys to Organizational Performance
10.1 The Regulatory Cycle
D1 Current Public Health Sector Distribution System
D2 Unfilled Posts in the Health Sector
F1 Tiers of Drug Retailers
F2 Accredited Drug Dispensing Outlet Program Outline
J1 Drug Costs as a Proportion of Total National Health Insurance Claims Costs
J2 Regional Analysis of National Health Insurance Per Capita Costs and Participation Rates
Tables
1.1 Top 10 Causes of Death by Income Group, 2004
1.2 Pharmaceutical Expenditures by Country Income Level, 2006
3.1 R&D Expenditures by Government and the Pharmaceutical Industry in Selected High-Income Countries, 2008
3.2 Top 10 Pharmaceutical Importing Countries in Africa, 1998
4.1 Summary of Three Ethical Views
7.1 Resources for Medicines and Medical Supplies in Liberia, 2007 and 2008
7.2 Pharmaceutical Financing: Comparing Options
8.1 Cumulative Percentage Markups in the Public and Private Sectors in 11 Countries
8.2 Affordability of Selected Medicines in the Middle East and North Africa
9.1 Limited Human Resources in Low-Income and Other Selected Countries
D1 Health Facilities
D2 Supply Chain Improvement Alternatives
J1 Top 100 Drugs in the National Health Insurance Scheme by Cost and Utilization
J2 Sources of Funding for Prescription Drug Purchases in 2008
