A Practical Approach to Pharmaceutical Policy
Andreas Seiter
June 2010 by World Bank ISBN: 0-8213-8386-8 ISBN-13: 978-0-8213-8386-5 SKU: 18386
Book [240p] available online at: http://bit.ly/aROO8L
“………..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…………”
TABLE OF CONTENTS
Chapter 1. Pharmaceutical Policy Goals
Pharmaceutical Policy Framework • Parameters for Monitoring the Effect and Progress of Pharmaceutical Reforms
Chapter 2. Introducing the Stakeholders
Multinational Research-Based Companies • Multinational Generics Companies • National Generics Companies • Brokers • Procurement Agents • Importers and Agents • Wholesalers • Central Medical Stores • Retail Pharmacists and Drug Sellers • Prescribers • Consumers • Public Policy Makers: Legislative and Executive • Regulatory and Executive Agencies • Expert Commissions and Advisers • Civil Society Organizations • International Agencies and Donors • Public Purchasers • Payers • Pharmaceutical Benefit Managers • Consultants
Chapter 3. Patterns of Dysfunction
Inadequate Regulation of Core Pharmaceutical Sector Functions • Lack or Misuse of Funds • Ineffective or Inefficient Procurement • Dysfunctional Supply Chains • Corruption, Abuse of Public Funds, and Unethical Business Practices • Inadequate Incentives for Providers and Policy Makers • Medicine Prices Perceived as Too High • Conflicts between Innovation and Cost Containment • Conflicts between Industrial Policy and Public Health Objectives • Irrational or Inappropriate Use of Drugs • A Tool to Assess the Sector and Diagnose Dysfunctions
Chapter 4. Key Elements of a Successful Pharmaceutical Policy
Ensuring Access to Safe and Effective Drugs through Well-Designed Supply Chains • Using Purchasing Power to Get Value for Money • Managing the Decision Process on Formulary Inclusion • Creating Adequate Information Systems • Ensuring Rational and Cost-Effective Use of Medicines • Securing Adequate Financing and Payment Mechanism for Pharmaceuticals • Reconciling Health Policy and Industrial Policy in the Pharmaceutical Sector • Ensuring Good Governance of the Sector
Chapter 5. Policy Packages to Achieve Strategic Long-Term Goals
Essential Medicines Policy • Generic Drugs Policy • Innovation-Friendly Drugs Policy • Combining Several Policy Models within One Country
Chapter 6. Factors Influencing Policy Implementation
Stakeholder Assessment and Involvement • Strategies to Neutralize Political Opposition
Chapter 7. Pharmaceutical Policy Illustrated in Country Examples
Chapter 8. Pharmaceutical Policy Outlook
Regulatory Framework • Drug Prices • Financing and Management of Drug Benefits • Effect on Markets and Industry • General Trend: Convergence toward Models That Work
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