Description
Oxford Pharmaceutical Economics and Policy Perspectives Promises and Problems 2018 Edition by Stuart O. Schweitzer, Z. John Lu
Pharmaceuticals constitute a
relatively small share of the total healthcare expenditure in most developed
economies, and yet they play a critical role in the ongoing debate over how
best to advance, improve, and afford healthcare. Despite this, and perhaps
because of this, the industry has had, for many years, an outsized claim to
fame and controversy, praise and criticisms, support and condemnation.
Unfortunately, many participants in the debate do not fully
understand the complexities of the industry and
its role in the overall healthcare system.
The analytical tools of economics provide a strong
foundation for a better understanding of the dynamics of the pharmaceutical
industry, its contribution to health and healthcare, its dual and often conflicting
priorities of affordability and innovation, as well as the various private and
public policy initiatives directed at the sector. This third edition of a
uniquely comprehensive and balanced examination of the industry includes
several new chapters on important topics such as the
full-fledged generics sector, the arrival of
biosimilars or generic biological drugs, the global consolidation of
manufacturers, the evolving reimbursement landscape, and the emergence of the
world's most populous nations, such as China, India, and Brazil, as both
suppliers and consumers of pharmaceutical
products. Other chapters have been fully rewritten
or extensively updated, covering such important topics as the cost efficiency
of research and development, pace of new innovations, economic evaluation and
value-based pricing of drugs, and public and private interventions in the
industry.
Introduction
The Big Picture
The Supply of Pharmaceuticals
The Demand for Pharmaceuticals
Pharmaceutical Prices
International Price Comparisons
Pharmaceutical Marketing
Pharmaceutical Patents
Regulatory Control of the Pharmaceutical Sector
Timing of Pharmaceutical Approvals
Part I. The Industry
Chapter 1 The Pharmaceutical Industry
The Competitive Structure of the Pharmaceutical Industry
Pharmaceutical Research and Development
Pharmaceutical R&D and Prices
The Pharmaceutical Research and Approval Process
Product Liability
Increasing Private Sector Research Activity
Drugs for Low-Income Countries
The Role of Pharmaceutical Marketing in Prescribing Decisions
Conclusions
Chapter 2 The Biotechnology Industry
Background
What is Biotechnology?
A Brief History of Modern Biotechnology Industry
Factors Distinguishing the Biotechnology from the Pharmaceutical Industry
Case Studies of Biotechnology Firm Growth and Failure
Conclusion
Chapter 3 Generics and Biosimilars
Introduction
A Brief History of Modern Generic Pharmaceutical Industry in the US
The Structure of the Generic Pharmaceutical Industry
Generic Entry and Price Competition in the Pharmaceutical Marketplace
Generic Entry and Strategic Behavior
Drug Shortage
Economic Analysis of Drug Shortage
The Emergence of Biosimilars
Conclusion
Chapter 4 The Global Pharmaceutical Industry
Geographic Patterns of Pharmaceutical Production and Sales
International Trade in Pharmaceutical Products
Pharmaceutical Research and Development: An International View
Does Government Drug Price Setting Influence R&D?
Global Mergers and Acquisitions
The Pharmaceutical Industry in Selected Countries and Regions
The Chinese Pharmaceutical Industry
Access to Appropriate Drugs in Developing Countries
Part II. The Consumer
Chapter 5 The Demand for Pharmaceuticals
The Problem of Drug Expenditures
How is Demand Determined?
Pharmaceuticals and Other Health Services: Substitutes or Complements?
The Changing Structure of the Pharmaceutical Market
Conclusion
Chapter 6 The Demand for Pharmaceuticals in Major International Markets
Comparison of Pharmaceutical Spending across Global Markets
Comparison of Pharmaceutical Consumption across Global Markets
Demand for Pharmaceuticals in Japan
Demand for Pharmaceuticals in China
Demand for Pharmaceuticals in France and Germany
Demand for Pharmaceuticals in the United Kingdom
Demand for Pharmaceuticals in Canada
Demand for Pharmaceuticals in Brazil
Conclusion
Part III. Pricing and Marketing of Pharmaceutical Products
Chapter 7 Pharmaceutical Prices
The Problem of Pharmaceutical Prices
Pharmaceutical Prices Over Time
Measuring Drug Prices: What Prices?
Measuring Drug Prices: Rate of Change
How Are Drug Prices Determined?
Economic Models from Industrial Organization Literature
Market Power, Generic Entry and Pricing
Chapter 8 Economic Evaluation of New Drugs
Optimizing Production of Health
Cost-Benefit Analysis
Cost-Effectiveness Analysis
Cost-Utility Analysis
Cost-Effectiveness League Table
Policy Applications
Conclusions
Chapter 9 Pricing Pharmaceuticals in a World Environment
Why Do Drug Prices Vary Across Country?
Comprehensive Comparison of International Drug Prices
Policy Implications
Conclusion
Chapter 10 Pharmaceutical Marketing
Size of the Pharmaceutical Promotion Effort
Pharmaceutical Promotion Directed at Healthcare Providers
Pharmaceutical Promotion Aimed at Patients: Direct-to-Consumer Advertising (DTCA)
Pharmaceutical Promotion to Third-Party Payers
Regulation of Prescription Pharmaceutical Promotion
False and Misleading Claims
Off-Label Promotion
Conclusion
Part IV. Public Policies in the Pharmaceutical Market
Chapter 11 Patent Protection
Introduction
Patent Law
Patentability
Patent Categories
How Patents Are Obtained?
What Protection Does a Patent Confer?
Duration of Patent Protection
Infringement of Patents
Strategic Responses by Pharmaceutical Firms
International Patent Treaties
Patent Procedures under International Conventions
Criticisms of the Patent System
Patent and Societal Choice
Chapter 12 Drug Approval Process in the United States
The Drug Approval Process in the United States
The Rising Cost of Pharmaceutical R&D
Major Drug Legislations in the United States
Annual NME Approvals by FDA since 2000
Regulatory Approval of Generic Drugs in the US
Regulatory Approval of Biosimilars in the US
Chapter 13 Pharmaceutical Regulation in the European Union
The European Union
Move Toward a Single Market
History of Drug Regulation in Europe
Structure and Role of the European Medicines Agency
Drug Review under the European Medicines Agency
EU Rules on Labeling of Medicinal Products
Regulations of Drug Advertising
Pharmacovigilance
Approval of Generic Drugs in the European Union
Approval of Biosimilars in the European Union
Comparison of International Drug Approval Lags
Chapter 14 Pharmaceuticals and Public Policy: A Look Ahead
Industry Structure
The Nascent Biosimilar Sector
Personalized Medicine and Digital Healthcare Information
Artificial Intelligence and Medicine
Outpatient Bundled Payment Program and Pharmaceuticals
Pharmaceutical Prices
The FDA
Conclusion.