Pharmaceutical Economics and Policy - Perspectives, Promises, and Problems

Pharmaceutical Economics and Policy provides comprehensive discussions on a wide range of pharmaceutical economics and policy issues. This third edition re-examines ongoing issues such as industrial organization, R&D and innovation, competition and pricing, intellectual property and regulation. It includes a number of new topics, such as the nascent biosimilar sector, globalization of supply chain, value-based pricing, evolving reimbursement landscape,and the emerging pharmaceutical market in large, developing economies such as China and India.

List of contents

• 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 RandD 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 RandD?


• 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 RandD


• 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

About the author

Stuart O. Schweitzer is Professor of Health Policy and Management at UCLA's Fielding School of Public Health. He has held other academic and research appointments at the Urban Institute and the White House Commission for a National Agenda for the Eighties. His research and consulting activities have dealt with pharmaceutical regulation and policy, health care financing, and technology assessment.

Z. John Lu is an Assistant Professor of Economics at the MVS School of Business and Economics, California State University, Channel Islands. Prior to this academic position, Dr. Lu was a health economist in the biopharmaceutical industry for 2 decades, including nearly 17 years at Amgen, where he was a director of global health economics and policy. Professor Lu's research interests include industrial economics and policy on pharmaceuticals, particularly in the United States and China.

Summary

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.

Additional text

This book is easy to read and provides an excellent overview of the pharmaceutical industry This book makes a useful contribution to anyone interested in understanding pharmaeconomic theory and the characteristics of the pharmaceutical industry.

Product details

• Authors: Z John Lu, Z. John Lu, Z. John (Assistant Professor Lu, Stuart O Schweitzer, Stuart O. Schweitzer, Stuart O. (Professor of Health Policy Schweitzer, Stuart O. (Professor of Health Policy and Management Schweitzer, Stuart O./ Lu Schweitzer
• Publisher: Oxford University Press
• Languages: English
• Product format: Hardback
• Released: 31.07.2018
• EAN: 9780190623784
• ISBN: 978-0-19-062378-4
• No. of pages: 432
• Subject: Social sciences, law, business > Business > Individual industrial sectors, branches