This book overviews and integrates the business and technical issues that pharmaceutical companies need to know in order to combat the major global problem of counterfeit medicines. In addition to discussion of the problems, the author Davison addresses analytical techniques scientists use to detect counterfeits and presents some possible solutions to the threat of counterfeit medical products. Coverage moves from basic overview of the problem, costs / risks to consumers (toxic products, mistrust of drug companies) and business (revenue loss, public trust), government oversight and regulation, authentication strategies (packaging, analytical techniques), product tracking and supply chain, and case studies from around the globe.
PREFACE xxi ACKNOWLEDGMENTS xxiii
PART 1 GENERAL THEMES
1 Introduction 3
Why Write This Book? 3
Doesnt This Book Just Help the Criminals? 4
Who Is the Book Aimed At? 5
2 Origins and Context of Counterfeiting in Healthcare 7
Background and Nature of the Threat 7
R&D Costs, Patent Life, and the Profit Imperative 9
A Low Cost, High Profit Business 10
Research and Development 10
Regulatory Approval 10
Manufacturing 11
Packaging 11
Marketing 11
Logistics 12
Permissive Legal Environment 12
Role of the Internet 13
Global Growth of Counterfeiting 14
3 A Snapshot of the Problem 15
Case Study: Malaria 18
4 Risks and Costs of Counterfeit Pharmaceuticals 21
Risks and Costs for Consumers 21
l“4