[Trust] Poor Quality Pharmaceuticals in Global Public Health Volume 5 ||

This book aims to clarify the global aspects of poor quality pharmaceuticals, generic products in particular, becoming complicated through the process of IMPACT (International Medical Products Anti-Counterfeiting Taskforce) organized by the initiative of the World Health Organization (WHO) in 2006. The findings from this book provide a long-term perspective to policymakers. This book discusses from the following points: industrial standardization, healthcare market accessibility, motivation on supply side, WHO medicines policy and intellectual property rights. Standardization regulates the quality and enabled the generic medicines spreading to developing/emerging countries through technology transfer. However, quality is a part of cost and reflected to price. When a healthcare service market is divided according to wealth gap, compliance to standardization for quality on supply side is divided accordingly. Thus, poor quality pharmaceuticals are prevalent worldwide. Generic pharmaceuticals are essential resources in public health. The WHO has been involved in the dispute around the intellectual property rights under its intention to promote the new drug development for neglected diseases. Global pandemic of AIDs is a critical factor to accelerate the confusion. This created feelings of distrust among developing/emerging countries against developed countries if the WHO was in favour of developed countries. In addition to that, an easy and optimistic start of IMPACT stirred up conflicts of interests in the international community. The problem of poor quality pharmaceuticals became more complicated through the conflicts on intellectual property rights; patented drugs to generic drugs. A key for quality generic products is the formation of a single healthcare service market where good motivation on supply side together with fair competitiveness with patented pharmaceuticals and equitable access to services (both for the rich and the poor) are ensured. Political commitment to investment and regulatory infrastructure for the market is crucial. Preface Development of This Book Purpose and Significance of This Book Scope and Approach for This Book Terms Acknowledgements Contents Abbreviations 1 Introduction: What “Goods” Are Pharmaceuticals? 1.1 Usage of Terms 1.2 Goods Contributing to Life and Health 1.2.1 Health Care and Pharmaceutical Products 1.2.2 Health Care and Pharmaceutical Products from the Perspective of Economists 1.3 Goods Controlled by the State 1.3.1 Risks of and Regulation for Pharmaceutical Products 1.3.2 Pharmaceutical Regulations Having the Nature of Police Laws, and Importance of the Pharmacopoeia 1.4 Goods as Public Health 1.4.1 Sociality and Public Nature of Pharmaceutical Products 1.4.2 Constitution of WHO and Pharmaceutical Products 1.4.3 Essential Medicines 1.4.4 Generic Medicines 1.4.5 International Support and NPOs 1.4.6 Technology Transfer and International Cooperation 1.5 Goods as Industries of Developed and Emerging Countries 1.5.1 Supply-Demand Relationship Linked with Global Network 1.5.2 Pharmaceuticals as Industrial Products 1.5.3 Newly Developed Medicines and Generics 1.5.4 Confrontation Between the Developed World and the Emerging World Regarding Intellectual Property Rights 1.5.5 Move of Pharmaceutical Companies Toward Globalization 1.6 Pharmaceutical Products as Illegally Distributed Goods 1.6.1 Concerns of the Developed World and of the Emerging and Developing World 1.6.2 Smuggling 1.6.3 Online Distribution 1.6.4 Distribution in Emerging and Developing Countries 1.7 Discussion References Pharmaceuticals in Globalization 2 Global Circulation of Imitated Products, Poor Quality Pharmaceuticals, Fake Products, and Health Problems 2.1 Business Handling Imitations in the World 2.1.1 Definition of Imitation 2.1.2 Size of Counterfeit/Piracy Business 2.2 Databases for Poor Quality Pharmaceuticals 2.2.1 WHO Database 2.2.2 Database of the Pharmaceutical Security Institute (PSI) 2.2.3 Media Reports on Medicine Quality: Database of the US Pharmacopeia 2.2.4 Medicine Quality Database & Poor Quality Medicines Alert 2.3 Definition and Actual Status of Poor Quality Pharmaceuticals 2.3.1 Definition by the IMPACT and the Actual Status of Poor Quality Pharmaceuticals 2.3.2 New Definition for Poor Quality Pharmaceuticals 2.3.3 Discussion About Reasons for Production of Poor Quality Pharmaceuticals 2.3.4 To Whom Are Poor Quality Pharmaceuticals the Problem? 2.4 Health Damage Caused by Poor Quality Pharmaceuticals 2.4.1 Serious Incidents of High Criminality 2.4.2 Estimation of Invisible Health Damage and Its Limitation 2.5 International Awareness of Poor Quality Pharmaceuticals 2.5.1 Acknowledgement by the WHO 2.5.2 Acknowledgement by the Other International Organizations 2.5.3 Acknowledgement by Individual National Governments 2.5.4 Acknowledgement by Associations Representing Research-Based Pharmaceutical Companies 2.6 Discussion References 3 The World Health Organization 3.1 Mission and Constitution of WHO 3.2 WHO Definition of Health References 4 Quality and Standardization for Globalization 4.1 What Is Quality? 4.2 Requirement of Compatibility Was the Foundation for the Concept of Specification 4.2.1 Emergence of the Concept of Compatibility 4.2.2 The Idea of Specification that Enables Handling of Networking 4.2.3 Benefits from Specification and Standardization that Enabled Mass Production 4.3 Setting Specifications and Standardization for Pharmaceutical Products 4.3.1 “Specifications” of Medicines Embody Requirements of Patients 4.3.2 Approval for Pharmaceutical Products and Setting Specifications for Drug Therapies 4.3.3 Extraction of Disease Concept from Disease Conditions and Symptoms, and Setting Specifications for Diseases 4.4 Newly Developed Medicines and Generic Medicines 4.4.1 Newly Developed Medicines (Originators) and Generics 4.4.2 Intellectual Property Rights and Business Model of Pharmaceutical Companies 4.4.3 International Agreement on Intellectual Property Rights 4.4.4 TRIPS Agreement Regarding Access to Pharmaceutical Products 4.5 Standardization of Pharmaceutical Products in the International Society 4.5.1 WHO Activities Regarding the GMP 4.5.2 PIC/S Aiming at Improving GMP and Quality Control System 4.5.3 Standardization of Quality Guidelines that Is Promoted by the ICH 4.6 Discussion References 5 Global Rising Tides Associated with Pharmaceuticals 5.1 The Times of Globalization 5.2 Growth of Pharmaceutical Industry in Emerging Countries 5.3 Intellectual Property Rights and Substance Patents 5.4 HIV/AIDS that Has Become a Challenge in Public Health 5.5 Acceleration of M&A and Reorganization of Pharmaceutical Industry in Developed Countries 5.6 Expanding Wealth Gap Between Poor and Rich, and Reproduction of Poverty 5.7 Asymmetry of Information References 6 A Dead End of IMPACT 6.1 Counterfeiting-Related Problems Became a Global Political Issue 6.2 Background for Establishment of IMPACT 6.3 Concept Paper Providing the Base for Establishment of IMPACT and the Declaration of Rome 6.3.1 The Optimistic Proposal of the Concept Paper 6.3.2 Declaration of Rome 6.4 Management Organization of IMPACT that Is Occupied by Developed Countries, and Its Strategies 6.4.1 Management Organization of IMPACT 6.4.2 Strategies of IMPACT 6.5 A Case as a Trigger to a Dead End of IMPACT 6.6 Criticisms Against IMPACT/WHO at a Meeting of the Executive Board of WHO 6.7 Discussion 6.7.1 Internal Structure of IMPACT and Leadership 6.7.2 Intellectual Property Right and Counterfeiting as a New Attribute Given to Generics 6.7.3 Limitations of IMPACT 6.7.4 Technical Support to Developing and Emerging Countries 6.7.5 Governance in Medicine Exporting Countries References Market and Access in Local Aspects 7 A Case Study in Indonesia: Self-medication and Limited Access 7.1 Self-medication Across the World 7.2 Research Methods 7.2.1 Rationale and Method for Selection of the Survey Target Area 7.2.2 Survey Subjects 7.2.3 Survey Methods 7.2.4 Analytical Methods 7.2.5 Ethical Consideration 7.3 Survey Results 7.3.1 Questionnaire Survey at Pharmacy Exit 7.3.2 Interview Survey on Pharmacists and Assistant Pharmacists 7.3.3 Other Survey Results 7.4 Challenges Found in On-Site Technology Transfer 7.5 Discussion 7.5.1 Health Insurance System and Self-care 7.5.2 Behavioral Patterns and Mentality of Self-care Performers 7.5.3 Reasons Why Antibiotics Are Frequently Used for Self-treatment 7.5.4 Pharmacists’ Roles and Self-medication Determined by Society 7.5.5 Sufficiency Rates of Medicines and Complicated Distribution Networks References 8 A Case Study in India: Market as a Safety Net 8.1 Criticism Against Emerging Countries 8.2 Research Methods 8.2.1 Research Purpose 8.2.2 Survey Methods 8.3 Survey Results 8.3.1 Survey Through Purchasing Drugs and Conducting Interviews in Delhi City 8.3.2 Survey Through Purchasing Drugs and Conducting Interviews in Uttar Pradesh State 8.3.3 Survey Results from Interviewing a Distributor of Pharmaceutical Products 8.3.4 Survey Results from Interviewing a Pharmacy Owner 8.4 Discussion 8.4.1 Structure of the Indian Pharmaceutical Industry and the Roles of GMP 8.4.2 Challenges Related to the Structure of Locally Based Pharmaceutical Companies 8.4.3 Sales Prices and Branding as Quality Indicators References 9 An Example of Healthcare Service Market in Japan 9.1 Distribution of Poor Quality Medicines in Japan 9.2 Article 25 of the Constitution of Japan 9.3 Two Insurance Acts and the Public Assistance Act 9.4 Outline of Japan’s Healthcare Scheme 9.5 Characteristics of the Public Healthcare Service Market of Japan from the Perspective of Patients 9.6 Characteristics of the Public Healthcare Service Market of Japan from the Perspective of Healthcare Providers 9.7 Characteristics of the Public Healthcare Service Market of Japan from the Perspective of Pharmaceuticals Suppliers 9.8 Characteristics of the Public Healthcare Service Market of Japan from the Viewpoint of Financial Resources 9.9 Discussion References 10 Aiming for Global Safety Net—An Interpretation and Lessons 10.1 Direction of the Observations and Discussions Described in the Previous Chapters 10.2 International Environment Surrounding Pharmaceutical Products 10.2.1 Generation of Conflicts of Interests Among Emerging, Developed, and Developing Countries 10.2.2 Conflicts of Interests Over Intellectual Property Rights Between the Developed and the Emerging Worlds 10.2.3 Factors that Have Complicated Interests Over Intellectual Property Rights 10.3 Internal Environment of Emerging Countries 10.3.1 Gap Between Industrial Promotion and Norms in Emerging Countries 10.3.2 Challenges of Markets in Emerging Countries 10.3.3 Constraints Due to Social/Cultural Conditions and Trade-off in Emerging Countries 10.3.4 Policy-Makers’ Will to Address Market Challenges and Public Health 10.4 WHO’s Policies on Pharmaceutical Products 10.4.1 WHO’s Policies on Pharmaceutical Products (1): Enhancement of Essential Medicines 10.4.2 WHO’s Policies on Pharmaceutical Products (2): Promotion of Access to Newly Developed Medicines 10.5 Significance of Existence of WHO/IMPACT and Their Limitations 10.5.1 Problems Which Were not Made Visible and Hastiness of IMPACT 10.5.2 Externalization of the Problem 10.5.3 Mistakes and Limitations of WHO/IMPACT 10.6 Challenges of International Cooperation for Technology Transfer 10.7 Lessons 10.7.1 Locality and Globalization of the Problem 10.7.2 Conflicts of Interests Over Intellectual Property Rights 10.7.3 Significance of Political Commitment 10.7.4 Responsibilities of International Organizations and Member States 10.8 What This Book Suggests References 11 Epilog References