Access to Medicines: The Interface Between Patents and Human Rights. Does One Size Fit All? (School of Human Rights Research 64)
By: Jennifer Sellin (author)Paperback
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Millions of people worldwide lack adequate access to medicines, particularly in developing countries where resources are scarce with devastating human, social and economic consequences. The example of HIV/AIDS, for which treatment has advanced so significantly in the last decade that a diagnosis no longer necessarily brings with it a death sentence, highlights the importance of ensuring that essential medicines are affordable and accessible to all. This book focuses on one aspect of access to medicines: the affordability of essential medicines, and its connection to human rights and patents. The argument often made is that patent protection for medicines results in higher prices which negatively impacts access. Patients having no or inadequate access to affordable medicines endangers the full realisation of human rights, particularly the right to health. This book investigates this issue from a legal perspective, taking both an international and domestic angle.
This study examines the interface of access to affordable medicines and patent protection from the perspective of international human rights law and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) within the framework of the World Trade Organisation. The essential question posed by this book is whether access to medicines and patent protection conflict or coexist. The discussion is deepened by including a developing country approach. Three country studies have been conducted, on South Africa, India and Uganda. These aim to provide a concrete insight into whether these countries recognise and acknowledge the interplay between patents and human rights with respect to access to medicines. Secondly these studies examine whether TRIPS leaves sufficient freedom for (developing) states to adopt a patent system suited to their domestic needs, enabling them to strike a fair balance between access to medicines and patent protection for medicines. In other words: does one size fit all? This book is targeted at both academics and human rights practitioners, including government officials, human rights advocates and NGOs.
It goes further than a mere theoretical discussion on the issue from an international law perspective by providing an in-depth examination of domestic (legal) frameworks relevant for the issue of access to medicines. It illustrates that the normative force of human rights in combination with social movement can provide a powerful tool for prioritising the health needs of the global poor.
Part I. Method and Problem Statement Chapter 1. Introduction & Methodology 1. Introduction 2. The Aim of This Research 3. The Research Questions 4. The Method 4.1. Sources 4.2. Manner of Interpretation 4.3. The Selection of Countries 4.4. Limitations of the Study Chapter 2. Access to Medicines: the Problem 1. Introduction 2. Access to Essential Medicines 2.1. Defining Essential Medicines 2.2. Access 2.3. Availability and Affordability in Developing Countries 2.4. Conclusion 3. The Pharmaceutical Market 3.1. Regulatory Review: Marketing Approval for Medicines 3.2. Conclusion 4. Patent Protection for Pharmaceuticals 4.1. What Are Patents? 4.1.1. Brief History of Patent Law 4.1.2. Why We need Patents: Rationales of Patent Protection 4.2. Research and Development 4.2.1. An Incentive to innovate? Neglected Diseases 4.3. Conclusion 5. Patents - Access: Interference? 6. Conclusion Part II. International Framework Chapter 3. A Human Right of Access to Medicines? 1. Introduction 2. The International Human Rights Framework 2.1. Brief History of the Concept of Human Rights 2.2. Civil & Political Rights vs. Economic, Social & Cultural Rights 2.3. The UN Human Rights Framework 3. The Human Right to Health: Introduction 3.1. Treaty Law: Article 12 ICESCR 3.1.1. The Principle of Non-Discrimination 3.1.2. Limitations 3.2. Soft Law: The Committee on Economic, Social and Cultural Rights 3.2.1. Scope of the Right to Health 3.2.2. States Parties' Obligations 3.3. Other Treaties protecting the Right to Health 3.4. Monitoring and Accountability 3.4.1. Violations of the Right to Health 3.4.2. Justiciability 3.4.3. Case Law 3.4.4. Conclusion 3.5. Special Rapporteur on the Right to Health 3.6. Conclusion: Is there a Right of Access to Essential Medicines within the Right to Health? 4. The Human Right to Life: Article 6 ICCPR 5. The Human Right to the Benefits of Science: Article 15 ICESCR 6. Access to Medicines under Customary International Law 6.1. The International Bill of Rights 6.2. A Customary Right of Access to Medicines? 7. Conclusion: A Human Right of Access to Medicines? Chapter 4. The TRIPS Agreement: Patent Protection for Pharmaceuticals 1. Introduction 2. The World Trade Organization 2.1. Negotiation Process of the TRIPS Agreement 2.2. Dispute Settlement. 3. The Agreement on Trade-Related Aspects of Intellectual Property Rights 3.1. General Provisions and Basic Principles 3.2. Objectives and Principles 3.3. Transitional Arrangements 3.4. Patents 3.4.1. Article 27 TRIPS: Patentable Subject Matter 3.4.2. Article 28: Rights Conferred 3.4.3. Article 33 TRIPS: Patent Term 3.4.4. Articles 30 & 31 TRIPS: Exceptions 3.4.5. Article 32 TRIPS: Revocation 3.5. Protection of Undisclosed Information 3.6. Enforcement of Intellectual Property Rights 4. Conclusion Chapter 5.The Interface between Patents and Human Rights in the Context of Access to Medicines 1. Introduction 2. ICESCR - TRIPS: Conflict? 2.1. Narrow Definition of Conflict: Inconsistent Obligations? 2.2. Broad Definition of Conflict: Tension? 3. How to Resolve the Tension? 4. The Principle of Human Rights Primacy 4.1. The Right to Health as a Superior Norm in International Law? 5. Harmonious Interpretation: The Principle of Systemic Integration 5.1. The Doha Declaration on the TRIPS Agreement and Public Health & Article 31bis TRIPS 5.2. WTO Dispute Settlement Mechanism: Interpreting TRIPS in Light of Human Rights Standards? 6. TRIPS-plus Developments 7. Conclusion Part III. Country Studies Chapter 6. Access to Medicines in South Africa 1. Introduction 2. HIV/AIDS and Access to Medicines 3. A Human Right of Access to Medicines? 3.1. The South African Constitution of 1996 3.2. Cases before the Constitutional Court 3.3. Conclusion 4. Patent Protection for Pharmaceuticals: Standards & Flexibilities 4.1. The Patents Act No. 57 of 1978 4.1.1. Patent standards 4.1.2. Exceptions 4.1.3. Conclusion 4.2. The Medicines and Related Substances Act No. 101 of 1965 4.2.1. Section 15C: Measures to Ensure the Supply of Affordable Medicines 4.2.2. Further Measures under the Medicines Act 4.2.3. Conclusion 4.3. The Competition Act No. 89 of 1998 4.3.1. Abuse of Dominance 4.3.2. Competition Cases 4.3.3. Conclusion 5. Conclusion: Striking a Balance? Chapter 7. Access to Medicines in India 1. Introduction 2. The Generic Pharmaceutical Industry and Access to Medicines 3. A Human Right of Access to Medicines? 3.1. The Indian Constitution of 1949 3.2. Cases before the Supreme Court 3.3. Conclusion 4. Patent Protection for Pharmaceuticals: Standards & Flexibilities 4.1. The Patents Act of 1970 4.1.1. Transitional Periods TRIPS 4.1.2. Patent Standards 4.1.3. Procedural Mechanisms: Opposition Proceedings & Revocation 4.1.4. Exceptions 4.2. Conclusion 5. TRIPS-plus Developments 6. Conclusion Chapter 8. Access to Medicines in Uganda 1. Introduction 2. Least-Developed Countries and Access to Medicines 3. A Human Right of Access to Medicines? 3.1. The Ugandan Constitution of 1995 3.2. Health Legislation and Policy 3.3. Conclusion 4. Patent Protection for Pharmaceuticals: Standards & Flexibilities 4.1. The Patents Act of 1993 4.2. Uganda's Law Reform: The Draft Industrial Property Bill of 2009 4.2.1. Patent standards 4.2.2. Exceptions 4.3. Conclusion 5. Conclusion Chapter 9. Findings, Conclusions and Recommendations 1. Patents - Access: Interference 2. A Human Right of Access to (Essential) Medicines 3. TRIPS Minimum Standards for Patent Protection 4. The Interface between Patents and Access: Tension? 5. Striking a Balance 6. Conclusion & Recommendations Bibliography Curriculum Vitae
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