Access to Medicines

Jennifer Anna Sellin studied law at Maastricht University. In 2005 she obtained her bachelor in law and, in 2007, she obtained a master European Law School (cum laude) specialising in international and European law. During her studies she worked as a student-assistant for the Maastricht Centre for Human Rights (Maastricht University) and did an internship at FIAN International, a human rights NGO located in Heidelberg, Germany. In 2007 Jennifer started working at the Faculty of Law of Maastricht University as a PhD researcher with the Maastricht Centre for Human Rights. During her appointment she taught various courses at the Faculty of Law mainly in the field of international and European law. She completed her PhD thesis titled "Access to Medicines. The interface between patents and human rights. Does one size fit all?" in 2014 under supervision by Prof. Fons Coomans and Prof. Anselm Kamperman Sanders. In addition to her research and teaching, she was active as the vice-chairperson of the PhD Committee of the Law Faculty and ProVUM, the Maastricht University Ph.D. Association. Since September 2012 she works full-time as a lecturer with the department of international and European law of the Faculty of Law, Maastricht University. She teaches various courses in the field of international law and European at the Faculty of Law and Arts and Social Sciences (European Studies Programme) of Maastricht University and the Faculty of Law of the University of Hasselt. She has also taught the summer course "Law and Politics, Current Topics in the EU" at the Centre for European Studies, Maastricht.

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