Cover -- Half-title -- Series-title -- Title -- Copyright -- Contents -- Contributors -- Editors -- Other Contributors -- Series Editors' Preface -- Editors' Preface -- Introduction: Access to essential medicines: public health and international law -- 1. Prologue -- 2. Connecting public and international law -- 3. The international institutions -- 3.1 The World Trade Organization -- 3.2 World Intellectual Property Organization -- 3.3 The World Health Organization -- 4. Structure of the volume -- 4.1 International trade -- 4.2 Innovation -- 4.3 Intellectual property -- 4.4 Healthcare -- 5. Conclusion -- Part I International trade -- 1 TRIPS and essential medicines: must one size fit all? Making the WTO responsive to the global health crisis -- 1. Introduction -- 2. TRIPS: substantive standards and their interpretation -- 3. Reconceptualizing TRIPS -- 4. Conclusion -- 2 The TRIPS Waiver as a recognition of public health concerns in the WTO -- 1. Introduction -- 2. The need for reform of the TRIPS Agreement -- 2.1 Objectives and principles of the TRIPS Agreement -- 2.2 Transitional access to generic medicines for developing countries -- 2.3 Ongoing exceptions for all members: articles 30 and 31 -- 3. Transitional solution: the interim waiver -- 3.1 Declaration on the TRIPS Agreement and public health -- 3.2 Decision implementing paragraph 6 of the Doha Declaration -- 3.3 Legal status of the Doha Declaration and the WTO General Council Decision of 30 August 2003 -- 3.4 The Chairman's statement and article 31(b) -- 4. Permanent solution: a formal amendment -- 5. The waiver in practice -- 6. FTAs and regional patents promoted for developing countries -- 7. Conclusion -- 3 Public law challenges to the regulation of pharmaceutical patents in the US bilateral free trade agreements -- 1. Introduction -- 2. The status of US bilateral trade agreements.

3. Three challenges of US bilateral trade agreements -- 3.1. Democratic deficit -- 3.2. Normative fragmentation -- 3.3. Regulatory failure -- 4. Public law perspective to the bilateral trade regulation of essential medicines -- 4.1. Legitimacy of TRIPS-Plus agreements -- 4.2. Input legitimacy -- 4.3. Output legitimacy -- 5. Conclusion -- 4 Global health and development: patents and public interest -- 1. Introduction -- 2. Role of the patent system -- 3. TRIPS Agreement: a tilt in global intellectual property rules towards developed countries -- 4. Development issues: WIPO Development Agenda: a step towards rebalancing the system -- 4.1 WIPO Development Agenda -- 5. Public interests: public health and access to medicine -- 5.1 Some observations on selected avenues of reform -- 5.2 Off-patent drugs -- 5.3 Patented drugs -- 5.3.1 Competition from generics -- 5.3.2 Parallel imports -- 5.3.3 Compulsory licensing -- 5.3.4 Consensual licensing: good corporate citizenship -- 5.3.5 Limiting patentability -- 6. Incentives for R&D: 'Third World/neglected' diseases -- 7. Conclusion -- Part II Innovation -- 5 The Health Impact Fund: better pharmaceutical innovations at much lower prices -- 1. Introduction -- 2. The problem -- 3. Reasoning -- 4. Solution -- 5. Conclusion -- 6 The Health Impact Fund: a critique -- 1. Introduction -- 2. The HIF: a short description -- 3. Concerns and criticisms -- 3.1 Justification of the HIF -- 3.1.1 Theoretical -- 3.1.2 Practical -- 3.2 The appropriateness of the HIF's eligibility rules -- 3.2.1 National patent criteria -- 3.2.2 The merits of insisting on any form of patent protection -- 3.2.3 An alternative eligibility threshold -- 3.3 The appropriateness of the scope of the HIF privilege -- 3.3.1 Duration -- 3.3.2 The calculation of the drug's permissible sale price -- 3.3.3 The calculation of a drug's health impact.

3.3.4 Residual rights at the conclusion of the HIF period -- 3.4 Securing compliance with the objectives of HIF -- 3.4.1 Dispute resolution -- 3.4.2 Reduced litigiousness -- 3.4.3 Compulsory licences as a response to non-compliance -- 3.5 Is there a better alternative to the HIF? -- 4. Conclusion -- 7 A prize system as a partial solution to the health crisis in the developing world -- 1. Introduction -- 2. Opportunities and hazards -- 3. Optimal design -- 3.1 Increased returns from other drugs -- 3.2 Mimicking the patent system -- 3.3 Fixed pot -- 3.4 Rewards for health benefits -- 8 Innovation and insufficient evidence: the case for a WTO-WHO Agreement on Health Technology Safety and Cost-Effectiveness Evaluation -- 1. Introduction -- 2. The WTO SPS Agreement and scientific assessment of evidence about public health impacts of trade -- 3. Pharmaceutical patents as private rights not monopoly privileges: United States origins -- 4. Pharmaceutical patents, market fundamentalism and the WTO -- 5. Bilateral trade agreements and their impact on pharmaceutical cost-effectiveness regulation -- 6. Increased support in trade agreements for health technology costffectiveness systems -- 7. Towards a WTO-WHO HSCE Agreement -- 8. Beyond the obstacles to a WTO-WHO HSCE Agreement -- Part III Intellectual property -- 9 Opening the dam: patent pools, innovation and access to essential medicines -- 1. Introduction -- 2. Patent pools and the global health crisis -- 2.1 The essential features of patent pools -- 2.2 Proposals for humanitarian patent pools for access to essential medicines -- 3. The growth of patent pools as a method of intellectual property aggregation -- 3.1 A potted history -- 3.1.1 Mandated pools -- 3.1.2 Other 'delivery' phase pools -- 3.1.3 Pools for standardization -- 3.2 Patent pools for humanitarian purposes -- 3.2.1 Delivery Phase - Golden Rice.

3.2.2 Delivery phase - HIV/AIDS -- 3.2.3 Discovery phase - SARS -- 3.2.4 Discovery through to delivery - vaccines for influenza, malaria and other pandemics -- 4. Benefits and costs of patent pooling -- 4.1 The benefits of patent pooling -- 4.2 Costs of patent pools -- 4.2.1 Return on investment -- 4.2.2 Patent pools and competition law -- 4.3 Balancing the benefits and risks -- 5. Conclusion: are patent pools really a solution to the conundrum? -- 10 Open Source drug discovery: a revolutionary paradigm or a Utopian model? -- 1. Introduction -- 2. Intellectual property rights, innovation and access to drugs: issues and initiatives -- 3. Organizing OSDD -- 3.1 Scientific commons -- 3.2 Open access drug companies -- 3.3 Open Source consortia -- 3.4 Product Development Partnerships -- 4. OSDD and other initiatives and proposals: synergies and problems -- 5. Conclusion -- 11 Accessing and benefit sharing avian influenza viruses through the World Health Organization: a CBD and TRIPS compromise thanks to Indonesia's sovereignty claim? -- 1. Introduction -- 2. Influenza as a CBD 'genetic resource' -- 3. The CBD and TRIPS context -- 4. CBD's framework for access and benefit sharing -- 5. TRIPS framework's effect on access and benefit sharing -- 6. WHO and avian influenza -- 7. WHO compromise arrangement -- 8. Discussion -- 12 The Lazarus Effect: the (RED) Campaign and creative capitalism -- 1. Introduction -- 2. The (RED) Campaign -- 2.1 The marketing of the (RED) Campaign -- 2.2 A critique of the (RED) Campaign -- 3. The Gates Foundation and 'creative capitalism' -- 3.1 The credos of 'creative capitalism' -- 3.2 A critique of 'creative capitalism' -- 4. The Clinton Foundation and the philosophy of 'giving' -- 4.1 The charity of the Clinton Foundation -- 4.2 A critique of 'giving' -- 5. Redwashing: conclusion -- Part IV Healthcare.

13 Beyond TRIPS: the role of non-state. actors and access to essential medicines -- 1. Introduction -- 2. Absent at the inception -- 3. Advocacy through proxies -- 4. Imagining alternatives -- 5. Conclusion -- 14 Securing health through rights -- 1. Introduction -- 2. Health rights praxis: the points of departure -- 3. Health rights praxis: two examples -- 3.1 South Africa: the Pharmaceutical Manufacturers' Association litigation -- 3.2 Ghana: the case against user fees -- 4. Conclusions: lessons from praxis -- 15 The role of national laws in reconciling constitutional right to health with TRIPS obligations:an examination of the Glivec patent case in India -- 1. Introduction -- 2. Patent laws in India -- 3. The Glivec battle in India: a case study -- 3.1 Patent claim by Novartis -- 3.2 The Novartis challenge -- 4. The Glivec case from a larger perspective -- 5. Conclusion -- 16 Tipping point: Thai compulsory licences redefine essential medicines debate -- 1. Introduction -- 1.1 The dispute -- 1.2 Essential medicines background -- 1.3 Framework for analysis -- 2. The Thai dispute: constructing the conversation -- 2.1 Legal requirements under TRIPS -- 2.2 Justifying the 'legal': TRIPS-Minimums or TRIPS-Plus? -- 3. New normative boundaries for access to essential medicines disputes -- 3.1 Identifying new normative boundaries -- 3.1.1 Brackish water: 'national emergency' and 'public non-commercial' requirements co-mingle -- 3.1.2 'Due process' in a public health emergency? Separating the demands of pragmatism and rhetoric -- 3.1.3. Defining 'essential medicines': both sides push the limits -- 3.1.4 Normative precedents as subsequent state practice affecting treaty interpretation -- 3.2 Reflections from/on article 31bis -- 3.3 TRIPS-Minimum or TRIPS-Plus reconsidered -- 4. Beyond TRIPS: the politics of access to essential medicines disputes.

4.1 Political will as currency.