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Understanding Patent Pools for Global Health: Assessing Their Value in Promoting

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Understanding Patent Pools for Global Health: Assessing Their Value in Promoting Understanding Patent Pools for Global Health: Assessing Their Value in Promoting Access to Essential Medicines by Ashley Eisenberg Duke Global Health Institute Duke University Date:_______________________ Approved: ___________________________ Randall Kramer, Co-Supervisor ___________________________ Anthony So, Co-Supervisor ___________________________ Jerome Reichman Thesis submitted in partial fulfillment of the requirements for the degree of Master of Science at the Duke Global Health Institute of Duke University 2014 ABSTRACT Understanding Patent Pools for Global Health: Assessing their Value in Promoting Access to Essential Medicines by Ashley Eisenberg Duke Global Health Institute Duke University Date:_______________________ Approved: ___________________________ Randall Kramer, Co-Supervisor ___________________________ Anthony So, Co-Supervisor ___________________________ Jerome Reichman An abstract of a thesis submitted in partial fulfillment of the requirements for the degree of Master of Science at the Duke Global Health Institute of Duke University 2014 Copyright by Ashley Eisenberg 2014 Abstract In response to a lack of access to essential medicines in the developing world, a number of mechanisms have developed that aim to promote greater access to essential medicines, particularly antiretroviral drugs for the treatment of HIV/AIDS and drugs for the treatment of neglected diseases. These mechanisms operate in a variety of different ways, but share a common theme in that they all ultimately aim to provide greater access to affordable drugs to patients in resource-poor settings. However, the existing mechanisms to facilitate increased access to essential medicines, while beneficial, all have a number of cons. Patent pools represent a novel approach to facilitating access to essential medicines and have the potential to go beyond the status quo as compared to various traditional alternatives. This paper aims to analyze patent pools recently formed in the field of global health and whether such approaches to intellectual property management can facilitate greater access to antiretroviral medicines for the treatment of HIV/AIDS and drugs for the treatment of neglected diseases in low- and middle-income countries, both in terms of fostering the developing of new drugs and increasing the affordability and availability of drugs current in the market. Two patent pools in particular⎯the Medicines Patent Pool and WIPO’s Re:Search Consortium⎯are evaluated and compared to existing mechanisms that aim to accomplish the same or similar goals. iv Dedication To all those living in low- and middle-income countries without access medical care, in hopes that the information presented in this thesis will increase awareness of your struggle. v Contents Abstract .......................................................................................................................................... iv List of Tables ................................................................................................................................. ix List of Figures ................................................................................................................................ x List of Abbreviations ................................................................................................................... xi Acknowledgements ................................................................................................................... xiii 1. Introduction ............................................................................................................................... 1 1.1 Access to Essential Medicines in the Developing World ............................................ 1 1.2 The Present HIV/AIDS Situation in LMICs .................................................................. 5 1.3 Neglected Disease Situation in LMICs .......................................................................... 8 2. IP Barriers to Access to Medicine ......................................................................................... 11 2.1 Overview of IP, TRIPS, and the Doha Declaration .................................................... 11 2.2 IP Barriers to ARVs ........................................................................................................ 16 2.2.1 India’s Role in Access to ARVs in LMICs .............................................................. 19 2.3 Barriers to ND Research ................................................................................................ 21 2.3.1 The Potential Role for India and other Emerging Economies in ND R&D ....... 24 3. Overview of Mechanisms to Facilitate Broader Access to Medicines ............................. 26 3.1 Facilitating Access to ARVs .......................................................................................... 26 3.2 Facilitating Access to ND Drugs .................................................................................. 27 3.3 Overview of Patent Pools for Global Health .............................................................. 28 3.3.1 Patent Pools Generally .............................................................................................. 28 vi 3.3.2 Patent Pools for Global Health ................................................................................ 29 4. Traditional Mechanisms that Facilitate Access to ARVs ................................................... 32 4.1 Voluntary Licensing ....................................................................................................... 32 4.2 Compulsory Licensing ................................................................................................... 36 4.2.1 Compulsory Licenses in Thailand .......................................................................... 39 4.3 Non-Assert Declarations ............................................................................................... 42 4.4 Drug Donations .............................................................................................................. 45 4.5 Tiered/Differential Pricing ............................................................................................ 48 5. The Medicines Patent Pool: A Novel Approach for Increasing Access to ARVs .......... 52 5.1 History and Overview of the MPP ............................................................................... 52 5.2 Theoretical Benefits of MPP .......................................................................................... 54 5.3 MPP Engagement ........................................................................................................... 57 6. Overview of Current MPP Licenses ..................................................................................... 59 6.1 NIH License ..................................................................................................................... 59 6.2 Gilead Sciences License ................................................................................................. 59 6.3 ViiV Healthcare License for Pediatric ABC ................................................................ 65 6.4 Roche Agreement ........................................................................................................... 69 6.5 Bristol-Myers Squibb License ....................................................................................... 72 6.6 ViiV Healthcare License for DTG for Adult and Pediatric Use and ABC for Adult Use .......................................................................................................................................... 76 7. Comparison of the MPP to Traditional Alternatives ......................................................... 82 8. Is the MPP better than the Alternatives? ............................................................................. 86 vii 9. R&D Efforts for NDs ............................................................................................................... 90 9.1 The ND R&D Landscape ............................................................................................... 90 9.2 ND R&D Collaborations ................................................................................................ 93 9.2.1 Product Development Partnerships ....................................................................... 93 9.2.2 Other ND R&D Collaborations ............................................................................... 98 10. WIPO Re:Search Consortium ............................................................................................ 100 10.1 History of WIPO Re:Search ....................................................................................... 100 10.2 Overview of Re:Search ............................................................................................... 102 10.3 Theoretical Benefits of Re:Search ............................................................................. 105 10.4 Re:Search so Far .......................................................................................................... 108 11. Does Re:Search Make a Positive Difference in Facilitating ND R&D? ........................ 111 12. Conclusion ............................................................................................................................ 113 Appendix A: Voluntary Licenses ............................................................................................ 115
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