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Stimulating Innovation, Improving Access

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The Medicines Patent Pool Presentation during the session "Market Interventions for Innovation and Access", UN High Level Meeting on HIV/AIDS …

The Medicines Patent Pool Presentation during the session "Market Interventions for Innovation and Access", UN High Level Meeting on HIV/AIDS
New York, 9 June 2011

Published in: Health & Medicine

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  • 1. The Medicines Patent Pool Stimulating Innovation, Improving Access Ellen ‘t Hoen UN High Level Meeting on HIV/AIDS New York, 9 June 2011
  • 2. Why do we need A patent pool for HIV medicines?
  • 3.
    • Growing HIV Treatment Needs
    • Generic competition central to treatment scale-up of past decade
    • Generic competition threatened by increased patenting in developing countries
    • Financial crisis  Budgets for HIV medicines flat
    • Important formulations often not developed: 16 missing adult, 18 missing pediatric formulations
    The Context
  • 4. Progress in access to HIV medicines, but significant unmet need
    • > 6 million people in developing countries on ART by end of 2009
    • +10 million people in need not yet accessing treatment
    • At least +18 million people will need treatment
    • 2009:
      • 1.2 million new people on treatment
      • 2.6 million new infections
    • ART = 96% reduction in HIV transmission to partner
    Source: World Health Organization. Towards universal access: Scaling up priority HIV/AIDS interventions in the health sector. http://www.who.int/hiv/pub/2010progressreport/summary_en.pdf
  • 5. Numbers of PLHIV on ART will Rise Source: UNAIDS Investment Framework - preliminary data. 2011 ART estimates: 2010: 6 million persons 80-90% drugs generic By 2015: 13 million (double 2010 levels) By 2020: 18.7 million (triple 2010 levels)
  • 6.
    • Growing HIV Treatment Needs
    • Generic competition central to treatment scale-up of past decade
    • Generic competition threatened by increased patenting in developing countries
    • Financial crisis  Budgets for HIV medicines flat
    • Important formulations often not developed: 16 missing adult, 18 missing pediatric formulations
    The Context
  • 7. Generic Competition & Treatment Scale-Up $10,400 $2700
  • 8.
    • Growing HIV Treatment Needs
    • Generic competition central to treatment scale-up of past decade
    • Generic competition threatened by increased patenting in developing countries
    • Financial crisis  Budgets for HIV medicines flat
    • Important formulations often not developed: 16 missing adult, 18 missing pediatric formulations
    The Context
  • 9. Changing ARV Patent Landscape 2011 1985     1990       1995       2000       2005       2010       2015       2020       2025     2030   TRIPS Transition for Developing Countries                                                     TRIPS Transition for Least Developed Countries                                   Zidovudine     Didanosine     Stavudine     Saquinavir     Nevirapine     Abacavir     Emtricitabine     Indinavir                 Efavirenz                                   1985     1990       1995       2000       2005       2010       2015       2020       2025     2030   `                   Lopinavir                             Atazanavir     Tenofovir DF     Fosamprenavir     Maraviroc     Etravirine     Rilpivirine     Darunavir     Elvitegravir     Heat-stable ritonavir     Raltegravir     Dolutegravir     Cobicistat                                             SPI-452       1985     1990       1995       2000       2005       2010       2015       2020       2025     2030
  • 10. More recent ARVs Reported prices for Darunavir (US$ per person per year) across HIV grants 1,095$ offered by patent holder to Sub-Saharan Africa and LDCs Source: The Global Fund to Fight AIDS, TB and Malaria, May 2011
  • 11.
    • Growing HIV Treatment Needs
    • Generic competition central to treatment scale-up of past decade
    • Generic competition threatened by increased patenting in developing countries
    • Financial crisis  Budgets for HIV medicines flat
    • Important formulations often not developed: 16 missing adult, 18 missing pediatric formulations
    The Context
  • 12. Trends in G8/EC & Other Donor Government HIV/AIDS Assistance, 2002-2009 In Billions Commitments (Enacted Amounts) Disbursements Sources: UNAIDS and Kaiser Family Foundation analyses; Global Fund to Fight AIDS, Tuberculosis and Malaria online data queries; UNITAID Annual Report, 2009; OECD CRS online data queries; UNAIDS, PCB(13)/02.5, 28 November 2002; UNAIDS, PCB(14)/03 Conference Paper 2a, 25 June 2003.
  • 13. ARVs as proportion of total treatment costs* *Based on 2009 weighted average costs across LMICs. Data from Schwartländer et al. May 2011.
  • 14.
    • Growing HIV Treatment Needs
    • Generic competition central to treatment scale-up of past decade
    • Generic competition threatened by increased patenting in developing countries
    • Financial crisis  Budgets for HIV medicines flat
    • Important formulations often not developed: 16 missing adult, 18 missing pediatric formulations
    The Context
  • 15. List of Missing ARVs Avail: http://www.who.int/selection_medicines/committees/expert/18/policy/Missing_HIV_formulations.pdf
  • 16. The Medicines Patent Pool
  • 17. The Medicines Patent Pool Public Health Vision Medicines Patent Pool Mission To improve access to appropriate affordable HIV treatments in developing countries The patent pool will bring down the prices of HIV drugs, facilitate the development and production of improved formulations (e.g., fixed dose combinations and paediatric and heat-stable formulations) by providing access to intellectual property relating to these products Established with the support of in July 2010
  • 18. Three Main Objectives
      • Enable the development of fixed dose combinations (FDCs) of which the patents are held by different entities
      • Enable the development of adapted formulations for children or for specific developing country needs (e.g., heat stable)
      • Accelerate the availability of generic versions of new ARVs in developing countries
  • 19. How the Pool Works Royalties Royalties Patents Patents Patents Patents Patents Licensor Licensor Licensor Licensor Licensor Pool Sub-Licensee Sub-Licensee Sub-Licensee Sub-Licensee Sub-Licensee Sub-Licensee Sub-Licensee
  • 20. The Global Market for ARVs
    • Developing countries represent a small proportion (6%) of the total global ARV market (~$14 billion in 2009)
    • But the majority of people on treatment globally (92% of ~7 million) and in need of treatment
    • High-volume, low-price, low-margin business model
    2009 Global ARV Sales 2010 Global ARV Volumes (person*years)
  • 21. Progress to date
  • 22. Patent Holder Engagement Patent Holder Q4 2010 Q1 2011 Abbott Laboratories Sent letter on 1 December Not currently in negotiations. Reply received 26 January Boehringer-Ingelheim* Sent letter on 1 December Not currently in negotiations. Reply received 19 January Bristol-Myers Squibb* Sent letter on 1 December Not currently in negotiations. Reply received 26 January F. Hoffman-La Roche Sent letter on 1 December In negotiations Gilead Sciences Sent letter on 1 December In negotiations Merck & Co.* Sent letter on 1 December Not currently in negotiations. Reply received 28 January Sequoia Pharmaceuticals   In negotiations Tibotec/Johnson & Johnson* Sent letter on 1 December Not currently in negotiations. Reply received 31 January US National Institutes of Health Licence granted September In negotiations ViiV Healthcare Sent letter on 1 December In negotiations
  • 23. Support for the Medicines Patent Pool “ The Medicines Patent Pool is a means to enhance availability and facilitate the development of new fixed-dose combinations and adapted formulations, such as paediatric formulations, through voluntary licence agreements.” - H IV Strategy 2011-2015, approved by WHA May 2011 “ We urge all public institutions and pharmaceutical companies to follow the measures taken by the NIH, and to share without delay their patents on this and other antiretrovirals with the Medicines Patent Pool, in order to facilitate access to these treatments at the lowest possible price for countries in need. ” -Prof. Michel Kazatchkine, Executive Director "A successful patent pool will help in accelerating the scaling up of access to care and treatment and will reduce the risk of stock out of medicines in the developing world “ - Michel Sidibe, Executive Director, July 2010 “ We welcome the Patent Pool Initiative launched by UNITAID…and we invite the voluntary participation of patent owners, private and public, in the project.” –G8 Summit, Deauville, France, May 2011 The Medicines Patent Pool has potential to support access …We will encourage the pharmaceutical sector to engage actively with the Medicines Patent Pool to support the availability of more appropriate and affordable ARVs. –UK Position Paper on HIV, May 2011 “ This licence underlines the U.S. Government’s commitment to the Medicines Patent Pool and its goal to increase the availability of HIV medicines in developing countries. We are now discussing licensing to the Medicines Patent Pool other patents that could have a positive impact on the treatment of HIV/AIDS.” - Francis S. Collins, NIH Director, Sept 2010
  • 24. THANK YOU www.medicinespatentpool.org