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Medicines Patent Pool

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A presentation about the important work of the Medicines Patent Pool by Ethan Guillen.

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Medicines Patent Pool

  1. 1. The Medicines Patent Pool:Promoting innovation and access through public health-oriented licences Ethan Guillen February 2013
  2. 2. WHY DO WE NEED A PATENT POOL FORHIV MEDICINES?
  3. 3. The Context• Significant HIV treatment needs in developing countries• International commitment to treat 15 million people by 2015• Generic competition central to treatment scale-up of past decade• Newer HIV medicines widely patented in developing countries• Important formulations needed in developing countries often not developed or barriers to access
  4. 4. Despite recent progress in access to HIV medicines, there is still significant need for additional treatment • More than 8 million people in 40 developing countries on ART by end of 2011 35 30 • But further 6.8 million people are in Will Need Treatment urgent need of treatment as per WHO 25 guidelinesPLHIV (M) Needing Treatment 20 Receiving Treatment • Approximately 19.4 million more people are also HIV positive in 15 developing countries and will need 10 treatment 5 • 1.4 million new people on treatment in 2011 0 Dec. 2011 • New evidence shows huge benefits of early start for treatment Source: The Global AIDS Epidemic Fact Sheet, UNAIDS, July 2012
  5. 5. The Context• Significant HIV treatment needs in developing countries• International commitment to treat 15 million people by 2015• Generic competition central to treatment scale-up of past decade• Newer HIV medicines widely patented in developing countries• Important formulations needed in developing countries often not developed or barriers to access
  6. 6. UN Political Declaration (2011)“Commit to accelerate efforts to achieve the goal of universalaccess to antiretroviral treatment for those eligible based onWorld Health Organization HIV treatment guidelines… with thetarget of working towards having 15 million people living withHIV on antiretroviral treatment by 2015” UN Political Declaration on HIV/AIDS, 2011
  7. 7. The Context• Significant HIV treatment needs in developing countries• International commitment to treat 15 million people by 2015• Generic competition central to treatment scale-up of past decade• Newer HIV medicines widely patented in developing countries• Important formulations needed in developing countries often not developed or barriers to access
  8. 8. Generic Competition & Treatment Scale-Up$2700 $10,400 $800 7 Millions $700 6 $600 5 $500 4 $400 3 $300 2 $200 1 $100 $0 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 People in LMICs on treatment Lowest generic price first line ARV regimen Originator price of first-line ARVs
  9. 9. The Context• Significant HIV treatment needs in developing countries• International commitment to treat 15 million people by 2015• Generic competition central to treatment scale-up of past decade• Newer HIV medicines widely patented in developing countries• Important formulations needed in developing countries often not developed or barriers to access
  10. 10. New HIV medicines are more widely patented in m tna V ie tan ekis Uzb y gu a 1995 and later ARVs U ru a in e U kr Total number of product patents pending or granted, by jurisdiction, for older d ilan Tha an k is t Taji fric a th A S ou ka Lan S ri developing countries… si a Rus ne s ippi Phil u Per n is t a Pre-1995 ARVs Pak compounds (pre-1995) and newer compounds (post-1995)* ) am a ries Pan u nt 6 co I (1 OA P g ua ara N ic o oc c M or a g ol i M on i co M ex ia ays Mal stan gyz Kyr Source: Patent Status Database on Selected HIV Medicines (MPP) an Jord si a on e In d ia In d as dur Hon a la tem Gua ) pt ries Egy unt 9 co O( E AP b ia om C ol na C hi le C hi z il Bra ina ent A rg eria A lg e s) enia n t ri A rm c ou ( 18 PO e A RI si b l pos AL TOT 8 0 12 4
  11. 11. …and have many years left before expiry1985 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 Lamivudine Indinavir Efavirenz1985 1990 1995 2000 2005 2010 2015 2020 2025 2030 Darunavir Ritonavir ` Lopinavir Atazanavir Tenofovir DF Fosamprenavir Maraviroc Etravirine Rilpivirine Raltegravir Elvitegravir Dolutegravir Cobicistat SPI-4521985 1990 1995 2000 2005 2010 2015 2020 2025 2030
  12. 12. ARVs as proportion of total treatment costs* $2,500 $2,000 $1,500 ARV Non-drug cost of ART $1,000 $500 $- 1st line 2nd line*Based on 2009 weighted average costs across LMICs. Data from Schwartländer et al. May 2011.
  13. 13. The Context• Significant HIV treatment needs in developing countries• International commitment to treat 15 million people by 2015• Generic competition central to treatment scale-up of past decade• Newer HIV medicines widely patented in developing countries• Important formulations needed in developing countries often not developed or barriers to access
  14. 14. Fixed Dose Combinations (or “three-in-one pills”)• Analysis of patent-related challenges to the uptake of Fixed Dose Combinations (FDCs) undertaken for the Global Fund Market Dynamics and Commodities ad hoc Committee• Out of 10 recommended FDCs with at least one supplier, potential IP barriers to generic competition for 7 in at least one developing country (greater barriers for 3 FDCs)• All 6 FDCs known to be either in development, or having very recently obtained regulatory approval, appear to face patent barriers to generic competition in some developing country jurisdictions
  15. 15. THE MEDICINES PATENT POOL
  16. 16. Medicines Patent Pool Goal and Mission 16
  17. 17. The Medicines Patent Pool: An Innovative Licensing Mechanism for HIV 1. Enable generics versions of existing compounds 2. Promote Fixed-Dose Combinations 3. Facilitate development of adapted formulations (e.g. paediatrics) Established in July 2010 with the support of
  18. 18. The Pool is governed by the Board and the Expert Advisory Group Medicines Patent Pool Governance Board Charles Clift, Chair Bernard Pécoul Malebona Precious Matsoso Sigrun Møgedal Paulo TeixeiraExpert Advisory GroupMaximilliano Santa Cruz, Chair Labeeb Abboud Jonathan Berger Alexandra Calmy Shing Chang Carlos Correa Nelson Juma Otwoma Eun-Joo Min Lita Nelsen Achal Prabhala Gracia Violeta Ross Wim Vandevelde 18
  19. 19. The Global Market for ARVs 2009 Global ARV Sales 2010 Global ARV Volumes (person*years) 6% 8% 94% 92%• 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
  20. 20. How We Work Negotiate Prioritise HIV Invite relevant Public Health- Sign Sub-licence to medicines patent holders Oriented Agreements generics LicensesBased on analysis To negotiate The Pool seeks Licences go to And others, such asof medical licences allowing licences that push the Pool product developmentneeds, potential others to make and the status quo partnershipspatent barriers sell generic forward, with the (PDPs), who are then versions of aim of ensuring free to patented medicines access to develop, produce and in developing medicines for all sell medicines in countries, or people living with agreed countries under develop adapted HIV in developing strict quality formulations countries assurance. Pool staff work with sub- licensees on product development and regulatory approval.
  21. 21. Identification of Patent Status of HIV Medicines • Patent status data collected for 24 HIV compounds in 76 low and middle income countries with support of WIPO and national patent offices • Provided for the first time a clear understanding of what is patented where • Included in a searchable database on our website • Today: most complete single source of patent status data on HIV medicines. Widely used by public health actors.
  22. 22. PROGRESS TO DATE
  23. 23. Patent Holder StatusPatent Holder Q4 2010 Q1 2011 Q2 2011 Q3 2011 Q4 2011 Q1 2012 Q2 2012Abbott Sent letter on Not currently in Not currently in Not currently in Not currently in Not currently in Not currently inLaboratories 1 December negotiations. negotiations. negotiations negotiations negotiations negotiations Reply received 26 January.Boehringer- Sent letter on Not currently in Not currently in In negotiations. In negotiations. In negotiations. In negotiations.Ingelheim 1 December negotiations. negotiations. Reply received 19 January.Bristol-Myers Sent letter on Not currently in Not currently in In negotiations. In negotiations. In negotiations. In negotiations.Squibb 1 December negotiations. negotiations. Reply received 26 January.F. Hoffman-La Sent letter on Preparing for In negotiations. In negotiations. In negotiations. In negotiations. In negotiations.Roche 1 December negotiations.Gilead Sciences Sent letter on In negotiations. In negotiations. Licence agreement Licence agreement Licence agreement Licence agreement 1 December Reply received 14 signed July 2011. signed July 2011. signed July 2011. signed July 2011. February Amended in Amended in Amended in November 2011. November 2011. November 2011.Merck & Co. Sent letter on Not currently in Not currently in Not currently in Not currently in Not currently in Not currently in 1 December negotiations. negotiations. negotiations. negotiations. negotiations. negotiations. Reply received 28 January.Tibotec/J&J Sent letter on Not currently in Not currently in Not currently in Not currently in Not currently in Not currently in 1 December negotiations. negotiations. negotiations. negotiations. J&J’s negotiations. Pool negotiations. Reply received 31 decision received in responds to J&J’s January December. decision in January.US NIH Licence agreement In negotiations. In negotiations. In negotiations. In negotiations. In negotiations. In negotiations. signed Sept 2010.ViiV Healthcare Sent letter on In negotiations. In negotiations. In negotiations. In negotiations. In negotiations. In negotiations. 23(GSK/Pfizer) 1 December
  24. 24. Geographical Scope of Voluntary Licences160140120100 High-income (HIC) Upper-middle income (UMIC) 80 Lower-middle income (LMIC) 60 Low-income (LIC) 40 20 0
  25. 25. Core Principles for Pool Licences • Licenses are negotiated from a public health, pro-access perspective Patent • Licences are transparent - text of licences Holders Generics available on Pool website • Significant improvement on the pre- existing situation for as many people living with HIV as possible • Aim to include all low and middle income EAG Board countries, including through the use of differentiated royalties according to income and disease burden • Ensure that terms and conditions arePatent MedicinesHolders Generics consistent with the use of TRIPs Patent Pool flexibilities/Doha Declaration TRIPS and Public Health Consultative Process • Raise the bar for licensing in the HIV field • Manage licences with a public health focus • Work with partners to promote the development of needed formulations
  26. 26. Achievements so far…• Unprecedented transparency on what HIV medicines are patented in which countries• Higher standard on number of countries covered by licences (but still long way to go)• Recognition of importance of licensing compounds as early as possible (e.g. late-stage pipeline)• Opening up of the market for generic tenofovir (key first-line ARV) in a large number of middle-income countries• Right to supply countries issuing a compulsory licence included in licence (probably for first time)• Unprecedented transparency in disclosing full text of licence• Recognition of a new business model for ARV licensing, through an entity with a public health mandate 26
  27. 27. …but a long way to go• Successfully negotiating public-health oriented licences with key flexibilities from more patent holders; pushing geographic scope with aim of all developing countries• Contributing to opening up the markets for second-line and third-line ARVs• Enabling the development of new fixed dose combinations that meet treatment needs• Providing for greater diversification in manufacturing of ARVs (e.g. local production)• Continue to change industry norms towards greater public health focus in licensing practices 27
  28. 28. Supporting Statements “"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, UNAIDS, July 2010 “Encouraging the voluntary use, where appropriate, of new mechanisms such as partnerships, tiered pricing, open-source sharing of patents and patent pools benefiting all developing countries, including through entities such as the Medicines Patent Pool, to help reduce treatment costs and encourage development of new HIV treatment formulations, including HIV medicines and point-of-care diagnostics, in particular for children.” -UN General Assembly Political Declaration on HIV/AIDS “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 “Encourage the use of new mechanisms such as the UNITAID Medicines Patent Pool to help reduce treatment costs and promote the development of new treatment formulations, including paediatric formulations and fixed-dosePartnership Forum combinations.” – Sao Paulo Parliamentary Declaration on Access to Medicines and Other Pharmaceutical Products, Global Fund Partnership Forum, June 2011 I commend UNITAID for taking the initiative to establish the Medicines Patent Pool and commend the companies that are in negotiations with the Patent Pool -Margaret Chan, Director General of WHO, July 2011
  29. 29. Thank You!www.medicinespatentpool.org

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