The Medicines Patent Pool Stimulating Innovation, Improving Access Ellen ‘t Hoen UN High Level Meeting on HIV/AIDS New York, 9 June 2011

Why do we need A patent pool for HIV medicines?

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)

Generic Competition & Treatment Scale-Up $10,400 $2700

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

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

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.

ARVs as proportion of total treatment costs* *Based on 2009 weighted average costs across LMICs. Data from Schwartländer et al. May 2011.

List of Missing ARVs Avail: http://www.who.int/selection_medicines/committees/expert/18/policy/Missing_HIV_formulations.pdf

The Medicines Patent Pool

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

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

Progress to date

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

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

THANK YOU www.medicinespatentpool.org