UNITAID The HIV/AIDS Medicines Patent Pool Initiative October 2010

Overview ► Background ► Policy Challenge ► What is a Patent Pool? ► Introduction: UNITAID & the Medicines Patent Pool

Source: MSF (2008) Untangling the Web of Antiretroviral Price Reductions. Geneva: MSF. Evolution of AIDS Drug Prices:

Number of people receiving antiretroviral therapy in low- and middle countries, Source: WHO, UNAIDS, UNICEF. (2009) Towards Universal Access: Scaling up priority HIV/AIDS interventions in the health sector. Progress Report Geneva: World Health Organization. Millions

The Policy Challenge ► Full implementation of global IP rules (WTO TRIPS Agreement) in key developing countries  new medicines increasingly patented in DCs ► Limited competition  impact on prices ► Financial crisis  squeezing budgets for medicines

Product+/- Expiry date Atazanavir (BMS)2017 Darunavir (Tibotec)2023 Etravirine (Tibotec)2019 Fosamprenavir (GSK)2018 Raltegravir (MSD)2025 Ritonavir hs (Abbott)2024 Tenofovir DF (Gilead)2018 Maraviroc (Pfizer)2019 Patents on New ARVs

Price comparison of first-lines, second-lines and possible third-lines Source: First-lineSecond-linePossible third-line

What is a Patent Pool? Portfolio of patents and other relevant intellectual property held by various actors made available on a non-exclusive basis to third parties against the payment of royalties.  Patent Pools come in different shapes and forms and are set up for different purposes  While we have learned from existing 'standards' pools, the Medicines Patent Pool is quite different

UNITAID Founded in 2006 by Brazil, Chile, France, Norway, and UK; today 29 countries & Gates Foundation Innovative financing: small air ticket levy Raised ~ 1.5 billion USD Innovative spending: market-based tools to expand access to quality medicines for HIV/AIDS, TB and Malaria e.g. stimulating higher volumes of production by guaranteeing a market for pharmaceutical manufacturers promoting competition among producers; thereby lowering prices of quality health commodities Home of the Patent Pool Initiative  2010 Medicines Patent Pool

History of Medicines Patent Pool CIPIH 2006 recommendation: "Patent pools of upstream technologies may be useful in some circumstances to promote innovation relevant to developing countries.” and proposed to UNITAID to set up a medicines patent pool. Broad stakeholder consultation Developed the implementation plan for the medicines patent pool Ongoing dialogue with patent holders and with other ARV drug manufacturers Decision by UNITAID Board to fund May 2008 WHO Global Strategy and Plan of Action included Voluntary Patent Pools July 2008 UNITAID Executive Board Supports the principle of establishing a patent pool and requests the secretariat to undertake all necessary actions for this establishment. Establishment of the Medicines Patent Pool Formal licensing negotiations can begin

13 Guiding Principles of the Medicines Patent Pool Public health driven Antiretroviral initial focus Voluntary Developing country focus (low & middle income) Price reductions Enable product development Flexible Quality assurance Standardized licenses Non discriminatory licenses Additional / complementary to existing mechanisms Operate within current intellectual property framework Independent entity

A successful patent pool will…  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

Pool Generic Royalties Patent Royalties

Priority ARVs Initial list of 19 products identified for Implementation Plan Possible FDCs and pediatric formulations to be targeted by the Pool identified by WHO Expert Committee on Essential Medicines Further work is being undertaken with expert group to refine priorities

Support for the Patent Pool "Pharmaceutical companies and other patent holders should sign up to the UNITAID patent pool to enable new fixed dose combinations (FDCs) and paediatric versions of HIV drugs, in return for a fair royalty on their patents" The UK All-Party parliamentary Group on AIDS (July 2009) "The European Parliament: (…) Calls on the Commission, the Council and the Member States of the EU to recognise the need for the UNITAID patent pool to ensure availability and affordability of HIV medicines for developing countries and to actively support the UNITAID HIV patent pool" Declaration of the European Parliament (Feb 2010) "This voluntary scheme provides an opportunity to improve access to affordable medicines, but its success will depend on the willingness of both patent holders (to put their patents into the pool) and generic manufacturers (to pay royalties, use the patents and adapt the medicines)." The UN MDG Gap Task Force Report 2009 "One promising initiative that can help decrease the cost of patents for the Index Countries is the patent pool initiative of UNITAID. " ATM Index 2010 (Engagement with PP included as one of the issues measured in the Index) "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, UNAIDS Executive Director (July 2010)

NIH Jumps In Sept 2010: NIH becomes first to license patents to the Pool Research by NIH National Cancer Institute and University of Illinois-Chicago (1999) Patents on protease inhibitors, including darunavir License text is publicly available License to benefit all low- and middle-income countries Royalty-free License not enough to clear legal path to generic production All HIV/AIDS medicine patent-holders invited to share their patents with the Pool (universities, public research institutions, companies) NIH and Pool discussing additional licenses

“This license 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.” -- NIH Director Francis S. Collins, M.D., Ph.D. “Kudos to the National Institutes of Health (NIH) for being the first in the world to share patents with the newly established Medicines Patent Pool! ….As a global leader in research and development, the United States has an important catalyzing role to play in promoting voluntary mechanisms that will increase competition to provide innovative, affordable health technologies to people in low- and middle-income countries.” --The White House, Office of Science & Technology Policy

Yes, if:  Patent owners and generic manufacturers collaborate  Global health financing remains of sufficient levels to ensure the market  Political support remains strong Will it work? and because:  No one can absorb the human and financial cost of failure

Thank You UAEM