millions are waiting for life-saving

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1 Updated May 2013 millions are waiting for life-saving HIV treatment. How can we deliver? advancing innovation, access, and public health ( 1 ) medicines patent pool

2 Right now, millions of people living with HIV are not getting the treatment they need: > By end 2011, 8 million people in developing countries were on treatment, but many were on medicines no longer recommended by the World Health Organization > Nearly 7 million people still lacked access to the medicines they need to survive > 330,000 children contracted HIV in Overall, there are 3.4 million children living with HIV worldwide, but only 562,000 of them have access to medicines > Recent research has shown that early treatment not only extends lives but also prevents new infections meaning treatment is a tool to end the epidemic > Overall, 34.2 million people around the world live with HIV, and will all eventually need medicines To address the complex HIV treatment crisis, all stakeholders -- governments, civil society, people living with HIV, donors, intergovernmental agencies and pharmacuetical companies -- must work together to increase access to affordable treatment. affordable hiv medicines can help save lives Early products to treat HIV were not patented in many developing countries. This allowed low-cost producers to enter the market. Competition between producers lowered the price of early treatment from $10,000 per person per year in 2000 to less than $100 in some countries today, and helped 8 million people access HIV medicines. But some early products are no longer recommended by the World Health Organization. Newer, better-tolerated, easier-to-take regimens that are recommended by WHO are increasingly patented around the world. Patents are designed to reward innovation, but a patent can prevent production or sale of cheaper generic medicines in a country where they are needed unless there is a licence. Because many developing countries import medicines from elsewhere, an un-licensed patent in a key generic- producing country can mean higher prices in many countries where drugs are needed. New medicines for children and fixed-dose combinations (single pills comprised of several medicines that help people maintain the right treatment regimen) are critical to scaling up access. To promote the development of these medicines, and increase access to existing treatments, licences are needed to facilitate generic production. medicines patent pool ( 2 )

3 THE MEDICINES PATENT POOL IS A WIN-WIN SOLUTION The Medicines Patent Pool is a solution that works for public health and for pharmaceutical companies. Patent holders have a way to share their innovative products in resource-poor settings and may be compensated by a fair royalty. Generic pharmaceutical companies will more easily be able to produce affordable new medicines. THE MEDICINES PATENT POOL CAN HELP The Medicines Patent Pool negotiates licences for key HIV medicines patents. These licences allow HIV medicines manufacturers to produce low cost, quality HIV treatments suitable for use in developing countries, even where patents exist. This will increase access to needed medicines at affordable prices. The MPP was founded in 2010 at the request of the international community through the innovative financing mechanism UNITAID. The MPP has been endorsed by the World Health Organization, the UN High Level Meeting on AIDS, and the Group of 8 as a promising innovative approach to improve access to HIV medicines. Donors and developing country governments will be able to stretch their budgets farther to treat many more people. And, most importantly, people living with HIV will gain faster access to quality, life-saving treatments. MPP LICENCES ARE UNIQUE The Medicines Patent Pool aims to negotiate terms and conditions in its licences that will achieve maximum public health impact and strives to continuously reduce restrictions in the licences that could impact access to medicines. MPP licences are also unprecedented in transparency: the full text of all licences are posted on the MPP s website for anyone to read and comment on. ( 3 ) medicines patent pool

4 How it works: step-by-step PRIORITISE HIV MEDICINES based on analysis of medical needs and existence of patents INVITE RELEVANT PATENT HOLDERS to negotiate licences allowing others to develop adapted formulations, or sell generic versions of patented medicines in developing countries NEGOTIATE PUBLIC HEALTH-ORIENTED LICENCES with the goal of increasing access to medicines for all people living with HIV in developing countries SIGN AGREEMENTS licences go into the Medicines Patent Pool SUB-LICENsE to HIV medicines manufacturers to develop, produce and sell medicines in agreed countries under strict quality assurance BRING DOWN PRICES, ENSURE ACCESS once generic manufacture has begun, robust competition ensures lower prices, and people living with HIV in developing countries can access the affordable, adapted treatment they need at prices they can afford

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6 success so far Milestone-setting Licences The MPP has signed three licensing agreements with HIV medicines patent holders: MPP has sublicensed to several companies, both those with a track record of producing quality HIV medicines and new players to the HIV field. These sublicensees are already working to bring lower-cost HIV medicines to people in developing countries who need them. With Gilead Sciences, on 5 critical medicines to treat HIV; 3 of which were new drugs licensed while in development. With ViiV Healthcare [a joint venture of GlaxoSmithKline, Pfizer, and Shionogi] on medicines needed to treat HIV in children. On-going negotiations The value of the Medicines Patent Pool increases with every new licence it signs. The MPP is in on-going negotiations with key HIV medicines patent holders, including: And with the US National Institutes of Health, an important sign of support from the world s largest funder of biomedical research. Bristol-Myers Squibb, Boehringer-Ingelheim, Gilead, Roche and ViiV Healthcare. It also remains in discussions with AbbVie, Merck & Company, and Johnson & Johnson. Sublicensing for Access The MPP has also begun to sublicence to generic companies for the production of lower-cost medicines to sell in developing countries. m e d i c i n e s pat e n t p o o l (6)

7 INTERNATIONAL SUPPORT The Medicines Patent Pool for HIV/AIDS medications [is] considered to be the best hope for ensuring sustained access to new first-line treatments for the disease. The Access to Medicines Index 2012 I strongly urge other pharmaceutical companies, especially companies holding antiretroviral therapy patents, to join the Pool and help improve the lives of children and adults living with HIV around the world. Michel Sidibé, Executive Director of UNAIDS, 28 February 2013 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 licensing agreements. The World Health Organization Global Health Sector Strategy on HIV/ AIDS truly an innovative endeavor in facilitating access to HIV treatment in developing countries. It showcases the success of public-private partnerships to improve availability of medicine. Licensing Executive Society Industry-University-Government-Interface Sector Chair, Ida Shum, presenting a Deal of Distinction award to the MPP and its partners, October 2012 Sharing Expertise Reliable patent information can be hard to find, though it is essential to access to medicines work. MPP works with the World Intellectual Property Organization (WIPO) and national and regional patent offices to gather and publicise HIV patent information. The MPP s Patent Status Database is the world s largest open-access repository of this information, and has been called an essential impartial reference source by the Global Fund and an invaluable step towards furthering access to treatment by the United Nation s Children s Fund (UNICEF). It currently includes data for 71 patents on 25 HIV medicines, in 79 countries. ( 7 ) medicines patent pool

8 The Medicines Patent Pool expands access to innovative HIV medicines, at affordable prices, by: > clearing the path for the production of generic HIV medicines > fostering development of better-adapted formulations for developing countries, including medicines for children > sharing expertise on intellectual property and access to medicines Medicines Patent Pool MedicinesPatentPool.org The Medicines Patent Pool was established with the support of UNITAID. Learn more at