The Medicines Patent Pool was created in response to the threat that crucial sources of affordable HIV medicines were drying up, while the need for innovative, inexpensive and quality HIV treatment continues to rise. The international community made a commitment to see 15 million people on HIV treatment by 2015. But to reach that goal, sources of affordable, appropriate HIV medicines must be expanded.
Why a Medicines Patent Pool?
Affordable HIV medicines allow millions of people around the world to lead longer, healthier lives. But key sources of these medicines are at risk, even as the need for them increases.
A global commitment to stopping the HIV epidemic has so far given 8 million people living with HIV in the developing world access to life-saving medicines. But despite this success, there is still a long way to go: Less than half of those who need HIV treatment have it, and even those on antiretroviral therapy are often using out-dated regimens that are no longer in line with the World Health Organization’s guidelines. HIV medicines gradually become less effective over time because people develop resistance, and will need continued access to newer drugs to survive in the long run. And many medicines are not adapted for use in developing country contexts – there is a need in particular for medicines to treat children living with HIV. [Read more about HIV/AIDS needs].
Even as the need for treatment becomes more urgent, funding for programmes that provide this treatment is stagnating or decreasing.
And treatment costs are rising as people need to move towards the better, but pricier, medicines now recommended by the WHO. Newer medicines are more expensive in part due to a changing international patent landscape. When a medicine is patented in a specific country, it prevents anyone but the patent holder from producing and selling it, usually for a patent term of 20 years. This creates a monopoly situation, where it is possible to charge the highest price for medicines that a market can bear because there are no competitors. People who can not afford such prices – particularly those who live in developing countries – are left empty-handed.
A World Health Organization action plan [pdf] that looks at the relationship between patents and access to medicines, suggested patent pools as one way to address the lack of access to affordable and adapted medicines in developing countries. The Medicines Patent Pool itself has been endorsed by the international community as a transparent, responsible way to increase access to medicines in the developing world at the UN General Assembly Special Session on HIV, the World Health Organization World Health Assembly, and at the Group of 8.
The Pool aims to ensure that the appropriately formulated medicines that are so desperately needed around the world will be available at affordable prices. Generic competition is key to how the Pool works.
Generic Competition Increases Access To Medicines
Ten years ago, access to HIV drugs was for many an unobtainable dream: At $10,000 per person per year, it was just too expensive. Generic competition brought the price down more than 99% – and brought medicines to 8 million people.
Until recently, patents for pharmaceutical products did not exist in many developing countries, including those with significant capacity to manufacture medicines. This allowed generic versions of medicines patented elsewhere to be produced and sold at a fraction of the prices charged in wealthy countries. The same HIV treatment regimen that cost US$10,000 per person per year in 2000 dropped precipitously in price by more than 99% to less than $70 in some countries because of robust competition among generic manufacturers, primarily in India.
Affordable HIV medicines produced in India are a key reason why 8 million people in developing countries now receive AIDS treatment, earning India the moniker ‘pharmacy of the developing world.’ In particular, Indian manufacturers were among the first to pioneer the ‘fixed-dose combination’ (FDC)for HIV medicines, whereby two or more medicines are combined into one pill, simplifying treatment for patients and medical staff alike and improving people’s ability to adhere to their treatment.
The drop in treatment prices directly correlated with increasing numbers of people in developing countries gaining access to antiretroviral treatment for the first time, aided by a renewed global commitment to providing treatment in the form of organisations like UNITAID, the Global Fund, and the US President’s Emergency Plan for AIDS Relief (PEPFAR).
Generic Competition & Treatment Access
in Lower- and Middle-Income Countries (LMICs)
Global patenting’s impact on access to medicines
New patent laws being enacted as a result of the World Trade Organization have meant that new HIV medicines are increasingly subject to monopolies in key generic-producing countries. This means the price of recommended treatments is rising, putting them out of reach of many people living with HIV who need them.
The World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights ( TRIPS) that was agreed in 1994 required key producing countries, and other developing countries, to begin granting pharmaceutical patents. The subsequent Doha Declaration on TRIPS and Public Health, agreed by governments at the 2001 WTO meeting in Doha, Qatar, clarified that patents should not stand in the way of ensuring people can access the medicines they need. It outlined several safeguards countries can use to ensure this, which include ‘compulsory licences’, and designing patent laws that put public health concerns first.
Nevertheless, newer medicines – which are needed to treat HIV/AIDS because of side effects and drug resistance that develops inevitably over time – are increasingly being patented in developing countries, including those countries that have been significant producers of low-cost medicines, such as India. This means that newer medicines will not be able to be produced as more affordable generics – much less as fixed-dose combinations – keeping prices high and medicines once again out of the hands of the people who need them.
How the Medicines Patent Pool can help
The Medicines Patent Pool can help by facilitating generic production, even where there are patent barriers.
Patents on newer medicines in countries with generic production capacity may block manufacturers of generic drugs from developing more affordable versions of newer medicines, and/or combining such products into new FDCs. In addition, patents in countries where the medicines are needed can form a barrier to access.
The Medicines Patent Pool is one way to address the challenges of access to affordable medicines in developing countries in the face of changing laws on patents.
The Pool focuses on helping get adapted and affordable HIV medicines to people living with HIV long before the 20-year patent terms run out, by providing a ‘one-stop shop’ voluntary licensing service to patent holders and interested producers. It will provide a win-win-win situation for all parties involved: patent holders get royalties on the sales of resulting generic medicines; generic manufacturers get access to broader markets; and people living with HIV can benefit from access to the adapted, affordable and safe medicines they need to survive.
How the Medicines Patent Pool came about
The Pool was formed in July 2010, but the idea was proposed by civil society groups many years earlier.
At the International AIDS Conference in Barcelona in 2002, the Consumer Project on Technology (now Knowledge Ecology International – KEI) first proposed an ‘Essential Health Care Patent Pool’ modeled on a patent pool that was created by U.S. aircraft manufacturers during the First World War. In 2006, together with Médecins Sans Frontières, KEI proposed a patent pool for medicines to UNITAID. Patent pools were discussed by the World Health Assembly in 2008 (and referenced in the WHO Global Strategy on Public Health, Innovation and Intellectual Property [pdf]) and considered a feasible mechanism to accelerate the availability of low-cost newer medicines in developing countries. In July 2008, UNITAID’s board decided to explore the possibility of establishing a voluntary patent pool for medicines, and in December 2009 agreed to create the Medicines Patent Pool as a separate entity, which would focus on increasing access to HIV medicines in developing countries. UNITAID is providing the funding for the Pool under a five-year Memorandum of Understanding, and maintains a strategic partnership with the Pool that helps guide its work.
For more information on how the Pool works, click here