The Medicines Patent Pool (MPP) was created to increase access to quality, appropriate, affordable medicines for people living with HIV in developing countries.
The MPP’s offers a public-health driven business model that facilitates the production of low-cost versions of existing medicines as well as the development of needed new formulations, such as “fixed-dose combinations” – one pill comprised of several medicines that increase treatment adherence – and formulations suitable for children.
It does this through voluntary licensing of key HIV medicines patents.
The MPP was formed at the request of the international community in 2010 through innovative financing mechanism UNITAID. It has been endorsed by the World Health Organization, the UN High Level Meeting on AIDS, and the Group of 8 as a promising approach to improve access to HIV medicines.
Why a Medicines Patent Pool is needed
Affordable HIV medicines allow millions of people around the world to lead longer, healthier lives. But millions more do not yet have access to affordable treatment. And new innovation is needed to ensure that the best medicines reach those who need them.
There are 26 million people eligible to receive HIV treatment now, according to the World Health Organization (WHO). But only 9.7 million currently have access, and many are on medicines no longer in line with WHO guidelines. There is also a need to adapt medicines for use in developing country contexts – such as fixed-dose combinations that simplify treatment regimens and increase treatment adherence, and medicines for children living with HIV.
The Medicines Patent Pool was founded to address this key challenge: the need to support further innovation, and simultaneously increase availability of existing medicines at affordable prices.
Solving the innovation and access problem
Supporting innovation and ensuring access requires finding ways to share patents.
Patents are designed to reward innovation and allow those who invent medicines to recoup the costs of research and development. But a patent can prevent production or sale of lower cost generic versions of needed medicines where it is in force – unless it is licensed, thereby granting permission to low cost medicines makers to manufacture and sell a patented medicine.
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 medicines are needed.
Following the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), HIV medicines are increasingly patented in developing countries (see the MPP’s Patent Status Database for details on what medicines are patented, and where). This means that WHO-recommended medicines could be priced out of reach of many people who need them, and could make it harder for medicines makers focused on developing country needs to make specialised formulations, such as medicines for children.
Sharing patents is a win-win solution. Through licences, patent holders have an effective way to share their innovative products in resource-poor settings and may be compensated by a fair royalty. Low-cost producers and product development partnerships will more easily be able to make affordable, adapted 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.
Robust market competition saves lives
At the turn of the Millennium, access to HIV drugs was for many an unobtainable dream: At $10,000 per person per year, it was just too expensive. Robust market competition brought the price down more than 99% to less than $70 in some countries – and brought medicines to 8 million people. This competition was possible because patents for pharmaceutical products did not exist in many developing countries, especially key producing countries.
Affordable and appropriate HIV medicines are a key reason why these 8 million people in developing countries now receive HIV treatment. In particular, low-cost manufacturers were among the first to pioneer the ‘fixed-dose combination’ (FDC) for HIV medicines, whereby multiple medicines are combined into one, affordable, pill, thus simplifying treatment. Low-cost versions of paediatric HIV treatments are also an important development because the vast majority of HIV positive children live in developing countries and financial incentives to develop treatments for them are comparatively low.
The drop in treatment prices directly correlates 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)
How it works
A step-by-step walkthrough of the MPP’s work:
The MPP develops a list of priority HIV medicines for inclusion in its pool based on medical needs of people living with HIV, and how widely needed treatments are patented.
Letters inviting relevant patent holders to enter negotiations to license to the MPP were sent on 1 December, 2010: World AIDS Day. So far, a majority of patent holders have answered positively. The status of the MPP’s interaction with relevant patent holders is tracked on the Company Engagement page.
Willing patent holders enter negotiations to licence to the MPP. This means that the patent holder allow other producers to manufacture and sell low-cost, quality versions of the patented medicine in developing countries, or develop adapted formulations, under certain terms and conditions. The MPP seeks licences that push the status quo in the direction of greater access to medicines — covering more countries and containing public-health oriented terms and conditions — with the ultimate aim of ensuring all people living with HIV in developing countries can access the treatment they need at affordable prices.
Before a licence is signed, it must be reviewed by the MPP’s Expert Advisory Group and Governance Board, which are made up of medical experts, experts in patent policy, and communities of people living with HIV. Once signed, all MPP licences are published in full on the MPP’s website. This represents an unprecedented level of transparency in a field where voluntary licences are negotiated in secret and kept that way.
Once licences are signed, generic manufacturers and other entities, such as product development initiatives, can obtain a sub-licence. The manufacturer is then free to develop, produce and sell the medicine in the agreed countries under strict quality assurance. The MPP will particularly ease the development and production of ‘fixed-dose combination’ drugs (FDCs) that have proven to simplify treatment for people living with HIV and facilitate treatment scale-up in developing countries, and medicines suited for the specific needs of children.
Once a sub-licence is signed, licence management is undertaken to ensure licences result in increased access to medicines. MPP staff work with sub-licensees on product development, regulatory approval, and technology transfer. Quality assurance is important to the MPP, and we work with mechanisms like the World Health Organization Prequalification of Medicines Programme [pdf] to ensure the quality, safety and efficacy of medicines made using MPP licences.
Once production has begun, robust market competition ensures lower prices and encourages innovation aimed at developing country needs. This means more people can be treated with the same amount of money, which is crucial in a climate of increasing needs and funding challenges. Patent holders can get a small royalty on the sales of the medicines, and people living with HIV get access to affordable, adapted treatment they need at prices they can afford. Working together, everybody wins.