The Medicines Patent Pool is a United Nations-backed organisation offering a public-health driven business model that aims to lower the prices of HIV medicines and facilitate the development of better-adapted HIV medicines, such as simplified “fixed-dose combinations” (FDCs) and special formulations for children, through voluntary licensing and patent pooling. Founded by UNITAID in 2010, the MPP works with a range of stakeholders — communities of people living with HIV, governments, industry and international organisations. To date, MPP has signed agreements for twelve antiretrovirals (ARVs) for countries home to 87-94% of people living with HIV in the developing world and for one medicine for an HIV opportunistic infection. MPP, together with UNITAID, the Drugs for Neglected Diseases initiative (DNDi) and the Clinton Health Access Initiative (CHAI), is a partner in the Paediatric HIV Treatment Initiative (PHTI) to accelerate the development of appropriate paediatric FDCs for resource-limited settings.
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 have access to affordable treatment. Innovation is needed to ensure that the best medicines reach those who need them the most.
There are 28.6 million people eligible to receive HIV treatment now according to the World Health Organization (WHO). But only 12.9 million currently have access. Moreover, of the 3.3 million children living with HIV today, no more than a quarter receive antiretroviral therapy. Low-cost, easy-to-take HIV medicines must therefore be made more available in developing countries where the vast majority of people living with HIV reside. There also is significant need to adapt medicines for use in developing country contexts and simplify treatment for children living with HIV. Currently, none of the WHO-recommended preferred regimens for children exist in paediatric fixed-dose combinations requiring caregivers to use adult formulations, unadapted paediatric drugs or alternative regimens.
Solving the innovation and access problem
Supporting innovation and ensuring access requires finding ways to share patents.
Patents are intended to reward innovation. But unless licensed, a patent can also prevent production or sale of lower cost, quality assured generic medicines or development of novel formulations. Moreover, because many developing countries import medicines from elsewhere, a patent in a key generic-producing country can mean higher prices in many countries where drugs are most needed. Licensing can both improve access to crucially important medicines as well as advance the delivery of new products.
The MPP offers a model that works for all stakeholders. 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 manufacturers are producing affordable new medicines more easily and rapidly. Donors and developing country governments are stretching their budgets farther to treat many more people. And, most importantly, people living with HIV are gaining faster access to quality, life-saving treatments.
Robust market competition saves lives
Without robust generic competition for patented antiretrovials (ARVs), prices remain unsustainably high placing a substantial burden on treatment programmes. MPP is currently managing more than 50 sub-licensing projects to speed the development of generic medicines and decrease prices, specifically for new therapies and pipeline products. Since January 2012, MPP’s generic partners have distributed 1.5 billion tablets, equivalent to 4.3million patient-years, of first-line medicineTDF and TDF combinations. This has saved the international community more than $40 million over the past two and a half years.
How it works
A step-by-step walkthrough of the MPP’s work
based on an analysis of medical needs and existing patents.
to negotiate licences allowing others to develop adapted formulations or sell generic versions of patented medicines in developing countries.
with the goal of increasing access to medicines.
and other HIV medicines manufacturers to develop, produce and sell medicines in agreed-upon countries under strict quality assurance.
to develop new fixed-dose combinations and paediatric formulations.
Once manufacture has begun, robust competition ensures lower prices and increases supply of available medicines.