Patent pooling to increase access to essential medicines

Bulletin of the World Health Organization
Volume 97, Number 8, August 2019, 513-580


Patent pooling to increase access to essential medicines
— Esteban Burrone, Dzintars Gotham, Andy Gray, Kees de Joncheere, Nicola Magrini, Yehoda M Martei, Charles Gore & Marie Paule Kieny
Access to medicines is key to achieving universal health coverage (UHC); however, such access can be hindered by unaffordable prices. A good example of improvement in access to medicines is treatment for human immunodeficiency virus (HIV) infection. Global coverage was very low in 2000, with only 611 000 people receiving treatment; however, in 2017, 21.7 million people were on treatment.1,2 This increase was partly due to access to affordable, quality-assured generic HIV medicines in low- and middle-income countries.1

One way to achieve better access to new medicines is patent pools, which allow third parties to acquire non-exclusive licences for the intellectual property needed to develop products. While patent pools have existed for several decades in other fields of technology, such as in digital technologies, they are a relatively new concept in public health, where they have been applied to address some of the access challenges in low- and middle-income countries.3

To improve access to antiretroviral treatment in low- and middle-income countries, Unitaid established the Medicines Patent Pool in 2010 as the first public health patent pool. Later, the patent pool’s mandate was expanded to treatments for tuberculosis and hepatitis C. The patent pool has negotiated most of the licensing agreements with pharmaceutical companies that have enabled competitive generic manufacture of antiretrovirals in low- and middle-income countries before patent expiry. These licences have also facilitated the development of new formulations that are particularly needed in resource-constrained settings, such as certain fixed-dose combinations and paediatric formulations. To date, the patent pool’s generic partners have distributed 22 million patient-years of treatment, allowing global savings of 1.06 billion United States dollars (US$), according to a biannual analysis undertaken by a leading auditing company.4

In 2016, the Lancet Commission on Essential Medicines Policies, the World Health Organization (WHO) and other stakeholders called for the patent pool to expand its mandate to a broader range of patented essential medicines.5,6 Here, we outline the findings of a released feasibility study on expanding the patent pool’s mandate,7 laying out the public health case for adapting its model to disease areas beyond the initial three focus diseases. In May 2018, the patent pool acted on the results of the feasibility study and expanded its mandate to include other patented essential medicines…