Gilead Agreement with the Medicines Patent Pool: A Significant Step in Promoting Access to Affordable AIDS Drugs but Concerns Remain

Universities Allied for Essential Medicines (UAEM) welcomes the recent announcement of an agreement by Gilead Sciences to place four of its antiretrovirals, as well as a fixed dose combination, into the Medicines Patent Pool.  The agreement—the first with a pharmaceutical company—marks an important milestone in the Medicines Patent Pool’s mission to promote access to affordable eligible medicines in low- and middle-income countries. 

The agreement encompasses tenofovir, emtricitabine, cobicistat, and elvitegravir as well as the “Quad”–a fixed dose combination containing all four of the drugs. Emtricitabine was developed at Emory University and licensed exclusively to Gilead.

“This agreement has special significance for UAEM, as it represents the license of a university-held patent into the Pool” said Rachel Kiddell-Monroe, President of UAEM’s Board of Directors.  “We trust that this announcement will help convince universities that they can and should adopt practices that ensure both current and future eligible patents on medical technologies will enter this Pool.”

The terms of the licenses to the Pool suggest that original patent holders, such as universities, can and do influence the conditions under which pharmaceutical companies make their medicines available in developing countries. “Universities have the power to ensure pro-access provisions are included in the deal when they out-license their discoveries to the pharmaceutical industry,” said Karolina Maciag, an MD/PhD student at Harvard and the Massachusetts Institute of Technology. “As original patent holders, universities should safeguard equitable access to the medical technologies that originate in their labs, as befits their mission in society.”

Several aspects of the license, such as the public availability of the full texts, the absence of both bundling provisions and “no patent challenge” clauses, as well as agreements on the transfer of know-how, are positive steps for public health.  However, although the geographical scope represents an improvement from previous Gilead voluntary licenses, it is more limited than the US National Institutes for Health (NIH) license granted to the Pool last year.  Unlike the NIH license, which covered all developing countries, the current license neglects a large portion of the world’s poor, excluding HIV-positive individuals in over 50 countries, including China and Brazil. The NIH license should form the benchmark for future licenses insofar as it relates to geographical coverage and manufacturing capacity.

The license also requires that the products be manufactured exclusively by Indian generic companies, and that these licensees purchase the active pharmaceutical ingredients (API) only from other licensees or from Gilead. These provisions restrict competition and further limit the scale of potential price reductions, particularly as tenofovir is already off patent in many countries. As such, these licenses do not encourage the development of local manufacturing capacity in other countries, a measure that can improving access to these life-saving medicines.

UAEM therefore calls on Gilead–and all companies which license to the Pool–to extend their geographic scope to include all low- and middle-income countries and to remove restrictions on production to countries beyond India. In addition, low- and middle-income countries excluded from the agreement should make full use of TRIPS flexibilities, including compulsory licensing, to ensure that their populations have access to affordable medicines.  Notably, the Gilead/Pool license explicitly allows for generic licensees to supply countries that issue compulsory licenses.

While there is room for improvement, UAEM congratulates Gilead for being the first pharmaceutical company to reach an agreement with the Pool.  UAEM calls on other patent holders, such as Tibotec (owned by Johnson & Johnson), Merck, and Abbott to enter into negotiations with the Pool without delay. 

For further inquiries please contact: Rachel Kiddell-Monroe at +15142267003 or rachel[dot]k[dot]monroe[at]essentialmedicine[dot]org.