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

Unni Gopinathan unni.gnathan at gmail.com
Thu Jul 14 08:15:46 PDT 2011

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

*Montreal, Quebec, Wednesday, 13 July 2011*

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 +1 514 226
7003 or rachel.k.monroe at essentialmedicine.org--
Rachel Kiddell-Monroe
President of the Board
Universities Allied for Essential Medicines

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