[Ip-health] Health GAP statement on Gilead's licensing agreement with the Medicines Patent Pool

Asia Russell asia at healthgap.org
Tue Jul 12 09:20:31 PDT 2011

Health GAP (Global Access Project)

Gilead’s access moves ‘disappointing’ say activists
Countries left behind by Gilead should break patent monopolies by
issuing compulsory licenses without delay

Health GAP applauded progress by the Medicines Patent Pool in securing
licenses for key AIDS medicines today, but expressed disappointment
with the terms and conditions of the licenses, issued for five Gilead
products: tenofovir, emtricitabine, and two medicines still in
clinical development: cobicistat and elvitegravir (as well as a pill
combining all four medicines). The problematic terms and conditions
include the following:

• Although Gilead has agreed to expand the number of territories
covered by the licenses slightly, and has included three important
products still under clinical development, Gilead has insisted on
maintaining its monopoly control over products in many middle-income
countries where there is a significant burden of untreated HIV as well
as HIV positive people on treatment in urgent need of affordable new
medicines as they develop resistance to old medicines.

• In addition to the harmful geographic exclusions, it is extremely
problematic that Gilead has restricted licensees to generic companies
from India only, as this excludes important generic manufacturers from
Asia, Africa, and Latin America.

• Gilead has also maintained excessive and unreasonable control over
the market for the Active Pharmaceutical Ingredients (APIs) needed to
make the licensed medicines, insisting that APIs be sourced from
Gilead itself or from other Indian licensees.

Activists had hoped that the Medicines Patent Pool could have held
firm on inclusion of all middle-income countries and of licensees from
everywhere in the world—the terms included in the first licensing
agreements with the Patent Pool, announced ten months ago by the
National Institutes of Health (NIH).

Fortunately, the Medicines Patent Pool extracted some improvements
over existing voluntary licenses by Gilead, including the provision
that licensees maintain the ability to fulfill compulsory and
government use licenses for these products in countries excluded by

Activists urged excluded countries such as Thailand, Brazil, and
others to take action, including through issuing compulsory licenses
where needed, to ensure that low cost generic versions of Gilead
medicines will be available even as Gilead attempts to unreasonably
exclude them.

Health GAP also called for scaled-up global action against companies
that have refused to license their medicines at all. Although there
are many important products awaiting inclusion, the refusal of Johnson
& Johnson/Tibotec and Merck to license their medicines creates an
unconscionable roadblock to desperately needed co-formulated regimens.

Activists applauded the dedication of leaders at the Medicines Patent
Pool in seeking greater access. But the Patent Pool, having negotiated
an open license from NIH and now a partial license from the first
participating pharmaceutical company, is demonstrating the inherent
limitations of voluntary measures to address the needs for affordable
medicines. Big Pharma will still seek to gain favorable publicity
while maintaining its patent monopolies in key markets—many of which
are essential to scaling up access and to developing a robust generic
market to achieve lower prices for new medicines. Governments
throughout the world will need to step in to ensure that people’s
lives, not profit, govern decisions about production and distribution
of essential drugs.

Contact for more information: Asia Russell (+1 267 475 2645) or
Matthew Kavanagh (+1 202 486 2488)


Asia Russell
Health GAP (Global Access Project)
email: asia at healthgap.org
tel: +256 776 574 729 (Uganda)
     +256 703 574 729 (Uganda)
     +1 267 475 2645 (US)
skype: asia_ilse

More information about the Ip-health mailing list