In a groundbreaking move, Gilead Sciences has agreed
to license four AIDS medicines to the Medicines Patent Pool, which is an
initiative designed to streamline patent licensing for producing generics of
patented HIV meds and lower prices in poor countries. The deal marks the first
time that a drugmaker has taken this step and follows more than a year of
criticism from patient advocacy groups and non-government organizations of the
pharmaceutical industry for failing to embrace the MPP concept.
The
licensing agreement between Gilead and MPP is also significant because it
involves two AIDS meds, Viread and Emtriva, that are important in treating the
virus. To date, most poor countries only have access to older, less effective
treatments. The deal also includes two more Gilead drugs that are under
development, cobicistat and elvitegravir, along with a combination of all four
meds known as the Quad. Viread, by the way, is also licensed for use in
treating hepatitis B.
“Today
marks a milestone in managing patents for public health. The license agreement
with Gilead Sciences will help make medicines available at a lower-cost and in
easier to use formulations without delays,” MPP executive director Ellen `t
Hoen says in a statement.
“People in developing countries often have to wait for years before they can
access new health technologies. Today`s agreement changed that.”
Not
everyone was as laudatory, though. Medicines Sans Frontieres, also known as
Doctors Without Borders, praised the agreement as a welcome step forward, but
cautioned that certain terms are lacking, such as limits placed on access to
people living in middle-income countries. The group complains there are limits
on “price-busting competition” by confining manufacturing to India and there are
narrow supply options for active pharmaceutical ingredients needed to make the
drugs (here is the
license agreement and the sublicensee
agreement.)
“This
agreement is an improvement over what other big pharma companies are doing to
ensure access to their patented AIDS medicines in developing countries,”
Michelle Childs, Policy and Advocacy Director at MSF`s Campaign for Access to
Essential Medicines says in a statement.
“But some caution is needed because in several key areas, Gilead is not going
beyond the status quo. More needs to be done to fulfil the vision of the Patent
Pool to provide a solution to all people living with HIV, so this licence
should not become the template for future agreements…If voluntary measures like
the Patent Pool are unable to ensure people access to the medicines they need,
countries that are left out will need to aggressively pursue non-voluntary
paths like compulsory licenses.”
The
deal comes three years after the MPP was launched by UNITAID with an eye toward
convincing multi-national drugmakers to license their AIDS meds, which would,
in turn be licensed to select generic makers that would pay inventors a small
royalty and sell copycats only in certain developing countries. The goal is to
lower prices substantially, although inventors would still get some revenue (read
here).
“UNITAID
has worked for four years to develop the Medicines Patent Pool concept. Today,
we are proud to see that it is becoming a tangible reality,” UNITAID executive
board chair Philippe Douste-Blazy says. “I salute this first important step by
Gilead and urge other pharmaceutical companies to place their intellectual
property at the service of global public health.”
The
initiative gained needed steam when the National Institutes of Health in October
2010 joined the MPP by agreeing to license a patent stemming from research
undertaken by the National Cancer Institute and the University of Illinois at
Chicago (see
this). However, none of the brand-name drugmakers had similarly agreed to a
licensing deal, prompting mounting criticism and protests.
In late
2010 letters were sent to senior executives at large drugmakers (look
here) imploring them to enter or accelerate nascent negotiations to license
meds to the MPP. Activists, meanwhile, camped outside Johnson & Johnson
offices after the healthcare giant struck its own deal with several generic
drugmakers, causing critics to call the move an end run around the MPP (see here,
here
and here).
Gilead,
however, was among the first drugmakers to enter talks and some say its deals may
add pressure on other drugmakers. “The pool has widened the door for generic
competition and lower prices for AIDS drugs in developing countries,” writes
Jamie Love of Knowledge Ecology International, a non-profit advocacy group that
focuses on intellectual property issues that affect access to medications.
“Gilead is the first, and should not be the last, to recognize the importance
of embracing the pool to formally share its technology to address this public
health crisis. The licenses are not perfect, and there will be justifiable
criticism of the geographic scope and several of the terms in the agreement.
That said, the agreement seems to be an important step forward.”
Adds
Diarmaid McDonald, coordinator of the Stop AIDS Campaign: “This deal is very welcome
but it excludes countries with serious poverty and HIV epidemics like Brazil
and China. This deal is a floor, not a ceiling, and we now need to see all
other companies reach agreement which exceed these terms. Alongside this,
countries which have been excluded must utilise their legal right to issue
compulsory licences to get the drugs their people need.”
The
terms will preserve the ability of generic drugmakers to supply countries if
those governments issue compulsory licenses, as well as waive data exclusivity
rights where they exist, according to the MPP, which vows to promote
“transparency in licensing practices” and, toward that end, will publish
licenses on its website.
The
licenses will allow Viread and Emtriva to be supplied in 111 countries, while
cobicistat will be available in 102 countries, elvitegravir and the Quad will
be supplied to 99 countries. However, the licenses do not include all
developing countries. Royalties, by the way, will range from 3 percent to 5
percent of generic sales, with royalties waived for any new pediatric
formulations.
“We
believe the pool is an innovative mechanism to increase access to patented
medicines in a way that works for the pharmaceutical industry and people living
with HIV,” Gilead exec vp Gregg Alton says in the statement. “And we hope to
see the pool become an effective mechanism for providing access to an
increasingly broader range of antiretrovirals to treat HIV in resource-limited
parts of the world.”
