[Ip-health] MSF responds to Patent Pool licences: Gilead Licence Expands Access, But Several Countries Left Out

Joanna Keenan joanna.l.keenan at gmail.com
Tue Jul 12 02:01:12 PDT 2011

*Gilead** Licence Expands Access, But Several Countries Left Out*

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*Excluded countries should be ready to issue compulsory licences to access
needed drugs  *

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*GENEVA, 12 July 2011* – An agreement announced today by pharmaceutical
company Gilead to licence several HIV/AIDS drugs to the Medicines Patent
Pool could improve access to medicines for patients, but excludes several
countries with large numbers of people living with HIV, the international
medical humanitarian organisation Médecins Sans Frontières (MSF) said today.

“This agreement is an improvement over what other big pharma companies are
doing to ensure access to their patented AIDS medicines in developing
countries,” said Michelle Childs, Policy and Advocacy Director at MSF’s
Campaign for Access to Essential Medicines. “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.”

On the positive side, the licence covers two promising drugs in the
pipeline, cobicistat and elvitegravir, one pipeline combination and the
crucial drug tenofovir. This could help ensure that new treatment options
are available in developing countries at the same time as in rich countries.

The licence also allows for new fixed-dose combinations and child-friendly
medicines to be developed. Critically, the licence is the first of its kind
to explicitly incorporate the potential use of public health safeguards: it
allows medicines to be exported to countries excluded from the agreement
when their governments choose to override the patent with a compulsory
licence, and also allows producers to exit the agreement for any one of the
drugs if Gilead loses a patent because of a legal challenge. The agreement
has also been made public, which sets an important precedent for

On the negative side, the agreement falls significantly short of what is
needed to fully meet the public health needs for HIV/AIDS: it limits
price-busting competition by confining manufacturing to one country (India)
and includes narrow supply options for active pharmaceutical ingredients
needed to make the drugs. Most critically, people living with HIV in certain
middle-income countries are excluded. This contrasts sharply to the first
Pool license granted by the US National Institutes of Health for all
developing countries. 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

Several of the countries that are excluded under the Gilead licences are
among the first in which MSF provided HIV/AIDS treatment ten years ago.

“We handed over many treatment programmes in Latin America and Asia to local
authorities in the confidence that they would be able to provide people with
the treatment they needed to stay alive,” said Dr Tido von Schoen-Angerer,
Executive Director of MSF’s Access Campaign. “If people in middle-income
countries are left out of such deals, their governments still need to pursue
compulsory licences to overcome patent barriers.”

The initial idea of the Patent Pool was to allow access for all people in
developing countries. Any producer meeting the right standards should be
able to make use of licenses to produce and sell. But in this agreement,
manufacturers in Thailand and Brazil, which have capacity to produce, have
been left out.

This agreement builds on existing contracts made in 2006 between Gilead and
generic producers of tenofovir (TDF), a backbone of improved first-line
treatment.  The new deal will allow these producers to make new drugs coming
from Gilead but has not overcome the issue of supply to countries facing
patent barriers such as China.

“Companies currently negotiating with the Pool should agree to licenses that
more fully meet public health needs,” said Childs.  “We expect all
companies, including Johnson and Johnson, Abbott and Merck to also put their
patents in the Pool, just as we hope that countries that don’t benefit from
this agreement will use all means including compulsory licenses to increase
access to HIV medicines for their people.”

*Background information*

*The Medicines Patent Pool*

The Patent Pool was established in 2010 and allows pharmaceutical companies
to voluntarily place licences on patents on their medicines in one
organisation – the Pool. Those pharmaceutical companies then receive a
royalty payment when someone wants to use that licence. Any company - but
especially generic medicine manufacturers - can seek a licence from the
pool, and could then produce generic, more affordable versions of the
medicines and export them to countries covered by the licence. This brings
down the cost of those drugs for developing countries through competition.
Licences can also be used to develop child-friendly versions of drugs or to
combine drugs in a fixed-dose combination pill.

For more information, watch the animation on our website that explains it

*Compulsory licences*

Compulsory licensing is when a government allows someone else to produce a
patented medicine without the consent of the patent owner. It is one of the
flexibilities on patent protection included in the WTO’s agreement on
intellectual property — the TRIPS (Trade-Related Aspects of Intellectual
Property Rights) Agreement. Countries would use this flexibility when they
need access to a patented medicine that is otherwise unaffordable. It can be
used for export or for domestic use.

Joanna Keenan
Campaign for Access to Essential Medicines
Medecins Sans Frontieres

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