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 M`decins Sans
Fronti`res (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 transparency.
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 licences.
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.`