E-drug: MSF letter to WTO-Pascal Lamy about access to medicines
----------------------------------------------
Mr Pascal Lamy
Director General
World Trade Organization
Rue de Lausanne 154
CH-1211 Geneva 21
Switzerland
20th September 2005
Dear Mr Lamy,
We are writing to you to congratulate you on your appointment as director
general of the World Trade Organization and to raise concerns about access
to medicines, an issue we know you are very familiar with.
The HIV/AIDS crisis has shown the urgent need to ensure that essential
medicines are available at affordable prices. Today approximately half of
the one million people in the developing world who receive antiretroviral
drugs rely on generic production. The fixed-dose combinations, produced in
India, greatly simplify the administration of antiretroviral therapy and
have been critical to scaling up treatment in resource-poor settings.
The 2001 WTO Doha Declaration on TRIPS and Public Health was a vital step
in increasing access to medicines. It provides unambiguous support to any
government that need to protect the health of their people to use the TRIPS
flexibilities to overcome the barriers posed by patents, and helps the
least developed countries by extending the transition period for enforcing
and granting pharmaceutical product patents until at least 2016.
Since then, however, there has been a systematic dismantling of the Doha
Declaration through bilateral trade agreements in which much higher levels
of intellectual property protection are demanded than required by the WTO.
The impact of patent protection on HIV programmes will become very apparent
in the coming years when large numbers of patients currently on treatment
will need to switch to newer, second line medicines. These drugs are at
least 4-10 times as expensive as first-line treatments, and almost all are
patented or are likely to be patented in those countries that have capacity
to produce them generically such as India, Brazil and Thailand.
Today MSF is treating 45000 people living with AIDS. Already, this
represents a major part of our overall spending. At current projections, we
estimate that overall programme costs could at least double in the next few
years as significant numbers of patients will require second-line
medicines. Obvious, MSF’s needs are just a small indication of the problems governments throughout the developing world will face. In addition, the impact of patents is not limited to antiretroviral drugs, but will increasingly be felt across all diseases with all medicines brought to
market from now on.
A second critical question for the WTO is how to ensure that innovation
meets the health needs of neglected patients in the developing world. The
WTO TRIPS agreement came with promises of increased innovation and
investment in research and development. As far as the needs of people in
developing countries are concerned these promises have not been fulfilled.
So far, increased patent protection in developing countries has not
contributed to increased innovation.
An R&D system that is driven by patent and profit motives neglects the
health needs of the poor. The patent system is intended as a stimulus for
innovation, but there is no mechanism for directing that innovation, and as
a result many diseases are completely ignored. We face the consequences on
a daily basis in our projects, for example to diagnose TB in HIV patients
and in children; to treat tropical diseases like leishmaniasis, which
affects 12 million people; to monitor HIV patient progress, and to treat
HIV in children.
Recently established product development partnerships provide some cause
for hope, but all are heavily dependent on philanthropic donations, with
negligible contributions by governments. For example, through its funding
of the Drugs For Neglected Diseases Initiative The Drugs for Neglected
Diseases Initiative (www.dndi.org) MSF is contributing more finances to
tackling the problem than the European Union and all European governments
combined. The New Landscape of Neglected Disease Drug Development.
LSE/Wellcome Trust Pharmaceutical R&D Policy Project, September 2005. p 30.
The few promising drug development projects that exist lack secure funding
to move them into clinical trials.
In view of the above, the WTO should increase its work to support access to
medicines. We ask you to take action to stop the erosion of the Doha
Declaration on TRIPS and Public Health through bilateral and regional FTAs.
We specifically ask you to hold a meeting to examine whether the current
WTO rules on patents and their flexibilities are sufficient to address the
needs in developing countries with regard to access to existing products
and ensuring the development of new therapies. In particular, the 2003
August 30 decision to allow production of generic medicines for exports
needs to be reviewed. This meeting should also address the question how
bilateral and regional trade agreements affect access to medicines and how
the WTO plans to provide effective technical assistance on the
implementation of the Doha declaration in an increasingly TRIPS-plus
environment.
It is crucial that the WTO addresses the question how it can contribute to
a better mechanism for essential health Research and Development to ensure
that health needs of people in developing countries are met. We ask you to
initiate a discussion at the WTO about how the failure of the TRIPS
Agreement to address essential health needs can best be addressed.
You have announced that the weeks to come will be devoted to internal and
external consultations. We would be more than happy to meet with you to
discuss our concerns in more detail.
Sincerely yours,
Dr Karim Laouabdia
Campaign for Access to Essential Medicines
Medecins Sans Frontieres
------------------------------------------------------------------
Seco GERARD
MSF Access to Medicines Campaign's EU Liaison Officer
C/O MSF
Rue Dupre 94
1090 Brussels
32 2 474 75 09 (dir off)
32 479 514 900 (mobile)
seco.gerard@msf.org