E-drug: MSF response to Pre-qualification of HIV/AIDS Drugs by WHO
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Comments by M�decins Sans Fronti�res to the WHO report "Access to
HIV/AIDS Drugs and Diagnostics of Acceptable Quality: Pilot
Procurement Quality and Sourcing Projects" (March 20, 2002)
An increasing number of drugs is being purchased to treat HIV/AIDS
patients throughout the world, and the need to have reliable,
centralized information on drugs available is urgent, as MSF and
others working with treatment projects in developing countries are
aware.
MSF welcomes the initiative by WHO, supported by UNICEF and UNAIDS, to
prequalify HIV/AIDS drugs. Comprehensive advice on quality medicines
provided by WHO is a much needed tool not only for UN agencies but
also for the governments of developing countries, as well as any NGO
dealing with drug procurement and attempting to purchase quality
drugs. MSF believes that WHO is the only organization with the role
and mandate to be doing this.
MSF especially welcomes the fact that generic manufacturers are
involved and that some generic drugs appear on the first list
published on March 20, 2002. It is encouraging that generic producers
are receiving detailed advice from WHO in preparing their dossiers and
complying with the standard WHO dossier format.
MSF strongly recommends that the WHO list be used in connection with
price and patent information which is available e.g. from WHO,
UNICEF, MSF, and others.
But MSF regrets that the WHO prequalification process was started so
late and that it has been so slow, considering that the first
expressions of interest from producers were received in December 2000.
MSF realises that the list will be updated as companies submit or
complete their dossiers, but regrets the absence of some essential
drugs (such as fluconazole) to treat HIV/AIDS and/or opportunistic
infections, and the false impression this absence may give to users as
to the quality of particular drugs or manufacturers.
Completing the existing list rapidly is particularly important since
it will help include quality generics in projects supported by the
Global Fund -- this isn't the case at the moment as the following
quote from the Malawian proposal to the Global Fund demonstrates:
"At present, we are assuming that the Global Fund will only finance
patented drugs. This is in line with consultations with WHO and the
donor community and initial documents from the technical Support
Secretariat. If however, Global Fund rules, post-Doha, permit the use
of generic drugs, the proposal and programme budget will be amended to
reflect this."
MSF urges WHO and its Member States to ensure that there are enough
resources to continue and speed up the prequalification process in the
short, medium and long term. The project should also be expanded to
include drugs for other diseases such as malaria and TB.
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For more details please contact the MSF Access to Essential Medicines
Campaign at ++41-22-8498 405 or www.accessmed-msf.org
Julia_DOUBLE@msf.org
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