MSF comments on first WHO quality standards list

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 the 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, attempting to purchase quality drugs. MSF believes that the WHO is the only organization with the role and mandate to be doing this. However, MSF also has some concerns. 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 the 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 too 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 the 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.