E-DRUG: Global Fund discusses procurement rules
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November 12th, 2004
MSF statement on the need for the Global Fund to fight AIDS, malaria and tuberculosis (use full official name) to extend the transition period for the procurement of single and limited-source products for at least one year.
Currently, the Global Fund procurement guidelines stipulate that, from January 1st 2005, Global Fund monies can only be spent on medicines which have either been pre-qualified by the World Health Organization or registered in ICH and/or PICS countries.
MSF calls on Global Fund Board members, meeting in Arusha, Tanzania on November 18th and 19th , to review this deadline and extend it by at least one year. Such an extension is essential, taking into account the potential impact on all existing and future projects.
The Global Fund's commitment to ensuring that its monies only buy quality-assured medicines is welcomed and supported by MSF. We also support the WHO pre-qualification project, believing it to be crucial to ensuring the safety, quality and efficacy of medicines. However, there has been a significant delay in bringing the pre-qualification project up to speed. On the one hand, the project has been under-resourced, and, on the other hand, it is taking time for manufacturers to submit adequate dossiers for evaluation.
As a result, we now face the prospect that the deadline, designed to ensure access to medicines of assured quality, could actually hamper access to treatment by restricting the number of medicines and manufacturers that may be purchased.
In the case of antiretrovirals, if thetransition period is not extended, recipient countries would not be able to purchase certain fixed-dose combinations which only exist in the generic form and which have not yet been pre-qualified. Some ARVs can only be purchased from originator companies who do not always offer discounted prices for developing and least developed countries. Furthermore, when available, the price of the generic ARVs is often cheaper than the discounted offer of originator companies.
Consequently, there would likely be a substantial cost increase for already approved treatment programmes, as IDA has shown ("Quality assurance of single and limited source pharmaceuticals: Implications of current Global Fund policy", 2004. http://www.ida.nl/documents/qualityassuranceofsingleandlimitedsourcepharmaceuticalsfin?.pdf ). The number of people treated with the same budget will be significantly reduced.
For tuberculosis treatment, there are a number of medicines which are either not pre-qualified or which have not been registered in PICS and/or ICH countries, including some FDCs and paediatric formulations. The absence of these products would make treatment programmes unfeasible.
This is also true in the case of malaria. An insufficient number of malaria medicines has been pre-qualified and the number of competitors per product is limited. This means that treatment programmes depend on only a few sources and availability of products is not guaranteed. The shortage of Novartis' Coartem illustrates the consequences of such a situation.
MSF urges the Board to extend the January 1st 2005 deadline by at least a year. The Global Fund should also discuss ways to prioritise products for pre-qualification with its technical partner, the WHO, based on the needs of programmes funded by the Global Fund.
For a more in-depth analysis of the impact of this situation on HIV/AIDS, malaria and TB, please consult www.accessmed-msf.org.
regards
Carmen Perez Casas, MsCPharm
Pharmaceutical Coordinator
Access to Essential Medicines Campaign
Medecins sans Frontieres
Tel + 34 630930587
carmen.perez@paris.msf.org