The Pilot Procurement, Quality and Sourcing Project for HIV Drugs was created in October 2000 by WHO, UNICEF, UNFPA, and UNAIDS, with support from the World Bank. Its objective is to prequalify manufacturers of medicines for HIV (antiretrovirals) and HIV-related illnesses (anti-infectives, anticancer medicines, and pain killers) as suppliers to United Nations and other public sector drug procurement agencies. Medicines for the treatment of HIV infection have been selected because they remain largely inaccessible in those countries that are most affected by HIV/AIDS.
For antiretrovirals, there is currently limited regulatory experience, and well-established quality standards such as pharmacopoeial monographs are not generally available. The overall aim of the project is to provide pre-qualification and quality assessment of a selected number of pharmaceutical products considered for purchase by UN agencies involved in the procurement of medicines and diagnostics. WHO manages the project and provides technical support and assistance. UNICEF provides administrative support and infrastructure. A spin-off objective is to develop a harmonized quality assessment system for use by public sector procurement agencies.
Progress in pre-qualification has been reported in Volume 16, Number 1 of this journal. The present summary considers experience in pre-qualification of generic HIV medicines and includes the eighth cumulative list of combined innovator and generic products published on 20 August 2003.