|Sources and Prices of Selected Drugs and Diagnostics for People Living with HIV/AIDS (UNAIDS, 2001, 36 p.)|
In an effort to improve access to drugs used in HIV-related conditions, the WHO Expert Committee on the Use of Essential Drugs included in the tenth (1997) and eleventh (1999) Model List of Essential Drugs a number of drugs used to treat opportunistic infections of special importance in HIV/AIDS. However, most of them were not included in the range of products distributed by international low-cost wholesalers, and access to them remained limited in developing countries. In addition, comparative price information for these drugs was difficult to obtain.
In response, the UNAIDS Secretariat, UNICEF, and WHO initiated a joint project designed to identify suppliers and supply-related information. MSF joined the project in 2000. Two surveys were carried out in 1999 and 2000, involving over 200 companies from 40 countries. Only companies that forwarded the requested documentation were included, as this was the basis for screening the suppliers and products. The information requested included:
· registration status of the product in the country of origin
· information on production capacity and lead times
· indicative prices in the country of origin
· whether the manufacturer is in possession of a manufacturing licence and a certificate of good manufacturing practices (GMP)* issued by the National Drug Regulatory Authority.
* In accordance with WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, 1996.
The subsequent sections of this document contains information relevant to procurement of HIV/AIDS drugs and diagnostics, for use by countries and donors. Although some of the suppliers involved have been screened by UNICEF, procurement agencies should follow their own procedures for pre-qualification of manufacturers and assessment of individual products. Licensing authorities in the respective countries of manufacture are expected to be responsible for the review and approval of the detailed composition and formulation when authorizing a pharmaceutical product to be marketed, including the specifications of its ingredients, as submitted by the manufacturer of the dosage form, and to oversee compliance with GMP requirements as recommended by WHO. It should also be noted that some of the drugs listed may be subject to patents in individual countries, precluding the introduction of generic alternatives in those countries. This matter is country specific and must be addressed at national level.
While all attempts were made to contact as many manufacturers as possible, the list remains incomplete and is open to further additions. The information will be regularly updated and further reports made available when appropriate.