Selection of Pharmaceutical Products
Global Fund resources may only be used to procure medicines that are listed in national, institutional or WHO standard treatment guidelines or essential medicines lists.
Preferably, the pharmaceutical products should be selected from national standard treatment guidelines. WHO and other international health agencies have recommended treatment guidelines for HIV/AIDS, TB and malaria, which can be very helpful to countries in developing their own guidelines. However, it is important that national guidelines be adopted to address local requirements and to provide national ownership of the treatment standards.
If national treatment guidelines or lists of essential medicines are not available, and cannot be developed within a timeframe consistent with the project’s needs, Country Offices (COs) can use such guidelines or lists developed by a national institution such as a National AIDS Council or National Malaria Control Programme.
If neither national/institutional guidelines nor essential medicines lists are available, then selection can be based on WHO-recommended treatment guidelines and/or lists of essential medicines.
WHO treatment guidelines and list of essential medicines can be found at the following sites:
- WHO Prequalification Programme
- WHO Model List of Essential Medicines
- Scaling up antiretroviral therapy in resource-limited settings—treatment guidelines for a public health approach
- Guidelines on care, treatment and support for women living with HIV/AIDS and their children in resource-constrained settings
- Treatment of Tuberculosis: guidelines for national programmes
- WHO TB page and publications
- Anti-malarial drug combination therapy—Report of a WHO Technical Consultation
- WHO malaria publications
- A strategic framework for malaria prevention and control during pregnancy in the Africa region
- New WHO guidelines for ART (June 2013)
- Guide to Global Fund Policies on Procurement and Supply Management of Health Products
Once it has been decided which standard treatment guidelines or essential medicines list will be used, the following steps should be taken to develop the list of products:
- Identify all products selected by generic names.
- Cross-reference with the Global Fund quality assurance policy to ensure compliance.
- Confirm whether it is possible to purchase products in fixed-dose combinations, once-a-day formulations or blister packs.
- Confirm if products are registered in-country by the national drug regulatory authority. If not, explore the possibility of fast-track registration or a temporary waiver of registration if the product has been prequalified by WHO.
- Confirm that there are no intellectual property obstacles to purchasing any products on the list.