Evidently, in considering whether or not to submit a finished pharmaceutical product (FPP) or active pharmaceutical ingredient (API) to WHO for evaluation for prequalification, manufacturers will seek to understand and review the potential donor-funded market for the product concerned.
WHO does not generate its own information regarding markets for quality-assured APIs and FPPs. Rather, its role focuses on verifying the quality of urgently-needed APIs and FPPs, and, when needed, facilitating improvements to their quality.
However, market information is prepared and made publicly by several other organizations. It includes substantial "market landscape" reports that both review recent product procurement (within a specific therapeutic area), including pricing, and outline anticipated market trends. Additionally, some organizations make publicly available information regarding what FPPs have been procured, at what price, with their funds, and/or what they are currently procuring (including price range information).
Current bidding opportunities will also provide manufacturers with important information about procurement opportunities.
As well as submitting an API or FPP for evaluation for prequalification, applicants may consider submission of FPPs for assessment by the Expert Review Panel (ERP). WHO-prequalified or products approved by a stringent regulatory authority are not available on the market for all needed medicines, or may be in short supply. Procurers may therefore find themselves in the position of having to urgently procure products about which little is known in terms of quality risk. ERP was created to help procurers assess such risk. The results of ERP assessments enable procurers — such as the Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria and UNFPA (United Nations Population Fund) — to make an informed decision regarding time-limited procurement of the products assessed. ERP assessment is therefore another route to markets.
Links to all this information can be found below.
Medicines Eligible Product Lists (The Global Fund):
- List of ARV pharmaceutical products classified according to the quality assurance policy
- List of antihepatitis pharmaceutical products classified according to the quality assurance policy
- List of malaria pharmaceutical products classified according to the quality assurance policy
- List of tuberculosis pharmaceutical products classified according to the quality assurance policy
The Medicines Patent Pool (MPP) is a United Nations-backed public health organization working to increase access to HIV, viral hepatitis C and tuberculosis treatments in low- and middle-income countries. Through its innovative business model, the MPP partners with governments, industry, civil society, international organisations, patient groups and other stakeholders to forecast, prioritize and license needed medicines. The organization encourages generic manufacture and the development of new formulations through patent pooling.
MPP's MedsPal (the Medicines Patents & Licences Database) contains comprehensive information on the patent and licensing status of selected HIV, hepatitis C and tuberculosis medicines
The MPP was founded and remains fully funded by Unitaid.