Risk Assessment

Medicines are needed urgently during health emergencies. But it may be that no finished pharmaceutical products (FPPs) that have been prequalified by WHO or approved by a stringent regulatory authority are available. Procurers are sometimes faced with a similar dilemma: for example, prequalified or stringently-approved products are needed for a treatment programme or for promoting reproductive health but are unavailable. In such situations risk–benefit assessment by experts can fill the gap. For medicines, WHO currently operates two mechanisms that provide this service: the Emergency Use Listing Procedure (EUL), and the Expert Review Panel (ERP).

WHO developed the EUL process to expedite the availability of unlicensed medical products needed in public health emergency situations, to assist interested UN procurement agencies and Member States in determining the acceptability of using specific products in the context of a public health emergency, based on an essential set of available quality, safety, and efficacy data.

ERP is a group of independent experts who review the potential risks and benefits associated with the use of FPPs that have not yet undergone stringent assessment. Following its review of products, the group makes recommendations regarding their potential procurement to the procurement agency that requested the assessment.