Approved by the Board on: 30 April 2010
1. The Board approves a restatement of the Interim Exception to the Global Fund's Quality Assurance Policy for Pharmaceutical Products as set out in Annex 4 to the MDC Report to the Board (GF/B21/8 Revision 1, Annex 4). This interim exception expires on 31 December 2010.
2. The Board requests the Secretariat to work on an urgent basis with WHO to establish a process for the Expert Review Panel (ERP) to specifically consider and assist to deal with exceptional cases in the future. Such exceptional cases would be limited to situations in which financing provided by the Global Fund would be used to procure a Finished Pharmaceutical Product (FPP) of a formulation for which:
(i) no available* FPP complies with the quality standards of the Global Fund's Quality Assurance Policy; and
(ii) WHO has made a determination, based on the available information, that no therapeutic alternatives exist that would be adequate for the specific country or region of intended use.
In such exceptional cases, ERP review should include an assessment of the clinical risk of providing ineffective or no treatment, in addition to a quality risk analysis. If necessary, the Terms of Reference of the ERP shall be revised accordingly.
* 'Available' means that the manufacturer can supply the requested quantity of the FPP within not less than 90 days of the requested delivery date.