1. 5 th Consultative Stakeholder meeting UN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010 Achievements and Impacts of prequalification to date The Global Fund Perspective 5 th Consultative Stakeholder meeting UN prequalification of diagnostics, medicines & vaccines 11 February 2010

2. 5th Consultative Stakeholder meeting UN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010 Presentation Outline 1.The Global Fund Principles 2.The Global Fund Quality Assurance Policy for Pharmaceuticals Main principles QSM and Global Fund : areas for collaboration 3.The Global Fund Quality Assurance Policy for Diagnostics Board request DLT and Global Fund : areas for collaboration

3. 5th Consultative Stakeholder meeting UN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010 The Global Fund The Global Fund is an international financing organization, not an implementing organization The Global Fund objectives include: to allow access to and continued availability of quality assured medicines and health products to fight AIDS, Malaria and TB About 45% of grant funds are spent on commodities and health products procurement. Principal Recipients are responsible for procurement and for ensuring adherence to Global Fund QA Policy requirements

4. 5th Consultative Stakeholder meeting UN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010 Rapid scaling up of results Interventionmid 2007mid 2008December 2009 HIV: People on ARV treatment 1.1 million1.75 m2.5 million TB: People treated under DOTS 2.8 million3,9 m6.0 million Malaria: Insecticide-treated nets distributed 30 million59 m104 million Malaria treatments.. 108 million Global Fund Top 3 result indicators (2009)

5. 5th Consultative Stakeholder meeting UN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010 Global Resources Distribution Rounds 1-8, (July 2009) OP/140709/2 Expenditure Component (July 2009) Estimates from Rounds 2-8 proposals 100% = $8.2 billion USD Overview of procurement of medicines by value

6. 5th Consultative Stakeholder meeting UN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010 Global Fund Policies for pharmaceuticals and other health products The Global Fund Approach for procurement Principles and minimum standards, not detailed procedures On international best practices Build upon existing systems GF Quality Assurance Policy for pharmaceuticals: revised policy effective from 1 July 2009 amended at the 20 th Board, November 2009, to respond to challenges faced for the procurement of certain FPPs defines: 1: quality criteria requirements 2: selection products process 3: monitoring quality GF Quality Assurance Policy for diagnostics: under development

7. 5th Consultative Stakeholder meeting UN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010 QSM and Global Fund areas for collaboration Prequalification Programs and Implementation of the GF Quality Assurance Policy QSM: Reference Technical Partner for The Global Fund

8. 5th Consultative Stakeholder meeting UN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010 1 - Authorization of the FPPS in Country of use GF requirements for all FPPSs “NDRAs are encouraged to expedite registration by accepting WHO pre-qualification inspection and supporting dossiers in lieu of national requirements.” 2 - Selection of products : GF requirements for all ARVs,anti-TB and antimalarial FPPs be: –Priority 1: Prequalified by WHO (Option A), or authorized for use by SRA (Option B) –Priority 2: Permitted for use based on the advice of the Expert Review Panel (ERP) Prequalification Programs and Implementation of the GF Quality Assurance Policy

9. 5th Consultative Stakeholder meeting UN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010 WHO Prequalified products purchases WHO Prequalified products: priority 1, with SRA approved products, unless no availability of enough number of FPPs in the WHO PQ list (eg. Certain ACTs or TB medicines) currently, more than 95% of ARVs purchases by PRs are WHO PQ

10. 5th Consultative Stakeholder meeting UN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010 Expert Review Panel reviewed products Permitted for use based on the advice of the Expert Review Panel (ERP): Priority 2 Expert Review Panel (ERP): An independent technical body, –Composed of external technical experts (mainly SRA experts) –Hosted by WHO Purposes: –To review the potential risks/benefits associated with the use of FPPs that are not yet WHO-prequalified or SRA-authorized. –To advise the Global Fund in its decision on whether to allow grant funds to be used to procure those FPPs ERP recommendations time limited: 12 months

11. 5th Consultative Stakeholder meeting UN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010 Evolution of FPPs reviewed by ERP TotalARVMalariaTB Number of products recommended by ERP – currently pre qualified by WHO – currently approved by SRA (USFDA) 28 9 5 15 7 5 3 1 NA 11 1 NA Number of products NOT recommended by ERP – currently pre qualified by WHO – currently approved by SRA (USFDA) 43 0 1 12 0 1 19 0 NA 12 0 NA Two ERP reviews (in May 2009 and October 2009) 78 FPPs dossiers submitted to ERP for review, 71 reviewed: 28 products permitted for use 43 not permitted for use

12. 5th Consultative Stakeholder meeting UN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010 Global Fund requirements: GF Secretariat responsible for “Random” quality control testing of ERP products PRs responsible at country level to monitor the quality of products all along the supply chain, including systematic random quality control testing Selection of the QC laboratory: a NDRA laboratory of the recipient country, or a laboratory recognized by the NDRA, and compliant to the following criteria : 1.WHO prequalified or, 2.ISO/IEC 17025 certified for the required scope of drug testing Prequalification Programs and Quality monitoring

13. 5th Consultative Stakeholder meeting UN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010 Prequalification Programs and Quality monitoring Critical role of WHO Prequalification program for Quality Control Laboratory : Selection of a QC laboratory contracted by the GF Secretariat, including : preparation of the request for proposal published in July 2009 technical evaluation committee for awarding the laboratory, in November 2009 Selection of laboratory by the PRs in country : Safer and Easier process where there is access to WHO Prequalified QC laboratories Sharing testing results with QSM Database of testing results published by GF in Q1 2010 Immediate alert for sub-standards products

14. 5th Consultative Stakeholder meeting UN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010 QSM: Technical Partner for The Global Fund Technical expertise –Global Fund technical partner and reference in case of concerns related to the quality of products –Member of the expert Technical Advisory Group who reviewed the GF QA policy (2008) and proposed an update policy –Participation as experts to the Global Fund Portfolio committees: amendment to revised QA policy ( 2009)

15. 5th Consultative Stakeholder meeting UN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010 QSM: Partner for The Global Fund QSM: Technical Partner for The Global Fund Development and Publication of finished product monographs in the International Pharmacopoeia Direct impact – on the methods and specifications used by the Laboratory contracted by the GF

16. 5th Consultative Stakeholder meeting UN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010 At its 18th Meeting, the Board requested the Secretariat, with the oversight of the PC, to “review the current status of quality assurance for diagnostic products and to make recommendations” Objective: to provide recommendation on the feasibility of establishing a QA policy for diagnostics GF Quality Assurance Policy for diagnostics Background DLT and Global Fund : areas for collaboration

17. 5th Consultative Stakeholder meeting UN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010 Quality Assurance Policy for Diagnostics On 2009, Phase I : review of the current status of quality assurance for diagnostic products – the Board signaled to Secretariat the importance of inclusion of WHO in such review –WHO Diagnostics and Laboratory Technology = key partner –Providing timely technical information and expertise, and preparation of background analysis and reports

18. 5th Consultative Stakeholder meeting UN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010 Quality Assurance Policy for Diagnostics GF Board MDC committee endorsed the approach and the continuation of the Technical Advisory Group On 2010, Phase II: recommendations and options for a GF QA Policy for Diagnostics –Need for the expertise and support of technical partners –WHO Diagnostics and Laboratory Technology key participant

19. 5th Consultative Stakeholder meeting UN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010 Global Fund challenges Increasing demands for –Malarial,TB, and OI medicines of assured quality –Quality Control Laboratories compliant with GF requirements –Rapid diagnostic tests prequalified Lack of NRA capacity Lack of consistent Quality assurance system of Procurement Agents

20. 5th Consultative Stakeholder meeting UN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010 Conclusion GF gratefully acknowledges the assistance, help and guidance provided in 2009 by WHO prequalification programs for Medicines Quality Control Laboratory and Diagnostics which was a key element to assure access of assured quality medicines to people in need

21. 5th Consultative Stakeholder meeting UN Prequalification of Diagnostics, Medicines and Vaccines 11 Feb 2010