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Achievements and Impacts of prequalification to date The Global Fund Perspective

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. Presentation Outline. The Global Fund Principles

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Achievements and Impacts of prequalification to date The Global Fund Perspective

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  1. Achievements and Impacts of prequalification to dateThe Global Fund Perspective 5th Consultative Stakeholder meeting UN prequalification of diagnostics, medicines & vaccines 11 February 2010

  2. Presentation Outline • The Global Fund Principles • The Global Fund Quality Assurance Policy for Pharmaceuticals • Main principles • QSM and Global Fund : areas for collaboration • The Global Fund Quality Assurance Policy for Diagnostics • Board request • DLT and Global Fund : areas for collaboration

  3. 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. Rapid scaling up of results Global Fund Top 3 result indicators (2009)

  5. Global Resources DistributionRounds 1-8, (July 2009) Expenditure Component (July 2009) Overview of procurement of medicines by value Estimates from Rounds 2-8 proposals 100% = $8.2 billion USD OP/140709/2

  6. 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 20th 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. 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. Prequalification Programs and Implementation of the GF Quality Assurance Policy 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)

  9. 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. 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) • HostedbyWHO • 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. Evolution of FPPs reviewed by ERP • 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. Prequalification Programs and Quality monitoring 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 : • WHO prequalified or, • ISO/IEC 17025 certified for the required scope of drug testing

  13. 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. 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. 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. DLT and Global Fund : areas for collaboration GF Quality Assurance Policy for diagnostics Background • 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

  17. 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. 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. 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. 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

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