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Quality for Medicines The Global Fund approach

Quality for Medicines The Global Fund approach. Sophie Logez Manager, QA and Data Quality Pharmaceutical Management Unit. T he Global Fund. Guiding principles Operate as a financial instrument Make available and leverage additional financial resources

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Quality for Medicines The Global Fund approach

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  1. Quality for MedicinesThe Global Fund approach Sophie Logez Manager, QA and Data Quality Pharmaceutical Management Unit

  2. The Global Fund Guiding principles • Operate as a financial instrument • Make available and leverage additional financial resources • Support programs that evolve from national plans and priorities • Performance-based funding mechanism “Making a “sustainable and significant” contribution to the achievement of the Millennium Development Goals” Financing 700 grants in 144 countries (May 2010)

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

  4. The Global Fund PSM Policy Principles • Quality-assured products • Lowest possible price • Transparent, fair and competitive procurement • National laws and international agreements • Build on existing systems Recipients are responsible for health products management

  5. Development of the Global Fund QA Policy for Pharmaceutical Products 2007 For limited and single source*: - WHO PQ SRA approved Or GMP site Or GMP site and submission to PQ * New definition of Single and limited source 2005 For limited and single source: - WHO PQ SRA approved Or - GMP site Or - GMP site and submission to WHO PQ 2008/2009 For all ARVs, anti-TB, anti malarials: - WHO PQ or SRA approved Or - ERP recommended 2010 Interim exception for some live saving anti malarial and anti TB 2002 For limited and single source: - WHO PQ SRA approved Or - GMP manufacturing site

  6. QA Policy for Pharmaceutical Products • Since 2002, medicines WHO PQed and or SRA authorized be a priority with a step approach to increase the number of formulations concerned: • Single and limited source ARVs and antimalarials (TB medicines multisource) • More stringent definition of single and limited source • More stringent criteria for all ARVs, antimalarials and anti TB medicines • the Expert Review Panel mechanism Possibility of purchasing products authorized by an ERP on the basis of a risk/benefit assessment of products dossier not yet WHO PQed or SRA for a time-limited period (1 year)

  7. QA Policy for Pharmaceutical Products (as of 2009) • Quality Criteria • For all products • Authorization for use in the recipient countries • For ARVs, anti-TB and anti-malarial products • WHO Prequalified or authorized by a Stringent Regulatory Authority; • or • Recommended for use by an Expert Review Panel, • OnlyIf <2 WHO PQed or SRA authorized products available • Monitoring Quality • Monitoring quality of products all along the supply chain • Systematic random quality control testing • Recipients report testing results to Global Fund • Clinical Criteria • Medicines listed in WHO or national or institutional Standard Treatment Guidelines • Require applicants/ recipients to provide justification for selection of unlisted products in one of the STGs + +

  8. Transparency and Accountability Establishment of the Price and Quality Reporting system for key health products, including ARVs, anti-malarial and anti TB medicines • Make publicly available price and quality information • Transparency • Informed procurement decisions by countries • Basis to develop demand forecasts • Monitor price and quality information • Analyze procurement information for policy purposes

  9. Publication of QC Results

  10. Distribution of Products by Quality Criteria WHO Prequalified and SRA approved products are purchased in priority, if available. Currently, 95% (in units) of ARVs purchased by PRs are WHO PQed

  11. Products reviewed by the Expert Review Panel since 2009 • Three ERP set of reviews (May, October 2009 and April 2010) based on an invitation for expression of interest to submit product dossiers • 98 product dossiers submitted and reviewed by ERP: • 38 products permitted for use for a one year period

  12. Partnerships in Quality Assurance • Close collaboration with WHO PQ • Expert advice • QA Policy implementation: ERP management • WHO Disease Programs: HIV, Malaria, TB • Collaboration/information sharing with other donors and suppliers, such as UNICEF, UNDP • Working toward policy harmonization with partners eg. GDF • Regular communication with manufacturers: annual meeting • Monitoring QA activities and publication of results

  13. Challenges • Increasing demands for • Malarial ,TB, and OI medicines of assured quality • Quality Control Laboratories compliant with GF requirements • Strengthening National Regulatory Authority capacity and regulatory networking and harmonization • Lack of consistent Quality Assurance system of Procurement Agents

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