1. RHSC Meeting Kampala, 27- 28 May 2010 Quality for Medicines The Global Fund approach Sophie Logez Manager, QA and Data Quality Pharmaceutical Management Unit

2. RHSC Meeting Kampala, 27- 28 May 2010 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. RHSC Meeting Kampala, 27- 28 May 2010 Global Resources Distribution Rounds 1-8, (July 2009) Procurement of medicines by value OP/140709/2 Expenditure Component (July 2009) Estimates from Rounds 2-8 proposals 100% = $8.2 billion USD

4. RHSC Meeting Kampala, 27- 28 May 2010 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. RHSC Meeting Kampala, 27- 28 May 2010 Development of the Global Fund QA Policy for Pharmaceutical Products 2002 For limited and single source: - WHO PQ SRA approved Or - GMP manufacturing site 2005 For limited and single source: - WHO PQ SRA approved Or - GMP site Or - GMP site and submission to WHO PQ 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 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

6. RHSC Meeting Kampala, 27- 28 May 2010 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. RHSC Meeting Kampala, 27- 28 May 2010 QA Policy for Pharmaceutical Products (as of 2009) 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 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, Only If <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 + +

8. RHSC Meeting Kampala, 27- 28 May 2010 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 Transparency and Accountability

9. RHSC Meeting Kampala, 27- 28 May 2010 Publication of QC Results

10. RHSC Meeting Kampala, 27- 28 May 2010 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. RHSC Meeting Kampala, 27- 28 May 2010 Products reviewed by the Expert Review Panel since 2009 NumberTotalARVAnti- Malarials Anti-TB Products permitted for use by ERP – pre qualified by WHO (feb10) – approved by SRA (USFDA) (Feb 10) 38 9 5 17 7 5 4 1 NA 18 1 NA Products NOT permitted for use by ERP – currently pre qualified by WHO – currently approved by SRA (USFDA) 60 0 1 16 0 1 23 0 NA 21 0 NA 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. RHSC Meeting Kampala, 27- 28 May 2010 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. RHSC Meeting Kampala, 27- 28 May 2010 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