1. TBS Meeting Geneva, November 2010 Procurement and Supply Management Policies WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, November 2010 Sophie Logez Pharmaceutical Management Unit

2. TBS Meeting Geneva, November 2010 Presentation Outline 1.Global Fund grants: portfolio update and results 2.Global Fund approach to pharmaceutical and health products management

3. TBS Meeting Geneva, November 2010 Status of Global Fund Grants Financial StatusProposals Approved (R1-8) Grants signed US$ Money disbursed US$ Global Fund financing (US$), November 2009 19.7 billion16.4 billion12.1 billion61% Financing 785 grants in 145 countries (Nov. 10) Objective of the Global Fund “making a “sustainable and significant” contribution to the achievement of the Millennium Development Goals”

4. TBS Meeting Geneva, November 2010 Rapid scaling up of results Intervention mid 2007mid 2008July 2009June 2010 HIV: People on ARV treatment 1.1 million1.75 m2.3 m2.8 m TB: People treated under DOTS 2.8 million3,9 m5.4 m7m Malaria: Insecticide-treated nets distributed 30 million59 m 88 m122 m Malaria treatment 142.4m Global Fund Top 3 result indicators (2010)

5. TBS Meeting Geneva, November 2010 Global Fund Approved Proposals By Region (Rounds 1-9) OP/140709/2 Source: Global Fund Grant Data

6. TBS Meeting Geneva, November 2010 Disease Components Distribution Rounds 1-9 (July 2010) Global Fund Resources by Disease Component 100% = US$ 16.4 billion Percentages of total funds approved by the Board, including Phase 2 & RCC OP/140709/3

7. TBS Meeting Geneva, November 2010 How are Grant Funds Used? Resources by Expenditure Component (July 2009) Estimates from Rounds 2-8 proposals 100% = $8.2 billion USD OP/140108/6

8. TBS Meeting Geneva, November 2010 The Global Fund Approach Pharmaceutical and Health Product Management Principles and minimum standards, not detailed procedures “Operational principles for Good Pharmaceutical Procurement” Build upon existing systems Principal Recipients responsible for all PSM activities

9. TBS Meeting Geneva, November 2010 What it can include Products Pharmaceuticals Health products Health equipment Equipment Services Registration Selection Forecasting Procurement Transport Quality assurance/QC Storage Distribution Monitoring Pharmacovigilance Activities Procurement costs Quality Assurance costs Distribution costs Training Technical Assistance Capacity Building

10. TBS Meeting Geneva, November 2010 Outline Global Fund principles on PSM QA Policy for pharmaceutical products (1 July 2009) Price & Quality Reporting

11. TBS Meeting Geneva, November 2010 Policies and Principles Quality-assured products Lowest possible price National laws and international agreements Transparent, fair and competitive procurement Guide outlines what PRs need to do

12. TBS Meeting Geneva, November 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 + +

13. TBS Meeting Geneva, November 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

14. TBS Meeting Geneva, November 2010 Publication of QC Results

15. TBS Meeting Geneva, November 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

16. TBS Meeting Geneva, November 2010 Policies Perspectives Study on the QA status of medicines other than ARVs, anti-TB and antimalarial products –Develop QA approach for such medicines Proposed QA Policy for Diagnostic Products –To be endorsed by the Board in December 2010

17. TBS Meeting Geneva, November 2010

18. TBS Meeting Geneva, November 2010 –Make publicly available price and quality information Transparency Informed procurement decisions by countries Basis to develop demand forecasts –Monitor price and quality information Price analysis report Price trend, regional comparison Purchase price report PQR usage & data audit status QA Compliance –Analyze procurement information for policy purposes Health Products to be reported: ARVs Antimalarial medicines Tuberculosis medicines Bednets Condoms Rapid Diagnostics Kits

19. TBS Meeting Geneva, November 2010 Budgeting & Grant negotiation –Proposal development, TRP Review, PSM Plan Review Grant Implementation –Monitoring of compliance with QA Policy –Review by PRs of prices achieved versus peers Grant Performance Reviews –Benchmarking of prices achieved versus peers –Review of QA issues Identification of value for money opportunities Transparency Use of PQR in Grant Lifecycle

20. TBS Meeting Geneva, November 2010