Procurement and Supply Management Policies WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, November 2009 Sophie Logez Pharmaceutical Management Unit TBS Meeting Geneva, 18 November 2009
Presentation Outline 1. Global Fund grants: portfolio update and results 2. Global Fund approach to pharmaceutical and health products management TBS Meeting Geneva, November 2009
6 78 gr a nt s in 1 40 Financial Status Proposals Grants Money co signed disbursed Approved u US$ (R 1 -8) nt ri Global Fund financing 18. 7 billion 13. 6 billion 9. 2 billion 45% (US$), November 2009 es (N ov. 0 Objective of the Global Fund 9) “making a “sustainable and significant” contribution to the achievement of the Millennium Development Goals” Status of Global Fund Grants TBS Meeting Geneva, November 2009
Rapid scaling up of results Global Fund Top 3 result indicators (2009) Intervention mid 2007 mid 2008 July 2009 HIV: People on ARV treatment 1. 1 million 1. 75 m 2. 3 m TB: People treated under DOTS 2. 8 million 3, 9 m 5. 4 m Malaria: Insecticide-treated nets distributed 30 million 59 m 88 m TBS Meeting Geneva, November 2009
Regional Distribution Rounds 1 -8, (July 2009) Global Fund Grant Resources by Region 100% = US$ 15. 9 billion Percentages of total funds approved by the Board, including Phase 2 & RCC TBS Meeting Geneva, November 2009 OP/140709/2
Disease Components Distribution Rounds 1 -8, (July 2009) Global Fund Resources by Disease Component 100% = US$ 15. 9 billion Percentages of total funds approved by the Board, including Phase 2 & RCC TBS Meeting Geneva, November 2009 OP/140709/3
How are Grant Funds Used? Resources by Expenditure Component (July 2009) Estimates from Rounds 2 -8 proposals 100% = $8. 2 billion USD TBS Meeting Geneva, November 2009 OP/140108/6
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 TBS Meeting Geneva, November 2009
What it can include • • Products Pharmaceuticals Health products Health equipment Equipment Activities • • • Procurement costs Quality Assurance costs Distribution costs Training Technical Assistance Capacity Building TBS Meeting Geneva, November 2009 Services • • • Registration Selection Forecasting Procurement Transport Quality assurance/QC Storage Distribution Monitoring Pharmacovigilance
Outline • Global Fund principles on PSM • QA Policy for pharmaceutical products (1 July 2009) • Price & Quality Reporting TBS Meeting Geneva, November 2009
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 TBS Meeting Geneva, November 2009
Revised QA Policy for Pharmaceutical Products (July 2009) Quality Criteria 1. Quality criteria for all products Authorization for use in the recipient countries 2. Quality criteria for ARVs, anti-TB and antimalarials: in addition to criteria 1. , Selection of FPPs: - WHO prequalified (option A) or SRA authorized (option B) Or - permitted for use based on the advice of the Expert Review Panel TBS Meeting Geneva, November 2009
Selection Process of ARVs, Anti-TB or Antimalarial products 2 or more A or B products Available? No ERP recommended Product available? Yes • Notify the GF • Receive no objection • Testing by GF Lab Procure A or B Product No GF request an ad hoc ERP committee to review eligible product Procure ERP recommended Product unavailability: Inability to supply sufficient quantity of product within not less 90 days of the requested delivery date TBS Meeting Geneva, November 2009
Revised QA Policy for Pharmaceutical Products Monitoring quality product • Monitoring quality of products all along the supply chain • Systematic random quality control testing • Recipients report testing results to Global Fund TBS Meeting Geneva, November 2009
Policies Perspectives • Study on the QA status of medicines other than ARVs, anti-TB and antimalarial products – Develop QA requirements for such medicines • Study on the QA status of Diagnostics – Development of a QA Policy for IVDs by 2010 TBS Meeting Geneva, November 2009
Policies and Initiatives Objectives • Significantly increase speed of grant implementation and grant performance • Reduce the burden on recipient by easing procurement bottlenecks in country • Coordination with partners. 1. 2. 3. MDR-TB treatment • Green Light Committee support services Voluntary Pooled Procurement and Capacity Building Services • Launched in June 2009 Affordable Medicine Facility for malaria (AMFm) • Approved in November 2008 TBS Meeting Geneva, November 2009
• It is mandatory, as a part of the Grant Agreement that PRs enter procurement and quality data for key health products in the PQR • Health Products to be reported: – ARVs – Antimalarial medicines – Tuberculosis medicines – Bednets – Condoms – Rapid Diagnostics Kits TBS Meeting Geneva, November 2009
How PQR Works? The Global Fund Price Quality Monitoring Principal Recipients Price Comparison Market Information Delivery Conditions General Public Partners Verify Data Local Fund Agent TBS Meeting Geneva, November 2009 Reports Principal Recipient Monitor
Objectives • Monitor procurement price and quality information on key health products procured with Global Fund funds: – Inform implementers on market conditions – Monitoring Pricing and supplier performance – Monitoring QA Policy compliance • Make publicly available price and quality information – Inform procurement decisions by countries – Basis for stakeholders to develop long-term demand forecasts • Analyze procurement information for various policy and decision-making purposes TBS Meeting Geneva, November 2009
TBS Meeting Geneva, November 2009
Work Plan • More features and reports are available (October 09) – – – • • Price analysis report Price trend Purchase price report PQR usage & data audit status QA Compliance regional comparison Data quality monitoring and follow-ups with PR Further Improve functionality and speed TBS Meeting Geneva, November 2009
TBS Meeting Geneva, November 2009
Planning Technical support to prepare the proposal: • PSM experts • Laboratory experts • Regulatory authorities • IPR experts Technical support PSM plan preparation Team work Proposal + Attachment B Preparation TBS Meeting Geneva, November 2009 Capacity building as planned TA as planned Phase 1 Proposal approved Grant signature Phase 2 review
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