Procurement and Supply Management Policies WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, October 2012 Sophie Logez PSM Hub

Global Fund Grants Objective of the Global Fund Financial Status Proposals Approved Grants signed US$ Money disbursed Global Fund financing (US$), November 2012 19.7 billion 16.4 billion 12.1 billion 61% Objective of the Global Fund “making a “sustainable and significant” contribution to the achievement of the Millennium Development Goals”

Global Fund Top 3 result indicators (2010) Intervention June 2012 HIV: People receiving antiretroviral treatment 3.6 m TB: new cases of infectious tuberculosis detected and treated 9.3m Malaria: Insecticide-treated nets distributed 270 m Malaria treatment delivered 260 m The Global Fund to Fight AIDS, Tuberculosis and Malaria was created in 2002 to dramatically increase resources to fight three of the world’s  most devastating diseases and to channel the money to areas of greatest need. While the majority of Global Fund investments support treatment and prevention efforts in the fight against HIV/AIDS, it has emerged as the predominant funder of tuberculosis and malaria programs, making up two-third of international commitments for these diseases.

Global Fund Approved Proposals By Disease Component (End 2011) Slide author: Ange-Joël DJOMAN (PIE Unit), January 2012. Data to be updated every 6 months. Source: Proposals data (Ombeni). Notes: All data correct to end of 2011 (Rounds 1-10). 100% = US$ 22.8 billion. Percentages of total funds approved by the Board, including Phase 2, RCC & NSA. Source: Global Fund Grant Data 4

Global Fund Approved Proposals By Region (2002 to mid-2011) Slide author: Ange-Joël DJOMAN (PIE Unit), January 2012. Data to be updated every 6 months. Source: Proposals data (Ombeni). - All data correct to end 2011 (Rounds 1-10). - 100% = US$ 22.8 billion. - Percentages of total funds approved by the Board, including Phase 2, Rolling Continuation Channel and National Strategy Applications (NSA). - NSA is an approach that enables funding requests to the Global Fund in the form of a national strategy; creating an incentive for country stakeholders to develop robust national strategies, eliminate parallel planning efforts and contribute to improving harmonization among donors. Source: Global Fund Grant Data 5

Distribution of funding Ttt to be increased with new ARVs treatment guidlines 37% of funds for health products

Outline Global Fund principles on PSM QA Policy for pharmaceutical products Price & Quality Reporting This is a good introduction to present the revised GF QA policy for PP

Policies and Principles for PSM Principles and minimum standards “Operational principles for Good Pharmaceutical Procurement” Build upon existing systems PSM activities Outlines what PRs need to comply with Quality-assured products Lowest possible price National laws and international agreements Transparent, fair and competitive procurement This is essential that applicants read the Guide on Policies before preparing the proposal- the guide exist in four langages. Beside, Guidelines for proposal round 8 And Round 8 frequently asked questions

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, Only If <2 WHO PQed or SRA authorized products available 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 Monitoring Quality Monitoring quality of products all along the supply chain Systematic random quality control testing Recipients report testing results to Global Fund + +

Monitoring product quality 1. Clinical Criteria 2. Quality Criteria 3. Monitoring Quality Monitoring product quality “The quality of FPPs procured with Global Fund grant funds must be monitored.” “PRs to conduct systematic random testing, and report testing results to Global Fund” Principles of quality monitoring: Concerns all products (including WHO-prequalified and SRA- authorized products) Monitoring done all along the supply chain Systematic random quality control testing (following a plan - not all products / lots will be tested)

1. Clinical Criteria 2. Quality Criteria 3. Monitoring Quality at country level “Guidance for Reinforcing and /or Establishing Pharmaceutical Quality Control Systems and Related Stock Management Activities in Countries Supported by the Global Fund “ : support implementation of the Global Fund’s QA Policy. provide technical guidance to recipients on quality control testing activities http://www.theglobalfund.org/documents/psm/PSM_QCMonitoringGFPRsVP_Guide_en.pdf Frequently Asked Questions

Quality monitoring at country level 1. Clinical Criteria 2. Quality Criteria 3. Monitoring Quality

Publication of QC Results

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

Make publicly available price and quality information Transparency Informed procurement decisions Basis to develop demand forecasts Monitor price and quality information Price analysis report Price trend, regional comparison Purchase price report QA Compliance Analyze procurement information for policy purposes Health Products reported: ARVs Antimalarial medicines Tuberculosis medicines Bednets Condoms Rapid Diagnostics Kits

Global Fund Financed Procurement of key products since 2009 From 2009-2011, more than US$ 2.122 billion1 of antiretrovirals, long-lasting insecticidal nets, antimalarial medicines and anti-TB medicines were delivered to Global Fund Principal Recipients and reported to the PQR. Product Category Total Product Cost (USD) Bednet $863,800,266 Anti-Retroviral $816,509,939 Anti-Malaria Medicine $145,187,211 Diagnostic test $135,067,022 Anti-TB Medicine $124,169,159 Condom $37,407,498 Grand Total $2,122,141,095 1 As reported to the PQR on 02 April 2012

Use of PQR in Grant Lifecycle 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