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TBS Meeting Geneva, November 2010
Procurement and Supply Management Policies
WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, November 2010
Sophie LogezPharmaceutical Management Unit
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
TBS Meeting Geneva, November 2010
Status of Global Fund Grants
Financial Status Proposals
Approved
(R1-8)
Grants signed
US$
Money disbursed
US$
Global Fund financing (US$), November 2009
19.7 billion 16.4 billion 12.1 billion 61%
Financing 785 grants in 145 countries (Nov. 10)Financing 785 grants in 145 countries (Nov. 10)
Objective of the Global Fund“making a “sustainable and significant” contributionto the achievement of the Millennium Development Goals”
TBS Meeting Geneva, November 2010
Rapid scaling up of results
Intervention mid 2007 mid 2008 July 2009 June 2010
HIV: People on ARV treatment 1.1 million 1.75 m 2.3 m 2.8 m
TB: People treated under DOTS 2.8 million 3,9 m 5.4 m 7m
Malaria: Insecticide-treated nets
distributed30 million 59 m
88 m 122 m
Malaria treatment 142.4m
Global Fund Top 3 result indicators (2010)
TBS Meeting Geneva, November 2010
Global Fund Approved ProposalsBy Region (Rounds 1-9)
OP/140709/2
Source: Global Fund Grant Data
TBS Meeting Geneva, November 2010
Disease Components DistributionRounds 1-9 (July 2010)
Global Fund Resources by Disease Component
100% = US$ 16.4 billion Percentages of total funds approved by the Board, including Phase 2 & RCC
OP/140709/3
Malaria28%
HIV/AIDS56%
TB16%
TBS Meeting Geneva, November 2010
Administration7%
Human Resources
21%
Commodities, Products, Drugs
45%
Monitoring and Evaluation
4%
Infrastructure and Equipment
9%
Other14%
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
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
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
TBS Meeting Geneva, November 2010
Outline
• Global Fund principles on PSM• QA Policy for pharmaceutical products (1 July 2009)• Price & Quality Reporting
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
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 productsAuthorization 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
+ +
TBS Meeting Geneva, November 2010
Distribution of Products by Quality Criteria
Number of Purchases Reported to the PRM/PQR by Quality Level
783
1126
1521 15901696
371
285
288
499
576
28
41
78
50
58
193
185
138
61
58
66
169
141
202
380
0
500
1000
1500
2000
2500
3000
2005 2006 2007 2008 2009
Nu
mb
er o
f P
urch
ases
GLC
C2
C1
B
A
WHO Prequalified and SRA approved products are purchased in priority, if available.Currently, 95% (in units) of ARVs purchased by PRs are WHO PQed
TBS Meeting Geneva, November 2010
Publication of QC Results
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
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
TBS Meeting Geneva, November 2010
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
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
TBS Meeting Geneva, November 2010