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
Status of Global Fund Grants
Financing 678 grants in 140 countries (Nov. 09)
Financial Status
Global Fund financing
(US$), November 2009
Proposals
Approved
(R1-8)
18.7 billion
Grants
signed
US$
13.6 billion
Money
disbursed
US$
9.2 billion
45%
Objective of the Global Fund
“making a “sustainable and significant” contribution
to the achievement of the Millennium Development Goals”
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
Middle East &
North Affrica
6%
East Asia &
Pacific
14%
Eastern Europe
& Central Asia
7%
Latin America &
the Caribbean
7%
Sub-Saharan
Africa
58%
South Asia
8%
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
Malaria
29%
HIV/AIDS
57%
TB
14%
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)
Other
14%
Monitoring and
Evaluation
4%
Infrastructure
and Equipment
9%
Commodities,
Products, Drugs
45%
Administration
7%
Human
Resources
21%
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
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
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
Price Comparison
Quality
Quality Monitoring
Market Information
Delivery Conditions
General
Public
Partners
Verify Data
Local Fund Agent
TBS Meeting
Geneva, November 2009
Principal
Recipients
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
TA as
planned
Phase 1
Proposal
approved
Grant
signature
Phase 2
Phase 2
review