Global Funds andGlobal Funds andInternational CollaborationInternational Collaboration
Essential Drugs and Medicines PolicyWorld Health Organization
October 2003
with thanks to:Stop TB Partnership
Global Fund to Fight AID, Tuberculosis, and Malaria
2 Global Funds.ppt
Global Fund to Fight A,T,M
Global Medicines FacilitiesGlobal Medicines Facilities
Millennium Development Goals Millennium Development Goals
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United Nations Millennium Declaration(18 September 2000)
Goal 1: Eradicate extreme poverty and hunger Goal 2: Achieve universal primary education Goal 3: Promote gender equality and empower women Goal 4: Reduce child mortality
Target 5: Reduce by two-thirds, between 1990 and 2015, the under-five mortality rate
Goal 5: Improve maternal health Target 6: Reduce by three-quarters the maternal mortality ratio
Goal 6: Combat HIV/AIDS, malaria and other diseases Target 7: Halt by 2015 and begin to reverse the spread of HIV/AIDS Target 8: Halt and begin to reverse incidence of malaria, other major diseases
Goal 7: Ensure environmental sustainability Goal 8: Develop a Global Partnership for Development
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MDG Target 17: In cooperation with pharmaceutical companies provide access to affordable essential drugs in developing countries
Indicator 46: Proportion of population with access to affordable essential drugs on a sustainable basis
How to measure? Informed expert opinion Household survey Facility survey
How to improve access Millennium Development Project Task Force
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Global Fund to Fight A,T,M
Global Medicines FacilitiesGlobal Medicines Facilities
Millennium Development Goals Millennium Development Goals
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HIV/AIDS, TB and Malaria are among the world's great killers.
In 2002... 3.1 million people died of AIDS Tuberculosis accounted for 2 million deaths Malaria killed more than 1 million people, mostly children
in Africa
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Figures refer to Rounds 1 and 2 only. Inflection in commitments in Q4 in 2003 is due to the completed signing of all initial agreements; inflection in Q4 of 2004 is due to the approval of funding for Years 3-5 of these programs. Approval of additional rounds during 2003-2005 will greatly increase these projections.
Commitments and Disbursements of Approved Proposals, Rounds 1 and 2 over 2002 – 2005(assuming renewal)
Medicines 30% of projected expenditures
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What is The Global Fund? The purpose is to: attract, manage and disburse additional resources work through a new partnership of public and private
stakeholders reduce infections, illness and death from HIV/AIDS,
tuberculosis and malaria in countries in need contribute to poverty reduction as part of the Millennium
Development Goals
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Agreement
of grantsProposal
developmentProposal
review
Programme implement–ation
Monitoring
& evaluation
Main global fund activities
The Global Fund mantra is:
…raise it (£$€..)
…spend it (£$€..)
… prove it (…had an impact)
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Global Fund administrative arrangements- receives, reviews, funds, monitors proposals
Instructionto disburse
Reporting
Funds
Funds
Reporting
Advice
Trustee
Subrecipient
Primary recipientLocal Fund
Agent
Secretariat
GlobalFund
CountryCoordinatingMechanism
The Local Fund Agent is the "eyes and ears" of the GF in country, assessing PR and advising the Secretariat on ongoing performance – can be local office of int'l audit/ accounting firm, regional bank, etc.
The Primary Recipient(s) is the legally accountable party in country which will disburse to subrecipients and ensure M&E reporting to GF – can be a public, NGO or private (or multilateral) party in the CCM
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190
320250
140
80
470
50
80
Global Fund support should substantially increase the number of people on HAART* in developing countries
HAART recipients in developing countries (000s)+270
+220
790
300
Current HAART recipients**
HAART recipients supported
by Round 1 Funds*
HAART recipients supported
by Round 2 Funds*
Total HAART recipients
after 2 Rounds*
2x
6x
3xIncrease over current recipients
All other developing countries
Sub-Saharan Africa
* Based on proposed figures by the end of 5 years or the end of the proposal period
HAART = highly active anti-retroviral therapy (ARV therapy)
Sub-Saharan Africa
All other developing countries
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Estimated number of Arteminisin-Based treatments available per year* (000s)
Additional treatments
made available through Round 1
The Fund will significantly increase the availability of Arteminisin-Based Derivative Treatments in Africa
+3250
+770
4050
15
~300x
Increase over current treatments
* Based on an estimated average cost of $1.50 per treatment
Current number of treatments available
Additional treatments
made available through Round 2
Total treatments available
with Rounds 1
and 2
* Based on estimated average cost of $1.50 per treatment
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PSM-TF: Critical elements for procurement and supply management
A. Selection and rational use – selection of medicines, diagnostics, other products - adherence, resistance, safety
B. Quality assurance – compliance to quality standards, drug registration, monitoring product quality
C. Procurement and pricing – procurement responsibilities, procurement principles, monitoring suppliers, achieving lowest possible price, international/national law, (domestic production)
D. Supply chain management – supply chain management, forecasting, preventing shortages, preventing diversion
E. Budgeting and finance – (direct payment), discourage duties/taxes, ensuring additionality, )in-kind donations)
F. Monitoring and evaluation – indicators and methods
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Global Fund - Procurement and Supply Management* Policies
See official records of Global Fund to Fight AIDS, Tuberculosis and Malaria for precise information on policies ( www.theglobalfund.org)
1. Procurement practices Interagency Pharmaceutical Procurement Principles
2. Procurement responsibilities Recipient responsible for all procurement if capable Regional/global procurement encouraged if lowers prices
3. Monitoring supplier performance Recipient must monitor and report
4. Quality assurance Supplier qualification – WHO or PIC/S standards after 2004 Routine product quality monitoring
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5. Lowest possible price Competitive purchasing from qualified manufacturers Recipients to apply national laws to achieve lowest price Encourages differential pricing Information on prices paid by Recipients to be made public
6. International and national law Encourages Recipients to use the provisions of the TRIPS and
Doha Declaration, including the flexibilities Fund to defer to appropriate dispute resolution mechanisms
Global Fund - Procurement and Supply Management* Policies
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Expected outcomes for Rounds 1 and 2 after five years
1. More than 500,000 people on antiretrovirals – x3 current
2. 30 million reached with HIV voluntary counseling & testing
3. 500,000+ orphans receiving health, education, community care
4. 2 million additional tuberculosis cases treated with DOTS
5. Over 7,000 new treatments of multi-drug resistant TB – x3
6. 20 million combination drug treatments for malaria delivered
7. 40 million bed nets to protect African families from malaria
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www.globalfundatm.org
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Global Fund to Fight A,T,M
Global Medicines FacilitiesGlobal Medicines Facilities
Millennium Development Goals Millennium Development Goals
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The need for a Global Drug Facility
0
10
20
30
40
50
60
70
80
1990 2000 2010Year
Ca
se
s n
oti
fie
d u
nd
er
DO
TS
(%
)
average rate of progress:target 2013
accelerated progress:target 2005
WHO target 70%
DOTS begins 1991
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New TB Drugs
TB/HIVDOTS-Plus
MDR-TBNew TB
DiagnosticsDOTS
expansion
W O R K I N G G R O U P SW O R K I N G G R O U P S
New TBVaccines
Global Partners Forum
Global TB Drug FacilityCoordinating Board
Partnership SecretariatWHO TechnicalAdvisory Group
Cross-cutting: Advocacy & Communications/ FinancingCross-cutting: Advocacy & Communications/ FinancingCross-cutting: Advocacy & Communications/ FinancingCross-cutting: Advocacy & Communications/ Financing
Global Partnership to Stop TB
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What does the GDF offer?
Grants of first line drugs, to support DOTS expansion A direct procurement mechanism for countries and NGOs,
for use in DOTS programmes A web-based tool for placing orders and tracking
shipments Support for in-country supply management
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GDF Operations
ApplicationEligibility criteria
Specific conditionsStandard form
Supporting documents
SupplyPooled procurementStandard products
High quality Low cost
ReviewIndependent Committee
12-15 membersmeets 3x/yearCountry visit
MonitoringQuarterly reports
Existing monitoringIndependent verification
Results based
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Activity streams for GDF - lessons for others?
Demand Stream
Policies on
rational use
Guidelines for
rational use
National Plan
Grant Appli-cation
Country Assess-
ment
Technical Review
Board Approval
Grant Agree-ment
Supply Stream
Product Specifi-cation
Quality standards
and process
Pre-qualify
suppliers
Quantify Products
Issue Tender
Place Order
Quality control
Freight & Insurance
Drug Manage-
ment Stream
Register & Import
Store & Distribute
Post-market
surveill-ance
Clinical Care &
Support
Monitoring Stream
Indicators
Routine Reports
on Program Results
External Assess-ment of Program
Drug Resistance Survell-
ance
External audit of reports
Key
WHO mandate
National mandate
Facility mandate
Partner mandate
Service function: contract
out
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GDF Products and Prices
Product Unit Cost (US$)
4-FDC (R150/H75/Z400/E275) Loose 1000 tabsBlisters 672 tabs
30.5022.00
2-FDC (R150/H100) Loose 1000 tabsBlisters 672 tabs
11.668.87
HE FDC (H150/E400) Loose 1000 tabsBlisters 672 tabs
11.778.92
Streptomycin 0.75g 50 Vials 2.70
Isoniazid 300mg Loose 1000 tabsBlisters 672 tabs
3.653.76
Ethambutol 400mg Loose 1000 tabsBlisters 672 tabs
10.928.67
Pyrazinamide 400mg Loose 1000 tabsBlisters 672 tabs
12.649.81
GDF Catalogue: www.stoptb.unwebbuy.org
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Performance Monitoring
Milestones DaysFrom To Expected Actual
Submission of application form First review by TRC 15 11First review by TRC Final decision of STB CB WC 72 47Final decision of STB CB WC Place order 11 106Place order Clean report of findings 53 91Clean report of finding Arrival in country 16 13Arrival in country Arrival in central drug store 5 0
TOTAL 172 267
-
50
100
150
200
250
300
Review Decision Order CRF Arrival
Achievement
Target
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GDF Lessons
Establish a partnership of agencies For political, technical, and financial support
Ensure total supply chain management Link demand, supply and monitoring to increase access and rational use
Create a ‘virtual supply agency’ Each critical function is carried out by organization best-placed to handle
Use product packaging to simplify logistics, promote rational use, enhance patient acceptability and compliance
Standard list of TB drugs, fixed dose combinations, patient packs Grants of drugs used to catalyse improvements in quality of health care
Develop a diverse funding base Donor grants to GDF Direct procurement - countries and NGOs use own resources Donors/lending agencies (eg WB/GFATM) for support to countries
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www.stoptb.unwebbuy.org
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What about HIV-AIDS and malaria?…current thinking and planning…
“GMS” = a “trio of disease-partnership efforts” with a common co-ordination mechanism within WHO:
GDF continues for TB – new facility for malaria AIDS care facilities for medicines and diagnostics (ACF? ADDF?)
Improve supply management and care through the supply of core commodities for HIV/AIDS, TB and Malaria
To facilitate a wide range of functions: forecasting needs selection quality assurance procurement market stimulation resource mobilisation IPR issues technical assistance
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Options for procurement of medicines, diagnostics, other health products within a global facility
Informed buying sharing information on prices and supplier, individual purchase
Coordinated informed buying joint market research, sharing supplier information and price monitoring individual contracting and purchasing
Group contracting joint supplier selection and price negotiation, agreement to purchase actual purchasing still between buyer (government, NGO) and supplier
Virtual supply agency central tendering and contracting with global procurement agent like GDF for TB
International supply agency – UNICEF, IDA
See Details in HandoutAdapted in part from: Options For Procurement Of Antimalarial Drugs, RBM-IOM Expert Consultation on Procurement and Financing Of Antimalarial Treatment, Washington, September 15, 2003, A. Edward Elmendorf
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Global Fund to Fight A,T,M
Global Medicines FacilitiesGlobal Medicines Facilities
Millennium Development Goals Millennium Development Goals
