Global Drug Facility:
Providing Access to Medicines and
Commodities for Tuberculosis
Thomas Moore
Manager GDF
Geneva, 19 November 2009
Structure
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Affiliated with Stop TB Partnership, housed at WHO
One stop access to medicines, commodities
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Free grants - fill TB program gaps
Direct procurements – TB program buys through GDF
Technical assistance and capacity building in-country
Current Donors
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USAID
CIDA
UNITAID
others
Mandate
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Increase access to high quality TB drugs
Through a unique procurement mechanism:
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Links demand for drugs to supply and monitoring
Outsources several services to partners on a
competitive basis (procurement agent, quality control)
Uses product packaging to simplify drug management
Links grants to TB programme performance
Products available – susceptible TB
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Adult medicines
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Some single drugs – H, Z, E, S
Fixed dose combination products (FDCs)
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Paediatric medicines
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RHZE, RHZ, RHE, RH, EH
Patient kits – contain all drugs needed to treat one patient
Mostly FDCs – RHZ, RH
Diagnostic kits
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Enough reagents, slides to prepare 1000 sputum tests
Can order only slides if needed
Can order a microscope if needed
Products available – resistant TB
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Adult medicines
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Single drugs – 16 products such as capreomycin,
kanamycin, levofloxacin, cycloserine, PAS, clofazimine
Diagnostics
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In collaboration with Global Laboratory Initiative
Laboratory commodities – various products such as
reagents, pipettes, centrifuges, work stations, incubators
Rapid diagnostic tests
Quality Assurance Process
Qualifies suppliers through three mechanisms:
1. WHO Prequalification program
2. Stringent Regulatory Authority
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National regulatory authority participates in the International
Pharmaceutical Inspectorate Scheme (PICS)
3. Expression of Interest Process
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Supplier applies to WHO Prequalification process
Manufacturing site is GMP inspected by WHO PQ
Supplier submits product dossiers to GDF
Experts review documents for bioequivalence, stability,
packaging, etc (is an interim approval until WHO PQ is
completed within 12 months)
Quality Control Process
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Supplier does batch testing and submits
certificate of analysis
GDF independent laboratory tests each batch
GDF independent agent does visual inspection at
supplier warehouse prior to shipment
Shipments are accompanied by quality certificate
Currently Approved Suppliers
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For susceptible TB
8 suppliers for 12 products
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For multi-drug resistant TB *
8 suppliers for 11 products
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For extensively drug resistant TB **
3 suppliers for 5 products
* MDR TB = TB bacteria are resistant to at least isoniazid and rifampicin
(2 most powerful anti-TB drugs today)
**XDR TB = MDR-TB is present, plus resistance to at least three of the six
classes of available second-line drugs
GDF Impact since 2001
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Total of 15.2 million patient treatments delivered
Number of countries receiving deliveries
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(1)
First-line drugs = 88
Second-line drugs = 42
Average order lead time
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First line drugs = 3-6 months
Second line drugs = 3 months
GDF Impact since 2001
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Diagnostic kits delivered
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Consumable kits = 3628
Microscope kits = 429
Sputum containers = 4064
Equipment starter kits = 785
Established stockpile (buffer stocks) for second
line drugs
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(2)
Used for emergency orders and to fill small order
Established revolving fund for second line drugs
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TB programs can order drugs while awaiting funds, but
only available next year
Contacts
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GDF website:
www.stoptb.org/gdf
Stop TB website:
www.stoptb.org
MDR/XDR-TB website:
www.stoptb.org/wg/mdrtb
Thank you