1. Global Drug Facility: Providing Access to Medicines and Commodities for Tuberculosis
Thomas Moore
Manager GDF
Geneva, 19 November 2009

2. Structure Affiliated with Stop TB Partnership, housed at WHO
One stop access to medicines, commodities
Free grants - fill TB program gaps
Direct procurements – TB program buys through GDF
Technical assistance and capacity building in-country
Current Donors
USAID
CIDA
UNITAID
others

3. Mandate Increase access to high quality TB drugs
Through a unique procurement mechanism:
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

4. Products available – susceptible TB
Adult medicines
Some single drugs – H, Z, E, S
Fixed dose combination products (FDCs)
RHZE, RHZ, RHE, RH, EH
Patient kits – contain all drugs needed to treat one patient
Paediatric medicines
Mostly FDCs – RHZ, RH
Diagnostic kits
Enough reagents, slides to prepare 1000 sputum tests
Can order only slides if needed
Can order a microscope if needed

5. Products available – resistant TB
Adult medicines
Single drugs – 16 products such as capreomycin, kanamycin, levofloxacin, cycloserine, PAS, clofazimine
Diagnostics
In collaboration with Global Laboratory Initiative
Laboratory commodities – various products such as reagents, pipettes, centrifuges, work stations, incubators
Rapid diagnostic tests

6. Quality Assurance Process
Qualifies suppliers through three mechanisms:
WHO Prequalification program
Stringent Regulatory Authority
National regulatory authority participates in the International Pharmaceutical Inspectorate Scheme (PICS)
Expression of Interest Process
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)

7. Quality Control Process
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

8. Currently Approved Suppliers
For susceptible TB
8 suppliers for 12 products
For multi-drug resistant TB *
8 suppliers for 11 products
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

9. GDF Impact since (1)
Total of 15.2 million patient treatments delivered
Number of countries receiving deliveries
First-line drugs = 88
Second-line drugs = 42
Average order lead time
First line drugs = 3-6 months
Second line drugs = 3 months

10. GDF Impact since 2001 (2) Diagnostic kits delivered
Consumable kits = 3628
Microscope kits = 429
Sputum containers = 4064
Equipment starter kits = 785
Established stockpile (buffer stocks) for second line drugs
Used for emergency orders and to fill small order
Established revolving fund for second line drugs
TB programs can order drugs while awaiting funds, but only available next year

11. Contacts GDF website: www.stoptb.org/gdf Stop TB website:
MDR/XDR-TB website:

12. Thank you