Global Drug Facility: Providing Access to Medicines and Commodities for Tuberculosis

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 2001 (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: www.stoptb.org • MDR/XDR-TB website: www.stoptb.org/wg/mdrtb

12. Thank you