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Global Drug Facility

An innovative approach to supplying anti-TB drugs. Andrea de Lucia Team Leader Applications, Review, and Monitoring 4 November 2010. Global Drug Facility. What is the GDF?. An initiative of the Global Partnership to Stop TB (operational in 2002)

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Global Drug Facility

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  1. An innovative approach to supplying anti-TB drugs Andrea de Lucia Team Leader Applications, Review, and Monitoring 4 November 2010 Global Drug Facility

  2. What is the GDF? • An initiative of the Global Partnership to Stop TB (operational in 2002) • Housed in WHO and managed by Stop TB Partnership secretariat • Aims to supplyuninterrupted,quality assured, affordable anti-TB medicines, where they are needed, when they are needed • More than a traditional procurement mechanism, GDF is a bundled facility (ie, supplies quality assured drugs AND provides TA in drug management)

  3. What will the GDF achieve? • Supply treatments for 15 million patients by 2010 (actually 16 million)and for 25 million by 2015 • Improve the quality and reduce prices (~USD 20 FLD, ~ USD 2000-6000 SDL) of anti-TB medicines worldwide • Contribute to the achievement of MDG 6 • Mitigate the emergence of drug resistance TB

  4. What services does the GDF provide? • Grant Service (1st line anti-TB drugs) for countries and NGOs that are donor-dependent for some or all of their drug supply (adult & paediatric formulations) or in Emergency situations • Direct Procurement (DP) Service for countries, NGOs and donors wanting to buy 1st line anti-TB drugs and diagnostic equipment, or 2nd line anti-TB drugs for GLC approved projects • Technical Assistance (TA) Servicefor Grant and DP recipients through annual missions for in-country drug management monitoring and training.

  5. GDF Conditions of Support 1st line products: • DOTS (expansion) programme, including that drugs and treatment should be free to patients • Grant support only to countries with GNI USD <3000 and GDF support should not replace/ displace government funding for anti-TB drugs • Agree to annual missions to look at use of GDF drugs and quantification for next year's need. 2nd line products: • Up to November 2010, Green Light Committee approval needed (new mechanism to be defined for 2011 and beyond)

  6. GDF Products • GDF offers standardized WHO-approved anti-TB products that are prioritized by the WHO Stop TB Department • GDF Quality Assurance harmonized with the Global Fund QA policy. Finish Pharmaceutical Products must meet the following criteria : • Products are pre-qualified by WHO under the WHO PQP; OR • Products are approved by a SRA • Quality risk assessment process managed by an independent Expert Review Panel (ERP). Products are eligible under two conditions: 1) GMP compliance 2) Dossier accepted for assessment by WHO PQP or SRA • Products and packaging contribute to rationale drug use, including use of Fixed Dose Combination (FDC) tablets, blister packaging, child formulations and patient kits • Diagnostic kits for drug susceptible TB • Equipment starter kit • Consumable kit • Microscope kit • Complete product catalogue available at www.stoptb.org/gdf

  7. Initiatives to improve access to Anti-TB drugs With support from UNITAID • Paediatric formulations available through grants and now direct procurement with GDF • MDR-TB Scale-up: grants to GF recipients with GLC approved projects to increase the number of patients with access to MDR-TB treatment and prevent treatment interruption • Strategic Revolving Fund: for countries who encounter problems in funding disbursements (Q1 2011) • Strategic Stockpiles for 1st and 2nd line drugs • Expand TB project (GLI, FIND, GDF, UNITAID): launched in 7 countries, new diagnostic test for DR-TB

  8. Thank you !Andrea de Lucia deluciaa@who.intwww.stoptb.org/gdf

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