Global Drug Facility An innovative approach to supplying anti-TB drugs Andrea de Lucia Team Leader Applications, Review, and Monitoring 4 November 2010
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 supply uninterrupted, 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)
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
What services does the GDF provide? • Grant Service (1 st 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 1 st line anti-TB drugs and diagnostic equipment, or 2 nd line anti-TB drugs for GLC approved projects • Technical Assistance (TA) Service for Grant and DP recipients through annual missions for incountry drug management monitoring and training.
GDF Conditions of Support 1 st 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. 2 nd line products: • Up to November 2010, Green Light Committee approval needed (new mechanism to be defined for 2011 and beyond)
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 : a) Products are pre-qualified by WHO under the WHO PQP; OR b) Products are approved by a SRA c) 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 • Complete product catalogue available at www. stoptb. org/gdf • • • Equipment starter kit Consumable kit Microscope kit
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 (Q 1 2011) Strategic Stockpiles for 1 st and 2 nd line drugs Expand TB project (GLI, FIND, GDF, UNITAID): launched in 7 countries, new
Thank you ! Andrea de Lucia deluciaa@who. int www. stoptb. org/gdf
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