global drug facility
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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) - PowerPoint PPT PresentationTRANSCRIPT
An innovative approach to supplying anti-TB drugs
Global Global Drug FacilityDrug Facility
Andrea de Lucia
Team Leader
Applications, Review, and Monitoring
4 November 2010
• 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 is the GDF?
• 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 will the GDF achieve?
• 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) Service for Grant and DP recipients through annual missions for in-country drug management monitoring and training.
What services does the GDF provide?
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)
GDF Conditions of Support
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; ORb) 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• Equipment starter kit• Consumable kit • Microscope kit
• Complete product catalogue available at www.stoptb.org/gdf
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
Initiatives to improve access to Anti-TB drugs