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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
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 (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.
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)
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
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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
Thank you !
Andrea de Lucia [email protected]
www.stoptb.org/gdf