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

Thank you !Andrea de Lucia deluciaa@who.int

www.stoptb.org/gdf