Global Drug Facility

1. Global Drug Facility “Securing timely access to quality, affordable Tuberculosis drugs & related supplies” GFATM Round 6 Proposals STB Consultants Briefing 16 March 2006, Geneva

2. Introduction • What is the GDF? • GDF the Direct Procurement Service? • How GDF can Support GFATM beneficiaries • Practical Steps for R6 Proposals

3. What is the GDF? • GDF is an initiative of the Global Partnership to Stop TB • GDF is housed in WHO & managed by Stop TB partnership secretariat • GDF aims to supply quality assured, affordable drugs in a timelymanner, for 10 million people with TB by 2010 • GDF is more than a procurement mechanism: • A bundled facility not a procurement agent

5. Partnership Framework Global Partners' Forum Global Drug Facility Coordinating Board Partnership Secretariat WHO Technical Advisory Group W O R K I N G G R O U P S DOTS EXPANSION TB/HIV MDR-TB DOTS PLUS New Vaccines New Diagnostics New Drugs Advocacy Communication Social Mobilization TASK FORCES : RESOURCE MOBILIZATION / FINANCING

6. Why the GDF? GDF was created to secure timelyaccess to affordable, high qualitydrugs to accelerate DOTS expansion GDF addresses 5 needs: • The need for more resources for TB drugs • The needfor high quality TB drugs • The needfor efficient procurement systems • The needfor standardized products • The needfor monitoring drug use & tech. assistance for drug management

7. What does GDF offer? • Now: 3 Services Grants of first line drugs, to support DOTS expansion 1 2A direct procurement mechanism for countries and NGOs, to buy 1st & 2nd line drugs for use in DOTS programmes 3A white list of ‘pre-qualified’ manufacturers of quality TB drugs • Future: +3 Services • Grants of Diagnostic Kits • Technical Assistance Service Line • Paediatric Formulations • Bundled with support for • Drug Management/Technical • Assistance

8. Key achievements • >7 million patient treatments committed in 5 years • Deliveries to >60 countries • Value for money: US$ 17 - 22 treatment cost per patient • Annual procurement volume valued at US$ 35 - 40 million • Introduction of innovative packaging: > 1,000,000 Patient Kits delivered to India, Indonesia, Kenya & Philippines • Wide range of Direct Procurement Clients: GFATM, DFID, WHO, World Bank, German Bank for Reconstruction, Caritas • >150 monitoring and technical assistance missions conducted

9. GDF DIRECT PROCURENT SERVICE

10. Who can use the Service? • Countries implementing the DOTS strategy in 90% or more of the population & NGOs supporting DOTS in these countries. • Countries or NGOs approved by the GDF for a grant of free TB drugs. • Countries or NGOs approved for a grant for tuberculosis control by the Global Fund to fight AIDS, Tuberculosis & Malaria • Organizations, donors and technical agencies supporting the above categories of countries or NGOs.

11. Why use the Service? • to save money - so that more funds can be used for other aspects of DOTS • to ensure quality - when adequate quality assurance programmes are not in place • to save time- e.g. in an emergency GDF provides rapid lead times for delivery • to save work - when a robust procurement mechanism is not yet established • to access quality assured fixed dose combination tablets • to standardise TB drug formulations • to access GDF technical support for drug management • GDF is ISO 9001: 2000 Certifiedtherefore offering a stringent and client oriented quality service

12. GDF: A solution for donors Direct Procurement turnover 2003 – 2005: $37 million • > 25 countries GFATM – $7.6 million • 14 countries: • Afghanistan • India • Indonesia • Bangladesh • Cote d'Ivoire • Liberia • Moldova • Mongolia • Namibia • Serbia & Montenegro • Sudan • Tajikistan • Uzbekistan • Ghana DFID - $ 62 million over 5 years • India

13. GFATM Round 6 & GDF

14. GFATM requirements • to procure quality assured products at the lowest possible price and in accordance with national laws and international agreements • to conduct procurement in a transparent fashion • Principal Recipients are accountable for security of the supply of all procured goods • All Second line TB drugs must be procured via Green Light Committee (GLC) approval: GDF & GLC are now converged = all-in-one-service for 1st & 2nd line drugs

15. Outsourcing Procurement • Where Principle Recipients capacity is unable to meet these principles, procurement can be outsourced • The GDF Direct Procurement Service provides an excellent outsourcing option adhering to all GF principles • The Service will assist PRs with key elements of the Procurement and Supply Management Cycle: • 1. Product Selection • 2. Forecasting • 3. Procurement (including low cost and assured quality) • 4. Drug Management support

16. Procurement & Supply Management (PSM) R6 Proposal Selection Management Use Procurement Support Distribution

17. Products RHZE (4FDC) RHE (3FDC) Units Loose 1000 tabs Blisters 672 tabs Loose 1000 tabs Blisters 672 tabs Loose 1000 tabs Blisters 672 tabs Loose 1000 tabs Blisters 672 tabs Loose 1000 tabs Blisters 672 tabs 50 Vials 1.1 Product Selection:Standardized list of products in blisters, patient kits and bulk following WHO guidelines and regimens RH150/75 RH150/150 EH400/150 E400, Z400, H300 S1g Cat. I & III Patient Kit Cat. II Patient Kit

18. 1.2 Product Selection:Diagnostic Kits Equipment starter kit Consumables kit

19. 2. Forecasting Procedures: • Principle Recipient completes and Order Form/Technical agreement • Principle Recipient works with GDF to finalize patient numbers & required quantities using Standardized GDF quantification tool: drugs & diagnostics • GDF supports Principle Recipient with technical and drug management support via annual monitoring mission

20. 3.1 Procurement • GDF competitively & transparentlycontracts its procurement agent • The Procurement Agent contracts manufacturersthroughLimited International Competitive Biddingaccording to World Bank rules • GDF Quality Assurance Process fully compliant with GFATM requirements • Bulk procurement, standardization and prompt payment policy secure low prices

21. 3.2 Procurement • All batches underpreshipment inspection and quality control via independent agent • GDF adheres to Interagency Operational Principles for Good Pharmaceutical Procurement • e-catalogue & e-tracking system for PrincipleRecipients orders • All anti TB products supplied by GDF are registered by National Regulatory Authority of the recipient country where required

22. R6 Proposal: practical steps - 1 Procurement and Supply Management Section of Proposal • In this section, applicants describe their arrangements for procurement & supply management of health products and must specify where purchasing occurs via the Global Drug Facility • Which of the following types of organizations will be involved in the procurement of health products? (Tick all that apply.) • Sub-contracted procurement organization (s) (international) (specify which one [s]) GLOBAL DRUG FACILITY • For each organization to be involved in procurement, please provide the latest available data on the annual value in Euro or US$ of procurement of drugs and related medical supplies by that agency. • Data on annual GDF turnover in US$ available on GDF website at: www.stoptb.org/GDF Tool kit for GFATM Proposals – Round 6

23. R6 Proposal: practical steps - 2

24. R6 Proposal: practical steps - 2 Key Budget Assumptions for requests from GFATM • Drugs, commodities and products Provide a full list of all drugs, commodities and products to be used in the proposed program, together with unit costs and volumes. These unit costs and volumes must be fully consistent with the detailed budget. If prices from sources other than those specified below are used, a rationale must be included. For GLOBAL DRUG FACILITY all available information is on GDF website at: www.stoptb.org/GDF Tool kit for GFATM Proposals – Round 6

25. After Proposal & PSM Plan approval: Practical 10 STEP approach on how to secure delivery of TB drugs via GDF Direct Procurement Service

26. Submit signed form to GDF at GDF.PRS@stoptb.org GDF PRC agent Sends contract for signature Obtain Order Form on GDF website PR sends signed contract to agent PR transfers funds or Bank Guarantee to agent account Steps 1 - 5 Lead time: 2.5 months 1 2 3 4 5 • Patient numbers • Regimens • Consignee details • Specifies terms of support • Specifies Payment Method • Includes pro-forma invoice • PR ensures clauses acceptable • PR Signs contract

27. Order recorded in WEB-based tracking system and PR issued username & password Products analysed independently before shipment then SHIPPED 4 to 6 months later GDF sends Technical Support Mission Agent places order with GDF prequalified & contracted suppliers Confirmation of receipt & clearance of goods sent to Agent Steps 6 - 10 Lead time: 1.5 to 6 months 6 7 8 9 10 • PR can track progress of shipment • E-mail updates sent at least monthly • Preclearance docs • sent in advance • (1 to 4 weeks) • Report on appropriate drug use, progress, needs • Agent liaises with • PR to ensure • REGISTRATION • procedures followed

28. Thank you for your support from the GDF Procurement Team!schmittsa@who.int & GDF.PRS@stoptb.org