Global TB Drug Facility

1. “Securing access to high-quality TB drugs” Global TB Drug Facility Montreal, October 2002

2. A novel approach to secure access to high quality drugs to accelerate DOTS expansion, addressing four needs: • The need for more resources for TB drugs • The need for high quality TB drugs • The need for efficient procurement systems • The need for standardised products • An initiative of the Global Partnership to Stop TB • Housed in WHO and managed by Stop TB partnership secretariat. • Aims to provide free drugs for 10 million people with TB by 2005 • Initial funding from Canada, Netherlands & US What is the GDF?

3. Grants of first line drugs, to support DOTS expansion • Countries who are donor dependent for some or all of their drug supply wishing to expand their DOTS programmes • A direct procurement mechanism for countries and NGOs, for use in DOTS programmes • Countries who are financially sound but without good procurement or quality assurance systems • A web-based tool for placing orders and tracking shipments • A white list of ‘prequalified’ manufacturers of quality TB drugs • Countries which are financially sound and with good procurement mechanisms but without a robust quality assurance system What does the GDF offer?

4. 10 Steps to Applying to the GDF GRANT MECHANISM

5. You can download the GDF application form and supporting notes from the GDF website (www.globaldrugfacility.org). You can also obtain them from your WHO regional office. • There are separate forms & notes for NGOs and for countries. • Application forms are available in French, Spanish, Russian and English 1. Obtain the GDF Application Form

6. Countries with a GNP per capita below US$3000 are eligible to apply for a grant of TB drugs through the GDF. • Countries with a GNP per capita below US$1000 will receive priority consideration. • States/provinces within countries meeting the above eligibility criteria can apply (usually decentralised federal political/administrative systems). 2. Determine if your country is eligible for a GDF Grant

7. The GDF has six conditions for support. Please make sure that you can fulfil each of these conditions before making an application to the GDF: • Applicant has multi-year plan for DOTS expansion to reach global targets & commits to treatment of TB patients, free of charge, in DOTS programmes, using WHO approved treatment regimens. • Applicant responsible for payment or waiver of import duty or tax, storage fees or insurance levied on GDF drugs & in-country distribution of drugs. • Where registration of GDF drugs is required, applicant will facilitate this process. • Applicant agrees to independent monitoring of programme performance. • Public sector funding for TB control activities will not be reduced as a consequence of, or during the period that GDF grants are received. • Co-financing and technical co-operation are available from other governments/donors for non-drug aspects of the multi-year plan. 3. Make sure you fulfil the GDF conditions for support

8. Multi-year DOTS Expansion Plan • Technical and operational guidelines for DOTS • Most recent external review of NTP • Most recent annual DOTS case finding and treatment outcome report (WHO annual data collection form) 4. Collect the supporting documents

9. National plan for 3 to 5 years, with first year budget and activities in detail. • Description of present status of the programme and resources, by source. Include all donors/partners, WB, bi-laterals, WHO and the present government resources (not budgeted or promised but the actually disbursed). For govt. indicate the contribution of health staff and infrastructure, without budgeting cost. • Demonstrate clearly in this plan the gap for TB drugs that GDF is expected to cover. • For each type of activity think who, how, when, will it be monitored. • Examples of model plans & applications are featured on the GDF website DOTS Expansion Plan

10. Key partners, technical and financial, should be aware of application to GDF. • Partner support should be demonstrated in writing: e.g. letter supporting application and/or co-signatory of application form. • Ideally applicant should complete application dossier in collaboration with regular partners: bi-lateral, multilateral, NGOs, donors. 5. Ensure you have the support of your partners

11. 6. Calculate the number of patients to be treated

12. Where indicated in the application form (Section C) identify the products and packaging specifications used/desired by the NTP by marking the appropriate check-box e.g. RHZE (150/75/400/275) YES  BLISTER  NO LOOSE HE (150/400) YES BLISTER NO  LOOSE 7. Identify the products and packaging

13. Where indicated in the application form (Section D) provide the consignee details requested. • Clearly indicate the name, address, telephone number, fax and e-mail of the consignee to whom the GDF shipment will be addressed and the same contact details for the person who will track the order/with whom the GDF procurement agent can liase/troubleshoot. • Clearly indicate the the preferred date of delivery & preferred port of delivery. • Clearly indicate any special requirements concerning markings on outermost containers. • Clearly indicate if any special preshipment inspection requirements exist. • Clearly indicate whether shipment can occur prior to registration of TB products, where applicable. • Clearly indicate period of advance notification required. 8. Provide consignee details

14. The covering letter should provide the following information: • Explanation of need for grant of TB drugs: the gap. • Outline proportion of DOTS needs (distinguish between drug & non-drug aspects) covered by govt. and partners (civil society, private sector, donors) to help contextualize gap. • Outline who are the beneficiaries, who will be the implementing partners and strategies for implementation. • Summary of DOTS coverage and success in country. 9. Prepare the covering letter

15. Any application submitted directly to the GDF should also be copied to the relevant WHO regional office. • For security purposes applications should be sent by express/secure carrier e.g. DHL, FedEx, UN pouch. • Applications should be signed and submitted in hard copy. Exact replicas of application form and supporting documents in electronic versions (e-mail or diskette) would also be appreciated. • The GDF contact address is: Global TB Drug Facility Tel: +41-22-791-2399 CDS/STB Fax: +41-22-791-4886 World Health Organization Email: gdf@who.int 20 Avenue Appia CH-1211 Geneva 27 Switzerland 10. Submit the application

16. GDF confirms receipt of application dossier. • If deemed to be complete, application dossier is submitted to next TRC meeting (TRC meet 3 times a year). • TRC makes recommendation on application to Stop TB Co-ordinating Board : Approve, place under further consideration, do not approve. • Stop TB Co-ordinating Board decides on final approval. • GDF organises a country visit to approved applicants and those under consideration. • For approved applicants, grant letter with final grant requirements and consignee details sent to applicant for signature. • Upon receipt of signed letter, GDF places order electronically. • The GDF procurement agent issues a user name and password to access the track and trace details. • Drugs are manufactured & checked for quality. • Drugs are sent to country. What Happens Next?

17. 5 Steps to Applying to the GDF DIRECT PROCUREMENT MECHANISM

18. Countries and NGOs can buy TB drugs for DOTS through the GDF - low cost and good quality • Why use the GDF procurement mechanism? • to save money - so that more funds can be used for other aspects of DOTS • to ensure quality - if adequate quality assurance mechanism not in place • to save time - eg in an emergency • to save work - if robust procurement mechanism not yet established • Available products and prices are listed in the GDF catalogue (www.stoptb.unwebbuy.org) • Additional charges for freight, insurance, quality control, overheads (10-20% of drug costs) • Apply to use the GDF direct procurement mechanism through the GDF secretariat (www.globaldrugfacility.org) Direct procurement mechanism

19. Countries with over 90% DOTS coverage are automatically included • Other countries may be included - visit www.globaldrugfacility.org (Direct Procurement mechanism) to see the list 1. Determine whether your country has been pre-qualified

20. Send a covering letter to the GDF secretariat asking to be prequalified. • Include the most recent WHO annual report • Include documentation of technical and operational policies for the National TB Programme 2. Apply to ‘Approval to buy process’ if you are not pre-qualified

21. 3. Calculate the number of patients to be treated

22. Identify the products and packaging specifications used/desired by the NTP. RHZE (150/75/400/275) YES  BLISTER  NO LOOSE HE (150/400) YES BLISTER NO  LOOSE 4. Identify the products and packaging

23. www.stoptb.unwebbuy.org 5. Place your order on the webbuy site

24. GDF working with WHO Essential Drugs and Medicines Department to prequalify TB products & manufacturers interested in supplying GDF • International EOI was requested by April 2002 • Document review of shortlisted manufacturers begins August 2002 • Physical audits begin October 2002 • Initial White list of TB products and manufacturers Prequalified to the highest standards expected to be available in public domain Dec 2002/Jan 2003 WHITELIST OF PREQUALIFIED MANFACTURERS

25. Eligible countries (and NGOs) can apply to both mechanisms. • Both the GFATM and the GDF support the principles of complementarity and additionality, therefore the GDF TRC will take GFATM TRP recommendations in account when reviewing applications and vice versa. • 3 GDF TRC members are also members of the TB expert group on the GFATM TRP, thereby providing an important link between the mechanisms. • GDF secretariat and GFATM secretariat are currently exploring means for further collaboration to avoid duplication/overlap vis à vis TB applications. • GDF would like to see beneficiaries of GFATM support for TB use the GDF direct procurement mechanism for TB drugs, where local procurement and quality control capacity is lacking. GDF & GFATM

26. www.globaldrugfacility.org gdf@who.int Thank you