“Securing timely access to quality, affordable TB drugs” Global TB Drug Facility

What is the GDF? An initiative of the Global Partnership to Stop TB Housed in WHO & managed by Stop TB partnership secretariat Aims to supply quality assured, affordable drugs, where they are needed, when they are needed More than a traditional procurement mechanism – A bundled facility not a procurement agent

Why do we need a GDF?

What will the GDF achieve? Catalyse DOTS expansion to reach global targets by 2005 Supply treatments for 15 million patients by 2010 & for 25 million by 2015 Contribute to the achievement of the health MDGs Mitigate the emergence of drug resistance Improve the quality of TB drugs world-wide Rationalize procurement mechanisms Create successful model of cooperation to confront a global epidemic

Contractual Partners Procurement services - UNDP/IAPSO Manufacture - Lupin Ltd., Svizera Europe, Sandoz India, Cadila Ltd. Quality control/PSI – SGS, Intertek, Proxy Freight forwarding - Kuhne & Nagle and Mahe Quality Assurance - WHO, SGS, Proxy Desk Audit - GLRA, MSH, STI Collaborating Partners Donors - CIDA, USAID, Govt. of Netherlands, Govt. of Norway Technical assistance - GLRA, IUATLD, KNCV, MSH, STI, JICA, World Vision, World Bank, WHO, JSI, TRC, LHL, Damien Foundation, CHD, Project Hope, EDM, Caritas Norway Coordination with countries - WHO Regional Offices GFATM GDF Partners

1. GDF GRANT SERVICE (GS)

Grant Cycle Application Eligibility criteria Specific conditions Standard form Supporting documents Supply Pooled procurement Standard products High quality Low cost Review Independent Committee members meets 3x/year Country visit Monitoring Quarterly reports Existing monitoring Independent verification Results based

Grant service overview Free drugs – to introduce, expand or maintain DOTS For countries that are donor dependent for some or all of their drug needs Eligibility criteria –GNP per capita under US$ 3000, multi-year DOTS expansion plan, other supporting documents, agreement to terms and conditions of support Regular 3-year grant or emergency 1-year grant Pre-delivery mission and annual monitoring mission

Applications & Review Eligibility for grants of first line drugs –Annual per capita GNP under $3,000 (low and lower middle income countries) –Priority for countries with a per capita GNP under $1,000 Documents needed to support application –National plan and budget for DOTS expansion to meet global targets –Technical guidelines demonstrating commitment to principles of DOTS –Annual report on DOTS performance (WHO TB database collection form) –Recent external review Review –Technical review committee of independent experts –Continuous application and review process, with TRC meetings at least 3 times a year –Emergency applications can be reviewed urgently –Support provided in principle for three years (renewable) (application forms from GDF website:

Monitoring Countries receive drugs every year subject to: –Monitoring of performance by an independent technical agency –Compliance with GDF terms and conditions –Progress reviews and reports Reporting –receipt of drugs, custom clearance, registration –quarterly reports on case finding and treatment outcome –annual report on DOTS performance and financing –annual independent monitoring mission, including programme, financial, and drug management Verified through desk audit Submitted to Monitoring mission and/or TRC for decision on continuation of support

Post delivery technical support: Monitoring and support missions by region & year 2001 AFRO: 48 EMRO: 14 EURO: 20 AMRO: 2 SEARO: 21 WPRO: 4

GDF competitively & transparently contracts its procurement agent Agent contracts manufacturers through LICB according to World Bank rules Products prequalified by WHO and independent expert committees Bulk procurement, standardization and prompt payment policy secure lowest prices All batches under preshipment inspection and quality control via independent agent GDF adheres to Interagency Operational Principles for Good Pharmaceutical Procurement e-catalogue & e-tracking system for PR orders All anti TB products supplied by GDF are registered by NRA of the recipient country Procurement: Low prices US$ WHO/GDF quality assurance Independent quality control Transparency/Competition

Selection Process: Procurement /Quality Control Agents Prospective procurement agents are preselected through a widely advertised Invitation for Expressions of Interest in order to ensure they meet certain mandatory criteria prior to being invited to participate in an international competition to offer their services to the GDF.

Selection Process: Suppliers Prospective manufacturers are pre-selected via processes that ensure that all drugs to be supplied are either prequalified under the WHO TB Prequalification Project or are approved via an transparent, independent expert committee, pending prequalification.

Current Supply Agents Procurement Agent –UNDP/IAPSO (Copenhagen) –web based system for placing and tracking orders Manufacturers –Lupin Ltd., Svizera Europe, Sandoz India, Cadila Ltd. Preshipment inspection –Independent international inspection agency Quality control –All batches tested according to pharmacopoeial standards –Independent laboratories subject to stringent regulatory authority –Freight: air or sea, depending on volume, route, timing and cost

Most Recent Supplier Tender Tender concluded April 2005 with aim of: –expansion of GDF's supplier network and the sources of raw materials to reduce the risk of supply bottlenecks –maintenance of affordable prices by promoting competition –development of buffers stocks to service urgent supply requests Outcome of tender: –x4 suppliers, x2 per product, plus a back-up supplier –3 raw material sources for Rifampicin –Buffer stocks of 25% for focus items

Lead times planned for 2006  months for small to medium sized orders (from buffer stock)  months for medium to large orders month lead time analysis : 1 – 4.5 months manufacture from scratch 1 – 2 weeks laboratory analysis & pre-shipment inspection 1 to 4 weeks freight (air, sea, land)

Web-based: Order placement, tracking, buffer stock management, performance monitoring

GDF Product Catalogue - 1

GDF Product Catalogue - 2

GDF Product Catalogue - 3

2. GDF DIRECT PROCUREMENT SERVICE (DPS)

Who can use the Direct procurement 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 Global Drug Facility 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.

Why use the service? Considerable benefits to countries/regions 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 monitoring of drug use

DP Progress 1 Service launched in 2003 Direct Procurement orders for 25 countries valued at approx. US$35 million Key clients: DFID, GFATM, KfW, World Bank, WHO 10 repeat clients so far

DP Progress 2 - GFATM Current GFATM supported countries (contracts executed): 12 –Afghanistan –India –Indonesia –Bangladesh –Cote d'Ivoire –Liberia –Moldova –Mongolia –Namibia –Serbia & Montenegro –Sudan –Tajikistan Pending GFATM countries (contracts under negotiation): 1 - Uzbekistan Expected GFATM countries R1-5 (firm interest expressed): 2 –DR Congo –Ghana

DP Progress 3 WHO/GDF-DFID MoU finalized for TB drug Supply to India: –Covers 500 million population under DOTS –850,000 Patient treatments Year 1 (2006) –US$ 12 million per year for 5 years for TB Drugs –US$ 3.5 million per year for 5 years for Technical Assistance Emergency Procurement for India World Bank Project –1,000,000 patient treatments –For 2006

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

Product Selection 1: Standardized list of products in blisters, patient kits and bulk following WHO guidelines and regimens Products RHZE (4FDC) RHE (3FDC) Units Loose 1000 tabs Blisters 672 tabs 50 Vials RH150/75 RH150/150 EH400/150 E400, Z400, H300 S1g Cat. I & III Patient Kit Cat. II Patient Kit

Product Selection 2: Paediatrics & Monosubstances to be added Products R60/H50/Z150 (3FDC) Units Loose 1000 tabs Blisters 672 tabs Paediatric Adjustable RH60/60 RH60/30 R150 H100 E100 and Z150 Cat. I & III Patient Kit

Rational Order Process 3: Client completes and Order Form/Technical agreement Works with GDF to finalize patient numbers & required quantities GDF supports client with technical and drug management support via annual monitoring mission

Practical 10 STEP approach on how to secure delivery of TB drugs via GDF Direct Procurement Service

Steps Submit signed form to GDF at GDF PRC agent (IAPSO) sends contract for signature Obtain Order Form on GDF website Patient numbers Regimens Consignee details Specifies terms of support Specifies Payment Method Includes pro-forma invoice PR ensures clauses acceptable PR Signs contract PR sends signed contract to IAPSO PR transfers funds or Bank Guarantee to IAPSO account Order Form, Sample Contract & other GDF Direct Procurement details on Website at:

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

3. GDF Quality Assurance Process

GMP The products GDF procures are subject to the following Quality Assurance criteria : Manufacturers' compliance with WHO/GMP standards as assessed under the TB Prequalification Project.

Product Compliance: Option I Product compliance with either: Option (I): WHO-recommended standards for medicines as assessed under the aforementioned WHO/PSM Procurement, Quality and Sourcing Project: Access to Anti-Tuberculosis Drugs of Acceptable Quality i.e. Product is Prequalified

Product Compliance: Option II Option (II): compliance with the assessment criteria as determined by WHO/PSM & product dossiers are assessed against these criteria by a transparent, independent expert committee convened by WHO/PSM at the request of GDF. The committee is drawn from the same team of evaluators who assess product dossiers for quality aspects and for efficacy and safety (or bio-equivalence) under the TB Prequalification Project. Where a product which complies with Option I has at least 3 manufacturers who comply with GDF tender criteria GDF limits procurement of that product to those manufacturers.

Quality Control All batches of all products procured by GDF, irrespective of whether product compliance falls under option I or option II, are subject to independent quality control testing by a laboratory that:  (a) is from a country that is a member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S)  (b) from a country that is party to the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) or  (c) has been assessed by WHO PSM/QSM and found to meet recommended international norms and standards for the analysis of products

Contact Information For more information on TB Prequalification, please refer to the Global Drug Facility web-site: or the WHO website at /medicines Or contact, via electronic mail:

4. GDF Technical Support

Ongoing Technical support Pre-delivery Country Visit organised by GDF/STB Partners Brief on GDF, assess terms/conditions of support and drug management >60 country visits carried out to date Annual monitoring mission organised by GDF/STB partners  Monitor adherence to GDF terms and conditions of support  Monitor program management (including case treatment outcomes), financial management and drug management  Determine drug needs for next year of GDF support  >80 monitoring missions carried out to date  >5 Technical Assistance missions carried out for DP clients to date  Monitoring checklists developed  All missions fully integrated into annual reviews, where possible  GDF offers training in areas in which GDF has direct impact on countries (4FDC, WHO Regimens and patient Kits)  Partners are mobilized for Technical Support to address constraints identified in GDF missions.

5. Drug Management

TB drug management GDF responsibility is to the port, GDF concern is to the patient Some countries have substantial problems in maintaining an uninterrupted supply of quality drugs to all patients MSH,GDF organised drug management workshops at IUATLD Symposia in: Oct 2003, 2004, 2005

Drug Management: Progress Ease stock management/ensure rational use –Promotion of FDCs and patient kits Monitor drug management plans –Incorporate DM indicators into routine monitoring –Publish guidelines on assessing TB drug management Drug management issues at WHO regional meetings of NTP managers –Implement drug management plans from Washington meeting –Incorporate DM plans in to DOTS expansion plans –Mobilise partners to provide technical assistance IUATLD Symposia Workshops –Follow up from Washington conference –Country success stories/lessons learnt –"Strengthening medicine supply in National TB Programmes: Practical Guidelines and Tools" seminar planned for IUATLD conference in Oct 2005 DM consultants workshops –Held in AFRO Sep 04 –Planned for SEARO/WPRO Nov. 05 & Central Asian Republics Feb. 06

6. Standardization

Why Standardisation? 19 TB products for 6 drugs on the WHO Model Essential Drugs List (and many other products in use by national programmes) 11 regimens approved by WHO in 3 treatment categories 2 recommended dosages - daily and intermittent 3 weight categories (not always consistent!) Variety of packaging: blisters, foil wrapped, loose tablets Confusion Inefficiency

Standardisation: Progress Blisters outselling bulk and 4FDC is #1 product so far Guide on introduction of FDCs published Patient kit trials –Successfully conducted in Kenya, Philippines and Indonesia Patient kits for Category I, II and III available

7. GDF Performance and Impact

Key Achievements >7 million patient treatments committed in 5 years Deliveries to >60 countries Value for money: US$ treatment cost per patient Annual procurement volume presently valued at US$ million Introduction of innovative packaging: > 550,000 Patient Kits delivered to Indonesia, Kenya & Philippines Wide range of Direct Procurement Clients: GFATM, WHO, World Bank, German Bank for Reconstruction, Caritas >150 monitoring and technical assistance missions conducted

DOTS population coverage in selection of GDF monitored countries by end 2004

Patient Treatments provided through GDF Grant & Direct Procurement (DP) Services Cumulative, millions of patient treatments Source: GDF Secretariat Treated patients (millions) DP Grant Total

Consistently Competitive Pricing

Growth in Donor Contributions

GDF Countries Countries under consideration for GDF support Countries approved for regular GDF support Countries approved for emergency GDF support Countries with direct procurement support from GDF Countries with both grant and DP support from GDF

Looking ahead: Plans & Challenges….

More drugs will be needed as a result of DOTS expansion Estimation of the global TB incidence and DOTS detection (Middle range, million patients) Incidence 4-6 million patients will need drugs in 2010 DOTS detection 70% of incidence

First Line TB Drug Gap (Public Sector) Global trend in the TB patients and expected funding (Mid-range, Million patients per year) * Includes governments, banks, and foundations Source: WHO data and estimation (assuming 0.8 million grant in 2005) GFATM GDF plus Others* Gap Possible range million patients will receive drugs under DOTS As a result of DOTS expansion, there is an expected million patient funding "gap" by 2010

Increase in demand for TB drugs has reduced global availability of critical raw materials Slow responsiveness of manufacturers participating in TB Prequalification Project & capacity constraints of Project

Increasing number of monitoring mission requires increased partner support and funding Sustained, long-term, predictable funding for GDF grants Successful convergence with DOTS-Plus/GLC

Development of an application process for Diagnostic Kits & funding for same subject to Coordinating Board approval Addressing Drug Management bottlenecks in GDF supported countries Harmonized implementation of Technical Assistance: TB-CAP, GDF, GFATM e.t.c.

Thank you for your support from the GDF Team!