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

Global TB Drug FacilitySecuring timely access to quality, affordable TB drugs

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?

Problem

GDF Response

Lack of resources

Grant Service: first line TB drugs & in future diagnostic kits

Inefficient procurement

Direct Procurement Service

Inadequate quality assurance

TB Prequalification Service

Non-specific international recommendations

Limited list of standardised

products and packaging

(FDCs and patient kits)

Non adherence to international recommendations

Diversity of products

Inadequate in-country management and monitoring

Facilitate technical assistance

(TB and drug management)

from partners

What will the GDF achieve?Catalyse DOTS expansion to reach global targets by 2005Supply treatments for 15 million patients by 2010 & for25 million by 2015Contribute to the achievement of the health MDGsMitigate the emergence of drug resistanceImprove 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 MaheQuality 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 GFATMGDF Partners

1. GDF GRANT SERVICE (GS)

Grant Cycle

Grant service overviewFree drugs to introduce, expand or maintain DOTS

For countries that are donor dependent for some or all of their drug needs

Eligibility criteriaGNP 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 & ReviewEligibility for grants of first line drugsAnnual per capita GNP under $3,000 (low and lower middle income countries)Priority for countries with a per capita GNP under $1,000Documents needed to support applicationNational plan and budget for DOTS expansion to meet global targetsTechnical guidelines demonstrating commitment to principles of DOTSAnnual report on DOTS performance (WHO TB database collection form)Recent external reviewReview Technical review committee of independent expertsContinuous application and review process, with TRC meetings at least 3 times a yearEmergency applications can be reviewed urgentlySupport provided in principle for three years (renewable)(application forms from GDF website: www.stoptb.org/GDF)

MonitoringCountries receive drugs every year subject to:Monitoring of performance by an independent technical agencyCompliance with GDF terms and conditionsProgress reviews and reportsReportingreceipt of drugs, custom clearance, registrationquarterly reports on case finding and treatment outcomeannual report on DOTS performance and financingannual independent monitoring mission, including programme, financial, and drug managementVerified through desk auditSubmitted to Monitoring mission and/or TRC for decision on continuation of support

Post delivery technical support: Monitoring and support missions by region & year2001AFRO: 48EMRO: 14EURO: 20AMRO: 2SEARO: 21WPRO: 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$ 14 -18

WHO/GDF quality assurance

Independent quality control

Transparency/Competition

Selection Process: Procurement /Quality Control AgentsProspective 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 AgentsProcurement AgentUNDP/IAPSO (Copenhagen)web based system for placing and tracking orders ManufacturersLupin Ltd., Svizera Europe, Sandoz India, Cadila Ltd.Preshipment inspectionIndependent international inspection agencyQuality 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 TenderTender 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 competitiondevelopment of buffers stocks to service urgent supply requests

Outcome of tender:

x4 suppliers, x2 per product, plus a back-up supplier3 raw material sources for RifampicinBuffer stocks of 25% for focus items

Lead times planned for 2006

1 - 3 months for small to medium sized orders (from buffer stock)

3 - 6 months for medium to large orders

3 - 6 month lead time analysis:1 4.5 months manufacture from scratch1 2 weeks laboratory analysis & pre-shipment inspection1 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 DOTSto ensure quality - when adequate quality assurance programmes are not in placeto 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 establishedTo access quality assured fixed dose combination tabletsto standardise TB drug formulationsto 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): 12AfghanistanIndiaIndonesiaBangladeshCote d'IvoireLiberiaMoldovaMongoliaNamibiaSerbia & MontenegroSudanTajikistan

Pending GFATM countries (contracts under negotiation): 1- Uzbekistan

Expected GFATM countries R1-5 (firm interest expressed): 2DR CongoGhana

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 DrugsUS$ 3.5 million per year for 5 years for Technical Assistance

Emergency Procurement for India World Bank Project1,000,000 patient treatmentsFor 2006

Outsourcing ProcurementWhere 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 Selection2. Forecasting3. 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 regimensProductsRHZE (4FDC) RHE (3FDC)

UnitsLoose 1000 tabs Blisters 672 tabsLoose 1000 tabs Blisters 672 tabs Loose 1000 tabs Blisters 672 tabsLoose 1000 tabs Blisters 672 tabsLoose 1000 tabs Blisters 672 tabs50 VialsRH150/75RH150/150EH400/150E400, Z400, H300S1gCat. I & III Patient KitCat. II Patient Kit

Product Selection 2: Paediatrics & Monosubstances to be addedProductsR60/H50/Z150 (3FDC)

UnitsLoose 1000 tabs Blisters 672 tabsLoose 1000 tabs Blisters 672 tabs Loose 1000 tabs Blisters 672 tabsLoose 1000 tabs Blisters 672 tabsLoose 1000 tabs Blisters 672 tabsLoose 1000 tabs Blisters 672 tabsPaediatric AdjustableRH60/60RH60/30R150H100E100 and Z150Cat. 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

DIRECT PROCUREMENT ORDER FORM & TECHNICAL AGREEMENT

SECTION A. CONTACT DETAILS

Country:

Contact person:

Position:

Address:

Telephone:

Fax:

Email:

SECTION B. ESTIMATES OF PATIENTS TO BE TREATED WITH DOTS

Year:

Date drugs required:

Category

Regimen

Total estimated cases to be treated with DOTS

Estimated cases to be treated with drugs supplied through the GDF

1

2

3

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

Steps 1 - 512345 Patient numbers Regimens Consignee details Specifies terms of support Specifies Payment Method Includes pro-forma invoice PR ensures clauses acceptable PR Signs contractOrder Form, Sample Contract & other GDF Direct Procurement details on Website at: http://www.stoptb.org/GDF/drugsupply/direct_procurement_process.asp

Steps 6 to 10678910 IAPSO liaises with PR to ensure REGISTRATIONprocedures followed PR can track progress of shipment E-mail updates sent at least monthlyLead time: 1 to 6 monthsReport on appropriate drug use, progress, needs Preclearance docssent in advance(1 to 4 weeks)

3. GDF Quality Assurance Process

GMPThe 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 IProduct 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 IIOption (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 ControlAll 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 InformationFor more information on TB Prequalification, please refer to the Global Drug Facility web-site:

www.stoptb.org/GDF or the WHO website at www.who.int /medicines

Or contact, via electronic mail:

GDF.PRS@stoptb.orgdoucelinc@who.int griffing@who.int

4. GDF Technical Support

Ongoing Technical support Pre-delivery Country Visit organised by GDF/STB PartnersBrief on GDF, assess terms/conditions of support and drug management>60 country visits carried out to dateAnnual monitoring mission organised by GDF/STB partnersMonitor 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 dateMonitoring checklists developedAll missions fully integrated into annual reviews, where possibleGDF 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 managementGDF 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 usePromotion of FDCs and patient kits

Monitor drug management plansIncorporate DM indicators into routine monitoringPublish guidelines on assessing TB drug management

Drug management issues at WHO regional meetings of NTP managersImplement drug management plans from Washington meetingIncorporate DM plans in to DOTS expansion plansMobilise partners to provide technical assistance

IUATLD Symposia WorkshopsFollow up from Washington conferenceCountry 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 workshopsHeld 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 intermittent3 weight categories (not always consistent!)Variety of packaging: blisters, foil wrapped, loose tablets Confusion Inefficiency

Standardisation: ProgressBlisters outselling bulk and 4FDC is #1 product so far

Guide on introduction of FDCs published

Patient kit trialsSuccessfully 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$ 14 -18 treatment cost per patient

Annual procurement volume presently valued at US$ 35 - 40 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

Chart4

0Albania30

92Bangladesh99

33DPR Korea100

55Eritrea82

30India84

30Macedonia50

0Moldova100

77Myanmar100

46Orrisa State India98

27Pakistan76

80Sudan100

0Zambia100

PRE GDF

POST GDF

DOTS POPULATION COVERAGE (%)

Chart1

92Bangladesh99

33DPR Korea100

30India84

0Moldova100

77Myanmar100

27Pakistan76

80Sudan100

0Zambia100

0Albania30

55Eritrea82

30Macedonia50

46Orrisa State India98

PRE GDF

POST GDF

DOTS POPULATION COVERAGE (%)

Chart2

33DPR Korea100

30India84

0Moldova100

77Myanmar100

27Pakistan76

80Sudan100

0Zambia100

0Albania30

55Eritrea82

30Macedonia50

46Orrisa State India98

PRE GDF

POST GDF

DOTS POPULATION COVERAGE (%)

Sheet1

Albania030

Bangladesh9299

DPR Korea3366100

Eritrea558282

India304584

Macedonia3050

Moldova032100

Myanmar7784100

Orrisa State India469898

Pakistan2776

Sudan8097100

Zambia00100

Sheet1

00

00

00

00

00

00

00

00

00

00

00

00

PRE GDF

POST GDF

DOTS POPULATION COVERAGE (%)

Sheet2

Sheet3

Patient Treatments provided through GDFGrant & Direct Procurement (DP) ServicesCumulative, millions of patient treatmentsSource: GDF SecretariatTreated patients (millions)DPGrant -0.7

0.7-0.8

0.8-1.4

1.40.50.8

1.30.4-0.70.7-1.1

1.1-1.80.8-1.10.7-1.1

1.5-2.20.9-1.20.8.-1.0

1.7-2.11.0-1.20.7-0.9

1.7-2.11.2-1.50.6-0.8

1.8-2.11.3-1.60.6-0.8

1.8-2.4Total

Consistently Competitive Pricing

Growth in Donor Contributions

GDF Countries

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)Incidence4-6 million patients will need drugs in 2010

DOTS detection70% 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 foundationsSource: WHO data and estimation (assuming 0.8 million grant in 2005)GFATMGDF plus Others*GapPossible range3-3.5 million patients will receive drugs under DOTS

As a result of DOTS expansion, there is an expected 0.5-2.5 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!

The GDF is optimistic that the outcomes of the tender will stabilize the supply of high-quality anti TB drugs to countries and ensure that prices remain competitive. Increasing the number of GDF suppliers to 4 from 3 will increase GDF supply capacity. Dividing the supply award between 2 suppliers will reduce the risk of supply chain bottlenecks and encourage better supplier performance due to competition. Diversifying the raw material supply base from reliance on 1 source to 3 sources is a significant and positive development for GDF. It will greatly reduce the risk of capacity bottlenecks of the kind experienced in late 2004/early 2005.Once the buffer stocks of priority TB drugs e.g. 4 drug and 2 drug fixed-dose combinations are built up (over the next 4 to 6 months) GDF will be able to service emergency and small to regular sized orders rapidly i.e. 1 to 2 month lead times.While prices have increased for FDCs, these prices still include the costs required to guarantee their high quality and remain well below the costs countries pay to independent suppliers of questionable quality drugs. The increases, moreover, were expected and reflect an international trend