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Global TB

Drug Facility
Securing timely access
to quality, affordable TB drugs

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

What is the GDF?

Why do we need a GDF?

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

What will the GDF achieve?

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 -

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

WHO, SGS, Proxy


Desk Audit - GLRA, MSH, STI

GDF Partners

1. GDF GRANT SERVICE (GS)

Application
Eligibility criteria
Specific conditions
Standard form
Supporting documents

Monitoring

Review

Quarterly reports
Existing monitoring
Independent verification
Results based

Independent Committee
12-15 members
meets 3x/year
Country visit

Supply
Pooled procurement
Standard products
High quality
Low cost

Grant Cycle

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

Grant service overview

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: www.stoptb.org/GDF)

Applications & Review

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

Monitoring

WPRO: 4
SEARO: 21
AMRO: 2
EURO: 20
EMRO: 14
AFRO: 48
2001

Post delivery technical support: Monitoring and


support missions by region & year

GDF competitively & transparently contracts its


Procurement:
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

Low prices US$ 14 -18


WHO/GDF quality assurance
Independent quality control
Transparency/Competition

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:
Procurement /Quality Control Agents

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.

Selection Process: Suppliers

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

Current Supply Agents

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

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 scratch
1 2 weeks laboratory analysis & pre-shipment inspection
1 to 4 weeks freight (air, sea, land)

Lead times planned


for 2006

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.

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

Why use the service?

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 1

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 2 - GFATM

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

DP Progress 3

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

Outsourcing Procurement

Products

Units

RHZE (4FDC)
RHE (3FDC)

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

RH150/75
RH150/150
EH400/150
E400, Z400, H300
S1g
Cat. I & III Patient Kit
Cat. II Patient Kit

Product Selection 1: Standardized list of


products in blisters, patient kits and bulk
following WHO guidelines and regimens

Products

Units

R60/H50/Z150
(3FDC)

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
Loose 1000 tabs
Blisters 672 tabs
Paediatric
Adjustable

RH60/60
RH60/30
R150
H100
E100 and Z150
Cat. I & III Patient Kit

Product Selection 2:
Paediatrics & Monosubstances to be added

Rational Order Process 3:

Client completes and Order


Form/Technical agreement

Works with GDF to finalize


patient numbers & required
quantities

DIRECT PROCUREMENT ORDER FORM &


TECHNICAL AGREEMENT

SECTION A. CONTACT DETAILS


Country:

GDF supports client with


technical and drug
management support via
annual monitoring mission

Contact
person:
Position:
Address:

Telephone:
Fax:
Email:

SECTION B. ESTIMATES OF PATIENTS TO BE TREATED WITH DOTS


Year:
Category

1
2
3

Date drugs required:


Regimen

Total estimated
cases to be treated
with DOTS

Estimated cases to be
treated with drugs
supplied through the
GDF

Practical 10 STEP approach


on how to secure delivery of TB drugs via
GDF Direct Procurement Service

Order Form, Sample Contract & other GDF Direct Procurement details on Website at:
http://www.stoptb.org/GDF/drugsupply/direct_procurement_process.asp

Obtain Order
Form on GDF
website

Submit signed
form to GDF at
matirur@who.int

Patient numbers
Regimens
Consignee details
Specifies terms of support

GDF PRC agent


(IAPSO) sends
contract for
signature

PR sends signed
contract to IAPSO

3
Specifies Payment Method
Includes pro-forma invoice
PR ensures clauses acceptable
PR Signs contract

Steps 1 - 5

PR transfers funds
or Bank Guarantee
to IAPSO account

Lead time: 1 to 6 months

IAPSO places
order with GDF
prequalified
& contracted
suppliers

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
E-mail updates
sent at least
monthly

Products analysed
independently
before shipment
then SHIPPED

Confirmation of
receipt & clearance
of goods sent to
IAPSO

8
Preclearance docs
sent in advance
(1 to 4 weeks)

Steps 6 to 10

4 to 6 months later
GDF sends
Technical Assis.
& Monitoring
Mission

10
Report on appropriate
drug use, progress,
needs

3. GDF Quality Assurance


Process

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.

GMP

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 I

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.

Product Compliance: Option II

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

Quality Control

For 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.org
doucelinc@who.int
griffing@who.int

Contact Information

4. GDF 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.

Ongoing Technical support

5. 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

TB drug management

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

Drug Management: Progress

6. Standardization

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

Why Standardisation?

Confusion
Inefficiency

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

Standardisation: Progress

7. GDF Performance and Impact

>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

Key Achievements

DOTS population coverage in selection of


GDF monitored countries by end 2004

Source: GDF Secretariat

Patient Treatments provided through GDF


Grant & Direct Procurement (DP) Services
Cumulative, millions of patient treatments

Treated
patients
(millions)

DP
Grant

0.7

0.8

1.4

0.5
0.8

0.4-0.7
0.7-1.1

0.8-1.1
0.7-1.1

0.9-1.2
0.8.-1.0

1.0-1.2
0.7-0.9

1.2-1.5
0.6-0.8

1.3-1.6
0.6-0.8

Total

0.7

0.8

1.4

1.3

1.1-1.8

1.5-2.2

1.7-2.1

1.7-2.1

1.8-2.1

1.8-2.4

Consistently Competitive Pricing

Growth in Donor Contributions

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
Countries under consideration for GDF support

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)
Incidence
70% of
incidence
DOTS
detection

4-6 million patients


will need drugs in
2010

First Line TB Drug Gap (Public Sector)


Global trend in the TB patients and expected funding
(Mid-range, Million patients per year)

Possible range
Gap

GFATM

GDF
plus
Others*
* Includes governments, banks, and foundations
Source: WHO data and estimation (assuming 0.8 million grant in 2005)

3-3.5 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!