Transcript Global TB Drug Facility - World Health Organization

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?
Problem
Lack of resources
Inefficient procurement
Inadequate quality assurance
Non-specific international
recommendations
Non adherence to international
recommendations
Diversity of products
Inadequate in-country
management and monitoring
GDF Response
Grant Service: first line TB drugs
& in future diagnostic kits
Direct Procurement Service
TB Prequalification Service
Limited list of standardised
products and packaging
(FDCs and patient kits)
Facilitate technical assistance
(TB and drug management)
from partners
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 $1,000
• Documents needed to support application
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National plan and budget for DOTS expansion to meet global targets
Technical guidelines demonstrating commitment to principles of DOTS
Annual report on DOTS performance (WHO TB database collection form)
Recent external review
• Review
– Technical review committee of independent experts
– Continuous application and review process, with TRC meetings at least 3
times a year
– Emergency applications can be reviewed urgently
– Support provided in principle for three years (renewable)
(application forms from GDF website: www.stoptb.org/GDF)
Applications & Review
• Countries receive drugs every year subject to:
– Monitoring of performance by an independent technical agency
– Compliance with GDF terms and conditions
– Progress reviews and reports
• Reporting
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receipt of drugs, custom clearance, registration
quarterly reports on case finding and treatment outcome
annual report on DOTS performance and financing
annual independent monitoring mission, including programme, financial, and
drug management
• Verified through desk audit
• Submitted to Monitoring mission and/or TRC for decision
on continuation of support
Monitoring
WPRO: 4
SEARO: 21
AMRO: 2
EURO: 20
EMRO: 14
AFRO: 48
2001
Post delivery technical support: Monitoring and
support missions by region & year
Procurement:
•
GDF competitively & transparently contracts its
procurement agent
•
Agent contracts manufacturers through LICB
according to World Bank rules
•
Products prequalified by WHO and independent
expert committees
•
Bulk procurement, standardization and prompt
payment policy secure lowest prices
•
All batches under preshipment inspection and
quality control via independent agent
 Low prices US$ 14 -18
•
GDF adheres to Interagency Operational
 WHO/GDF quality assurance
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
 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$35 million
• Key clients: DFID, GFATM, KfW, World Bank, WHO
• 10 repeat clients so far
DP Progress 1
 Current GFATM supported countries (contracts executed): 12
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Afghanistan
India
Indonesia
Bangladesh
Cote d'Ivoire
Liberia
Moldova
Mongolia
Namibia
Serbia & Montenegro
Sudan
Tajikistan
 Pending GFATM countries (contracts under negotiation): 1
- Uzbekistan
 Expected GFATM countries R1-5 (firm interest expressed): 2
– DR Congo
– Ghana
DP Progress 2 - GFATM
• WHO/GDF-DFID MoU finalized for TB drug Supply to
India:
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Covers 500 million population under DOTS
850,000 Patient treatments Year 1 (2006)
US$ 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:
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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
1
Submit signed
form to GDF at
[email protected]
2
• 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
4
PR transfers funds
or Bank Guarantee
to IAPSO account
5
Lead time: 1 to 6 months
IAPSO places
order with GDF
prequalified
& contracted
suppliers
6
• IAPSO liaises with
PR to ensure
REGISTRATION
procedures followed
Order recorded
in WEB-based
tracking system
and PR issued
username &
password
7
• 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
9
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:
[email protected]
[email protected]
[email protected]
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
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•
•
•
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
Why Standardisation?
• 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
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DOTS POPULATION COVERAGE (%)
100
90
80
70
60
50
40
30
20
10
0
DOTS population coverage in selection of
GDF monitored countries by end 2004
PRE GDF
POST GDF
Source: GDF Secretariat
Patient Treatments provided through GDF
Grant & Direct Procurement (DP) Services
Cumulative, millions of patient treatments
20.0
18.0
16.0
Treated
patients
(millions)
14.0
7.8
12.0
6.2
DP
4.7
10.0
Grant
3.5
8.0
2.3
6.0
1.2
4.0
0.5
2.0
2.9
3.7
4.8
5.9
7.8
8.6
9.4
6.9
2007
2008
2009
2010
0.7
1.5
2001
2002
2003
2004
2005
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
0.0
2006
Consistently Competitive Pricing
80,000
70,000
60,000
50,000
US$ Value of Donor
Contributions '000
CUMULATIVE
40,000
30,000
20,000
10,000
0
2001
2002
2003
2004
2005 Mar.
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)
10
9
Incidence
8
7
6
70% of
incidence
5
4
3
DOTS
detection
2
1
19
98
19
99
20
00
20
01
20
02
20
03
20
04
20
05
20
06
20
07
20
08
20
09
20
10
0
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)
6
Possible range
5
Gap
4
3
GFATM
2
1
0
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
* Includes governments, banks, and foundations
Source: WHO data and estimation (assuming 0.8 million grant in 2005)
GDF
plus
Others*
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!