Securing timely access

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Global TB Drug Facility

• Securing timely access
• to high-quality, affordable TB drugs

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Introduction
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Reminder What does GDF offer?

• Now 3 Services
• Grants of first line drugs, to support DOTS
  expansion 1
• 2 A direct procurement service for countries
  and NGOs, to buy drugs for use under DOTS
• 3 A white list of prequalified manufacturers
  of quality TB drugs
• Future 2 Services (subject to CB approval)
• Grants of Diagnostic Kits
• Technical Assistance Service Line

Bundled with support for Drug
Management/technical assistance
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Process Impact Indicators
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Key Facts Figures - 1

• Total raised for grants US 42.6 million
• Approved gt75 applications from countries, NGOs,
  states and PPPs
• Drugs delivered to 58 countries
• Direct procurement contracts negotiated for 20
  countries
• Drugs ordered for 4.48 million patients (as of
  Dec. 2004)
• Total value of direct procurement orders US 13
  million
• 50 pre-delivery country visits organized by
  GDF/STB Partners
• 56 monitoring missions organized by GDF/STB
  partners
• Drug cost per patient US15 - 17

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Key Facts Figures - 2

• Procurement 126 drug orders placed, 4
  manufacturers contracted average lead time of 4
  months (Small to regular sized orders)
• Quality Percentage of GDF batches rejected
  through independent preshipment quality control
  lt1
• Drug Management of GDF countries which
  followed up on at least 50 of drug management
  recommendations 84 (Jul.-Dec. 2004)
• Standardization Blisters supply gt bulk 4FDC 1
  (inten. phase) product
• Additionality of countries that maintained or
  increased Govt. expenditure for TB drugs post GDF
  support 91 (Jul.-Dec. 2004)
• Introduction of innovative packaging 150,000
  Patient Kits
• delivered to Indonesia gt90,000 to Philippines

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GDF Countries
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Supply Update- Diagnostic Kit pilot studies-
Prequalification- Lead times tender results-
Direct Procurement Service update- Technical
Assistance/Drug Management
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Diagnostics/Prequalification

• Diagnostic Kits
• 3 pilot studies initiated in Congo, Nigeria and
  Tajikistan
• Prequalification
• 8 manufacturing sites WHO GMP approved
• 4 out of 9 catalogue products WHO prequalified
• Successful training workshop Kuala Lumpur Feb.
  2005

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Delivery Lead Times

• Q3 Q4 2004 2 to 4 months for small to regular
  orders
• Q3 Q4 2004 6 to 9 months (from 4 to 6 months)
  for large orders
• (e.g. Bangladesh, DR Congo, Philippines,
  Pakistan, India, Myanmar, DPR Korea)
• Delayed deliveries in Q4 2004 Q1 2005 for
  large orders due to rifampicin raw material
  bottlenecks

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TB drug Tender 2005

• New 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
• BUT rise in prices of 30 to 40 for 4FDC and RH
• (GLOBAL TREND)

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Direct Procurement Progress

• 20 countries have concluded contracts
• 3 out of 20 countries using GFATM monies
  (proportion still low)
• 9 repeat clients so far
• Orders placed valued at gtUS 13,000,000

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Technical Assistance (TA) - 1

• GDF conducting Strategic Analysis with an aim
  to
• Strengthen current TA support for Drug
  Management
• thereby enhancing overall GDF impact and
• ensuring long-term sustainability in delivering
  mandate
•  

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Technical Assistance - 2

• Process
• Drug Management survey to identify need for
  improved TA
• Demand assessment to identify interest in service
  line for free and/or purchased TA
• Supply assessment to map partners' activities,
  identify different models of TA delivery,
  determine cost
• Expected Outcome
• Strategy paper, including time-line and start-up
  process
• of TA service line, for presentation to CB in
  Nov. 2005

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GDF Team Update
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Operations Staffing

• New information/Knowledge management system being
  implemented which
• tracks the work plans of GDF staff and alerts
  them to probable next steps, reducing response
  lead-times promoting adherence to SOPs
• automatically captures business critical
  information from staff activities, facilitating
  timely and consistent reporting to donors and
  interested parties
• GDF staff being hired
• Operations Manager
• Procurement Officer
• Missions Officer
• Regional technical officers for Africa region
  (x1) and SE Asia region (x1)

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• Issues/challenges 2005
• Increase in demand for TB drugs has reduced total
  global capacity for production of critical raw
  materials
• Slow responsiveness of the manufacturers
  participating in the prequalification project for
  TB drugs
• No prequalified paediatric products
• GDF lead times for very large orders are not
  optimal
• Greater visibility awareness for GDF Direct
  Procurement Service needed
• Increasing no. of monitoring missions requires
  more partner support funding
• Addressing Drug Management bottlenecks in GDF
  countries
• Sustained, long-term, predictable funding for GDF
  grants from
• multiple sources

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• Pathway forward for next 8 months
• Strengthen GDF through new staff
  decentralization of staffing to regions
• Implement tender results
• Engage TB manufacturers to catalyze availability
  of quality paediatric TB drugs
• Complete TA study to support countries in drug
  management
• Complete 3 pilot studies on introduction of new
  diagnostic kits
• Further training for TB drug manufacturers on WHO
  prequalification process
• Consolidate implementation of new Knowledge and
  Information management system
• Introduce new GDF brand
• Widely disseminate first ever GDF Achievements
  Report

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CB Decision ISO Certification for GDF
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Introduction

• In 4 years of operation, GDF provided
• over 4 million patient treatments
• to more than 58 countries
• GDF's rapid expansion and huge increase in volume
  
• of procurement orders for Grants and Direct
  Procurement
• Monitoring missions
• Requires urgently
• an information technology (IT) based knowledge
• data management system (Introduced Jan. 2005)
• a quality management improvement system
• the formalization and implementation of
• standard operating procedures (SOPS)

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What is ISO Certification?

• ISO (International Office for Standardization)
• sets standards for putting in place a
• Documented
• and Audited
• Quality Management System
• this requires SOPS
• documented following a standard layout
• of every main activity of the organisation
• adhered to by all staff

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Expected benefits of ISO Certification?

• Improve and streamline internal functioning of
  GDF
• Maintain further improve high quality outputs
  of GDF
• Allow GDF to expand, while remaining lean
  effective
• Safeguard GDF from costly human errors (Legal)
• Maintain improve GDF's credibility as a
• donor/broker for supply of high quality drugs
• Maintain improve GDF's credibility as a
• business partner

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Action Steps toward ISO Certification

• Appoint ISO focal person inside GDF
• Contract Consultancy Firm
• Perform GAP analysis
• Train and assist staff in SOP writing for their
  own tasks responsibilities
• Trial of new Quality Management (QM) system
• Self audit of QM system
• Inspection by ISO certifying organisation
• ISO Certification process

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Timeline and Costs

• Timeline
• 7 9 months until ISO Certification
• but benefits will start showing right from the
  start of the process
• Estimated Costs
• US 40,000 to 50,000 for
• Consultancy
• Registration Fee
• Plus ongoing Staff Time

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Thank you for your support from the GDF Team!