GLOBAL FUND STAKEHOLDERS briefing

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• GLOBAL FUND STAKEHOLDERS briefing
• 05.FEB.2009

Robert Matiru Manager, GDF
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Outline

• Update stakeholders on GDF activities
• Update on GDF QA Process c.f. GF
• Update on potential GDF linkage with VPP

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GDF SERVICES
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GDF Operational update

• New multi-year Agreement to be signed with USAID
  for US 15M p.a. making USAID main GDF donor for
  first-line Grants
• CIDA, Netherlands and Norway continue to be
  donors
• US 71M for MDR-TB drugs from UNITAID over 5
  years
• US 11M from UNITAID for Paediatric Grants over 4
  years
• GDF to supply new Diagnostic Tools funded by
  UNITAID in partnership with FIND and GLI over 3
  years
• External evaluation of STB Partnership/GDF gives
  GDF strong vote of confidence confirmation of
  mandate for 2008 2012
• GDF retains ISO 90012000 certification new
  quality manager hired
• GDF signs MoU with Global Fund

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Technical Support and ME missions
GDF Missions by Region and Year 2001 -
2007 Key WPRO Western
Pacific, SEARO South-East Asia, EURO Europe,
EMRO Eastern Mediterranean (Middle East), AMRO
the Americas and AFRO Africa.
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• Restating the fundamentals

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Procurement Supply Management (PSM)
Selection
Management
Procurement
Use
Support
Distribution
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1.1 Product Selection 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 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
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1.2 Product Selection Paediatric TB drugs
Products RHZ (3FDC)
Units Loose 1000 tabs Strips Loose 1000 tabs
Strips Loose 1000 tabs Strips Loose 1000 tabs
Strips 50 Vials
RH60/30
RH60/60
E100, H100, Z150
S1g
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1.3 Product Selection Second line drugs
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1.4 Product Selection
Diagnostic Kits
Equipment starter kit
Consumables kit
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2. Forecasting Procedures

• Client completes and Order Form/Technical
  agreement
• Client works with GDF to finalize patient
  numbers required quantities using Standardized
  GDF quantification tool drugs diagnostics
• GDF supports client with technical and drug
  management support via annual monitoring mission

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3.1 Procurement

• GDF competitively transparently contracts its
  procurement agent
• The Procurement Agent contracts manufacturers
  through Limited International Competitive Bidding
• GDF Quality Assurance Process fully compliant
  with Global Fund requirements
• Bulk procurement, standardization and prompt
  payment policy secure low prices

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3.2 Procurement

• Batches under preshipment inspection and quality
  control via independent agent
• GDF adheres to Interagency Operational Principles
  for Good Pharmaceutical Procurement
• e-tracking system for country orders
• All anti TB products supplied by GDF are
  registered by National Regulatory Authority of
  the recipient country where required

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Key Topics

• Quality Assurance policy update
• Global Fund VPP value of formal linkage with GDF

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GDF Quality Assurance Policy

• Effective July 2009, all anti-TB Drugs supplied
  by GDF required to be in compliance with the new
  GDF Quality Assurance Policy
• Option A WHO Prequalification (PQ)
• Option B Stringent National Drug Regulatory
  Authority approval
• Option C Interim Assessment Approval Process
• Note
• Products shall be found acceptable to the GDF
  where they are (i) manufactured at a site meeting
  the standards defined in options A or B and (ii)
  approved through an Expert Review Committee in an
  Interim Assessment Approval Process which
  assesses products based on the information
  provided in a Pharmaceutical Product
  Questionnaire (PPQ) under the condition that the
  product approval process described under either
  options A or B (ii) is pending.

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GDF and VPP

• GDF in discussion with GF about formal linkage to
  VPP
• Including TB drugs under the VPP via GDF would be
  in keeping with the spirit of practical
  collaboration envisaged by Stop TB
  Partnership-Global Fund MoU
• Would offer PRs a full service package via one
  mechanism
• Would facilitate improved consolidation of demand
  and forecasting for suppliers (as per next slide)
• Would support harmonized reporting on pricing and
  adherence to GF/GDF QA policies
• Collaboration already underway
• GF to be involved in GDF procurement agent
  selection processes
• GDF and GF will harmonize quality control
  procedures using same service provider from Q2
  2009

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(No Transcript)
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Thank you