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Global Drug Facility: Procurement Arm of the Stop TB Partnership

Global Drug Facility: Procurement Arm of the Stop TB Partnership. John Loeber Procurement Team Manager. Meeting of WHO Prequalification Programme with European manufacturers and EU marketing authorisation holders Copenhagen, November 2009.

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Global Drug Facility: Procurement Arm of the Stop TB Partnership

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  1. Global Drug Facility: Procurement Arm of the Stop TB Partnership John Loeber Procurement Team Manager Meeting of WHO Prequalification Programme with European manufacturers and EU marketing authorisation holders Copenhagen, November 2009

  2. An initiative of the Global Partnership to Stop TB (2002) Housed in WHO and managed by Stop TB Partnership secretariat Aims to supplyuninterrupted,quality assured, affordable anti-TB medicines, where they are needed, when they are needed More than a traditional procurement mechanism, GDF is a bundled facility (ie, supplies drugs, provides TA in drug management, and conducts quality assurance) What is the GDF?

  3. Global TB estimates Estimated number of cases (incidence) Estimated number of deaths p.a. All forms of TB Greatest number of cases in Asia; greatest rates per capita in Africa 9.15 million (139 per 100,000) 1.65 million (25 per 100,000) Multidrug-resistant TB (MDR-TB) ~489,000 ~130,000 Extensively drug-resistant TB (XDR-TB) ~20,000 ~35,000 HIV-associated TB ~709,000 (8%) ~231,000

  4. GDF SERVICES

  5. Supply treatments for 15 million patients by 2010 and for 25 million by 2015 Improve the quality and reduce prices of anti-TB medicines worldwide Contribute to the achievement of health MDGs Reduce the emergence of drug resistant (MDR-) TB Diagnosis and treat MDR-TB patients What GDF aims to achieve

  6. The GDF/GLC model: One Stop Access Country/Project NTP Delivery Application WHO GDF GDF/ GLC Secretariat Tech. Review Comm. GLC Expert Comm. Procurement Grant/Tech. Agreement LoA Technical Support / M&E Pharmaceuticals

  7. Orders Placed First-Line Anti-TB Drugs (USD) No. of shipments in 2008: 375 No. of purchase order lines: 816

  8. Orders Placed Second LineAnti-TB Drugs (USD) Approx. 70 % y-on-y growth rate

  9. Second line drug quantities delivered 2007 - 08

  10. STRATEGIC ROTATING STOCKPILE 5,800 patient treatments

  11. Countries receiving First Line TB drugs

  12. GLC / GDF Second Line Drug Deliveries

  13. TB-product portfolio • Susceptible TB • Adult medicines • single drugs & FDC • Patient kits – contain all drugs needed to treat one patient • Paediatric medicines • Mostly FDCs • Diagnostic kits • 4 separate kits –serve a lab for 1,000 sputum tests • Resistant TB • Adult medicines • single drugs • Diagnostics • In collaboration with Global Laboratory Initiative • Rapid diagnostic tests • Laboratory commodities – reagents, pipettes, centrifuges, work stations, incubators

  14. Products RHZE (4FDC) RHE (3FDC) Units Bulk 1000 tabs Blisters 672 tabs Bulk 1000 tabs Blisters 672 tabs Bulk 1000 tabs Blisters 672 tabs Bulk 1000 tabs Blisters 672 tabs Bulk 1000 tabs Blisters 672 tabs 50 Vials Product Selection:Standardized list of products in blisters, patient kits and bulk following WHO guidelines and regimens RH150/75 RH150/150 EH400/150 E400, Z400, H300 S1g Cat. I & III Patient Kit Cat. II Patient Kit

  15. Products RHZ (3FDC) Units Bulk 1000 tabs Strips Bulk 1000 tabs Strips Bulk 1000 tabs Strips Bulk 1000 tabs Strips 50 Vials Product Selection:Paediatric TB drugs RH60/30 RH60/60 E100, H100, Z150 S1g

  16. Prices and Sources of Second Line Anti-TB drugs delivered through GDF (USD): *Limited quota/partnership Prices are subject to change. Please refer to GDF webpage for most recent list: http://www.stoptb.org/gdf/drugsupply/drugs_available.asp

  17. Product Selection:Diagnostic Kits Equipment starter kit Consumables kit

  18. Approved Suppliers (Nov. 09) • For susceptible TB 8 suppliers for 12 main products • For multi-drug resistant TB * 8 suppliers for 11 products • For extensively drug resistant TB ** 3 suppliers for 5 products * MDR TB = TB bacteria are resistant to at least isoniazid and rifampicin (two most powerful anti-TB drugs today) **XDR TB = MDR-TB is present, plus resistance to at least three of the six classes of available second-line drugs

  19. Forecasting Procedures(First Line Drugs) • 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

  20. GLC approved projects at beginning 2009 • Azerbaijan • Armenia • Belarus • Bulgaria • Estonia • Georgia • Kazakhstan • Kyrgyzstan • Latvia • Lithuania • Moldova • Romania • Russia • Serbia • Ukraine • Uzbekistan Uncertain demand • Bangladesh • India • Indonesia • Myanmar • Nepal • Timor-Leste • Belize • Bolivia • Costa Rica • Dominican Republic • Ecuador • El Salvador • Guatemala • Haiti • Honduras • Mexico • Nicaragua • Paraguay • Peru • Uruguay • Egypt • Jordan • Lebanon • Pakistan • Syria • Tunisia • Burkina Faso • Cameroon • DR Congo • Ethiopia • Guinea • Kenya • Lesotho • Mozambique • Rwanda • Uganda • Tanzania Higher price • Cambodia • China • Micronesia • Mongolia • Philippines • Samoa • Vietnam GLC-approved projects in 60 countries ~ 50'000 patients approved for enrolment

  21. MDR-TB Patient enrollment Total of 130,842 patients have been approved for funding by Global Fund from 2003 until 2013 To date a total of 61,205 patients have been approved by the GLC to be treated from 2003 until 2011

  22. Drug Coefficients The coefficients assigned to each drug have been estimated according to the data collected and analysed from different sources, i.e.: • Treatments and regimens described by the programs in their GLC applications • Coefficients calculated based on percentage of total drugs delivered within their particular subgroup and using the recommendations on treatment guidelines

  23. FORECAST OF DRUGS UNITS FOR 2009

  24. Drug Costs as share of Annual Costs based on median required quantities of drugs per patient

  25. GF Round 9 - 2.38 billion USD is the total requested for TB - 44/48 proposals have an MDR component

  26. Proportion of GLC-enrolled MDR-TB casesin 2007 Estimated MDR total Estimated MDR SS+ Reported MDR cases

  27. GDF Funding Horizon • New multi-year Agreement to be signed with USAID for US$ 15M p.a. making USAID main GDF donor • 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 5 years • Direct Procurement External evaluation of STB Partnership/GDF gives GDF strong vote of confidence & confirmation of mandate for 2008 – 2012 GDF retains ISO 9001:2000 certification

  28. Procurement • GDF competitively & transparently contracts its procurement agents • The Procurement Agent contracts manufacturersthroughLimited International Competitive Bidding • GDF Quality Assurance Processfully compliant with Global Fund requirements • Bulk procurement, standardization and prompt payment policy secure low prices • Products supplied by GDF are registered by the National Regulatory Authority where required • GDFadheres to Interagency Operational Principles for Good Pharmaceutical Procurement, WHO Manual on Procurement of Goods and Services

  29. Integrity Competition Equal treatment WHO / GDF objectives Customer Service Transparent and fair Competitive tendering Same conditions Meets programme objectives Customer satisfaction while best value for money GUIDING PRINCIPLES Same as UN guiding principles Added by WHO / GDF

  30. GDF Quality Assurance Policy • All anti-TB Drugs supplied by GDF are subject to GDF's new Quality Assurance Policy, effective July 2009: • Option A: WHO Prequalification (PQ) • Option B: Stringent (Strict) 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.

  31. GDF Quality Assurance Policy: WHO Prequalification Programme PQ website: http://mednet3.who.int/prequal/

  32. GDF Procurement Mechanism WHO (legal entity) Stop TB Partnership/GDF LICB Procurement Agents LICB Suppliers/Manufacturers GDF Order Management System Control Agent/PSI (Sampling) Laboratory/Quality Assurance Freight Forwarders & Insurance Client (National TB Programme)

  33. Supplier/Product Sourcing • Trade fairs • UN Global Marketplace (www.ungm.org) • Publications, journals, Chambers of Commerce, business seminars • Databases • Previous tenders, recommendations (e.g. FIND) • Procurement Agent • Other market research (internet) • Approaches by suppliers • Expressions of Interest (every 2 – 3 years; last: September 2008; now rolling submissions with window for entry every 12 months), advertisements

  34. ITB/RFP ELEMENTS • Cover Letter - pages 1 and 2 • Section 1: Instructions to Bidders – page 3 • Section 2: Bid Data Sheet – page 6 • Section 3: Bid Submission Form – page 8 • Section 4: Special Contract Conditions – page 9 • Annex 1: Price Schedule Form/Delivery Schedule • Annex 2: Packing and Delivery Schedule Sheet • Annex 3: General Purchase Conditions • Annex 4: Standard Operational Procedures (to be sent electronically) • Annex 5. Long Term Agreement (LTA) • Annex 6. Data Sheet for Suppliers • Annex 7: Code of Conduct • Annex 8: Product Specifications (CD ROM) • Annex 9: Any other specific P.A. requirements Public Bid opening, consensus-based Evaluation Committee, recourse facility

  35. First Line TB Drugs LTAAward Criteria Technical / quality compliance Currently, 6 - 7 suppliers are competing for 18 products (52 short listings)

  36. First Line TB Drugs LTAs Realisable volume bandwidths

  37. First Line TB DrugsIndividual RFQ Competitions RFQ awards based on best value, including: • Price (IQC or lower) • Lead time • Registration • Vendor Performance

  38. MDR TB Drugs:Procurement Challenges butGrowth Area and High-Profile Market -> WHO/GLC/GDF Price Negotiation Task Force -> Direct Contracts with Suppliers • High level of prices leads to constraints in country planning and increased donor vigilanceLimited number of products, increasing number of suppliers; changing production capacity / production on demand • Forecasting poses a challenge (variations in treatment regimes; dependency on first-line TB treatment success, diagnostics) • Volatility of demand; DF Strategic Rotating Stockpile • Registration issues (regulations, fast track / waiver, supplier representation, costs) • Short expiry dates: 24, 36 months • Cold chain needed for PASER • Disbursement of funds, delays; GDF Strategic Revolving Fund • MDR Treatment Scale Up through breakthrough in Diagnostics • Profile: High media and public awareness

  39. GDF Staffing • 19 Staff at HQ and 4 in the regions • GDF staff divided into sub teams: • Susceptible TB: 4 • MDR-TB: 3 • QA: 1 • Applications and Review, Monitoring: 5 • Others: data management, business coordination, GDF Manager, technical assistance (TB Team), administrative (2)

  40. Thank You For Your Attention

  41. Q & A

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