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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. Conference on Quality of Pharmaceutical In gredients Beijing, China, 29 - 31 March 2010

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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 Conference on Quality of Pharmaceutical Ingredients Beijing, China, 29 - 31 March 2010 Tutorial 3: Quality of essential anti-tuberculosis medicines

  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 medicines, diagnostics, 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 ~231,000

  4. New Diagnostics GDF SERVICES

  5. Supply treatments for 25 million patients by 2015 (16 million provided until 2009) Improve the quality and reduce prices of anti-TB medicines worldwide Diagnose and treat drug susceptible and MDR TB* patients Reduce the emergence of drug resistant M/XDR TB** Contribute to the achievement of Health MDGs Eliminate TB by 2050 What GDF aims to achieve * MDR TB = TB bacteria are resistant to at least isoniazid and rifampicin (two most powerful anti-TB medicines today) ** XDR TB = MDR-TB is present, plus resistance to at least three of the six classes of available second-line medicines

  6. The GDF / GLC model: One Stop Access Country/Project NTP / Delivery QC, FF Application WHO PA GDF / GLC Secr / GLI / FIND Tech. Review Comm. GLC Expert Comm. FIND Expert Review Procurement GDF Grant/Tech. Agreement/ LoA Technical Support / M&E Pharmaceuticals

  7. GDF TB Product Portfolio GDF TB product portfolio • Susceptible TB • Adult medicines • single medicines & 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 medicines • Diagnostics • In collaboration with Global Laboratory Initiative (GLI), Foundation for Innovative New Diagnostics (FIND) • Rapid diagnostic tests • Laboratory commodities – reagents, pipettes, centrifuges, work stations, incubators

  8. 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 Full treatment for 1 patient Cat. I & III Patient Kit Full treatment for 1 patient Cat. II Patient Kit

  9. 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

  10. Paediatric Product Portfolio

  11. Products and Sources of Second Line Anti-TB Medicines

  12. Product Selection: Diagnostic Kits Equipment starter kit Microsope kit Consumables kit Sputum container kit

  13. GDF Global Market Share (USD)First Line Medicines Public Sector (USD 130 m) Total Market (USD 325 m) 2010 Data and Estimates

  14. GDF Global Market Share (USD)Second Line Medicines Public Sector (USD 120 m) Total Market (USD 300 m ?) 2009 delivery data; Public Sector estimate based on 2008 treatment numbers

  15. Orders Placed First LineAdult Anti-TB Medicines (USD) No. of shipments in 2008: 375

  16. Orders Placed First LinePaediatric Anti-TB Medicines (USD)

  17. Orders Placed Second LineAnti-TB Medicines (USD) Approx. 70 % y-on-y growth rate 16 m USD UNITAID funding approved for India 2010 - 2011

  18. First Line Adult TB MedicinesTop 15 Products in 2009

  19. First Line Adult TB MedicinesTop Suppliers in 2009

  20. First Line Paedeatric TB MedicinesTop 12 Products in 2009 Suppliers: Cadila, Fatol, Lupin, Macleods

  21. Second Line TB MedicinesTop 15 Products in 2009

  22. Strategic Rotating Stockpile 5,800 patient treatments Stockpile composition subject to change

  23. Individual MDR Medicines Costs as share of Total MDR Medicines Costs based on average required quantities of medicines per patient Individual Medicines Costs as share of Total Medicines Costs based on average required quantities of medicines per patient

  24. Countries receiving Adult First Line TB Medicines

  25. MDR Medicines Deliveries to Countries

  26. Approved Suppliers (March 2010)

  27. Forecasting Procedures(First Line TB Medicines) • Stock levels, patient enrolment and mortality numbers, order plans are collected from the NTP • Planning data is validated against historical analysis of supply data vs. planning data • Specific factors such as funding delays, regulatory matters (e.g. registration) • 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 Distinction between H/L/unknown probability

  28. Forecasting Procedures(Second Line TB Medicines) • GLC patient approvals and enrolments • Medicines coefficients per treatment • Country planning • Donor funding • Epidemiology • New diagnostics for TB • Market dynamics, advocacy, political agenda (national and global), diplomacy

  29. 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

  30. MDR-TB Patient enrollment Total of 130,842 patients have been approved for funding by Global Fund from 2003 until 2013 As of 2009 a total of 61,205 patients have been approved by the GLC to be treated from 2003 until 2011

  31. Medicines Coefficients The coefficients assigned to each medicine 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 medicines delivered within their particular subgroup and using the recommendations on treatment guidelines

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

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

  34. 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 bilateral donors • US$ 54 m for MDR-TB drugs from UNITAID over 5 years • US$ 12 m from UNITAID for Paediatric Grants over 5 years. Pending proposal for additional US$ 33 m. • GDF to supply US$ 55 m of new Diagnostic Tools funded by UNITAID in partnership with FIND and GLI to 27 countries over 5 years • Direct Procurement, including TGF, UNDP, UNICEF, World Bank funding External evaluation of STB Partnership/GDF gives GDF strong vote of confidence & confirmation of mandate for 2008 – 2012 GDF retains ISO 9001:2000 certification

  35. Procurement • GDF competitively & transparentlycontracts its procurement agents • The Procurement Agent contracts manufacturersthroughLimited International Competitive Bidding • GDF Quality Assurance Processcomplies 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

  36. 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 for Procurement In line with UN guiding principles on procurement

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

  38. 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; in future likely: dynamic entry), advertisements

  39. Under GDF's Drug Quality Assurance Policy, manufacturers and products need to meet the following quality criteria: A. Manufacturing Site GMP certified by: 1) WHO 2) Stringent (strict) national medicines regulatory authority (SNMRA), i.e. International Conference on the Harmonisation of (ICH) or Associated Member 3) Pharmaceutical Inspection Cooperation Scheme (PIC/S) Selection of products and suppliersGDF Quality Assurance Policy

  40. B. Product Approval: Products shall be in compliance with national regulatory standards and 1) Products shall be pre-qualified by WHO under the WHO PQ Project; 2) Products shall be approved by an SNMRA as defined under point A 2) above 3) Products shall be found acceptable to the GDF through an interim risk assessment process involving a Technical Review Panel, 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 1) or 2) is pending. Products shall be eligible for this interim process under specific conditions. Approvals under 3) shall of limited duration. For orders funded by The Global Fund (TGF), GDF complies with the TGF's supplier qualification policy. Selection of products and suppliersGDF Quality Assurance Policy (cont'd)

  41. 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, Evaluation Report, recourse facility

  42. First Line TB Medicines LTAAward Criteria Technical / quality compliance: PQ / SNMRA / Interim 7 suppliers have competed for 18 products (52 short listings)

  43. First Line TB Medicines LTAs Realisable volume bandwidths

  44. First Line TB MedicinesIndividual Request for Quotations (RFQ) Competitions RFQ awards based on best value, including: • Price (IQC or lower) • Lead time • Registration • Vendor Performance (e.g. lead times, responsiveness, registration, stockpiles)

  45. Challenges - Quality Assurance

  46. Challenges - Drug Delivery and Drug Management

  47. GDF Staffing

  48. Thank You For Your Attention

  49. Q & A

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