Procurement Overview and Tender Process

1. Pre Tender Meeting UNICEF Supply Division Copenhagen 11th December 2008 Katinka Rosenbom Procurement Overview and Tender Process

2. Consultations with Industry • 2000-2001: First industry-wide consultation on UNICEF approach to procurement • Feedback received was a major contributor to UNICEF’s change in procurement strategy from obtaining short term best value for money to ensuring Vaccine Security for children • Result: Major changes to procurement approach • Move to 3-year global (OPV on own schedule) • Move to RFP from ITB for multi-year • Move to multiple awards per vaccine • Establishment of vaccine procurement principles • Continued dialogue with industry through dialogue with current and potential suppliers, invitation to formal updates (April), participation in meetings with industry Type your title in this FOOTER area and in CAPS

3. Findings • Overall there tends to be similar opinions between manufacturers. • Multi-year (normally 3-year is considered best) • Multiple vaccines procured in one tender • Vaccine should not be procured as a commodity • However, there are variances on specific issues. • Public opening (ITB) vs. public posting of awards • Our procurement process is also informed by inputs from other stakeholders: • Benchmarks with other buyers • Review with WHO • Procurement Reference Groups • etc.. • Our donors’ commitments and funding also influence the horizon and types of procurement we can consider embarking on Type your title in this FOOTER area and in CAPS

4. UNICEF experienced vaccine shortages and developed strategy to address them: • VACCINE SECURITY: Ensuring an uninterrupted sustainable supply of affordable vaccines of assured quality Type your title in this FOOTER area and in CAPS

5. Elements of Vaccine Security • CONTRACTING OF AFFORDABLE VACCINES • Forward commitments • Healthy vaccine industry - variety of manufacturers from both industrialized and developing countries • SURE FUTURE FUNDING • Donors, Countries • Working with Finance Ministries • ACCURATE, LONG-TERM FORECASTING OF DEMAND • Improve accuracy and length of forecasting (1-3 year plans at country level) • Manufacturers need to give accurate forecasts as well • Include buffer stocks Type your title in this FOOTER area and in CAPS

6. Availability development of the 4 basic vaccines to UNICEF Implementation of the Vaccine Security principles helps vaccine availability Type your title in this FOOTER area and in CAPS

7. Foundations to UNICEF Vaccine Procurement Type your title in this FOOTER area and in CAPS

8. UNICEF Vaccine Procurement Principles • A healthy industry is vital to ensure uninterrupted and sustainable supply of vaccines Procurement from multiple suppliers for each vaccine presentation Procurement from manufacturers in developing countries and industrialized countries Paying a price that is affordable to Governments and Donors and a price that reasonably covers manufacturers minimum requirements UNICEF should provide manufacturers with accurate and long-term forecasts; Manufactures should provide UNICEF with accurate and long-term production plans As a public buyer, providing grants to manufacturers is not the most effective method of obtaining capacity increases The option to quote tiered pricing should be given to manufacturers—in accordance with the World Bank classification. Type your title in this FOOTER area and in CAPS

9. UNICEF Vaccine Procurement Objectives • Vaccine Security: Ensure an uninterrupted, sustainable supply of affordable, quality vaccine • Compliance to UNICEF Vaccine Procurement Principles • Compliance to UNICEF Financial Rules and Regulations • Compliance to Public Procurement Principles • Integrity • Competition • Client Service • Equal Treatment • Organizational Objectives Type your title in this FOOTER area and in CAPS

10. Additional specific GAVI tender objectives • A healthy market: ensuring the sustainable quantity of supply through a diverse supplier base • Select products and presentations that best meet the need of client countries • Achieving a long-term affordable price that countries can eventually finance in a sustainable manner Type your title in this FOOTER area and in CAPS

11. GAVI Vaccine procurement Principles • In 2005 the GAVI Board updated the vaccine procurement principles applicable for GAVI. • incorporate and expand on the UNICEF’s principles • Are not conflicting • As a procurement agency on GAVI’s behalf for a number of vaccines, UNICEF is guided by the GAVI principles for the GAVI funded vaccines. Type your title in this FOOTER area and in CAPS

12. GAVI Vaccine Procurement Principles • GAVI recognizes immunization as an important and potentially cost-effective intervention that can enhance the right of all children to a healthy life, that has positive effects in combating poverty and that is a critical contribution to the achievement of public health gains and to the attainment of the Millennium Development Goals (MDGs) for Health. • GAVI commits itself to the immediate and long-term aim of vaccine security – the sustained supply of affordable quality vaccines designed to meet the needs of developing countries for sustainable use. • GAVI, based on the work of national partners, commits itself to enhancing reliability and predictability in vaccine demand and supply, strengthening the planning and forecasting of vaccine needs in the immunization programs it supports, and ensuring that updated information is readily available to industry - thereby enabling the efficiency of vaccine supply for greatest affordability of vaccines. • GAVI recognizes the importance of innovation in the vaccine sector and commits itself to working with industry and national partners to ensure increased use of appropriate under-used vaccines relevant to benefit children most in need, recognizing that success in this will greatly motivate increased research and development of new vaccines including those of relevance to children in developing countries. Type your title in this FOOTER area and in CAPS

13. GAVI Vaccine Procurement Principles • GAVI commits itself to working with national partners and with all industry to ensure increased use of appropriate under-used vaccines to benefit children most in need, recognizing that this in turn will have a positive effect on innovation and development of new products of importance to the developing world. • GAVI commits itself to develop effective procurement strategies based upon the type of vaccines, level of maturity and market conditions of the product in question. These strategies will be based on recognition of competition as critical to achieving long-term sustainability, but may also include longer-term contracting arrangements or guaranteeing of minimum volumes with a single supplier. • GAVI recognizes the vital role of the vaccine industry in world health improvements and establishes strategies that ensure the participation of both industrialized and developing country manufacturers in providing vaccines for developing countries. Type your title in this FOOTER area and in CAPS

14. The Expected Tender Outcome: • Establishment of 3 year Supply Arrangements for vaccines included in this tender • Current Arrangements cover supply through 2009 • Next Arrangements will cover 2010-2012 • UNICEF establishes “framework arrangements” called Long Term Arrangements (LTA’s) • Purpose: To establish forecasts between manufacturer and UNICEF on quantities to be produced and quantities to be bought over the time period; • Defines Technical, Quality and Commercial requirements Type your title in this FOOTER area and in CAPS

15. Why are they arrangements for what is forecasted and not more firm? • UNICEF is fully funded by voluntary contributions • Roughly 2/3 Governments and 1/3 Private • UN Financial Rules and Regulations • UNICEF to fiscal policy to be zero risk • UNICEF cannot make external financial commitment without having internal committed commensurate funding • Funding and Budgetary Cycles of vaccines • Over 500 funding streams for vaccine procurement each year • Normally arrives 4-12 weeks prior to delivery • Funding changes from year-to-year (one donor is not • Government budgets are annual and subject to their release cycles • Working on behalf of the poorest countries Type your title in this FOOTER area and in CAPS

16. LTA Management • UNICEF issues monthly forecast updates / Manufacturer provides monthly production schedule (12 month period…) • UNICEF places Purchase orders upon receipt of funding for Countries (from 1 week to 6 mo. in advance) • UNICEF / Manufacturer hold regular meetings • During early 4Q, UNICEF confirms next year’s annual forecast projection / Manufacturer confirms production • Vaccine is shipped direct to Countries • via UNICEF Contracted Freight Forwarder • via Manufacturer • Vaccine is inspected upon receipt in country • Goal is forward funding so that we can place firm commitments with manufacturer’s earlier Type your title in this FOOTER area and in CAPS

17. Any firm portion requires Establishment of Long Term Arrangements for supply of vaccines for 3 years 2 $ Purchase Order Invoice Paid Purchase Order Invoice Paid Purchase Order Invoice Paid Purchase Order Invoice Paid 3 6 4 Manufacturer Shipment Manufacturer Shipment Manufacturer Shipment Manufacturer Shipment 5 Country Inspects Country Inspects Country Inspects Country Inspects Procurement Overview UNICEF Issues Formal Tender and Evaluates Offers 1 $ If there are disputes on quality, WHO advice governs $ Type your title in this FOOTER area and in CAPS

18. Supply Management The continuous changes in both supply and demand creates a dynamic market that requires continuous monitoring and management • Systems are in place to monitor demand against supply and to report regularly both to manufacturers, countries and partners 80-100 countries ~ 40 Vaccines from ~ 16 Suppliers~ 14 Immunization devices from ~ 8 Suppliers UNICEF has the capacity to reallocate demand and supply between Countries and Suppliers, to avert crisis and reduce the impact of demand or supply fluctuations Type your title in this FOOTER area and in CAPS

19. Vaccine Procurement Process and Methodology Type your title in this FOOTER area and in CAPS

20. The tender process (develop, issue, receipt) • Development of procurement strategy and objectives • Demand / Forecast development • Development of draft tender document with PRG* • Pre-tender meeting with industry • Feedback from industry and finalization of tender document • Issuance of tender • Clarifications • Receipt of proposals (Validity) Type your title in this FOOTER area and in CAPS *PRG: Procurement Reference Group established for some GAVI supported vaccines

21. The tender process (evaluation and award) • Technical review (by WHO) • Quantitative and Qualitative review • Clarification meetings with suppliers • Evaluation of proposals per Evaluation Criteria & Procurement Objectives • Consultation with PRG • Recommendation of awards based on evaluation • UNICEF internal award approval process • GAVI approval, and provision, of any financial requirements • Information of outcome to PRG • Notification of awards to proposers • Public posting of awards (www.unicef.org) • Debriefing • Establishment of Arrangements Type your title in this FOOTER area and in CAPS *PRG: Procurement Reference Group established for some GAVI supported vaccines

22. 2010-2012 Tender Timelines • October – December 2008: Review and Development • Strategy • Quantities / Forecast • Commercial and Technical Terms and Conditions • Feedback and input received from partners • December 2008: Pre-tender meeting with manufacturers (10th-11th) • Provide programmatic update • Present tender process, terms, quantities, to manufacturers • Manufacturers provide feedback • Adjustments are made as necessary • Mid January 2009: Tender Issuance • End February 2009: Closing of Tender; target 6 weeks response time • March - May, 2009: Evaluation and Negotiation • June 2009: Recommendation, issuance of awards • July-august 2009: Debriefings • January 2010: Deliveries commence Type your title in this FOOTER area and in CAPS

23. In general, UNICEF has opted for: Multi-year tenders: RFP Single-year tenders: ITB Tender Methodology – Request for Proposal • Request for Proposal (RFP) vs. Invitation to Bid (ITB) • Tendering for products that are not simple commodities; various factors will be considered in evaluation • RFP Provides manufacturers the opportunity to develop a proposal of what is needed for their vaccines to be produced and sold • RFP Allows for discussion on different presentation options, production volumes, timing of production for linked and competing vaccines • Public opening vs. public posting of awards Type your title in this FOOTER area and in CAPS

24. In general, UNICEF has opted for: 1-year tender: ad hoc needs 3-year tenders: EPI vaccines introduced in routine programmes Tender Duration • Single-year vs. Multiple-year • Single year: demand is more ad hoc and changing; but not very responsive to manufacture production planning • Multi-year: more appropriate for production planning cycles • But how long? 2, 3, 5, 10 years • Based on feedback from manufacturers • Balance between bringing stability to the market and keeping the market active • UNICEF opted for 5-year for OPV (2000-2004), but this had varying results • Manufacturer had difficult time offering prices over 5-year period • Demand changed significantly during that period • Current OPV tender 2 year (2009-2010) programme characteristics Type your title in this FOOTER area and in CAPS

25. In general, UNICEF has opted to invite: Multi-year tenders: All manufacturers Single-year or single delivery tenders: WHO PQ mfrs Invitee List • Only WHO PQ manufacturers vs. All manufacturers • UNICEF buys from WHO PQ manufacturers • UNICEF used to only invite WHO PQ manufacturers • Optimal duration – procurement agreements for 1yr, 3yr, 5yr? • But as we move to multi-year procurement, we don’t want to cut out a potential mfr that becomes WHO PQ during multi-year period • We also want ‘new’ manufacturers to become familiar with UNICEF procurement process Type your title in this FOOTER area and in CAPS

26. In general, UNICEF has opted for: Separate tender for OPV: Large volumes, changing demand Separate tender ‘specials’: eg, Rabies, IPV, etc. 01-06 Combined tender: for all vaccines (except OPV, specials) 07-09: Separate tender: EPI Vaccines 07-09: Separate tender: GAVI funded HepB and Hib vaccines 07-09: Separate tender: Yellow Fever 10-12: Separate tender: EPI Vaccines 10-12: Separate tender: GAVI funded HepB/Hib 10-12: Separate tender:YF vaccines Product Range • Many vaccines in one tender vs. Separate tender for each vaccine • Many products have linkages- in forecast (eg, DTP and combos with DTP; lyopholized products) • Vaccine procurement has large number of terms and conditions- lengthy document • Lengthy tender process when establishing 3-year arrangements • Specific tender objectives and processes for some vaccines Type your title in this FOOTER area and in CAPS

27. In general, UNICEF has opted for: Multi-year tenders: option (c) Single-year or single-delivery tenders: option (a) Evaluation Criteria Options • Various options to evaluation criteria: • Option a) Lowest price is awarded full offered quantity, then second lowest, etc, until required quantity is fulfilled. • Option b) Pre-defined weightings of each factor (past on-time delivery performance, price, delivery schedule, future production plans, VVM, shelf-life, ability to maintain buffer stock, timeline for emergency response (packaging), shipping performance, etc.) • Option c) Quantitative and Qualitative review (of above factors) against Pre-defined procurement objectives and principles. Type your title in this FOOTER area and in CAPS

28. Why not ‘conditional awards’ for non-WHO PQ products? • UNICEF attempted this in 2001-2003 period • Experience: • We were not good at ‘picking winner’ • None of conditional award timelines were met (projected time for WHO PQ and production start-up) • Several were not met even during the 3-year period • Change in approach: • We no longer issue conditional awards • When a manufacturer product becomes WHO PQ, then award process is initiated (if applicable) • Let competitive process determine the ‘winner’ (in terms of timing) Type your title in this FOOTER area and in CAPS

29. What happens when manufacturer gets WHO PQ in the middle of a UNICEF multi-year tender? • 1.In order to allow for the entrance of new manufacturers in the market UNICEF includes a set of conditions under which award(s) would be considered after the initial award(s). • 2. If the supplier was not WHO pre-qualified for the product offered at time of tender, their proposal must have included a detailed plan on the timeline to obtain WHO pre-qualification, including: • Product Development • Clinical Trials • National Regulatory Licensing • File submission to WHO • 3. If the manufacturer’s proposal was deemed of commercial interest to UNICEF, UNICEF and WHO should be kept informed about the progress of the submitted timeline. Type your title in this FOOTER area and in CAPS

30. What happens when manufacturer gets WHO PQ in the middle of a UNICEF multi-year tender? • 4. If the proposed vaccine obtained WHO pre-qualification and upon confirmation that the mandatory requirements of the RFP are met, UNICEF considers establishing an awarded/re-allocated quantity to the manufacturer under one or more of the following conditions: • UNICEF is facing a monopoly situation or a near-monopoly situation; • Lack of performance of current manufacturer(s); or • Insufficient supply from current manufacturer(s) • 5. The quantities considered for award would be those not met under established contracts or quantities that could be reallocated from existing arrangements after negotiation with the corresponding suppliers. Type your title in this FOOTER area and in CAPS

31. When to firm contract? • Context of UNICEF global vaccine supply and funding availability. • 95% of funding (non GAVI funding) for over 2 billion doses of vaccines arrives 1-3 months prior to delivery. • UNICEF procures for 80-100 countries; each country has 3-7 funding sources • UNICEF is cautious to make major changes with industry that will set precedent or expectations that cannot be applied to all vaccines, or may not be sustainable • In any case, UNICEF has issued firm contracts; • Vaccine in scarce supply and quantity needs to be assured • Secure a more favourable commercial offer Type your title in this FOOTER area and in CAPS

32. When to firm contract? • There are many reasons to firm contract: • Avert risk • Obtain more favourable commercial conditions • Provide assurance to manufacturer(s) • And many reasons not to firm contract: • Manufacturer not willing to offer reciprocal terms (mfr does not want to accept penalty if production is not available- due to cGMP or batch failure, etc.) • May prevent other manufacturer from entering market (either because it is exclusive, or it is perceived as exclusive) • Precedent, and unable to sustain, etc. (as mentioned earlier) • Therefore, each case needs specific review. • UNICEF is dependent on firm funding to firm contract, hence not possible in all markets. Type your title in this FOOTER area and in CAPS

33. Post-award Debriefings“What can we know about our competitor’s offer?” • All manufacturers are advised of the outcome of their proposal • Manufacturers receiving an award are invited to a formal debriefing • Manufacturers not receiving an award may request a debriefing • During a debriefing session, the strengths and weakness of the manufacturer’s proposal may be discussed. Details concerning the evaluation, results of a competitor will not be discussed, other than to indicate that which is publicly available. Type your title in this FOOTER area and in CAPS

34. Public Notification of Awards • UNICEF has standard procedures for publication of awards on website: • Tender, duration, total value, material(s), supplier name • This is UNICEF standard procedure (not just immunization) • To meet request for information sharing, all Proposers will receive, after awards are made a letter including the following information: • Total vaccine quantity awarded per year per presentation at an aggregate level • Number of suppliers awarded per year per vaccine presentation • Yearly awarded weighted average price (WAP) per vaccine presentation • Total contract value awarded to each supplier, with listing of included vaccines. • Annual awarded weighted average price for each vaccine presentation will be posted on the UNICEF web-site. Type your title in this FOOTER area and in CAPS

35. Examples of Controls and Oversight • Internal Oversight • UNICEF Financial Rules and Regulations • UNICEF Procurement Procedures • Ethical Code • Contracts Review Committee (independent from contracting staff) • Procurement Training and Certification of contracting staff • External Oversight • UN External Audit (French audit in mid-2004 focused on vaccine procurement; no major findings) • UNICEF Internal Audit Type your title in this FOOTER area and in CAPS

36. Ensuring equal treatment, no bias and ethics • Contracting staff are government by Financial Rules and Regulation and procedures related to ethical behaviour • During tender period- communication is more formal and written, in accordance with tender instructions • Bids/proposals are received and validated by an independent ‘Bid Section’ (QA) and then transferred to Contracting staff • UNICEF does not accept manufacturers to fund trips, hotels, etc. or gifts • Business should be conducted during normal working hours • Meetings should be with min. two UNICEF staff members • Suppliers not invited to UNICEF staff offices Type your title in this FOOTER area and in CAPS

37. Tender document and Proposals review: Type your title in this FOOTER area and in CAPS

38. Overview of 2010-2012 Tender Document • Some changes in the structure of the document, but any important content changes will be highlighted in the background section • 5 Main Sections: • 1- Purpose • The objectives of the tender • 2- Background • Procurement Principles • Forecasting Methodologies • Programmatic background relevant to understand the requirement • Information highlighting changes or specific points such as; scenarios for vaccines, and USD/EURO description • 3- Instruction to proposers • How to make and submit a proposal • Information on how UNICEF will handle proposals, incl definition of mandatory requirements • Information on how UNICEF will debrief and share result of tender outcome. Type your title in this FOOTER area and in CAPS

39. Overview of 2010-2012 Tender Document • 4- Terms and Conditions (list not exhaustive) • Mandatory technical requirements WHO Technical Requirements • Mandatory financial and commercial requirements, such as; • UNGM registration • Financial Requirements / Approval by UNICEF Supplier Evaluation Unit • VVM, Shipping and Packaging Instructions, ETTMD, Vaccine Arrival Report, weight and volumes, samples • Commercial Requirements; currency, MFN, Incoterm • Account Management, past performance, affordable prices, monthly Allocations, Emergency response preparedness • Special terms and conditions; ethical clauses • General Terms and Conditions • Evaluation of proposals and basis for awards • Methodology, process and criteria Type your title in this FOOTER area and in CAPS

40. Overview of 2010-2012 Tender Document • 5- Answering sheets • RFP Proposal form • Qualitative Proposal sheets – for guidance • Quantitative Proposal sheets – one for each vaccine, and alternative offered • 2010-2012 Tender Quantities • Presentation specific • Requested information: Quantities, price, currency, commercial factors, lead time, packaging/weight/volume, VVM Type your title in this FOOTER area and in CAPS

41. Overview of 2010-2012 Tender Document • Annexes • UNICEF General Terms and Conditions • Shipping Guidelines • VVM Specifications • WHO Model Inserts • UNICEF Supplier Financial Evaluation Form • Vaccine Arrival Report Type your title in this FOOTER area and in CAPS

42. Proposals from Manufacturers • Manufacturers are invited to submit a comprehensive proposal • Responsive to projected quantities for each product presentation • The type of vaccine being proposed, and specifications • Unit price per vial and per dose • Annual and monthly production for first year • Alternative vaccine presentations/products • Comply with all MANDATORY REQUIREMENTS • Comply with the INSTRUCTIONS TO PROPOSERS and information requested there within • Provide explanations to any request for exceptions or clarification on the RFP PROPOSAL FORM • UNICEF and WHO will review the proposal and hold discussions with manufacturers Type your title in this FOOTER area and in CAPS

43. Proposal Evaluation Process • Review of Mandatory Requirements • WHO Pre-qualification • Financial Review by UNICEF Supplier Evaluation Unit (SEU) • Compliance to UNICEF General Terms and Conditions • Quantitative Review of Proposal • Products offered, quantities, price, delivery schedule, lead-times, ability to maintain buffer stock, shelf life, VVM • Qualitative Review of Proposal • Proven experience and past performance • Ability to perform account management / good communication • On-time delivery performance Type your title in this FOOTER area and in CAPS

44. Technical Review of Proposals • All proposals are reviewed by WHO • Key areas that WHO review are: • compliance to mandatory technical requirements • compliance to preferred technical requirements • for products not WHO pre-qualified at time of offer, WHO conducted an assessment of timeline given for pre-qualification • other technical issues (Regulatory oversight, etc..) Type your title in this FOOTER area and in CAPS

45. Basis for Awards • The allocation of awards to each supplier will be made in accordance with the UNICEF Vaccine Procurement Principles and with the objective of • Ensuring an uninterrupted sustainable supply of affordable, quality vaccine. Type your title in this FOOTER area and in CAPS

46. Thank you ! Type your title in this FOOTER area and in CAPS

47. Strategic tender issues pertaining to 2010-2012 tender: Type your title in this FOOTER area and in CAPS

48. Overview of 2010-2012 Tenders • 3-year Duration: 2010-2012 • Request for Proposal • Traditional EPI: DTP, TT/DT/Td, HepB, Measles, MMR, MR, BCG • HepB/Hib in combination • Yellow Fever Type your title in this FOOTER area and in CAPS

49. Middle Income countries (MICs) • Some MIC quantities are included in the EPI tender • Countries were UNICEF has a history of procuring on their behalf through VII (Morocco and Philippines) • Additional MIC forecasts received for combination vaccines. • Currently being assessed • Will be identified as MIC/non-GAVI eligible country demand or tendered for separately • Feedback from industry on UNICEF’s role in supplying MICs is welcome. Type your title in this FOOTER area and in CAPS

50. Country preference and interchangeability • Country preference: • For vaccines with two pharmaceutical forms available: • Vaccines covering the same diseases will be considered as one product for the purpose of the request; • however in the tender, we will also indicate the estimated number of doses required for each formulation based on country preferences. • Non-Interchangeability: • Restricts the short term supply management flexibility, but not the longer term security achieved by a healthy market with multiple suppliers. Type your title in this FOOTER area and in CAPS