How to Boost Introduction of Vaccines into Routine Immunization Programs: implications of procurement approaches on program costs

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1 How to Boost Introduction of Vaccines into Routine Immunization Programs: implications of procurement approaches on program costs 13 th International Rotavirus Symposium, Minsk, Belarus UNICEF/SUDA2014-XX228/Noorani

2 UNICEF supplies and procures vaccines & vaccine related supplies 2017 Vaccines: US$ 1.32 billion 2.44 billion doses 2,504 shipments Full Schedule Partial Schedule Vaccines BCG, DTP, DT, TT/Td, OPV, IPV, HepB, Penta, MCV, YF, Meningitis, PCV, HPV, JE, TCV, OCV, Rota, HepA, Seasonal Influenza, Rabies and other vaccines/immunizing agents at request of countries. This map does not reflect a position by UNICEF on the legal status of any country or territory or the delimitation of any frontiers.

3 The complex journey of a vaccine Vaccine Product Profile High Product Sensitivity Limited Supply Long lead times for vaccine production Source: International Federation of Pharmaceutical Manufacturers & Associations

4 Detailed product profile for RV Visit Gavi webpage on detailed product profile and wastage adjusted price. Country specific actual wastage rate required. English: French: Manufacturer Bharat Biotech (India) GlaxoSmithKline Vaccine type Doses / Course Click to edit Master subtitle style (Belgium) RV WHO PQ Presentation Form. RV dose vial Liquid RV dose vial Liquid RV dose tube Liquid 1 dose applicator Liquid Merck (USA) RV dose tube Liquid Serum Institute of India (India) RV5 3 RV5 3 Expected 2018 Expected dose vial Lyophilised 2 dose vial Lyophilised Shelf life 60 months 60 months 24 months 24 months 24 months 30 months 30 months VVM 2 Cold Chain Vol / Course 12.6 cm³ Storage -20 C cm³ -20 C Note *: WHO recently amended GlaxoSmithKline vaccine prequalification reducing the shelf life from 36 to 24 months, and prequalifying for use with a VVM7 instead of a VVM14. Source: World Health Organization 7 n/a n/a cm³ cm³ cm³ 17.6 cm³ 10.5 cm³ 2-8 C 2-8 C 2-8 C 2-8 C 2-8 C

5 Forecasting The forecast process is an integrated part of Immunisation Programmes in country and an essential step for the effective vaccine management. Forecasting is the foundation for all elements of Vaccine Security: Basis for production at manufacturers Basis for funding needs The outcome of the forecast is a key input for a number of processes: Aligning annual country government budgeting and planning for health sector Securing better pricing and availability with industry Planning and implementation of vaccine procurement and delivery activities on timely manner in coordination with partners A mechanism to foster on-going information and knowledge sharing Supply planning by industry; inaccurate demand forecasting can create supply disruption

6 Vaccine tender and contracting approach Strategy development Product-specific procurement strategies, based on analysis and experience Informed by industry and partner consultations and alignment of objectives Tender process RFPs for strategic products flexibility for manufacturers to shape the offer to highlight how they can bring best value Multi-year tender & award period provides planning horizon and more certainty to manufacturers Wide invitee-list; all manufacturers are invited to participate (including pipeline) Awards Long Term Arrangements (LTA): contracting for more than one year will impact savings; higher level of visibility for suppliers to plan production Multiple suppliers (pending demand) increase vaccine security in the event of production disruptions or failures (alternative products) 6

7 Healthy Markets Framework HMF represents a set of attributes that should be used to measure the health of a market and a process to evaluate each attribute that is vaccine specific. Total System Effectiveness Long Term Competition Product Innovation The highest level achieves positive system features such as the effect of the market on immunization system effectiveness, long term competition and product innovation Buffer Capacity Individual Supplier Risk NRA Risk A more healthy market has additional supply security attributes Accommodate Country Presentation Preference A healthy market meets country preferences for specific vaccine characteristics Click to edit Master Supply of subtitle Antigen = style Demand for Antigen The minimum of a healthy market is supply meets demand Inadequate Supply Markets without adequate supply are not healthy Developed in collaboration with BMGF and Gavi, the Vaccine Alliance

8 Which factors do Industry say they consider when setting vaccine prices? Source: Access to Vaccines Index

9 Key Market Updates Visit UNICEF s website on market updates here:

10 Transparency Prices Visit UNICEF s webpage on vaccine price data: Source: World Health Organization, Vaccine Product, Price and Procurement (V3P) database; UNICEF Supply Division

11 Vaccine tender and contracting approach Strategy development Product-specific procurement strategies, based on analysis and experience Informed by industry and partner consultations and alignment of objectives Tender process RFPs for strategic products flexibility for manufacturers to shape the offer to highlight how they can bring best value Multi-year tender & award period provides planning horizon and more certainty to manufacturers Wide invitee-list; all manufacturers are invited to participate (including pipeline) Awards Long Term Arrangements (LTA): contracting for more than one year will impact savings; higher level of visibility for suppliers to plan production Multiple suppliers (pending demand) increase vaccine security in the event of production disruptions or failures (alternative products) 11

12 Development of tender document: Guiding Procurement Principles Fairness, integrity and transparency through competition Clear & appropriate regulations/rules applied to all suppliers, fair process, equal treatment of suppliers, transparent system Minimise/Avoid specific labelling requirements, testing requirements, agents in country, etc that may incur premiums to the price Economy to minimize cost and effectiveness to meet end-user interest Meet requirement in terms of quantity, quality, timeliness at the right place. Delivery costs including cold chain capacity/requirements, training of HCWs Best value for money Consider the optimum combination of factors in meeting the end user needs

13 Types of competition Open Open competition / Maximized access Public advertising of a tender All qualified can participate Limited Predetermined qualifications for participation in the tender Short listing Direct procurement Waiver of competition / Single source / Sole source

14 Vaccine tender and contracting approach Strategy development Product-specific procurement strategies, based on analysis and experience Informed by industry and partner consultations and alignment of objectives Tender process RFPs for strategic products flexibility for manufacturers to shape the offer to highlight how they can bring best value Multi-year tender & award period provides planning horizon and more certainty to manufacturers Wide invitee-list; all manufacturers are invited to participate (including pipeline) Awards Long Term Arrangements (LTA): contracting for more than one year leads to cost savings; price commitments have been provided by manufacturers under specific conditions and for a limited period of time, higher level of visibility for suppliers to plan production Multiple suppliers (pending demand) increase vaccine security in the event of production disruptions or failures (alternative products) Multi-year commitments required for MICs to realise cost savings 14

15 UNICEF Pre-Financing; Vaccine Independence Initiative (VII) Request for CE CE issuance CE acceptance advance payment received procurement initiates Request for CE CE issuance CE acceptance + waiver of advance payment + cash guarantee Procurement initiates Funds arrive CE: Cost Estimate (UNICEF quotation) VII provides a streamlined mechanism for procurement steps 15

16 THANK YOU! THANK YOU! UNICEF/UN /Abramson