Tendering to support new vaccine introduction in Middle Income Countries UNICEF Supply Division Presentation to Partners 28 November 2012
Tendering to Support New Vaccine Introduction in Middle Income Countries Background/rationale Strategy and process outline Engagement with partners Next steps
UNICEF s Strategy: Addressing Inequity UNICEF s development of a Middle Income Country (MIC) strategy is consistent with its inequity-fighting mandate and agenda UNICEF s 2010 position paper Progress for Children: Achieving the MDGs with Equity re-committed UNICEF to addressing disparities in children s survival, development and protection among the world s developing regions and within countries Nearly75%oftheworld spoorliveincountriesclassifiedasmic(incontrast,in 1990,over90%ofworld spoorlivedinsteadinlowincomecountries(lic)) 1 21 of the 54 countries categorized as Lower Middle Income (LMIC) are GAVIeligible; the remainder and all of the Upper Middle Income Countries(UMIC) are eitherunabletoaccessgavisupportormaybe graduating inafewyears Although UNICEF programmatic focus has traditionally centered around those countries in the LIC band, accelerating economies still have left many children behind 1) Source: Institute for Development Studies, Global Poverty and the New Bottom Billion: Three Quarters of the World s Poor Live in Middle Income Countries, found at http://www.ids.ac.uk/index.cfm?objectid=d840b908-e38d-82bd-a66a89123c11311f
New Vaccine Adoption in MICs Increasing disparity between rates of or plans for new vaccine adoption in MICs versus GAVI-eligible countries and HICs UNICEF sstrategyprimarilyfocuseson the introduction of new, more expensive vaccines: PCV, HPV, Rotavirus
Factors Affecting New Vaccine Adoption in MICs Lack of access to affordable new vaccines (or even knowledge of comparators) Lack of comparable advocacy and technical advisory/assistance compared to other countries Sustainability / lack of funding sources (both internal budget and external support) Uneven political will, in some countries Variable institutional capacity (NITAGs, procurement capacity, burden studies, etc.)
Partnerships to Support New Vaccine Introduction in MICs Some examples: WHO V3P project to establish an information sharing platform on vaccine prices, presentations and procurement methodologies to share information between countries and provide increased transparency WHO procurement assessments WHO EMRO PVP initiative GAVI support to graduating countries (AMC PCV, HPV tender, co-financing) Advocacy (MSF, Save the Children) UNICEF procurement mechanism
Hybrid Strategy Pooled Procurement New Vaccine Introduction in MICs Reference Prices (for cont d selfprocurement) Providing aggregated demand forecasts to industry, availability and product information to countries, pooling procurement and establishing reference pricing Time-limited intervention with the aim of countries incorporating these vaccines in their regular vaccine procurement processes within a few years Expect initially small, but evolutionary and flexible process Key Dependencies: Iterative country demand forecasting Advocacy Funding options to support alternative contracting, etc. Complementarity with regional initiatives (e.g. WHO/EMRO PVP) Partner engagement
Elements of the Procurement Strategy Solicitation method: Request for Proposal to allow offers based on multiple factors Duration: Multi-year (i.e. 2.5 years) to provide visibility, yet keep market dynamic Products: Rotavirus, PCV, HPV vaccines May need to consider alternative presentation due to current supply constraints Requesting bundled prices as an option, in addition to single product prices Invitee list: All manufacturers with LTAs with UNICEF and posted on UNICEF website to signal launch of this initiative and receive pipeline offers Demand: Maximum demand scenario, indicating levels of certainty, potential country names included Alternative contracting: Requesting offers for alternative contracting terms in order to access best commercial offers Process: Consultation with countries based on offers (country subscription) and partners Awards: Will require flexibility depending on timing of country readiness for introduction Publication / information sharing: Awarded prices and reference prices to be published on UNICEF website Time bound intervention to establish markets that can be sustained by countries
Sizing the Opportunity to Help Children LMICs (GNI $1,006 - $3,975) Total Birth Cohort 90% Birth Cohort Angola Kosovo Samoa Armenia Marshall Islands Sri Lanka Bhutan Micronesia (Fed States) Swaziland Capo Verde Moldova Syria Congo Mongolia Tonga Egypt Morocco Turkmenistan Fiji Nauru Tuvalu Georgia Niue Ukraine Iraq Philippines West Bank / Gaza Kiribati 8,555,000 7,699,500 Less: Indonesia India TACRO LMICs GAVI-eligible (GNI<$1,520) UMICs (GNI $3,976 - $12,275) Albania Jordan Montenegro Algeria Kazakhstan Namibia Azerbaijan Latvia Palau Belarus Lebanon Romania Bosnia-Herzegovina Libya Serbia Botswana Lithuania Seychelles Bulgaria Macedonia South Africa Equatorial Guinea Malaysia Tunisia Gabon Maldives Turkey 5,487,000 4,938,300 Less: China Iran Russia Thailand TACRO UMICs Total 14,042,000 12,637,800 Note: this does not reflect eligibility but assumptions on procurement modality
Early Country Indications on Strategy Preferences Responses are indicative and non-binding; however they point to strong interest
Planned Tender Process Issuance of tender with general assessment of country participation estimated by UNICEF (4Q) Manufacturers submit offers indicating prices and volumes Countries will formally subscribe for volumes once initial pricing results are available UNICEF compiles countryspecific data & preferences in consultation with partners ( PRG ) Tender awards Procurement activities to take place in 1H 2013 with objective of having agreements in place for first deliveries in mid-2013.
Anticipated Pricing Results Reference Price Higher Development Volume-based (etc.) Country Negotiations Lower Development Volume-based (etc.) (non-mfn) Country Negotiations UNICEF MIC Pooled-Procurement Price Higher Development Volume-based (etc.) Pricing Lower Development (non-mfn) Volume-based (etc.) Pricing UNICEF - GAVI eligible GAVI Price MFN
Pricing Precedents DTP-HepB-Hib( Pentavalent ) Pentavalent pricing has always had a difference for non-gavi and GAVI pricing, but they have followed similar trends and have increasingly converged.
Engagement with Partners Multiple consultations throughout the year informing strategy development
Date Process Item 25-26 January Industry consultation where initial strategy was presented 5 March Informal polling of UNICEF Regional Health and Immunization Advisors including view of appropriateness and initial country preferences to two bookend options. 12 13 March Presentation and discussion of initial considerations and proposed optionsat WHO Meeting of the Minds meeting in Geneva (including WHO, GAVI, NGOs, Consultants and Academia). Mid-to-late March April Initial Qualitative Feedback Received from UNICEF Regional Offices (ROs) and construction of Summary Feedback document which was re-distributed to ROs; Hib-containing, Rota, PCV, HPV Preferences and future introduction plans reported; initial discussions regarding country / regional preference for two conceptual options. Construction of draft strategy document incorporating available feedback and select country data points or known preferences. 16 May Distribution of completed draft strategy concept note to UNICEFROs(Regional Directors, Health Advisors and Immunization Advisors); Ros have shared with country offices. 16 May Presentation of draft strategy at WHO NUVI Conference (Marrakech) and discussions with select countries and partners, including WHO, GAVI, Morocco, Bhutan, Philippines, Moldova. Early-to-Mid June UNICEF SDbegins receiving multiple inquiries regarding ability to provide access to Cost Estimates and procurement of new vaccines include PCV, HPV and Rotavirus from select Middle Income Countries. 7 June 19 June 2 nd Round of consultation with all UNICEF ROs and written feedback provided from countries especially frommena, WCARO, ESARO in response to draft strategy. Alternatively, feedback verbally provided via RO 27June July 2012 August October Consultation Process with Stakeholders Secondindustryconsultation,two conceptual bookends of pooled procurement & reference prices presented and soliciting feedback / discussions Issuance of non-binding Interest Assessment surveys to ALL MICsthrough ROs; collected country preference for participation in pooled procurement vs. reference prices and product specific preferences (HPV, Rotavirus, PCV) Continued consultations with Countries, UNICEF Country Offices, Manufacturers, and Partners. Joint WHO-UNICEF Presentation to EMRO RC; Presentation to PAHO TAG on Immunization; Consultation with MSF 8 November Presentation to SAGE in Middle Income Country session 28-29 November Consultation (webinar) with countries, manufacturers and partners September Finalization of Procurement Strategy Implementation Plan and Drafting of Tender Document November Q4 2012 (December) Anticipated launch of MIC tender (HPV, PCV, Rotavirus)
Engagement with Partners Multiple consultations throughout the year informing strategy development Consultation with partners to receive specific feedback on the strategy prior to issuance to industry Soliciting input from partners through a Procurement Reference Group mechanism when offers are received Financial backing for contracts to be determined (depending on offers received) Financial support to countries directly or through a funding mechanism to be determined Asks to partners -support creation of a sustainable model(advocacy, demand creation, technical support)
Planned Tender Process Issuance of tender with general assessment of country participation estimated by UNICEF (4Q) Manufacturers submit offers indicating prices and volumes Countries will formally subscribe for volumes once initial pricing results are available UNICEF compiles countryspecific data & preferences in consultation with partners ( PRG ) Tender awards Procurement activities to take place in 1H 2013 with objective of having agreements in place for first deliveries in mid-2013.
Conclusion Q4 2012 (December) tender launch for PCV, Rotavirus, and HPV vaccines Collaborative development of country demand forecasts for desired vaccines (incl. quantity, preferences and timing) Countries to consider various sources of funding for new vaccine introduction Alignment with partners critical for supporting MICs Continued engagement with industry to develop models to support sustainable vaccine introduction
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