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UNICEF Update

UNICEF Update. IPC Meeting Washington, 6-7 June 2016. UNICEF expenditure by material groups, 2015. Global & local warehousing & transport. Inventory- as of 31 Dec $199 M Globally $44 M by SD SD Managed Warehouses- 2015 $130 M Value of throughput 319,173 kits packed and shipped

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UNICEF Update

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  1. UNICEF Update IPC Meeting Washington, 6-7 June 2016

  2. UNICEF expenditure by material groups, 2015

  3. Global & local warehousing & transport Inventory- as of 31 Dec$199 M Globally $44 M by SD SD Managed Warehouses- 2015 $130 M Value of throughput 319,173 kits packed and shipped Copenhagen: highly automated, largest humanitarian warehouse; all hazards & GDP certified Dubai: nutrition, natural disasters Shanghai: Education kits Panama: serves LAC, natural disasters Djibouti: serves Yemen Kit-packing targets Reduce lead-time Health kit-packing in Africa & India

  4. ACCESS TO HEALTH TECHNOLOGIES: UNICEF STRENGHTS • FIT FOR PURPOSE: Government programmatic needs, policy, quality • SCALABILITY: network, experience and capacity in procurement for new and large scale programmes • ADDRESSING MARKET NEEDS: Suppliers-users, funding.

  5. Medicines and Nutrition: Procurement >120 suppliers in 35 countries Delivery to >110 countries

  6. MNC: some figures Antiretrovirals (ARVs) 2015: 5.63 million packs of ARVs procured. Equivalent treatment for an estimated 403,500 adult patients for one year of first-line therapy in 37 countries (52 per cent decrease). Iron Folic Acid 2014: 400 M tabs (98% bottle 1,000 tabs) 2015: 935 M (100% pack of 100 tabs) ORS-Zinc Co-Pack 2014: 1.8 M packs 2015: 10 M packs (sources in India, Bangladesh, Kenya and Nigeria) Amoxicillin DT 2014: 8.5 M pneumonia treatments 2015: 17.2 M pneumonia treatments. Supply to 33 countries Ready to Use Therapeutic Food (RUTF) 2015: 34,817 MT procured (2.35 M cartons). Half of manufacturers and 38%of procurement in programme countries. Development of a Codex guideline for RUTF to facilitate the regulation and inclusion of quality RUTF into government programmes including adaptation to local formulas.

  7. Amoxicillin DT – UNICEF engagement with Manufacturers 2007- 2009 • Better medicines for children project 2010 • Inclusion of Amoxicillin Dispersible tablets in priority list of Essential medicines • 1st UNICEF tender to explore market (REOI). Only 2 suppliers participated. 1 LTA established. 2012 • 2nd UNICEF tender to expand supplier base. 5 Suppliers participated. 2 LTAs established. • Product shelf life established as main barrier • UNICEF proactively worked with unsuccessful suppliers to establish shelf life 2013 • UNICEF engagement with 13 potential suppliers in India, Bangladesh and Africa • Number of LTAs increased to 3 • UN Commission funding to conduct ERP. 1st ERP REOI published with requirement for BE studies (9 manufacturers participated). AmoxDT from 2 manufacturers received ERP risk category 3 • UNICEF feedback to unsuccessful manufacturers and active engagement to meet ERP requirements especially BE studies 2014 • UNICEF increase number of LTAs to 4 2015 • 2nd UNICEF ERP REOI published (11 suppliers participated) • 1 manufacturer from Africa (barriers for African suppliers; GMP, BE, product development) 2016 • ERP 2 finalized. Total of 4 manufacturers attained ERP risk category 3. • More work needed to engage with suppliers to complete recommendations of ERP 2 and to enter market.

  8. Technical Barriers to product development

  9. Enablers to product development

  10. UNICEF’s QUALITY Assurance system • WHO “Model Quality Assurance System for Procurement Agencies MQAS” - TRS 986 Annex 3 • Pharmaceutical Inspection Cooperation Scheme (PIC/S) principles on Quality System Requirements for GMP Inspectorates • European Union - Good Distribution Practice Guidelines • Documentation system in place • Quality manual • Division procedures • Centre procedures • All procurement activities are centralized in UNICEF Supply Division (procurement by UNICEF country offices requires authorization) Source: UNICEF Supply Division

  11. Pre-qualification ACTIVITIES • Medicinal Products • Product Questionnaire as in WHO “Model Quality Assurance System for Procurement Agencies MQAS” - TRS 986 Annex 3 • Nutrition Products • Interagency Food Product Questionnaire • Manufacturers/ Suppliers • Review of Good Manufacturing Practice information: • - Technical Questionnaire • - Manufacturing license • - GMP or ISO certificates • - Site Master File • - Recent Inspection Reports • Contract Manufacture is accepted if both the manufacturer and the sub-contractor are approved by UNICEF Source: UNICEF Supply Division

  12. inspections – KEY FACTS • 145 GMP inspections carried out 2010 -2015 • 24 manufacturers found GMP non-compliant • Re- inspection based on a risk based approach (frequency 2-5 years) • Annual inspection plan established Source: UNICEF Supply Division

  13. INTERNATIONAL Collaboration ON INSPECTIONS • UNICEF relies on WHO PQ of vaccines, HIV, Malaria and TB products • Joint inspections with WHO PQ, ICRC, MSF • UNICEF is a Partner to the Pharmaceutical Inspection Cooperation Scheme (PIC/S) • UNICEF shares inspection reports and information with international partners and vice versa • GMP reports and information from partners is used to prioritize and in some cases to waive GMP inspections • Good Manufacturing / Good Distribution Practice- Training • It is expected that manufacturers that are found GMP non-compliant by UNICEF partners inform UNICEF immediately. Source: UNICEF Supply Division

  14. UNICEF Supply Division warehouse • UNICEF SUPPLY DIVISION • holds an Emergency Relief Authorization issued by the Danish Health and Medicines Agency • is legally authorized to procure, hold, supply and export medicinal products including narcotics and psychotropics • has to comply with Danish and EU Pharmaceutical Legislation – Compliance with EU Good Distribution Practice Guidelines • operations subject to repeated inspection by the Danish Health and Medicines Agency Source: UNICEF Supply Division

  15. UNICEF Ideation for BMGF Pediatrics Initiative • Purpose: • Take stock of previous work, pull together existing data, and identify key experts within UNICEF • Brainstorm current challenges & opportunities related to drug platforms or delivery technologies • “Rank” potential solutions according to Impact + Chance of Success • Participants: • Technical specialists from Medicine & Nutrition; • Health Technology procurement centres; • Programme specialist from Health Programme Division (NYHQ); • Ideation leads from Innovation Unit • Outcomes • Priority technology areas identified • Challenges (tech, manufacturing, implementation) identified • Basis for further elaboration with WHO

  16. Priorities for Exploration

  17. VACCINES- Appropriate emergency and outbreak response OPV Switch Globally synchronized replacement of tOPV with bOPV within a two week window (17th April to 1st May 2016). Involving 155 countries and territories, 77 of them received their bOPV supply through UNICEF-SD. Planning • Two years of planning with partners , manufacturers, regions and countries • The challenge of vaccine supply management was unprecedented for UNICEF, manufacturers and Countries Switch Implementation • Close collaboration with all partners at the global , regional and country level to mitigate all potential risks and challenges to the Switch • Internal UNICEF Supply Division cross-center switch project team • Bridge financing mechanisms to support countries that had delayed funding for bOPV. Impact • Timely delivery of bOPV to 76 countries. Ukraine received bOPV after Switch due to regulatory delays • 18M doses ($2.5M) of tOPV that would have been wasted were saved through coordination and advice to countries on tOPV order cancellations and conversion to bOPV Future Cessation • Post switch surveys and lessons learnt are being documented for a successful cessation by 2020

  18. Innovation and Process Improvement – Pentavalent tender 2017-2019: a multi-phased tender Context: Mature supply and demand market: • Vaccines: have high barriers to entry for new mfrs, 10years to establish new vaccine and plan and long production lead time for already pre-qualified vaccines (6-24 months) • Predictable demand: All countries fully introduced. A flat 150 million dose annual forecast through Unicef • Competitive supply: 7 manufacturers with WHO pre-qualified products, estimated 2-300 % overcapacity in the market. Tender scope: • Covering 3 years: 2017-2019 • RFP covering total forecasted demand in 2017 through 2019, including MICs not supported by Gavi. Modality and structure: • Multi-phased tender to enable to establish longer term visibility for production. but at the same time benefit from the market to relate to an reposition based on pricing/award information from phase 1. • All phases pursue the tender objectives, but expect these can only be partially achieved in each phase, with focus on enabling price discovery in the first phase.

  19. Innovation and Process Improvement – Pentavalent tender 2017-2019: a multi-phased tender The lessons learned that incentivized a new approach; shared with industry in the procurement strategy development Experience has shown that: • We need multiple suppliers, to ensure security of supply and to maintain long-term competition. • The major price shifts have been associated with - competition - market production capacity - price transparency - catalytic contracting incentives • Limited or no price incentive to have long duration tenders • Suppliers are different; in motivation, strategies, objectives, dependencies, cost structure • There is industry and partner desire for greater transparency on the trade off considerations in the award decision making

  20. Innovation and Process Improvement – Pentavalent tender 2017-2019: a multi-phased tender Description of the multi-round tender Mechanics 2016 • PHASE I: • January: Issuance of the RFP for supply of Pentavalent vaccines demand in 2017 through 2019. • April: Conclusion of the first awards for up to 80% of the demand in 2017 and 2018 supply years. • May: UNICEF publication of PHASE I awarded prices. • PHASE II: • June: Bidders will be invited to confirm or amend offers for remaining quantities; • September: Finalization of awards for up to 100% demand in 2017 and 2018 supply years and intend to award up to 20% of 2019 supply year. • October: UNICEF publication of PHASE II awarded prices. 2017 • Commencement of supply to countries from awarded suppliers. 2018 • PHASE III: If decided that this will be pursued, then timing would be Q1 2018 (possibly following new GOI tender) • January: Bidders will be invited to confirm or submit amended offers for the remaining quantities; • March: Finalization of awards, up to 100% of 2019 supply year. • April: Publication of the PHASE III awarded prices.

  21. GAVI COLD CHAIN EQUIPMENT OPTMISATION PLATFORM • An innovative mechanism to strengthen and rapidly scale country cold chain systems; includes a component of installation and training services provided by the manufacturer on-site. • Total estimated funding for the Platform USD 240 – 310 million over 5 years (excluding India). • June GAVI board allocated USD 50 million to launch the implementation of the Platform. • Countries are expected to co-finance 20-50% of investment upfront. • Application windows are aligned with applications for HSS funding; HSS funds may be used for co-financing

  22. Gavi has established the CCE optimisation platform to support countries to improve their supply chain • What will the platform do? • Cold chain equipment is an essential component of the vaccine supply chain that suffers serious challenges currently • The platform will address cold chain equipment challenges in three ways: • Strengthening the coverage and equity of immunisation • Promoting the right technology for each facility • Incentivizing reliable and robust equipment performance • 1 • How will it work? • The platform will support the purchase, delivery, installation and training of higher-performing CCE devices • Specifically, the platform will support eligible countries using a tiered co-investment model depending on a country GNI segment • In addition to providing funding to countries, the platform will involve all key stakeholders to improve the CCE market situation • 2 • How will countries apply? • The platform application is in line with the HSS process and includes additional information covering the platform • Specific country application process will be adapted to the country situation: • Countries applying for a new HSS grant will submit a single application for HSS and the platform • Countries with an existing HSS grant or countries not using HSS money will only submit a supplementary document covering the platform • 3 1 Fund re-allocation only possible if either CCE or SC are part of the country HSS objectives

  23. 55 countries are eligible for co-investment from the platform • Initial self-financing countries – Country co-investment: at least 20% / platform co-investment up to 80% • Somalia • Afghanistan • Mozambique • Bangladesh • Haiti • South Sudan • Kenya • Nepal • Benin • Congo, DRC • Tajikistan • Niger • Burkina Faso • Eritrea • Tanzania • Korea, Dem. Rep. • Guinea • Rwanda • Burundi • Ethiopia • Togo • Liberia • Guinea-Bissau • Senegal • Cambodia • Gambia • Uganda • Madagascar • Sierra Leone • Central African Rep. • Zimbabwe • Malawi • Chad • Mali • Comoros • Preparatory transition phase countries (excl. India1)– Country co-investment: at least 50% / platform co-investment up to 50% • Myanmar • Cameroon • Lao PDR • Sao Tome & Principe • Cote d'Ivoire • Lesotho • Pakistan • Djibouti • Kyrgyz Republic • Mauritania • Yemen, Rep. • Accelerated transition phase countries with at least 2 full years from date of review by IRC prior to becoming fully self-financing (i.e., until at least 20182)– Country co-investment: at least 50% / platform co-investment up to 50% • Nicaragua • Solomon Islands • Vietnam • Ghana • Nigeria • Sudan • Zambia • Papua New Guinea • Uzbekistan 1 India excluded from the CCE platform as it will be considered in the context of the India strategy 2 This period allows at least 2 years from the time of IRC review to allow a minimum of time to complete the grant prior to the end of Gavi’s support to a country.

  24. ZIKA Product Profiles Rapid Diagnostic Test Vaccine Need/Challenge: • >95% of Zika diagnosis are clinical • Lead-time for lab diagnosis is 4-8 weeks, if lab is available Outcome: • TPP launched April 13th jointly with WHO, to drive development of a product • Lab based AND Point of Care • Viral load & antibody • Prefer differential diagnosis (Zika-Dengue-Chikungunya), but min. is Zika Need/Challenge: • Vector control measures largely ineffective • Epidemic modelled to continue for 2-5 years, spreading further. Outcome: • TPP under development with WHO • 1st target population likely: child-bearing age women (15-39) and their male sexual partners • 2nd priority target pop: full population catch-up; then part of EPI programme.

  25. Key Next Steps- pulling commercial issues forward

  26. Supply Financing Solutions

  27. Pre-Financing: VII– Throughput and Utilization Efficiency

  28. SpecialContracting

  29. Supply chain strengthening projects aim to address critical bottlenecks in collaboration with governments DEFINITION OF NEED PROCUREMENT INSPECTION BUDGETING & PLANNING DELIVERY & CLEARANCE WAREHOUSINGDISTRIBUTION, & REORDER UTILIZATION BY END USER MONITORING & EVALUATION • SD works closely with country offices and Governments to strengthen and optimize key supply chains for targeted products to reduce costs, stock-outs, wastage, and improve performance – with a focus on sharing UNICEF expertise on markets, products, procurement, warehousing, inventory management, transportation, system design, monitoring and evaluation

  30. Capacity Development supports government initiatives to achieve long term results in Results Areas: Health HIV/AIDS WASH) Nutrition Education DEFINITION OF NEED PROCUREMENT INSPECTION BUDGETING & PLANNING DELIVERY & CLEARANCE WAREHOUSINGDISTRIBUTION, & REORDER UTILIZATION BY END USER MONITORING & EVALUATION Sustainable National Supply Chains

  31. Convening countries for horizontal learning Immunization SC Forum 15 countries : 31 May – 3 June Nutrition SC Practitioners Forum 9 countries : 21 – 23 June CMS CEO Consultation 6 countries : 24 June Vaccine Procurement Practitioners Forum May 2015, Q3 2016 Share knowledge, experiences, innovative solutions and best practices.

  32. Key Partnerships WHO – UNICEF iSC HUB GAVI Alliance Global Fund – UNICEF MoU Interagency Supply Group

  33. Supply in Health Emergencies Preparations 2016 • Affirm the Priority and Organise Ourselves: • Part of PD-EMOPS-SD matrixed project team taking the preparation forward • Internal SD Project Team • Liaising with Regional and Country Supply • Disease Specific Preparations: Supplies as a part of the Packages of Support • Review of standards products to revise/expand • Top-up pre-positioned inventory at global level and guidance on local inventory • Identify high risk countries that require health systems strengthening support • R&D pipeline • Institutional Strengthening: • Expand supply surge (IRT) rosters to include Infection Prevention Control and experience in public health outbreaks • HEPI training package for supply & logistics staff • Staff Safety: deployment kits for different disease outbreaks • Cooperation with Partners • WHO-WFP Pandemic Supply Chain work (supportive, but not full partner) • World Bank Pandemic Financing

  34. Disease Categories Category 1 Focus to start: Zika-Dengue-Chikungunya, Coronavirus (SARS CoV, MERS CoV), Ebola, Marburg & Novel Influenza A (Avian, Swine, Pandemic) However, work is also needed on Yellow Fever and Meningitis

  35. Disease Specific Preparation- Products as a part of Packages of support • Review of existingproducts needed for prevention, diagnosis, treatment • Category 1 diseases • Include products for Category 1 in SD’s Emergency Supply List (ESL) • Quantify inventory, based on adaptable models • Establish commercial arrangements • Provide technical notes on new products as a part of programme package • Category 2 diseases • Establish commercial arrangement for Category 2 products, but don’t inventory Decision-making Steps for increasing Inventory Identify products Quantify potential demand scenarios Cost the demand scenarios Compare with existing inventory and non-emergency demand Refine and present scenarios for decision Inventory increased as appropriate by 3Q 2016 • Quantification assumptions • At risk population of population of 250,000 (same as CCCs/ESL) • Response for first three months response • Based on actual outbreaks/historical data • Used to estimate patient numbers to determine stock requirements • Patient numbers, staff numbers, population used to calculate supply quantities

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