Safe Injection Equipment

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1 Safe Injection Equipment Industry Consultation 21 st 22 nd April 2015 Overview of UNICEF procurement of Safe Injection Equipment Rob Matthews, HTC

2 Objective of Session Provide an overview of UNICEFs engagement in Safe Injection Equipment (SIE) procurement Strengths and Challenges faced Share Findings from Analysis undertaken

3 UNICEF has a key role in Immunization procurement, including Vaccines, Safe Injection Equipment and Cold Chain Equipment; procuring immunization supplies on behalf of around 100 countries annually 2014 Safe Injection Supplies: US$ 42.2 million 907 Million Pieces doses 1320 Transactions Source UNICEF Supply Division 613 Shipments Immunization Supplies Vaccines Safe Injection Equipment Cold Chain Equipment Countries UNICEF procures Injection devices on behalf of: Full schedule Partial schedule Source: UNIICEF Supply Division

4 Scope of Activities covered Commercial Responsible for the supply operation including strategic market intelligence, forecasting, procurement, delivery, innovation and analysis of product groups and procurement strategies Ensure on-time delivery and operational efficiency Collaborate with partners to increase access, decrease prices, establish a healthy, competitive supplier base and sustainable supply, including that can be accessed by government buyers Ensure appropriate Emergency Response Support optimization projects Support knowledge sharing via communication pieces on key products/markets and publication of information Achieve targeted supply outcomes for relevant result areas Technical Quality Assurance Technical oversight and review Provision technical assistance and knowledge management Responsible for ensuring expertise on products Complaints Handling Support knowledge sharing via communication pieces on key products/markets and publication of information Product performance assessments Product Innovation Product Pipeline Engagement with Technical Partners

5 Safe Injection Equipment UNICEF Product Scope Commodity Overview 5 Commodity Groupings Programme Focus Areas Usage/ Application Product Strategic Profiling Auto-Disable (AD) Syringes Immunization Injection for Immunization 29 Standard Stock Materials Safety Boxes Disposable Syringes Re-Use Prevention (RUP) Syringes Immunization & Curative Safe Disposal of Syringes Immunization & Curative Immunization & Curative Needles Curative Health Kits Reconstitution of Vaccines; As part of Health Kits All considered Strategic due to their role in Immunization and Emergency response and UNICEF s role in the market Primary Demand Immunization (>90%); Curative Demand principally for Kits Contributing Directly to 2 MTSP Result Areas Result 1: Survival during delivery and the neonatal period and living free from preventable diseases and disability; Result 2: Protected from HIV infection and free from AIDS.

6 Immunization Devices UNICEF Product Scope

7 Injection Devices Supply Overview What s Good Positive Market developments Supply base for Injection Devices is good* 5 year shelf life Comparative cost (to vaccines) 0.5ml AD syringe used for multiple vaccines Opportunities to improve delivery efficiency Engaged Partners and established partner forums What s Challenging Geographically spread supply base Sea Shipment lead times (2-4 months) Timely Funds Availability Poor Forecast Accuracy*, particularly for supplementary activities Focus on Vaccines, not Injection Devices Large storage capacity required Demand driven by multiple vaccines & programmes Technically acceptable supplier base for Safety Boxes Price levels for RUP and SIP featured Syringes Bundled deliveries of all safe injection materials EffectiveWaste Management remains an unsolved issue

8 Immunization frequently cited as the most cost effective health intervention.. 32% of child mortality is from vaccine preventable diseases Where safe injection equipment plays a key role

9 Product Diversity within the Immunization Context Profile Vaccines Injection Devices Product profile Biological Plastics Quality Assurance WHO PQ, GMP, Batch Release WHO PQS, UNICEF Tech. Assessment, Field Test, Inspection Production Lead time 6-24 months 2-4 weeks Storage requirements Temp controlled (Cold Chain) Dry Stores Supply Base Restricted Healthy (Ability to respond dependent on forecast accuracy) Shelf life 2 years 5 Years Shipment Mode Air Sea Procurement Value 2013 No of Shipments 2013 Procurement Volume 2013 Average shipment time excl. Order LT and FFwdr 2013 (Days)

10 Influencing Markets AD Syringes Reduction in the WAP (>10%), estimated savings >$5m for tender period ( ) Implementation of Landed cost evaluation Quality Assured supply base Healthier market, 4 suppliers, more balanced Injection Safety Programmatic Preference for disabling technology implemented on activation of Device Focus on Sustainability All 0.5ml suppliers contracted > 1,3m pieces per 40 Container (Offers rcvd: 500k 1.8m) Safety Boxes Reduction in the WAP in prior tender round (>10%), estimated savings >$500,000 for tender period Implementation of Landed cost evaluation Quality Assured supply base Healthier market challenged by technically acceptable supplier base Reconstitution Syringes Demand moving towards Re-Use Prevention (RUP) syringes, principally funded by GAVI, not countries Pricing of RUP and RUP with SIP (stick-injury protection) remains a barrier WHO Policy issued for use of RUP and SIP featured syringes for therapeutic markets Manage the transition from Disposable to RUPs for Reconstitution Disposable Syringes and Needles Highly volatile demand profile due to emergency response

11 AD Syringe Volumes and WAP

12 Safety Box Volumes and WAP

13 Disposable and RUP Volumes and WAP

14 5ml Reconstitution Syringe Volumes and WAP

15 Needles Volumes and WAP

16 Value of UNICEF SIE procurement

17 Safe Injection Device Development and Innovation AD SB 1999 Joint UNICEF, WHO, UNFPA Policy Issued Auto-Disable (AD) as a stepstage technology (added attribute to already established technology) AD start 2005 UNICEF Expressed preference for early activation of the disabling mechanism (to reduce risk of reuse) leading to redefining technology and improve product design 2008 Adequate Supply Available with preferred AD mechanism for full award -with multiple suppliers 2009 start RUP/SIP RUP Introducing the RUP & RUP/SIP feature for reconstitution of freeze dried vaccines NEW 2015 Introducing the RUP & RUP/SIP in therapeutic injections-who Policy issued in Feb 2015 RUP/SIP RUP Needle-free devices

18 Service Delivery The Dream The Reality Opportunity for Efficiencies, expansion, refinement Key Success factor, critical management and monitoring

19 The ordering process by design creates an increasing number of activities The Dream The Reality Country Example

20 Service Delivery: ensuring focus on the whole supply chain, engaging all Stakeholders

21 Throughout the process collaborative planning is key: Campaign Safe Injection Equipment order timelines Scheduled Campaign date January 2015; Devices indicated to arrive in February 2015 Orders driven by funds release, not program needs and realistic lead times Reprioritising orders of routine orders impacts other countries supplies where planning was adequate Alternative remedies sought - Potential use of local stock to be investigated Risk of poor results, delayed campaigns which could be avoidable through better planning; earlier funding Increased Advocacy with key stakeholders required

22 Opportunities for Supply Chain improvement initiatives 2014: Changed operating approach to consolidate GAVI shipments (50% of total orders) Country Example UPDATE

23 Procurement development over the past 5 years GAVI playing an increasing role Consolidation of shipments shows a reduction in Shipments, most notably for GAVI Savings gained in the last tender round reflected in the Value/ Volume statistics Data Source: UNICEF SD ZSOS based on PO Year covering all IID products

24 Supply and Demand Mapping of AD Syringes; Safety Boxes; Reconstitution Syringes 9% 2% 13% 7% LTA Supply Base AD Syringes Reconstitution Syringes AD and Reconstitution Syringes Safety Boxes ADand Recon Syringes and Safety Boxes Demand Profile by Region 40% XX % Shownas a Percentage of total UNICEF demand by UNICEF Region 3% 26% Source: UNICEF SD PO quantities by region

25 Analysis of Sea shipment lead times for Injection Devices over a 4 year period ( ) A wide range of transit times, depending on source and consignee country with an average of 43 days and a standard deviation of 24 days. Freight Forwarder lead times for securing shipments is 14 days. Supplier lead times vary from days for forecast demand following placement of the order, depending both on the supplier and the order volumes. Using a 20 day order lead time, 14 freight planning, shipment transit time - assuming no delays, and not considering customs clearance and in country distribution requirements gives a lead time of : = 98 days

26 Country Specific Shipment Lead times Products are sourced Globally Order lead times are supplier specific Shipment lead times are supplier consignee specific Safe injection Equipment is sourced globally by product and often not consolidated across products before shipment, unless shipped from SD Warehouse or suppliers contracted for multiple products

27 Supply Chain strengthening through collaborative planning Myanmar MR Campaign. Target Population17.5m Logistics challenge: Insufficient warehousing capacity for dry stock; Bottleneck at Central level Solution: Share regional distribution plans before order placement; Procure containers; Pack for direct regional distribution; Combine all devices (AD s Recon syringes, Safety Boxes) at central level for onward distribution Enabler: Early planning and Funding, Collaboration across stakeholders along the supply chain

28 Changing Focus - Engaging partners along the supply chain to address challenges and country constraints MOH Vaccine Centre UNICEF Country Offices UNICEF Program Division Measles Rubella Initiative GAVI Alliance UNICEF Country Offices WHO PQS Industry UNICEF Program Division Vaccine Centre International Transport Unit Freight Forwarders UNICEF Country Offices Customs Clearance Agent MOH UNICEF Country Offices SCSC Health Care Worker WHO CO Developing synergies improving the overall performance of the supply chain

29 Supply Chain improvement initiatives Structured framework and iterative approach for Forecast Improvement Past 3 years forecast accuracy > 20% variance Reviewed Forecast approach for Injection Devices Identify & Implement Corrective Action Adjust & Develop Forecast Methodology Structured Empirical Methodology Prioritize & Identify Key Drivers Identify causes of variance/ volatility IMPROVEMENT Undertake Forecast Exercise Engage Stakeholders Analyze Monitor Forecast Accuracy

30 Performance Monitoring On Time Arrival

31 Performance Monitoring On Supplier performance

32 Emergency Response Emergency response provisions in established LTAs Stocks in Copenhagen warehouse for emergency response Forecasting and Warehouse replenishment for emergency demand challenging identified risk area 2014 Performance 9 of 40 Emergency response lines late 6 shipments, All ex-warehouse, Due to consolidation and closed borders (CAR)

33 2015 UNICEF Supply Focus Areas Engage Key Countries, Donors and Industry to address Supply related issues along the whole supply chain Key Countries Work together to Improve forecast accuracy Key Donors Leveraging funds early order placement; improve contractual terms Industry Engage industry in addressing challenges, improving program results UNICEF Supply Division Develop a Procurement Strategy to address program needs Opportunities for improving operational efficiency Leverage Partnerships