UNICEF Procurement Strategy for Safe Injection Equipment Tender for 2020-2021 - RFP-DAN-2019-502979 - Safe Injection Equipment Industry Briefing ...
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Safe Injection Equipment
Industry Briefing Webinar
RFP-DAN-2019-502979
3rd June 2019
UNICEF Procurement Strategy for Safe
Injection Equipment Tender for 2020-2021
RFP-DAN-2019-502979
Rob Matthews, Health Technology Centre, UNICEF Supply Division
Safe Injection Equipment
Industry Briefing Webinar
RFP-DAN-2019-502979
3rd June 2019
Welcome and Introduction
Welcome and Introduction
• Webinar Modality
• Questions and Answers
• We will disable the voice from other participants not to disrupt the presentation
• You have the opportunities for writing questions during the presentation which
we will endeavor to answer at the end.
• The presentation from this webinar will be available at
https://www.unicef.org/supply/index_103574.html
• Presentations from the previous tender round, providing insight into
the planned approach are available at
https://www.unicef.org/supply/index_94621.html
Introduction to Safe Injection Equipment Tender Industry Briefing Webinar Changed approach from the previous Industry Consultations due to: • Limited change in the Strategic Approach from the prior tender round • More sustainable, avoiding travel air travel for +/- 60 participants • 2/3 of responders from the industry survey issued in February were in favour of a Webinar • More efficient process
Webinar Overview • Assessment of prior SIE Tender round outcome and 2018 Year end review against the strategic objectives and identified risks • Landscape changes and Impact on procurement Approach • Procurement Strategy • Tender Scope • Tender Objectives and Targets • Forecast Quantities • Tender Document Structure • Response Templates • Evaluation Criteria and Approach • Planned Tender Timelines • Reference Material • Communication • Q&A
Safe Injection Equipment
Industry Briefing Webinar
RFP-DAN-2019-502979
3rd June 2019
RFP-DAN-2017-502431 Tender Strategy
Assessment Outcome
Assessment of the 2018-2019 Tender Strategy • When developing the Procurement Strategy for SIE for 2018-2019, assessment metrics were identified to assess the effectiveness of the approach and identified risks. • An assessment of the recommended awards was undertaken at the time of CRC submission and at the end of 2018 to provide a mid-term assessment of the strategy developed for the 2018-2019 SIE Tender to inform the strategy going forward. • 8 Objectives and 2 Targets were set for the 2018-2019 Tender
2018-2019 Tender Objectives 1. Ensure an uninterrupted, sustainable supply of affordable products that are in compliance with the required quality and technical requirements. This is the overarching objective. 2. Strengthen injection safety by (i) reducing the risk of re-use, through a tender strategy that supports a preference for devices that have an activation of the auto-disabling feature commencing prior to delivery of the fixed full dose. 3. Maintain a healthy market with multiple suppliers in the markets where this has been achieved and further improve the healthy market status where this is required, seeking further reductions in the weighted average price (WAP). 4. Engage Industry to address programmatic and supply challenges, including new immunization strategies, reducing lead times and increased bundling of SIE offered products and resultant shipments. 5. Reduce the overall cost to programs through the continued application of a landed cost evaluation criteria to better assess the full cost to programs. 6. Implementing a more sustainable procurement approach encouraging product innovations that reduce the overall carbon footprint and waste disposal requirement. 7. Support Bundling of vaccines and injection devices and that the delivery of such is done in an efficient manner. 8. Improve the efficiency of the tendering, procurement and delivery processes.
2018-2019 Tender Targets Two Supply Outcome Targets were set to be achieved by 2021. Sustainability Target (under Objective 6) • To develop local industry, we included a target of 20% of awards made to new local manufacturers by 2021, to (i) stimulate local production facilities to reach the required quality standards and (ii) to grow local production. Delivery Efficiency (under Objective 7) • To improve delivery efficiency through bundling awards for AD syringes, Safety Boxes and Reconstitution Syringes with the same proposer, a target of 80% of awards be bundled by 2021.
Objective Assessment Metrics Evaluation of Award at CRC Submission Mid Term Strategy Review End 2018 1. To ensure an uninterrupted, sustainable No supply interruptions, All All recommended awards are compliant No supply interruptions occurred and supply of affordable products that are in awarded products met the with required quality and technical improved market health for the two previously compliance with the required quality and required technical standards requirements. Improved market for items constrained markets. technical requirements. This is the 20 & 30 0,05ml and 0,1ml AD Syringes. overarching objective. 2. To strengthen injection safety by (i) All awards made for devices All awards of AD syringes made with All awards for AD’s made with early activation reducing the risk of re-use, through a having an activation of the disabling mechanism at onset of injection. of the disabling device. tender strategy that supports a preference disabling feature prior to for devices that have an activation of the delivery of the full dose where auto-disabling feature commencing prior there is available supply of these to delivery of the fixed full dose; products. 3. Maintain a healthy market with Multiple suppliers awarded, Market health improved with more Actual WAP for AD’s declined by 1.7%, market multiple suppliers in the markets where reduced WAP; Awards made suppliers for AD’s, particular items 20 & 30. health improved for the 0,05ml and 0,1ml AD this has been achieved and further using a landed cost price WAP increased by 0,5% but sustainability syringes (Items 20 & 30) improve the healthy market status where evaluation gains achieved. this is required, seeking further reductions in the weighted average price (WAP). 4. Engage Industry to address Improved outcomes over prior 62% bundled awards for AD’s and Safety Bundled awards have enabled the reduction of programmatic and supply challenges, tender rounds; Number of Boxes. shipments by 11% in 2018 from 2017 figures including reducing lead times and alternative offers received with an associated increase in item requests increased bundling of SIE offered products by 7% and resultant shipments.
Market development and applied procurement approach • In 2013, HTC revised the tender approach for Safe Injection Equipment, merging four separate ITBs for AD syringes, RUPs, Safety Boxes and Disposable syringes and needles into one RFP covering all SIE related commodities for the 2014-2015 demand. • In the following tender issued in 2015, covering 2016 and 2017 demand, 40% of awards were made for bundled supply – awarding the same supplier with the full range of SIE products allowing for bundled supply. • In 2017, targets were set for awarding 80% of demand as bundled product by 2021; 62% of awards were bundled for the 2018-2019 award period.
Objective Assessment Metrics Evaluation of Award at CRC Submission Mid Term Strategy Review End 2018
5. Reduce the overall cost to programs Awards made using landed cost Awards based on landed cost evaluation. Actual overall WAP across the entire range
through the continued application of a evaluation criteria. Increased WAP of 1.1% however anticipate of SIE products has remained constant
landed cost evaluation criteria to better Decline in the volume of waste a reduction in number of shipments and between 2017 and 2018 based on the
assess the full cost to programs. based on awards made associated delivery and handling costs. specific order profiling.
6. Move towards a more sustainable Awards made factoring in Tender activity and Award 7% reduction in waste achieved in
procurement approach encouraging sustainability criteria in recommendations resulting in anticipated comparative actuals from 2017 to 2018. It is
product innovations that reduce the Evaluations. 12% reduction in waste generated; anticipated that the waste reduction will
overall carbon footprint and waste Reduction in the unit weight and 6% reduction in transport volumes; increased in the remainder of the award
disposal requirement. volume of awards made from 5% of value award to new local producer. period.
prior rounds. Electronic tendering process reduced paper
wastage and increased process efficiency. 4% of quantities shipped from new local
suppliers in 2018
7. Support Bundling of vaccines and Range of product award by 62% bundled awards for AD’s and Safety Bundled awards have enabled the reduction
injection devices. The Bundling Principle supplier Boxes on track for 2021 target. of shipments by 11% in 2018 from 2017
denotes that for each vaccine dose Anticipate further reductions in shipments. figures with an associated increase in items
delivered, there are a sufficient number of Improve Delivery performance Will monitor during LTA implementation requested by 7% and volumes increased by
AD syringes, reconstitution syringes period. 3%.
(where applicable) and safety boxes and
that the delivery of such is done in an
efficient manner.
8. Improve the efficiency of the tendering, TAD performance, Proportionate 62% bundled awards and award approach Bundled awards have enabled the reduction
procurement and delivery processes. Reduction in overall Freight costs positions UNICEF for a more efficient of POs and shipments by 10% and 11%
Proportionate number of procurement and delivery process. respectively with an associated increase in
shipments and transactions vs SO Electronic bid process and automated data item requests by 7%.
requests in comparison to 2015 extraction reduced the overall evaluation
baseline. by approximately 50%.Delivery efficiency gains • The benefits of the bundled award strategy are shown in the Table and Graph on the right, with the decreasing number of shipments made and POs issued, in comparison to the increased quantity of goods shipped. • The number of shipments made has been declining since 2015, with 2018 reporting a reduction in shipments of 11% when the number of items requested increased by 7% and quantities by 3%. This trend supports the continuation of the bundling approach, validating the 2021 target of bundling 80% of awards. • In addition to the bundled delivery approach, a revision to the GAVI decision letter structure consolidating all GAVI related device approvals of routine programs to one approval per country, introduced in 2017, reduced the number of requests for SIE significantly (39%).
Assessment of risk at
Assessment of Risk at CRC Mid Term Strategy Review
Potential Risk Risk Mitigation strategy Strategy Development
Submission (end 2018)
Stage
Supply interruptions Multiple suppliers contracted, 10% Low (due to applied Low. Improved market for Low. Market status
buffer stock requirement. Should approach); though possibly items 20 & 30 0,05ml and improved for items 20 &
demand outweigh supply for 0.1ml AD problematic for 0.1ml AD 0,1ml AD Syringes. 30).
then the wider supply base including syringe demand depending
activation of the disabling mechanism on the Polio program plans.
at the end of injection will be
considered.
Questionable SIE Quality assurance criteria in place Low (due to applied Low. All Recommended Low. All recommended
quality approach) awards meet UNICEF products met UNICEF
Quality requirements. Quality requirements
Increase in the WAP Increased transparency through Medium (based on the The recommended award Actual WAP for items 10-30
for AD syringes posting of awarded prices, switch from increased focus on reflects an increase of 0,5% for 2018 reduced by 1.7%
ITB to RFP for bidders to leverage their sustainable procurement) from prior round for items
comparative advantage. 10 - 30. The Business unit
considers that the
sustainability gains from
the recommended award
justify the price increase.
Opportunity for bidders to include a Low. No price increase
Low, considering that the oil
Price premium due to price option pegged to raw material requests received – noting
price has ‘bottomed out’ Low. Prices appear
fluctuating raw markets would increase this risk but that planned LTA duration of
and is more likely to competitive
material prices reduce the risk buffer placed if no 2 years limits this risk from
increase than decrease.
option was provided. a supplier perspectiveAssessment of risk at
Assessment of Risk at CRC Mid Term Strategy Review
Potential Risk Risk Mitigation strategy Strategy Development
Submission (end 2018)
Stage
Currency Fluctuation Offers are accepted in US$ and Euro. Medium (considering the Low. Only one supplier Low. Reduced number of
US$: Euro While there is a risk that the WAP will current fluctuations seen contracted in Euros. awards in Euro. Actual
be affected by currency fluctuations, within the currency Bundling approach has spend in Euro dropped from
accepting offers in both currencies is markets. reduced the level of Euro 7 to 4% of total spend
considered lower than requiring offers contracting (unanticipated). reducing exchange rate risk
in US $ as bidders would include a
premium to cover such risk.
Deterioration of AD Multiple suppliers contracted, Low (due to applied Low. Positive market Low. Positive market status.
syringe current healthy evaluation approach not only on price approach) development. Additional suppliers
market contracted for items 20 and
30 than previous tender.
WHO exit as a UNICEF to take over Quality Assurance Low Low Low. No plan from WHO to
prequalifying body and remove WHO pre-
its implications for qualification.
quality assurance
Challenges of timely Buffer stocks established with Medium Low. LTAs require 10% Low. Improved supplier
outbreak response vs. suppliers; Geographically diverse buffer stock for emergency base for 0,1ml reduced the
long lead time due to supplier base; Industry engagement in response. Improved supply risk of low responses.
sea shipment transit addressing this issue base for items 20 & 30 Increased overall demand
time 0,05ml and 0,1ml AD levels for 0,1ml due to IPV
Syringes for fractional fractional doses has
doses. increased supplier
confidence in this market.Assessment of risk at
Assessment of Risk at Mid Term Strategy Review (end
Potential Risk Risk Mitigation strategy Strategy Development
CRC Submission 2018)
Stage
Negative Industry Option for industry to respond as Low, do not anticipate a Low. Very positive Low. Industry has reacted positively
response to the in prior rounds negative response from approach from to this approach with an increase in
proposed approach industry. Prior tender round Industry. the number of suppliers offering
using a similar approach technically acceptable bundled offers
produced positive results. and another AD syringe supplier has
just obtained WHO pre-qualification
for safety boxes, increasing the
opportunity for bundled offers
Inaccurate forecasts Close follow up on changes in Medium. (new vaccine Low. Proposed awards Low. Forecast accuracy was as
demand forecasts; regular introduction delays and are based on predicted, with good forecast
participation in key partnership variations in campaign conservative accuracy on the 0,5ml AD syringes
calls, keep informed of key partner plans) forecasts. Good and safety boxes; good forecast
plans availability in the accuracy on the reconstitution
markets syringes overall but variance between
the disposable syringes and RUP
syringes and poor forecast accuracy
overall for the curative demand. This
supports the type of LTA used for
award (Target bound LTAs for AD
syringes and Safety boxes and Time
bound LTAs for the remainder of the
products.Assessment of risk at
Assessment of Risk at CRC Mid Term Strategy Review
Potential Risk Risk Mitigation strategy Strategy Development
Submission (end 2018)
Stage
Product innovation Monitor product pipeline, product Low (Due to contract period Low. New technologies Low. No scale up on new
making contracted innovations, and pre-qualification and under development but technologies.
products obsolete field test criteria) not close to scale up in
markets
Increased focus on Risk is acknowledged though seeks to Medium WAP increase of 1,1% Low. A 1.7% WAP reduction
sustainable encourage industry to develop smaller under recommended on actual AD syringe
procurement resulting products and lighter, less bulky award. The Business unit procurement; a 0,6%
in increased pricing packaging considers that the reduction in WAP on overall
sustainability gains from AD and SB actual
the recommended award procurement; and zero
justify the price increase. variance on all
Immunization SIE product
actual procurement
occurred.Progress towards the 2 targets set for 2021 20% of the awards to new local producers by 2021 • The awards made under RFP-DAN-2017-502431 (5%) is under the desired linear progression. The full award to eligible new local producers was made in the 2018-2019 tender round, though there were limited eligible suppliers. The bundling of 80% of the awards by 2021 to improve delivery efficiency • The awards made under RFP-DAN-2017-502431 are on track (currently at 62%) to achieve the 80% bundling in the next tender round (2020-2021).
2018 Forecast Accuracy and applied Award Strategy • The forecast accuracy for the Target bound LTA items is considered good, with the only deviation outside of the 20% accuracy for the 0,1ml AD syringe. • For the 0,1ml AD Syringe, Considering that the overall quantities for this product are relatively small and the current demand is volatile due to unknown polio fractional dose response strategies, the current outcome is considered acceptable. • The applied award strategy, establishing target bound LTAs for AD syringes and Safety boxes, and Time bound LTAs for the remainder of syringes and needles proved to be a successful approach in supporting delivery efficiency and is recommended to be maintained during the next ender round.
Summary Assessment of the 2018-2019 Procurement Strategy The Procurement strategy developed for the 2018-2019 tender for SIE, supporting the achievement of the objectives and targets set for 2021, has proven to be successful in achieving the objectives set; noting that the linear progression for the local production target is under target.
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Landscape ChangesThe New Joint Injection Safety Policy New joint injection safety policy • Recommending the sole use of Re Use Prevention (RUP) Syringes for vaccine reconstitution. • This will impact the demand for 2ml and 5ml disposable syringes with fixed needles, shifting the immunization related disposable syringe demand over to 2ml and 5ml RUP syringes with needles.
Structural changes within UNICEF Supply Division Merging of the former Medical unit and SIE units within the Health Technology Centre (HTC) in 2018 • Having merged the two portfolios of the former business units, there are efficiency gains to achieve by including related products formerly procured under separate tenders into this tender to leverage off the overall volumes and shared supply base. • These include cannula’s, spinal needles, scalp vein needles and three- way valves. • The total value of 2018 procurement of these 11 additional products was $534,000; in comparison to the SIE procurement value of $29,250,000.
Safe Injection Equipment
Industry Briefing Webinar
RFP-DAN-2019-502979
3rd June 2019
2020-2021 SIE Procurement StrategyProcurement Strategy for SIE for 2020-2021
Considering that:
• that the applied strategy has proven effective based on the mid-term
review, and
• that targets were set for 2021;
The 2020-2021 objectives will remain the same as the procurement
strategy for the 2018-2019 period.
UNICEF is extending the duration of the existing procurement strategy
(2018-2019) to cover the 2020 -2021 period, with minor adjustments to
address the landscape changes by:
• Not limiting the awards for RUP syringes to those suppliers receiving
awards for AD Syringes alone (the LTAs will remain timebound);
• To facilitate this market shift and ensure supply security, awards for RUP syringes will
not be limited to those suppliers receiving awards for AD Syringes alone as per the
current tender period but will allow for flexibility in the award of RUPs to ensure
adequate coverage and supply security.
• Inclusion of 11 additional products covering cannula’s, spinal needles,
scalp vein needles and three way valves.Safe Injection Equipment
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2020-2021 SIE Tender ScopeScope of Products included under this Tender
The range of products to be included under this procurement strategy
are Auto-Disable (AD) Syringes, Safety Boxes (SB) and Re-Use
Prevention (RUP) Syringes Disposable Syringes and Needles, Spinal
Needles, Scalp-vein Needles, Cannulas and 3-way valves
• RUP with SIP are excluded from this tender due to single country historic
demand for the 1ml RUP with SIP through UNICEF and no forecast demand
for the 1ml, 3ml or 5ml, therefore not justifying the establishment of an LTA
• Should demand materialize for RUP with SIP during the 2020-2021 period
separate tenders covering the required demand will be issued.
• The consolidation of these commodity groups under one tender is
based upon
• their interdependent usage in both immunization and curative settings (as
part of emergency response health kits) to support safe injection and waste
management;
• providing the opportunity to make bundled awards across the product range
enabling delivery and transactional efficiencies;
• offered product range from industry; and
• providing efficiency gains through reducing the number of individual tenders
undertaken.List of Products included under this Tender
Item # Material Number Product Description Item # Material Number Product Description
AD Syringes Disposable hypodermic syringes
10 S0002016 Syringe,A-D,0.5ml,w/ndl/BOX-100 80 S0782110 Syringe,disp,2ml,w/ndl,21G/BOX-100
20 S0002013 Syringe,A-D,BCG,0.05ml,w/ndl/BOX-100 90 S0782111 Syringe,disp,5ml,w/ndl,21G/BOX-100
30 S0002012 Syringe,A-D,BCG,0.1ml,w/ndl/BOX-100 100 S0782112 Syringe,disp,10ml,w/ndl,21G/BOX-100
Sharps safety boxes 140 S0782203 Syringe,disp,1ml,ster/BOX-100
150 S0782205 Syringe,disp,2ml,ster/BOX-100
40 S0782208 Safety box f.used syrgs/ndls 5lt/BOX-25
160 S0782405 Syringe,disp,5ml,ster/BOX-100
RUP Syringes 170 S0782413 Syringe,disp,10ml,ster/BOX-100
50 S0782316 Syringe,RUP,2ml,w/ndl,bi-pack/BOX-100 180 S0782425 Syringe,disp,20ml,ster/BOX-100
51 S0782321 Syringe,RUP,2ml,w/ndl,fixed,21G/BOX-100 Cannula, Needles and Three-way valve
60 S0782317 Syringe,RUP,5ml,w/ndl,bi-pack/BOX-100 240 S0709235 Cannula,IV short,16G,ster,disp
61 S0782322 Syringe,RUP,5ml,w/ndl,fixed,21G/BOX-100 250 S0709231 Cannula,IV short,18G,ster,disp
70 S0782318 Syringe,RUP,10ml,w/ndl,bi-pack/BOX-100 260 S0709232 Cannula,IV short,20G,ster,disp
71 S0782323 Syringe,RUP,10ml,w/ndl,fixed,21G/BOX-100 270 S0709233 Cannula,IV short,22G,ster,disp
110 S0782311 Syringe, RUP 2ml w/o ndl 280 S0709234 Cannula,IV short,24G,ster,disp
120 S0782312 Syringe, RUP 5ml w/o ndl 290 S0709236 Needle,scalp vein,21G,ster,disp
130 S0782313 Syringe, RUP 10ml w/o ndl 300 S0709237 Needle,scalp vein,25G,ster,disp
Disposable hypodermic needle 310 S0747996 Needle,spinal,22G(0.7x40mm),ster,disp
190 S0747420 Needle,disp,19G,ster/BOX-100 320 S0709238 Needle,spinal,22G(0.7x90mm),ster,disp
330 S0709239 Needle,spinal,20G(0.9x90mm),ster,disp
200 S0747432 Needle,disp,21G,ster/BOX-100
340 S0709240 Three-way valve, Luer, w/caps
210 S0747440 Needle,disp,22G,ster/BOX-100
220 S0747452 Needle,disp,23G,ster/BOX-100 Alternative Offers (including bundled offers)
230 S0747445 Needle,disp,25G,ster/BOX-100 350 U481800 Syringes and safe injection equipmentSafe Injection Equipment
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Historic Procurement volumes of SIE
products 2013-2018UNICEF Historic Procurement quantities of SIE products (2013 – 2018)
Within the SIE procurement
volumes undertaken by UNICEF,
the key market within this product
range is the 0.5ml AD Syringe
market in terms of volumes and
value and where UNICEF has an
ability to influence the marketUNICEF Procurement Value across SIE products included under this tender (2013 – 2018) From a value perspective the key commodities to be established under the resultant LTAs are AD syringes and Safety Boxes amounting to over 90% of the total historic procurement value (2013-2018)
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2020-2021 SIE Tender Forecast
QuantitiesSpecific Note - 0,1ml AD Syringe demand • Volatility of demand for the 0.1ml AD UNICEF 0,1ml AD Syringe demand profile 2013-2018 syringe. • Used for intradermal fractional dose delivery of IPV (fIPV) and YF vaccines where acute vaccine shortages prevailed at times of outbreak • Increased, procurement volumes since 2016 which are anticipated to continue during 2020 and 2021 should the Polio Program and countries elect to utilize the fractional dose for IPV. • The 0,1ml AD Syringe market situation has improved so it is not anticipated to make specific awards for outbreak response stockpiling as per previous years but rather to source that from within LTA awards made for the 2020 – 2021 period. • UNICEF requests suppliers offering this product to consider carrying a finished stock of 5 million syringes to be available in case of outbreak.
Resultant planned awards
1. Target bound Long Term Arrangements (LTAs) for AD
syringes and Safety boxes (2 year duration)
2. Time bound LTAs covering the immunization demand for
the associated disposable and RUP syringes used for the
reconstitution of vaccines (2 year duration)
3. Time bound LTAs for the RUPs, Disposable syringes and
Needles for kit packing and emergency response
a. based on the low volumes and value and highly variable demand
levels (driven by Health kit demand). (2 year duration)
4. Time bound LTAs for the Spinal Needles, Scalp vein sets, 3
way valves for kit packing and emergency response
a. based on the low volumes and value and highly variable demand
levels (driven by Health kit demand). (2 +1+1 year duration)Safe Injection Equipment
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Tender DocumentDocument Structure 4 Sections 1. Instruction to Proposers 2. Specific Terms and Conditions 3. Technical Provisions 4. Evaluation of Proposals and Basis for Awards 7 Annexes A. Tender Products and Quantities B. Technical Specifications C. UNICEF Technical Requirements for Medical Devices (MD) D. Technical Proposal Response Template E. Commercial Proposal Response Template F. Background Information, including the Safe Injection Procurement Strategy G. UNICEF General Terms and Conditions Same format and templates as the prior tender round.
1. Instruction to Proposers Outlines requirements proposers must meet when submitting their proposals. Highlights: • Use the Response Templates provided for the standard requested information fields under the relevant section of the Response Templates • Annex D: Technical Proposal Response Template • Annex E: Commercial Proposal Response Template • Additional information to be submitted under in Section 17 of Annex D for technical information or Section 14 of Annex E for commercial information • All requested information must be provided by the proposer • Proposals must be submitted by email to supplybid@unicef.org • Maximum file size 25 MB • Must reference RFP Number and Company name in the subject line on all communication • Technical proposal and commercial proposal must be sent as separate files and clearly marked
2. Specific Terms and Conditions
Provides information on:
• the purpose and requirements of the Request for Proposal
• the Proposal submission schedule
• Acknowledgement of receipt of the Solicitation document
• Questions from Proposers
• Contact email for communication – sietender@unicef.org
• Important – Proposals are not to be sent to sent to the above email address. Any
proposals sent to the above email will be disqualified
• Deadline for questions/ clarifications on the tender document 23h59 Copenhagen time
30th June 2019.
• Submission deadline – 23h59 Copenhagen time 31st July 2019
• Proposal validity requirements
• Preparation of OffersCommercial Response Structure • The Commercial Proposal should be prepared in accordance with the quantities, terms and conditions and specifications outlined in the Solicitation Document • The table provides an overview of the required response structure for the commercial submission including references and guidance on the completion of Annex E requirements. • Scanned signed pdf copies in addition to the electronic (excel) versions of the templates provided under sections 1, 2, 3, 4, 5, and 6 of Annex E are required to be submitted. • Where variances between the scanned and electronic versions occur, the scanned signed version will prevail
3. Technical Provisions
• All Technical Provisions are detailed in Section 3.
• Product Technical Specifications are detailed in Annex 2.
• Technical Requirements are split into Medical Devices and Non-Medical
devices.
• For AD and RUP syringes not previously supplied to UNICEF, UNICEF
requires demonstration of a successful ‘user-friendliness’ field trial of
production-run syringes for AD and RUP products.
• Proposers are encouraged to submit field trials already undertaken with
all supporting documentation for evaluation by UNICEF. If the field trial
is deemed sufficient by UNICEF no further field trial would be required.
• Sample products may be requested.
• UNICEF Technical requirements are listed in Annex C.Technical File Submission • All technical documentation and information submitted for the products requested under this RFP is to be included and submitted as per the structure in Annex D. • A check list for the documents required is provided under section 3.6 of the tender document.
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Annex E: Commercial Proposal
Submission Template and FormsAnnex E Commercial Templates
• 14 Sections
• Scanned signed pdf copies in addition to the electronic (excel) versions of the
templates provided under sections 1, 2, 3, 4, 5, and 6 of Annex E are required
to be submitted.
• Sections 4,5, and 6 to be completed for individual products
• Table under section 2.6.5.10 provides an overview of the required
documentation or information to be submittedAnnex E Commercial Templates
• Shared as winzip files
• Guidance as well as the response sheets
are provided (where required)Annex E Commercial Templates Guidance is provided and Forms are provided in the folders where required.
Section 4 Proposal sheets Select the relevant tab for the products to offer, making a copy of the tab for each product offered.
Proposal sheets The individual tabs are different by product category so ensure you select the right tab for the products offered.
Safe Injection Equipment
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RFP-DAN-2019-502979 Tender
Evaluation Criteria and ApproachEvaluation Approach
• After opening the Proposals, UNICEF will carry out the following
steps in the following order:
• First, each Proposal will be evaluated for compliance with the
mandatory requirements of the Solicitation Document
• Mandatory requirements will be indicated throughout the RFP by the words
"mandatory", "shall", "must", or "will" in regard to obligations on the part of the
Proposer.
• Second, UNICEF will evaluate each Proposal to determine whether
the products offered are acceptable commercially and technically and
are of the required quality.Mandatory requirements
Commercial Evaluation: Technical Evaluation:
• Compliance with Instructions to • Compliance with Technical specifications
Proposers
• Independent laboratory test results within valid 4
• Compliance with Financial Requirement years (for AD, RUP, SB)
• UNICEF General Terms and Conditions • WHO prequalification status (for AD, RUP, SB)
• Declaration of Country of Origin • Conformity to the required Product Quality
System Standards
• Currency of offer (USD or Euro only)
• Conformity to required QMS standards
• Fixed and firm pricing (outside of
alternative proposals) • Compliance with shelf life and sterility
requirements
• Technical proposals and commercial
proposals submitted in separate • Compliance with packing and shipping marking
files/mails requirements
• Compliance with inspection requirements
• Submission of samples to UNICEF Supply
Division Quality Inspection Unit (QIU)
• Successful sample review and approval by QIU
• QMS audit of manufacturer not older than 4 years
• Validated user acceptability studiesEvaluation of Proposals and Basis of Award • The evaluation consists of two main reviews: a Review of Mandatory Requirements and an Evaluation of Quantitative and Qualitative Data of the proposal. • Following the Mandatory requirements evaluation, using the qualitative and quantitative information provided in the proposals, the proposals will be evaluated on their responsiveness and ability to meet the objectives of the tender and achieve the targets set, and considered against the other proposals received. • The evaluation will be informed by the historic volumes and profile of demand per product.
Evaluation of Proposals in Support of the Objectives • Objective 1: To ensure an uninterrupted, sustainable supply of affordable products that are in compliance with the required quality and technical requirements. • Objective 2: To strengthen injection safety by reducing the risk of re-use, through a tender strategy that supports a preference for devices that have an activation of the auto-disabling feature commencing prior to delivery of the fixed full dose. • Objective 3: Maintain a healthy market with multiple suppliers in the markets where this has been achieved and further improve the healthy market status where this is required, seeking further reductions in the weighted average price (WAP). • Objective 4: Engage Industry to address programmatic and supply challenges, including new immunization strategies, reducing lead times and increased bundling of SIE offered products and resultant shipments. • Objective 5: Reduce the overall cost to programs through the continued application of a landed cost evaluation criteria to better assess the full cost to programs. • Objective 6: Implementing a more sustainable procurement approach encouraging product innovations that reduce the overall carbon footprint and waste disposal requirement. • Objective 7: Support bundling of vaccines and injection devices. • Objective 8: Improve the efficiency of the tendering, procurement and delivery processes.
Evaluation in support of achieving the Targets Target 1: 20% of awards made to new Local Manufacturers by 2021 • This target has been included to (i) incentivize current WHO pre-qualified manufacturers in UNICEF Program countries to meet the full scope of UNICEF technical requirements, (ii) to grow local production and (iii) reduce environmental emissions from reduced shipment of finished goods. • 6 percent of AD syringe awards were made to new local manufacturers under RFP-DAN-2017- 502431 covering 2018-2019 demand. • Local manufacturers are considered as manufacturers in UNICEF program countries that have not received an award from UNICEF previously (pre 2017). There is a UNICEF preference for ‘On continent’ (Africa) production. Target 2: 80% of awarded quantities are bundled by 2021 • This target is established to (i) improve the overall efficiency of the procurement process and (ii) reduce the number of shipments required. • 62 percent of AD syringe awards were made under bundled awards under RFP-DAN-2017-502431 covering 2018-2019 demand, increasing from 40 percent in the prior tender round. The achievements of these targets by 2021 will be taken into consideration in the evaluation process subject to meeting tender objectives.
Evaluation of Proposals across the tender objectives and targets Considering the objectives and targets the following approach will be taken in terms of the prioritization of the evaluation of proposals meeting the mandatory requirements: • Ensuring supply security and a sustainable interrupted supply of affordable products compliant to the required technical and quality requirements (objective 1) is the priority objective. • Objective 3 further builds on this focus on ensuring a healthy market - with multiple suppliers (actual number dependent on the overall demand volumes) and prioritizing such over awarding to the lowest priced offer, and only after having healthy competition within a market, focusing on price. • For the AD syringe demand the aspect of early activation of the disabling mechanism (objective 2) will be implemented as soon as the market has the capacity to provide such and would take priority over cost savings in the evaluation. • Achieving Target 1 (20% of awards made to new local producers by 2021) will be prioritized over other objectives for products meeting (i) the mandatory, quality and technical requirements and (ii) preference for early activation of the disabling device provided the bids are considered reasonable. It is considered complementary to the development of healthy markets, supports objective 6 and is seen as complementary to objective 1 and 3. • Sustainability criteria (objective 6) form 30% of the commercial evaluation criteria and will be incorporated within that scoring alongside the landed cost evaluation methodology (objective 5). • Offers providing for consolidation opportunities and bundled deliveries supporting the achievement of objective 7, 4 and 8 and Target 2 (80% bundled awards [by Value] by 2021) will be considered following the fulfilment of objective 1, 2 and target 1 and will be reviewed considering the final commercial scoring after the inclusion of the sustainability and landed cost criteria.
Proposals for AD Syringes not meeting the UNICEF preference for the early activation of the disabling mechanism • If the proposer is WHO pre-qualified for the product offered but does not meet the preference for the location of the disabling mechanism and meets all mandatory requirements, the Proposal must include a detailed plan on the timeline outlining all steps to be taken to make the required changes and obtain WHO pre-qualification for the new product for the proposal to be considered. • If the Proposal is deemed of interest to UNICEF, UNICEF will advise the Proposer of such and will request that UNICEF be kept informed about the progress of the submitted timeline. • If the proposed AD Syringe meets the preference for the disabling mechanism and obtains WHO pre-qualification during the award period and upon confirmation that the mandatory requirements of the RFP are met, UNICEF would consider awarding a 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 supplier(s); • Insufficient supply from current supplier(s); or • If it meets the specific objectives of the tender. • 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.
Quantitative Data considered for evaluation
Objective Evaluation to be undertaken based on the following factors
Affordable Product • Price FCA nearest named international seaport/airport
• Price DAP UNICEF Copenhagen warehouse
• Payment terms
• Gross Weight and volume
• Product offered
• Shelf life
Quality Product • Technical review
Uninterrupted, sustainable supply • Quantity offered; conditions of quantity offered, demonstration of capacity to provide quantities offered; possible
effects of quantities offered on capacity for other products offered.
• Order Lead-time
• Total production capacity
• Validity of Proposal
• 10% emergency buffer stock
Healthy Market • Number of valid offers
• Reduction of weighted average price
Industry engagement in programmatic • Alternative offers provided leveraging industry comparative advantage to get better results for children
and supply challenges
Reduce the overall cost to programs • Landed cost as an evaluation criteria
Sustainable Procurement • Product Volumes, Product Weight
Bundling • Alternative proposals for bundled Safe Injection Equipment
• Range of products offeredQualitative Data considered for evaluation
Commercial Scoring
• The landed cost of the product will make up seventy (70) percent of the
commercial score and factors in the geographic profile of demand
• Proposers are required to submit their prices based on (i) FCA containerized nearest
named port, and (ii) DAP Copenhagen Warehouse Incoterms.
• The price evaluation will be based on an apportionment of 90% of the tender quantities
under FCA incoterms, 10% of the tender quantities under DAP incoterms for Immunization
related demand (Items 10 – 71) and 90% of the tender quantities under DAP incoterms,
10% on FCA Incoterms for the Health Kit/Curative demand (Items 80 – 340).
• The sea shipment cost for a 40’ container for the seven identified ports from the
named FCA ports submitted in the proposals will be provided by UNICEF
contracted freight forwarders at the time of tender closure. The number of
syringes per 40ft container will be factored in to get an average per unit cost for
freight that will be added to the unit FCA price.
• The maximum number of points (i.e. 70 points) will be assigned to the lowest
landed cost proposal. All other landed cost proposals will receive points in inverse
proportion to the lowest landed cost.Commercial Scoring
• The sustainability score will make up thirty (30) percent of the overall commercial
score.
• The specific measurables to assess the sustainability elements relate to the
weight and volumes of the products, based on the shipping carton and
apportioned per product.
• These two components both impact on the volume of product to be shipped around the world
and the weight of the product (and packaging) that needs to be disposed of and are under the
control of the producer in terms of design.
• The total amount of points allocated for the sustainability component is 30. The
maximum number of points (i.e. 15 points) will be assigned to the lowest weight
and to the lowest volume proposal to factor the transportation of the product and
the disposal of the product. All other weight and volume proposals will receive
points in inverse proportion to the lowest weight/ volume.Commercial Scoring Example
Based on Landed Cost Only ranking would have been Supplier 3,1,2,4, then 5Safe Injection Equipment
Industry Briefing Webinar
RFP-DAN-2019-502979
3rd June 2019
2020-2021 SIE Planned Tender TimelinePlanned SIE Tender Timeline
ACTIVITY TIMELINE
Draft procurement strategy Mid-March 2019
Bidders’ Conference (Webinar) – pre-tender 3rd June 2019
Issuance of Tender 4th June 2019
Period for Tender Clarifications 4th June – 30th June 2019
Closing of tender 31st July 2019
Evaluation August - September 2019
CRC approval CRC Submission Early October 2019
Announcement of awards End October 2019
Commencement of LTAs 1st January 2020Safe Injection Equipment
Industry Briefing Webinar
RFP-DAN-2019-502979
3rd June 2019
Additional reference materialsAdditional Reference Materials • Reference information from the industry consultation for the prior tender round is available at the following links on the UNICEF Website for reference. • https://www.unicef.org/supply/index_94621. html (Link to the last SIE industry consultation held in 2017) • https://www.unicef.org/supply/index_10061 9.html [Link to Bid Conference (webinar) held in 2017]
Safe Injection Equipment
Industry Briefing Webinar
RFP-DAN-2019-502979
3rd June 2019
CommunicationCommunciation • All clarification requests related to the tender via email address: • sietender@unicef.org • Note: All invitees will be copied on responses to clarifications
Safe Injection Equipment
Industry Briefing Webinar
RFP-DAN-2019-502979
3rd June 2019
Questions and Answers SessionSafe Injection Equipment
Industry Briefing Webinar
RFP-DAN-2019-502979
3rd June 2019
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