Call for partners – Diabetes supplies Q&A

Call for partners – Diabetes supplies Q&A

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Supply of blood glucose meters, test strips and lancets for low- and middle-income countries via the FIND marketplace

Questions & Answers

Questions received between 12–31 May 2020

Q1: Our company has established distribution networks in some of the nine FIND target countries. Is it possible for the manufacturer to include only a subset of countries in the partnership proposal, or are you looking for manufacturers who can cover all nine countries?

A1: FIND’s Call for Partners indicates an initial nine pilot target countries, namely Bangladesh, Brazil, Ethiopia, India, Peru, Senegal, South Africa, Tanzania, and Uganda. It is not compulsory for a manufacturer to provide a proposal that includes all nine of the pilot countries. The country coverage and access of a manufacturer is included as part of the manufacturer assessment criteria (please refer to Appendix II), amongst other criteria as indicated in the appendix.

Q2: With respect to the supply network and distribution up to the end user, will FIND handle this or does the manufacturer have to establish a supply network up to the end user (including distributor set up)?

A2: The existence of an established supply and distribution network will be taken into consideration for supplier evaluation (please refer to Appendix II). Should a manufacturer not have an established supply and distribution network in a country for which a registration for sale of the proposed product is in place (or in progress), the setup of such a network can be considered in the context of this Call. Where needed, the FIND marketplace may assist to facilitate distribution activities, leveraging current distribution channels for both public and private sector channels. FIND also considers to leverage Procurement Services Agents, but preference will be for leveraging or helping to build out manufacturers’ distribution channels. Please indicate the status of the supply and distribution network per country that you include in the proposal.

Q3:  When there are different (reference) prices in the public market according to several municipalities or districts in larger countries, what are the considerations that will be taken into account when evaluating price? Given the fact that in some cases these districts are independent from each other and ruled according to its own statues.

A3: The Call for Partners asks for an Ex Works global price proposal, as well as individual Landed Prices per country (please refer to “Financial specifications” of the associated Excel document of the Call). FIND’s aim is to ensure comparable and fair prices of glucose meters and tests strips to patients, to overcome inequality in access due to cost.

As indicated in the section on Pricing of the Call document, as well as Appendix II, FIND is open to explore innovative business models supporting sustainable access, as suggested by IVD industry partners in the context of this Call. Taking into account the affordability aspect of the product to the end user, these may go beyond a single-price proposal. Evaluation of such a business model is part of the manufacturer assessment, as outline in Appendix II.

Q4: Who is the owner of the marketplace and how does it fit within the available sources of products in the countries? Does the marketplace mean a virtual place where, according to demand, products will be delivered to certain institutions or populations? Can you explain further the supply chain and how the marketplace fits into the delivery process to the end users? 

A4: With this Call for Partners, FIND is explicitly seeking partnerships to co-create and explore innovative supply chain solutions across the entire value chain to ensure price stability for the patient.  Please also refer to the relevant sections of the Call document (Marketplace, Products and Appendix I).

Q5: Is the demand forecasted additional to the current market consumption in both private and public markets? Is it correct to understand that this potential demand is additional to current available strips sold by different manufacturers on those markets?  What populations is the demand pretending to reach in the following years?

A5: The demand forecast has been modelled using current market volumes, across both the public and private markets, with 2019 being the base year. This means that this demand forecast is not in addition to the current market consumption. The growth that has been projected is based mainly on the increasing prevalence of diabetes in these markets. The potential of these markets could be a lot greater with improvement in access, expansion and adherence to self-monitoring of blood glucose and health system strengthening, however this has not been considered in the current forecast.

Q6: Given the fact that the demand forecasted includes the public and private market, is it correct to assume that the public forecast will be covered/paid by national, federal, public budget/institutions and the private forecast is intended to reach “out of pocket” patients?  We would like to understand where the budget for acquiring these products is coming from.

A6: The demand forecast has not considered any change in the current reimbursement or source of payer for self-monitoring of blood glucose. Across all of the nine target countries, there is a mixed approach to the way people with diabetes access and pay for their blood glucose testing supplies. We recognize that in the majority of countries the cost is largely an out of pocket expense. As such, your assumption is currently correct.

Q7: In terms of product registration in the nine mentioned country markets, how will FIND assist and address the product registration requirements in each of these country markets?

A7: FIND will not assist with product registration in the countries. Products included in the proposal should already be registered for sale or receive registration by the end of 2020. It is not compulsory for a manufacturer to provide a proposal that includes all nine of the pilot countries (please see Q1 above).

Q8: In many countries importing products is subject to third party inspections, how does FIND address the process in this regard? Which party will be responsible for the relevant costs incurred from this process?

A8: FIND will not cover any costs incurred during the importation process. These costs should be taken into consideration when making a pricing offer for meters and strips in the proposal.

Q9: In terms of the ordering process under this project, which party would be issuing the purchase order and which party would be involved in the order payment?

A9: Product purchase will be triggered by in-country procurers, through the FIND marketplace. FIND is currently in the process of determining the details of the ordering process.

Q10: In terms of marketing material, such as supportive educational material and product packaging, instruction leaflets or user guides in local language, to what extend can the supplier decide freely on the scale and scope of these?

A10: It will be necessary to have product instructions for use and user manual in local language. For educational support material, each supplier can decide freely what kind of material to make available to patients and healthcare providers. Evaluation of this material is included as part of the manufacturer assessment criteria (please refer to Appendix II).

Q11: Where can we preview the detail regarding the in-market accuracy testing that will be conducted independently?

A11: FIND is currently in the process of identifying a designated service provider to conduct in market accuracy testing and further details can be made available, once this service provider has been selected.

Q12: In one of the nine countries, we are supplying our product via an OEM business. The product is equal to the globally available one, but has a different brand name. The globally available product is CE and FDA approved but the local product is only registered with the in-country registration authority (not CE/FDA).

1. Which brand should we offer to FIND in this market?
2. For the local product, which SRA should we indicate in the Excel document?

A12: 1. You should offer the product registered in the country. For the other countries, you can offer the globally available equivalent (if it is registered in the respective countries). 2. As the Excel document only allows to enter one brand name, please enter the globally available one and the name of the SRA this is approved by. In the additional text document, please explain the OEM situation for that particular country and provide evidence that the globally and locally available products are the same and of the same quality.

Q13: Regarding the sources or method for forecasting the demand generated in 2019, what elements were taken into consideration (population, segments, others)? The purpose of this question is to understand and match the figures with our current available data to assess the potential demand for the upcoming years.

A13: The sources used for the demand forecasting model were based on secondary and primary research, as part of a customized market analysis. The forecast for 2019 (base year), was based on current demand in these markets. The demand represents institution, personal and professional use of blood glucose monitoring. We recognize in these markets particularly, that self-monitoring of blood glucose (home based) is in its infancy. In addition, in-country resources/intelligence was considered to support the estimation of the public/private split of the markets. The predicted forecast beyond the base year of 2019, was based on the IDF predicted growth of the prevalence of diabetes in these countries and increased market place coverage (starting in year 1 with 5% and 0.5% for the public and private market, respectively, and increasing to 20% and 12% by year 5 for the public and private market, respectively).

Q14: How were the countries included in this RFP chosen? What is the criteria behind the chosen countries in order to understand if there is a special situation for this countries or negotiation already settled with country health ministries?

A14: As expressed in the introduction of the Call for Partners document, FIND plans to enter into strategic alliances with a set of countries and other partners to strengthen procurement systems, accelerate development of LMIC-appropriate tests, increase test availability, reduce prices, and generate robust data. The pilot countries were chosen based on initial conversations between FIND and local government stakeholders (and other local reputable organizations) to evaluate their interest to enter into a strategic alliance with FIND. There is no special situation in these countries which would differentiate them from other LMICs based on the above planned activities. Discussions and details of the country-specific strategic alliance frameworks are ongoing.

Q15: Are there already local agreements in place with country Ministries of Health? And will those agreements allow the expected projects and pilots to be implemented or these agreements will have to be done by the manufacturers selected? Is there an ongoing conversation among FIND and Local governments and Ministries of Health to make the project viable at each country?

A15: Currently, the details of the strategic alliance frameworks are in the process of being discussed with the countries. FIND will not enter into binding agreements with countries to commit to procurement through the market place. The aim of the strategic alliance is to support countries in understanding current and predicting future diagnostic demand and the impact improved availability and affordability of diagnostic products will have on the population and health system. The manufacturers do not have to enter into agreements with any country government under this Call for Partners. There is an ongoing conversation among FIND and local governments to make the marketplace viable in each country.

Q16: Regarding the post-sale service, how is it expected to be provided, related to the expected tracking of patients having access to the mentioned devices, how could a manufacturer partner link with patients, is there a plan to link both in order to promote post-sale service and warranty of the devices and consumables.

A16: Any post-sales services should be available to all customers of a manufacturer’s product, regardless if the customer received their product from a procurer of the FIND marketplace, or another source. Currently, it is not planned to implement product-specific links between manufacturers and patients in the context of this partnership. However, should you have specific suggestions for targeted post-sales support, which may positively impact demand for the product proposed under this partnership, please include them in the proposal.

Q17: Regarding PWD and healthcare provider product training, educational material and support is available, and in local language, mentioned in page 4. What is the expectation to cover this requisite, onlin, F2F, and to what extent is this training expected to be delivered in terms of number of hours, number of PWD, healthcare providers, specific topics, technical training, others? And the materials related to training in local language could be done in PDF format or they are expected to be printed, if so, in which quantities?

A17: There are no specific expectations and the manufacturers are encouraged to make proposals based on in-country capacity and experience of local support required. The quality and concept of educational and training support will be evaluated during the proposal assessment process (see Appendix II of the Call for Partners document).

Q18: How many glucose meters can you roughly confirm for five consecutive years?

A18: We do not propose volumes for glucose meters. You should assume a volume of glucose meters based on your experience of need for glucose meters in the respective or similar markets.

Q19: Market and demand: With your foundation not being a procurement agent, how do you find the market and demand in the listed countries?

A 19: Per the Call for Partners document Section 3, FIND is establishing a global diagnostics marketplace and through this will engage with governments and private sector actors in country to understand the demand which will be aggregated across countries. FIND is a trusted partner in the diagnostics space and with governments. The marketplace aims to establish reliable supply and fair market pricing for public and private sector addressing current access and pricing challenges.

Q20: Order spans: Are you going to purchase a fixed amount regularly, e.g. every two months?

A 20: Through this Call for Partners we are looking to establish partnerships to establish reliable supply and fair market pricing through a volume based and innovate pricing strategy which will be driven by the proposals we receive. As part of your submission, please outline relevant information i.e. lead times, conditions etc. for consideration of these partnerships

Q21: Role of local distributors: What are the roles of our current distributors (e.g. customs and stock management with the registered products in each country?

A21: Local distributors will have the option to procure through the marketplace or provide the distribution channel to support local buyers; i.e. in providing landed pricing, your distributor can take responsibility for the delivery. If there are other conditions you require given your distribution relationship, please outline these in your response.

Q22: Tender price: How do we deal with prices agreed upon with your foundation? (as we already have a contract with distributors who are eligible to sell registered products in the territory with agreed price in the contract.)

A22: Distributor can sell into those markets, offering the preferential pricing agreed with FIND.

Q23: With respect to the distribution process and supply chain, it is not clear for us if the cost of distribution has to be included in the price of the product. Based on this question, our question is the following; for large countries, there are already different local agreements in place with distributors which vary depending on volume to distribute, reach of distribution, state(s) to reach/ distribute within the same country and payer (public or private). We kindly request more details on the distribution according to the elements provided in this question in order to be accurate in the proposed pricing.

A23: Outlined in the Call for Partners document (Excel template in Annex I) we are requesting both the ex-works price (which does not include distribution costs) and the landed price (which includes costs for distribution, insurance, clearing etc.), as we would like to explore both options. For the latter, you can provide indicative pricing where that is available to you, however, please specific to what specific location i.e. border, central medical stores, 1st line distributor, national lab etc.

FIND’s aim is to make the product available to the patient at an affordable price. In order to achieve this, we need to know and understand the price-effect of the multiple components of the supply chain, which affect end-user prices. The more developed your supply and distribution network is in the different countries, the better can we understand effects on end-user price and discuss ways to keep these at an acceptable level.

It is not the intent of FIND to displace current actors in this value chain but leverage these and increase overall demand. It is FIND’s intent through this Call for Partners to collaborate and co create with partners like yourself to determine the most optimal way to achieve this.

Q24: In order to respect local agreements already established within distributors and governments, it is relevant for us to understand who the payer is for each country and market linked to a potential volume. To be more specific, we would like to understand several aspects as listed under a) – h)

A24: FIND’s aim is to increase access to quality affordable diagnostics. It is not the intent of FIND to displace current actors in this value chain but rather leverage them and through this Call for Partners to collaborate with partners like yourself to determine how best to achieve this.

The FIND global diagnostics marketplace is still in development, the intent is for the platform to capture market demand (public & private buyers), and to facilitate direct and indirect procurement between buyers and sellers. The intent is to onboard manufactures and distributors where distributors can act as either the buyer or seller. This will provide the opportunity for broader geographical reach for organizations like yours. FIND looks to collaborate with partners to determine the most appropriate options to achieve the objectives of increasing access to quality affordable diagnostics.

a) What is the role of FIND in the process of invoicing and supply?  FINDs role will be to either facilitate or conduct procurement; in conducting procurement that may or may not be conducted using a Procurement Services Agent (PSA).

b) Who is paying for the goods? And if the payment is direct to the country, is it to the manufacturer locally? Are there specific terms for payment? FIND may or may not be the payer depending on the circumstances. At this stage it is not expected that FIND will have a Global Fund type model where funding would be provided directly to a buyer (i.e. government or lab) to procure diagnostics. In regards to local manufacturers, if a long term agreement is in place with local manufacturer, it would be expected that any payments would go directly to them by the payer.

c) To whom would the manufacturers selected have to invoice the goods? This will depend on how the purchase orders have been set up; it is expected several options could apply i) invoice buyer directly, ii) invoice FIND, iii) invoice FINDs PSA and/or iv) invoice through distributor.

d) How are the goods reaching the final user? How and where have the goods to be placed and distributed? Is it through the manufacturer’s regular distribution processes? For Ex-works products which are available at Factory Door, you will need to advise in your response where specifically that is. It is expected the buyer and/or FIND (or FINDs PSA) will manage the distribution process from there. However, if there are opportunities to leverage the manufacturers regular distribution process, that will also be explored.

For landed products, we will expect the manufacture to manage the distribution process.

e) Is there a risk in having cannibalization of the forecasted demand (FIND) into the ongoing demand (Local) at the markets? How the offer to the local market, public and private will be done by FIND? It is not FIND’s intent to cannibalize any of the current demand but rather build on increasing the access to these diagnostics. It is expected that the marketplace provides a channel for buyers who are not currently buying or do not have the appropriate channels to procure through. The approaches will differ by market and product penetration in those markets and it is FIND’s intention through this Call for Partners to work with partners like yourself to design and implement the most appropriate approaches for the benefit of all.

f) What is the contractual and commercial relationship between FIND and the manufacturer’s local legal entity? FIND will take guidance from each manufacturer on how they would like the contractual and commercial relationships to be set up.

g) Do specific agreements with FIND need to be executed? If yes, what kind of agreements? FIND will look to set up long term agreements with manufacturers outlining volume and preferential pricing commitments.

h) Considering that FIND is an NGO, does the entity obtain any profit from this transaction? It is not expected that FIND will profit from these transactions. FIND is in the process of defining a sustainable business model to cover operational costs.

Q25: Regarding volumes to be acquired, how would this be handled? Or what is expected from FIND with expired products if the demand is not accomplished in a certain country? Is this a maximum volume? Will it be acquired all in one delivery?

A25: Orders will only be based on actual local demand. FIND will look at negotiating volumes and preferential pricing; it is expected that buyers will place purchase orders against those agreements and will have products shipped on a regular basis, not an annual orders.

Q26: Which “robust data” will FIND generate (page 2)? Will the suppliers have access to it?  

A26: FIND is in the process of conducting in-country analyses of the use and need for diagnostic products, based on historic procurement data, disease burden and health system readiness. Based on this, we will generate a demand forecasting model to support countries in predicting needs of diagnostic products more accurately, to meet demand and address availability gaps. The provision of access to these data can be agreed upon based on needs.

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