Request for Proposals: Market interventions for critical tools needed for drug-resistant TB care

This Request for Proposals (RfP) is issued by the Tuberculosis Foundation (KNCV) and Unitaid in the context of their work under the ASCENT project and will focus on market interventions to promote access to critical tools needed for drug-resistant TB (DR-TB) care.
Any information submitted in response to this RfP is provided to KNCV and Unitaid on a voluntary basis. KNCV and Unitaid shall be under no obligation to procure any of the services or products described in this document and the issuing of this RfP shall not be construed as a commitment by KNCV or Unitaid to engage in commercial or other business relations.

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Webinar Unitaid and KNCV TB Plus – RfP Market interventions for critical tools needed for drug-resistant TB care 

Unitaid and KNCV TB Plus will host a webinar to present the scope and content of the request for proposals and answer any process-related questions on Monday, 15 January 2024 at 14:00 CET. During the webinar submitted questions on the RfP will be addressed and there will be an opportunity to raise questions during the webinar.

Please register for the webinar with the following link:
Registration form Webinar on RFP Market access for TB cascade (office.com) 

Please find here the link to the webinar: https://zoom.us/j/94118133447 (meeting ID: 941 1813 3447).

If you are unable to participate in the webinar, a recording of the session will be made available below shortly after the webinar takes place. 

RfP – Design, Development and Implementation of market access interventions for Drug-resistant TB projects in LMI Countries – webinar recording (part 1)

RfP – Design, Development and Implementation of market access interventions for Drug-resistant TB projects in LMI Countries – webinar recording (part 2)

RfP – Design, Development and Implementation of market access interventions for Drug-resistant TB projects in LMI Countries – webinar recording (part 3)

 

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A. Introduction

The purpose of this RfP is to solicit detailed proposals to select a competent Market Access Technical Partner (MATP) to act as a sub-implementer on the ASCENT project funded by Unitaid. The responsibility of the MATP will be to conduct a robust market analysis, design an appropriate access strategy and in coordination with KNCV Tuberculosis Foundation (KNCV) implement the proposed market shaping interventions of health products[1] relevant to the drug-resistant tuberculosis cascade of care In Low- and Middle-Income Countries (LMICs).

B. Background

The original ASCENT (Adherence Support Coalition to End TB) project, funded by Unitaid, built on existing evidence, innovations in adherence technology and growing global momentum to implement integrated Digital Adherence Technology (DAT) interventions in five key countries namely Ethiopia, the Philippines, South Africa, Tanzania, and Ukraine) for all types of TB[2]. With its strong consortium of partners (KNCV Tuberculosis Foundation as lead implementer, the Aurum Institute, the London School of Hygiene & Tropical Medicine, and PATH) and partnership with the governments of the implementing countries, the ASCENT project contributed and still contributes to the adoption and uptake of digital adherence technologies.

Following the WHO’s recommendation for improved treatment methods for rifampicin or multidrug-resistant TB the ASCENT project expanded its goals. From October 2023 to October 2025, ASCENT will help countries swiftly implement newer, shorter treatments in alignment with WHO (World Health Organization) guidelines and their national TB strategies, thinking through access to the gamut of supportive tools required for quality DR-TB care. This involves mapping gaps, providing technical aid, and ensuring efficient use of resources without redundancy. The project’s actions will complement partners’ efforts and adhere to existing roadmaps.

The ASCENT project will pay special attention to patients’ treatment literacy (enabling patients to exercise their rights and participate in treatment decision-making), with community demand generation for the new regimens; access to comprehensive packages of treatment support including digital options as per countries’ priorities, with options to tailor treatment delivery to people’s needs and optimization of active drug safety monitoring & management (aDSM) and clinical management. In the event of gaps, not addressed in the full cascade of care for drug resistant TB, the project will provide some targeted technical assistance on how to address these gaps and/or capacity building, while leveraging other resources, like the Global Fund, GDF (Global Drug Facility), domestic funding etc., for eventual (wider) implementation.

The project is focused on essential diagnostics, treatments, and supportive technologies for DR TB as endorsed by the WHO. The project will collaborate with WHO offices at country, regional, and global levels to increase awareness, strengthen countries in decision-making concerning adoption and eligible patient groups, support guideline revisions, forecasting drug and diagnostic volumes, plan transitions, and build capacities as required. The objective during the project duration is to support efforts to ensure rapid uptake and implementation of WHO recommended treatments, diagnostics, and other supportive tools in a holistic quality package of care.

About KNCV

KNCV has been fighting TB since its establishment in 1903 as a collaborative effort by several private local TB control initiatives in the Netherlands. Over the past 120 years, the organization has acquired indispensable knowledge and experience in the field of effective TB prevention and care, resulting in pre-elimination in the Netherlands and significant contributions to global evidence generation, policy development and TB program implementation worldwide.

About Unitaid

We save lives by making new health products available and affordable for people in low- and middle-income countries. We work with partners to identify innovative treatments, tests and tools, help tackle the market barriers, and get them to the people who need them most – fast. Since we were created in 2006, we have unlocked access to more than 100 ground-breaking health products to help address the world’s biggest health challenges, including HIV, TB and malaria; women’s and children’s health; and pandemic prevention, preparedness, and response. Every year, more than 170 million people benefit from the products we have helped roll out.

C. Overview and Purpose

The purpose of this request for proposals is to select a Market Access Technical Partner (MATP) organization, with a proven record of developing and executing market strategies to secure adequate, equitable access conditions in low- and middle-income countries with specific focus on tools relevant to the drug-resistant tuberculosis cascade of care.

The MATP will be responsible for, in collaboration with Unitaid and the ASCENT consortium, designing and executing market shaping interventions to help secure a global affordable market for WHO recommended diagnostics, treatment regimens and supportive tools. The MATP would be a sub-implementer on the ASCENT project and be eligible as third-party recipient of Project Funding.

A sub-agreement will be executed between KNCV and the MATP. It is estimated that the duration of the Terms of Reference relating to Access will be 18 calendar months with a possible extension for one additional month including periods for responsible close-out and transition to country governments and other scale-up partner(s) who will sustain and expand of the implementation beyond the project timeline. The maximum duration would not exceed October 2025.

D. Scope of Work

This scope of work in relation to this RFP is as follows:

  1. Gap analysis: Unitaid and ASCENT will map health technology tools across the cascade of care, identify key gaps preventing the accelerated introduction of new, shorter MDR-TB regimens in MDR TB high burden countries and recommend a set of products (screening, diagnostics, treatments, and supportive tools) to take forward for detailed market analysis. Unitaid and KNCV will review and make a final selection of products to move to the market analysis stage.
  2. Market analysis: the MATP will perform a market analysis and lead the development of landscape report (or similar document) for TB diagnostics and therapeutics products with an aim to improve equitable access in focus countries. As a priority, the MATP will leverage existing market data and build on work conducted by partners (TPMAT, USAID (US Agency for International Development), Global Fund etc) and experts and contribute to other knowledge product(s) by global stakeholders.
  3. Design of access strategy: working in collaboration with the ASCENT consortium and with oversight by Unitaid Secretariat (in consultation with TB MAT and relevant stakeholder groups), the MATP will coordinate the design of access strategies to address screening, diagnostics, treatment and supportive tools gaps in alignment with access-related objectives The design of the intervention must consider transition and scalability within the project timelines and subject to approval by Unitaid.
  4. Implementation: the MATP, in collaboration with KNCV and Unitaid, will ensure that the implementation of the access program is carried out through close collaboration with other partners like The Global Fund, USAID and other international donors to ensure that the opportunities are scaled and sustained. As a member of the KNCV consortium, the MATP will collaborate with other consortium members, but will not be required to implement site-specific activities or programmatic support.

The MATP will ensure that all products selected to receive financial and/or technical support through the Project, or to be the subject of a market intervention, are selected in accordance with an open and transparent selection process supported by an external independent committee of experts (including representatives of communities and civil society) and subject to approval by Unitaid Secretariat. The MATP will provide details in the Access/ Market Shaping Strategy Document of the proposed membership and terms of reference for the committee, the proposed process for selection of products to be supported through the Project by the committee, and the procedure for managing and mitigating potential conflicts of interest.

5. Access-related programmatic and monitoring support: the MATP will contribute to the development of Country Technical Assistance Plans and recommendations which KNCV will develop and lead the implementation of the access-related components including, but not limited to, product regulatory and registration support, WHO Prequalification Programme (PQ), Global Fund/Unitaid Expert Review Panel (ERP), US FDA and/or another WHO Listed Regulatory Authority (as appropriate), participation in Portfolio Access management team and negotiation with manufacturers. The MATP will help develop the Monitoring and Evaluation approach in terms of identifying metrics and data sources that could be used to track progress and any unintended consequences.

E. Eligibility Criteria

KNCV/Unitaid is seeking an organization with the following expertise, experience, skills, and technical qualifications.

Essential

  • Demonstrated expertise and experience in generating market landscape reports, market analyses of medicines and diagnostics and related health technologies.
  • Demonstrated expertise and experience in designing or developing market shaping or access interventions focused on low- and medium-income countries (LMICs).
  • Demonstrated experience in implementation of access programs for medicine and diagnostics in LMICs.
  • Demonstrated expertise in diagnostics and/or medicines (ideally one organization with both capabilities)
  • Demonstrated experience in negotiating access and procurement terms with the diagnostics and/or pharmaceutical industry.
  • Experience in managing diseases and health areas in the scope of Unitaid’s mandate (HIV, TB, malaria, reproductive maternal and child’s health, pandemics).

Desirable

  • Proven experience in and knowledge of health product regulatory mechanisms across geographies (especially in LMICs).
  • Demonstrated experience in monitoring and evaluating an intervention’s impact on both market and global health outcomes.
  • Proven experience conducting similar work for global health and/or industry or similar stakeholders.
  • Demonstrated commitment and initiatives in support of sustainability – Climate and Environment – (particularly in relation to carbon footprint) e.g.: past/ongoing initiatives to reduce carbon emissions, compensation of emissions) and how sustainability will be reflected in this market shaping activities. Bidders are expected to include any relevant certification or supportive documentation in their proposal.

F. Submission of Proposals

All proposals for this RFP must be submitted before 5pm GMT, 1 February 2024, solely through the designated email address: ascent@kncvtbc.org

Only those proposals submitted via the designated email address will be accepted by KNCV/Unitaid. Under no circumstances shall proposals be submitted to Unitaid by any other means, including, without limitation, to another email address or in hard copy.

The technical and financial parts of the proposal must be submitted in two separate documents using the template provided. Upon submission, proposals become automatically sealed, and accessible to Unitaid once the deadline for submission of proposals has passed. The proposal shall include the complete technical and financial proposals and requested supporting documents.

Technical Proposal

The bidders should provide the technical proposal as a separate document using the template provided. All bidders are expected to submit their proposed workplan, general approach and methodology, project management, coordination, and quality assurance.

General approach and methodology: the proposed approach and methodology should be sound, convincing, adequate, and appropriate to cover the four (4) thematic areas. The bidder should propose an approach appropriate and feasible to meet KNCV/Unitaid’s requirements and expectations have been satisfactorily addressed as per the scope of Work.

Project management, coordination, and quality assurance:  the proposal should describe how access areas of work will be organized, resourced and quality assured to deliver on the scope of work. The approach for coordination, reporting and quality assurance aspects should be described in the proposal.

Experience in managing access focusing on TB and other diseases: the proposal should highlight experience in managing diseases and health areas in scope of Unitaid’s mandate (HIV, TB, malaria, reproductive maternal and child’s health, pandemics).

Experience and Team Structure: the proposed resources, e.g., team management and composition (seniority mix, size of team, allocated time/level of effort), should be optimal to meet project requirements and quality standards. The proposal should highlight experience of the bidder in carrying out similar projects or assignments, and evidence should be provided to demonstrate this in the proposal (including references from past or current clients or related parties). The qualifications, competence and experience of staff proposed for the assignment should be summarized in a tabular form along with a one-page CV for each staff proposed highlighting the 4 thematic areas.

Sustainable procurement and Access: the proposal should demonstrate commitment and initiatives in support of sustainability, climate, and environment (particularly in relation to past/ongoing initiatives to reduce carbon emissions, compensation of emissions etc as applicable) and how sustainability will be reflected in this market shaping activities. Please include any relevant certification or supportive documentation.

Workplan: a workplan in months should be provided to describe high-level activities relating to the Scope of Work in this RFP while noting the maximum number of months should not exceed 19 months. The work plan should be broken down across the four (4) thematic areas as described in the scope of work (namely gap analysis, market analysis, design, implementation, programmatic and monitoring support).

All proposals will be scored (for the scoring grid see annex 1)

Mandatory Passing score: A minimum of 70 % of aggregate score for the bidder’s Technical Proposal is required for consideration of its financial proposal.

Financial proposal

The bidders should provide the financial proposal as a separate document using the template provided. The financial proposal is divided into two sections namely staffing budget and full budget.

Staffing budget

Bidders are expected to propose a team composition that is deemed most appropriate and practical to carry out the work effectively and efficiently, in both technical and financial terms.

Bidders are requested to propose staffing dedicated to the project, skills set and team structure/leadership commensurate to the scope of work of this RFP and responsive to Unitaid’s specified timeline and focus. The proposed team members who have been agreed on and accepted by Unitaid following the RFP evaluation process shall be available throughout the effective project duration and shall not be changed unless requested or agreed to by Unitaid. The staffing budget should be provided in the financial proposal using the template provided and pre-populated from the first tab of the template.

All bidders are expected to submit their proposed staffing budget, broken down across the four (4) thematic areas as described in the scope of work (namely market analysis, design, implementation, and programmatic support).

Full budget

The full budget incorporates elements of staff budget, travel related expense, Equipment other than Health related, communication material and publications and other project expenses. Details about these expenses are provided in the financial proposal template. The financial proposal excludes the commodity budget (health commodity and health equipment) and related logistics costs (procurement and supply chain) and external procurement services. These excluded components are covered under the main grant managed by KNCV.

The bidders should include General and Administrative Expenses which are expenses associated with the general running of the head office administration of the different consortium members, indirectly supporting the implementation of the Unitaid-funded project. This should be set as a % of other project expenses excluding (1) health commodities and equipment, procurement and supply chain, external procurement services and (2) other significant pass-through costs. Pass-through costs relate to sub-grants and subcontracts where services or products delivery payment are directly procured from and passed to a third party; they generally do not involve general administrative expenses and the management of such sub implementer and subcontracts is expected to be managed by the grant implementer’s project team. GAE should be provided as per their organizational policy. Please refer to the article 5 of these financial guidelines where GAE definition and Unitaid funding approach is explained which can found here: https://unitaid.org/assets/Financial-guidelines-for-Unitaid-Grantees.pdf

The financial proposal should assume a maximum duration of 19 months from the time of Grant Agreement signature. The approved financial proposal of the successful bidder will be converted to the sub-implementer budget and included in the Grant Agreement Amendment for the ASCENT project.

The financial proposal should be provided in both PDF and MS Excel format, free from any computational errors. The offer currency must be the same as the bank account of the Contractor that will be used to receive payment for the to-be contract. For comparison purpose only, financial proposals that are submitted in currency other than USD (US Dollar) will be converted into USD using the UN exchange rate as of the tender closing date of this RFP.

The bidder’s Financial Proposal must be signed by a duly authorized representative of the bidder and stating:

–    That the bidder undertakes on its own behalf and on behalf of its possible partners and Contractors to perform the work in accordance with the terms of the RFP;

–    The total cost of the proposal, indicating the United Nations convertible currency used (preferably US Dollars);

Exclusions from Financial proposal

The cost of implementing any access related interventions (including procurement of medicines and therapeutics, associated procurement fees and logistics costs) should not be included in the financial proposal.

The nature, scope and financial resources required to implement access interventions will be determined and allocated from a separate budget line in coordination with the ASCENT project and Unitaid.

G. Submission Instructions

  1. Request for Proposals
    1. All responses to this RfP should be submitted in English and be signed by an authorized representative of the respondent.
    2. A complete response to this RfP must include a fully completed Proposal Form and all relevant annexes (as detailed in Section C above and attached to the e-mail message).
    3. Responses to this RfP should be submitted via e-mail with the subject line “Request for Proposals MATP” to ascent@kncvtbc.org
    4. Following the submission, KNCV may contact bidders individually, with requests for further information or clarification.

2. Timeline

RfP released 11 December 2023
Questions deadline (via email) 20 December 2023
Q&A response document shared, and seminar planned 10 January 2024
RfP Closing Date 1 February 2024*

*please note that the RfP closing date has been extended from 26 January 2024 to 1 February 2024

 

3. Questions and Answers:

Questions regarding this RfP should be sent by 20 December 2023 17:00 GMT via email to ascent@kncvtbc.org. All questions and answers will be shared with you by e-mail (please see above timeline).

Any request for clarification on technical, contractual, or commercial matters is to be submitted exclusively via designated email and subject matter appropriately named as “Questions or Clarifications – RFP 2023-323” later than the date stated above using the format below.

Question # Reference to RFP (paragraph #) Question text

Unitaid will respond in writing to any request for clarification of the RFP that it receives by the deadline indicated above. A consolidated document of Unitaid’s responses to all questions (including an explanation of the query but without identifying the source of enquiry) will be sent to all prospective bidders who have received the RFP.

There shall be no individual presentation by or meeting with bidders until after the closing date for submission of proposals. From the date of issue of this RFP to the final selection, contact with KNCV/Unitaid officials concerning the RFP process shall not be permitted, other than through the submission of queries as per the process described above, and/or through a possible presentation or meeting called for by Unitaid, in accordance with the terms of this RFP.

H. Evaluation of Proposal

Following the preliminary examination of proposals as per Scope of Work, a two-stage procedure will be implemented, with the evaluation of the technical proposal being completed prior to the evaluation of the financial proposal.

The evaluation panel will evaluate the technical merits of all the proposals which have passed the Preliminary Examination of proposals based on the following weighting:

Technical Weighting 70 % of total evaluation
Financial Weighting 30 % of total evaluation

Financial proposals will remain sealed until the completion of the technical evaluation. During the financial evaluation, only the price proposals of those bids which have achieved the minimum technical threshold will be opened and compared.

A minimum of 70 % technical threshold is required a passing score to be considered responsive for financial evaluation. The most responsive bid would be determined by combining the technical score of the eligible bid with the respective financial score.

KKCV/Unitaid shall not in any way be obliged to reveal, or discuss with any bidder, how a proposal was assessed, or to provide any other information relating to the evaluation/selection process.

I. Costs of preparing documents

All costs associated with preparing and submitting a response to this RfP will be borne by the Bidder.

J. Confidentiality

Information submitted by bidders in response to this RfP will be received by Unitaid and promptly shared in full with KNCV. The Information will be used by KNCV and Unitaid as described in the section headed “Disclaimer” above.

Any confidential information submitted in response to this RfP should be clearly marked as such by the Bidder on the completed form. Unitaid and KNCV will take all reasonable measures to maintain the confidentiality of information marked confidential. Information marked Confidential will not be shared with other entities or individuals outside Unitaid and KNCV, including with the Partners identified in the Disclaimer above, without the Bidder’s written authorization.

Nevertheless, this confidentiality commitment shall not apply if the information concerned, or any part of it: (a) was known to Unitaid or KNCV  prior to any disclosure by the Bidder; or (b) was in the public domain at the time of disclosure by the Bidder; or (c) becomes part of the public domain through no fault of Unitaid or KNCV ; or (d) becomes available to Unitaid or KNCV  from a third party who is not in breach of any legal obligation of confidentiality to the Bidder.

Information not marked as confidential may be shared with partners or individuals outside Unitaid and KNCV without the respondent’s written authorization, provided it has first been anonymized and/or aggregated by Unitaid and KNCV, to deter identification of individual companies (e.g., used without specifying individual Bidder or Organization names, product names, geographical location).

If processing the information submitted in response to this RfP involves the recording and processing of personal data (such as name, address), such data will be processed by KNCV and Unitaid in accordance with any applicable law and/or policies. Information relating to the assessment of the RfP shall not be disclosed to entities or individuals not officially concerned with this process.

K. Clarifications regarding process

Following detailed due diligence, Unitaid and KNCV will be the primary source of project funding provided through this RfP. It is nevertheless underlined that nothing in this RfP commits Unitaid, KNCV or their partners to provide subsequent financial or technical support.

Annex 1: Scoring Grid

Technical Evaluation Max Score Passing Score Scoring Weight
Understanding of Requirements 8 5 16%
(I) Demonstrate understanding of the work to be performed and its context 4
(ii) Overall proposal quality meets Scope of Work requirements?
– Structure / logical flow, Comprehensiveness (e.g. concise, addressing requirements under each deliverable), Overall presentation (e.g. clear, compelling language, easy to comprehend)
4
Implementation and Approach 8 5.6 48%
(I) General approach and methodology 4
(iii) Project management, coordination, and quality assurance 4
Expertise and experience of the firm and its proposed team members 32 22.4 32%
(ii) The firm and the team have the required experience and expertise in health product regulatory mechanisms across geographies (in particular in LMICs). 4
(iii) The firm and the team have the required experience and expertise in negotiating access and procurement terms with diagnostics manufacturer(s) or industry. 4
(iii) The firm and the team have the required experience and expertise in negotiating access and procurement terms with pharmaceutical industry. 4
(iv) Demonstrated expertise and experience in generating market landscape report, market analysis of medicine and diagnostics and related health technologies to identify root causes 4
(v) Demonstrated expertise and experience in designing or developing market shaping or access interventions focused on low- and medium-income countries (LMICs). 4
(v) Access implementation experience in TB or related disease areas of HIV, malaria etc. 4
(iv) Demonstrated experience and expertise conducting similar work for global health actors or the private sector 4
(v) Coordination, reporting and quality assurance aspects deemed suitable for the scope of work 4
Climate and Environment 2 1.4 4%
(I) Demonstrated commitment and initiatives in support of sustainability – Climate and Environment. 2
Total Scores 50 35 100%

Annex 2: Technical Proposal template

Annex 3: Financial Proposal template

[1] “Health Products” in this context means any medicines, including shorter drug-resistant tuberculosis (“DR-TB”) regimens, diagnostics, and medical equipment, including products relating to digital adherence technologies, purchased with Project Funding in accordance with the Project Plan.

[2] DS-TB – Drug-Susceptible Tuberculosis, DR-TB – Drug-Resistant Tuberculosis, LTBI – Latent Tuberculosis Infection.

KNCV has been fighting TB since its establishment in 1903. Over the past 120 years, the organization has acquired indispensable knowledge and experience in the field of effective TB prevention and care, resulting in pre-elimination in the Netherlands and significant contributions to global evidence generation, policy development and TB program implementation worldwide.

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