Unitaid is seeking proposals to investigate the heat stability of critical health products under climate change scenarios with three key objectives:

1. 1. Strengthen the evidence base of real-world conditions and worst-case scenarios (both current and future – aligning with agreed-upon climate scenarios from the Intergovernmental Panel on Climate Change) that products are exposed to, globally, across their lifecycle. Utilize this evidence to assess the vulnerabilities and possible impact on key products and product classes, making direct linkages to the impact on the health of communities, where possible;
   2. Guided by the evidence from objective #1, map the solution and opportunity space for improving heat resilience of health products;
   3. If appropriate and aligned with evidence, advance solutions in an opportunistic manner, including lighthouse projects that could demonstrate proof-of-concept for priority innovations to mitigate heat vulnerability.

This work aims to assess the resilience of a range of health products and supply chains within Unitaid’s programmatic portfolio, while exploring high-impact, scalable adaptations to improve heat stability, with a particular focus on product access for climate-vulnerable populations.

Through this call, Unitaid seeks to make a strategic, foundational investment to generate critical evidence that will shape future investments and inform decision-making for Unitaid and its partners, while also providing generalizable information to inform where this topic sits in comparison to other global priorities. Importantly, this initiative represents a pivotal learning opportunity to deepen understanding at the intersection of health and heat, with the potential to unlock novel, high-impact insights that will strengthen Unitaid’s knowledge base and drive value across its ecosystem of partners. Building on the findings from the “Milligram to Megaton” study, which assessed the climate risks of 10 key health products, Unitaid aims to further investigate critical variations in heat stability and take a forward-looking perspective that anticipates the compounded risks of future climate change.

Proposals should specify how these objectives will be met in partnership with key stakeholders across the ecosystem of health products, especially climate and health decision-makers in specific countries.

(1) Evidence generation on real-world conditions, product heat vulnerabilities and  possible linkages to community health

Project proposals should prioritize reviewing and generating critical evidence on the current and future heat and humidity vulnerabilities of health products considering both evolving climate scenarios and pre-existing heat and humidity vulnerabilities that will be exacerbated by climate change. Evidence generation should focus on answering the three questions discussed below.

What real-world conditions are products being exposed to across their lifecycle and how might those evolve over time due to climate change?

An initial step must prioritize building confidence in both typical and worst-case scenarios that products are exposed to during their lifecycle, including establishment of archetypes based on reasonable groupings, such as geography, level of care (e.g. products used in urban pharmacies versus rural primary care clinics versus refugee settings, etc), or product type, where possible. This should include identification of possible hotspots across the supply chain where products are at greatest risk. These real-world conditions should be analyzed in comparison to current product specifications, global testing standards, and quality assurance approaches that govern product development, regulatory processes, and product shipping, handling, and storage decisions. Growing the evidence base and confidence in current and future climate-driven scenarios will:

• • Inform guidance and standards on product requirements in warm and humid settings that can drive product design and testing decisions, along with procurement criteria and shipping and storage processes
  • Identify hotspots with the need/opportunity for innovation based on risk to product (geographically and operationally)
  • Provide better visibility into conditions and risks at decentralized locations where there is less control over products and where there are more unknowns

This evidence work should account for the unique characteristics and dynamics of global health supply chains to and within low- and middle-income countries, including the challenges associated with globalized and concentrated supply sources, downstream sea transport, last-mile inland delivery, decentralized distribution points, storage, and infrastructure gaps.

Methods for generating evidence and confidence can include some combination of the following, but could also consider other innovative approaches:

• • Literature reviews
  • Gaining access to existing program or study data from country stakeholders, manufacturers, implementers, and/or innovators
  • Field studies and/or lab testing to generate new evidence, such as active temperature monitoring in certain settings/scenarios
  • Building relevant modeling approaches that incorporate climate and weather data to effectively determine both current and future scenarios for product or region-specific supply chains (Note: this must be complementary to real data – modeling as a stand-alone method for evidence generation will not be considered)

Proposals should suggest potential scenarios (e.g. geographies, levels of care) that could be evaluated throughout this process with justification for how those can lead to generalizable conclusions that can inform a more standardized understanding of real-world conditions. These scenarios must consider geographies of interest to Unitaid, primarily Sub-Saharan Africa, Southeast Asia, and Latin America and should prioritize locations based on risk of hot temperatures and high humidity. Scenarios should also be connected to science-based climate change projections to understand possible future implications.

The learnings from answering this question should also consider how the information may be disseminated globally and how it can be built on over time and for geographies, products, etc that are not included in this initial scope. This can be in the form of recommendations and/or plans for expanding on this work (e.g. partnerships, building databases/dashboards, etc). For example, might there be benefit of an open source global database that maps out scenarios across geographies to inform supply chain planning, especially as those scenarios evolve over time?

What impact are these conditions/scenarios having on the quality of priority products?

The impact of these scenarios on products and product classes is unknown and likely variable. Even individual products in a specific class may be more heat resilient than others, as some literature has shown.

Ideally, this question can be answered concurrently with the first question, utilizing some of the same methods and approaches. This analysis may also complement those methods with laboratory testing to assess heat stability and degradation under varying conditions. Additionally, there may be opportunities to incentivize manufacturers to share their data on challenge scenarios and results from testing they have completed during product development and validation.

This should include assessing how climate change may influence the stability, efficacy, safety, materials, designs, and overall performance of Unitaid’s priority products and/or for key product classes (long acting formulation, rapid tests, point-of-care (POC) testing platforms, etc) across all stages of the supply chain, from product design and manufacturing to transportation, storage, delivery, and end-use.

Unitaid is open to including a range of products, but below are product classes that are of particular interest and should be given priority consideration. Proposals should include justification for the inclusion of specific products:

• • Shelf-stable oral tablets, such as antiretrovirals (ARVs), artemisinin-based combination therapies (ACTs), tuberculosis (TB) treatments, and chemoprevention tablets, that are used in decentralized care models and that are stored in unknown environments, including with patients and/or community health workers (CHWs)
  • POC Diagnostics, such as malaria rapid diagnostic tests (RDTs) and HIV self-test kits, which enable decentralized testing, but have shown possible susceptibility to extreme environmental conditions
  • Long-acting injectables, such as Lenacapavir, which is an emerging product and for which environmental conditions should not be a barrier to scale and impact
  • Molecular platforms for diagnosing and monitoring different diseases (e.g. HIV, TB, human papillomavirus (HPV), hepatitis C virus (HCV)), especially to decentralize laboratory services
  • Vector control products with a specific focus on insecticide treated nets (ITNs) and spatial emanators
  • MNH products for postpartum hemorrhage (PPH), anemia, pre-eclampsia (PE), and/or elimination of vertical transmission (EVT)

Unitaid will only consider funding projects that prioritize products in alignment with our 2023-2027 strategy.

Is there a direct impact on the health of communities due to products being exposed to extreme conditions?

The proposal should include a literature review and other data collection methods to begin understanding the possible connection between product degradation and the potential impact on health systems and the health of communities. For example, KIIs could be completed in communities at high risk of extreme temperatures and/or in geographies aligned with hotspots identified through complementary analysis. Additionally, retrospective analysis could be completed on these same locations to identify learnings and any potential causality between health outcomes and products’ exposure to extreme conditions, and to draw possible conclusions on the impact of product quality on disease epidemiology. This analysis could be geography or product specific. Potential impact could include changes in disease burden, increased risk in drug resistance, stock outs, reduced confidence in products and/or health systems, etc, as previously stated in the context section.

The scope is not intended to include intensive prospective research that would require an extensive timeline or a large percentage of the project budget.

(2) Mapping the heat management solution space

In alignment with generated evidence, project proposals should also explore the solution space for the selected products, aiming to build a comprehensive knowledge base and conduct in-depth analyses of heat-resilient, climate proofed solutions. This includes evaluating technical, regulatory, market, and cost barriers and enablers while identifying product adaptations and alternatives that mitigate heat and humidity stressors. Where available, the cost and cost-effectiveness of solutions should be provided. Landscaping activities should also identify existing partners supporting specific solutions. When possible, it should also evaluate the climate mitigation impact in terms of carbon footprint on a subset of high-priority innovations.

The scope of this landscaping work should prioritize analyzing the suite of solutions that could address the hotspots, challenges, and product vulnerabilities identified during the evidence generation activity described above. Existing solutions and innovation gaps or needs should be clearly mapped to challenges across the product lifecycle. The landscape might include, as necessary:

• • Heat-stable products: Using better materials, designs, manufacturing processes and formulations—such as transitioning from liquid to solid-state medicines, long-acting products, and thermal shields or heat-resistant materials for diagnostics.
  • Energy-efficient storage: Expanding passive cooling systems and solar-powered refrigeration to reduce dependency on conventional cold chain systems.
  • Heat-protective packaging: Using packaging and shipping solutions that reduce temperature sensitivity during transport and storage.
  • Monitoring systems: Applying real-time temperature and humidity monitoring, with quick-response tools like point-of-care quality testing.
  • Agile delivery models: Reducing time in hot environments by using more direct and flexible delivery routes, especially to end users and/or remote facilities.
  • Predictive analytics: Leveraging data to assess climate scenarios and plan safer transport routes and timing based on climate and seasonal risks.
  • Regulatory engagement: Revising/guiding product standards and testing methods to ensure they are responsive to climate scenarios.

The analysis should culminate in a prioritization process that identifies a high-impact portfolio of innovations that could inform investments by funders, innovators, government, academia, etc. Additionally, the prioritization process should identify gaps in the solution space, if any exist, where new solutions are needed and/or where solutions are immature. The analysis should include creation of an innovation framework that can be utilized now and for future prioritization processes, including identification of key factors, such as cost.

(3) Early-stage advancement of heat resilience solutions

Guided by evidence, Unitaid may accelerate action on heat management for priority health products by funding targeted, high-impact activities that complement partners’ efforts and lay the groundwork for larger-scale initiatives and ongoing innovation beyond the scope of this project. Therefore, the proposal’s scope should also explore opportunities to advance the development of relevant technical solutions and/or technologies within the prioritized portfolio of innovations through small-scale funding. This funding should be milestone-driven to answer specific questions or inform the potential for larger follow-on investments and should be catalytic to advance priority innovations along their development pathways. Funded innovations will need to have a direct link to Unitaid’s mandate to expand access to health products within our programmatic priority areas. Examples of investments could include, but are not limited to:

• • Achieving proof-of-concept on the effectiveness of new technologies in real-world conditions
  • Adaptation of a specific solution to a more decentralized level of care
  • Building a roadmap for mature solutions to scale into new markets
  • Incentivizing new ideas in innovation spaces where solutions do not exist or are insufficient

Preference should be given to advancing solutions that have been developed in the global south, where possible.

The method to fund these innovations will be dependent on the mapping process, but proposals should specify possible mechanisms that could be utilized and how this process might be implemented by partners. For example, through open innovation approaches, direct-funding to innovators, milestone-based payment structures, etc.

Defining success

At the end of this foundational investment, Unitaid will define success based on the following criteria:

• • The evidence-base of real-world scenarios that products are exposed to, and how they will be impacted by climate change, is established.
  • Heat vulnerabilities for the selected health products have been comprehensively assessed.
  • The range of potential solutions has been analyzed, with priority solutions evaluated from financial, technical, market, climate impact (where possible), and regulatory perspectives.
  • Appropriate knowledge products consolidating all findings from the evidence and analyses have been publicly disseminated and widely accepted by key stakeholders (e.g. the public health community, regulatory bodies, etc), serving as a guide for ecosystem partners and Unitaid’s future investments.
  • Informed by evidence, a small number of targeted investments have been initiated for critical solutions aimed at reducing heat vulnerabilities.

• Product selection: The scope will be limited to a reasonable number of health products, encompassing both therapeutics, diagnostics, and other products (e.g. vector control) for disease areas aligned with Unitaid’s priorities. Proponents are expected to propose an initial selection with clear justification based on the considerations outlined in this call.
• Country selection: Applicants are encouraged to include specific countries for activities in the proposal with a clear rationale for their selection. Unitaid will welcome proposals that include the following countries where it already has existing programs and partnerships that are relevant to this call: Kenya, South Africa, Nigeria, India, Senegal, Brazil.

However, other countries will also be considered based on priority criteria. For example, candidate countries could be those that:

• • Demonstrate government demand and interest in the topic of product heat stability as a priority area for evidence building and innovation
  • Have a high disease burden in priority health areas and/or increasing epidemiological trends that may be linked to environmental conditions
  • Use products that have known or suspected vulnerabilities
  • Are more susceptible to the effects of climate change, including heatwaves and humidity and precipitation fluctuations, that may increase temperatures and humidity
  • Have a solid PHC platform (e.g. strong CHW program, etc.) that is reliant on decentralized care in locations with infrastructure and temperature-control challenges
  • Have an established and/or growing in-country innovation ecosystem that can lead on developing and implementing solutions in response to local evidence

Note: This list is intended to be illustrative, not exhaustive.

• Environmental scenarios: Proposals should specify the scenarios that will be evaluated and how and why those can be generalized for additional contexts, as applicable (e.g. based on geography, level of care, etc.)
• Approach to innovation: Applications should indicate how they intend to identify and evaluate possible innovations, along with the approach and mechanisms that will be utilized to fund potential priority solutions.
• Stakeholder engagement. Proponents should clarify the key stakeholders with whom they will engage, and how this will be achieved. It is important to include a country engagement model that outlines coordination and cooperation with countries in decision making around activity design,  dissemination of learnings, prioritization and selection of critical innovations, and assessing impact. By actively involving government stakeholders in all phases of planning and implementation, projects will gain valuable insights into local contexts, policy frameworks, and stakeholder priorities. This collaboration will lead to more informed and effective project design, increased buy-in from government partners, and greater sustainability of project outcomes beyond the grant funding period.
• Consortium expertise and skillsets: Unitaid expects the following to be reflected in the makeup of a consortium (non-exhaustive)
  • Partners with expertise in both the risks of climate change and the technical aspects of health product stability, with the ability to assess the impact of climate-related risks (such as extreme heat and humidity) on health products and their supply chains.
  • Partners with expertise across multiple disease areas, or a mechanism to include representation and inputs from partners in other disease areas if not included in the consortium itself
  • Partners with technical expertise in health product testing norms, standards, and guidelines to evaluate how environmental stressors are integrated into product development, regulatory and registration processes. This should include an ability to efficiently conduct both field and laboratory studies, where needed.
  • Partners with a demonstrated ability to source, analyze, and support high-priority innovations, especially those developed in the global south.
  • Community-based organizations who can lead on ensuring approaches, methods, and innovations are contextually relevant, demand-driven and informed by real-world experiences and insights.

Unitaid expects any consortium to operate with a lean and agile structure. The focus will be on effectively managing the initial investment, ensuring clear milestones and deliverables, while demonstrating strong organizational capacity to engage key stakeholders across the climate and health ecosystem on this innovative and emerging issue.

• Funding envelope: The total approximate funding for all work outlined in this Call for Proposals will depend on proposals received and the scope of work undertaken – but is expected to be approximately US$ 10 million for this initial investment. Preference will be given to funding a single consortium that fulfills all objectives of the call and positions the future investment as both a technical and partnership-oriented platform.
• Co-funding: Proponents are encouraged to indicate potential, or secured, sources of co-funding for the program or for complementary activities. This is not required, but will strengthen proposals if included.
• Project duration. Unitaid aims to position this initial investment phase as a springboard for potential follow-on investments, contingent on the successful implementation of the early stages. Unitaid solicits project proposals that should not exceed a maximum of three years.
• Theory of change. Proponents should clearly describe their overall project design in alignment with the shared Theory of Change, showing how it meets the objectives of the initiative and how the proposed activities form part of a coherent whole. Proposals should explicitly state the contributions the project will make to the specific outcomes and the results that will be achieved within the project lifetime (see below).
• Project assumptions and risks. Applicants should be clear about the underlying assumptions made in their proposed approach and should highlight any major risks or other factors that may affect the delivery of results. Finally, proposals are expected to outline a lean, concrete, and clear pathway to results and impact.

• Communities. Unitaid considers working with communities a critical part of generating demand and strongly encourages adopting inclusive approaches, and the early and continued meaningful engagement of communities towards improving the lives and health of the most vulnerable people. The role of affected communities and planned collaborations with other relevant groups including grassroots community organizations and Civil Society Organizations at all stages of a project/programme including ideation is essential, with this engagement a key determinant for success. Activities should be clearly budgeted in proposal submissions. Community-led approaches are important to consider and adequately fund and resource when designing, planning, implementing, and evaluating activities and programmes.
• South based lead implementers. Unitaid will prioritize proposals from South-based lead implementers with experience in implementation and expertise in the technical and market intervention areas needed for the project. Additionally, Unitaid supports the meaningful inclusion of South-based sub-implementers, where feasible and relevant, in proposed project implementation consortia. Unitaid’s objective of progressively engaging an increased number of lead implementing partners from the global South does not preclude proposals that are led by or including partners from the global North. In all cases, we encourage coordination and collaboration across implementors and seek proposals with regional impact across key low- and middle-income countries’ markets and a clear path to global impact.
• Climate and environmental action. Unitaid is committed to climate and environmental action in its investments and expects its partners to make similar commitments. Proposals should clearly indicate: (i) Efforts that will be made to minimize carbon emissions from project activities; (ii) Potential opportunities to contribute to broader climate and/or environmental co-benefits, in synergy with core project objectives. More detailed guidance and definitions are provided in the proposal template.
• Value for money and impact. Proposals should demonstrate value for money and measurable impact. Proposals should also include analysis of pathways to impact, scalability, and sustainability of key interventions.

Proposals under this Call for Proposals are expected to contribute to a Theory of Change (TOC). Unitaid presents this TOC; however, Unitaid expects proponents to build on this and articulate how projects will contribute to this initiative and achieve impact. Proposals should explicitly state what can be achieved within the timeframe of the project.

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When developing a proposal, please note that answers to Frequently Asked Questions relevant to proposal development can be found here: [PDF: 200 KB] (this document is regularly updated).

Applicants should be clear about the underlying assumptions made in their proposed approach and should highlight any major risks or other factors that may affect the delivery of results. Finally, proposals are expected to outline a lean, concrete, and clear pathway to results and impact.

After assessment of the proposals and endorsement by the Unitaid Board all applicants will be officially notified as to whether they will be invited to develop a full grant agreement for Unitaid funding.