Context

The global reproductive, maternal, newborn and child health burden has decreased significantly in the last 30 years, but progress is now stalling. Nearly 300,000 pregnant women and 2.4 million neonates die every year, mostly in low- and middle-income countries (LMICs). Another 1.9 million babies are stillborn, making collective pregnancy-associated deaths more than 5 million annually.

More effort, new approaches and greater collaboration are needed to meet the goals of WHO’s Global Strategy for Women’s, Children’s, and Adolescents’ Health (2016-2030), as well as SDGs 3.2.1 and 3.2.2. Given the slow progress, the Every Woman Every Newborn Everywhere agenda has set a number of service delivery-based targets that are necessary to accelerate progress toward these global goals. In order to reach these targets, countries will need catalytic support to drive improvements in care quality, delivery of National Acceleration Plans, and integration of impactful tools into these strategies.

Building on the recent insights and growing momentum in reducing lives lost due to postpartum hemorrhage, there are compelling opportunities to spearhead progress against pre-eclampsia and anemia as leading contributors to poor maternal and newborn health outcomes.

Pre-eclampsia/eclampsia (PE/E) is a hypertensive disorder in pregnancy and the second leading cause of maternal death globally after postpartum hemorrhage. PE/E is responsible for 76,000 maternal deaths and 500,000 fetal and newborn deaths annually, including 200,000 stillbirths. In the past 30 years, the incidence of PE has increased by 11% globally. One of the key drivers is the increased prevalence of non-communicable diseases (NCDs), like chronic hypertension, obesity, and diabetes, which increase risk. PE can lead to severe, life-long morbidity, as women who experience PE are at elevated risk for hypertension, kidney disease, metabolic disorders, cardiovascular disease, and dementia. The condition also has intergenerational impacts, with infants born too small or too soon, due to PE, being more likely to have life course complications and higher risk of NCDs decades later.

Similarly, anemia is a major, persistent public health issue. WHO estimates that anemia affects 1.8 billion people worldwide – including 37% of all pregnant women. Among pregnant women alone, anemia caused 50 million Disability-Adjusted Life Years in 2019, with the greatest prevalence in sub-Saharan Africa and South Asia. Although anemia is a significant health burden itself – causing symptoms such as fatigue, weakness, dizziness and shortness of breath, it can also significantly increase risk of major drivers of maternal and newborn morbidity and mortality. The risk of postpartum hemorrhage nearly doubles in women with severe anemia compared to women with moderate anemia, and women with severe anemia have significantly higher risk of PE. Moderate and severe anemia in pregnant women puts infants at increased risk of being preterm, low birth weight or stillborn.

In addition to the primary drivers of PE and anemia in pregnancy, climate change is also increasing the prevalence of these conditions. Salinity in drinking water is associated with increased risk of PE/E and gestational hypertension, which is a growing concern given the pace of sea level rise and coastal flooding in some settings. Heat extremes and consequences of poor air quality also increase the risk of PE, fetal growth restriction, stillbirth and perinatal mortality. Vulnerability to anemia is increased due to the effects of climate change on food security, limiting sustainable access to essential nutrients. Additionally, extreme weather events and forced migration can lead to delays in receiving appropriate antenatal care (ANC), including essential services and interventions to detect and manage PE and anemia.

In LMICs, high rates of mortality and morbidity from PE and maternal anemia are partially due to gaps in access to lifesaving prevention, diagnosis, and management tools and effective delivery strategies. This includes health products that are new and require catalytic support to come to market, and underutilized products that face persistent access barriers. High-quality ANC is the critical underpinning factor shaping access to essential interventions during pregnancy. Women whose pregnancy is characterized by low ANC attendance, late-attendance, or visits that do not provide all quality services are at increased risk of adverse maternal outcomes. These quality gaps can include delays in care seeking and in reaching appropriate health facilities– particularly for women based in rural or remote settings. Delays in receiving appropriate and consistent care can be due to many factors, including gaps in health care worker knowledge and adherence to clinical guidelines, and limited uptake of the latest WHO recommendations for quality care. Typical organization of ANC services often limits the delivery of quality, woman-centered care, and results in both provider and client dissatisfaction and frustration, further limiting quality and coverage. The global health community, including WHO, has prioritized transitioning to maternal and newborn health models of care that prioritize the needs of women – such as Group-ANC and midwifery models of care. Innovative approaches to delivering services – such as networks of care – have also proven to be highly impactful, but warrant renewed attention to support their transition to scale. In addition, recent evidence from the E-MOTIVE trial, and others, again emphasize the importance of implementation strategies that include identification of facility champions, low-dose/high-frequency training, audit and feedback, and other approaches that drive sustained clinical behaviors and durable integration of new approaches and service strategies.

Barriers in the commodities ecosystem also prevent access, delivery and uptake of optimal care. Many maternal and newborn health (MNH) products have limited availability due to supply chain weaknesses, including inconsistent procurement, demand and supply forecasting, distribution planning and inventory management. Quality issues, such as the prevalence of substandard and falsified products, can limit product efficacy, and local regulatory and procurement bodies can struggle to implement effective quality assurance systems. Lack of affordability of new and innovative tools can restrict access and uptake, as well as insecurity from concentrated product supply bases. Incomplete provider or community understanding of both the conditions and the appropriate management of the conditions can result in limited demand for proven interventions, leading to further disruption of supply.

Prevention

There has been limited adoption of prevention interventions for PE and maternal anemia. WHO recommends that low-dose aspirin (acetylsalicylic acid, 75 mg/day) be administered to women at risk of PE, beginning before 20 weeks’ gestation. While aspirin is widely available, there are gaps in access to low-dose pill formulations as well as gaps in uptake in national policies and adherence by healthcare workers. There is similarly low uptake of WHO’s recommendations for calcium supplementation for PE prevention, as supplements are not consistently stocked in ANC and in some settings affordability is a concern. For anemia, daily iron and folic acid (IFA) is recommended by WHO for pregnant women in areas of high anemia prevalence. However, few pregnant women receive the full IFA course in LMICs. While the supplement has been long-recommended and is affordable, it is known to cause nausea and gastrointestinal side-effects, and carries a large pill burden, which makes adherence difficult, particularly in low resource setting.

There are developments that could offer opportunities for progress in prevention– but these innovations have access issues of their own. For PE, new evidence on calcium supplements has shown that a lower-dose (500mg) regimen is just as effective as the recommended higher-dose approach (1500mg). Lower doses have potential to overcome affordability barriers and improve adherence. For anemia prevention, there is potential for multiple micronutrient supplements to replace IFA. These supplements are conditionally recommended for use by WHO and are generally considered more acceptable than IFA, potentially helping to address adherence challenges. They contain additional essential vitamins and minerals which offers expanded health benefits to mother and newborn beyond anemia reductions – such as reducing low-birth weight.

Diagnosis and management

Diagnosis and management of PE and anemia in LMICs is complicated by limited availability, accuracy and affordability of existing diagnostic tools, poor quality of medicines, and gaps in access to effective management approaches. To improve PE outcomes, it is critical to reduce delays in identifying and managing pregnant women at risk. The primary clinical indicators of PE are proteinuria (protein in urine) and high blood pressure (BP). However, urine dipsticks for detecting proteinuria have demonstrated low accuracy and lab-based tests are costly, complex, and infrequently available. BP measurement is often inconsistent, with devices frequently broken, missing, or in use elsewhere in a health facility. Other manual devices are inaccurate without frequent calibration and maintenance, and mercury sphygmomanometers are being phased out due to toxicity concerns. Fortunately, there are new innovations with potential to make a difference, including semi-automated BP devices that incorporate clinical decision-support functions, or digital tools, such as those offering BP measurement by mobile phone. Such innovations hold strong potential for improved clinical care as well as home-based monitoring by community agents (such as community health workers) or self-monitoring among at-risk women. Unitaid’s recently published landscape assessment on pre-eclampsia provides more detail on these promising tools and approaches.

Other innovations for diagnosis and management include biomarker-based diagnostic tools. Novel testing methods have been introduced in high-income countries in recent years for PE risk assessment and management. These biomarkers, such as placental growth factor (PlGF) and soluble fms-like tyrosine kinase 1 (sFlt-1), can detect imbalance in angiogenic factors, which is a sign of placental dysfunction. They have been recommended for use by the International Federation of Gynaecology and Obstetrics (FIGO) and the International Society for the Study of Hypertension in Pregnancy (ISSHP) to “rule out” PE in women with other noted risk factors, and research is underway to evaluate their ability to support decision-making around safe delivery timing. Point-of-care tests are in development, and more work is needed in terms of validation, market entry and evidence generation on use cases.

Therapeutics for PE include antihypertensive drugs to manage blood pressure and magnesium sulphate to prevent eclamptic seizures in women with severe PE. Four antihypertensive drugs are safe for use in pregnancy and effective in lowering the risk of developing severe hypertension. These include oral nifedipine, methyldopa, and labetalol, as well as intravenous labetalol, and intravenous hydralazine. While WHO recommends these drugs be stocked in every antenatal, labor, and maternity unit, availability varies and there are issues with drug quality as well. Magnesium sulphate is an inexpensive, lifesaving drug, but it faces similar challenges with availability and quality. Administration challenges also limit use. The dosing regimens are complex, and although potential risks of toxicity are extremely rare, this causes hesitation among health care workers. As PE is commonly associated with pre-term birth, a comprehensive package of interventions should also consider essential medicines like dexamethasone, a corticosteroid that helps speed lung maturity and reduce morbidity and mortality from early pre-term birth, and caffeine citrate to treat apnea of prematurity. To improve the availability, quality, and uptake of these therapeutics, well-coordinated efforts related to the supply chain, data collection, quantification and procurement are needed.

Screening for anemia during ANC is common in many parts of the world but is less accessible in many LMIC settings. The gold standard test is through use of venous blood measured on an automated hematology analyzer, but these are complex, costly and require sophisticated lab infrastructure – and are rarely available in low-resource settings. At the point-of-care, handheld devices that measure hemoglobin concentration (an indicator of anemia) called hemoglobinometers are widely available on the market, but there are gaps in consistent use, accuracy, and uptake, particularly at primary health facilities. Access barriers that prevent uptake in LMICs include challenging data collection methods, complex data analysis and feature extraction processes, low affordability, portability, and accuracy. Moreover, the recommended process for collecting a blood sample to accurately screen for anemia (venous blood draw) is challenging in many settings where anemia prevalence is high. There is some disagreement in the anemia community around the level of variability that is acceptable for point-of-care devices for anemia screening and diagnosis, and thus acceptable method of sample collection.

Diagnosing anemia to enable appropriate management has added complexity beyond screening. Once anemia is detected, treatment needs be informed by an understanding of the root cause. Anemia has many different causes including iron deficiency (the most common cause – responsible for anywhere from 10% to over 60% of cases, depending on the setting), other nutritional deficiencies, infections – such as malaria and neglected tropical diseases, inherited red blood cell disorders, and causes linked to nutrient loss – such as blood loss from childbirth or menstruation. In order to determine the cause, use of complex biomarker-based tests are needed. Although there are some promising candidates such as ferritin (which can be complicated in case of infection and inflammation) and reticulocyte Hb (which is still in the pipeline development stage), currently there are no biomarker-based tests accessible for use at the point-of-care in LMICs. Without specificity on the cause of anemia – it is difficult to provide targeted and appropriate management. There is lacking consensus on product design needs to guide manufacturing requirements of point-of-care anemia biomarker diagnostics, and the regulatory space for these tools is complex. As a result – preemptive iron supplementation is often provided, which does not address many of the underlying causes required to manage the anemia case, and can be potentially harmful if iron deficiency is not present.

To treat the most common cause of anemia – iron deficiency – WHO recommends a higher dose of iron until hemoglobin level returns to normal. Oral dosing is most common in LMICs, but uptake is low. Intravenous (IV) iron preparations provide a promising option that can enable rapid replenishment in severe cases. However, IV iron requires delivery at higher levels of the health system, can take a long time to administer, in some cases requires multiple infusions (often at different visits), and is often unaffordable in low-resource settings. Modern IV iron products like ferric carboxymaltose (FCM) provide an opportunity to give a repletion dose of iron in a single short infusion, does not require prolonged or multiple infusions, and has lower risk of adverse reaction. However, this is only effective in iron-deficiency anemia cases – reiterating the challenges in the diagnostics space. Furthermore, the product has a limited supply base and is not affordable in LMICs. In severe cases, and without these important management tools – women may require further treatment measures – such as blood transfusion – which is even more difficult to access in low-resource settings.

Across maternal, newborn and child health commodities, sustainability and scalability of interventions remains a challenge due to persistent issues with commodity access. The funding landscape is fragmented, with scale-up relying primarily on domestic funding and some global organizations offering support (e.g. Global Financing Facility, USAID, Beginnings Fund). Close coordination with the partner ecosystem will be critical to sustaining access and building effective and replicable models for scaling effective tools and delivery approaches.

To address these challenges, catalytic action is needed to drive adoption of a comprehensive range of effective, adapted PE and anemia tools within ANC platforms. This will require targeted action to resolve product-specific access barriers – but also support to adopt effective models of care for ANC delivery.

Call scope

In response to this clear need, and the opportunities for accelerating progress – Unitaid is launching two calls for proposals. Proponents may apply to one or both. If applying to both, then two separate proposals are required.

Call for Proposals 1: Accelerate demand and adoption of new and underused tools through optimized and locally tailored models of care for pre-eclampsia and maternal anemia

Note: For Call for Proposals #1, Unitaid is seeking a project from a consortium that is led by a South-based implementer – i.e. an organization that is headquartered in a low-or middle-income country. The approximate funding allocation for work outlined in Call for Proposals #1 is expected to be up to US$ 25 million – with a balanced emphasis on PE- and anemia-focused activities.

Unitaid is soliciting proposals to accelerate uptake and consistent use of available, underutilized tools to address PE and anemia in high-burden LMICs through large scale, multi-country demonstration projects with robust evidence generation to inform broader uptake. Projects should aim to catalyze a pathway to product adoption at national scale in intervention countries by the end of the project period.

In terms of target commodities – projects should include a comprehensive focus on preventive, diagnostic and management tools for both pre-eclampsia and anemia across the care cascade. For pre-eclampsia this should include a locally defined package of care including essential screening and diagnostic interventions like validated BP testing and monitoring, clinical assessments of risk factors including using algorithms to guide care strategies (such as use of preventative interventions like low-dose aspirin and calcium), biomarker screening tools (if appropriate and prioritized by country partners), and antihypertensives and magnesium sulphate for management. For anemia, this includes timely and consistent delivery of appropriate micronutrient supplements, anemia screening throughout pregnancy with appropriate additional diagnostic testing, and triage to appropriate care as required – including early adoption of modern IV iron formulations such as ferric carboxymaltose (FCM) when indicated.

Projects should undertake demonstration activities that catalyze adoption of tools and delivery strategies across different levels of the health system in select geographies in intervention countries. Proposals should include plans to co-design appropriate strategies with national stakeholders across policy, provider, patient and community levels, with needs analysis and subsequent co-design approaches. Proposals should take a comprehensive approach to overcoming adoption barriers and integrating these strategies into existing health systems, including programming in national guidelines, health worker training packages, and monitoring and evaluation systems. Activities should include registration of quality products and inclusion within national essential medicines lists, integration into product supply chains and different administrative departments and functions at both national and subnational levels to ensure consistent supply of products. Utilization of a networks of care approach has been shown to be beneficial in providing connected care across multiple levels of a health care system, and should be included in proposals where appropriate. Proposals that include activities to ensure women most vulnerable to these conditions are reached where they seek services will be considered favorably.

Demand generation and advocacy activities should also be included in projects, with the purpose of raising awareness and knowledge, and building political support for programs. Proposals should outline activities to build demand for ANC strategies through people-centered and locally tailored roll-out approaches, including strong, funded community engagement, advocacy and literacy activities. Engagement of appropriate professional organizations for broader technical advocacy and service transformation is encouraged.

Planning for and catalyzing national scale of the approaches and models of care will be an essential consideration for proposal selection. Proposals should outline a clear pathway from project to scale that will help enable further deployment. It is expected that by the end of the project, countries will be progressing toward national level scale – with detailed country scale-up plans, national uptake targets, demand forecasting, and financial avenues to support these commitments. To this point, proposals should demonstrate close coordination with national programs, regional bodies and other entities facilitating scale-up of MNH commodities (e.g. Global Financing Facility, USAID, UNFPA, Beginnings Fund, etc.). As implementation in countries will be catalytic in nature and time-bound, efforts should include mechanisms to explore and test sustainable financing mechanisms for transition to scale. This will require both an understanding of domestic allocation and spending on MNH commodities, as well as approaches to leverage innovative financing strategies for eligible products of sufficient maturity.

Along with addressing the key product-specific access barriers, increased access to and consistent utilization of ANC services is considered an essential mechanism to increase uptake of new and underused tools. Projects should demonstrate efforts to deploy tools through innovative delivery approaches with strong potential to increase uptake – such as Group ANC platforms, blended community/facility models of care, midwifery models of care, and other mechanisms appropriate to specific settings. These models should demonstrate transferability to other high-burden, non-project countries to facilitate more rapid, consistent, and equitable access to interventions.

Strategy implementation should be supported by prioritized and appropriately scoped evidence generation that responds to pertinent knowledge gaps. This could include feasibility, acceptability and costing to guide delivery approaches beyond intervention sites, and impact data to respond to key questions considered critical by country stakeholders or other key partners. In addition to improved effective coverage of the target interventions, measurement of project success should include, for example, an increase in achieving early entry into ANC and the recommendation for at least four visits during pregnancy (ANC4).

Ongoing, strong stakeholder engagement throughout project implementation will be critical to driving demand and adoption of PE/E and anemia interventions. To ensure complementarity with ongoing activities and plans, project design should be country-led and informed by meaningful engagement with community and civil society organizations and other implementing and funding partners. Implementation should incorporate person-centered strategies, such as targeted educational initiatives, and other activities to build knowledge at the policy, provider and patient levels. Proposals are expected to demonstrate early community engagement in design, and proposals that demonstrate gender transformative approaches to address structural barriers to health care access will be looked on favorably.

Settings of interest

To maximize impact, proponents are encouraged to consider implementation in countries in a range of geographies, prioritizing settings with a high burden of maternal and newborn mortality. Given the impact of climate change on pre-eclampsia and anemia risk, the development of effective care approaches in settings particularly affected by climate change (e.g. heat stress) is a priority as well.

Selection of intervention countries should be driven by the following criteria. Included countries should:

• Be able to demonstrate a strong drive to implement packages of care for maternal and newborn health – with priorities for pre-eclampsia and anemia as demonstrated in available country plans or letters of support from country governments and stakeholders.
• Demonstrate a financial pathway to scale through inclusion in key scale platforms – such as demonstrated access to Global Financing Facility eligible countries, USAID priority settings, emerging funding mechanisms such as Beginnings Fund allocation, or confirmed country commitments to product procurement through national budgets with additional enablers, such as UNFPA’s Match Fund or UNICEF procurement support.

Note: As with all Unitaid Calls for Proposals, final determination of the most appropriate countries for the programs’ focus will be based on consideration of numerous factors and will be determined during the grant development process, in partnership with Unitaid. Proponents should demonstrate readiness for and flexibility with country selection adjustments by including a detailed description of the consortium’s geographic footprint and its country product access knowledge, and thus, the ability to pivot to different implementation countries, if determined to be relevant during grant agreement development. Please provide details on your ability to implement this project in alternative intervention countries in section 2.1 Project Design, part C.

Call for Proposals 2: Supply-side activities to support equitable access to pre-eclampsia and anemia products

This Call is also soliciting proposals to advance targeted product development, market access or other supply-side activities for a distinct subset of products described below. Access strategies for priority products should consider factors such as quality assurance, affordability, registration, regulatory approvals, sufficient supply, supply logistics management, and climate resilience considerations.

Note: For Call for Proposals #2, the approximate funding allocation is expected to be up to US$25 million, with the expected allocation per area outlined below. Proponents can apply to one or all outlined areas, with a preference for proposals including a consortium capable of comprehensively covering all areas.   

i) Support product development, validation, and introduction of new and highly affordable point-of-care biomarker-based diagnostics for PE (indicative budget: up to US$ 8m)

To accelerate access to point-of-care biomarker-based PE testing, two phases of work are envisioned. First, there is a need for consensus-building around a target product profile (TPP) and manufacturer outreach to identify companies with products in development or expressed interest in development. Selected products aligning with TPP criteria should undergo diagnostic performance evaluations to compare their accuracy against validated, lab-based biomarker assays (e.g. Elecsys immunoassay sFlt-1/PLGF ratio by Roche Diagnostics).  Successful product(s) would advance to a second phase of work focused on market entry and product introduction. Research should be taken forward on how best to implement biomarker-based testing, considering the clinical impact, feasibility and cost-effectiveness of different use cases and delivery approaches. Biomarker-based PE testing is not currently recommended by WHO for pre-eclampsia care. Research approaches should be informed by in-depth consultation with partners to identify priority use cases and evidence gaps most critical to informing clinical care, with an understanding of how to generate evidence which would be considered in the formation of a WHO recommendation. Access strategies should be developed, including market-shaping interventions to address affordability barriers to use of these assays. Activities to support product registration, regulatory processes, and procurement and supply chain management aspects should be included as well.

ii) Support validation of the digital blood pressure measurement tools and implementation research on their introduction for self-monitoring in pregnancy (indicative budget: up to US$4m)

Promising digital tools, including smart phone applications, for pre-eclampsia care are detailed in Unitaid’s landscape assessment.  For tools that incorporate blood pressure measurement, such as OptiBP™, there is a need to validate their accuracy in high-risk pregnancies to support regulatory submissions. This validation would confirm performance in both identifying and tracking BP among high-risk women. In parallel to validation efforts, access strategies should be developed and taken forward, considering pricing, licensing, and other opportunities to support long-term equitable access and sustainable use.

Following validation, there are opportunities to assess the feasibility, acceptability, and impact of introducing digital tools for self-monitoring of BP. WHO recommends appropriate and affordable use of home-based BP monitoring, but there is less data on this approach in LMIC settings. Implementation research should assess the use of such tools within a tailored package of care for pregnant women at risk of pre-eclampsia. Activities should be undertaken to better understand the barriers and facilitators of sustainable use in LMICs, as well as the need for further market interventions to ensure equitable access.

It is expected that country-based efforts, including research, will align with intervention country activities taken forward in Call for Proposals #1. This alignment will be coordinated with Unitaid during grant agreement development.

iii) Establish anemia diagnostic landscape and direction through market coordination (indicative budget: up to US$4m)

Unitaid is seeking proposals that undertake targeted efforts to address fragmentation and gaps in the anemia diagnostics space that would help enable appropriate detection of anemia in pregnancy in LMICs – and thus help realize impact of promising new management tools.

For hemoglobinometers, drawing on existing work that has been delivered on anemia diagnostic landscaping and assessment of tools, Unitaid is seeking activities that could assess the most appropriate available and late-stage development tools for deployment in high-burden, low-resource settings. This could include validation of promising available and pipeline tools for screening anemia (alone or with other conditions), field assessments to identify promising candidates to be used in different settings, and potentially reassessment of existing target product profiles for appropriate nuance for clinical application in low-resource settings.

For point-of-care biomarkers to identify the root cause of anemia, such as ferritin (potentially including markers of inflammation) and reticulocyte Hb, proponents could support development of a target product profile (TPP) to guide manufacturers in their development of these essential tests. For products that are already or near available, proponents could provide support by helping establish regulatory pathways for these products, along with market preparatory activities to accelerate availability.

Activities delivered under this scope of work will support the anemia diagnostics space by providing coordination on key questions within the ecosystem that need to be addressed in order to respond to the current gap. These efforts will provide alignment and a pathway forward for essential tools (including identifying future areas of work in the space) to help address the diagnostic gap. It will be important that efforts under this scope of work coordinate closely with implementation efforts taken forward under Call for Proposals #1.

iv) Targeted supply-side activities for available PE products (indicative budget: up to $6m)

In order to improve the quality and availability of PE prevention, diagnosis, and management tools, market interventions are needed. Drug quality concerns have been raised for many critical PE medicines, including magnesium sulphate (50% solutions), aspirin (75mg), calcium (500mg), and multiple antihypertensives. Supplier engagement to identify quality assured manufacturers or offer technical assistance to support cost and quality optimization should be considered, including opportunities to advance innovative supply models like regional manufacturing and regulatory harmonization initiatives. To improve demand for quality products and support their availability, efforts to include PE/E products in priority lists for regional and global pooled procurement mechanisms should be considered, as well as approaches that align with the pre-qualification (PQ) process and make quality more transparent to procuring agencies, funders, and consumers. Broader efforts to support the design and implementation of post-market quality surveillance mechanisms also holds promise for reducing the quantity of substandard and falsified products in circulation.  Furthermore, to help address availability issues, supply chain mapping activities would help identify opportunities for improved coordination and increased efficiency in product procurement and distribution. All activities will require close collaboration with partners leading the demonstration work advancing under Call for Proposals #1. This should include activities that support the success of the implementation program (achieved through Call for Proposals #1), such as technical assistance to support procurement and supply management activities, including demand forecasting, quantification, stock management systems, etc. Country-level activities should take steps to ensure that appropriate doses of aspirin and calcium, and pregnancy safe antihypertensives are available as well. Specifically for the CRADLE VSA device, in certain settings, efforts may be needed to support product registration and ordering and procurement systems, working closely with the manufacturer and distributors to ensure consistent access and supply security. In addition, and where needed, efforts to validate the accuracy of fit-for-purpose BP monitors in pregnant populations may be considered as well.

v) Targeted supply-side activities to strengthen the market for modern IV iron (indicative budget: up to US$3m)

Building on existing efforts within the global ecosystem, proponents should deliver activities that increase access to modern IV iron formulation ferric carboxymaltose. Given the current market status, proponents should identify potential generic manufacturers through an Expression of Interest, or building on existing sector knowledge of suitable candidates, with subsequent capacity assessments. Projects would be expected to provide appropriate technical assistance to identified manufacturers of generic equivalents throughout the grant lifecycle, with commitment to appropriate access conditions – including affordability, registration footprint, and procurement and supply support.

Activities could include bioequivalence studies, stability tests, designing field testing protocols, assisting ethical review approval, and undertaking mock site inspections. With a vision for quality assurance by appropriate bodies, efforts may include assistance with required regulatory approval for quality assurance dossier development and submission, accelerating review, and managing corrective and preventive action feedback and responses. In parallel, projects may also include activities to support manufacturers and countries to enable rapid market entry – for example supporting product registration, and integration into country guidelines and procurement mechanisms.

It is expected that any country-based efforts will align with intervention country activities taken forward under Call for Proposals #1. This alignment will be coordinated through Unitaid during grant agreement development, with a possibility that Unitaid will request a change to country composition at this point.

Note: As a reminder, all activities in Call for Proposals #2 will be expected to coordinate closely with implementation work advancing under Call for Proposals #1, including activities in the same countries. All proponents should provide a detailed description of the consortium’s geographic footprint, country selection rationale, and ability to pivot to different implementation countries, if requested during grant agreement development.

Project Guidance

While execution of the initiative will be the responsibility of the lead implementer, technical guidance and input should be shared across key partners. To this end, the lead should consider the formation of an expert advisory group or steering committee to guide project activities at national, regional and global levels. The expert advisory group will be the strategic support structure for the grant, providing the lead grantee with thought partnership, a forum for problem-solving, relationship support, and considering strategic and/or operational shifts over the course of the project. The structure and design of this advisory body can be best defined during grant development to ensure it is fit-for-purpose. Alignment and coordination mechanisms across grants focused on Call for Proposals #1 and #2 are encouraged to support collective success.

Proposal requirements

Proponents should clearly describe their overall project design with a 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 what impact will be achieved within the project life-time, as well as what, and how, lasting impact will be achieved. Please refer to the Theory of Change provided in the “Impact we are seeking” section below to guide design efforts.

Consortia may apply for either or both Calls for Proposals outlined above. Unitaid has a preference for proposals that undertake the full complement of activities described for each Call for Proposals.  Consortia should clearly demonstrate strong expertise in the different technical and market intervention areas needed to undertake the project, including the implementation of large-scale multi-country projects, and product focused activities described above.

Beyond the consortium, broad collaboration with relevant stakeholders will be vital to achieving the project objectives, including effective coordination mechanisms and well-articulated partnerships. 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 tailoring the design of elimination programs, monitoring introduction, 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.

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.

Additional information

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/program 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.

Unitaid sees value in proposals from South-based lead implementers (i.e. organizations that are headquartered in a low-or middle-income country) with experience in leading the implementation of large-scale multi-country projects that support access to health products in LMICs. For Call for Proposals #1, Unitaid is explicitly seeking a project from a consortium that is led by a South-based implementer. We also support the meaningful inclusion of South-based sub-implementers, where feasible and relevant, in proposed project implementation consortia. When adjudicating proposals,  Unitaid will also consider the budget proportion allocated to Global South partners, recommending a minimum of 50%. To be clear, Unitaid’s objective of progressively retaining 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. Transitional leadership models that transfer leadership from a Global North- to South-based consortium partner during implementation are welcome as well, including capacity building activities. In all cases, we encourage coordination and collaboration across implementors and seek proposals with regional impact across key LMIC markets and a clear path to national and global impact.

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.

Proposals should demonstrate value for money and measurable impact. Proposals should also include analysis of pathways to impact, scalability, and sustainability of key interventions.

Areas out of scope for this Call include: single-country interventions; algorithms to test general pregnancy risk categorizations that is not-specific to the health conditions in this call; strategies and approaches to reduce anemia in the general population or among non-pregnant women of reproductive age; other anemia nutritional interventions (e.g. fortification of food); early stage research and development for products more than five years away from market entry; infrastructure development; generalized workforce development non-specific to this call scope; demonstration projects focused exclusively on the private-sector.

Impact we are seeking

Through this Call for Proposals, Unitaid aims to accelerate progress against pre-eclampsia and maternal anemia by improving access to lifesaving prevention, diagnosis and management tools and effective care delivery strategies. Unitaid expects investments to catalyze positive change towards achieving sustainable development goal (SDG3) health targets on maternal and neonatal mortality, leading to significant public health and economic impact. This Theory of Change provides a high-level description of the public health problem, key access barriers to critical products and services, and the pathway to change captured by the outputs and the outcomes that will ultimately drive impact. Please use it as a reference to guide project design efforts.

[Click image to enlarge]

Process for proposal submission

When developing a proposal, please note the following resources:

Answers to frequently asked questions relevant to proposal development (this document is regularly updated), please click here [PDF : 500 Ko].

For Unitaid’s preliminary rationale for working in this area, please click here [PDF: 1.5 Mb].

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.

Important dates

Submission and format of proposals

• Proposal form for Call for Proposals 1, [DOC: 700 KB]
• Proposal form for Call for Proposals 2, [DOC: 700 KB]
• Annex 1: GANTT and expected results for Call for Proposals 1, [XLS: 250 KB]
• Annex 1: GANTT and expected results for Call for Proposals 2, [XLS: 250 KB]
• Annex 2: Budget and co-funding for Call for Proposals 1, [XLS: 25 KB]
• Annex 2: Budget and co-funding for Call for Proposals 2, [XLS: 25 KB]
• Annex 3: Organizational details and CVs of key team members [no template]
• Annex 4: Country engagement support Letters [no template]
• Annex 5: Declaration of relevant interest template, [DOC: 21 KB]
• Annex 6: Applicable ethics, anti-discrimination and environmental policies template, [DOC: 21 KB]
• Annex 7: Declaration regarding tobacco entities template, [DOC: 24 KB]
• Annex 8: Anti-Terrorism Declaration template, [DOC: 30 KB]
• Annex 9: Audited financial statements for the past 3 years [no template]

If you have any questions about the application processes throughout any stage of the application review process, please send your queries to the Grant Application Manager:  proposalsUnitaid@who.int

You will find further guidance in the Unitaid proposal process document [PDF: 530 KB]. Additional guidance can be found in the following documents:

• Guidance on Impact Assessment [PDF: 160 KB]
• Financial Guidelines for Unitaid Grantees [PDF: 1,2 MB]
• Unitaid Results Framework [PDF: 1.3 MB]
• Unitaid Scalability Framework [PDF: 466 KB]