Context

This Call aims to develop additional and complementary project(s) to existing and planned interventions related to Unitaid’s Postpartum Hemorrhage (PPH), Malaria and HIV programmatic priorities.  Unitaid intends to leverage its prior experience on innovative approaches to facilitate product access, including support for product/formulation development, quality assurance, market shaping, and other critical interventions that have facilitated the acceleration of equitable access to affordable, quality-assured health product innovations through manufacturers in Low- and Middle-Income Countries (LMICs).

This CFP aims to identify partners (or a consortium of partners) that can design and implement technical and market-shaping interventions to support manufacturers in achieving sustainable manufacturing and market entry of cost-competitive, quality-assured products within Unitaid’s current portfolio.  The CFP will build on prior work that Unitaid conducted to identify products within its 30 x 2030 portfolio[1] where it is feasible for manufacturers in Africa to contribute to the respective value chains while building the desired capabilities for supply chain resilience and pandemic preparedness. Opportunities have been identified to support the manufacturing of therapeutics (small molecule APIs and finished formulations – oral solids and injectables) and diagnostics (rapid diagnostics tests) across Unitaid’s PPH, Malaria, and HIV portfolios (see Section 9: reference documents). Unitaid now seeks to identify technical partners (or a consortium of partners) to design projects that will work directly with manufacturers and other ecosystem stakeholders to develop and facilitate market readiness of cost-competitive, quality-assured products.

This CFP aligns with recent calls to action, such as the “Declaration for accelerated malaria mortality reduction in Africa”[2] and the “Lusaka Agenda: Conclusions of the Future of Global Health Initiatives Process”[3] that have been unequivocal on the need for urgent action for a speedy and coordinated approach to accelerating regional manufacturing as an enabler to equitable access. Similarly, the decision by the African Union for the Africa Centres for Disease Control and Prevention (Africa CDC) to broaden the mandate of the Partnerships for African Vaccine Manufacturing to encompass therapeutics and diagnostics and the African Union’s appointment of a Presidential champion for local manufacturing, underscore the strong political commitment on the continent to this agenda. Furthermore, the establishment of the African Medicines Agency and the regulatory harmonization initiatives by the African Union Development Agency-NEPAD, illustrate the collective efforts at a continental level to address industry challenges and implement strategies outlined in the business plan for the Pharmaceutical Manufacturing Plan for Africa adopted in 2012.

The pathfinder investments that will be made based on this CFP will initially focus on interventions in Africa. The investments will strategically leverage the platforms and partnerships that Unitaid and other partners have established, including supply-and-demand-side interventions from Unitaid’s existing investment portfolio. Unitaid will also aim to align and combine its investments with those of other financing partners where relevant and appropriate, including both grant funding and development financing institutions.

Background

Equitable access to affordable, context-specific, quality-assured health products is crucial for the success and sustainability of public health programs and Universal Health Coverage (UHC). Strengthening pharmaceutical manufacturing in Africa is critical to meeting the health-related Sustainable Development Goals (SDGs), supporting climate targets by reducing transport costs and carbon emissions, and ensuring sustainable access to affordable, context-specific, quality-assured, climate-smart health products. Strengthening regional manufacturing also generates quality job opportunities and contributes to socioeconomic development. However, with most of the world’s health products produced in just a few high-income and upper-middle-income countries, most low- and middle-income countries do not produce the affordable and accessible tests, treatments, and tools they need. This leaves countries vulnerable to price volatility, supply chain disruptions, or unavailability of essential health products, particularly during periods of supply scarcity in the face of surges in regional or global demand or after climate-related shocks or extreme weather events.

Unitaid, a global health organization with a unique role in identifying and investing in new health products and approaches in LMICs, has engaged in extensive consultations at local, regional, and global levels as well as conducted extensive analyses, to identify a priority set of health product categories (see below) that could contribute to sustainable access to health care and pandemic preparedness through regional manufacturing. Unitaid has comprehensively assessed the feasibility, cost-effectiveness, and potential partners required to strengthen regional manufacturing for each of these product categories.

Unitaid’s definition of regional manufacturing of health products is as follows: “Some stakeholders use the term “local manufacturing”, but Unitaid and others are using a more holistic definition, where “local” is extended beyond domestic (national or subnational) to regional (which can also include supply to continental and global markets). Furthermore, manufacturing of health products can be defined as all activities, including some or all value-added manufacturing operations, leading to the production of the respective health products. These include the synthesis of active pharmaceutical ingredients (APIs), antigens or antibodies and other constituents of in-vitro diagnostics, and final formulation of finished pharmaceutical and diagnostics products.”

The Unitaid approach to regional manufacturing prioritizes sustainable and viable production that addresses, at the same time, the unmet needs for medicines and diagnostics supply as persistent major public health problems. The approach also places a premium on agile interventions that create capabilities to pivot capacity utilization to surge demand for priority pandemic products as needed. Unitaid’s approach aims to address the challenges faced by many LMICs during the COVID-19 pandemic (i.e., exacerbation of access issues for both COVID-19 tools, as well as other essential medicines and tools, due to supply chain vulnerabilities arising from, inter alia, manufacturing concentration in a limited number of geographical locations). This is required to address the emerging consensus on the need to build resilience regarding regional capacities for production before the next pandemic. However, such investments must be viable and sustainable. Unitaid supports strategic dual-purpose investments for which demand in inter-crisis periods can assure viability and expertise that can pivot to producing pandemic-priority products (including therapeutics, oral and injectables, and diagnostics) as required.  An example of Unitaid’s multifaceted approach to regional production is summarized in Figure 1 below:

Figure 1: Example of intervention package required from a potential implementing partner (or consortium) for regional production of a generic medicine.[4]

[Click image to enlarge]

In addition, Unitaid is committed to optimizing strategies that prioritize equitable access to life-saving products while promoting environmental sustainability by integrating climate-smart practices into health product manufacturing and investing in climate-smart supply chains. This approach has multiple potential benefits: it can enable the leapfrogging of regional supply chains towards low-carbon and climate-smart models, making them more sustainable and competitive; it can make supply chains more resilient to climate risks; and it can foster innovation towards sustainable products and manufacturing processes.

Unitaid is committed to aligning investments with continental and regional priorities. In addition, Unitaid aims to strengthen partnerships in Africa with key institutions such as the Africa Centers for Disease Control and Prevention, the African Union Development Agency-NEPAD, the African Medicines Agency (AMA), the African Continental Free Trade Area (AfCFTA) Secretariat, and the United Nations Economic Commission for Africa (UNECA). By collaborating with these organizations and regional economic communities (RECs[5]), Unitaid seeks to build on existing work and enhance the coordination of regional manufacturing initiatives. This collaborative approach aims to create a synergistic effect that promotes equitable access to health products and supports environmental sustainability while maximizing the impact of investments, long-term sustainability, and resilience of health supply chains in Africa.

Unitaid solicits proposals from organizations or consortia, including technical support organizations, non-government organizations (NGOs), market-shaping organizations, academic and research institutions with demonstrated competencies in upstream product development and manufacturing, and downstream activities, including in-country product access. Consortia should be constructed to address the scope of work described under ‘Intervention package and work areas’ (below). This call does not apply to manufacturers in Africa, contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs). A separate announcement of a Call for Expressions of Interest (EOI) to African manufacturers, CDMOs and CROs will be issued in June 2024, soon after this CFP.

Other ongoing or planned regional manufacturing interventions that complement this CFP but are not in scope include Unitaid’s work to increase production capacities and supply resilience for medical oxygen and potential opportunities to build business models to facilitate manufacturing and expanded access to monoclonal antibodies in LMICs.

Call Scope

This Call for Proposals is aimed at developing a manageable number of initial project(s) (e.g., up to three) that will design and implement bespoke packages of interventions targeted at interested, eligible and competitively selected manufacturers in Africa to secure quality-assured products that are: (i) of comparable or lower total costs (factoring in delivery and storage costs), (ii) offer expanded and improved access to the health technologies, and (iii) have potential to ensure reduction of climate impact compared to existing options. The package of interventions should also strengthen and catalyze the expansion of manufacturing and clinical research capacity and capabilities that could be leveraged to address current endemic disease response and future pandemics. The products in scope for the CFP are a viable subset of the products supported by existing Unitaid projects on treatment and/or prevention of postpartum hemorrhage, medicines for the prevention and treatment of malaria (including new non-artemisinin-based medicines), as well as therapeutics and diagnostics for HIV and related co-infections.

Proponents can submit one proposal (with different sections) focusing on one or multiple disease areas (and related product categories) as detailed in Table 1 below, namely (i) HIV, HCV, and co-infections, (ii) Malaria, and (iii) Post-partum hemorrhage. The disease area(s) should clearly be indicated in the proposal, and budget assumptions should reflect the individual proposal(s).  However, strong preference will be given to proposals that are comprehensive enough to deliver expected results across multiple disease areas.

The overall focus of the project(s) will be to demonstrate the feasibility and benefits of regional manufacturing as an accelerator and enabler of sustainable, equitable access. The proponents are expected to demonstrate how Unitaid’s existing projects, complemented by these new investment(s), could play a pathfinder role, and catalyze further development of the health products manufacturing ecosystem on the African continent. The proposals should include measures to answer important questions of identifying the right products, appropriate markets, and feasible forecasts, as well as suitable manufacturing and market entry strategies that would guarantee the overall impact (best value for money, sustainability, and scalability) of the interventions to be delivered. 

Summary of target products

1. Better Medicines for the Prevention and Treatment of Post-Partum Haemorrhage (PPH) 

Each year, about 14 million women experience PPH, resulting in about 70,000 maternal deaths, with nearly all maternal deaths of PPH occurring in LMICs, primarily sub-Saharan Africa and South Asia (80% of all deaths). Wider accessibility e.g., of tranexamic acid (TXA), oxytocin, and misoprostol can help change the trajectory of PPH-related mortality. However, considerable market access barriers exist in LMICs for existing formulations of these priority WHO-recommended drugs in terms of availability, affordability, and adoption at scale. Manufacturing affordable, quality assured PPH medicines on the African continent would be a critical strategic opportunity that could further enhance access in multiple ways. Unitaid seeks to support the market entry of generic manufacturers of quality assured, affordable PPH medicines to improve access.

The supported interventions are co-funded by the European Union under the project “Safe Birth Africa.”

2. New Malaria Treatments, including non-artemisinin-based drugs 

The global malaria burden persists, with progress plateauing in recent years. Most cases occur in Africa (95%), and 77% of deaths affect children under five. Access to quality malaria case management and treatment options remains a significant challenge in low-resource settings.  Antimalarial drug resistance in Africa is an urgent threat to the fight against malaria.

Building on the manufacturing capabilities currently on the continent, Unitaid plans to support viable African pharmaceutical manufacturers to nurture the manufacturing of cost-competitive, quality-assured newer antimalarials.

3. Therapeutics for HIV and related Co-infections 

The HIV medicines market size in Africa in 2022 was estimated to be ~USD1.2 billion, with a penetration of ART of 86%. Tenofovir, Lamivudine, and Dolutegravir (TLD) constituted USD ~ 800 million (67% of the market by value, 86 % by volume) in 2022. Purchasing power is concentrated across three major procurers: the Global Fund (GF), the President’s Emergency Plan for AIDS Relief (PEPFAR), and the South African Government, which engages in national tendering. Impetus from the major procurers has already triggered a focus on local manufacturing in Africa. The concentration of on-continent ARV manufacturing capacity in South Africa is attributed to the demand pulled by the South African Department of Health. PEPFAR has now laid down the explicit commitment to work alongside other partners and buyers to shift at least 2 million people onto first-line ARV treatments to African-made products (which translates to an annual demand volume of ~ 720 million tablets/~360 million tablets per supplier if serviced by two companies). While the demand-pull provides the impetus, structural challenges imply that additional interventions will be essential for the sustainable impact of regional manufacturing. Beyond ARVs, there are complementary medicines for the treatment and/or prevention of opportunistic infections that may be considered for Unitaid support, especially those required for the management of Advanced HIV Disease (AHD).

4. Rapid diagnostic test kits

Rapid Diagnostic Tests (RDTs), including self-tests, are identified as a priority investment given their potential public health impact and market readiness. While there are few African manufacturers of RDTs in the near term, there are opportunities for scaling up production. Most RDTs in Africa are currently procured from external manufacturers, and the regional growth of manufacturing is hindered by barriers and the need for targeted policies. However, there is an opportunity to support HIV and Malaria RDT manufacturers in the region to become competitive and include Hepatitis C/ Hepatitis B RDTs as part of their portfolio.

The proposed projects should target the following product platforms and technologies as detailed in Table 1 below:

• Oral solid dosage formulations of small molecule therapeutics
• Sterile small-volume injectable formulations of small-molecule therapeutics
• Active pharmaceutical ingredients (API) of small molecule therapeutics
• Rapid Diagnostic Tests

Table 1: Description of products or finished product formulations[6] across disease areas and estimated number of unique products targeted

The Unitaid project portfolios to be complemented by these investments include the treatment and/or prevention of postpartum hemorrhage, mitigating Antimalarial Drug Resistance (AMDR) in Africa, and the HIV portfolio, including therapeutics and diagnostics (see Section 9: reference documents). The CFP focus also includes interventions that will contribute to existing interventions by other ecosystem stakeholders on cross-cutting systemic barriers to enhancing access through regional manufacturing, such as those related to product regulation (strengthening national capacities, regional harmonization mechanisms, quality assurance capabilities, intellectual property, and technology transfer). Preference will be given to proposals from proponents that demonstrate capabilities to unlock complementary and sustainable financing (from governments, private sector, and development finance institutions) as well as those that demonstrate synergies with pandemic planning, preparedness, and response, as well as climate and health.

Responses to this CFP are expected to be targeted in the budget, with intervention duration ranging (indicative) from 2 – 4 years, with clear milestones and deliverables over time. The potential for further interventions will be informed by the success of these initial phases of work and the evolution of context-specific manufacturing capabilities and needs.

As stated above and reiterated here: Unitaid solicits proposals from organizations or consortia, including technical support organizations, non-government organizations (NGOs), market-shaping organizations, academic and research institutions with demonstrated competencies in upstream product development and manufacturing, and downstream activities, including in-country product access, to address the work areas outlined below. This call does not apply to manufacturers in Africa, contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs). A separate announcement of a Call for Expressions of Interest (EOI) to African manufacturers, CDMOs and CROs will be issued in June 2024 after this CFP.

Intervention package and work areas:

The objective of this Call for Proposals is to identify partners (or consortium of partners) that can design and implement a package of technical and market-shaping interventions to support manufacturers in achieving sustainable manufacturing and market entry of cost-competitive, quality assured products within Unitaid’s current portfolio.  The proponent’s intervention package should offer end-to-end support to create bespoke solutions for each product. The proponent’s intervention can address a partial scope of a comprehensive intervention package; however, preference will be given to proponents that can offer end-to-end support. Proponents must demonstrate the capacity to perform an evidence-based assessment of each case, using existing data and generating new insights to deliver on the objectives stated above. Specifically, the following elements should be considered by proponents in the design of an intervention package as applies to the identified gaps in each product category:

Intellectual Property (IP) and Technology:

• IP licensing support.
• Facilitation and support for formulation development and technology transfers.
• Development and deployment of climate-smart health products.
• Technology improvements targeting affordability and environmental impact of Active Pharmaceutical Ingredients (APIs) and other essential manufacturing inputs.
• Technical support and partnerships to improve delivery standards of contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs).

Procurement and Market Shaping:

• Market shaping interventions for domestically manufactured products, e.g., catalytic procurement and product introduction.
• Strengthening of pooled procurement mechanisms and climate-smart supply chains.
• Solutions to expand access to affordable quality-assured APIs and other essential manufacturing inputs.

 Quality and Regulatory Systems:

• Technical assistance for compliance with regulatory filing for quality assurance to match procurement requirements of target markets for accelerated market entry.
• Innovation on incentive structures for manufacturers’ continuous quality improvement.

Preparation for Pandemics:

• Considerations of arrangements for commitments to dedicate production capacity to priority pandemic products as required in the event of need.
• Specific attention to diversity and expansion of capacity for production lines and formulations with a high likelihood of scarcity during health emergencies (e.g., injectables, antivirals).

Cross-cutting:

• Contribute to regional regulatory strengthening processes, e.g., African Medicines Agency (AMA)/ African Medicines Regulatory Harmonization (AMRH) initiative, including support, in collaboration with AUDA-NEPAD, WHO, and other partners, for streamlining product focus and agility of regulatory mechanisms for pandemic response.
• Support Africa CDC and regional economic communities in strengthening pooled procurement.

Engage with relevant government stakeholders, relevant industry/ecosystem players, and community-based organizations from relevant LMIC regions to ensure their input in the analysis of demand, supply, and viable routes to market. Government stakeholders, industry/ecosystem, and community-based organizations need to be engaged at all stages of the work. This should include meaningfully contributing to the depth of knowledge required to scope and size market potential, the most promising use cases and formulations, and the business models needed to render fit-for-purpose products equitably accessible.

Additional Information

Expectations for consortium partners and skillsets

Unitaid expects the following to be reflected in the makeup of an implementing partner or consortium (non-exhaustive):

• Partners with technical expertise in the provision of technical assistance on manufacturing of medicines (oral solids, injectables, and small molecules APIs), including potential opportunities to lower costs, reduce climate impact, and simplify products through optimized processes
• Partner(s) with technical expertise and experience in negotiating access and procurement terms, managing relationships/engagement with diagnostics and/or pharmaceutical industry (including but not limited to product developer/ development partnership, Contract Development and Manufacturing Organization, Clinical Research Organization, and Contract Manufacturing Organization).

• Partner(s) with experience in Intellectual Property, technology transfer, and related services in the pharmaceutical and/or diagnostics industry. Partner(s) with experience and expertise in technical assistance for compliance with regulatory filing for quality assurance to match procurement requirements of target regional and international markets for accelerated market entry

• Partner(s) with the expertise to analyze and navigate markets (including regulatory pathways) for accelerated market penetration and sustainable commercial viability
• Community-based and civil society organizations relevant to the potential product use cases, demand generation, and access advocacy.
• Partner (s) with expertise across multiple disease areas within Unitaid’s mandate -or a mechanism to include representation and input from partners in other disease areas if not included in the consortium.

Proposals that incorporate efficiency in the design and composition of the project consortium are encouraged (for example, where one organization may contribute expertise in one or multiple domains or cross-cutting areas as listed above).

Proposals should highlight the proponents’ experience working with key institutions and initiatives in Africa and how collaboration with these entities, such as Africa CDC, AUDA-NEPAD, Africa Pharmaceutical Technology Foundation (APTF), Afreximbank, WHO, UN agencies and financing institutions[7], on various aspects of the initiatives would be fostered.

Impact we are seeking

Investment in regional manufacturing represents a pivotal opportunity to catalyze positive change toward achieving global health targets for the key morbidities leading to significant public health and economic impact.

Potential key drivers of impact are:

• Climate-smart health products: products and supply chains that are less harmful to the environment (less greenhouse gas emissions, reduced pollution, and nature impact), more resilient to climate change, more responsive to the needs of communities affected by climate change, and locally adapted.
• Increased resilience for Pandemic Response: with always-on strategic manufacturing capacity at the local and regional level that serves the persistent needs of the markets and, as the need arises, can support countries meeting the surge in demand for priority pandemic products.
• Increased supply security: reduced logistical barriers and transportation costs, and less fragility and external dependencies of the supply chains attained by expanding regional capacity of production, would potentially facilitate not only routine access but also rapid response when global markets are disrupted, thereby bolstering the resilience of local healthcare systems to weather health emergencies. Regional manufacturing could reduce

• Shortages arising from the risk of supply disruption due to natural disasters- increasing with climate change-, cyberattacks, and lockdowns due to pandemics or epidemics abroad, affecting traditional production points.
• Lower cost: e.g., because of reduced shipment distances and fewer intermediaries in the value chain, thus improved affordability.

• Empowerment and improved innovation capacities: by collaborating with healthcare professionals and researchers, manufacturers can develop innovative products that address prevalent health concerns specific to the region and provide solutions tailored to the needs of the local population. Such improved capacity for product optimization at the manufacturer level can enable the production of necessary materials for their clinical evaluation in required clinical trials (e.g., clinical batches) and regulatory processes (e.g., bioequivalence studies).
• Stimulate economic growth: Beyond its impact on public health, regional manufacturing stimulates economic growth and fosters job creation within communities. Employment opportunities are created, but also procurement of raw materials and ancillary services from local suppliers
• Enhanced quality: improved regional production capacity can promote quality assurance by ensuring regional manufacturing meets the required quality standards, potentially discouraging the production and/or importation of falsified products.

Process

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.
• Unitaid’s preliminary rationale for working in this area Regional-Manufacturing.pdf (unitaid.org)
  1. 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. Proposals are expected to outline a lean, concrete, and clear pathway to results and impact.
  2. After proposals are assessed by Unitaid, and subject to endorsement of Joint Review Committee recommendations by the Unitaid Board, all applicants will be officially notified whether they will be invited to develop a full grant agreement for Unitaid funding.
  3. Applicants are encouraged to consider partnering with other applicants to submit a consortium-based proposal if they are only able to/or intend to focus on a partial scope of a comprehensive intervention package, as preference will be given to proponents that can offer end-to-end support. Unitaid reserves the right to request the consolidation of proposed individual intervention packages into one consolidated intervention package, with a clearly identified lead implementer, as a condition of a funding award.
  4. A separate announcement of a Call for Expressions of Interest (EOI) for manufacturers, CDMOs and CROs interested in partnering with implementing partners selected through this CFP will be issued shortly after this CFP to collect information relating to product-specific manufacturing and associated capacities and indicative costs. Unitaid and the ultimately selected implementing partner(s) (or consortia) will then jointly invite identified manufacturers (and CDMOs, CROs) to submit detailed proposals through a Request for Proposal process, through which product manufacturing and associated capacities as well as budget details, will be obtained.
  5. Partnerships based on complementarity between eligible manufacturers identified through the EOI process and technical partners will be facilitated by Unitaid during the grant agreement development stage.

Additional considerations

Unitaid sees value in proposals from South-based lead implementers with experience in leading the implementation of large-scale multi-country projects that support access to health products in LMICs. We also support the meaningful inclusion of South-based sub-implementers, where feasible and relevant, in proposed project implementation consortia. To be clear, Unitaid’s objective of progressively engaging an increased number of lead-implementing partners from the global South does not preclude proposals that also include partners from the global North, where their role is deemed complementary and important for the success of the proposal. 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 global impact.

Unitaid is committed to climate and environmental action in its investments and expects its partners to make similar commitments. Proposals should indicate efforts that will be made to minimize carbon emissions from project activities (e.g., greener procurement practices and reduced travel through more reliance on in-country-based teams and service providers).  Estimated budget requirements should be explicitly mentioned in the relevant section of the proposal form.

Proposals should be carefully targeted, reflecting focused interventions to establish viable business models for therapeutics and in-vitro diagnostics in LMICs. Proposals should clearly indicate the level of effort and budget for each activity.

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 upstream new product development (pre-clinical development stages), interventions targeting traditional medicines, and interventions/projects focused only on product delivery or program implementation. Regional manufacturing of oxygen and oxygen-related products (to be addressed in the current investment portfolio and through future Calls) are also out of scope.

[1]  Further details on the Unitaid 30 x 2030 products can be found here: https://unitaid.org/assets/Unitaid_Strategy_2023-2027.pdf (page 43)

[2] “Declaration for accelerated malaria mortality reduction in Africa: Commitment that ‘No one shall die from malaria’”, Issued by the Ministers of Health of High Burden High Impact countries in Africa, accessed 18 April 2024, https://minsante.cm/site/sites/default/files/Yaounde%20Declaration%20on%20 Malaria.pdf

[3] “The Lusaka Agenda: Conclusions of the Future of Global Health Initiatives process”, Future of Global Health Initiatives co-chairs, accessed 18 April 2024, https://d2nhv1us8wflpq.cloudfront.net/prod/uploads/2023/12/Lusaka-Agenda.pdf

[4] This is an example of a case study; the actors and activities are illustrative and non-exhaustive.

[5] Economic Community of West African States (ECOWAS), Southern African Development Community (SADC), East African Community (EAC), Common Market for Eastern and Southern Africa (COMESA)

[6] This may include work on APIs across all disease areas where it is feasible.

[7] Examples of financing institutions include, but are not limited to, the African Development Bank (AFDB), the African Export-Import Bank (Afreximbank), the European Investment Bank (EIB), British Investment International (BII), the International Finance Corporation (IFC), or private capital firms.

Important dates

Submission and format of Proposals:

Proposals, including all annexes, should be submitted electronically to proposalsUnitaid@who.int. A complete proposal consists of the following documents:

• Proposal form with scanned version of signed Front page template, [DOC: 300 KB]
• Annex 1: Log frame and GANTT chart template, [XLS: 278 KB]
• Annex 2: Budget details template, [XLS: 24 KB]
• Annex 3: Organizational details and CVs of key team members [no template]
• Annex 4: Country engagement support Letters [no template] (not applicable for this call)
• 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 three years [no template] 

Reference documents and links[8]:

Unitaid’s Investment Areas

• Core Investment Areas
• Area for intervention: Mitigating Antimalarial Drug Resistance in Africa
• Postpartum Haemorrhage portfolio

Regional Manufacturing for Equitable Access

• Issue brief: Regional Manufacturing
• Report: Antimalarial manufacturing in Africa: A call for regional action
• Opinion Paper: Enabling a market-based approach to manufacturing quality-assured health products in Africa: A differentiated coordination approach

Climate and Health

• Report: From milligrams to megatons: A climate and nature assessment of 10 key health products
• Executive Summary: From milligrams to megatons: A climate and nature assessment of 10 key health products
• Climate and Health Strategy 2023-2027
• Issue Brief: Climate and Health 

Pandemic Prevention, Preparedness and Response

• Issue Brief: Pandemic Prevention, Preparedness and Response
• Presentation: Access is not an afterthought: Equitable access to therapeutics during pandemics
• Report: Access is not an afterthought: Learnings and opportunities for equitable access to lifesaving therapeutics in future pandemics
• Briefing note: Access is not an afterthought: Equitable access to therapeutics for pandemic preparedness and response
• Q&A: Monoclonal Antibodies

Initiatives in Africa

• Africa CDC: The New Public Health Order: Africa’s health security Agenda
• UNECA: Preliminary survey report on the assessment of manufacturing capacity status, good manufacturing practice and adherence to environmental, health and safety standards among selected local pharmaceutical manufacturers in 10 pilot countries (uneca.org)
• UNECA: Situational analysis and feasibility study for pooled procurement and local production of maternal, neonatal and child health products in 10 selected countries: Quality-assured maternal and child health products in Africa (uneca.org)
• AUDA NEPAD: African Union Development Agency (AUDA NEPAD) through the African Medicines Regulatory Harmonisation (AMRH) initiative – Call for Industry Applications: Pilot of the Continental Listing of Medicinal Products

[8] Reference documents provided are indicative but exhaustive.