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
Disease areas |
Illustrative examples of target products/formulations |
Estimated target number of unique products across regions and suppliers that reach regional and global supply. |
Postpartum haemorrhage products
|
Oral solid dosage and injectable formulations of small molecule therapeutics, e.g.
Misoprostol and tranexamic acid respectively, |
5
|
HIV and co-infections |
Rapid diagnostic test kits for HIV and co-infections
First-line antiretrovirals (ARVs) and/or Pre-exposure prophylaxis (PrEP) medicines, e.g., Tenofovir, Lamivudine, and Dolutegravir (TLD) |
4 |
Malaria |
First-line antimalarial medicines, e.g., artesunate-pyronaridine (ASPY),
Dihydroartemisinin-Piperaquine (DHAP) |
2 |
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.