Overview and funding priorities for reproductive health in East and Francophone West Africa

Full title: Medical manufacturing and regional regulatory harmonization efforts. Overview and funding priorities for reproductive health in East and Francophone West Africa

Executive summary

This report provides a high-level overview of key opportunities to strengthen reproductive health (RH) product access in Africa by examining the intersecting areas of regulatory harmonization, manufacturing, and product introduction.

Regulatory harmonization efforts

Initiatives like the African Medicines Regulatory Harmonization (AMRH), regional harmonization initiatives, and the African Medicines Agency (AMA) aim to reduce cumulative regulatory burdens on manufacturers in two primary ways: joint application and review procedures (where representatives from various agencies collaborate) and reliance (in which one agency places weight on, or even accepts the judgment of, another agency’s deliberations).

The AMRH has facilitated regulatory collaboration at the regional level, piloting successful frameworks like the East African Community Medicines Regulatory Harmonization (EAC-MRH), which has halved registration timelines. However, inconsistent adoption across Regional Economic Communities (RECs) and burdens for manufacturers hinder broader impact. The AMRH’s support of the new African Medicines Agency (AMA) is a promising entry point to promote RH product inclusion in continent-wide frameworks.

While progress has been made, and RH products are part of many initiatives, experts noted significant gaps and opportunities for improvement, including practical difficulties, political competition among regulatory actors, and insufficient capacity in low and middle-income country (LMIC) regulatory agencies. Experts also emphasized that registration alone does not ensure access, pointing to the critical role of procurement policies and Essential Medicines Lists (EMLs).

WHO Prequalification of Medicines (PQ, or PQP) ensures global quality standards and is often used for regulatory reliance, but has limited RH product coverage. Experts cautioned against over-reliance on PQ as the sole quality benchmark, emphasizing the importance of broader quality assurance measures. Supporting advocacy and technical assistance to include RH products on national EMLs and aligning procurement systems offers a route to greater impact.

Advancement of RH pharmaceutical manufacturing in sub-Saharan Africa (SSA)

Africa’s pharmaceutical manufacturing landscape remains concentrated and limited, with just 600 manufacturers across the continent as of 2020 and 80% of those in just eight countries (of which Kenya is the only country in scope for this research). We found that facilities producing RH products are scarce, with Nigeria hosting the only known existing misoprostol facility, and three others planned. Moreover, experts we interviewed had mixed views on the promise of promoting RH product manufacturing in SSA, and noted that impactful grantmaking would likely require significant investment. Experts and a recent study by the U.S. Agency for International Development (USAID) suggested that manufacturing RH products in SSA would not be economically viable and could waste scarce resources for RH product access.

There are several continental, regional, and other initiatives promoting African pharmaceutical manufacturing, primarily for vaccines due to momentum following Covid-19. The Pharmaceutical Manufacturing Plan for Africa (PMPA) identifies challenges and opportunities, detailing an implementation plan to achieve its goal of a sustainable pharmaceutical ecosystem on the continent. The African Continental Free Trade Area (AfCFTA) aims to create a unified market of 2.2 billion people by 2050—with a current reach of 1.3 billion—to increase competitiveness with Asian manufacturers and create opportunities for regional value chain development. Regional industrialization initiatives, such as the EAC Industrialization Policy and East African Development Bank, aim to transform the sector by leveraging states’ comparative advantages to foster collaboration and focusing on regional integration and skills development. Funders such as the European Union and the International Finance Corporation (IFC) are pouring billions of dollars into pharmaceutical manufacturing on the continent.

Multi-actor efforts for product introductions or improvements

Efforts to develop and scale access to new RH, maternal health (MH), and family planning (FP) products sometimes go hand in hand, and are largely driven by development agencies and international initiatives. FP2030 is a global initiative supporting local governance and advocacy for family planning, although its Implants Group appears to be only a nascent successor to FP2020’s Implant Access Initiative.

Aid agencies like the UK’s Foreign, Commonwealth & Development Office (FCDO), USAID, and the UN Population Fund (UNFPA) play key roles. The FCDO’s Catalytic Opportunity Funds (COFs) exemplify a rapid and flexible funding model to address health challenges. Experts highlighted their effectiveness in coordinating provider training, procurement, and demand creation across countries. COFs also incubate working groups for key products, which several experts highlighted as crucial initiatives for scaling lesser-known RH innovations, and for capacity-building to empower local stakeholders. Programs like USAID’s Contraceptive Technology Innovation (CTI) Initiative and Innovate FP target contraceptive innovation, while UNFPA strengthens RH product supply chains and policies.

Private-sector initiatives are important for innovation in the RH space and beyond. MSD for Mothers takes a holistic approach to MH, with initiatives like LifeBank in Nigeria addressing postpartum hemorrhage. However, its narrow focus on MH limits broader RH engagement. Broader global innovation platforms such as Grand Challenges and the Global Innovation Fund (GIF) offer sector-agnostic support with potential to expand RH product innovation and novel product introduction.

Contraceptive prevalence rates (CPRs) and method skew

We gathered United Nations (UN) World Contraceptive Use 2024 data to assess the current states and trends over time of contraceptive prevalence rates (CPR) in the countries within this project’s target regions. There are 26 countries within the agreed-upon scope for this report, including 16 from East Africa (as defined by the African Union) and 10 from Francophone West Africa. Four countries’ most recently reported CPRs exceed 60%, while 10 countries’ CPRs are below 20%. However, 10 of the 23 countries’ most recent CPR estimates are over five years old, and three contain no data on their overall CPRs. In our view, CPR trends suggest a greater need for support in Francophone West Africa, given that flatlining/declining trends there appear to be most prevalent in low-CPR countries (as opposed to East Africa, where such trends occur in higher-CPR countries).

Regarding method skew, contraceptive injectables and implants are popular in both regions, jointly comprising the majority of modern methods in most countries. Contraceptive pills are also popular, while IUDs and other methods rarely comprise a significant proportion of contraceptive prevalence. Experts identified several methods—some existing (e.g., IUDs) and some new (e.g., on-demand pills)—for which further market assessment is needed. Such assessments may be especially useful in low-CPR countries with nascent RH product markets.

Top recommendations

We have identified 11 promising opportunities for grantmaking, three of which we selected as our top recommendations, noting that the selection was difficult. We suggest that interested funders use this research to zero in on primary objectives, then vet these options with multiple experts based on those objectives, re-prioritizing accordingly. We have indicated with an asterisk (*) the recommendations suggested by experts.

Top three recommendations

Our top three recommendations are: (1) alleviating cash flow problems in the procurement of priority reproductive health products in target countries; (2) conducting or commissioning research to align country-level or regional reproductive health landscapes with women’s needs and preferences in key countries/regions, and (3) supporting a manufacturer of a priority reproductive health product in applying for the African Medicines Agency (AMA)’s pilot assessment.

Alleviate cash flow problems in procuring contraceptives*

Chris Purdy, President of DKT International, emphasized that floating cash to purchase products is difficult and costly for procurers. For example, DKT may order condoms from Thailand for $500,000, and they have to send $250,000 in advance of production, wait 4-7 months for the goods to ship and clear customs, and another 1-3 months to sell the products, for which they have to give 60-90 days of credit to sellers. DKT often ends up asking manufacturers for extra time to make payments, and the associated cost of doing so gets added onto the unit cost of their product. Funders could alleviate cash flow constraints by floating cash on behalf of procurers, e.g., to pay for advances.

In essence, the recommendation is to provide zero-interest loans to procurers to lower product costs in the markets where procurers, such as DKT, operate. Ntindah Luembe (Director of Membership Engagement and Initiatives at the Reproductive Health Supplies Coalition) was in favor of this intervention, suggesting that it would help to smooth distribution and prevent supply stockouts. One path forward would be to work with DKT to trial this intervention for 1-3 product-country pairings (e.g., implants in Mauritania) in a given region. Then, advocate for such arrangements on a larger scale—for instance, from regional development banks—if it proves useful to reduce supply-side delays/stockouts and unnecessary cost increases. Given that the intervention is essentially in the form of a loan, it may be highly cost-effective.

Commission research to align R&D and procurement with women’s true RH needs*

Regarding women’s demand, one expert, an independent consultant, suggested commissioning research to synthesize the large amount of existing data on (paraphrased) “why women choose particular contraceptives, barriers to methods’ uptake, and whether there are options missing” to “answer the question of what we don’t know.” Similarly, Metin Gülmezoglu, the Executive Director of the Concept Foundation, suggested an effort to identify women’s needs is “doable” and “would not be that expensive,” taking 12-18 months to conduct such research across multiple countries. He suggested a method used by the James Lind Alliance in the UK.

One expert suggested there is a knowledge gap regarding demand for pills of various consumption frequencies (e.g., daily, weekly, or monthly), as well as the six-month injectables currently funded by USAID and the Gates Foundation. They also wondered if IUD uptake would be much higher—and whether uptake would be from switching or new users—if there were dedicated funding for its introduction and scale up.. Purdy additionally suggested two products in the R&D phase, including the use of mifepristone in different dosages as weekly or emergency contraception.

In his discussion of pericoital contraceptives (e.g., barrier methods and on-demand pills), Gülmezoglu expressed regret that the field of sexual and reproductive health is “always a little apologetic” about putting money and effort behind the products that women want and need, unlike in other fields (e.g., HIV). Therefore, research to identify the most in-demand products—whether existing or aspirational—may require strong advocacy for those products.

Conducting such research seems quite promising and could have outsized impacts, perhaps particularly in areas with high need, poor sexual and reproductive health (SRH) outcomes, and an unformed RH product market. For instance, expert interviews offer some indication (supported by our data visualizations) that certain countries (e.g., Mauritania) or regions (e.g., perhaps Francophone West Africa, though we would need to conduct further analysis to confirm) are characterized by high maternal mortality and strong motivation to improve their reproductive healthcare, but are in the early stages of this journey. Purdy suggested that Mauritania fits this profile, and that DKT International has recently started working there. Conducting early-stage research to ensure that the market develops in alignment with women’s preferences for RH products could fill an important gap.

Support RH application and participation in AMA pilot assessment*

The AMA recently launched a pilot program (AUDA-NEPAD, 2023a) of the continental procedure on evaluation of medicinal products through its Evaluation of Medicinal Products Technical Committee (EMP-TC) supported by the continental technical committee on Good Manufacturing Practices (GMP-TC). This initiative, led by the AMRH, was open for applications meeting the criteria outlined in its guidance document (AMRH, 2024), according to one expert at the time of our conversation. The pilot program is intended to validate the continental evaluation of medicinal products, procedures and processes. The lessons learned from the pilot will then inform improvements to the continental processes and procedures and ensure the AMA is built on robust systems.

One expert highlighted this as a promising opportunity to advocate for RH products to be part of the pilot’s focus. Providing technical or financial support to manufacturers of key RH products could enable their participation in this initial AMA GMP assessment, which would not only enhance the visibility of RH within the AMA’s framework but could also accelerate the availability of high-quality RH products in underserved markets. Ultimately, this intervention could establish RH as a priority area within AMA’s efforts and open the door to more streamlined registration processes for RH products.

To advance this effort, we recommend reaching out to stakeholders engaged with the AMA to confirm the open window for applications, as we are unsure if the program is indeed still open to applications. The first phase appears to have closed to applications in March 2024, but there may be upcoming phases or other opportunities to get involved. If so, funders could work to identify potential manufacturers or products well-positioned for inclusion.

Other promising recommendations

Support capacity building for medical regulation*

Building capacity for medical regulation at multiple levels will be critical to improving regulatory harmonization and access to essential medicines, including RH products. However, this effort might be quite expensive and require sustained commitment.

At the regional and continental levels, capacity building could involve supporting the development and deployment of IT systems, such as centralized tracking and dossier management platforms. For example, the West Africa Medicines Regulatory Harmonization Project (WA-MRH) has identified a need for improved dossier tracking systems and operational streamlining. Luembe suggested that such efforts may be underway, but are not harmonized across countries yet, and recommended reaching out to experts at the African Union Development Agency New Partnership for Africa’s Development (AUDA-NEPAD) for more information. One expert emphasized that providing payroll support for specialized regulatory workers—such as assessors, IT experts, or pharmacovigilance specialists—could significantly enhance system functionality, as human resources are a key bottleneck. Where relevant, support could include resources for legal reform, advocacy for political commitment, and technical assistance to adopt and enforce harmonized policies.

Given the scale and complexity of these interventions, capacity-building efforts might be best directed toward regions or countries where political will and infrastructure readiness align, ensuring that investments yield tangible outcomes.

Speed up Pfizer Accord or AU Model Law adoption in priority countries/regions

The Pfizer Accord aims to partner with countries to implement faster regulatory pathways, product registration, and procurement systems, but it does not appear to focus on regional regulatory harmonization. Of the countries in scope, Uganda (East Africa) and Senegal (Francophone West Africa) are the only ones listed among the first five signatories to the Accord. Similarly, the AU Model Law on medical products regulation outlines a baseline regulatory framework including the establishment of a national medicines regulatory authority (NMRA) and basic medical regulations. Although the law has made initial progress, only a small number of countries have fully domesticated it, hindered by challenges like resource constraints, legal bottlenecks, and slow implementation processes.

Funders could seek opportunities to speed up the adoption of the Accord or Model Law among high priority countries, and/or to advocate for regional harmonization of the steps taken to improve regulation, registration, and procurement. Such efforts could help streamline approval processes for RH products.

Fund and/or coordinate a regional convening of stakeholders and experts for focused discussions on reproductive health, potentially attached to a larger gathering*

Yemeserach Belayneh, a Senior Advisor for the Packard Foundation’s Global Reproductive Health team, suggested that there is a role for coordinating key actors for focused discussions aimed at identifying solutions for reproductive health at a regional level. For instance, we discussed a potential role for regional-level coordination on provider training for long-acting methods, or on entry points for reproductive health in existing regulatory harmonization efforts. Luembe spoke in support of convenings between Ministries of Health and private sector suppliers to plan for private sector involvement in filling gaps in the market, which she said has proven helpful in Ghana, Zambia, and possibly Malawi.

In our view, the contents of such a discussion could be driven by a funder’s takeaways from this (and possibly additional) research, e.g., coordinating regional provider training efforts around a particular contraceptive (or set of contraceptives) that have proven popular among women in the region (see recommendation to commission such research below),^[1] and perhaps where there may also be manufacturing potential.

Leverage existing service delivery to screen for RH diseases with simple and effective treatments*

One expert mentioned a USAID-funded initiative in Mozambique and Malawi that screened tens of thousands of women for cervical cancer by training women in the waiting room for a family planning visit to self swab. The program was able to triage out perhaps ~70% of women, while the remaining ~30% who test positive for human papillomavirus (HPV) could receive referrals for treatment. The treatments (cryotherapy or ablation) are simple and low-cost. The expert’s best guess was that the service delivery component (i.e., stripping out other costs, such as costs of donated equipment) likely cost USAID under $1 million per country per year.

The expert suggested that cervical cancer and STIs are “chronically underfunded, while both have a direct correlation to family planning need, risk of unplanned pregnancy, maternal mortality, and even child health (with congenital syphilis rates rising).” They said that such a program is not only cost-effective, but also offers an opportunity to become a global leader in a space that is not currently funded.

Cover costs of RH product registration

One potential route to increase RH product access is to provide financial support for RH product registration. This intervention might be effective at national or regional levels, or alternatively for applications for WHO PQ or stringent regulatory authority (SRA) registration. Registration costs, often cited as a significant barrier, deter manufacturers from pursuing market entry, especially in countries or blocs where the expected market returns are limited. An expert at USAID emphasized that manufacturers frequently forgo registration due to high fees and labor-intensive processes, which disproportionately affect smaller markets or low-demand products.

Supporting the registration of priority RH products could directly address these challenges. For example, a targeted grant program could cover national registration costs, which we believe are a few thousand dollars per product per country. This financial support could incentivize manufacturers to expand their reach, ensuring RH products are more widely available in underserved regions.

Funders could engage with stakeholders—such as researchers, healthcare professionals, and governments—to identify priority products for registration support. Priority-setting could focus on innovative or underutilized RH products, such as hormonal IUDs or emerging contraceptive methods, which align with regional needs but face access barriers due to limited registration.

Commission mapping of and/or invest in local R&D capacity*

One expert noted that USAID wants more local R&D partners in low- and middle-income countries (LMICs), though capacity is uncertain. Core facilities (animal, microscopy, tissue labs) are either non-existent or have historically been difficult to locate and encourage to apply for funding. The payoff of such an exercise may be somewhat distant (e.g., two decades). We note that the Clinton Health Access Initiative (CHAI) and PATH appear to have recently undertaken such a research initiative for mapping vaccine manufacturing, and funders could support similar research for reproductive health products.

Identify and fund preventive measures for DMPA-SC risks

There is currently a major push to introduce the DMPA-SC injectable in multiple markets across sub-Saharan Africa (SSA). Purdy expressed concern that the movement would repeat an unforeseen consequence of the Implant Access Initiative, which guaranteed purchase of a vast quantity of implants that it ultimately donated to Ministries of Health. The products then entered the public sector, which was flooded with implants that found their way to middlemen and sold for an artificially cheap price, ultimately hindering private sector investment and crowding out other products. Purdy says this phenomenon is already happening in Tanzania and Kenya, and our past conversations with a DMPA-SC supplier in Nigeria highly suggests that this phenomenon is also occurring there. Such flooding artificially suppresses prices and crowds out other products, such as DMPA-IM.

Purdy is skeptical that the risk can be mitigated given existing momentum, but we wonder if there may be scope for funders to identify and fund preventive measures, which could result in more private sector investment in DMPA-SC while also contributing to maintaining a more diverse array of available methods.

Harmonization of the African regulatory landscape for reproductive health products and medicines

Key question: What is the current status of medicines/devices regulatory harmonization efforts across East Africa and Francophone West Africa and are there opportunities for the inclusion of reproductive health (RH) products in those efforts?

Takeaways: While African regulatory harmonization programs aim to address systemic barriers such as fragmented policies, lengthy timelines, and uneven regulatory capacity, they do not generally focus on just one group of medical products. Initiatives like the African Medicines Regulatory Harmonization (AMRH), regional harmonization initiatives, and the African Medicines Agency (AMA) aim to reduce cumulative regulatory burdens on manufacturers in two primary ways: joint application and review procedures (where representatives from various agencies collaborate) and reliance (in which one agency places weight on, or even accepts the judgment of, another agency’s deliberations).

Although most of the initiatives include many RH products as key medicines, there are still opportunities to support and improve them to expand access to RH products. Experts such as Belayneh and another expert highlighted the progress and importance of existing initiatives, while Purdy noted that regulatory harmonization does not yet work well in practice. Gülmezoglu pointed out that regulatory agencies in LMICs lack sufficient capacity to assess and approve devices and diagnostics, which adds delays and gaps in product availability compared to agencies like the FDA or EMA. Gülmezoglu also noted ongoing competition among harmonization actors, such as AMRH and national regulatory authorities (NMRAs), over jurisdiction and authority. This competition poses challenges to coordination and effectiveness.

Regulatory harmonization is not the only determinant of RH product access. Coley Gray, Senior Advisor to the Packard Foundation’s Reproductive Health Program,emphasized that registration and inclusion on essential medicines lists are often not the primary determinants of access in African countries. An expert at USAID noted that they have not typically viewed product regulation and registration as the primary barrier to country-level product access, and procurement policies such as essential medicines lists (EMLs) might be a more potent route to real impact.

The AMRH drives regulatory coordination by supporting regional harmonization initiatives and laying the groundwork for the AMA. Harmonization efforts started formally with the establishment of the East African Community Medicines Regulatory Harmonization (EAC-MRH) program in 2009 under the African Union Development Agency’s New Partnership for Africa’s Development (AUDA-NEPAD) program. EAC-MRH served as a pilot for other regions. Participation in the AMRH still varies regionally, with five of eight officially recognized regional blocs implementing medicine regulatory harmonization (MRH). One expert explained that AUDA-NEPAD has run the AMRH initiative since 2009 as a support for bloc-level MRHs. This support involves improving medicine registration processes and operational inefficiencies, resulting in a reduction in registration times and enhanced quality of registration decision making. AMRH is now scaling to a continental approach, which has been the main focus since 2019-20. For the many countries which have not yet done so, it may be valuable to advocate in favor of domesticating the AU Model Law on Medical Products Regulation, which was developed by AMRH in 2016 as a legislative template to harmonize regulatory frameworks, including NMRA establishment and governance, without specific provisions for any particular area of medicine such as reproductive health. There may be opportunities to accelerate adoption and to advocate for RH-specific provisions in domesticated versions of the law.

Regional Economic Communities (RECs) implement regional regulatory frameworks to reduce duplication and expedite product approvals by allowing manufacturers to submit a single dossier for registration in multiple countries. RECs have seen some successes. For example, the EAC-MRH has halved medicine registration timelines, while the Economic Community of West African States (ECOWAS)’s Joint Assessment Procedure (JAP) has also made progress. Despite these gains, gaps in IT infrastructure, inconsistent adoption, and limited manufacturer engagement hinder broader impact. We see potential for further capacity support to improve the functionality of the MRHs. One expert noted that the products of interest for RH advocacy are likely already included on the eligible product lists that the regional MRHs publish, so RH-specific efforts would not likely be the most promising routes to impact.

Since the AMA Treaty was adopted by African Heads of States and Government in 2019, work has been ongoing to consolidate key regulatory processes across the continent. However, slow ratification and funding gaps limits its reach, with fewer than 40 of 55 eligible countries ratifying its treaty.^[2] Expanding AMA’s mandate to explicitly include RH products and funding its operations could strengthen its impact. One expert emphasized that a critical consideration across the AMA, regional MRH and national systems is ensuring minimal duplication of effort while maintaining effective regulatory oversight. It’s possible that targeted financial support could allow for careful management of product pathways to determine which products should be handled at national, regional, or continental levels. The AMA recently initiated a continent-wide pilot (supported by AMRH) for good manufacturing practice (GMP) evaluations, offering a potential entry point for RH product advocacy.

WHO Prequalification of Medicines (PQP) ensures global quality standards for a small set of priority medicines, facilitating “reliance” approaches that reduce national and regional workloads. However, the program’s limited RH product coverage and central administration make it an unlikely target for grantmaking.

Ultimately, national governments are in control of their own medical products regulations, and there may be opportunities to support RH product access at the national level. For example, several experts mentioned the need for capacity strengthening in national regulators, which might be an opportunity for financial support. It may also be beneficial to advocate in favor of ratifying the AMA. Furthermore, it may be useful to advocate for the priority consideration of RH products, or for their inclusion in national Essential Medicine Lists (EMLs), which drive procurement decisions.

In this section, we will describe each organization and initiative in turn, including academic assessments, discussion of their strengths and weaknesses, expert insights, and suggestions for possible opportunities for improvement or grantmaking. This discussion is followed by a synthesis of grantmaking ideas and recommendations in this space, grouped thematically to give a better understanding of the breadth of options available to improve regulatory harmonization and to ensure the inclusion of critical RH products.

Organizations and efforts in support of regulatory harmonization

African Medicines Regulatory Harmonization (AMRH) Initiative

The African Medicines Regulatory Harmonization (AMRH) initiative^[3] is a continent-wide effort to streamline and enhance the regulatory environment for medical products in Africa. Initially launched in 2009, AMRH focuses on strategically supporting regional alignment efforts through various working groups (AMRH, 2022).^[4] Its ongoing pilot assessment of thirty targeted medical products, executed through the new AMA, may be a key opportunity to prove the viability of a continent-wide approach and to propose the inclusion of RH products.

In the past, a lack of intergovernmental coordination meant that manufacturers must submit individual applications to each national medical regulatory authority (NMRA, sometimes referred to as NRAs). The uncoordinated system resulted in prolonged approval timelines—often four to seven years longer than in high-income countries (Ndomondo-Sigonda et al., 2023), as well as high registration costs, little movement of goods, and reduced access to high-quality products. The AMRH was established to coordinate efforts to improve coordination and reduce the regulatory burdens of the existing national-level regulatory system.

Until recently, the initiative’s structure has relied heavily on regional MRH initiatives established within five African Regional Economic Communities (RECs)^[5]—EAC, ECOWAS, Southern African Development Community (SADC), the Intergovernmental Authority on Development (IGAD), and the Economic Community of Central African States (ECCAS). These regional initiatives employ unique approaches tailored to their member countries’ needs but share core activities, such as guideline harmonization, capacity building, and joint regulatory processes (Ndomondo-Sigonda et al., 2023).

AMRH has recently begun to move beyond the regional-support approach, establishing a regulatory foundation for the continent-wide African Medicines Agency (Sithole et al., 2023). The initiative’s remit is also gradually expanding to cover more product types, including new drugs, vaccines, diagnostics, and eventually broader regulatory functions like clinical trials and safety monitoring (Ndomondo-Sigonda et al., 2018, p. 3). We are not currently sure whether AMRH efforts have explicitly included or even focused on RH products. We found one source noting that the focus of AMRH is on medicines and products targeting “priority disease conditions identified by MRH plus reproductive health products” (Tanzanian Medicines and Medical Devices Authority, 2022), but have not seen reference to the targeted products on the AMRH’s own website.^[6] In addition, the same source notes that the AMRH is supposed to prioritize medicines from domestic manufacturers within the region, as well as biotherapeutics products and biosimilars (Tanzanian Medicines and Medical Devices Authority, 2022).

One unnamed expert mentioned that the intention was to operate regionally before scaling up to a continental level. Accordingly, since 2019-20, medical products with continent-wide relevance such as the Covid-19 vaccines have served as key opportunities for regulatory alignment. According to the expert, the AMRH is now conducting a pilot continent–wide procedure on evaluation of thirty key medicinal products through its Evaluation of Medicinal Products Technical Committee (EMP-TC) supported by the continental technical committee on Good Manufacturing Practices (GMP-TC). This validates and improves systems as part of operationalisation of the new African Medicines Agency.

While the AMRH has made strides in regulatory alignment, particularly in East Africa, it remains hampered by inconsistent adoption across RECs, and relies on external funding. The initiative is supported by a multi-donor trust fund managed by the World Bank, with contributions from funders like the Gates Foundation and FCDO, as well as technical partners like WHO and Swissmedic (Ndomondo-Sigonda et al., 2023).

Strengths:

• Collaborative continent-wide approach: AMRH strengthens national and regional regulatory authorities through training and collaborations, particularly in quality control and post-market surveillance, and provides tools for compliance (Ncube et al., 2022).
• Several studies argue that the AMRH frameworks have already led to faster regulatory timelines and improved standardization, especially in the EAC region (Mwangi, 2016; Ndomondo-Sigonda et al., 2018).

Weaknesses:

• Inconsistent adoption: Despite AMRH’s efforts, only five of the eight RECs have established MRHs (Ndomondo-Sigonda et al., 2023). Of those, some NMRAs had not fully adopted the outcomes of the regional joint dossier review processes as of 2018, limiting its overall impact (Ndomondo-Sigonda et al., 2018, p. 1).

Opportunities:

• Support general harmonization work.
• Align with existing AMRH efforts in relation to RH.

Regional Economic Communities (RECs) and their Joint Regulatory Initiatives

As we have established, the African Medicines Regulatory Harmonization (AMRH) initiative leverages the Regional Economic Communities (RECs)^[7]—EAC, ECOWAS, SADC, IGAD^[8], and ECCAS—to streamline the regulatory environment for medicines and medical devices across Africa. These regional initiatives aim to reduce regulatory duplication, improve timelines for product approvals, and address significant disparities in regulatory capacity between member states. The snapshot tab of our spreadsheet on contraceptive prevalence rates includes columns indicating which countries are members of which blocs.

According to our conversation with one unnamed expert, REC MRH efforts have the potential to increase manufacturer interest in registration in certain regions. In the past, some manufacturers have avoided registering in certain regions, for example Central Africa, due to high per-country costs and a small addressable market size. RECs can reduce the costs and increase the benefits of attaining registration. Another expert also pointed out that regional product registration could be particularly impactful for “low-use” products, which often face financial sustainability challenges under country-by-country registration systems. They emphasized that moving to a regional registration system could reduce costs by bundling markets, making it feasible to support both high- and low-use products. In addition, one expert noted that some regions are working toward fee reform to make their regulations financially sustainable (through cost recovery mechanisms) and more efficient.

However, we are not sure if the regional MRH approach is as useful in practice as its proponents say it is in theory. Purdy of DKT said that although he was familiar with the REC-MRHs, he has found that they do not reduce burdens or shorten timelines in practice. Indeed, even with the additional credential of WHO prequalification, Purdy has found that countries do not consistently engage in “reliance” and tend to want ultimate control over their registration process. In reality, then, each country still needs its own separate registration, and success in one country does not necessarily help in another. He expressed skepticism about the value of pursuing further harmonization in this specific area given the entrenched challenges. We are not sure how much weight to put on Purdy’s experience as opposed to the proponents, but present both perspectives for the reader.

Purdy noted that the difficulties with reliance and harmonization are not unique to reproductive health products but apply broadly across pharmaceuticals. However, medical devices, such as condoms and copper IUDs, tend to face fewer regulatory hurdles compared to hormonal products. He also pointed out that there are no meaningful harmonization efforts for abortion-related products in Africa, primarily due to the political sensitivities surrounding their use.

Each REC has adopted a unique approach to harmonization, with some notable successes and challenges. Of the eight officially recognized blocs in Africa, five have MRHs as part of the AMRH (Ndomondo-Sigonda et al., 2023). The three initiatives relevant in our target nations are projects of the East African Community (EAC), Economic Community of West African States (ECOWAS), and the Intergovernmental Authority on Development (IGAD). We have profiled the first two in this report. Our weakly held impression is that IGAD’s effort is more similar to that of ECOWAS than to EAC-MRH since it has been recently established. However, we have not found much information regarding IGAD’s effort.

Strengths:

• Regional collaboration: Initiatives facilitate joint product assessments, reducing regulatory delays and improving resource efficiency within RECs. ZAZIBONA, while not in one of our target regions,^[9] is sometimes given as a particular example of success, both in the literature and in our conversation with Purdy (Ndomondo-Sigonda et al., 2018a, p. 4).
• Targeted capacity building: RECs provide region-specific support—including training and resources—that addresses unique challenges within member states (Mashingia et al., 2021, p. 19).
• Operational improvements: In the EAC-MRH, for example, regulatory approval timelines improved significantly, as discussed below (Mashingia et al., 2021, p. 14).

Weaknesses:

• Jurisdictional constraints: REC initiatives lack enforceable authority across member states, and compliance remains voluntary, reducing effectiveness (Ndomondo-Sigonda et al., 2017).
• Variable participation: Some NMRAs within RECs engage more actively than others, leading to uneven regulatory strength and impact (Mashingia et al., 2020).
• Operational challenges: Fragmented dossier submissions and limited resources have been ongoing challenges; improvements could be seen with centralized tracking and payment systems (Ngum et al., 2022).

Opportunities:

• Support centralized tracking and efficient handling of dossiers in WA-MRH effort.
• Provide technical assistance to ensure consistency across REC processes, or potentially across NMRAs within RECs.
• Establish an RH-focused committee or working group to enhance focus on RH needs within an REC.

EAC (EAC-MRH)

According to one expert, the East African Community Medicines Regulatory Harmonization (EAC-MRH) is the oldest and most advanced MRH initiative amongst the RECs. The EAC-MRH started in 2012 as a pilot to inform other such regional harmonization initiatives (Ndomondo-Sigonda et al., 2018, p. 3-4). Among and within partner states, the goals of the MRH included agreement of a shared technical medicine registration document across states, establishment of a common information management system for medicines registration, creation of quality management systems in states’ NMRAs, and an information sharing system for stakeholders, capacity building to implement the system, and establishment of a process for mutual recognition (p. 4). The EAC product eligibility criteria stipulates that priority is given to products addressing “medical conditions with regard to maternal, neonatal and children health” (Eligibility criteria, further information available in the EAC (2020; 2021) Regulatory Guidelines).

The EAC-MRH has seen considerable successes and is an ongoing and expanding effort to this day. As the first pilot on the continent, its model has since expanded and become the continent-scale AMRH (Sithole et al., 2023). Furthermore, the expert asserted that the relatively large amount of pre-existing treaties within the EAC regional bloc gave the region some advantages in harmonization.

However, the initiative is still weighed down by fragmented policies, inconsistent compliance, and operational difficulties. For example, Mwangi and Makokha (2023) find that Tanzania saw considerable success with adopting the regulations of the EAC-MRH, but Kenya and Uganda have not fully taken advantage of the process. As a result, the authors found that Kenya and Uganda still have a ways to go to support faster access to health products and medicines (p. 8).

Strengths:

• Improved timelines: Ndomondo-Sigonda et al. (2018) claim that the EAC Joint Assessment Procedure had led to a 30-40% faster rate of application evaluation than national level assessments by 2017.^[10]
• Capacity building: The EAC has strengthened NMRA capabilities with achievements like ISO certification, improving standards and regulatory effectiveness (Ndomondo-Sigonda et al., 2021).
• Scope expansion: EAC-MRH has extended its work to include post-marketing surveillance and adverse drug reaction reporting, plus a streamlined application process for all EAC countries (Arik et al., 2020).
• Industry support: Pharmaceutical companies in the region generally support EAC regulatory harmonization (Dansie et al., 2019).

Weaknesses:

• Market appeal constraints: Limited free trade within EAC affects attractiveness of smaller markets (Dansie et al., 2019).
• Remaining inefficiencies and fragmented policies: Inefficiencies and policy fragmentation indicate a need for improved IT systems, data collection processes, and a unified payment system (Mashingia et al., 2023; Dansie et al., 2019; Ngum et al., 2022).
• Lack of registration: Many essential medicines remain unregistered in EAC countries, with rates ranging from 28% to 50%. Even registered essential medicines often have limited availability (Green et al., 2021).
• Sustainability: Suggestions include introducing industry user fees and strengthening legal frameworks to make joint decisions binding, especially as the initiative expands to include “pharmacovigilance”^[11] (Giaquinto et al., 2020).

ECOWAS (WA-MRH)

The West Africa Medicines Regulatory Harmonization (WA-MRH) initiative, launched in 2017 by the West Africa Health Organization (WAHO, 2020), seeks to improve the availability of high-quality, safe, and effective medicines and vaccines across the 15 ECOWAS countries (WAHO, 2020).

WA-MRH has focused on streamlining the approval process via a joint assessment procedure (JAP), enabling manufacturers to submit a single dossier that can be assessed simultaneously by multiple countries (WAHO, 2018). This procedure reduces the time to market entry across multiple nations and has strengthened technical capacity in some NMRAs (Owusu-Asante et al., 2022). Eligible products for the program are listed in section 2 on page 4 of this document (WAHO, 2022), and include products on the WHO’s EML as well as Life-Saving Commodities (LSC) by the UN Commission on Life-Saving Medicines for Women and Children.

The harmonization process uses the Common Technical Document (CTD), developed in collaboration with ECOWAS, WAEMU, and AUDA-NEPAD, and supported technically by WHO. This document aligns evaluation standards and requirements, simplifying the process for granting market supply authorization across the region (WAHO, 2018). By using shared standards, WA-MRH reduces redundant assessments and facilitates a more consistent regulatory environment for medicines and vaccines (Owusu-Asante et al., 2022).

WA-MRH has in the past struggled somewhat with industry uptake due to long approval timelines, high fees, and restrictive application windows, according to one expert. These gaps have led some firms to favor other regulatory pathways in ECOWAS member states (Owusu-Asante et al., 2023). The expert confirmed in conversation that some companies find it particularly attractive to simply register in Nigeria and Ghana at the national level, but noted that WA-MRH has recently made changes in the hope of encouraging use of the CTD and the WA-MRH pathway, including widening the application window to year-round.

WAHO is actively enhancing the technical capacity of NMRAs, which involves targeted training on CTD standards and collaborative assessments to ensure uniformity in standards across ECOWAS countries (WAHO, 2018; Owusu-Asante et al., 2022). Plans to improve the system include establishing an IT platform for dossier tracking and introducing a mechanism to link approved products with regional and national procurement systems, ensuring these products are prioritized by regional and national buyers (Owusu-Asante et al., 2022).

Strengths:

• Efficiency gains: the WA-MRH’s JAP offers time savings for manufacturers by allowing one submission to cover multiple countries, which improves market access across ECOWAS nations. The procedure also allows NMRAs to access and enhance their technical evaluation skills through collaborative assessments (Owusu-Asante et al., 2022).

Weaknesses:

• Resource constraints: Lack of a robust IT system and limited human resources have made centralized tracking and efficient handling of dossiers difficult (Owusu-Asante et al., 2022).
• Poor manufacturer experience: Despite the benefits, industry engagement with the JAP has been lower than expected, partly due to slow timelines, tight application windows, and high fees. Various types of dossier took 120 to 226 calendar days to complete the WA-MRH review process (Owusu-Asante et al., 2022). Manufacturers cited these challenges and proposed improvements in communication and faster processing at both regional and national levels (Global Forum, 2024).
• Low industry uptake: Lack of centralized IT systems, variability in NMRA regulatory performance, and limited guidance for applicants have deterred some manufacturers from using the ECOWAS-MRH route in favor of simply applying at the national level.

African Union Model Law

In January 2016, African Union (AU) leaders adopted the AU Model Law on Medical Products Regulation as a framework for harmonizing medicine regulation across AU member states.^[12] Developed with the support of the Access and Delivery Partnership (ADP), the Model Law aims to harmonize regulatory systems, strengthen collaboration among countries, foster a conducive environment for scaling health technologies, and accelerate patient access to new medical technologies (Ncube et al., 2023).

The AU Model Law represents a foundational but underutilized opportunity to enhance regulatory harmonization. Although the law has made initial progress, only a small number of countries have fully domesticated it, hindered by challenges like resource constraints, legal bottlenecks, and slow implementation processes. Supporting efforts to expedite the law’s domestication—or to create RH-specific provisions—could help streamline approval processes for RH products.

The Model Law focuses generally on provisions for medical product regulation, and does not include specific information on particular classes of products, including those relevant to reproductive health. For any state which domesticates it, the Model Law includes the creation of a national regulatory agency with clearly defined powers, functions, and governance structures to oversee product approval, quality control, surveillance, and enforcement. Additionally, it promotes international cooperation and harmonization across the continent, aiming to align regulatory standards regionally and encourage information sharing. The Model Law also includes provisions for administrative appeals, transparency, and conflict of interest management, with the intent to foster a robust, consistent regulatory environment across Africa (AU Model Law on Medical Products Regulation).^[13] Local policymakers appear to find the direct results of the law to be clear benefits:

“[T]he perceived benefits of model law implementation [by national governments] include enabling the establishment of a [NMRA],^[14] improving [NMRA] governance and decision-making autonomy, strengthening the institutional framework, having streamlined activities which attract support from donors, as well as enabling harmonisation, reliance, and mutual recognition mechanisms”

Ncube et al., 2023, p. 1

As of 2023, only 7 of the 21 countries assessed by Ncube and co-authors had fully domesticated the law, though the majority of respondent countries that had not done so planned to domesticate the law at least in part.^[15] National governments cited lack of resources, lengthy legal reforms, overlapping government roles, and slow legislative processes as key barriers to domestication and implementation, and noted that factors such as political support and participation in international harmonization were potential enablers of implementing the Model Law (Ncube et al., 2023).

The AMRH is preparing a Strategic Framework (2023-2026) to further accelerate Model Law adoption. The framework targets 30 AU member states for domestication and will incorporate lessons from early adopters (Wellcome Trust, 2023). Simultaneously, there are plans to update the Model Law in response to new regulatory developments, ensuring that it remains relevant and adaptive to the evolving medical products landscape (Wellcome Trust, 2023).

In 2023, the AMRH’s Medicines Policy and Regulatory Reforms Technical Committee (MPRR-TC) began a critical review of the model law’s domestication process, aiming to gather best practices and guide future efforts (AMRH, 2023). The review process included identifying countries that would receive support in the domestication journey in 2024, though we have not found a list of the target countries. We are not yet clear whether this “critical review” process is the same as the “Draft Continental Reliance Framework” discussed in the AMRH section. Furthermore, in August 2023, the MPRR-TC and the Namibia Medicines Regulatory Council partnered to create a roadmap for AU Model Law domestication—complete with timelines and an advocacy plan to engage stakeholders—to foster a unified regulatory approach across Africa (AUDA-NEPAD, 2023b).

Strengths:

• Framework for harmonization: Provides a comprehensive structure for aligning medical product regulations across AU member states, reducing fragmentation and duplication of efforts.
• Empowerment of NMRAs: Establishes clear powers and governance for national regulatory authorities, strengthening institutional frameworks and decision-making autonomy.
• Administrative safeguards: Includes provisions for transparency, administrative appeals, and conflict of interest management, promoting accountability and robust regulatory processes.

Weaknesses:

• Limited domestication: As of 2023, only 7 out of 21 assessed countries have fully domesticated the law, signaling slow adoption across the continent.
• Lack of RH-specific provisions: The law does not explicitly address reproductive health (RH) products, which limits its immediate applicability to RH advocacy efforts.

Opportunities:

• Provide support to countries to domesticate the Law.
• Support AMA and AMRH to develop and advocate for RH-specific provisions in the AU Model Law.

African Medicines Agency (AMA)

Established in 2019 by the Assembly of the African Union,^[16] the AMA is a specialized agency of the AU that aims to harmonize regulatory standards across African countries, ensuring safe and effective medicines and supporting local production and trade (AUDA-NEPAD, 2009). The AMA aims to address vulnerabilities in Africa’s pharmaceutical supply chain, underscored by high costs and prevalence of substandard medicines, and aims to streamline regulatory processes continent-wide (Sidibé et al., 2023; Ogbodum et al., 2023).

As the AMA is still a relatively new organization, there are many potential ways to support it or to advocate that it includes RH as a priority. The Wellcome Trust announced a recent grant of more than $12 billion to the AMRH and its efforts to build up the AMA (AUDA-NEPAD, 2024a). This funding followed a key recommendation in Wellcome’s report on strengthening regulatory systems in LMICs (Wellcome Trust, 2022a, p. 7).

According to one expert at the time of our interview in late 2024, a pilot continental listing procedure was conducted for evaluation of medicinal products through the Evaluation of Medicinal Products Technical Committee (EMP-TC) supported by the continental technical committee on Good Manufacturing Practices (GMP-TC). The expert stressed that the list of targeted products was still open for submissions, and could be a key way to get RH products included under consideration for the pilot scheme. We found little reference to this pilot scheme except for this call for applications (AUDA-NEPAD, 2023a), the first phase of which closed in February 2024 and was extended to May (AUDA-NEPAD, 2024b), but interested funders could get in touch with AMA contacts to find opportunities to get involved with current or future phases.

In addition, supporting advocacy for broader AMA ratification, or advocating for the inclusion of RH-specific priorities within the AMA’s mandate, could help expand and target the agency’s regulatory efforts to better support RH product availability.

Strengths:

• Streamlining regulatory operations: By consolidating regulations, the AMA reduces duplication of work across member states, accelerating access to medicines and ensuring compliance with safety standards (Sidibé et al., 2023).
• Harmonized regulatory framework for manufacturers: The AMA can foster a more stable regulatory environment, enhancing conditions for local manufacturers to meet quality standards and expand production capacity (Ogbodum et al., 2023, p. 4).

Weaknesses:

• Incomplete and uncertain regional participation: Ratification of the 2019 AU treaty that established the AMA as an agency has been slow, limiting its operational reach and effectiveness across the continent (Chattu et al., 2021). As of April 2024, PATH reported that 27 of 55 eligible AU member countries had ratified it (PATH, 2024). Conversely, Abdulwahab et al. (2024) found that 37 countries had ratified it as of late 2023 (p. 354). We are not yet sure of the reason for this discrepancy, but regardless of which figure is correct, the AMA is now an established agency,^[17] but does not cover all eligible African nations.
• Resource constraints: With limited financial and human resources, AMA’s ability to oversee and enforce regulations is restricted (Sidibé et al., 2023). The European Union (EU)’s European Medicines Agency (EMA) recently announced €10 million in support for the AMA, (EMA, 2024), but Abdulwahab et al. (2024) estimate that the AMA needs about $20M USD per year to operate, so we expect that funding gaps will persist (p. 355).

Opportunities:

• Conduct research to understand reasons underlying low ratification.
• Advocate for countries to ratify the AMA.
• Advocate for the AMA to focus specifically on neglected RH products.
• Support the expansion of the AMA process for product lifecycle management to include post-approvals changes (PACs) (suggested in Wellcome Trust, 2022b, Priority 3).
• Develop an integrated management system to bring together national, regional, and continental activities (suggested in Wellcome Trust, 2022b, Priority 5).
• Support development of regulatory pathways for clinical trial approval to incorporate ethics reviews and data transparency (suggested in Wellcome Trust, 2022b, Priority 6).

National Medicines Regulatory Authorities (NMRAs)

Each country’s NMRA oversees the local regulation of medicines and medical devices, focusing on product approval, safety, quality control, and post-market surveillance. NMRAs are ultimately responsible for adopting, adapting, and implementing the policies and recommendations of the various continental and regional regulatory and harmonization initiatives.

Strengths:

• Locally established oversight: NMRAs have direct control over their regulatory practices, allowing them to address local health needs and priorities more effectively (Ussai et al., 2022, p. 4). This structure also helps them to enforce compliance and manage country-specific issues.

Weaknesses:

• Operational challenges: Many African NMRAs struggle with high staff turnover, limited technical expertise, and constrained budgets, impeding their regulatory effectiveness (Ncube et al., 2022).
  • Weak regulatory enforcement can, in turn, lead to local market supply of substandard or forged products (AUDA-NEPAD, 2024c, p. 3).
  • RECs provide some training to NMRAs but cannot fully address the technical gaps across all countries (Sithole et al., 2024, p. 9).
• Fragmented standards: Without full integration with regional frameworks, NMRAs apply inconsistent standards, which complicates efforts toward broader regulatory harmonization (Sithole et al., 2023, p. 1).

Opportunities:

• Provide targeted operational support to ensure smooth registration of key RH products in key interested countries, such as those identified by Purdy in the section on scaling up access to new products.
• Build NMRA capacity to support a continental pharmacovigilance system (suggested in Wellcome Trust, 2022b, Priority 7), as well as the development of an African network of reference laboratories for testing (suggested in Wellcome Trust 2022, Priority 10).
• Support NMRA maturation: Prioritize NMRAs in manufacturing countries to identify and address critical bottlenecks preventing them from achieving WHO Maturity Level-3/4 status (suggested in Wellcome Trust, 2022b, Priority 9).
• GDP oversight: Support NMRA capacity for Good Distribution Practice oversight (suggested in Wellcome Trust, 2022b, Priority 8).

Essential Medicines Lists

The WHO Essential Medicines List (EML) was first introduced in 1977 to address gaps between healthcare needs and medicine availability (Laing et al., 2003, p. 1723).^[18] The current WHO EML includes core medicines essential to basic healthcare and complementary items for specialized care needs, including more than 30 kinds of RH products. Both adult and pediatric versions (EMLc) are updated biennially by an expert committee evaluating medicines based on public health need, safety, efficacy, and cost-effectiveness (WHO, 2014). While the committee’s review process is rigorous, it lacks a standardized framework and set thresholds for these criteria. This structure contributes to significant lead times—averaging 10 years in some cases—for new medicines to be added following FDA approval (Kudymowa et al., 2023).

National EMLs serve as critical tools for guiding procurement decisions and ensuring medicines are available at appropriate levels of care, particularly in national stockpiles and public health systems. Over 150 countries rely on the WHO’s EML to inform their national Essential Medicines Lists (NEMLs), although these are often adapted and frequently lag behind the WHO’s updates (WHO, 2020a).

We compiled data from 2017 on countries’ inclusion of WHO-listed RH medicines (WHO, 2020b) in their NEMLs. This data, from Persaud et al. (2019) (accessed at Global Essential Meds), highlights countries that may need support in adopting EML protocols, like Benin and Tanzania, which list only a few RH medicines. Conversely, countries with high overlap, like Kenya and Ethiopia, present opportunities for targeted policy improvements.

Belayneh emphasized that countries are serious about adhering to their lists, which approve both products and suppliers. However, she noted, capacity to revise NEMLs varies significantly, with some countries regularly updating their lists while others face long intervals between revisions due to resource constraints (WHO, 2020a). Although NEMLs often mirror the WHO’s EML, the variability in updates and national capacity limits the consistent inclusion of RH products.

As one expert highlighted in our conversation, however, EMLs are primarily benchmarks for essential drugs and guide procurement decisions, such as products that should be available at each level of care. That said, the expert asserted that—in contrast to high-income countries—regulatory authorities in most LMICs focus on registering products rather than integrating EML recommendations into procurement strategies. As a result, based on our understanding, we expect that changes to national EMLs might impact procurement decisions, but would not have a direct impact on regulatory harmonization.

Strengths:

• Global influence on medicine procurement: The EML guides medicine procurement globally, encouraging adoption by governments and agencies. Products must often be on the NEML to be procured effectively within public health systems (Belayneh). Including RH drugs could boost RH access when aligned with national priorities (Kishore et al., 2018).
• Adaptability for local needs: The EML framework allows countries to adjust medicine lists based on local health needs, though this flexibility can create variability in RH product inclusion (Taglioni & Persaud, 2021).

Weaknesses:

• Limited applicability for regulatory harmonization: One expert noted that EMLs are used more for procurement than for registration or approval.
• Limited RH product inclusion: RH products have been historically underrepresented on the EML, which can reduce access to essential RH medicines in LMICs and lead to gaps in RH service quality (Hutchings et al., 2010).
• Variable country adoption: Many African countries only partially align their NEMLs with the WHO EML, particularly for RH items, leading to disparities in access and reducing impact on RH outcomes.
• Central funding limitations: Despite estimated expenditures of $5-10M annually, the WHO EML/EMLc faces a funding gap, estimated at about 25% of its current budget. However, as the EML is a core WHO function, the program does not typically accept external funding, though it may benefit from additional staff secondments (Kudymowa et al., 2023).
• Capacity challenges in NEML updates: Countries’ capacity to revise NEMLs is uneven and dependent on health systems’ resources and their ability to respond to new pharmaceutical developments, as Belayneh pointed out in conversation.

Opportunities:

• Advocate or conduct research to support RH Product Inclusion in the WHO EML, including potentially supporting quality improvements for EML applications for relevant products. Staff secondments to the WHO’s relevant bodies may also help.
• Support technical assistance for NEML updates: As discussed in the “weaknesses” above, there are several countries which might be ideal for policy advocacy. Belayneh suggested this as an important opportunity to improve access.
• Fund cross-national EML collaboration: Belayneh noted that collaboration at AU summits or other regional levels could be a strategic opportunity to support NEML updates, although countries must retain their autonomy over national policies.

WHO Prequalification of Medicines

The WHO Prequalification of Medicines Program (PQP) was established in 1987 (for a small subset of vaccines) and 2001 (for medicines) to assess the quality, safety, and efficacy of essential medicines. Initially focused on HIV/AIDS, tuberculosis, and malaria medicines, the PQP has expanded to include RH products (Blaschke et al., 2019, p. 68; Leow et al., 2023).^[19] The PQP’s primary objective is to ensure that approved medicines meet international quality standards, thereby facilitating procurement by United Nations agencies and other global health organizations (Blaschke et al., 2019, p. 68).

According to one expert, WHO-PQ plays a pivotal role in the “reliance” model, where some NMRAs in LMICs defer to decisions made by “stringent regulatory authorities (SRAs)”^[20] like the EMA or FDA. This structure reduces duplication of effort while maintaining national sovereignty over regulatory decisions. Some countries have explicitly signed up for this “prequalified finished pharmaceutical products (FPPs)” program and are listed on the right-hand side of this page (WHO, 2020c). The expert also highlighted the WHO Collaborative Registration Procedure (CRP), which further accelerates registration timelines from an average of two years to about 90 days by asking the reference regulatory authority to share the results of their own approval process with the WHO to reduce administrative load.

Two experts noted specific challenges with the PQ process, including delays caused by understaffing, the limited scope of the PQP, and the nature of long-acting contraceptives and needing to demonstrate safety and efficacy over many years. This can lead to a focus on other products or short-acting pill methods over other innovations like non-daily contraceptive pills or injectable contraceptives tailored for LMIC markets. One expert noted that much has been done to improve the PQ process, and another suggested that streamlining the PQP process would significantly benefit LMICs, allowing for faster approvals and procurement of critical RH products. In this context, a version of the existing regional harmonization efforts, perhaps modeled after the EMA, could complement WHO-PQ processes and reduce bottlenecks.

Purdy offered a nuanced perspective on the role of WHO-PQ in our conversation. He emphasized that while WHO-PQ is a useful tool for assessing product quality, it should not be viewed as the sole determinant of safety or efficacy. Conversely, products without WHO-PQ certification are not inherently substandard. WHO-PQ is simply one of many ways to evaluate quality, and Purdy warned that focusing exclusively on WHO-PQ could drive up costs for funders and end-users. Luembe also emphasized the substantial investment WHO-PQ demands, including fees, upgrades to facilities and establishing robust quality management systems to ensure compliance with Good Manufacturing Practice (GMP), key for WHO-PQ approval. Most of the African pharmaceutical manufacturing companies may be deterred from investing in quality due to various factors, ranging from financial constraints to technical capacity.

Purdy noted that the narrow focus on WHO-PQ risks alienating good actors in the private sector, who often offer competitively priced products that may still meet quality standards. Luembe mentioned a misoprostol product from her time at MSI that was “good enough” and attained WHO-PQ, after which local sales did not change, suggesting that the status may only be worthwhile if targeting international buyers. Purdy also highlighted the tension between international and local oversight, arguing that localization efforts should prioritize strengthening NMRAs rather than relying on international bodies to monitor quality. Moreover, Purdy raised concerns about the unintended consequences of funder policies that require WHO-PQ certification for all procurements.

Strengths:

• Global Recognition and quality assurance: PQP standards facilitate procurement by international organizations, and are also used for reliance.
• Capacity Building: PQP includes training for regulatory authorities and manufacturers, building expertise within national regulatory agencies (NRAs) and companies.

Weaknesses:

• Relatively small scope of products: WHO-PQ currently covers only about 10% of products on the Essential Medicines List (EML). Some products have particular difficulty with the process, including non-daily contraceptive pills, and one expert noted that other bodies such as the EMA may be another route for regulatory approval.
• Limited RH product inclusion: Few RH products, such as IUDs and condoms, are PQ-approved, and most are produced outside Africa. As of 2022 and 2023 (respectively), no prequalified manufacturers of IUDs (UNFPA, 2022; six in India, one in Brazil) nor male condoms^[21] (UNFPA, 2023; 21 in Asian countries, one in Mexico) are located in Africa (RHSC, 2016).
• Resource and accessibility constraints: African manufacturers may struggle with the high costs and technical demands of PQP standards.

Opportunities:

• Expand RH product prequalification: Expanding the program to better cover RH products and support regional manufacturers could greatly enhance product availability in Africa (Dey et al., 2020, p. 21330).
• Support for African manufacturers to pass PQP or other stringent regulatory standards: Provide technical and financial support to help African manufacturers meet PQP standards, reducing barriers to entry and increasing local production capacity (Belayneh;^[22] unnamed expert).
• Support WHO-PQ program in cold chain oversight (suggested in Wellcome Trust, 2022b, Priority 8).

Synthesis: gaps and potential opportunities to support RH products

RH products can benefit from general regulatory harmonization efforts

RECs in particular appear to be foundational to harmonizing medicines regulation across member states, but they have encountered practical issues like fragmented policies and variable participation. Indeed, RH and medical products seem to suffer from similar issues resulting from the under-resourced and fragmented NMRA systems. Maternal, neonatal, and child health product manufacturers cited “ignorance of regional or national regulatory requirements, language disparities, high registration fees, and unclear dossier approval timelines” as barriers to use of regional mechanisms for product registration (AUDA-NEPAD, 2024c).

Funding could help to address these issues holistically by:

• Supporting capacity building such as training and the development and deployment of IT systems, e.g., to support the centralized tracking and efficient handling of dossiers in WA-MRH effort, or providing payroll support for specialized workers to improve system operations. One expert stressed that such measures are extremely impactful ways to support harmonization, as human resources are a key bottleneck. A 2022 report by the Wellcome Trust also suggested capacity building (Wellcome Trust, 2022b, Priority 2).
• Providing technical assistance to ensure consistency across REC processes: One expert mentioned Swissmedic’s program Marketing Authorisation for Global Health Products (MAGHP), which asks the regulatory authorities to participate in joint and “stringent regulatory authority (SRA)” product assessments so that they can have “well informed reliance”. A funder might be able to support this program or a targeted sub-program focusing on RH products.
• Model Law domestication support: Identify which countries need support to adopt the AU Model Law, and provide assistance to adopt and enforce harmonized policies. Support might include additional resources, support for legal reforms, advocacy for political support. This recommendation was also made by the Wellcome Trust (Wellcome Trust, 2022b, Priority 1).

Increasing focus on RH products within existing harmonization efforts

In addition to supporting the general efforts of existing harmonization initiatives, an interested funder might also consider specific support targeted at reproductive products. Such grants would have the benefit of tangibly addressing gaps in RH regulation, but may not align as smoothly with the day-to-day priorities of the harmonization efforts. As we discuss in the section on AMRH, we have identified one source noting the RH products are specifically prioritized in the initiative, but otherwise have encountered little discussion of RH in regional harmonization efforts.

Opportunities to increase the focus on RH products might include:

• Modifying the Model Law: Supporting AMA and AMRH to develop and advocate for RH-specific provisions in the AU Model Law. This effort may be tractable if there is work being done to update the Model Law, although we are not sure if that is the case.
• Establishing an RH-focused committee or working group to enhance focus on RH needs within the AMRH, AMA, or RECs.
• Supporting RH fast-tracking or Joint Product Assessments for RH Products in RECs: Funding the development of specific guidelines or processes for fast-tracking RH medicines, or expanding joint assessment capabilities for RH products.
• Ensuring that the AMRH and other continent-wide efforts include RH as eligible products: Continent-level initiatives do not explicitly mention RH as a key area for eligible products, although they may qualify as one of the existing categories, and, although one expert confirmed that some the regional initiatives do specifically include such products.
• Supporting applications for the inclusion of RH products into the pilot AMA assessment.

Supporting applications for WHO Prequalification, SRA, and other regulatory approval

Prequalification appears to be a useful process with clear benefits for approved medicines and other types of SRA approval, including that of the European Medicines Authority, can be used for “reliance” to reduce barriers in African markets and to smooth procurement processes for RH products. Indeed, Dong and Mirza (2015) note that WHO prequalification could be a key lever to increase pharmaceutical manufacturing, suggesting that “African countries interested in strengthening their pharmaceutical sector should encourage their pharmaceutical manufacturers to apply for WHO prequalification. National regulatory authorities also benefit from such developments.”

Our prior report (Leow et al., 2023) on prequalification explores potential ways that better resourcing could promote greater inclusion of RH products. Many of these may also apply for applications to SRAs and even to national agencies and regional joint MRH processes:

• By causing WHO-PQ to extend to more RH products or new product streams;
• By speeding up prequalification and country registration processes, for example through the use of abridged assessments; and
• By working toward expanding WHO-PQP eligibility for maternal, newborn, and child health (MNCH) products, or, in our case, RH products (suggested in AUDA-NEPAD, 2024c call to action for funders).

In addition, one potential route to increase RH product access could be by increasing the number of applications to WHO-PQ for RH products. Funders could engage with many stakeholders (e.g., researchers, healthcare professionals, governments) to identify priority products to support individual applications. An expert at USAID emphasized that manufacturers frequently choose not to pursue registration in a given country or bloc due to onerous costs or time-consuming applications, particularly if the process would not give access to a particularly lucrative market. As a result, there may be an opportunity to financially support a targeted product’s application to one or many countries or blocs.

Aligning WHO EML with National EMLs

As national EMLs are often used to guide procurement and health system management, the decision of which products are placed on an EML can have serious implications for product access. Our prior published report on EMLs includes some suggestions for improvements at the WHO level, including support for application evaluation, and addressing discrepancies between the EML and WHO treatment guidelines (Kudymowa et al., 2023). However, our impression is that the more relevant suggestions are at the national level.

Opportunities might include:

• Provide resources and technical assistance to countries for adapting the WHO EML to fit local contexts, especially for RH products.
• Facilitate greater alignment between national EMLs and the WHO EML—including advocating for closing specific gaps between the lists.
  • We were surprised to find that Persaud et al. (2019) is the most recent and complete source available to compare EMLs. It may be a promising grant opportunity to fund research to create or maintain a registry of up-to-date EMLs to facilitate policy and funder coordination.
• Support implementation capacity, including alignment with reimbursement systems, national treatment guidelines, and regulatory frameworks.
• Advocate that EML-listed RH products are integrated into UHC efforts to promote accessibility and affordability.

Supporting national-level regulation and compliance efforts

At the national level, NMRAs often face significant capacity constraints, limiting their ability to effectively implement and enforce harmonized policies. Supporting training, technology (such as digital dossier tracking systems), and infrastructure for NMRAs, specifically for RH medicines, would have immediate, practical benefits.

AUDA-NEPAD (2024c) recently issued a “Call to Action” to NMRAs, Governments and Ministries of Health (MoHs), funders and development partners, manufacturers, researchers, and civil society to work together specifically toward increasing registration of safe and effective maternal, neonatal, and child health products. It is unclear to us whether the call to action has led to any follow-up action or coordination across these various stakeholders, and there is no mention of contraception or abortion services in its call (due to legal restrictions on USAID).

The call to action for funders includes (p. 5-6, paraphrased):

• Providing technical and financial support for NMRAs, including to develop financing mechanisms and institutional goals.
• Advocating for enforcement of mutual reliance between REC or AMA member states.

As discussed in the recommendations on WHO-PQ and SRA approval, another potential opportunity could be to directly cover the costs of targeted applications in certain states where it would not otherwise be economically feasible to pursue registration.

Advancement of African medicine and reproductive health product manufacturing

Key question: What is the current status of efforts to advance African medicines/devices manufacturing and are there opportunities for the inclusion of RH products in those efforts?

Takeaways: There are significant efforts to advance African pharmaceutical manufacturing from myriad continental, regional, and external stakeholders (e.g., funders and development partners). Most such efforts focus on vaccines, with continued momentum following Covid-19. Experts had mixed views on whether manufacturing RH products in SSA should be a priority. Perhaps the most knowledgeable expert we interviewed on the topic—Purdy of DKT International—strongly suggested it should not be a priority, primarily due to economic viability, a concern supported by a recent USAID assessment of injectable and oral contraceptives.

Likewise, Luembe at RHSC suggested that the business case for manufacturing RH products in SSA is dwindling, given high regulatory burdens and the decline in donor funding which traditionally finances the procurement of quality assured family planning supplies. Furthermore, although she highlighted recent policy progress in pharmaceutical manufacturing,^[23] Luembe also noted that the absence of policy to support procurement of locally manufactured products, high cost and complexities in obtaining WHO-PQ approval, along with lack of financing mechanisms and technical support for the sector, mean that manufacturing of RH products would be a “longer journey” without targeted investments and appropriate market interventions.

Given mixed views on its value and the scale of solutions, we are not confident that there will be impactful opportunities for funders to meaningfully advance manufacturing initiatives.

Africa’s pharmaceutical manufacturing landscape remains concentrated and limited, with about 600 manufacturers across the continent as of 2020,^[24] 80% of which were based in just eight countries: Egypt, Algeria, Morocco, Tunisia, Nigeria, Ghana, Kenya, and South Africa. Among these, only four countries hosted more than 50 manufacturers, while 22 countries had no local production at all (Ussai et al., 2022, p. 1). Africa’s share of global pharmaceutical manufacturing is just 3%, with sub-Saharan Africa relying on imports for 70-80% of its medicines and Africa accounting for over 40% of counterfeit drug cases (Buckholtz, 2021). Only two African countries, Morocco and South Africa, meet over 70% of their pharmaceutical needs through local production (Wambui, 2022).

However, changes over the last decade have increased the economic viability of African pharmaceutical manufacturing, as populations have increased and countries have increasingly adopted social security and health insurance programs that increase the affordability of many (particularly longer term) treatments (Wambui, 2021).

Efforts to advance medicines and medical device manufacturing exist across the African continent, in large part centering around the goals set out in the Pharmaceutical Manufacturing Plan for Africa. Regional economic communities, as well as free-trade initiatives like the African Continental Free Trade Area (AfCFTA), could eventually create a unified trade market for health products, which could reduce costs and attract local pharmaceutical investment.

Regional industrialization efforts like the East African Community (EAC)’s Industrialisation Policy and Strategy aim to increase regional manufacturing capabilities, which could theoretically support RH products though they have not yet been a central focus. The success of regional and continent-wide market expansion efforts may also rely on the success of the regulatory harmonization efforts discussed in the prior section.

In particular, there is significant and increasing momentum to grow vaccine manufacturing in sub-Saharan Africa post-Covid. For example, the African Vaccine Manufacturing Accelerator (AVMA), backed by Gavi with up to $1B USD in funding, is a new initiative designed to support local vaccine manufacturing in Africa by facilitating global market access and by helping producers achieve WHO prequalification standards, a requirement for entering global procurement markets like UNICEF tenders. Belayneh mentioned that CHAI is an important player in the space, particularly engaging in interventions related to capacity building, supply chains, and data. For instance, the ACDC, CHAI, and PATH undertook an exercise to map vaccine manufacturing in Africa in 2023-2024 and identify priority actions (All Africa, 2024). We introduce several additional vaccine manufacturing initiatives below.

Belayneh mentioned that efforts are underway following the Covid-19 pandemic to establish two manufacturing hubs—one in South Africa and one in Senegal—that will be mostly focused on vaccines, though she suggested there may be opportunity for the inclusion of reproductive health products. These hubs are intended to supply regional markets, not solely national markets. In East Africa, she mentioned that a global collaboration led by BioNTech had resulted in a mRNA vaccine manufacturing facility opening in Kigali, Rwanda in 2022, which is expected to produce vaccines for (potentially among others) Covid-19, malaria, and tuberculosis. She mentioned that Rwanda is making concerted efforts toward creating an enabling environment for pharmaceutical manufacturing “by investing in infrastructure, regulatory frameworks, and research.” She suggested that many funders behind the various pharmaceutical manufacturing efforts—with African CDC leading the charge—are also reproductive health funders.

Multiple experts indicated that the amount of funding required to make a difference in this space is quite vast, and Purdy’s view is that introducing manufacturing capacity for RH products is not a good idea given the inevitable inability to compete with (primarily South/Southeast Asian) manufacturers.^[25] Purdy’s assertion is consistent with the findings of recent economic assessments spearheaded by USAID’s Global Health Supply Chain Program, which presented a meager outlook for the manufacture of oral contraceptives and injectables on the continent.

Experts suggested that a business plan and local demand assessment should inform any local manufacturing plan. Experts disagreed over whether long-acting methods—which, though valuable, are difficult to produce and expensive to demonstrate safety, efficacy, bioequivalence, and the like—might be cost-effective to manufacture in Africa. Moreover, Luembe noted that quality assurance and ineligibility for WHO Prequalification, along with lack of financing mechanisms and technical support for the sector, mean that manufacturing RH products would be a “longer journey” than manufacturing maternal and menstrual health products.

Ultimately, we would not strongly recommend that funders prioritize RH product manufacturing in sub-Saharan Africa, unless a clear and justifiable opportunity arises.

Case study: Economic prospects for MPA-IM in sub-Saharan Africa (USAID)

The USAID Global Health Supply Chain Program-Procurement and Supply Management (GHSC-PSM) is a key initiative addressing reproductive health manufacturing, with a recently commissioned report^[26] focusing on MPA-IM (“intramuscular medroxyprogesterone acetate”), a widely used contraceptive in SSA (USAID, 2024, p. 4). An initial modeling exercise on oral and injectable contraceptive production in SSA^[27] suggested little to no promise for the manufacture of oral contraceptives and DMPA-SC. However, it was indicative of positive (albeit limited) returns for MPA-IM manufacturing.

Further investigation of the prospects for the manufacture of MPA-IM cited potentially significant barriers, including:

• Market uncertainty: MPA-IM demand may decline due to donor-supported MPA-SC initiatives, Pfizer’s commitment to supply MPA-SC at $0.85 through 2030 (Pfizer, 2023), and Gates Foundation support for MPA-SC capacity and generics (Gates Foundation, 2021). Additionally, low prices—such as UNFPA’s 2022 price of $0.76 per vial and Ethiopia’s procurement at $0.61 per vial—further limit revenue. Substandard private-sector products may also capture market share, exacerbated by limited national quality control capacity.
• WHO prequalification: Donor procurement and some SSA countries require WHO Prequalification (PQ) or other Stringent Regulatory Authority (SRA) approval, as discussed in the section on PQ.^[28] Manufacturers face significant delays: PQ can take 4–9 years due to requirements such as prior registration in the manufacturing country. Moreover, the complexity of hormonal manufacturing combined with skill shortages and high employee turnover present additional challenges to prequalification of MPA-IM in particular. Manufacturers interviewed by USAID indicated that technology transfer would be essential to enable MPA-IM production in SSA.
• Access to capital and foreign currency: USAID estimates a modeled facility for MPA-IM manufacturing would cost $14M, a level of investment too big for most social impact investors or philanthropic funds, which would need around $65-100M to make such an investment realistic. In addition, expected returns (below 10%) fall short of the 12% over 5–8 years typically sought by impact investors. National development banks could co-invest but require additional backing. Moreover, construction materials, equipment, and inputs require USD or similarly stable foreign currencies, limiting export ambitions and increasing delays and costs when foreign currency is unavailable.

USAID provides a list of priority actions to overcome these primary barriers, which they summarize in a table reproduced as Table 1 below.
Table 1: USAID priority actions to address keys barriers to MPA-IM manufacturings in SSA

Note. This table is a reproduction of Table 1 (p. 10) and Table 2 (p. 16) of USAID (2024). Dark green shading indicates USAID’s classification as “priority 1” while light green shading indicates “priority 2” and no shading indicates “priority 3.”

The authors of the USAID report additionally include a timeline for overcoming these barriers based on their priority levels, though they ultimately suggest that “it’s possible that the time for an MPA-IM facility [in SSA] has passed” due to lack of both funding support and supply constraints, as Purdy claimed.^[29] The report concludes that “sustainable manufacture of MPA-IM will [likely] only be possible if it can either be part of a larger hormonal or highly active pharmaceutical ingredient portfolio or it can serve markets on other continents where prices are higher” (p. 17).

One unnamed expert spoke to us with knowledge of USAID’s involvement in late-stage R&D for family planning products. The expert said that there is a local manufacturing component of USAID’s MATRIX project, a 20-organization partnership focused on early-stage product R&D for prevention of HIV in women in Africa.^[30] According to the expert, USAID’s Research, Technology, and Utilization Division supports manufacturers with prequalification to facilitate USAID’s procurement (which requires SRA approval); for instance, they supported Pregna with WHO-PQ for its postpartum IUD inserter through technical assistance (e.g., providing in-house expertise and funding FHI 360 to assemble the dossier).

Organizations and efforts

Below we highlight several organizations and initiatives focused on the expansion of manufacturing on the African continent. We prioritized inclusion of those that experts mentioned (i.e., PMPA and AfCFTA) and those spearheaded regionally (e.g., EAC’s Industrialisation Policy).

Pharmaceutical Manufacturing Plan for Africa (PMPA)

The Pharmaceutical Manufacturing Plan for Africa (PMPA) is an initiative spearheaded by Ngozwana et al. (2012) aimed at building Africa’s capacity to manufacture pharmaceuticals and reduce its reliance on imported medicines. This initiative started in 2007 by AUDA-NEPAD, but the current version was originally proposed in a business plan^[31] (Ngozwana et al., 2012) in 2012 (Adebisi et al., 2022; Folorunsho-Francis, 2020). It has been frequently cited in African health policy discussions, particularly regarding self-sufficiency and resilience in health systems (Mynhardt and Ndembi, 2023; Adebisi et al., 2022) and laid the foundation for the AMRH.

PMPA’s approach involves multi-stakeholder efforts to establish regional manufacturing hubs and encourage the local production of active pharmaceutical ingredients (APIs),^[32] with the goal of creating a sustainable pharmaceutical ecosystem (Awuor and Amponsah, 2023). The initiative identified pooled procurement as a means to incentivize leading generic pharmaceutical manufacturers to engage in local manufacturing, either through building of local plants or partnering with local manufacturers. AUDA-NEPAD suggests that the initiative will create avenues for significant foreign direct investment, boost human capital investments and create new jobs, accelerate technology transfer agreements, and strengthen regulatory systems.

To move forward, PMPA may require targeted external funding and support to establish regional manufacturing hubs, enhance regulatory frameworks, and develop infrastructure to support sustainable pharmaceutical production across Africa (Abbott et al., 2021; Makenga et al., 2019).

Strengths:

• Framework for African self-sufficiency: PMPA establishes a long-term goal of reducing dependence on imported medicines.
• Risk reduction: PMPA’s focus on local production could enhance access to essential medicines and vaccines during public health crises.

Weaknesses:

• Insufficient political and financial commitment: Lack of coordinated support across African nations hinders PMPA’s implementation.
• Market challenges: Fragmented regulatory frameworks and limited facilities impede the production of high-quality medicines.

Opportunities:

• Capacity building for GMP compliance: Fund training programs to improve manufacturing quality and compliance with good manufacturing practices (GMP).

African Continental Free Trade Area (AfCFTA)

Currently, demand for packaged medicines is approximately $18B annually, which is satisfied by imports (61%), locally produced products (36%), and intra-African trade (3%) (Munyati & Signé, 2023). The AfCFTA is an ambitious trade agreement that aims to reduce trade frictions on the African continent—including for medicines and devices—creating opportunities for improved economies of scale through higher production volumes, increasing the competitiveness of local manufacturers with Asian manufacturers, and ultimately reducing reliance on imports (Kamara et al., 2024). In effect, the AfCFTA has transformed a patchwork of fragmented domestic markets into a wider market of 1.3 billion people (and an intended 2.2 billion by mid-century; Byaruhanga, 2020), with 54 (out of a possible 55) AU member state signatories as of January 2024. World Economic Forum (2023) suggests that the AfCFTA can support scaling of regional regulatory harmonization efforts by acting as the primary liaison between the AMA and local manufacturers, while supporting the alignment of standards and regulations in countries not covered by the AMA (p. 15).

As a result of AfCFTA-facilitated improvements in the competitive environment for local manufacturing, one of the largest global pharmaceutical manufacturing companies (Novartis^[33]) has committed to a 5x-increase in patient reach in SSA. The company cited the AfCFTA’s ability to improve sustainable and resilient health systems through incentivizing partnerships among public and private actors, to facilitate intellectual property laws that support innovation, to support transparent and robust regulatory harmonization, and to build an enabling environment to attract regional investment (Munyati & Signé, 2023).

Melaka Desta of the UN Economic Commission for Africa (ECA) has argued that the AfCFTA provides an opportunity to build regional and specialized value chains, from extracting and processing raw materials through to assembling final products, with massive job creation potential. Modeling by the UN ECA suggests that “full implementation of the AfCFTA by all AU member states could boost intra-African trade by over a third ($196 billion) by 2045 compared with a situation without AfCFTA” (Desta, 2023). Regional value chains could additionally contribute to intra-African technology transfer and knowledge sharing, leading to greater innovation and technological capabilities continent-wide. Finally, the CEO of a pan-African investment bank (Frannie Léautier of SouthBridge Investments) noted that improving the medical products that are available to doctors and nurses can lead to greater talent retention and increase healthcare seeking behaviors, thereby contributing more broadly to stronger local health systems (World Economic Forum, 2023, p. 15).

Strengths:

• Unified market creation: By creating a unified market, AfCFTA encourages investments in local production and can make locally manufactured medicines more cost- competitive across the continent (Sidibé et al., 2014).
• Market expansion: Lowering trade barriers allows efficient distribution of medicines and devices, creating potential for market expansion (Kamara et al., 2024).
• Multi-stakeholder engagement: Bringing together multiple actors can lead to knowledge sharing, technology transfer, and regional innovation and growth.

Weaknesses:

• Slow realization of benefits: Due to varying regulatory systems and readiness levels, AfCFTA’s trade benefits will take time to be realized across the continent (Kamara et al., 2024).
• Dependent on successful coordination: Success of AfCFTA to promote manufacturing growth depends on closely coordinating with AMA and AMRH to ensure that regulatory standards match the benefits of free trade (Sidibé et al., 2023).

Opportunities:

• A report published in October 2024 by the Overseas Development Institute (Abudu & Ayela, 2024) in collaboration with the Nelson Mandela School of Public Governance at the University of Cape Town contains a number of concrete policy recommendations (p. 33-36). A conversation with either organization may identify promising funding opportunities.

Regional industrialization policies

The East African Community (EAC)’s Industrialisation Policy and Industrialisation Strategy aim to transform the manufacturing sector across the eight EAC member states (DRC, Burundi, Kenya, Rwanda, South Sudan, Tanzania, and Uganda) between 2012 and 2032 (EAC, 2012).

The Policy and Strategy both focus on leveraging the comparative advantages of each member state to foster a collaborative, rather than competitive, industrial base. They provide a foundation for advancing pharmaceutical and medical device production within East Africa, with pharmaceuticals included as a key strategic industry (EAC, 2012, p. 6) and the industry scoring well in a strategic assessment of attractiveness and feasibility (EAC, 2012, p. 35). The Industrial Policy makes specific mention of investment opportunities related to family planning.^[34]

The Industrialisation Policy (EAC, 2012) targets sector and value chain development (prioritizing strategic industries); institutional and business environment strengthening; infrastructure, skills, and information systems; and inclusive and sustainable growth (p. v).

The East African Development Bank (EADB, 2021a) has noted that the contribution of industry to GDP in all but one EAC country (Tanzania) declined in the five years following the establishment of the Industrial Policy. The EADB is committed to improving the quality and cost of manufacturing in EAC countries, including through regional integration (EADB, 2021a) and skills development (EABD, 2021b) (such as providing scholarships to teachers and lecturers in STEM to improve regional human capital and innovation), though it urges leadership by the public sector across the region. For instance, the EADB highlights Rwanda’s announcement of a “US$24m programme (financed by the World Bank) to train 9,000 youth in the manufacturing, energy, transport and logistics industries that operate under the Made in Rwanda campaign,” which is “part of a wider 7-year Government programme that hopes to build a competitive workforce and create 1.5 million jobs (in a population of just 12.2 million currently)” (EADB, 2019).

Strengths:

• Focus on capacity building: Prioritizes skills/workforce development.
• Incentivizes investment: Promotes favorable business conditions, industrial parks, and streamlined trade procedures.

Weaknesses:

• Limited RH product focus: While the policy promotes pharmaceutical manufacturing broadly, there is no specific emphasis on RH.

Opportunities:

• Support cross-border trade platforms and digital health tools: Improve digital infrastructure to streamline cross-border trade and tracking of RH products.
• Build capacity for RH manufacturing: Guided by EAC-IP successes, provide technical assistance for workforce development focused specifically on RH products.
• Advocate for RH product inclusion: Identify leveraged opportunities in EADB’s and/or the World Bank’s human capital development and regional integration initiatives—and in IFC’s manufacturing support, e.g., through its funding of Aspen—to include the manufacture of reproductive health supplies.

Some additional pharmaceutical (primarily vaccine) manufacturing initiatives

We have identified many other organizations and efforts with potential relevance to manufacturing that we did not have time to fully investigate. We highlight a few such efforts below.

African Vaccine Manufacturing Initiative (AVMI): AVMI is a program intended to develop Africa’s vaccine production capacity, with the ultimate goal of producing 60% of the continent’s own vaccine needs by 2040, up from 1% in 2021 (Thompson et al., 2023; Ekström et al., 2021). The AVMI was launched at the 2010 International Vaccine Technology Workshop by a group of African stakeholders with a shared vision of enabling Africa to produce its own vaccines and biological products for both routine use and emergency response (AVMI, 2017). AVMI seeks to coordinate efforts among vaccine manufacturers, governments, regional bodies, NGOs, private sector entities, academic institutions, and key opinion leaders to foster an environment conducive to the development and sustainability of high-quality vaccine manufacturing on the continent (AVMI, 2017).

Partnerships for African Vaccine Manufacturing (PAVM): PAVM is an initiative of the African Union and the Africa CDC with a Framework for Action (Africa CDC, 2023a) that “sets forth the key diagnostic findings on the current vaccine manufacturing environment in Africa and recommends eight bold programs to unlock Africa’s potential to grow and scale vaccine development and manufacturing over the next two decades.”

African Vaccine Manufacturing Accelerator (AVMA): AVMA is a new Gavi initiative to incentivize vaccine manufacturers in Africa through distribution of up to $1B in funding over the next decade (Garriga and Keaten, 2024; Africa CDC, 2023b). Key goals include helping local manufacturers meet WHO prequalification standards and facilitating their access to global procurement markets, such as UNICEF tenders.

African Health Diagnostics Platform (AHDP): The African Health Diagnostics Platform (AHDP) is a collaborative initiative supported by the European Investment Bank (EIB, 2020) and the Gates Foundation (2019). It launched in late 2020 with plans to spend about €150M (Prosper Africa, p. 55), though the timeframe for this spending is unclear. AHDP focuses on improving access to quality laboratory and diagnostic services for low-income populations in sub-Saharan Africa (EIB, 2020). The platform targets both private and public sectors, depending on the country of implementation, to strengthen healthcare infrastructure and ensure better clinical decision-making and treatment outcomes (EIB, 2020). AHDP’s primary focus is establishing a robust diagnostic infrastructure for diseases, which is not necessarily relevant to all aspects of reproductive health. However, the platform’s focus on access to a higher quality of care might help to foster an environment which favors the local manufacturing of high-quality medical products more broadly.

United States Pharmacopeia: USP works to “strengthen regional and local manufacturing capacity of medicines, vaccines, personal protective equipment, medical devices, and other health products” to achieve equitable global access to pharmaceuticals (USP, 2023). It published a recent study assessing the needs of manufacturers in SSA for misoprostol^[35] (among other maternal health products outside the scope of this research). The research found that there is one manufacturer of misoprostol on the continent (in Nigeria, with APIs sourced from China; Stephens et al., 2024, p. 23), with three additional manufacturers of non-RH products—all in Nigeria—planning to begin manufacturing the product (Stephens et al., 2024, p. 34).

Funding sources

Below is a non-exhaustive list of funding sources we identified for manufacturing of pharmaceuticals—again, primarily vaccines—in Africa.

Team Europe Initiative on Manufacturing and Access to Vaccines, Medicines, and Health Technologies (MAV+)

MAV+ is a collaborative effort launched by the EU in 2021 to bolster Africa’s capacity to produce essential health products. Announced by European Commission President Ursula von der Leyen at the G20 Global Health Summit, the initiative aims to create an enabling environment for local vaccine manufacturing in Africa, tackling barriers on both the supply and demand sides (European Commission, 2021a). With an initial €1B from the EU and institutions like the EIB, MAV+ has mobilized additional contributions from EU member states, for a total of nearly $2B as of October 2024 (Global Gateway, 2024). Partners include the African Union, Africa CDC, AUDA-NEPAD, AMA, WHO, and the Bill & Melinda Gates Foundation, all working to enhance regulatory capacity, facilitate technology transfer, and develop regional manufacturing.

MAV+ uses a “360-degree approach” to enhance Africa’s health manufacturing and access (European Commision, 2024). This strategy covers supply side (de-risking investments), demand side (strengthening regulatory frameworks to consolidate demand, encourage market integration, and build confidence in locally produced goods), and system strengthening (human resources and skill building, support for research capacity and scientific cooperation, addressing substandard and falsified drugs) (European Commission, 2021a). Since the program’s launch in 2021, MAV+ has begun several projects to boost local manufacturing, including in Senegal (building a vaccine manufacturing plant; European Commission, 2021b), Rwanda (ongoing support for the NMRA; Global Gateway, 2024; plus a €40M agreement to support a BioNTech manufacturing site in Kigali; European Commission, 2023a), and South Africa (European Commission, 2023b).

International Finance Corporation (IFC, World Bank Group)

The IFC—a member of the World Bank Group—is the “largest global development institution focused on the private sector in emerging markets,” and it has taken a keen interest in pharmaceutical manufacturing in emerging markets since the Covid-19 pandemic. It is focused on creating a mature and lucrative pharmaceutical industry for both APIs and assembled products by co-creating projects and financing structures with local and international pharmaceutical companies and working with governments on regulatory reforms (Buckholtz, 2021).

IFC invested over $14B in Africa last year—$8.5B of its own (50% supporting “projects with a gender lens”), and $5.7 billion that it mobilized from other investors—which is up 23% from the previous year and represents the most it has ever invested in the continent (IFC, 2024a). A quick search identified recently announced IFC (and others^[36]) support for Aspen, a South Africa-based manufacturer. The €500M loan supports Aspen’s “Manufacturing in Africa for Africa” strategy, which sets out to increase the manufacture and distribution of “critical medicines on the continent, including insulins and pediatric vaccines” through partnerships with multinational pharmaceutical companies (IFC, 2024b). The announcement does not contain any mention of reproductive health supplies.

Multi-actor efforts toward new and improved products

Key question: What multi-actor efforts (similar to FCDO’s catalytic opportunity fund) currently exist to support the introduction of new or improved products (e.g., the hormonal IUD)?

Takeaways: The global effort to support RH and maternal health (MH) product development and introduction is ambitious but uneven, driven largely by development agencies and multilaterals rather than by local national governments. Broader innovation programs, while not RH-specific, could play a more significant role in driving innovation in this field.

The Catalytic Opportunity Funds (COFs) launched by the UK’s FCDO, deploy rapid funding to support targeted health challenges, including hormonal IUDs, DMPA-SC, medical abortion combipacks, and postpartum hemorrhage medicines. The Hormonal IUD Access Group exemplifies this approach, harmonizing efforts like provider training, demand creation, and procurement in countries such as Kenya, Malawi, and Ethiopia. Gray and two unnamed experts all underscored this access group’s significance, with the latter specifically highlighting the Access Group’s value in coordinating operations across multiple countries. The COF has also supported similar working groups for the DMPA-SC, medical abortion combipack, and postpartum hemorrhage medicine funding streams, which were themselves highlighted by experts as important actors in the field.

MSD for Mothers takes a comprehensive approach to maternal health, emphasizing systemic interventions like provider accreditation, supply-side management, and community-driven solutions. Experts highlighted programs such as Nigeria’s LifeBank initiative, which focuses on improving access to postpartum hemorrhage medicines,. However, the program’s narrow scope—prioritizing MH over broader RH challenges—limits its applicability to the priorities of this report.

FP2030, the successor to FP2020, emphasizes sustainable financing, evidence-based practices, and community-led approaches. Projects like REFED in Togo and Sikika in Tanzania integrate family planning into governance and advocacy. Yet FP2030 appears less impactful in contraceptive innovation than FP2020, which spearheaded transformative market-shaping efforts like the Implant Access Program.

The DISC Program, funded by CIFF and implemented by Population Services International (PSI), supports self-care solutions like self-administered contraceptives. One expert praised its innovative demand-generation strategies and stressed the need for self-care solutions to be scalable and integrated into the broader health care system.

The UNFPA, through its Supplies and Transformative Action workstreams, plays a key role in improving supply chains, policy, and access to new contraceptives. Belayneh noted its partnerships with national supply chains as a critical strength. USAID, meanwhile, combines global coordination with country-level support through initiatives like Innovate FP and the CTI Initiative. One expert described USAID’s “air traffic control” function as essential for ensuring streamlined procurement and distribution but flagged legislative restrictions as a limitation.

Experts highlighted ongoing needs for high-quality research. Gülmezoglu and another expert agreed that innovative methods that meet user needs are important, but noted high costs (~$10M) for Phase III trials can be a barrier due to lack of funding. Gülmezoglu emphasized that current efforts often prioritize feasibility and cost-effectiveness rather than starting with questions about what women want, which diverges from the approach used in other medical fields, such as disease treatment. In addition, efforts to innovate in contraceptives, such as mifepristone as a weekly method, face significant regulatory hurdles, partially due to lack of high-quality clinical trial data.

Beyond RH-specific initiatives, several global innovation platforms offer indirect but potentially transformative support for RH efforts. Grand Challenges, originally launched by the Gates Foundation, fosters innovation across global health and development issues, including maternal and child health. Its Africa-based counterpart, the Science for Africa Foundation, emphasizes local capacity-building and clinical research infrastructure. While not RH-specific, its focus on empowering African scientists and supporting health innovation could be leveraged for RH product development. The Global Innovation Fund (GIF) takes a sector-agnostic approach to funding social impact innovations. While RH has not been a focus, its flexible financing models and gender lens suggest it could support impactful RH projects, particularly if they align with measurable social outcomes. Other programs like Wellcome Leap and the Johnson & Johnson Africa Innovation Challenge similarly target high-risk, high-reward innovations, emphasizing capacity-building and scalable solutions. Although these initiatives currently prioritize broader health challenges, their structures could accommodate RH-specific innovations with targeted engagement.

Several experts highlighted systemic issues related to new product development, introduction and scale-up, many of which transcend individual initiatives. Belayneh raised concerns about the recent emphasis on long-acting methods in many programs given their high costs and complexity, noting that these challenges could pose significant financial burdens for ministries of health facing budget gaps. Several interviewees emphasized the need for regional coordination, noting that fragmented, country-by-country approaches lead to inefficiencies in the product introduction space just as much as in regulation.

Organizations and efforts

FCDO’s Catalytic Opportunity Funds, including access groups

A Catalytic Opportunity Fund (COF) is a “rapid funding mechanism” developed by the UK’s Foreign, Commonwealth & Development Office (FCDO) which aims to efficiently use donor funds and existing resources to foster innovative solutions to health and development challenges (FCDO, 2020, p. 23). COFs use existing product specific global processes and structures to approve funding applications, in collaboration with existing nonprofit, international, and industry groups (FCDO, 2020, p. 23). Each COF funding stream focuses on a specific challenge. We are aware of four active funding streams: DMPA-SC, hormonal IUD, medical abortion combipack,^[37] and lesser-used postpartum hemorrhage medicines.

The COF we have seen the most reference to is dedicated to the introduction and scale-up of hormonal IUDs (Cain, 2024) in LMICs. This COF is partially funded by the Gates Foundation and CIFF in addition to FCDO, and is managed by CHAI (Cain, 2024; FCDO, 2020, p. 23). This Hormonal IUD Access Group is ongoing, with COF Cycle 8 applications due in January 2025 (COF). Gray and two experts all mentioned this access group as a key player. An expert from USAID noted that the group operates as a “harmonization structure” through multiple missions (including Kenya, Malawi, and Ethiopia). They described its operations as including provider training and procurement, putting together pamphlets and provider materials, coordinating pricing negotiations, as well as following a demand creation approach.

Separately, DMPA-SC Access Collaborative, a global partnership led by PATH, includes several key components to support the introduction and scale-up of DMPA-SC, a self-injectable contraceptive. Among these is the Learning and Action Network (LAN), which facilitates peer learning and country-to-country exchange (PATH, 2023a; PATH, 2023b, p. 4). One expert described the LAN as an important vehicle for sharing best practices and building institutional capacity across settings. Separately, the DMPA-SC Catalytic Opportunity Fund (COF), administered by CHAI, provides rapid, application-based funding to support introduction and scale-up activities in selected countries (COF). This includes provider training, supportive supervision, demand generation, and supply chain strengthening (CHAI, 2021, p. 5). According to one expert, the COF plays a key role in managing supply-side dynamics and supporting access to self-injectables like DMPA-SC, with the long-term goal of expanding to other products.

Finally, the New and Lesser-Used Postpartum Hemorrhage Medicines (NLUM-PPH) COF awards grants to research organizations to support activities like training healthcare workers and implementing facility-based interventions. It is managed by RHSC and CHAI and funded by MSD for Mothers and FCDO.

Strengths:

• The COF program is a catalytic, flexible funding model
• It has incubated several successful working groups.
• Collaborative approach: administration by external partners allows the program to benefit from sector-specific expertise.

A brief search did not identify any weaknesses of the COF program, although this does not indicate that gaps do not exist.

Opportunities:

• Get involved in the various working groups and provide top-up funding, particularly to the nascent ones such as the Combipack group.
• Establish a dedicated funding stream for a targeted product.
• Support pilot projects to test the feasibility of scaling lesser-known RH innovations, such as biodegradable implants or extended-duration injectables.
• Provide grants for capacity-building initiatives to empower local stakeholders to take ownership of COF outcomes.

Merck for Mothers (rebranded to MSD for Mothers)

MSD for Mothers is a global initiative launched by the Merck Group (known as MSD outside the US and Canada) to improve maternal health and reduce maternal mortality worldwide. Established in 2011 with a $500M commitment over 10 years ($650M as of 2024), the program (MSD for Mothers, 2024) supports the development of innovative solutions, partnerships, and community-driven approaches to make childbirth safer for mothers (Merck, 2013).

The initiative addresses various maternal health issues, including access to essential maternal medicines, quality of care, and strengthening health systems to improve maternal health outcomes (Global Health Progress, 2011). MSD for Mothers also engages in initiatives that indirectly support regulatory and health system improvements, such as helping to establish standards for RH product quality, accreditation, and provider training (MSD for Mothers, 2023, p. 5; Merck, 2023).

Programs are quite diverse, and focus on maternal health rather than family planning and other reproductive health services. The Strengthening Systems for Safer Childbirth initiative supports local coalitions in countries like India, Nigeria, and Kenya to address maternal health challenges through “community-driven solutions” (MSD for Mothers, 2022). In some programs, MSD’s work includes both provider accreditation and developing and deploying private sector innovations (Merck, 2023, p. 2). MSD supports LifeBank’s SmartAccess initiative, which aims to scale access to new and lesser-used medicines used for prevention and treatment of postpartum hemorrhage in key regions of Nigeria (Merck, 2023, p. 4)

Strengths:

• Comprehensive Maternal Health Focus: MSD for Mothers addresses maternal health holistically, from increasing product access to strengthening health systems.

Weaknesses:

• Narrow Scope: The program is primarily focused on maternal health, which may limit its engagement with broader RH work.

Opportunities:

• Support companion projects for RH access: expand access to contraceptives alongside MSD’s MH interventions.
• Provide grants to local organizations to take ownership of community-driven solutions, ensuring long-term impact beyond corporate funding cycles.

FP2030

FP2030 is a global partnership aimed at advancing access to family planning in support of Sustainable Development Goal 3.7. Building on the foundation of Family Planning 2020 (FP2020, which ran 2012-2020), FP2030 unites governments, donors, nongovernmental organizations (NGOs), and private-sector actors to expand contraceptive access and reproductive health services globally (FP2030). The partnership operates through five regional hubs, including the East & Southern Africa (ESA) Hub (25 countries, hosted by Population Council, 2022) and the North, West, and Central Africa (NWCA) Hub (30 countries, hosted by AMREF).

FP2030 has supported a number of relevant projects to facilitate access to family planning products in African markets (FP2030, 2024). One recent grantee partner, REFED, is a women-led organization that integrates family planning into local governance by educating mayors in Togo’s underserved Savanes region, updating Communal Development Plans, and empowering civil society organizations for advocacy. Another, Sikika, promotes family planning in Tanzania by analyzing budgets, engaging communities, and mobilizing resources.

The partnership’s predecessor, FP2020, laid the foundations for the Implant Access Program (Cutherell et al., 2023), which cut prices in half and almost tripled the quantity of implants available globally. Experts speculated that the Implant Access Program may have ended and has now been replaced with the Implants Group, but recommended reaching out to Jhpiego, which may have more current information. We haven’t been able to find any public information about this group.

The initiative operates with a number of priorities, including the below three priorities which are particularly relevant to this report (FP2030):

• Promote increased, diversified, and efficient use of sexual and reproductive health financing to ensure sustainability: Increase sustainable funding for family planning by engaging governments, private sector actors, and high-net-worth individuals to alleviate the financial burden women often face.
• Support scale-up of evidence-based practices to accelerate impact: Scale evidence-based practices proven to expand voluntary, rights-based family planning, including High Impact Practices, to maximize contraceptive use across diverse settings.
• Resource local actors to solve local issues: Strengthen local solutions by funding and supporting women- and youth-led organizations, fostering community-driven approaches to reproductive health needs.

Strengths:

• Global coordination with regional focus: Effectively unites diverse stakeholders, including governments, donors, NGOs, and private-sector actors, to align on family planning goals at the regional level.
• Support for local actors: Prioritizes empowering women- and youth-led organizations, enabling community-driven solutions to family planning challenges.
• Legacy of impactful programs: Builds on the success of FP2020, including transformative initiatives like the Implant Access Program.

Weaknesses:

• Unclear transition of key programs: The replacement for FP2020’s Implant Access Program, the Implants Group, lacks visibility and clear leadership, creating uncertainty about its scope and impact.

Opportunities:

• Fund the Implants Group to become a true successor to the Implant Access Program, perhaps focusing on high-impact contraceptives like implants and hormonal IUDs.

United Nations Population Fund (UNFPA)

The UNFPA plays a pivotal role in enhancing reproductive health product manufacturing and access in Africa, with a particular focus on introducing new products. Belayneh cited the Fund as a key partner in making RH products available in the public sector, and strengthening supply chains at national and potentially regional levels. She suggested that interested readers look further into the UNFPA’s (2021a) online documentation. Central to the UNFPA’s (2021b) efforts is the Supplies Partnership, which includes two relevant workstreams:

1. Supplies: Funds the distribution of a range of donated contraceptives and maternal health medicines, with an emphasis on new and lesser-used products (UNFPA, 2021a, p. 6).
2. Transformative Action: Focuses on strengthening supply chains,^[38] improving policies, diversifying financing, and expanding access to new and lesser-used contraceptive methods (UNFPA, 2021a, p. 6).

UNFPA secures funding and forms partnerships to advance RH product access. In late 2023, the program announced long-term funding commitments from the Gates Foundation (up to $100M), CIFF (up to $100M, including $50M toward commodity financing), the German government ($50M), the United Kingdom, and the Netherlands (UNFPA, 2023)

Strengths:

• Critical supply chain role: Plays a key role in distributing products and strengthening national and regional supply chains for RH products.
• Focus on new and underutilized products: Addresses gaps in the contraceptive method mix.
• Regional and global reach: Operates at both national and regional levels, facilitating cross-border coordination and sharing of best practices.

In our brief review of the UNFPA, we did not come across any obvious gaps or weaknesses to highlight, nor any circumstances that particularly highlighted opportunities for grantmaking.

USAID programs to develop new family planning methods

USAID plays a central role in advancing family planning (FP) innovation, manufacturing, and new product introduction, focusing on both global-level coordination and country-specific implementation. According to one expert, approximately $500M of USAID’s annual $600M FP budget is allocated to country missions for commodity procurement and service delivery, while its headquarters-level work emphasizes global coordination with $100M annually. As this expert noted, the global coordination work includes managing supply chain mechanisms, registering new products, and preparing commodities for global distribution. Such an “air traffic control” function at HQ enables streamlined procurement of contraceptives, hopefully leading to wider availability. An expert also mentioned that USAID faces legislative restrictions, such as prohibitions on funding abortion-related services outside of post-abortion care, which vary based on US executive policies.

We have found two flagship initiatives which emphasize contraceptive innovation. Envision FP (2015-2022) focused on addressing gaps in the contraceptive method mix, improving safety and acceptability of existing products, and resolving product-related challenges from the field (FHI360, 2022). Building on this foundation, Innovate FP (2020-2025) focuses on refining current contraceptive options, addressing barriers to product uptake, and developing innovative methods to address unmet needs, such as long-acting, self-administered, or non-hormonal options (FHI360, 2021).

Strengths:

• Dual-level focus combines global coordination with country-specific implementation, ensuring both strategic oversight and locally relevant interventions.
• Innovation-driven initiatives are targeted to address gaps in the existing contraceptive method mix, including flagship programs like Innovate FP.

Weaknesses:

• Legal restrictions such as prohibitions on funding abortion-related services outside of post-abortion care, which vary based on the US administration.
• Dependency on country missions, which likely ensures local relevance while potentially fragmenting efforts to develop and scale new contraceptive methods.

Opportunities:

• Collaborate with country missions on specific or pilot projects, such as integrated service delivery models that pair new contraceptive methods with comprehensive reproductive health services.

Contraceptive Technology Innovation (CTI) Initiative

The CTI Initiative (FHI360, 2016), led by FHI360 and funded by USAID and the Gates Foundation, focuses on global partnerships to develop and introduce “new and strategically important contraceptives” to address unmet family planning needs. The initiative is now in Phase 2 of implementation, which focuses on R&D for six contraceptive approaches: a microneedle patch; two biodegradable implant systems; a 6-month DMPA self-injectable (LLMI); an extended duration DMPA self-injectable; and an alternative copper intrauterine device (FHI360, 2016).

The CTI Exchange (Contraceptive) is a knowledge-sharing platform under the initiative, designed to foster collaboration and disseminate resources on contraceptive technology innovation. It provides a centralized library of reports, case studies, and guidance documents, while offering opportunities for professionals to network and share insights. Importantly, the Exchange includes a repository of contraceptive R&D funding opportunities (Contraceptive, 2021) which could be highly relevant for interested funders.

Strengths:

• Focus on strategic innovation.

Weaknesses:

• Reach: While the CTI Exchange is robust, it might not reach all relevant stakeholders, particularly in low-resource settings.

Opportunities:

• Fund efforts to expand the reach of the CTI Exchange, such as creating localized, non-digital resources or organizing regional workshops to share findings with stakeholders in underserved areas.
• Provide grants for behavioral research to understand cultural, social, and systemic factors influencing the adoption of new contraceptives. Use these findings to tailor demand-generation strategies, and to ensure new methods align with user preferences and needs (recommended by Guzemoglu and one other expert).

Research on mifepristone as a contraceptive

Several experts mentioned an ongoing but promising trial to study weekly use of mifepristone (ISRCTN, 2024). One expert noted that weekly, monthly, and on-demand pills face particularly difficult challenges in getting regulatory approval, partially due to the lack of large-scale safety and efficacy data. They indicated that women and country governments have shown interest in pursuing such contraceptive methods, but that safety and efficacy data is still scarce.

Expanding the pipeline of RH drugs, including abortion-related compounds, could also benefit from comprehensive analysis across chemical fields to identify promising candidates. Despite the strong evidence base generated 20 years ago, this area has been neglected due to stigma. Trials in Brazil and the US were prematurely halted due to funding shortages, and Gülmezoglu asserted that some notable funders are hesitant to support this area due to concerns about association with abortion products. On the other hand, Purdy pointed out that making new contraceptive methods available could potentially reduce barriers to access. Gülmezoglu suggested partnerships with research organizations to support compound exploration and scientific research on mifepristone.

Opportunities:

• Provide targeted supplemental funding to support clinical trials: this support would help address the critical data gap and pave the way for regulatory approval, but would likely require a significant amount of funding

Other work to introduce new hormonal products

Purdy highlighted several ongoing efforts to introduce new hormonal products, noting an increasing focus on generic hormonal IUDs like AVIBELA and LILETTA, including by PATH. In addition, he mentioned that the generic DMPA-SC is being introduced in multiple markets, but Purdy flagged concerns about the impact of abundant low-priced supply, noting that such availability can crowd out private sector involvement, similar to issues faced during the Implant Access Initiative, which undermined private sector engagement by guaranteeing bulk product purchases for donation. While DMPA-SC is intended to replace DMPA-IM due to its potential for self-injection, Purdy observed that self-injection has not yet scaled significantly.

Additional organizations and initiatives

We did not have time to thoroughly investigate every organization and initiative we identified in this space. Below, we list some additional organizations which seem potentially promising or relevant for the subject of this report, with brief descriptions of our understanding of their work.

The Ouagadougou Partnership (2021) is a coalition of governments, donors, and civil society organizations focused on expanding family planning and RH services in Francophone West Africa (Ouagadougou Partnership, 2021). It appears to be a region-specific initiative which is otherwise quite similar to FP2030 (USAID). The Partnership’s objectives include doubling the number of modern contraceptive users in its member countries by 2030 (Ouagadougou Partnership, 2021).

One expert recommended the DISC Program (2020), implemented by PSI and funded by CIFF, is a five-year initiative (2020-2025) focused on advancing self-care solutions in sexual and reproductive health. It aims to expand access to self-care methods, such as self-administered contraceptives, to empower individuals, particularly women and youth, with greater autonomy over their reproductive health, and one expert highlighted its particular support for demand generation for self-care methods. We are not sure if the Program will continue after 2025, so this may be a key opportunity for a new funder to extend any particularly impactful activities beyond the current time frame of the project.

Gülmezoglu noted that the Gates foundation has funded a joint collaboration between Medicines for Malaria Ventures and the Concept Foundation to convene stakeholders in March to address clinical trial regulations and approval processes for SRH products. This meeting aims to highlight RH diagnostics and products, but Concept intends to broaden the focus from pregnancy and childbirth to women’s health more generally. Gülmezoglu stressed that many trials, particularly in antimalarial drug research, exclude pregnant women, leading to missed opportunities for data collection, inequities, and suboptimal care.

MATRIX, a USAID-led regional HIV-prevention coordination initiative also discussed in a prior section, engages in multi-actor efforts to streamline the introduction and scale-up of HIV-related health products. While MATRIX’s primary focus is HIV, one expert mentioned that the initiative’s regional approach to harmonizing regulatory processes, supply chains, and data-sharing could be adapted for RH products. We are also interested in its various workstreams, which appear to include several efforts of interest to this report: the Technology Accelerator (Tech), Design to Delivery (D2D), Business Market Dynamics and Commercialization (BACH), Capacity Strengthening Engagement and Mentorship (CaSE), and Clinical Trials.

The Pledge Guarantee for Health (PGH) is a financing mechanism designed to improve the timely delivery of health commodities. It operates by providing “bridge financing” to allow countries and organizations to procure essential health products while waiting for disbursements. By reducing delays in procurement, PGH ensures that life-saving commodities reach their destinations faster, addressing critical supply chain challenges. While PGH has traditionally focused on vaccines, bednets, and other high-priority health products, its model could be expanded to support RH commodities. In our conversation, Purdy noted that funding timelines and the delay between product procurement and repayment in the social marketing model are key drivers of cost and uncertainty in DKT’s work. Extending something like the PGH model for targeted RH products may be a key opportunity to support access.

The Population Council (2022) conducts research and develops programs to improve access to contraceptives and RH services worldwide. It has played a role in developing and scaling contraceptive methods, including the copper IUD and contraceptive implants.

The Access and Delivery Partnership (ADP) is a collaboration led by the United Nations Development Programme (UNDP) alongside World Health Organization (WHO), PATH , and the Special Programme for Research and Training in Tropical Diseases (TDR). It is designed to strengthen health systems for the introduction of new health technologies in LMICs. ADP supported the development of the AU Model Law (Ncube et al., 2023).

Other organizations in support of pharmaceutical innovation

We also found several global initiatives and organizations which provide financial, technical, and logistical support of the development and introduction of new medical and pharmaceutical products in Africa. Many of these efforts have supported projects related to reproductive health, women’s health, or other relevant topics, but do not have a specific focus on these areas. We have included information about these efforts below.

Global Innovation Fund (GIF)

The Global Innovation Fund (GIF) is a non-profit, impact-first investment fund established in 2015 and supported by aid agencies (UK, Canada, USA, Sweden, Australia), African partners such as South Africa’s Department of Science and Technology (DSTI), and private partners such as the Omidyar Network, Sint Antonius Stichting (AHAM), Dioraphte, and Unilever. GIF offers grants, loans, and equity investments from $50,000 to $15M to support cost-effective products, services, business models, or policy reforms (GIF). GIF’s sector-agnostic approach focuses on measurable social impact, funding a variety of projects, including new technologies and policy innovations, though not exclusively in the health sector. GIF also applies a “gender lens” to investments, supporting initiatives that empower women and girls in areas such as education, employment, and decision-making (GIF).

Although we have found no mention on their website of funding pharmaceutical or medical device innovation, GIF seems well positioned to do so. We found mention of one project specifically focused on supporting supply chains in technical agricultural support (GIF, 2022). In addition, the “gender lens” might indicate that GIF could be interested in specifically supporting innovations in the reproductive health space.

Grand Challenges

Grand Challenges is a family of initiatives that fosters innovation to address critical global health and development issues. Established in 2003 by the Bill & Melinda Gates Foundation as Grand Challenges in Global Health (2003), the program initially targeted 14 major scientific challenges (GCGH) aimed at advancing the prevention, treatment, and cure of diseases contributing to global health inequities. In 2014, it was relaunched (Gates Foundation, 2014) with an expanded scope encompassing broader global development challenges (Grand Challenges).

Grand Challenges has led projects to support local manufacturing for various health products, including Empowering Women and Girls by Investing in Menstrual Health (Weinstock, 2016), the 2015 Vaccine Manufacturing challenge (GCGH, 2015), and the 2023 mRNA initiative (Gates Foundation, 2023).^[39] In addition, the Challenges have supported various efforts toward innovation and the introduction of new products, including Strengthening the African Contraceptive R&D Ecosystem (GCGH, 2022), Saving Lives at Birth (Grand Challenges Canada, 2013), and Low-Cost Diagnostic Technologies (Nosal, 2013). In addition, the initiative has funded the malaria “gene drive” and fostered connections between scientists and advocates, funders, policymakers, and regulators, including in Francophone West Africa (Tesfagiorgis, 2023).

Grand Challenges operates as a network of initiatives, including Grand Challenges Africa (otherwise known as the Science for Africa Foundation). This organization supports Africa-led scientific innovations with seed and scale-up grants, emphasizing the translation of scientific research into practical products and services (Science for Africa, 2023a).

Relevant initiatives within the Science for Africa Foundation include Science Innovation (Science for Africa, 2023b), Translation, and Entrepreneurship (SITE) and Clinical Research & Trials Community (CRTC; Science for Africa, 2023c). The former aims to bridge the gap between scientific research and market-ready products, and includes four strategic pillars: a three-tier model for translational sciences, think tank activities, sustainability, and optimized synergies and support. The latter seeks to create a sustainable clinical trials ecosystem in Africa by increasing investments in ethical clinical trials, fostering trust among stakeholders, and strengthening clinical research capacity.

Opportunities:

• Create sub-pools focused specifically on R&D for targeted issues, e.g., a reproductive health-focused challenge within the Grand Challenges Africa initiative.
• Invest in Science for Africa’s CRTC to support RH product trials, especially for contraceptives and maternal health innovations.

Wellcome Leap

Wellcome Leap is a global health initiative launched by the Wellcome Trust, modeled after the rapid-innovation approach of DARPA (the US Defense Advanced Research Projects Agency, referenced on the Wellcome Leap).

Wellcome Leap seems to operate mainly with $50M grant programs. The initiative’s In Utero Program (Wellcome Leap, 2022a), for instance, is working to develop non-invasive prenatal monitoring techniques, with the ambitious goal of halving stillbirth rates by creating tools that can assess and predict gestational development. The Human Organs, Physiology, and Engineering (HOPE) Program (Wellcome Leap, 2023) is focused on creating bioengineered tissues and organ platforms that could lead to innovative treatments for organ failure or damage. Additionally, the Surgery: Assess, Validate, Expand (SAVE) Program (Wellcome Leap, 2022b) is investing in the training of surgical providers, with an annual goal to double the number of trained providers.

Johnson & Johnson Africa Innovation Challenge

The J&J (2018) Africa Innovation Challenge (AIC) is an initiative aimed at supporting healthcare entrepreneurs and innovators across Africa, with an emphasis on maternal and child health, as well as areas like environmental health and community empowerment. The AIC provides financial grants, mentorship, and access to a global network. J&J does run other challenges, including Quickfire (Johnson & Johnson), but the AIC appears to be the most relevant for our purposes.

The AIC program has supported several projects to address RH and maternal health needs. For example, recent winners (Rabbitt, 2019) include Crib A’Glow (a solar-powered, portable phototherapy crib designed to treat jaundice in newborns), LifeBank (focuses on connecting blood banks with hospitals in need), and mScan (a low-cost mobile ultrasound scanner for rural clinics in Uganda).

Gaps and potential opportunities to support RH product introduction and product access

Below is a list of potential opportunities to make grants to support local engagement, research, service delivery, and expansion of existing efforts.

Supporting local governments and civil society

• Empower local stakeholders: Provide grants for capacity-building initiatives that enable local actors to take ownership of the outcomes of existing programs.
  • Purdy identified Chad, Niger, and Sierra Leone as countries with large access gaps, and Mauritania as a highly motivated country with very high maternal mortality where DKT is only recently establishing a presence.

Opportunities identified by other projects and efforts

• Gates/Grand Challenges: Women’s Health R&D Opportunity Map
• CTI Exchange: repository of contraceptive R&D funding opportunities

Research, knowledge management, and innovation

• Enhance behavioral research: Provide funding for behavioral studies to understand adoption barriers, user preferences, and cultural factors, ensuring that new methods align with user needs (recommended by Gülmezoglu and one other expert). Gülmezoglu emphasized that funder-driven agendas in such efforts sometimes impose priorities that may not align with women’s needs. He indicated that a relatively modest investment, such as $500,000, could fund an assessment of women’s needs in multiple countries over 12-18 months, leveraging methodologies like the James Lind Alliance’s priority-setting partnerships.
• Support development of non-hormonal contraception and/or new pill forms of contraception: Support early-stage R&D for novel non-hormonal methods that better meet women’s needs and preferences. Support clinical trials to address safety and efficacy questions (and for regulatory approval) for new durations of contraceptive pills like on-demand, weekly and/or monthly (noted by Purdy, Gülmezoglu, and one other expert).
• Leverage Grand Challenges Africa for RH focus: Create a reproductive health-specific sub-pool under the Grand Challenges framework to support African-led contraceptive R&D and clinical trials.

Service delivery, regional coordination, and financial sustainability

• Support pilot projects that explore innovative supply chain models
• Support access groups and the revitalization of the Implants Group.
• Promote sustainable financing models: Co-fund public-private partnerships or explore innovative financing mechanisms like social impact bonds to diversify funding for RH programs (FP2030, UNFPA).
• Supporting gap funding mechanisms, as suggested by Purdy.

Business, regulatory, and expansion support for recently-developed products

• Support for EML/ PQP inclusion for specific products
• Develop demand-creation campaigns to increase public awareness and uptake of new RH products
• Fund post-market surveillance programs to monitor the safety and effectiveness of newly introduced RH products in African countries
• Give follow-up grants to program grantees with short-term needs

Analysis of country-level contraceptive prevalence rates

Key question: Conducting a shallow review of what data is available on country-level contraceptive prevalence rates (CPR) and contraceptive method skew to inform potential future research efforts on gaps and opportunities to advance method choice.

Takeaways: We gathered UN World Contraceptive Use 2024 data to assess the current states and trends over time of contraceptive prevalence rates (CPR) in the countries within the project’s target regions. This data can be accessed here. There are 26 countries in scope for this report, including 16 from East Africa (as defined by the African Union) and 10 from Francophone West Africa.

Of 26 countries, four countries’ most recently reported CPRs exceed 60%, while 10 countries’ CPRs are below 20%. However, 10 countries’ most recent CPR estimates are over five years old, and three countries in scope for this research contain no data on their overall CPRs. In our view, there is some indication that CPR trends are suggestive of greater need in Francophone West Africa, given that flatlining/declining trends appear to be most prevalent in low-CPR countries (as opposed to such trends occurring in high-CPR countries in East Africa). Experts identified several contraceptive methods—some existing (e.g., IUDs) and some new (e.g., on-demand pills) for which further market assessment is needed, and such assessments may be especially useful in low-CPR countries with nascent markets for RH products.

Data

We began our data exploration by listing countries considered to be in East Africa and Francophone West Africa and indicating whether they belonged to various regional harmonization initiatives (EAC, SADC, ECOWAS, and IGAD), in addition to membership to the AU. To provide a sense of the importance of low CPR rates within each country, we additionally sought data on the number of women of reproductive age (WRA) in the countries in our sample, which we found in the UN World Population Prospects data (UN, 2024a). We cross-checked this source with that used by a prominent model in the family planning space, MSI’s Impact 2 model (MSI, 2023).

To explore CPR trends, we identified the UN World Contraceptive Use (UN, 2024b) dataset as a comprehensive source of data on a number of family planning indicators over time, including overall CPR and CPR by contraceptive method. All records are based on country-level surveys, and given that surveys are administered at different times, the years for which data are reported is not entirely consistent across countries, and several countries’ most recent data is at least 10 years old so we caution their interpretation; these countries include Congo, Djibouti, Equatorial Guinea, Eritrea, Réunion, Sudan, and Mauritius; see Table A1 in the appendix).^[40] Nonetheless, multiple data points are available for each country in our sample with three exceptions that contain no or minimal data—South Sudan, Mayotte, and the Seychelles, the latter of which also have the lowest populations of women of reproductive age in our sample (81K and 29K, respectively).^[41] Additionally, survey administration varies across countries, so there may be some unobservable discrepancies in the estimates.

The UN uses this dataset for monitoring relevant Sustainable Development Goals (indicator 3.7.1: “WRA who have their need for family planning satisfied with modern methods”; UN, 2024b). The majority of data come from the Demographic and Health Surveys (DHS) and Multiple Indicator Cluster Surveys (MICS/UNICEF, 2015). The remainder come from national surveys, Performance Monitoring for Action (PMA) surveys, Pan Arab Project for Family Health (PAPFAM) surveys, and the Contraceptive Prevalence Survey (CPS; Mauritius Institute of Health, 2014). We have worked with DHS and MICS data and know them to be reliable sources that are widely available, and we have also seen PMA data published in reputable research (e.g., Glennerster et al., 2022). We are less familiar with PAPFAM (Djibouti’s data source) and CPS (Mauritius’ data source) data, though we believe that the UN sourced the most reliable data available, and therefore deprioritized a deeper critical assessment. We did, however, elicit the perspective of Kaitlyn Hobbs, a researcher and data scientist at Family Empowerment Media, who suggested that the UN data we analyze is likely the best source for inter-country comparisons due to the UN’s attempts to harmonize and calibrate across data sources.

We note that the Gates Foundation is one of several investors in an initiative with the Reproductive Health Supplies Coalition called the Global FP Visibility and Analytics Network (VAN; Reproductive Health Supplies Coalition, 2017). The initiative sets out to track the order and delivery of various contraceptive products, including which companies make them, to better manage supply chains.

Contraceptive prevalence rates

Over the sample of countries in scope for this research, the four countries with the highest CPRs are (in order) Réunion, Rwanda, Mauritius, and Kenya, all of which had a CPR above 60% when data was most recently collected (see Figure 1).^[42] The most recently measured CPR for the remaining countries in our sample are all below 50%, steadily declining to 6.9% in Somalia (measured in 2019).

The countries with the lowest CPRs are South Sudan—for which only a measure of modern contraceptive prevalence rates (mCPRs) from 2015 is available—Somalia, and Eritrea, all of which report CPRs below 10%. An additional seven countries—Guinea, Comoros, Sudan, Mauritania, Niger, Mali, and Djibouti—report CPRs below 20%.

As indicated by focusing on just the blue bars in Figure 1, the ordering changes somewhat if we focus on modern CPR (mCPR) rather than overall CPR. We explore the extent to which this phenomenon may be driven by the year of the survey—given that the share of the CPR attributable to modern methods may simply increase over time—and we see a slight positive association between this share and the year the survey data were collected when we exclude outliers in the sample (see Figure A1 in the appendix). Thus, we must use caution in interpreting these measurements—in particular the mCPR and method-specific prevalence—in less recent data.

Figure 1: Contraceptive prevalence rates for all countries in our sample

Note. Data sourced from UN World Contraceptive Use (UN, 2024b) and accessible here. Bars with lighter shading indicate that estimates are based on data that is older than 2019. Data is missing for South Sudan, Mayotte, and Seychelles, so we removed them from the analysis. Percentages to the right show the modern and traditional CPRs (respectively), with the year of the most recent data available in the dataset shown in parentheses.

Trends

Methodological notes

To visualize contraceptive prevalence rates over time, we used the year-by-year estimates provided in the trends sheet. Visualization was restricted to countries deemed in scope, with two in-scope countries (Seychelles and Mayotte) excluded due to a lack of data. We focused our visualizations of the data starting in 1995, based on a quantitatively informed subjective judgment: starting around 1995 there tended to be consistently more data reported, and this data also represents a reasonable retrospective time frame of approximately the last three decades.

In some years, there was more than one data point for each country and contraceptive method (e.g., due to an assessment occurring in the same year in different quarters). We took the mean of the estimates in such cases, but we also used an error bar around the mean line to depict where the highest and lowest estimates in that year landed. It appears that there was, at most, moderate disagreement between estimates in these instances.^[43]

When looking at more specific breakdowns of modern methods used over time, we chose to individually display estimates for injectables, implants, pills, male condoms, and IUDs, with other modern methods collapsed into an “other” category. All methods in this “other” category individually had, across the countries in scope, a median prevalence less than 1%, a mean prevalence less than 1%, and a max prevalence less than 10%.

Each plot shows not just the prevalence estimates, but also indicates the African region of the country (darker shading of the background facet represents the East Africa region, while lighter shading represents the Francophone West Africa region), as well as countries’ REC memberships.

Modern and traditional contraceptive prevalence rates over time

Looking at Figure 2, it generally appears that modern methods are increasing over time,^[44] whereas traditional methods are decreasing or staying roughly flat. It is also clear that some countries have much higher contraceptive prevalence than others. For instance Kenya, Rwanda, Uganda, Madagascar, Ethiopia, and Tanzania have reached prevalence rates for modern methods of over 30% in recent years, while prevalence in countries such as Mali, Niger, Somalia, and Guinea, among others, is below 20%.

To identify countries characterized by mCPR flatlining or declining—i.e., countries that have not recently experienced upward trends, according to available data—we visually inspect recent mCPR trends in countries in our sample with more than 1 million WRA and with data collection in the last five years. In order of most to least WRA, Ethiopia, Tanzania, Kenya, Uganda, Madagascar, Niger, Burkina Faso, Senegal, Benin, and Mauritania appear to be at risk of such a phenomenon. Rwanda (and to a lesser extent Togo and Côte d’Ivoire) seem to have experienced a recent increasing trend in mCPR, and we do not have recent data for DRC, Sudan, Mali, Somalia, Guinea, and South Sudan.

If we take the mCPRs in the United States and United Kingdom as targets,^[45] flatlining should be expected to be between about 60-70% (US) or 70-85% (UK). Kenya has flatlined just below 60%, and Rwanda’s most recent estimates are approximately equal to Kenya’s, suggesting that these two countries may have little room for improvement.

Figure 2: Prevalence of modern and traditional contraceptive methods across countries, over time

Note. Darker background shading of a facet indicates the East Africa region, and lighter shading indicates the Francophone West Africa region. Countries are ordered from highest to lowest according to the maximum total CPR they reached. African Union membership is not noted for each country, as only Réunion is not a member. South Sudan did not report the prevalence of traditional methods after 2010.

Contraceptive method skew

The specific contraceptive methods women use vary across countries, as shown in Figure 3. We focus our attention on modern method prevalence. Based on countries’ most recent measurements, in East Africa, the contraceptive pill is the most widely used modern contraceptive in Réunion (where IUD use is also highest, despite having been measured almost three decades ago), Djibouti, and Sudan, while injectable and implanted contraceptives jointly make up the majority of measured contraceptive use in most other countries. In Francophone West Africa, injections and implants are also popular, and the contraceptive pill comprises the majority of modern contraceptive use in Mauritania only.

Figure 3: Breakdown of mCPR of by method, by country

Note: Data sourced from UN World Contraceptive Use (UN, 2024b) and accessible here. The data are sorted from top to bottom by countries’ mCPRs. Some data is not available for specific modern methods, and as such the bar height does not consistently decline from top to bottom. Countries for which data is unavailable do not appear (South Sudan, Mayotte, and Seychelles). Figure A3 shows the breakdown across all methods for which data is available.

In both East Africa and Francophone West Africa, there are three countries in our sample with at least ten methods in use, with Togo reporting the most at 10 (see source data here).^[46] Of the countries in our sample, those with the fewest methods reportedly in use are:

• Côte d’Ivoire, Somalia, and Djibouti with four methods;
• Sudan, Mauritania, and Benin with five methods; and
• Comoros, Réunion, Tanzania, Eritrea, Niger, and Mauritania with six methods.

However, in effect, the number of modern contraceptives in use is sometimes more limited given very low but non-zero rates of use for particular modern contraceptives. Two examples stand out: Djibouti and Sudan,^[47] though both estimates are 10+ years old so it is quite possible that outdated estimates are obstructing our understanding of CPRs in these countries.

Most countries with method-specific CPR estimates from the last five years (2019-2024) show a fairly balanced mix of injectable contraceptives, contraceptive implants, and contraceptive pills, with injectables and implants tending to dominate. Of countries with recent estimates, the highest IUD prevalence rate is in Kenya, where 4.4% of women reported using IUDs in 2022, followed by Senegal, where 2.4% of women reported using IUDs in 2023. Thus, it appears that IUD uptake has remained low in the regions of interest,^[48] representing a possible opportunity for funders to support.

We learned late in our research of DKT’s Contraceptive Social Marketing Statistics (DKT International, 2011), which seems to be a useful and up-to-date resource on its within-country product sales of various methods for countries in which DKT operates. Purdy highlighted a particularly great need in several countries including Somalia, Sudan, South Sudan, Burundi, and Mauritania. Specifically, he said there is barely any effort to increase contraceptive access in Somalia, and that work in Sudan is losing ground due to the war. As we discuss above in the section on work to introduce new products and improve access, he was particularly keen to recommend supporting work in neglected areas in Francophone West Africa. Looking at the countries with mCPRs below 20% in Francophone West Africa—Guinea, Mauritania, Niger, Mali, Benin, and DRC, from lowest to highest—we note that the five with the lowest mCPRs are spatially clustered around Mali and collectively have 19.1M WRA, while DRC contains 23.5M WRA, together comprising almost 70% of WRA in the FWA region (though only about 25% of WRA across all in-scope countries).

Trends

Looking at the specific modern methods employed in Figure 4 (see methodological notes in the previous section), in several of the high-prevalence countries we see an early increase in the prevalence of injectable contraceptives. In some countries, these shifts are quite large and sudden: for example, around 2005, injectables rapidly increased in Rwanda. Use of injectables typically started to rise as early as 1995 to 2000 among other high-prevalence countries. More recently, around 2005 to 2010, there is an increase in the prevalence of implant contraceptives, which in some cases is taking over from injectables as the most prevalent modern method of contraception. Within the last decade, we see a general trend toward increasing implant uptake and declining injectable use in high-prevalence East African countries.

While Belayneh suggested that funders focus their attention on short-acting methods due to lower unit costs and the capacity constraints of the health workforce, one expert suggested a market assessment and funding analysis for expansion of existing methods or development of new ones including pills and long-acting methods like injectables and implants.

When asked about the relatively high CPR of implants and injectables in several countries, one expert credited their uptake to their discreteness and convenience given women’s lifestyles. Given that the intended use of contraceptives is disproportionately for birth spacing (rather than limitation) in SSA relative to intended uses in other LMICs (Track20, 2020), short-acting methods may have an advantage over long-acting methods in the near term, though Maisha Meds’ data^[49] suggest that cost may be one of the primary barriers to long-acting methods. One expert suggested that other methods like IUDs could see similar levels of uptake to that of injectables and implants if sufficient funding for supply and demand were available.

Figure 4: Prevalence of specific modern methods across countries, over time

Note. Darker background shading of a facet indicates the East Africa region, and lighter shading indicates the Francophone West Africa region. Countries are ordered from highest to lowest according to the maximum total CPR they reached. Vertical bars represent the full range of estimates in the UN date for a given country-year pair. African Union membership is not noted for each country, as only Réunion is not a member. Figure A4 shows the same figure with a separate category for LAM, for which DRC and Guinea have seen relatively recent increases. Figure A5 shows faceted plots for each of the RECs separately.

Appendix

Throughout this project, we came across many materials which appeared to be promising or which were recommended by experts, but that we ultimately deprioritized reviewing in detail. We recommend these materials for interested readers who would like to further explore the topics discussed in this report.

• Regulation and harmonization
  • The Wellcome Trust has commissioned several studies on related topics, which may be of interest, including Funding priorities for regulatory systems strengthening in Africa (Wellcome Trust, 2022b), Strengthening regulatory systems in LMICs: Vaccine innovation sustainability (Wellcome Trust, 2022b), and Sustainable markets regulatory systems (Wellcome Trust, 2021). We have incorporated some of their findings and recommendations into this report.
  • We deprioritized looking deeply into IGAD-MRH due to a lack of external references to this program, but acknowledge that several IGAD countries may have a particularly acute need for increased access to RH care. Interested readers could start on the initiative’s website (IGAD) for more information.
• Manufacturing
  • The United Nations Fund for Population Activities (UNFPA) plays a pivotal role in enhancing RH product manufacturing and access in Africa, with a particular focus on introducing new products. Belayneh suggested that interested readers look further into their online documentation (UNFPA).
• R&D, new product introduction, and access
  • The Gates/Grand Challenges Women’s Health R&D Opportunity Map (Scharp et al., 2023) contains many specific recommendations related to R&D in this space.
  • The CTI Exchange maintains a repository of contraceptive R&D funding opportunities (CTI Exchange, 2021).

Table A1: Survey start and end year for most recent contraceptive prevalence rate data

Note. Data sourced from UN World Contraceptive Use (UN, 2024b) and accessible here.

Figure A1: Share of CPR attributable to modern methods across survey years

1. All countries with sufficient data to calculate the share

1. Excluding outliers (Réunion and Somalia)

Note. Data sourced from UN World Contraceptive Use (UN, 2024b) and accessible here. Note the change in the range of values on the y-axis (50%-100% instead of 0%-100%) in (b) to better visualize the association.

Figure A2: Contraceptive prevalence rates in the United Kingdom and United States since 1995

Note. Unlike in African countries, surveys in the UK and US are often spread over several years. The year on the x-axis above represents the survey start year. Source data can be found here.

Figure A3: CPR of all specific modern methods for which data is available, by country

1. East Africa
2. Francophone West Africa

Note. Data sourced from UN World Contraceptive Use (UN, 2024b) and accessible here. The data are sorted from left to right by countries’ mCPRs. Some data is not available for specific modern methods, and as such the bar height does not consistently decline from left to right. Countries for which data is unavailable do not appear (South Sudan, Mayotte, and Seychelles).
Figure A4: Prevalence of specific modern methods (including LAM) across countries, over time

Note. Darker background shading of a facet indicates the East Africa region, and lighter shading indicates the Francophone West Africa region. Countries are ordered from highest to lowest according to the maximum total CPR they reached. Vertical bars represent the full range of estimates in the UN date for a given country-year pair. African Union membership is not noted for each country, as only Réunion is not a member.
Figure A5: Prevalence of specific modern methods in each REC over time

1. EAC countries

1. ECOWAS countries

(c) IGAD countries

(d) SADC countries

Note. Countries are ordered from highest to lowest according to the maximum CPR reached. Vertical bars represent the full range of estimates in the UN date for a given country-year pair.

1. Funders could, for instance, commission such research for a particular region or set of countries, and attempt to coordinate gatherings to build networks and momentum toward a desired outcome identified in the research. ↑
2. Some experts put the number as less than thirty. ↑
3. The AMRH, a program of the African Union, was founded in 2009 under the Pharmaceutical Manufacturing Plan for Africa (PMPA; Ngozwana et al., 2012). The latter itself resulted from weak legislative frameworks, slow product registration processes, process duplication, among other challenges NMRAs were facing. Collaborators include the African Union Commission, Pan-African Parliament, the World Health Organization, the Gates Foundation, the World Bank, the UK Foreign, Commonwealth, and Development Office (FCDO), GAVI, and PEPFAR (AUDA-NEPAD, 2018). Ndomondo-Sigonda et al. (2018) additionally mention the Clinton Health Access Initiative (CHAI) (p. 2). ↑
4. AMRH has formed regional expert and technical working groups supported by continental-level Technical Committees and Steering Committees. These groups focus on quality assurance, device and vaccine regulation, pharmacovigilance, blood safety, regulatory reforms, capacity building, good manufacturing practices, marketing authorization, and information management (AMRH, 2022). ↑
5. RECs are groups of African countries formed to promote economic integration and regional cooperation (EU Africa Knowledge Platform, 2024). ↑
6. The Tanzanian source notes that priority is given to the products included in the “List of UN Commission for Live-Saving Commodities for Women and Children,” which includes three RH products with commodity-specific technical reference groups as of 2012, each with specific convenors and organizations that expressed interest (EWEC, 2012, p. 10): female condoms (convened by UNFPA, also expressed interest: USAID, WHO, Reproductive Health Supplies Coalition, PATH, the Universal Access to Female Condoms Joint Programme); contraceptive implants (convened by the Gates Foundation/DFID on behalf of the Family Planning 2020 Reference Group, also expressed interest: USAID, UNFPA, Children’s Investment Fund Foundation, WHO, RHSC), and emergency contraception (convened by WHO, also expressed interest: UNFPA, RHSC). ↑
7. RECs are groups of African countries formed to promote economic integration and regional cooperation. Established by the 1991 Abuja Treaty as foundations for the African Economic Community, RECs support wider African Union goals like trade, peace, and development, each with a unique structure tailored to regional priorities (EU Africa Knowledge Platform, 2024). ↑
8. IGAD and the EAC have considerable overlap. IGAD is composed of eight member states: Djibouti, Eritrea, Ethiopia, Kenya, Somalia, South Sudan, Sudan, and Uganda. EAC currently has the following eight member states: Burundi, Kenya, Rwanda, South Sudan, Tanzania, Uganda, and the Democratic Republic of Congo (DRC). We deprioritized investigating IGAD-MRH in detail because we found very little reference to this initiative online or in conversations with experts. ↑
9. According to their website, “ZAZIBONA is a collaborative medicines registration initiative in Southern Africa focusing on dossier assessments and good manufacturing practice (GMP) inspections. ZAZIBONA was founded in October 2013 by four countries [Zambia, Zimbabwe, Botswana and Namibia] with the support of WHO prequalification and the Southern Africa Regional Program on Access to Medicines (SARPAM).” While ZAZIBONA does not include this report’s target countries, we have seen it as a positive example in Ndomondo-Sigonda et al. (2018) and in Purdy’s experience. ↑
10. We caveat that the claim is based on an unpublished source from the EAC itself. They cite two additional sources—one of which no longer is accessible—suggesting that the median timeline from dossier submission to national marketing authorization had shortened from 1-2 years to seven months, and that approval timelines for branded medicines through joint EAC dossier assessments had reduced 40-60% (Schofield, 2017). Mashingia et al. (2020) similarly find that since its launch in 2012, the EAC-MRH initiative had halved medicine registration times and registered 36 products. Mashingia et al. (2021) confirm that regulatory approval timelines in the EAC joint assessment process decreased between 2015 and 2020 (p. 14). ↑
11. According to the European Medicines Agency (2024), “Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.” ↑
12. We are currently unsure whether the AUML was initially created by the AU, the AMRH, or an alliance of individual states or RECs. Chattu et al. (2021) claims that the AMRH developed the law, but it is generally discussed as an AU effort. ↑
13. Our understanding comes from our reading of the Model Law’s text (AU Model Law on Medical Products Regulation). Interested readers can refer to the Appendix for a table which lays out the specific provisions included in each article of the Model Law. ↑
14. Ncube and co-authors use “NRA” to mean the same as NMRAs. ↑
15. The most commonly adopted components have included international cooperation and harmonization provisions, core regulatory functions, and provisions for regulatory autonomy. The least adopted components have included the establishment of an administrative appeals committee, as well as the scheduling, classification, and control of medical products (Ncube et al., 2023). ↑
16. The initial authorizing legislation passed in 2019 and went into effect in 2021 (AUDA-NEPAD, 2009). ↑
17. “The Treaty for establishing the African Medicines Agency is an international treaty, pending ratification and accession by at least 15 member states of the AU, to establish the AMA as its specialized agency” (Chattu et al., 2021). ↑
18. Interested readers can turn to our prior report (Kudymowa et al., 2023) on the WHO EML, which discusses the list in much greater detail than the present document. ↑
19. Our prior report (Leow et al., 2023) on WHO prequalification discusses the program in considerable detail, and also lays out some strengths, weaknesses, and opportunities for improvement. ↑
20. One expert noted that the phrase “stringent regulatory authorities” is regarded as somewhat controversial, as it was a term started by Pharmaceutical Inspection Cooperation Scheme (PIC/S) founders. In the eyes of some, the term SRA prioritizes the perspectives of developed-country regulators with original PIC/S membership rather than stressing stringency. As a result, the WHO’s new “maturity level” framework is an increasingly common replacement for the concept of an SRA. ↑
21. Similarly, all four prequalified female condom suppliers are in Asia (RHSC, 2016), though prevalence of female condoms is negligible in East and Francophone West Africa (see contraceptive method skew). Similar RHSC documentation is unavailable for other contraceptive methods. ↑
22. Our interviews noted some potential confusion about where the burden falls to apply for WHO-PQ. three unnamed experts all agreed that manufacturers are responsible for applying, but Belayneh asserted that the burden sometimes falls on national governments (at least in the case of Ethiopia) and they might benefit from regional collaboration to reduce per-country costs. ↑
23. Luembe highlighted the progress made by AUDA-NEPAD and Africa’s CDC in strengthening Africa’s pharmaceutical manufacturing, with a focus on priority vaccines due to the scale of health threats such as COVID-19, MPOX and other recent outbreaks that have impacted multiple countries. However, she noted that few initiatives included reproductive health (RH) supplies, thus a pressing need to ensure RH supplies are integrated into key strategic documents and policy discussions to ensure their prioritization in the broader manufacturing agenda. ↑
24. “By comparison … China and India, each with roughly 1.4 billion people in population, have as many as 5,000 and 10,500 drug manufacturers, respectively” as of 2021 (Wambui, 2021). ↑
25. Purdy does not believe a manufacturer in Africa will be able to compete on price and quality in the short- to medium-term. Even if they were able to compete on price, his view is that African distributors would actually prefer an established and trusted product from Asia over a product manufactured in Africa. Purdy suggested that there are already many high-quality products available at reasonable prices, such that availability does not represent a major barrier to access across the African continent. ↑
26. The primary sources of the documentation are conversations with several relevant market actors—including pharmaceutical manufacturers in SSA, pharmacy university departments in SSA, and a national quality control lab in SSA, as well as two international pharmaceutical manufacturers and a development bank—which the authors supplemented with literature reviews. ↑
27. GHSC-PSM commissioned work from IQVIA Government Solutions to model the costs, revenue, market size, and other financial considerations (e.g., corporate tax, depreciation) associated with establishing a manufacturing facility in SSA for injectable and oral contraceptives. The model suggested a non-positive ROI for manufacturing oral contraceptives—with sales in FP2020 SSA countries and South Africa—and limited hope for a positive ROI for an injectable contraceptive system similar to that of MPA-SC (i.e., “subcutaneous presentation of medroxyprogesterone”; USAID, 2024, p. 4). The returns in the model suggest a 6% compound annual growth rate for MPA-IM, falling short of the 11-22% range indicated by one manufacturer in SSA and in interviews with local SSA manufacturers. Further details on the model can be found in USAID (2024, p. 5-6). ↑
28. One expert highlighted that while WHO-PQ is one of the SRAs recognized by USAID for procurement eligibility, USAID can also recognize decisions by the EMA or even issue waivers for unregistered products in cases like clinical trials or unmet needs. EMA’s pathways for non-European products, which require fewer studies on European populations, also offer a replicable model for fast-tracking approvals in Africa, especially for regions lacking robust regulatory infrastructure. They described recent regulatory harmonization efforts as helpful, as they enable mutual reliance and faster approvals. These regional approaches could help USAID avoid the high costs and requirements of full FDA or EMA approval for LMIC-focused products, like certain injectable contraceptives which are often not marketed in the US or EU due to limited demand. ↑
29. Purdy also mentioned a Chinese manufacturer of DMPA that abandoned plans to manufacture in Africa about five years ago, though he could not recall which and we did not identify it in a brief search. ↑
30. Products include the “non-ARV/non-hormonal dual-purpose monthly vaginal ring, monthly dapivirine vaginal film, TAF/EVG fast dissolving vaginal insert, and monthly dapivirine and levonorgestrel dual-purpose vaginal film” (MATRIX). ↑
31. The business plan (Ngozwana et al., 2012) proposes a “generic solutions package” that includes a range of broad solutions, including technical assistance on critical regulatory functions, human capital development, legislative and policy guidance (including which issues should be tackled regionally), tools to increase access to capital, and support in strengthening manufacturers’ associations (both national and regional; p. 59). ↑
32. Although technologies like continuous flow synthesis have been proposed to make API production more feasible and affordable in Africa (Riley et al., 2019; Sagandira et al., 2020), we are not sure if PMPA is actively involved in promoting or funding these innovations. Currently, Africa is highly dependent on India and China for its APIs (Buckholtz, 2021). ↑
33. A brief search suggests Novartis does not produce RH products. ↑
34. “The imports of chemicals and pharmaceuticals account for about 5% of total imports in the region. A few pharmaceuticals in the form of tablets, syrups, capsules, liquid mixtures, disposable syringes, surgical gauze, aspirin and paracetamol and injectables are manufactured in the region. Investment opportunities exist in the manufacture of drugs for the treatment of various tropical diseases, the provision of modern family-planning services, and the manufacture of medical equipment and sundries (surgical cotton/gauze, sanitary pads, syringes, bandages, infusion syrups, oxygen). The rich biodiversity of the region also provides an opportunity in the processing of herbal medicines. The processing of pyrethrum extracts and the production of vaccines, antibiotics and vitamins also offer investment opportunities.” (EAC, 2012, p. 6). ↑
35. Misoprostol is a common medication abortion product. ↑
36. IFC provided €150M; other financiers included Proparco, the German Development Finance Institution (DEG), and the US International Development Finance Corporation (DFC). ↑
37. The combipack scale-up COF is discussed in a COF overview (COF, 2023), as well as on the RHSC website. We have seen less reference to this COF than to the others, and we are unclear about what work has been done on this fund thus far. We believe that the “nascent working group” on combipacks that one expert mentioned may come from this COF, but are not sure. ↑
38. We believe that the UNFPA’s work mostly focuses on product distribution and supply chain support, but its work appears to be extremely large in scope and contributes to the efforts discussed throughout this report on regulatory reform and manufacturing support as well. ↑
39. This may be the same project as MAV+ Senegal. We are not yet sure of the distinction. ↑
40. We cross-checked the UN data with World Bank data collected and processed by Our World In Data (OWID) in their overview of the “share of women using modern contraceptive methods” (OWID, 2025). While OWID provides overall CPR and mCPR rates for Congo in 2015 (30.1% and 18.3%, respectively), they do not have more recent data than the UN for the remaining countries in this list. Oddly, we noted that there are some discrepancies in the two datasets; for instance, the reported mCPR for Madagascar in the UN data is 34.1% in 2021, whereas it is 42.7% in the World Bank data, which seems likely due to either adjustments UN makes for cross-country comparison or the data that is included. We spoke with Kaitlyn Hobbs, a researcher and data scientist with Family Empowerment Media, who suggested that a difference in denominator could also explain variability in mCPRs across sources; for example, the World Bank mCPR (World Bank, 2016) likely includes married women only, while the UN World Contraceptive Use (UN, 2024b) data we refer to may include married and in-union women. ↑
41. South Sudan has a relatively high population (over 2.8M) compared to Mayotte and Seychelles, though Hobbs sharesour suspicion that data for South Sudan may not exist due to tractability issues. We therefore deprioritized a bespoke search for CPR data for the country. ↑
42. The data for Réunion is from 1997, making it the most dated record in the dataset and suggesting the mCPR has been relatively high for almost three decades (assuming no stark decline since then). We would guess that the mCPR is now highest in Réunion of any country in our sample given the high baseline in 1997 and general increases in demand for and availability of contraceptives globally. Similarly, the data for Mauritius is from 2014, suggesting that the large fraction accounted for by traditional methods may be smaller today. ↑
43. Hobbs has attempted to identify the source of such discrepancies between sources reporting mCPR for the DRC, and has spoken with another expert in the field who is equally perplexed by them. She is awaiting a response from PMA regarding how PMA derives their mCPR to continue investigating the variability of mCPR estimates. ↑
44. This finding is consistent with analyses from other sources, such as Track20 (2020). ↑
45. See trend figures in Figure A2. ↑
46. Note that we do not have this data for South Sudan, Mayotte, or the Seychelles. ↑
47. In Djibouti, 95% of modern contraceptive use is attributable to just two contraceptive types—injectables and pills—while implants and “other modern methods” comprise the remaining 5%. Similarly, in Sudan, 78% of reported modern contraceptive use is attributable to the contraceptive pill, followed by injectable contraceptives at just 12% of reported modern contraceptive use and the three others (IUDs, implants, and lactational amenorrhea method) each accounting for 3.5% of modern contraceptive use or less. These two countries are home to 12.7 million women of reproductive age, while South Sudan—for which we lack data but presume low contraceptive access—is home to an additional 2.8 million. ↑
48. By comparison, IUD uptake in the US and UK was most recently 10.5% (2018) and 8.9% (2012), respectively, which in turn is somewhat low relative to several European countries, some nearing 30% (Statista, 2023). ↑
49. Maisha Meds provides subsidized care for family planning, as well as malaria and HIV prevention. They have found that “[wo]men opted for long-acting contraception nearly 6 times more often when we subsidized the cost through our app. Our study also found most patients switched from less effective short-term methods like emergency and oral contraceptives.” Maisha Meds currently operates in three East African countries in scope for this research—Uganda, Kenya, and Tanzania—in addition to Nigeria and Zambia (Maisha Meds, 2021). ↑