By Morgan Pincombe and Javier Guzman
COVID-19 has reinforced the need for strong regulatory systems. The success of new technologies rapidly developed to mitigate the pandemic depends in no small part on key regulatory functions, such as oversight for clinical trials; review and authorization of medical products like vaccines, treatments, diagnostics, and personal protective equipment; and safety surveillance to identify adverse side effects. Strengthening regulatory systems on the African continent by developing, pooling, and using the limited regulatory expertise available; harmonizing standards and procedures across the 55 African countries; and conducting joint assessments will advance access to essential medicines like vaccines.
African countries have taken important steps to enhance their regulatory ecosystem, setting up collaborative regulatory mechanisms within Regional Economic Communities (RECs) and coordinating across countries and regions through the African Medicines Regulatory Harmonization (AMRH) initiative—a continental platform. November 2021 marked a milestone long in the making: the establishment of the African Medicines Agency (AMA). This specialized health agency of the African Union promises to ensure the quality of medicines produced and sold in Africa, facilitate efficient and credible regulatory reviews of new products, and ultimately increase the supply of quality-assured medicines.
AMA has already achieved broad support. Twenty-two African countries have already ratified the treaty and an additional 8 have signed it, surpassing the 15 ratifications needed for the treaty to enter into force. AMA must build on this momentum to secure additional ratifications and operationalize the agency. Decisions made during AMA’s early days are pivotal, as they will institutionalize governance and financing structures, determine its relationship to existing regulatory platforms, and establish its initial priorities.
online event in February that brought together key stakeholders from multilateral entities and development agencies, funders, and regulators from the national, regional, and international levels to discuss near-term priorities for AMA to secure broad and sustainable support, establish functional structures, and achieve maximum impact. Below are four key takeaways from the conversation about how to set AMA up for success.CGD co-hosted an
1. AMA should build from, and leverage the experience of, existing initiatives and structures
AMA is a landmark achievement for medicines regulation in Africa, but it is not the first initiative for improved regulation on the continent. This continental agency is a celebrated outcome of the AMRH initiative, formalized in 2009. As Andreas Seiter, global lead for the Private Sector for the Health, Nutrition, and Population Global Practice at the World Bank, pointed out, AMA demonstrates the success of joint capacity-building measures. With more than a decade of experience through AMRH, African regulators have developed trust and laid the groundwork for collaboration, giving AMA a head start on harmonizing efforts across the continent. AMA is therefore not starting from scratch and should build from the foundation set by the AMRH to most efficiently and effectively regulate essential health technologies to increase access to safe, effective, quality-assured medicines.
Margareth Ndomondo-Sigonda, head of the Health Unit at the African Union Development Agency’s New Partnership for Africa’s Development (AU-NEPAD), outlined the main functions of the AMRH that have prepared the way for AMA:
First, AMRH worked with regional agencies to harmonize guidelines, joint reviews, and inspections, reducing the overall timelines for manufacturers to receive marketing authorization for their products. AMA will follow the same approach to coordinate efforts across the continental, regional, and national levels.
Second, AMRH supported the African Union Model Law on Medical Products Regulation, which strengthened the translation of decisions made at the continental and regional levels to implementation at the national level. AMA must continue these efforts to support appropriate legal arrangements to facilitate the uptake of a broad range of regulatory decisions among all member states.
Third, AMRH launched Regional Centers for Regulatory Excellence (RCOREs) to foster sustainable capacity-building programs through information exchange among member states and partner institutions. Today, there are 11 such RCOREs focused on different regulatory functions, including clinical trial oversight, pharmacovigilance, and productive registration. AMA can learn from what has and has not worked with the RCORE model and expand these capacity building initiatives to strengthen medicines regulation across the continent.
Finally, AMRH has established a robust governance framework. AMRH’s initial advisory group evolved into a formal governing body and is now supported by a committee and partnership platform, which coordinate the regulatory systems strengthening activities happening across the continent, as well as a secretariat jointly convened by AU-NEPAD and the World Health Organization (WHO). This governance structure creates a strong foundation for AMA. Ndomondo-Sigonda and Jude Nwokike, vice president of US Pharmacopeia and director of the USAID Promoting the Quality of Medicine Plus Program, referenced two specific technical committees that will fold into AMA’s governing structure: the African Vaccines Regulatory Forum and African Medicines Quality Forum.
AMA is also entering an ecosystem of other regulatory agencies, including the RECs, national regulatory authorities (NRAs), and global processes and decisions such as the WHO prequalification program. As the first REC to implement the AMRH initiative in 2012, the East African Community (EAC) has worked closely with AMRH to make noteworthy progress in pooling technical expertise from the region and harmonizing technical guidelines. The timeline for national assessments of medicines in the EAC was roughly cut in half between 2012 and 2017—in large part because of the EAC’s partnership with AMRH. Jane Mashingia, technical advisor for the EAC Medicines Regulatory Harmonization Program, called for AMA to reinforce the regional harmonization systems and monitoring mechanisms already in place under AMRH in order to minimize transaction costs and avoid the duplication of efforts.
The experience of the other African Union specialized health agency—Africa Centres for Disease Control (Africa CDC)—can also provide valuable lessons for AMA. Similar to AMA, Africa CDC, founded in 2017, works with regional entities to coordinate efforts. The strategies Africa CDC has developed in working with regional blocs during its first five years will be especially important for AMA, as regulatory agencies in other regions of the world—such as the European Medicines Agency and the US Food and Drug Administration—differ by working directly with countries and states. Seiter also highlighted that funders like the World Bank can apply their experience in supporting Africa CDC to establish suitable, effective partnerships with AMA.
2. The success of AMA depends on its ability to clearly define and articulate the roles and responsibilities of NRAs, regional harmonization efforts, and AMA’s continental mandate
Operating in a regulatory ecosystem means that AMA will have support from well-established agencies—and that AMA must define its own scope in relation to these other entities. AMA must clarify the division of responsibilities between RECs and NRAs. David Mukanga, senior program officer of Regulatory Affairs at the Bill and Melinda Gates Foundation, emphasized the two paths ahead of AMA, which have distinct implications for its resourcing and functioning: on the one hand, AMA could adopt an EMA-like model, where regulators conduct assessments led by NRAs. In this case, AMA’s key challenge would be to coordinate the involvement of national resources and expertise in the continent-wide activities. On the other hand, AMA leadership could implement a blended approach, in which expertise based at the AMA secretariat would complement NRA-based experts. In this model, AMA would need to establish a robust technical staff. Seiter warned that attracting talent to AMA could weaken NRAs, as regulators may opt for the greater job security and higher salaries often offered at the continent level. Since AMA will only be as strong as the NRAs that comprise it, AMA must mitigate the potential outflux of technical staff in NRAs and help ensure appropriate resourcing at the national level.
In that vein, as it refines its complementarity to RECs and NRAs, AMA must work to strengthen capacity across these levels. AMA can build from the RCORE model introduced by AMRH as well as the innovative capacity building measures implemented by RECs. For example, the EAC provides training to strengthen the uptake of regional decisions among national regulators and bolster competency in a broader range of regulatory activities. Mashingia explained that the EAC identifies lead regional agencies for different regulatory activities based on comparative advantage. Within the EAC, Tanzania leads on scientific review and registration, Uganda on joint inspections, and Kenya on pharmacovigilance and post-marketing surveillance. This model empowers regulatory authorities to play to their strengths and support comparatively weaker agencies in these areas. The EAC also uses the narrower concept of “twinning”—in which stronger agencies partner with emerging, less mature ones for trainings and information exchange. As a result of such capacity-building measures, Mashingia cited that since the EAC started the AMRH program in 2012, the number of semi-autonomous NRAs has more than doubled, from three to seven. Its position to support the harmonization of standards and facilitate knowledge sharing makes AMA a prime catalyst to advance the maturity levels of RECs and NRAs.
As AMA works with RECs and NRAs to determine optimal functions to conduct at each level, funders will similarly need to find an appropriate, effective balance for their investments. Financial investment is necessary to get AMA off on the right foot (see point 4 below), but investors must also sustain their investments in key regulatory functions at the regional and national levels to fortify the African regulatory ecosystem.
3. In its early days, AMA should focus on “quick wins” to prove value add, demonstrate impact, and secure additional support
These first few months and years will be critical for AMA to prove its worth through “quick wins”—objectives that AMA can deliver on in the near term. Such evidence of effectiveness can maintain and strengthen buy-in from existing member states as well as stimulate additional interest from other countries that have not yet ratified the AMA treaty, including big economies like South Africa, Ethiopia, and Nigeria. “Quick wins” can also induce additional investment from donors.
Nwokike identified three key priority regulatory functions AMA can target for “quick wins.” First, AMA can focus its efforts on the market authorization process, which will yield significant, visible results. Jean Baptiste Nikiema, regional advisor for Essential Medicines for the WHO Africa Regional Office, supported this point and underscored that AMA can focus on pooling the expertise needed to review product dossiers, publishing guidelines for industry and regulators, and streamlining the process for approving medical products for COVID-19. AMA can also further accelerate access to COVID-19 vaccines by partnering with countries seeking to expand vaccine manufacturing capacity that have already ratified the AMA treaty—such as Ghana, Rwanda, and Tunisia—to ensure that the vaccines produced in one member state can be procured in others. Second, AMA should conduct regulatory inspections, especially considering the multi-country nature of the envisioned vaccine manufacturing network. Finally, AMA is well positioned to coordinate lot release testing and can identify member states with strong lot release capabilities that are already part of the national control laboratory network to champion these efforts.
4. Securing sustainable financing for the agency is essential
AMA will only be able to deliver on its promises to harmonize medicines regulation on the African continent if it secures appropriate, sustainable financing. Different sources and levels of financing will likely be needed during AMA’s life cycle, with donor support needed most at the outset, and industry fees ramping up in time to create a self-sufficient agency. AMA has had an encouraging start, with several donors already pledging funds to support its operationalization. Nikiema shared that the WHO is contributing finances—a significant demonstration of the WHO’s support for AMA, as the WHO generally does not act as a donor agency. Mukanga emphasized the Gates Foundation’s commitment to funding AMA, acknowledging that once operational costs have been met, donors like the Gates Foundation can transition to supporting capacity-building efforts and other development activities to expand the scope and impact of AMA. In the wake of its Multi-Donor Trust Fund that supported regulatory systems strengthening initiatives, the World Bank has committed bridge funding to sustain operational activities until it can define its role in supporting AMA and allocate appropriate funding, according to Seiter.
As multiple partners commit to supporting AMA, Mukanga and Seiter called for coordination among donors to ensure efforts reinforce and complement each other rather than create redundancies. Since AMA’s ability to function effectively is contingent on the strength of NRAs and RECs as well, donors also must coordinate to ensure sufficient financing for the African regulatory ecosystem as a whole. The Gates Foundation and the European Commission’s recent joint statement demonstrates this holistic, coordinated approach, integrating support for AMA into a broader announcement of €100 million for African regulatory initiatives.
While stimulating critical donor support, AMA must also draw up plans to charge industry fees. These fees will help reduce AMA’s dependence on government budgets, which often do not prioritize regulatory functions, and establish a degree of independence, which will reinforce the agency’s credibility. Mashingia outlined the top-up fees that EAC is exploring to replace donor funding in order to sustain the joint regulatory activities that have proven efficient to conduct at the regional level, encouraging AMA to introduce similar fees to support activities best conducted at the continental level to save money and time while advance access to quality, effective medicines. As AMA explores the use of user fees, it will need to determine the distribution of fees between the national, regional, and continental levels to ensure it operates in a strong regulatory ecosystem.