African Medicines Regulatory Harmonization Week: Setting the Tone for Africa’s Regulatory Future

This week marks the third African Medicines Regulatory Harmonization (AMRH) week—a critical touch point in ongoing efforts to expand access to quality-assured medicines across the African continent. At the biennial conference, hosted this year in Ghana, partners and stakeholders will review progress on regulatory strengthening and harmonization and consider the path forward. This year, AMRH participants have several reasons to celebrate: the continental African Medicines Agency (AMA) has been established, regulatory harmonization has taken off in several regions, and five National Regulatory Authorities (NRAs)—Tanzania, Ghana, Egypt, Nigeria, and South Africa—are now considered functional by the World Health Organization (WHO), with two, Egypt and South Africa, recognized at this level for vaccines regulation. However, a big concern looms: how to best ensure long-term sustainable funding for regulatory systems to protect recent gains and make further progress. A report by the Wellcome Trust earlier this year highlighted the significant investment across multiple domains that is needed over at least the next decade to improve regulation in Africa.

This blog describes a few levers to make the case for regulatory systems strengthening and outlines three key recommendations to secure sustainable financing and build on the current momentum.

Current opportunity—and need—for further strengthening

Stronger regulatory systems in Africa are not just a precondition for success in crucial continental initiatives; they are also a great way to help funders deliver on the difficult but important goal of health system strengthening. Calls to increase local vaccine manufacturing and improve access to critical medical countermeasures—a cornerstone of bolstered capacity for pandemic preparedness and response—require efficient and effective regulation. African countries will only be able to meet the ambitious target to manufacture 60 percent of its vaccine needs locally by 2040 if sufficient regulatory capacity is built in vaccine producing and consuming countries.

Building strong regulatory systems also helps countries and funders to move away from siloed, vertical programs in favor of health systems strengthening. This transition is possible because the path to build regulatory systems as well as the metrics for success have been agreed on and are clearly outlined in the WHO Global Benchmarking Tool. More broadly, goals such as expanding health coverage, eliminating substandard and falsified medicines, and making supply chains for quality-assured products more resilient require strong regulators.

Unfortunately, African countries and funders have not yet met this demand with adequate financing support. AMRH week creates a critical opportunity for this to change. Three elements should be considered to best ensure long-term sustainable funding for regulatory systems:

1. The African Union must draw up a clear funding plan for regulatory system strengthening in the continent

A clear plan must be finalized, clearly communicated, and actively implemented for the what, why, and how for funding African regulatory system strengthening. New entities have entered the continent’s regulatory ecosystem, such as AMA, and regulatory processes at all levels have gotten more complex and interconnected as they become more advanced. It is up to the head governing body—the African Union—and its implementing agency, the African Union Development Agency (AUDA-NEPAD) to take stock and identify funding needs for AMA; AMRH, including its continental technical agenda and capacity development; RECs; and NRAs—including the relevant scales and timeframes. Building on the workplans already in development, clear objectives and asks to funders can incentivize strategic investments. Convenings like this week’s AMRH Week are an important first step to coordinate and set priorities among the various national regional, continental, and global initiatives and networks in the African regulatory system.

A funding plan will help map out the critical transition away from donor financing towards a self-funded African regulatory system. Fees charged to companies that submit products for regulatory review will be a key source of funding for a self-sufficient, harmonized system. The African Union will need to help implement these industry fees for harmonized regional and continental activities and determine their distribution between the national, regional, and continental levels, given the separate yet coordinated nature of medicines regulation. A successful fee-based system will be dependent on industry users’ ability to reap benefits through faster, simpler, and less onerous procedures. So while fees can help the African regulatory agencies establish independence and credibility, and therefore reduce their dependence on aid and government budgets, they are likely a long-game in many countries. Therefore, the continent will need technical, financial, and advocacy support in the interim to create a conducive environment for a self-sufficient, fee-based system.

2. African governments should increase financing for regulatory authorities

A good business case should be made to heads of states and ministries of finance in African governments in order to secure higher levels of domestic financing for regulatory strengthening. These calculations should factor in the economic and public health gains likely to result from more effective and efficient systems that speed up patient access to quality products and remove substandard and falsified products from the market. At current budget levels, domestic financing often accounts for a small proportion of funding for regulation. For example, government funding accounted for less than 20 percent of the annual funding for Tanzania’s NRA, on average. Low contributions from African Member States reflects a lack of value placed on regulation in a well-functioning health system, competition for limited resources, and a historic reliance on donor financing to access essential medical products that have been prequalified by the WHO or quality assured by global procurement mechanisms. Budget levels for regulation must increase through significant injections from domestic financing and by ramping up industry fees. Until domestic funding can increase to sufficient levels, donor funds must be made available to support this essential component of the health system, particularly where there is a risk of preference being given to lower cost products by procurers.

Additionally, NRAs must be legally and financially empowered to collect fees and reinvest sufficient amounts into their own systems. As it stands, several African countries do not have autonomous or semi-autonomous regulatory authorities. As a result, these countries lack mechanisms for collecting industry fees and/or are forced to route fees straight to their Treasuries, bypassing opportunities to strengthen their systems.

3. Donors should increase funding, use new funding vehicles, and improve coordination

While governments work to increase domestic contributions and industry fees are ramped up for harmonized activity, donor support will be critical for the African regulatory system. Historically significant sources of funding and technical assistance are no longer available, due in part to the reduction in the UK’s aid budget and the lapse of the World Bank’s Global Medicines Regulatory Harmonization Multi-Donor Trust Fund. Currently, a small handful of donors, including the Gates Foundation and now the European Union, provide the bulk of financial support for regulatory systems strengthening, with funding allocations split between for the nascent AMA and AMRH, including directly to NRAs in key countries. Other donors, including the Swiss Development Corporation, USAID, and the German government (through several channels, such as the Federal Institute for Drugs and Medical Devices; GIZ, the German Agency for International Cooperation; the Paul-Ehrlich-Institute; and the Physikalisch-Technische Bundesanstalt), distribute funds and technical support across the regulatory landscape to the WHO, RECs, AMRH, and several NRAs.

Donor funding provides critical support, but gaps remain that must be filled to ensure comprehensive funding for Africa’s regulatory system. For example, funds and technical assistance have been extended to some but not all RECs, leaving out the Common Market for Eastern and Southern Africa and the Economic Community of Central Africa States, among others. Similarly, NRAs in countries such as Ghana, Liberia, Sierra Leone, Nigeria, Tanzania, Kenya, Senegal and South Africa have received funding and technical assistance from multiple partners, but many other countries have not.

Regulatory strengthening initiatives should be integrated into efforts to increase vaccine manufacturing. Funding vehicles like grants, debt and equity financing, and loans have been deployed to expand manufacturing capacity in Africa for health products. Many of these significant recent investments to increase vaccine manufacturing in Africa have overlooked the need to fund regulatory authorities—and, as mentioned, stronger regulatory systems are needed for successful local manufacturing initiatives. These existing initiatives should incorporate benchmarks for regulatory capacity building to leverage existing funding vehicles and reinforce the importance of strong regulatory systems. In parallel, donors should deploy similar funding instruments for efforts specific to regulatory systems strengthening.

In addition to leverage funding from existing sources, new funding sources should be secured, including development banks, global procurement agencies, and other high-income countries. These donors can help mobilize and allocate private sector funding while insulating regulators from political pressures—a risk of domestic public funding. As more donors enter the space, increased coordination will be needed to avoid redundancy.

All eyes on AMRH week

The African regulatory ecosystem has made marked progress in the past few years. But there is still work to be done. African governments, regulators and donors must build on the current momentum and secure sustainable financing. Adequate funding is necessary to protect recent gains in the efficiency and effectiveness of regulation across the African continent and to continue expanding access to quality-assured medicines. We will have our eye on the discussions at AMRH Week and hope the conference sets the tone for a strong and coordinated regulatory future in Africa.

With thanks to Rachelle Harris and Divya Shah for helpful comments