Ensuring the Financial Sustainability of an African National Medicines Regulatory Authority

The Problem

Financial sustainability is a foundational attribute of a mature and effective national medicines regulatory authority. Without it, an NRA cannot recruit and retain technical expertise, invest in the systems and infrastructure required for modern regulatory practice, or commit to the long-term programmes of work that underpin public health protection. Financial sustainability is also a precondition for an authority to credibly support broader national health-system ambitions, including the local production of quality-assured medical products, which is increasingly a strategic priority across African health systems.

Our clients were a national medicines regulatory authority (NRA) of an African country and an international philanthropic organisation that works to improve global health, reduce poverty, and expand access to education and technology.

The NRA in this case had been established as a division within the ministry of health. This arrangement created the potential for conflicts of interest and constrained the authority’s ability to function independently and efficiently, ultimately undermining its long-term sustainability. Recognising these limitations, the government revised its National Medicines Policy and adopted a comprehensive set of policy goals and implementation strategies designed to ensure the availability of safe, efficacious and quality-assured essential medicines as part of a wider commitment to health for all citizens.

A central element of the revised policy was the promotion of local pharmaceutical production and the establishment of the NRA as an autonomous statutory body accountable to the Minister of Health. In order for the NRA to function independently, it needs to be able to fund and sustain its operations over time; realising this vision of a credible and autonomous medicines regulator therefore required a credible assessment of the potential strategies towards financial sustainability for the NRA.  The NRA was operating at World Health Organization (WHO) maturity level 1 and was actively working towards maturity level 3, which requires compliance with WHO Global Benchmarking Tool standards (notably RS06.01 and RS07.04) that mandate autonomy in financial management and human resource decisions. As with many regulatory bodies on the continent, the pursuit of partial or full independence from the ministry responsible for health was a critical step in the journey towards a stable, well-functioning regulatory system capable of supporting domestic manufacturing and regional regulatory cooperation.

The aim of the project was therefore to develop a financial sustainability plan for the NRA. Specifically, the project sought to:

• assess the agency’s organizational structure and make recommendations on its suitability for the mission of the NRA

• identify the NRA’s human and financial (operating and capital) needs required to reach and maintain sustainable and optimum levels of efficiency; and

• outline a fee structure approach that would support the operations of the NRA and its Secretariat.

The Solution

The project required the simultaneous application of expertise in regulatory affairs, local pharmaceutical production, financial sustainability and organisational development; Market Access Africa (MAA) deployed a multidisciplinary team that drew on each of these competencies. To accelerate the NRA’s journey towards autonomy and WHO maturity level 3, MAA conducted a comprehensive institutional and financial assessment. This entailed analysing the NRA’s organisational structure, departmental functions, governance arrangements and financial status in order to identify strengths, gaps and areas for improvement, and to define the institutional architecture required to support an autonomous regulator capable of overseeing both imported and locally manufactured medical products.

MAA benchmarked global and regional best practices in regulatory governance, financing models and fee structures to align the NRA with internationally recognised frameworks, including the African Union Model Law on Medical Products Regulation and the WHO Global Benchmarking Tool. The benchmarking exercise drew on comparator authorities from the region and beyond, allowing the NRA to position its proposed structure against peers at varying stages of regulatory maturity. To ensure that the proposed frameworks were adaptable and implementable in the client’s context, MAA collaboratively engaged the NRA’s stakeholders, including staff, industry players (notably local manufacturers and importers), the ministry of health, the ministry of finance, and existing development partners, to gather insights on operational challenges and to test the feasibility of proposed reforms. Drawing on this evidence base, MAA developed a phased set of organisational and financial recommendations to guide the NRA’s transition from pre-autonomy to a mature, autonomous regulatory authority.

The Outcome

MAA delivered a comprehensive financial sustainability plan that set out a phased growth budget supporting three staffing scenarios, a redesigned organisational structure aligned to international best practice, and a revised fee structure approach. Together, these clearly identified the financial requirements, resources available and funding gaps for the NRA over an eight-year horizon, and consolidated stakeholder perspectives on the institution and the broader operating environment. The plan was presented by the client to the Ministry of Health and the wider government to make the case for the feasibility of the NRA’s autonomy and to serve as a justification for the revision of the current gazetted fees.

Beyond the deliverables themselves, the work has materially strengthened the NRA’s position to advance its strategic agenda. Specifically, the NRA is now better positioned to:

• make an evidence-based case to government for autonomy, supported by a costed organisational structure, a defensible fee model and a clear articulation of the financial sustainability pathway required to underpin the transition;

• attract and structure development partner support more effectively, on the basis of a credible institutional and financial roadmap that demonstrates a clear trajectory towards reduced donor dependence and provides partners with defined entry points for catalytic investment;

• operate with stronger organisational systems, through clearer governance arrangements, improved role definition, fit-for-purpose departmental structures and a phased human resource plan that collectively position the authority to discharge its mandate more efficiently;

• advance towards WHO maturity level 3, by addressing key institutional and financial indicators of the WHO Global Benchmarking Tool that previously constrained progression; and

• support national ambitions for local pharmaceutical production, by laying the foundations for a regulator with the technical capacity, institutional credibility and financial footing required to oversee domestic manufacturers and to participate meaningfully in regional regulatory harmonisation initiatives.

While the realisation of full financial sustainability will ultimately depend on legislative reform and sustained implementation by the NRA itself, the project has equipped the authority with the strategic, organisational and financial architecture required to pursue that goal from a substantially stronger position. In doing so, it has also reinforced the principle that financial sustainability is not an administrative concern peripheral to regulatory practice, but a core element of a mature and effective NRA and a precondition for the broader public health and industrial ambitions that African health systems are increasingly seeking to advance.

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