As of October 2023, only 14 countries globally, 5 from the African region (Egypt, Ghana, Nigeria, South Africa, and Tanzania), have had their national medicines regulatory authorities (NRAs) reach WHO maturity levels 3 and 4.1.

As I write this article, the Rwanda Food and Drug Authority (FDA) could be about to join the party.

The significance of WHO-listing is that qualified NRAs take their positions as the world’s regulators of reference.

Not a bad position to be in.

According to the WHO Global Benchmarking Tool, a regulatory authority with maturity level 3 indicates a stable, well-functioning, and integrated regulatory system, while level 4 implies a regulatory system operating at an advanced level of performance and continuous improvement.2

3 and 4 are the levels many NRAs aspire to operate at but somehow seem to always fall short.

One of the key reasons, particularly in Africa, why many regulatory authorities are yet to reach these levels is their mechanism of financing. Many lack stable financing provisions that would allow them to operate in an efficient and sustainable manner.

Below are 5 financing benchmarks that NRAs need to reach to be in contention of reaching maturity levels 3 and 4.

 

 

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Establish clear sources of funding to carry out all regulatory functions

 

 

It’s well documented the critical role national regulatory authorities play in the implementation of guidelines, standards, and procedures that ensure that the medical products in their respective markets are of good quality, effective, and safe for the masses.

Yet, many still struggle to achieve sustainable financing.

Without financing, it becomes extremely difficult for these agencies to execute their mandate, thereby creating vulnerabilities that manifest as substandard and falsified medicines flowing into their markets.

 

 

World Health Organization Headquarters in Geneva (Image Source: Getty Images)

 

 

Government funding, donor grants, and industry fees are common financing options that NRAs utilize. And there are risks in over relying on a single source; hence, many agencies have elected to use a combination of the three rather than solely relying on one.

Regardless of the source, for an NRA to achieve maturity level 3 (ML3), it has to establish clear sources of funding that will allow it to adequately finance its budget and perform its mandate in a stable and sustainable manner.3

To ensure this is achieved, African countries should ensure that sources of funds for NRAs are ring-fenced through government policy, legal frameworks, and updated fee systems.4

 

 

Define clearly the amounts collected for fees, taxes, tariffs or dues payable and make them public

 

 

The amounts charged for services offered by the NRA should neither be ad hoc nor a secret.

Regulatory authorities need to establish a clear and concise document that indicates the exact fees, taxes, tariffs, or dues payable. This provides clarity, structure, and guidance to companies seeking to register a medical product, conduct a clinical trial, or set up a manufacturing plant.

Making these fees public also fosters a culture of transparency and predictability, allowing for scrutiny and audits and ensuring the proper channels are taken to collect all charges.

No regulatory authority can achieve WHO ML3 without defining all their fees as well as making this information available to the public.

Important to note: fees don’t have to be consistent with a pre-set universal standard fee. In fact, studies have shown great variability in the amounts charged for the different services offered by different NRAs.4

The regulatory fees charged by NRAs are ideally proportional to the market size of their jurisdictions.5 So, whatever the rates may be, the agency should just ensure that they are well defined and accessible to all.

Establish provisions relating to reduction or exemption of fees and other charges in defined situations for public health interest

 

 

The main role of the NRA is to facilitate, as opposed to being a barrier to accessing safe, effective, and quality health products by the public.

For a medicine regulator to show true maturity, it has to have mechanisms in place that prioritize public health and safety through exemptions during times of outbreaks, shortages, and emergencies.

The importance of these provisions was highlighted during the COVID-19 pandemic.

In 2020, as the world grappled with the new wave of deaths that swept across the globe, there was an urgent need for commodities such as ventilators, personal protective equipment (PPE), testing kits, and vaccines, whose consumption superseded their availability.

Major NRAs invoked their exemption clauses, allowing these lifesaving commodities (which were in extreme shortage at the time) to be fast-tracked during their registration and approval processes.6

This move saved many lives and laid the foundation upon which many countries were able to contain the virus.

This is the bare minimum for an NRA hoping to achieve level 4 maturity.

 

 

The NRA has authority to manage the funds allocated and/or generated internally

 

 

At the core of any national medicine regulatory authority is its ability to remain independent, autonomous, and unbiased in executing its mandate.

How it spends the income it generates or allocates through different budget lines should be an internal activity.

Unfortunately, this is not always the case.

In certain countries, income generated by NRAs is rerouted to the respective ministries, who dictate how the money should be spent. In turn, crippling some of the initiatives that may have been prioritized by these institutions.

Since the agencies are more in touch with the unique needs that they face, it is important, through legislation, policy, or otherwise, to gain authority to decide how to spend the allocated or internally generated funds.

It’s only through this that NRAs can be in contention to achieve maturity level 4 and be able to ensure that key issues with regards to regulatory oversight are prioritized.

 

 

The regulatory body should periodically publicize its budget

 

 

Ask key stakeholders, including NRA employees, how their annual budget looks, and half (maybe more) have no clue about the budget lines or contents therein.

This is by no means a fault of their own, since in most institutions, budgets are the purview of only a select few.

This is not the right practice.

 

 

 

 

Regulatory authorities that are striving to achieve maturity level 4 need to publicize their budgets, clearly indicating how much they intend to spend on the priority areas of regulation and oversight.

To ensure this occurs on a consistent basis, there should be legal provisions in place mandating these institutions to periodically publicize their budgets.

This creates transparency and trust towards the authority and attracts the necessary support for their activities.

 

 

Conclusion

 

 

When NRAs are not operating at their optimum, countries lose revenue, or worse, lives, as substandard and falsified medicines start to creep in through regulatory loopholes.

It is therefore vital for governments to ensure that these agencies are well funded and are granted the autonomy to drive the safe, quality, and effective medical products agenda.

At the end of the day, financing on its own may not be enough to achieve WHO maturity level 3/4, but it is certainly a key facet and starting point in strengthening the national regulatory systems and public health in general.

 

 

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