Rwanda, the AMA Headquarter announced it was hosting the WHO benchmarking team on 29 October - so when will the results be available?

On October 29th Rwanda announced on LinkedIn and X that it was again hosting the WHO Regulatory Systems Strengthening for a two day mission to complete the WHO Benchmarking assessment of whether Rwanda has reached Maturity Level 3 of the World Health Organisation (WHO) Global Benchmarking Tool (GBT) following un unsuccessful assessment earlier this year and a fourth attempt since 2022. The WHO assessment of regulatory authorities is based on the Global Benchmarking Tool, which checks regulatory functions against a set of more than 260 indicators beginning with ML1 describing the existence of some basic elements of a regulatory system. Maturity level 3 confirms a stable, well-functioning and integrated regulatory system is in place. The highest level, maturity level 4, is achieved by a regulatory system operating at an advanced level of performance and with continuous improvement. Rwanda which is currently a maturity level 2 authority meaning that it is “still evolving and partially performs essential regulatory functions” said that this was an important milestone on its journey to be recognized as a competent authority meeting international standards for healthcare product regulation.

If it succeeds, Rwanda would join six national medicines regulatory authorities that are mature and operating at level 3 maturity – that is South Africa, Zimbabwe, Ghana, Tanzania, Nigeria and Egypt. Almost six weeks have passed since the WHO assessment, but the results have not been announced by either the WHO or Rwanda. Meanwhile, there are rumors that the WHO did in fact recommend Rwanda for ML3 status which if true would be a good thing. However, if this is the case, it raises an important question. Why is the WHO taking so long to make its recommendation public? Could it be that there is no consensus on whether Rwanda has indeed reached maturity level 3 and is it normal for the WHO to reach this kind of decision and not announce it? If it is, how does the appearance of lack of transparency impact how countries perceive the WHO processes? Why should the results of Rwanda FDA be made public? There are a number of reasons.

First of all, Rwanda is not just any country. It is the hosting country for the African Medicines Agency. If Rwanda fails to attain this milestone, it would result in a situation where a country with an ML2 authority is the host of the African Medicines Agency , an agency with a mandate to drive the development of the African medicines regulatory environment and its harmonization. That an under-developed regulatory environment would host the African Medicines Agency when there are six nations with higher level maturity might cause embarrassment. As a result, there is tremendous politically pressure for Rwanda to reach this milestone. The question however, is whether political necessity and the technical practical reality of where Rwanda is in its regulatory development are aligned? Also, many donor organizations and African experts have worked hard to support Rwanda FDA with technical expertise and financial resources needed to achieve this. As a young agency created in 2019 , it appears that it needed extraordinary support to be able to make the transition and it has received significant donor support in kind and financially with millions of dollar invested in its effort. In the interest of transparency and accountability, those who have supported Rwanda deserve to know the outcome of WHO’s October assessment.

What is at risk from such a long delay is that it may create the impression that Rwanda FDA has not reached this technical milestone and the only reason it may achieve it is for political expediency. If one considers that for the October assessment, Rwanda had big backlogs of applications for marketing approval that was an open secret know across the continent and yet, the hope was that in spite of that glaring gap, Rwanda would still succeed might suggest an expectation that Rwanda might be treated differently. If the results were simply announced, it would stop speculations about the real reasons behind this long delay and what it means. Millions of dollars on donor funds may have been invested to help Rwanda achieve this milestone which means that people and resources are not the limitation. After four attempts to achieve ML3 with unclear results, one has to wonder, what is standing in Rwanda’s way and whether the country simply needs more to develop. Clearly, achieving the WHO benchmarking is a journey that takes time to make and cover the distance.

The issue of Rwanda FDA’s assessment outcomes is a matter of public interest to African people and African institutions. This is because Rwanda is the hosting nation of the African Medicines Medicines Agency, which has the responsibility to support regulators across the continent do a better job of protecting the safety of patients on the African continent including by reducing the prevalence of counterfeited medical products killing Africans. There is also a question of transparency or its lack thereof. How regulatory agencies perceive the transparency of WHO processes impacts their perceptions about the outcomes of those processes and their confidence and trust in them which affects regulatory development of the region. The appearance of being secretive about the Rwanda FDA’s benchmarking results is damaging to the credibility of the process and its outcomes.

This matters for Africa’s regulatory harmonization efforts with Rwanda as the headquarters of the African Medicines Agency. Rwanda should set an example of  its commitment to transparency and accountability by asking the WHO to make public the results of its recent assessment. It is expected that Rwanda will succeed in attaining the ML3 status and when it does, Rwanda should also consider releasing its WHO assessment results as Zimbabwe has done calling others to do so in order to demonstrate that it did not achieve that milestone for reasons of political expediency. It earned it. Such transparency will inspire confidence and trust in Rwanda as the host of the headquarters of the AMA who wields tremendous power in the African Medicines Agency as a member of the board of the African Medicines Agency. Rwanda can of course choose not to do either and people will speculate and make their own conclusion about these developments.

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