Access to quality-assured, safe, and efficacious medical products is fundamental to achieving Africa’s goal of Universal Health Coverage and attaining Sustainable Development Goal 3: Ensure Healthy Lives and Well-being for All. However, this can only be guaranteed by having effective medicines regulatory systems on the continent, which ensure that all pharmaceutical products on the market are safe, effective, and consistently meet approved quality standards.
The quality of medicines in a country is directly related to the stringency of its National Medicines Regulatory Authority (NMRA). Hence, for Africa’s medicine supply chains to resist the introduction of substandard or falsified medicines, the NMRA of each country needs to be strengthened. Robust and effective regulatory systems must possess five fundamental characteristics: they must be independent, predictable, outcome-oriented, risk-proportionate, and responsive. Unfortunately, most NMRAs in Africa are far from meeting these criteria.
The current state of medicines regulatory systems in Africa
Although there are 54 NMRAs and quasi NMRAs in Africa, most of them are incapable of performing the core functions expected of NMRAs; only 7% have moderately developed capacity with over 90% having minimal or no capacity.
The types of medicines that can be regulated by the NMRAs of respective African countries vary widely. In an analysis that was carried out on NMRAs within the WHO-AFRO region, it was reported that only 15% of these NMRAs had a legal mandate to carry out the full range of regulatory functions.
The challenges faced by NMRAs in Africa stem from a wide range of factors, including insufficient funding and unsustainable financing mechanisms, lack of an efficient and common medicines regulatory framework, and shortage of personnel to perform critical regulatory functions.
Strategies to strengthen medicines regulatory systems in Africa
The dream of the African Medicines Agency is to achieve a harmonisation of efforts made by the national and regional regulatory agencies, creating a unified continental regulatory framework that facilitates access to safe and affordable medicines across the continent.
Worthy of mention is the pivotal role of the WHO Global Benchmarking Tool (GBT). The GBT is a significant part of the five-step program created by the WHO to increase the capacity of NMRAs. By using the GBT, NMRAs are able to identify where their strengths and weaknesses lie, and then collaborate with the WHO and other international experts to carry out a formal benchmarking process and create an effective institutional development plan that is tailored to their unique needs. Unfortunately, most African countries are still at level 1 of the WHO GBT. Only the Food and Drug Authority (FDA) Ghana and FDA Tanzania have achieved a maturity level 3 (ML3) rating in Africa.
In view of these, key strategies to strengthen medicines regulatory systems in Africa include:
1. Strategic collaboration between NMRAs and stakeholders in the pharmaceutical and public health sector to provide expert guidance. There is a need to benchmark African NMRAs in a more transparent and objective manner, based on agreed criteria, to identify the different levels of capacities and performance. A good example of this strategic collaboration is the support provided by Bloom Public Health to African countries to establish a strategic plan and roadmap, which can lead to the migration of NMRAs to a high level of the WHO Global Benchmarking tool category.
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2. Establishment of a single centralising regulatory body for pharmaceuticals in Africa. The need to strengthen capacity for regulation of medical products and promote harmonisation across the continent led to the approval for the establishment of the centralised African Medicines Agency (AMA). However, slow bureaucratic procedures in several African countries have resulted in delays in the required treaty ratification. Although 19 countries have signed the treaty, 15 countries are required to ratify it, but it has only been ratified by 8 countries. There is an urgent need for other African governments to speed up all political processes required to ratify the treaty. When it becomes operational, the AMA is expected to work collaboratively with NMRAs to facilitate coordination of regional harmonisation efforts, provide technical guidance, and reduce duplication of efforts, ensuring cost-effective use of the scarce resources and sustainability.
3. Training of regulatory personnel and skills development. Most NMRAs in Africa lack qualified experts to perform critical regulatory functions. Reports indicate a general lack of qualified assessors and inspectors. There is a crucial need for increased investment by governments and development partners in the training of regulatory experts whose expertise and competencies can match key regulatory functions. It is important that NMRAs on the continent take advantage of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) membership to build the capacity of its inspectors as promoted by the Africa-wide PIC/S Initiative. There is an urgent need for massive capacity building, not just for inspectors, but also for other regulatory functions.
It is paramount to ensure the strengthening of medicines regulatory systems in Africa, as it is a non-negotiable pathway towards advancing the pharmaceutical industry, promoting public health, and building resilient health systems.
Professor Anyakora is the CEO of Bloom Public Health and a public health expert.
Odibeli is a pharmacist and the Research and Communications Coordinator at Bloom Public Health.
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