The COVID-19 pandemic revealed the vulnerability of Africa’s health care system. Despite the speed in the development of unprecedented volumes of COVID-19 vaccines, the vast majority of the African populace have limited access to these lifesaving products.
The pandemic emphasized the urgent need for a strong regulatory framework that strengthens domestic manufacturing capacity for pharmaceutical products and medical supplies.
However, the need for stringent and effective pharmaceutical product regulations didn’t start with COVID-19. Substandard and falsified medicines have plagued the continent for decades resulting in insufficient access to quality, safe, effective, and affordable medical products and pose an enormous challenge to achieving health security in Africa.
This opportunity can rapidly transform into reality by using the experience gained from a decade of harmonization activities on the continent, learnings gained during the pandemic and the swift implementation of modern and innovative solutions
Addressing these challenges, the African Union (AU) recently took a big step forward after at least 15 member states ratified the treaty to create the African Medicines Agency (AMA), a new continent-wide regulator that will complement national and regional efforts to protect and promote public health in Africa.
Journey towards regulatory harmonisation in Africa
Africa’s long journey towards regulatory harmonisation significantly began in 2009 with the establishment of the AU Development Agency’s African Medicines Regulatory Harmonization (AMRH) initiative to harmonize technical standards and optimize regulatory processes on the continent. The initiative includes 11 regional centres for regulatory excellence and the African Vaccines Regulatory Forum, which helped expedite vaccines for meningitis, malaria, and Ebola.
Building on this progress, in 2019, the AU Assembly adopted a treaty to establish the AMA to enhance regulatory oversight across the continent and complement national and regional efforts in developing a robust, predictable, accountable, and efficient regulatory system for medicines and health products. The ratification of the treaty by September 2021 allowed for the establishment of the AMA and, more recently, in July 2022, the AU approved Rwanda to host its headquarters.
Establishment of the AMA will revolutionise Africa’s pharma sector
The value of the AMA in harmonizing regulatory systems for pharmaceutical products across Africa holds tremendous benefits for the continent:
• Harmonising drug regulations: The AMA would play a critical role of coordinating and strengthening ongoing initiatives, such as the AMRH initiative to harmonize regulations on medicines and medical products marketed across Africa, as well as increasing the capacity of national regulatory authorities.
The establishment of clear, efficient, science-based regulatory pathways will encourage pharmaceutical companies to pursue approvals of medical products, by reducing the time, money, and effort required to register the same medical product in different countries.
• Strengthening local manufacturing capacity: The AMA will support the growth of local pharmaceutical production, evaluate medical products to treat priority diseases, coordinate joint reviews of clinical trial applications for vaccines and assessment of “highly complex” product dossiers and coordinate joint inspections of Active Pharmaceutical Ingredients (API) manufacturing sites.
• Harmonising standards to combat counterfeit medicines: As countries in Africa become more integrated into the global economy, with an increase in movement of goods and services, the AMA, by supporting the harmonization of regulations and providing guidance on the marketing authorization process, would assist joint country efforts for the control of a growing cross-border market of unregulated and fake medicines in circulation in the continent.
• Monitoring the safety and effectiveness of marketed medicines and vaccines: The AMA will coordinate and support pharmacovigilance on the continent, addressing concerns over the safety and effectiveness of drugs marketed in African countries. This will help overcome the pervasive distrust in pharmacological interventions among the population that has been sown by a history of unscrupulous pharmaceutical practices carried out in Africa.
Bloom Public Health and the African agenda
Given the selection of Rwanda to host the headquarters of the AMA, Bloom Public Health is well positioned to support the birthing of this great institution through our office in Rwanda.
The successful establishment of the AMA will require the full support of all relevant continental and international stakeholders to put in place robust organizational and oversight arrangements, and in operational matters, staffing issues, drawing up annual work programs and sustainable budgets, and the establishment of scientific committees and expert working groups to support countries.
Through strategic partnerships, Bloom Public Health will provide its expertise and wealth of experience in creating strategic roadmaps and technical support for the strengthening of the national regulatory systems and provision of evidence and risk-based interventions for the improvement of pharmaceutical quality systems.
It is noteworthy that Bloom Public Health was recently inaugurated along with global institutions such as WHO, UNICEF, and USAID, into the Technical Working Group (TWG) Committee that will support the mRNA technology transfer for local vaccine development and manufacturing in Nigeria.
The AMA has the unique opportunity to become one of the most efficient and modern regulatory systems in the world.
This opportunity can rapidly transform into reality by using the experience gained from a decade of harmonization activities on the continent, learnings gained during the pandemic and the swift implementation of modern and innovative solutions.
There is, therefore, a crucial need for all interested parties across the continent and beyond to join forces and support the AMA establishment within their area of influence.
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