By Iyemah David
The African Union has renewed pressure on the remaining 24 member states to ratify the African Medicines Agency (AMA) Treaty to safeguard the continent against substandard and falsified medical products.
This is contained in a statement issued by the African Medicines Agency (AMA) on Monday in Abuja.
The renewed push came at a High-Level Presidential Breakfast convened by the AMA on the margins of the 39th Ordinary Session of the Assembly of Heads of State and Government of the African Union in Addis Ababa.
The meeting brought together Heads of State and Government, AU leadership, and senior representatives of key continental institutions, including the Africa Centres for Disease Control and Prevention (Africa CDC), and the African Continental Free Trade Area Secretariat, (AfCFTA) to accelerate universal ratification, strengthen governance structures, and secure sustainable financing for the Agency.
Although 31 of the AU’s 55 Member States have ratified the AMA Treaty, leaders expressed concern that the remaining 24 countries have yet to do so, creating regulatory gaps that weaken continental protection against unsafe medical products.
It noted that while the AMA headquarters in Kigali has been operationalised and foundational structures are in place, full functionality depends on universal ratification and domestication of the Treaty across Member States.
It quoted Vice President of Seychelles, Mr Sebastien Pillay, who reaffirmed his country’s political and financial commitment to the Agency, announcing a contribution of 200,000 dollars, double the 100,000 dollars seed funding required of State Parties.
Pillay urged larger economies on the continent to demonstrate similar commitment, stressing that a robust continental regulator would enhance Africa’s pharmaceutical manufacturing capacity and competitiveness.
Tunisia’s Minister of Health, Dr Mustapha Ferjani, underscored the centrality of regulatory sovereignty to Africa’s broader health and economic ambitions.
“Today, a single truth imposes itself: Africa’s health sovereignty depends on regulatory sovereignty,” he said.
Dr Ferjani called for urgent ratification and strengthened institutional capacity, urging Member States to equip the Agency with adequate resources, technical skills, clear procedures and effective governance systems.
“Our people deserve it, our health security demands it, and our sovereignty depends on it,” he added.
Dr Delese Mimi Darko, Director General, AMA, updated leaders on progress made since the Treaty’s adoption in 2019, noting that the Agency has transitioned from a legal framework on paper to a functioning continental institution.
“Over the past five years, we have moved from a Treaty on paper to a living institution,” she said.
Darko outlined the Agency’s 2030 targets, including achieving universal ratification, attaining World Health Organisation (WHO) Listed Authority status, and becoming financially self-reliant.
She explained that the AMA is already collaborating with ratifying Member States to strengthen national regulatory systems, streamline joint assessments of medical products and promote reliance mechanisms that reduce duplication and accelerate approvals.
Meanwhile, the AU Commissioner for Health, Humanitarian Affairs and Social Development, Ambassador Amma Twum-Amoah, described the AMA as a strategic pillar of the continent’s health and development architecture.
She said universal ratification and sustainable financing were achievable within the current political cycle, positioning the Agency as integral to delivering on the African Health Strategy 2030 and Agenda 2063.
Amb. Twum-Amoah said that the Assembly’s deliberations framed the AMA not only as a health initiative but also as a key driver of industrialisation and intra-African trade, particularly within the context of the AfCFTA.
Experts at the meeting noted that a unified African medicines regulatory system would boost investor confidence, support local pharmaceutical manufacturing, facilitate cross-border trade in medical products, and strengthen Africa’s collective bargaining power in global health markets.
AU Heads of State and Government adopted the AMA Treaty during their 32nd Ordinary Session in February 2019.
The Agency is mandated to enhance the capacity of State Parties and AU-recognised Regional Economic Communities to regulate medical products effectively, improving access to quality, safe and efficacious medicines across the continent.
It builds on the African Medicines Regulatory Harmonisation initiative launched in 2009 and is the AU’s second specialised health agency, after the Africa CDC.
With global health security challenges becoming increasingly complex, from pandemics to antimicrobial resistance, African leaders emphasised that regulatory convergence through the AMA is no longer optional but imperative.
The 39th AU Assembly thus marked a defining moment in Africa’s pursuit of health sovereignty, as leaders signalled readiness to transform political commitments into concrete legal and financial action aimed at protecting the continent’s 1.4 billion people.
As calls for universal ratification intensify, the focus now shifts to whether the remaining Member States will act swiftly to close the regulatory gaps and unlock the full benefits of a unified African medicines regulatory authority.
