Africa’s most powerful countries need to ratify the African Medicines Agency (AMA) to ensure its credibility – and civil society organisations can lobby them to do so , said Dr Michel Sidibe, the African Union’s (AU) Special Representative on the AMA.

“It is important to have countries like South Africa, Nigeria, Kenya, Ethiopia, the DRC, and other countries on the continent ratifying the treaty. It is important to continue for the credibility of the AMA to drive the ratification agenda, and it is very important to not lose momentum,” Sidibe told a webinar organised by the African Medicines Agency Treaty Alliance (AMATA), a civil society network that supports AMA’s formation.

“We don’t have another way to do it except making sure that we maintain we sustained our advocacy and we mobilise political leaders,” he added, commending AMATA for its advocacy work in support of AMA.

The aim of AMA is to harmonise the regulatory system for medical products across the continent’s 55 nations to enable faster approval processes and to support local pharmaceutical production.

But its establishment has been slow, first starting back in 2009. In February 2019, the  AU adopted a treaty to establish the agency but it took until November of that year before the bare minimum of 15 member state had ratified the treaty, enabling the AU to move ahead to set it up.

In July this year, the AU selected Rwanda as the host for AMA, and Sidibe said that he was confident the process of operationalising the agency would move fast in the hands of Rwanda’s President Paul Kagame.

World Health Organization (WHO) Director General Dr Tedros Adhanom Ghebreyesus met Kagame on the sidelines of the UN General Assembly in New York last week to offer WHO’s support for AMA.

Great conversation with my brother @PaulKagame about the African Medicines Agency – I assured him of @WHO’s commitment to continue providing technical and financial support to make it a success together with a strong continental regulatory body. #UNGA pic.twitter.com/sQZ1g6Arnr

— Tedros Adhanom Ghebreyesus (@DrTedros) September 24, 2022

“Our continent cannot be always the second in line when we have a crisis. When I was UNAIDS Executive Director, we waited for seven years before getting the [antiretroviral] drugs to the poor people,” said Sidibe. 

“Global health security will not happen without making sure that we can provide our poor people with quality medicine that is affordable. Almost 95% of our medicines are coming from abroad when India is importing a maximum of 15% and China 5% for the same level of population.”

Sidibe has been lobbying African countries extensively himself to ensure their ratification of AMA, and so far 22 countries have done so “after intensive engagement and interaction”, he said. 

Processes to make AMA functional

Sidibe said that he expected the AMA office in Rwanda to become operational “soon”, but outlined six processes to ensure that the agency is fully functional:

• Ensuring its ratification by all countries, particularly Africa’s largest and wealthiest countries
• Articulate the AMA strategy and plan widely to ensure it has the support of the continent
• Develop a funding strategy and roadmap for fundraising
• Start to build the skeleton of the organisation, including identifying its major functions and leaders
• Build AMA partnerships and coalitions. 
• Identify and deliver three to five major impacts for AMA in order to establish its credibility.

Stressing that these six points were his personal views, Sidibe called for the launch of “the first replenishment for an African-based health institution” to secure money for AMA’s future.

“The ratification process has highlighted the importance of critical stakeholders – regulators, researchers, academic institutions, private industry and passionate civil society organisations,” said Sidibe.

“AMA should not be just replacing national regulatory authorities or regional harmonisation processes. I think it will be a huge mistake and it will not work. AMA will just come in complement of those and a strong AMA will depend on strong national capacities,” stressed Sidibe, appealing to academics and civil society to help strengthen ethics committees and the implementation capacity of weaker countries.