Africa’s most powerful countries need to ratify African Medicines Agency (AMA) In order to ensure their credibility – and civil society organizations can pressure them to do so, said Dr. Michel Sidibe, Special Representative of the African Union (AU) at the AMA.
“It is important that countries such as South Africa, Nigeria, Kenya, Ethiopia, the Democratic Republic of the Congo and other countries on the continent ratify the treaty,” Sidibe said at a webinar organized by the African Medicines Agency Treaty Alliance (AMATA), a civil society network that supports the formation of the AMA.
“We have no other way to do this except to make sure that we maintain the sustainability of our advocacy and mobilize political leaders,” he added, praising AMATA’s advocacy work in support of the AMA.
The goal of the AMA is to harmonize the regulatory system for medicinal products across the continent’s 55 countries to enable faster approval processes and support local pharmaceutical production.
But its establishment has been slow, as it first began in 2009. In February 2019, the African Union adopted a treaty to establish the agency, but it took until November of that year before at least 15 member states ratified the treaty, enabling the African Union to move forward to prepare it .
In July this year, AU Rwanda choice As the host of the AMA, Sidibe said he is confident that the process of operationalizing the agency will move swiftly into the hands of Rwandan President Paul Kagame.
WHO Director-General Dr Tedros Adhanom Ghebreyesus met Kagame on the sidelines of the United Nations General Assembly in New York last week to offer WHO support for the AMA.
Great conversation with my brother Tweet embed About the African Medicines Agency – assured him @Who is theIts commitment to continue providing technical and financial support to make it a success along with a strong continental regulatory body. #UNGA pic.twitter.com/sQZ1g6Arnr
– Tedros Adhanom Ghebreyesus (@DrTedros) September 24, 2022
“Our continent cannot always be second in line when we face a crisis. When I was the Executive Director of UNAIDS, we waited for seven years before we got [antiretroviral] “Drugs are for the poor,” Sidibe said.
Global health security will not be achieved without making sure that we can provide our poor with affordable, high-quality medicines. Almost 95% of our medicines come from abroad when India imports a maximum of 15% and China 5% for the same level of the population.”
He said Sidibe has been lobbying African countries extensively to ensure they ratify the AMA, and so far 22 countries have done so “after extensive participation and interaction”.
Operations to make AMA functional
Sidibe said he expects the AMA’s office in Rwanda to start operating “soon,” but has outlined six processes to ensure the agency is fully operational:
- Ensure that it is ratified by all countries, especially the largest and richest countries in Africa
- Formulating the AMA’s strategy and planning at scale to ensure it has the continent’s support
- Develop a funding strategy and fundraising roadmap
- Start building the skeleton of the organization, including identifying its main functions and leaders
- Building AMA Partnerships and Coalitions.
- Identify and present three to five major AMA influences in order to establish their credibility.
Emphasizing that these six points were his personal views, he called for Sidibe to launch “the first renovation of an African-based health institution” to secure funds for the future of the AMA.
“The ratification process has highlighted the importance of the primary stakeholders – regulators, researchers, academic institutions, private industry and enthusiastic civil society organizations,” said Sidibe.
“The AMA should not just be replacing national regulatory authorities or regional coordination processes. I think it would be a huge mistake and it will not work. It would be a huge mistake and it will not work,” stressed Sidibe, appealing to academics and civil society to help strengthen ethics committees and enforcement capacity in weaker countries, “The AMA will just come as a complement to those, and will adopt Strong AMA on strong national capabilities.”
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