NAIROBI — The African Union needs the legal commitment of 13 countries in order to set up a continentwide regulatory agency tasked with ensuring access to safe, effective, and good quality medicine and health technologies.
The African Medicines Agency would work to harmonize regulations on products such as drugs, vaccines, medical devices, blood products, diagnostic tools, and traditional medicine across Africa. It would also create a unified voice that would hopefully give the continent more leverage in global negotiations with pharmaceutical companies and others, said Dr. Margaret Agama-Anyetei, head of health, nutrition, and population at the African Union Commission.
“We need one continental body, at the highest level, to speak on behalf of everybody,” she said.
If established in the coming years, AMA could help African nations to fight COVID-19 by ensuring that only high-quality drugs, vaccines, and other health-related supplies developed to fight the virus reach African populations.
“Instead of talking to eight regional economic communities or 55 countries, you have one organization speaking on behalf of the continent.”
— Dr. Margaret Agama-Anyetei, head of health, nutrition, and population, African Union CommissionHarmonizing regulations
Currently, there is a patchwork of regulations from country to country — some countries have strong medicine regulatory bodies, while others have none at all, Agama-Anyetei said. Because of the porous nature of the borders across the continent, drugs can enter the continent through one country with a weak system and find their way into the markets of other countries.
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“If you have fake drugs, which can land on the beach somewhere in one country and enter its market, it can now easily cross the border into other markets,” Agama-Anyetei said. “With the COVID pandemic, we are already seeing that fake drugs and medicines are floating across the continent.”
Currently, regulatory coordination happens at a regional level. The African Medicines Regulatory Harmonization Initiative, led by AUDA-NEPAD, the African Union’s development agency, works with the eight regional economic communities across the continent. But this system is not harmonized, Agama-Anyetei said, and the different economic communities have varying standards of regulation.
AMA would create a harmonized platform for global players in health, such as the Gavi, the Vaccine Alliance, to engage with the continent as a whole.
“Instead of talking to eight regional economic communities or 55 countries, you have one organization speaking on behalf of the continent,” she said.
The agency would also coordinate application reviews for clinical trials.
The treaty to establish AMA was endorsed by African leaders in February 2019. AMA needs the signature and ratification of 15 African Union members before it can come into force. Algeria, Benin, Chad, Gabon, Ghana, Guinea, Madagascar, Mali, Morocco, Niger, Rwanda, Saharawi Arab Republic, Senegal, Sierra Leone, Seychelles, and Tunisia have signed it. But only two countries — Mali and Rwanda — have ratified it. A number of countries have told AU that they are close to ratification, Agama-Anyetei said.
Ratification is a national process where a country puts in place a law that allows it to implement the AMA treaty. But this process has been slow and is the main barrier currently facing efforts to bring the agency into existence — further exacerbated by the pandemic.
“COVID has slowed down the ratification processes in many countries because national systems are preoccupied with COVID,” Agama-Anyetei said.
Agama-Anyetei said she hopes that enough countries will ratify the treaty by the next African Union assembly meeting in February. Following its ratification, the AU would release a call for bids to host the agency’s headquarters.
The agency would follow a similar mandate to other global medicine regulatory agencies, such as the European Medicines Agency and the U.S. Food and Drug Administration, which craft central agreements on regulations that govern the territories they cover.
The future director-general and governing board of AMA will determine many functions of the agency following its establishment.
Fighting COVID-19
Because AMA is not yet established, it's not functioning within the context of the ongoing COVID-19 pandemic.
Currently, the Africa Centres for Disease Control is leading the continentwide response in addressing the pandemic — but this agency is focused on detection, surveillance, and testing. Once AMA is established, the two agencies would work closely together, Agama-Anyetei said.
Estimates suggest that potential vaccines for COVID-19 might not be available for another year, or longer. Health experts hope that an effective treatment might be found sooner.
Once a vaccine is developed or effective treatments are found, AMA, if established in the coming years, could lead discussions with the global community around access to quality drugs and vaccines, Agama-Anyetei said.
“We are all hoping that whatever drug is approved will be approved as quickly as possible because our world has come to a standstill. And given that we only have two ratifications, I cannot tie AMA down to COVID. What I can say is that once it's established, it will definitely hit the ground running,” she said.
