The African Medicines Agency was ratified: What's next?

The African Medicines Agency — a body aimed at harmonizing the regulation and standardization of medicines, health products, and technologies across the continent — has nearly met the threshold of coming into existence. It will be the second cross-continental African health agency, following the Africa Centres for Disease Control and Prevention. “The African Medicines Agency’s strongest role and voice would be in guiding the continent through regulatory matters,” said Dr. Margaret Agama-Anyetei, acting director of health and humanitarian affairs directorate at the African Union Commission. For the agency to come into existence, 15 countries needed to ratify the treaty that established it — through a legal process that varies depending on the country. They also need to submit the documentation certifying the national ratification of the treaty with the AU. So far, 16 countries have ratified the treaty but the AU is waiting on four of these countries to submit their documentation to reach that threshold. After receipt of documents from the 15th country, the treaty will come into force after 30 days, operationalizing the agency. The member states that ratified it can then make decisions on what form it will take. Algeria, Benin, Burkina Faso, Ghana, Guinea, Mali, Namibia, Niger, Rwanda, Seychelles, and Sierra Leone have ratified the treaty and submitted their documentation. Chad, Cameroon, Gabon, Morocco, and Tunisia have ratified the treaty but they still need to submit the paperwork. Eight others have signed but are yet to ratify the treaty. The big decisions When operationalized, the AU will host the first meeting of state parties that ratified the treaty. Following that, the meeting of the AU assembly of heads of state will take place at the beginning of next year, where a lot of the questions around operationalizing the agency are slated for discussion, Agama-Anyetei said. This includes discussions around which country will host the agency. The AU has invited countries to submit proposals looking at factors such as security, availability of housing, quality of schooling, health care access and capacity, and ease of travel will play a role. After it assesses country proposals, the AU will report back to the assembly at their meeting next year. “There will certainly be competition,” said John Mwangi, co-chair of the Africa Regulatory Network. “I can assume that any country would want to host a continental body.” The AU also needs to nominate the nine governing board members and recruit a director general, as well as establish rules and financial regulations for the agency. “How will it — in practical terms — be structured? What governance structures will be in place? What kind of regulatory activities will it start with?” Mwangi asked. It’s expected AMA will have a lean structure at the secretariat level, Agama-Anyetei said. Ensuring quality Regulation is a process, not an event, Agama-Anyetei said, and AMA is expected to help countries steer through it. The precursor to AMA is the African Medicines Regulatory Harmonization initiative, which works with African Regional Economic Communities, such as the East African Community, to harmonize health regulations and speed up registrations. While this initiative has worked to increase regulatory harmonization, it is still fragmented, Agama-Anyetei said. “AMA should become a reality in the next one year or so if everything goes well. I'm optimistic that in 2022, latest 2023, we'll see a ribbon-cutting.” --— John Mwangi, co-chair, Africa Regulatory Network While the AMRH is a bridge that led to AMA, it doesn’t have the structure of a regulatory agency, Mwangi said. In the current context, national authorities adopt global and regional guidance on standards locally, Agama-Anyetei said. This helps in efforts to ensure that when an imported product arrives on their shores, it meets standards. “It will be up to AMA to ensure that those standards, which have been set and agreed to at the global level, are met when dealing with the continent,” Agama-Anyetei said. AMA is expected to take on the responsibility of inspecting manufacturing plants outside of Africa, for pre-shipment assessments, to ensure products landing on the continent are of proper quality, she said. The continent also receives a lot of medical donations, and AMA will work to ensure these products are safe. There are also post-shipment inspections, as many of these products are repackaged or reassembled on the continent, and market surveillance, which involves assessing consumer markets to ensure that what’s available meets standards. Northern Africa has a sizable health manufacturing sector. But the products are not necessarily shipped to sub-Saharan Africa, Agama-Anyetei said. Instead, many find their way to markets in Europe or Asia. But a lot of north African countries have either signed or ratified the AMA treaty, which Agama-Anyetei hopes will increase the flow of these products across the continent. AMA is also expected to support countries that want to boost local manufacturing. “When you decide you want to manufacture, AMA should be involved right from the beginning in the frequent inspections of your plants and ... your products,” Agama-Anyetei said. In this work, the agency is expected to play a key role in targeting counterfeit drugs, which will help fight antimicrobial resistance. “The continent, unfortunately, is awash with fake drugs,” Agama-Anyetei said. Limited participation The ratification process signifies that a country is prepared to align its national laws with the “spirit and merit” of the treaty, Agama-Anyetei said. Broadly, AMA will not serve countries that haven’t ratified. This differs from the Africa CDC, which was birthed by a statute of the AU assembly, meaning all member states benefit from it. Because of this, there is ongoing advocacy to encourage more countries to ratify. “It's going to be the more, the merrier,” Agama-Anyetei said. Michel Sidibé, former minister at Health and Social Affairs of Mali and former executive director at UNAIDS, is the AU’s special envoy for AMA, encouraging countries to ratify. Right now, key influential countries — such as Kenya, South Africa, and Nigeria — have not ratified the treaty, Mwangi said. “My perception is, especially for the big countries, there could be fear of losing control,” he said. Because of the porous borders on the continent — if a country that ratified is next to one that hasn’t, poor quality drugs can flow between the two. This makes post-market surveillance extremely important, Agama-Anyetei said, adding the agency will also help with cross-border negotiations. But even so, it's expected there are other ways for the agency to represent a broader base of countries. If a regional economic community, for example, asks AMA to represent it, this will draw in countries that are part of that regional economic community that haven’t ratified. “AMA, therefore, then becomes the centralized voice of member states,” Agama-Anyetei said. The launch The actual launch of the agency is yet to be determined. “AMA should become a reality in the next one year or so if everything goes well,” Mwangi said. “I'm optimistic that in 2022, latest 2023, we'll see a ribbon-cutting.” And building up the institution is a process. In the years to come, the agency needs to build its reputation, Agama-Anyetei said, adding that she hopes funding for the agency comes from “everyone, everywhere, and anywhere.” “It will all be about credibility, transparency, and good leadership to attract the funds, invest them, and use them wisely and maintain relationships,” Agama-Anyetei said.