Next up for the African Medicines Agency: Appoint a director general

The African Medicines Agency, a specialized health agency of the African Union, enters into another year of setting up its structures. Key to this is the appointment of a director general, which some speculate could happen in the coming months. Once operationalized, the new agency will be tasked with improving regulatory harmonization of medicines across the continent. Countries across the continent face challenges in ensuring medicines are not fake or substandard and fragmented, often weak regulatory systems and porous borders make fighting this difficult. The continent currently imports the majority of its drugs and vaccines so countries are also working to boost their pharmaceutical manufacturing sectors. Because of this, AMA is expected to play many roles, such as ensuring the quality of drugs that are imported, providing scientific guidelines, as well as ensuring the quality of drugs manufactured locally is up to par. Setting up the agency has been a slow process, years in the making — even though there are growing calls for its rapid establishment. The AMA treaty was adopted in 2019 by African heads of state and what has followed is a process of encouraging countries to ratify the treaty. The AU reached the threshold to move forward with operationalization in 2021, when 15 countries ratified the treaty. The process of encouraging more countries to sign and then ratify, as well as creating the structures of the new agency, is ongoing. According to a research officer for AMA, 23 countries have ratified the treaty, 30 have only signed the treaty, and 22 countries have neither signed nor ratified. AMA is the AU's second cross-continental health agency, after the Africa Centres for Disease Control and Prevention. AMA’s new home In July, Rwanda was chosen to host AMA. The country is becoming a hub for health initiatives; last year it was also chosen to host the new African Pharmaceutical Technology Foundation, as well as a BioNTech messenger RNA vaccine manufacturing facility. In an interview with Devex on his last day in office in late November, Dr. Daniel Ngamije, the former minister of health, said the country is currently in the middle of negotiating the host agreement — which outlines the responsibility for the host country and AMA — which he expects will be signed by both parties early this year. The search for a host country was a competitive process, in which countries put forth their offering. Ngamije said the AU had a list of more than 175 points that countries had to address in their proposals. As part of its offering, Rwanda put forth a fully equipped building to serve as AMA’s headquarters, as well as offered the new agency the use of its national laboratory for the first five years, as AMA constructs its own lab. He said Rwanda has laws that encourage international agencies to settle in the country that include tax exemptions and that facilitate the relocation of foreign staff within its borders, such as making it easy to import cars from abroad. He said the Rwanda Development Board works to ensure these processes run smoothly. “Rwanda is competitive for its strong leadership, clear vision of what we want and how we want to reach our vision, strong enabling environment with good governance, legal frameworks, and engagement with all stakeholders,” Ngamije said. Defining its structure Some of the key partners in establishing AMA are the African Union Commission, the AU Development Agency, or AUDA-NEPAD, the World Health Organization, and Africa CDC. The African Medicines Regulatory Harmonization program, which commenced in 2009, is seen as the foundation on which AMA is built. Last year, the AU Conference of State Parties of AMA held their first ordinary, as well as their first extraordinary session, where they began laying the groundwork for AMA’s operationalization. During a press briefing at the International Conference on Public Health in Africa held in Kigali in December, Dr. Ahmed Ogwell Ouma, the acting director of the Africa CDC, said the next key step is putting the leadership of AMA in place. He said the AU has initiated the process of recruitment for the new director general. The director general will be appointed by the AU Conference of State Parties of AMA upon recommendations of the governing board. “We are looking forward to that happening quickly,” Ouma said. The AU Commission’s department for health, humanitarian affairs and social development, where AMA is housed, have also created a technical team to establish the governing structures to provide a path forward for the new leadership, Ouma said. In November, the AU Conference of State Parties of AMA also set forth the process of appointment of members of AMA’s governing board. A statement published by the African Medicines Agency Treaty Alliance in December called for AMA’s headquarters in Rwanda to become operational and the appointment of a director general to happen “without undue delay.” Ouma said that in the meantime, Africa CDC is working to strengthen the network of national and regional regulatory authorities on the continent, because they will serve as “the strong base for AMA.” Dr. Githinji Gitahi, the group CEO of Amref Health Africa, told Devex that AMA needs a coordination framework which will provide a foundation for this network of national regulators across the continent to work together. Each national regulator has domestic laws that govern their operations. AMA cannot overtake sovereign laws, so it needs a clear regulatory coordination framework that respects sovereign law and regulation, he said. AMA also needs legal instruments supported by the AU so that this coordination is not dependent simply on goodwill. AMA will also need to achieve the WHO threshold of becoming a Stringent Regulatory Authority, Gitahi said, which brings with it levels of international respect and recognition — so that products regulated and manufactured on the continent are accepted globally. But a lot of these are longer-term aims, whereas he said realistically this year the AU is likely to continue focusing on setting up AMA’s structures. Even though not all African countries have ratified AMA, Gitahi said he’s not concerned. As with other AU instruments, such as the African Continental Free Trade Agreement, implementation moves forward even without the participation of every country. "We shouldn't worry that some countries haven't ratified. We should say that we have an adequate number of critical mass that have ratified it and that allows us to start,” he said, adding that ratification at the country level is a complex process, involving approval by parliament. Managing the rhetoric Ensuring adequate levels of sustainable funding and expertise will also be critical, Karrar Karrar, interim head of health policy at Save the Children UK, told Devex. Regulatory authorities are often constrained by a lack of technical capacity needed to assess regulatory dossiers of products seeking approval. This can create long delays in gaining access to certain markets. The longer that process takes, the more companies lose out on potential revenues they could otherwise be earning. Karrar said he expects that one of the issues for AMA in its infancy might be the volume of work. “How do you not become a victim of your success and all of a sudden, on day one of operations, you have hundreds of dossiers on your desk?” he said. “For this reason, it is critical to manage expectation and rhetoric to ensure AMA achieves its goals and becomes a success.”