Ministers of Health from four African countries (Algeria, Democratic Republic of Congo, Egypt and Cabo Verde), representatives from international organizations, patient groups and the pharmaceutical industry reiterated today at a high-level roundtable event the urgency of establishing a regulatory authority across Africa, especially in the context of the COVID-19 pandemic. The current fragmented regulatory systems across the continent are making it difficult to mount an appropriate response.

Ministers of Health and roundtable participants outlined the first areas of work for the AMA and agreed that it has the unique opportunity to become one of the most efficient and modern regulatory systems in the world. Once established, it will perform a vital task in overseeing rapid and effective market authorisation of safe, quality, effective and accessible vaccines, medicines, and health devices to control and treat disease across Africa to robust regulatory standards. Crucially, it will foster reliance and regulatory harmonization across the continent. In practice, this means that national regulatory authorities will be able to build on the work done by counterparts in other countries, significantly cutting down the time it takes for medicines, vaccines or diagnostics to reach the market. For many countries, the AMA also holds the promise of driving industrial and economic growth, through encouraging the development of local pharmaceutical industry and the establishment of centres of excellence for research across the continent.

But while commitment to the AMA mission and vision is strong, it has not translated into concrete actions. A new cross-stakeholder alliance announced at the roundtable, the African Medicines Agency Treaty Alliance (AMATA), will seek to push for rapid ratification of the Treaty, as well as meaningful engagement with patients, industry and other relevant parties once the Agency becomes operational.

Michel Sidibé, Special Envoy of the African Union, said: “The delay in establishing the African Medicines Agency is hindering much-needed improvement of the regulation of medicines, medical products and technologies across the continent. I am heartened to see the launch of the African Medicines Agency Treaty Alliance, today and urge ministers of health who have not yet done so, to set the process in motion for the rapid ratification of the AMA”.

Kawaldip Sehmi, CEO of IAPO, said: “The launch of the African Medicines Agency Treaty Alliance represents a key milestone in our campaign for patients’ interest in Africa. Respecting the principle of ‘nothing about us without us’, we are stressing that the AMA needs to establish a particular framework and structure to engage with African patients and consumers like their European or American counterparts already do”.

Karim Bendhaou, chair of the IFPMA Africa engagement committee echoed the new alliance’s goals: “The African Medicines Agency will contribute to regulatory harmonization across Africa to enable collaboration, work-sharing and the use of reliance procedures, which will mean a win-win for national regulators, patients and industry. We hope we’re reaching a tipping point on establishing the AMA and hope to see significant progress in the ratification process by the end of the year”.

Philippe Lamoureux, Director general of Leem, said: “We are delighted to support this initiative and look forward to engaging with the AMA Treaty Alliance to achieve its goals for better patient access to medicines in Africa”.