The African Medicines Agency

: Impacts of a new supranational health agency on clinical research and access to medicines

Abstract

Background: Most African countries host only a few hundred trials per year and therefore few new medicines are marketed. Yet these countries suffer from numerous public health problems and lack accessible medicines to face them. To address these concerns the African Union (AU) established in 2019 a treaty to create a new health agency: the African Medicines Agency (AMA). Its objective is to strengthen the regulation of health products. Indeed, many African countries do not have the appropriate legal framework. This context makes access to health products complicated. In creating a continental agency, the AU's wish is to bring together the strengths of all African countries to improve their access to Medicines.
Aim: The aim of this work is to assess the impact that the creation of the AMA might have on clinical research and access to medicines. These effects will be assessed at the African continent level and to a lesser extent at the international level. This work will also provide an opportunity to explore the context of clinical research in Africa, which is not well represented on the world stage. Methods: The first part of the work is based on a review of the literature to formulate hypotheses. These will enable an evaluation of the potential impacts of the agency on Africa's relations with the public and private sectors and the international scene in general. In the second part of the study, these hypotheses will be confronted with the opinions of experts gathered through interviews.
Analysis: Literature and experts agree that the regulatory harmonisation objectives proposed by the AMA are necessary to allow better access to medicines. This harmonisation could stimulate the entry of industries that currently suffer from the complex regulatory context on the continent. The agency could also increase the regulatory capacity of less developed African countries and serve as an intermediary with international actors. However, this harmonisation must consider the specificities of the continent to avoid any drift to the detriment of the populations.
Conclusion: Numerous recent initiatives focused on Africa suggest that many actors anticipate the positive impacts of the agency. However, AMA is not yet fully operational and does not seem to want to focus on clinical trials first. In addition, there are disputes at a political level that are delaying the ratification of the treaty. Therefore, it is not possible to confirm any assumptions yet.

Date of Award	17 Jan 2023
Original language	English
Awarding Institution	University of Namur
Supervisor	Yves Geysels (Supervisor)