Best Practices for Strengthening African Regulatory Systems
February 19, 2025
The client was an international charitable foundation that funds research on pressing global health challenges.
Access to safe, quality-assured and efficacious medical products poses a significant challenge on the continent of Africa. This is partly due to weak regulatory systems, limited capacity and inadequate human resources in national medicines regulatory authorities (NRAs), a lack of regulatory harmonisation and a legal mandate to perform all critical regulatory functions. For context, in sub-Saharan Africa, 40 out of 46 countries have legislation dealing with medicines regulation, and only 15% of the NRAs have a legal mandate to perform all critical regulatory functions.
To address this challenge, the African Union (AU) Model Law on Medical Products Regulation was adopted in January 2016 by African Heads of State and Government at an AU summit. Among other aims, the intention of the AU Model Law is to provide a comprehensive legislative template that can be used by African countries and regional economic communities to achieve regulatory harmonisation in line with international standards and best practices. The AU Model Law also outlines key regulatory functions and standards that should be part of a well-functioning regulatory system, to ensure that patients have access to quality-assured, safe and efficacious medical products. Seven years after the adoption of the AU Model Law, only 15 countries were reported to have completed the process of domestication – incorporating essential provisions of the model law to make it applicable and enforceable in a country’s own legal framework. Without domestication at the national level, the Model Law would have limited effect on protecting populations. The African Medicines Regulatory Harmonisation (AMRH) initiative sought to accelerate the domestication of the AU Model Law in at least 30 African countries, building on lessons learned from the countries that have already undergone domestication. The AMRH initiative also sought to update some substantive provisions of the AU Model Law in response to new developments in the medical product regulatory environment.
To support the accomplishment of these aims, Market Access Africa was contracted to undertake a study to understand the best practices, challenges and lessons learnedfrom countries that had initiated the process of domesticating the AU Model Law.
Over the course of this three-phase project, Market Access Africa began by reviewing and refining the domestication process of the AU Model Law across select African countries. Leveraging in-depth analyses and broad stakeholder engagement, best practices and challenges were identified from the 13 early adopter countries, and recommendations subsequently developed to improve future adoptions of the law.
The work involved a detailed examination of the AU Model Law itself, identifying areas of potential improvement, and considering the inclusion of provisions reflective of international best practices and recent advancements in medicine regulation. Drawing on this evaluation, we proposed draft provisions and amendments aimed at enhancing the law's efficacy and applicability. Finally, we developed an adaptable and detailed operationalisation roadmap for future domestications from our findings. This roadmap, formulated through a collaborative design sprint, now serves as a robust guide for the client and other stakeholders, streamlining the adoption process in additional countries.
This initiative sought to ensure that the AU Model Law remains relevant, effective, and aligned with the rapidly evolving field of medicine regulation, ultimately enhancing public health across the continent.
The insights from our analyses are now the basis for a reinvigorated approach to providing technical support to accelerate the domestication process in countries. Our findings and proposed amendments on the Model Law were presented to continental policymakers and leaders. This included a formal submission of the Draft Model Law to the African Ministers of Health, the AU Specialised Technical Committee on Health, Population and Drug Control and the Specialised Technical Committee on Justice and Legal Affairs. The proposed amendments to the AU Model Law are now under consideration and awaiting endorsement by the relevant continental bodies prior to rollout. MAA’s contributions are supporting the African Union in its efforts to ensdure that the AU Model Law remains relevant, effective, and aligned with the rapidly evolving field of medicine regulation, ultimately enhancing public health across the continent.
