Increasing access to quality-assured, safe and effective health technologies across Africa

By Access and Delivery Partnership

Harmonizing regulatory systems and improving regulatory efficiency, which will speed up access to COVID-19 vaccines and other health technologies across Africa, has taken on greater urgency during the COVID-19 pandemic. Photo: Braňo on Unsplash

The high disease burden and mortality rate from preventable diseases on the African continent is attributed in part to inadequacies in national health systems, and to the lack of access to safe, quality-assured and efficacious medicines and other health technologies. The increasing demand for health technologies warrants urgent focus and investment in their effective regulation.

In many countries, there are still limited capacity and resources to approve medicines and other health technologies in a timely manner and to ensure adherence to quality, safety and efficacy standards. Another persistent challenge is weak, outdated or varying national policy frameworks. This can lead to differences in application requirements across countries, which result in researchers and manufacturers navigating multiple regulatory systems to register the same health technology.

Harmonized policy frameworks can provide a foundation for effective regulation, as well as being a force for increased collaboration. Recognizing this, the Access and Delivery Partnership (ADP) has supported the development and ongoing implementation of the African Union (AU) Model Law on Medical Products Regulation. So far, 19 countries have domesticated the law in part or in full.

The AU Model Law, endorsed by the AU Member States in 2016, serves as a template for countries to strengthen and align their regulatory frameworks, which is critical to improving the predictability and efficiency of regulatory approvals. The law is one of two key pillars of the African Medicines Regulatory Harmonization initiative, which aims to remove regulatory barriers that hinder patient access to health technologies in Africa through regional harmonization and capacity-strengthening. Regional harmonization initiatives of this kind have been shown to reduce duplication of regulatory reviews, facilitate mutual recognition and accelerate access, expediting the delivery of new health technologies.

Increasing access to quality-assured, safe and effective health technologies across Africa

ADP provided expert legal advice and technical support throughout the process of developing the AU Model Law. ADP support also extended to legal advice and technical support for the proposed establishment of the African Medicines Agency (AMA). As the specialized regional technical agency, the AMA is expected to play a major role in providing regulatory guidance and technical assistance to AU Member States, as well as promoting the use of the AU Model Law to facilitate regulatory and legal reforms at continental, regional and national levels.

The COVID-19 pandemic has given these issues even greater urgency. Harmonizing regulatory systems across Africa and improving regulatory efficiency help ensure faster access to COVID-19 vaccines and related health technologies.

ADP has long partnered with the African Union Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD), and have worked together to promote the development of the AU Model Law and, since its adoption in 2016 by African Heads of State and Government at the AU Summit, its domestication within the national legal and regulatory frameworks of AU Member States.

To date, four countries have reported completing the domestication process, while others are in the midst of ongoing national processes, including national consultation processes and, in some cases, draft laws or bills are undergoing legislative processes for adoption.

ADP continues to actively collaborate with AUDA-NEPAD to increase the number of countries working towards domestication of the law and to provide ongoing technical assistance to navigate through the process.

In Ghana and Senegal, for example, ADP has supported the organization of national stakeholder consultations, as well as legal and policy reviews, and the process of legal drafting is currently under way.

A Guidance Document developed by AUDA-NEPAD, with ADP support, aims to improve understanding of key concepts, and provides guidance on how to draft legislation with a chapter-by-chapter analysis of the AU Model Law, offering useful drafting suggestions.

Together, these efforts are helping countries to align their regulatory laws to the AU Model Law and not only facilitate effective regulation but also advance the goal of harmonizing regulatory systems across the region.

“A harmonized legal and regulatory environment will enable the effective operation of the continent-wide AMA. As such, domestication of the AU Model Law by AU Member States will be a crucial step towards such regulatory harmonization," said Dr. Margareth Ndomondo-Sigonda, Head of Health Programme and the African Medicines Regulatory Harmonization initiative, AUDA-NEPAD.

"The COVID-19 pandemic has shown us how important this is, and we hope this awareness will translate into greater focus on this issue. We look towards our continued partnership with ADP to further mobilize AU Member States in their domestication processes. With the Guidance Document, we are also responding to the needs of AU Member States who may require some technical assistance in adapting the provisions of the AU Model Law to suit the national needs and priorities."

Further information:

AUDA and ADP, ‘A guidance document for domestication of the African Union Model Law on Medical Products Regulation’, 2021

ADP, ‘UNDP and Ghana Food and Drug Authority join forces to strengthen regulation of health technologies’, 10 October 2021

ADP, ‘Issue brief: African Union Model Law for Medical Products Regulation’, 2017

AUDA, ‘AU Model Law on Medical Products Regulation’, 2016

This is part of a collection of impact stories highlighting the work of the Access and Delivery Partnership in ensuring access to health technologies for those in need. For more information and to read additional impact stories, please visit the ADP website.