<details> <summary>text_image</summary>
Scientist in lab coat using a microscope in a lab with visible instructional posters and text on the wall </details>
Increasing access to high-quality, safe health technologies across Africa
African Union Model Law on Medical Products Regulation
Introduction
The regulation of health technologies is a critical component of every country's public health system and ensures that high-quality, safe health technologies reach the people who need them most. Unfortunately, the capacity of many low- and middle-income countries (LMICs) to evaluate and approve health technologies—and to monitor their safety, efficacy, and quality—is limited, due to inadequate resources, overburdened staff, and incoherent policy frameworks. Additionally, regulatory legislation differs from country to country, resulting in delays for researchers and manufacturers who must navigate multiple regulatory systems to register the same health technology across countries.
Recognizing the importance of efficient and aligned regulatory systems in ensuring access to health technologies, the African Union (AU) Heads of State recently adopted the Model Law on Medical Products Regulation. This comprehensive legislation can now be taken up by national governments and regional economic communities (RECs) to harmonise regulatory systems and increase collaboration across countries. Ultimately, the Model Law is meant to accelerate access to lifesaving interventions, and ensure that promising health technologies are developed, tested, and scaled up to improve health impact.
Challenges in regulatory capacity and harmonisation
Access to high-quality, safe, and effective health technologies has been a challenge on the African continent for decades, due in part to weak or non-existent medicines regulatory systems. In most countries, legislation gives national governments the mandate to regulate medical products and research within their territory, through National Regulatory Authorities (NRAs). NRAs are responsible for ensuring the safety, efficacy, and quality of health technologies; they also regulate clinical trials, manufacturing, and the marketing of medical products. The comprehensiveness of regulatory legislation—and therefore the strength of NRAs—varies from country to country, however, and many countries have not developed plans to fully implement their regulatory legislation.
Due to weak implementation of national regulatory legislation and gaps in resource allocation, many NRAs are inadequately funded, understaffed, and overburdened. As a result, NRAs often lack the expertise and experience to provide guidance to product developers who are seeking clinical trial or product registration, nor do they have proper control over numerous products that are studied, introduced, and used in their countries. Additionally, many NRAs rely on approval from Stringent Regulatory Authorities (SRAs)—such as the European Medicines Agency, the United States Food and Drug Administration, and the World Health Organization (WHO)—as guidance for product registration, as they are well-resourced and more experienced. Yet even with the assistance of SRAs and the WHO, insufficient capacity of NRAs can lead to costly delays in product development and introduction, ultimately impacting patients in need of treatment.
Because regulatory legislation—where it exists—is created at the national level, neighbouring countries can have vastly different ways of regulating and approving health