Challenges of pharmaceutical Regulation and access to health products in Africa

Access for all essential, effective, and quality health products is one of the Sustainable Development Goals. This access is essential to achieve universal health coverage as part of the continental agenda. The continued availability of affordable health products is an important aspect of health development policies. Offering quality health products at a reduced price to populations is a complex undertaking ranging from the identification and selection of products to the supply, storage, and quality assurance of products in the healthcare network.

The assessment of National Medicines Regulatory Agencies (NMRAs) by the World Health Organization (WHO) in 2018 and NEPAD – African Union/West African Health Organization (WAHO) in 2011 showed serious discrepancies. In the region, health products regulatory systems have not yet reached a satisfactory level of maturity (ML<3). The health product regulatory sector is faced with a lack of infrastructure and staff who are skilled and motivated and who have to deal with the exponential growth of counterfeit health products and the illicit market. Therefore, the finalization and operationalization of regulatory harmonization programs in sub-regional economic regions to support local pharmaceutical production initiatives and group purchasing of health products is a critical issue.