Medicine shortages have become a critical public health issue globally, affecting not only during pandemics or public health emergencies but also in everyday healthcare. In South Africa, the management of medicine shortages is not clearly defined, unlike in countries such as the US, where the Federal Food, Drug, and Cosmetic Act defines a medicine shortage as a period when demand exceeds supply. Dr. Andy Gray, a pharmaceutical sciences expert at the University of KwaZulu-Natal, highlights the need for better management of medicine shortages in South Africa.
In the US, marketing authorization holders have been under a legal obligation to report shortages to the medicines regulator since 2012. The US Food and Drug Administration (FDA) maintains a publicly accessible database of current resolved shortages and discontinuations. Similarly, the European Medicines Agency and its national agencies have recognized medicine shortages as a critical public health issue, requiring manufacturers to report shortages to the European Shortages Monitoring Platform since 2022.
In contrast, the South African Health Products Regulatory Authority (Sahpra) has no equivalent reporting requirement, nor does it make any such data publicly accessible. Sahpra's online register includes products with current registration and those where the status is noted as "Cancelled", but there is no date of cancellation stated, nor any reason provided for discontinuation of the product. Health professionals and patients only find out about product discontinuations after the fact, and the regulator has no advanced warning of the decision.
The national health department's website includes a "hotlist" of essential medicines with stock availability below 90% and total orders exceeding supplier stock on hand. The list documents the root cause for the supply challenge and proposed remedial actions for each listed item. The August 2026 version lists 29 "new" items, 98 described as "longer term", and 120 resolved items. A separate tab lists products not being supplied to particular provinces due to non-payment of accounts.
The reasons for shortages vary considerably, from delays in quality assurance procedures to delays in accessing critical components, whether active ingredients, excipients, or packaging materials. Global supply constraints were also identified, as were local regulatory actions or delays in obtaining regulatory approval for changes in production. The health department's website provides a link to the current Master Health Product List, which includes all medicines for which a contract has been awarded.
One way to mitigate the risk of medicine shortages is to contract multiple suppliers of a vital medicine. Such split contracts are used for some essential medicines, notably the first-line antiretrovirals used to treat HIV, but not for all medicines listed as vital. The private sector in South Africa lacks an equivalent of the public sector's "hotlist" and one of the key responses used by the public sector to manage shortages.
The lack of access to a vital medicine, for which alternatives might not exist, would be expected to have immediate and serious health consequences for patients. A valuable resource, the health department's "hotlist", provides critical information on medicine shortages, but it is limited to the public sector. The development of a similar system for the private sector could help improve the management of medicine shortages in South Africa.
Key points
- South Africa lacks clear regulations and data on medicine shortages.
- The US, Europe, and Australia have implemented reporting requirements and publicly accessible databases for medicine shortages.
- The South African health department's "hotlist" provides critical information on medicine shortages, but it is limited to the public sector.
