News24 | Inside The Box with Dr Andy Gray | How should medicine shortages be managed in SA?

Imagine you have been taking a medicine for years. Then one day you are told at the pharmacy that supplies have run out. In his latest Spotlight column, Dr Andy Gray zooms in on how governments can monitor and plan for such shortages.

The draft text of the United Nations High-Level Declaration on Pandemic Prevention, Preparedness and Response, which failed to get consensus support at the General Assembly on 25 September 2026, contained this paragraph:

“Deeply concerned by the inequities at national and international levels that hindered timely and equitable access to health products, including vaccines, diagnostics and therapeutics to address coronavirus disease (Covid-19), and recognizing the need to address serious shortcomings at the national, regional and global levels in prevention, preparedness, response and health system recovery for public health emergencies of international concern, including pandemic emergencies;” 

However, it is not only during pandemics or public health emergencies that shortages of medicines and vaccines are experienced and have to be actively managed. In fact, in recent decades, the issue has become so serious that several high-income countries have taken legal and regulatory steps to address it.

Global access to medicine shortage data 

South African health and medicines law does not clearly define what is meant by a “medicines shortage”. By contrast, the US Federal Food, Drug, and Cosmetic Act simply defines it as a period of time when the demand or projected demand for a medicine exceeds its supply.

Since 2012, marketing authorisation holders in the US have been under a legal obligation to report shortages to that country’s medicines regulator. These obligations were strengthened during the Covid-19 pandemic and now require manufacturers to report any interruption in their manufacturing process that is likely to lead to a meaningful disruption in supply, as well as to disclose the reasons for the interruption. Manufacturers are also required to give advanced warning of permanent discontinuation of production, and the reasons for that decision. The US Food and Drug Administration (FDA) maintains a publicly accessible database of current resolved shortages and discontinuations. In addition, the American Society of Health-System Pharmacists maintains a separate database.

READ | How should the compounding of medicines be regulated? 

Medicine shortages have also been recognised as a critical public health issue by the European Medicines Agency (EMA) and its national agencies. Since 2022, manufacturers have been required to report shortages to the European Shortages Monitoring Platform. The EMA maintains an accessible database of current and resolved shortages, as do each of the national agencies.

A similar resource is provided by the Australian Therapeutic Goods Administration (TGA).

The gap in South Africa 

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 not only those products with current registration, but also those where the status is noted as “Cancelled”. Unfortunately, while the date of registration is recorded, 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, nor is it provided with the reasons for discontinuation. There is also no accounting for how many medicines have been withdrawn from the South African market.

Section 19(2) of the Medicines and Related Substances Act allows Sahpra to request any information from manufacturers, sellers or prescribers of medicines, but the intent is to enable a response to a specific request, within a stipulated time period. This provision does not create an ongoing obligation or a permanent reporting process, so it cannot be used to impose the type of reporting demanded in the US, Europe or Australia.

A valuable resource – the health department’s ‘hotlist’ 

The National Health Department’s website includes a recent innovation, in the form of a “hotlist”, defined as “a list of all essential medicines on contract with stock availability of below 90% and with total orders exceeding supplier stock on hand and total provincial stock on hand less than two months of forecasted demand”. Importantly, the list also documents “the root cause for the supply challenge and proposed remedial actions for each listed item”. The list is updated on a monthly basis and the August 2026 version lists 29 “new” items, 98 described as “longer term” and 120 resolved items. Of particular note, a separate tab lists products which were not being supplied to particular provinces because of 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).

ALSO READ | Are there real consequences for breaking SA’s medicines laws? 

The health department’s website also provides a link to the current Master Health Product List, which includes all medicines for which a tender has been awarded. One of the columns on the spreadsheet documents the “VEN” status of the medicine. This refers to a judgment on whether a medicine is considered “vital”, “essential” or “non-essential”, in terms of the immediate health consequences of a shortage. 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. One way to mitigate that risk would be to contract multiple suppliers of a vital medicine. Such split tenders 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 – adrift 

Not only is there no equivalent of the “hotlist” for the private sector in South Africa, but one of the key responses used by the public sector to manage shortages is also not available. The National Department of Health Contract Management Unit’s website lists the products for which Sahpra has granted the public sector permission, in terms of section 21 of the Medicines and Related Substances Act, to import unregistered medicines in bulk. In the private sector, similar bulk approvals are not issued, and individual applications are required for every patient seeking access to an alternative product, should there not be a registered alternative on the local market.

Health professionals in the private sector are therefore at a distinct disadvantage, lacking access to timely information about medicine shortages and also denied access to a key mechanism for responding to shortages.

In Australia, the equivalent legal provision (section 19A) enables access to unregistered, imported medicines to manage a medicine shortage considered to be of public health importance. Access is enabled for the entire health system, not only for facilities operated by the state.

The concept of ‘critical medicines’ 

European authorities have extended the concept of VEN status to create a list of “critical medicines”. In May 2026, a political agreement was reached on the Critical Medicines Act, which will enable a number of important interventions to promote resilience in the pharmaceutical market. One of these interventions will require manufacturers to hold contingency stocks of critical medicines and mandate sharing of data on such stocks when reallocation is required, triggering a call for solidarity between Member States. Procurement of medicines will also be required to promote regional manufacturing in the EU.

Many reasons, key gaps 

There can be many reasons for medicines shortages, some related to the national market, others impacted upon by global shifts. Regulatory action by Sahpra in response to non-compliance with good manufacturing standards has resulted in a number of disruptions in supply, notably in the small-volume injectable market.

Although the second single exit price adjustment in 2026 will be welcomed by the pharmaceutical industry, other actions noted in the joint government-industry-regulator statement in August 2026 still require attention. Some immediate actions include a joint review of the pricing regulations, to improve transparency and predictability and also explore alternative reimbursement models for specific medicines. In the longer term, the industry is seeking appropriate incentives, including public sector procurement that supports local production and attracts new investment.

READ MORE | How medicine pricing works and how it might change 

According to the FDA definition, a medicine such as lenacapavir is already showing signs of a shortage, with demand exceeding supply. Improved transparency, applied across both public and private sectors, is crucial if medicine shortages are to be prevented, identified and acted upon with the urgency they deserve.

- Gray is a senior lecturer at the University of KwaZulu-Natal and co-director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence-Based Practice.

Disclosure: Gray serves on three technical advisory committees at the South African Health Products Regulatory Authority.

*This column was produced by Spotlight – health journalism in the public interest. Sign up for the Spotlight newsletter.