While some desperate patients are turning to veterinarians for their epilepsy medicines as the national medicine shortage crisis reaches alarming levels, it turns out the Health Department has been relying on Section 21 medicines – legally authorised but unregistered or unlicensed – for a decade, reports News24.
Nationwide shortages are due, in part, to ballooning unpaid debts by all provinces (except the Western Cape) to struggling suppliers, who are owed R24bn – with the Auditor-General having long flagged poor financial controls, inadequate record-keeping and a lack of accountability as the root causes of the escalating crisis.
And while the department has been trying to reassure South Africans that everything is under control amid the drug shortage issue, it turns out it has been using Section 21 medicines as a “last resort” to source alternative medication for 10 years.
This is according to Khadija Jamaloodien, head of procurement for health products at the department, in an interview with Newzroom Afrika last week.
Section 21 medicines are those authorised by the South African Health Products Regulatory Authority (SAHPRA) for sale or use under specific, exceptional circumstances, reports News24’s sister publication Rapport.
It is typically granted when no suitable registered alternative is available, or when the medicine is required for a specific patient’s treatment.
South African public health patients are going without essential medicines for chronic conditions like diabetes, asthma, heart disease, epilepsy, schizophrenia and bipolar disorder because the state has not paid its debt to suppliers.
People with epilepsy are turning to vets out of desperation for their meds, while a nurse in the public sector fears patients will start dying because they can’t get their medicines. She is also concerned there are no clear timelines on when new stock will be received.
In the private sector, patients are also struggling to lay their hands on epilepsy medication, and drugs for autoimmune conditions like lupus, among others.
Despite the alarm, the national Department of Health said, in response to a parliamentary question on 16 September, that it had no records of patients dying from preventable diseases caused by stock shortages. It said existing systems, including RxSolution and the Stock Visibility System, enable monitoring of stock levels and management of shortages across facilities.
It admitted, however, that its health information systems do not record deaths or disease outcomes in a way that would allow deaths to be directly attributed to stock shortages or to patients not having received their treatment.
On why the state has needed to procure Section 21 medicines for a decade, Jamaloodien said that in oncology, for example, a number of suppliers no longer make specific medicines still used in South Africa because it is no longer profitable.
Phenobarbitone (used, among other things, to treat epilepsy) is also problematic because suppliers are withdrawing it from the market, while there is also a global shortage of rifampicin, used to treat TB, which is affecting its availability in South Africa.
Jamaloodien said the local manufacture of medicines is an option for South Africa, but many suppliers don’t comply with SAHPRA’s regulations.
For example, a local contraceptive manufacturer withdrew from the market in 2019 because it did not comply with SAHPRA’s regulations, while international suppliers also pulled out of the country.
“The unintended consequence here is that you create a monopoly – but then the monopoly manufacturer also cannot supply the market.”
On who should be held accountable for the crisis, Jamaloodien said it was a “complex environment with weak links everywhere”.
“The department has contracts for pharmaceutical tenders, but the provinces must pay the suppliers themselves, and the suppliers must give us the data so that we can plan properly,” she said.
Department of Health spokesperson Foster Mohale said provinces are responsible for their own budgets and payments and that the national department monitors the situation.
The latest Auditor-General’s report shows that the provinces’ outstanding debt was R24bn at the end of last year, with the Western Cape the only province able to service its debt.
This meant that nearly a fifth of the money available for services and supplies had to be used to pay off old debt rather than to procure new medicines and equipment.
The pressure has been compounded by medical litigation against health services. In the 2023/24 financial year, claims of R62bn were lodged, with R1.4bn paid out across all nine provinces. In the next financial year, R58bn in claims were lodged, with R1.5bn paid out.
In Gauteng, with the largest debt burden, accumulated debt and escalating medical litigation have created annual shortfalls of between R5bn and R8bn, leaving every new financial year saddled with pre-existing commitments. The Eastern Cape is the other problem province in the current medicines crisis, grappling with liabilities of about R22bn and accumulated debt of R7bn.
In North West, poor financial management, outdated systems and vacant senior posts have been contributing factors to the department’s problems, but the AG also identified irregular payments of R38.2m between 2021 and 2025.
See more from MedicalBrief archives:
Patients turned away as national medicines stock levels drop
North West struggles with medicines shortage
Gauteng hospitals suffering essential medicines shortage
SA patients suffer and pharmacies under pressure as essential medicines run low