Judge slams Ivermectin supervisory order against SAHPRA, health minister

THE South African Health Products and Regulatory Authority (SAHPRA) has won its appeal to overturn a supervisory order which required it to report to a judge every three months in relation to the drug Ivermectin.

While demand for the drug was at an all-time high in 2020/21, as Covid vaccines were slowly becoming available and vaccine hesitancy was strong, SAHPRA maintained strict controls.

SAHPRA and the Health Minister were then hauled to court by the ACDP, among others, to make the drug available. The ACDP, as well as the applicants in three similar matters, SAHPRA and the second appellant, the Minister of Health, reached a settlement that would cover all four matters. The four settlement agreements were consolidated into one order which was issued in April 2021. Under its Controlled Compassionate Use Programme, SAHPRA allowed Ivermectin access in accordance with the provisions under the Medicines Act.

A supervisory order that came with the settlement did not sit well with SAHPRA and the minister as it involved reporting back to the court, by way of affidavit, every three months. They decided to take the matter, specifically related to the supervisory order, on appeal.

SCA Judge Clive Plasket found that the first difficulty that arose in respect of the supervisory order was that the previous judge failed to afford the SAHPRA and the minister a hearing, despite knowing that they opposed the supervisory order.

“He had agreed to a hearing but inexplicably changed his mind and made the order, including the supervisory order, in the absence of the parties and without hearing argument. In these circumstances, an oral hearing was, without doubt, essential.

“Secondly, the fact that the supervisory order had not been applied for by any of the parties and was not an issue in the pleadings requires that it be set aside. Thirdly, the supervisory order was granted despite the complete absence of evidence to justify it. In this case, not only was there no evidence as to the necessity of a supervisory order but the fact that the SAHPRA and the Minister had settled the matter and agreed to an order, suggests that there was probably no necessity for one,” Judge Plasket said.

“The appeal must succeed for the three interrelated reasons of a failure to hear the SAHPRA and the Minister before making the supervisory order; the fact that it was not an issue on the pleadings and was not applied for by any party; and that it was granted in the absence of any evidence to establish that it was necessary.”