The South African Regulatory Authority for Health Products (Sahpra) wins case against ACDP order on Ivermectin

A health worker shows a box containing a bottle of ivermectin, a medicine authorised by the National Institute for Food and Drug Surveillance (Invima) to treat patients with mild, asymptomatic or suspicious Coivd-19, as part of a study of the Center for Paediatric Infectious Diseases Studies, in Cali, Colombia, on July 21, 2020. Picture: Luis Robayo/ AFP

A health worker shows a box containing a bottle of ivermectin, a medicine authorised by the National Institute for Food and Drug Surveillance (Invima) to treat patients with mild, asymptomatic or suspicious Coivd-19, as part of a study of the Center for Paediatric Infectious Diseases Studies, in Cali, Colombia, on July 21, 2020. Picture: Luis Robayo/ AFP

Published Nov 22, 2022

Share

Cape Town - The Supreme Court of Appeal has upheld an appeal by the South African Regulatory Authority for Health Products (Sahpra) and the health minister against a supervisory order in favour of the ACDP.

The order issued by the high court last year concerned access to, and use of, ivermectin, a livestock and parasitic worm drug used in veterinary medicine.

In 2020, at the height of the Covid19 pandemic, the drug made international headlines as a so-called “miracle cure” for Covid-19.

After an initial blanket ban, Sahpra relented and said it would allow a controlled, compassionate, access programme for use of ivermectin to treat Covid-19.

In April 2021 four applicants, including the ACDP, brought separate applications against Sahpra and the minister to compel them to make adjustments to the programme.

The high court sitting in Pretoria heard the applications as one and said it wanted a supervisory order to be added to the settlement.

In the order, Sahpra was ordered to report back to the court, by way of affidavit, every three months about why such adjustments were necessary for the prevention or treatment of Covid-19.

They were also told to provide the court with the particulars of health care facilities authorised to hold stock of unregistered ivermectin products.

Sahpra and the minister registered their objection and submitted heads of argument to oppose such an order being granted.

Despite that, shortly before the matter was to be heard, the judge made the settlement and the supervisory order an order of court.

The SCA found that he did so without hearing the parties and without furnishing reasons, and when asked for his reasons for making the supervisory order, he gave reasons that made no mention of it.

The SCA ruled that the supervisory order had to be set aside because it was made without Sahpra and the minister being heard.

The SCA also said that as it had never been raised in the papers, nor had it been relief that had been applied for by any of the parties, the order had not been an issue before the court.

Finally, the SCA said there had been no evidence before the judge to justify granting the order.

The appeal was unopposed, although the ACDP had initially opposed it.

[email protected]

Cape Argus