The Supreme Court of Appeal (SCA) has set aside a controversial supervisory order, granted in April 2021, compelling the South African Health Products Regulatory Authority (Sahpra) to report back to court every three months on access to Ivermectin in the treatment of COVID-19 patients.
Writing in GroundUp, Tania Broughton reports that the court ruled there was no evidence to justify the order made by Gauteng High Court (Pretoria) Judge Cassim Sardiwalla, that affected parties had not asked for the order, and that they had not been heard before he made it.
The judge also failed to provide his reasons for making it, the court said. The issue relates to four applications, one by the African Christian Democratic Party (ACDP) in 2021 against Sahpra, seeking access to Ivermectin for the treatment of COVID.
Sahpra had said there was no reliable research to prove the efficacy of Ivermectin, and had already initiated its "controlled compassionate use" programme in response to reports of illicit Ivermectin products entering the South African market. The programme was stopped in May this year.
Under that programme, five importers of unregistered oral solid dosage forms of Ivermectin were green-lighted and health facilities were permitted to hold bulk stock, but individual applications were still required. Sahpra was to monitor its use.
The ACDP and others approached the court requesting that Sahpra remove restrictions … such time as clinical evidence demonstrated that it was not effective in the treatment of COVID.
The matter was settled along the same lines as Sahpra’s programme.
Sardiwalla, in making the settlement agreement an order of court, had also granted a "supervisory order", putting Sahpra under his judicial authority in respect of Ivermectin.
Sahpra and the Minister of Health applied for, and were granted, leave to appeal the order to the SCA. The judge, Sahpra said, had improperly made findings on matters not in dispute and his written reasons for the supervisory order "do not constitute reasons at all".
In the SCA ruling, Judge Clive Plaskett said Sardiwalla had suggested to the parties that he "regarded himself as seized of all matters involving Ivermectin" and had proposed the supervisory order.
Both Sahpra and the Minister indicated they would oppose this and filed further papers.
While the judge said he would hear the parties on 6 April, 2021, his registrar had informed Sahpra’s attorney that morning that he had made a decision, he would not hear arguments, and would send his order to the parties shortly. No reasons accompanied the order.
Sahpra and the Minister asked for reasons, but when these were furnished, they made no mention of the supervisory order or why he granted it.
Plaskett said the first difficulty with the order was that Sardiwalla had not given Sahpra and the Minister a hearing, despite knowing they did not agree to it.
"He agreed to a hearing, but inexplicably changed his mind. In these circumstances, an oral hearing was… essential.
"Courts decide matters, particularly opposed matters, in open court and the exceptions to this rule are limited."
Plaskett said the fact that the order had not been applied for by any party required that it be set aside, and further, there was a complete absence of evidence to justify it.
Important as supervisory orders may be in appropriate cases, the granting of this type of relief must be carefully considered – and justified on the facts – particularly because of its separation of powers implications.
"In this case, not only was there no evidence as to the necessity of a supervisory order, but the fact that Sahpra and the Minister had settled the matter and agreed to an order suggests that there was probably no necessity for one.
"Had he allowed the parties to argue the matter, he would have been informed of the separation of powers problem…
"Finally, it strikes me as telling that the reasons he furnished made no mention of the supervisory order – and this despite being pertinently asked to furnish reasons on this very issue," Plaskett said, upholding the appeal, and setting aside the order.
The ACDP originally opposed Sahpra's appeal, but shortly before the SCA hearing, it withdrew its opposition on the basis that no cost order would be made against it. The SCA, therefore, did not order costs.
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News24 article ¬- Supreme Court of Appeal reverses controversial ivermectin ruling (Open access)
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