Health regulatory authority mum on legal action over Ivermectin

The SA Health Products Regulatory Authority (SAHPRA) has remained mum on the pending court action against it by AfriForum in a bid to get the drug Ivermectin to be prescribed to treat Covid-19.

Ivermectin is used in the treatment and control of parasites in animals (usually livestock), but is not used currently locally for human use.

“Both SAHPRA and the minister [of health Dr Zweli Mkhize] have been subpoenaed so SAHPRA cannot comment [on the matter because it was under the court’s jurisdiction],” said SAHPRA spokesperson Yuven Gounden.

AfriForum has filed an urgent court application against the regulatory authority and the minister to have Ivermectin available to doctors who wanted to prescribe it to patients to treat the virus.

SAHPRA was reportedly opposing the urgent application and had until Tuesday to file the papers, while AfriForum had until Thursday to respond to the opposing papers.

The application was expected to be heard on Tuesday, 2 February.

AfriForum’s head of research Barend Uys said they had filed the papers for the court application last week.

He said they not only wanted for it to be allowed for Ivermectin to be prescribed by doctors, but also because the World Health Organisation had reportedly listed it as an essential medicine and had been proven safe, even in children.

“Studies undertaken in, among others, the US, Argentina, India, Egypt and Spain all show that the drug has the potential to treat Covid-19 and reduce deaths,” Uys said.

According to SAHPRA’s website, Ivermectin was used to treat a variety of tropical diseases in humans which were not usually seen in South Africa along with scabies and head lice.

The drug was reportedly a synthetic derivative of the anti-parasitic class of compounds known as avermectins.

It was registered for use in South Africa for use under Act 36 of 1947 by the Department of Agriculture.

AfriForum said it was taking Mkhize and SAHPRA to court because they had allegedly failed to approve applications which had been brought forward by doctors to have the medication approved for the treatment of Covid-19.

“The balance between risk and benefit is evident,” said Uys.

“This is why we are taking these steps to ensure its availability under what is extraordinary circumstances where people are dying daily and medical practitioners are inundated with patients.

“Every day costs more lives. Under such circumstances, the potential risks and benefits of a decision should be decisive.”

Meanwhile, SA Agri Initiative (SAAI) chairperson of the board Dr Theo de Jager said farmers were currently the biggest consumers of veterinary medicine which contained Ivermectin.

“More and more people are using these products, which causes challenges to farmers in terms of availability and affordability.

De Jager, however, said they they were supporting the effort to urgently ensure the availability of Ivermectin, which he believed was fit for human consumption.

In a statement issued earlier this month, SAHPRA said it had indicated in December 2020 that Ivermectin has not been approved by them for use in humans.

“There is no confirmatory data on Ivermectin available as yet for its use in the management of Covid-19 infections,” their statement read.

The statement added that with regards to safety and efficacy, there was no evident support for the use of Ivermectin nor was there any clinical trial evidence to justify the use thereof.

Veterinarians and “other trained personnel” were the only ones allowed to prescribe Ivermectin as an anti-parasitic agent for a variety of animals.

SAHPRA, however, admitted that it “occasionally” granted Section 21 permits for the use of topical Ivermectin as an unregistered product for the treatment of individual patients with conditions such as scabies or head lice.

The Department of Health has yet to respond to Rekord’s enquiry.

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