AfriForum goes to court over Ivermectin as Covid-19 treatment

Civil rights organisation AfriForum has announced it would be taking health minister Zweli Mkhize and the SA Health Products Regulatory Authority (Sahpra) to court to allow for the drug Ivermectin to be prescribed by doctors to treat Covid-19.

“Ivermectin is listed by the World Health Organisation as an essential medicine and it has been proven safe, even in children,” the organisation’s head of research Barend Uys said.

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

According to Sahpra’s website, Ivermectin is used in the treatment and control of parasites in animals (usually livestock) but was not currently registered locally for human use.

The applications were said to have been brought forward in terms of section 21 of the medicines and controlled substances act.

“The balance between risk and benefit is evident, this is why we are taking these steps to ensure its availability,” Uys said, adding that people found themselves in extraordinary circumstances where people were dying daily and medical practitioners inundated with patients.

“Everyday costs more lives and under such circumstances, the potential risks and benefits of a decision should be decisive.” SA Agri Initiative (Saai) board chairperson Dr Theo de Jager said farmers were currently the biggest consumers of veterinary medicine which contained Inverctim.

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

Saai has direct interest in the welfare of family farmers, their families and their workers,” De Jager said, adding that they were supporting the effort to urgently ensure the availability of Inverctim which was fit for human consumption. In a statement issued earlier this month, Sahpra said it had, in December 2020 already, indicated that

“Ivermectin is not indicated nor approved by Sahpra for use in humans”.

“There is no confirmatory data on Ivermectin available as yet for its use in the management of Covid-19 infections,” the statement read, adding that in terms of safety and efficacy, there was no evidence to support the use of Ivermectin nor did they have any clinics trial evidence to justify the use thereof.

In the statement, the regulatory authority further said that Ivermectin, in South Africa, was registered for use in animals under act 36 of 1947 by the department of agriculture.

“This means that veterinarians and other trained personnel are allowed to prescribe it as an antiparasitic agent for a variety of animals. “The drug is not currently registered for human use, but Sahpra occasionally grants 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 statement read.

Meanwhile, the civil rights organisation’s court application, among others, requested the following:

• The failure of Saphra to approve the section 21 applications be reviewed and set aside and that the court approves the applications;
• A declaratory order that Ivermectin is safe drug for use in humans, subject to proper administration in a controlled manner under the management of a treating medical practitioner; and
• A declaratory order that qualified doctors and pharmacists are entitled, in terms of section 14(4) of the medicines act to compound medicine on the prescription of a medical practitioner which included Ivermectin.

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