Covid-19: AfriForum takes SAHPRA, Mkhize to court to approve ivermectin for patients

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  • AfriForum has brought an urgent court application against the South African Health Products Regulatory Authority and Health Minister Zweli Mkhize over the use of ivermectin for Covid-19 patients.
  • It says SAHPRA has failed to approve applications by doctors which were brought in terms of Section 21 of the Medicines and Related Substances Act.
  • This, as the University of the Free State prepares clinical trial protocol to determine ivermectin's efficacy for Covid-19.

AfriForum has brought an urgent court application against the South African Health Products Rights Regulatory Authority (SAHPRA) and Health Minister Zweli Mkhize to ensure that ivermectin is available to doctors who want to prescribe it to treat Covid-19.

According to the civil rights group, SAHPRA has failed to approve applications by doctors, which were brought in terms of Section 21 of the Medicines and Related Substances Act – to have ivermectin approved for the treatment of Covid-19 patients.

READ | 20 million doses of Covid-19 vaccines are coming, says Ramaphosa

The application to the Gauteng High Court in Pretoria is brought on behalf of Dr George Coetzee and two patients.

In a letter to the SAPHRA this week, lawyers for the applicants indicated that three applications in terms of Section 21 had been submitted and should have been processed within 24-72 hours.

They had not received any response and a third patient had since died.

The applicants ask for (among others):
  • The failure of SAHPRA to approve the Section 21 applications be reviewed and set aside and that the court approves the Section 21 applications;
  • A declaratory order that ivermectin is a safe drug for the use of humans, subject to it being properly administered in a controlled manner under the management of a treating medical practitioner; and
  • A declaratory order that qualified medical 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 includes Ivermectin.

The parties are set to appear in court on Tuesday. SAHPRA, Mkhize and the health department have until Monday to oppose the application, should they wish to.

"Ivermectin is listed by the World Health Organization as an essential medicine, and it has been proven safe – also in children. Studies undertaken in among others the US, Argentina, India, Egypt and Spain all show that ivermectin has the potential to treat Covid-19 and reduce deaths," said AfriForum's research head Barend Uys.

Chairperson of the Board of the AfriForum-aligned Southern African Agri Initiative, Dr Theo de Jager, said that farmers were currently the largest consumers of veterinary medicine that contains ivermectin.

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

Clinical trial

In a guidance note earlier this month, SAHPRA  said it "encourages and supports all well- designed, ethically approved, scientific studies designed to identify new or existing medicines that are used for the treatment or prophylaxis of Covid-19".

On Sunday, it was announced that FARMOVS, a wholly owned clinical research company of the University of the Free State (UFS), together with several medical and scientific experts at the university, were in the process of preparing a clinical trial protocol to determine the efficacy of ivermectin for Covid-19 in a randomised, controlled study according to the requirements of the legal professions, in order to submit it for approval to the relevant national regulatory authority.

"By participating in the preparation of the clinical trial protocol, FARMOVS and the UFS remain supportive of and committed to contributing to the development of treatments and treatment strategies to battle the Covid-19 pandemic," the university said in a statement.

Should the clinical trial protocol be approved by the relevant national regulatory authority, the UFS would apparently be the first university in South Africa to attempt such a study.

"The UFS is committed to rigorous science and evidence-based research, and both FARMOVS and the university fully support the published opinions and guidelines of the SAHPRA and the scientific advisory boards established by the scientific community, as well as the stance of the South African government on ivermectin for Covid-19." 

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