Ivermectin for use in urgent Covid-19 cases allowed before Section 21 applications are approved

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  • Medical practitioners can now use ivermectin to treat Covid-19 on an urgent basis without waiting for the outcome of an application for the use of the drug in a patient.
  • This was made an order of the Gauteng High Court on Tuesday following an agreement between Sahpra, AfriForum and others.
  • AfriForum, a medical doctor and two of his patients launched an urgent bid to be allowed to use ivermectin for Covid-19 without having to go through the long application processes.

Ivermectin can now be used by medical practitioners to treat Covid-19 without having to wait for the outcome of an application to use the drug - if treatment is needed urgently.

The concession was made an order of the Gauteng High Court in Pretoria on Tuesday after an interim settlement was reached between, on the one side, general practitioner Dr George Coetzee, two of his patients, AfriForum, and, on the other side, the South African Health Products Regulatory Authority (Sahpra).

The legal challenge was launched in January with the intention of legalising the use of ivermectin to treat Covid-19 patients and allowing doctors to do so at their own direction.

Sahpra applied for a postponement and subsequently announced it will allow for the use of the drug in exceptional circumstances, in a controlled, compassionate access programme, through the use of a Section 21 application.

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

Sahpra finally accepted demands for the use of ivermectin to treat Covid-19 but said doctors would have to apply and be approved before being allowed to use the drug for their patients.

In terms of the Medicines and Related Substances Control Act, a Section 21 application is the process used to apply for the prescription of medicine not registered for human use in South Africa.

However, in the interim settlement agreement doctors, in some cases, will now be able to start ivermectin treatment as soon as a Section 21 application has been made, without having to wait for the outcome on the application.

This will be allowed in cases where doctors deem it urgent and crucial to treat a patient using the drug.

READ | SAHPRA to allow for ivermectin use in Covid-19 in 'controlled, compassionate' programme

News24 previously reported that in court papers, the applicants indicated that three applications had been submitted to Sahpra. The applicants said the applications should have been processed within 24 to 72 hours but they had not received any response and one of the patients had since died.

Sahpra has been hesitant to allow the use of the drug for Covid-19 treatment, arguing that there was not enough clinical evidence to promote its use.

While an agreement has been reached, the parties are still set to meet in court to argue the right of doctors and pharmacists to compose medicine according to article 14(4) of the Medicines and Related Substances Control Act.

This involves the right to administer medicine as medical professionals deem necessary.

This part of the application will be placed on the normal court roll and parties will be allowed to approach the Deputy Judge President for a court date.

A case by the ACDP, which has a similar application, will be heard together with the AfriForum matter.

Health Minister Dr Zweli Mkhize, who was also cited as a respondent, has filed a notice to abide by the court's decision on the pending application, which will still be argued in court. 

READ | Understanding ivermectin for humans vs what's available for animal use. We speak to vet experts

AfriForum has touted this as a breakthrough victory as doctors can now decide to proceed with treatment using their own judgment and would not have to wait for an application to approved in urgent cases.  

"The hurdle of pre-authorisation is no longer an issue. It is an important first step in our effort to ensure access to ivermectin," head of research at AfriForum Barend Uys said following the court order.

"I am thankful for the assurance the court order gives that doctors can use their clinical judgement to commence ivermectin treatment when access to it is urgent," Coetzee said.

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