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By Zelda venter 
4h ago
Pretoria – The Gauteng High Court, Pretoria, issued an order by agreement with the South African Health Products Regulations Authority (SAHPRA) that will allow physicians to begin treatment with ivermectin, which is not yet registered for human use in South Africa.
This will allow physicians to begin ivermectin treatment simultaneously with the submission of an Article 21 application, in cases where the physician considers urgent access to ivermectin to be crucial for a patient.
In accordance with the Medicines and Related Substances Control Act, physicians wishing to prescribe medicines that are not registered for human use in South Africa must submit a section 21 application to SAHPRA.
AfriForum, which is one of the parties to an urgent request to obtain a green light for the use of ivermectin, said it is a pioneering decision because doctors will not have to wait for approval of an Article 21 request before starting treatment. .
It is also a great victory, as doctors can decide to continue treatment using their own judgment. Additionally, the court order determines that anyone can qualify for access to ivermectin and that physicians have the right to request access to ivermectin.
The remaining question in the application, which will be discussed in its entirety by all parties at a later date, will involve whether SAPRA has the right to prevent doctors and pharmacists from using this drug without first requesting permission from the regulatory authority, as it must now do.
The core of the questions to be raised is whether SAPRA has the right to regulate ivermectin for each and every patient in the midst of a pandemic, where thousands of people fall ill, explained attorney Willie Spies. He said that as things stand now, each patient, through a physician, must obtain an individual permission from SAPRA before they can use ivermectin.
Judge Peter Mabuse, who turned the agreement between the parties into a court order, noted that the parties can approach the judge’s vice president for a preferred date to determine the issues.
Pretoria East physician George Coetzee launched the urgent request, along with two of his patients, for permission to use ivermectin as a treatment.
The African Christian Democratic Party (ACDP) also submitted a similar request, which will be heard alongside Coetzee’s request.
The ACDP will seek, among others, an order to remove restrictions on the use of ivermectin in South Africa, provided it has been prescribed by a doctor. Their arguments will be based mainly on the constitutional rights of people to consume this drug.
Regarding the agreement between the parties pending the adjudication of the two urgent requests, AfriForum confirmed that it is now a court order that a doctor can start treating a patient with ivermectin without having to wait for the approval of a request from the Article 21 filed.
“Quick access to medical treatment is a great advance for health care freedom and our battle against Covid-19, as the pre-authorization hurdle is no longer an issue. It is an important first step in our effort to ensure access to ivermectin, ”said Barend Uys, head of research at AfriForum.
Coetzee responded that he is grateful for the assurance the court order provides that physicians can use their clinical judgment to begin ivermectin treatment when access to it is urgent.
Meanwhile, a group of doctors and healthcare professionals, calling themselves “I can make a difference,” will also join the fray as an independent applicant on major applications that have yet to be heard.
They initially indicated they wanted to join as a stakeholder, but Durban attorney Kuben Moodley of the Pather and Pather law firm has now confirmed that they will now bring their own application.
The group of about 50 healthcare professionals said in court documents that many of the group wanted to legally take ivermectin themselves as a prophylactic, to obtain it from a trusted and recognized supplier, given their continued risk of contracting Covid-19 due to their exposure to the virus.
They also want to use it in relation to their desperately needy patients.
Pretoria News
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