Pretoria - The first official step in the use of ivermectin as a medicine for Covid-19 patients has been given the green light by the Gauteng High Court, Pretoria.
The court yesterday issued an order by agreement with the South African Health Products Regulations Authority (Sahpra) which will enable doctors to start ivermectin treatment – which is not yet registered for human use in South Africa.
This will enable doctors to start ivermectin treatment concurrently with the submission of an Article 21 application in cases where the doctor deems urgent access to ivermectin as crucial for a patient.
According to the Medicines and Related Substances Control Act, Article 21 application has to be submitted to Sahpra by medical practitioners who want to prescribe medicine which is not registered for human use within South Africa.
AfriForum, one of the parties in the urgent application for the use of ivermectin, said this was a ground-breaking breakthrough because doctors would not have to wait for approval of Article 21 application before starting treatment.
It was also a huge victory as doctors could decide to proceed with treatment using their own judgement. In addition, the court order determines that any person can qualify for access to ivermectin and that medical practitioners are entitled to apply for access to the drug.
The remaining question in the application, which will be argued in full by all the parties at a later date, will involve whether Sahpra has the right to stop doctors and pharmacists from using this medication without first approaching the regulatory authority for permission.
The core of the issues to be raised is whether Sahpra has the right to regulate ivermectin in the case of each and every patient in the midst of a pandemic, when thousands of people are falling ill, lawyer Willie Spies said.
As things stood now, he said, each patient, through a doctor, must individually obtain permission from SAHPRA before they can use ivermectin.
Judge Peter Mabuse, who made the agreement the order of court, noted that the parties may approach the deputy judge president for a preferential date on which to make a determination on the issues.
Pretoria East doctor George Coetzee launched the urgent application together with two of his patients for permission to use ivermectin as treatment.
The African Christian Democratic Party (ACDP) also brought a similar application, which will be heard together with Coetzee’s application.
The ACDP, will, among others, ask for an order to remove the restrictions on the use of ivermectin in South Africa, as long as it has been prescribed by a doctor.
Their arguments will predominantly rest on the constitutional rights of people to use this drug.
Regarding yesterday’s agreement between the parties pending the adjudication of the two urgent applications, AfriForum confirmed that it was now an order of the court that a medical practitioner could start treating a patient with ivermectin without having to wait for approval of a submitted Article 21 application.
“The quick access to medical treatment is a breakthrough for healthcare freedom and our battle against Covid-19 as the hurdle of pre-authorisation is no longer an issue. It is an important first step in our effort to ensure access to ivermectin,” Barend Uys, head of research at AfriForum, said.
Coetzee was thankful for the assurance the court order gave doctors that they could use their clinical judgement to commence ivermectin treatment when access to it was urgent.
Meanwhile, a group of doctors and medical practitioners who call themselves I Can Make A Difference will also join the fray as a separate applicant in the main applications process.
They initially indicated that they wanted to join as an interested party, but Durban lawyer Kuben Moodley of the law firm Pather and Pather confirmed late yesterday that they will now bring their own application..
The group of about 50 health practitioners said in court papers that most of them wanted to lawfully take ivermectin as a prophylactic, to be obtained from a reputable and recognised supplier, given their risk of contracting Covid-19 because of their exposure to the virus.
Naseeba Kathrada, a doctor from Westville in KwaZulu-Natal,, said in an affidavit that as they were facing the ravages of the pandemic in their everyday work, they wanted the go-ahead from the court to legally use ivermectin for their many patients who dearly wanted to use it too. She said the main application – still to be heard – was extremely urgent as it dealt with matters of life and death. The latest weekly average of 482 deaths a day in the country due to Covid-19 proved the urgency, she said.
Kathrada said that should ivermectin prove in the long run to be just 10% efficient, this would result in 48 lives being saved a day.