The Gauteng High Court has issued an order in agreement with the South African Health Products Regulations Authority (SAHPRA) to allow doctors to administer Ivermectin as a treatment for COVID-19 in urgent cases, despite it not yet being registered for human use in South Africa.
According to the Control of Medicine and Related Middle Act, a section 21 application must be directed by medical practitioners to SAHPRA to prescribe medicine that is not registered in South Africa for human use.
Doctors may begin ivermectin treatment as soon as they submit an article 21 application and do not need to wait for the outcome of the application to administer the drug. This is allowed only in cases where doctors deem urgent access to Ivermectin for a patient is needed, the court conceded on Tuesday [February 2].
The court order also rules that any person may qualify for access to Ivermectin and that medical practitioners may apply for access to Ivermectin.
One question the court order does not answer is whether SAHPRA may prevent doctors from using this medication if they do not receive permission from the regulatory authority, as is the current rule.
This court order comes after AfriForum and other parties heavily pushed for Ivermectin to be granted urgent use approval.
“It is now an order from the court that a medical doctor can begin with the treatment of a patient with Ivermectin without waiting for the approval of a submitted section 21 application. This rapid access to Ivermectin is a breakthrough for freedom in medical care and our fight against COVID-19, as the obstacle of pre-approval is now out of the way. This is an important first step in our attempt to ensure access to Ivermectin,” says Barend Uys, head of research at AfriForum.
“I am happy for the certainty that the court orders that doctors can lay their clinical judgment on the day to begin with Ivermectin treatment when admission is urgently needed,” added Dr George Coetzee, the first applicant in the application.