Cape Town – Doctors in South Africa are now able to prescribe ivermectin as a treatment against Covid-19 in cases where urgent access for a patient is necessary and where a section 21 application has been submitted.
According to lobby group AfriForum, an agreement has been reached with the South African Regulatory Authority for Health Products (Sahpra) that will enable doctors to prescribe the drug without having to wait for the approval of the Section 21 application before starting treatment.
Last week, Afriforum filed an urgent High Court application in Pretoria against Sahpra and Health Minister Zweli Mkhize to authorise the use of ivermectin to treat coronavirus infections.
Judge Peter Mabuse made the ruling for the use of ivermectin in cases where treatment is necessary in the North Gauteng High Court in Pretoria on Tuesday.
Head of Research at AfriForum, Barend Uys said the ruling was groundbreaking and an important first step to ensure access to ivermectin.
“It is also a great victory because the decision to start treatment is left to the judgement of medical doctors. The court order further stipulates that any person is eligible for access to ivermectin and that medical doctors are entitled to apply for access to ivermectin,“ he said.
A Section 21 authorisation involves processing and evaluating applications from healthcare practitioners for access to unregistered medication within South Africa.
Ivermectin continues to be an unregistered product according to Sahpra, however doctors can apply to access the drug for human use if they submit a Section 21 application.
First applicant in the court application, Dr George Coetzee, said: “I am pleased with the certainty that the court order gives that doctors can demonstrate their clinical judgement to start ivermectin treatment when access is urgently needed.”
Earlier this week Sahpra said during an online press conference it would allow a controlled, compassionate, access programme for use of ivermectin to treat Covid-19.