Pretoria – The Gauteng High Court, Pretoria, 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 within 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, an 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, which is one of the parties in an urgent application to get the green light for the use of ivermectin, said this is a groundbreaking ruling because doctors will not have to wait for approval of an article 21 application before starting treatment.
It is also a huge victory as doctors can 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 ivermectin.
The remaining question in the application, which will be argued in full by all the parties at a later date, will involve whether SAPRA has the right to stop doctors and pharmacists from using this medication without first approaching the regulatory authority for permission – as it must now do.
The core of the issues to be raised is whether SAPRA has the right to regulate ivermectin in the case of each and every patient in the midst of a pandemic, where thousands of people are falling ill, lawyer Willie Spies explained. He said as things now stand, each patient, through a doctor, must individually obtain permission from SAPRA before they may use ivermectin.
Judge Peter Mabuse, who made the agreement between the parties an order of court, noted that the parties may approach the deputy judge president for a preferential date on which to determine on the issues.
Pretoria East doctor George Coetzee launched the urgent application, together with two of his patients, for permission to be able to use ivermectin as a 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 medical doctor. Its arguments will predominantly rest on the constitutional rights of people to use this drug.
Regarding the agreement between the parties pending the adjudication of the two urgent applications, AfriForum confirmed that it is now an order of the court that a medical practitioner can 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,” said Barend Uys, head of research at AfriForum.
Coetzee responded that he is 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.
A group of doctors and medical practitioners, who call themselves “I Can Make a Difference”, will meanwhile also join the fray as a separate applicant in the main applications still to be heard.
They initially indicated that they wanted to join as an interested party, but Durban lawyer Kuben Moodley, of the law firm Pather and Pather, now confirmed that they will now bring their own application.
The group of about 50 health practitioners said in court papers that many of the group wanted to lawfully take ivermectin themselves as a prophylactic, to be obtained from a reputable and recognised supplier, given their ongoing risk of contracting Covid-19 due to their exposure to the virus.
They also want to use it in relation to their patients who desperately need it.