A Pretoria high court on Tuesday ruled that doctors can start to prescribe ivermectin treatment while waiting for a formal authorisation from the South African Products Regulatory Authority (Sahpra).
The court order was based on the agreement reached between Dr. George Coetzee, AfriForum and Sahpra, which brought the matter to the courts. The effect of the order is that doctors can start ivermectin treatment concurrently with the submission of article 21 application under the circumstances that a medical practitioner considers urgent to administer to a patient.
AfrForum’s Barend Uys, who heads the forum’s research hailed the court order, saying this is an important development in their effort to ensure access to ivermectin. He added that it is a victory for healthcare freedom and the battle against the Covid-19 because it removes what some medical practitioners viewed as draconian condition. Dr. Coetzee also expressed excitement about the order saying he is grateful because it allows doctors to use their “clinical judgment” to use ivermectin treatment on an urgent basis.
However, the court refused to entertainment part of the original application which relates to the right of doctors and pharmacists to compose medicine according to article 14(4) of the act. The matter has been postponed to a future date and will be placed on the normal court roll.
In its reaction, Sahpra said it is “erroneous” to suggest that it “buckled under pressure” as a direct consequence of the court action. The authority said the court order was a culmination of yesterday “court deliberations”, which repeat the position it communicated last month.
According to Sahpra’s chief executive officer, Dr. Boitumelo Semete-Makokotlea, in their statement released last month they “noted the limited treatment options for the Covid-19 pandemic” and that it “is also concerned about the escalation of positive cases of Covid-19 and deaths”. She added that Sahpra is currently meeting and consulting with “the scientific and medical community to explore the options for controlled, monitored access to reliable quality ivermectin-containing products for human use with simple but essential reporting requirements”.
Currently, medical practitioners are obliged, in terms of the Medicines and Related Substances Control Act, to apply for article 21 with the Sahpra in order to get permission before prescribing the drug. This is because ivermectin is not registered for human use in South Africa.
The prescription of ivermectin has split the medical and scientific community. On the one hand, there are those calling for the Sahpra to allow doctors to administer the drug without the section 21 application.
On other hand, some argued that it will be premature to authorise a drug registered to treat animals for human use. They said ivermectin like other drugs should undergo mandatory scientific tests before it can be authorised for humans.