A settlement reached with SAHPRA in the High Court this week, effectively means that if doctors deem it necessary, they can start Ivermectin treatment concurrently with the submission of an article 21 application to the medicines regulator for permission.
A court challenge by Afriforum, as well as a doctor and patients, aimed at legalising the use of Ivermectin in the treatment of COVID-19 – and giving doctors unfettered discretion on how to administer it – has been settled, notes a GroundUp report by legal writer Tania Broughton. The Gauteng High Court (Pretoria) application was launched by Dr George Coetzee, two of his patients, and AfriForum “in the public interest”.
They claimed the drug – not registered for human use in South Africa – “may well be the wonder drug that can save the nation’” And they wanted a judge to force the SA Health Product Regulatory Authority (SAHPRA) to declare it a “safe drug”, subject to it being properly administered by a medical practitioner.
SAHPRA did not file opposing papers. Instead, it said last week it would approve individual applications, in terms of its section 21 process (of the Medicines Act), for its use “on compassionate grounds”.
While lawyers for the applicants reportedly told GroundUp SAHPRA’s willingness to use the section 21 process was a “step in the right direction”, it said it would persist with the urgent court application “to ensure that the section 21 process is expedited and streamlined”.
Now the parties have filed a draft order, likely to be made an order of court, that refers to SAHPRA’s “Ivermectin Controlled Compassionate Use Programme Guidelines”. It states that in terms of this programme Ivermectin will be made available, subject to section 21 applications, and that anyone can access it via this process.
The applicants were also seeking a declaratory order that medical doctors and pharmacists be allowed to compound medicines, particularly those containing Ivermectin, in a quantity required for treatment of their patients, reports GroundUp.
The debate on this revolves around interpretations of section 14 (4) of the Medicines Act and whether or not “has been registered” means “is now registered” or “has been registered at any time”. (There is some confusion over the past registration status of Ivermectin.) This issue will be held over for determination by a court at a future date after more papers are filed during the course of this month.
The Times reports that the order means doctors can 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.
AfriForum said the court order was a breakthrough because doctors will not have to wait for approval of an article 21 application before starting treatment. The organisation said it was also a huge victory as doctors can decide to proceed with treatment using their own judgment.
Other interested parties have joined the fray. The African Christian Democratic Party (ACDP) and Doctors for Life – a group of about 50 doctors – are seeking to join the original case, says a City Press report. The ACDP’s application was lodged last Wednesday, on the same day SAHPRA announced it would allow a ‘controlled, compassionate’ access to the drug through its section 21 authorisation platform.
The ACDP wants all doctors to be able to prescribe the controversial drug. "We will be seeking various orders, including removing any and all restrictions on the use of the drug in South Africa, provided it has a been prescribed by a registered medical doctor.
As well as an order declaring that the failure by Health Minister Dr (Zweli) Mkhize, and SAHPRA to ensure that Ivermectin is accessible to all those who need it is, inconsistent with the Constitution and invalid," the party said.
The order is stirring some controversy. Willie Spies, lawyer of AfriForum in the application, is quoted in Beeld as saying they view every case of a confirmed COVID-19 infection as an “urgent matter” or medical emergency “as it is a life-threatening condition”.
But Dr Gerhard Verdoorn, a toxicology expert from the Griffon Poison Information Centre, says he and other clinicians view an “urgent case” as one where the patient’s life is endangered.
“The guy who walks in and tests positive is not an emergency. (The use of Ivermectin) is acceptable when a patient has already been admitted in a hospital or clinic and the admission (of the drug) is constantly monitored.”
Full GroundUp report (Open access)
Full report in The Times (Open access)
Full City Press report (Restricted access)
Full Beeld report (Restricted access)
See also MedicalBrief archives:SAHPRA to allow the use of Ivermectin to treat COVID-19
Fact File: Making sense of the Ivermectin controversy
Lower mortality for hospitalised COVID-19 patients taking Ivermectin – ICON study
5-day course of ivermectin may reduce duration of COVID-19
Ivermectin stops SARS-CoV-2 virus growing in cell culture within 48 hours