Pretoria - The Gauteng High Court, Pretoria, finally issued an order yesterday allowing for medicine that contained ivermectin as an active ingredient to also be used for the treatment of Covid-19 if so prescribed by a doctor.
This followed a settlement reached between civil rights organisation AfriForum and Pretoria East doctor George Coetzee in the fight for access to ivermectin.
Judge Cassim Sardiwalla now formally made the settlement an order of court.
This followed an agreement that was earlier reached between the applicants and the South African Health Products Regulatory Authority for the compounding of, and access to, ivermectin.
This court order determines that a medicine containing ivermectin as an active ingredient was registered by the regulator in March. The effect of the registration is that ivermectin may be compounded and made accessible in accordance with the provisions of the Medicines Act.
The order also determines that access to imported ivermectin may be provided in accordance with the provisions of the act.
With a medicine that contains ivermectin as an active ingredient now registered and the drug listed as a schedule 3 substance, it can now be used for other purposes than stated on the label of the registered medicine (off-label use) – which includes the treatment of Covid-19.
“Access in accordance with the act practically means that doctors can prescribe the drug on their own judgement and that no Section 21 application or reporting is required for compounded ivermectin.
“Patients can then use this prescription to buy ivermectin from any pharmacy where it is available,” said Barend Uys, the head of research at AfriForum.
Coetzee meanwhile said he was glad that the settlement had been made an order of court as this provided certainty for doctors and patients.
The order meanwhile further determines that the regulator must report back to the court every three months about the state of affairs relating to ivermectin.
Any party to the application may also approach the court by way of a notice of motion and supplementary affidavits, for relief pertaining to any further aspects relating to the administration and allowance of the use of ivermectin as a treatment against Covid-19.
This part of the order did not form part of the original settlements that were agreed to between the parties.
The parties did reach an agreement last week, but the judge did not make it an order of court at that stage as he wanted more input from the parties on what had been agreed upon, so as not to confuse the public.
Four different groups, apart from Coetzee and AfriForum, brought applications to allow for the use of ivermectin.
The applicants include the Pharma Valu pharmacy group, the ACDP, and a group of KwaZulu-Natal doctors.
The effect of the agreement reached between the parties is that a doctor can ask a pharmacist to compound a medicine containing the registered component of ivermectin, or issue an Article 21 application to the health watchdog, asking on an individual basis that a patient be allowed to use the drug.
The regulator made it clear that it had not authorised ivermectin for the treatment of Covid-19. It said its position remained that the drug may not be prescribed and dispensed without a Section 21 authorisation.
However, the effect of its registration of a cream containing ivermectin made it in law possible for compounding of this product on the basis of a prescription by a medical doctor.
The regulator and Ministry of Health were ordered to jointly and severally contribute R1.8 million towards the case.