The civil rights organisation AfriForum and Dr George Coetzee today achieved a further success in the fight for access to ivermectin when the settlement for the compounding of and access to ivermectin with the South African Health Products Regulatory Authority (SAHPRA) was made an order of court.
This court order determines that a medicine containing ivermectin as an active ingredient has been registered by SAHPRA on 16 March 2021. The effect of the registration is that ivermectin may be compounded and made accessible in accordance with the provisions of Section 14(4) of the Act.
The order also determines that access to imported ivermectin may be provided in accordance with the provisions of Section 21 of the Act. The order further determines that SAHPRA and the Minister of Health, jointly and severally, will pay a total contribution to the costs of the four applicant groups in the amount of R1,8 million (plus VAT).
Because a medicine that contains ivermectin as an active ingredient is now registered and ivermectin is listed as a schedule 3 substance, ivermectin 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 Section 14(4) of the Act practically means that doctors can prescribe ivermectin 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 compounded ivermectin is available,” says Barend Uys, Head of Research at AfriForum.
“We are very glad that the settlement was made an order of court as this provides certainty for doctors and patients,” says Dr George Coetzee.
The order further determines that SAHPRA must report back to the court every three months about the state of affairs relating to ivermectin and that any party to the application may 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 was agreed to between the parties.
We also want to acknowledge the contribution of our excellent legal team, Dr George Coetzee and other stakeholders like the Pharma Valu pharmacy group, the ‘I can make a difference’ doctors group and the ACDP that worked with dedication to ensure accessibility to ivermectin for citizens.