The civil rights organisation AfriForum and Dr George Coetzee successfully obtained a settlement regarding the compounding of and access to ivermectin with the South African Health Products Regulatory Authority (SAHPRA).
This settlement determines that a medicine containing ivermectin as an active ingredient has been registered by SAHPRA in terms of the Medicines and Related Substances Act 101 of 1965 on 16 March 2021. The effect of the registration is that medicines containing ivermectin may be compounded and made available and accessible in accordance with the provisions of Section 14(4) of the Act. SAHPRA and the Minister of Health, jointly and severally, will pay a contribution to the costs of the applicants in the amount of R500 000 (plus VAT).
“We all know that COVID-19 is a dangerous disease and unfortunately there is no single wonder drug that can defeat the pandemic on its own. The most important factor in the fight against COVID-19 is every person’s immune system. Ivermectin makes a big contribution in this regard, and access to and availability thereof is, especially for the more vulnerable and needy majority of the population, indispensable for us to heal people. This settlement brings me great joy because it is a big victory for patients and doctors who take their oath to heal people seriously,” says Dr George Coetzee, first applicant in this matter.
“The practical implication of this settlement is that doctors can prescribe ivermectin to patients if, in their judgement, it is required and patients can then take this prescription to any pharmacy where compounded ivermectin is available and buy ivermectin. No Section 21 application or reporting is required for compounded ivermectin. We are very glad as easy access to ivermectin for doctors and patients are now possible,” says Barend Uys, Head of Research at AfriForum.
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), that includes the treatment of COVID-19.
The settlement was not made an order of court and the case proceeds on Thursday.