AfriForum and its legal team dropped a bombshell on Thursday when it announced the medicine had been legal all along but SAHPRA had kept this a secret.
“SAHPRA had failed to publish a notice in the Government Gazette (as the Medicines and Related Substances Act 101 of 1965 requires) that requires registration of Ivermectin as a medicine. Moreover, SAHPRA has so far kept this fact from the public,” reads the statement.
“Hannes Strydom, the well-known pharmacist, owner of the Pharma Valu pharmacy group and former Springbok rugby player, has brought a court application to put these facts before the court when the court applications of AfriForum and other organisations, also the ACDP, are heard simultaneously on 29 to 31 March this year.”
The group said it would now amend its court application to provide for these new facts and to obtain a declaratory order that Ivermectin is a legal Schedule 3 medicine and therefore does not require registration by SAHPRA.
Willie Spies, a legal representative of the interested parties, said the Medicine and Related Substances Act 101 of 1965 regulates the distribution of medicines and medical products.
He said the Act also requires certain medicines to be registered before these may be sold.
“An important aspect of the restriction on unregistered medicines is that unregistered medicines are not automatically illegal. The regulator is compelled to first publish a notice in the Government Gazette,” said Spies.
This notice gives medicine providers and pharmacies, or pharmaceutical companies who want to continue providing that medicine, six months to register the medicine. It is only when this six-month period after publication of the notice in the Government Gazette expires, that the unregistered medicine becomes illegal.”
The group said that in the 30 years that Ivermectin has been available and listed as a Schedule 3 medicine, SAHPRA had failed to publish a notice in the Government Gazette to declare it illegal. Ivermectin is therefore not a registrable medicine but is listed in Schedule 3 of the Act.