The civil rights organisation AfriForum claims that a slip-up by the health regulator means that the medicine has been legal all along for human use in South Africa.
AfriForum and Dr George Coetzee are involved in a legal challenge against the South African Health Products Regulatory Authority (SAHPRA) to allow doctors to prescribe Ivermectin that is formulated for human use to treat patients with COVID-19.
AfriForum and its legal team recently concluded that this medicine – which can be used to treat people who contracted COVID-19 – had been legal all along because SAPHRA 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 medicine. Moreover, SAPHRA has so far kept this fact from the public.
Hannes Strydom – the well-known pharmacist, owner of the Pharma Valu pharmacy group and former Springbok rugby player – has just brought a court application to put these facts before court when the court applications of AfriForum and other organisations, also the ACDP, are heard simultaneously on 29 to 31 March this year.
AfriForum will 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 therefor does not require registration by SAPHRA.
Willie Spies, legal representative of the interested parties, explains that the Medicine and Related Substances Act 101 of 1965 regulates the distribution of medicines and medical products. 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. 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. Therefore, medicine simply does not automatically become illegal. It must first be announced as a registrable medicine, and it is only when it is recalled and not registered that it becomes illegal,” Spies explains.
However, in the 30 years that Ivermectin has been available and listed as a Schedule 3 medicine, SAHPRA has 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.
“It is clear to us that Ivermectin is a medicine that may be prescribed freely by doctors in terms of legislation. AfriForum will therefor continue its court battle to obtain a declarative order in this regard. Ivermectin is safe and has already been approved by other governments for the treatment of COVID-19, while proof of its effectiveness is on the increase. There is no reason to prevent doctors from or obstruct doctors in using their judgement to employ Ivermectin in their attempts to save lives. Every day that goes by without Ivermectin being used optimally in the fight against COVID-19 is costing the lives of loved ones. We want to prevent that the same error is made with ivermectin and COVID-19 as was made with antiretrovirals and HIV/Aids,” says Barend Uys, AfriForum’s head of research.
The court last month issued an order by agreement between the parties as a first step in the legal bid. This will enable doctors to start Ivermectin treatment.
They must, however, first submit an article 21 application to the medicine watchdog in cases where they want to use Ivermectin for a patient.
According to SAHPRA, Ivermectin is not registered in South Africa for human use. More clinical studies must first be conducted regarding its potential risks and benefits for human use.
[link url="https://www.politicsweb.co.za/politics/new-twist-in-ivermectin-case–afriforum"]Full statement on the Politicsweb site[/link]
See also MedicalBrief archives:
[link url="https://www.medicalbrief.co.za/archives/50-doctors-in-new-sahpra-court-challenge-over-ivermectin-access/"]50 doctors in new SAHPRA court challenge over Ivermectin access[/link]
[link url="https://www.medicalbrief.co.za/archives/high-court-settlement-allows-doctors-immediate-use-of-ivermectin/"]High Court settlement allows doctors immediate use of Ivermectin[/link]
[link url="https://www.medicalbrief.co.za/archives/fact-file-making-sense-of-the-ivermectin-controversy/"]Fact File: Making sense of the Ivermectin controversy[/link]
[link url="https://www.medicalbrief.co.za/archives/sahpra-to-allow-the-use-of-ivermectin-to-treat-covid-19/"]SAHPRA to allow the use of Ivermectin to treat COVID-19[/link]