Ivermectin confiscated at OR Tambo International Airport. Picture: SAPS
Ivermectin confiscated at OR Tambo International Airport. Picture: SAPS

Doctors believe they are winning ivermectin battle

By Zelda Venter Time of article published Mar 1, 2021

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Pretoria - While the much-awaited application to legalise the use of ivermectin for human use to treat patients with Covid-19 will be heard at the end of this month, a doctor and other parties who are advocating for the use of this medicine believe they are a step closer in achieving their goal.

Several applicants, including a group of doctors and medical practitioners, who call themselves “I Can Make a Difference” have joined Dr George Coetzee and Afriforum in their Gauteng High Court, Pretoria, urgent application in the fight for the legal use of ivermectin.

Pretoria pharmacist Hannes Strydom, who is a former Springbok rugby player and owner of a pharmacy chain, is the latest to join the proceedings.

They are challenging the South African Health Products Regulatory Authority (SAHPRA) to allow doctors to prescribe ivermectin that is formulated for human use to treat patients.

In the latest development, the applicant’s legal team said they have concluded that this medicine had been legal all along because SAPHRA had failed to publish a notice in the Government Gazette (as the Medicines and Related Substances Act requires), asking for the registration of ivermectin as medicine.

Strydom had launched a separate application, but which will be heard together with the other, to put these facts before court when the matter is heard over three days – from March 29 to 31.

AfriForum said it 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 therefore does not require registration by SAPHRA.

Lawyer Willie Spies said the Medicine and Related Substances Act 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 expires that the unregistered medicine becomes illegal.”

He said that 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.

He said that in the 30 years 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. We will therefore continue with the court battle to obtain a declarative order in this regard.”

Spies said 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.

The applicants feel there is no reason to prevent doctors from using their judgement to use ivermectin in their attempts to save lives.

Meanwhile, 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. Thus, it says, more clinical studies must first be conducted regarding its potential risks and benefits for human use.

Pretoria News

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