Civil Rights Group, AfriForum, medical doctors and the South African Health Products Regulatory Authority (Sahpra) will be back in the High Court in Pretoria later this week to get clarity on the right of doctors and pharmacists to use Ivermectin to treat COVID-19 patients.
The case was on the court roll this morning and a proposed draft order was presented to Judge Cassim Sardivalle. He, however, requested the legal teams to discuss the matter further to present a more detailed draft order.
Currently, healthcare workers have to wait for Sahpra’s approval of an article 21 application before they can use it for treatment under the regulator’s Ivermectin Controlled Compassionate Use Programme Guideline.
Sahpra maintains there is still insufficient scientific evidence on the efficacy of the drug for the prevention or treatment of COVID-19.
AfriForum Head of Research, Barend Uys, says they will present the amended draft order later this week to court.
“The full legal teams of the four different groups that brought applications met with he judge and the legal representatives from Sahpra. And they did not come to a specific conclusion, or judgment, or ruling today. So, the legal teams will now speak to each other and hopefully, we will have some finality on the matter.”
Some health practitioners have been calling for the use of Ivermectin to treat coronavirus:
Safety of patients
Managing Director from the Soweto Clinical Trial centre, Dr Qasim Ebrahim Bhorat, says that healthcare professionals should not do as they please, especially with unregistered drugs.
He says they have a responsibility to prescribe medicines that they can guarantee will not cause harm to patients.
Dr Bhorat says undeclared substances in medication cast doubt on their safety.
“How do you prescribe and give someone something that you cannot vouch for? Each healthcare professional can’t just say but I bought it like this. It’s not registered in the country, you are taking a risk. You have to then say, I’m going to get it analysed, I know what it contains and I’m safely dispensing it. With unregistered medication, you don’t know what you are getting. That’s the bottom line. Even if you are a doctor, the use of Panado is legislated. You, as a doctor, are not allowed to do anything you want with any tablet. That’s ridiculous. So, please just follow the law.”
Study on risks and benefits of Ivermectin
Doctor Maria Van Kerkhove, the World Health Organisation’s Technical Head for COVID-19, says the WHO is reviewing data on global studies on the risks and benefits of Ivermectin.
“The clinical team is looking at data right now on different studies that have been evaluated on Ivermectin. They are synthesising the data from different studies. Some had small sample sizes and the idea is to pool all those together into a meta-analysis and apply it to assess the certainty, benefit, or risk based on each of those studies. They have a steering committee and are following the results of clinical trials around the world and that is being used to trigger the development of the guidance by the WHO team,” says Kerkhove.
Sahpra is stepping up its clampdown on illegal drugs and is working with SARS customs officials and the police to stop it from entering the country. Four people from India have already been arrested for smuggling the drug, Ivermectin, into South Africa.
The drugs, with an estimated street value of more than R6 million, were concealed in luggage.
Sahpra Regulatory Compliance Manager, Daphney Fafudi, says no one should be in possession of the drug without their consent.
“We have been getting reports from the public, social media platforms, customs, police regarding contravention. We sent an inspector and found an undeclared shipment that was nicely packed … inside was Ivermectin. This was at OR Tambo. The three were arrested and are currently out on R50 000 bail. In Durban, also undeclared personal luggage – it was an Indian national as well. This one is out on R5 000 bail,” says Fafudi.