Ivermectin climbdown comes with multimillion price tag for SAHPRA and DoH

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Government resistance to the use of Ivermectin is over, reports MedicalBrief. A settlement agreement with the four groups that had gone to court to contest the ban on the medicine was this week made an order of the court, with SAHPRA and the Department of Health agreeing to pay the litigants almost R2m in costs.

It is estimated that the legal costs of the two respondents will be of a similar order.

The SA Health Products Regulatory Authority (SAHPRA) settlement agreement opens the way for the compounding of and access to the drug, reports News24. SAHPRA and Minister of Health, who is listed as a respondent in the matter, were also ordered to pay close on R2m towards the costs of the four applicant groups. This includes contributing R350,000 to the legal fees of the pharmacies, R500,000 in the case brought by Dr George Coetzee and Afriforum, R500,000 to the legal bills of the ACDP and Doctors for Life and R450,000 to I Can Make a Difference.

In an order agreed upon by all parties and granted on Tuesday, the Pretoria High Court ruled a registered pharmacist or medical practitioner might compound and sell compounded medicine that contained Ivermectin as an active ingredient.

"Registered medical practitioners who are entitled to prescribe medicines in schedule 3 of the act, may, in their professional discretion, prescribe Ivermectin to be compounded into a medicine that contains Ivermectin as an active ingredient for the treatment of their patients, on condition that the medicine is compounded by the holder of a licence," the order read.

 

The settlement in four different cases, has effectively provided another avenue to access the drug other than applying to use it through the SAHPRA compassionate programme, reports Daily Maverick.

DM reports that Judge Cassim Sardiwalla also ordered SAHPRA to report every three months on developments around the availability of ivermectin for the treatment of COVID-19.

Ivermectin is an anti-parasitic drug. It has been registered in South Africa for the treatment of a skin condition and is used elsewhere to treat river blindness and other diseases caused by parasites in humans. Since the outbreak of the global COVID-19 pandemic, there have been small trials showing both that it is effective against COVID-19 and that it is not.

DM reports that in December a Rapid Review by the COVID-19 subcommittee of the National Essential Medicines List Committee (NEMLC) recommended that the regulatory authority wait for more large randomised controlled trials to be published before deciding whether Ivermectin should be used to treat COVID-19 in South Africa.

According to the court order, SAHPRA must report to the court every three months to indicate if any adjustments have been made to the programme providing access to Ivermectin for the treatment of COVID-19.

This report must include if there are any newly approved unregistered Ivermectin products available, if there are any newly authorised importers, how many products, containing Ivermectin, have been made available to patients under the programme and who has been authorised to hold Ivermectin stock.

DM reports that the order also keeps the door open for further litigation if there are problems in accessing the drug for the treatment of COVID-19.

 

Full News24 report (Open access)

Full Daily Maverick report (Open access)

 

 

See also MedicalBrief archives:

SAHPRA settles over Ivermectin; AfriForum gets R500,000 costs

Afriforum joins doctor and patients for declaratory order on Ivermectin

High Court settlement allows doctors immediate use of Ivermectin


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