Cape Town – The SA Health Products Regulatory Authority (Sahpra) said it would appeal the part of a high court order requiring it to report back every three months regarding access to ivermectin for use as a treatment in Covid-19 patients.
This follows a victory for several parties including the ACDP, Doctors for Life, “I Can Make a Difference” group of medical practitioners, AfriForum and others in the Pretoria High Court when Judge Cassim Sardiwalla ordered that ivermectin be made available and accessible on prescription in regulated quantities.
The court order was as a result of settlement agreements reached between Sahpra, the Minister of Health and the applicants in four cases.
“Sahpra is enabling the purpose of treating or preventing Covid-19 at the discretion and responsibility of the prescribing clinician,” the agreement stated.
The court ordered that Sahpra was required to report back to it every three months and parties would be permitted to return to court under the same case number for further relief if required.
“However, this was not agreed to by the parties nor were they asked for, by any of the applicants. Sahpra will therefore be appealing these specific orders as per the legal advice it has obtained,” the regulator said in a statement.
“In relation to compounding the court order confirmed that medicines containing ivermectin may be compounded and accessed in accordance with the provisions under the Medicines Act (section 14.4).
’’Further, unregistered ivermectin containing finished pharmaceutical products for human use remain accessible only under the programme through the authorised suppliers of such products. The Controlled Compassionate Use Programme remains firmly in place.”
Sahpra also maintained there was not enough evidence of the drug’s efficacy.
“There is insufficient scientific evidence on the efficacy of ivermectin for the prevention or treatment of Covid-19. We wish to assure the public that Sahpra has been and will continue to monitor emerging data regarding the use of ivermectin for the treatment of Covid-19.
’’Sahpra has received no application for the registration of an ivermectin-containing medicine for Covid-19,” Sahpra chief executive Dr Boitumelo Semete-Makokotlela said.
Cape Times