Sahpra says court ruling on Ivermectin for Covid-19 was 'not a victory'
The South African Health Products Regulatory Authority (Sahpra) says this week's high court ruling allowing the use of Ivermectin to combat Covid-19 was not a "victory" against itself or health minister Zweli Mkhize.
Pretoria high court judge Cassim Sardiwalla granted an order on Tuesday in favour of AfriForum, the ACDP and Doctors for Life, a group of pharmacies and the “I Can Make a Difference” group of medical practitioners, allowing pharmacists and doctors to make up small batches of medicines containing Ivermectin on prescription by a doctor and in small quantities.
The order was made after a settlement agreement reached between the parties and Sahpra as well as the health minister.
Sahpra CEO Dr Boitumelo Semete-Makokotlela said in a statement on Friday that any claim of victory by the parties who brought cases against Sahpra and the health minister were "inaccurate and misleading".
"Without admission of any liability, a joint contribution to part of the applicants’ costs by Sahpra and the minister of health was agreed to as part of the settlement in order to put an end to what, in Sahpra’s view, could be protracted litigation."
According to the court order, Sahpra will contribute almost R2m to their legal fees.
Semete-Makokotlela said the authority would appeal part of Sardiwalla's order which required them to report back to the court every three months, detailing any developments in the use and availability of the drug.
"The court ordered that Sahpra is required to report back to the court every three months and parties will 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 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.
A compounding pharmacy is one where ingredients are combined or mixed on site to create a drug tailored to the needs of an individual patient, as opposed to a pharmacy which only sells retail and packaged medication.
Semete-Makokotlela reiterated that there was 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.”