Following the settlement in four different cases to gain access to ivermectin for the treatment of Covid-19 in South Africa, the high court in Pretoria has also ordered that small batches of custom-made medicine containing ivermectin can now be legally prescribed “off-label” for the treatment of specific patients with Covid-19.
This has effectively provided another avenue to access the drug other than applying to use it through the South African Health Products Regulatory Authority’s (SAHPRA) compassionate programme.
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.
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.
SAHPRA also agreed to contribute more than a million rand in total to cover the legal fees in each of the four cases before court.
The cases were brought by a general practitioner George Coetzee, two of his patients and Afriforum, a group of pharmacies, the African Christian Democratic Party (ACDP) and Doctors for Life, and a group of medical practitioners who called themselves “I can make a difference.”
According to the court order, SAHPRA will “contribute” R350,000 to the legal fees of the pharmacies, R500,000 in the case brought by 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.”
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.
The order also keeps the door open for further litigation if there are problems in accessing the drug for the treatment of Covid-19.
SAHPRA has agreed to continue monitoring the use of ivermectin for the treatment of Covid-19 and to allow continued access to the drug through its compassionate programme and also to publicly report accurate information on the safety, efficacy and quality of ivermectin and “any other potential treatment or preventative medicine for Covid-19.”
The order states that pharmacists or a doctor or anybody who is registered under the Health Professions Act and holds the necessary license will be allowed to make up small batches of medicine containing ivermectin for patients, with Covid-19 on condition that it had been prescribed by a doctor and that it is not done in large quantities.
Yuven Gouden from SAHPRA said that the CEO, Boitumelo Semete-Makokotlela, needed to consult with their legal team before responding to any questions.
“Access in accordance with Section 14(4) of the Act practically means that doctors can prescribe ivermectin on their own judgement and that no Section 21 application (in terms of the compassionate programme) or reporting is required for compounded ivermectin. Patients can then use this prescription to buy ivermectin from any pharmacy where compounded ivermectin is available,” Barend Uys, the Head of Research at AfriForum said.
“We are very glad that the settlement was made an order of court as this provides certainty for doctors and patients,” Coetzee said. DM/MC
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