Pretoria - The public will finally know tomorrow exactly how they will be able to use ivermectin if they so wish in the treatment of Covid-19.
Various parties, including AfriForum and Pretoria East medical doctor George Coetzee, fought in the Gauteng High Court, Pretoria, for the legal use of the so-called ’wonder drug’ in combating the virus.
Settlements were reached in the four different applications before court yesterday with the South African Health Products Regulatory Authority (Sahpra).
But Judge Cassim Sardiwalla called the parties to chambers later, as he wanted them to negotiate one consolidated order rather than four different orders on the same subject.
It was said that one order would be less confusing to the public and it is due to set out exactly what the way forward would be regarding the use of this drug.
It is expected that the final settlement agreement will be made an order of court tomorrow.
A draft order which was handed to court yesterday, but not yet made an order of court in the application by AfriForum and Coetzee, stated that an agreement was reached between them and regulator.
The agreement read that a topical formulation of a medicine containing ivermectin as an active ingredient has been registered this month by the regulator for treatment of moderate to severe inflammatory lesions in adult patients.
It is said that the effect of the registration is that medicines containing ivermectin may be compounded and made accessible in accordance with the provisions of Medicines and Related Substances Act.
AfriForum has confirmed that it had obtained a settlement – although not yet officially an order of court – regarding the compounding of and access to ivermectin with Sahpra.
AfriForum’s Barend Uys explained that because a medicine that contains ivermectin as an active ingredient is now registered and ivermectin is listed as a schedule 3 substance, it can now be used for other purposes than stated on the label of the registered medicine (off-label use), which includes the treatment of Covid-19.
A doctor can ask a pharmacist to compound a medicine containing the registered component of ivermectin or issue an Article 21 application to the health watchdog, asking on an individual basis that a patient be allowed to use the drug.
Coetzee said he was happy that a settlement was reached.
“We all know that Covid-19 is a dangerous disease and unfortunately there is no single wonder drug that can defeat the pandemic on its own. The most important factor in the fight against Covid-19 is every person’s immune system.
“Ivermectin makes a big contribution in this regard and access to and availability thereof is, especially for the more vulnerable and needy majority of the population, indispensable for us to heal people,” he said.
Sahpra made it clear that it had not authorised ivermectin for the treatment of Covid-19. It said its position remained that ivermectin may not be prescribed and dispensed without a Section 21 authorisation.
However, the effect of its registration of a cream containing ivermectin made it in law possible for compounding of this product on the basis of a prescription by a medical doctor.
However, the regulator said an unregistered ivermectin product may only be accessed under its controlled compassionate use programme.
Pretoria News