Lobby group, AfriForum, says it is continuing with its High Court action against the South African Health Products Regulatory Authority (SAHPRA) over Ivermectin despite the body’s decision to approve the drug for use in controlled compassionate circumstances to treat COVID-19.
In a virtual media briefing earlier today, SAHPRA said it will announce guidelines for the drug’s use in the next few days.
Ivermectin is not authorised for human use in South Africa, but some medical practitioners have been calling for it to be used for the treatment of COVID-19.
AfriForum’s Head of Research, Barend Uys says although the announcement is a step in the right direction they are still not convinced about SAHPRA’s latest action.
“It is the step in the right direction although it’s extremely restrictive. It does not provide the necessary relief and certainty that we urgently need. That is why we will be continuing with our legal action. The current reality is that everyday people die while medicine exists that will probably save lives. SAHPRA has not yet even reacted to the first applicant’s section 21 applications.”
SAHPRA says discussions are ongoing with its legal team regarding the high court application. The court hearing is expected to be held next week.
CEO Dr Boitumelo Semete-Makokotlela says the outcomes of engagements with their lawyers regarding the court action will be made public.
“And then in terms of court action, I am going to ask that we don’t discuss this now in the public forum because this is the matter that we are in discussion with the lawyers around and we will be, whatever update that comes from that, that needs to be in the public we will definitely be communicated.”
SAHPRA says it will facilitate an access programme for the drug.
“As a regulator, we are saying we have heard you. We are putting in this a compassionate access programme that will be controlled. We will communicate in the next day or so with very clear guidelines in terms of what is controlled, going to look like and again we’ve considered the risk-benefit of having this product available.”
The regulator’s chairperson, Professor Helen Rees, says more data is needed to ascertain whether the use of Ivermectin meets the standard for human use. She says the global scientific community is concerned regarding its use.
“Unfortunately, it goes back to what we and everyone is saying. Globally, everyone who is in the scientific community is saying at the moment simply that we got. We don’t know if it works and we don’t know if it doesn’t work and that is the compassionate use and that is why we desperately need to get decent data so that we can tell the community whether or not something is a good idea to take for self-medication or there is professional treatment or whether it’s not; whether it’s safe in this context or whether it’s not.”
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Meanwhile, SAHPRA also announced its approval of the COVID19 vaccine produced by AstraZeneca for emergency use. Professor Rees says SAHPRA is currently reviewing applications by rival manufacturers, Johnson and Johnson and Pfizer. Rees says Health Minister, Zweli Mkhize, will provide more details on this at a later stage.
“In this case, this is the mechanism that was used for the Serum Institute AstraZeneca vaccine and the applicant there was the Department of Health. And actually, around the question of whether this has been authorised or so, there was a public statement that was published by the Department of Health on Friday. And as indicated later this evening, we will be having a discussion in vaccine where we indicated that the section 21 authorisation has been granted.”
South Africa is awaiting the first batch of vaccines, which is expected to be delivered from the Serum Institute in India by the end of the month.
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