Health department says it will oppose Ivermectin court action
The department of health’s legal team says it is prepared to oppose any court action by National Freedom Party (NFP) MP Ahmed Munzoor Shaik Emam to secure an urgent audience with health minister Zweli Mkhize about the controversial drug Ivermectin.
Shaik Emam and a group of scientists have separately thrown their weight behind a call for the anti-parasitic drug - used to combat the transmission of Covid-19 in some quarters internationally - to be studied and considered for human consumption in SA.
Ivermectin, hailed as a revolutionary drug in the 1980s and which works by paralysing and killing parasites including lice and worms in livestock, has been gaining traction as a “miracle cure” for Covid-19 patients.
However, the SA Health Products Regulatory Authority (Sahpra) prohibited the drug for human consumption on December 22 after it emerged on several social media platforms that the drug was being promoted on local groups as having “cured” people of Covid-19.
Sahpra indicated on Tuesday, in response to a SABC report that it had approved the drug, that this was incorrect.
The regulatory body said it was reviewing data and would provide “updated communication”.
Some experts suggest that for patients who have tested positive for the coronavirus, the drug inhibits viral loads and keeps those with early Covid-19 symptoms from progressing to the hyper-inflammatory phase of the disease, and even helps critically ill patients recover.
The two parties — 11 clinicians, public health specialists, community health workers and medical scientists called the Ivermectin Interest Group (IIG) and Shaik Emam — have petitioned the health minister, saying the drug could potentially save thousands of lives and the government millions of rand to “mitigate the affect of the pandemic until such time as we can roll out a comprehensive vaccination programme”.
Dr Andrew Hill Snr, a respected academic and World Health Organisation (WHO) researcher, recently reported at an international Ivermectin conference that a meta-analysis of data from the first 11 randomised controlled trials pointed to a “promise of Ivermectin as a low-cost, widely available therapy potentially useful in Covid-19”.
In a letter to Mkhize, Sahpra CEO Dr Boitumelo Semete-Makokotlela and board chair Dr Helen Rees, Shaik Emam’s lawyer Prabashni Subrayan Naidoo said Shaik Emam had made unsuccessful attempts to meet the minister and the health department to discuss the use of Ivermectin to combat the transmission of the coronavirus.
Shaik Emam’s lawyer said in light of the information about the drug, he was seeking an urgent meeting with the minister and Sahpra to consider testing the drug in SA, and if this was not effective, to provide a written explanation detailing the reasons.
Subrayan Naidoo said if they didn’t receive a favourable response by close of business on Wednesday, they would turn to the high court for urgent relief.
Threat of court action is ‘frivolous’
In a written response to Subrayan Naidoo, a health department legal representative said it noted “your threat to approach the courts”, adding its position on the matter had been clarified in the correspondence.
“Therefore any urgent court application will be regarded as frivolous.
“The department will therefore oppose same and further seek a punitive cost order. We hope this will not be necessary.”
The department letter said it was “quite unusual” for a member of parliament and of the health portfolio committee, to which Mkhize reports, to write to him via a lawyer. Instead he should have requested the minister appear before the committee to raise specific issues and concerns.
Unfortunately, the honourable minister does not have any legal authority to license and register medicines.Health department legal representative
It said the minister had “already received a request from chairperson Dr Sibongiseni Dhlomo for a meeting to be held on January 7 2021”.
“It would therefore be more appropriate for your client to raise issues or concerns at this sitting.”
The letter urged Subrayan Naidoo to explain Sahpra’s role as a regulator to Shaik Emam.
“Unfortunately, the honourable minister does not have any legal authority to license and register medicines.
“This a Sahpra process. If your client has lodged this application with Sahpra, please share with us such correspondence and the standard acknowledgment letter from Sahpra so we can follow up on progress made.”
The letter said an application to Sahpra did not occur through meetings, and the onus was on Subrayan Naidoo to provide information to the regulator if “your intention is for Sahpra to confirm the efficacy of any drug at your disposal”.
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