A GROUP of doctors and medical professionals joined the legal push to have the ivermectin drug made more easily accessible as the Covid-19 infection and death rates continue to gather momentum.
The medics who have named their group “I can make a difference doctors and medical practitioners group”, filed their application with the Pretoria High Court this week.
They’ve largely accused the South African Health Products Regulatory Authority (Sahpra) of lacking the will to have ivermectin registered for human consumption by using “red tape” as a means to stall the process.
Thus, preventing medics from having access to a drug that could potentially improve the condition of coronavirus infected patients and also save lives.
Sahpra is listed as the first respondent in the matter.
The Minister of Health, Zwele Mkhize, Boitumela Semete-Makokotla, the Sahpra’s chief executive and President Cyril Ramaphosa are the other respondents.
Only Sahpra has indicated they will be challenging the group’s action and are expected to file their legal response before tomorrow’s deadline.
Rights group AfriForum and the African Christian Democratic Party have each taken issue with Sahpra’s handling of ivermectin recently and lodged their respective court actions.
AfriForum has essentially called for the drug to be cleared for use in Covid-19 infection cases, while the ACDP wants doctors to be given the power to prescribe ivermectin.
All the ivermectin matters are set down for argument on February 22.
The medics, represented by attorney Kuben Moodley of law firm Pather and Pather Attorneys, said their clients attempted to avoid court action but it was now a “last resort”.
And, as medical practitioners, their main concern was the well-being and treatment of their patients.
Some in the group are also seeking to consume ivermectin themselves, as a prophylactic (a preventer of disease), from approved suppliers due to the ongoing risk of contracting the Covid-19 virus as frontline workers.
The group has called on the court to make 21 declarations, which includes making the drug accessible to all South Africans, doctors be entitled to access and prescribe ivermectin to patients, and that all the respondents have failed in their constitutional and statutory duties.
They also demanded that Sahpra’s Section 21 process, particularly its “compassionate use” application programme, where doctors make applications on behalf of patients to prescribe the drug, be declared “procedurally unfair”.
Dr Naseeba Kathrada, who previously wrote an open letter to Ramphosa about their impasse with Sahpra over ivermectin, is member of the group and deposed an affidavit on behalf of the others.
Kathrada said they spent days trying to avoid court action and there was “simply no other manner in which we are able to obtain the relief sought.”
“The relief sought is the public’s interest and we have no personal financial incentive in ensuring that people have adequate, effective and proper access to ivermectin.
“Our underlying motive in bringing the application is our desire to save lives.”
She said Sahpra had “failed dismally” to act in a “reasonable and equitable” manner after announcing they permitted the use of ivermectin through their “Compassionate Use” programme.
Previously, Ivermectin was available in the country for topical skin treatment and in tablet form to treat scabies and lice.
Pharmaceutical giant Merck (Pty) Limited introduced it in the country. However, the patent on the drug has since expired and can now be made by any manufacturer.
Due to this, the manufacturers realise the profit margin will be greatly reduced and have not expended the effort to register it. Hence, the drug’s unregistered status.
“Had the registration of ivermectin not lapsed, it would have been readily available.” Kathrada said ivermectin had shown significant promise as both a prophylactic and in treating Covid-19, and was used by hundreds of millions people to date.”
But Kathrada cleared that they were not asking for ivermectin to be used in Covid-19 treatment protocols, dispensed without prescription, to replace vaccines, and they were not propagating for other preventative measures such as mask wearing and hand washing to be scrapped.
Therefore, she said Sahpra’s December 22 threat of legal repercussions for those who attempted to import the drug because it was unsafe for human use was “unlawful and untrue”.
She also pointed out that Sahpra had the power to seek the necessary information it required to approve ivermectin. “It simply did not do that”.
“It can make the medicine available without an application for registration under the Medicines Act,” Kathrada said.
While Sahpra relented in January and allowed application the for the use of the drug via Section 21 applications, Kathrada said the process was tedious and was left in the dark about the outcome.
“I personally completed two such applications on behalf of patients, and to date of deposing this affidavit, both are still pending.”
Kathrada said one of the patients has since died without ivermectin being administered.
“I have been denied the right and opportunity to use all available and safe treatments to save the lives of my patients.”
On January 28, Sahpra announced ivermectin can be used for Covid-19 patients in certain circumstances and this related to applications that could be made under their “Compassionate Use” programme.
But Kathrada said applications made on that programme were also not being approved by Sahpra either and the Compassionate Use applications were the same as the Section 21 process.
She believes the applications needed to be treated with urgency because delays could cost lives.
Another challenge doctors faced was finding approved suppliers of ivermectin as she had applications still “pending” for that reason.
Kathrada said she and her staff had spent long hours sourcing vendors as this information has not been provided by Sahpra, as they are the ones who approve suppliers.
“It should have been published on their website.”
Kathrada maintains there were only three factors Sahpra needed to consider in making the medicine available-safety, quality and efficacy.
The quality can be achieved because Sahpra were the ones who approved suppliers. She said safety had already been established, Sahpra only needed to look at the history of the medicine.
On its efficacy, she said ivermectin showed promise of improved outcomes for patients already ill and shortening the duration of the illness in some trials.
Kathrada said while ivermectin had not been proven in rigorous scientific trials, considering the threat of Covid-19, it was more prudent to give a patient the chance to live.
While some learned and experienced professionals describe the ivermectin to be a ”miracle drug”, Kathrada believes in time it might be proven so.
“In light of what is still unknown about Covid-19 and the lack of treatment options, those of us who are medically trained should have ivermectin available as a treatment option.
“Failure to provide such an option is an infringement of patients’ human rights.”
She said if they were successful with their court action, it would be “cold comfort” for families of patients who have died due to Covid-19, but it could very well be the difference between life and death for those infected with the virus.
When approached for comment Sahpra referred the Sunday Tribune to its previous media statements.
Sunday Tribune