South African Report: Ivermectin to be Accepted by SAHPRA for Widespread Societal Use During the COVID-19 Pandemic but That Won’t Matter Much

South African Report Ivermectin to be Accepted by SAHPRA for Widespread Societal Use During the COVID-19 Pandemic but That Won’t Matter Much

In what appears to be a bittersweet victory in South Africa for ivermectin proponents, TrialSite has access to court documents out of that country that on Monday March 15, 2021 the South African Health Products Regulatory Authority (SAHPRA) communicated to a legal challenger that the regulatory body would change its policy to accept the use of ivermectin as a means of targeting SARS-CoV-2, the virus behind COVID-19. Reports are that starting Wednesday March 16, once a particular ivermectin-based product (a cream) is registered, doctors can prescribe ivermectin without having to apply to SAHPRA to do so and compounding pharmacists and licensed doctors can then compound ivermectin for human use. A victory in spirit only for a group that was taking legal action, led by the African Christian Democratic Party (ACDP) and an activist group known as AfriForum as they  filed court motions against SAHPRA and the Minister of Health for access to the drug. Yes, in a twist, the ingredients to produce the drug must be accessed within the country. If production relies on imports, then the Section 21 rules apply, meaning each and every treatment requires a consultation with SAHPRA. Hence from Wednesday onward, while there is a legal pathway for prescribing physicians and pharmacists to compound ivermectin for purposes of treating COVID-19, the actual practicalities of compounding and distributing the medication make pragmatic implementation nearly impossible. The decision has essentially created more layers of bureaucracy, which serve to keep cost-effective, generic treatments at bay. Only a regulatory waiver by the Minister of Health could change this situation.

COVID-19 in South Africa

One of the worst hit countries in the African Continent, South Africa, experienced two large waves during the pandemic thus far. The first during July of 2020 where as many as 13,000 cases per day were recorded. A second and more severe spike occurred at the end of 2020 and into January 2021. While cases have again waned the vaccination situation is by no means stable or secure (in that there are a lot of people to vaccinate), and with no approved therapeutic treatments for mild to moderate cases the many positive results from dozens of studies led to interest in ivermectin as a treatment.

Reports from the country indicate the distribution of SARS-CoV-2 follows race and economic class lines. According to one member of the group known as the Ivermectin Interest Group, about 70%  of those individuals with Black heritage produced the coronavirus antibodies; 50% of Asian populations have been exposed while 40% of so-called mixed-race produce coronavirus antibodies. Of the white population, that figure is 20%. 

Also, indications are that in poorer areas of major urban areas, such as Soweto, experience such high concentrations of exposure that the topic of herd immunity even is mentioned.

These general demographic trends can be seen in America as well given the social determinants of health represent a global condition.

Vaccination in South Africa

As TrialSite reported in February, the AstraZeneca vaccine was put on hold as data from a university study revealed that particular product afforded the population minimal protection against mild-to-moderate infection caused by that nation’s predominant SARS-CoV-2 variant.

Now the Johnson and Johnson vaccine has arrived. Thus far, about 150,000 people in this country have been vaccinated between February and March. But with nearly 60 million people, the current pace of inoculation would take years to ensure the entire population was vaccinated. Many health professionals here believe therapeutic options such as ivermectin represent a key tool in a holistic strategy to care for as many people as possible.

The Fight for Ivermectin as a Treatment

As TrialSite has chronicled, South Africa as it turns out represents a key battleground for the use of the drug to treat people against COVID-19. In February, the AfriForum and the ACDP launched a legal action against SAHPRA and the Minster of Health to secure access to the drug as a treatment for COVID-19. In parallel, as TrialSite reported, SAHPRA first criminalized importation and potentially use but then allowed limited access via a program based on the country’s law known as section 21 of the Medicines and Related Substances Act. TrialSite commended SAHPRA for at least softening its stance, if just a bit.

Bureaucratic Layers

But the dependence on Section 21 causes just as many challenges because each time a doctor wanted to prescribe ivermectin for a COVID-19 case, they were subjected to a cumbersome bureaucratic process taking far too long, especially in pandemic conditions. Although they (SAHPRA) made some exceptions for emergencies, the level of bureaucracy had no place in the context of treating people during a pandemic.

Hence, AfriForum and the ACDP took legal action to change the situation.  They believed that this program based on Section 21 failed to support the purpose intended—that is, rather than help doctors it hindered them from treating patients who were ill as a consequence of SARS-CoV-2 infection.  Under the new rules, doctors had less resources to treat patients, too much time was passing, and too many patients ill. Before the enactment of Section 21 and the importation rules, doctors actually were entitled to prescribe the drug and credentialled, licensed doctors and pharmacists could compound it without having to submit applications to SAHPRA. But the new SAHPRA program precluded the ability for physicians and pharmacists to compound ivermectin medicine, hence reducing public’s access to the drug during the pandemic.

The Breakthrough

On Monday 15 March 2021, SAHPRA informed the ACDP that an ivermectin product should be registered by Wednesday 16, March 2021. This means that as soon as this product is registered, doctors can prescribe ivermectin without having to apply to SAHPRA to do so and compounding pharmacists and physicians can compound ivermectin for human use.

Deemed a great victory for the people of South Africa who have suffered under the scourge of the pandemic as a therapy that when prescribed under licensed, credentialed physicians numerous studies show it to have an positive impact on the disease, cutting the duration of illness and even in some studies evidencing it can reduce the mortality rate.

Moreover, as the ACDP was concerned about not only the lack of access during the pandemic but also a burgeoning black market where profiteers and criminal gangs would exploit the situation to maximize their profits, the move reported today, although it must be validated, is a big one.

The Reality

SAHPRA maneuvered and used the law that ironically was used against them by their opponents. As ivermectin was in fact registered in the past, they selected a cream-based product that includes ivermectin as an ingredient. Now the rules stipulate that licensed individuals can compound ivermectin based on this particular product registration. But this act doesn’t help any doctor that wants to produce hundreds of thousands of doses to treat at least 1.5 million cases in the country.  While South Africans must continue to wait for vaccination, although Johnson and Johnson continues to plan to send more doses, there isn’t much practically that physicians can do from this apparent compromise.

Call to ActionTrialSite will provide updates as they are available.  Governments and health authorities around the world have focused on vaccination, and importantly financing with public money pharmaceutical therapeutics, such as monoclonal antibodies used as prophylaxis but the prospect of generic, low cost ivermectin doesn’t look promising. The groups in South Africa taking on the legal battle for a low cost generic at least stood for something important and admirable and should be commended.

Responses

  1. As of 08:00 GMT on Thursday, 18 March, there has been no announcement concerning any registration of an Ivermectin product in South Africa. In a presentation to the Parliamentary Portfolio Committee on Health on 17 March, SAHPRA made no mention of any registration, or change in status. They did not mention any settlement agreement concerning the court case brought by Afriforum and the ACDP set down for the end of March. The only mention of Ivermectin related to the inconclusive nature of the evidence arising from various Trials. It would therefore be helpful to see any source document of communication from SAHPRA that indicates what has changed.