The North Gauteng high court application was launched by GP Dr George Coetzee, two of his patients, and Afriforum “in the public interest”. They claimed the drug — not registered in South Africa for human use — “may well be the wonder drug that can save the nation”. And they wanted a judge to force the South Africa Health Product Regulatory Authority (SAHPRA) to declare it a “safe drug”, subject to it being properly administered by a medical practitioner.
Judge Peter Mabuse made the ruling for the use of ivermectin in cases where treatment is necessary in the North Gauteng High Court in Pretoria on 2 February 2020. The court order stipulates that any person is eligible for access to ivermectin and that medical doctors are entitled to apply for access to ivermectin,“ he said. First applicant in the court application, Dr George Coetzee, said: “I am pleased with the certainty that the court order gives that doctors can demonstrate their clinical judgement to start ivermectin treatment when access is urgently needed.”.
In an accompanying press statement, SAHPRA wrote that it has been reviewing new evidence on the safety and efficacy of ivermectin for the treatment and prevention of Covid-19. “To date, there is insufficient evidence for or against the use of ivermectin in the prevention or treatment of Covid-19. Furthermore, no regulatory authority with which SAHPRA is aligned (such as the US FDA, EMA or MHRA) has recommended the use of ivermectin in the management of Covid-19.” While lawyers for the applicants told GroundUp SAHPRA’s willingness to use the section 21 process was a “step in the right direction”, it said it would persist with the urgent court application “to ensure that the section 21 process is expedited and streamlined”. “Our concern is the section 21 process is still extremely defective and administratively burdensome.”
The parties have filed a draft order, likely to be made an order of court. The proposed order refers to SAHPRA’s “Ivermectin Controlled Compassionate Use Programme Guidelines”. It states that in terms of this programme ivermectin will be made available, subject to section 21 applications and that anyone can access it via this process. Medical practitioners may apply for access and where they believe urgent access is required, and ivermectin is available, treatment may be initiated at the same time as the application is made.
In terms of the process, medical practitioners will have to report back to SAHPRA on any adverse side-effects which, SAHPRA says, will be used to collect much-needed data on the performance of the drug, pending proper clinical trials. The applicants were also seeking a declaratory order that medical doctors and pharmacists be allowed to compound medicines, particularly those containing ivermectin, in a quantity required for treatment of their patients.
The debate on this revolves around interpretations of section 14 (4) of the Medicines Act and whether or not “has been registered” means “is now registered” or “has been registered at any time”. (There is some confusion over the past registration status of ivermectin.) This issue will be held over for determination by a court at a future date after more papers are filed during the course of this month.
But many doctors GroundUp has spoken to are sceptical of using ivermectin before a clinical trial shows whether it is effective. There is no consensus on what dose, form, duration or stage of illness the drug can or should be taken. Dr Aslam Dasoo wrote: “The authority, designed for a normal functional democracy, was unable to withstand abnormal pressure from lobby groups and its decision shows up the lack of protection from a strong government.”
ACDP heads back to court on use of Ivermectin in the treatment of Covid-19 Media Statement by Bongani Khayile-Luthuli, ACDP NEC . SAHPRA’s Controlled Compassionate Use Programme is onerous, restrictive and unworkable
The ACDP has together with doctors and some others pressurised SAPHRA to acknowledge that Ivermectin is safe in the treatment of Covid-19 when prescribed by doctors. This pressure resulted in the so-called SAHPRA Controlled Compassionate Use Programme.
However, Doctors must first apply to prescribe Ivermectin in terms of the provisions of the programme pending the outcome of the court case. The sudden publication of the programme by SAHPRA forced the ACDP to postpone its urgent application in order to give the programme a chance to demonstrate itself.
However, the programme is onerous, restrictive and unworkable. It is crucial to save lives, and the ACDP will continue to hold SAHPRA and the Minister of Health accountable to the scientific evidence. The ACDP expects to be back in court in the week of 22 February 2021.”
Favilavir is an antiviral drug that is approved in Japan for common influenza treatment and is now approved to treat symptoms of COVID-19 in China. Moreover, Chloroquine and hydroxychloroquine, drugs used to treat malaria and arthritis, respectively, were recommended by the National Health Commission of the People’s Republic of China for treatment of COVID-19. Presently, chloroquine and hydroxychloroquine are under investigation by the US Food and Drug Administration (FDA) as a treatment for COVID-19.
Ivermectin was a revolutionary drug in the 1980s, the forerunner of a new group of antiparasitic agents with activity against both parasitic nematodes and arthropods. Initially it was marketed for veterinary use by Merck & Co. Inc.; it was used largely for nematode control in cattle, horses, pigs and dogs and became the standard for control of the ectoparasitic disease, scabies. The injectable cattle formulation, Ivomec, became the world’s most profitable veterinary drug. Merck recognized Ivermectin’s potential for human use, particularly in the control of filariasis and most notably onchocerciasis, the cause of river blindness in West Africa, in the early 1980s.
Heukelbach et al. (pp.563–579) report a study that investigates changes in parasitological parameters and the occurrence of side-effects after treatment with ivermectin in a Brazilian community heavily parasitized with intestinal helminths and ectoparasites. The trial was unblinded and uncontrolled, but provided valuable information. Community members, ineligible for ivermectin, were treated with mebendazole, albendazole or deltamethrin to achieve a high level of coverage. Of particular importance was the finding that ivermectin was highly effective against Strongyloides stercoralis, with a 94% reduction in prevalence that was sustained for nine months.
Ivermectin has valuable public health applications for controlling strongyloidiasis and scabies (by breaking the infection cycle through its therapeutic effect) and filariasis, through its effect on transmission. Ivermectin also acts against other intestinal nematodes, but it is not the most effective drug available. In control programmes for filariasis, ivermectin is the drug of choice in areas with onchocerciasis, but can be replaced by diethylcarbamazine for control of other filarial diseases.
SAHPRA is tasked with regulating (monitoring, evaluating, investigating, inspecting and registering) all health products. This includes clinical trials, complementary medicines, medical devices and in vitro diagnostics (IVDs). Furthermore, SAHPRA has the added responsibility of overseeing radiation control in South Africa. SAHPRA’s mandate is outlined in the Medicines and Related Substances Act (Act No 101 of 1965 as amended) as well as the Hazardous Substances Act (Act No 15 of 1973).
SAHPRA has three pillars to ensure that medicines, medical devices and IVDs meet the requisite standards to protect the health and well-being of South Africans:
2.1.2. The Constitution of the Republic of South Africa, 1996
In terms of the Constitutional provisions, the Authority is, amongst others, guided by the following sections and schedules: The Constitution of the Republic of South Africa, 1996, places obligations on the state to progressively realize socio-economic rights, including access to health care. Section 27 of Chapter 2 of the Bill of Rights of the Constitution states the following with regard to healthcare, food, water and social security:
- Everyone has the right to have access to health care services, including reproductive health care; sufficient food and water; and social security, including, if they are unable to support themselves and their dependents, appropriate social assistance.
- The state must take reasonable legislative and other measures, within its available resources, to achieve the progressive realization of each of these rights; and no one may be refused emergency medical treatment.