The civil rights organisation AfriForum and Dr George Coetzee have successfully obtained a settlement and R500,000 costs agreement with the SA Health Products Regulatory Authority (SAHPRA) regarding the compounding of and access to Ivermectin.
SAHPRA has also reached three other settlement agreements on actions challenging its rulings on Ivermectin use, which will be consolidated into a single agreement that is to likely be made an order of the court today (Thursday, 1 April).
AfriForum said in a statement that the settlement determines that a medicine containing Ivermectin as an active ingredient has been registered by SAHPRA in terms of the Medicines and Related Substances Act 101 of 1965 on 16 March 2021. The effect of the registration is that medicines containing Ivermectin may be compounded and made available and accessible in accordance with the provisions of Section 14(4) of the Act. SAHPRA and the Minister of Health, jointly and severally, will pay a contribution to the costs of the applicants in the amount of R500,000 (plus VAT).
The key to the settlement with AfriForum was SAHPRA allowing the registration of a topical cream, Soolantra, which contains 1% Ivermectin and is used to treat a type of skin rash in adult patients. Due to the fact that Soolantra contains Ivermectin as an active ingredient and is now registered, Ivermectin now can be compounded for other purposes and used off-label, reports IOL. This allows doctors to prescribe Ivermectin in tablet form on a per script basis.
SAHPRA said at the time that the registration of the cream is not in response to any of the current pending court cases regarding access to ivermectin for the prevention or treatment of Covid-19.
Head of research at AfriForum, Barend Uys, said doctors will no longer need to file a Section 21 application if they require compounded Ivermectin from a compounding pharmacy. “The practical implication of this settlement is that doctors can prescribe Ivermectin to patients if, in their judgement, it is required, and patients can then take this prescription to any pharmacy where compounded Ivermectin is available and buy Ivermectin,” he said.
General practitioner and founder of the Covid Home Management Team, Dr Naseeba Kathrada, said the registration of Soolantra was a victory in their fight to have ivermectin registered as a Covid-19 treatment. Compounding pharmacies will be able to compound and produce ivermectin in tablet form which Sahpra said is allowed in accordance with the provisions of section 14(4) of the Medicines Act such as for specific patients, on the basis of a prescription by a medical practitioner.
Kathrada said doctors can send a script to a compounding pharmacy such as Galderma.
“It’s a huge victory for us and it’s amazing that we can do this and be prepared for the third wave. This will get people off the black market tablets, and people will be able to get the right tablets in the right dose.
“We can send a script to a compounding pharmacy and they will compound the drug for us. When I give the drug to my patient I have to explain to them that the Ivermectin pill is off-label and I will need to get their consent,” Kathrada said.
IoL reports, in a separate article, that settlements were reached in the four different applications before court yesterday with SAHPRA. Judge Cassim Sardiwalla called the parties to chambers later, asking them to negotiate a single consolidated order rather than four different orders on the same subject.
Coetzee, the first applicant in the matter, is quoted in the AfriForum statement as saying: “We all know that COVID-19 is a dangerous disease and unfortunately there is no single wonder drug that can defeat the pandemic on its own. The most important factor in the fight against COVID-19 is every person’s immune system. Ivermectin makes a big contribution in this regard, and access to and availability thereof is, especially for the more vulnerable and needy majority of the population, indispensable for us to heal people. This settlement brings me great joy because it is a big victory for patients and doctors who take their oath to heal people seriously,” says Coetzee.
Barend Uys, head of research at AfriForum, is quoted as saying: “The practical implication of this settlement is that doctors can prescribe Ivermectin to patients if, in their judgement, it is required and patients can then take this prescription to any pharmacy where compounded ivermectin is available and buy ivermectin. No Section 21 application or reporting is required for compounded Ivermectin. We are very glad as easy access to Ivermectin for doctors and patients are now possible.”
“Because a medicine that contains Ivermectin as an active ingredient is now registered and Ivermectin is listed as a schedule 3 substance, Ivermectin can now be used for other purposes than stated on the label of the registered medicine (off-label use), that includes the treatment of COVID-19.”
Coetzee, the first applicant in the case, said COVID-19 is a dangerous disease and that no single wonder drug can defeat it on its own, in a TimesLive report.
“The most important factor in the fight against COVID-19 is every person’s immune system. Ivermectin makes a big contribution in this regard, and access to and the availability thereof is, especially for the more vulnerable and needy majority of the population, indispensable for us to heal people.
“This settlement brings me great joy because it is a big victory for patients and doctors who take their oath to heal people seriously,” Coetzee said.
Barend Uys, head of research at AfriForum, said that, practically-speaking, the settlement meant that “doctors can prescribe ivermectin to patients if, in their judgment, it is required”.
“Patients can then take this prescription to any pharmacy where compounded ivermectin is available and buy ivermectin. No section 21 application or reporting is required for compounded ivermectin. We are very glad as easy access to ivermectin for doctors and patients is now possible,” he said.
In a statement earlier in the week, SAHPRA said that Ivermectin may be prescribed and dispensed to patients without awaiting section 21 (emergency use of unregistered medicine) authorisation, but was still subject to receiving section 21 authorisation, informed consent and all reporting requirements normally required under section 21.
SAHPRA said it had however registered Soolantra cream which is for topical treatment of moderate to severe inflammatory lesions of papulopustular rosacea in adult patients. It said the cream is not for the treatment or prevention of Covid-19.
[link url=“https://www.iol.co.za/news/politics/sa-doctors-can-now-prescribe-compounded-ivermectin-5e6b1165-062b-483b-9c38-49bf45e8eb71"]Full first IoL report (Open access)[/link]
[link url=“https://www.iol.co.za/pretoria-news/news/court-to-rule-on-ivermectin-use-for-covid-19-7a0f2058-c0ba-4ffc-b91d-0ee18513bf75"]Full second IoL report (Open access)[/link]
[link url=“https://www.timeslive.co.za/news/south-africa/2021-03-30-regulator-says-no-green-light-yet-for-ivermectin-while-afriforum-claims-victory-in-court-case-for-drugs-use/"]Full TimesLive report (Open access)[/link]
See also MedicalBrief archives:
Afriforum joins doctor and patients for declaratory order on Ivermectin
High Court settlement allows doctors immediate use of Ivermectin