AfriForum and Solidarity have launched an urgent court application to request more information concerning the conditions imposed on Johnson & Johnson (J&J) by the SA Health Products Regulator, reports Pretoria News.
They will also ask the Gauteng High Court (Pretoria), to review and set aside SAHRPRA’s’s alleged decision to impose certain conditions on the procurement of the J&J vaccines. The regulator has approved the J&J vaccine, which is manufactured by Janssen Pharmaceuticals, but on condition that the vaccine be purchased only by the government, the applicants said. This, in effect, means that both the provincial governments and the private sector, including pharmacies, may not buy the vaccine directly from the manufacturer.
The applicants said in court papers that if there were conditions attached to the purchasing of this vaccine, these must be published in the Government Gazette. AfriForum and Solidarity said they have been unable to find any such publication.
“The regulator is supposed to look after the effectiveness of vaccines and other medications and not its centralisation and nationalisation," said Anton van der Bijl, head of legal services at Solidarity. "We are of the opinion that such a condition of centralisation is unlawful.”
SAHPRA denies having placed a prohibition on the private and provincial procurement of COVID-19 vaccines. It said it received an application by Janssen for the registration of its COVID-19 vaccine – J&J – but this was made in the context of its intent to supply it to the national Department of Health for purposes of its vaccine plan.
The regulator said it was bound by the Medicines Act not to disclose these conditions. The applicants said they were not convinced the regulator had not placed a prohibition on the private and provincial procurement of this vaccine. The regulator still had to file its responding papers.
Full Pretoria News report (Open access)
See also from the MedicalBrief archives:
Only national government can buy J&J vaccine — SAHPRA
Afriforum: Govt admits private sector may buy COVID-19 vaccines
SA awards first vaccine import and distribution contracts and makes up with J&J
Full BusinessLIVE report (Open access)