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. According to a Pretoria News report, the applicants launched a two-legged application in which they will also ask the Gauteng High Court (Pretoria), to review and set aside the regulator’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 is 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 and therefore urgently request this information.
Furthermore, ‘the regulator is supposed to look after the effectiveness of vaccines and other medications and not its centralization and nationalization. We are of the opinion that such a condition of centralization is unlawful,’ said Anton van der Bijl, head of legal services at Solidarity. The Pretoria News report notes that the medicine regulator denied it had placed a prohibition on the private and provincial procurement of Covid-19 vaccines. It said that 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 that 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.