AFRIFORUM and Solidarity have launched an urgent court application to request more information concerning the conditions imposed on Johnson & Johnson (J&J) by the South African Health Products Regulator.
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 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 and therefore urgently request this information. The urgent application will be heard this week.
According to them, the decision is unlawful as there are no provisions that enable them to impose these conditions.
“The regulator is supposed to look after the effectiveness of vaccines and other medications and not its centralisation and nationalisation. We are of the opinion that such a condition of centralisation is unlawful,” said Anton van der Bijl, head of legal services at Solidarity.
He said the government’s vaccine roll-out programme so far had been problematic and it is in no position to deal with the purchase and distribution of vaccines on its own.
Van der Bijl stated that the prohibition on the private or provincial procurement of the Covid-19 vaccines was unlawful and that it was the right of private institutions to also purchase vaccines, particularly the J&J vaccine.
The applicants wrote various letters to the regulator to obtain details regarding the conditions imposed on the registration of this vaccine.
The medicine regulator denied that 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 - Johnson & Johnson - 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.
They said the issue must come under legal scrutiny urgently as they fear that there may be an unlawful condition regarding the J&J vaccines which had the effect of barring private individuals from procuring a possibly life-saving vaccine.
The applicants said the government made it clear that it had no policy to prevent private procurement and distribution of Covid-19 vaccines, but they are accusing the regulator of not playing open cards.
According to the applicants, it is vital that clarity is obtained as soon as possible as to who can procure these vaccines, especially as the third wave of the pandemic is upon the country.
The regulator is expected to file its court papers in response this week.