The announcement follows a High Court decision on the legality of provisional vaccine approvals
The New Zealand government has announced that a bill amending the Medicines Act has been introduced to accommodate the rollout of COVID-19 vaccines following a High Court decision regarding the legality of provisional vaccine approvals.
Health Minister Andrew Little said in a media release yesterday that the new legislation is “a technical amendment to modernise the law.” The Medicines Amendment Bill is expected to be passed “under urgency” to “protect New Zealanders’ early access to medicines when needed.”
Little’s announcement comes after High Court Judge Rebecca Ellis ruled on the case of Nga Kaitiaki Tuku Ihu Medical Action Society Incorporated v The Minister of Health, which questioned whether the provisional approval of Pfizer’s COVID-19 vaccine by the government and its rollout to a significant chunk of the population was within the bounds of the Medicines Act.
“It is reasonably arguable that the decision to provisionally approve the vaccine for much wider use is problematic,” Ellis said in the decision.
As reported by the NZ Herald, the judge said that the approval overstepped the powers granted by section 23 of the Medicines Act. She also highlighted the vaccine’s availability to New Zealanders over 16 years old.
“While I acknowledge that this is a more ‘limited’ class of persons than ‘all New Zealanders,’ a class of that size seems well beyond what is contemplated by a straightforward, purposive, reading of the section,” Ellis said.
Nonetheless, the judge shied away from halting the rollout of the vaccine, saying that the consequences “are too great, by some very considerable margin.”
COVID-19 Response Minister Chris Hipkins said that the provisional approval had been interpreted by the courts in “a way that doesn't reflect the current practice,” and that Ellis’ ruling reflected a “weakness in the Medicines Act.”
“It affects the flu jab and a variety of other things that have been approved using the provisional approval in the Medicines Act,” he said in a statement published by the Herald.
Hipkins said that the government planned to urgently present a bill to Parliament that would clarify what was “largely a technical issue rather than a substantive issue.”
Little pointed out that the High Court’s ruling could impact six medical products currently passed for use under section 23 of the Medicines Act: two types of contraceptives, two pandemic flu vaccines, Pfizer’s COVID-19 vaccine and an electrolyte solution utilised by hospitals.
“The law has for some time now, lacked clarity over how it can be applied. We already knew the Medicines Act was out of date, which is why we were planning to replace it with a new Therapeutic Products Act,” Little said. “Treatments approved under Section 23 go through a rigorous Medsafe approvals process. There are occasions when the health needs of a population call for urgent access to a medicine, vaccine or treatment and we need to keep this option available for some circumstances.”
The Therapeutic Products Act is intended to go before Parliament next year.
