18 May 2021

'Technical anomaly' spurs urgent law change for Covid-19 vaccine

5:31 pm on 18 May 2021

The government will urgently change the law to ensure the Covid-19 vaccine rollout is legal following a High Court decision today.

A woman receives a dose of the Pfizer/BioNTech Covid-19 vaccine during the first rollout in Australia at the Castle Hill Medical Centre in Sydney on February 21, 2021.

A woman receives a dose of the Pfizer/BioNTech Covid-19 vaccine. Photo: AFP / Steven Saphore

In her decision, Judge Rebecca Ellis ruled it was "reasonably arguable" that the government's approval of the Pfizer vaccine went beyond what the Medicines Act allowed.

Ellis said Section 23 of the Act gave the Health Minister the right to approve medicines for "a limited number of patients", whereas the Covid-19 vaccine would cover all New Zealanders over the age of 16.

Covid-19 Response Minister Chris Hipkins told reporters the ruling had highlighted a "technical anomaly" with the law, but raised no safety issues.

Health Minister Andrew Little said the government would pass legislation under urgency tomorrow to rectify the problem.

"The law has, for some time now, lacked clarity over how it can be applied," Little said.

Little said the legislation had been used for decades by successive governments to grant early access to substances when it was in the public good.

Six products are potentially affected by the Court decision, including the Pfizer vaccine, two flu vaccines, two types of contraceptives, and an electrolyte solution.

"We already knew the Medicines Act was out of date, which is why we were planning to replace it with a new Therapeutic Products Act.

"Treatments approved under Section 23 go through a rigourous 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."

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