By Grant Jacobs 19/05/2021


The High Court has declined an attempt to halt New Zealand’s vaccination rollout. It does asks the Crown to consider how their plans sit within current law. The government plans to pass a Bill under urgency today to tackle this.

I think a fair question is if the deeper issue lies with a lack of mechanism for emergency use approval in New Zealand. (This is not a criticism of the court ruling: the judge is obliged to consider what is put before them, and rule on that.)

The ruling

A request for an interim order seeking to stop New Zealand’s vaccine rollout was brought to the High Court in Wellington by Nga Kaitiaki Tuku Ihu Medical Action Society Incorporated (KTI).

This was declined —

(Ultra vires means ‘beyond ones legal power or authority’.)

Basically, the court declined the attempt to stop the vaccine rollout, but asked the government to consider how their plans matched the current law.

The court does not rule that government “did wrong”, as many people are saying on social media.

What the ruling does is note the claim about ‘limited numbers’ was “reasonably arguable”, and asks that the Crown (government) consider it.

As Senior Lecturer in Law Eddie Clark put it, “The High Court made absolutely no ruling one way or another on the arguments about legal authorisation, but did expressly say (and I agree) that one argument about the wording of provisional authorisation under the Medicines Act was reasonably arguable.”

Not shoddy

The ruling strongly emphasises that the government’s checking of the vaccine was excellent, going ‘above and beyond’ —

The ruling goes on to say, ‘And it is difficult to see how the assessment process, considering the circumstance, could have been more thorough’.

Subsequent sections 70 and 71 detail how the government has done well on this, and that the interim ruling cannot realistically be granted. These are extensive. They cover how the government actions compared favourably with other nations, and the likely serious impact of pausing the immunisation programme.

Asking the Crown to consider how their plans sit with current law is not saying the vaccine approval was shoddy.

A case of urgency and changing plans

The ruling notes that this issue arises from a change in plans. Originally the intent was to use the provisional approval to vaccinate the border workers.

As the pandemic continued, it become clear that NZ needed to vaccinate more widely.

Large outbreaks overseas are one issue. New variants with greater transmissibility are another.

A recent example is the B.1.617 variant commonly found in India. Cases of this variant are rising in the UK, and found in outbreaks in Singapore and Japan.

Border workers workers have a different risk profile than the general public. For them a provisional use makes sense. For a wider rollout the terms of the provisional consent law is awkward.

The judge notes the provisional use wording is not just for limited time, but for a limited number of people.

The government response

The government has responded with a press release,

Health Minister Andrew Little says Section 23 has been used over 40 years by successive Governments to grant early access to approved therapeutic substances when it is in the public good.

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

“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 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.

“There are six products currently in use under Section 23, including two types of contraceptives, two pandemic flu vaccines, the Pfizer COVID-19 vaccine and an electrolyte solution used in hospitals, potentially affected by the decision.

“The Government will introduce a Bill tomorrow to make sure New Zealanders continue to have timely access to the medicines and treatments they need. The Medicines Amendment Bill is expected to be passed under urgency tomorrow in order to protect New Zealanders early access to medicines when needed,” Andrew Little said.

The Therapeutic Products Bill that will replace the outdated Medicines Act is expected to be introduced into Parliament next year.

Need for emergency use law

(I’m not a lawyer; this section is speculative, but I think it is a point worth raising. I raise it to encourage others with expertise in this area to discuss it.)

Is the real issue is a lack of emergency use law or process?

According to Medsafe1 they do not have the ability to grant an Emergency Use Authorisation —

Taken from Medsafe’s COVID-19 Therapeutic Products – Questions and Answers page. Last revised 20 April, 2020.

My read of that is that there is no mechanism for them to offer an emergency use authorisation.

The court ruling centres around a section of law allowing provisional consents.

My understanding is that original purpose of that is to allow consent for, say, treatment of rare diseases where it is unlikely there will be a case for approval across the nation as a whole.

Emergency use is different. It wants quick actions to respond to threats. The actions might be sweeping, and across a large number of people.

A critical element is the balance of risks. There is need to consider ‘better than not’. As epidemiologists point out, if you wait for perfection, you will lose. You have to act.

Other nations have used emergency authorisations to act quickly. We are lucky in not having the same urgency—but only by relying on border controls. As Taiwan’s recent outbreak illustrates, this is not a given.

As I said earlier, I’m not a lawyer. I find it hard to see how these different aims can be reconciled in a single section of law.

It would be good to hear from lawyers and public health experts on the need for emergency approval law for situations like this.

Employment issues

One talking point amongst those opposed to vaccines is that the government is, according to them, ‘forcing’ workers to take the vaccine.

In practice the vaccine is not mandatory, as the ruling notes.

As the ruling notes, where there are requirements for vaccination, is is not across most of the nation, nor about individual rights per se. There it is about businesses, and a need to meet safety requirements.

The judge noted the court had no jurisdiction over employment matters. (You’d think, or wish, those filing the case should know this.)

KTI and Sue Grey

The court case is brought by KTI. KTI arranges their legal challenges to be made by (only) Sue Grey —

Sue Grey is widely known for cases featuring pseudoscience and railing at the government. (I am being polite.) Senior political writer Marc Daalder described her as an “anti-vax, anti-5G, anti-1080 conspiracy theorist” —

Many of the people supporting Grey’s efforts talk of their ‘rights’ and protest  ‘oppression’. In practice, unless they choose to be employed in a business with health and safety rules requiring vaccination, they’re free to not take the vaccine if they choose not to. If the option to choose not to is important to them, they should respect others’ wishes to choose to.

Final thoughts

Existing law may not always reflect what is needed. There’s a place for revising it as we learn more. I’m not convinced challenging the Crown in court is the best way of taking this.

There is definitely a place for more forward planning on things like pandemics. We will likely to face more disease challenges. Climate change is likely to bring some of these.

Legal frameworks need to be part of the wider long-term planning efforts for managing future pandemics. This may be the useful lesson from this court case. Some would argue, the only useful thing about it.

Footnotes

The court ruling can be found on published by KTI on their website. I would give an outline of the case brought to court, but that would take more time. Briefly, the judge has set aside all but one specific issue raised. I would like to have written earlier on the case argued by KTI. Like the judge I felt only the one issue of ‘limited number of people’ was relevant or appropriate. A lot of the rest is sourced from typical ‘complaints’ expressed on social media by those opposed to vaccines. In my humble opinion, there the issue is understanding (and communicating) science, not law per se.

Alison Campbell, also writing at Sciblogs, has previously tackled ‘Plan B’s support of the court case.

  1. The ruling outlines how the approval of the vaccines is deputised to NZ’s Medicines and Medical Devices Safety Authority, Medsafe. Medsafe, in turn, advised it be passed to the Medicines Assessment Advisory Committee. MAAC’s role is to advisor the Minister of the risk-benefit profile of new medicines. Several hands are involved in the deputising, and many committees and bodies. If I attempted to list them all you’d have quite a headache. Suffice to say a lot of players are involved: this vaccine approval was not some trivial action done a few.

About the author

I’m a scientist (a computational molecular biologist) and writer. I’ve tracked this pandemic from early on by fortuitous accident. Most of 2019 I was researching zoonoses for writing projects. Part of that was looking for examples of outbreaks. In early December 2019, a ‘pneumonia of unknown cause’ from China caught my attention, and I’ve followed the science and specialists’ discussions closely since.

Article by Grant Jacobs, ©2021-.

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Featured image

Website of the Courts of New Zealand, open on their ‘COVID-19: Related judgments’ page. In time I would expect the ruling to appear on this page.