Limiting RATs

This post is a form of companion piece to an earlier post “Jacinda’s Labyrinth” which examined some of the legal underpinnings to the management of the COVID pandemic in New Zealand. In this piece I consider the way in which the law has been deployed to manage (or prevent) the use of rapid antigen (RAT) tests

In February 2022 some 30,000 JusChek Rapid Antigen Tests (RAT) were seized by Customs. They had been ordered by Auckland Grammar School and were proposed for school use. It appears that the school was being pro-active in attempting to monitor occurrences of COVID-19 within the school itself. It seems like it was a responsible approach[1].

So why were the tests seized? This was not part of the Government’s “consolidation” (read “sequestration”) of ordered tests. The reason for the seizure was that the tests were banned.

In this post I examine the processes that lie behind the banning of RATs and suggest that the process demonstrates the way in which the Government and the Ministry of Health are determined to maintain strict control of the pandemic and the tools available to counter it.

The starting point must be the COVID-19 Public Health Response Act 2020. There are two important sections – section 9 and section 11. Section 11 gives the Minister the power to make certain Orders. Section 9 sets out the requirements for making such Orders.

Those requirements are:

(a) The Minister must have had regard to advice from the Director-General about—

(i)  the risks of the outbreak or spread of COVID-19; and

(ii)  the nature and extent of measures (whether voluntary or enforceable) that are appropriate to address those risks; and

(b)  the Minister may have had regard to any decision by the Government on the level of public health measures appropriate to respond to those risks and avoid, mitigate, or remedy the effects of the outbreak or spread of COVID-19 (which decision may have taken into account any social, economic, or other factors); and

(ba)  the Minister must be satisfied that the order does not limit or is a justified limit on the rights and freedoms in the New Zealand Bill of Rights Act 1990; and

(c)  the Minister—

(i)  must have consulted the Prime Minister, the Minister of Justice, and the Minister of Health; and

(ii)  may have consulted any other Minister that the Minister (as defined in this Act) thinks fit; and

(d)  before making the order, the Minister must be satisfied that the order is appropriate to achieve the purpose of this Act.

Once there has been compliance with those requirements the Order may be made under section 11. There is nothing in section 11 that provides for a power to make an Order prohibiting the import of certain testing kits. The closest that I can find – and it would require a rather generous interpretation – would be in section 11(1)(a) which provides that the Minister may make an order for the following purpose

•  to require persons to refrain from taking any specified actions or to take any specified actions, or comply with any specified measures, so as to contribute or be likely to contribute to either or both of the following:
•  preventing, containing, reducing, controlling, managing, eliminating, or limiting the risk of the outbreak or spread of COVID-19:
•  avoiding, mitigating, or remedying the actual or potential adverse public health effects of the outbreak of COVID-19 (whether direct or indirect):

The examples contained in section 11(1)(b) do not include importing prohibited items nor providing for an import prohibition. A broad interpretation may be that the Order prevents a specified action (the importation of prohibited items) to avoid actual or potential adverse public health effects of the COVID-19 outbreak.

One further basis for making the Order may be found in section 11(1)(d)

…to require specified actions to be taken, require compliance with any specified measures, or impose specified prohibitions, so as to contribute or be likely to contribute to either or both of the following:

•  preventing, containing, reducing, controlling, managing, eliminating, or limiting the risk of the outbreak or spread of COVID-19:
•  avoiding, mitigating, or remedying the actual or potential adverse public health effects of the outbreak of COVID-19 (whether direct or indirect):

Once again a generous interpretation is required.

Clearly it is envisaged that there can be restrictions on the importation of goods. Section 11(4) provides

“All goods prohibited from import under a COVID-19 order are deemed to be included among goods prohibited from import under section 96 of the Customs and Excise Act 2018, and the provisions of that Act apply to those goods accordingly.”

The COVID-19 Public Health Response (Point-of-Care Tests) Order 2021 came into force on 22 April 2021. The order prohibits a person from importing, manufacturing, supplying, selling, packing, or using a point-of-care test for SARS-CoV-2 or COVID-19 unless the Director-General of Health has:

• authorised the person’s activity; or
• exempted the point-of-care test from the prohibition.

The Order replaces a Notice issued pursuant to section 37 of the Medicines Act 1981. Section 37 gives the Minister the power to prohibit the import of medicines.

The section in full states:

•  The Minister may from time to time, by notice, prohibit the import, manufacture, packing, sale, possession, supply, administration, or other use of medicines of any specified description or medical devices of any specified kind, either absolutely or subject to such conditions as he thinks fit, for any specified period not exceeding 1 year; but he shall not exercise this power more than once in respect of medicines or medical devices so specified.

•  Where the Minister gives a notice under subsection (1), he shall, on the written request of any person, state his reasons for doing so.

•  Every person commits an offence against this Act who contravenes any notice given under subsection (1).

•  A notice under this section is secondary legislation (see Part 3 of the Legislation Act 2019 for publication requirements).

By Notice dated 22 April 2020 the Minister of Health prohibited the importation, manufacture, packing, sale, supply or use of any kits and/or other test materials intended for use as point of care testing for COVID-19 infection or for post-infection confirmation using an antigen or antibody detection system unless the particular test kit and/or test materials.

The only exceptions were kits approved by Medsafe and to be used for testing by a specified category of health care professionals.

The Notice expired on 22 April 2020.

It was on that date that the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 came into force. That order provided for a prohibition on the importation, manufacture, supply, sale or use of a point of care test unless the person activity was authorized under clause 8 of the Order or the test was exempt from the prohibition under clause 9.

Clause 9 gives the Director-General of Health the power to exempt any point-of-care tests from the prohibitions contained in the Order. The criteria for exemption are that the Director-General must be satisfied that:

•  the point-of-care test or class of point-of-care tests is sufficiently accurate and reliable so as not to pose a material risk to the public health response to COVID-19; and
•  the exemption is not inconsistent with the purpose of the Act; and
•  the exemption is no broader than is reasonably necessary to address the matters giving rise to it.

The exemptions that have been granted are contained in the New Zealand Gazette and the most recent one is dated 24 February 2022[2]. This exempts a total of 11 Rapid Antigen Tests from the prohibition.

The Notice dated 24 February 2022 replaces another notice published on 4 February 2022 and dated 3 February 2022. In turn that notice approved for exemption 11 RATS.

There is something of a history of Notices under the Point of Care Order. These preceding Orders are dated 28 January 2022, 25 January 2022 and 21 January 2022. These earlier orders related to the authorization of persons who may import RATS or expanding the import and supply of RATs.

If the RATs referred to in the opening of this piece were seized in the first 8 weeks of the year a review of the Orders reveals that the JusChek brand of RATs was not approved for import. However, the JusChek RATs had been approved in Australia by the Therapeutic Goods Administration. It seems curious that RATs that were approved in one jurisdiction are deemed unfit for purpose in another.

There are a number of issues that arise from this unusual situation.

The first is the blanket prohibition on the importation of RATs unless they have been approved. This is not unusual in and of itself but in the context of the COVID pandemic is another example of this Government’s approach to the law which is that everything is prohibited unless it is permitted.

The normal approach is that everything is permitted unless it is prohibited. Once again the Government has turned legal theory on its head.

The second issue lies in the approach of the Government to the use of RATs. Throughout the pandemic the Government and the Health Mandarins have consistently turned their faces from advice that would prove beneficial to the New Zealand public and in the management of the pandemic.

This includes apparently ignoring the report of Sir Brian Roche and Heather Simpson which was made available in September of 2020 but for some inexplicable reason was not released until mid-December 2020. It is claimed that some of the recommendations were implemented or underway but these were difficult to discern.

Then there were the various efforts by Sir Ian Taylor directed to a more nimble and nuanced approach to managing the pandemic. His suggestions were directed towards issues around self-isolation, the use of RATs, alternatives to MIQ and other alternatives. It is clear that his approach does not coincide with Government policy nor indeed the Government narrative to the point that Taylor claimed that he had been asked by the Associate Health Minister to stop writing “bad faith” columns. It seems that anything that is slightly critical of Government policy or that departs from the “party line” is “bad faith”.

The resistance to any form of testing other than the slow and unpleasant PCB test was continuous until the onset of the Omicron variant when it became abundantly clear that the systems in place surrounding PCB testing were quite inadequate to meet the increased demand as a result of the highly infectious new variant. The Director-General of Health had to fall on his sword and apologise for the delays that were being occasioned in the return of PCB test results. Clearly the Government wasn’t responsible, for if it was it would be yet another example of failure to deliver a solution.

Once it became apparent that RAT tests were going to be necessary to keep a track of cases and to (more importantly) allow citizens to find out promptly whether or not they had the disease, things began to move. One only has to look at the flurry of activity as the Director-General started to grant exemptions to the RAT import and use prohibitions which I have detailed above.

The justification for the tardy response has been two-fold. PCB testing is a very accurate way of detecting COVID infections. That is the first justification for staying with the present system. The second reason for the tardy – almost reluctant – response is that RAT tests are not as accurate as the PCB tests.

There might seem to be another reason. PCB testing takes place at testing stations. Those being tested have to check in and provide their details including their health number. The test results can therefore be traced to an individual who may or may not have the disease. And, of course, the tests – managed by the Health Department – provide data that the Department claims is necessary to advise Government as to policy surrounding the pandemic.

RAT testing presents a different scenario and one where the Health Mandarins have no control at all. RAT tests are available over the counter. They can be conducted in the privacy of the home rather than under the surveillance of a PEP clad functionary. And more significantly it is left to the individual as to whether the results are communicated to the authorities. There are a number of reports of people who are NOT reporting a positive test and I imagine that there are a number of reasons.

If I may digress for a moment for the recording of the results of RAT tests may be accomplished through use of the My Covid Record application. Indeed most of the advice about ascertaining information or communicating outcomes specifies an online response.

This requirement is based on a number of assumptions. One is that everyone – and I mean everyone because no one is immune from COVID – has access to an online provider and has the necessary hardware be it a smart phone, laptop or desk top computer by which this access can be accomplished. This is an appalling bourgeois assumption which seems to underpin many aspects of modern communications and seems to be based on the assumption on the part of officials that, because they have access to online systems everyone else may have similar access. Although uptake of the Internet in New Zealand is high that attitude fails to recognize that there is a digital divide in this country where a proportion of the populace do not have access to online systems or are not adept in their use. The provision of an 0800 number assumes that a telephone system will work efficiently but it does not. The system is overburdened and waiting times for pickup are reportedly very long. Yet another piece of bad planning on the part of the Government and its agencies.

Another feature of the individual management of the pandemic – for it is clear that the Government can no longer control the direction of the disease – is the refusal of the Health Mandarins to consider not only a wider variety of RAT tests – such as were sought by the Auckland Grammar School – but also any other form of testing such as saliva testing. I understand that there has been very limited use of saliva testing for COVID – for border workers, health care workers and those in MIQ when it was still required. But saliva testing is not more widely available. Furthermore saliva can be used as a sample for rapid antigen testing. It seems curious that this form of detection is not available.

The slow response to allowing RATs seems to echo the slow response to the introduction of vaccines. It has long been my view that the harshness to the vaccine mandate programme could well have been mitigated by having the unvaccinated undergo a RAT before entering, say, a workplace, and if they test negative all is well. Of course the Health Mandarins say that RATs are inaccurate and that the odd case may slip though but the reality is that RATs are the prime source of detection. Did they suddenly become more accurate? I do not think so. I can understand the reaction of the principal of Auckland Grammar School. In good faith he, no doubt under advice, took steps to ensure health and safety of those for whom he was responsible. The school wanted to be proactive about offering students and staff another layer of protection. His bona fide efforts were thwarted by a punctilious bureaucracy that will admit of no other way than that which it decrees. It seems that it is the Government’s way or the highway when it comes to dealing with COVID. It is yet another example of the failure by the authorities to act reasonably and nimbly in the face of this pandemi

---

[1] Covid 19 Omicron outbreak: 30,000 rapid antigen tests seized at borders, high school says situation ‘nonsensical’ NZ Herald 6 March 2022 https://www.nzherald.co.nz/nz/politics/covid-19-omicron-outbreak-30000-rapid-antigen-tests-seized-at-borders-high-school-says-situation-nonsensical/CMAIV2FSHCVEIL44MWU3UENMG4/ (Last accessed 7 March 2022)

[2] https://gazette.govt.nz/notice/id/2022-go587 (Last accessed 7 March 2023)

Advertisement

Talking About “Misinformation”

The following was written some weeks ago before the Parliament Garden Ocupation began, Since then the term “misinformation” has been bandied about largely as a motivating basis for the protesters and occupiers.

But misinformation is not new, by any stretch. The advent of the printing press and the growth in the amount of printed material rocketed to 4,038 items printed in 1642 alone – just before the beginning of the English Civil War. Clare Jackson in her book “Devil-land: England under seige 1588 – 1688 states

“Moreover all information – whether audaciously printed or whispered rumour – could be denounced as erroneous, misleading or damaging. Royal courtiers and foreign ambassadors alike detected an unwelcome rise in “false news”, fearing that London’s Royal Exchange could rival the Rialto in Venice or the Piazza Navona in Rome as a notorious site for rumour-mongering”

Chris Keall in the NZ Herald (4 March) sets out ways to address “misinformation” while failing to define the term. In short, he subscribes to the suggestion by Don Christie that all that is needed is for existing laws to be enforced.

In the “bad old days” the information technology of the printing press was regulated quite severely especially during the reign of Charles II and James II with the enactment of the Licensing Act 1662. This set up a rigorous licensing regime that came to an end in 1696 when the Act was not renewed. An unintended consequence of that was the enactment of the Statute of Anne 1710 which formed the foundation for our modern law of copyright.

Plus ca change?

The term “misinformation” is a curious one. It is frequently used in commentary, especially in the context of the Covid pandemic. It has been used in a number of official publications (The Disinformation Pandemic; Sustaining Social Cohesion in Aotearoa New Zealand). In those publications it has not been defined. It seems to be assumed that its meaning is understood. Yet the way in which it is used seems to suggest that it is a veto word and that the subject matter to which it refers is to be discounted as misinformation without further explanation.

My training as a lawyer and as an academic has taught me to question assumptions. As a lawyer I have been concerned in establishing a proposition by supporting it with specialized information which lawyers call evidence. As a judge I was required to give reasons for decisions. As a PhD candidate I had to justify every assertion and assumption that I made. In all three examples intellectual rigour is required.

If a speaker or writer asserts that there is misinformation, the question that first springs to mind is “what is misinformation”. What does the critic mean when he or she asserts that the subject matter of the criticism is misinformation. What is the definition of misinformation. Or is it a term that has a number of meanings and the correct meaning depends on the context in which it is used.

Perhaps we should start by breaking the word down.

“To Inform” is a verb and means to give or impart knowledge of a fact or circumstances[1] – to tell someone about something.[2]

“To misinform” qualifies the word “inform” with the modifier “mis” and means to give someone false or misleading information (we will look at “information” in a moment) – to tell someone something that is not correct.[3]

“Information” like the verb “to inform” derives originally from Latin informare – to inform. It is the nominative (noun) version of the word and has a variety of meanings. The most common synthesis of these meanings is material that informs.

Information need not be verbally transmitted. It may be by way of written material or material that is gathered by the senses and which may then be interpreted into something that provides meaning to or knowledge about what has been experienced. Information may be data which is then analysed and interpreted into a form that has meaning to the person being informed.

Some might say that “misinformation” is a contradiction in terms. If information is to apprise one of something that informs – that is knowledge of a fact or circumstances – something that misinforms and gives false or misleading information cannot be information because information must necessarily be factually true.

There are some who would say that this is the sort of argument that is pettifogging and to a certain extent I would agree. Yet  it is probably typical of much of the intellectual laziness that characterizes discourse in these times.

I go back suggestion in the first paragraph of this post that “misinformation” is used as a veto word. A veto word effectively shuts down the debate. In a sense it prohibits the continued exchange of ideas. To say that one if “offended” is a form of veto word because it fails to address the argument and often does not explain why an argument suggests offence. Accusations of “racism” and “racist” are veto words in that they do not progress the argument and are often tantamount to “in personam” attacks.

So it is with “misinformation”. The way it is used, without proper definition or understanding is vague and imprecise. To characterize a position as “misinformation” generally means that there is disagreement with the position or that the position is contrary to a view held by a majority or that the evidence begs a different conclusion.

Yet it is considered that to characterize a position as misinformation is an answer to the argument whereas in proper discourse there should be some explanation of why it is that a position may be characterized as misinformation.

Frequently what is considered “misinformation” is an opinion or one person’s interpretation of the facts. It may be that the facts selected are selective and do not tell the whole story. Or the interpretation of the facts selected lacks context and nuance. Or that there is a line of authority that refutes the basis for the opinion held.

But to dispose of a position as “misinformation” without more is intellectually lazy and seems to suggest disagreement rather than a reasoned and logical answer to a position.

The problem is that “misinformation” has become so misused that there seems to be a move afoot to either stamp it out, eliminate it or stem its spread. Many of the Internet based platforms are accused of spreading misinformation. And this should be stopped. But how? How do you separate honest opinion from a wilful attempt to mislead. And is such a move rather insulting to listeners, viewers or consumers. Should they not be able to make up their own minds and exercise their own judgement?

Neil Young has decided to remove his music from Spotify because that platform hosts John Rogan whose podcasts contain “misinformation”. In a general sense the criticism of Rogan is that he has spread vaccine misinformation but sadly the detail of the misinformation is missing. I suppose I could listen to Rogan’s podcasts to work out where the misinformation lies – if any – or if what is characterized as misinformation is in fact a statement of opinion but frankly, I have better things to do with my time.

It would have been helpful for the argument to have been clearly stated but those who throw the word “misinformation” about are more concerned with expressing their disagreement than engaging with an issue in a meaningful way.

The current drive against “misinformation” seems to me to be another attack of the freedom of expression and upon the ability to express views that may be contrary to those of the majority. A justification for this is often cited as the need for “social cohesion” – another term for blind conformity – but in reality it is really yet another manifestation of well-meaning but misguided “liberals” who know better than everyone else what is good for them.

---

[1] Collins English Dictionary

[2] Cambridge English Dictionary

[3] Cambridge English Dictionary