NGA KAITIAKI TUKU IHO MEDICAL ACTION SOCIETY INC v MINISTER OF HEALTH & ORS [2021] NZHC 1107 [18 May 2021]

NGA KAITIAKI TUKU IHO MEDICAL ACTION SOCIETY INC v MINISTER OF HEALTH & ORS[2021] NZHC 1107 [18 May 2021]IN THE HIGH COURT OF NEW ZEALANDWELLINGTON REGISTRYI TE KŌTI MATUA O AOTEAROATE WHANGANUI-A-TARA ROHECIV-2021-485-181[2021] NZHC 1107IN THE MATTER of an application under the Judicial ReviewProcedure Act 2016, the Medicines Act1981, the Fair Trading Act 1986, the NZ Billof Rights Act 1990 and the Health andDisabilities Commissioner Act 1994BETWEEN NGA KAITIAKI TUKU IHO MEDICALACTION SOCIETY INCORPORATEDPlaintiffAND THE MINISTER OF HEALTHFirst DefendantTHE DIRECTOR-GENERAL OF HEALTHSecond DefendantCHRISTOPHER JAMESThird DefendantTHE PRIME MINISTER OF NEWZEALANDFourth DefendantTHE MINISTER FOR COVID-19RESPONSEFifth DefendantTHE ATTORNEY-GENERALSixth DefendantPFIZER NEW ZEALAND LIMITEDSeventh DefendantHearing: 12 May 2021Counsel: W J Pyke and S J Grey for PlaintiffJ K Gorman, K F M Wevers and J M Irwin for First to SixthDefendantsE B Moran for Seventh DefendantJudgment: 18 May 2021JUDGMENT OF ELLIS J[1] On 3 February 2021 provisional consent was given under s 23 of the MedicinesAct 1981 (the Act) for the sale, supply or use of the Comirnaty COVID-19 vaccine,manufactured by Pfizer Manufacturing Belgium NV. Pfizer Manufacturing BelgiumNV is represented in New Zealand by Pfizer New Zealand Limited (Pfizer).1 Theprovisional consent is stated to last for a period of nine months.[2] Pursuant to that consent, the Comirnaty vaccine is now being "rolled out" on astaggered basis across the country. Over the next few months it will be made availableto all New Zealanders over the age of 16, in accordance with the manufacturer'sindication.[3] Nga Kaitiaki Tuku Iho Medical Action Society Incorporated (KTI) wasincorporated in March this year. Its rules of incorporation state that its purposesinclude:To educate, empower and take all actions the Society deems appropriate byCommittee, including the taking of legal action against individuals ororganisations as well as promoting informed decision making andaccountability in respect of wellbeing.[4] In April, KTI filed judicial review proceedings aimed at preventing or haltingthe rollout of the Comirnaty vaccine. It challenges the legality of the s 23 provisionalconsent but also mounts a much broader attack on the safety and efficacy of thevaccine and, indeed, criticises the wider national and international response toCOVID-19.[5] Because the vaccine rollout had already begun when the review proceedingwas filed, KTI also filed an application for interim orders. While the orders soughtwere almost as wide ranging as the relief sought in the substantive proceeding, it was1 "Provisional Consent to the Distribution of a New Medicine" (3 February 2021) New ZealandGazette 2021-go338.later agreed that a more focused approach would be required, if the application was tobe heard and determined urgently, on an interim basis. Accordingly, the interim ordersapplication—and this judgment—focuses solely on the legality of the provisionalconsent given under s 23.Preliminary comments[6] There are two matters that should be recorded at the outset.[7] First, and as just noted, KTI's substantive attack on the Comirnaty rollout iswide ranging. It is predicated, at least in part, on scepticism both about the seriousnessand significance of the COVID-19 epidemic and, more specifically, about the safetyand efficacy of the Comirnaty vaccine. Concern is also expressed at the prospect thatvaccination will, in effect, be made compulsory for those engaged in certain types ofemployment. The meaningfulness of the role that informed consent will play in thevaccination programme is also questioned.[8] But it is neither possible nor appropriate for me to engage with matters of thatkind in this judgment. Rather, I necessarily proceed on the basis that:(a) the nature and scale of the public health risk posed nationally andinternationally by the COVID-19 epidemic are as assessed by thosecharged with administering New Zealand's public health system;(b) there is a public health benefit in the administration of lawfullyapproved vaccinations to those at risk of COVID-19;(c) vaccination is not, and will not be, compulsory for the vast majority ofthe New Zealand public;(d) any question of "mandatory" vaccinations for certain individuals is anemployment matter (over which this Court has no jurisdiction) for thosespecifically affected by any such requirement; and(e) informed consent will otherwise be sought and obtained before any actof vaccination.[9] Secondly, there are issues of confidentiality around certain commerciallysensitive materials said to be potentially relevant to the wider issues raised by KTI.KTI's counsel have not agreed to give a confidentiality undertaking of the breadthsought by the respondents and so have not yet seen that material. As it turned out, thatmaterial was barely referred to during the hearing, and it is not necessary to refer to itin this judgment, which may, accordingly, be published without redaction.The Medicines Act and approval of new medicines[10] The Act regulates the approval, classification, manufacture, distribution,advertising, and prescribing of medicines in New Zealand. It replaced the RestrictedDrugs Act 1960 and the Food and Drug Act 1969.[11] The word "medicine" is extensively defined and includes any substance orarticle that "is manufactured, imported, sold, or supplied wholly or principally foradministering to 1 or more human beings for a therapeutic purpose". The term"therapeutic purpose" is, in turn, defined to include the purpose of "preventing,diagnosing, monitoring, alleviating, treating, curing, or compensating for, a disease,ailment, defect, or injury". There is, accordingly, no dispute that vaccines are includedin the definition of "medicine".[12] And the term "new medicine" is defined to mean:(a) Any medicine that has not been generally available in New Zealand—(i) Before the commencement of this Act; or(ii) At any time during the period of 5 years immediatelypreceding the date on which it is proposed to become soavailable:[13] The Comirnaty vaccine is therefore a "new medicine".Sale and supply of new medicines[14] The statutory provisions at the heart of the present case are contained in Part 2of the Act. I record at the outset that there has previously been judicial criticism ofthese sections. Almost 17 years ago, Cooper J said:2[8] As will, I think, become apparent during the course of this judgmentthe legislative provisions which have to be interpreted and applied in this caseare replete with difficulty and lack the clarity and coherence which would bedesirable in such an important field of regulation. Those difficulties have beencompounded in a case such as the present which involves dealing inprescription medicines by means of orders placed over the internet, a methodof commerce with did not, of course, exist when the Act was enacted.[15] Although the Court is not dealing today with the sale of prescription medicinesover the internet, the point remains the same. The Act is 40 years old, with many ofits provisions traceable back to even earlier statutes. The COVID-19 epidemic has,from the outset, presented novel challenges to all facets of health regulation inNew Zealand. It is difficult not to view the inapt—and in Cooper J's words, unclearand incoherent—provisions at issue in this case as an accident waiting to happen.[16] In any event, it is necessary to begin with s 20(2) of the Act, which prohibitsthe sale or supply of new medicines:(a) before the Minister of Health has notified his consent or provisionalconsent in the Gazette; or(b) otherwise than in accordance with any conditions imposed by theMinister on giving his consent or provisional consent.[17] Subsection (3) refers to a "consent given under this section", but the sectiondoes not directly confer the authority to consent on the Minister. That is, perhaps,because s 20 appears principally to be an offence provision.2 Ministry of Health v Ink Electronic Media Ltd HC Hamilton CRI 2004-419-84, 18 August 2004.That case was centrally concerned with s 24 of the Act (which is not at issue here) but also involvedalleged breaches of ss 18, 20, and 45.[18] Section 21 governs applications for consent. Subsection (1) contains certainprocedural requirements, including that every application shall be accompanied by astatement of the particulars specified in subs (2).[19] There are 16 of those specified "particulars". The first eight of these, (a) to(h), largely require the provision of basic information, including the new medicine'sname, ingredients, recommended dosage, and claimed usefulness. The latter eight, (i)through (p), require the provision of more substantive, safety focused information,namely:(i) reports of any tests made to establish the safety of the medicine forthe purposes for which and in the manner in which it is intended to beused:(j) reports of any tests made to control the strength, quality, purity, orsafety of the medicine and of the method of testing:(k) any reports relating to the efficacy of the medicine:(l) a translation into English, authenticated in such manner as theDirector-General may require, of any report referred to inparagraph (i) or paragraph (j) or paragraph (k) that is not in English:(m) any evidence to show that the distribution in any country other thanNew Zealand of the medicine in the form and for the purposes that itis proposed to be distributed in New Zealand has been approved orconsented to by the appropriate authorities in that country:(n) the intended method of distribution of the medicine in New Zealand:(o) a coloured specimen of every label and other descriptive matterproposed to be used on or included in, or to accompany, packages orcontainers containing the medicine:(p) the name and address of the place or places where the manufacture,preparation, or packing is intended to be carried out.[20] Section 21(4) authorises the Director-General, before the Gazetting of theMinister's consent, to require an applicant to provide further information or particularsconcerning the medicine or its manufacture, intended sale, distribution, or advertising.[21] Section 22 details the process for determining applications for consent.Substantively, the Minister is required to:(a) Consider all the particulars and information relating to the medicinesubmitted under section 21 of this Act, and such other matters asappear to him to be relevant; and(b) As far as practicable, weigh the likely therapeutic value of themedicine against the risk (if any) of the use of the medicine injuriouslyaffecting the health of any person.[22] The remainder of s 22 contains a series of steps that the Minister must followif not then satisfied that consent should be given. These are:(a) First, to refer the matter to the "appropriate committee".3 Thatcommittee is then to consider the matter and report back to the Ministerwith a recommendation as to the decision that should be made.(b) Secondly, if the committee's recommendation is to refuse consent, theMinister must notify the applicant of the recommendation and thereasons for it.(c) Thirdly, once notified, the applicant then has 28 days to object inwriting to the committee's recommendation.(d) Lastly, on receipt of such an objection, the Minister must refer thematter to the Medicines Review Committee,4 which must then reportback to the Minister and make yet another recommendation as to thedecision he should make.[23] I interpolate at this point that, although s 20(2) plainly contemplates grantinga full consent with conditions, there is no separate provision authorising suchconditions or governing their content.5Provisional consents under s 23[24] Provisional consents are governed by s 23, subs (1) of which is key in this case.It states:3 The appointment of advisory and technical committees is authorised by s 8 of the Act.4 Established under s 10 of the Act.5 A point also noted by Cooper J in Ink Electronic Media Ltd, above n 2, at [65].Notwithstanding sections 20 to 22 of this Act, the Minister may, by notice inthe Gazette, in accordance with this section, give his provisional consent tothe sale or supply or use of a new medicine where he is of the opinion that itis desirable that the medicine be sold, supplied, or used on a restricted basisfor the treatment of a limited number of patients.[25] Subsection (2) relevantly requires that an application for provisional consentmust:(a) state, or be accompanied by a statement of, the particulars specified inparas (a) to (h) of s 21(2); and(b) be determined by the Minister in accordance with s 22.[26] And subs (3) expressly deals with conditions. It provides that on granting aprovisional consent the Minister may impose, as he thinks fit:(a) conditions relating to the persons to whom the medicine may be sold orsupplied; or(b) conditions relating to the area in which the medicine may bedistributed; or(c) other conditions that are not inconsistent with the purposes of thissection.[27] It is clear that the essence of a provisional consent is that it is time limited.Subsection (4) states that every provisional consent has effect for a period of only twoyears or less, although subs (4A) (inserted in 1985) permits two-year extensions of theperiod determined under subs (4).[28] Unlike ss 20 and 21, which essentially replicated provisions formerlycontained in the Food and Drug Act 1969, s 23—and the concept of provisionalconsents—was new in 1981. That is confirmed by the explanatory note to theMedicines Bill, which stated that its purpose is to allow the Minister to "giveprovisional consent to the distribution of a new medicine on a trial basis". That isfurther reinforced by the Hansard second reading debate on the Bill, during which thethen Minister of Health (the Hon George Gair) said:6A provisional consent for medicines for which there is a limited market is nowavailable also. That development is unique to New Zealand, and is designedto assist the availability of suitable medicines for uncommon medicalailments.Occasionally a medical practitioner wants to prescribe for a number of patientsa new medicine for which application for consent for general distribution isconsidered by the proprietor to be unjustifiable economically. Clause 21[which later became s 23] enables consent for a limited distribution to be givenon an abbreviated submission.[29] Mr Pyke also pointed me to other parliamentary statements about the purposeand actual use of s 23 that resurfaced in 1987, when subs (4A) was inserted to permitprovisional consents to be renewed. The debates refer to the grant of provisionalconsents for "orphan drugs"—the term adopted for "the types of medicine that areneeded for a small number of patients, and that would not be profitable if they weremarketed".7 A different Minister of Health, the Hon Michael Bassett, said:8Very few medicines come into that category. In fact, only two medicines havebeen considered for provisional consent. Both are injections, one of themproviding for intravenous nutrition of patients who may otherwise die. Otherpossible uses of the provisional consent would be for the treatment of tropicaldisease and some of the newer cancer therapies.9 It has become apparent thatdistributors will not be able to submit sufficient documentation to support afull consent to market within the 2 years allowed by the legislation in all cases.As it stands, the provisional consent cannot be renewed, and the distributionwould therefore cease. Under section 29 of the Medicines Act there is anexemption provision that permits supply to named patients by specific doctorsof unregistered medicines, but that procedure is unsuitable to be used for themaintenance of treatment of the small number of patients we are considering.No one would want to see a handful of patients denied their treatment becausethe allotted 2 years had elapsed and some formalities had not been concluded.6 (26 August 1981) 440 NZPD 2984–2986.7 (5 December 1985) 468 NZPD 8687.8 (10 February 1987) 477 NZPD 6914 (emphases added).9 Drugs for the treatment of tropical diseases such as malaria were the example most often given ascandidates for a provisional consent during the debates because, although such diseases are not aproblem in New Zealand, a small number of individuals might contract one while overseas.[30] Lastly, s 35 provides that the Minister may, by notice in the Gazette, revoke orsuspend a consent given under either s 20 or s 23 at any time if of the opinion that themedicine is no longer satisfactory in respect of its safety, manufacture, or efficacy.The provisional consent process in this case[31] The Minister has delegated his consent and related functions to the Director-General of Health, who has, in turn, sub-delegated it (with the Minister's writtenconsent) to Mr Christopher James, the Group Manager of the New Zealand Medicinesand Medical Devices Safety Authority (Medsafe).10 Medsafe is a business unit of theMinistry of Health that deals largely with matters under the Act.[32] Pfizer first approached Medsafe about applying for consent for the Comirnatyvaccine in September 2020. Medsafe suggested that Pfizer apply for provisionalconsent under s 23, which Pfizer did (on 21 October), proposing an indication for thoseaged 16 years and over.[33] After an initial review, Medsafe asked Pfizer to resubmit an application for fullconsent under s 20. Mr James' evidence was that this request was simply a matter ofMedsafe wanting to keep its options open; the possibility of a provisional consentremained on the table. But a consequence of applying for a full consent was that Pfizerwas required to submit the supporting information required by s 21(2)(i) to (p), and topay the full assessment fee. Pfizer submitted a full application on 13 November.[34] Mr James deposed that both the government and Medsafe were acutely alert toevidence of new COVID-19 variants appearing overseas at around this time. Theyperceived an urgent need to protect New Zealand workers in Managed Isolation andQuarantine Facilities (MIQ), customs, and those working at the border (frontlineworkers). For this reason, Medsafe considered the application on a "rolling" basis—as new information came in—rather than waiting to receive the full "dossier", as theywould have, ordinarily.11 As well, Mr James was himself personally involved in theprocess, and attended weekly meetings and reviewed drafts of the reports.10 Under the State Sector Act 1988.11 Mr James' evidence is that a similarly expedited process was used when considering an MeNZBvaccine during the 2003/2004 meningococcal outbreak.[35] During the assessment process:(a) Medsafe consulted with its Australian equivalent, the TherapeuticGoods Administration (TGA), which was considering an applicationfrom Pfizer for Comirnaty. The TGA shared its evaluation reports withMedsafe, including its final report in late January 2021, whenprovisional registration of Comirnaty under the Therapeutic Goods Act1989 (Cth) was granted.12(b) The COVID-19 Vaccine Advisory Group (COVAG) was established bythe Ministry of Health to assist Medsafe with the evaluation. COVAGis comprised of independent experts in vaccine manufacture, quality,safety, and efficacy.(c) Medsafe also consulted with the Ministry of Health Science andTechnical Advisory Group (STAG), a technical group established bythe Ministry of Health COVID response team. In particular, Medsafeasked STAG to advise it about the risk that new COVID-19 variantscould have increased transmissibility—a matter relevant to any benefit-risk assessment. STAG's advice was that the new United Kingdomvariant was more transmissible by around 30–50% and so was likely tospread faster and be harder to contain. STAG's recommendation wasthat, in the event of such strains reaching New Zealand, the vaccinemight need to be deployed rapidly to protect vulnerable groups.(d) The Medicines Advisory and Research Committee (MARC) was calledupon to assess Pfizer's Risk Management Plan (RMP) for Comirnaty,which outlines its known and potential risks. MARC convened an out-of-session meeting in January to consider the RMP and recommendedthat Medsafe ask Pfizer to address and amend certain aspects of theRMP, which Pfizer did.12 The relevant provisions of that Act are different from the relevant provisions in the New ZealandAct.[36] Mr James' evidence was that as the evaluation went on, he formed the viewthat any consent should be provisional because the data was still incomplete in somerespects. He believed a provisional, time-limited consent would allow Medsafe toimpose conditions requiring Pfizer to continue to provide data while enabling theComirnaty vaccine to be provided to frontline workers.[37] But that thinking developed further. It was thought that there was no clinicalreason to limit the vaccine to frontline workers. While they were at greater risk ofharm from COVID-19, there was no suggestion that the vaccine would be less safe oreffective for those not working at the border. Mr Allen and Medsafe came to the viewthat it was for the government, and its vaccine rollout plan, to determine which groupswould be the first to receive the vaccine. It was decided that the only limit on potentialrecipients would be in accordance with the Pfizer's therapeutic indication: namely thatadministration would be confined to those aged 16 and over.[38] Medsafe's evaluation team completed its reports, which were peer reviewed—and reviewed again—before being given to Mr James in late January 2021. The keypoints made in the reports were:(a) The available data showed that two doses of the Comirnaty vaccinegiven three weeks apart provided 95 per cent protection againstsymptomatic COVID-19 (although it was not known for how long theprotection would last).(b) There was sufficient information that the vaccine was adequately safeand effective, but the data was limited compared to other vaccinesapproved in New Zealand. There was not yet long-term safety data,given the speed at which the vaccine had been developed. Themanufacturing process for clinical trials was also different to that usedfor commercial supply.(c) Key to the benefit-risk balance was the probability of exposure toCOVID-19, as well as its mortality and morbidity burden. The fullpicture of the benefit-risk balance was not available because of the datalimitations. Nevertheless, a provisional consent was appropriate inlight of the high clinical need, the quickly increasing experience withthe vaccine, and the expectation of further data around April 2021.[39] Medsafe nonetheless recommended to Mr James that the application bereferred to yet another committee for further consideration: the Medicines AssessmentAdvisory Committee (MAAC). MAAC's purpose is to advise the Minister about thebenefit-risk profile of new medicines.13[40] On 3 February, MAAC unanimously recommended that a provisional consentbe granted for a nine-month period. The minutes of its special meeting note thatcertain risks to particular groups (for example, those who are immunosuppressed)could be managed by the Ministry of Health and its rollout plan. MAAC consideredthe proposed conditions (of which there were then over 50) and suggested some minoradditions and amendments.[41] On 3 February, after receiving and reviewing MAAC's recommendation,Mr James granted provisional consent for the Comirnaty vaccine for nine months, with58 conditions. The provisional consent was notified in the Gazette on that day, in thefollowing terms:14Provisional Consent to the Distribution of a New MedicinePursuant to section 23(1) of the Medicines Act 1981, the Minister ofHealth hereby provisionally consents to the sale, supply or use inNew Zealand of the new medicine set out in the Schedule hereto:ScheduleProduct: Comirnaty (COVID-19 mRNA vaccine)Active Ingredient: BNT162b2 [mRNA] 0.5mg/mLDosage Form: Concentrate for injectionNew Zealand Sponsor: Pfizer New Zealand LimitedManufacturer: Pfizer Manufacturing Belgium NV, Puurs, BelgiumNote: This consent is given subject to the following conditions:Provisional consent is to be granted for nine months to address an urgentclinical need.13 It is comprised of 11 independent experts and one lay person.14 Above, at n 1.[42] Then, the notice states that the "New Zealand Sponsor" (Pfizer) must fulfil the"58 listed obligations within the timelines specified, the dates of which may be alteredby mutual agreement with Medsafe". They largely involve requirements to providefurther data, as it emerges.[43] It can be noted in passing that there were then two further Gazette noticestouching on the vaccine.[44] First, on 11 February, a direction by the Minister of Health to every DistrictHealth Board was issued under s 32 of the New Zealand Public Health and DisabilityAct 2000 and s 103 of the Crown Entities Act. Its purpose was stated to be: to specify the persons who are eligible to receive publicly funded COVID-19 vaccination under the [Health and Disability Services] Act.The notice is stated to apply to any consented (or provisionally consented) COVID-19 vaccine. Under the heading "eligibility", the notice states:(1) A person is eligible to receive COVID-19 vaccination funded underthe Act if the person is in New Zealand at the time.(2) A person is eligible under clause (1) whether or not the person isotherwise eligible for publicly funded health services under the Healthand Disability Services Eligibility Direction 2011.[45] Secondly, on 16 February, a notice was Gazetted under s 106(1) of theMedicines Act, declaring that:1. The medicines listed in Schedule 1 to this notice is classified as aprescription medicine.[46] And Schedule 1 states:Prescription MedicinesCOVID-19 Vaccines; except when administered by a vaccinator who hassuccessfully completed a training course approved by the Ministry of Healthand who complies with the immunisation standards of the Ministry of Health.[47] Neither of these Notices were issued under s 23 and neither has any real bearingon the matter presently at hand. They do, perhaps, serve to emphasise the intendedbreadth of the vaccine rollout; even the "prescription only" restriction is substantiallyqualified.The application for interim orders[48] As noted earlier, the application that is presently before the Court seeks onlytwo interim orders. They are in the form of declarations that: the approval of the Pfizer vaccine pursuant to s 23(1) of the Medicines Act1981 ("the Medicines Act") without identifying criteria for identifying the"limited number of patients" the provisional consent applies to, may be anerror of law, and that until further order of the Court, the Crown ought not takeany further action that is or would be consequential on the exercise of thestatutory power; the vaccine rollout plan of the Pfizer vaccine, which has only provisionalconsent pursuant to s 23(1) of the Medicines Act, to everyone in New Zealandaged 16 years and older may be unlawful, and that until further order of theCourt, the Crown ought not take any further action that is or would beconsequential on the exercise of the statutory power;[49] In other words, the first order is concerned with the lawfulness of the consentitself. The second is concerned with the consequential legality of the subsequentrollout. Both seek to restrain the Crown from further action until the substantive claimis resolved.[50] Section 15(1) of the Judicial Review Procedure Act 2016 states:15 Interim orders(1) At any time before the final determination of an application, the courtmay, on the application of a party, make an interim order of the kindspecified in subsection (2) if, in its opinion, it is necessary to do so topreserve the position of the applicant.[51] If the applicant can establish that it has a position to preserve, then the Courthas a wide discretion to consider all the circumstances of the case, including theapparent strengths or weaknesses of the applicant's claim for review, and all therepercussions, public and private, of granting interim relief.1515 Ministry of Fisheries v Antons Trawling Company Ltd [2007] NZSC 101, (2007) 18 PRNZ 754 at[3].Does KTI have a position to preserve?[52] The plaintiff says, and the Crown accepts, that the Courts generally take agenerous approach to questions of standing in a public law case where the legality ofstate action (or inaction) is at issue. A liberal approach is closely aligned with, andreflects, the keen public interest in such matters.[53] But the Crown says that standing to bring the substantive claim for review doesnot mean that KTI itself or its individual members have a position to preserve, untilthe hearing of that claim. Other than in relation to a relatively small number ofemployment cases (none of which involve members of the plaintiff and over whichthis Court has no jurisdiction), there is no suggestion that anyone will be required tobe vaccinated.[54] That said, in recent times this Court has taken a liberal approach to thepreservation threshold. As Walker J said in Christiansen v Director-General ofHealth:16[58] The purpose of s 15 is generally to preserve the position of theapplicant, not improve it. However, preservation is not interpreted so narrowlythat it means only preserving the status quo. In Greer v Chief Executive ofDepartment of Corrections, Francis Cooke J held that interim relief canencompass orders which place the applicant in the position they would havebeen in but for the alleged illegality. It can also encompass orders whichpreserve an applicant's remedy in the event he or she prevails in thesubstantive proceeding. As the Court said in Greer:Like all legislation, s 15 should be interpreted in light of its purpose.There are two evident purposes of the interim relief power – to relievethe applicant from the adverse effects of a challenged decision untilthe challenge is heard and determined, and to preserve the ability ofthe Court to grant effective relief if the challenge is successful. Thethreshold question should be interpreted and applied in light of thesepurposes.[59] I find further support in Part 30 of the High Court Rules 2016. Rule30.14 recognises the inherent power of this Court and is another route to thesame end without the same express threshold requirement. In short,whichever approach is adopted, I find that I have the jurisdiction to make aninterim order in the terms sought.16 Christiansen v Director-General of Health [2020] NZHC 887, [2020] 2 NZLR 566 (citationsomitted).[55] On that analysis, it is arguable that KTI does have a position to preserve,because by the time the substantive claim is heard, the vaccine will have been largelyrolled out and the relief it now seeks on an interim basis will be unavailable. For thatreason, and in light of the nature and significance of the issues at hand, I am preparedto consider the application on its merits, and I do so below.Is it reasonably arguable that the provisional consent granted to the Comirnatyvaccine was not capable of authorisation by s 23?[56] All references to "the Minister" in the discussion that follows should be readas references to his delegate, Mr James.Provisional consent under s 23 generally[57] I set out s 23(1) again, for convenience:Notwithstanding sections 20 to 22 of this Act, the Minister may, by notice inthe Gazette, in accordance with this section, give his provisional consent tothe sale or supply or use of a new medicine where he is of the opinion that itis desirable that the medicine be sold, supplied, or used on a restricted basisfor the treatment of a limited number of patients.[58] It is clear—and I did not understand the Crown to dispute—that the purpose ofs 23 is to permit time-limited ("provisional"17) authorisation of a new medicine inspecial circumstances, namely where:(a) there is a clear and immediate need for the medicine; but(b) it is not possible to go through a "full" consent process because all theinformation necessary to establish safety and efficacy is not available.[59] This is plain from the fact that an application for a provisional consent is notrequired to be accompanied by the particulars set out in s 21(2)(i) to (p). Thoseparticulars go beyond the more administrative and logistical ones provided for inparas (a) to (h), instead focusing on safety and efficacy. The fact that those more17 While "provisional" can also mean "subject to conditions", s 23(3) makes it clear that a provisionalconsent may or may not be so subject. Moreover, s 20(2) makes it clear that conditions can alsoattach to an "ordinary" consent. So it cannot be the potentially conditional nature of a provisionalconsent that is its defining feature.substantive particulars are not required then necessarily colours the benefit-riskassessment under s 22(1)(b)18 and is, no doubt, the reason why that assessment isexpressly said to be required only "as far as practicable".19[60] For better or worse, the additional s 23(1) requirement—that the Minister mustbe "of the opinion that it is desirable that the medicine be sold, supplied, or used on arestricted basis for the treatment of a limited number of patients"—is consistent withthe underlying premise that the new medicine's safety and efficacy has not been fullytested. It seems unlikely that this requirement would be empty, and the words are notcomplicated. Rather, for reasons that are entirely consistent with the purpose of theprovision, the clear intention is to make it a prerequisite to the exercise of theprovisional consent power that the Minister be of the view that it is desirable for themedicine to be supplied and used:(a) on a restricted basis; and(b) for the treatment of a limited number of patients.[61] I have no particular difficulty with the submission made by Ms Gorman for theCrown that the words "restricted basis" refer to the temporal restriction that is placedon a provisional consent. But that does not mean that the words "for the treatment ofa limited number of patients" can then be ignored. It is at least reasonably arguablethat the Minister must also be of the opinion that the new medicine will not be madewidely available. And if that is so, then it makes sense that the "restricted basis" alsorefers to the fact that it will only be to a limited class of patients that the medicine canbe supplied.[62] I accept that in some cases the intended or indicated use of the medicine itselfwill suffice to satisfy the "limited number" restriction. It is self-evident, for example,that if a medicine's intended and indicated use is confined to treating a rare disease (ora disease that is rare in New Zealand), then it will in fact only be used to treat a "limited18 Section 23(2)(d) requires the Minister to determine the provision consent application inaccordance with s 22.19 It is notable that, like s 23, s 22 did not have an equivalent in the predecessor to the Act (the Foodand Drug Act 1969).number of patients". That appears to be the thinking underlying a random selectionof previously Gazetted provisional consents granted in the late 1980s20; none that Ihave seen contain express conditions specifically limiting the potential patient pool.21[63] It does not follow, however, that a provisional consent can simply be grantedfor any new medicine on the basis of its indicated use. One way or another, there mustbe compliance with the section. Where provisional consent is sought for a newmedicine that has potentially widespread application, then the terms of subs (3) makeclear what kinds of conditions are envisaged, namely those that:22(a) restrict the persons to whom the medicine may be sold or supplied; or(b) restrict the area in which—and so, again, the people to whom—themedicine may be distributed (presumably, for example, in the case of alocalised outbreak of an infectious disease).Provisional consent in this case[64] Here, it seems clear that thought was initially given to the possibility ofrestricting the availability of the vaccine to frontline workers. A decision on thoselines might well fit within the parameters of s 23. And as Mr Pyke submitted, thes 22(1)(b) benefit-risk assessment for those people is logically different for thoseworkers than for the general population because the health risk faced by them (thelikelihood of contracting COVID-19) is greater.[65] But that is not what occurred. Rather, the provisional consent granted toComirnaty does not refer to any specific class of patients to be treated with the vaccineat all—not even those who are aged over 16. As noted earlier, that omission accords20 See for example "Provisional Consent to the Distribution of a New Medicine" (15 May 1986) 72New Zealand Gazette 2123; and "Provisional Consent to the Distribution of a New Medicine" (19November 1987) 72 New Zealand Gazette 5203.21 The alternative explanation is that the problem identified in this judgment is a longstanding andwidespread one. But without expert assistance as to the nature and use of the medicines for whichprovisional consent has in the past been granted, it is impossible to say.22 It may be noted in passing that a breach of conditions of these kinds would, no doubt, constitutean offence under s 20. By contrast, the conditions imposed in the present case appear not to be ofthat kind; the fact that they are stated to be able to be altered by agreement suggests that they aresome quite different creature.with what appears to have been the historical Gazetting practice noted above, whichsuggests this work has been left to the medicine's indicated use.[66] In my view it is reasonably arguable that the decision to provisionally approvethe vaccine for much wider use is problematic. If the interpretation I have articulatedabove is right, then s 23 does not contemplate the grant of provisional consent for anew medicine that will, before the end of the year, be made available to treat the threeand a half million New Zealanders who are over the age of 16. While I acknowledgethat this is a more "limited" class of persons than "all New Zealanders", a class of thatsize seems well beyond what is contemplated by a straightforward, purposive, readingof the section. Nor is it an answer to suggest that the temporal limit of nine monthsimposed in this case will somehow act as the relevant limitation. As I understand it, itis the present intention that the vaccine will, in fact, be available to all New Zealandersover the age of 16 within that nine-month period.23[67] The short point is that it is reasonably arguable that the Minister's opinion asto the existence of a relevant and limited class of potential patients is a mandatoryprerequisite to the exercise of the s 23 consent power.24 And it is reasonably arguablethat the necessary opinion did not exist here. If that is right, the granting of provisionalconsent to the Comirnaty vaccine was ultra vires s 23 of the Act.The public and private repercussions of granting interim relief[68] Notwithstanding the conclusion just reached, I consider the public and privaterepercussions here clearly militate against granting interim relief. I say this for anumber of reasons.[69] First, it must be recognised that the process gone through here was not anorthodox provisional consent process—it went above and beyond. Although s 23applications are not required to provide the s 21 particulars about the safety andefficacy of the vaccine, it is clear that those particulars were, in fact, provided by23 The most recent government statements on the rollout indicate that vaccinations for "group 4" (thegroup with least priority) will be available from July. The provisional consent does not expireuntil November.24 In the old days, the opinion might have been termed a "jurisdictional fact", in the absence of whichthe Minister could not act.Pfizer, in part (no doubt) because an application for full consent was also made. Andit is difficult to see how the assessment process could, in the circumstances, have beenmore thorough. As set out above, Mr James' evidence makes it clear that there werea number of layers of reflection and review in addition to those that would ordinarilybe expected in a provisional consent assessment. The risks with which s 23 isconcerned—and the reason for the restrictions around granting a provisionalconsent—have therefore been considerably diminished.[70] Secondly, it could scarcely be said that the decision taken here places theMinister out on a limb internationally. On the contrary. In terms of safety (and asnoted earlier), similar decisions have been made by the TGA and other national healthauthorities around the world.25 And in terms of efficacy, Dr Bloomfield has referredto:(a) A British Medical Journal article published within the last monthreporting that preliminary findings from the United Kingdom'simmunisation programme show that new COVID infections havereduced by 70 per cent after two doses of the Pfizer vaccine.(b) A recent paper published in Nature analysing the impact of Israel'snational vaccination campaign (using the Pfizer vaccine) on the entirepopulation. The paper reports a 77 per cent drop in cases a little overtwo months after the initiation of the campaign (at which point 85 percent of those over 60 had received two doses).[71] As well, Dr Bloomfield has identified a series of further significant matters thatwould count against interim relief here. These include:(a) The risk to public health. Pausing the immunisation programme wouldmean that COVID-19 remains a real threat to the population ofNew Zealand, and a particularly grave threat to vulnerable groups,including not only the elderly and infirm, but also Māori and Pasifika.25 Among those are the United Kingdom's Medicines and Healthcare products Regulatory Agency(MHRA) and the United States' Food and Drug Administration (FDA).The vaccine rollout is designed to mitigate such inequitable COVID-19outcomes.(b) Logistics. Many people have only received the first dose of thevaccination, and it is not known what impact delaying the second wouldhave. These people have consented to full vaccination and protection,not to a 50 per cent vaccination and partial (and possibly ineffectual)protection. Restarting the rollout after a pause would also be moredifficult to organise, particularly since many staff may be forced to sitidle or have their fixed-term contracts terminated early. This wouldnecessarily come at a significant cost.(c) Vaccine expiry. If stored at minus 70 degrees, the Pfizer vaccine isstable for six months from the date of manufacture. Because of the timeit takes to get the vaccine to New Zealand, it has a shelf life of onlyaround three months once it arrives. Pausing the programme couldresult in significant vaccine expiry and wastage. That is difficult tocountenance when the global need for vaccines is so acute.(d) Delay to national COVID-19 recovery. The vaccination programme isa key part of the country's plan to deal with COVID-19. Halting itwould mean continuing other restrictions currently in place to protectthe public, such as alert levels and border restrictions. Given theundoubted and obvious impact these restrictions have on the nationaleconomy, there would be wider social and economic cost in suspendingthe rollout.(e) Reduced public confidence. If the rollout is paused, public confidencein the vaccine may be significantly undermined. Vaccinationprogrammes are at their most effective when as many people aspossible support them.(f) Public health risks to Pacific neighbours. New Zealand has committedto providing our Pacific neighbours with vaccinations. Pausing therollout would prevent any exportation in the meantime. As well,vaccine confidence would also be diminished in those nations.[72] Against all that, I acknowledge that KTI and its supporters have strong andsincerely held views that the vaccine is neither safe nor efficacious, and some alsohave strong and sincerely held views that the COVID-19 pandemic does not constitutea public health crisis of the order described by Dr Bloomfield and the World HealthOrganisation. I also acknowledge that they are sceptical about the reality of informedconsent. Those views and that scepticism will, no doubt, be played out in theindividual vaccination decisions that are made by them. There is also another forumin which any employment issues arising for others can be addressed.[73] As noted at the outset, however, the signal point is that the Court cannotpossibly engage with those concerns in the present context. A very significant marginof appreciation must be afforded to those who are charged with making public healthdecisions—including decisions about managing public health risk—of a verysignificant kind. In the present case, the evidence is that the Minister has been advisedby a plethora of experts in the relevant fields. And as just noted, the approval of thevaccine is in step with international developments.Conclusion[74] I have chosen not to determine this application on the basis of the threshold"position to preserve" test. For the reasons explained above, I would be reluctant toregard that as an absolute bar in the present circumstances, and there are contraryarguments that can be made.[75] I have also found that it is reasonably arguable that the provisional consentgranted to the Comirnaty vaccine was ultra vires s 23 of the Act, and I would urge theCrown now to consider that question carefully. For now, I decline to exercise mydiscretion to grant the interim orders sought. The adverse public and privaterepercussions of doings so are too great, by some very considerable margin.[76] The application for interim orders must therefore be declined.[77] I did not hear from counsel on costs. Although KTI has not ultimatelysucceeded, in light of my conclusion on reasonable arguability, my inclination is to letthem lie where they fall. Counsel may submit memoranda if they disagree.____________________Rebecca Ellis JSolicitors:Sue Grey, Lawyer, Nelson for PlaintiffCrown Law, Wellington for First to Sixth DefendantsDLA Piper, Wellington for Seventh Defendant