Huikeshoven v Secretary, Department of Education, Skills and Employment

Statutory framework 5 The applications for financial assistance that led to the Tribunal's decision were made in late 2018 and early 2019. Division 4 of Part 3 of the Family Assistance Act provided for the circumstances in which a person was eligible for a form of financial assistance known as child care benefit. Division 4 of Part 3 was part of the Act as at 30 June 2018 and, it appears, applied for the 2017/2018 financial year (and was then repealed). It seems that the application in the present case engaged the eligibility requirements in s 44 of the Family Assistance Act, which relevantly included at s 44(1)(e) that an individual was eligible for child care benefit for a past period for a session of care provided by an approved child care service to a child if the requirement relating to immunisation set out in s 44(2) was met in respect of the child. The requirement in s 44(2) was that, if the child was under 20, the child must have met the immunisation requirements set out in s 6 of the Family Assistance Act. 6 The criteria for eligibility for child care subsidy, which was introduced into the statutory scheme on 2 July 2018, are in s 85BA of the Family Assistance Act. Section 85BA(1)(a)(iii) provides that an individual is eligible for child care subsidy for a session of care provided by an approved child care service to a child if (amongst other requirements) the child meets the immunisation requirements in s 6. 7 One way a child may meet the immunisation requirements (for either the prior form of child care benefit, or the current child care subsidy) is to be immunised in accordance with an applicable vaccination schedule determined under s 4 of the Family Assistance Act: s 6(2) and definition of 'immunised' in s 3. But another way, which is the one relevant to this case, is as follows, in s 6(3): The child meets the immunisation requirements if: (a) a general practitioner, a paediatrician, a public health physician, an infectious diseases physician or a clinical immunologist has certified in writing that the immunisation of the child would be medically contraindicated under the specifications set out in the Australian Immunisation Handbook … 8 At all relevant times s 3 has defined the 'Australian Immunisation Handbook' as the latest edition of that document published by the Australian Government Publishing Service. Various editions of that document were in evidence in this proceeding but the parties agreed on a single version that the Court could use in order to determine the appeal. It will be necessary to review the contents of that version in some detail later. 9 Two other subsections of s 6 are also relevant: Secretary's decision (6) The child meets the immunisation requirements if the Secretary determines in writing that the child meets the immunisation requirements. (7) In making a determination under subsection (6), the Secretary must comply with any decision-making principles set out in a legislative instrument made by the Minister for the purposes of this subsection. 10 A legislative instrument of the kind referred to in s 6(7) has been made, namely the Family Assistance (Immunisation and Vaccination) (Education) Determination 2018 (Cth). Relevantly, s 8 and s 13 of that Determination permit the respondent (Secretary) to determine that a child meets the immunisation requirements if a 'listed medical practitioner' has certified in writing that immunisation of the child would result in an unacceptable risk of physical harm to the child and the Commonwealth Chief Medical Officer has certified in writing that he or she agrees with the listed medical practitioner. A listed medical practitioner is defined in s 7(1) of the Determination as a medical practitioner whose name has been given to the Commonwealth Chief Medical Officer by the Chief Health Officer of a State or Territory for the purpose of giving such certificates under s 13. 11 The parties did not make submissions as to the content of the specific statutory powers under which the decisions that the Tribunal reviewed were made. Since the Secretary was the respondent to the proceeding in the Tribunal, and since no party suggested otherwise, I will proceed on the basis that the Secretary or her delegate exercised a statutory power to determine the applicant's eligibility for child care subsidy and child care benefit, and that the Tribunal had jurisdiction to review the exercise of that power. Nothing turns on the content of the specific decision making power; the dispute was effectively about the meaning of one of the statutory requirements for eligibility.

Factual background 12 The child was born in 2016. It is common ground that she has not received the vaccinations necessary to be 'immunised' under s 6(2) of the Family Assistance Act. 13 On 21 December 2018 the applicant made a claim for child care benefit in respect of the year ending 30 June 2018. On the same day, the applicant lodged a claim for child care subsidy in respect of the child. 14 On 22 December 2018, Services Australia rejected the claim for child care benefit. On 14 January 2019 it decided to grant the claim for child care subsidy, effective from 3 December 2018, but at the same time to cancel the child care subsidy effective from 31 December 2018 (it is not clear from the material before the Court why Services Australia tinkered with the dates in this way, but nothing turns on it). The adverse decisions were made on the basis that the child had not been immunised. 15 On 21 January 2019 the applicant lodged another claim for child care subsidy. On the same day she lodged an 'Australian Immunisation Register - Immunisation medical exemption' form (Form) annexing a letter dated 21 December 2018 from a general practitioner whom I will call the doctor (First Report). It was common ground that the doctor was qualified to provide a certificate of the kind contemplated by s 6(3)(a) of the Family Assistance Act. The question in this case is whether that is in fact what she did. 16 The Form was signed by the doctor. It contained a tick box to indicate that 'The individual identified on this form has a permanent vaccine exemption due to medical contraindication because of the following:' (emphasis in original - there was also a tick box for temporary vaccine exemption). This was ticked. There were then further boxes on the Form to indicate that the contraindication was because of previous anaphylaxis or significant immunocompromise. Those boxes were not ticked. Further below, there were boxes for a number of vaccines that, it appears, the form contemplated could be contraindicated. All but two of those boxes were ticked. 17 The First Report relevantly said: This letter is to certify that I have seen [the child] and her mother, [the applicant], in my rooms today, on 21 December 2018. This letter is to accompany the IM011 Medical Exemption form as it does not include provisions for me to provide the reasons for the medical exemption that I describe below. I have considered [the child's] individual medical history and obtained an extensive family history. [The child] has an extensive family history of autoimmune disorders, and sensitivities, and her mother has had an adverse reaction to a vaccine when she was a child. [The child] is also showing signs of sensitivities including a potential allergic reaction to latex. 18 There was then reference to the results of genetic tests and adverse conditions that are associated with particular genes which had been detected in the child. There was reference to an aspect of the child's family history which (the First Report says) is mentioned in a vaccination information statement required to be given to patients by United States law. According to the First Report, that statement says that a family history of that kind makes it inappropriate to receive a measles, mumps, rubella and varicella (MMRV) vaccine. The First Report went on: I have consulted the guidelines in the Australian Immunisation Handbook, the latest published information from the World Health Organisation, and referred to the Product Information documents for each vaccine that [the child] is due for. In my clinical judgement based on the best available evidence, my review of [the child's] medical history indicates an increased risk of a serious adverse reaction, including allergy to vaccine components. [The child] is 2.5 years of age and is no longer in the high-risk period for vaccine preventable diseases in Australia. The consequence of suffering an adverse reaction cannot be accurately predicted but can be quite serious and irreversible. Therefore, in reviewing the risk vs benefit for [the child] for each individual vaccine, I have considered that the risk of an adverse reaction to vaccination outweighs the benefits. 19 On 21 February 2019 Services Australia decided to reject the claim for child care subsidy that had been lodged on 21 January 2019. 20 The applicant unsuccessfully pursued review options internal to Services Australia. During those review processes, an authorised review officer varied the date of cancellation of the child care subsidy applied for in 2018, from 31 December 2018 to 3 December 2018, in effect cancelling the period of time for which the subsidy was otherwise granted to the applicant. The applicant then took up her entitlement to two layers of review in the Tribunal. She was unsuccessful in both. The second Tribunal decision, handed down on 29 June 2021, which was a review of the first Tribunal decision, is the subject of the present appeal.

The Tribunal decision of 29 June 2021 21 The Tribunal's decision commenced by saying that there were three decisions that had been reviewed and affirmed in the previous Tribunal decision: the decision to refuse child care benefit; the decision to cancel the child care subsidy for 2018 from 3 December 2018 (instead of 31 December 2018); and the decision to reject the application for child care subsidy in 2019. The correctness of all three decisions depended on whether the child met the relevant immunisation requirements. 22 The Tribunal noted what it described as the 'both general and very specific information regarding all of the relevant vaccines' in the Handbook, as well as the information regarding contraindications. Its decision included a table, apparently prepared by the Tribunal or one of the parties, which showed whether anaphylaxis, pregnancy or immunocompromise were contraindications for vaccines for a range of named diseases. The decision said that there was no evidence before the Tribunal to suggest that any of those three contraindications applied to the child. 23 The Tribunal described the procedural history summarised above, and quoted from the First Report. It said that the Secretary conceded that there was no issue with the form of the First Report, rather the issue was one of substance as to whether the First Report addressed itself to relevant contraindications in the Handbook. 24 The Tribunal then described the legislative framework, in a way that distilled the issue down to whether the child met the immunisation requirement in s 6(3)(a) of the Family Assistance Act. According to the Tribunal, both the applicant and the Secretary accepted that the matter was 'to be determined by asking the question: does the medical report contain an expression of opinion that vaccination is medically contraindicated under the specifications of the then current Australian Immunisation Handbook?': paragraph 54. 25 The Tribunal then quoted passages from the Handbook about two 'absolute contraindications' that apply to all vaccines, and two 'further contraindications' that apply to live vaccines. Those passages will be considered below. It also gave a brief excerpt of a passage about 'False contraindications to vaccination', which will also be considered below. It noted that the Handbook also contains information relevant to specific vaccines. 26 The nub of the Tribunal's decision was then expressed as being that the First Report 'did not certify that immunising [the child] would be medically contraindicated by reference to the Australian Immunisation Handbook, as was required' (paragraph 58, emphasis in original). According to the Tribunal, although the form to which the First Report was attached made provision for a practitioner completing the form to certify that the contraindications specified in the Handbook applied, the doctor did not do so. The Tribunal then said (at paragraphs 60-62, footnote omitted, emphases in original): The reasons outlined in the [First] Report may have been relevant to [the doctor's] clinical judgement not to provide [the child] with immunisations. They did not, however, corresponded [sic] with contraindications set out under the specifications of the Australian Immunisation Handbook as required by section 6(3)(a) of the [Family Assistance] Act. This is so notwithstanding the fact that [the doctor] states, 'I have consulted the guidelines in the Australian Immunisation Handbook'. The legislative requirement is not that a general practitioner (or other health practitioner mentioned in section 6(3)(a)) merely consult the Australian Immunisation Handbook among other sources, in coming to a clinical judgement as to whether immunisation would be desirable. They must certify that immunisation would be medically contraindicated under its specifications (rather than due to any other consideration). [The child] did not meet the immunity [sic] requirements by virtue of section 6(3)(a) of the [Family Assistance] Act, because the [First] Report is not evidence that a general practitioner, a paediatrician, a public health physician, an infectious diseases physician or a clinical immunologist has certified in writing that immunisation would in her case be medically contraindicated under the specifications set out in the Australian Immunisation Handbook. That is notwithstanding [the doctor's] opinion that: 'in reviewing the risk vs benefit for [the child] for each individual vaccine, I have considered the risk of an adverse reaction to vaccination outweighs the benefits'. The problem for the Applicant is that the substance of [the doctor's First] Report did not meet the requirement of section 6(3)(a) of the [Family Assistance] Act, and in particular the Australian Immunisation Handbook specifications. 27 The Tribunal then described a communication that it received from the applicant after the hearing and after it had notified the parties that it was going to publish its decision the following day. The submission contended that the Secretary had changed the nature of the reasons for rejecting the child's medical exemption form. Accompanying the communication was a further report from the doctor dated 21 June 2021 (Second Report). 28 Notwithstanding what the Tribunal described as strong public policy reasons for refusing the applicant's request to submit evidence after the hearing, it decided to admit the further material into evidence so as to put the applicant 'beyond any doubt that her case has been fully considered'. That Second Report, which was reproduced as an appendix to the Tribunal's decision, relevantly said: I refer to my medical contraindication certification for [the child], now 5 yrs … dated 21 December 2018. To clarify, as was noted in that certification, I considered the clinical guidance in the Australian Immunisation Handbook, which provides for the exercise of clinical judgement and consideration of guidance from other sources. As a result, I determined that vaccination of [the child] would be contraindicated under the specifications of the Australian Immunisation Handbook. 29 For reasons that will be quoted further below, the Tribunal determined that the Second Report did not change the evidence relevant to the determination of the matter. 30 Accordingly, the Tribunal found that the child was not exempt from vaccination under s 6(3)(a) of the Family Assistance Act, found that the three primary decisions were correct, and affirmed the first Tribunal decision that was under review.

The appeal 31 The applicant appeals from the Tribunal's decision under s 44(1) of the Administrative Appeals Tribunal Act 1975 (Cth), which provides for appeals on questions of law only. 32 There are nine grounds of appeal. Grounds 1 to 3 may be grouped together. Ground 1 is just an introductory assertion that the Tribunal erred in finding s 6(3)(a) of the Family Assistance Act was not fulfilled. Ground 2 is a more specific contention that the Tribunal erred in appearing to find that the only relevant contraindications that could fulfil s 6(3)(a) were the ones referred to in the table near the beginning of the Tribunal's reasons, that is, anaphylaxis, pregnancy and immunocompromise. It will be convenient to refer to these as the three contraindications. It is common ground that none of those apply to the child. But according to ground 2 (emphasis in original): a. in addition to 'absolute contraindications', the Handbook also referred to relative contraindications; b. when read as a whole, the Handbook defines contraindications as being 'A medical condition or risk factor in a recipient/person that makes receiving a specific vaccine potentially harmful', and provides for a role for a medical practitioner to use clinical guidance and make a clinical judgment call in relation to the particular patient under consideration, including their particular circumstances and risks; c. contraindications can include, but are not limited to, the potential for allergic reactions to ingredients in the vaccines under consideration. 33 According to ground 3, therefore the Tribunal erred in failing to find that the doctor did express the medical opinion that vaccination of the child would be contraindicated under the specifications of the Handbook. So, the issue raised by the first three grounds is whether the certificate required by s 6(3)(a) must be one that the child has one of the three contraindications. 34 Grounds 4 to 8 may also be grouped together. Ground 4 contends that the Tribunal 'erred in failing to find that it is the role of the medical practitioner to provide the relevant certification, and that it is not the role of the decisionmaker [sic] or Tribunal to go behind or second guess that certification'. Ground 5 asserts that the Tribunal did go behind and second guess the doctor's medical opinion 'as to whether the vaccines under consideration (or the ingredients of those vaccines) were potentially harmful to the Child'. By ground 6, the appellant contends that the Second Report of 21 June 2020 was a certificate for the purposes of s 6(3)(a) of the Family Assistance Act because the Second Report said that the doctor had 'determined that vaccination of [the child] would be contraindicated under the specifications of the Australian Immunisation Handbook', without more being required. Ground 7 says that the Tribunal failed to give adequate reasons for finding that the Second Report did not amount to a certificate for the purposes of s 6(3)(a) of the Family Assistance Act. Ground 8 contends that the Tribunal erred in finding that the First Report was not a certificate for the purposes of s 6(3)(a) of the Act when read in isolation, and when read in conjunction with the Second Report. 35 However, it emerged in oral submissions that this second group of grounds would not need to be considered, whichever way the other grounds went. That is because, subject to a limited qualification concerning procedural fairness to which I will come, the applicant's counsel effectively accepted that if the applicant fails on grounds 1 to 3, then she fails in the appeal. Likewise, the Secretary's counsel accepted that if the Secretary failed on that first group of grounds, the matter would need to be remitted to the Tribunal, so that there would be no need to consider the second group of grounds. 36 Both counsel were correct in those concessions. The question that arises from the first group of grounds is whether, on the proper construction of s 6(3)(a) of the Family Assistance Act read with the Handbook, a certificate by a medical practitioner must certify the existence of one or more of the three contraindications in order to satisfy the 'immunisation requirement' in s 6(3)(a). If that question is answered in the affirmative, then the First Report (with or without the Second Report) did not satisfy the immunisation requirement. If it is answered in the negative, then the Tribunal proceeded on the basis of a wrong construction of the Family Assistance Act and the matter must be remitted for it to decide according to law. Either way, the second group of grounds will not arise, because the outcome will be based on matters that appear on the face of the doctor's purported certificates, without regard to whether the Tribunal went behind them. 37 That being so, there was no real difference between the parties in relation to the second group of issues. The Secretary accepts that it is not her role nor that of the Tribunal to substitute their own judgement for that of the medical practitioner. Nor is it for the Secretary or the Tribunal to go behind the certificate. But the clinical judgement of the practitioner, and the certificate, must be directed at the right question. If the Secretary is correct that the right question is the existence or not of the three contraindications, then clinical judgements or certificates about other questions are irrelevant. 38 By the same token, the applicant accepted (subject to the procedural fairness point) that if the three contraindications were the only contraindications that answered the description in s 6(3)(a) of the Family Assistance Act, and if the medical practitioner gives reasons for the certificate showing that it was given on a basis other than the three contraindications, then the purported certificate would not satisfy the immunisation requirements of the Act. That concession was correctly made. A purported certificate that says in terms that there are contraindications set out in specifications in the Handbook, but which, on its face, is in fact based on different contraindications, could not be a certificate of the kind required by s 6(3)(a). 39 As a result of these mutual concessions, with one exception the second group of grounds of appeal will not arise for consideration on this appeal, and it will not be necessary to say anything more about them. The exception is that, as explained further below and for completeness, I will determine ground 7, which contends that the Tribunal gave insufficient reasons for its conclusion about the Second Report. 40 The final ground, ground 9, alleges that the Tribunal denied procedural fairness to the appellant in so far as its reasons referred to 'the lack of precise evidence as to the relevant contraindications relating to the Child, because, if that was the issue before the Tribunal, the Applicant could have conducted her case differently and obtained that evidence'. The ground asserts that the issue that arose out of the decisions under review was whether the doctor was allowed to include additional information on the form which formed part of the First Report. The implicit point appears to be that if there was any departure from that issue in the Tribunal review now appealed from, so that the Tribunal's decision was to deal with further or different issues, the appellant should have been given a fair opportunity to address those issues. The applicant tendered a further report of the doctor, dated 29 August 2021 (Third Report), which obviously was not before the Tribunal, and was the subject of an interlocutory application to adduce new evidence in the appeal. It was convenient to hear full argument and to rule on the application at the same time as determining the appeal as a whole, and I will decide the application when I come to consider ground 9 below. 41 I will come to that ground last because, while it is often appropriate to determine procedural fairness grounds before determining other grounds, that is not the case in this appeal. As I have explained, it was all but common ground that the appeal would stand or fall on the first group of grounds and the main issue I have described as arising out of it. I say 'all but' because, as I have noted, there was a limited qualification to the applicant's position in that regard. Her counsel accepted as a general proposition that if the Secretary succeeds on the main issue, then the doctor's reasons, set out in the Third Report, as to why she had expressed the opinion in the First Report in the way she had, could not bear on the approach the Tribunal should have taken in the Tribunal review appealed from. The qualification was that this was so only if 'the answer is obvious'. Counsel submitted that if the answer is not obvious then the doctor's expertise might be of assistance in interpreting the Handbook. 42 As well as grounds of appeal, r 33.12(2)(b) of the Federal Court Rules 2011 (Cth) requires the notice of appeal to state the precise questions of law that arise in the appeal. The refinement of the issues in oral submissions that has just been described means that, for the most part, it is not necessary to describe the questions of law that the applicant has listed in the notice of appeal here. Setting aside the application to adduce new evidence, the Secretary did not submit that the appeal sought to raise questions of fact as opposed to questions of law. I will proceed on the basis that only questions of law are raised. Question 4 in the notice of appeal is worth mentioning though, because it states the issue at the heart of the appeal as follows (emphasis in original): What does the phrase 'would be contraindicated under the specifications set out in the Australian Immunisation Handbook' in s 6(3)(a) of the Act mean, including: a. are the specifications limited only to the three (3) contraindications referred to in [the table near the beginning of] the Tribunal's reasons? b. to what extent, if any, does the Handbook give a general practitioner, a paediatrician, a public health physician, an infectious diseases physician, or a clinical immunologist, a judgment call to make using clinical guidance and expertise? 43 In order to answer that question, it is necessary to consider the Handbook in some detail. It is necessary because of the way the applicant puts her case, which invites the Court to draw conclusions from the tenor of the Handbook as a whole. It is therefore not possible to confine attention to any small part of that very large document.

The nature of the Handbook 44 It is helpful to make a few preliminary observations about the Handbook before describing its content. First, the version of the Handbook that was put into evidence in this proceeding, and which was reviewed by me for the purposes of the proceeding, was a portable document format (pdf) document which took up more than 1,100 pages. But it seems that the Handbook is primarily intended to be an online resource. It contains the following note: Printed content may be out of date. For up to date information, always refer to the digital version: https://nginx-immunisationhandbook-feature-22-december-2018.govcms.amazee.io/node/1461. A similar note, with different URL references apparently to different sections of the online version, is included at multiple points in the Handbook. And under a section on 'How to use the Handbook' that is described as explaining the 'Structure of the Australian Immunisation Handbook and how to use the website functions', the Handbook says 'We're creating a new Australian Immunisation Handbook website that's easier to understand and use'. 45 However easy to understand and use the online version may be, the pdf version that was in evidence was difficult to navigate. For example, its 'table of contents' did not appear until the 29th page, and that table contained no page numbers for the headings of the main parts of the Handbook. Then, the main parts themselves appeared in the text in a different order to the order in which they appear in the table of contents. There was a similar jumbling of sections within some of the parts themselves. A section on 'How to use the Handbook' is found at the 629th page of the pdf version and a 'What's new' section appears at the 869th page. The relevance of all of this is that it would not be sound to draw any conclusions from the order in which the various parts of the text appeared. It appears to be designed to be viewed online with the aid of hyperlinks, so that the physical location of different sections is of little or no relevance. 46 The second observation about the nature of the Handbook is that it is a collection of recommendations and guidelines. It contains recommendations that have been developed by the Australian Technical Advisory Group on Immunisation (ATAGI) and approved by the National Health and Medical Research Council (NHMRC). It contains a formal note headed 'Publication approval' which records that the 'guideline recommendations' were approved by the Chief Executive Officer of the NHMRC on 9 July 2018 under s 14A of the National Health and Medical Research Council Act 1992 (Cth). Section 14A(1) authorises the CEO to, 'on the advice of the Council, approve guidelines prepared by a person or body from outside the NHMRC'. That approval does not mean that the guidelines are statutory instruments: s 9(3). This is contextually relevant to the next and final preliminary observation about the Handbook. 47 That observation is this: unsurprisingly, for a detailed technical document over 1,100 pages long (in pdf), the purposes of the Handbook go well beyond the specification of contraindications that will satisfy immunisation requirements for eligibility for child care benefit and child care subsidy. Rather, as is said at the very beginning of the Handbook, it 'provides clinical advice for health professionals on the safest and most effective use of vaccines in their practice'. Elsewhere the Handbook refers to itself as containing 'vaccination recommendations' and says that it 'informs clinicians about the safest and most effective vaccination strategies in Australia'. The fullest statement of its purpose, under a heading 'Introduction' in the part 'About the Handbook', is: The Australian Immunisation Handbook provides clinical guidelines for healthcare professionals and others about the safest and most effective use of vaccines in their practice. The guidance is based on the best scientific evidence available, from published and unpublished literature. 48 Plainly, then, the main function of the Handbook is to serve as a clinical resource for doctors and other health professionals who are administering health care. It contains guidelines and recommendations but, at least in so far as it fulfils that main function, it is not in any sense mandatory, and is not intended to act as a substitute for the clinical judgements of medical professionals. The controversy in this proceeding is largely a product of the difference between that main purpose, and the purpose for which the Family Assistance Act seeks to enlist the Handbook, by using it as a way of specifying immunisation guidelines. 49 The controversy arises because the Handbook contains no express signposting as to where it contains specifications as to when immunisation of a child would be medically contraindicated for the purposes of s 6(3)(a) of the Family Assistance Act. It briefly mentions family assistance payments in connection with the Australian Immunisation Register, but does not refer to the Family Assistance Act at all.

The structure of the Handbook 50 Subject to the caveats above, the structure of the Handbook appears from the following excerpt from the section 'How to use the Handbook': The Handbook is divided into sections: • About the Handbook - includes background, how the Handbook is developed, how to use it, and what's changed • Fundamentals of immunisation - how immunisation works, frequently used terms and concepts in vaccination, and information about passive immunisation using immunoglobulins • Vaccination procedures - what to do before and after vaccination, and how to administer vaccines • Catch-up vaccination - information and tools to help you assess whether a person is up to date with their recommended vaccinations, and how to calculate which vaccines they need and when • Vaccination for special risk groups - recommendations for groups with special vaccination requirements • Vaccine-preventable diseases - information about the 24 diseases that can be prevented with vaccines in Australia, and recommendations for vaccination 51 This section also describes these main parts and, in particular, the 24 chapters that deal with vaccine preventable diseases. It says that all those chapters follow the same format, which is comprised of a number of standard headings including one for 'Contraindications and precautions' and one for 'Variations from product information'.

Fundamentals of immunisation 52 The part titled 'Fundamentals of immunisation' contains 'Information about active and passive immunisation, key concepts in vaccine safety and effectiveness, and information about adverse events'. The Handbook focusses on active immunisation, which uses vaccines to induce an immune response, as distinct from passive immunisation, which 'is the direct transfer of antibodies to a non-immune person to provide temporary protection'. 53 In a summary of the part, the Handbook notes: 'Some vaccines have contraindications or precautions for their use. This helps ensure that they are not given to people who have a high risk of serious adverse events'. There is discussion of the types of vaccines later in this part of the Handbook, including those that use live attenuated pathogens. Under a heading about live vaccines, it says (footnote references have been removed from all quotes from the Handbook): There is a theoretical risk that the live attenuated pathogen in the vaccine could revert to the wild-type virulent pathogen and cause disease in the vaccine recipient. This is more often an issue for people who are immunocompromised. Because of this, people who are significantly immunocompromised should not receive live vaccines. Their weakened immune systems may not be able to control the replication of the pathogen in the vaccine. 54 However, under a heading 'Killed, subunit and toxoid vaccines': Non-live vaccines present no risk of reverting back to a virulent wild-type form. People who are immunocompromised can safely receive these vaccines. An exception to this is the Q fever vaccine, which is contraindicated in people who are immunocompromised. 55 This section also notes under a heading 'Dosage and administration' that the disease-specific chapters in the Handbook 'include details on available vaccines and recommendations for their use'. 56 The 'Fundamentals of immunisation' chapter also includes the following section on contraindications (minor formatting changes have been applied to quotes from the Handbook to help with clarity): Vaccine contraindications and precautions A contraindication is a reason a vaccine should not be given. This might be when a person has a pre-existing condition that significantly increases their chance of having a serious adverse event after a specific vaccine. Insufficient safety data about a vaccine may also be a contraindication, if there is a theoretical but significant risk of harm in a particular age group or group of people. An example might be use of a particular vaccine in people with specific medical conditions. Vaccines should not be given if there is a contraindication, except under expert medical advice from an immunisation specialist. This advice would consider both the benefits and the risks of giving the vaccine, in consultation with the person to be vaccinated, or their parent or carer. A precaution is a condition that may increase the chance of an adverse event following immunisation or compromise the vaccine's ability to produce immunity. If there is a precaution, sometimes the benefits of giving the vaccine outweigh the potential risks. Consulting with an immunisation specialist or a specialist clinic may be helpful. Contact your state or territory health department for more details about services for immunisation adverse events. See Vaccination for people who have had an adverse event following immunisation. Each disease-specific chapter in the Handbook indicates whether there are contraindications or precautions for administering vaccines.

Preparing for vaccination 57 The next part, according to the structure given above, is 'Vaccination procedures', which is broken into three chapters, 'Preparing for vaccination', 'Administration of vaccines' and 'After vaccination'. The first of these contains a passage: All vaccines must be administered in accordance with the relevant legislation, best practice, and the guidelines and recommendations in this Handbook. Also follow other relevant guidelines, such as National Vaccine Storage Guidelines: Strive for 5 and Australian Guidelines for the Prevention and Control of Infection in Healthcare. 58 The chapter sets out detailed procedures on pre-vaccination screening. It says that immunisation providers 'need to comprehensively screen everyone who wants to be vaccinated' and that they should, among other things, 'check whether there are any contraindications or precautions for the vaccines the person is receiving'. 59 The chapter on preparing for vaccination includes a standard questionnaire (called a checklist) and a table that gives guidance on what to do depending on the answers to the questions. The checklist includes questions as to whether the person to be vaccinated has a disease that lowers immunity or is having treatment that lowers immunity, has had a severe reaction following any vaccine or has any severe allergies to anything. The table that is to be consulted following the administration of the checklist contains a column headed 'Condition or circumstance of person to be vaccinated'. This includes an item for 'Anaphylaxis following a previous dose of the relevant vaccine', against which the action listed is 'Do not vaccinate. Seek further medical advice to confirm causality … See also Contraindications to vaccination' and in the column for 'Rationale' it says 'Anaphylaxis to a previous dose of a vaccine is a contraindication to receiving the same vaccine'. There is also an item for 'Severe allergy to a vaccine component' which includes as an action listed, 'Do not vaccinate, but seek specialist advice. The person may still be able to receive the vaccine, depending on the allergy' and in the 'Rationale' column says 'Anaphylaxis to a vaccine component is generally a contraindication to receiving the vaccine'. There is also an item which indicates that 'Live attenuated vaccines may be contraindicated' in people who have diseases that lower immunity or are receiving treatment that lowers immunity (or for an infant whose mother received immunosuppressive therapy during pregnancy). But the remainder of the recommendations are not presented as contraindications, but as having an impact on recommended vaccine timing or format; for example, if a person has received a live attenuated viral parenteral vaccine in the past four weeks, the recommendation is only to delay any dose of a vaccine of that same kind. In one case (Guillain-Barré syndrome) there is mention of a risk benefit analysis in relation to influenza vaccine, but there is no suggestion that the outcome of that analysis may be that the vaccine is contraindicated; the ultimate recommendation is to 'seek expert advice if needed'. 60 The 'Preparing for vaccination' section also contains the following passage (emphasis in original): Contraindications to vaccination Only 2 absolute contraindications apply to all vaccines: • anaphylaxis following a previous dose of the relevant vaccine • anaphylaxis following any component of the relevant vaccine (see Table. Components of vaccines used in Australia) 2 further contraindications apply to live vaccines (both parenteral and oral): • People who are significantly immunocompromised should not receive live vaccines. This is regardless of whether the immunocompromising condition is caused by disease or treatment. Exception: With further advice, people with HIV who are mildly immunocompromised can receive MMR (measles-mumps-rubella), varicella and zoster vaccines. See Vaccination of people who are immunocompromised, and individual disease chapters. • Pregnant women should not receive live vaccines, in general. Women should be advised not to become pregnant within 28 days of receiving a live vaccine. See Table. Vaccines that are contraindicated in pregnancy: live attenuated vaccines in Vaccination for women who are planning pregnancy, pregnant or breastfeeding. 61 Further on, there is a passage on false contraindications, as follows (emphasis in original): False contraindications to vaccination No-one should be denied the benefits of vaccination by withholding vaccines for inappropriate reasons. Conditions listed in this section are not contraindications to vaccination. People with these conditions can receive all recommended vaccines … False contraindications then listed include, for example, 'family history of any adverse events following immunisation' and 'asthma, eczema, atopy, hay fever or "snuffles"'.

Vaccination for special risk groups 62 There is also a part on 'Vaccination for special risk groups'. This contains sections that mention contraindications. The section on 'Vaccination for people who are immunocompromised' says, for example: It is important to carefully review people who are potentially immunocompromised for their suitability to receive a live vaccine. Live vaccines are generally contraindicated for most people who are severely immunocompromised. If there is uncertainty about how severely a person is immunocompromised and whether it is safe for them to receive a vaccine, do not vaccinate them. Seek expert advice from their treating physician or an immunisation specialist. 63 Similarly, in a section on 'Vaccination for women who are planning pregnancy, pregnant or breastfeeding' the Handbook says: Live attenuated viral vaccines … Live attenuated viral vaccines are contraindicated in pregnant women. This is because of the hypothetical risk of harm if the vaccine virus replicates in the fetus. 64 There is a chapter headed 'Vaccination for people who have had an adverse event following immunisation' (AEFI) with the subheading 'People who have had a serious AEFI can usually be vaccinated under medical supervision, unless they have a contraindication for that vaccine'. Further down in the section, in a passage on which the applicant places particular reliance, the Handbook says (emphasis in original): Serious adverse events following immunisation … People who have experienced a serious AEFI can usually receive further doses under close medical supervision. The exception is where the person has a contraindication, such as anaphylaxis confirmed to have been triggered by a vaccine or one of its components. … Allergies … Components that may be implicated in allergic reactions … People allergic to latex may be at risk from some vaccines. This is usually from latex in the equipment holding the vaccine, such as vaccine vial stoppers (bungs) and syringe plungers, not from the vaccine formulation itself. However, very few vaccine bungs contain natural latex. Before giving the vaccine, consult the product information to check whether it contains latex. … Assessing people for a history of allergies Immunisation providers must assess each person for a history of allergies and previous reactions to vaccines before giving any vaccine dose. Depending on the allergy identified, there may not be a contraindication to vaccination. For example, if a history of allergy to antibiotics is linked to β-lactams or related antibiotics, this is not a contraindication to vaccines that contain other classes of antibiotics such as neomycin, polymyxin B or gentamicin. Previous skin-related reactions to neomycin (such as rashes) are not considered a risk factor for a severe allergic reaction or anaphylaxis to vaccines made with neomycin, because there are only trace amounts of this antibiotic in the final product. Similarly, the measles and mumps components of MMR (measles-mumps-rubella) vaccine contain only a negligible quantity of egg protein (ovalbumin). MMR vaccine is not contraindicated in people with an egg allergy, including anaphylaxis. See Vaccinating people with a known egg allergy. People who experience an allergic reaction associated with a vaccine dose should be fully investigated to determine: • the possible causal relationship to vaccination • if, and under what circumstances, the person can receive repeat doses of vaccine Seek specialist advice, if appropriate. Contact your state or territory health authority for details of specialist immunisation clinics, or paediatricians or medical specialists with experience in managing people with adverse events following immunisation. Vaccinating people with a known egg allergy Influenza vaccines In the past, a history of anaphylaxis or a serious allergic reaction to eggs was an absolute contraindication to influenza vaccination. However, several studies now suggest that most people with an egg allergy, including anaphylaxis, can safely receive influenza vaccines that contain less than 1 μg of ovalbumin per dose …

The disease-specific chapters 65 The final main part of the Handbook, at least according to the order given in the structure outlined above, contains the 24 chapters on the diseases that can be prevented with vaccines in Australia. As has been said, each chapter follows the same format. The 'Recommendations' heading in each describes the persons for whom the vaccine is recommended, often including children at specified ages. There are also more detailed recommendations, such as the specific vaccination schedule recommended for each vaccine. As has been said, each of the disease-specific chapters includes a heading for contraindications and precautions and a heading for variations from product information. Five examples follow. The extracts given below are long, but it is necessary to present them to give the reader an understanding of the consistent layout that the disease-specific chapters have: (1) For diphtheria: Contraindications and precautions Contraindications The only absolute contraindications to diphtheria-containing vaccines are: • anaphylaxis after a previous dose of any diphtheria-containing vaccine • anaphylaxis after any component of a diphtheria-containing vaccine Precautions People with latex allergy The product information for ADT booster states that the tip cap of the syringe contains latex. Consider using an alternative product in people with an allergy or sensitivity to latex. … Variations from product information Contraindications The product information for all vaccines except ADT Booster states that these vaccines are contraindicated in children with either: • encephalopathy of unknown aetiology, or • neurologic complications occurring within 7 days after a vaccine dose ATAGI recommends that the only contraindications are: • anaphylaxis after a previous dose of any diphtheria-containing vaccine • anaphylaxis after any component of a diphtheria-containing vaccine (2) For Hepatitis B: Contraindications and precautions Contraindications Hepatitis B vaccines are contraindicated in people who have had: • anaphylaxis after a previous dose of any hepatitis B vaccine • anaphylaxis after any component of a hepatitis B vaccine • anaphylaxis to yeast Precautions Women who are pregnant or breastfeeding Hepatitis B vaccine is not routinely recommended for pregnant or breastfeeding women. However, the World Health Organization states that pregnancy and breastfeeding are not contraindications for hepatitis B vaccination. See Table. Vaccines that are not routinely recommended in pregnancy: inactivated viral vaccines in Vaccination of women who are planning pregnancy, pregnant or breastfeeding for more details. People with latex allergy The product information for H-B-Vax II states that the vial stopper, syringe plunger stopper and tip cap of the syringe contain latex. Consider using an alternative product in people with an allergy or sensitivity to latex. … Variations from product information … The product information for Infanrix hexa states that this vaccine is contraindicated in children with either: • encephalopathy of unknown aetiology, or • neurologic complications occurring within 7 days after a vaccine dose ATAGI recommends that the only contraindications are: • anaphylaxis to a previous dose • anaphylaxis to any of the vaccine components (3) For Japanese encephalitis: Contraindications and precautions Contraindications Japanese encephalitis (JE) vaccines are contraindicated in people who have had: • anaphylaxis after a previous dose of any JE vaccine • anaphylaxis after any component of a JE vaccine Imojev is contraindicated in people who are immunocompromised and in pregnant women because it is a live attenuated viral vaccine. Women should avoid pregnancy for 28 days after vaccination. Breastfeeding women should not receive Imojev because it is not known whether the virus is excreted in breast milk. See Table. Vaccines contraindicated in pregnancy: live attenuated vaccines in Vaccination for women who are planning pregnancy, pregnant or breastfeeding for more details. Precautions People with an acute febrile illness should not receive JE vaccines. People who are immunocompromised JEspect is an inactivated vaccine, so it is not expected to cause any safety concerns in people who are immunocompromised. However, there are few data on the safety and efficacy of JEspect in those who are immunocompromised. These people may not mount an adequate immune response to the vaccine. Women who are pregnant or breastfeeding JE vaccine is not routinely recommended for pregnant or breastfeeding women. However, pregnant women at risk of acquiring JE are recommended to receive JEspect. JE virus infection during the 1st and 2nd trimesters has been associated with miscarriage. No adverse outcomes of pregnancy have been attributed to vaccination with JEspect. Breastfeeding women who are at increased risk of acquiring JE are recommended to receive JEspect. However, no specific data are available about using JEspect in breastfeeding women. Vaccination after immunoglobulin or blood product administration Do not give Imojev within 6 weeks after giving immunoglobulins or immunoglobulin-containing blood products. It is preferable to wait 3 months. (4) For measles: Contraindications and precautions Contraindications Anaphylaxis to vaccine components MMR and MMRV vaccines are contraindicated in people who have had: • anaphylaxis after a previous dose of any MMR-containing vaccine • anaphylaxis after any component of an MMR-containing vaccine … Pregnant women MMR-containing vaccines are contraindicated in pregnant women. … People who are immunocompromised MMR-containing vaccines comprise live attenuated viruses and are contraindicated in people who are immunocompromised. This means that MMR-containing vaccines are contraindicated in: • people who are significantly immunocompromised because of a medical condition(s) • people receiving high-dose systemic immunosuppressive therapy, such as chemotherapy, radiation therapy or oral corticosteroids … Precautions Vaccination after receiving immunoglobulin or a blood product A recent blood transfusion with washed red blood cells is not a contraindication to MMR or MMRV vaccines. People who have received an immunoglobulin-containing blood product should wait 3-11 months before receiving a measles-containing vaccine. This is because the immunoglobulin may impair the expected immune response to the vaccine. … Immunoglobulin or blood product administration after vaccination People who have received a measles-containing vaccine should not receive immunoglobulin-containing products for 3 weeks after vaccination, unless the benefits of receiving the blood product outweigh the benefits of vaccination. … … People with HIV The following people with HIV may receive MMR vaccine: … … People receiving corticosteroid therapy People on low-dose systemic corticosteroids can receive MMR-containing vaccines. … … Household contacts of people who are immunocompromised Household contacts of people who are immunocompromised should ensure that they are age-appropriately vaccinated against, or are immune to, measles, mumps, rubella and varicella. … People receiving long-term aspirin or salicylate therapy There is no need to avoid salicylates before or after receiving MMR or MMRV vaccine. … People with a history of thrombocytopenia Thrombocytopenia is a rare adverse event after MMR vaccination (see Adverse events). In children who have had an episode(s) of idiopathic thrombocytopenia purpura (ITP), the risk of vaccine-associated thrombocytopenia after a dose of MMR vaccine is uncertain. However, a systematic review concluded that MMR vaccination, either a 1st or 2nd dose, did not lead to a recurrence of ITP. In children due for their 2nd dose, serological testing can be used to determine whether the child needs the extra dose of MMR or MMRV vaccine. Personal or close family history of seizures or convulsions Children with a personal or close family history of seizures or convulsions can receive MMR or MMRV vaccine. … Tuberculin skin testing after MMR vaccination The measles virus inhibits the response to tuberculin. Tuberculin-positive people may become tuberculin-negative for 4-6 weeks after measles infection, and measles-containing vaccines have a similar effect. Because of this, a tuberculin skin test (TST; Mantoux) may be unreliable for at least 4-6 weeks in people who have received MMR vaccine. … Variations from product information People with egg allergy The product information for Priorix, M-M-R II and Priorix-tetra states that people with a history of anaphylactic or anaphylactoid reactions to egg should not receive these vaccines. The Australian Technical Advisory Group on Immunisation (ATAGI) recommends that these people can receive Priorix, M-M-R II, Priorix-tetra or ProQuad. Women planning pregnancy The product information for M-M-R II and ProQuad recommends that women of child-bearing age should avoid pregnancy for 3 months after vaccination. ATAGI recommends that these women should avoid pregnancy for 28 days after vaccination, as for Priorix and Priorix-tetra. … (5) For pertussis: Contraindications and precautions The only absolute contraindications to acellular pertussis-containing vaccines are: • anaphylaxis after a previous dose of any acellular pertussis-containing vaccine • anaphylaxis after any component of an acellular pertussis-containing vaccine … Variations from product information … Contraindications The product information for all pertussis-containing vaccines states that these vaccines are contraindicated in children with either: • encephalopathy of unknown aetiology, or • neurologic complications occurring within 7 days after a vaccine dose ATAGI recommends that the only contraindications are: • anaphylaxis after a previous dose of any acellular pertussis-containing vaccine • anaphylaxis after any vaccine component of an acellular pertussis-containing vaccine 66 As another example, in the disease-specific chapter on influenza, Guillain-Barré syndrome (noted above with respect to the pre-vaccination checklist) is listed only as a precaution. 67 The Handbook also contains a 'Glossary of technical terms' (omitted from the version the parties agreed I could rely on, but appearing in other versions that were in evidence). It defines 'contraindication' to mean a 'medical condition or risk factor in a recipient/person that makes receiving a specific vaccine potentially harmful'.

The parties' cases on the main issue 68 The applicant submits that the Handbook does not have the effect of prescribing only three contraindications for vaccines, namely anaphylaxis, pregnancy and immunocompromise. She submits that would be contrary to the broad definition of 'contraindication' in the Handbook glossary, and contrary to 'many other passages that require a judgment to be exercised in a particular case'. The contraindications given are, she says, given as non-exhaustive examples. Taken as a whole and in the context of the relevant regulatory framework, the task of certifying whether a particular child is contraindicated for a particular vaccine is a matter of clinical judgement to be exercised by an appropriately qualified medical practitioner. That leads to the applicant's point that it is not the role of a non-medical decision-maker like the Secretary or the Tribunal to 'second guess' or go behind a medical certificate. 69 The applicant relies on definitions of contraindication in resources other than the Handbook which are said to refer to two types: relative and absolute. A relative contraindication is said to involve a risk benefit analysis; an absolute contraindication is a contraindication in all circumstances. The applicant submits that the issue for determination is whether the Handbook only deals with absolute contraindications or whether it contemplates that a medical practitioner may conduct a risk assessment in order to determine whether the benefits of vaccination outweigh the risks, that is, whether there is a 'relative contraindication'. 70 The applicant submits that the Handbook does contemplate occasions where 'contraindications' need to be assessed on a case by case basis. It is a guideline, not a complete code. It does not purport to list contraindications exhaustively. It does acknowledge a need to assess and weigh up risks. The applicant points to the list of false contraindications and submits that this connotes that there will be contraindications that are neither listed as false nor included in the 'absolute' contraindications that are identified elsewhere in the Handbook. The applicant thus submits that the Handbook connotes that the medical practitioner may need to make a judgement call about the appropriateness of a vaccine in weighing the risks in a particular situation. 71 As far as the doctor's reports go, the applicant submits that they met the requirement in s 6(3)(a) of the Family Assistance Act that a general practitioner has certified in writing that the immunisation of the child would be medically contraindicated under the specifications set out in the Handbook. In relation to the First Report, this is said to be because it states the doctor's opinion that the risks of vaccination to the child outweigh the benefit. Those risks include the risk of a serious adverse reaction, which, according to the applicant's main written submissions, 'is one of the matters to be considered in the specifications to the Handbook involving a judgment call'. So the applicant submits that the First Report is a certificate of the doctor's opinion and therefore a certificate under the specifications of the Handbook. The Second Report is explicit in stating that the vaccination of the child 'would be contraindicated under the specifications of the Australian Immunisation Handbook', so it meets the requirements of s 6(3)(a). The applicant also submitted that the Third Report met those requirements for the same reason. 72 In reply, the Secretary submits that there was no error in the Tribunal approaching the review on the basis that only the three contraindications were specified in the Handbook. She submits that the legislative text and the content of the Handbook indicate that for a medical contraindication to be a 'specification' for the purposes of s 6(3)(a), it must be expressly referred to in the Handbook, and the specifications that are the subject of express reference are the ones that are summarised in the table early in the Tribunal's reasons. The Secretary also says that the First Report does not on its face identify anything that could conceivably amount to a contraindication, and the Second Report simply refers to and relies upon the First Report rather than being a fresh assessment of the child's suitability for immunisation. Therefore, she submits, the Tribunal had to 'do more than simply accept at face value' the assertion as to contraindication in the Second Report, and the Tribunal's findings as to whether the Second Report was a certificate for the purposes of s 6(3)(a) were correct.

Consideration 73 The applicant's submissions, as described above, focussed on various ways in which the Handbook leaves room for medical practitioners to exercise judgement in deciding whether to vaccinate a patient. I accept that the Handbook has those features. The difficulty for the applicant's argument, though, is that the legislative requirement that must be satisfied is not for a medical practitioner to certify an opinion, having regard to the guidelines and recommendations in the Handbook, that the child should not be vaccinated. The legislative requirement is the existence of a certificate by an appropriate medical practitioner that 'the immunisation of the child would be medically contraindicated under the specifications set out in' the Handbook. The Family Assistance Act therefore contemplates that there are specifications, of contraindications, that are set out in the Handbook. 74 Dictionary definitions must be used cautiously in statutory interpretation, recalling that the task is always to construe words in their context having regard to the purpose and objects of the legislation: see Vincentia MC Pharmacy Pty Ltd v Australian Community Pharmacy Authority [2020] FCAFC 163; (2020) 280 FCR 397 at [53] (Perry and Stewart JJ). But it is useful here to see that the Shorter Oxford Dictionary (6th ed, 2007) relevantly defines 'specify' as 'Speak or treat of a matter etc. in detail; give details or particulars' and 'Mention or name (a thing, that) explicitly; state categorically or particularly …'. 'Specification' is relevantly defined as an 'explicit or detailed enumeration or statement'. That understanding of the word is reinforced in s 6(3)(a) by the use of the phrase 'set out', which connotes an explicit statement of the thing that is set out, in this case the contraindication. The phrase 'set out' is relevantly defined in the Shorter Oxford Dictionary as meaning to 'declare, proclaim; express, denote', and to 'put down in writing or in print in explicit or detailed form; describe or enumerate exhaustively or in detail'. As a result, there is a disconnect between the applicant's main argument and the words of the legislation; if a contraindication is any condition where a doctor forms the opinion that the risks outweigh the benefits for a particular patient, it could not be the subject of 'specifications set out in' the Handbook. 75 In truth, when one turns to the text of the Handbook, there is no ambiguity about what it states or specifies or sets out to be a contraindication. Relevant excerpts from the Handbook are set out above, and I will now comment on the significance of passages of particular relevance (emphases added below). 76 First, the Handbook says in a section explaining live vaccines that 'people who are significantly immunocompromised should not receive live vaccines' (as extracted at [53] above, emphasis added). That is a specific statement where the words I have emphasised impose clear constraints as to when a particular vaccine should not be administered at all, that is, is contraindicated. It then goes on to contrast this with non-live vaccines, and to say that people who are immunocompromised can safely receive those. It then makes a specific exception to that statement in relation to the Q fever vaccine. 77 Second, and importantly, the introductory section that is specifically about contraindications (extracted at [56] above) draws a distinction between a contraindication, described as 'a reason a vaccine should not be given' and a precaution, which is 'a condition that may increase the chance of an adverse event following immunisation or compromise the vaccine's ability to produce immunity' and for which there should be consideration of whether 'the benefits of giving the vaccine outweigh the potential risks'. The Handbook thus conceives of contraindications as absolute, in the sense that they mean that the vaccine should not be given (except under expert medical advice from an immunisation specialist), or at least should not be given until the contraindication no longer applies to the patient. That concept does not admit of a risk benefit analysis; rather, the Handbook contemplates that analysis (expressly) in the case of precautions. 78 It is true that in the introductory section, examples of contraindications are given in a general way that could introduce questions of judgement: 'This might be when …'; 'Insufficient safety data about a vaccine may also be a contraindication …'. But the examples are evidently given for the purpose of explaining how something comes to be identified as a contraindication; they are not given in order to confer discretion to determine what is or is not a contraindication for the purpose of the Handbook. Rather, the section concludes with a clear statement that 'Each disease-specific chapter in the Handbook indicates whether there are contraindications or precautions for administering vaccines' (emphasis added). To the extent that this section contemplates that a risk benefit analysis may be conducted in relation to the contraindication, it is only by an immunisation specialist, and only on the assumption that it has first been identified as a contraindication. 79 Third, the table of actions to take in response to a patient's answers to the standard pre-vaccination screening questionnaire is also clear (described at [59] above). Anaphylaxis following previous doses of the vaccine and anaphylaxis following previous administration of a vaccine containing a relevant component are categorically identified as circumstances where the patient is not to be vaccinated (save on specialist advice). And while, for example, the statements about live attenuated vaccines are less categorical in form ('Live attenuated vaccines may be contraindicated' and, if people 'have significant immunocompromise, they should not receive live vaccines') that reflects the fact, already stated in the section on live vaccines, that only significant immunocompromise is a contraindication. The other matters with which the table deals are not presented as contraindications, whether absolute or relative. 80 Fourth, the section in the chapter on preparing for vaccination that deals specifically with contraindications is unambiguous (see [60] above). Two matters are specified as absolute contraindications to all vaccines - anaphylaxis following a previous dose of the relevant vaccine and anaphylaxis following any component of the relevant vaccine - and two are specified as contraindications applying to live vaccines - significant immunocompromise and pregnancy (present or imminent). Nothing else is identified as being, or possibly being, a contraindication. While it is true as the applicant submits that this passage does not expressly say that these are the only possible contraindications recognised by the Handbook, that is implied by saying that only two contraindications apply to all vaccines and that there are two further contraindications that apply to all live vaccines. That does not indicate that there are a number of other potential contraindications, that are not there specified, that might apply. And it is consistent with the other parts of the Handbook, such as the disease-specific chapters extracted at [65], in which contraindications are specified. 81 I do not consider that the use of the word 'absolute' here implies that the Handbook contemplates that there can be other contraindications that are 'relative'. The Handbook does not speak elsewhere of relative contraindications; as has been said, what it speaks of in contrast to contraindications is precautions. The use of 'absolute' in this passage is explained by the fact that it is indicating that anaphylaxis after a previous dose or component is a permanent contraindication to the vaccine or component in question. That is shown by the contrasting reference to 'further contraindications' which only apply to conditions that are or may be temporary, such as pregnancy or immunocompromise. 82 Fifth, the passage in the same chapter on false contraindications is also unambiguous (see [61] above). It can be inferred from the fact that the Handbook takes the trouble to mention these specific conditions that its purpose is to make it clear that those conditions are not contraindications, even though they are sometimes thought to be. Nothing about the contents or context of the list suggests that it sets out false contraindications exhaustively. And in view of its evident purpose, and contrary to the applicant's submission, it does not imply an intention on the part of the authors of the Handbook to leave to the judgement of the medical practitioner whether a matter that is not listed in it, and is not stated elsewhere to be an 'absolute' contraindication, may still be a contraindication. 83 Sixth, in the chapters on vaccination of special risk groups ([62]-[64] above), where contraindications are mentioned they are described in a way that is consistent with the description of contraindications elsewhere in the Handbook. For example, in relation to people who are immunocompromised, it is said that live vaccines should not be administered to them, albeit there is also a recommendation to seek advice from their treating physician or an immunisation specialist. That reflects the point made above that an assessment about whether the immunocompromise is significant needs to be made. Also, the tenor of the discussion of how to deal with people with allergies is that a history of allergic reaction short of anaphylaxis to a vaccine or vaccine component is not a contraindication. 84 Finally, and also importantly, each of the disease-specific chapters follows a standard format which includes a section for contraindications and precautions (see [65] above). To the extent that s 6(3)(a) requires one to identify particular places in the Handbook where contraindications are specified, they are specified there. They are specified because the conditions which are contraindications for each vaccine are expressly identified under a heading 'Contraindications'. And the things listed there are consistent with the contraindications identified specifically elsewhere in the Handbook. Anaphylaxis from a previous dose of a vaccine and anaphylaxis from a previously administered vaccine component are stated categorically in each case to be contraindications. With a few isolated exceptions, the only other contraindications listed for particular vaccines are immunocompromise and pregnancy in the case of live vaccines. Only one of those isolated exceptions - previous anaphylaxis to yeast in the case of Hepatitis B vaccine - applies to the vaccinations relevant to the child. And it is not material here, as the child has no prior history of anaphylaxis to yeast. Save for that immaterial point, the Tribunal was correct to conclude that only the three contraindications were specified in relation to the diseases that were relevant to the child. Other circumstances, such as acute febrile illness or immunocompromising conditions (in the case of vaccines that are not live vaccines), are included under the heading 'Precautions'. 85 Several of the disease-specific chapters also contain information on variations from product information, that is, circumstances where ATAGI recommends that the product information for a vaccine not be followed, and in multiple cases this includes a recommendation to disregard contraindications on the product information. The Handbook is consistent in this regard throughout. That is, the same small number of conditions are identified as contraindications, which mean that a vaccine should not be given or should not be given except on the expert advice of a specialist. 86 Reading the Handbook as a whole, there is no room for doubt about which conditions have been specified and set out as contraindications, in the sense of expressly and particularly identified as such, and which are not. If something is not a condition indicating that a vaccine should not be given at all (or only under expert supervision), it is not called a contraindication. It is called a precaution, or given no label at all.

Specific submissions of the applicant 87 I therefore do not accept the applicant's submissions about the construction of the Handbook or, what is the more precise subject of inquiry, about the construction of s 6(3)(a) of the Family Assistance Act in so far as it applies and incorporates the Handbook. It is necessary to make that distinction because of the multiple purposes of the Handbook and because of its main purpose as a set of guidelines and recommendations about clinical practice. To the extent that it fulfils that main function it can be accepted, as the applicant submits, that it is comprised of guidelines that leave room for the judgement of medical practitioners as to whether the risk of administering a given vaccine exceeds the benefits for any given patient. But for the reasons given, when the Family Assistance Act refers to medical contraindications 'under the specifications set out in' the Handbook, it can only be referring to a small and readily identifiable set of conditions which, if present in a patient, mean that a given vaccine should not be administered. 88 For that reason, the two possibilities identified in the applicant's question of law 4 set out at [42] above are not mutually exclusive. The question asks whether the Handbook limits the specified contraindications to the three contraindications, and whether the Handbook gives medical practitioners 'a judgment call to make'. But the Handbook can do both; it can specify particular contraindications, and at the same time can give medical practitioners the professional latitude to make a broader judgement about what is in the best interests of their patients. In pointing to specifications set out in the Handbook, s 6(3)(a) of the Family Assistance Act directs attention only to the first of these two things. So the answer to the first part of the question is, yes, the specifications are limited to the three contraindications, and the answer to the second part is that, whether or not the Handbook permits or requires a 'judgment call' for other reasons, that does not affect what is specified as a contraindication as set out in the Handbook. 89 The particular passages from the Handbook on which the applicant relies do not lead to any contrary conclusion. The submissions take those passages out of context and so obscure the purpose for which the statements are made, and they disregard the clear and consistent approach expressed in the Handbook as to which specific conditions are and are not contraindications. Even more importantly, they disregard the words of s 6(3)(a) of the Family Assistance Act. With respect, the applicant's submissions simply did not engage with those words. 90 For example, the applicant emphasises a statement in the Handbook about ensuring that vaccines 'are not given to people who have a high risk of serious adverse events', as if the quoted phrase is a free standing criterion that a medical practitioner can use to determine what is a contraindication according to the Handbook. But it is not that; it is just an explanation of the composite purpose of specifying contraindications and precautions. It appears in an introductory bullet point about both contraindications and precautions in a summary of the contents of the 'Fundamentals of immunisation' part. 91 The applicant points to the definition of 'contraindication' in the glossary to the Handbook as a medical condition or risk factor that makes receiving a specific vaccine potentially harmful. She combines that with a small part of the description of a contraindication in the chapter on fundamentals of immunisation, to produce a combined statement of the meaning of the word, that it is a medical condition or risk factor in a person that makes receiving a vaccine potentially harmful, which may be by significantly increasing the chance of a serious adverse effect after a vaccine. The applicant appears to emphasise the references to potential harm and increasing a chance. But the Handbook is not a statutory instrument. It is not even a legal instrument. It is primarily a practical clinical guide, and it is not correct to join separate definitions or phrases up in that way by proceeding on the basis that the Handbook must be taken to intend to use the same word in the same way wherever it appears. When the true purpose of the Handbook is appreciated, it is clear that the glossary is simply a guide to help the reader understand technical terms used, not a collection of defined terms that are to be applied rigorously throughout in order to arrive at a correct construction of the document. 92 In any event, such an exercise cannot be used to answer the question raised by the Family Assistance Act, the actual statutory instrument here, which is: what contraindications are set out in specifications in the Handbook? The applicant's argument is that the doctor has identified contraindications that accord with the definition in the glossary but, whether or not that is so, they are not the contraindications to which s 6(3)(a) of the Act points. 93 The applicant submits that if the 'bright line' approach advocated by the Secretary, and approved by me above, is adopted, the definition of contraindication would not have work to do and would need to be completely read down. But this is, once again, to read the Handbook as if it were a statutory instrument. 94 The applicant also submits that 'reading down' the term contraindication and limiting it to the three contraindications would lead to absurd results. The example given is that if the Handbook is not updated timeously, it could become inconsistent with the state of medical knowledge. But that is not an absurdity, and does not mean that the construction of the Family Assistance Act adopted above cannot be correct. It is merely a temporary lag between the Handbook and the state of medical knowledge. In any event, the online nature of the Handbook, its preparation by ATAGI and approval by the NHMRC, and its evident purpose to assist in millions of clinical decisions across Australia every year, provide powerful institutional incentives and mechanisms to minimise any such lag. That is confirmed by the very first page of the Handbook, which says that 'The Australian Immunisation Handbook is an up-to-date reference' and lists pages which it says have been updated recently. 95 The applicant similarly relied on what she said was an absurdity that would arise on the Tribunal's construction of the Family Assistance Act with the Handbook, namely that Parliament would be taken to intend that if a child's particular genetic disposition puts them at risk of a serious adverse reaction, the child must nevertheless be vaccinated or suffer the loss of child care benefit or child care subsidy. But s 6(6) of the Family Assistance Act and the Family Assistance (Immunisation and Vaccination) (Education) Determination 2018, described above, mean that if a listed medical practitioner and the Commonwealth Chief Medical Officer each certify that immunisation of the child would result in an unacceptable risk of physical harm to the child, then the immunisation requirements will be satisfied. So an absurdity of the kind identified (if an absurdity is what it is) will not arise. 96 The applicant also submits that, had Parliament intended to limit the immunisation requirement aspect of child care benefit and child care subsidy eligibility to 'absolute' rather than 'relative' contraindications, it could have said this, but it did not. With respect, arguments about what an instrument could have said are rarely helpful in understanding the true meaning of what it does say. By the same token, it could be pointed out that the Family Assistance Act does not provide that an immunisation requirement is satisfied if a medical practitioner certifies that in his or her opinion the risks of vaccination outweigh the benefits. If there is a legal dispute over the meaning of an instrument, it is a safe bet that it does not expressly say what either party submits it means. But in this case the statutory provision does at least require one to look for where, in the Handbook, contraindications are specified. The doctor must certify that those specified contraindications are present. That is a different thing to requiring the doctor to make a 'judgment call' that is merely consistent with the Handbook. 97 The applicant also relies on the passage quoted above at [57] about administering vaccines in accordance with 'best practice' and recommending the following of 'other relevant guidelines', as if this gives a wide discretion to the medical practitioner. But whether or not it does that, it does not mean that the reason identified by a practitioner for an opinion that a vaccine should not be administered to the patient is a contraindication found in specifications set out in the Handbook. I have also set out the passage about allergies in some detail above (at [64]) because the applicant placed particular reliance on it. But the unsurprising acknowledgment in the Handbook that allergies need to be taken into account does not mean that all allergies are contraindications, or that allergies other than anaphylaxis after a previous vaccine dose or previously administered vaccine component are specified as contraindications in the Handbook. 98 Likewise, the applicant's division of contraindications into absolute and relative may or may not be medically sound, but it is not found in the Handbook; the division employed there is instead between contraindications and precautions, with the content of the first of those concepts clearly delineated. For the purposes of s 6(3)(a) of the Family Assistance Act, whether or not the Handbook contemplates that there may be other contraindications (in a broader clinical sense) is beside the point; the question is: which are the subject of specifications set out in the Handbook? 99 In my view, the preferred approach outlined above is consistent with the evident purpose and object of the Family Assistance Act in imposing the immunisation requirements in the first place. It can be inferred that those requirements reflect a view that it is generally desirable that children are immunised against diseases, including before they mix with other children at child care centres. The statement in the explanatory memorandum to the A New Tax System (Family Assistance) Bill 1999 (Cth), that the purpose of measures in the Family Assistance Act was 'to encourage to the greatest extent possible age-appropriate immunisation' tends to confirm that. The applicant also referred to the explanatory memorandum for a bill amending the Family Assistance Act, the Social Services Legislation Amendment (No Jab, No Pay) Act Bill (Cth). It said that a requirement to be introduced by that bill, for contraindications to be certified by a general practitioner rather than other immunisation providers, reflected that 'the assessment of medical contraindication can be complex' and it is 'appropriate that this assessment is made by a general practitioner'. But that passage refers to the change made by the 2015 amendment to require that only a medical practitioner, and not, for example, a nurse or pharmacist, could certify, and other changes to tighten the exemption requirements were also made. So it sheds no light on the question of what contraindications are specified and set out in the Handbook. 100 Plainly, the immunisation requirements are intended to encourage the vaccination of each child unless there is good reason why the child should not be vaccinated. It best promotes that purpose to confine what will constitute a good reason in this context to a relatively circumscribed and clearly defined set of conditions. The contrary approach, being the one urged by the applicant, is to leave it in each case to the clinical judgement of the medical practitioner. But that would lead to inconsistency of approach and would make it easier for parents who do not want to vaccinate their children to 'shop around' for a doctor who is prepared to certify an opinion against vaccination.

Whether the doctor's reports were certificates of the necessary kind 101 Returning to the doctor's reports with this understanding of the Family Assistance Act and the Handbook, it is plain that the First Report did not certify that the immunisation of the child would be medically contraindicated under the specifications set out in the Handbook. The First Report does not say that. Read with the Form, it does express an opinion that the child should be exempt from vaccination due to medical contraindication. But it eschews basing that on any of the three contraindications, as permitted by the form. Rather, the First Report indicates that the opinion is based on the doctor's clinical judgement that the child's medical history indicates an 'increased risk' of a serious adverse reaction, including allergy to vaccine components. That medical history as described in the First Report does not include anaphylaxis after past vaccinations, or immunocompromise (or, of course, pregnancy). It does include, for example, 'a potential allergic reaction to latex' where latex allergies are expressly identified in the Handbook in relation to all relevant vaccines as precautions, not contraindications. The First Report says only that the Handbook and other published information has been consulted, not that the contraindications are those specified in the Handbook. The Tribunal was correct to conclude that the First Report was not evidence that a general practitioner had certified in writing that immunisation would be medically contraindicated under the specifications set out in the Australian Immunisation Handbook. 102 The Second Report is expressed to be a clarification of the First Report, which it refers to as 'my medical contraindication certification'. It says in order to 'clarify, as was noted in that certification' that the doctor 'considered the clinical guidance' in the Handbook (in the past tense) and that she 'determined' (in the past tense) that vaccination of the child would be contraindicated under the specifications of the Handbook. The Second Report therefore needs to be read together with the First Report. When that is done, it is evident that the basis of the 'certificate' in the Second Report, that vaccination is contraindicated, is the opinion formed in the First Report, based on an increased risk of adverse reaction and not based on any of the three contraindications. Therefore, despite the use of the correct words as a matter of form, it is not in substance a certificate that immunisation is contraindicated under the specifications set out in the Handbook. As I have said, counsel for the applicant properly accepted that if only the three contraindications could satisfy s 6(3)(a) of the Family Assistance Act, and if reasons given for a purported certificate showed that it was not based on any of the three contraindications, then the certificate would not satisfy the immunisation requirements of the Family Assistance Act.

Conclusions on grounds 1 to 8 103 For those reasons, the Tribunal's decision was correct. Ground 1, being a general contention that the Tribunal erred, is not upheld. Ground 2, which contends that contraindications other than the three contraindications could satisfy s 6(3)(a) of the Family Assistance Act, is not upheld. Ground 3, which asserts that the doctor did express the medical opinion that vaccination of the child was contraindicated under the specifications of the Handbook, is not upheld. As explained above, these conclusions mean that grounds 4 through to 8 fall away. 104 I should, however, refer specifically to ground 7, which contends that the Tribunal did not give sufficient reasons for its conclusion that the Second Report did not satisfy the requirements of s 6(3)(a). If that ground were made out then conceivably the appeal should be allowed on that basis, even if the Tribunal was correct to say that only the three contraindications can form the basis of a valid certificate under the section. But ground 7 has not been made out. Little argument was devoted to it, but in my view the Tribunal's reasons for rejecting the Second Report, while brief, were adequate. They were (at paragraph 70, emphasis in original): I have considered the Applicant's submissions and the [Second] Report. Importantly, [the doctor] indicates that she has used the Australian Immunisation Handbook for 'clinical guidance' and that the Handbook provides for the exercise of 'clinical judgement and consideration of guidance from other sources'. This summary of [the doctor's] position is not materially different to that contained in her earlier Report. In my view, the [Second] Report does not change the evidence relevant to the determination of this matter from the position as it was at the conclusion of the hearing on 10 June 2021. 105 In this the Tribunal expresses the view that the Second Report does not advance the position further than the First Report did. The paragraph indicates that the doctor's reference in the Second Report to having used the Handbook for guidance confirms that her approach has not changed since the First Report. In the context of the Tribunal's rejection of the approach taken in the First Report elsewhere in its reasons, this paragraph is sufficient indication of its reasons for rejecting the Second Report as a certificate that complies with s 6(3)(a).

Ground 9 - procedural fairness; and application to adduce new evidence 106 As has been said, subject to one qualification the applicant's counsel conceded that if the Court determines that the three contraindications were the only ones that could satisfy s 6(3)(a) of the Family Assistance Act, ground 9 relating to procedural fairness must fail. In effect, ground 9 depends on the proposition that the applicant did not appreciate at the commencement of the second Tribunal hearing that the substance of the First Report was in issue, rather than its form. She submits that if she had appreciated that, she could have produced further evidence which could have made a difference to the outcome. The substance of that further evidence is contained in the Third Report. The concession was properly made, though, because if that evidence could not bear on the outcome, because it would not be evidence based on the three contraindications, then the applicant will have suffered no practical injustice, and so will not have been denied procedural fairness. Since I have found that only the three contraindications can form the basis of a certificate that satisfied s 6(3)(a) it follows that, subject to the qualification, the applicant accepts that ground 9 falls away. 107 The qualification was that the applicant's counsel said that the answer had to be obvious, that is, the conclusion that only the three contraindications would satisfy the requirements must be so clear that no medical evidence such as that in the Third Report would assist the Court to come to a correct understanding of the Handbook. In that regard, the Third Report does contain a section setting out the doctor's view as to the extent to which the Handbook is prescriptive or requires a clinical judgement to be exercised, and a discussion of what clinical judgement involves. 108 It is not clear to me that the opinion of a medical expert (whose prior 'certificate' is in issue) is admissible as evidence to assist the Court to interpret the Handbook. But even if it is, for the reasons given above I do not consider that the doctor's opinion could bear on the result anyway. In my view the conclusion that emerges from the Handbook read together with s 6(3)(a) of the Family Assistance Act is clear; in the case of the child, only the three contraindications can satisfy the provision. The doctor's opinion that the Handbook requires and permits clinical judgement in many circumstances appears to be correct. But it is correct as a general proposition only, and is not to the point, because what the section requires is a certificate as to the contraindications specified in the Handbook. While clinical judgement may be required in order to determine whether those specified contraindications are in fact present in a given patient, the broader clinical judgements to which the doctor refers are not judgements of that kind. 109 For that reason, there was no procedural unfairness. The Third Report does not assist the Court to determine the issues on the appeal, and the application for leave to adduce it as evidence is dismissed.

Disposition 110 The appeal must be dismissed, with costs. I certify that the preceding one hundred and ten (110) numbered paragraphs are a true copy of the Reasons for Judgment of the Honourable Justice Jackson.