Statement of Principles concerning giant cell arteritis (Balance of Probabilities) (No. 12 of 2021)

Giant cell arteritis is defined in subsection 7(2) as a systemic autoimmune vasculitis that involves large and medium‑sized arteries, principally affecting the cranial branches of the carotid arteries. The definition is exhaustive for the purposes of this SoP, meaning that a diagnosis under a different name (e.g. temporal arteritis) will be accepted only if it meets this descriptor. The instrument also cross‑references ICD‑10‑AM codes M31.5 and M31.6, but note (3) makes clear that the definition in subsection (2) governs, not the code assignment. Death from GCA is separately addressed in subsection 7(5): it includes death from a terminal event or condition that was contributed to by the person’s GCA. Terminal event is defined in the Dictionary as pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function.

One pack‑year is defined in the Dictionary, as amended in 2022, as the amount of tobacco consumed in smoking 20 cigarettes per day for one year, or an equivalent amount of tobacco products. The definition includes a note stating that 7,300 grams of smoking tobacco by weight (in cigarettes, pipe tobacco or cigars, or a combination) is equivalent to one pack‑year. The calculation method is given: pack‑years equal (cigarettes per day ÷ 20) × years smoked. This replaces an earlier, possibly less precise definition. The amendment history shows that the notes under subsections 9(1) and 9(2) were substituted to reflect this revised definition.

Relevant service is defined in the Dictionary and means: (a) eligible war service (other than operational service) under the VEA; (b) defence service (other than hazardous service and British nuclear test defence service) under the VEA; or (c) peacetime service under the MRCA. This is a narrower category than all service covered by the VEA or MRCA. Operational service under the VEA, hazardous service, and British nuclear test defence service are explicitly excluded. The practical consequence is that the SoP applies only to those who served in peacetime or in non‑operational eligible war service or defence service. For operational service claimants, different standard of proof and different SoPs may apply (the standard of reasonable satisfaction rather than balance of probabilities, but this SoP is the balance‑of‑probabilities version).

Balance of probabilities is the evidentiary standard used throughout, as indicated by the instrument’s title and the basis statement in section 8. The RMA states that it is more probable than not that GCA can be related to relevant service. The factors in section 9 reflect that standard.

Clinical onset and clinical worsening are not separately defined in this SoP but are used in section 9. Clinical onset appears in factor (1) as a temporal anchor: the person must have smoked at least 10 pack‑years before the onset, and if smoking ceased, the onset must occur within 20 years of cessation. Clinical worsening appears in factor (2) with the same smoking threshold and time window. The distinction is important: factor (1) is for new disease; factor (2) is for aggravation of a pre‑existing condition. Note that factor (2) and (3) are limited by subsection 10(2) to cases where the GCA was suffered or contracted before or during (but did not arise out of) the person’s relevant service. This means a person who first contracts GCA during service without a causal link to service cannot use factor (1) for that new disease, but after the condition exists, a subsequent worsening can be related to service if a factor (2) or (3) exists and is service‑related.

Inability to obtain appropriate clinical management is the third factor in subsection 9(3). It is not further defined in the instrument. The term ‘appropriate clinical management’ would likely be interpreted by reference to accepted medical practice for GCA. This factor is a catch‑all that does not depend on smoking or any other specific exposure. It applies only to material contribution or aggravation (subsection 10(2)), not to the initial contraction of GCA. This is a significant point: a claimant who already has GCA and whose service denied them proper medical care (e.g. due to remote posting or lack of timely diagnosis) may succeed in linking a worsening of the disease to service.

The instrument directly affects three categories of persons: (1) veterans who rendered eligible war service (other than operational service) under the VEA; (2) veterans who rendered defence service (other than hazardous service and British nuclear test defence service) under the VEA; and (3) members who rendered peacetime service under the MRCA. These are the persons whose claims under section 120B of the VEA or section 339 of the MRCA are governed by this SoP. The definition of relevant service in the Dictionary explicitly excludes operational service, hazardous service and British nuclear test defence service, meaning that veterans with those service types cannot use this SoP; they would rely on other SoPs or on direct medical evidence under a different standard.

The instrument also indirectly affects their dependants and legal personal representatives if a claim arises from death from GCA. Subsection 7(5) extends the definition to death contributed to by GCA, so a widow or widower seeking pension or compensation for dependent’s benefits may need to rely on this SoP.

Clinicians who diagnose and treat GCA, particularly those who provide medico‑legal reports for veterans’ claims, are affected by the definitions and factors. They must be aware that a diagnosis of ‘temporal arteritis’ will be accepted only if it meets the description in subsection 7(2). They also need to calculate pack‑years precisely and document the timing of clinical onset and cessation relative to service.

The Repatriation Medical Authority itself is the maker of the instrument and is affected in the sense that it must maintain the SoP based on sound medical‑scientific evidence. Under the VEA, the RMA is required to determine SoPs for specified kinds of injury, disease or death. The RMA is not a party to individual claims but its determinations bind the decision‑makers (the Repatriation Commission, the Veterans’ Review Board, and the Administrative Appeals Tribunal).

Legal practitioners and advocates representing veterans must understand the structure of the SoP to advise clients on the likelihood of success. The presence of only three factors means many claims will stand or fall on smoking history or the inability‑to‑obtain‑clinical‑management argument. The narrow definition of relevant service also limits the pool of potential claimants.

The instrument does not affect civilians or veterans with operational service, hazardous service or British nuclear test defence service, because the standard of proof and the applicable SoP for those service types is different (the reasonable‑hypothesis standard under the VEA for operational service, and potentially different SoPs on the balance of probabilities for other service types). The SoP is expressly stated to apply to claims under section 120B of the VEA and section 339 of the MRCA, which are the provisions that require claims to be determined on the balance of probabilities.

The instrument imposes no duties or rights in the ordinary sense of a regulatory law. Instead, it creates conditions precedent for the legal right to compensation or pension for GCA. The key right for a claimant is the ability to rely on a factor in section 9 to establish the connection between GCA and relevant service, without needing to prove a direct causal link from first principles. Once a factor is established and is related to service, the decision‑maker must accept that the disease is connected with service on the balance of probabilities, unless there is contrary evidence sufficient to displace that conclusion.

The mirror duty (or obligation) on the claimant is to prove the existence of at least one factor. Under section 9, the factor must exist before it can be said that GCA is connected with the circumstances of relevant service. This is not a presumption in favour of the claimant; it is a threshold that must be met. The standard of proof is the balance of probabilities, meaning it is more likely than not that the factor exists.

For factor (1) and (2), the claimant has a duty to provide evidence of smoking history: the number of pack‑years smoked before clinical onset or worsening, and the cessation date if applicable. The definition of one pack‑year is now precise (amended in 2022), so the calculation must be exact. The instrument does not specify what evidence is acceptable, but typical proof includes medical records, self‑reports corroborated by clinical notes, or documentary evidence from service records. The claimant also bears the onus of proving the timing of clinical onset or worsening relative to smoking cessation (within 20 years).

For factor (3), the claimant must show an inability to obtain appropriate clinical management for GCA. This factor does not require a specific event; it could arise from a lack of specialist availability during service, misdiagnosis, or system failures. The claimant must establish that the inability was related to relevant service, which may be easier to demonstrate if the service was in a remote location or during a period when GCA treatment standards were lower. However, the instrument does not define ‘appropriate clinical management’, so the decision‑maker has discretion to assess what was appropriate in the circumstances.

The RMA’s duty, under subsection 196B(3) of the VEA (the source of authority noted in section 3), is to ensure that the SoP is based on sound medical‑scientific evidence. The RMA must review and, if necessary, amend the SoP when evidence changes. The amendment of the pack‑year definition in 2022 is an example of that duty being exercised. The instrument itself invokes no further duties on the RMA; it is a one‑time determination.

The decision‑maker (the Repatriation Commission or MRCA delegate) has a duty to apply the SoP faithfully. If the instrument is inconsistent with other provisions of the VEA or MRCA, the SoP prevails on the factual question of connection, because it is a legislative instrument made under the Act. The decision‑maker also has a duty to consider the relationship between the factor and service under section 10. For factor (2) and (3), the decision‑maker must be satisfied that the GCA was suffered or contracted before or during (but did not arise out of) relevant service; that is a jurisdictional fact that must be established before those factors can be used.

There is no private right of action created by this instrument. It is purely an evidentiary rule within the veterans’ compensation system.

This instrument does not prescribe any penalties. It is a legislative instrument made under the VEA that sets out evidentiary rules; it does not create offences, impose fines, or provide for injunctions or other enforcement mechanisms. The only ‘penalty’ is the practical consequence of failing to meet the factors: a claim for compensation or pension for GCA will be rejected on the balance of probabilities. That is not a punishment in the criminal sense but a civil determination of eligibility.

Enforcement of the SoP is indirect. If the Repatriation Commission or other decision‑maker incorrectly applies the SoP (e.g. by accepting a factor that does not exist, or ignoring the 20‑year cessation window), the claimant may seek review by the Veterans’ Review Board or the Administrative Appeals Tribunal. If the decision‑maker fails to apply the SoP at all, the error may be corrected on appeal. However, the instrument itself contains no mechanism for the RMA or any other body to enforce compliance. The VEA contains its own enforcement provisions for fraud or misrepresentation in claims, but those are outside this instrument.

The only amendment history (the 2022 amendment) did not introduce any penalties; it merely clarified the calculation of pack‑years. There is no provision in the SoP for penalties against the RMA or officials for incorrect drafting or failure to update. Similarly, there are no penalties for a claimant who misrepresents their smoking history, though such misrepresentation could lead to civil or criminal consequences under the Criminal Code or the VEA’s provisions on false statements.

Because the SoP is a determination under subsection 196B(3), it has the force of law and binds all decision‑makers. Any decision that purports to grant a claim in the absence of any factor in section 9 (or without proper consideration of the relationship to service) would be ultra vires and subject to judicial review. Conversely, a decision that rejects a claim without considering a factor that is present could also be set aside. The enforcement of the SoP therefore relies on the ordinary administrative law mechanisms of merits review and judicial review, not on any penalty inherent in the instrument.

The instrument is made under subsection 196B(3) of the Veterans’ Entitlements Act 1986 (VEA), and it identifies in section 5 that it applies to claims under section 120B of the VEA and section 339 of the Military Rehabilitation and Compensation Act 2004 (MRCA). This creates a hierarchy: where a claim is for GCA and the claimant has relevant service as defined, this SoP overrides any general medical evidence about causation that might otherwise be considered. The decision‑maker must assess whether one of the three factors is present; if not, the claim fails regardless of other medical opinions. If a factor is present and related to service, the claim succeeds unless contrary evidence sufficiently undermines the factor.

Section 11 provides that if a factor in section 9 refers to an injury or disease covered by another SoP determined under subsection 196B(3), then the factors in that other SoP apply on the same terms. This is a cross‑reference mechanism. For example, factor (3) refers to “inability to obtain appropriate clinical management for giant cell arteritis”. That factor does not directly refer to another disease, so no cross‑reference is triggered. However, if a factor referred to, say, ‘pneumonia’ as a terminal event (which appears in the definition of terminal event), and there is a separate SoP for pneumonia, then the pneumonia SoP’s factors would need to be considered for the death‑from‑GCA chain. The instrument does not specify which other SoPs apply, leaving that to be identified on a case‑by‑case basis.

The definition of relevant service interacts with the VEA’s definitions of eligible war service, defence service, hazardous service, and British nuclear test defence service. The SoP excludes operational service (which is a different category under the VEA) and hazardous service and British nuclear test defence service under defence service provisions. This means a veteran who served in a theatre of war (operational service) cannot use this SoP; they would rely on a different set of SoPs for the reasonable hypothesis standard. Similarly, a veteran with hazardous service (e.g. certain peacekeeping missions) would use a different SoP or direct evidence.

The SoP also interacts with the VEA’s section 120B, which requires that a claim for a disease not listed in the statement of principles be determined on the balance of probabilities. If GCA were not covered by an SoP, the decision‑maker would have to consider all medical evidence to decide whether the disease is connected to service on the balance of probabilities. Because this SoP exists, it narrows the inquiry to the listed factors. This reduces the scope for expert medical disagreement but also imposes a rigid framework that may not account for unusual presentations.

The MRCA’s section 339 operates similarly, requiring that claims be determined in accordance with the applicable SoP. Section 5 of the instrument states it applies to claims under section 339 of the MRCA, but only for peacetime service (as per the relevant service definition). For MRCA members with warlike or non‑warlike service, different SoPs may apply.

The ICD‑10‑AM codes referenced (M31.5 and M31.6) are not binding definitions but are used for statistical and record‑keeping purposes. The instrument’s own definition prevails. If a later edition of ICD‑10‑AM reclassifies GCA, that change does not automatically affect this SoP; an amendment would be required. The instrument as compiled reflects the Tenth Edition effective 1 July 2017.

No conflict with other laws is apparent. The SoP is subordinate legislation under the VEA, and in case of inconsistency with the Act itself, the Act would prevail. However, the SoP is consistent with the VEA’s framework for disease‑specific determinations.

The instrument was originally registered on 4 January 2021 as F2021L00010 and commenced on 25 January 2021. Only one amendment has been made. The Veterans’ Entitlements (Statements of Principles,definition of “one pack‑year”) Amendment Determination 2022 (No. 94 of 2022), registered on 26 August 2022, commenced on 19 September 2022. This amendment affected three provisions: subsection 9(1) note, subsection 9(2) note, and the definition of one pack‑year in the Schedule 1 Dictionary. The notes were substituted to reflect the amended definition.

The primary effect of the amendment was to change how pack‑years are calculated and expressed. The original 2021 instrument may have had a different or less precise definition. The amendment introduced the equivalence of 7,300 grams of tobacco and the calculation formula (cigarettes per day ÷ 20 × years). It also added Note 1 clarifying the equivalent weight for pipe tobacco, cigars or combinations. Note 2 provides an example calculation. This change likely aimed to reduce disputes about what constitutes a pack‑year for non‑cigarette tobacco products, which had been a source of uncertainty. The amendment history in endnote 4 shows that section 2 and section 4 were repealed earlier (by LA s 48D and LA s 48C respectively) - these were likely placeholder or formal provisions that are now omitted from the compiled version. Section 2 (perhaps ‘Commencement’) and section 4 (perhaps ‘Repeal’) were removed in accordance with the Legislation Act 2003 provisions for self‑repealing clauses.

No further amendments are shown. The compilation date of 19 September 2022 suggests that the instrument is current as of that date. The endnote on uncommenced amendments states that there are none. The RMA has not produced a subsequent version, although it is possible that a new version exists but is not included in this compilation.

The amendment history is notable for being limited to a single, technical change. This suggests that the RMA considered the substantive factors (smoking threshold, clinical management) to be sound since 2021 and only adjusted the definition of pack‑years to improve precision. The 20‑year cessation window and the 10 pack‑year threshold have remained constant.

The source document does not mention any litigation history. There are no references to court cases, tribunal decisions, or judicial interpretations of this instrument. This is consistent with the nature of a Statement of Principles: it is a legislative instrument that is applied in administrative decisions rather than litigated directly. Challenges to decisions under the VEA or MRCA that rely on this SoP may occur in the Administrative Appeals Tribunal or the Federal Court on questions of law, but no such cases are recorded in the source.

The absence of litigation history does not mean the instrument is uncontroversial. Claimants may challenge decisions where a decision‑maker misapplies the definition of pack‑years, misinterprets “inability to obtain appropriate clinical management”, or fails to consider the 20‑year cessation window. However, without specific cases cited, one can only infer that the instrument’s clear language (especially after the 2022 amendment) has limited grounds for dispute.

The RMA itself is not subject to litigation for making the SoP, as it acts under statutory authority. Judicial review of the SoP itself would be limited to jurisdictional error or unreasonableness in the sense of Wednesbury unreasonableness, but such challenges are rare because the SoP is based on the RMA’s assessment of medical evidence, which is given wide discretion.

Practitioners should be aware that in the absence of reported decisions, the interpretation of ambiguous terms (e.g. “appropriate clinical management”) is left to decision‑makers in the first instance, with merits review available. The Veterans’ Review Board and the Administrative Appeals Tribunal may have issued unpublished decisions, but they are not binding precedent.

Several traps await the unwary claimant or advisor. First, the 20‑year cessation window in factors (1) and (2) is strict. If a person stopped smoking more than 20 years before clinical onset or worsening, those factors cannot be used, even if they smoked 50 pack‑years. The instrument does not provide any discretion to extend that window. This will catch long‑term ex‑smokers who develop GCA in their 70s or 80s after decades of abstinence.

Second, the pack‑year calculation is now precise and includes all tobacco products. A claimant who smoked 10 cigars a day for 20 years may not realise that 10 cigars of, say, 5 grams each equals 50 grams per day, which is equivalent to 50 cigarettes per day. Using the formula in the Dictionary, 50 cigarettes per day ÷ 20 = 2.5 pack‑years per year, so 20 years = 50 pack‑years. But if the adviser incorrectly calculates using only cigarette equivalents, the claim might be undervalued or missed. Conversely, a claimant who smoked a pipe occasionally may overestimate their consumption. The Note about 7,300 grams per pack‑year is the definitive conversion.

Third, factor (1) requires smoking before the clinical onset. If the onset occurs while the person is still smoking, the temporal requirement is satisfied as long as the 10 pack‑year threshold is reached before that date. But if the person later reduces smoking and the onset occurs after cessation, the 20‑year window must be met. The timing of clinical onset must be precisely documented. Many medical records may not specify the exact date of onset for a chronic autoimmune disease.

Fourth, factor (3) - inability to obtain appropriate clinical management - is a double‑edged sword. It does not require the person to have been denied care that would have prevented the worsening; it only requires an inability to obtain appropriate management. However, the factor applies only to material contribution or aggravation (subsection 10(2)), not to initial contraction. That means a person who never had GCA before service cannot use this factor to link the first occurrence to service, no matter how poor the medical care they received. This is a limitation that might surprise claimants who expect “inability to obtain clinical management” to cover any harm from service‑related medical gaps.

Fifth, the definition of relevant service excludes operational service, hazardous service, and British nuclear test defence service. A veteran who served in a combat zone (operational service) cannot use this SoP at all. They must rely on a different SoP (the reasonable hypothesis version) or direct evidence. Advisors who assume this SoP applies to all veterans will mislead their clients.

Sixth, section 11 cross‑references other SoPs. If a factor in section 9 refers to a disease that has its own SoP, that other SoP’s factors must be satisfied. This could create a chain of requirements. For example, the definition of terminal event includes pneumonia. If a claimant dies from pneumonia contributed to by GCA, and there is a separate SoP for pneumonia, the pneumonia SoP’s factors might need to be considered in determining whether the death is connected to service. The instrument does not spell this out explicitly, but the cross‑reference mechanism in section 11 suggests that approach.

Seventh, the instrument applies to claims under section 120B of the VEA and section 339 of the MRCA. Claimants under other provisions (e.g. for operational service under the VEA) are not covered. The SoP’s title includes “(Balance of Probabilities)” to distinguish it from a reasonable‑hypothesis version that may exist for other service types. Advisors must confirm which version applies.

Eighth, the note in subsection 7(2) lists examples of affected arteries but does not limit the definition. A claimant with atypical GCA affecting only the aorta but not cranial arteries might still qualify if it fits the description of systemic autoimmune vasculitis of large and medium arteries. But if a decision‑maker applies the examples restrictively, the claim could be refused. The instrument’s definition is broader than the examples, but in practice, decision‑makers may rely on the note.

Ninth, the instrument provides no guidance on what constitutes “appropriate clinical management”. This leaves room for inconsistency. Claimants with limited access to rheumatologists during service may succeed, but the decision‑maker may require evidence that the lack of access directly caused worsening of GCA. The mere fact that management was less than ideal may not be enough.

Tenth, the amendment in 2022 changed the pack‑year definition. Claims made between 25 January 2021 and 18 September 2022 using the original definition may have been assessed differently. The current compilation reflects the amended definition, so those earlier decisions might be reopened if the original definition was narrower or ambiguous.

Compliance is not a concept that applies to the instrument itself - it is a rule for decision‑makers, not a code of conduct for individuals. However, from the perspective of a claimant seeking to satisfy the factors, the following steps are necessary.

First, obtain a definitive medical diagnosis of giant cell arteritis that matches subsection 7(2). The diagnosis should specify involvement of large or medium arteries, particularly cranial branches. Ensure the treating doctor uses terminology consistent with the SoP’s definition, and if the ICD‑10‑AM code is assigned, confirm it is M31.5 or M31.6. For death claims, obtain a death certificate that identifies a terminal event (pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function) contributed to by GCA.

Second, document smoking history thoroughly. Calculate pack‑years using the formula in the Dictionary: (average cigarettes per day ÷ 20) × years smoked. For pipe tobacco or cigars, convert to grams and divide by 7,300 to get pack‑years. Obtain evidence of the smoking history, such as medical records with smoking status, service records (if smoking was documented), or sworn statements from the claimant or family. The claimant must be able to state when they started smoking, when they stopped (if applicable), and the average daily consumption.

Third, establish the timing of clinical onset (for factor (1)) or clinical worsening (for factor (2)). This requires medical records showing when symptoms first appeared or when significant deterioration occurred. If the claimant smoked, the onset or worsening must occur within 20 years of cessation. If the claimant is still smoking, the 20‑year window does not apply, but the smoking must precede the onset. A medical report linking the onset date to the smoking history is advisable.

Fourth, check whether the claimant’s service qualifies as relevant service under the Dictionary definition. If the claimant had operational service, hazardous service, or British nuclear test defence service, this SoP does not apply; use the appropriate other SoP. For peacetime service under the MRCA, confirm the member is covered.

Fifth, for factor (3) (inability to obtain appropriate clinical management), gather evidence of what clinical management was considered appropriate for GCA at the time of service, and why it was not obtained. This might include service medical records showing delayed referral, lack of specialist availability, or failure to diagnose. The claimant must show that the inability was related to service (e.g. remote postings, inadequate medical facilities). A medical expert may need to opine on what management was appropriate and how its absence contributed to worsening.

Sixth, for all factors, ensure the factor is related to service as required by section 10. For factor (1), the smoking must have occurred during or be attributable to service (e.g. smoking habits formed or worsened due to service conditions). For factor (2) and (3), the GCA must have been present before or during service but not caused by service, and the factor must contribute to material worsening. Evidence of pre‑existing GCA (e.g. medical records before enlistment) may be needed.

Seventh, if a factor refers to another disease covered by another SoP (section 11), consult that SoP and ensure its factors are also met. This is most likely to arise in death claims where the terminal event is a separate disease with its own SoP.

Eighth, prepare a written submission that identifies which factor or factors are satisfied, supported by documentary evidence. The claim must be lodged with the Repatriation Commission or MRCA delegate. If the initial decision is adverse, seek merits review by the Veterans’ Review Board or the Administrative Appeals Tribunal, where the same SoP will be applied.

Finally, note that the SoP does not require the claimant to prove that the factor directly caused GCA; it only requires the factor to exist and be related to service. Once that is established, the connection is presumed. Compliance therefore focuses on factual proof of the factor, not on medical causation beyond the factor’s existence.