Statement of Principles concerning myocarditis (Balance of Probabilities) (No. 18 of 2024)

The core legal concept in this instrument is the “factor” that must exist to establish a causal connection between myocarditis and relevant service. Each factor is a specified event, condition, exposure, or treatment that, according to the Repatriation Medical Authority’s assessment of medical‑scientific evidence, is sufficiently associated with the development or worsening of myocarditis. The existence of a factor alone is not enough: section 9(1) requires that the factor “must be related to the relevant service rendered by the person”. That linkage is a separate question, governed by the VEA and MRCA definitions of “relevant service”.

The standard of proof is the balance of probabilities, as indicated by the title of the instrument. This is the civil standard (more likely than not). The instrument’s authority is explicitly under subsection 196B(3) of the VEA, which allows the Authority to determine SoPs for the balance of probabilities standard. The Authority’s view, expressed in section 7, is that there is sound medical‑scientific evidence supporting the potential for a connection. That view is not a finding of fact in any individual claim; it is a legislative determination that the claims decision‑maker must apply.

“Clinical onset” and “clinical worsening” are crucial temporal concepts. Most factors require that they occur before or at the time of clinical onset or clinical worsening. For example, factor (3) requires a systemic viral infection within the 4 weeks before clinical onset or clinical worsening. Factor (13) requires treatment with a listed medication within the 3 months before onset or worsening. Factor (16) requires a COVID‑19 mRNA vaccine within the 4 weeks before onset or worsening. These temporal windows vary from 24 hours (envenomation by scorpion, wasp, etc.) to 4 years (haematopoietic stem cell transplant). Factor (10) (cardiac graft acute cellular rejection) applies only “at the time of clinical onset”, not worsening. Factor (14) (clozapine) uses a 2‑year window. The temporal precision is a critical feature: a claimant could have the relevant exposure but, if it falls outside the specified window, the factor is not satisfied.

The instrument also defines “myocarditis” in subsection 6(2) as inflammation of the heart muscle (myocardium) that excludes inflammation associated with coronary artery disease. This exclusion is medically important because coronary artery disease is common in veteran populations and its inflammatory component (e.g., post‑infarction pericarditis) is not considered myocarditis for purposes of this SoP. The ICD‑10‑AM codes listed (I40, I41, I01.2, I09.0, I51.4) are referenced only for classification; the operative definition is the textual one.

Terminal event is defined in the dictionary to include pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function. This definition allows the SoP to cover death where myocarditis contributed to such an event.

“Relevant service” as defined in the dictionary is limited: eligible war service (other than operational service) under the VEA, defence service (other than hazardous service and British nuclear test defence service) under the VEA, or peacetime service under the MRCA. This means the SoP does not apply to operational service (which uses a different standard) or to hazardous service or British nuclear test defence service. Claimants who served in combat zones or under those other categories will have their myocarditis claims assessed under the reasonable hypothesis standard using a different SoP (likely an earlier instrument or one specifically for the reasonable hypothesis standard).

A further concept is the incorporation of other SoPs. Section 10 provides that if a factor in section 8 refers to a disease or injury for which another SoP has been determined under subsection 196B(3) of the VEA, then the factors in that other SoP apply according to its terms as in force from time to time. For example, factor (3) refers to “having a systemic viral infection”. If the claimant has a viral infection that is itself a disease covered by its own SoP (e.g., for myocarditis? Actually unlikely; but for other conditions), the criteria of that SoP must be met. This creates a chain of causation that may require multiple SoPs to be consulted.

The primary persons affected are veterans and members of the Australian Defence Force who have rendered “relevant service” as defined. Specifically, persons who served in peacetime (MRCA), as well as those who rendered eligible war service (other than operational service) or defence service (other than hazardous or British nuclear test) under the VEA. The SoP does not apply to those who rendered operational service (active service in wartime or warlike operations) for VEA claims, nor to those whose service is classified as hazardous service or British nuclear test defence service. The separation between operational and non‑operational service is a feature of the VEA that allocates different standards of proof. This instrument only governs the balance of probabilities standard.

Dependants of such veterans and members may also be affected if they claim compensation under the VEA or MRCA in relation to the veteran’s death from myocarditis. The definition of death from myocarditis in subsection 6(5) includes death from a terminal event contributed to by myocarditis, so a claim for dependants’ benefits would be assessed using this SoP.

Decision‑makers in the Department of Veterans’ Affairs (DVA) are directly affected. They must apply the SoP when determining whether myocarditis is causally connected to a claimant’s relevant service. The SoP binds them: if a factor is established and related to service, the decision‑maker must accept the connection on causation. Similarly, the Veterans’ Review Board (VRB) and the Administrative Appeals Tribunal (AAT) must apply the SoP. Medical advisers and independent medical examiners providing opinions for these claims must be familiar with the factor list and the temporal requirements.

Legal practitioners and advocates representing veterans before DVA and the VRB must understand the SoP to structure their submissions. They need to identify which factor(s) might apply, gather evidence on clinical onset and worsening dates, and show that the factor was related to service. For example, if a veteran developed myocarditis after a COVID‑19 mRNA vaccine received during a period of relevant service, factor (16) may be invoked, provided the vaccine was given within 4 weeks of clinical onset. The advocate must also prove the vaccine was administered in the course of service (e.g., a defence‑mandated vaccination).

Medical professionals who diagnose and report on myocarditis are affected indirectly. They may be asked to date clinical onset and worsening, confirm the presence of a listed infection or treatment, and exclude coronary artery disease as the cause of inflammation. The exclusion in subsection 6(2) means a diagnosis of “myocarditis” in the context of a myocardial infarction may not fall within the SoP’s definition, which could lead to claim denial.

The Repatriation Medical Authority itself is the body that issues and may later amend or revoke this instrument. It must maintain the SoP based on evolving medical‑scientific evidence. The Authority is not affected by compliance burdens, but its determinations have direct fiscal and administrative consequences for the DVA claims system.

Finally, taxpayers bear the ultimate cost. If the SoP causes more claims to succeed, the compensation payments arise from consolidated revenue. The SoP expands the range of recognised causal pathways compared to a narrower list, potentially increasing liability.

The Statement of Principles does not impose enforceable duties on claimants or any private party. Its legal effect is to create an evidentiary standard that the decision‑maker must apply. In that sense, the “duty” lies on the decision‑maker. Section 120B of the VEA and section 339 of the MRCA require that, when the balance of probabilities standard applies, the decision‑maker must determine claims in accordance with any relevant SoP. This duty is non‑discretionary: if a factor in section 8 exists and is related to service, the decision‑maker must find a causal connection, provided no contrary medical evidence overrides the SoP (but in practice, the SoP is conclusive on causation as a matter of law).

Claimants have the right to have their claims assessed under this SoP. They also bear the practical onus of proving that at least one factor exists and that it is related to service. The SoP itself does not shift the legal burden of proof, but it structures the evidence required. The claimant must produce medical evidence of clinical onset (the date when the condition first became symptomatic or diagnosable) and, for worsening claims, evidence of material aggravation after the start of service.

If a claimant cannot satisfy any factor, the claim will fail on causation, even if there is some other plausible causal pathway not listed. The SoP is exhaustive: the factors are the only recognised means of proving a causal connection under the balance of probabilities standard for this condition. The instrument contains no savings clause allowing other causes not listed to be considered. This is a deliberate feature: the Repatriation Medical Authority has determined that only these factors are supported by “sound medical‑scientific evidence” to the required standard. Claimants cannot argue that their myocarditis was caused by, say, an environmental toxin not listed unless that toxin falls within one of the factors (e.g., organophosphate poisoning - factor 22, or chronic lead poisoning - factor 23).

Section 9(2) clarifies that the clinical worsening aspects of factors apply only to “material contribution to, or aggravation of, myocarditis where the person’s myocarditis was suffered or contracted before or during (but did not arise out of) the person’s relevant service.” This means that if a person already had myocarditis before rendering relevant service (or contracted it during service but not as a result of service), the factor may still be used to show that service worsened the condition, provided the factor occurred after the initial onset and contributed materially.

There is no right to opt out of the SoP. Claimants whose service is not “relevant service” (e.g., operational service claims) are not covered; they will be assessed under the reasonable hypothesis SoP for myocarditis. That potential inconsistency between the two standards is a consequence of the dual‑track system in the VEA.

This SoP contains no penalties. It is a determinative tool for claims, not a regulatory instrument with compliance obligations. There is no fine, imprisonment, or civil penalty for failing to comply with any provision. The “enforcement” of the SoP occurs through the claims determination process. If a decision‑maker fails to apply the SoP, that decision may be appealed to the VRB or AAT, and if upheld, the matter could be remitted for reconsideration in line with the SoP. In extreme cases, a pattern of non‑application could lead to judicial review in the Federal Court, but that is a remedy under administrative law, not a penalty under the instrument.

The Repatriation Medical Authority could theoretically revoke or amend the SoP if it considers that the medical‑scientific evidence no longer supports the factors. That is not a penalty but a routine legislative function. Similarly, the Authority may issue a new SoP that supersedes this one. The instrument itself contains no sunset clause or review date, but as a matter of practice the RMA reviews SoPs periodically.

The only risk to a claimant is that if they make a false statement in relation to a factor, they may be subject to the criminal provisions of the VEA or the Criminal Code (e.g., obtaining a financial advantage by deception). But that is not a penalty created by this SoP.

For practitioners, there is no penalty for misinterpreting the SoP, though professional standards bodies may take an interest if an advocates grossly misadvises a client. But again, that is external.

The SoP is made under subsection 196B(3) of the VEA. That provision gives the Repatriation Medical Authority power to determine statements of principles for the balance of probabilities standard. The instrument explicitly applies to claims under section 120B of the VEA and section 339 of the MRCA. It therefore operates within the framework of those two Acts.

Under the VEA, the balance of probabilities standard applies to claims for “eligible war service” (other than operational service) and “defence service” (other than hazardous service and British nuclear test defence service). Operational service claims use a different standard (reasonable hypothesis) and are governed by a separate SoP (determined under subsection 196B(2) of the VEA). Thus, a veteran who served in both operational and non‑operational periods may have different SoPs applied depending on which period is the basis of the claim. The distinction is crucial: the same medical evidence could lead to different outcomes based solely on the type of service.

The SoP also interacts with other Statements of Principles via section 10. If a factor in section 8 refers to a disease or injury for which there is an existing SoP under subsection 196B(3), that SoP must be consulted. For example, factor (3) refers to “having a systemic viral infection”. While there may not be a specific SoP for “viral infection” per se, there are SoPs for conditions such as hepatitis C, HIV (factor 4), or tuberculosis (factor 5). The note indicates that the definition of the factor may incorporate the criteria of its own SoP. This prevents fragmentation: the decision‑maker does not need to independently determine what constitutes “tuberculosis” - the SoP for tuberculosis will define it.

The instrument incorporates the ICD‑10‑AM classification (Tenth Edition, 2017) for coding purposes, but the actual definition of myocarditis is the textual one in subsection 6(2). This means that even if a medical record lists an ICD‑10 code for myocarditis, the decision‑maker must still confirm that the condition meets the exclusion for coronary artery disease. Conversely, a condition coded as I41 (myocarditis in diseases classified elsewhere) may or may not qualify depending on the underlying cause.

The dictionary defines “relevant service” by reference to the VEA and MRCA. The concepts of “eligible war service”, “defence service”, “peacetime service”, “operational service”, “hazardous service”, and “British nuclear test defence service” are all defined in those Acts. The SoP does not modify those definitions. Practitioners must cross‑refer.

The public service legislation that governs DVA decision‑making (the Public Service Act 1999) is not directly relevant, but the SoP interacts with the Veterans’ Entitlements (Transitional Provisions and Consequential Amendments) Act 1986 and the Military Rehabilitation and Compensation (Consequential and Transitional Provisions) Act 2004. These transitional provisions may affect claims that straddle the commencement of this SoP.

The instrument is titled “Statement of Principles concerning myocarditis (Balance of Probabilities) (No. 18 of 2024)”. It was made on 22 February 2024 and commences on 26 March 2024. Its number (18 of 2024) suggests it is the 18th SoP made in 2024, but there is no indication that it replaces a prior instrument. The Repatriation Medical Authority periodically issues new SoPs that revoke and replace earlier versions, but this instrument does not contain a revocation clause. It is possible that the previous SoP for myocarditis (balance of probabilities) was revoked by a separate instrument or that the Authority considered this to be an entirely new determination. Without an express reference, we cannot state that it supersedes a specific predecessor.

The legislative basis (subsection 196B(3) of the VEA) has been in place since amendments in 1994. The SoP is a disallowable legislative instrument under the Legislation Act 2003, meaning it is subject to tabling and possible disallowance by either House of Parliament within 15 sitting days. No indication of disallowance exists in the instrument itself.

The Authority may amend the SoP at any time if the medical‑scientific evidence changes. Any future amendment would be made by a new instrument, which would likely reference that it revokes and replaces this one. The instrument provides no automatic review date, but the Authority has a practice of reviewing SoPs periodically, often every few years, when new treatments or epidemiological data emerge.

The dictionary definitions may change if the underlying Acts are amended. For example, if the VEA were amended to redefine “relevant service”, that change would flow through to this SoP because the SoP uses the terms as defined in the VEA. No amendment history is recorded in the instrument.

The instrument itself contains no mention of any litigation history. It is a legislative instrument, not a court decision. However, Statements of Principles generally have been the subject of litigation in the Federal Court and the AAT, particularly regarding the validity of factors and the application of the standard of proof. Cases have challenged whether a factor is supported by “sound medical‑scientific evidence”, but those challenges typically involve the Reasonable Hypothesis SoPs (under subsection 196B(2)) because the standard of proof is different. The balance of probabilities SoPs have been less litigated, but decisions exist.

Notable relevant cases may include Repatriation Commission v Gorton (2002) 192 ALR 599 and Repatriation Commission v Hancock (2003) 37 AAR 383, which dealt with SoP interpretation, but those are not referenced in this instrument. The instrument is silent, so we cannot discuss any particular case.

Given that this instrument is new (commenced March 2024), there has been little time for litigation specific to it. Any litigation would likely arise from disappointed claimants arguing that a factor should have been satisfied, or that the temporal window was incorrectly applied, or that the exclusion of coronary artery disease inflammation was improperly used. AAT decisions involving this SoP may emerge in 2025 and later.

The instrument should be read in light of the high‑profile debate about COVID‑19 mRNA vaccines and myocarditis. Factor (16) is likely to be a contested point: claimants will argue that a vaccine received in the context of service (e.g., a Defence‑mandated vaccination) caused their myocarditis. The DVA may argue that the temporal window (4 weeks) is not met, or that the vaccine was not related to service (e.g., if received on leave). Expect litigation on the interpretation of “related to the relevant service” in section 9(1) for vaccines administered by a civilian provider.

Several provisions in this instrument can easily trip up claimants and practitioners.

First, the definition of myocarditis excludes inflammation associated with coronary artery disease. This is a medical fine line. A veteran who has a heart attack complicated by pericarditis (which may clinically resemble myocarditis) will not qualify under this SoP if the inflammation is judged to be associated with coronary artery disease. The decision‑maker may require a cardiac MRI or endomyocardial biopsy report specifically stating myocarditis and excluding ischaemic aetiology. Without such evidence, the claim may fail.

Second, the temporal windows are strict. Factor (3) requires a systemic viral infection within 4 weeks before clinical onset. If the viral infection occurred 5 weeks before, it is not sufficient. Factor (16) uses the same 4‑week window for COVID‑19 mRNA vaccines. Factor (13) uses a 3‑month window for medications. Factor (14) uses a 2‑year window for clozapine. Factor (19) (scorpion, wasp, bee envenomation) uses a 24‑hour window. Factor (20) (brown recluse spider) uses one week. A single day outside the window means the factor is not established.

Third, factor (10) (cardiac graft acute cellular rejection) applies only “at the time of clinical onset” - it does not cover worsening. This is unusual; most factors apply to both clinical onset and clinical worsening. If a person already had myocarditis and later received a heart transplant and experienced graft rejection, that rejection could worsen the myocarditis only if the rejection occurred “at the time of clinical onset”? That is impossible, as onset is before. So factor (10) is essentially only for new cases of myocarditis caused by rejection.

Fourth, factor (15) is a catch‑all for medications not explicitly listed, but it requires that the medication was “associated in the individual with the clinical onset of myocarditis during medication therapy” and that symptoms increased during therapy and ceased within weeks of discontinuing. This is a demanding burden: the claimant must show a temporal association with dechallenge, and that the medication was taken for at least 7 days. The factor does not list the specific medication, so the claimant must prove the association through medical literature or a specialist opinion.

Fifth, factor (25) is “inability to obtain appropriate clinical management for myocarditis before clinical worsening”. This factor only applies to worsening, not to initial onset. It requires that the inability to obtain appropriate clinical management contributed to worsening. The phrase “inability to obtain” may be interpreted as a barrier beyond the claimant’s control, but the SoP does not define it. A veteran who refused treatment or failed to attend appointments may not qualify.

Sixth, the instrument does not allow for cumulative factors. Only one factor need exist, but if a claimant has multiple partial factors, none of which satisfies all elements of a single factor, the claim will fail. For example, if a claimant had a viral infection 5 weeks before onset and was on a non‑listed medication for 2 days, neither factor is satisfied.

Seventh, the exclusion of “relevant service” for operational service, hazardous service, and British nuclear test defence service means that a veteran who only had operational service cannot use this SoP. Their claim will be assessed under the Reasonable Hypothesis SoP (likely a different instrument). A veteran with mixed service must identify which period of service is being relied upon and ensure that the service is “relevant” as defined.

Eighth, section 10 incorporates other SoPs by reference. If the factor refers to a disease like tuberculosis, the claimant must also satisfy the SoP for tuberculosis (balance of probabilities). That SoP may have its own difficult factors. This creates a cascading burden of proof.

Ninth, the dictionary defines “terminal event” narrowly. Only the listed conditions (pneumonia, respiratory failure, cardiac arrest, circulatory failure, cessation of brain function) qualify. If the person died from, say, a pulmonary embolism or suicide that was contributed to by myocarditis, that would not be a terminal event under this SoP unless it falls within one of the five categories. The decision‑maker may argue that the death is not “from myocarditis” as defined.

This instrument imposes no direct compliance obligations on individuals or businesses. Instead, compliance is about correctly applying the SoP in claims for compensation.

For claimants (veterans or their dependants), compliance means ensuring that the claim is supported by medical evidence that addresses the factors in section 8. The first step is to secure a diagnosis of myocarditis that meets the definition: inflammation of the myocardium not associated with coronary artery disease. A cardiologist’s report should expressly state the diagnosis and rule out ischaemic causes. If the ICD‑10 code is I40, I41, I01.2, I09.0, or I51.4, that may be helpful but is not conclusive.

Next, the claimant must identify the relevant factor or factors that apply. This requires a careful history of exposures during the relevant service period. For example, if the myocarditis occurred in a veteran who was prescribed an immune checkpoint inhibitor for cancer treatment while in service, factor (13)(g) may apply. The medical evidence must show the treatment occurred within 3 months before clinical onset. The claimant should also provide evidence that the medication was related to service (e.g., prescribed by a military medical officer or while on duty).

Temporal evidence is critical. The clinical onset date should be established: the date when symptoms first appeared or when the condition was first diagnosed. All relevant dates (vaccination, infection, medication start, envenomation, etc.) must be documented and compared to the onset date. If the interval is marginal, a specialist opinion may be needed to argue that the onset date can be fixed more precisely.

For factor (16) (COVID‑19 mRNA vaccine), the claimant must also show that the vaccine was administered in connection with service. If the veteran received the vaccine as part of a Defence Force‑directed program, that is likely sufficient. However, if the vaccine was obtained privately, the relation to service may be harder to establish; section 9(1) requires the factor to be “related to the relevant service”. The DVA may argue that a vaccine received while on leave at a local pharmacy, even if during service, is not sufficiently related. The claimant should gather orders, appointment records, or service records that link the vaccination to military requirements.

For factor (25) (inability to obtain appropriate clinical management for worsening), the claimant must show that there was a material worsening of myocarditis due to a lack of access to care. This requires evidence of missed or delayed treatment, such as a failure to provide immunosuppressive therapy, and a causal link to the worsening. This factor may be used if the veteran was in a remote posting or had administrative barriers to care.

Decision‑makers within DVA must comply with the SoP by applying it strictly. They should not consider factors not listed. They must ensure that each element of a factor is satisfied, including the temporal relationship. Where a factor refers to another SoP (e.g., tuberculosis), they must consult that SoP and verify its requirements. Decision‑makers should also document their reasoning, showing which factor was relied upon and how it was related to service.

Medical practitioners providing reports for claim purposes should be familiar with the SoP’s definitions and temporal windows. They should give precise date estimates for clinical onset and worsening, and state whether the condition meets the definition of myocarditis (excluding coronary artery disease). For medication‑associated myocarditis (factor 15), the practitioner should document the dechallenge response (symptom improvement after stopping the drug) and rechallenge if applicable.

Legal practitioners should advise claimants to gather evidence early, including service records showing exposure to specific factors. The absence of contemporaneous records for a viral infection can be fatal, as the temporal window is tight. Claimants may need sworn statements from witnesses about symptoms and dates.

The overall compliance burden is not regulatory but evidentiary. The SoP channels the inquiry into 25 specific pathways. It reduces discretion but increases the need for detailed and timely documentation.