Statement of Principles concerning pericarditis (Balance of Probabilities) (No. 91 of 2023)

Understanding this SoP requires grasping several statutory and medical concepts. First, 'pericarditis' is defined in subsection 6(2) as 'an inflammation of the pericardium' and includes acute, chronic, recurrent, and constrictive pericarditis. It excludes haemorrhage from pericardial injury not associated with inflammation. The instrument cites ICD-10-AM codes I30, I31.0, I31.1, I01.0, and I09.2, but the definition in subsection (2) controls over those codes. This is important because a diagnosis that falls within those codes but does not meet the definition (e.g., a traumatic pericardial effusion without inflammation) would not be covered.

Second, 'relevant service' is defined in Schedule 1 as: (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 explicitly excludes operational service and hazardous service under the VEA and warlike/non-warlike service under the MRCA for which the reasonable hypothesis standard applies. The distinction matters because the same SoP cannot be used for all types of service; a claimant with operational service would need a different SoP (or would need to rely on the reasonable hypothesis standard without the SoP's restrictions, though in practice the RMA issues separate SoPs for each standard).

Third, the factor list in section 8 is the core of the instrument. Each factor is a medical event, exposure, or treatment that the RMA considers sufficient on the balance of probabilities to connect pericarditis to service. The factors range from immediate causes (e.g., having a systemic viral infection within four weeks before clinical onset - factor 10) to longer latency exposures (e.g., inhaling respirable asbestos fibres for a cumulative period of at least 1,500 hours in an enclosed space with at least 10 years since first exposure - factor 31). Factor 33 is unique: 'inability to obtain appropriate clinical management for pericarditis before the clinical worsening of pericarditis'. This allows aggravation claims even where the original onset was not service-related, provided the inability to obtain treatment was due to service.

Fourth, 'clinical onset' and 'clinical worsening' are not defined in the SoP but are terms of art in veterans' law. The factors refer to both, and subsection 9(2) clarifies that the clinical worsening aspects apply only to material contribution to or aggravation of pericarditis where the pericarditis was suffered or contracted before or during (but did not arise out of) the person's relevant service. This preserves claims for aggravation of pre-existing pericarditis by service.

The primary class of persons affected are veterans and members of the Australian Defence Force who have rendered relevant service as defined - that is, eligible war service (non-operational), defence service (non-hazardous), and peacetime service under the MRCA - and who develop pericarditis. Dependants of such persons making a claim for death from pericarditis are also affected, because subsection 6(5) includes death from a terminal event contributed to by pericarditis. 'Terminal event' is defined in Schedule 1 as including pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function.

Decision-makers in the Department of Veterans' Affairs and the Military Rehabilitation and Compensation Commission are directly affected because they must apply this SoP when determining claims under the relevant provisions. The SoP is binding on them: if a factor exists and is related to service, they must find the condition is service-related (subject to any other requirements of the VEA or MRCA). If no factor exists, they must still consider other medical evidence but the RMA has effectively declared that the factors exhaust the known causal pathways on balance of probabilities, so a successful claim without a factor is unlikely.

Medical practitioners who provide reports for claims are indirectly affected. They may be asked to opine on whether a claimant has or had pericarditis as defined, whether any of the 33 factors existed, and whether those factors were related to service. The SoP provides a checklist that can streamline expert evidence but also can limit clinical discretion. For example, a doctor might believe that a particular drug not listed in the 'specified list' caused pericarditis in their patient, but factor 26 only covers drugs on that list. Factor 27 covers any drug if the individual shows improvement on discontinuation and redevelopment on rechallenge, but that requires specific documentation that may not exist.

The legal profession representing veterans is also affected. Practitioners must be familiar with the factor list to advise whether a claim is viable. The structure encourages early identification of which factor or factors apply. There is also an impact on the tribunal (the Veterans' Review Board and the Administrative Appeals Tribunal) and the courts if appeals occur, because the SoP frames the issues narrowly.

Private enterprise is not directly regulated by this instrument, but the cost of compensation is ultimately borne by taxpayers. The SoP does not impose compliance burdens on businesses; it is a claims-processing tool. However, to the extent that the factor list includes occupational asbestos exposure (factors 30-32), it may indirectly affect employers and insurers in historical contexts, but only through the veteran's service record.

The SoP does not create new duties or rights in the usual sense of a statute. Instead, it modifies the existing claim determination process. The relevant duty falls on the decision-maker: when assessing a claim to which section 120B of the VEA or section 339 of the MRCA applies, the decision-maker must apply this SoP if the condition is pericarditis. They must check whether any factor in section 8 exists, and then whether that factor is related to the person's relevant service as required by section 9. If both criteria are satisfied, the decision-maker must accept that the pericarditis is service-related, unless some other provision of the VEA or MRCA overrides.

The claimant's right is to have their claim determined in accordance with the SoP. This is a procedural right coupled with a substantive benefit: the SoP makes it easier to prove service connection because the RMA has already made the causal determination. The claimant does not have to prove general causation; they only have to prove that a listed factor existed and that it arose out of service. For example, a claimant who had open heart surgery within 20 years before clinical onset and who had that surgery as part of treatment for a service-related condition would satisfy factor 1. The claimant does not need to call medical experts to explain why open heart surgery causes pericarditis; the SoP deems that causal link established.

The SoP also creates a right to rely on a factor that refers to 'having' a condition (e.g., factor 7: having a peptic ulcer that erodes the pericardium). The definition of terms like 'having' is not spelled out in the SoP itself, but case law under the VEA generally requires that the condition be clinically diagnosed. Claimants should obtain corroborating medical evidence.

The SoP does not impose duties on claimants to disclose any particular information beyond that already required under the VEA or MRCA. However, strategically, a claimant has a duty to raise all possible factors to maximise chances of success. If a factor is missed and not put before the decision-maker, the claim might be rejected even if another factor existed but was not identified. There is an implicit duty on the decision-maker to consider all factors if raised by the evidence, but they are not required to speculate.

The clinical worsening aspects impose a nuance: if the pericarditis pre-existed service, the claimant must show that the factor contributed to worsening, and that the worsening was due to service. Factor 33 (inability to obtain appropriate clinical management) is specifically designed for aggravation claims and requires a temporal connection: the inability to obtain treatment must occur before the worsening.

This instrument does not contain penalty provisions. Enforcement is not a concept that applies directly to a Statement of Principles. The SoP is a legislative instrument that sets out the framework for deciding claims; it does not impose obligations on private persons that can be breached. Therefore, there are no fines, criminal penalties, or infringement notices.

However, there are indirect enforcement consequences. If a decision-maker fails to apply the SoP correctly, a claimant can seek review of the decision. If the decision-maker incorrectly refuses to accept that a factor exists, or incorrectly finds that the factor is not related to service, the claimant can appeal to the Veterans' Review Board, then to the Administrative Appeals Tribunal, and ultimately to the Federal Court on a question of law. The enforcement mechanism is the standard administrative review process under the VEA and the MRCA, not any special power in the SoP.

Similarly, if a claimant fraudulently asserts a factor that does not exist, that could lead to prosecution under the general criminal law for making false statements to obtain a benefit. But the SoP itself does not address that. The burden of proof is on the claimant, but the standard is only balance of probabilities, so a mere assertion without evidence may be rejected, but it is not a penalty.

The lack of penalties is a notable feature of SoPs. They are designed to guide decision-making and to provide certainty, not to enforce compliance. The real cost of non-compliance is that a claim may be wrongly granted or wrongly denied. If wrongly granted, public money is paid out. If wrongly denied, the claimant may suffer financial hardship until review corrects the error. The SoP attempts to minimise both errors by reducing discretion, but it cannot eliminate all error.

The SoP is made under the VEA and also applies to claims under the MRCA by virtue of its application provision (section 4). It interacts directly with the primary Acts. The key interaction is with sections 120B of the VEA and 339 of the MRCA, which set out the standard of proof for claims involving non-operational service. Those sections require that the RMA determine Statements of Principles for injuries and diseases, and that decision-makers must apply them. Therefore, this SoP overrides any general medical evidence that might suggest a causal link different from the listed factors. The SoP is binding, not merely advisory.

Section 10 of the SoP provides for interaction with other SoPs: if a factor in section 8 refers to an injury or disease for which another SoP has been determined under subsection 196B(3) of the VEA, then that other SoP applies to determine whether the factor exists. For example, factor 18 requires 'having a myocardial infarction within the 4 weeks before the clinical onset or clinical worsening of pericarditis'. Myocardial infarction is itself a disease for which there is an SoP. The decision-maker must then apply the myocardial infarction SoP to determine whether the person 'had' a myocardial infarction in the sense required by that SoP. This creates a chain of SoPs that can complicate claims where multiple conditions are involved.

The SoP also interacts with the general provisions of the VEA and MRCA regarding eligibility for pension or compensation. For example, it does not affect the requirements that the claimant be a veteran or member, that the condition be permanent if seeking a disability pension, or that the claim be lodged within time limits. Those remain governed by the primary legislation.

There is no interaction with common law torts because the VEA and MRCA are no-fault compensation schemes that preclude common law claims for service-related conditions against the Commonwealth. The SoP operates within that exclusive statutory framework.

The SoP may interact with state or territory workers' compensation laws if a person has both service and civilian exposure, but that interaction is handled by the VEA and MRCA themselves, not by this instrument. The SoP only addresses the service connection, not whether civilian factors might also have contributed.

The instrument itself provides no amendment history. It is a standalone instrument (No. 91 of 2023) that commenced on 28 November 2023. It does not state which previous SoP it revokes or replaces. However, section 196B of the VEA requires that SoPs be reviewed and determined from time to time, so earlier SoPs on pericarditis would have been in force before this one. The RMA typically revokes the previous SoP when a new one is made, but the revocation is not mentioned in this instrument. A researcher would need to check the Federal Register of Legislation for the previous SoP (likely "Statement of Principles concerning Pericarditis (Balance of Probabilities) No. X of 2020" or similar) and for the revocation instrument.

The absence of explicit amendment history in the instrument is a practical gotcha: a practitioner relying on this SoP must ensure they have the current version. The commencement date (28 November 2023) means that claims determined before that date are governed by the earlier SoP, unless the new one is found to be retrospective - which it is not, as it says it commences on that date.

The Schedule 1 definitions are substantive and could change over time. For example, the list of "drug from the specified list" includes various drugs and could be updated as medical evidence changes. The RMA might also add or remove factors in section 8. The amendment history is a matter of tracking by the RMA, not contained in this document.

There is no litigation history contained in this instrument. The SoP itself does not cite any court or tribunal decisions. However, practitioners should be aware that the validity of the RMA's factors can be challenged on grounds such as that the factor is not based on sound medical-scientific evidence or that the RMA acted beyond power. Such challenges are rare because the RMA is composed of medical experts and the courts give significant deference to its determinations. There has been litigation on other SoPs, such as whether the RMA has to consider all relevant medical evidence and whether it can exclude certain causal pathways. The High Court in Repatriation Commission v Vietnam Veterans' Association of Australia (2009) confirmed the RMA's wide discretion. But that case is not specific to this SoP.

For pericarditis specifically, there may be tribunal decisions applying the previous SoP, but they are not binding and are merely persuasive. The SoP is designed to minimise litigation by providing clear factors, but disputes inevitably arise over whether a factor is 'present' and whether it is 'related to service'. For instance, factor 10 requires 'having a systemic viral infection within the 4 weeks before the clinical onset or clinical worsening'. The meaning of 'systemic viral infection' could be contested: does a common cold qualify? Probably not, but there is no definition. The tribunal might have to interpret it.

Factor 28 (COVID-19 mRNA vaccine within 4 weeks) is almost certain to generate disputes, given the controversy around vaccine injuries. Claimants may argue that receiving a vaccine during service is related to service, but the relationship to service may be weak if the vaccine was not mandated. The SoP does not require that the vaccine be service-mandated; it only requires that the factor (receiving the vaccine) be related to service. If a veteran received the vaccine while on defence service, that fact itself may satisfy the relationship because it occurred during service. That interpretation could lead to many claims.

Several traps lie in the wording. First, the definition of pericarditis in subsection 6(2) excludes haemorrhage from pericardial injury not associated with inflammation. A person who has a traumatic haemopericardium without pericarditis is not covered, even if the ICD code would suggest otherwise. Decision-makers must look past the diagnosis code to the clinical definition.

Second, the relationship to service requirement in section 9 is not automatically satisfied just because the factor existed. The factor must be 'related to the relevant service rendered by the person'. For example, factor 1: having open heart surgery within 20 years. If the veteran had open heart surgery for a congenital condition that predates service, and the surgery was performed at a civilian hospital not as a result of service, then the factor is present but not related to service. The claimant must show that the factor itself arose out of service. This is a separate hurdle.

Third, factor 27 (drug not on specified list) is often overlooked. It requires both improvement within one month of discontinuing or tapering and redevelopment on rechallenge. That is a high evidentiary bar. Many adverse drug reactions are not rechallenged for safety reasons, so factor 27 will rarely be satisfied. Claimants should not assume any drug can qualify.

Fourth, factor 33 (inability to obtain appropriate clinical management) is a catch-all but requires that the inability to obtain treatment occurred before the worsening. If a veteran developed pericarditis while on peacetime service and the treatment was delayed because of service requirements, that might count. But if the veteran simply did not seek treatment, it is not 'inability to obtain' - there must be some external barrier related to service.

Fifth, the asbestos exposure factors (31 and 32) require cumulative hours and a 10-year latency. This is a very specific threshold. The claimant must prove not just exposure, but the cumulative duration. That may be almost impossible without detailed work records. The note says disturbance of debris or dust already present may result in exposure, but the burden of proof remains on the claimant.

Sixth, the drug specified list is long but not exhaustive. Some drugs known to cause pericarditis, such as certain chemotherapeutic agents, are listed (e.g., anthracyclines, 5-fluorouracil, immune checkpoint inhibitors). But others may not be. Factor 27 might help, but as noted it is hard to prove.

Seventh, the SoP covers death from pericarditis only if the terminal event was contributed to by pericarditis. That requires a causal chain. If a veteran with pericarditis dies of an unrelated cause, the claim fails.

For a claimant, compliance means filing a claim that identifies at least one factor from section 8 and provides evidence that the factor existed and is related to service. The first step is to obtain a medical diagnosis of pericarditis that meets the definition in subsection 6(2). The doctor should specify whether the pericarditis is acute, chronic, recurrent, or constrictive. An ICD-10-AM code alone is insufficient; the narrative must confirm inflammation.

Second, the claimant must review the factor list and determine which factors could apply. This often requires a careful medical history. For example, was there recent open heart surgery, a viral infection, a myocardial infarction, or a vaccination? The claimant should gather records of any relevant procedures, illnesses, or exposures. If the claimant is unsure, a legal representative or a doctor familiar with the SoP can assist.

Third, the claimant must link the factor to service. This means showing that the medical event or exposure occurred during or because of service. For example, open heart surgery might have occurred while serving if the surgery was for a service-related condition. A systemic viral infection might be linked if it was contracted during service (e.g., in a military setting). Asbestos exposure requires proof that the claimant was exposed while on service, which may involve service records or testimony.

Fourth, the claimant should provide supporting documents: medical reports, hospital records, service records, and any expert opinion. The decision-maker will apply the SoP, but if the evidence is unclear, the claim may be rejected for lack of proof.

For decision-makers, compliance means applying the SoP strictly. They must check if pericarditis as defined is claimed. They must go through each factor and see if the evidence supports its existence. They must not rely on medical opinion that says pericarditis can be related to service in some other way; the SoP is binding. However, if a factor exists but the decision-maker doubts that it is related to service, they must assess that relationship separately.

The SoP also requires decision-makers to consider factor 33 only in aggravation claims. They must distinguish between onset and worsening. If the claim is for initial onset, factor 33 cannot be used.

For legal practitioners, compliance involves advising clients based on the factor list and ensuring that all possible factors are raised. Ignoring a factor could lead to a loss. They should also check whether a factor refers to another SoP (e.g., myocardial infarction) and incorporate that SoP's requirements.

For medical practitioners providing reports, compliance means being aware of the definition and the factors. A report should state not only the diagnosis but also whether any factor likely existed and, if possible, whether it was related to service. The doctor should avoid speculative causation statements that contradict the SoP.

Overall, the SoP reduces discretion and makes the process more formulaic. The cost is that some genuine claims may fall through the cracks if a factor is narrowly missed (e.g., viral infection symptoms began 5 weeks before onset, not 4 weeks). The benefit is faster decision-making and reduced need for expensive expert evidence. Claimants and advisors must be meticulous with dates and medical records. The instrument does not create any formal compliance burdens outside the claims process.