Statement of Principles concerning hepatitis D infection (Reasonable Hypothesis) (No. 71 of 2025)

The core legal and medical concepts in the Statement of Principles are defined and interconnected in the instrument, and they govern how a claimant establishes a reasonable hypothesis linking hepatitis D infection or death from that infection to service. The principal medical concept is the meaning of hepatitis D infection. The instrument defines it as infection with the hepatitis D virus, as a co‑infection or superinfection with hepatitis B virus, producing liver inflammation, and confirmed by laboratory testing for hepatitis D serological or nucleic acid markers; both acute and chronic forms are included, s7(2)(a)-(b). The instrument notes that laboratory confirmation will usually follow clinical onset, and it provides a specific definition of clinical onset in the Schedule, namely the point in time backwards from the first date of laboratory confirmation to when symptoms were persistently present as assessed by a registered medical practitioner, Schedule 1 definition of clinical onset and s7(2) Note 2.

Causation is expressed through the statutory threshold “reasonable hypothesis”, as applied by the Repatriation Medical Authority via this Statement. The instrument operationalises that threshold by prescribing that at least one of the enumerated factors in s9 must exist; that factor must be related to the person’s relevant service, s10(1). The enumerated factors are: percutaneous or permucosal exposure to a body substance from a hepatitis D‑infected person at least 14 days before clinical onset, s9(1); presence of hepatitis B infection at clinical onset, s9(2); inability to access appropriate hepatitis B vaccination before exposure or appropriate post‑exposure prophylaxis before clinical onset, s9(3); and inability to obtain appropriate clinical management for hepatitis D infection before clinical worsening, s9(4). The instrument specifies what counts as body substances, and defines post‑exposure prophylaxis as provision of immunoglobulin or vaccine, Schedule 1.

The concept of “relevant service” is defined in the Schedule as certain categories of service under the VEA or MRCA, including operational, peacekeeping, hazardous, British nuclear test defence service under the VEA, and warlike or non‑warlike service under the MRCA. Those categories determine whether a claimant’s service sits within the scope of the instrument, Schedule 1.

Death is treated as part of the illness for causation purposes; hepatitis D infection includes death from a terminal event or condition contributed to by the person’s hepatitis D infection, s7(4), with “terminal event” defined in Schedule 1 to cover proximate or ultimate causes such as pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function.

Interplay with other Statements of Principles is encapsulated in s11: where a factor in s9 refers to an injury or disease covered by another Statement determined under subsection 196B(2) of the VEA, the factors in that other Statement apply according to their terms. This creates a mechanism for integrating medically related conditions across multiple Statements.

Finally, the instrument references ICD‑10‑AM codes B16.0, B16.1 and B18.0 as codes that attach to hepatitis D infection, but the instrument emphasises that, for application of the Statement, the statutory meaning is the text in subsection 7(2) rather than relying solely on code assignment, s7(3)-(4).

The Statement affects persons lodging or pursuing claims under the Veterans' Entitlements Act 1986 and the Military Rehabilitation and Compensation Act 2004 where hepatitis D infection or death from hepatitis D infection is asserted to be connected with relevant service. The instrument expressly applies to a claim to which section 120A of the VEA or section 338 of the MRCA applies, s5. Schedule 1 defines “relevant service” to include operational service, peacekeeping service, hazardous service, British nuclear test defence service under the VEA, and warlike service or non‑warlike service under the MRCA. Therefore members and former members of the Australian Defence Force and certain Peacekeeping Forces whose service falls within those categories are the population whose claims are affected.

The Repatriation Medical Authority is the decision maker of the Statement, in that it determines the Statement under subsection 196B(2) of the VEA, s3. The instrument is thus intended to be applied by the decision‑makers who adjudicate claims under the VEA and MRCA framework, and to provide the medical framework for assessing whether a reasonable hypothesis exists. The Statement interacts with other Statements of Principles, s11, so persons whose factor is also covered by a different Statement are affected by the terms of that other Statement.

Practitioners who prepare claims, medical practitioners who supply clinical assessments, and advisers who gather evidence to satisfy the factors in s9 are materially affected because the Statement prescribes the form and content of the factors that must be established. For example, claimants and their medical witnesses will need to address laboratory confirmation of hepatitis D serology or nucleic acid markers and establish the timing of clinical onset, Schedule 1 definition of clinical onset, and the existence of any of the listed factors set out in s9.

Because the instrument includes death from hepatitis D infection where the infection contributed to a terminal event, s7(4), dependants, estates, and legal representatives bringing death claims under the VEA or MRCA are within scope. The instrument does not itself provide entitlements, but it sets the medical nexus threshold for claims that seek entitlements under those Acts, s5 and s3.

The repeal provision, s4, means persons and practitioners who relied on the 2017 Statement must now apply this 2025 Statement for claims within its commencement and application dates, s2 and s4. The instrument does not itself identify administrative processes, claim forms, or evidentiary checklists, but it changes the substantive medical criteria decision‑makers are to apply for hepatitis D matters.

The Statement of Principles is not a statute creating new criminal or civil liabilities; rather it prescribes the medical and causal factors that, in the view of the Repatriation Medical Authority, must exist to raise a reasonable hypothesis linking hepatitis D infection or death from hepatitis D to relevant service. The instrument therefore creates duties in the practical, evidentiary sense rather than statutory obligations. The duty it places on a claimant is to establish at least one of the factors in s9 and to show that the factor is related to relevant service, s9 and s10(1). The requirement that a factor be related to relevant service means claimants must adduce evidence tying exposure, vaccination status, hepatitis B co‑infection, or clinical management gaps to the time and circumstances of their service, s10(1).

Medical practitioners supplying evidence have an implicit duty to document and assess clinical onset as defined in Schedule 1, that is, to assess backward from the first date of laboratory confirmation to when symptoms were persistently present. The instrument notes that laboratory confirmation is usually after clinical onset, s7(2) Notes 1 and 2, which places a practical duty on clinicians to provide expert opinion on timing and symptoms.

The instrument gives claimants the right to have the existence of a reasonable hypothesis evaluated against these specific factors. Where a factor in s9 overlaps with an injury or disease covered by another Statement of Principles, the claimant has the right to have that other Statement applied in accordance with its terms, s11. That creates a right to cross‑reference and rely upon other Statements that may be more specific or better tailored for particular co‑morbid conditions.

The instrument does not itself create entitlement rights to monetary compensation or services. Instead it operates within the VEA and MRCA claim frameworks, and the rights to benefits will be determined under those Acts; the instrument only prescribes the medical causal framework for establishing a reasonable hypothesis under those statutory claim pathways, s5 and s3. It does not set procedural rules for lodging claims, deadlines, or standards of proof beyond the “reasonable hypothesis” threshold implicit in its operation.

There are implicit duties in evidentiary burden. For example, establishing inability to access appropriate vaccination or to obtain appropriate post‑exposure prophylaxis or appropriate clinical management, s9(3)-(4), requires factual proof of inability and an assessment against “contemporary medical standards” or what is “appropriate”. The instrument uses those terms but does not define “contemporary medical standards” or “appropriate” within the instrument, introducing a practical duty on decision‑makers and expert witnesses to interpret those standards in the context of the claimant’s circumstances.

Finally, the instrument places a temporal duty relating to exposure and clinical onset: where the causal factor is percutaneous or permucosal exposure to an infected body substance, that exposure must have occurred at least 14 days before clinical onset, s9(1). Therefore claimants and clinicians must provide evidence of timing that satisfies that minimum interval.

The Statement of Principles contains no penalty provisions and does not itself create enforcement mechanisms. The instrument is a medical‑causal standard determined by the Repatriation Medical Authority under subsection 196B(2) of the Veterans' Entitlements Act 1986, s3. Its role is to inform the assessment of claims under the VEA and MRCA, as specified in s5. Enforcement of entitlements, compliance or disputes arising from claims will therefore be found in the VEA and MRCA frameworks and their administrative and judicial review mechanisms, but those are external to this instrument and are not set out in the text.

Operationally, the “enforcement” function of the Statement is that decision‑makers processing VEA or MRCA claims will apply the Statement as the Authority’s view of the medical factors required to raise a reasonable hypothesis. The instrument describes the minimal factors that must exist, s9, and the temporal and relational constraints that apply, s10. If a claimant cannot establish at least one relevant factor related to service, decision‑makers will not be able to conclude that a reasonable hypothesis has been raised, which in practice will result in the claim being rejected under the applicable statutory standard. The instrument itself does not state the administrative consequence words such as "rejection" or "acceptance", but that is the operational interaction with decision‑making under the VEA/MRCA framework, s5.

There is no criminal or civil penalty specified for providing false information in a claim within this instrument. Any penalties for false or misleading statements, or sanctions for fraudulent claims, would derive from the VEA or MRCA or other general law, not from this Statement. The Statement does not set evidentiary standards such as admissibility rules; it simply enumerates the medical factors that must be present to raise a reasonable hypothesis. It leaves determination of sufficiency of evidence, and any consequent administrative actions, to the applicable claim processes.

Because the Statement cross‑references other Statements of Principles where relevant, s11, enforcement in relation to overlapping conditions may involve consulting multiple Statements in the same adjudication. The instrument does not provide an appeal route, nor does it set time limits, those mechanisms remain in the VEA and MRCA and associated administrative law.

This Statement is made under the authority of the Veterans' Entitlements Act 1986, subsection 196B(2), s3, and it expressly applies to claims governed by section 120A of the VEA and section 338 of the Military Rehabilitation and Compensation Act 2004, s5. Therefore it is an instrument that sits within the statutory claim and compensation regimes established by those Acts and is used as the medical framework for assessing whether a reasonable hypothesis exists linking hepatitis D infection to relevant service.

The instrument cross‑references other Statements of Principles and provides for their application where a factor in s9 refers to an injury or disease already covered by a different Statement determined under subsection 196B(2) of the VEA, s11(1)-(2). In practice this means that where, for example, inability to obtain appropriate clinical management or inability to access vaccination relates to another diagnosable condition covered by a separate Statement, the other Statement’s factors and terms apply. That creates an inter‑Statement dependency that decision‑makers must respect.

The instrument also references external medical classification standards by citing ICD‑10‑AM codes B16.0, B16.1 and B18.0 as codes that hepatitis D infection attracts, but it clarifies that for the purposes of applying this Statement the statutory meaning is the textual definition in subsection 7(2), s7(3)-(4). The ICD reference is therefore informative rather than determinative.

The Schedule defines post‑exposure prophylaxis as provision of immunoglobulin or vaccine, Schedule 1, which is a medical intervention term that may also be governed by public health law and clinical guidelines. The instrument requires assessment of whether inability to access or receive appropriate vaccination or post‑exposure prophylaxis occurred in accordance with contemporary medical standards, s9(3) and Schedule 1 definition of post‑exposure prophylaxis. That requirement anticipates interplay between the Statement and contemporary clinical practice, public health policy, and possibly employer or military medical protocols, although the Statement itself does not specify how to resolve conflicts between those external standards and claim assessment.

Because the Statement operates within the VEA and MRCA claims frameworks, other statutory rules in those Acts, such as time limits, evidentiary presumptions, and appeal rights, remain relevant to any claim where the Statement is applied. The Statement does not displace procedural or substantive rules in the parent Acts, it informs only the medical causation assessment. The repeal of the 2017 Statement, s4, means that past decisions relying on the earlier Statement may need reconsideration in future claims, but the instrument does not itself prescribe retrospective application rules.

This Statement of Principles is dated 22 August 2025 and commences on 22 September 2025, ss1 and 2. It expressly repeals the Statement of Principles concerning hepatitis D (Reasonable Hypothesis) (No. 11 of 2017), Federal Register of Legislation No. F2017L00020, s4. The instrument therefore replaces the 2017 Statement as the operative Statement of Principles for hepatitis D infection from its commencement date.

The instrument itself contains no other amendment provisions, savings provisions, transition rules, or staged commencements. There is no textual provision in this document for transitional handling of claims lodged but not determined before commencement. The only explicit historical action recorded in the instrument is the repeal of the 2017 Statement, s4. The instrument does not list prior amendments or versions other than the immediate repeal of the 2017 instrument.

Changes of substance, when comparing the 2017 and 2025 Statements, cannot be inferred from this text alone because the 2017 instrument is not reproduced here. The only concrete amendment history available in this instrument is the single repeal. The Schedule of definitions and the enumerated factors in s9 are the operative content of the 2025 Statement; any differences with the 2017 Statement would have to be identified by direct comparison with the 2017 document that this instrument repeals, s4.

Because the Statement relies on clinical concepts and “contemporary medical standards”, future amendments could occur if the Repatriation Medical Authority revises the Statement in light of new medical evidence. The instrument does not specify a review mechanism or expiry, so any amendment would be by a subsequent Statement determined under the same statutory power, subsection 196B(2) of the VEA, s3.

The instrument itself contains no record of litigation. It is a Statement of Principles determined by the Repatriation Medical Authority under subsection 196B(2) of the VEA, and it does not include references to judicial decisions or legal challenges. The text contains no cases or litigation citations.

Because the Statement is a medical‑causal instrument intended for use within the VEA and MRCA claims frameworks, disputes concerning its interpretation or application may arise in administrative review or judicial review contexts under the VEA or MRCA, but this instrument provides no litigation history or examples of contested applications. The instrument’s text does not state that it has been the subject of proceedings, nor does it identify any binding judicial interpretation.

Practitioners should therefore note that there is no litigation record within this document to guide how courts or tribunals have treated specific terms such as “reasonable hypothesis”, “related to the relevant service”, “contemporary medical standards”, or how to apply the Schedule’s clinical onset concept in contested cases. Decisions on those questions would be sourced from VEA and MRCA jurisprudence or administrative determinations outside this text, but the instrument itself contains no such references.

Where disputes arise about factors that overlap with other Statements of Principles, s11 allows for reliance on other Statements as in force, which may themselves have administrative or litigation histories that could be relevant. This text, however, does not supply that material.

This Statement contains several technical and evidentiary points that can materially affect claim outcomes, and which practitioners should flag early in case preparation. The first is the timing rule for exposure. Section 9(1) requires percutaneous or permucosal exposure to an infected body substance at least 14 days before clinical onset. Clinical onset is defined in Schedule 1 as the point backwards from the first date of laboratory confirmation to when symptoms were persistently present. Because the instrument notes laboratory confirmation will usually be after clinical onset, s7(2) Note 2, careful medical evidence is required to establish the symptom onset date, and to show the exposure preceded that date by at least 14 days. That creates a potential evidentiary gap in cases where symptom chronology is imprecise.

Second, the instrument requires hepatitis D to be confirmed by laboratory testing for hepatitis D serological or nucleic acid markers, s7(2). If laboratory confirmation is absent or equivocal, clinical descriptions alone will be insufficient under the instrument’s definition. Practitioners must therefore secure the specific serological or nucleic acid test results, and expert interpretation where necessary, to meet the statutory definition.

Third, the Statement makes hepatitis D a co‑infection or superinfection with hepatitis B, and identifies as a separate factor the existence of hepatitis B infection at the time of clinical onset, s9(2). This means that establishing hepatitis B status at the relevant clinical onset date is a discrete evidentiary requirement, and its absence may prevent reliance on that factor. The interaction between hepatitis B testing dates and the clinical onset construct can be complex.

Fourth, the “inability to access appropriate hepatitis B vaccination” and “inability to access appropriate hepatitis B post‑exposure prophylaxis, in accordance with contemporary medical standards, before clinical onset”, s9(3), introduce concepts that are fact‑sensitive and require clarification of what “appropriate” and “contemporary medical standards” mean in the claimant’s circumstances. The instrument does not define “contemporary medical standards” or set an objective list of acceptable vaccinations or prophylaxis protocols, meaning expert evidence and contemporaneous clinical guidelines will be needed to establish what was appropriate at the time and whether inability existed.

Fifth, s9(4) allows reliance on inability to obtain appropriate clinical management for hepatitis D infection before clinical worsening, but s10(2) restricts the operation of s9(4) to claims for material contribution to, or aggravation of, hepatitis D infection where the infection was suffered or contracted before or during (but did not arise out of) relevant service. That subsection narrows the availability of s9(4) for service‑related causation where the original infection arose out of service; practitioners must therefore be attentive to whether the claim is for primary causation or for material contribution/aggravation.

Sixth, the instrument’s Schedule of body substances includes a broad list, but the key exposure requirement in s9(1) is to a body substance from a person infected with hepatitis D virus at least 14 days before clinical onset. Where exposure history is uncertain, proof that the source person was infected, and timing of that infection relative to the claimant’s exposure, may be difficult to establish.

Seventh, the Statement cross‑references other Statements where a factor refers to another injury or disease, s11. This can create procedural complexity when preparing a file: practitioners must identify and apply the current versions of any other relevant Statements as they stand, because s11 applies those factors “as in force from time to time”.

Finally, while the instrument lists ICD‑10‑AM codes associated with hepatitis D, s7(3)-(4) clarifies that the statutory meaning is the definition in subsection 7(2). Relying solely on an ICD code in medical records without the required serological or nucleic acid confirmation and the clinical onset analysis will not satisfy the instrument’s definition.

To present a claim that engages this Statement of Principles, practitioners and claimants should structure the evidentiary file to directly correspond to the instrument’s definitions and factors. Start by establishing laboratory confirmation of hepatitis D serological or nucleic acid markers, because the Statement’s definition of hepatitis D infection requires such confirmation, s7(2). Obtain the first date of laboratory confirmation and request a clinician’s assessment that establishes the date when symptoms were “persistently present”, in accordance with the Schedule 1 definition of clinical onset. Because the instrument notes that laboratory confirmation will usually follow clinical onset, s7(2) Note 2, expert medical opinion should be sought to draw the backward timeline from lab confirmation to symptom‑onset.

If relying on the exposure pathway in s9(1), secure contemporaneous records or credible witness statements documenting the nature of the exposure, the type of body substance involved, and, where feasible, evidence that the source person was infected with hepatitis D at the relevant time. Remember that exposure must be percutaneous or permucosal, and must have occurred at least 14 days before clinical onset, s9(1). Match the dates precisely, and have a clinician opine on plausibility of incubation periods relative to the claimant’s symptom history.

If relying on hepatitis B co‑infection as the factor, s9(2), obtain hepatitis B test results that demonstrate infection at the time of clinical onset. Evidence must tie the hepatitis B status to the clinical onset moment defined in the Schedule, not merely to a distant test result.

Where the factor is inability to access vaccination or post‑exposure prophylaxis, s9(3), collect documentary evidence showing attempts to obtain vaccination or prophylaxis, any denial or lack of availability, military health records, clinic logs, or public health records, and expert evidence about what constituted “appropriate” vaccination or post‑exposure prophylaxis at the relevant time. The Schedule defines post‑exposure prophylaxis as provision of immunoglobulin or a vaccine, Schedule 1, but the instrument requires assessment against contemporary medical standards, s9(3). Therefore include contemporaneous clinical guidelines or public health advisories as part of the file.

If relying on inability to obtain appropriate clinical management for hepatitis D infection prior to clinical worsening, s9(4), assemble records of medical consultations, referrals, wait times, and any documented refusal or absence of appropriate treatment. Remember s10(2) limits the operation of s9(4) to material contribution or aggravation where the infection was suffered or contracted before or during, but did not arise out of, service. Clarify whether the claim is for causation arising from service or for aggravation of pre‑existing infection, and obtain an expert opinion that addresses material contribution or aggravation as required.

For death claims, establish that hepatitis D infection contributed to a terminal event or condition as defined in Schedule 1 and s7(4), and obtain death certificates, coroner reports, and clinical opinions linking the infection to the proximate or ultimate cause of death (for example, pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function).

Because the instrument cross‑references other Statements where applicable, s11, practitioners should identify any other Statements that may be engaged by the facts and procure the relevant medical evidence specified in those Statements. Verify that any other Statements cited are the versions in force at the time of claim assessment.

Finally, assemble and present the material in a way that maps each evidentiary item to the specific subsection in this Statement (for example, label evidence that supports s9(1) exposure, evidence for s9(2) hepatitis B infection, and so on). Since the Statement does not define “contemporary medical standards”, include contemporaneous clinical guidelines and authoritative statements to ground expert opinions on what was appropriate at the time. This will reduce ambiguity for decision‑makers applying the Statement to determine whether a reasonable hypothesis has been raised.