Statement of Principles concerning hepatitis E infection (Reasonable Hypothesis) (No. 39 of 2024)

This instrument is a Statement of Principles (SOP) determined by the Repatriation Medical Authority under subsection 196B(2) of the Veterans' Entitlements Act 1986, and it sets out the medical and factual criteria that must be met to raise a reasonable hypothesis connecting hepatitis E infection, or death from hepatitis E infection, to a person’s relevant service (s 3, s 8). It commences on 23 July 2024 and expressly repeals the previous Statement of Principles on hepatitis E (No. 112 of 2015) (s 2; s 4). The SOP applies to claims that fall under section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004 (s 5).

Mechanically, the instrument does three things. First, it defines the scope and clinical meaning of “hepatitis E infection” for the purposes of entitlement decision‑making: laboratory confirmation of hepatitis E serological or nucleic acid markers, together with an illness characterised by liver inflammation, is required (s 7(2)). It also treats death from a terminal event or condition contributed to by hepatitis E infection as within scope (s 7(5)). Second, it lists the discrete exposure pathways and clinical risk or aggravating factors that, if present and related to relevant service, will satisfy the minimum factual threshold for a reasonable hypothesis that the condition is connected to service (s 9). Third, it clarifies temporal and causal limits on how some factors are applied , for example, the exposure window for direct virus exposure (14 to 70 days before clinical onset) and conditions under which factors are treated as material contribution or aggravation (s 9; s 10(2)).

The SOP is a diagnostic threshold instrument, not a benefits schedule. It does not itself create entitlements or specify quantum; rather, it provides the medical-factual yardstick for administrative decision‑makers assessing whether the statutory reasonable hypothesis threshold is met in claims under the stated provisions of the VEA and the MRCA (s 5; s 3). It refers to external classification (ICD‑10‑AM code B17.2) but overrides bare coding with its own substantive definition of hepatitis E infection (s 7(3)-(4)). The Schedule supplies key definitions (for example, “clinical onset”, “relevant service”, “terminal event”) that govern how timing and service connection are to be assessed (Schedule 1).

The instrument operates around a small set of tightly defined concepts drawn from clinical features, laboratory confirmation, exposure pathways, temporal windows and service connection.

• Hepatitis E infection, as defined for the SOP, requires both laboratory confirmation of hepatitis E serological or nucleic acid markers and an illness characterised by hepatic inflammation. The instrument notes common signs and symptoms and distinguishes chronic infection as persisting for at least six months (s 7(2); Notes to s 7(2)). The SOP explicitly warns that the ICD‑10‑AM code B17.2 corresponds to hepatitis E infection but that the SOP’s definition is what governs (s 7(3)-(4)).

• Clinical onset is a backward-looking medical construct defined in Schedule 1: it is the point from which symptoms were “persistently present”, assessed by a registered medical practitioner, determined by reference back from the first date of laboratory confirmation of hepatitis E markers (Schedule 1: clinical onset). This definition matters because several exposure windows and the causal linking depend on the date of clinical onset rather than date of laboratory confirmation (s 7(2) Note 3; Schedule 1).

• The SOP lists specific exposure mechanisms that constitute qualifying factors for a reasonable hypothesis. These are set out in s 9(1)(a)-(f) and include being in the same living quarters or immediate work environment as an infected person, consuming contaminated food or water, direct contact with faecal material, direct physical contact with an infected human or primate, percutaneous exposure to contaminated blood or body fluids, or receipt of a transfusion of contaminated blood products. The exposure must occur between 14 and 70 days before clinical onset (s 9(1)).

• Additional factors cover transplantation scenarios, pregnancy at death or at liver transplantation, immunosuppressed states (HIV infection, chemotherapy), and inability to obtain appropriate clinical management prior to clinical worsening (s 9(2)-(7)). The instrument treats certain clinical events as “clinical worsening” (for example, death due to hepatitis E infection or liver transplantation necessitated by the infection) and notes that chronic hepatitis E may indicate clinical worsening (s 7(2) Note 2; s 9(4) Note).

• Relevant service is enumerated in Schedule 1 and includes operational, peacekeeping, hazardous and British nuclear test defence service under the VEA, and warlike and non‑warlike service under the MRCA (Schedule 1: relevant service). The SOP requires that any factor relied on under s 9 be related to the person’s relevant service (s 10(1)).

This SOP affects persons making claims under provisions of the Veterans’ Entitlements Act 1986 and the Military Rehabilitation and Compensation Act 2004 for conditions alleged to be connected to relevant service where hepatitis E infection is alleged, or death resulting from hepatitis E infection is alleged (s 5). The Schedule defines “relevant service” to include various service categories under both the VEA and MRCA (Schedule 1: relevant service), so the population affected comprises veterans, members of Peacekeeping Forces, and members of the Forces covered by the two Acts whose claims are assessed under the statutory sections referenced (s 8).

Three groups are principally implicated in practice:

• Claimants and their representatives who need to assemble medical and service evidence that meets the SOP’s thresholds: they must establish laboratory confirmation, date of clinical onset as assessed by a registered medical practitioner (Schedule 1), and one or more of the qualifying factors in s 9 that is related to relevant service (s 7; s 9; s 10(1)).

• The Repatriation Medical Authority, which determined the SOP under its statutory power, and administrative decision-makers who use the SOP as the medical yardstick to determine whether a reasonable hypothesis exists linking the condition to service (s 3; s 8). The text does not itself allocate decision‑making functions beyond establishing the SOP; it is an input into entitlement determinations under the cited statutory provisions (s 5).

• Healthcare providers and record custodians, whose records (laboratory results, transplant documentation, pregnancy records, chemotherapy/HIV status, transfusion records, clinical management records) will be material evidence to establish the factors the SOP requires. The SOP’s definitions (for example, clinical onset, terminal event) require clinical assessment by a registered medical practitioner and documentary support from clinical records (Schedule 1).

The instrument also affects how overlapping conditions are handled. If a s 9 factor refers to an injury or disease already covered by another SOP, then that other SOP’s factors apply (s 11). That mechanism can influence which set of medical-factual rules govern composite claims and where evidentiary focus must be placed.

Who bears the burden of producing the evidence is not directly stated in the SOP, but functionally claimants will need to provide the laboratory, clinical and service evidence that corresponds to the SOP’s definitions and time windows to satisfy the reasonable hypothesis threshold under the relevant statutory provisions (s 7; s 9; Schedule 1). The SOP changes the evidentiary shape of claims involving hepatitis E by stipulating what counts as the relevant exposure pathways, timing, and clinical milestones.

The instrument does not itself impose civil duties or confer statutory rights outside its role as a Statement of Principles for entitlement assessment. It specifies medical-factual criteria that must be present to raise a reasonable hypothesis that hepatitis E infection or death from it is connected to a person’s relevant service. Practically, these criteria impose the following duties and produce corresponding rights as they operate within the VEA and MRCA decision-making framework.

Duties (as implied by the SOP’s structure and definitions)

• Duty to establish laboratory confirmation and clinical onset. The SOP requires hepatitis E infection to be “confirmed by laboratory testing for hepatitis E serological or nucleic acid markers” and defines clinical onset requiring assessment by a registered medical practitioner (s 7(2); Schedule 1). Evidence must therefore demonstrate both laboratory proof and a clinician’s assessment of onset timing.

• Duty to establish qualifying exposure or risk factors. At least one of the factors listed in s 9 must exist for a reasonable hypothesis to be raised (s 9). That requires documentary or testimonial proof of the exposure, transplant history, pregnancy status, immunosuppressed status, chemotherapy, or clinical management failures relevant to the person’s course.

• Duty to relate factors to relevant service. Section 10(1) requires that any factor relied upon “must be related to the relevant service rendered by the person.” This imposes a factual nexus duty: the claimed exposure or circumstance must be tied to the service activities or environments defined in Schedule 1.

• Duty to treat certain factors as material contribution or aggravation in limited circumstances. Subsection 10(2) confines the application of s 9(3)-(7) to situations where the person’s hepatitis E infection was suffered or contracted before or during, but did not arise out of, their relevant service. This narrows the circumstances in which aggravation or contribution can be asserted under those factors.

Rights and practical entitlements (as they flow from the SOP’s role)

• Right to have a claim assessed against an objective set of medical-factual criteria. The SOP provides a standardised checklist for assessing whether the statutory reasonable hypothesis threshold is met for hepatitis E infection claims (s 9). Claimants have the right to rely on the SOP’s criteria in administrative decision-making under the VEA/MRCA (s 5).

The Statement of Principles itself does not create criminal offences, civil penalties or direct enforcement mechanisms. Its legal effect is procedural and evidentiary: it prescribes the medical and factual factors that must be present for a reasonable hypothesis to be raised linking hepatitis E infection, or death resulting from it, to relevant service for claims assessed under specified sections of the VEA and MRCA (s 3; s 5; s 8). Put differently, enforcement is administrative rather than penal or coercive in the criminal sense.

How the SOP is enforced in practice

• Administrative application. The SOP is applied by decision-makers considering claims under s 120A of the VEA or s 338 of the MRCA (s 5). The RMA’s SOP provides the medical-factual standard; enforcement consists of accepting or rejecting the factual linkage as part of the entitlement determination process under those Acts. The SOP therefore influences administrative outcomes (acceptance or refusal of service connection), but it does not itself prescribe sanctions.

• Evidentiary outcomes and consequences. The immediate practical enforcement consequence of failing to establish the SOP’s factors is that a reasonable hypothesis will not be made out, and the claimant’s assertion that hepatitis E infection is connected to relevant service will not succeed at that threshold. That in turn can lead to denial of benefits or entitlements which are administered under the VEA/MRCA; however, those administrative consequences flow from the broader statutory schemes, not from the SOP text itself (s 5).

• Interaction with other SOPs. Section 11 provides that where a s 9 factor refers to an injury or disease covered by another SOP, the factors in that other SOP apply. Enforcement in such overlap situations will follow the terms of the relevant SOPs, which may alter the factual or temporal standards applied in the adjudicative process.

Limitations and practical enforcement risks

• The SOP relies on clinical and documentary proof (laboratory markers, clinician assessments of clinical onset, transplant and transfusion documentation, pregnancy records, evidence of chemotherapy or HIV infection, records of clinical management). The instrument does not prescribe procedural rules for document submission, evidentiary presumptions, or statutory time limits; these procedural enforcement mechanisms will be found in the administering statutes and departmental practice, not in the SOP (s 7; s 9; Schedule 1).

The SOP is expressly made under the statutory power in subsection 196B(2) of the Veterans’ Entitlements Act 1986 (s 3). Its operative interaction with other laws is mediated in two main ways: by the Acts under which claims are made and by other Statements of Principles that cover related injuries or diseases.

Interaction with the VEA and MRCA claims framework

• Application to statutory claims. The SOP applies only to claims “to which section 120A of the VEA or section 338 of the MRCA applies” (s 5). It thus functions as an input into the decision-making machinery of those Acts. The SOP provides the medical criteria used to determine whether a reasonable hypothesis exists linking the condition to “relevant service” as defined in the Schedule (s 5; Schedule 1).

• Service definitions. The Schedule’s definition of “relevant service” maps to categories under the VEA and MRCA (operational, peacekeeping, hazardous, British nuclear test defence, warlike, non-warlike). This is how the SOP ties medical facts to the legal categories of service in the parent Acts (Schedule 1).

Interaction with other Statements of Principles

• Cross-reference mechanism. Section 11 establishes a concrete interaction mechanism: if a s 9 factor refers to an injury or disease covered by another SOP, then the factors in that other SOP “apply in accordance with the terms of that Statement of Principles as in force from time to time” (s 11). This means the RMA intended the SOPs to be read together where conditions overlap. Practically, a claimant or decision-maker must check whether a referenced factor is itself governed by a separate SOP and then apply that SOP’s rules.

• Supersession of earlier SOP. The instrument repeals the earlier Statement of Principles concerning hepatitis E (No. 112 of 2015) (s 4). That repeal produces a temporal interaction: claims and assessments must be made with reference to the currently in-force SOP (No. 39 of 2024) from commencement (23 July 2024) forward, while assessments made under the prior SOP will have been governed by its terms until repeal took effect (s 2; s 4).

Interaction with medical classification systems

• ICD‑10‑AM reference. The SOP notes that hepatitis E infection attracts ICD‑10‑AM code B17.2 but specifies that for application of the SOP the meaning of hepatitis E infection is the instrument’s own definition in s 7(2) (s 7(3)). It then defines the reference to ICD‑10‑AM code and edition in s 7(4). This both acknowledges external coding systems used in clinical and administrative settings and fixes the SOP’s substantive definition as the legal standard for claims purposes.

The instrument itself contains a succinct amendment history consisting of its commencements and repeal of prior material. The Statement of Principles concerning hepatitis E infection (No. 39 of 2024) is dated 21 June 2024 and commences on 23 July 2024 (front matter; s 2). It expressly repeals the earlier Statement of Principles concerning hepatitis E (No. 112 of 2015), which had been made under subsection 196B(2) of the VEA (s 4).

What the amendment history in the instrument provides and what it does not

• Provided: The SOP records the replacement of the 2015 instrument by the 2024 instrument (s 4). That is a legal substitution: from the commencement date the 2015 SOP is no longer in force and the 2024 SOP governs the medical-factual standard for claims to which it applies.

• Not provided: The instrument does not provide an itemised list of the substantive changes between No. 112 of 2015 and No. 39 of 2024, nor does it include an explanatory memorandum or legislative note within its text explaining the policy reasons or the practical differences between the two instruments. The instrument does, however, include a cover statement that it is determined under subsection 196B(2) of the VEA and bears the dated signature authority of the RMA Chairperson (front matter; s 3).

Implications of repeal and replacement

• Temporal effect on claims. Because the SOP is procedural for the purpose of the reasonable hypothesis test, the changeover means that claims assessed on or after the commencement date must be evaluated against the No. 39 of 2024 criteria (s 2; s 4). Practitioners dealing with claims spanning the repeal date should note that the operative SOP for a claim will be the instrument “in force” when the decision is made or as guided by the parent statutory provisions, which are outside the SOP text.

• Necessity of comparative review. The instrument’s repeal of the prior SOP implies that practitioners who previously relied on the 2015 text must compare the two texts to identify substantive differences affecting evidence thresholds, exposure windows, or definitional changes. The SOP itself does not summarise such differences.

Administrative record

• The instrument is recorded with the RMA and dated 21 June 2024 (front matter). The Chairperson signs on behalf of the RMA, registering the SOP as an RMA determination (front matter). The Schedule provides the operational definitions that underpin how the instrument will be applied going forward (Schedule 1).

The text of the Statement of Principles contains no litigation history, judicial interpretations, or references to cases. It is a standalone RMA instrument and does not recite any litigation or appeals that have arisen in relation to the prior 2015 SOP or to the 2024 SOP (there are no case citations in the instrument). The instrument’s content is confined to definitions, factors, and the scope of application (entire text).

Consequences of the absence of litigation history in the instrument

• No direct precedential guidance in the SOP text. Because the instrument does not include any litigation history or interpretive notes, users do not get guidance within the SOP text on how courts or tribunals have treated similar RMA determinations or the evidentiary thresholds in practice. The SOP therefore stands as an administrative standard; its interaction with judicial review or merits review processes is not documented in the instrument itself.

• Need for external review for legal precedent. Practitioners requiring litigation or tribunal precedents will need to consult external sources (cases, tribunal determinations, administrative guidance) to see how the reasonable hypothesis enquiries and RMA SOPs have been applied or challenged. The instrument does not provide that material.

• Repealed SOP and potential historic cases. While the SOP repeals the 2015 instrument (s 4), the 2024 instrument does not reference whether any litigation under the earlier SOP affected particular interpretive points. The absence of such references in the instrument means that any litigation history arising from the prior SOP is outside the instrument’s text.

Practical implications

• For claims and appeals practitioners, the absence of litigation history in the SOP means that reliance on the document alone will not provide an understanding of how its terms have been scrutinised by courts or tribunals. The SOP sets the administrative standard; to assess likely adjudicative outcomes, practitioners will need to consult case law, tribunal decisions and administrative guidance external to the instrument.

• For fact-intensive disputes (for example, contested dates of clinical onset, disputed exposure pathways, or disagreements about whether a factor relates to relevant service), the SOP provides the substantive test but not the evidentiary rules or precedent on proof , again, those must be sourced from decisions under the VEA, MRCA or administrative review bodies outside the SOP text.

This SOP contains several technical and evidentiary traps that can materially affect claims if not handled precisely. The instrument’s wording sets narrow factual and temporal rules; practitioners must attend to these specifics.

1. Laboratory confirmation versus clinical onset timing (s 7(2); Schedule 1). The SOP requires confirmation by laboratory testing for hepatitis E serological or nucleic acid markers (s 7(2)). Crucially, Schedule 1 defines “clinical onset” as a point determined by looking backwards from the first date of laboratory confirmation to the date when symptoms were persistently present as assessed by a registered medical practitioner. The implication is that clinical onset can be earlier than the date of lab confirmation, but it must be supported by a clinician’s retrospective assessment. Missing or poorly documented clinician assessments of symptom persistence can leave the clinical onset date vulnerable to challenge.

2. The exposure window is narrow for direct exposure pathways (s 9(1)). For the exposures listed in s 9(1)(a)-(f) the SOP requires that hepatitis E virus exposure occurs between 14 and 70 days before clinical onset. This is a tight, evidence-sensitive window. If documentary proof does not permit precise dating of exposure or symptom onset, the claim can fail on a timing technicality even where a plausible exposure existed.

3. ICD‑10‑AM code is not determinative (s 7(3)-(4)). Although hepatitis E carries ICD‑10‑AM code B17.2, the SOP states that the legal meaning for claims is the instrument’s definition at s 7(2). Practitioners cannot rely on coding alone; they must produce the laboratory markers and clinical-inflammation evidence required by the SOP.

4. “Clinical worsening” and the scope of aggravation (s 7(2) Note 2; s 9(3)-(7); s 10(2)). Sections 9(3)-(7) apply to material contribution or aggravation only where the hepatitis E infection was suffered or contracted before or during, but did not arise out of, the person’s relevant service (s 10(2)). That is a nuanced causal formulation: the SOP allows aggravation claims only in specific temporal and causal relations to service. The effect is that where the infection arose out of service, some aggravation factors may not be available in the same way. Practitioners must demonstrate both the pre-existing nature of the infection and the timing to qualify under these subsections.

5. Transplant and transfusion evidence requirements (s 9(2); s 9(6); s 9(1)(f)). Several factors turn on whether donated tissue, organs or blood were contaminated with hepatitis E virus. Proving contamination of a donor organ or blood product will ordinarily require donor testing records, pathology reports, or contemporaneous documentation. The SOP does not prescribe presumptions about donor status; absence of donor testing records can be a decisive evidentiary weakness.

Compliance in the context of this Statement of Principles means assembling and presenting the material necessary for a decision-maker to find that a reasonable hypothesis exists linking hepatitis E infection, or death from it, to relevant service under the VEA or MRCA. The SOP sets out discrete, documentable elements; compliance is therefore primarily evidentiary and clinical.

Core documentary and clinical items to obtain and present

1. Laboratory confirmation of hepatitis E infection (s 7(2)). Obtain the laboratory reports demonstrating serological or nucleic acid markers for hepatitis E. The SOP requires laboratory confirmation; lab results are necessary evidence.

2. Clinician assessment of clinical onset (Schedule 1). Because “clinical onset” is defined by an assessment of symptom persistence anchored to the first date of lab confirmation, secure a registered medical practitioner’s contemporaneous notes or a retrospective medical assessment stating when symptoms were persistently present relative to the date of lab confirmation. The SOP will treat clinical onset as the key temporal anchor for exposure windows (s 7(2); Schedule 1).

3. Evidence of exposure pathway(s) in s 9(1)(a)-(f) and timing (s 9(1)). For exposure-based factors, assemble evidence showing:

   • Presence in the same living quarters or immediate work environment as an infected person (rosters, accommodation records, witness statements) (s 9(1)(a));
   • Consumption of potentially contaminated water or food (deployment or location records, food/water safety incident reports) (s 9(1)(b));
   • Direct contact with contaminated human or primate faecal material (incident reports, unit reports, clinical notes) (s 9(1)(c));
   • Direct physical contact with an infected person or primate (incident reports, witness accounts) (s 9(1)(d));
   • Percutaneous exposure to contaminated blood or body fluids (injury reports, sharps injury forms, clinical exposure records) (s 9(1)(e));
   • Receipt of transfusion of blood or blood products (transfusion records, donor testing where available) (s 9(1)(f)). All such exposures must be dated and tied to the period 14 to 70 days before clinical onset to meet the SOP’s timing requirement (s 9(1)).

4. Transplant and tissue records (s 9(2)-(3)). Where a transplant is relied on, produce operative notes, transplant assessment, donor testing, and post-transplant infection documentation showing whether tissue or organs were derived from an infected person and the timing relative to clinical onset. For s 9(3), show that a liver, kidney, heart, lung, stem cell or bone marrow transplant occurred before clinical worsening.