Statement of Principles concerning hepatitis B infection (Balance of Probabilities) (No. 10 of 2026)

Hepatitis B infection is defined in section 7(2) as infection with hepatitis B virus resulting in an illness characterised by inflammation of the liver, confirmed by laboratory testing for hepatitis B serological or nucleic acid markers. It includes both acute and chronic infection. The definition notes that clinical worsening may be indicated by development of chronic from acute, reactivation, or flare-up. Importantly, the definition is tied to ICD-10-AM codes B16, B18.0 and B18.1, but the meaning given in the instrument overrides the code classification for the purpose of applying the SoP. Death from hepatitis B infection includes death from a terminal event contributed to by the infection, with terminal event defined in the Dictionary as pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function.

Clinical onset is defined in the Dictionary as the point backwards in time from the first date of confirmation of laboratory evidence of hepatitis B serological or nucleic acid markers, to the date at which the symptoms of hepatitis B were persistently present, as assessed by a registered medical practitioner. This definition is critical because many factors require a temporal connection to clinical onset (e.g., exposure at least 30 days before clinical onset). The definition creates a backward extrapolation from a known lab date to the first persistent symptoms. For chronic infections where symptoms may be absent or vague until late, this can be difficult to establish.

Relevant service is defined in the Dictionary as 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 applies to the lower threshold claims - where the standard of proof is balance of probabilities, not the reasonable hypothesis standard that applies to operational service.

Other key concepts include post-exposure prophylaxis (immunoglobulin or vaccine given after exposure to prevent disease), iron overload (excess iron confirmed by elevated ferritin or transferrin saturation, caused by haemochromatosis or blood transfusions), and the factor-specific concepts like “percutaneous or permucosal exposure to a body substance”, “immediate proximity”, “inability to access appropriate hepatitis B vaccination … in accordance with contemporary medical standards”, and “severe hepatic iron overload”. The instrument also distinguishes between initial infection and clinical worsening. Factors 9(4) to 9(15) apply only to material contribution to or aggravation of hepatitis B infection where the infection was suffered or contracted before or during (but did not arise out of) the person’s relevant service, as per section 10(2). That section limits those factors to cases of worsening of pre-existing infection, not initial causation.

The SoP primarily affects three groups. First, veterans and members of the Australian Defence Force who have rendered relevant service - specifically, eligible war service (non-operational), defence service (non-hazardous, non-British nuclear test), or peacetime service under the MRCA. These individuals may lodge claims for compensation or benefits for hepatitis B infection or death from that infection. The SoP establishes the medical framework they must satisfy to succeed. Because the SoP sets fixed factors, claimants have a clearer roadmap of what evidence they need, but also face the risk that their circumstances may not match any listed factor.

Second, the SoP binds decision-makers in the Department of Veterans’ Affairs and the Military Rehabilitation and Compensation Commission. When assessing a claim that falls within the balance of probabilities pathway, the decision-maker must apply the SoP. They cannot accept a causal connection that falls outside the listed factors unless they are satisfied the SoP does not cover the claim (which is unlikely given the broad definition of hepatitis B infection). This reduces decision-maker discretion but also creates rigidity; a claim that is medically sound but does not fit a factor will be rejected.

Third, the SoP affects health professionals who provide medical reports for claimants. The definitions of clinical onset, iron overload, post-exposure prophylaxis, and the factor requirements demand precise medical evidence. For example, clinical onset requires a registered medical practitioner’s assessment of when symptoms were persistently present. The alcohol consumption factors (9(8) and (9)) require quantification in kilograms over a 10-year period, calculated using the Australian Standard of 10 grams per standard drink. This puts a burden on clinicians to estimate historical alcohol intake with reasonable accuracy.

The instrument also indirectly affects legal representatives and advocates who advise claimants, as they must understand the interplay between the SoP and the underlying VEA and MRCA provisions. The SoP does not create duties or rights for the general public; it is confined to the military compensation system.

The SoP imposes a duty on the Repatriation Medical Authority to determine and update the instrument based on sound medical-scientific evidence, which it exercised here by repealing the 2017 SoP and issuing this new one. The Authority’s view, expressed in section 8, is that on the available evidence it is more probable than not that hepatitis B infection and death from hepatitis B infection can be related to relevant service.

Decision-makers (DVA delegates and the MRCC) have a duty to apply the SoP when deciding claims to which VEA section 120B or MRCA section 339 applies. This means they must consider each factor and determine whether the claimant has at least one factor that exists and is related to their service. They must also apply the cross-reference provision in section 11: if a factor refers to an injury or disease covered by another SoP (e.g., human immunodeficiency virus infection), the factors in that other SoP apply as in force from time to time. This duty is binding and not discretionary; a decision that ignores the SoP is likely reviewable.

Claimants have the right to have their claim assessed under the SoP. They bear the evidentiary burden of establishing the existence of a factor and its relationship to service. The SoP does not create a right to compensation itself; that right arises from the VEA or MRCA if the criteria are met. However, the SoP gives claimants a specific pathway: if they can show, for example, that they had percutaneous exposure to infected body fluid at least 30 days before clinical onset and that exposure occurred during relevant service, the decision-maker must accept the connection.

The SoP also creates a procedural right: because it is a legislative instrument registered on the Federal Register of Legislation, it is publicly available and can be relied upon. Claimants can access the instrument and prepare evidence accordingly. The note in section 7 gives examples of signs and symptoms, which can assist in understanding what evidence a medical practitioner needs to assess. There is no explicit right to challenge the SoP itself, but a decision applying it can be reviewed by the Veterans’ Review Board and the Administrative Appeals Tribunal.

This SoP does not itself create any penalties or enforcement mechanisms. It is a medical-scientific instrument that operates within the broader framework of the VEA and MRCA, which contain their own penalty provisions for fraudulent claims or false statements. For instance, making a false or misleading statement in connection with a claim under the VEA may lead to prosecution under the Criminal Code or loss of entitlement.

Enforcement of the SoP occurs through the claims adjudication process. If a decision-maker incorrectly applies the SoP - for example, by misinterpreting the definition of clinical onset or rejecting a factor without proper consideration - the claimant can seek internal review and then external review by the Administrative Appeals Tribunal. The Tribunal can set aside the decision and substitute its own, properly applying the SoP. The federal courts also have limited jurisdiction to review legal errors in applying the instrument.

The SoP also has an enforcement effect on medical evidence. Claimants who submit reports that do not meet the evidentiary standards of the SoP (e.g., failing to quantify alcohol consumption in kilograms or not specifying the precise timing of exposure relative to clinical onset) risk having their claim rejected. The practical enforcement is that the SoP raises the bar for claim success; it does not punish non-compliance but rather filters out claims that lack the required medical foundation.

Because the SoP is a disallowable legislative instrument, it is subject to parliamentary scrutiny. If the Parliament disallows the instrument, it ceases to have effect, but that is a political enforcement mechanism, not a legal penalty. The Attorney-General and the Minister for Veterans’ Affairs may also direct the Repatriation Medical Authority to review a SoP, but that is not an enforcement action.

The SoP is made under subsection 196B(3) of the VEA and operates exclusively within the military compensation framework. It interacts directly with two principal Acts: the VEA and the MRCA. The application provision (section 5) states that the SoP applies to a claim to which VEA section 120B or MRCA section 339 applies. Section 120B of the VEA establishes the balance of probabilities standard for claims relating to eligible war service (other than operational service) and defence service (other than hazardous and British nuclear test defence service). Section 339 of the MRCA does the same for peacetime service under that Act. This means the SoP does not apply to operational service claims under the VEA, which use the reasonable hypothesis standard and are governed by separate SoPs.

Section 11 of the SoP provides for interaction with other SoPs. If a factor in this SoP refers to an injury or disease for which a separate SoP has been made under the same VEA subsection, the factors set out in that other SoP apply as in force from time to time. For example, factor 9(5) refers to “having infection with human immunodeficiency virus before clinical worsening of chronic hepatitis B infection”. HIV infection is covered by its own SoP. When applying this factor, the decision-maker must also satisfy the factors under the HIV SoP. This cross-referencing prevents a gap in the causal chain and ensures consistency across instruments.

The SoP also incorporates by reference the ICD-10-AM codes (B16, B18.0, B18.1) but explicitly states that the definition in the SoP overrides the code classification for the purposes of the instrument. This avoids confusion where a medical certificate lists a different ICD code but the condition meets the SoP’s definition.

The instrument does not interact with state or territory workers’ compensation laws, nor with general tort law. It is a closed system for military compensation. However, the concepts in the SoP, such as “contemporary medical standards” for vaccination, may indirectly reference Australian public health guidelines, meaning that external clinical standards are imported without being reproduced in the instrument.

This SoP (No. 10 of 2026) is a new instrument that repeals and replaces the previous Statement of Principles concerning hepatitis B (Balance of Probabilities) No. 14 of 2017 (Federal Register of Legislation No. F2017L00007). The previous instrument was made on an earlier date and had been in force for approximately nine years. The repeal is explicit in section 4. The new instrument was made on 19 December 2025 and commences on 19 January 2026, providing a one-month gap between making and commencement to allow affected persons to become aware of the changes.

The instrument does not contain any transitional provisions. Claims that were lodged before commencement but not yet decided would be assessed under the new SoP from its commencement date, because the instrument applies to claims (section 5) without regard to when the claim was made, unless the previous instrument has a savings provision (which it does not). This could disadvantage claimants who had prepared evidence based on the old factors, only to find the new SoP alters or adds factors.

There have been no earlier amendments to this specific instrument because it is newly made. The amendment history of the earlier 2017 SoP is not provided in the source, but such instruments are occasionally updated when the Repatriation Medical Authority reviews the sound medical-scientific evidence. The note in section 8 indicates the Authority has considered the current evidence and formed its view. The new SoP likely reflects updated medical knowledge about hepatitis B epidemiology, vaccination, and risk factors.

Because the SoP is a legislative instrument, any further amendments would be made by the Repatriation Medical Authority issuing a new or amending instrument, which would be registered on the Federal Register of Legislation. The instrument does not have a sunset clause, but it could be repealed by a later instrument or disallowed by Parliament.

The source text does not refer to any litigation concerning this specific SoP or its predecessor. SoPs are frequently litigated in the Administrative Appeals Tribunal and the Federal Court, where claimants challenge decisions that apply or fail to apply them. There is a well-established body of case law on the interpretation of SoPs generally, including on topics such as the meaning of “clinical onset”, the requirement for factors to be related to service, and the standard of proof. However, this SoP is new, and until it is tested in litigation, its specific provisions have no judicial gloss.

Key areas where future litigation may arise include: the backward extrapolation in the definition of clinical onset (how far back symptoms must be persistent, and what evidence suffices); the “inability to access” factor (what constitutes inability - lack of availability, medical contraindication, personal choice); the 180-day continuous period for high-prevalence areas (whether periods of leave break continuity); the quantification of alcohol consumption over a decade (what evidence is acceptable); and whether a claimant who had no symptoms but positive serology can have “clinical onset” at all (since the definition requires persistent symptoms). The cross-reference provision in section 11 may also generate disputes about whether the decision-maker must independently satisfy all factors in the referenced SoP.

Because the instrument is made under subsection 196B(3) (balance of probabilities) rather than subsection 196B(2) (reasonable hypothesis), litigation is likely to focus on the correct application of the factors rather than on whether the SoP itself is invalid. The Authority’s determination is generally final on medical matters, and courts give it substantial deference. However, if a factor is so ambiguous that it fails to provide sufficient guidance, a court might find the instrument invalid for uncertainty. That is unlikely with this SoP, as the factors are detailed.

No prior SoP on hepatitis B has been the subject of a leading case, but general SoP litigation principles from cases like Repatriation Commission v Hancock (2003) and Repatriation Commission v Hill (2002) would apply. Those cases underscore that the SoP replaces common law causation standards.

Several features of this SoP may catch both claimants and decision-makers off guard.

First, the definition of clinical onset is not the date of first positive lab test. It is the date when symptoms were persistently present, assessed by a registered medical practitioner, assessed backward from the first lab confirmation. This means a claimant with no symptoms but who has chronic hepatitis B detected incidentally may have no clinical onset date, making it impossible to satisfy factors that require a temporal relationship to clinical onset. The Note to section 7(2) says it will usually be the case that the date of lab evidence is after clinical onset, but that assumption may not hold for asymptomatic detection.

Second, the “inability to access appropriate hepatitis B vaccination before exposure to hepatitis B virus, or appropriate hepatitis B post-exposure prophylaxis, in accordance with contemporary medical standards” (factor 9(3)) is one of the few factors that does not require explicit exposure. However, the factor requires that the inability existed before exposure. If a claimant was vaccinated but the vaccine was not given within the recommended schedule, or if they received post-exposure prophylaxis but it was not in accordance with contemporary standards at the time, this factor might still be met. But “inability” implies more than a mere failure to vaccinate; it suggests a systemic or individual barrier. Mere non-vaccination without a documented inability may not be enough.

Third, the alcohol consumption thresholds (factor 9(8) for females: 75 kg over 10 years, factor 9(9) for males: 150 kg over 10 years) apply only to clinical worsening of chronic hepatitis B, not to initial infection. The 10-year period immediately preceding clinical worsening must be proven. Converting self-reported drinking to kilograms over a decade is imprecise. The Australian Standard of 10 g per drink is used. Practitioners will need to estimate total intake, and small errors could tip the scales.

Fourth, factor 9(2) requires living or working for a continuous period of at least 180 days in an area with a population prevalence of hepatitis B chronic infection of at least 2% at that time. The rate of 2% is relatively low - it covers many countries in Asia, Africa, and the Pacific. But the requirement of continuous 180 days may exclude personnel who spent 90 days in one high-prevalence area and 90 in another, unless those periods can be aggregated - the text says “in an area”, singular. This is a strict reading that could deny many claims.

Fifth, section 10(2) limits factors 9(4) to 9(15) (immunosuppressants, HIV, transplant, radiotherapy, alcohol, pregnancy, iron overload, schistosomiasis, other hepatitis, and inability to obtain clinical management) to cases where the person’s hepatitis B infection was suffered or contracted before or during (but did not arise out of) the relevant service. These factors can only support a claim for aggravation or material contribution, not a claim for initial infection. Claimants seeking to rely on, say, immunosuppressive medication to explain chronic hepatitis B must first establish that the infection was pre-existing in relation to service.

Sixth, the definition of iron overload includes “blood transfusions” as a cause. A veteran who received multiple blood transfusions during service might develop iron overload, which in turn could worsen chronic hepatitis B. But the factor requires severe iron overload at the time of clinical worsening, and the definition requires confirmation by elevated ferritin or transferrin saturation. Casual inference from having had transfusions may not satisfy the confirmed requirement without contemporaneous lab results.

Finally, the note for “clinical worsening” under section 7 includes “reactivation of past hepatitis B or a hepatitis B flare-up”. Claimants with past resolved infection who later experience reactivation due to an immunosuppressive medication during service may succeed under factor 9(4), but only if the clinical worsening occurred after the medication. The definition of clinical worsening itself is not separately defined in the instrument - it relies on the general concept of worsening from the clinical onset definition context. This ambiguity could lead to disputes about whether a flare-up meets the threshold.

Compliance with this SoP is relevant for two distinct actors: claimants and their representatives, who must marshal evidence to satisfy a factor; and decision-makers, who must apply the SoP correctly in assessing claims.

For a claimant, the first step is to obtain a confirmed diagnosis of hepatitis B infection by laboratory testing (serological or nucleic acid markers). Without that confirmation, the SoP does not apply. Next, a registered medical practitioner should assess clinical onset - the date when symptoms were persistently present. This assessment should be documented in a report that explains the reasoning, including a timeline from the first lab evidence backward to when symptoms began. If the claimant has no symptoms, the dating of clinical onset becomes problematic, and alternative arguments (e.g., that clinical onset occurs at the time of acute seroconversion even if asymptomatic) would need to be tested against the definition.

The claimant then identifies which of the 15 factors in section 9 may apply. For initial infection, factors 9(1) (percutaneous/permucosal exposure), 9(2) (180 days in high-prevalence area), and 9(3) (inability to access vaccination/post-exposure prophylaxis) are the primary pathways. For clinical worsening, factors 9(4) through 9(15) apply, but only if the infection was pre-existing and not related to service. Each factor has specific evidentiary requirements. Exposure under 9(1) requires evidence that the body substance was derived from a person infected with hepatitis B virus - not just any exposure, but exposure to an infected source. For some veterans, this may be impossible to prove if the source person is unknown or cannot be tested retrospectively. The alternative under 9(2) (high-prevalence area) may be more practical for those who served in countries like Vietnam, Papua New Guinea, or parts of Africa. Proof of continuous 180 days could come from service records, posting orders, unit diaries, or personal diaries. For 9(3), the claimant must show that they could not access vaccination or post-exposure prophylaxis at the time of exposure, and that the inability was contrary to contemporary medical standards. This may require medical records showing contraindications, or evidence that vaccination was unavailable at the particular posting.

For the alcohol consumption factors, detailed self-reporting supplemented by corroborating evidence (e.g., purchase records, testimony from peers) will be essential. Conversion to kilograms of alcohol using the Australian Standard (10 g per standard drink) should be calculated by a health professional or accountant.

Decision-makers must ensure they correctly apply the temporal order and the relationship to service. If a factor is established, they must then consider section 10(1): the factor must be related to the relevant service. For factor 9(2) (high-prevalence area), the relationship is usually satisfied if the claimant was posted there. For factor 9(4) (immunosuppressive medication), the medication must have been given for a service-related condition, or the inability to obtain clinical management (factor 9(15)) must itself be service-related. The decision-maker must also apply the cross-reference provision in section 11: if a factor refers to a disease covered by another SoP, the factors in that SoP must also be applied. For example, determining factor 9(5) (HIV infection) means the decision-maker must apply the HIV SoP, even if the HIV infection itself was not service-related, because the SoP only requires that the factor (HIV infection) exists, not that it is service-related. The relationship to service is assessed only for the hepatitis B factor pathway, not for each component.

Those managing the system should maintain templates for medical reports that address each factor and the clinical onset definition. Claimants should be advised to collect all relevant service documents, vaccination records, travel history, and alcohol consumption history early, because the SoP’s 10-year lookback periods mean that evidence degrades with time. The instrument imposes a high evidentiary burden, and compliance is largely about meeting that burden with sufficient medical and documentary support.