Statement of Principles concerning hepatitis C (Balance of Probabilities) (No. 14 of 2018)

This instrument is a Statement of Principles (SOP) made by the Repatriation Medical Authority (RMA) under subsection 196B(3) of the Veterans' Entitlements Act 1986 (s3). It defines, for the purposes of claims under specified provisions of the VEA and the Military Rehabilitation and Compensation Act 2004 (MRCA), the medical criteria and temporal relationships that the RMA regards as establishing, on the balance of probabilities, a connection between hepatitis C (including death from hepatitis C) and a person's relevant service (s5, s7, s8, s9).

Mechanically, it:

• Names the instrument and sets its commencement date as 29 January 2018 (ss1-2).
• Revokes the previous Statement of Principles concerning hepatitis C No. 55 of 2008 (s4).
• Specifies the medical meaning of "hepatitis C" for claims processing, requiring laboratory confirmation for acute symptomatic illness (serological or nucleic acid markers) and for chronic infection of at least six months duration (nucleic acid markers) (s7(2)).
• Lists the specific factors that must exist, at least one of which is required for the RMA to consider hepatitis C or death from hepatitis C connected with relevant service, including exposure events, co-infections, transplantation, quantified alcohol use over ten years, iron overload, schistosomiasis, and inability to obtain appropriate clinical management (s9).
• States the standard of causation applied: the RMA is of the view that, on the available medical‑scientific evidence, it is more probable than not that hepatitis C and death from hepatitis C can be related to relevant service (s8). The instrument repeatedly frames its tests in terms of the balance of probabilities (s9 intro, s8).

The SOP is an evidentiary instrument. It provides the RMA's view about which factors, when established and related to a person's relevant service, will satisfy the civil standard of connection for the purposes of claims under the referenced provisions (s5, s8). It does not itself create benefit entitlements, nor does it prescribe penalties; its operational effect is to provide the criteria adjudicators will use in assessing whether a claimant's hepatitis C or death from hepatitis C is connected with relevant service.

The instrument operationalises a set of medico-legal concepts used to determine connection between hepatitis C and relevant service. Core concepts and their definitions are located in the main body and in Schedule 1 , Dictionary (ss6, Schedule 1).

Hepatitis C, as used here, is defined narrowly for claims purposes. For acute disease it requires a symptomatic clinical illness characterised by liver inflammation plus confirmation by laboratory testing for hepatitis C serological or nucleic acid markers. For chronic infection it requires at least six months duration and laboratory confirmation by hepatitis C nucleic acid markers (s7(2)). The instrument clarifies that ICD‑10‑AM codes B17.1 and B18.2 may apply but that the legal meaning is the statutory definition in s7(2) rather than the code alone (s7(3)-(4)).

"Being exposed to the hepatitis C virus" is defined in Schedule 1 to mean either percutaneous exposure (intravenous, intramuscular, subcutaneous or intradermal) or permucosal exposure to a specified body substance derived from an infected person, or receipt of tissue or organ transplant from an infected donor (Schedule 1, Definitions). "Specified body substance" is defined to include blood, blood products or any body fluid containing blood, and semen or vaginal secretions (Schedule 1). This links the exposure concept to specific transmission routes and to transplant events as distinct categories.

The instrument sets out a list of discrete factors any one of which must be established to show connection on the balance of probabilities (s9). Those factors include: a temporally proximate exposure (at least one week before clinical onset) (s9(1)); prior infection with other hepatitis viruses (A, B, D, E) before clinical worsening of hepatitis C (s9(2)); for chronic infection only, HIV co‑infection, solid organ/stem cell/bone marrow transplantation, quantified alcohol consumption thresholds over the preceding ten years, documented severe hepatic iron overload at the time of clinical worsening, or evidence of chronic schistosomiasis involving the liver (s9(3)(a)-(f)); and inability to obtain appropriate clinical management for hepatitis C (s9(4)). The Schedule defines "iron overload" as excess iron confirmed by elevated ferritin or transferrin saturation levels, with causes including haemochromatosis or blood transfusions (Schedule 1).

"Relevant service" is defined in the Schedule to mean 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 (Schedule 1). Section 10 requires that any factor established for connection must be related to the person's relevant service.

The instrument operates as an evidentiary guideline for adjudicators and as a substantive test claimants must meet where their claims fall within the specified statutory gateways. It expressly applies to a claim to which section 120B of the VEA or section 339 of the MRCA applies (s5). Those statutory references identify the types of claims that rely on SOPs for establishing service connection; the instrument itself does not alter those statutory provisions but supplies the RMA’s view of the medical criteria that will satisfy the balance of probabilities.

Primary affected groups:

• Veterans and members of the Forces who lodge claims under the VEA or MRCA where hepatitis C or death from hepatitis C is alleged to be connected with their relevant service. The SOP's definition of "relevant service" limits coverage to eligible war service (other than operational service), defence service (other than hazardous service and British nuclear test defence service) under the VEA, or peacetime service under the MRCA (Schedule 1).
• Adjudicative bodies and claims assessors who must apply the RMA's Statement of Principles when determining whether hepatitis C or death from hepatitis C is connected to relevant service. The SOP provides the factors and tests those decision‑makers must apply (ss7-11).
• Medical experts and treating clinicians preparing opinions for claims, because the instrument prescribes the types of laboratory confirmation and the specific medical or exposure factors that must be addressed (s7(2), s9, Schedule 1). For example, lab evidence of nucleic acid markers is required for chronic infection (s7(2)); ferritin or transferrin saturation testing is relevant for iron overload (Schedule 1).
• Parties who may contest claims, including internal review bodies and legal representatives, since the SOP frames the evidentiary landscape for medical causation disputes by setting out what the RMA regards as sufficient factors on the balance of probabilities (s8).

Secondary practical impacts arise for record custodians and employers. Because exposure is defined to include percutaneous and permucosal contact with specified body substances (Schedule 1), occupational records (for example, needlestick incidents, transfusion or transplant records) and clinical management records (for inability to obtain treatment) become material evidence for claimants asserting connection (s9(1), s9(4), Schedule 1).

Finally, there is immediate legal effect on prior case processing because this SOP revokes the earlier No. 55 of 2008 (s4) and commenced 29 January 2018 (s2). Adjudicators must apply this SOP for claims within the statutory application, subject to the terms of the enabling Acts and any transitional provisions those Acts contain, which are not included in this instrument.

The SOP itself does not impose statutory "duties" in the sense of criminal or regulatory obligations. Its legal function is directive and evidentiary: it details the factors the Repatriation Medical Authority regards as satisfying the balance of probabilities connection between hepatitis C (or death from hepatitis C) and relevant service (s8-9). From that functional role follow practical duties and rights within the claim process.

Decision‑maker duties and constraints:

• Apply the RMA’s tests when determining whether a claimant’s hepatitis C or death from hepatitis C is connected with relevant service under the VEA or the MRCA. The SOP articulates the threshold that at least one of the factors in s9 must exist before the RMA will consider the condition connected with service on the balance of probabilities (s9 intro).
• Require laboratory confirmation aligned with the definition of hepatitis C in s7(2). For acute symptomatic disease this means serological or nucleic acid markers; for chronic infection at least six months duration and nucleic acid marker confirmation (s7(2)). ICD‑10‑AM coding alone is not the operative definition (s7(3)-(4)).
• Where a factor refers to an injury or disease covered by another SOP, the adjudicator must apply that other SOP according to its own terms (s11). This creates a duty to cross‑reference the SOP corpus.

Claimant evidentiary obligations and rights:

• Claimants must substantiate that one or more of the listed factors exists and that the factor is related to their relevant service (s9, s10). For example, to satisfy s9(1) they must show an exposure event at least one week before clinical onset; to rely on s9(3)(c)/(d) they must establish quantified alcohol consumption in the ten years before clinical worsening (s9(3)(c)-(d)).
• Claimants have the right to have their condition assessed against the RMA’s Statement of Principles when a claim under s120B of the VEA or s339 of the MRCA is made (s5). The RMA’s view expressed in s8 sets the standard of proof (balance of probabilities) that will be applied.

Medical practitioner and expert duties:

• When providing evidence, practitioners will need to address the specific elements the SOP requires. For iron overload, Schedule 1 requires confirmation by elevated ferritin or transferrin saturation levels. For transplant‑related factors, documentary evidence of the transplant and donor status will be relevant (Schedule 1; s9(3)(b)). For inability to obtain appropriate clinical management (s9(4)), clinicians may be asked to document referrals, access issues, or the absence of treatment.

This instrument contains no penalties, sanctions, or criminal enforcement provisions. It is an administrative statement of medical criteria adopted by the Repatriation Medical Authority under its power in subsection 196B(3) of the VEA (s3). Its enforcement regime is therefore procedural and evidentiary rather than punitive.

How enforcement operates in practice:

• The practical effect of the SOP is to govern decisions made under the VEA and MRCA claim processes. Adjudicators and decision‑makers will use the SOP as the RMA’s determinative view about what medical facts, when established and linked to relevant service, satisfy the balance of probabilities standard for connection (s8-9). The "enforcement" mechanism is therefore the acceptance or rejection of service connection in a benefits decision, not a penalty imposed by the SOP itself.

Standard of proof:

• The RMA frames the causal test in terms of the civil standard, stating that it is of the view that it is more probable than not that hepatitis C and death from hepatitis C can be related to relevant service (s8). This clarifies the evidentiary standard decision‑makers should apply when the SOP is relied upon in claims.

Administrative remedies and review:

• The SOP does not specify appeal, review or reconsideration mechanisms. Those processes are governed by the VEA and the MRCA and the administrative law and merits review regimes that apply to decisions under those Acts. The SOP is a determinative medical instrument within that broader statutory framework, but it does not itself establish enforcement, review, or penalty procedures.

Limits on RMA discretion:

• The RMA’s instrument is explicit about which factors it regards as sufficient on a balance of probabilities (s9). Where a factor refers to another SOP, the other SOP governs (s11). The SOP thereby constrains medical relevance to the enumerated factors and definitions; adjudicators must apply these specified criteria when using the SOP as the basis for a connection finding.

In short, the SOP is an administrative instrument that shapes claim outcomes by defining required medical and temporal relations. Its "enforcement" is via its central role in adjudication under the relevant statutes rather than by any separate sanctioning power within the instrument itself.

The Statement of Principles operates within the statutory framework of the Veterans' Entitlements Act 1986 and the Military Rehabilitation and Compensation Act 2004. The instrument is made under subsection 196B(3) of the VEA (s3) and expressly applies to claims to which s120B of the VEA or s339 of the MRCA applies (s5). The SOP therefore functions as a binding RMA articulation of medical causation that decision‑makers must apply when those statutory claim provisions rely on SOP determinations.

Interaction specifics in the instrument:

• Enabling statute: The SOP expressly records its statutory authority and purpose as a determination under subsection 196B(3) of the VEA. Thus its legal weight derives from the RMA's legislated power to determine Statements of Principles for specified conditions when those SOPs are invoked in claims under the VEA and MRCA (s3).
• Claim application: The instrument’s scope is limited to claims that fall within the identified statutory gateways (s5). It does not purport to apply outside the VEA and MRCA claim contexts.
• Cross‑SOP application: Section 11 creates direct operational interaction with other SOPs. If a factor in s9 refers to an injury or disease already covered by another SOP determined under subsection 196B(3) of the VEA, then that other SOP applies according to its own terms as in force. This requires adjudicators to consult the corpus of SOPs and apply the relevant SOP where factors overlap (s11).
• Medical coding: The SOP addresses the relationship between its statutory definition and ICD‑10‑AM coding. Section 7(3) and (4) state that while hepatitis C attracts specific ICD‑10‑AM codes (B17.1 or B18.2), the meaning of hepatitis C for this SOP is the statutory definition in s7(2), not the code alone. This clarifies that classification under a clinical coding regime does not automatically satisfy the SOP’s legal definition.
• Definitions and statutory terms: The SOP uses statutory terminology such as "relevant service", "MRCA", and "VEA" and defines them in the Schedule (Schedule 1). The SOP’s definition of relevant service mirrors categories in the enabling statute but also excludes certain categories (for example, it excludes operational service and hazardous service and British nuclear test defence service for the VEA categories) (Schedule 1). These delineations interact directly with which service types may give rise to an entitlement claim under the VEA or MRCA.

What the SOP does not do:

• It does not amend the VEA or MRCA. It does not change statutory eligibility criteria beyond supplying the RMA’s medical causation criteria that decision‑makers must apply for the specified conditions.

This instrument is the Statement of Principles concerning hepatitis C (Balance of Probabilities) No. 14 of 2018. The document records its dating and commencement and expressly revokes the prior Statement of Principles concerning hepatitis C No. 55 of 2008 (ss1-4). Key chronological entries in the instrument are:

• Dated 22 December 2017: the instrument was executed and bears the RMA’s seal and direction of the Chairperson, Professor Nicholas Saunders AO, as recorded in the instrument heading.
• Commencement: the instrument commenced on 29 January 2018 (s2). From that date the RMA’s determinative medical criteria as set out in this SOP superseded the previous instrument.
• Revocation: the SOP No. 55 of 2008 is revoked by s4. The instrument does not provide transitional provisions or savings; it simply states revocation.

The instrument does not record any subsequent amendments. It does not include a schedule of prior amendments because it replaces a prior SOP and stands as the current RMA determination for hepatitis C as at its commencement date. The SOP does not include any express sunset clause, periodic review timetable or automatic amendment mechanism. Any further amendments or revocations after commencement would need to be effected by subsequent formal RMA instruments made under the enabling subsection 196B(3) of the VEA and published accordingly. Those later changes are not present in this instrument.

Practitioners should therefore treat this SOP as replacing the 2008 SOP from its commencement date and should check the RMA registry or authoritative legislative instruments for any later instruments that may have modified or replaced it since 29 January 2018. The instrument itself contains no further amendment history.

The Statement of Principles document supplied contains no litigation history. It does not reference any court decisions, appeals, or tribunal determinations concerning the SOP No. 14 of 2018, nor does it cite any cases. The text makes no mention of challenges, judicial review proceedings, or administrative appeals relating to either this instrument or the prior No. 55 of 2008.

Given the absence of litigation references in the instrument itself, the document provides no source‑based material on how courts or tribunals have interpreted its provisions, how strictly adjudicators have applied its factors, or any jurisprudential disputes about the definitions or thresholds it contains. The instrument is therefore a pure administrative determination of medical factors and does not include, within its text, case law or adjudicative guidance.

If a practitioner requires litigation precedents or interpretative guidance about the application of this SOP in contested decision‑making, they must consult external case law, tribunal decisions and administrative review rulings arising after the SOP’s commencement. Those materials are not included in this instrument and would need to be located independently of the SOP itself.

The instrument contains several technical features and definitional choices that can produce traps for claimants, clinicians and decision‑makers if not carefully addressed. These features affect evidentiary strategy, scope of coverage and the timing of events the claimant must establish. The following are concrete items drawn directly from the SOP.

Narrow statutory meaning of hepatitis C

• The SOP’s operative definition requires laboratory confirmation. Acute symptomatic hepatitis C must show liver inflammation plus confirmation by serological or nucleic acid testing; chronic infection requires at least six months duration confirmed by nucleic acid markers (s7(2)). Relying on ICD‑10‑AM coding alone will not satisfy the SOP (s7(3)-(4)). Practitioners should not assume that a diagnostic code in a medical record is legally sufficient without the specified laboratory evidence.

Timing of exposure and clinical onset

• To satisfy s9(1) for exposure, the SOP requires that the exposure occurred at least one week before clinical onset. This imposes a discrete temporal test that can be legally material. Claimants must be able to place exposure and onset in time. The SOP defines "being exposed" in Schedule 1 with routes that require particular kinds of evidence (for example, needlestick incident records, transfusion or transplant documentation, or reliable contemporaneous clinical notes).

Relationship-to-service constraints for aggravating factors

• Subsection 10(2) restricts application of subsections 9(2) to 9(4) to circumstances where the person's hepatitis C "was suffered or contracted before or during (but did not arise out of) the person's relevant service" and where the factor applies only to material contribution or aggravation. This means that certain factors in s9 are explicitly framed as aggravating conditions rather than primary causes arising out of service. Claimants must establish not only the factor but also the precise temporal relation between infection and service. If the hepatitis C arose out of service, the s9(2)-(4) aggravation pathway may not be the correct route; adjudicators must apply the proper relationship test in s10(2).

Alcohol consumption thresholds stated as kilograms of alcohol

• The SOP uses an unusual metric: total alcohol consumption of at least 75 kilograms for females and 100 kilograms for males within the ten years before clinical worsening of hepatitis C (s9(3)(c)-(d)). The SOP then instructs that alcohol consumption is calculated using the Australian Standard of ten grams of alcohol per standard alcoholic drink (notes to s9(3)(c)-(d)). Concretely, 75 kilograms equals 75,000 grams, which equates to 7,500 standard drinks over ten years, or approximately 2.05 standard drinks per day averaged over ten years. For males, 100 kilograms equals 10,000 standard drinks over ten years, or approximately 2.74 standard drinks per day averaged over ten years. Claimants will need sufficiently detailed drinking histories, corroboration and calculations to meet this threshold. The unit choice increases the evidentiary burden and can be counterintuitive to lay claimants and clinicians if not carefully explained.

Compliance in this context means assembling the evidence and expert opinions necessary for a decision‑maker to find, on the balance of probabilities, that one or more of the factors in s9 exists and is related to the claimant’s relevant service (s9, s10). The instrument prescribes specific types of evidence and definitions; the following sets out concrete steps and documentary items directly tied to the SOP’s language.

1. Establish the medical diagnosis of hepatitis C as defined

• Acute symptomatic disease: produce clinical notes documenting symptomatic liver inflammation and laboratory confirmation by hepatitis C serological or nucleic acid markers (s7(2)). Include dates of symptom onset and dates of relevant tests.
• Chronic infection: obtain documented evidence of at least six months' duration together with laboratory confirmation by hepatitis C nucleic acid markers (s7(2)). Provide serial test dates to establish the six‑month duration.

2. Prove an exposure event where that factor is relied on

• If relying on s9(1), document the exposure and show it occurred at least one week before clinical onset. Use contemporaneous incident reports, occupational health records (for needlestick injuries), hospital transfusion records, surgery/transplant documentation, or credible contemporaneous clinical notes showing permucosal exposure (Schedule 1).
• If exposure was via transplantation, provide surgical and donor records showing the transplant and, if available, donor infection status (Schedule 1).

3. For co‑infections and aggravating diseases (s9(2) and s9(3))

• For hepatitis A, B, D or E infections alleged to have preceded clinical worsening (s9(2)), supply laboratory tests and clinical timelines showing the prior infection occurred before the worsening of hepatitis C.
• For HIV co‑infection and organ/stem cell/bone marrow transplantation (s9(3)(a)-(b)), provide laboratory confirmation and transplant documentation with dates relative to clinical worsening.
• For schistosomiasis (s9(3)(f)), provide parasitological, serological, or clinical evidence establishing chronic infection involving the liver.

4. For alcohol consumption thresholds (s9(3)(c)-(d))

• Document alcohol consumption over the ten years prior to clinical worsening. Convert consumption to grams and then to standard drinks using the Australian Standard of ten grams per standard drink (notes to s9(3)(c)-(d)). Remember the thresholds are 75,000 grams (75 kilograms) for females and 100,000 grams (100 kilograms) for males over ten years. Provide corroborating evidence where possible: medical histories, clinicians’ notes, witness statements, workplace records, or contemporaneous records such as hospital admissions for alcohol‑related conditions. Explicitly show the calculation: total grams of alcohol = number of standard drinks × 10 grams.