Statement of Principles concerning hereditary haemochromatosis (Balance of Probabilities) (No. 24 of 2021)

This instrument is a Statement of Principles (SoP) issued by the Repatriation Medical Authority (RMA) about hereditary haemochromatosis and death from hereditary haemochromatosis. It sets the medical and causal criteria the RMA regards, on the balance of probabilities, as necessary for a finding that hereditary haemochromatosis (HH) or death from HH can be related to relevant service for the purposes of claims under specified provisions of the Veterans' Entitlements Act 1986 (VEA) and the Military Rehabilitation and Compensation Act 2004 (MRCA). The instrument is made under subsection 196B(3) of the VEA (see s3) and commences on 25 January 2021 (s2). It repeals the prior Statement of Principles concerning haemochromatosis No. 22 of 2012 (s4).

Mechanically, the SoP does three principal things. First, it defines the kind of condition covered: a specific, non‑exhaustive medical definition of hereditary haemochromatosis that requires a genetic disorder of iron transport/metabolism with documented iron overload in parenchymatous organs or clinical evidence of iron‑related organ or tissue dysfunction, and it expressly includes classical (HFE) and non‑HFE forms (s7(2)). Second, it prescribes the discrete list of factors one or more of which must exist before a causal link between the condition and relevant service can be established on the balance of probabilities (s9). These factors are quantified alcohol‑consumption thresholds (different for males and females), hepatitis C infection at the time of clinical worsening, steatohepatitis at the time of clinical worsening, and an inability to obtain appropriate clinical management (s9(1)-(5)). Third, it sets relational constraints: the listed factors must be related to the person's relevant service (s10(1)), and the factors in s9 apply only to material contribution to, or aggravation of, HH where the HH was suffered or contracted before or during (but did not arise out of) the person's relevant service (s10(2)). The SoP also cross‑references other SoPs where a listed factor is itself an injury or disease covered by another RMA Statement (s11).

The instrument ties eligibility assessment for claims under section 120B of the VEA or section 339 of the MRCA to these medical and causal criteria (s5). It does not itself authorise payments or specify entitlement quantum; it supplies the RMA’s medical criteria used to determine whether HH is related to relevant service under the statutory claims pathways identified (s3, s5). The RMA states its view that, based on the available medical‑scientific evidence, it is more probable than not that HH and death from HH can be related to relevant service (s8); the SoP records that view and the specific factors the RMA considers necessary for finding a service connection.

The SoP sets out a compact conceptual framework that governs how hereditary haemochromatosis is treated for causation purposes in specified veteran claims. Core concepts and their operational roles are:

• Definition of the medical condition: "Hereditary haemochromatosis" for this instrument has the precise meaning in s7(2): a genetic disorder of iron transport and metabolism causing iron accumulation with either documented parenchymal iron overload or clinical evidence of iron‑related organ/tissue dysfunction. The definition explicitly includes HFE (classical, type 1) and non‑HFE hereditary haemochromatosis (s7(2)(a)-(b)). The instrument notes the ICD‑10‑AM code E83.1 is associated with HH but directs that the meaning for this SoP is the statutory definition in s7(2) (s7(3)-(4)).

• Clinical worsening: The instrument repeatedly refers to "clinical worsening of hereditary haemochromatosis" as the relevant temporal marker for assessing factors (s9 and notes). The notes identify that clinical worsening typically manifests as hepatic fibrosis or cirrhosis (s9 notes), which focuses the timing of the causal test on progression to liver pathology or similar iron‑related organ dysfunction.

• Causal factors as conjunctive thresholds: Rather than an exhaustive list of causes, s9 lists alternative factors, at least one of which must exist for the RMA to treat HH or death from HH as related to service on the balance of probabilities. The factors include quantified alcohol exposure over a five‑year window (sex‑specific thresholds in s9(1)-(2)), active hepatitis C infection at the time of clinical worsening (s9(3)), presence of steatohepatitis at the time of clinical worsening (s9(4)), and inability to obtain appropriate clinical management (s9(5)). The instrument specifies how alcohol consumption is to be calculated, using the Australian Standard of ten grams of alcohol per standard alcoholic drink (s9 notes).

• Temporal and service‑relation constraints: Section 10 imposes that any of the factors in s9 must be "related to the relevant service rendered" (s10(1)). Section 10(2) limits the application of s9(1)-(5) to circumstances where the HH was suffered or contracted before or during relevant service but did not arise out of that service; the factors therefore operate as criteria for material contribution or aggravation of a pre‑existing or contemporaneous condition, not for conditions that arose out of service (s10(2)).

• Cross‑Statement interaction: Section 11 provides that where a listed factor refers to an injury or disease that is the subject of another RMA Statement, the factors in that other Statement apply as they are in force from time to time (s11). This creates a mechanism for harmonisation and delegation where factors overlap with other defined conditions.

This SoP directly affects veterans, members of the Forces, and claimants who bring claims under the claims pathways identified in section 5: claims to which section 120B of the Veterans' Entitlements Act 1986 or section 339 of the Military Rehabilitation and Compensation Act 2004 applies (s5). The instrument does not specify benefit types or payment amounts; its effect is to control, for the purposes of those claim provisions, whether hereditary haemochromatosis or death from hereditary haemochromatosis is related to relevant service. The Schedule defines "relevant service" to include 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).

Who bears the practical cost of complying with the SoP? The primary burden falls on claimants seeking to establish a service connection under the specified statutory pathways. The SoP sets out the medical and factual criteria the RMA will use; claimants must therefore adduce medical records, diagnostic evidence, and factual material that establish the SoP’s elements on the balance of probabilities. The instrument itself does not allocate payment of costs, but it conditions successful access to whatever entitlements flow from a finding of service connection under the VEA or MRCA.

Health professionals and treating clinicians are also affected indirectly. The SoP requires specific medical findings to be linked to service (for example documented iron overload in parenchymatous organs or clinical evidence of iron‑related organ dysfunction per s7(2)). Medical records that document iron overload, genetic testing, evidence of hepatitis C infection, steatohepatitis, or clinical management attempts become evidence used in administrative causation assessments.

Administrators and decision‑makers within the Department and the RMA will use this SoP to assess causation. The RMA’s statement that it is "of the view" on the evidence that HH can be related to service (s8) functions as the expert medical position used to moderate administrative decisions under the linked statutory claims provisions.

Families and dependants who pursue death claims under the VEA or MRCA are affected where death is alleged to be related to HH. The SoP defines death from HH to include deaths where a terminal event was contributed to by HH (s7(5)), and the Schedule lists examples of terminal events. Where a terminal event is one of the examples, evidence must link that event to a contribution by HH.

Other affected parties include those whose claims depend on factors that are also the subject of other SoPs. Section 11 requires that where a listed factor refers to an injury or disease covered by another SoP, the provisions of that other SoP apply, which creates interdependence between SoPs and potential evidentiary consequences for claimants whose submissions rely on conditions covered elsewhere.

The SoP creates normative criteria that shape duties and rights in the administrative claim process, although it does not itself prescribe statutory duties to pay benefits. Its operative duties and rights are manifest in the obligations it places on claimants, decision‑makers, and the evidentiary rules it establishes.

Duties placed on claimants and their advisors:

• Establish the condition according to the SoP’s medical definition. The claimant must show hereditary haemochromatosis as defined in s7(2), which requires documentation of iron overload in parenchymatous organs or clinical evidence of iron‑related organ/tissue dysfunction. Genetic identification of HFE or non‑HFE mutations is encompassed (s7(2)(b)(i)-(ii)).
• Prove, on the balance of probabilities, that at least one of the factors listed in s9 existed prior to the clinical worsening and that it was related to relevant service (s9; s10(1)). The SoP explicitly sets the causation standard as "on the balance of probabilities" in s8 and s9.
• Quantify alcohol consumption using the Australian Standard (ten grams of alcohol per standard drink) where alcohol is relied upon as a factor (Notes to s9). For males, demonstrate at least 60 kilograms of alcohol consumed within any five‑year period before clinical worsening (s9(1)); for females, at least 40 kilograms in any five‑year period (s9(2)).
• Where the claimant relies on infection with hepatitis C virus or steatohepatitis, demonstrate that the condition was present at the time of the clinical worsening (s9(3)-(4)).
• If reliance is placed on inability to obtain appropriate clinical management, provide evidence supporting that inability (s9(5)).

Rights and decision‑maker duties:

• The SoP states the RMA's expert view on the medical‑scientific evidence (s8) and supplies the criteria that decision‑makers must apply when determining whether HH or death from HH is related to relevant service under the specified claim provisions (s5). Decision‑makers are not given new discretionary powers by the SoP beyond applying these criteria; rather they must treat the RMA’s specified factors as the medical test for connection.
• Where a listed factor overlaps with a condition covered by another SoP, decision‑makers must apply the factors in that other SoP as they stand from time to time (s11). This imposes a duty on administrators to cross‑check relevant SoPs and apply the most current text.

Constraints on the application of factors and related duties:

The instrument is a statement of medical principles rather than a statute that creates criminal offences, civil penalties, or administrative sanctions. The text contains no enforcement provisions, fine schedules, or penal clauses. Its enforcement effect is administrative and indirect: the SoP provides the RMA’s medical criteria that decision‑makers use to determine whether hereditary haemochromatosis or death from hereditary haemochromatosis is connected with relevant service under the statutory claims pathways identified in s5 (section 120B of the VEA and section 339 of the MRCA). Consequently, the practical enforcement mechanism is denial or acceptance of entitlement claims under those Acts based on the RMA’s criteria.

Operationally, the SoP modifies the evidentiary benchmark applied by administrators and adjudicators in claims processing. If a claimant cannot establish, on the balance of probabilities, one or more of the factors listed in s9 that are related to relevant service (s10(1)), a decision‑maker will lack the RMA‑identified grounds to accept HH as service‑connected within the SoP framework. The result for the claimant may be denial of a claim or reduced prospects of establishing material contribution or aggravation. Conversely, where the SoP’s criteria are satisfied, a decision‑maker may find a service connection, which triggers whatever entitlements are available under the VEA or MRCA, as governed by those Acts. The SoP itself does not describe those entitlements or the processes for administering them.

Because the SoP may interact with other RMA Statements (s11), administrative enforcement can involve cross‑application of criteria from other SoPs when a listed factor concerns an injury or disease covered elsewhere. Decision‑makers must therefore enforce compliance with multiple SoPs as relevant to a particular claim.

There is no provision in this instrument for civil sanctions for non‑compliance with the SoP’s content by medical practitioners, claimants, or administrators. Any penalties or enforcement measures arise only as downstream consequences of claim decisions under the VEA or MRCA, or under any statutory provisions in those Acts that authorise sanctions for false statements, non‑disclosure, or fraudulent claims; those provisions are outside the text of this SoP.

The RMA’s statement (s8) that the view is based on "sound medical‑scientific evidence" indicates the SoP is intended to be the authoritative medical position for administrative causation. Enforcement is therefore implemented through administrative application of an expert medical standard rather than through direct punitive measures in the instrument itself.

The SoP is expressly framed to operate within the statutory architecture of the VEA and MRCA. It is made under subsection 196B(3) of the VEA (s3), and it applies to claims to which section 120B of the VEA or section 339 of the MRCA applies (s5). The instrument therefore serves as an evidentiary and medical benchmark for determining causation in the administrative processes created by those Acts. It does not, on its face, create or modify rights or obligations under other Acts; rather, it informs how decision‑makers apply the VEA and MRCA causation provisions.

Inter‑SoP interaction is handled directly by s11. If a factor in s9 refers to an injury or disease that is the subject of another SoP determined under s196B(3) of the VEA, 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" (s11). This creates a dynamic linkage: overlapping conditions or comorbidities will be assessed using the contemporaneous text of the relevant SoP(s). Administratively, decision‑makers must cross‑reference SoPs to ensure consistent application where factors intersect.

The SoP references but does not substitute for ICD coding. Section 7(3) notes that hereditary haemochromatosis attracts ICD‑10‑AM code E83.1, and s7(4) clarifies that in applying the SoP a reference to an ICD‑10‑AM code means the code assigned in the specified edition of the ICD‑10‑AM (Tenth Edition, effective 1 July 2017). However, s7(3) also states that the meaning of HH for this SoP is that given in s7(2). That means ICD coding is an ancillary reference but the statutory definition controls the SoP’s scope.

The Schedule defines "relevant service" in a way that maps to categories in the VEA and MRCA, and thereby limits the pool of claims to which the SoP can be applied (Schedule 1). Because the SoP’s factors apply only where HH was suffered or contracted before or during relevant service (but did not arise out of service) (s10(2)), the instrument delineates which factual scenarios under the VEA/MRCA are to be handled under its criteria versus other analytical routes in those Acts for conditions arising out of service.

The SoP does not reference other federal, state or territory health or compensation legislation beyond the VEA and MRCA. It does not purport to override clinical guidelines, medical practice standards, privacy or health records regimes, or statutory appeal mechanisms in the VEA/MRCA claim processes. Administrative procedures for claim lodgement, evidence gathering, decision review, appeals and other rights are governed by the VEA and MRCA and their regulations; the SoP supplies medical criteria to be applied within those procedures.

The instrument contains limited internal amendment history. It is dated 24 December 2020 and commences 25 January 2021 (s2; instrument heading). Section 4 expressly repeals the previous Statement of Principles concerning haemochromatosis No. 22 of 2012 (Federal Register of Legislation No. F2012L00451) that was also made under subsection 196B(3) of the VEA. The text therefore records a replacement of the 2012 Statement with this 2021 Statement (s4).

No subsequent amendments, schedules of variation, or transitional provisions are included within the instrument itself. The instrument does not state any savings, grandfathering clauses, or how existing decisions under the repealed SoP should be treated; it simply repeals the earlier SoP. Any transitional or retrospective application would need to be assessed against the VEA/MRCA administrative rules or guidance external to this SoP; the SoP itself contains no such guidance.

Because the instrument states in s11 that factors from other Statements apply "as in force from time to time," it anticipates that other SoPs may be amended and that the operative cross‑references will pick up contemporaneous amendments. However, this SoP’s own amendment record within its text is limited to the explicit repeal of SoP No. 22 of 2012 and the new commencement date.

The RMA seal and signatory certification are part of the instrument’s formal record: the instrument bears the common seal of the Repatriation Medical Authority affixed at direction of the Chairperson and is dated (instrument heading). That formal attestation is the instrument’s record of adoption rather than an amendment history item.

If future amendments are made to the SoP, they would presumably be published as new instruments under the same subsection of the VEA and would amend or replace this text; none are recorded within the current instrument. Practitioners working with claims should therefore confirm they are using the current instrument in force and whether any subsequent Statements have amended the RMA’s position or repealed this Statement after its commencement date.

The instrument itself contains no litigation history. It does not refer to any court decisions, nor does it record appeals or judicial review outcomes. The text names no cases and makes no mention of any prior judicial interpretation of the earlier SoP or this replacement instrument. The absence of litigation references in the instrument means that, within the scope of this text, there is no recorded case law that has considered or interpreted the RMA’s definitions, factors or the effect of the SoP.

Practitioners should therefore treat the SoP as an administrative expert instrument in force from 25 January 2021 (s2), replacing the 2012 instrument (s4), and recognise that any judicial authority that may exist or arise will be recorded and considered outside the text of the SoP. This instrument does not itself supply background about disputes, reviews, or precedents, nor does it enumerate any administrative rulings or determinations that applied the prior SoP.

Because the SoP is to be applied within the claim processes under the VEA and MRCA (s5), any litigation or tribunal decisions that later interpret how the SoP should be applied in particular factual circumstances would be consequential for practitioners and claimants. However, those authorities are external to and not referenced by this instrument. The SoP’s silence on litigation history is therefore an absence of recorded judicial engagement in the instrument itself, not evidence that no litigation exists; it simply means any such litigation is not documented within this statutory text.

The instrument contains several features that can produce unintended evidentiary or administrative consequences if overlooked. These are points where careful attention to the SoP’s language and structure is required.

1. Alcohol thresholds are specified in kilograms of alcohol over five years (s9(1)-(2)), with the calculation note referencing ten grams of alcohol per standard drink. The unit choice is unusual and requires conversion. For example, 60 kilograms of alcohol equals 60,000 grams; at ten grams per standard alcoholic drink (note to s9), that represents 6,000 standard drinks over any five‑year period for a male claimant relying on s9(1). For females, 40 kilograms equals 4,000 standard drinks over a five‑year period. These are high cumulative totals. Practitioners must ensure any calculation evidence ties reported drinks or consumption records to the SoP’s ten‑gram standard and the five‑year retrospective window measured against the clinical worsening point identified in the claim.

2. The temporal anchor is the "clinical worsening of hereditary haemochromatosis," which the notes describe as typically manifesting as hepatic fibrosis or cirrhosis (notes to s9). The SoP therefore focuses causal assessment on progression events rather than initial diagnosis of HH. Failure to identify and document the date and medical character of the clinical worsening event could undermine a causal argument, because the eligibility of s9 factors hinges on their timing in relation to that worsening.

3. The definition of hereditary haemochromatosis requires documented iron overload in parenchymatous organs or clinical evidence of iron‑related organ or tissue dysfunction (s7(2)(a)). Genetic mutation alone is not sufficient under the statutory definition unless the clinical/biochemical manifestations are present. A claimant relying only on genetic test results without demonstrating organ iron overload or organ dysfunction may not meet the SoP’s definition.

4. Section 10(2) limits s9 factor application to HH that was "suffered or contracted before or during (but did not arise out of) the person's relevant service." This means that where a claimant alleges HH arose out of service, the s9 list for material contribution/aggravation does not apply. Parties must distinguish between HH arising out of service and HH aggravated by service. The SoP creates different routes: the s9 factors are for aggravation/material contribution to pre‑existing or contracted‑before/during conditions, not for primary causation arising out of service.

To align a claim with the SoP and maximise its prospect of satisfying the RMA’s criteria, the following practical steps, grounded in the instrument’s text, should be followed:

1. Establish the SoP diagnosis using the statutory definition. Assemble medical evidence that shows hereditary haemochromatosis as defined in s7(2). This means either documented iron overload in parenchymatous organs or clinical evidence of iron‑related organ/tissue dysfunction. Include imaging, liver biopsy reports, serum ferritin and transferrin saturation levels, specialist hepatology or haematology reports, and genetic testing that identifies HFE or non‑HFE mutations as applicable (s7(2)(a)-(b)).

2. Identify and document the "clinical worsening" event and its date. The SoP frames causation in relation to the clinical worsening of HH, noted as typically manifesting as hepatic fibrosis or cirrhosis (notes to s9). Provide clinical notes, diagnostic imaging, histopathology, or specialist letters that date the onset or recognition of fibrosis, cirrhosis or another iron‑related organ dysfunction that constitutes the clinical worsening.

3. Quantify and evidence alcohol consumption when relied upon. If relying on s9(1) or s9(2), obtain contemporaneous records, workplace alcohol testing data, alcohol treatment records, general practice notes, or validated consumption histories that permit conversion to the SoP’s unit. Apply the SoP’s calculation base: ten grams of alcohol per standard alcoholic drink (note to s9). Prepare a clear spreadsheet or affidavit that converts reported drinking into total grams and kilograms of alcohol over relevant five‑year windows preceding the clinical worsening. For males, the threshold is at least 60 kg over any five years before the clinical worsening; for females, 40 kg (s9(1)-(2)).

4. Demonstrate presence of hepatitis C or steatohepatitis at time of clinical worsening when relied upon. For s9(3) and s9(4), provide laboratory evidence of active hepatitis C infection (PCR, RNA tests) or histological/clinical evidence of steatohepatitis contemporaneous with the worsening event. Ensure the records show presence at the relevant point in time rather than remote history.

5. If relying on inability to obtain appropriate clinical management (s9(5)), document attempts to obtain care and the barriers encountered. This may include referral letters, appointment records showing delays or cancellations, correspondence indicating lack of specialist availability, refusal of service, or records of living in locations without access. Because the SoP does not define "appropriate clinical management", provide expert medical evidence explaining what management was clinically indicated and how the absence of that management plausibly contributed to clinical worsening.