Statement of Principles concerning Wilson disease (Balance of Probabilities) (No. 48 of 2023)

The central legal and medical concepts in the instrument are defined and constrained within the text. Key concepts are:

• Wilson disease: Defined in section 7(2) as a genetic disorder of copper metabolism characterised by impaired biliary copper excretion and toxic accumulation of copper in organs, for the purposes of the SoP. The SoP therefore confines itself to that diagnostic description; any determination under the VEA/MRCA process must engage that definition when applying the SoP.
• Death from Wilson disease: Expanded beyond immediate terminal events to include death from a terminal event or condition that was contributed to by the person’s Wilson disease (section 7(3)). The Schedule gives examples of terminal events (pneumonia, respiratory failure, cardiac arrest, circulatory failure, cessation of brain function).
• Relevant service: Defined in Schedule 1 to mean one of three categories , (a) eligible war service (other than operational service) under the VEA; (b) defence service (other than hazardous service and British nuclear test defence service) under the VEA; or (c) peacetime service under the MRCA. The SoP therefore applies only to claims that arise from these specified categories of service (Schedule 1).
• Factors that must exist: The instrument identifies a closed list of two factors which must exist, at minimum, for the connection to be established on the balance of probabilities (section 9). Those factors are limited to (1) pregnancy at the time of clinical worsening of Wilson disease; and (2) inability to obtain appropriate clinical management for Wilson disease.
• Relationship to service: Section 10 requires that any factor in section 9 must be related to the person’s relevant service. Subsection 10(2) further confines the SoP to material contribution to, or aggravation of, Wilson disease where the disease was suffered or contracted before or during, but did not arise out of, the relevant service. Thus the SoP is expressly not framed to determine causation where the disease itself arose out of service.
• Interaction with other Statements: Section 11 provides that if a section 9 factor refers to an injury or disease covered by another SoP, then the factors in that other SoP apply in accordance with that SoP as in force from time to time.

The instrument’s stated evidentiary posture is “balance of probabilities.” Section 8 records the RMA’s view, grounded in the “sound medical‑scientific evidence available,” that it is more probable than not that Wilson disease and death from Wilson disease can be related to relevant service. The SoP operationalises that view into the specified factors claimants must establish, and the limits on application identified above.

These concepts together create a structured causation test: diagnosis within the defined medical concept, establishment of at least one enumerated factor, proof that the factor is related to the defined relevant service, and that the disease pre‑existed or was present during service (but did not arise out of it). For death claims, the causal chain can run through a terminal event to which Wilson disease contributed.

The instrument applies to claims to which section 120B of the VEA or section 339 of the MRCA applies (section 5). Those references identify the population whose claims are governed by the SoP; the instrument itself defines “relevant service” narrowly in Schedule 1 so the population affected is further constrained to persons whose service falls into one of the three enumerated categories: eligible war service (excluding operational service), defence service (excluding hazardous service and British nuclear test defence service), and peacetime service under the MRCA.

Directly affected persons are therefore:

• Veterans or members of the Forces seeking to establish, for the purposes of the VEA/MRCA claims process, that Wilson disease (as defined in section 7(2)) is connected with their relevant service; and
• Dependants or estates making death claims where death is alleged to be from Wilson disease or where Wilson disease is alleged to have contributed to a terminal event causing death (section 7(3) and Schedule 1).

Indirectly affected parties include medical practitioners and medico‑legal experts who will be asked to provide evidence: the SoP identifies medical facts and causation factors decision‑makers will use when assessing claims. Decision‑makers within the Department or tribunal considering VEA/MRCA claims will apply the SoP’s criteria; the RMA itself made the instrument (section 3), but it is the SoP’s instructional force in claims processes that affects outcomes.

Not affected (by design) are persons whose Wilson disease arose out of their relevant service. The SoP explicitly applies only to “material contribution to, or aggravation of, Wilson disease where the person's Wilson disease was suffered or contracted before or during (but did not arise out of) the person's relevant service” (section 10(2)). This drafting delimits claims where the SoP is operative.

Geographically or jurisdictionally, the instrument speaks to Australian statutory claims under the VEA and MRCA frameworks only; it is made under subsection 196B(3) of the VEA and names MRCA in the schedules, so its application is within that statutory architecture (section 3; Schedule 1).

The repeal of the previous SoP (No. 34 of 2015) by this instrument (section 4) affects any pending or future claims that might have relied on the earlier SoP: from the commencement date this instrument supersedes the earlier one for those claims covered by the VEA/MRCA provisions cited.

This SoP creates no criminal offences or civil fines; rather it sets out the legal and evidential duties that claimants must satisfy for Wilson disease or death from Wilson disease to be accepted as connected with relevant service under the VEA or MRCA. The principal duties and operative rights in the text are:

• Duty to establish factors: A claimant seeking acceptance under the relevant claim provisions must establish that at least one of the factors in section 9 exists. The SoP is explicit that “At least one of the following factors must exist before it can be said that, on the balance of probabilities, Wilson disease or death from Wilson disease is connected with the circumstances of a person's relevant service” (section 9). That requirement functions as an evidentiary duty on claimants.
• Standard of proof: The SoP is framed around the balance of probabilities standard. Section 8 records the RMA’s view that “it is more probable than not” that Wilson disease can be related to relevant service and section 9 adopts the threshold language “on the balance of probabilities.” Thus the right to have a claim accepted turns on establishing facts to that civil standard.
• Duty to show relationship to service: Section 10 requires the existence of any section 9 factor to be “related to the relevant service rendered by the person.” Therefore, beyond proving that, for example, pregnancy coincided with clinical worsening, a claimant must show the link between that factor and the person’s relevant service. The SoP instructs decision‑makers to consider not only the factor in isolation but also its relation to the defined relevant service.
• Limitation on temporal relationship: Subsection 10(2) confines the SoP to situations where Wilson disease was “suffered or contracted before or during (but did not arise out of) the person's relevant service.” This creates a duty for the claimant to demonstrate the timing of onset relative to service. The SoP is not framed to attribute primary causation where the disease arose out of service.
• Right to rely on other SoPs: Section 11 provides that where a section 9 factor refers to an injury or disease covered by another SoP, those other SoP factors “apply in accordance with the terms of that Statement of Principles as in force from time to time.” This affords claimants the right to have inter‑SoP linkages considered and to rely on the ongoing terms of other Statements where relevant.

Operationally, the SoP imposes duties mainly on claimants and on decision‑makers: claimants must marshal the specified evidence to satisfy the listed factors and their relation to relevant service, and decision‑makers must apply these criteria when assessing medical causation in claims under the cited provisions. The RMA’s role is to set the SoP (section 3), not to make claim determinations; the SoP functions as an evidentiary instrument used in those determinations.

The instrument does not create procedural rights such as timeframes, review rights, or appeal mechanisms; those are governed by the VEA/MRCA and their associated procedural rules, which are outside the text provided. It also does not specify compensation quantum or entitlement categories; it only prescribes causation criteria.

The Statement of Principles contains no penalties, fines, or criminal sanctions. It is not an enforcement instrument in the penal sense; rather it is a determinate, statutory medical-causal framework that must be applied within the relevant claims process under the VEA and MRCA (section 5). Enforcement and consequences therefore arise only through the claims adjudication mechanisms that sit in the VEA/MRCA frameworks, which are outside the instrument’s text.

What the SoP does enforce, substantively, is a binding evidentiary rule for decision‑makers who apply these Statements in the context of claims. The RMA’s position as the maker of the SoP is statutory (section 3) and the instrument is made under subsection 196B(3) of the VEA. In practice, the SoP functions as a directive that:

• Sets the causation thresholds decision‑makers should apply to determine whether Wilson disease or death from Wilson disease is “connected” with relevant service. Sections 8 and 9 show that unless the enumerated factors exist and are related to relevant service in accordance with section 10, connection cannot be said to exist on the balance of probabilities.
• Replaces a prior SoP about Wilson’s disease (section 4). From the commencement date (section 2), decision‑makers must apply this instrument rather than Statement No. 34 of 2015.

The instrument does not itself provide inspection, sanction, or penalty mechanisms for non‑compliance by providers, hospitals, or others. If a claimant fails to satisfy the SoP’s criteria, the likely practical enforcement outcome is a refusal or negative finding in the relevant claims process; the SoP does not prescribe the administrative consequences beyond its application in that claims context.

Because the SoP cross‑refers to other Statements of Principles where section 9 factors invoke other injuries or diseases (section 11), enforcement of causation for complex claims will also depend on the content of any other applicable SoPs in force. Implementation risks and interpretive disputes about the meaning of factors , for example, what constitutes “inability to obtain appropriate clinical management” , will typically be resolved within the claims administration and review mechanisms provided by the VEA/MRCA, not by penalties set in this document.

The instrument is embedded in the VEA/MRCA statutory architecture and explicitly links to other Statements of Principles. The key interactions in the text are:

• Statutory basis: The SoP is made under subsection 196B(3) of the VEA (section 3). The document therefore functions as a statutory instrument intended to be applied in the adjudication of claims under the VEA and, by cross‑reference, the MRCA (section 5).
• Application to specific claim provisions: Section 5 says the instrument “applies to a claim to which section 120B of the VEA or section 339 of the MRCA applies.” The SoP must therefore be read and applied in conjunction with the substantive and procedural provisions of those sections; those Acts (VEA, MRCA) and the cited sections determine who may claim, what is claimable, and what administrative processes apply. The SoP does not restate or replace those claim provisions; it supplies the causation criteria that decision‑makers use when applying those provisions.
• Definitions drawn from the Acts: Schedule 1 defines MRCA and VEA by reference to the statutes and defines “relevant service” using categories that are statutory in character. That ties the SoP’s scope to the statutory definitions and exclusions contained in the VEA and MRCA architecture (Schedule 1).
• Interaction with other Statements of Principles: Section 11 expressly deals with cross‑SoP interaction. If a section 9 factor in this SoP “refers to an injury or disease in respect of which a Statement of Principles has been determined” then the other Statement’s factors “apply in accordance with the terms of that Statement of Principles as in force from time to time.” This provides an ongoing, dynamic linkage: the current terms of other SoPs govern how their factors are used to satisfy or interpret an attribute of a section 9 factor in this SoP.
• Temporal and causal limits relative to service law: Section 10(2) places a temporal/causal interaction limit , the SoP’s factors apply only to material contribution or aggravation where Wilson disease was suffered or contracted before or during, but did not arise out of, the relevant service. That interacts with the wider legal tests in the VEA/MRCA regarding when a disease “arises out of” service or is “service‑related”, meaning that if an adjudicator determines a disease arose out of service, this SoP’s factors (as drafted) would not be the operative route to acceptance for material contribution/aggravation , other legal tests or SoPs may then be relevant.

Because the SoP is a medical causation instrument, it assumes the existence of broader administrative and procedural frameworks in the VEA and MRCA that govern claim lodgement, evidence, review, and appeal. The SoP does not rework those processes; it provides the medical criteria that intersect with them. Any change to the VEA or MRCA provisions determinative of claim process, review rights, or benefit categories would interact with this SoP in a way that is not specified in the instrument itself.

Finally, the express repeal of the earlier Wilson’s disease SoP (No. 34 of 2015) means that, from commencement, this instrument is the operative SoP for claims covered by the cited sections. Decision‑makers must therefore apply its wording and cross‑references rather than the terms of the repealed 2015 instrument (section 4).

The SoP records its own creation and immediate legislative ancestry within its short text. The concrete amendment and instrument history in the document is:

• Made by the Repatriation Medical Authority under subsection 196B(3) of the VEA, dated 24 April 2023 (as shown in the instrument header and signature block) (section 3 and instrument preamble).
• Commencement is fixed at 23 May 2023 (section 2). From that date the instrument is operative for relevant claims.
• The instrument expressly repeals the Statement of Principles concerning Wilson’s disease No. 34 of 2015, recorded in the Federal Register of Legislation as F2014L01849 (section 4). That repeal indicates this instrument replaces the prior SoP on the same subject for the statutory purposes identified.

No further amendments, transitional provisions, or savings clauses are contained in the text provided. There is no schedule of historical amendments prior to the 2015 instrument included in this document. The only explicit historical reference is to the previous SoP being repealed by this instrument.

Because the instrument cross‑refers to “other Statements of Principles as in force from time to time” (section 11), the effective substantive content of causation for particular claims may change over time as other SoPs are revised or replaced. That means the operational effect of this instrument, in relation to other injuries/diseases it references, may vary with future amendment or repeal of those other SoPs. The instrument itself, however, provides no mechanism for incremental amendment; any future change would be effected by a new SoP instrument under the same statutory power (subsection 196B(3) VEA) or by amendment to the underlying statutes.

Because the instrument contains no transitional rules, the repeal clause (section 4) and the commencement date (section 2) define the amendment history succinctly: as of 23 May 2023, this instrument supplants the 2015 statement for claims covered by sections 120B of the VEA or 339 of the MRCA.

The instrument contains no citations to, or references to, any judicial decisions or tribunal determinations. It does not name any cases and includes no litigation history. The SoP therefore has no in‑text record of being considered, interpreted, or tested by courts or reviewers as at the date of the instrument.

Two consequences follow from the absence of litigation history in the instrument:

• Interpretive issues arising from the SoP’s language (for example, the scope of “inability to obtain appropriate clinical management” in section 9(2), the meaning of “related to the relevant service” in section 10, or the proper application of the temporal limitation in section 10(2)) remain matters for administrative application and potential future review. Such issues would be resolved in the statutory decision process under the VEA/MRCA and, if disputed, in any available merits or judicial review processes contained in those Acts, but no authority or precedent is supplied within this instrument itself.
• Where a section 9 factor refers to another injury or disease covered by a separate SoP, section 11 makes those other SoPs’ factors applicable “as in force from time to time.” Because the instrument contains no litigation history, it does not provide guidance on how courts or tribunals have previously reconciled cross‑SoP interactions. Future litigation or tribunal decisions could clarify cross‑application, but no such history is contained in the text.

For practitioners, the practical implication is that factual disputes about whether a claimant has satisfied the SoP will be litigated solely against the statutory wording and the underlying evidentiary record (medical notes, service records, etc.), and any jurisprudential development will come from later cases and determinations interpreting these or related SoPs. As of the instrument’s date and text there are no reported decisions to cite about its application.

The instrument is concise but several features create points of interpretive or evidential difficulty for claimants, advisers and decision‑makers. These are concrete, source‑grounded observations:

• Narrow, enumerated factors: Section 9 limits the necessary factors to two items: pregnancy at the time of clinical worsening, and inability to obtain appropriate clinical management. There is no catch‑all or broader “any other relevant factor” provision. If a claimant cannot supply evidence that one of these two factors existed and was related to relevant service, the SoP says connection cannot be established on the balance of probabilities. The closed list can therefore be decisive.
• Temporal/causal exception: Section 10(2) restricts application to situations where Wilson disease was “suffered or contracted before or during (but did not arise out of) the person's relevant service.” Practically, if an adjudicator finds that Wilson disease “arose out of” service (a legal finding outside the SoP’s text), then these section 9 factors will not be the route to acceptance for material contribution or aggravation. That phrasing requires careful factual and legal assessment of onset timing and causal origin.
• Limited definition of “relevant service”: Schedule 1 defines “relevant service” narrowly and excludes operational service from “eligible war service” and excludes hazardous service and British nuclear test defence service from “defence service.” Practitioners should not assume the SoP applies to all kinds of military service; the Schedule’s exclusions can preclude the SoP’s application to certain claimants.
• Ambiguity in “inability to obtain appropriate clinical management”: The SoP provides no definition, criteria, or examples of what constitutes “appropriate clinical management” or what level of “inability” suffices. That gap leaves significant interpretive discretion to decision‑makers and invites factual disputes about access to care, standards of care at time‑relevant points, and whether the care available was “appropriate” for Wilson disease management.
• Pregnancy timing requirement: The pregnancy factor is tied to the moment of “clinical worsening” of Wilson disease (section 9(1)). Adjudicators will therefore need medical evidence pinpointing intervals of clinical stability and worsening, and evidence of pregnancy status at the relevant time. Clinical records must support these temporal links; absence of precise records may be fatal to a claim relying on this factor.
• Cross‑SoP complexity: Section 11 mandates that if a section 9 factor refers to an injury or disease covered by another SoP, that other SoP’s factors apply “as in force from time to time.” In practice, this can generate complexity where multiple SoPs interact and where one SoP is amended while a claim is live. Claimants and advisers must track current terms of related SoPs and be prepared to show how the cross‑referenced factors are satisfied.
• Death causation chain: Section 7(3) allows death from Wilson disease to include death from a terminal event to which Wilson disease contributed, and Schedule 1 provides examples of terminal events. However, proving contribution to a terminal event requires evidence of the causal chain from Wilson disease to the terminal event. Decision‑makers will need medical causation evidence linking Wilson disease to the listed terminal events; mere presence of Wilson disease on a death certificate may not suffice absent a demonstrated contribution.
• Repeal and transitional considerations: The instrument repeals the 2015 SoP (section 4). Practitioners should verify which SoP was in force at the time a claim was lodged or a relevant medical event occurred, as the instrument contains no transitional provisions in the text provided. Where events straddle the repeal/commencement date, administrative practice will determine which SoP applies; the SoP text itself does not supply transitional rules.
• No procedural prescription: The SoP does not specify evidentiary forms, burdens beyond “balance of probabilities,” or process for resolving disputes over the meaning of factors. Those procedural elements are governed by the VEA/MRCA frameworks, so practitioners must ensure compliance with the relevant Acts’ procedural requirements and evidence rules outside the SoP.

Each of these “gotchas” arises directly from the instrument’s definitional choices, limits on factors, and absence of clarifying detail within the SoP text. They are operational issues that will affect the practical course of claims and will require careful evidence‑gathering and argument in adjudicative forums.

For claimants, advisers, and decision‑makers, compliance means preparing and considering evidence in line with the SoP’s explicit requirements. The following steps, grounded in the instrument’s terms, outline the practical evidence and argument that will be material.

1. Confirm jurisdictional applicability

   • Verify the claim falls under section 120B of the VEA or section 339 of the MRCA (section 5). The SoP applies only to claims to which those statutory provisions apply; ensure the claim is within their ambit before applying the SoP.
   • Confirm the person’s service falls within the SoP’s definition of “relevant service” (Schedule 1). Check whether the service is: eligible war service (other than operational service), defence service (other than hazardous service and British nuclear test defence service), or peacetime service under the MRCA. If service is of a type excluded by the Schedule’s wording, this SoP will not apply.

2. Establish the medical diagnosis

   • Obtain contemporaneous medical records, specialist letters, diagnostic test results, and expert reports confirming a diagnosis consistent with the SoP’s definition of Wilson disease (section 7(2)). The SoP defines Wilson disease for its purposes; claims should be supported by medical evidence demonstrating the diagnosis and its manifestations (liver, brain, etc.).

3. Identify and prove at least one section 9 factor

   • If relying on pregnancy (section 9(1)), assemble obstetric records, pregnancy test results, antenatal notes, and clinical documentation demonstrating the timing of pregnancy relative to the documented clinical worsening of Wilson disease. Records should show the date(s) of clinical deterioration and evidence the person was pregnant at that time.
   • If relying on inability to obtain appropriate clinical management (section 9(2)), collate evidence demonstrating attempts to access care and the nature of the care available. This may include referral letters, clinic wait times, correspondence noting service denial or absence of specialist services, records of travel barriers, timelines showing missed or delayed interventions, and contemporaneous clinical notes describing the impact of management gaps. Because “appropriate clinical management” is undefined in the SoP, practitioners should assemble objective evidence of the local standard of care at the relevant time and why the available care was inadequate for managing Wilson disease.

4. Demonstrate relationship to relevant service

   • The claimant must link the factor to relevant service (section 10(1)). Evidence may include service records showing where and when the person served, posting histories, records of access to medical services while in service, and contemporaneous medical complaints or incidents that connect the factor (for example, lack of access to specialist care while posted) to the relevant service period. Where the factor is inability to obtain management, connect that inability to conditions of service (service location, available facilities, or administrative barriers) if relevant.

5. Satisfy temporal constraints

   • Show that Wilson disease was suffered or contracted before or during relevant service, and that it did not “arise out of” the service if the claim is for material contribution or aggravation (section 10(2)). Provide evidence of disease onset dates, diagnostic milestones, and medical histories that place the disease onset relative to service dates.

6. For death claims, establish contribution to the terminal event

   • If the claim concerns death, obtain clinical cause‑of‑death documentation, medical records leading to death, and expert opinion linking Wilson disease to the terminal event or condition listed in Schedule 1. Demonstrate a causal contribution by medical evidence showing how Wilson disease materially contributed to the terminal event.

7. Where section 9 factors reference other injuries/diseases, apply cross‑SoP factors

   • If a section 9 factor invokes another disease covered by another SoP, identify that SoP and ensure the claim satisfies its factors “as in force from time to time” (section 11). Collect evidence required by the other SoP and track any amendments to that SoP during the claim period.

8. Prepare for interpretive disputes

   • Anticipate areas of possible administrative discretion: the meaning of “appropriate clinical management,” the quality and sufficiency of medical evidence documenting “clinical worsening,” and the standard required to show a factor is “related to” relevant service. Draft witness statements, affidavits, and expert reports that address these interpretive gaps explicitly and provide comparative standards where possible.

9. Recordkeeping and contemporaneous evidence

   • Because the SoP requires factual proof on the balance of probabilities, contemporaneous records (medical notes, appointment letters, referrals, service postings, correspondence) will be critical. Where records are thin, obtain explanatory witness evidence from treating clinicians or service colleagues who can attest to the relevant circumstances.

10. Monitor which SoP is in force and important dates

• Note that this instrument repealed the 2015 SoP and commenced on 23 May 2023 (sections 2 and 4). If events or evidence pre‑date the commencement and the 2015 SoP may have different factors, carefully assess which SoP is applicable at the relevant time and whether transitional administrative practice applies.

By following these steps, claimants and their advisers can align evidentiary preparation with the explicit requirements of the SoP: a confirmed diagnosis within the definitional frame of section 7(2), proof of at least one enumerated factor in section 9, a clear link between that factor and the person’s defined relevant service per section 10, and any cross‑SoP matters resolved under section 11.

Careful documentation of attempts to obtain care, precise dating of clinical worsening, and robust expert medical opinion focused on the causal links the SoP requires will be determinative in satisfying the instrument’s requirements.