Statement of Principles concerning Paget disease of bone (Reasonable Hypothesis) (No. 62 of 2023)

The primary legal and medical concepts established or clarified by this instrument are set out in Part 7 and the Schedule. These concepts are the reference point that decision makers must use when assessing whether a reasonable hypothesis exists linking Paget disease of bone or death from Paget disease to relevant service.

Paget disease of bone is defined as "a focal disease of bone at single or multiple sites, with repeated episodes of accelerated bone resorption followed by disorganised new bone formation, resulting in bone of impaired integrity and structure" (s 7(2)). The instrument notes common clinical manifestations and sites in the explanatory note in subsection 7(2). Although the ICD‑10‑AM code M88 is noted, the operative meaning is the textual definition in s 7(2), with the ICD reference used only as a cross‑classification (s 7(3)-(4)).

Death from Paget disease of bone is included where death resulted from a terminal event or condition to which the disease contributed (s 7(5)). The Schedule defines "terminal event" as proximate or ultimate causes of death, and provides examples including pneumonia, respiratory failure, cardiac arrest, circulatory failure, and cessation of brain function (Schedule 1, terminal event). This inclusion makes explicit that causal contribution to a terminal event is within scope.

Causation in this SoP is operationalised through a "reasonable hypothesis" standard. The instrument requires that at least one factor in section 9 exist before a reasonable hypothesis can be said to be raised (s 9). The only enumerated factor is inability to obtain appropriate clinical management for Paget disease of bone before clinical worsening (s 9(1)). That factor is linked to relevant service by section 10, which requires that the factor be related to the relevant service rendered, and limits the use of the inability-to-obtain-management factor to cases of material contribution or aggravation where the disease was suffered or contracted before or during relevant service but did not arise out of it (s 10(1)-(2)).

The instrument also sets interaction rules for cross‑referenced conditions: if a factor in this SoP refers to an injury or disease covered by another SoP, the factors in that other SoP apply in accordance with its terms (s 11). The Schedule defines MRCA, VEA, and the detailed categories of "relevant service" (operational, peacekeeping, hazardous, British nuclear test defence service under the VEA; warlike and non‑warlike service under the MRCA) (Schedule 1, relevant service).

This Statement of Principles affects three categories of actors directly, as specified in the instrument: persons lodging claims under the VEA or MRCA; the Repatriation Medical Authority as the issuing body; and the administrative decision makers who apply SoPs when adjudicating claims.

Persons bringing claims. The instrument applies to "a claim to which section 120A of the VEA or section 338 of the MRCA applies" (s 5). Those provisions in the primary statutes govern when and how Repatriation Commission or other decision makers must have regard to Statements of Principles when determining whether a disease or death is connected to service. The corollary is that veterans, members of Peacekeeping Forces or members of the Forces whose claims fall under those statutory hooks are the primary claimants affected. The Schedule defines "relevant service" and thus delimits which categories of service render a claim within scope (Schedule 1, relevant service).

The Repatriation Medical Authority. The RMA is the authorising body that made this instrument under its delegated statutory power (s 3). The instrument records the RMA’s view that "there is sound medical‑scientific evidence" indicating that Paget disease and death from it can be related to relevant service (s 8). The RMA therefore sets the medical framework that administrative decision makers will apply.

Decision makers under the VEA and MRCA. While the instrument itself does not name the decision making offices, by operation of s 5 and the made-under authority in s 3, the SoP will be used by decision makers who must adjudicate entitlement claims under the referenced statutory provisions. These decision makers must determine whether a "reasonable hypothesis" has been raised connecting Paget disease (or death from it) to relevant service, based on the existence of the factor(s) enumerated in s 9 and their relationship to service per s 10.

Indirectly affected parties include medical practitioners and service record administrators. Decisions will turn on clinical characterisation of disease and on timing and access to management, as defined in the SoP (s 7, s 9). The instrument’s emphasis on inability to obtain appropriate clinical management before clinical worsening necessarily focuses attention on medical treatment history and access during the relevant timeframe. The Schedule’s definition of terminal event is also important for cases involving death (s 7(5); Schedule 1).

The instrument repeals the prior SoP (s 4). That repeal means applicants and decision makers must rely on the new instrument for claims commencing on or after its commencement date (s 2). The new SoP’s narrower or different framing of factors will therefore change the evidentiary and legal frame for new determinations as of 25 July 2023.

This instrument does not itself create duties enforceable by criminal sanction; rather it defines the medical and factual criteria that decision makers must apply when assessing whether a reasonable hypothesis exists connecting Paget disease of bone, or death from it, to relevant service, for claims under the VEA or MRCA (s 5). The principal "duties" implicit in the instrument are the obligations on decision makers to apply the SoP’s definitions and factors when determining entitlement claims and the corollary obligation on claimants to establish the existence of the enumerated factor(s) and their relationship to relevant service.

Duty of RMA to publish SoP under statutory authority. The instrument was made by the RMA under subsection 196B(2) of the VEA (s 3). The RMA’s view that there is sound medical‑scientific evidence linking Paget disease and death from it to relevant service is recorded as the evidentiary basis for this SoP (s 8). The RMA therefore performs the statutory duty of producing medical guidance for subsequent determinations.

Duty of decision makers to apply SoP to specified claims. By its application clause the instrument binds the claims process for matters within the statutory hooks of section 120A VEA and section 338 MRCA (s 5). Those primary statute provisions set the procedural duties for decision makers; this instrument supplies the medical criteria they must apply. The SoP requires decision makers to ask whether at least one factor in s 9 exists and whether it is related to relevant service per s 10. Where factors in this SoP refer to other SoPs, the decision maker must apply the factors in those other SoPs as in force from time to time (s 11).

Rights of claimants. Claimants have the opportunity to raise a reasonable hypothesis that Paget disease or death from it is connected to relevant service by demonstrating the requisite factor(s) and service relationship (s 9, s 10). The instrument also specifies that death from Paget disease includes death where the disease contributed to a terminal event or condition (s 7(5) and Schedule 1), so claimants in fatality cases may rely on contribution to listed terminal events in their causation arguments.

Limits and qualifiers on duties and rights. The instrument narrowly defines the factor set: only the inability to obtain appropriate clinical management before clinical worsening is listed (s 9(1)). Section 10(2) qualifies that this factor applies only to material contribution to, or aggravation of, Paget disease where the disease was suffered or contracted before or during, but did not arise out of, relevant service. This imposes a temporal and causal limitation on the claimant’s ability to use that factor to establish a reasonable hypothesis.

No penal or enforcement regime in the SoP itself. The instrument does not prescribe penalties, sanctions, or enforcement measures. Its function is evidentiary and definitional within the statutory claims framework. The primary statutory instruments (VEA and MRCA) will govern entitlement determinations and any downstream enforcement related to entitlements, but those provisions are not reproduced in this instrument.

The Statement of Principles does not create criminal or civil penalties, nor does it set out an enforcement regime in this instrument. It is a medical‑evidentiary instrument made under subsection 196B(2) of the Veterans' Entitlements Act 1986 and, as such, supplies criteria for adjudication of claims rather than imposing sanctions (s 3; s 5). There are no provisions in the instrument that authorise penalties for non‑compliance with the SoP, nor does it prescribe enforcement mechanisms like inspections, notices, fines, or other coercive measures.

Enforcement, to the extent it exists, is procedural and operational within the claims system. The SoP sets the factual and medical benchmarks that decision makers must consider when deciding whether a reasonable hypothesis has been raised that Paget disease of bone, or death from it, is related to relevant service (s 9; s 10). The practical "enforcement" effect is that if a decision maker accepts the requisite factor(s) and relationship, an entitlement decision under the VEA or MRCA framework may follow; conversely if the factor(s) and relation are not established, liability for entitlement will not be found. Those outcomes are governed by the VEA and MRCA statutory schemes, not by sanctions contained in the SoP itself (s 5).

Administrative review and merits processes. The instrument does not set out appeal or review mechanisms. Any appeal, review or merits reconsideration rights will arise under the VEA and MRCA or their associated administrative review regimes, rather than under this instrument. The SoP will be evidence that decision makers and review bodies must consider when applying the statutory test for service connection under sections referenced in s 5.

Record keeping and procedural effects. The SoP’s criteria focus on the existence of a particular factor,"inability to obtain appropriate clinical management for Paget disease of bone before the clinical worsening" (s 9(1)),and the relationship to relevant service (s 10). Administrative consequences for parties follow from whether this factual and medical standard is met during claims processing. The instrument itself does not mandate how decisions are recorded, what evidence must be collected, or how long records must be retained.

Copyright and classification statements. The instrument notes the ICD‑10‑AM reference and identifies the edition and copyright holder for the classification system (s 7(4)). That is a bibliographic and definitional statement and does not constitute an enforcement provision in the SoP, although decision makers will use the referenced classification in clinical cross‑referencing.

This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986 (s 3) and expressly applies to claims to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004 applies (s 5). Therefore the SoP operates within, and is dependent on, the statutory frameworks of the VEA and the MRCA. The SoP supplies medical‑scientific criteria that decision makers must apply when those statutes require consideration of Statements of Principles.

Cross‑reference to other Statements of Principles. Section 11 provides an operative rule for interactions among SoPs: where a factor in this SoP refers to an injury or disease that is itself the subject of another SoP, the factors in that other SoP apply in accordance with its terms as in force from time to time (s 11). That establishes a hierarchy of relevance rather than a unilateral rule: the instrument permits decision makers to incorporate the content of other SoPs where cross‑referenced factors require it. The clause ensures that the most recently valid terms of other SoPs govern the cross‑referenced matters.

Interaction with diagnostic classification systems. The instrument acknowledges the ICD‑10‑AM code M88 as associated with Paget disease of bone but makes plain that for the purposes of the SoP the definition in subsection 7(2) controls (s 7(3)). The instrument also identifies the edition and effective date of the ICD‑10‑AM and cites its copyright owner (s 7(4)). That interaction is bibliographical and definitional; the SoP does not import any broader legal effect from the ICD classification beyond cross‑reference.

Temporal interaction with past instruments. The instrument repeals the earlier Statement of Principles concerning Paget’s disease of bone No. 49 of 2015 (s 4). Repeal replaces the prior SoP with the current instrument from its commencement date (s 2). Claims and decisions made after commencement will therefore be governed by the new SoP rather than the repealed instrument. The instrument does not itself direct transitional arrangements; any transitional operation will be determined by the VEA/MRCA claims processes in practice.

Scope vis‑à‑vis primary statutes. The SoP does not create entitlement or procedural rights independently of the VEA or MRCA. Its role is to define medical and factual criteria for use under the statutory provisions that require or permit reliance on Statements of Principles. Consequently, interaction with other laws governing evidence, administrative decision making, review rights, and entitlement calculation will be governed by those statutes rather than by the SoP itself (s 5).

Definitions and statutory terms. The Schedule provides definitions of MRCA, VEA, relevant service categories and terminal event (Schedule 1). Those definitions determine the SoP’s intersection with the statutory categories used in the VEA and MRCA and therefore affect which persons and which events fall within the statutory hooks identified in s 5.

The instrument records its key dates and replacement of a prior instrument. It was dated 23 June 2023 (instrument header) and commences on 25 July 2023 (s 2). The Repatriation Medical Authority affixed its common seal to the instrument at the direction of the Chairperson, as recorded in the instrument. The instrument explicitly repeals the earlier Statement of Principles concerning Paget’s disease of bone No. 49 of 2015 (Federal Register of Legislation No. F2015L00255) (s 4). The new instrument is identified as No. 62 of 2023.

There is no text within this instrument that records earlier amendments to the 2015 instrument other than the repeal. The instrument does not include schedules of amendment history beyond noting the repeal or list any prior variations. It does not include a transitional provision clause that would prescribe how previously decided claims are to be treated following commencement. Consequently, from the commencement date the 2015 SoP is no longer in force and the 2023 instrument is the operative Statement of Principles for Paget disease of bone for claims falling within s 5.

The instrument refers to the ICD‑10‑AM classification, specifying the Tenth Edition with an effective date of 1 July 2017 as the edition referenced (s 7(4)). That bibliographic reference can be treated as a fixed point in the instrument. The instrument also includes a Schedule of definitions that codifies the meanings of MRCA, VEA, relevant service and terminal event at the time of making. Any future amendments to those external instruments or to other SoPs referenced under s 11 could change the application of factors that cross‑refer to other instruments, because s 11 requires factors in other SoPs to apply "as in force from time to time".

The instrument records no internal amendment mechanism. Any future changes to the content of this SoP would require the Repatriation Medical Authority to make a further statement under subsection 196B(2) of the VEA and to publish and commence that statement. The instrument itself is silent on review periods, scheduled updates, or a legislative sunset.

The instrument contains no litigation history references. It does not cite case law, judicial decisions, or tribunal determinations. There are no judicially reported matters or administrative appeals recorded within the text of the instrument. The only legal authorities mentioned are statutory: the Veterans' Entitlements Act 1986 (under which the instrument is made) and the Military Rehabilitation and Compensation Act 2004 (the MRCA) which is referred to for application of the SoP (s 3; s 5; Schedule 1).

Because no cases or decisions are named, the instrument offers no judicial interpretation or precedent within its text. Any litigation or administrative review that may arise from application of this SoP will appear in external records of the tribunals and courts and is not summarised here. The instrument’s silence on litigation history means that practitioners must look to the primary statutory regimes and to external tribunal and court decisions for precedential guidance on how decision makers apply Statements of Principles in contested cases.

The instrument records the RMA’s medical‑scientific view that there is sound evidence supporting the connection between Paget disease and relevant service (s 8). That statement is evidentiary and administrative. Whether tribunals or courts accept the RMA’s SoP reasoning in particular disputes will depend on how decision makers and reviewers apply the statutory reasonable hypothesis test in specific fact patterns. Such adjudicative material will be found in case law and tribunal reasons outside the instrument, because the instrument itself contains no litigation references.

This SoP contains a number of specific drafting choices and limitations that materially affect how it will be applied. Practitioners and claimants should note these features and the sections that frame them.

Single enumerated factor. The SoP lists only one factor that can raise a reasonable hypothesis: "inability to obtain appropriate clinical management for Paget disease of bone before the clinical worsening of Paget disease of bone" (s 9(1)). There are no alternative factors in this instrument. That means a claimant must show that at least this factor existed and that it is related to relevant service (s 9; s 10(1)). The limited factor set can be a decisive gate: where neither inability to obtain appropriate management nor a cross‑referenced factor exists, a reasonable hypothesis may not be raised under this SoP.

Temporal and causal limitation for aggravation. Section 10(2) narrows the applicability of the inability‑to‑obtain‑management factor to cases of material contribution or aggravation where the Paget disease was suffered or contracted before or during relevant service but did not arise out of it. In practical terms the SoP distinguishes between disease arising out of service and disease materially contributed to or aggravated by service through lack of management. The instrument therefore does not treat inability to obtain management as a basis for a claim where the disease arose out of service. The precise statutory language must be observed when framing causation arguments (s 10(2)).

ICD code not determinative. Although the instrument acknowledges that Paget disease of bone attracts ICD‑10‑AM code M88, it states that the meaning of the disease for this SoP is the textual definition in subsection 7(2) (s 7(3)). Practitioners should therefore rely on the textual medical definition in the SoP rather than on a mere diagnostic code as determinative of the SoP’s coverage. The instrument also cites a specific ICD edition (Tenth Edition, effective 1 July 2017) and its copyright holder, which is a bibliographic detail but does not alter the operative textual definition (s 7(4)).

Death inclusion via terminal events. The SoP expressly includes death from Paget disease where death was contributed to by the disease via a terminal event or condition (s 7(5)). The Schedule provides examples of terminal events, such as pneumonia and respiratory failure (Schedule 1, terminal event). It is important to note that the instrument links death coverage to contribution to terminal events rather than to any broader notion of contributory cause; practitioners must ensure that factual arguments map to the Schedule’s definition.

Interaction with other SoPs. If the sole factor in s 9 refers to an injury or disease that is covered by another SoP, the factors in that other SoP apply as in force from time to time (s 11). That creates a potential complexity: the operative content of cross‑referenced factors may change over time as other SoPs are amended. Practitioners must check the current text of any cross‑referenced Statements of Principles.

Repeal of previous SoP. The 2015 SoP is repealed (s 4). Parties relying on earlier interpretations or evidentiary frameworks embodied in the 2015 instrument must verify whether those assumptions survive under the new 2023 instrument. The repeal may change the available factors or the interpretive approach.

Narrow concept of "inability to obtain appropriate clinical management". The instrument does not elaborate what constitutes "appropriate clinical management" nor does it define the threshold for "inability to obtain" or for "clinical worsening". Those terms are left to assessment by decision makers in individual circumstances. Practitioners should therefore be prepared to frame factual material to show how the particular facts meet the textual criteria in s 9(1) and to connect them to relevant service per s 10.

Definition of relevant service. The Schedule contains a precise list of the service categories that constitute relevant service for the SoP (Schedule 1, relevant service). Differences between operational, peacekeeping, hazardous, British nuclear test defence service, warlike and non‑warlike service may be material to whether the SoP applies to a given claimant because s 5 links the instrument’s application to statutory claims procedures.

No transitional text. The instrument contains no express transitional or savings provisions describing treatment of pending claims or previously decided matters. The repeal and commencement clauses (s 2; s 4) therefore require attention to administrative practice and to the primary statutes for guidance on transitional treatment.

Compliance in this context means framing a claim or an adjudicative submission in a way that meets the SoP’s textual thresholds so that a reasonable hypothesis that Paget disease or death from Paget disease is connected to relevant service is raised under the statutory claims processes referenced in s 5. The instrument defines what must exists and how it must be related to service; practitioners should structure submissions to address each element expressly set out in the SoP.

1. Identify the statutory hook. Confirm that the claim falls under section 120A of the VEA or section 338 of the MRCA so that the SoP applies (s 5). If a claim does not fall under those provisions, the instrument will not govern the decision.

2. Establish the medical definition. Ensure the condition being claimed matches the textual definition of Paget disease of bone in subsection 7(2). The operative definition is the textual one, not merely the ICD code (s 7(2)-(3)). For fatality cases, show how death resulted from a terminal event or condition to which Paget disease contributed, using the Schedule’s definition of terminal event where relevant (s 7(5); Schedule 1).

3. Demonstrate the factor in s 9(1). The SoP requires at least one factor from section 9 to exist to raise a reasonable hypothesis (s 9). In this instrument the sole enumerated factor is inability to obtain appropriate clinical management for Paget disease of bone before clinical worsening (s 9(1)). Submissions should therefore explicitly link factual materials to that textual criterion and explain how the claimant’s circumstances satisfy it.

4. Connect the factor to relevant service. Section 10(1) requires that the factor be related to the relevant service rendered by the person. If relying on aggravation or material contribution, verify the temporal limitation in s 10(2): the inability‑to‑obtain‑management factor applies only where the person’s Paget disease was suffered or contracted before or during, but did not arise out of, the relevant service. Address this sequencing and causal framing clearly.

5. Check for cross‑referenced SoPs. If the factor relied upon refers to an injury or disease that is covered by another SoP, apply the factors of that other SoP as they are in force at the time (s 11). That requires checking the current text of any cross‑referenced Statements of Principles.

6. Use the Schedule definitions. The Schedule defines MRCA, VEA, relevant service categories and terminal event. Ensure submissions align with these statutory meanings rather than colloquial or non‑statutory usages (Schedule 1).

7. Be mindful of the ICD reference. While the ICD‑10‑AM code M88 is noted, the SoP’s operative definition remains textual (s 7(3)-(4)). Use the ICD classification for clinical mapping as appropriate, but anchor legal argumentation to the SoP’s words.

8. Address absence of guidance on certain terms. The SoP does not define "appropriate clinical management", "inability to obtain", or "clinical worsening". In the absence of definitional detail, submissions should explain how the available facts and medical evidence meet the ordinary meaning of these terms in the context of the SoP and link that explanation to the required relationship to relevant service.

9. Consider timing and repeal. The instrument commenced on 25 July 2023 and repealed the 2015 SoP (s 2; s 4). For claims near the transition, confirm which instrument governed the decision period in question. The SoP itself contains no transitional provisions; practitioners should check administrative practice and the primary statutes for transitional treatment.

10. Prepare to address evidentiary gaps. The SoP prescribes factual thresholds rather than procedural evidence rules. Decision makers will look for factual material showing the existence of the factor(s) and their relationship to service (s 9; s 10). Submissions should therefore set out a coherent factual narrative that maps available evidence onto the SoP criteria, and flag any cross‑referenced SoPs relied upon under s 11.

These steps follow directly from the instrument’s operative text. The SoP does not prescribe documentary checklists or procedural forms. Compliance is therefore achieved by aligning factual and medical submissions with the textual tests in sections 7, 9, 10 and the Schedule, and by ensuring the claim falls within the statutory application in section 5.