Statement of Principles concerning hereditary spherocytosis (Reasonable Hypothesis) (No. 41 of 2023)

The instrument contains a small number of core legal and medical concepts that structure its operation. Each concept is defined or referenced in the body of the SoP and the Schedule 1 - Dictionary. The main concepts are:

• Hereditary spherocytosis: Defined in s7(2) as a group of genetic disorders of red blood cells producing spherical cells that are susceptible to haemolysis. Clinical manifestations listed as examples include haemolytic anaemia, jaundice and splenomegaly. The instrument also notes the ICD‑10‑AM code D58.0 applies to the condition but states that, for the purposes of the SoP, the statutory definition in s7(2) governs (s7(2)-(4)).

• Death from hereditary spherocytosis: Treated as the condition including death from a terminal event or condition that was contributed to by the person's hereditary spherocytosis (s7(5)). The Schedule 1 - Dictionary defines "terminal event" as the proximate or ultimate cause of death and gives examples such as pneumonia, respiratory failure, cardiac arrest, circulatory failure, and cessation of brain function (Schedule 1).

• Relevant service: Defined in Schedule 1 to include various forms of service under the VEA and MRCA: operational, peacekeeping, hazardous, British nuclear test defence service under the VEA, and warlike and non-warlike service under the MRCA (Schedule 1). The instrument applies to claims to which s120A of the VEA or s338 of the MRCA applies (s5).

• Reasonable hypothesis and factors: The instrument implements the statutory concept of a "reasonable hypothesis" by prescribing the factors that must, at minimum, exist to raise that hypothesis for hereditary spherocytosis (s9). Those factors are narrowly framed and temporally specific: acute viral infection within six weeks before clinical worsening (s9(1)); pregnancy within six weeks before clinical worsening (s9(2)); inability to obtain appropriate clinical management (s9(3)). The instrument requires that the existence of any such factor be related to the person's relevant service (s10(1)), and clarifies that these factors apply to material contribution or aggravation only where the hereditary spherocytosis was suffered/contracted before or during (but did not arise out of) relevant service (s10(2)).

• Cross-reference to other Statements: If a factor refers to another injury or disease for which an SoP exists, that other SoP applies according to its terms (s11).

• Administrative authority and temporal effect: The RMA made the SoP under subsection 196B(2) of the VEA (s3); the instrument commences on a stated date (s2) and repeals an earlier specific SoP (s4). The instrument is an administrative determination about the evidentiary and causal nexus required in claims processes, not a primary statute or a code of clinical standards beyond the factors it prescribes.

These concepts structure who must show what, and when. The instrument is compact and focused on causal criteria. It provides definitional clarity for the condition and for terminal events, establishes a short list of qualifying factors and a temporal window for those factors, and establishes the requirement that the factor be related to relevant service. It does not elaborate evidentiary standards for proving those factors, nor does it define "clinical worsening" or "appropriate clinical management" within the text. It also does not itself set out the decision-making procedures under the VEA or MRCA beyond stating the SoP applies to claims covered by specific sections of those Acts.

The instrument affects three principal groups by its scope and terms: claimants (veterans and former members), decision-makers and administrators applying the VEA/MRCA claims provisions, and the Repatriation Medical Authority as the rule-making body.

• Claimants and their representatives: The SoP applies to "a claim to which section 120A of the VEA or section 338 of the MRCA applies" (s5). Those references identify the subset of claims under the two Acts for which the RMA's SoP operates as the medical-causation framework. The text uses the Schedule definition of "relevant service" to specify the kinds of service that can give rise to claims: operational, peacekeeping, hazardous, British nuclear test defence (VEA), and warlike and non-warlike (MRCA) service (Schedule 1). A person lodging such a claim for hereditary spherocytosis or death from hereditary spherocytosis must engage with the SoP's prescribed factors in s9 and the relationship-to-service requirement in s10(1) and s10(2).

• Decision-makers: Administrative decision-makers who determine whether there is a "reasonable hypothesis" that the condition is related to service must apply the SoP's terms to the facts of the claim. The instrument specifies which factors, if established and related to service, are sufficient as a minimum to raise the reasonable hypothesis (s9). If a factor refers to an injury or disease that another SoP covers, decision-makers must apply that other SoP according to its terms (s11). The RMA is explicit that the instrument is made under the authority of subsection 196B(2) of the VEA (s3), signalling that RMA determinations are the relevant administrative source for medical causation criteria in this statutory context.

• The Repatriation Medical Authority: The RMA is both the maker of the instrument and, by s8, the body asserting the medical-scientific basis for the SoP. The instrument bears the RMA's view that "there is sound medical-scientific evidence" indicating hereditary spherocytosis and death from it can be related to relevant service (s8). The RMA also repealed the prior SoP and provided the new set of factors that will be operative for claims from the commencement date (s4).

The instrument does not expressly affect other actors (for example, treating clinicians, hospitals, or insurers) beyond how their records may be used in evidence, because it makes no procedural or regulatory obligations on third parties. It does not itself define consequences in terms of benefits paid or liability, that instead remains governed by the VEA and MRCA processes to which this SoP applies (s5). The instrument’s definitions and narrow list of qualifying factors mean that claimants whose cases do not meet those factors as a minimum will not, on the basis of this SoP alone, satisfy the reasonable-hypothesis requirement; conversely, claimants who can establish the factor(s) and a service relationship must have that considered in the statutory claims process.

The instrument prescribes substantive criteria rather than procedural duties or explicit rights. Its operative legal effect is to set the minimum factual-medical criteria that must exist to raise the "reasonable hypothesis" connecting hereditary spherocytosis (or death from it) to relevant service for the purposes of specified claims under the VEA and MRCA (s9). The key obligations and entitlements that follow from that structure are as follows.

Duties or obligations implicit in the instrument

• To demonstrate a qualifying factor: A claimant wishing to rely on hereditary spherocytosis in a claim covered by s120A VEA or s338 MRCA must establish at least one of the three factors in s9 as a minimum threshold: acute viral infection within six weeks of clinical worsening (s9(1)); pregnancy within six weeks of clinical worsening (s9(2)); inability to obtain appropriate clinical management (s9(3)). The instrument sets these as the threshold facts that must exist before the reasonable hypothesis can be said to be raised.

• To relate the factor to relevant service: The instrument requires that any such factor "must be related to the relevant service rendered by the person" (s10(1)). Thus the claimant must put forward facts that connect the factor to a form of relevant service as defined in Schedule 1 (operational, peacekeeping, hazardous, British nuclear test defence, warlike, or non-warlike service).

• Temporal and causal limits: The factors of s9 apply only to material contribution to or aggravation of hereditary spherocytosis where the hereditary spherocytosis was suffered or contracted before or during (but did not arise out of) the relevant service (s10(2)). That imposes an implicit duty on claimants to demonstrate that the condition pre-dated or existed during service, or was contracted earlier, rather than having arisen as a direct result of service.

Rights and entitlements implicit in the instrument

• Right to have the SoP applied: Persons with claims covered by s120A VEA or s338 MRCA have the right to have this SoP used to assess whether a reasonable hypothesis exists tying hereditary spherocytosis (or death from it) to their relevant service. The instrument is the operative RMA statement for these claims from commencement (s5, s2).

• Right to rely on other SoPs where relevant: If a factor in s9 refers to an injury or disease for which another SoP exists, the claimant is entitled to have that other SoP applied according to its terms (s11). This means cross-references to other SoPs can expand or refine how a particular factor is assessed, as a matter of RMA practice incorporated in the instrument.

What the instrument does not do (important negative duties/limits)

• It does not set procedural duties on RMA or Departmental staff for evidentiary standards, timing, or appeals; those processes remain in the VEA/MRCA legislative scheme. The SoP does not prescribe how to prove "clinical worsening", or what constitutes "appropriate clinical management", nor how to prove inability to obtain it; these terms are used without definition in the instrument (see s9(1)-(3), s10).

• It does not itself create criminal or civil penalties, nor does it prescribe payment rates or entitlement outcomes. It is an evidentiary/causation tool to be used within the statutory claims framework (s5).

In sum, the instrument imposes a factual burden on claimants to establish at least one factor and a service link, grants the right to have these specific criteria applied by decision-makers for particular claims, and leaves procedural matters and entitlement determinations to the VEA and MRCA processes into which the SoP dovetails.

The Statement of Principles instrument itself contains no provisions imposing penalties, sanctioning behaviour, or specifying enforcement mechanisms. Its text is confined to medical definitions, the identification of factors that raise a reasonable hypothesis relating hereditary spherocytosis to relevant service, commencement and repeal of a previous instrument, and a dictionary of terms. Relevant textual authorities: s3 (authority under s196B(2) VEA), s4 (repeal), s5 (application to claims), s7 (definition of the condition and death), s8 (RMA view as to evidence), s9-s11 (factors and relationships), and Schedule 1 (definitions). None of these sections create penal offences or administrative sanctions.

Enforcement in practice therefore operates indirectly through the VEA and MRCA claims processes to which the SoP applies. The instrument expressly applies to claims to which section 120A of the VEA or section 338 of the MRCA applies (s5). Those statutory provisions (not reproduced in this instrument) will contain the procedural, review and appeal mechanisms, and any consequences for entitlement or benefit payment. The SoP is a component of the medical-causation assessment that administrative decision-makers apply in adjudicating claims; it informs whether the threshold of a reasonable hypothesis is met. But the instrument does not specify the procedural steps by which decision-makers use it, nor does it specify remedies, penalties, or enforcement mechanisms for non-compliance by third parties.

Because the instrument prescribes factors and definitions (including a defined list of terminal events in Schedule 1), enforcement or effect is operationalised when an administrative decision-maker uses the SoP as the medical-causation standard in adjudicating claims under the VEA/MRCA. Any formal sanctions, remedies, reassessments, or entitlements flow from those Acts and their associated administrative processes rather than from the SoP text itself. The instrument therefore functions as an evidentiary or determinative instrument within an administrative framework that contains its own enforcement and review mechanisms, but the instrument does not itself create or describe those mechanisms.

The instrument is expressly designed to operate within and attach to the VEA/MRCA legislative framework and to reference other Statements of Principles where relevant. The text contains a number of explicit cross-references and definitional linkages.

• Statutory authority and application: The instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986 (s3). It applies to a claim to which section 120A of the VEA or section 338 of the MRCA applies (s5). Therefore its legal effect is as a medical-causation instrument to be used in the decision-making processes governed by those Acts, rather than as free-standing primary legislation.

• Repeal of prior RMA instrument: The instrument repeals the Statement of Principles concerning hereditary spherocytosis No. 67 of 2015 (s4). That means decision-makers must apply No. 41 of 2023 from its commencement date (s2), and not the prior 2015 instrument, for claims to which it applies.

• Interaction with other SoPs: Section 11 provides an explicit mechanism for inter-SoP interaction: if a factor in s9 refers to an injury or disease in respect of which another SoP has been determined under subsection 196B(2) of the VEA, then the factors in that other SoP apply according to its terms as in force from time to time. This creates a rule-of-recognition for cross-referenced medical conditions and tethering between RMA instruments.

• Medical classification reference (ICD‑10‑AM): The instrument states that while hereditary spherocytosis attracts ICD‑10‑AM code D58.0, in applying the SoP the meaning is that given in s7(2) (s7(3)). It further defines the particular ICD edition referenced (Tenth Edition, effective 1 July 2017) and provides a copyright attribution (s7(4)). This links the SoP to a recognised international classification for purposes of coding and record alignment, but the statutory definition prevails for application of the SoP.

• Definitions of relevant service: The Schedule 1 - Dictionary aligns the SoP to particular categories of service under the VEA and MRCA (operational, peacekeeping, hazardous, British nuclear test defence for VEA; warlike and non-warlike for MRCA). That creates an explicit intersection between the SoP and the service categories in those Acts.

• Absence of procedural or penalty provisions: The instrument does not itself set procedural rules, appeal rights or penalties; those are found in the VEA and MRCA. Consequently, the SoP is a substantive evidentiary instrument that must be applied alongside the procedural architecture of the Acts to which it is tied. Any tension or gap between what the SoP requires to raise a reasonable hypothesis and the procedural or evidentiary rules in the VEA/MRCA must be resolved within the statutory decision-making and review mechanisms of those Acts.

In practical terms, decision-makers will apply the SoP together with the procedural and evidentiary rules in the VEA/MRCA. Where a factor in s9 implicates another injury/disease covered by a separate SoP, the other SoP's terms take effect (s11). The instrument therefore fits as a component in a network of RMA instruments and statutory provisions, with definitional and temporal alignment dictated by the Schedule.

The instrument records a limited but specific amendment history and lifecycle as set out in its text.

• New instrument number and date: The Statement of Principles concerning hereditary spherocytosis (Reasonable Hypothesis) is designated No. 41 of 2023 and is dated 24 April 2023 (s1 and the front matter). It commences operation on 23 May 2023 (s2). The common seal is noted as affixed at the direction of the RMA Chairperson (front matter).

• Repeal of prior instrument: Section 4 expressly repeals the Statement of Principles concerning hereditary spherocytosis No. 67 of 2015 (Federal Register of Legislation No. F2015L00649), which was previously made under subsection 196B(2) of the VEA. The repeal is specific and identifies the earlier instrument by number (s4). No transitional provisions are contained in the instrument text about claims pending at the time of commencement; the implication of s4 is that the 2015 SoP is no longer in force as of the commencement date in relation to claims to which the new instrument applies.

• Authority and mechanism for amendment: The instrument is made under subsection 196B(2) of the VEA (s3). That subsection is the statutory mechanism by which the RMA determines Statements of Principles. Any further amendments or future repeals to this SoP would, by the same statutory design, be effected by new RMA determinations made under the same statutory power.

• No other amendments recorded: The instrument does not record prior amendments to the 2015 SoP beyond the repeal, and it does not incorporate schedules for staged repeal or phased application. It contains the definitions and operative factors that will be current from the stated commencement date (s2). There are no provisions in this instrument amending the VEA or MRCA themselves.

• Cross-SoP relationship: Section 11 provides that if a factor in this SoP refers to an injury/disease covered by another SoP, then the factors in that other SoP apply "as in force from time to time". This clause implicitly allows for future changes to other SoPs to have effect in relation to cross-references from this instrument without necessitating amendment of this instrument for that purpose.

In summary, the amendment history recorded in the text is narrowly focused: a replacement instrument (No. 41 of 2023) commences on a fixed date and repeals a specified 2015 instrument. The statutory authority is cited. No transitional or savings rules appear in the text, and future changes would follow the RMA's statutory process.

The instrument contains no references to case law, judicial review, or litigation. It does not cite or summarise any judicial decisions, nor does it record any disputes or determinations arising from prior practice that led to its making. The text is purely an RMA determination of medical-causation criteria and cross-references only to other administrative instruments and statutory provisions (s3, s5, s11).

Because the instrument does not include or reproduce any litigation history, and because it states only the RMA's view that "there is sound medical-scientific evidence" (s8) without identifying specific authorities, there is no litigation material contained in the instrument itself. Any judicial or administrative decisions that interpret or apply this SoP would be found in case law or administrative determinations outside the text; such materials are not part of this instrument and are not referenced in it.

Practitioners needing litigation history relevant to how these SoPs have been interpreted in claims decisions must therefore consult decisions under the VEA and MRCA administrative review and judicial review processes, which are external to this instrument. The instrument does provide the precise text that decision-makers and courts will consider when addressing causation questions for hereditary spherocytosis in claims to which the SoP applies, but it contains no account of how courts or tribunals have previously treated such SoPs or the particular factors listed in s9.

The instrument is concise and narrowly focused, and that brevity creates a number of practical pitfalls or sources of uncertainty for claimants, decision-makers and advisers. These are matters to watch for when preparing or assessing claims governed by this SoP.

• Narrow, specific factors: The instrument requires at least one of the three listed factors in s9 to "as a minimum exist" to raise a reasonable hypothesis. The list is deliberately short and temporally constrained: acute viral infection or pregnancy must occur "within the 6 weeks before the clinical worsening" (s9(1)-(2)). If a claimant cannot establish one of these factors (or inability to obtain appropriate clinical management under s9(3)), the SoP provides no alternative pathway to raise the reasonable hypothesis. The SoP therefore focuses adjudication on narrowly framed temporal and clinical events.

• Undefined terms: Key terms that matter to proof are left undefined. For example, the instrument refers to "clinical worsening" without defining what constitutes clinical worsening, how it is to be measured, or what documentation suffices to show it (s9(1)-(2)). "Inability to obtain appropriate clinical management" is also not defined; the instrument does not specify what counts as "appropriate" management, what degree of unavailability or refusal is sufficient, or what causal link to service must be shown (s9(3)). These undefined terms will leave scope for administrative discretion and may be the focal point of dispute between claimants and decision-makers.

• Temporal limits and onset rules: Section 10(2) limits application of the s9 factors "only to material contribution to, or aggravation of, hereditary spherocytosis where the person's hereditary spherocytosis was suffered or contracted before or during (but did not arise out of) the person's relevant service." That is a specific rule: if the hereditary spherocytosis arose out of service (i.e. directly caused by service), the s9 factors do not apply under this SoP. Practitioners must be alert to the wording "did not arise out of" because it requires demonstrable pre-existence or contraction at a time other than as an injury arising out of service.

• Relationship-to-service proof requirement: Section 10(1) requires that the existence of any factor in s9 "must be related to the relevant service rendered by the person." The instrument does not describe what evidentiary standard or kind of causal connection will suffice. Claimants must therefore both prove the factor itself (for example, an acute viral infection within the 6-week window) and also tie that factor to a service episode as defined in Schedule 1. The SoP does not provide a method for establishing that causation, leaving it to the procedural processes of the VEA/MRCA.

• Cross-SoP dependence: Section 11 makes factors that refer to other injuries/diseases subject to the terms of those other SoPs. This can be a complexity rather than a simplification: when a factor implicates another SoP, claimants may need to apply multiple SoPs, each potentially with its own definitional gaps or temporal windows. Section 11 imports other instruments "as in force from time to time", so changes to other SoPs after the commencement of this instrument can affect how cross-referenced factors are treated.

• Repeal of the 2015 SoP: Section 4 repeals the earlier No. 67 of 2015 instrument. If a claim straddles the commencement date, or relies on evidentiary or definitional language in the old instrument, practitioners must ensure they are applying the new instrument (No. 41 of 2023) from the commencement date (s2) and not relying on the 2015 text.

• No procedural guidance: The instrument does not provide procedural guidance about how evidence is to be collected, what records are decisive, or how to resolve medical conflicts. Administrative practice and the VEA/MRCA procedural legislation must be consulted for those matters. The absence of guidance increases the risk of divergent interpretations by decision-makers.

• ICD coding is subordinate to statutory definition: While s7(3) notes that hereditary spherocytosis attracts ICD‑10‑AM code D58.0, it also provides that the meaning used for the SoP is that in s7(2). Therefore reliance on medical coding alone without reference to the statutory definition (s7(2)) may be insufficient.

These features combine to create a tight, technical test that is simple in words but potentially complicated to prove in practice because of undefined but consequential terms, temporal constraints, and cross-references. Advisers should plan evidence strategies that address both the narrow factors and the service link, and be prepared to frame arguments about what "clinical worsening" and "appropriate clinical management" mean in the claimant’s case because the instrument itself does not provide those definitions.

Complying with the instrument in the course of making or assessing a claim requires focusing on the elements the SoP sets out and aligning the evidentiary record to those elements. The instrument prescribes what must be shown, not how to show it, so compliance is about proving the facts the SoP requires and ensuring those facts are related to relevant service. The following steps describe what to assemble and demonstrate, grounded in the instrument’s text.

1. Confirm applicability of the SoP to the claim

• Check that the claim is one "to which section 120A of the VEA or section 338 of the MRCA applies" (s5). The instrument applies only where those statutory claim provisions are engaged. Identify whether the claimant’s facts fall within the relevant service definitions in Schedule 1.

2. Establish the diagnosis and statutory meaning of hereditary spherocytosis

• Ensure the medical record supports the condition as defined in s7(2): a genetic disorder of red blood cells producing spherical red blood cells susceptible to haemolysis. While ICD‑10‑AM code D58.0 is acknowledged (s7(3)-(4)), documentation should address the statutory definition (s7(2)) and clinical manifestations such as haemolytic anaemia, jaundice or splenomegaly if present. For death claims, evidence must show the death was from a terminal event or condition contributed to by the hereditary spherocytosis (s7(5)), and consideration should be given to the Schedule 1 list of terminal events.

3. Prove at least one qualifying factor in s9

• s9(1): If relying on an acute viral infection, obtain medical records demonstrating diagnosis or clinical evidence of an acute viral infection within six weeks before the documented clinical worsening of hereditary spherocytosis. The instrument requires the infection to be within the six-week window before clinical worsening.

• s9(2): If relying on pregnancy, obtain obstetric records, antenatal notes or hospital records showing pregnancy within six weeks before clinical worsening.

• s9(3): If relying on inability to obtain appropriate clinical management, assemble contemporaneous records that show attempts to access care, referrals and responses, and any systemic barriers. Note the instrument provides no definition of "appropriate clinical management", so records should describe the usual standard of care and how it was unavailable or inaccessible in the claimant’s case.

4. Demonstrate the temporal and causal relationship to relevant service

• For any factor relied upon, show how its existence is related to the person's relevant service (s10(1)). This requires aligning the timing and circumstances of the factor with the service episodes defined in Schedule 1 (operational, peacekeeping, hazardous, British nuclear test defence, warlike, or non-warlike service). For example, if inability to obtain appropriate clinical management is alleged as related to an overseas posting, supply records showing the posting dates, local medical capacity issues, and contemporaneous medical notes.

• Remember s10(2): the s9 factors apply only where the hereditary spherocytosis was suffered or contracted before or during (but did not arise out of) the relevant service. Establish that the condition pre-existed or was contracted before/during service and was not caused by the service itself.

5. Address cross-references to other SoPs where necessary

• If a s9 factor implicates another injury/disease for which an SoP exists, identify that other SoP and evaluate its terms because s11 provides that the other SoP's factors apply according to its terms. Practically, this may mean assembling evidence that also matches the cross-referenced SoP.

6. Anticipate and document "clinical worsening"

• Because "clinical worsening" is not defined, provide clear medical narratives showing baseline status, objective measures of deterioration (haemoglobin levels, symptoms, hospital admissions, transfusion records) and dates. Link the deterioration to the factor relied upon within the six-week windows in s9(1)-(2).

7. Prepare to explain undefined standards

• Given the absence of definitions for "appropriate clinical management" and "clinical worsening", prepare medico-legal opinions that define these terms in the claimant’s clinical context and explain why the evidence meets those definitions. The instrument explicitly leaves such terms undefined, so tailored clinical explanation will be useful.

8. Be mindful of the repeal and the operative date

• For claims around the commencement date, confirm which SoP governed the claim at the relevant time. The new SoP commences on 23 May 2023 and repeals the 2015 SoP (s2, s4). Where a claim’s relevant events or decisions straddle that date, note which instrument is operative under the procedural rules of the VEA/MRCA.

9. Use the SoP as a checklist in decision drafting

• Decision-makers should explicitly reference the SoP sections when assessing reasonable hypothesis: confirm diagnosis per s7, identify factor(s) per s9, assess service relationship per s10, and note any cross-reference under s11. That will make transparent whether the SoP’s statutory minima are met.

10. Realistic evidentiary planning

• Gather contemporaneous clinical records, service records showing dates and locations, hospital admission records, laboratory data indicative of haemolysis and haemoglobin trends, pregnancy records if relevant, and correspondence demonstrating inability to obtain care if relying on s9(3). While the SoP does not prescribe evidence formats, these document types map directly to the factual elements required by the instrument.

In short, compliance means assembling medical and service evidence that aligns to the precise statutory elements the SoP sets out: (1) a diagnosis within the statutory definition (s7), (2) at least one of the enumerated factors within the specified temporal window (s9), and (3) a demonstrable relationship between the factor and relevant service (s10). Because key terms are not defined in the instrument, clinicians’ explanations and medico-legal evidence will be important to translate clinical records into the categories the SoP uses.