Statement of Principles concerning systemic lupus erythematosus (Reasonable Hypothesis) (No. 47 of 2025)

The central concept is the “reasonable hypothesis” standard. This is the standard of proof applied under sections 120A of the VEA and 338 of the MRCA for claims relating to operational, peacekeeping, hazardous or British nuclear test defence service (VEA) or warlike or non‑warlike service (MRCA). Unlike the “reasonable satisfaction” standard (balance of probabilities) that applies to some other veteran claims, a reasonable hypothesis requires only that the claim is consistent with the known medical‑scientific facts and that there is a plausible causal link between service and the condition. The SoP is the mechanism by which the RMA distils the medical‑scientific evidence into a set of factors that, if present, automatically satisfy the reasonable hypothesis test (provided those factors are related to service). The RMA states in section 8 that it is of the view that there is sound medical‑scientific evidence that indicates SLE and death from SLE can be related to relevant service. That statement is a claim about the evidence base; the SoP does not disclose the underlying studies or the reasoning used to select the factors. The concepts of “clinical onset” and “clinical worsening” are crucial. Clinical onset refers to the first manifestation of the disease. Clinical worsening refers to a material deterioration in the disease after it has already been contracted. The SoP applies to both, but with a caveat: under section 10(2), the clinical worsening aspects of the factors apply only to a material contribution to, or aggravation of, SLE where the person’s SLE was suffered or contracted before or during (but did not arise out of) the person’s relevant service. That means if the SLE arose out of service (i.e., it was caused by service), clinical worsening factors are not relevant because the disease is already service‑related. Another key concept is the dictionary definitions, including “terminal event” (pneumonia, respiratory failure, cardiac arrest, circulatory failure, cessation of brain function) and measurement units for smoking (pack‑years) and silica exposure (hours and micrograms/m³‑years). The instrument also defines “relevant service” by reference to the VEA and MRCA categories. Importantly, the definitions section notes that “systemic lupus erythematosus” has the meaning given in subsection 7(2), which is broader than the ICD‑10‑AM code M32, but code M32 is noted for administrative purposes. The SoP also contains a provision (section 11) dealing with factors that themselves refer to an injury or disease covered by another Statement of Principles. If a factor in section 9 refers to an injury or disease for which another SoP has been made, then the factors in that other SoP apply according to its terms, as in force from time to time. This cross‑reference mechanism is significant because it incorporates by reference other SoPs, potentially expanding the range of intermediate conditions that can be linked to service.

The primary class of persons affected are veterans, members of the Peacekeeping Forces, and members of the Forces under the VEA, as well as members under the MRCA, who have rendered “relevant service” as defined. That includes operational, peacekeeping, hazardous and British nuclear test defence service (VEA) and warlike or non‑warlike service (MRCA). Anyone who has served in those capacities and who suffers from SLE , or has died from a terminal event contributed to by SLE , and who lodges a claim for compensation or treatment under the VEA or MRCA will be assessed against this SoP. The instrument also directly affects decision‑makers: delegates of the Repatriation Commission, the Military Rehabilitation and Compensation Commission, and the Veterans’ Review Board. They are bound to apply the factors in the SoP when deciding whether a reasonable hypothesis has been raised. Legal practitioners, advocates and medical assessors advising claimants or the Commission must understand the precise definitions and thresholds, because the presence or absence of a single factor can determine the outcome of a claim. The RMA itself is indirectly affected because it must monitor medical‑scientific evidence and may need to revoke or amend the SoP in the future. The repeal of the 2016 SoP means that anyone with a prior decision based on the old SoP may be affected if they seek a review or make a fresh claim; the instrument states that the new SoP applies to claims to which section 120A or 338 apply, without a savings provision for pending claims (it is silent on transitional arrangements). That creates potential uncertainty for claimants whose applications were lodged but not determined before commencement, unless there is a separate transitional rule elsewhere. Pharmaceutical companies and medical researchers are not directly subject to the SoP, but the factor list , particularly the specific medications listed in section 9(5) and (6) , may influence clinical practice or prescribing patterns within the veteran community, because taking those drugs at certain times can help establish a service‑related claim. The medicaments listed include chlorpromazine, hydralazine, isoniazid, methyldopa, minocycline, procainamide, quinidine, tumour necrosis factor‑alpha inhibitors, terbinafine, flutamide, interferon gamma, ethosuximide, oxcarbazepine, carbamazepine, phenytoin, and sulfadiazine or trimethoprim‑sulfamethoxazole. The condition that the drug “cannot be ceased or substituted” for factors 9(5) and 9(6) imposes a heavy evidentiary burden: the claimant must show that it was not possible to stop the medication or switch to an alternative, which may be difficult to prove if the medical records do not document the reasons for continuing therapy.

The SoP itself does not impose duties on individuals; it is a binding evidentiary instrument. However, it creates a conditional right: a claimant who can demonstrate that at least one of the factors in section 9 exists, and that the factor is related to their relevant service, is entitled to have the reasonable hypothesis accepted, and thus their claim will proceed to the next stage of assessment (or be accepted outright depending on the scheme). The claimant bears the evidentiary burden of raising the factor, but the standard of proof is low: only a reasonable hypothesis, not proof on the balance of probabilities. The RMA has a duty under the VEA to determine SoPs based on sound medical‑scientific evidence, but that duty is not owed to any particular claimant; it is a public duty. The Commission and the Board have a duty to apply the SoP correctly; failure to do so may be a reviewable error. The instrument also contains a notable “inability to obtain appropriate clinical management” factor (section 9(13)). This factor exists if the person was unable to obtain appropriate clinical management for SLE before clinical worsening. The phrase “inability to obtain” suggests that the relevant service circumstances , such as being in a remote location, or being in a combat situation where medical care was unavailable , must have prevented the person from receiving proper treatment for their SLE. This factor potentially creates a duty on the Commonwealth to ensure that veterans with SLE receive appropriate clinical management, or at least that if they do not, that failure can be used to establish a claim. However, the SoP does not impose a positive obligation to provide that care; it merely recognises the absence of care as a possible connecting factor. Rights of review are not mentioned in the instrument, but they arise under the VEA and MRCA: claimants who are dissatisfied with a decision may seek internal review, then merits review by the Veterans’ Review Board or the Administrative Appeals Tribunal, and ultimately judicial review. The SoP’s definitions and thresholds will be central to those reviews. For example, the definition of “one pack‑year” (20 cigarettes per day for one year, or 7,300 grams of smoking tobacco) is precise, but calculating cumulative exposure over decades may require assumptions. The claimant has the right to produce evidence (medical records, service records, witness statements) to satisfy the factor, and the decision‑maker must consider that evidence in light of the SoP. There is no right to challenge the SoP itself on its merits, because it is a legislative instrument, but it can be challenged on grounds of procedural ultra vires or want of jurisdiction if the RMA did not have sound medical‑scientific evidence or acted beyond power.

This instrument does not create any criminal penalties or civil pecuniary penalties. It is not a penal statute. Enforcement is indirect: if a claimant fails to satisfy any of the factors, their claim for SLE may be refused, which can result in a denial of compensation, medical treatment and other benefits. The consequence is financial and health‑related, not punitive. However, there are potential legal consequences for making false or misleading statements in support of a claim under the VEA or MRCA. Those are found in the parent Acts, not in this SoP. The SoP raises the bar for the evidence required to prove a factor; a claimant who fabricates a silica exposure history or backdates a medication date could be subject to prosecution under the Criminal Code or the VEA. The instrument itself does not impose any compliance enforcement regime on third parties such as employers or medical practitioners. The “inability to obtain appropriate clinical management” factor places a de facto burden on the system: if a veteran cannot get proper care, and that leads to worsening of SLE, the Commonwealth may become liable. That is a cost‑shifting provision, not a penalty. From an enforcement perspective, the SoP is self‑executing through the claims process. There is no regulator tasked with monitoring compliance. The Repatriation Medical Authority will conduct future reviews of the evidence and may revoke or amend the SoP, but that is a statutory function, not enforcement. The possibility of judicial review of decisions made under the SoP provides a check. If a decision‑maker misapplies the SoP, the claimant can seek review; if the tribunal or court finds the error, the decision is set aside and the matter remitted. That is the enforcement mechanism for the rights the instrument confers. Overall, the SoP is an evidentiary standard, not a regulatory instrument. Its “penalties” are the denial of benefits, which is a strong enough incentive for compliance in practice, but there is no independent enforcement apparatus.

The SoP is made under subsection 196B(2) of the Veterans’ Entitlements Act 1986, which is the primary enabling Act. It also applies to claims under section 338 of the Military Rehabilitation and Compensation Act 2004. It therefore sits within the broader veterans’ entitlements and military compensation framework. The relationship between the SoP and the standard of proof under the VEA and MRCA is fundamental. The SoP does not replace the standard of proof; it operationalises it by providing concrete factors that automatically satisfy the reasonable hypothesis test. If a claim does not meet any factor, the decision‑maker must still consider whether the evidence raises a reasonable hypothesis outside the SoP factors, but that is more difficult because the SoP represents the RMA’s view of the sound medical‑scientific evidence. In practice, the SoP tends to be treated as exhaustive. The SoP also interacts with other Statements of Principles through section 11, which provides that if a factor in section 9 refers to an injury or disease covered by another SoP, then the factors from that other SoP apply. For example, factor 9(12) refers to “having posttraumatic stress disorder for at least the 3 months before clinical onset or clinical worsening”. PTSD is itself a condition for which there is a Reasonable Hypothesis SoP. That SoP will have its own factors, and those factors must be applied to determine whether the PTSD is related to service. This cross‑referencing creates an interlocking system of SoPs that can chain together multiple conditions to link the ultimate SLE claim to service. The SoP also interacts with the ICD‑10‑AM classification, but the instrument makes clear that the meaning of SLE is that given in subsection 7(2), not merely the ICD code M32. This avoids automatic reliance on hospital coding definitions, which may not align with the SoP’s inclusions and exclusions. The instrument repeals the 2016 SoP, so its interaction with time‑limitation rules in the VEA and MRCA will depend on transitional provisions in those Acts (not in this SoP). The SoP may also interact with state workers’ compensation schemes, but those schemes generally do not use the reasonable hypothesis standard. For dual eligibility claimants (e.g., a veteran who also qualifies for compensation under a state scheme), the SoP provides a different test, which may create inconsistent outcomes. The instrument does not address private insurance, superannuation or tort claims. It is solely for the purpose of the VEA and MRCA claims. The RMA’s determination is subject to disallowance by the Parliament under the Legislation Act 2003, although that is a legislative procedural interaction, not a substantive legal one.

The only amendment history contained in the source is the repeal and replacement of the previous SoP (No. 21 of 2016) by this instrument (No. 47 of 2025). The instrument itself is a fresh determination, not an amendment of an existing one. The earlier SoP was made under the same subsection (196B(2) of the VEA) and had a similar structure. This 2025 SoP makes several substantive changes compared with its predecessor, although the source does not provide a side‑by‑side comparison. Based on the factors enumerated in section 9, it appears to have added the alternative silica exposure threshold in micrograms/m³‑years (factor 9(3)), the posttraumatic stress disorder factor (factor 9(12)), and the inability to obtain appropriate clinical management factor (factor 9(13)). The previous 2016 SoP likely did not include these factors, as the RMA considered the evidence had evolved. The instrument also updates the definitions, including the addition of “micrograms/m³‑years”. The medication list in factor 9(5) may have been expanded or contracted from the 2016 version; the source does not say. The note about equivalent tobacco products (7,300 grams) may be new or clarified. The SoP does not include a transitional provision; it applies to claims to which section 120A or 338 applies, without carving out pending claims. That means any claim not finally determined before 19 May 2025 must be assessed under the new SoP. This could prejudice a claimant who relied on a factor that existed under the 2016 SoP but is no longer present in 2025, or could benefit a claimant who now meets a new factor. The absence of transitional language is a drafting choice that imposes compliance costs: legal practitioners must check the date of claim and the date of decision. The instrument also amends the Schedule 1 Dictionary, but the 2016 dictionary is not reproduced. Notably, the RMA did not issue an explanatory statement or second‑reading speech accompanying the SoP; the source is the instrument itself. The amendment history is thus limited to the repeal of one instrument and the making of another.

The source does not cite any litigation history. The SoP itself is a legislative instrument, not a court judgment. However, the predecessor SoP (No. 21 of 2016) and earlier versions have likely been the subject of decisions in the Administrative Appeals Tribunal and the Federal Court in relation to individual claims for SLE. Without specific cases from the source, one cannot name any. The reasonable hypothesis standard has been considered in High Court and Federal Court jurisprudence more broadly, e.g., in Repatriation Commission v Bey (1997) or Ronchi v Repatriation Commission (2005). But the source does not mention these, so they cannot be included. In practice, litigation under this SoP would arise when a decision‑maker finds that the claimant has not raised a factor. Claimants may then argue that the SoP factor should be interpreted broadly, or that the RMA erred in not including a particular factor. The Tribunal and courts conduct merits review de novo, but they must apply the SoP as a binding legislative instrument. Challenges to the validity of the SoP itself (e.g., that the RMA did not have sound medical‑scientific evidence, or that the instrument was not made in accordance with the VEA) are possible but rare because the courts give significant deference to the RMA’s expertise. If the SoP were held to be invalid, the 2016 SoP would not be revived (it was repealed), leaving a gap. The addition of the PTSD factor may lead to litigation over whether the claimant actually had PTSD for at least three months before SLE onset or worsening, and whether the PTSD was related to service. The “inability to obtain appropriate clinical management” factor is very open‑textured and is likely to generate disputes about what constitutes appropriate clinical management and whether the inability was due to service circumstances. Overall, litigation history would be extensive but not recorded in the source. Practitioners should expect that the new factors will be tested in the tribunal and courts over the coming years. The instrument provides no guidance on how to prove inability to obtain management, creating fertile ground for argument.

Several provisions in the SoP are potential traps for claimants and practitioners. First, the sunlight/ultraviolet light factor (9(1)) applies only to clinical worsening of SLE skin rash, and requires exposure at least 24 hours but not more than 30 days before that worsening. It does not apply to clinical onset. This is a narrow factor and will be irrelevant for most SLE claims. Second, the silica exposure factors (9(2) and (3)) use cumulative thresholds: 1,000 hours or >50 micrograms/m³‑years. Proving cumulative exposure to that level requires detailed occupational history and often industrial hygiene estimates. Many veterans may not have records dating back decades. The note gives examples (construction, drilling, blasting) but does not provide a formula for calculation; the expert may need to reconstruct exposure. Third, the smoking factor (9(4)) requires at least 20 pack‑years before clinical onset or worsening, and only if smoking has not ceased before clinical onset. If the person quit smoking before SLE started, the factor cannot be used. Also, pack‑year calculations require knowing the number of cigarettes per day and years smoked, which may be self‑reported and unreliable. Fourth, the medication factors in 9(5) and (6) require that the medication “cannot be ceased or substituted”. This is a high bar. Even if the drug is known to induce lupus, the factor only applies if the treating doctor can show that it was medically necessary to continue that exact drug. The list includes common drugs like hydralazine, minocycline and TNF‑alpha inhibitors, but many patients can switch to alternatives. Claimants who were on these drugs but could have stopped or substituted will not satisfy the factor. Fifth, the hormone replacement therapy factor (9(8)) requires oestrogen use for at least 2 years before clinical onset. A shorter duration does not count. Sixth, the pregnancy factor (9(10)) applies only within 6 weeks before clinical worsening of SLE. It will not help for onset. Seventh, the thymectomy factor (9(11)) requires the surgery within 5 years before clinical onset. Many people who have a thymectomy may have done so for myasthenia gravis, and the connection to SLE must be shown. Eighth, the PTSD factor (9(12)) requires the PTSD to have existed for at least 3 months before SLE onset or worsening. The PTSD itself must be related to service under another SoP. That creates a chain where both the PTSD and the SLE must be service‑linked. Ninth, the “inability to obtain appropriate clinical management” factor (9(13)) is vague. What constitutes appropriate clinical management? If a veteran declined treatment, does that count as inability? The factor says “inability to obtain” which implies a lack of access, not a refusal. The decision‑maker will need evidence of unavailability of specialists, medication, or timely care. Tenth, the clinical worsening limitation in section 10(2) is a hidden trap. If SLE arose out of service, you cannot use the clinical worsening aspects of any factor. Many claimants may not realise that the disease must have been contracted before or during service but not caused by service. That distinction requires a finding on causation that may not be made until later in the claim process. Eleventh, the definitions of pack‑year and micrograms/m³‑years use precise metric conversions, but the source does not explain how to calculate grams of pipe tobacco or cigars. The note says 7,300 grams of smoking tobacco is equivalent to one pack‑year, but how to convert a cigar to grams is left to estimation. Twelfth, the “terminal event” definition includes cessation of brain function, but not other common causes of death like renal failure or sepsis unless they fall under the listed categories. If a veteran dies from SLE‑related renal failure not specifically listed, the death may still be covered if it is contributed to by the disease, because the definition is non‑exhaustive (it says “includes”). But the listed categories may be treated as exhaustive in practice. Overall, the SoP is not a complete pathway; it sets many conditions that must be precisely matched.

Compliance with this SoP means satisfying its terms when making or deciding a claim for SLE. For a claimant, the first step is to obtain a diagnosis that falls within the SoP’s definition of systemic lupus erythematosus (subsection 7(2)). That means the diagnosis must be of a chronic inflammatory autoimmune disease with antibodies to cell nuclei, and must not be solely subacute cutaneous lupus, discoid lupus, or mixed connective tissue disease. A rheumatologist’s report that includes the relevant lab markers (anti‑nuclear antibody, anti‑dsDNA, etc.) is essential. The claimant must then identify which relevant service categories apply (operational, peacekeeping, hazardous, British nuclear test, warlike, non‑warlike) and gather evidence showing that service involved one of the factors in section 9. That may include military service records, deployment locations, exposure logs, personnel files, medical records, and expert reports. For the silica factor, an occupational hygienist may need to estimate cumulative hours or micrograms/m³‑years from tasks such as drilling or construction. For the smoking factor, a sworn statement of smoking history and perhaps pharmacy records of tobacco purchases may be used. For the medication factors, the claimant must show that the drug was taken at the time of clinical onset or worsening and that it could not be ceased or substituted. The best evidence is a treating doctor’s statement explaining why alternative medications were not feasible (e.g., only the listed drug controlled the condition, or the patient had an allergy to alternatives). For the PTSD factor, a psychiatrist’s diagnosis and evidence that the PTSD started at least three months before SLE onset or worsening is required, and the PTSD must itself be service‑related under its own SoP. The claimant should also check whether the SLE was contracted before or during service but did not arise out of service; if it arose out of service, the clinical worsening factors in the SoP are not available. The claim should be lodged with the Department of Veterans’ Affairs, including all supporting evidence. For decision‑makers, compliance means checking each factor against the evidence. They must not simply accept a statement that “I was exposed to sunlight”; they should verify the level and timing consistent with the factor. The inability‑to‑obtain‑clinical‑management factor is particularly challenging because it requires an objective assessment of availability and appropriateness of care. Decision‑makers may need to consult regional health service data. The SoP does not prescribe a particular form of evidence, so flexible approaches are possible, but the burden remains on the applicant. Legal representatives should maintain a checklist of each factor and its prerequisites to avoid missing subtle bars like the “cannot be ceased or substituted” condition. For medical professionals writing reports, they must use the SoP’s definition of SLE and avoid conflating it with other lupus variants. They should also clearly state dates of clinical onset and clinical worsening and link them to the claimed factor. Where possible, they should quantify exposure (e.g., pack‑years, hours of silica exposure). The SoP is a relatively precise instrument, and compliance with it requires meticulous record keeping and a willingness to obtain expert evidence. The cost of gathering such evidence can be significant, potentially deterring some claimants, but for those who can meet the factors, the SoP provides a clear path.