Statement of Principles concerning systemic lupus erythematosus (Balance of Probabilities) (No. 48 of 2025)

Systemic lupus erythematosus (SLE) is defined in section 7(2) as a chronic inflammatory autoimmune disease characterised by the presence of antibodies directed against cell nuclei. The definition explicitly includes drug-induced SLE, lupus nephritis and lupus pneumonitis, but excludes subacute cutaneous lupus erythematosus, discoid lupus erythematosus, and mixed connective tissue disease. The ICD-10-AM code M32 is referenced but the legal meaning is that given in subsection 7(2), not the classification code itself. The note lists common clinical manifestations such as polyarthritis, arthralgia, photosensitivity, rash, serositis, and renal, haematological and neurological disorders. Death from SLE is defined in subsection 7(5) to include death from a terminal event (such as pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function) that was contributed to by the person’s SLE. This means the SoP extends to secondary causes of death that stem from the disease, but only if the SLE itself was a contributing factor.

Relevant service is defined in the Dictionary. It means three categories: eligible war service (other than operational service) under the VEA; defence service (other than hazardous service and British nuclear test defence service) under the VEA; or peacetime service under the MRCA. This is critical: the SoP applies only to non-operational service and to peacetime service. Veterans with operational service, hazardous service, or British nuclear test defence service are not covered by this instrument; they would fall under a separate SoP made under subsection 196B(2) of the VEA using the reasonable hypothesis standard. The distinction reflects the different burdens of proof Parliament has prescribed for different types of service.

Factors are set out in section 9. At least one factor must exist for the connection to be established. The factors are:

1. Exposure to sunlight or ultraviolet light sufficient to induce erythema (sunburn) at least 24 hours but not more than 30 days before clinical worsening of SLE skin rash (note: this factor applies only to worsening, not to initial clinical onset; and only to skin rash, not to other manifestations).
2. Inhaling respirable crystalline silica dust for a cumulative period of at least 2,000 hours before clinical onset or clinical worsening.
3. Inhaling respirable crystalline silica dust in an amount greater than 100 micrograms/m3-years of cumulative exposure before clinical onset or clinical worsening.
4. Smoking at least 20 pack-years before clinical onset or clinical worsening, where smoking has not ceased before clinical onset.
5. Taking any of twelve specified medications (chlorpromazine, hydralazine, isoniazid, minocycline, tumour necrosis factor-alpha inhibitors, terbinafine, flutamide, interferon gamma, ethosuximide, oxcarbazepine, carbamazepine, phenytoin) at the time of clinical onset or clinical worsening, where the medication cannot be ceased or substituted.
6. Taking sulfadiazine or trimethoprim-sulfamethoxazole at the time of clinical worsening (again, cannot be ceased or substituted).
7. Taking any medication that is associated with development of SLE including laboratory markers, and with cessation of SLE within 3 months of discontinuing, where treatment continued for at least the 3 days before clinical onset or clinical worsening.
8. Having a clinically symptomatic bacterial, viral or fungal infection at the time of clinical worsening.
9. Being pregnant within the 6 weeks before clinical worsening.
10. Inability to obtain appropriate clinical management for SLE before clinical worsening.

Clinical onset and clinical worsening are not separately defined in the instrument, but the factors distinguish between them. Factors 2, 3 and 4 apply to both onset and worsening. Factors 1, 6, 8, 9 and 10 apply only to clinical worsening. Factor 5 applies to both but with the “cannot be ceased or substituted” condition. Factor 7 also applies to both. The distinction has practical significance: a claimant seeking to rely on a worsening-only factor must first establish that the SLE existed before or during (but did not arise out of) the relevant service, under section 10(2). That provision states that the clinical worsening aspects of factors apply only to material contribution to, or aggravation of, SLE where the disease was suffered or contracted before or during (but did not arise out of) the person’s relevant service.

Balance of probabilities is the standard expressed in the instrument’s title and in section 8, which states that the Repatriation Medical Authority is of the view that it is more probable than not that SLE and death from SLE can be related to relevant service. This standard applies to the existence of the factors and their relationship to service. It does not apply to the diagnosis itself, which must be established as a matter of fact.

The instrument affects three primary groups.

First, claimants: veterans and members of the Australian Defence Force who have rendered relevant service as defined. This includes veterans with eligible war service (non-operational), defence service (non-hazardous, non-British nuclear test), and members with peacetime service under the MRCA. It does not cover those with operational service, hazardous service, or British nuclear test defence service , those persons must rely on a separate SoP under the reasonable hypothesis standard. The practical effect is that a veteran who served in a theatre of war (operational service) but whose SLE claim is assessed under the balance of probabilities SoP for a non-operational period of service is subject to a higher evidential threshold. This can create anomalies where a single claimant has both types of service and the decision-maker must determine which service is the relevant service for the claim.

Second, decision-makers: the Repatriation Commission, the Veterans’ Review Board, and the Administrative Appeals Tribunal are bound by this instrument when determining a claim for SLE. They cannot accept a claim unless at least one factor in section 9 is satisfied and that factor is related to relevant service. This reduces their discretion compared to a pure merits assessment, but also provides a structured framework. The Commission must also apply section 11 when a factor refers to an injury or disease covered by another SoP (for example, if the factor involves smoking and the claimant has chronic obstructive pulmonary disease, the SoP for that disease may be relevant).

Third, medical professionals and legal advisers: they need to be familiar with the specific thresholds and definitions. A rheumatologist’s diagnosis of SLE might not satisfy the legal definition if it captures subacute cutaneous lupus or mixed connective tissue disease. The temporal requirements (e.g., sunlight exposure within 24 hours to 30 days before worsening) require careful historical evidence. The smoking threshold of at least 20 pack-years is a high bar. The silica exposure thresholds (2,000 hours or 100 µg/m³-years) require occupational and environmental exposure data that may not be readily available. The requirement that certain medications “cannot be ceased or substituted” invites dispute about whether a claimant could have reasonably changed medication.

The instrument also indirectly affects the Commonwealth’s finances: accepted claims for SLE entitle the claimant to compensation under Part II or Part VI of the VEA, or under the MRCA. The SoP controls which claims are accepted, and therefore the total liability of the Compensation Fund. By narrowing or broadening the factors relative to the 2016 SoP, the instrument can shift cost burdens. The amendment to section 9 (see history) may have altered which medications are listed or changed the silica thresholds, affecting the pool of eligible claimants.

The instrument itself does not impose duties directly on private persons. It imposes a duty on the decision-maker to apply the factors when determining a claim. Under section 120B of the VEA, the Repatriation Commission must be satisfied, on the balance of probabilities, that the disease is connected with service. The SoP is the mechanism for that satisfaction: if a factor exists, the connection is established; if no factor exists, the connection cannot be established. The decision-maker has no power to deviate to recognise a factor not listed, even if medical evidence suggests causation. The SoP is exhaustive.

The right of the claimant is to have their claim determined in accordance with the SoP. This includes the right to produce evidence relating to any of the listed factors. If the claimant cannot meet any factor, they may still argue that the SoP does not apply because the definition of SLE in section 7(2) is not met (for example, if the disease is better characterised as mixed connective tissue disease). But that is not a right under this instrument; it is a right under the VEA generally.

The instrument also creates an evidential burden on the claimant to prove the existence of a factor. The burden is on the balance of probabilities. For smoking, the definition of “one pack-year” and the calculation method are prescribed in the Dictionary, which reduces ambiguity. For silica exposure, the claimant must show cumulative thresholds, which may require expert evidence from industrial hygienists. For medications, the claimant must show that the drug could not be ceased or substituted , a subjective or objective test depending on interpretation. The note to factor 1 (sunlight) says it applies only to worsening of SLE skin rash, not to other manifestations or to onset. The claimant must therefore match the factor to the specific clinical event.

Section 10(2) imposes a further condition: the clinical worsening aspects of factors apply only where the person’s SLE was suffered or contracted before or during (but did not arise out of) the person’s relevant service. This means that if the SLE first arose after service, the worsening factors cannot be used to connect the disease to service , only the onset factors can. And if the SLE arose during service (but not out of service), then factors like sunlight or pregnancy that trigger worsening can be used to aggravate the condition. This limits the utility of those factors for many claimants whose SLE first manifests after discharge.

There is a deemed right under section 11: if a factor refers to an injury or disease for which another SoP exists (e.g., if the claimant has a separate condition and the factor “inability to obtain appropriate clinical management” is relied upon), the factors in that other SoP apply as in force from time to time. This cross-referencing mechanism ensures consistency, but it also means that the claimant’s rights may depend on the state of another instrument, which could change without direct notice to the claimant.

This instrument does not create any criminal offences or pecuniary penalties. It is not enforced by police or regulatory agencies. Its enforcement is through the administrative and merits review system.

If a decision-maker fails to apply the SoP correctly, the claimant may seek review by the Veterans’ Review Board under Part XI of the VEA, and then appeal to the Administrative Appeals Tribunal. An error of law, such as misinterpreting the definition of SLE or misunderstanding the temporal relationship in a factor, is grounds for the AAT to set aside the decision and substitute its own. The AAT is bound by the SoP to the same extent as the original decision-maker.

If the Commission or the Board makes a decision that is contrary to the SoP, the decision may be invalid for jurisdictional error, but that would be challenged in the Federal Court under the Administrative Decisions (Judicial Review) Act 1977 or section 39B of the Judiciary Act 1903. This is rare because the SoP is designed to be applied routinely.

There is no private right of action for breach of the SoP. The only consequence of non-compliance is that a decision is liable to be set aside or varied on review. There is also no penalty for a claimant who makes a false claim under this SoP; false statements are dealt with under the Criminal Code for fraud, not under this instrument.

The Repatriation Medical Authority itself is not subject to penalty for the content of the SoP. The Authority’s determinations are legislative in character, and they can be disallowed by either House of Parliament under the Legislation Act 2003. That is a political check, not a legal penalty.

The instrument includes self-repealing provisions in endnotes. It appears that the amendment history shows sections 2 and 4 were repealed by operation of sections 48C and 48D of the Legislation Act (these are standard provisions that deal with commencement and repeal of legislative instruments). That is a technical matter, not a penalty.

In summary, enforcement is entirely through administrative review. The cost of incorrect application is borne by the claimant in the form of a rejected claim, and by the Commonwealth if the claim is wrongly accepted.

The instrument is made under subsection 196B(3) of the VEA. It does not replace the VEA; it operates within its framework. The VEA section 120B requires the Repatriation Commission to determine claims for diseases that are not war-caused injuries or diseases by having regard to the relevant SoP. The SoP is the exclusive source of the factors the Commission must consider. The Commission cannot rely on general medical evidence of causation if it does not match a listed factor.

The instrument also relates to the Military Rehabilitation and Compensation Act 2004 through section 339 of that Act, which applies the same standard of proof (balance of probabilities) for peacetime service. The definition of “relevant service” in the Dictionary includes peacetime service under the MRCA. So the SoP applies to MRCA claims for SLE for peacetime service, but not for warlike or non-warlike service (which are covered by separate provisions using a different standard).

The interaction with other SoPs is governed by section 11. If a factor in this SoP refers to an injury or disease covered by another SoP (e.g., “inability to obtain appropriate clinical management” may refer to a mental health condition that has its own SoP), then the factors in that other SoP apply. This creates a network of interlocking instruments. For example, if a claimant relies on the factor “having a clinically symptomatic bacterial, viral or fungal infection”, and that infection is itself a compensable disease under another SoP, the claimant must satisfy the factors of that SoP as well. But section 11 is written as an “if” condition , it applies only where the factor “refers to an injury or disease in respect of which a Statement of Principles has been determined”. A clinically symptomatic infection is a condition; it may or may not have its own SoP. The decision-maker must check.

The instrument operates alongside the ICD-10-AM classification, but the legal definition of SLE in subsection 7(2) is autonomous. The ICD-10-AM code M32 is referenced only as a note; it is not decisive. A disease that is coded as M32 but is excluded by subsection 7(2) (e.g., discoid lupus) is not covered.

The instrument replaces the prior SoP from 2016. Claims that were incomplete or pending at commencement must be determined under the new SoP, because section 5 says it applies to a claim to which section 120B or section 339 applies. There is no saving provision for claims already made under the old SoP, unless the Commission chooses to continue applying the old instrument , but the VEA does not give it that discretion once a new SoP is in force.

The interaction with the Safety, Rehabilitation and Compensation Act 1988 (the Comcare scheme) is not directly relevant because that Act covers different employees. The SoP is specific to the military compensation system.

The instrument is compiled as at 19 May 2025. The original instrument, Statement of Principles concerning systemic lupus erythematosus (Balance of Probabilities) (No. 48 of 2025), was registered on the Federal Register of Legislation on 16 April 2025. It was then amended before commencement by the Amendment Statement of Principles concerning systemic lupus erythematosus (Balance of Probabilities) (No. 55 of 2025), registered on 9 May 2025. Both instruments commenced on the same day: 19 May 2025. The amendment amended section 9, the factors section.

The compilation notes indicate that sections 2 (Commencement) and 4 (Repeal) were repealed by operation of sections 48C and 48D of the Legislation Act 2003. This is standard machinery: once the instrument has commenced and the repeal of the earlier instrument has taken effect, those provisions are spent. Section 2 originally set the commencement date (19 May 2025); after commencement, it is no longer necessary. Section 4 repealed the 2016 SoP; after repeal, that provision is also spent. Their repeal does not affect the operative provisions.

The amendment history table shows only section 9 as “am No. 55 of 2025”. The exact nature of the amendment is not described in the source text, but it is reasonable to infer that the Authority adjusted the list of medications or modified the silica thresholds, or added or removed a factor. The 2025 version of the SoP may differ from the 2016 version in several respects. The compilation includes the amendment, so the factors in section 9 as printed are the final version.

The instrument does not include application, saving or transitional provisions, as noted in the legislation history table. This means the new SoP applies to all claims made on or after 19 May 2025, and likely to claims that were undetermined before that date. The standard rule in administrative law is that a decision-maker applies the law as it stands at the time of decision. So the 2025 SoP replaces the 2016 SoP for all decisions made after 19 May 2025, regardless of when the claim was lodged.

The instrument has no uncommenced amendments. Endnote 3 lists no future amending laws. The SoP is currently in force and stable.

The source text does not refer to any litigation history. It is a legislative instrument, not a court judgment. However, the preceding SoP (No. 22 of 2016) was likely the subject of challenges in the Administrative Appeals Tribunal and possibly the Federal Court. The nature of SoPs is that they are frequently considered in applications for review. Claimants may argue that a factor was incorrectly applied, or that the definition of SLE was misinterpreted, or that the temporal requirements were wrongly assessed. There is no publicly reported case specifically regarding the SLE SoP cited in the source, but it would be unusual for no case to have arisen.

In the general context, the Federal Court has considered the validity of SoPs under section 196B. In Repatriation Commission v Gorton (2001) 110 FCR 321, the Court held that the RMA must base its determination on sound medical-scientific evidence and cannot insert arbitrary requirements. The High Court in Comcare v Martin (2016) 258 CLR 467 considered the role of SoPs under the Safety, Rehabilitation and Compensation Act, but that is a different scheme. For the VEA, the leading case is Repatriation Commission v Hancock (2003) 131 FCR 169, which confirmed that the RMA must consider all relevant medical evidence and that the factors must be consistent with the legislation.

Given that the 2025 SoP is new as of May 2025, there is no litigation history specific to it. Future litigation may arise if the amendment to section 9 narrows the factors relative to the 2016 version, potentially disadvantaging claimants who could have succeeded under the old instrument. Any such claim would raise issues of retrospectivity, but the application clause (section 5) is clear: the instrument applies to claims to which section 120B or 339 applies, and there is no transitional provision. The Commission would likely argue that the new SoP is procedural and applies to all decisions after commencement.

The lack of cited litigation in the instrument itself is not surprising. SoPs are made by a medical authority, not a court. They are challenged in review bodies, but those decisions are rarely compiled into the instrument.

Several aspects of this instrument can catch both claimants and advisers off guard.

The definition of SLE excludes common variants. Section 7(2)(c) expressly excludes subacute cutaneous lupus erythematosus, discoid lupus erythematosus, and mixed connective tissue disease. A person diagnosed with discoid lupus (skin-only lupus) cannot claim under this SoP, even if they develop systemic involvement later. The definition requires the presence of antibodies directed against cell nuclei; some patients with lupus symptoms but negative ANA may not meet the definition. The ICD-10-AM code M32 is not determinative. Claimants must ensure their diagnosis matches the legal definition.

The sunlight factor is only for worsening of skin rash and only within a narrow time window. Factor 1 requires sunburn (erythema) between 24 hours and 30 days before clinical worsening of SLE skin rash. It does not cover onset of SLE, and it does not cover worsening of other manifestations such as arthritis or nephritis. A claimant whose SLE flares after sun exposure but whose rash does not worsen cannot use this factor. The time window is short: if the flare occurs more than 30 days after sunburn, the factor fails.

The medication factor “cannot be ceased or substituted” is a high bar. For factors 5 and 6, the medication must be one that cannot be ceased or substituted. This likely means the medication is medically necessary with no alternative, or that ceasing it would cause harm. It is not enough that the claimant was taking the drug; they must show that stopping was not possible. For factor 7 (other medications), the condition is slightly different: the drug must be associated with development and cessation of SLE within 3 months of discontinuing, and treatment must have continued for at least 3 days before clinical onset or worsening. This factor may apply to a wider range of drugs, but the association must be established.

The smoking threshold of 20 pack-years is high. A pack-year is 20 cigarettes per day for one year. 20 pack-years means smoking, for example, 40 cigarettes per day for 10 years, or 20 per day for 20 years. Lighter smokers (e.g., 10 per day for 10 years equals 5 pack-years) cannot meet this factor. The factor also requires that smoking had not ceased before clinical onset for the onset aspect; if the person quit before onset, the factor cannot be used for onset.

Silica exposure thresholds are technical and require quantification. Factor 2 requires 2,000 cumulative hours of inhalation. That is roughly one year of full-time work (40 hours per week for 50 weeks) in a dusty environment. Factor 3 uses a dose metric of 100 micrograms/m3-years, which requires measuring concentration over time. The notes give examples of activities but not guidance on how to estimate exposure retrospectively. Many claimants may lack records. The burden of proof is on the claimant to produce evidence of exposure (e.g., occupational hygiene reports, job history, trade qualification documents).

“Relevant service” excludes the most common types of service. Operational service, hazardous service, and British nuclear test defence service are explicitly excluded from the definition. Veterans who served in combat zones or who were exposed to radiation are not covered by this SoP for the balance of probabilities standard. They must rely on a reasonable hypothesis SoP, which is more claimant-friendly. This means a veteran with mixed service must be careful to link the disease to the non-operational period, or use the separate instrument.

The clinical worsening factors apply only to material contribution to aggravation where SLE existed before or during service but did not arise out of service. Section 10(2) is a gateway: if SLE first appeared after service ended, the worsening factors cannot help. The claimant must use an onset factor. And if SLE arose during service (i.e., the service contributed to its onset), then it is already connected; worsening factors are redundant. The practical effect is that the worsening factors are only useful for pre-existing SLE that was aggravated by service but not caused by it.

“Inability to obtain appropriate clinical management” is not defined. Factor 10 is vague. It does not specify what constitutes appropriate clinical management, or what qualifies as an inability. Does it mean the claimant could not access a rheumatologist? Does it mean the claimant did not have health insurance? Is the standard subjective or objective? Decision-makers will need to interpret this factor, and it may lead to inconsistent outcomes. The note to section 9 does not provide guidance.

Cross-reference to other SoPs (section 11) can create a chain of requirements. If a factor points to another injury or disease that has its own SoP, the claimant must also satisfy the factors of that SoP. For example, if the factor is “inhalation of respirable crystalline silica dust” and the claimant has silicosis, the SoP for silicosis may impose additional requirements. This can multiply the evidential burden.

The instrument does not apply to claims for operational service. This is a gotcha for practitioners who habitually use the balance of probabilities SoP without checking the service type. A claim for SLE arising from operational service must be determined under the reasonable hypothesis SoP, which has a lower threshold and different factors.

For a claimant seeking to establish entitlement to compensation for SLE under the balance of probabilities standard, the first step is to confirm that the relevant service is eligible war service (non-operational), defence service (non-hazardous), or peacetime service under the MRCA. If the service is operational or hazardous, a different SoP applies.

Next, obtain a definitive diagnosis that matches the legal definition in section 7(2). The diagnosis should be made by a rheumatologist and confirm the presence of antibodies directed against cell nuclei (e.g., positive ANA, anti-dsDNA). Exclusions must be noted: if the diagnosis is subacute cutaneous lupus, discoid lupus, or mixed connective tissue disease, the claim will fail under this SoP. The ICD code is not sufficient; the doctor should expressly state that the condition is systemic lupus erythematosus as defined.

Third, identify which factor or factors in section 9 may be satisfied. Gather evidence:

• For sunlight: document episodes of sunburn and the timing of worsening of skin rash. Photos, medical records, and diaries may help.

• For silica: collect employment records, occupational hygiene reports, and any exposure monitoring. The cumulative hours must be 2,000 or the cumulative dose must exceed 100 µg/m³-years. If the claimant worked in construction, mining, tunnelling, or manufacturing, an industrial hygienist may need to estimate exposure levels.

• For smoking: calculate pack-years precisely. Obtain medical records confirming smoking history. If the claimant quit before clinical onset, the factor may still be available for clinical worsening if smoking continued after onset.

• For medications: obtain a list of all medications taken at the time of onset or worsening, especially those listed in factor 5. For factor 5 or 6, the claimant must show that the medication could not be ceased or substituted. A treating doctor’s statement explaining medical necessity (e.g., “patient required hydralazine for hypertensive crisis with no alternative available”) would be strong evidence.

• For infection: document any bacterial, viral or fungal infection that was clinically symptomatic at the time of clinical worsening. The medical record should show the infection and the temporal relationship to lupus flare.

• For pregnancy: show that the claimant was pregnant within the 6 weeks before clinical worsening. This requires obstetric records.

• For inability to obtain appropriate clinical management: document the circumstances, such as lack of access to a rheumatologist, treatment delays, or lack of health insurance. This factor is likely to be contentious; the claimant should provide a detailed narrative and corroborating evidence.

Fourth, ensure the factor is related to the relevant service under section 10(1). This means the exposure (smoking, silica, medication, etc.) must have occurred during or as a result of the service. For example, smoking while on leave may not be related to service unless the smoking was caused by service-related stress or conditions. The Tribunal and Commission have developed a body of law on “related to service”; it is not automatic.

Fifth, if relying on a clinical worsening factor, confirm that the SLE was present before or during service but did not arise out of service. This may require expert evidence distinguishing the aetiology of the initial onset from the aggravation.

Finally, compile a submission that maps each factor to the evidence, and explicitly state which subsection of section 9 is claimed. The decision-maker is required to consider each factor; a structured argument will reduce the risk of incomplete assessment.

For decision-makers (Commission delegates), compliance requires a systematic checklist: verify the definition of SLE, confirm the service type, identify which factor(s) are claimed, check temporal requirements, check section 10(2) for worsening, apply any cross-referenced SoP under section 11, and then record reasons. The SoP is exhaustive; the decision-maker cannot accept a factor not listed, even if medical evidence strongly supports causation. The decision should explicitly state which factor (if any) exists and why it is related to service.

For legal advisers, the best practice is to obtain independent rheumatological and occupational exposure reports before lodging the claim. The thresholds in the SoP are quantitative; a lawyer cannot simply rely on a veteran’s self-report. A claim that fails to meet any factor will be rejected, and the only recourse is to argue that the SoP itself is invalid or that a different diagnosis applies. Neither avenue is likely to succeed. Compliance with the SoP is the most efficient path to a successful claim.