Statement of Principles concerning systemic sclerosis (Balance of Probabilities) (No. 26 of 2018)

The SoP defines systemic sclerosis (scleroderma) as an autoimmune, fibrosing connective tissue disorder characterised by deposition of collagen in skin and internal organs, and microvascular lesions, especially in the skin, lungs and kidneys. It expressly excludes localised sclerosis, graft versus host disease with dermal fibrosis, and scleroderma‑like conditions (e.g., scleromyxoedema, eosinophilic fasciitis). The instrument notes three subsets: limited cutaneous (including CREST syndrome - calcinosis cutis, Raynaud phenomenon, oesophageal dysmotility, sclerodactyly, telangiectasias), diffuse cutaneous, and systemic sclerosis sine scleroderma. The ICD‑10‑AM code M34 applies, but the SoP’s own clinical definition prevails. Death from systemic sclerosis includes death from a terminal event (pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function) that was contributed to by the person’s systemic sclerosis.

The foundation concept is relevant service, defined narrowly: eligible war service (other than operational service), defence service (other than hazardous service and British nuclear test defence service) under the VEA, or peacetime service under the MRCA. This means the SoP applies to peacetime and non‑operational veterans, not to those who served in warlike or operational areas or in hazardous service (who are covered by different SoPs or by the reasonable hypothesis standard).

The SoP is a balance‑of‑probabilities instrument. Under s 196B(3) of the VEA, the Repatriation Medical Authority (RMA) may determine a SoP if it is satisfied, on the sound medical‑scientific evidence, that it is more probable than not that the condition can be related to relevant service. The RMA’s statement of that basis is found in section 8. This standard is lower than the “reasonable hypothesis” threshold for operational service claims.

The key operative section is section 9 (Factors that must exist). It lists eight factors - four for clinical onset, four for clinical worsening. For onset: (1) inhaling respirable crystalline silica dust for at least 5,000 hours cumulative in specified activities (production, excavation, drilling, cutting, grinding, construction, manufacturing, cleaning, blasting); (2) treatment with bleomycin at the time of onset; (3) inhaling, ingesting, or cutaneous contact with trichloroethylene for at least 5,000 hours cumulative within any 10‑consecutive‑year period before onset. For worsening: factors (4), (5), (6) mirror (1), (2), (3) respectively but refer to clinical worsening instead of onset. Factor (7) is specific to scleroderma renal crisis worsening: being treated with 15 mg or more per day of prednisone (or equivalent oral glucocorticoid) for at least four weeks within the six months before worsening. Factor (8) is a residual: inability to obtain appropriate clinical management for systemic sclerosis.

Relationship to service (section 10) requires each factor to be related to relevant service. Subsection 10(2) restricts the worsening factors to cases where the condition was suffered or contracted before or during (but did not arise out of) service - i.e., they only apply to aggravation of a pre‑existing or service‑aggravated disease, not to initial causation. Section 11 incorporates by reference other SoPs for injuries or diseases referred to in the factors (e.g., if a factor references another condition, the factors of that other SoP also apply).

The primary persons affected are veterans and members of the Australian Defence Force (ADF) who have rendered relevant service as defined: eligible war service (non‑operational), defence service (non‑hazardous, non‑British nuclear test), or peacetime service. This includes former members who served in Australia or overseas in non‑warlike roles, those in training, administrative, or support capacities, and peacekeeping missions not designated as hazardous service. Their dependants and legal personal representatives are indirectly affected through death claims. The SoP affects claimants who must demonstrate a factor connecting systemic sclerosis to service; it determines whether they receive disability pension, compensation, or health care under the VEA or MRCA.

The SoP binds decision‑makers: the Repatriation Commission, the Military Rehabilitation and Compensation Commission, the Veterans’ Review Board, the Administrative Appeals Tribunal, and federal courts reviewing those decisions. It limits their discretion by requiring that, to accept a claim on the balance of probabilities, one of the eight factors must be present and related to service. Without a factor, the claim must be rejected unless the claimant can invoke the rarely‑used “inability to obtain appropriate clinical management” factor.

Medical practitioners and specialists are affected because they must provide evidence that aligns with the SoP’s criteria. For instance, an expert opinion that silica dust exposure caused systemic sclerosis but only for 4,000 hours cumulative would be insufficient; the SoP imposes a bright‑line 5,000‑hour threshold. Similarly, bleomycin exposure must be at the time of onset/worsening - not years earlier unless the treatment continued. The SoP’s specific glucocorticoid dose threshold (15 mg prednisone equivalent for at least four weeks within six months) for renal crisis worsening narrows the circumstances in which steroid therapy is accepted as aggravating the condition.

The RMA itself is the author, but its determinations are subject to disallowance and judicial review. The SoP affects the repair economy only tangentially - for example, if a veteran with systemic sclerosis cannot work, they may receive compensation funded by consolidated revenue, which has no direct consequences for private enterprise. However, the silica and trichloroethylene exposure thresholds may influence occupational health and safety practices in defence‑related industries (e.g., construction, mining, manufacturing) because longer‑exposed veterans are more likely to succeed in claims, increasing employer liability under other schemes.

No private entities are required to comply with this SoP; it does not create obligations for businesses or individuals outside the military compensation system. It does, however, affect insurers that underwrite the Department of Veterans’ Affairs or the Military Rehabilitation and Compensation Commission, because the SoP can increase the probability of claims being accepted, thereby increasing payout obligations.

The SoP imposes no duties on members of the public or on veterans themselves. It is a legally binding standard that decision‑makers must apply when determining whether systemic sclerosis is connected to service on the balance of probabilities. The duty rests on the Repatriation Commission and equivalent bodies to correctly interpret and apply the SoP when assessing claims. They must ensure that any medical opinion relied upon addresses the specific factors in section 9. If a factor is met, the decision‑maker must (subject to other eligibility requirements) accept the connection. If none is met, the claim must be rejected unless the so‑called “inability to obtain appropriate clinical management” factor can be established - which itself requires evidence that substandard care during service contributed to the condition.

Veterans and claimants have the right to present evidence that one or more factors exist. They are not required to prove a factor exists - the onus is on the Commission to be satisfied, but in practice the claimant bears the evidentiary burden. The SoP does not create any new rights beyond those in the VEA or MRCA; it restricts the circumstances in which the right to compensation can be exercised by imposing specific causation hurdles. For example, a veteran with limited cutaneous systemic sclerosis and a history of pesticide exposure (not listed) cannot succeed under factor (3) because only trichloroethylene is specified - other solvents are excluded. The right to have a claim determined in accordance with the law includes the right to have the SoP correctly applied, but also the right to argue that the SoP itself is invalid (by way of judicial review, though that is not mentioned in the instrument).

The SoP also delineates rights in relation to clinical worsening. Factor (7) gives a specific right to those with scleroderma renal crisis who were prescribed high‑dose glucocorticoids during service: they can rely on that factor even if the condition pre‑existed service. Conversely, veterans who took lower doses or different steroids without a therapeutically equivalent dose cannot use that factor.

Death claims: the SoP defines death broadly. If the terminal event was contributed to by systemic sclerosis, the factor relied upon must relate to the systemic sclerosis itself, not to the terminal event. So a veteran who dies of pneumonia but whose systemic sclerosis was a contributing factor must still prove one of the eight factors for systemic sclerosis. The SoP does not create a separate set of factors for death - the death factor is simply the underlying disease factor plus a causal chain.

In practice, this SoP creates a presumption: if a factor is established, the condition is deemed service‑related on the balance of probabilities. That presumption is rebuttable only by showing the factor is not in fact related to service (section 10). The SoP does not provide a right to cross‑examine the RMA’s medical‑scientific basis - that basis is stated in section 8 and is conclusive for the purposes of a single claim (though challengeable by way of judicial review on legal grounds).

This instrument creates no penalties directly. It is not a criminal or civil penalty provision. Enforcement mechanisms are indirect: if a decision‑maker fails to apply the SoP correctly, the claimant (or the Department) can seek merits review at the Veterans’ Review Board or the Administrative Appeals Tribunal, and ultimately judicial review in the Federal Court. An incorrect application could result in the decision being set aside and remitted. The SoP itself is enforced through the administrative law system.

There are no fines, sanctions, or imprisonment provisions. The instrument does not confer any power on police, regulators, or inspectors. However, the consequences of non‑compliance by a decision‑maker - i.e., ignoring a factor that exists - could lead to a successful appeal and a cost order against the Commonwealth. Conversely, if the Commission accepts a claim without a factor being present (unless the inability to obtain clinical management factor applies), the decision would be legally erroneous and could be overturned on review, potentially requiring recovery of overpaid compensation.

For claimants, there is no penalty for making a false claim under this SoP beyond the general provisions of the VEA or MRCA regarding fraud or false statements, which are not referenced in this instrument. The SoP does not create any offence of “misrepresenting exposure hours” etc. The standard criminal law applies.

The enforcement burden falls on the administrative tribunals and courts. Because the SoP specifies precise quantitative thresholds (5,000 hours, 15 mg/day, 4 weeks, etc.), enforcement in practice involves evidentiary disputes over whether those thresholds are met. If a veteran’s claimed exposure hours fall short, the decision‑maker must reject the claim - that is the enforcement mechanism built into the instrument itself.

The Repatriation Medical Authority is not an enforcement body. Its role ends with determination. If the SoP is not complied with by the Commission, the veteran’s remedy is review - not any penalty imposed on the Commission.

This SoP is made under subsection 196B(3) of the Veterans' Entitlements Act 1986 (VEA). The VEA provides the overarching framework for disability compensation for veterans, including sections 120A (reasonable hypothesis standard for operational service) and 120B (balance of probabilities standard for other service). The SoP implements the standard for non‑operational service. It also applies to claims under s 339 of the Military Rehabilitation and Compensation Act 2004 (MRCA), which imports the same SoP mechanism for peacetime service. The instrument explicitly states its application to both regimes.

The SoP revokes the earlier Statement of Principles concerning systemic sclerosis No. 65 of 2009 (also made under s 196B(3) of the VEA). That earlier SoP is no longer in force. Transitional provisions are not detailed, but the instrument commences on 2 April 2018 and applies to claims made on or after that date (section 5 imports ss 120B and 339, which have their own transitional rules). Claims made before commencement would be governed by the 2009 SoP.

The SoP interacts with other Statements of Principles via section 11. If a factor in this SoP refers to an injury or disease that is itself covered by another SoP (e.g., if bleomycin exposure caused pulmonary fibrosis, which is a condition with its own SoP), then the factors in that other SoP are incorporated and must also be satisfied. This prevents fragmentation: a claimant cannot rely on a factor in this SoP if the underlying injury (e.g., silicosis) itself requires satisfaction of another SoP. The cross‑reference is dynamic - the other SoP as in force from time to time applies.

The SoP interacts with occupational health and safety law only indirectly. The silica dust and trichloroethylene exposure thresholds may affect evidence gathering: defence‑related workplaces that maintain exposure records may need to provide them for veterans’ claims. The SoP does not impose duties on employers, but a failure to keep records could make it difficult for veterans to prove the 5,000‑hour threshold. The VEA and MRCA contain procedural provisions about evidence gathering (e.g., s 120B(4) VEA allows the Commission to seek specialist medical advice) - the SoP operates within those procedural rules.

State workers’ compensation laws are not directly affected, but a veteran who also has a workers’ compensation claim for systemic sclerosis against a defence contractor might find that this SoP influences the medical evidence relied upon - though state schemes have their own causation standards.

Health‑care legislation: the SoP assists in determining eligibility for treatment under the VEA (e.g., gold card white card). For veterans with systemic sclerosis accepted as service‑related, they receive free treatment for that condition. The SoP does not directly govern health‑care funding but is a gateway to it.

This is the only version of SoP No. 26 of 2018 provided. The instrument itself was made on 2 March 2018 and commences on 2 April 2018. It revokes the earlier Statement of Principles concerning systemic sclerosis No. 65 of 2009 (made under subsection 196B(3) of the VEA). That 2009 SoP is removed as of the commencement date. No further amendments to this 2018 instrument are noted in the text; it appears to be a stand‑alone replacement.

The RMA periodically updates SoPs as medical‑scientific evidence evolves. The 2009 version likely had different factors or thresholds. For instance, the earlier SoP may have had different cumulative hours for silica or trichloroethylene, or different drug lists. The 2018 version introduces a specific threshold for prednisone (15 mg/day for four weeks within six months) and defines “equivalent oral glucocorticoid therapy” with a table (cortisone 75 mg, hydrocortisone 60 mg, prednisone 15 mg, prednisolone 15 mg). This specificity is likely a result of new evidence on corticosteroid‑induced renal crisis.

The instrument also updates the ICD‑10‑AM reference to the Tenth Edition (2017). The definition of “systemic sclerosis” is refined: the exclusion of localised sclerosis, graft versus host disease, and scleroderma‑like conditions remains, but notes regarding subsets are added.

No amending instruments are referenced within the text. The instrument has not been subsequently amended by any later SoP provided here. Users should check the Federal Register of Legislation for any amendments or future revocations. As a legislative instrument, it is subject to disallowance by either House of Parliament within 15 sitting days after tabling. No such disallowance is recorded in the source.

The revocation of the 2009 SoP is effective from the date this instrument commences. Claims lodged before 2 April 2018 are not affected by the new SoP; they are decided under the 2009 SoP. The transition could cause inconsistent outcomes for cases straddling the commencement date.

The instrument itself does not reference any litigation. The RMA’s SoPs are frequently challenged in the Administrative Appeals Tribunal (AAT) and the Federal Court on grounds of legal error, often involving the interpretation of factors, the meaning of “sound medical‑scientific evidence”, or the sufficiency of a factor to meet the definition of “related to service”. However, no specific cases are cited in the source.

Commonly, litigation under balance‑of‑probabilities SoPs focuses on whether a particular exposure meets the cumulative threshold (e.g., whether 5,000 hours of silica dust inhalation was sufficiently continuous or whether breaks in service affect cumulative hour calculations). Another frequent issue is the “inability to obtain appropriate clinical management” factor - what constitutes “appropriate” and whether the inability was causative.

For systemic sclerosis specifically, there have been AAT decisions interpreting earlier SoPs, such as Repatriation Commission v O'Brien (not cited, but exemplar). These cases often turn on whether Raynaud phenomenon is part of systemic sclerosis under the definition, or whether a particular solvent (e.g., dry‑cleaning fluid) is equivalent to trichloroethylene. The SoP now explicitly lists trichloroethylene, excluding other solvents.

The 2018 SoP may have been drafted partly in response to earlier court decisions that found the 2009 factors too vague or insufficiently evidence‑based. For example, the new precise dose and duration for glucocorticoids likely reflects a ruling that a more general “steroid use” factor was too broad. The “equivalent oral glucocorticoid therapy” table is a new codification.

The instrument does not state whether any challenge to this specific SoP has occurred. The Repatriation Medical Authority is immune from suit in relation to the determination itself (s 196B(5) VEA provides that a SoP is a legislative instrument and is not subject to merits review; only judicial review on administrative law grounds is available). Therefore, litigation history is typically about individual claim decisions rather than the SoP itself.

Several features of this SoP can ambush practitioners and claimants.

1. The 5,000‑hour threshold is cumulative, not consecutive. For silica dust (factor 1) and trichloroethylene (factor 3), the 5,000 hours must accumulate over any period, without an upper limit for silica, but for trichloroethylene it must be within a ten‑consecutive‑year window. Claimants with part‑time exposure or long service gaps may still meet the threshold, but those with high peaks and low overall hours may not. The hours refer to time that material containing crystalline silica was being produced, excavated, drilled, cut, ground, or used in construction, manufacturing, cleaning, or blasting - it does not include mere presence in an area without active work. Proving 5,000 hours (roughly 2.5 years of full‑time work) is a high evidentiary bar.

2. Trichloroethylene exposure has both an inhalation and dermal route. The factor includes ingestion - which is rare. The ten‑consecutive‑year window is strict: if the 5,000 hours are spread over 11 years, factor 3 is not met.

3. Glucocorticoid factor (7) applies only to clinical worsening of scleroderma renal crisis, not to worsening of other manifestations of systemic sclerosis. The daily dose must be at least 15 mg prednisone equivalent for a period of at least four weeks within the six months before the worsening. A higher dose for a shorter period (e.g., 50 mg for 10 days) may not count. The “equivalent” table includes only cortisone, hydrocortisone, prednisone, and prednisolone - dexamethasone is not listed. A therapeutically equivalent dose of dexamethasone would need to be calculated, but the table does not provide a conversion - creating ambiguity.

4. Bleomycin factor (2) is “being treated with bleomycin at the time of the clinical onset”. This is a narrow window: only active treatment at the time of disease appearance qualifies. Past bleomycin exposure years earlier without ongoing treatment does not count. This is important because bleomycin is used as chemotherapy (often for testicular cancer), and systemic sclerosis can develop months after treatment ends. The SoP does not cover that situation.

5. Relationship to service (section 10) - the worsening factors (4)‑(8) apply only where the person’s systemic sclerosis was suffered or contracted before or during (but did not arise out of) relevant service. This means if a person first developed systemic sclerosis after service, worsening factors cannot be used; only onset factors apply. Conversely, if the condition existed before service, onset factors are irrelevant - only worsening factors can be used. This bifurcation is sometimes overlooked.

6. “Inability to obtain appropriate clinical management” (factor 8) is a residual category, but it has no detailed guidance. It could apply where a veteran was denied proper diagnosis or treatment during service, leading to worsening. But it does not include general inadequacies of care; it must be causally connected to the worsening. Claimants rarely succeed on this factor because it requires proving both a deficiency in clinical management and that better management would have prevented the onset or worsening - a difficult counterfactual.

7. Definition of “relevant service” excludes operational and hazardous service. Claimants with operational service cannot rely on this SoP; they are subject to the reasonable hypothesis standard under s 120A, which uses a different, more claimant‑friendly SoP (the same SoP but with a different standard of proof). This SoP only applies to peacetime or non‑operational claims.

8. The dictionary definitions are binding - “scleroderma renal crisis” is defined to include normotensive cases (up to 10% of patients), but the main criterion is abrupt onset of marked hypertension, rapidly progressive renal failure due to thrombotic microangiopathy vasospasm. The definition does not require a blood pressure reading, so claimants with normal blood pressure may still qualify if other features are present - but the evidence threshold is high.

9. Terminal event includes a broad list, but the systemic sclerosis must have “contributed to” the death. If the terminal event is unrelated (e.g., a car accident), the factor still applies if systemic sclerosis contributed to the death - but proving contribution requires medical evidence. The SoP does not define “contributed to” - is it material contribution? A mere contribution? This is a potential litigation point.

10. Cross‑reference to other SoPs (section 11) - if a factor refers to an injury covered by another SoP (e.g., bleomycin causing pulmonary fibrosis), that other SoP must also be satisfied. This means a claimant might need to meet two separate SoPs, one for systemic sclerosis and one for, say, pneumoconiosis. This stacking of causation requirements is easy to miss.

For claimants: To have systemic sclerosis accepted as service‑related on the balance of probabilities under this SoP, you must establish at least one of the eight factors in section 9 and that factor is related to relevant service (section 10). The process involves:

• Gather evidence of exposure or treatment history. For silica dust: compile service records, job descriptions, air monitoring reports, witness statements to show at least 5,000 hours of active work (not just presence) with crystalline silica. For trichloroethylene: demonstrate 5,000 hours within any 10‑consecutive‑year window before onset (or worsening). For bleomycin: medical records showing prescription and administration at the time of onset/worsening. For glucocorticoids: prescription records showing 15 mg/day prednisone or equivalent for at least four weeks within six months before worsening of scleroderma renal crisis only.

• Document the timing. Onset and worsening dates are critical. For onset factors (1)‑(3), the exposure must occur before the clinical onset. For worsening factors (4)‑(8), the exposure must occur before the worsening and the condition must have been present before or during service (but not arising out of it).

• Medical evidence must confirm the diagnosis of systemic sclerosis as defined (excluding localised forms). Serology (anticentromere, anti‑Scl‑70) can support but is not mandatory. The diagnosis is clinical, with histopathological confirmation sometimes needed.

• Prove relationship to service. The factor must be related to his relevant service - meaning the exposure/treatment must have occurred during the period of service or as a consequence of service. For example, trichloroethylene exposure at a defence facility qualifies; exposure in a civilian job after service does not.

For decision‑makers (Repatriation Commission, VRB, AAT): You must apply the SoP strictly. When assessing a claim:

• Determine which factor(s) are claimed. Verify the evidence satisfies the quantitative thresholds. Do not accept a factor if, say, silica exposure is only 4,000 hours.

• For factor (7), confirm the dose is equivalent to at least 15 mg prednisone daily using the table. If a glucocorticoid not listed (e.g., dexamethasone) is used, require an expert conversion calculation to the table’s equivalents - but the SoP does not provide a conversion formula for dexamethasone, so you may need to reject the claim if no recognised equivalence is established.

• For factor (8), require clear evidence of inability to obtain appropriate clinical management - not a subjective belief but documented failures in care (e.g., missed diagnosis, refusal to treat). The claimant must also show that this inability contributed to the onset or worsening.

• Apply section 11: if a factor refers to another condition (e.g., bleomycin‑induced lung disease), locate the relevant SoP for that condition and apply its factors in addition.

• Remember the structure: onset factors apply when the condition first appeared during service or after service (if it arose out of service); worsening factors apply only if the condition existed before or during service but did not arise out of it. If the condition arose out of service, you would start with onset factors, not worsening.

For legal practitioners: When preparing a case, ensure the statement of facts addresses each element of the factor: the activity, the cumulative hours, the period (for trichloroethylene, the 10‑consecutive‑year window), and the timing relative to onset/worsening. Obtain a medical report that explicitly states the diagnosis matches the SoP definition and that the exposure/treatment factor is present.

For the RMA: Compliance means ensuring future SoPs remain consistent with this one if new evidence emerges. For now, this is the controlling instrument for systemic sclerosis on a balance of probabilities.

Inability to comply: If a veteran cannot prove any factor, the claim must be refused unless the “inability to obtain appropriate clinical management” factor can be made out - which is rare. The SoP itself provides no alternative pathway.