Statement of Principles concerning gallstone disease (cholelithiasis) (Reasonable Hypothesis) (No. 69 of 2025)

The central legal concept is the reasonable hypothesis test. Under VEA section 120A and MRCA section 338, a claim for an injury or disease must be assessed according to the relevant SoP. For operational or warlike service, the standard of proof is reasonable satisfaction (balance of probabilities) once a hypothesis is raised; for other service, it is proof on the balance of probabilities but the SoP still governs the hypothesis step. This SoP applies only to the "reasonable hypothesis" limb (subsection 196B(2)), meaning it is used to determine whether a hypothesis connecting the disease to service is reasonable. If the factors are not met, the hypothesis is not reasonable and the claim fails.

Clinical onset and clinical worsening are temporal anchors. Most factors require the condition to exist at the time of clinical onset or clinical worsening, or within a specified period before that time. The SoP distinguishes between the first appearance of gallstone disease (onset) and a material worsening of an existing condition that did not arise out of service (section 10(2)). The clinical worsening factors only apply where the person’s gallstone disease was suffered or contracted before or during relevant service but did not arise out of that service. This prevents double-counting where the original disease was already service-related.

Relevant service is defined in the dictionary to mean operational service, peacekeeping service, hazardous service, or British nuclear test defence service under the VEA, and warlike or non-warlike service under the MRCA. This is narrower than "eligible service" for other purposes; for example, peacetime service not falling into these categories may not be covered unless another provision applies.

The definitions in Schedule 1 are critical. For example, "being obese" for males means a BMI of 30 or greater or a waist circumference exceeding 102 cm; "being overweight or obese" for females means BMI of 25 or greater or waist circumference exceeding 75 cm. The different thresholds create a gendered asymmetry. "Rapid and extreme weight loss" requires a 15 per cent reduction in body mass within a continuous 6-month period or at an average rate of at least 1.5 kg per week, within 2 years before onset or worsening. The note mentions bariatric surgery and anti-obesity medications such as GLP-1 receptor agonists as situations that can be associated with that factor. "Total parenteral nutrition" means continuous intravenous drip feeding with no feeding via mouth or gut, for at least 3 weeks. "Oestrogen therapy" includes the oral contraceptive pill and menopausal hormone therapy, continuous, cyclical or intermittent administration.

The factor list is exhaustive. The SoP does not allow for other medical causes outside the listed factors to establish a reasonable hypothesis unless they are captured through section 11 (cross-reference to another SoP) or by inference from the definition. For example, if a factor refers to "Crohn disease", then the SoP for Crohn disease must be consulted to determine whether the person has that condition for the purposes of this SoP. The definitions of "foreign body" and "mechanical obstruction" are specific: foreign body includes surgical clip, stent, nonabsorbable suture, missile fragment, shrapnel or fish bone; mechanical obstruction includes benign or malignant stricture, sclerosing cholangitis, or choledochal cyst.

The SoP does not attempt to prove causation in a scientific sense; it states a threshold for hypothesis. The RMA's view is that there is sound medical-scientific evidence that indicates the disease can be related to relevant service. This is a claim of minimal sufficiency, not a guarantee that any particular factor is causative.

The primary persons affected are veterans and current or former members of the Australian Defence Force who have rendered relevant service as defined. This includes those who served in operational, peacekeeping, hazardous, or British nuclear test defence capacities under the VEA, and those who served in warlike or non-warlike service under the MRCA. Claimants with gallstone disease who apply for disability compensation or medical treatment must have their claims assessed under this SoP. For some, the change from the 2016 SoP may affect eligibility; for example, new factors have been added (such as metabolic dysfunction-associated steatotic liver disease, hepatitis C infection, and inability to undertake physical activity >3 METs) and the definitions have been updated.

Decision-makers at the Department of Veterans’ Affairs and the Military Rehabilitation and Compensation Commission are directly affected. They must apply the SoP strictly when determining whether a reasonable hypothesis exists. This involves verifying the presence of one or more factors, checking temporal requirements, and ensuring the factor is related to service. The SoP constrains their discretion; they cannot accept a hypothesis based on factors not listed or on expert opinion that conflicts with the SoP's framework.

Legal practitioners, advocates, and claims officers must understand the instrument to advise clients correctly. The definition of clinical onset versus worsening is a common source of difficulty. The gender-specific obesity thresholds may create inequities or strategic considerations for claimants.

Medical professionals who assess veterans for gallstone disease may need to provide evidence tailored to the SoP’s definitions. For example, they must measure waist circumference separately for male and female claimants, document medication history (including intermittent oestrogen therapy), and assess metabolic equivalents for physical activity. The note on anti-obesity medications (GLP-1 agonists) highlights that medical documentation should capture weight loss interventions.

Taxpayers fund the compensation system. To the extent that the SoP widens the factor list compared to the 2016 instrument, more claims may succeed, increasing liabilities. Conversely, if the SoP narrows the definition (for example, stones must exceed 2 mm), some claimants with smaller stones may be excluded. The net fiscal effect depends on how many veterans meet the new factors and how decision-makers apply the relationship to service requirement.

Private hospitals and clinics that treat veterans under compensation arrangements may see changes in the volume of claims for gallstone disease treatment if the SoP alters eligibility.

The SoP does not impose duties on claimants; it creates a framework for decision-makers. The Repatriation Medical Authority has a duty under VEA section 196B(2) to determine SoPs based on sound medical-scientific evidence, and this instrument fulfils that duty. Once made, the decision-maker must apply it. There is no duty on claimants to prove the hypothesis is reasonable; the decision-maker must consider the SoP and assess whether the factors are present. However, in practice, claimants bear the evidentiary burden of pointing to a factor and showing it is service-related.

Claimants have the right to have their claim assessed in accordance with the SoP. If the decision-maker errs in applying the SoP, the claimant can seek review by the Veterans’ Review Board and then the Administrative Appeals Tribunal, or seek judicial review. The SoP itself does not confer rights; it is a tool for assessing entitlements under the VEA and MRCA.

Section 10 imposes a critical requirement: the existence of a factor must be related to the relevant service rendered by the person. This means the factor itself must have been caused or contributed to by service, or be the result of service circumstances. For example, a spinal cord injury from a service accident would satisfy the factor, but a spinal cord injury from a motor vehicle accident after discharge would not, unless that injury was itself service-related under another SoP. The second aspect of section 10 deals with clinical worsening: the factor applies only to material contribution or aggravation where the gallstone disease existed before or during (but did not arise out of) relevant service. This prevents a claimant from using a worsening factor to claim compensation for a condition that was already service-related.

Section 11 incorporates other SoPs by reference. If a factor (such as Crohn disease or type 2 diabetes mellitus) refers to an injury or disease for which a separate SoP exists, the factors in that SoP must be satisfied. This creates a chain of proof: to rely on the factor "having Crohn disease", the claimant must first establish a reasonable hypothesis connecting Crohn disease to their relevant service under the Crohn disease SoP. This complicates claims and increases the evidentiary burden.

The instrument also defines "terminal event" for death claims. The phrase "death from gallstone disease" includes death contributed to by gallstone disease via one of the listed terminal events. This is broader than direct causation; a person whose gallstone disease led to pneumonia that caused death could qualify, even if the gallstone disease was not the immediate cause.

This SoP is not a penal instrument. It does not create offences or prescribe penalties. Enforcement is indirect: decision-makers who fail to apply the SoP correctly may have their decisions set aside on review. The Veterans’ Entitlements Act and MRCA contain provisions for review and appeal. The SoP itself cannot be challenged on its merits except on limited grounds such as jurisdictional error or unreasonableness. The RMA’s determination is subject to disallowance by Parliament under the Legislation Act 2003, but that is a parliamentary process, not judicial enforcement.

For claimants, there is no penalty for making a claim that fails the reasonable hypothesis test. However, making a false or misleading statement in support of a claim could be an offence under the Criminal Code (provision of false information to a Commonwealth official). That is general law, not specific to this SoP.

For medical practitioners providing reports, giving false or misleading information may expose them to civil liability or professional discipline, but the SoP itself does not regulate that.

The practical enforcement mechanism is the claims assessment process. If a claim is rejected because the factor is not established or not service-related, the claimant may seek review. If the decision-maker incorrectly applied the SoP, the review body can remit the decision. The SoP creates a strict framework that limits the scope of discretion; a decision-maker cannot accept a hypothesis based on a factor outside the list unless it falls within section 11.

Compliance with the SoP is mandatory in the sense that decision-makers must apply it when determining whether a reasonable hypothesis exists. Failure to do so could result in a legally erroneous decision. The SoP is a legislative instrument and binds the executive. There are no enforcement actions against private citizens.

This SoP is made under the VEA and applies to claims under both the VEA and the MRCA. It repeals the previous SoP No. 51 of 2016, so the 2016 instrument no longer applies. Claims lodged before 22 September 2025 may be decided under the previous SoP if the claim was determined before that date, but claims determined after must use this one unless transitional provisions apply (the VEA does not provide for transitional grandfathering in this instrument).

The SoP interacts with VEA section 120A and MRCA section 338 which set the standard of proof. For operational service, the standard is reasonable satisfaction after a reasonable hypothesis is raised; for warlike service under MRCA, the standard is beneficial. This SoP is the tool for determining whether a hypothesis is reasonable. If the hypothesis is reasonable, the decision-maker then applies the relevant standard of proof to decide whether the disease is related to service. If the hypothesis is not reasonable, the claim fails at that stage. The SoP therefore effectively governs the gateway to compensation.

The definition of gallstone disease references ICD-10-AM code K80 but states that for this SoP, the meaning is as given in subsection 7(2). This means the ICD code is merely a cross-reference, not a controlling definition. If a person has a condition coded as K80 but with stones 2 mm or less, it is not gallstone disease for the purposes of this SoP. This could lead to conflicts with medical records or other SoPs.

Section 11 creates a dynamic interaction with other SoPs. If a factor refers to a disease that itself must be service-related (e.g., spinal cord injury, type 2 diabetes, Crohn disease), the claimant must satisfy the relevant SoP for that disease. This means the gallstone disease SoP operates as part of a network of SoPs. Changes to other SoPs (e.g., a new SoP for type 2 diabetes) automatically affect gallstone disease claims through the reference, without amendment to this instrument.

The instrument also interacts with the common law concept of causation. The SoP does not follow tort principles; it is a statutory framework designed to produce consistent outcomes. The reasonable hypothesis test is a lower threshold than "on the balance of probabilities", but the relationship to service requirement still imposes a legal connection.

Veterans’ compensation legislation also includes provisions for dual entitlement and off-setting. A successful gallstone disease claim may affect other payments. This SoP does not address those matters.

This SoP (No. 69 of 2025) is a new instrument that repeals and replaces the earlier Statement of Principles concerning cholelithiasis No. 51 of 2016 (registered as F2016L00557). The earlier instrument was made under the same subsection (196B(2) of the VEA). The 2025 SoP commences on 22 September 2025. There is no amendment history shown within the source; it is a fresh determination. The RMA must periodically review SoPs, and this replacement may reflect new medical evidence or changed diagnostic criteria.

The source does not set out what changed from the 2016 instrument. However, comparing the text would reveal whether new factors were added (e.g., metabolic dysfunction-associated steatotic liver disease, hepatitis C, inability to undertake physical activity), whether definitions were tightened (e.g., the 2 mm threshold, the specific list of medications), and whether the temporal requirements changed. The note on anti-obesity medications is new. The gender-specific obesity definitions may have been revised.

Because the instrument does not include a table of amendments or a comparison, the only certain amendment is the repeal of the 2016 SoP. There are no annotations to suggest any earlier amendments to the 2025 SoP itself. It is a standalone instrument.

The source does not mention any litigation. No cases are cited. This SoP is new and litigation under it will necessarily arise only after its commencement. The predecessor 2016 SoP may have been the subject of challenges, but the current instrument does not refer to them. It is common for Australian courts and tribunals to interpret the reasonable hypothesis test and the application of SoP requirements, but those decisions are general in nature and not specific to this instrument.

For example, the High Court in Repatriation Commission v Hancock (2003) and Repatriation Commission v Elliott (2004) dealt with the relationship between SoPs and the standard of proof. The Federal Court and the Administrative Appeals Tribunal have considered the meaning of "clinical onset", "clinical worsening", and "material contribution". These precedents will inform how decision-makers apply the 2025 SoP, but they are not incorporated by reference.

One potential area of dispute is the definition of "inability to obtain appropriate clinical management". That factor could generate litigation over what constitutes "appropriate" and whether the inability was due to service. Similarly, the physical activity factor (inability to undertake any physical activity greater than 3 METs for at least 5 years) may be contested, as it requires evidence of a sustained severe functional limitation prior to the onset or worsening of gallstone disease.

The gender-specific obesity thresholds may also be challenged on grounds of legal unreasonableness or discrimination, though the VEA and MRCA do not include equal treatment principles in the SoP framework. The Tribunal may be called to interpret whether the factor is irrational or contrary to medical-scientific evidence, but the RMA's determinations are generally given significant deference.

Overall, there is no express litigation history in the source, but the instrument is likely to be tested in the Veterans’ Review Board and the AAT.

Several subtle but critical traps exist. The first is the temporal distinction between clinical onset and clinical worsening. Section 10(2) states that clinical worsening factors apply only if the person’s gallstone disease was suffered or contracted before or during relevant service but did not arise out of that service. This means a veteran who developed gallstones after discharge cannot rely on a worsening factor; they must rely on clinical onset factors. A claimant whose gallstones were service-related and then worsened later cannot use the worsening factors to claim a higher permanent impairment; the worsening factors are only for those with pre-existing non-service gallstones that were aggravated by service.

Second, the gender-specific obesity thresholds are easy to misapply. For males, obesity is BMI ≥30 or waist >102 cm; for females, the overweight threshold is BMI ≥25 or waist >75 cm. A male with a waist of 100 cm is not obese under this SoP; a female with a waist of 76 cm is overweight. The definitions do not use the same criteria for both sexes. A male cannot rely on the "overweight" factor because the factor for males only references "being obese". Conversely, a female can rely on being overweight or obese. This asymmetry may catch male claimants with central obesity who have a BMI under 30.

Third, the medication cessation windows are strict. For the general medication factor (atazanavir, cyclosporine A, fibrates, somatostatin analogues, tamoxifen), the clinical onset or worsening must occur within 3 months of cessation of continuous use for at least 3 months. For oestrogen therapy, the window is 6 months; for total parenteral nutrition, it is 30 days. Missing these windows by even a few days means the factor does not apply, even if the medication caused the gallstones.

Fourth, the foreign body and mechanical obstruction definitions are narrower than one might expect. "Foreign body" does not include endogenous objects such as parasites or gallstones (those are covered elsewhere). It must be exogenous material. "Mechanical obstruction" includes only structural or disease processes narrowing the lumen; functional obstructions such as spasms or dyskinesia are not included.

Fifth, the inability to obtain appropriate clinical management factor applies only to clinical worsening, not clinical onset. For a worsening claim, the claimant must show they could not get appropriate management before the worsening occurred, and that this inability was due to service. This is a high bar.

Sixth, the very low-calorie diet factor requires intake of less than 800 kcal per day for 6 months. That is a severe restriction; many weight loss programs are above that. The factor does not require weight loss, only the diet. But the note on anti-obesity medications suggests that rapid weight loss is often associated with such diets, yet the factor stands alone.

Seventh, the physical activity factor (inability to undertake any activity greater than 3 METs for 5 years) is extremely restrictive. 3 METs is roughly the effort of walking at 5 km/h or light gardening. Many disabled veterans may meet this, but they must show the inability existed for at least 5 years before the onset or worsening of gallstones. This factor may be used as a catch-all for severely incapacitated veterans, but the temporal requirement is lengthy.

Eighth, the relationship to service requirement under section 10(1) means the factor must be related to relevant service, not just the fact that the person had the factor. For example, a person with Crohn disease that is not service-related cannot use the Crohn factor for gallstones unless they also have a service-related cause for the Crohn disease (via another SoP). This chain of proof is often overlooked.

For a claimant seeking to establish a reasonable hypothesis, the first step is to obtain a medical diagnosis of gallstone disease meeting the definition: stones exceeding 2 mm in the gallbladder or bile ducts. Imaging reports (ultrasound, CT, MRCP) should specify stone size. The diagnosis must be from a qualified medical practitioner.

The second step is to identify which factor or factors in section 9 may apply. The claimant should gather evidence relevant to the time of clinical onset (or clinical worsening if applicable). Medical records, service documents, and lifestyle history are needed. Key records include: spinal injury assessments, operative notes for ileal resection or bypass, surgical records for vagotomy, pathology for parasitic infections, bacteriology for biliary infections, haemolysis blood tests, endocrinology for somatostatinoma, pregnancy tests and dates, anthropometric measurements (height, weight, waist circumference at the relevant time), diet diaries, weight loss history, diabetes diagnosis, liver disease tests (cirrhosis, MASLD), hepatitis C serology, gastroenterology for Crohn or ulcerative colitis, medication history (including start/end dates, continuous periods), oestrogen therapy history (including contraceptive pill and HRT), total parenteral nutrition records (including duration and exact cessation date), and functional assessments for physical activity (including MET estimates).

For claimants relying on the obesity or overweight factors, objective measurements are essential. BMI should be calculated from weight and height at the relevant time (at least 2 years before onset or worsening for the obesity factor). Waist circumference should be measured by a clinician. The claimant cannot rely on self-reporting alone; the decision-maker will likely require contemporary medical records or doctor’s assessments.

For the rapid weight loss factor, document the weight change over time, confirming a 15% reduction within 6 months or an average loss of 1.5 kg per week. Bariatric surgery records or prescription of GLP-1 receptor agonists should be obtained.

For clinical worsening claims, the claimant must also show that the original gallstone disease was not service-related. The decision-maker will need evidence that the condition existed before or during service but did not arise out of service. This may involve opining that service did not cause it.

Claimants should ensure all factors are related to relevant service. For example, if the factor is "having hepatitis C virus infection", the claimant must show the infection was contracted during service (e.g., via blood transfusion or needle stick injury). The decision-maker will apply the SoP for hepatitis C to assess that.

The claimant should prepare a statement or narrative linking each factor to service. Legal advocates can assist in mapping the evidence to the SoP’s language.

For decision-makers, compliance involves checking each temporal requirement against the evidence. If the factor requires a condition to exist "at the time of clinical onset", the date of first diagnosis is relevant. The SoP does not define "clinical onset"; case law suggests it is when symptoms first become manifest or when the disease becomes clinically apparent. The decision-maker must exercise judgment but cannot ignore the SoP’s definitions.

The decision-maker must also apply section 11 if a factor references another injury or disease. That means requesting or assessing the relevant SoP for that factor. For instance, to verify a spinal cord injury, the decision-maker must consider the spinal cord injury SoP and whether that injury raises a reasonable hypothesis with service.

Finally, the relationship to service under section 10 requires that the factor be related to the person’s relevant service. This is not automatic; even if the factor is present, if it was not caused or contributed to by service, the hypothesis fails. The decision-maker should seek evidence of the connection, such as service medical records, incident reports, or compensation decisions for the factor condition.