Statement of Principles concerning gallstone disease (cholelithiasis) (Balance of Probabilities) (No. 70 of 2025)

The SoP introduces several distinct concepts that are central to its operation. The first is clinical onset and clinical worsening. Clinical onset refers to the first appearance of gallstone disease that meets the definition. Clinical worsening refers to a material deterioration in the disease after it was already present. Many factors in section 9 apply to both onset and worsening, but some (especially factor 25 - inability to obtain appropriate clinical management) apply only to worsening. The distinction matters because of the timing rules: for clinical worsening, the factor must occur before the worsening, and section 10(2) restricts worsening claims to situations where the disease was contracted before or during service but did not arise out of it. This prevents a veteran from claiming that a pre-existing condition that was worsened by service is compensable unless there is a material contribution.

Relevant service is defined in the Dictionary. It means 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. Operational service and hazardous service are excluded from this SoP because they are governed by the reasonable hypothesis standard and a different SoP (made under subsection 196B(2) of the VEA). The SoP thereby only applies to the lower standard of proof - balance of probabilities - for non-operational service. This is an important limitation: a veteran who served on operational service cannot rely on this SoP for a gallstone disease claim; they must instead satisfy the reasonable hypothesis standard which requires a different SoP.

The balance of probabilities standard is the touchstone. Under section 120B of the VEA, when determining a claim for non-operational service, the decision-maker must be satisfied on the balance of probabilities that the disease is connected to service, and they must do so in accordance with a SoP determined by the RMA. This SoP supplies the exclusive set of factors that can establish that connection. If none of the factors exist, or if the factor cannot be related to service, the claim must fail. This limits discretion and imposes a uniform evidence-based framework across all claims, reducing inconsistency but also reducing flexibility for unusual cases not captured by the listed factors.

Clinical onset and clinical worsening are not defined in the Dictionary, but they are used throughout section 9 with specific time windows. For example, factors such as having a gastric or oesophageal resection within 5 years before clinical onset or clinical worsening, or having rapid and extreme weight loss within 1 year before clinical onset or clinical worsening. The SoP does not specify what constitutes the “time of clinical onset” when a disease develops gradually; presumably it means when symptoms first appear or when stones reach the requisite size. This ambiguity could be a source of dispute.

The Dictionary defines many terms with precision. “Being obese” is defined as a BMI of 30 or greater, or for males a waist circumference exceeding 102 cm. “Being overweight or obese” is defined as BMI 25 or greater, or for females waist circumference exceeding 75 cm. These gender-based thresholds reflect epidemiological differences but also mean that a female veteran with a BMI of 28 might qualify under factor 14 if she also has a waist circumference above 75 cm. “Foreign body” includes surgical clips, stents, nonabsorbable sutures, missile fragments, shrapnel, or fish bone - a broad range covering both wartime and peacetime injuries. “Mechanical obstruction of the biliary tract” includes benign or malignant stricture, sclerosing cholangitis, or choledochal cyst. “Somatostatinoma” is defined as a neuroendocrine neoplasm with excessive somatostatin secretion. “Spinal cord injury” requires injury to the long tracts with permanent motor or sensory deficits below the lesion - not all spinal injuries qualify. “Total parenteral nutrition” means continuous intravenous drip feeding with no gut feeding.

The SoP also introduces a note system: notes provide examples or clarifications but are not legally binding. For instance, the note to factor 16 (rapid and extreme weight loss) lists bariatric surgery and GLP-1 receptor agonists as examples. These notes can guide decision-makers but do not create new factors.

One economically significant concept is factor 25: “inability to obtain appropriate clinical management for gallstone disease (cholelithiasis) before clinical worsening.” This factor captures situations where a veteran’s service (e.g. remote posting, lack of access to medical care) prevented them from receiving timely treatment, leading to worsening. It potentially opens a large class of claims where the disease itself might not be service-related, but the inability to treat it is. It imposes an obligation on the respondent to show that appropriate clinical management was available and obtainable, or that the failure to obtain it was not due to service. The burden of proof on this factor is unclear, but it may shift significantly depending on the facts.

The primary subjects of this SoP are veterans, members of the Forces, and members of the Defence Force who have rendered relevant service (as defined) and who suffer from gallstone disease (cholelithiasis) or who have died from it. These individuals are the claimants or potential claimants in compensation proceedings under the VEA or MRCA. The SoP determines whether they can establish a connection between their disease and their service, which is a prerequisite for compensation. Veterans with operational service are not directly affected because this SoP does not apply to them; they are subject to a different SoP under the reasonable hypothesis standard. However, a veteran who had both operational and non-operational service may have claims assessed under different standards depending on which period of service is alleged to be connected.

Dependants of deceased veterans are also affected. Section 7(5) provides that gallstone disease includes death from a terminal event contributed to by the disease. This enables dependants to claim compensation for death if the gallstone disease itself is connected to relevant service. The definition of “terminal event” in the Dictionary includes common causes of death such as pneumonia, respiratory failure, and cardiac arrest. A dependant would need to show that the disease contributed to the terminal event and that at least one factor from section 9 exists and is service-related. This broad definition increases the likelihood of successful death claims, but it also increases the evidentiary burden on the Department to disentangle the contributions of gallstone disease from other causes.

The Repatriation Medical Authority is the body that made this SoP. It is affected in the sense that it has ongoing responsibilities to review and update SoPs based on sound medical-scientific evidence. The RMA must ensure that each factor is supported by the available evidence and that the SoP meets the legal standard under section 196B of the VEA. The RMA also has a role in determining whether the SoP should apply to clinical worsening as distinct from onset, and in setting time limits.

Decision-makers at the Department of Veterans’ Affairs and the Military Rehabilitation and Compensation Commission are directly bound. When processing a claim to which section 120B of the VEA or section 339 of the MRCA applies, the decision-maker must apply this SoP as the sole basis for determining whether the disease is connected to service. They cannot use their own general medical knowledge or other sources; they must match the facts of the case to the factors in section 9. This reduces discretion and standardises outcomes but also creates a rigid system that may produce harsh results for claimants whose clinical presentation does not fit neatly into any listed factor. Decision-makers also have to apply the cross-reference mechanism in section 11, which requires them to consult other SoPs for factors like spinal cord injury.

Medical practitioners and health professionals who treat veterans may be called upon to provide evidence regarding the presence of factors (e.g. BMI records, medication history, surgical history). They may need to be aware of the specific definitions in the Dictionary to ensure their reports address the correct criteria. For example, they must know that “being obese” for a male is BMI 30 or waist >102 cm, not simply a clinical judgment of obesity. They must also be able to document timing relative to clinical onset or worsening.

The broader taxpayer community is indirectly affected because the SoP influences the cost of the veterans’ compensation system. Each factor that is easier to satisfy increases the number of successful claims and the total amount of compensation paid. The SoP includes factors that are highly prevalent in the general population - type 2 diabetes, obesity, use of oral contraceptives, and rapid weight loss from popular diet drugs (GLP-1 agonists are explicitly noted). This may lead to a significant fiscal expansion if large numbers of veterans with non-operational service meet the criteria. The cost is concentrated on the Department and ultimately on taxpayers, while the benefits are concentrated on veterans and their dependants.

For claimants (veterans and dependants), the SoP confirms a right to have a claim for gallstone disease determined in accordance with its provisions. That right arises from section 120B of the VEA and section 339 of the MRCA, which require decision-makers to apply the relevant SoP. The right is to a decision that uses the factors in section 9 as the exclusive gateway. Claimants also have a correlative duty to provide evidence establishing that at least one factor exists and is related to their relevant service. This includes medical records, service records, and any other documentation that addresses the specific definitions in the Dictionary. For example, to rely on factor 14 (obesity for females), a female claimant must provide evidence of BMI of 25 or greater, or waist circumference exceeding 75 cm, for at least 5 years before clinical onset - not just a physician’s note saying “overweight.”

For the Repatriation Medical Authority, the duty under section 196B(3) is to determine a SoP based on “sound medical-scientific evidence” that it is more probable than not that the disease can be related to relevant service. The RMA must also set out the factors that must exist and the standard of proof. The RMA has no duty to update the SoP in real time, but it does have a power to revoke or replace it. The statement in section 8 that the RMA is of the view that the condition can be related to service is a formal prerequisite but not a matter that can be contested in a claim - it is part of the legislative instrument.

For decision-makers (DVA and MRCC), the duty is to apply the SoP correctly. This means identifying the relevant factor, considering whether the evidence supports it, and ensuring the factor is related to service. They also have a duty under section 11 to consider any other SoP that defines an injury or disease referred to in a factor. For instance, if a claimant relies on factor 1 (spinal cord injury), the decision-maker must consult the SoP for spinal cord injury to see if the claimant meets that condition. Decision-makers have no discretion to create new factors or to ignore the time limits specified. They must also separate clinical onset from clinical worsening claims and apply section 10(2) appropriately.

For the Minister and the Department, there is a duty to ensure that the SoP is published and accessible. The instrument is registered on the Federal Register of Legislation. There is no explicit duty to provide explanatory material, but the notes in the SoP serve as a guide.

Rights of review are not detailed in the SoP itself, but claimants have a general right under the VEA and MRCA to seek reconsideration or appeal to the Veterans’ Review Board, the Administrative Appeals Tribunal, and ultimately the Federal Court. The SoP may be challenged on the grounds that it was not properly made, or that a decision-maker misinterpreted it. However, the SoP itself cannot be challenged on merits in a claim; it is binding secondary legislation. Claimants can argue that their circumstances fall within a factor, or that the factor relates to service, but they cannot argue that the factor is scientifically unsound.

For medical practitioners, there is a de facto duty to provide evidence in the terms defined by the Dictionary. A medical report that says “patient is obese” without reference to BMI or waist circumference may be insufficient. The practitioner may need to calculate BMI or measure waist circumference specifically. They may also need to give an opinion on when clinical onset occurred, which can require retrospective analysis.

This SoP does not itself create any penalties or enforcement mechanisms. It is a standard for determining entitlement to compensation, not a prohibitory or regulatory instrument. There are no civil penalties for non-compliance with the SoP by claimants or medical practitioners. However, false or misleading statements made in support of a claim could attract penalties under other legislation, such as section 137.1 of the Criminal Code Act 1995 (Cth) (providing false or misleading information to a Commonwealth entity) or specific provisions in the VEA and MRCA relating to fraud. Those penalties are not referenced in the SoP but apply independently.

For decision-makers, a failure to apply the SoP correctly could lead to an adverse decision being overturned on review. There is no penalty on the individual decision-maker, but systemic non-compliance could result in increased litigation costs and reputational harm for the Department. The SoP itself does not prescribe any enforcement action; enforcement is through the review system.

The RMA is not subject to penalties under the SoP. Its determinations are legislative in nature and can be disallowed by Parliament under the Legislation Act 2003 (Cth) or challenged by judicial review if the instrument exceeds the regulation-making power. No penalties attach to the RMA for the content of the SoP, provided it was made in good faith and on the basis of sound medical-scientific evidence.

The absence of penalties means that the SoP’s effectiveness relies on its legal binding force and the professionalism of decision-makers. The economic incentive for claimants to comply (by providing truthful evidence) is that a successful claim results in compensation. Conversely, the risk of detection and penalties for fraud may act as a deterrent, but that deterrence is not calibrated to this SoP.

The SoP is made under subsection 196B(3) of the VEA and is expressly tied to claims under section 120B of the VEA and section 339 of the MRCA. It applies only to those provisions. For operational service under the VEA and hazardous service under the MRCA, a different SoP made under subsection 196B(2) would apply, which uses the reasonable hypothesis standard. That SoP is not this instrument; it is a separate determination. Therefore, a veteran with operational service cannot rely on this SoP even if they meet one of its factors - they must find a SoP that relates to operational service. In practice, the RMA usually issues paired SoPs (one for reasonable hypothesis and one for balance of probabilities) with identical factors, but they are separate legislative instruments. This SoP is specifically the balance of probabilities version.

Section 11 of the SoP creates a cross-reference mechanism: if a factor in section 9 refers to an injury or disease covered by another SoP (e.g. spinal cord injury, cirrhosis, Crohn disease, type 2 diabetes), then the factors in that other SoP apply. This means that to satisfy factor 1 (spinal cord injury), the claimant must meet the definition and factors in the spinal cord injury SoP. That other SoP must be in force under subsection 196B(3) as well (balance of probabilities). This prevents a claimant from relying solely on a medical diagnosis; they must also show that the spinal cord injury itself is connected to service under its own SoP. This creates a chain of causation evidence requirements that can increase the administrative burden.

The SoP interacts with the Veterans’ Entitlements Act 1986 generally. Section 120B of that Act provides that the commission must be satisfied, on the balance of probabilities, that the disease is connected to service, and that the SoP is binding. Section 196B gives the RMA the power to make the SoP. The SoP also interacts with the MRCA through the same mechanism. Note that the SoP defines “relevant service” as including peacetime service under the MRCA but not hazardous service or British nuclear test defence service. This means that service under the MRCA that is hazardous (which covers most active deployments) is excluded from this SoP.

The SoP interacts with the common law of causation, but only at the margins. The VEA and MRCA are intended to be codes for veterans’ compensation, and the SoPs are intended to supplant general common law principles of causation. However, where the SoP is silent (e.g. on the meaning of “clinical onset”), decision-makers may need to rely on general principles. The SoP does not override any other Commonwealth, state or territory laws that provide compensation for gallstone disease, but generally a claimant cannot receive double compensation.

Finally, the SoP implicitly interacts with the Legislation Act 2003 (Cth) and the Acts Interpretation Act 1901 (Cth) (or the Legislation Act replacement provisions) for interpretative principles.

The SoP states in section 4 that it repeals the Statement of Principles concerning cholelithiasis No. 52 of 2016 (Federal Register of Legislation No. F2016L00558). That earlier instrument was made under the same subsection 196B(3) of the VEA. This instrument therefore replaces it with an updated set of factors based on more recent medical-scientific evidence. The RMA did not include an explanatory memorandum or a table of changes in the instrument. Amendments to the 2016 SoP would have been made by subsequent RMA determinations, but those are not referenced. Only the repeal is stated.

The instrument itself is numbered No. 70 of 2025 and commences on 22 September 2025. It is the only version currently in force for cholelithiasis under the balance of probabilities standard. There is no grandfathering or transitional provision: from 22 September 2025, any claim to which this SoP applies must be decided under this instrument, not the 2016 one. Claims that were lodged but not yet determined before that date would fall to be decided under the new SoP, unless the previous SoP had been applied and the claim was pending review - but the instrument does not specify transitional arrangements, so the default rule is that the law as in force at the time of decision (for merit review) or at the time of the original decision (for later reviews) may apply. This could create complications if a claim was filed under the old SoP but the decision is made after commencement.

The SoP includes no date of expiry. It remains in force until repealed or replaced by a later instrument. The RMA typically reviews SoPs periodically, but there is no statutory timeframe for review.

From a practical standpoint, the amendment from the 2016 SoP to the 2025 SoP represents a change in the factors and definitions. Some factors may have been added (for example, Helicobacter pylori infection of the biliary tract - factor 6 - is not likely to have been in the 2016 SoP? Not stated, but we cannot assume. The weight thresholds for obesity appear to be new or modified: the 2016 SoP may have had different BMI thresholds or gender-specific criteria. Also, the inclusion of rapid weight loss from bariatric surgery and GLP-1 medications reflects the rise of these treatments. The 2025 SoP also notes “glucagon-like peptide 1 receptor agonists” in the note to factor 16, indicating that the RMA considered this emerging cause. This suggests a broader shift to include more iatrogenic and lifestyle-related factors, enlarging the pool of potential claims.

The instrument itself does not contain any reference to litigation, case law, or court decisions. No cases are cited in the text. This is typical for legislative instruments. However, as a matter of general administrative law, SoPs have been the subject of challenges in the Administrative Appeals Tribunal and the Federal Court. Claimants may argue that a decision-maker misapplied the SoP, or that the SoP itself is invalid because it was not made on the basis of sound medical-scientific evidence. For example, in Repatriation Commission v Gorton (2001) 110 FCR 321, the Full Federal Court considered whether a SoP was validly made, and the High Court has considered the standard of proof under section 120B. But none of these cases are referenced in this instrument.

Because this SoP is new (commencing 22 September 2025), there is no specific litigation history for this particular instrument. Factors that may be litigated in future include the meaning of “clinical onset” when stones are discovered incidentally on imaging, the definition of “inability to obtain appropriate clinical management” (factor 25), and the temporal relationships (e.g., whether rapid weight loss occurring more than one year before clinical worsening but still within the 1 year window of a later worsening), and the requirement that a factor be “related to” relevant service. The gender-specific obesity thresholds may also be challenged as discriminatory under the Australian Human Rights Commission Act 1986 but the SoP is a legislative instrument and may be immune from such challenge unless it exceeds power.

The cross-reference provision in section 11 may generate litigation: if a claimant relies on a spinal cord injury, but the spinal cord injury SoP has its own strict requirements, a decision-maker may incorrectly apply the wrong version or interpret the cross-reference too broadly. No cases are known.

Several nuances in the SoP can trap unwary claimants, decision-makers, and advisers.

Stone size threshold: The definition requires stones exceeding 2 millimetres in diameter. Biliary sludge, microlithiasis (stones under 2mm), or isolated cholesterol crystals do not satisfy the definition, even if they cause symptoms. This is a bright-line rule that may exclude many clinically significant conditions. Claimants with symptomatic but small stones may not succeed, and medical reports must explicitly state the size.

Clinical onset vs clinical worsening: Many factors apply to both, but factor 25 (inability to obtain appropriate clinical management) applies only to clinical worsening. Section 10(2) says that the clinical worsening aspects of factors apply only to material contribution to or aggravation of the disease where the disease was suffered or contracted before or during (but did not arise out of) the person’s relevant service. This means that if a veteran developed gallstone disease after service ended, they cannot use factor 25 to claim worsening, because the disease did not exist before or during service. The worsening provision is only for cases where the disease pre-existed service (or was contracted during service but not caused by it). This can be a subtle distinction.

Temporal windows are strict: Many factors require the exposure to occur within a specific period before clinical onset or worsening. For example, having a gastric or oesophageal resection within the 5 years before clinical onset. If the surgery was 6 years before, the factor does not apply, even if there is a plausible causal mechanism. Similarly, pregnancy must be within 3 months of onset/worsening; taking oestrogen therapy for at least 6 months, and if ceased, onset must occur within 3 months. Claimants and their advisers must be meticulous about dates.

Gender-specific obesity thresholds: Factor 13 applies to males “being obese” (BMI ≥30 or waist >102 cm). Factor 14 applies to females “being overweight or obese” (BMI ≥25 or waist >75 cm). A female veteran with BMI 27 but waist 74 cm is not overweight under the definition, and cannot use factor 14. A male veteran with BMI 28 but waist 103 cm satisfies factor 13. The definition uses “being obese” for males and “being overweight or obese” for females, so the threshold is lower for females. However, this may cause confusion if a female has a high BMI but does not meet the waist threshold, or a male has a low BMI but high waist. The rule is clear in the Dictionary but may not be intuitive.

Factor must be related to service - a double test: Section 10(1) requires that the existence of any factor must be related to the relevant service. It is not enough that the factor exists; the factor itself must have been caused or contributed to by service. For example, a veteran with type 2 diabetes (factor 20) must show that the diabetes is service-related, not just that the diabetes exists at the time of clinical onset. This means a veteran who developed type 2 diabetes after service cannot use that factor unless the diabetes is independently connected to service. For common conditions like obesity, the veteran may need to show that the obesity resulted from service-related inactivity, medication, or injury. This adds a significant evidentiary burden.

“Inability to obtain appropriate clinical management” is vague: Factor 25 uses a term not defined in the Dictionary. What constitutes “appropriate clinical management”? Whether it includes non-surgical options like lifestyle advice or only medical interventions? What if the veteran refused treatment? The burden is on the claimant to show inability, not mere difficulty. The factor also only applies to clinical worsening, not onset. This could be a fruitful source of litigation.

Cross-referencing can make a claim complex: If a claimant relies on spinal cord injury, the spinal cord injury SoP must be applied. That SoP itself has factors that must be met, and those factors must also be related to service. This could create a chain that is hard to satisfy and increases the cost of preparing a claim.

Terminal event definition is broad but requires contribution: For a death claim, the gallstone disease must contribute to a terminal event. The list in the Dictionary (pneumonia, respiratory failure, cardiac arrest, etc.) is non-exhaustive but includes items like “cessation of brain function.” The contribution must be more than negligible; the disease must have played a part in the terminal event. If the veteran had severe gallstone disease but died from a car accident unrelated to it, the claim would fail.

Notes are not binding but may be used against claimants: The notes provide examples of what can cause conditions (e.g. GLP-1 receptor agonists for rapid weight loss). While helpful, a decision-maker could argue that because the factor is stated precisely, the note does not expand it. Also, if the note lists examples, claimants cannot rely on unlisted agents unless they fall within the factor wording.

Commencement date may cause transitional issues: Claims lodged before 22 September 2025 will be decided under the 2016 SoP if the decision is made before commencement. If the decision is made after commencement, the new SoP applies, even if the claim was lodged earlier. This could disadvantage a claimant who relied on a factor in the old SoP that no longer exists or has tightened time limits.

The instrument does not specify how to calculate BMI for amputees or those with prosthetics: The definition formula uses weight and height, but for veterans with amputations or other disabilities, BMI may be inaccurate. The Dictionary does not address how to adjust. This could lead to inconsistent decisions.

Factor 23 - total parenteral nutrition: must be continuous for at least 3 weeks. If interrupted for even a day, the factor may not apply. TPN is usually administered in hospital, so this factor may be relevant only for those who had major surgery.

Medication factors require continuous period of at least 6 months and then cessation within 3 months. If the veteran started taking tamoxifen for breast cancer but only for 5 months, factor 22 does not apply. If they took it for 6 months but stopped 4 months before clinical onset, it also does not apply.

Compliance with this SoP is primarily the responsibility of claimants (veterans and dependants) and decision-makers. The instrument sets a standard that determines whether a claim succeeds or fails. Here is a step-by-step approach to complying with the SoP’s requirements.

For claimants: First, ensure that the disease meets the definition: obtain imaging (ultrasound, CT, MRI) demonstrating one or more stones exceeding 2mm in diameter in the gallbladder or bile ducts. A diagnosis without imaging or with “sludge” will not suffice. Second, identify which factors from section 9 are present. This requires a thorough medical history covering:

• Prior spinal cord injury (with permanent motor/sensory deficits)
• Foreign body in biliary tract (from surgery or shrapnel)
• Ileal resection or bypass (within 25 years)
• Gastric or oesophageal resection with vagotomy (within 5 years)
• Parasitic infections (ascariasis, clonorchiasis, fascioliasis, opisthorchiasis) of biliary tract
• Helicobacter pylori infection of biliary tract
• Cholangiohepatitis or recurrent pyogenic cholangitis
• Acquired haemolytic disease (e.g. autoimmune haemolytic anaemia) within 1 year
• Worsening of inherited haemolytic disease (e.g. hereditary spherocytosis) within 1 year
• Somatostatinoma
• Pregnancy within 3 months
• For males: obesity (BMI ≥30 or waist >102 cm) for at least 5 years before onset/worsening
• For females: overweight/obese (BMI ≥25 or waist >75 cm) for at least 5 years
• Rapid and extreme weight loss (≥15% body mass in 6 months, or average ≥1.5 kg/week) within 1 year
• Very low-calorie diet (<800 kcal/day) for 1 year
• Type 2 diabetes mellitus at time of onset/worsening
• Cirrhosis of liver
• Crohn disease
• Medications: atazanavir, cyclosporine A, fibrates, somatostatin analogues, tamoxifen - taken for at least 6 continuous months, and if ceased, onset within 3 months
• Oestrogen therapy (including OCP and HRT) for at least 6 continuous months, cessation within 3 months
• Total parenteral nutrition for at least 3 continuous weeks, cessation within 30 days
• Inability to undertake physical activity >3 METs for at least 5 years
• Inability to obtain appropriate clinical management before clinical worsening

For each potential factor, collect documentary evidence: medical records, prescription histories, weight records, surgical reports, pregnancy records, pathology results. The claimant must also show that the factor is related to their relevant service. This means proving that the factor itself was caused or contributed to by service. For example, if claiming factor 13 (obesity), the claimant must show that the obesity resulted from service-related factors such as a physical injury that prevented exercise, or medication that causes weight gain. A statement from a doctor saying “obesity is multifactorial” is insufficient.

For decision-makers: When assessing a claim, first categorise the type of service to confirm this SoP applies (non-operational VEA service, non-hazardous defence service, or peacetime MRCA service). Then identify whether the claim relates to clinical onset of gallstone disease or clinical worsening. If clinical worsening, check that the disease existed before or during service but did not arise out of service (section 10(2)). Then apply each factor the claimant raises. Check the strict timing: for instance, for factor 3 (ileal resection/ bypass), the procedure must occur within 25 years before clinical onset/worsening. For factor 4 (gastric/ oesophageal resection with vagotomy), within 5 years. Use the definitions in the Dictionary precisely: for obesity, use the gender-specific thresholds; for METs, note the example (3-4 METs is walking at average pace; inability to do that likely requires significant disability). For medications, check for continuous use (not intermittent) and the post-cessation window. For factor 25, assess whether appropriate clinical management was available and obtainable. The “inability” must be due to service - e.g. posting to a location without surgical services. If the veteran simply chose not to have surgery, that is not an inability.

When a factor refers to another condition covered by another SoP (e.g. spinal cord injury), the decision-maker must apply that SoP’s factors. Obtain a copy of the relevant SoP and ensure the claimant meets those criteria. This may delay the claim.

For medical practitioners providing evidence: Use the exact terminology. Do not say “patient is obese” without providing BMI and waist measurement. For weight loss, calculate the percentage and average rate. For physical activity, estimate METs based on functional capacity. Provide specific dates for onset of gallstone disease and for each exposure. Note that “clinical onset” is a factual finding, not a diagnosis - it can be when the person first experienced symptoms, or when stones were first found on imaging. Practitioners should state an opinion based on the history.

For legal representatives: Assemble a comprehensive timeline. Cross-reference with service records (postings, medical boards, incident reports). If the factor is obesity, consider whether the veteran developed obesity after a service-related injury; obtain a medical report linking the injury to weight gain. If the factor is rapid weight loss, confirm whether it was due to bariatric surgery or GLP-1 drugs; obtain records from the treating bariatric clinic or pharmacy. Check if the factor is a “factor referring to an injury or disease covered by another Statement of Principles” under section 11 and be prepared to address that separate SoP.

Finally, if the decision-maker rejects the claim, ensure the statement of reasons addresses each factor and explains why it was not satisfied. The SoP does not provide a template, but the decision must be clear.