Statement of Principles concerning malignant neoplasm of the stomach (Balance of Probabilities) (No. 75 of 2023)

The instrument directly affects veterans and members of the Australian Defence Force who have rendered “relevant service” as defined in the Schedule. That means veterans with eligible war service (non‑operational service) under the VEA, members with defence service (non‑hazardous) under the VEA, and members with peacetime service under the MRCA. It does not apply to those with operational service, hazardous service, or British nuclear test defence service, because those categories use a different standard of proof (reasonable satisfaction) or are covered by separate instruments.

The instrument also affects decision‑makers at the Department of Veterans’ Affairs (DVA) and the Repatriation Commission, who must apply the factors when assessing claims for stomach cancer. It binds the Veterans’ Review Board and the Administrative Appeals Tribunal when reviewing decisions. It indirectly affects medical practitioners who provide evidence for claims, because they must address whether the claimant’s circumstances satisfy the specific conditions (e.g. pack‑year calculation, H. pylori testing, BMI records).

The compliance burden falls on claimants and their representatives to gather evidence to demonstrate a factor and its relationship to service. This may require obtaining medical records, calculating ionising radiation doses using the ARPANSA Guide, confirming H. pylori status, documenting smoking history, and in the case of non‑cardia stomach carcinoma, establishing a history of proton pump inhibitor use and its temporal relationship to onset.

The instrument also affects the Commonwealth’s liability. For every successful claim where a factor is established, the Commonwealth incurs a pension and/or medical treatment liability. The tighter the factors, the fewer claims succeed. Conversely, the 2014 version may have had different smoking thresholds or omitted the PPI factor, so the change affects the volume of claims and budget outlays. There is no cost‑benefit analysis in the instrument, but the replacement of the 2014 version suggests the Authority considered updated evidence.

The principal duty imposed by the instrument is on the decision‑maker: if a claimant demonstrates that at least one factor in section 9 exists and that the factor is related to the person’s relevant service, the decision‑maker must find that the cancer or death is connected with service (on the balance of probabilities). This duty flows from subsection 196B(3) of the VEA, which requires the Repatriation Medical Authority to determine Statements of Principles, and from sections 120B (VEA) and 339 (MRCA), which require the decision‑maker to apply the relevant Statement.

The claimant has a right to rely on any of the factors, but bears the evidentiary burden of proving the factor exists and is related to service. The claimant also has the right to rely on section 11, which imports factors from other Statements of Principles if a factor in section 9 refers to an injury or disease covered by another Statement. For example, factor 9(4) refers to chronic atrophic gastritis. That condition has its own Statement of Principles. If the claimant has chronic atrophic gastritis, they must satisfy the factors in that Statement as well (e.g. smoking, H. pylori, pernicious anaemia). This creates a chain of causation that may be difficult to prove.

Section 10 distinguishes the relationship to service. Factor 9(10) - inability to obtain appropriate clinical management before clinical worsening - applies only to material contribution to or aggravation of a cancer that was suffered or contracted before or during (but did not arise out of) the person’s relevant service. This is the only factor that explicitly deals with worsening rather than onset.

The instrument does not create any private rights of action. It is a rule of evidence within the veterans’ compensation system. Claimants cannot sue the Commonwealth for failing to comply; the remedy is to seek review before the Veterans’ Review Board or the Administrative Appeals Tribunal, which can remit the matter with a direction to apply the Statement correctly.

This instrument does not impose penalties or create enforcement mechanisms. It is not a penal instrument; it is a rule of evidence for determining the causal link between service and gastric cancer. The only consequences flow from its misapplication: a decision‑maker who fails to apply the correct Statement (or misapplies the factors) may have their decision set aside on review. There is no penalty against a claimant who provides false information, though the general law (including criminal sanctions for fraud against the Commonwealth) would apply. The instrument itself has no penalty provision. The Veterans’ Entitlements Act provides for recovery of overpayments if a pension is paid based on false or misleading information, but that is not within this instrument.

Enforcement in practice is through the review system. If the Repatriation Commission decides a claim using the wrong edition of the Statement or misinterprets a factor (e.g. wrongly calculates pack‑years or misidentifies a cardia versus non‑cardia carcinoma), the claimant can appeal. The instrument’s binding force comes from VEA section 196B(4), which provides that the Repatriation Medical Authority’s Statements must be applied in determining whether an injury or disease is service‑related. There is no civil penalty for non‑compliance, but the decision will be invalid if the Statement is not applied.

The instrument does not confer any enforcement powers on any person or body. It is purely evidentiary. The Repatriation Medical Authority itself has no enforcement role; it only determines and revokes Statements.

The instrument is made under the VEA, specifically subsection 196B(3). It must be read in conjunction with the VEA sections that govern claims: sections 120, 120A, 120B, and 13. Section 120B explicitly requires that a claim for a disease not diagnosed until after service must be determined by applying the relevant Statement of Principles. If no Statement applies, the decision‑maker must be reasonably satisfied of the connection. This Statement applies to claims that fall under section 120B (i.e. non‑operational service claims). For operational service, the standard is reasonable satisfaction under section 120(1) and (3), but the Statement may still be relevant as evidence.

The instrument also interacts with the MRCA via section 339, which mirrors the VEA provisions. For peacetime service claims under the MRCA, this Statement applies. For hazardous service or British nuclear test defence service, different standards or Statements may apply, but this Statement specifically excludes those service types from the definition of “relevant service”.

Section 11 of the instrument incorporates by reference other Statements of Principles. For example, if the claimant relies on factor 9(3) - H. pylori infection - the infection itself is a disease. There is a Statement of Principles for H. pylori infection. The claimant would need to satisfy the factors in that Statement to establish the infection. This creates a cascading effect: the gastric cancer factor may require proving another condition that has its own causal requirements. This can increase compliance burden and complexity.

The instrument repeals the 2014 Statement. Any claim made after 25 July 2023 must be assessed under this new instrument. Claims made before that date may still be determined under the old Statement if the claim was lodged before commencement, but section 5 says the instrument applies to claims to which sections 120B (VEA) or 339 (MRCA) apply, which may include pending claims depending on the date of decision.

The instrument uses ICD‑10‑AM coding for reference only; the definition of the disease in subsection 7(2) is the operative one, not the Code. This avoids conflict with updates to the ICD classification. The ARPANSA methodology for calculating cumulative equivalent dose is incorporated by reference (as in force on 2 August 2017). Any amendment to that Guide after that date does not automatically change the factor; the Authority would need to issue a new Statement.

The instrument is a standalone legislative instrument, not an amendment to an Act. It replaces the earlier Statement of Principles concerning malignant neoplasm of the stomach No. 59 of 2014 (registered as F2014L00938). That earlier instrument was also made under subsections 196B(3) and (8) of the VEA. The main changes between 2014 and 2023 can be inferred from the text: the 2023 version includes new factors not present in the 2014 version, specifically factor 9(9) (proton pump inhibitor use for non‑cardia carcinoma) and factor 9(8) (autoimmune disease from the specified list of dermatomyositis and pernicious anaemia). The 2014 version may have had different smoking pack‑year thresholds or different temporal conditions. The 2023 version also updates definitions: the definition of “cumulative equivalent dose” now explicitly references the ARPANSA Guide as in force on 2 August 2017, whereas the 2014 version may have referred to an earlier edition. The list of excluded neoplasms (subsection 7(2)(b)) may have been expanded; gastroblastoma and haematolymphoid tumours are now specifically excluded. The definition of “terminal event” is now part of the Schedule. The 2023 instrument also includes a note about calculating pack‑years for pipe tobacco and cigars (1 gram equals one cigarette), which may not have been explicit in the 2014 version.

The authority for the instrument is solely subsection 196B(3) (Balance of Probabilities). The 2014 version was made under both subsections (3) and (8), which allowed for a higher standard of proof (reasonable satisfaction). The 2023 version is limited to the balance of probabilities standard, meaning it is intended only for claims where that standard applies. There may be a separate Statement of Principles for malignant neoplasm of the stomach under the reasonable satisfaction standard (if any).

The repeal is explicit in section 4. The instrument commences on 25 July 2023, 33 days after it was made (23 June 2023). This is standard for legislative instruments to allow for registration and notification.

The instrument itself has no litigation history because it only commenced on 25 July 2023. No court or tribunal has yet interpreted it. However, the previous 2014 version may have been the subject of litigation before the Administrative Appeals Tribunal and federal courts. The most common issues in such litigation include: whether a particular smoking history meets the pack‑year threshold; whether the claimant actually had Helicobacter pylori infection at the required time; whether the dose of ionising radiation can be proven using the ARPANSA methodology; and whether the disease is indeed malignant neoplasm of the stomach under the instrument’s definition (e.g. disputes about whether a tumour is a MALT lymphoma or excluded). There may also be litigation over the meaning of “clinical onset” and “clinical worsening”, as those terms are not defined in the instrument.

Given that the 2023 instrument is new, any litigation will likely focus on the new factors: the proton pump inhibitor factor requires proving continuous use for at least 2 years within the 5‑year period before onset, with last dose at least 1 year before onset. This creates scope for disputes about what constitutes “continuous period” and whether a gap in treatment breaks the continuity. The autoimmune disease factor requires the disease to exist “at the time of the clinical onset”, not before. This may be hard to prove if the autoimmune disease is diagnosed later. The non‑cardia carcinoma distinction (factor 9(6) and 9(9)) means claimants must prove the anatomical location of the tumour, which may require histopathological evidence. Disputes could arise over whether the tumour arose in the cardia or non‑cardia region.

Section 11 incorporation of other Statements may also generate litigation. For example, to prove chronic atrophic gastritis, the claimant might need to satisfy the Statement of Principles for that condition, which may have its own smoking factor. The cumulative effect could be complex.

Several potential traps arise from the precise wording of the instrument.

First, the smoking factor (9(1)) requires an “amount of at least 25 pack‑years” and also that smoking “commenced at least 10 years before the clinical onset”. This is cumulative; a claimant who smoked 25 pack‑years but started only 8 years before onset does not satisfy the factor. Also, “if smoking has ceased before the clinical onset … then that onset occurred within 15 years of cessation”. A claimant who stopped smoking 16 years before onset fails, even if they smoked 50 pack‑years. This is stricter than some other cancer Statements.

Second, factor 9(6) for cardia stomach carcinoma requires obesity (BMI ≥30) for at least the 5 years before onset. The definition of “being obese” is based on BMI. Weight fluctuations may cause the BMI to drop below 30 during that period; the factor requires obesity for “at least the 5 years before” onset, implying continuous obesity, not merely at some point. This will be difficult for claimants with variable weight.

Third, factor 9(9) for non‑cardia stomach carcinoma requires “taking a proton pump inhibitor drug for at least a continuous period of 2 year within the 5 years before the clinical onset … and where the last dose of the drug was taken at least 1 year before the clinical onset”. This means the PPI use must have ended at least one year before the cancer is diagnosed. If the claimant was still taking a PPI up to the month before diagnosis, the factor does not apply. Also “continuous period of 2 year” likely means an uninterrupted 2‑year period, not cumulative total. A gap of a few days might break continuity.

Fourth, factor 9(4) requires chronic atrophic gastritis to have “commenced at least 5 years before the clinical onset of malignant neoplasm”. That means the gastritis must have been diagnosed or manifest at least 5 years prior. A claimant diagnosed with gastritis only 3 years before the cancer will not satisfy this factor, even if the gastritis was likely present earlier.

Fifth, the definition of “relevant service” excludes operational service, hazardous service, and British nuclear test defence service. Claimants with those service types cannot use this instrument. This is not always obvious to claimants or their representatives.

Sixth, the cumulative equivalent dose factor (9(2)) references a detailed ARPANSA methodology. The dose must be “to the stomach”, not whole body. Claimants must show that at least 0.5 sievert was received by stomach tissue. Medical exposures (e.g. CT scans of the abdomen) may contribute, but the dose must be calculated per the Guide.

Seventh, the automatic disease factor (9(8)) is limited to a “specified list of autoimmune diseases”: dermatomyositis or pernicious anaemia only. Other autoimmune conditions (e.g. lupus, rheumatoid arthritis) do not qualify.

Eighth, section 11 incorporates other Statements. If a factor (e.g. chronic atrophic gastritis) is itself a disease, the claimant must satisfy the factors in that other Statement. This can create a chain of causation that may be impossible to prove. For example, to prove chronic atrophic gastritis, the claimant might need to show H. pylori infection, which itself requires another Statement.

Ninth, factor 9(10) (inability to obtain appropriate clinical management) applies only to clinical worsening, not onset. The worsening must be “before” the worsening occurred, and the factor relates to material contribution or aggravation. The term “inability to obtain appropriate clinical management” is not defined; it could be interpreted as the service‑related inability (e.g. remote posting, lack of access to specialists). The claimant must show that proper management was not available and that this worsened the condition.

For a claimant or representative, compliance means gathering evidence to match one or more factors in section 9 and then showing that factor is related to the person’s relevant service. The easiest factor to prove may be smoking, but the threshold of 25 pack‑years with temporal limits is high. Claimants should obtain a complete smoking history: start date, average cigarettes per day, gaps, cessation date. Calculate pack‑years using the formula in the Schedule: (cigarettes per day ÷ 20) × years. For pipe or cigar smokers, convert to weight (7,300 grams per pack‑year) and then convert to cigarettes (1 gram = 1 cigarette) for equal calculation.

If the claimant has H. pylori infection, obtain serology or breath test results dated at least 10 years before cancer diagnosis, or strong evidence of chronic infection. If the claimant had a partial gastrectomy for benign disease, secure operation notes dated at least 10 years before cancer onset.

For the ionising radiation factor, calculate the cumulative equivalent dose using the ARPANSA Guide. This may require radiologist reports and dose estimates from medical procedures (e.g. CT scans, nuclear medicine). Normal background radiation is excluded. If the claimant was a nuclear test participant or had occupational exposure, obtain service records and dose reconstruction reports.

For the obesity factor (cardia carcinoma only), obtain weight records showing BMI ≥30 for a continuous 5‑year period before onset. This can be from medical records, fitness assessments, or personal records. For the PPI factor (non‑cardia carcinoma only), obtain pharmacy records or prescription history showing continuous use of a PPI for at least 2 years within the 5 years before onset, and that the last dose was at least 1 year before onset. Prescription dates are usually available from Medicare or military health records.

For autoimmune disease factor, obtain a diagnosis of dermatomyositis or pernicious anaemia that was present at the time of cancer onset (not diagnosed later). Serology for intrinsic factor antibodies or muscle biopsy may be required.

The relationship to service under section 10 means the factor must have occurred or been present because of the person’s service. For smoking, this is straightforward if the claimant smoked during service and the smoking habit continued. For H. pylori, it may be harder to link to service unless the claimant served in an endemic area. The “inability to obtain clinical management” factor requires showing that the service prevented access to treatment (e.g. remote posting, operational constraints).

Representatives should ensure the cancer diagnosis matches the definition in section 7. Obtain a histopathology report confirming primary epithelial adenocarcinoma of the stomach, and note whether it is cardia or non‑cardia (for factors 6 and 9). Exclude neuroendocrine, haematolymphoid, melanoma, sarcoma, and gastroblastoma. If the pathology report does not specify the subsite, request a re‑review.

If the claim relies on a factor that refers to another disease (e.g. chronic atrophic gastritis), locate the current Statement of Principles for that disease and ensure the factors in that Statement are also satisfied. This layered proof is often the most complex.

The instrument is used by decision‑makers, not by claimants directly. Claimants and their advocates should frame the claim around a specific factor and provide the supporting evidence in the format the DVA expects. The Statement itself does not prescribe a form of evidence, but clinical records, specialist reports, and service records are typical. Getting a medical practitioner to calculate pack‑years and sign a report is common. For the cancer definition, a specialist oncologist or pathologist report stating “primary malignant neoplasm arising from epithelial cells of the stomach, excluding [specific exclusions]” would be helpful.