Statement of Principles concerning malignant neoplasm of the liver (Balance of Probabilities) (No. 32 of 2020)

The central concept is “malignant neoplasm of the liver,” which the instrument defines strictly as a primary malignant neoplasm arising from the hepatocytes, excluding carcinoid tumour, Hodgkin’s lymphoma, malignant neoplasm of the bile duct, non-Hodgkin lymphoma, and soft tissue sarcoma. The ICD-10-AM code C22.0 is referenced for classification consistency, but the operative definition is the pathological one in subsection 7(2). This ensures that the SoP applies only to hepatocellular carcinoma and not to secondary liver metastases or other primary liver tumours. For death claims, the SoP includes death from a terminal event contributed to by the malignant neoplasm, with “terminal event” defined in the dictionary as pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function.

The SoP operates on the “balance of probabilities” standard. This is explicitly stated in its title and is consistent with its authority under subsection 196B(3) of the VEA. Section 8 records the RMA’s view that it is more probable than not that the condition can be related to relevant service - a claim that gives a basis for the instrument but does not itself bind decision-makers; the binding content is the list of factors in section 9.

The factors themselves are the heart of the instrument. They fall into several categories. Medical conditions: cirrhosis (any cause), chronic viral hepatitis (B, C, D), HIV, chronic hepatitis, diabetes mellitus with at least ten years’ duration before onset, and obesity (BMI at least 30) for at least ten years within the twenty years before onset. Behavioural/lifestyle: alcohol consumption thresholds that vary by sex (150 kg cumulative for males, 75 kg for females within any ten year period, with a five-year latency), and cigarette smoking equivalent to at least 20 pack-years, with onset permitted only within 20 years of cessation (if smoking has ceased). Occupational and environmental: ionising radiation to the liver (0.5 sievert cumulative equivalent dose, using the ARPANSA guide for calculation); dietary aflatoxins from living or working in high-risk regions; vinyl chloride inhalation in two alternative formulations - 2,500 ppm-years or 10,000 cumulative hours working in production or processing. Medical treatment: immunosuppressive therapy for solid organ, stem cell or bone marrow transplantation. Finally, factor 17: inability to obtain appropriate clinical management for the malignant neoplasm itself, but this factor applies only to material contribution or aggravation, not to initial causation.

The definitions in the dictionary are critical. “Chronic infection” for hepatitis B, C, or D requires laboratory-confirmed infection lasting at least six months. “Being obese” uses BMI formula (weight in kilograms divided by height in metres squared). “Cumulative equivalent dose” incorporates the ARPANSA guide, not an open-ended assessment. “Pack-years” is defined in a hybrid way: 20 tailor-made cigarettes per day for a year equals one pack-year, or 7,300 cigarettes, or 7.3 kg of smoking tobacco. The instrument also provides that where a factor refers to another disease (e.g., cirrhosis), the relevant SoP for that disease applies (section 11), so the system is interlocking.

“Relevant service” is defined narrowly: it excludes operational service and hazardous service. That means this SoP cannot be used for claims based on combat service or service in declared hazardous areas; those require a reasonable hypothesis SoP. This is a structural feature of the VEA and MRCA, not a flaw, but it is a trap for practitioners who assume one SoP covers all service.

The primary affected group is veterans and members of the Australian Defence Force who have rendered “relevant service” as defined in the dictionary: eligible war service under the VEA that is not operational service, defence service under the VEA that is not hazardous service or British nuclear test defence service, and peacetime service under the MRCA. Within this group, the instrument is relevant to those who have developed or die from primary hepatocellular carcinoma. Given the latency of liver cancer, many claimants will be older veterans whose service occurred decades earlier. The SoP also applies to dependants making death claims, as subsection 7(5) includes death from a terminal event contributed to by the malignant neoplasm.

It directly affects decision-makers in the Department of Veterans’ Affairs and the Military Rehabilitation and Compensation Commission, who must apply the SoP as a legislative instrument. It also affects advocates, lawyers, and claims officers who advise veterans on the evidence needed. Medical practitioners who provide reports must be familiar with the specific definitions - for example, chronic hepatitis B infection must be confirmed by laboratory testing, and the duration must be at least six months. The SoP compels a particular evidentiary structure: a claimant cannot simply assert a risk factor; they must prove compliance with the quantitative thresholds (e.g., 150 kg of alcohol, 20 pack-years, BMI ≥30 for ten years). This raises the cost of claim preparation and may discourage claims with plausible but poorly documented exposures.

Indirectly, the SoP affects Australian taxpayers who fund the compensation schemes. By codifying causation factors, the instrument also influences the distribution of compensation dollars. For example, veterans whose liver cancer is linked to obesity or alcohol consumption may receive compensation even if those behaviours were not directly caused by service, as long as the factor itself is related to service. That relation must be shown: obesity must have arisen from or been aggravated by service; alcohol consumption must have been influenced by service conditions. The SoP does not relax the service-connection requirement for the factor - section 10(1) insists on that nexus. Therefore, the ultimate effect depends on how easily a veteran can link, say, their smoking to service (e.g., smoking initiated during service) or their obesity to service-induced dietary habits. This internalises to the Department a portion of the public health burden of lifestyle diseases, arguably shifting costs from the health system to the compensation system.

Private medical specialists may see increased demand for tests such as liver biopsies, hepatitis serology, and fibroscans, as claimants attempt to prove cirrhosis or chronic hepatitis. Private health insurers are not directly affected, but the compensation system may cover treatment costs that would otherwise fall on Medicare or private insurance.

The Repatriation Medical Authority itself is the rule-maker. Its role is to determine SoPs based on “sound medical‑scientific evidence”, as stated in section 8. This gives the Authority significant power to define legal causation in a way that may diverge from mainstream epidemiology. The instrument is not merely a summary of medical evidence; it is a legislative decision that can be judicially reviewed for exceeding power or failing to consider relevant material.

The SoP does not create duties in the ordinary sense of a statute imposing obligations on persons. Rather, it confers on claimants a right to have their claim assessed against a predetermined set of causal factors, and imposes on the decision-maker an obligation to apply those factors. The key right for a claimant is that if at least one factor in section 9 is satisfied and related to the person’s relevant service, then the decision-maker under the VEA or MRCA must find that the malignant neoplasm of the liver is connected with the circumstances of that service on the balance of probabilities. This is a presumptive effect: the relevant section 120B(3) of the VEA and section 339 of the MRCA direct the decision-maker to apply the SoP. The right is conditional on the claimant providing evidence that complies with the instrument’s definitions. The claimant does not have a right to have a claim decided outside the SoP unless the SoP does not apply (e.g., if the claim relates to operational service, this particular SoP does not apply, but a separate reasonable hypothesis SoP would apply if one exists).

The decision-maker’s duty is to apply the SoP correctly. That includes determining the clinical onset date, verifying that any factor existed before that onset, and ensuring the factor is related to service. For factor 17 (inability to obtain appropriate clinical management), the duty is narrower: it applies only where the disease was suffered or contracted before or during (but did not arise out of) service, and the factor relates only to material contribution or aggravation (section 10(2)).

The Repatriation Medical Authority had a duty under the VEA to determine this SoP based on sound medical‑scientific evidence. That duty is procedural, not substantive, but it can be challenged. The notes in the instrument, such as the examples of geographical regions for aflatoxin exposure and the list of acceptable methods for radiation dose calculation, are not themselves legally binding but signal the Authority’s view of what evidence meets the definitions.

Claimants do not have a right to rely on factors not listed. If a veteran has a rare cause of liver cancer, such as a genetic mutation or exposure to a chemical not in the list, they cannot use this SoP unless they can bring it within “inability to obtain appropriate clinical management” or rely on another SoP (e.g., for a precursor disease). That is a limitation on individual choices about medical evidence; the SoP truncates the kind of evidence that is legally sufficient.

The instrument also gives indirect rights to veterans through the cross-reference in section 11: if a factor refers to another injury or disease (such as cirrhosis), the SoP for that other condition applies. So a claimant can use a bundle of SoPs to build their case. For example, a veteran with cirrhosis may need to satisfy the cirrhosis SoP to establish that factor, and then use this liver cancer SoP for the ultimate condition.

This SoP itself does not create penalties. It is a legislative instrument that sets out evidentiary standards, not a source of criminal or civil sanctions. However, it operates within a statutory scheme that does include penalties for fraud, false statements, and misuse of compensation. Under the VEA, making a false or misleading statement in connection with a claim can lead to prosecution and repayment of benefits. The SoP indirectly influences enforcement because it defines the elements a claimant must prove; if a claimant fabricates evidence to meet a factor (such as claiming a BMI of 30 when it was lower), they may face penalties under section 155 of the VEA (offences in relation to claims) or the Criminal Code.

The SoP is subject to disallowance by the Parliament as a legislative instrument under the Legislation Act 2003. That is a form of political enforcement: if the instrument is considered unsound or unfair, it can be disallowed. Additionally, the SoP can be challenged in the Federal Court on administrative law grounds, such as that the RMA did not have the power to make it (ultra vires), or that it failed to take into account a mandatory relevant consideration, or that it was irrational. Because the SoP is made under subsection 196B(3), which requires the Authority to be “of the view” based on sound medical‑scientific evidence, a challenge may assert that the view was not reasonably open. However, the courts have shown deference to the RMA’s expertise in such matters.

The instrument also interacts with the internal review and merits review mechanisms under the VEA and MRCA. A decision to refuse a claim can be reviewed by the Veterans’ Review Board and, on questions of law only, by the Administrative Appeals Tribunal. The SoP must be applied by those bodies. If a decision-maker misapplies a definition (e.g., miscalculates the alcohol threshold), the error can be corrected on review.

Enforcement of the compliance burden falls on claimants. They must assemble and pay for medical reports, pathology results, and historical records to prove each element of a factor. That cost is not recoverable even if the claim succeeds, unless the claimant qualifies for fee assistance under the scheme. This creates a deterrent effect: claimants with less documented evidence or lower financial resources may be discouraged from pursuing a legitimate claim.

This SoP is made under the Veterans’ Entitlements Act 1986 and the Military Rehabilitation and Compensation Act 2004, specifically subsections 196B(3) and the corresponding MRCA provision via the application provisions in section 5. It directly interacts with the substantive provisions of those Acts that deal with the standard of proof. For the VEA, section 120B sets out that where a SoP exists, the decision-maker must make a determination in accordance with the SoP. This SoP therefore displaces the general rule in section 120(4) for the balance of probabilities standard, replacing a hypothetical causal inquiry with a structured checklist. The same applies for section 339 of the MRCA.

The SoP interacts with its predecessor: it repeals the 2011 SoP (No. 22 of 2011). Claims that were pending at the commencement date (25 May 2020) would be determined under this SoP, because the instrument applies to claims to which section 120B or section 339 applies - it does not have transitional provisions saving the old instrument. This is standard for SoPs, but it means a change in the factors could affect outcomes for existing claimants. The new SoP introduced some changes from the 2011 version (though the source does not detail the changes; we can only note that it is a replacement). Claimants should check the date of their claim relative to commencement.

The instrument also incorporates by reference the ICD-10-AM Tenth Edition and the ARPANSA guide on cumulative equivalent dose. These external documents are not reproduced in the SoP, but they are legally relevant because the definitions point to them. Any amendment to those external documents would not automatically change the SoP; the SoP refers to the specific edition (effective date 1 July 2017 for ICD-10-AM; as in force on 2 August 2017 for the ARPANSA guide). So the SoP is locked to those versions unless amended.

Section 11 provides that if a factor refers to an injury or disease covered by another SoP, that other SoP applies. This integrates the SoP system. For example, “cirrhosis of the liver” is a separate condition with its own SoP (likely under the VEA). To prove factor 9(1), a claimant must meet the definition and requirements of the cirrhosis SoP. This can add layers of complexity, as each SoP has its own set of factors, definitions, and timing requirements. The practical consequence is that a claim for liver cancer may require navigating multiple SoPs - one for the precursor and one for the cancer.

The SoP does not interact with state workers’ compensation schemes because veterans’ compensation is exclusively federal. It may interact with the Defence legislation (such as the Defence Act 1903) for administrative matters, but not causally.

This instrument (No. 32 of 2020) is a replacement for the earlier Statement of Principles concerning malignant neoplasm of the liver No. 22 of 2011, which was made under subsections 196B(3) and (8) of the VEA. The repeal is effected by section 4. The 2011 SoP was originally registered on the Federal Register of Legislation as F2011L00502. The new SoP was made on 24 April 2020 and commenced on 25 May 2020. There is no indication in the source of any other amendments; the instrument appears in its original form. The authority for making the instrument is subsection 196B(3) of the VEA alone, not subsection (8) which was used for the 2011 version. Subsection (8) relates to SoPs that combine balance of probabilities and reasonable hypothesis; this SoP is solely balance of probabilities. That is a structural change: the 2011 SoP may have been a combined instrument, but the new one is split. This is consistent with the RMA’s practice in recent years of separating the two standards.

The RMA is required to review SoPs periodically under the VEA and may revoke or amend them. The five-yearly review cycle often leads to replacement instruments. Claimants and practitioners should be aware that the 2011 SoP may have contained different factors or definitions (for example, the smoking factor or alcohol thresholds may have been updated). Because the source does not reproduce the 2011 SoP, we cannot specify the differences, but the fact of repeal means any claim determined after 25 May 2020 must use this instrument.

The source itself contains no reference to any court cases. However, Statements of Principles generally have been the subject of litigation in the Federal Court and the High Court, particularly regarding the standard of review, the meaning of “sound medical‑scientific evidence”, and the application of factors. For example, in the past, courts have considered whether the RMA must consider all relevant evidence, and whether a SoP can be invalid if it excludes a known causal factor. Because this SoP is recent (2020) and the source provides no case references, it would be speculation to name any specific cases. Instead, it is prudent to note that the instrument is subject to the general law of judicial review. A person aggrieved by a decision applying this SoP could challenge the decision on the basis that the SoP itself is invalid (e.g., for error of law, unreasonableness, or failing to meet the statutory condition of being based on sound medical‑scientific evidence). Such a challenge would likely be brought in the Federal Court under the Administrative Decisions (Judicial Review) Act 1977 or section 39B of the Judiciary Act 1903. There is also a possibility of appeals from the Administrative Appeals Tribunal on questions of law.

The note in section 8 states that the RMA’s view is based on the sound medical‑scientific evidence available. That statement is a jurisdictional fact. If it could be shown that the RMA did not have such evidence, the SoP might be set aside. However, courts have given the RMA a wide margin of appreciation in assessing the evidence. The practical upshot is that litigation over this SoP is unlikely to succeed unless there is a clear procedural error, such as failing to consult the prescribed medical advisory committees or misinterpreting a term in the VEA.

Given the specificity of the factors, litigation may also arise over interpretation of defined terms. For example, what constitutes “working in the production or processing of vinyl chloride monomer or polyvinyl chloride” for factor 9(16)? Or what counts as “regularly contaminated” for aflatoxins? The dictionary provides some guidance but not exhaustive. Disputes over the meaning of “high levels” of aflatoxins or “chronic infection” as requiring laboratory confirmation may lead to judicial consideration.

Several features of this SoP can trap claimants and even experienced advocates if not read carefully.

1. Relevant service excludes operational and hazardous service. This SoP applies only to claims where the balance of probabilities standard is used. For a veteran who performed operational service (e.g., in a war zone) or hazardous service (e.g., radiation exposure), this SoP is not the correct instrument. A different SoP made under subsection 196B(2) for reasonable hypothesis must be sought. Using the wrong SoP will lead to a refusal. Always check the type of service before applying the instrument.

2. The factor must itself be related to service. Section 10(1) is easy to overlook. A veteran may have cirrhosis from long-term alcohol use, but if the drinking was not related to service (e.g., it began after discharge and was unrelated to service stressors), the factor does not satisfy the SoP. Claimants must show not just that they have the factor, but that the factor was caused or contributed to by service, or arose out of service conditions. For example, obesity from a service-acquired disability that limits exercise might be related; obesity from choice is not, unless service caused weight gain.

3. Alcohol and obesity have long latency and retrospective thresholds. The alcohol factor requires consumption of a cumulative amount over at least a ten-year period, ending at least five years before onset. For a 60-year-old veteran, proving that they drank that much 5-15 years before diagnosis is difficult without medical records or sworn testimony. Similarly, obesity for at least ten years within the twenty years before onset requires historical weight records. Lacking those, the factor cannot be established.

4. Smoking factor has a cut-off period. If a veteran quit smoking more than 20 years before clinical onset of the liver cancer, the smoking factor does not apply, even if they smoked 20 pack-years. This is explicitly stated in factor 9(11)(b). Many veterans who quit decades ago will miss out. Those who never quit have no cut-off (the cessation requirement does not apply if still smoking at onset).

5. Ionising radiation factor requires at least 0.5 sievert to the liver, using a specific calculation methodology. Many veterans may have had diagnostic X-rays or CT scans that would not approach this threshold. Aircrew receive cosmic radiation but the level to the liver may be below 0.5 sievert unless they have many years of flying. The ARPANSA guide is a technical document; experts must be engaged. Without a formal dose reconstruction, the factor is not proved.

6. Dietary aflatoxin factor requires living or working in a high-risk region and a major part of the diet consisting of contaminated foods. A veteran who served briefly in Southeast Asia may not meet the ten-year exposure within twenty years before onset. The time requirement is onerous.

7. Vinyl chloride factor 9(15) uses ppm-years, a cumulative dose. Many workplaces monitor exposure, but a veteran would need employment records showing ppm levels and years of exposure. The alternative calculation in 9(16) uses cumulative hours (10,000 hours) in production or processing, but does not require ppm data. That second formulation is easier to prove if the job history is clear.

8. Factor 17 is narrow. “Inability to obtain appropriate clinical management” applies only to material contribution or aggravation after the disease was already contracted or suffered before or during (but not arising out of) service. It cannot be used to establish the original onset of the disease. This factor is essentially a backstop for veterans whose cancer already existed before service and was worsened by lack of management.

9. Definitions are technical. “Chronic hepatitis” requires biochemical evidence for at least six months, not just a clinical diagnosis. Many veterans may have been told they have “fatty liver” or “abnormal liver function” but not documented for six months. “Chronic infection with hepatitis B virus” requires laboratory confirmation; a positive surface antigen test one time is not enough without evidence of persistence for at least six months. The dictionary marginal notes contain examples that do not have legal force but can influence decision-makers.

10. The SoP does not cover all liver cancers. It is limited to primary hepatocellular carcinoma. Other primary liver cancers (e.g., cholangiocarcinoma, angiosarcoma) and metastatic cancers are not covered. Malignant neoplasm of the bile duct is expressly excluded. A veteran with cholangiocarcinoma would need a different SoP (if one exists) or rely on a general causation argument without the benefit of a SoP.

11. The commencement date matters. The SoP applies to claims to which section 120B or 339 apply, but does not specify whether it applies to claims lodged before commencement. The general principle is that the instrument in force at the time of decision applies, but this is not explicit. Practitioners should check the date of the claim and the date of the decision.

Compliance with this SoP is not a matter of obeying prohibitions but of structuring evidence to meet its requirements. For a claimant seeking to rely on this SoP, the steps are:

1. Determine the applicable service type. Confirm that the veteran’s relevant service is eligible war service (non-operational), defence service (non-hazardous, non-British nuclear test), or peacetime service under the MRCA. If the service is operational or hazardous, this SoP does not apply; seek the reasonable hypothesis counterpart.

2. Establish the clinical onset date of the malignant neoplasm of the liver. Clinical onset is the date when the disease first became manifest or diagnosable. This is critical because many factors require that the condition existed before or within a certain period before onset. Obtain medical records, imaging reports, and biopsy results to pinpoint this date.

3. Select the most promising factor(s) from section 9. Evaluate which factor best fits the veteran’s history. Commonly, cirrhosis, hepatitis B or C, alcohol consumption, smoking, and obesity are the most frequent. For each, compile evidence:

   • For cirrhosis: liver biopsy, fibroscan, or imaging evidence of cirrhosis, plus evidence that the cirrhosis is related to service (e.g., from service-acquired hepatitis or alcohol misuse caused by service stress).
   • For chronic hepatitis B/C/D: laboratory serology (HBsAg, anti-HCV, anti-HDV) showing infection lasting at least six months, with dates of positive tests. Note that past classification as non-A, non-B hepatitis can be used for hepatitis C.
   • For alcohol consumption: total of 150 kg (male) or 75 kg (female) over any 10-year period, with the period ending at least five years before onset. This requires reliable self-reporting, medical records of alcohol-related conditions (e.g., pancreatitis, elevated GGT), or red cross records of purchase. A formal reconstruction may be needed.
   • For smoking: 20 pack-years, with evidence of smoking history (records of purchase, medical notes, respiratory function tests). Ensure that if smoking ceased, the onset occurred within 20 years of cessation.
   • For obesity: BMI of 30 or greater, documented at multiple points over at least 10 years within the 20 years before onset. Weight records from health checks, military medical records, or recruit documentation are ideal.
   • For ionising radiation: dose reconstruction using the ARPANSA guide. Engage a health physicist to calculate cumulative equivalent dose to the liver from all sources (excluding normal Australian background). Acceptable sources: diagnostic medical procedures (if sufficiently high), nuclear weapons tests, aircrew exposure.
   • For dietary aflatoxins: evidence of residence or posting in sub-Saharan Africa, Southeast Asia, Eastern Mediterranean or China for a cumulative period of at least 10 years within 20 years before onset, plus evidence that the diet was primarily local grains and nuts likely contaminated.
   • For vinyl chloride: employment records showing work in production or processing of vinyl chloride monomer or polyvinyl chloride, with exposure duration of at least 10,000 hours or cumulative dose of 2,500 ppm-years. Industrial hygiene records are needed.

4. Prove that the factor is related to service. This is separate from proving the factor exists. For example, if using the alcohol factor, the veteran must show that the pattern of drinking was related to service (e.g., initiated during service due to combat stress, or aggravated by service-related mental health conditions). For obesity, show that weight gain was caused by a service-related injury that limited mobility, or by medications prescribed for a service condition. Without this nexus, the factor is ineffective.

5. Obtain medical evidence that addresses the definitions. For chronic hepatitis, ask the pathologist to state that the infection was chronic (present for at least six months). For cirrhosis, confirm the diagnosis using accepted criteria. For BMI, compute using the formula. The decision-maker will look for literal compliance.

6. Consider interplay with other SoPs via section 11. If the factor is a disease like cirrhosis, locate the current SoP for cirrhosis (balance of probabilities) and ensure evidence meets its factors. That SoP may itself have a complex set of requirements.

7. If none of factors 1-16 apply, evaluate factor 17. This requires showing that the veteran had malignant neoplasm of the liver before or during service (but it did not arise out of service) and that the veteran was unable to obtain appropriate clinical management for that condition, leading to material contribution or aggravation. This is a narrow pathway and requires evidence that treatment was not available (e.g., due to remote posting, lack of medical resources, denial of care). The factor cannot be used to prove original causation.

8. Prepare a comprehensive submission. This should include a narrative linking each element to the SoP’s language. A template might list each factor, state why it is met, provide the supporting evidence, and explain how the factor relates to service. The decision-maker will then apply section 10(1) to require that the factor itself is related to service.

9. Keep abreast of any repeal or amendment. SoPs are replaced periodically. Check the Federal Register of Legislation for the current version for the relevant standard (balance of probabilities or reasonable hypothesis). Using an outdated SoP will result in an invalid application.

10. Be prepared for the cost of evidence gathering. Tests, expert reports, and historical records can be expensive. The VEA does not provide for reimbursement of claim preparation costs. Some veterans may obtain free assistance from veterans’ advocacy organisations or legal aid.