Statement of Principles concerning malignant neoplasm of the prostate (Balance of Probabilities) (No. 4 of 2023)

Balance of probabilities standard. The SoP is made under subsection 196B(3) of the VEA. This subsection authorises the Repatriation Medical Authority to determine a SoP setting out factors that, on the balance of probabilities, can connect a disease to service. The standard is less demanding than the “reasonable hypothesis” standard under subsection 196B(2). In practice, this means a claimant need only show that it is more probable than not that the factor exists and is service‑related. The RMA stated in section 8 that it is satisfied, on the sound medical‑scientific evidence available, that it is more probable than not that the disease can be related to relevant service.

Malignant neoplasm of the prostate. The instrument defines the disease in section 7(2) as a primary malignant neoplasm arising from the epithelial cells of the prostate gland. It expressly includes high‑grade prostatic intraepithelial neoplasia (HGPIN), a premalignant lesion that is not invasive cancer but is considered a precursor. This inclusion expands the scope beyond what many clinicians or the ICD‑10‑AM code C61 would ordinarily cover. The definition excludes haematolymphoid tumours, low‑grade PIN, malignant melanoma, mesenchymal tumours, and primary neuroendocrine tumours. The ICD‑10‑AM code is given as C61, but the instrument states that the definition in subsection 7(2) controls, not the code. Death from prostate cancer includes death contributed to by a terminal event such as pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function.

Factors and their conditions. The four factors are specified in section 9. Each has detailed conditions:

• Arsenic factor: requires exposure to arsenic “as specified” - consuming drinking water with at least 50 µg/L for a cumulative 10 years, or an equivalent cumulative total, or clinical evidence of chronic arsenic toxicity. The first exposure must have occurred at least 10 years before the clinical onset of the cancer.

• Smoking factor: requires at least 15 pack‑years of tobacco smoking, commencing at least 5 years before the clinical worsening of the cancer. If the person had ceased smoking before worsening, the worsening must occur within 10 years of cessation. This factor applies only to worsening, not onset.

• Obesity factor: requires the person to have been obese (BMI ≥ 30, or waist circumference > 102 cm for men or > 88 cm for women) for at least 10 years within the 20 years before the clinical worsening. This also applies only to worsening.

• Clinical management factor: inability to obtain appropriate clinical management for the cancer. This is a residual category that can apply to both onset and worsening, depending on the circumstances.

Pack‑year. The instrument defines one pack‑year as 20 cigarettes per day for one year, or 7,300 g of smoking tobacco by weight. This is a standard epidemiological measure. The definition includes pipe tobacco and cigars by weight equivalence, which is important for veterans who used non‑cigarette products.

Obesity. Defined by BMI (weight in kilograms divided by height in metres squared) of 30 or greater, or by elevated waist circumference. The waist circumference thresholds differ by sex. This dual definition gives flexibility but also creates evidentiary complexity: a person might have a BMI below 30 but a waist circumference above the threshold and still satisfy the factor.

Relevant service. The term is defined in the Schedule 1 dictionary and governs which claims this SoP can support. It includes eligible war service (other than operational) under the VEA, defence service (other than hazardous and British nuclear test defence service) under the VEA, and peacetime service under the MRCA. “Peacetime service” under the MRCA generally means service that is not warlike or non‑warlike service. This definition is narrower than the full range of service covered by the VEA and MRCA, and claimants must check which service type applies.

Terminal event. The definition lists specific medical events that can be the proximate or ultimate cause of death contributed to by the cancer. This ensures that even if the cancer was not the immediate cause of death, a claim can succeed if the cancer contributed to one of these events.

Clinical onset and worsening. The instrument uses both terms. Clinical onset is the date when the disease first became manifest. Clinical worsening refers to a material deterioration after the disease was first contracted. The smoking and obesity factors are specifically tied to clinical worsening, not onset. This distinction is critical: a veteran who never smoked before diagnosis cannot use the smoking factor to establish the disease itself, but might use it if the cancer worsened after service due to continued smoking.

Material contribution or aggravation. Section 10(2) states that factors 9(2) to 9(4) apply only to material contribution to, or aggravation of, malignant neoplasm of the prostate where the disease was suffered or contracted before or during (but did not arise out of) the person’s relevant service. This language mirrors the concept of “material contribution” used in workers’ compensation and veterans’ law. It means the factor must have played a part in worsening the pre‑existing condition, not merely have coincided with it.

Primary claimants. The SoP directly affects veterans and members of the Australian Defence Force who have rendered relevant service as defined and who suffer from prostate cancer or die from it. Their dependents, in the case of death claims, are also affected. Because the definition of “relevant service” excludes operational service and hazardous service, a large cohort of veterans - those who served in combat zones or in nuclear test areas - cannot use this SoP. They must rely on the reasonable hypothesis SoP for the same condition.

Claims administrators and decision‑makers. The Department of Veterans’ Affairs (DVA) must apply this SoP when assessing claims under section 120B of the VEA or section 339 of the MRCA. The Veterans’ Review Board (VRB) and the Administrative Appeals Tribunal (AAT) must also apply it on review. The SoP is binding unless it is found to be invalid on administrative law grounds.

Legal and medical practitioners. Lawyers representing veterans need to understand the differences between this SoP and its reasonable hypothesis counterpart. Medical practitioners providing reports must be familiar with the definitions of pack‑year, obesity, and arsenic exposure, and with the distinction between onset and worsening. Expert witnesses may be required to calculate cumulative arsenic exposure or to opine on whether the temporal conditions are met.

The Repatriation Medical Authority (RMA). The RMA is the maker of the instrument and is responsible for keeping it up to date. The recitals note that the RMA is satisfied on the sound medical‑scientific evidence available that the connection is more probable than not. This imposes an accountability burden on the RMA to ensure that the factors reflect current evidence and that the thresholds are not arbitrary.

The Commonwealth as respondent. Where a claim is disputed, the Commonwealth (represented by DVA) bears the burden of rebutting the claim once a factor is raised. However, the SoP itself does not shift the burden of proof; it merely sets out what factors, if proved, will satisfy the connection.

Other government bodies. The Independent Hospital Pricing Authority (copyright holder of ICD‑10‑AM) and the Australian Bureau of Statistics (via BMI and waist circumference data) are indirectly involved through the definitions. The Department of Health may have an interest in how the SoP interacts with Medicare and public hospital data.

Duty on the claimant to prove a factor and its relationship to service. Section 10(1) requires that the existence of any factor referred to in section 9 must be related to the relevant service rendered by the person. This is a substantive duty: it is not enough that the factor exists; the claimant must also link it to their specific period, location, or circumstances of service. For example, a veteran who smoked after discharge cannot automatically rely on that smoking unless the smoking was itself related to service (e.g., commenced or increased due to service‑related stress, or the smoking history includes time during service). The “related to service” requirement is not merely temporal; it must be causal or contributory in a legal sense.

Right to rely on the SoP to establish connection. If a claimant satisfies at least one factor and the relationship to service, the SoP provides a deemed connection on the balance of probabilities. The decision‑maker must then find that the disease is connected to service, unless some other provision of the VEA or MRCA overrides (which is rare). This is a powerful right because it removes the need for the claimant to prove general medical causation; the RMA has already done that.

Right to have the claim determined under the correct SoP. The SoP applies only to claims under section 120B VEA or section 339 MRCA. Claimants with operational service have a right to have their claim assessed under the reasonable hypothesis SoP (No. 5 of 2023 presumably). Misapplying the balance‑of‑probabilities SoP to an operational service claim would be an error of law.

Duty on decision‑makers to apply the SoP as it stands. The SoP is a legislative instrument. Decision‑makers cannot add or subtract from the factors, nor can they substitute their own medical opinion for the RMA’s determination that the factors are sufficient. However, they retain the role of weighing the evidence on the existence of the factor.

Duty to consider the clinical management factor. This factor (9(4)) is open‑ended. It imposes a duty on decision‑makers to consider whether the claimant was unable to obtain appropriate clinical management for the cancer, and whether that inability was related to service. This could arise if service in a remote location prevented timely diagnosis or treatment, or if service‑related conditions (e.g., post‑traumatic stress disorder) led to avoidance of medical care. The factor is broad but will require careful factual analysis.

Right to refer to other SoPs. Section 11 provides that if a factor refers to an injury or disease for which another SoP has been made, the factors in that other SoP apply. For example, if the inability to obtain clinical management is based on a mental health condition that itself has an SoP, that SoP’s factors will govern the analysis. This creates a layered application of multiple instruments.

No duty to treat the SoP as retrospective. The instrument commences on 23 January 2023. Claims that were finally determined before that date are unaffected. Claims that were pending on that date are governed by the new SoP, unless a transitional provision in the VEA or MRCA directs otherwise. Practitioners should check the commencement and application clauses carefully.

The SoP itself does not create offences or penalties. It is a legislative instrument that sets out evidentiary standards. Enforcement of the compensation scheme is through the normal processes of internal review, the VRB, the AAT, and the Federal Court. A decision‑maker who disregards the SoP - for example, by rejecting a claim that satisfies a factor without a proper basis - could have that decision set aside on review.

Under section 241 of the VEA, a person who knowingly makes a false or misleading statement in connection with a claim for a pension or allowance commits an offence punishable by imprisonment for up to 12 months. This applies to statements made about factors such as smoking history, obesity, or arsenic exposure. If a claimant fabricates a smoking history of 15 pack‑years, they face criminal liability. However, the SoP itself does not add any new penalty.

Similarly, under the Criminal Code (Cth), there are general offences for giving false information to a Commonwealth entity. The DVA may also seek recovery of overpayments if a claim is later found to be based on false evidence.

The instrument is enforceable in the sense that it is binding on the Commonwealth. If the DVA misapplies the SoP, a claimant can apply for merits review or judicial review. The AAT may substitute its own decision applying the correct interpretation. The Federal Court has jurisdiction under the Administrative Decisions (Judicial Review) Act 1977 (ADJR Act) to review the decision for legal error, such as failure to take into account a relevant factor or taking into account an irrelevant one.

There is no penalty within the SoP for non‑compliance by decision‑makers; the remedy is reversal of the decision. The RMA itself is not subject to penalties for making an SoP that is later found to be invalid, but such invalidity would be rare and would be decided by the courts in a challenge.

Veterans’ Entitlements Act 1986 (VEA). The SoP is made under subsection 196B(3) of the VEA. It operates within the framework of the VEA, particularly section 120B, which provides that the Commission must be reasonably satisfied that a disease is service‑related, and that a SoP determines the factors that are sufficient for that satisfaction. The SoP does not override other provisions of the VEA, such as the requirement that the disease actually exists or that the person rendered specific service.

Military Rehabilitation and Compensation Act 2004 (MRCA). The SoP also applies to claims under section 339 of the MRCA. That section is the equivalent of section 120B VEA for members covered by the MRCA. The definitions of “relevant service” in the SoP include peacetime service under the MRCA. This means veterans who served after 1 July 2004 (the MRCA commencement) may still be covered by this SoP for peacetime service, but not for warlike or non‑warlike service (which would require the reasonable hypothesis SoP).

The reasonable hypothesis SoP for prostate cancer. The RMA has a separate SoP made under subsection 196B(2) for malignant neoplasm of the prostate. That SoP is for operational or hazardous service where the standard is reasonable hypothesis. The two SoPs can coexist. A veteran with operational service who also has non‑operational service may use the balance‑of‑probabilities SoP for the non‑operational component if the disease is claimed to have been caused or aggravated by that service. However, practitioners must be careful not to mix standards: a single claim can involve different service periods and different SoPs.

Other Statements of Principles. Section 11 of this SoP provides that if a factor refers to an injury or disease covered by another SoP, the factors in that other SoP apply. For example, a veteran who claims inability to obtain clinical management because of a psychiatric condition would need to satisfy the SoP for that psychiatric condition first. This creates a cascading system where multiple SoPs may need to be satisfied to prove one factor.

ICD‑10‑AM. The instrument references ICD‑10‑AM code C61 for prostate cancer, but note that the SoP’s definition of malignant neoplasm of the prostate is broader than the ICD code because it includes HGPIN. This means a person with a diagnosis of HGPIN (which may not be assigned code C61 in all jurisdictions) is still covered by the SoP. The ICD code is merely a reference; the SoP’s own definition controls.

Safety, Rehabilitation and Compensation Act 1988 (SRCA). The SRCA covers Commonwealth employees, including some Defence civilians, but not most veterans. This SoP does not apply to SRCA claims. The SRCA has its own medical causation provisions, and the RMA’s SoPs are not binding under that Act.

State workers’ compensation laws. The SoP has no direct interaction with state compensation schemes. However, if a veteran also has a state workers’ compensation claim for prostate cancer (e.g., due to asbestos or herbicide exposure outside service), the SoP’s factors may be used as persuasive evidence, but they are not binding.

This instrument is the fourth Statement of Principles for malignant neoplasm of the prostate made on the balance of probabilities. It repeals the previous SoP, No. 54 of 2014. The instrument does not explain why the 2014 SoP was repealed, but recites that the RMA is satisfied on the sound medical‑scientific evidence available that the disease can now be related to service on the balance of probabilities. This suggests the RMA reviewed the evidence and concluded that the factors and thresholds needed adjustment.

The 2014 SoP likely had different definitions or thresholds. For instance, the earlier SoP may have had a different pack‑year requirement, a different arsenic concentration threshold, or may not have included the obesity factor. Because the text of the 2014 SoP is not provided, practitioners must be careful to apply only the 2023 version. Claims made after 23 January 2023 must be assessed under the new SoP, even if the disease or the service occurred years earlier. Claims pending before that date are governed by the new SoP as it applies to “a claim to which section 120B of the VEA or section 339 of the MRCA applies” (section 5). There is no general savings provision for claims already lodged; the instrument applies to any claim not finally determined.

The instrument was made on 23 December 2022 and commences 23 January 2023, a 30‑day post‑making period. This is standard for RMA instruments, which are disallowable by Parliament but rarely disallowed. The instrument was registered on the Federal Register of Legislation and is publicly available.

Future amendments are likely as medical evidence evolves. The RMA typically reviews SoPs every few years. Practitioners should monitor the Federal Register of Legislation for any further amendments or revocations. The current instrument does not contain a sunset clause, but the VEA requires the RMA to keep SoPs under review.

The instrument itself does not record any litigation. As a legislative instrument, it could be challenged on grounds of procedural error, error of law, or unreasonableness under the ADJR Act. However, the RMA has a strong record of having its SoPs upheld in the Federal Court, provided they are based on sound medical‑scientific evidence. No specific case involving this particular SoP is known because it is too new. The predecessor SoP, No. 54 of 2014, may have been litigated, but no such history is recorded in this instrument.

It is worth noting that the RMA’s decisions about what factors to include and what thresholds to set are subject to judicial review. In past cases, veterans have challenged SoPs on the basis that the RMA failed to consider certain evidence or that the factors were too restrictive. The courts have generally deferred to the RMA’s expertise, but have occasionally set aside SoPs if the RMA made a clear legal error. Practitioners should be aware that this SoP could be challenged, but as of the date of writing there is no reported case.

The instrument also interacts with the broader veterans’ compensation litigation system. Claims decisions based on this SoP are frequently reviewed by the AAT and occasionally by the Federal Court. The AAT will consider factual disputes about whether a factor exists (e.g., whether a person had a waist circumference exceeding 102 cm for the required period). Such decisions do not challenge the SoP itself but apply it.

Given the importance of the SoP to many claims, any future litigation that successfully challenges the validity of a factor would have significant consequences for the DVA and for veterans. For now, the SoP is presumed valid and must be applied.

Smoking and obesity only for worsening, not onset. This is the most important limitation. A veteran who was diagnosed with prostate cancer years after leaving the military and who never smoked during service cannot use the smoking factor to link the disease to service. The factor requires that the smoking contributed to the clinical worsening of the cancer, which presupposes the cancer already existed. If the cancer was first diagnosed after service and there is no evidence of a pre‑service or in‑service lesion, the smoking factor is irrelevant. Similarly for obesity: a veteran who became obese after service cannot use the obesity factor to establish the onset of the cancer.

The cessation window for smoking is tight. If a veteran quit smoking before the clinical worsening occurred, the worsening must happen within 10 years of cessation. A veteran who quit 12 years before a recurrence or progression cannot satisfy the factor, even if he or she smoked heavily for decades. This is a common trap for older veterans who quit after health scares.

Arsenic threshold is high. The threshold of 50 µg/L for a cumulative 10 years is well above Australian drinking water guideline values (usually 10 µg/L or less). A veteran who drank bore water with intermittent arsenic levels may not meet the cumulative requirement. The equivalent cumulative total alternative (paragraph (b) of the definition) might help, but proving the daily volume and concentration over decades is difficult without contemporaneous tests. Clinical evidence of chronic arsenic toxicity is very strict: it requires objective signs such as keratosis or skin changes, which are rare.

“Being obese” requires a 10‑year period within the 20 years before worsening. This temporal window can be hard to satisfy if the worsening occurred shortly after service, leaving only a narrow band of years in which obesity could have existed. Also, waist circumference measurements from decades ago are unlikely to be available; BMI records may be absent. Claimants may need to rely on anecdotal evidence, which the tribunal may treat skeptically.

“Inability to obtain appropriate clinical management” is a wild card factor but carries risk. It could be interpreted broadly by the AAT, but it may also be construed to require that the inability was due to service‑related circumstances (e.g., remote posting prevented PSA screening, or service‑related stigma deterred seeking help). If the veteran simply chose not to see a doctor, that is unlikely to qualify. The factor also requires that the inability existed before the clinical onset or worsening, which may be hard to prove.

High‑grade PIN counts as cancer for this SoP. This is both a gotcha and an opportunity. Many clinicians will not diagnose a patient with “malignant neoplasm” for HGPIN; the pathology report may say “prostatic intraepithelial neoplasia, high grade” without using the word carcinoma. However, the SoP definition includes HGPIN, so a claim can be made even if no invasive cancer is present. The ICD‑10‑AM code C61 will not have been assigned, but that does not matter because the SoP definition controls. Claimants should ensure the pathology report uses the term “high‑grade prostatic intraepithelial neoplasia” or “HGPIN”.

Relevant service excludes operational and hazardous service without exception. Even if a veteran with operational service satisfies every factor, this SoP does not apply. The claim must be assessed under the reasonable hypothesis SoP. Some practitioners may mistakenly use this SoP for operational service claims, leading to a wrong decision. Conversely, a veteran with a mix of service types might be able to use this SoP for the non‑operational portion and the other SoP for the operational portion, but this requires careful apportionment.

The factor must be related to service, not just to the person’s life. For example, a veteran who was obese because of a post‑service sedentary job might not satisfy the relation‑to‑service requirement unless there is evidence that the obesity itself was caused or contributed to by service (e.g., a service‑connected injury that limited physical activity). The “related to service” test is not just a temporal one; it requires a causal or contributory link. This can be a very high bar, especially for lifestyle factors like obesity and smoking.

Material contribution versus original causation. As noted, factors 9(2) to 9(4) apply only to material contribution or aggravation. This means the disease must have been present before or during service and must have been made worse by the factor. If the disease first appeared after service and the factor is smoking, the claim will fail because the disease did not exist to be worsened. Claimants must distinguish between onset and worsening in their evidence.

The instrument uses ICD‑10‑AM for reference only, but decision‑makers may over‑rely on it. The SoP explicitly states in subsection 7(3) that the meaning of malignant neoplasm of the prostate is given in subsection 7(2), not the ICD code. A decision‑maker who sees code C61 may assume that HGPIN is excluded because it is not typically coded C61. That would be a legal error. Claimants should ensure that the evidence addresses the SoP’s definition.

For claimants and their representatives. First, confirm that the person rendered “relevant service” as defined - i.e., eligible war service other than operational, defence service other than hazardous, or peacetime service under the MRCA. If the person has operational service, do not proceed under this SoP; request the reasonable hypothesis SoP instead. Next, obtain a definitive pathological diagnosis of malignant neoplasm of the prostate, ensuring the report either states “prostatic adenocarcinoma” or “high‑grade prostatic intraepithelial neoplasia”. Exclude any of the excluded tumour types. If the claim is for death, ensure the death certificate or medical records show that prostate cancer contributed to a terminal event listed in the definition.

Identify whether the claim is for clinical onset of the cancer, or for clinical worsening after a pre‑existing condition. For onset, the only potentially applicable factors are arsenic (9(1)) and inability to obtain appropriate clinical management (9(4)). For worsening, all four factors are theoretically available, but note that arsenic is not explicitly limited to worsening; it can be used for either, but the latency period runs from first exposure to clinical onset, not worsening, so it may not assist for worsening unless the worsening is itself considered a new onset of the aggressive form - unlikely.

For the smoking factor, calculate pack‑years using the formula in the dictionary. The person must have smoked at least 15 pack‑years, with the smoking commencing at least 5 years before the worsening. If they quit before worsening, the worsening must be within 10 years of cessation. Assemble evidence of smoking history: DVA medical records, GP notes, service records, or sworn statements. Do not rely on memory alone without corroboration.

For the obesity factor, document the person’s weight and height history going back at least 10 years within the 20 years before worsening. BMI calculations or waist circumference measurements are preferred. If waist circumference is used, ensure the correct sex‑specific threshold. Proving the 10‑year duration may require access to multiple health assessments, life insurance records, or uniform sizes. If the person became obese after service and the worsening occurred soon after, the factor may not be satisfied.

For the arsenic factor, obtain records of drinking water sources during service and afterward. If the veteran served in a region known for high arsenic (e.g., parts of rural Australia or overseas postings), obtain water testing results or expert opinion. The cumulative exposure must equal at least 50 µg/L for 10 years; partial exposures can be aggregated using the equivalent cumulative method in paragraph (b). If clinical evidence of chronic arsenic toxicity exists, that alone satisfies the definition without water testing.

For the clinical management factor, identify what appropriate clinical management would have been (e.g., regular PSA testing, active surveillance, surgery, radiation, hormone therapy) and why the person was unable to obtain it. Link the inability to service: for example, posting to a remote location with no urology services, or service‑related psychiatric condition that caused avoidance of follow‑up. The factor does not require that the inability caused the disease, only that it existed before onset or worsening.

Throughout, maintain a clear chain linking the factor to the person’s relevant service. For example, if smoking was initiated or increased during service because of operational stress or free tobacco rations, document that. If obesity resulted from a service‑acquired physical injury that reduced mobility, obtain medical evidence of the injury and its effect on weight.

For decision‑makers. When assessing a claim, first check the service type. If the person has operational or hazardous service, set aside this SoP and use the reasonable hypothesis SoP. If non‑operational or peacetime, apply this SoP. Determine whether the claim is for onset or worsening. If for worsening, verify that the disease existed before or during service; request records of earlier diagnoses or symptoms. If no such records exist, the worsening factors cannot apply.

Evaluate each factor the claimant raises. Ensure the temporal conditions are satisfied precisely: for example, the 10‑year latency for arsenic is measured from first exposure to clinical onset, not from last exposure. For smoking cessation, check the date of cessation and the date of clinical worsening; if the gap exceeds 10 years, the factor fails. For obesity, require proof that the person was obese for at least 10 years out of the 20‑year window. This can be proven by serial BMI readings, medical records, or robust lay evidence.

If the claimant relies on “inability to obtain appropriate clinical management”, consider whether the person actually had a need for clinical management that was not met. Inability does not mean mere preference; it must be objective - for example, no urologist within reasonable distance, or the person was refused treatment because of service‑related factors. The decision‑maker should also consider whether the inability caused or contributed to the worsening.

Finally, apply section 10(1) strictly: the factor must be related to the person’s relevant service, not just to the person’s life in general. This is a separate legal requirement distinct from the existence of the factor. For example, a smoking history that began after discharge and has no connection to service will not satisfy the relationship test, even if the pack‑year threshold is met. The decision‑maker should ask: Did the factor arise from, or was it materially contributed to by, the person’s service? If not, the claim must be rejected, even if all other elements are proved.