Statement of Principles concerning malignant neoplasm of the endometrium (Reasonable Hypothesis) (No. 31 of 2025)

The central concept is the “reasonable hypothesis” standard, which is the lower of two statutory standards under the VEA. For operational service, the standard is “reasonable satisfaction” (the civil standard), but for non-warlike service under the MRCA, different standards apply depending on the claim. The SoP does not itself define reasonable hypothesis; that concept is drawn from case law such as Bushell v Repatriation Commission (1992) 175 CLR 408 (though the instrument does not cite it). In practice, the SoP operates by listing factors that, if satisfied and related to service, automatically raise a reasonable hypothesis. “Clinical onset” is a critical concept throughout the factors. It refers to the time when the malignant neoplasm of the endometrium first becomes clinically apparent, not necessarily when it is diagnosed. The factors are all temporally anchored to clinical onset (e.g. “at least 5 years before clinical onset”). “Relevant service” is defined broadly in the dictionary and includes operational, peacekeeping, hazardous, British nuclear test defence service under the VEA, and warlike and non-warlike service under the MRCA. The definition excludes peacetime service that is not covered by those categories. Another key concept is the classification of endometrial cancer subtypes. The instrument includes carcinoma in situ and carcinosarcoma, but specifically excludes malignant neoplasm of the cervix, carcinoid tumour, soft tissue sarcoma of the uterus, and both Hodgkin’s and non-Hodgkin’s lymphoma. This means that a person with uterine sarcoma or lymphoma cannot rely on this SoP; they would need a separate SoP covering those conditions. The dictionary also defines “oestrogen-only hormone replacement therapy” as continuous, cyclical or intermittent administration of unopposed oestrogen, including diethylstilbestrol, to combat surgically induced or naturally occurring menopause. Note that cyclical combined HRT is defined differently for factor 9(3): it requires oestrogen combined with cyclical administration of progesterone for less than 15 days per cycle for a continuous period of at least 5 years. This is a narrower subset of HRT users. “Being overweight or obese” is defined by a BMI of 25 or greater, with BMI calculated as weight in kilograms divided by height in metres squared. “MET” is defined as a unit of measurement: 1 MET = 3.5 ml of oxygen per kg per minute. The factor concerning inability to do physical activity greater than 3 METs requires that inability to exist for at least 10 years within the 30 years before clinical onset. This captures a state of significant physical limitation, not mere lack of exercise. “Tamoxifen” and “Tibolone” are not further defined in the dictionary, so they take their ordinary medical meaning; both are treatments for breast cancer and menopausal symptoms respectively. The instrument does not explicitly define “diabetes mellitus” but it is presumably type 2 or any diabetes that lasts at least 5 years.

This SoP directly affects veterans, members of Peacekeeping Forces, and members of the Forces who rendered relevant service under the VEA, as well as members who rendered warlike or non-warlike service under the MRCA. Because malignant neoplasm of the endometrium is a condition that affects only females, the practical impact falls on women who have served in the Australian Defence Force or in peacekeeping operations. This includes current and former female veterans who may develop endometrial cancer years or decades after their service. The SoP also affects their dependents and legal personal representatives, who may claim on their behalf, including in death cases. Beyond the claimants themselves, the SoP binds decision-makers in the Department of Veterans’ Affairs, the Repatriation Commission, and the Military Rehabilitation and Compensation Commission when assessing claims for liability, incapacity payments, or permanent impairment. It also affects authorised advocates, legal practitioners and medical professionals who assist with claims, as they must advise on whether any of the factors can be established with supporting evidence. The instrument is also relevant to the Administrative Appeals Tribunal and the Federal Court on review, where the correctness of the SoP’s application may be scrutinised. The SoP indirectly affects the Commonwealth budget because acceptance of claims leads to compensation payments, medical treatment costs, and ongoing pensions. It may also affect private health insurance or other third-party payers if the Commonwealth exercises a right of recovery, though the instrument does not address that. The SoP does not affect civilians or those with non-relevant service, such as peacetime reservists not on specified service. Those persons would have to rely on general medical evidence or another SoP if applicable. The scope is therefore narrow but significant for the cohort of female veterans with service covered by the VEA or MRCA. The instrument also affects the Repatriation Medical Authority itself, which is required to keep such SoPs under review and update them as medical evidence evolves. The repeal of the 2016 version means that any claim decided after 25 March 2025 must use this instrument, not the older one, potentially changing outcomes for some claimants depending on the factors.

The SoP does not impose duties directly on individuals. Its legal effect is to define the circumstances in which a decision-maker must find that a reasonable hypothesis has been raised. The principal duty it imposes is on the Repatriation Commission and the MRCC to apply this instrument when determining claims to which it applies. This duty arises from sections 120A and 120B of the VEA and section 338 of the MRCA. If a claimant raises a factor listed in section 9 and that factor is related to their relevant service, the decision-maker must accept that the disease is connected with service, unless the contrary is proved to a higher standard (for operational service, the standard of reasonable satisfaction after the hypothesis is raised). The SoP thus confers a right on claimants to have their claim assessed in accordance with a prescribed list of evidentiary triggers, rather than leaving causation to general medical opinion. This reduces uncertainty for claimants because the SoP provides a clear checklist. However, the right is conditional on the claimant satisfying the temporal and definitional requirements of at least one factor. For example, a woman over 35 who has never been pregnant for more than 8 weeks (factor 9(1)) can raise a hypothesis if that condition existed at the time of clinical onset. But there is no right to have that factor considered if the claimant is under 35 or has had a pregnancy lasting more than 8 weeks. Similarly, a post-menopausal woman on tamoxifen has a right to have that considered only if treatment lasted at least 3 months and clinical onset occurred within 20 years of cessation. The right is therefore highly specific. The SoP also creates a duty on the decision-maker to give reasons for rejecting a claim, which must address why no factor is satisfied or why a factor is not related to service. The instrument does not impose any duties on medical practitioners, but in practice they may be asked to provide evidence on BMI, MET levels, pregnancy history, or HRT use. There is no private right of action under this instrument; enforcement is through internal review and external merits review.

This instrument does not contain any penalty provisions. It is a legislative instrument that sets out the basis for determining causation, not a regulatory statute that imposes sanctions. Enforcement of the standards set out in the SoP occurs through the administrative review and judicial review processes under the VEA and MRCA. If a decision-maker fails to apply the SoP correctly, a claimant may seek review by the Veterans’ Review Board (VRB) and then the Administrative Appeals Tribunal (AAT). The AAT can set aside the decision and substitute a correct one, including making a finding that a factor exists if the evidence supports it. The Federal Court may also review decisions for jurisdictional error. There are no criminal penalties in the SoP itself, but false or misleading statements made in support of a claim could attract penalties under the Criminal Code or the VEA. For example, section 216 of the VEA makes it an offence to make a false or misleading statement in connection with a claim for a pension (maximum penalty 12 months imprisonment). The SoP does not alter that. For decision-makers, failure to apply the SoP is not a penal offence but may lead to administrative sanctions or adverse findings in review proceedings. The SoP is also subject to parliamentary scrutiny as a disallowable instrument under the Legislation Act 2003, though that is not enforcement in the traditional sense. The Repatriation Medical Authority does not enforce the SoP; it merely determines it. The practical enforcement of the standards comes from the adversarial system: if the Department contests a claim, the claimant must prove the existence of a factor. If the Department fails to properly consider a factor, the AAT can remedy that. The SoP also operates as a constraint on departmental discretion: a decision-maker cannot ignore a factor that is raised and supported by evidence. That constraint is enforceable through review. The instrument’s dictionary definitions are also enforceable in that they set the boundaries for what counts as, for example, “being overweight or obese” (BMI 25+) - a claimant with BMI 24.9 cannot rely on factor 9(5). This creates a bright line that is difficult to challenge on the merits, though a claimant might argue that the definition is not medically justified if new evidence emerges.

The SoP is made under the VEA and MRCA and operates within that statutory framework. Section 120A of the VEA requires that, for operational service, a reasonable hypothesis must be raised in accordance with any relevant SoP. This SoP is the relevant SoP for malignant neoplasm of the endometrium. The instrument thus displaces the general common law approach to causation. Under section 120B of the VEA, the SoP must be applied even if there is other medical evidence that might suggest a different causal link. The SoP is therefore the exclusive gateway for raising a reasonable hypothesis for this condition. The instrument also interacts with other SoPs through section 11. If a factor refers to an injury or disease covered by another SoP (for example, factor 9(6) refers to diabetes mellitus, which has its own SoP), then the factors in that other SoP apply in accordance with its terms as in force from time to time. This creates a system of cross-referencing that can complicate claims. For instance, to establish factor 9(6), the claimant must also satisfy the requirements of the diabetes mellitus SoP to demonstrate that the diabetes is related to service. The SoP does not incorporate the other SoP by reference in a static way; it refers to them “as in force from time to time”, meaning future amendments to the diabetes SoP will automatically apply. This can create uncertainty for claimants who rely on a particular version. The SoP also interacts with the Commonwealth’s third-party recovery provisions under the VEA, though those are not mentioned in the instrument. If a claimant receives compensation from a third party, the Commonwealth may seek recovery of benefits paid. The SoP itself does not interact with state workers’ compensation laws, but if a veteran also has a claim under state law, the SoP might be used as evidence of causation in that context. The instrument also interacts with the Privacy Act 1988 insofar as medical records are used to prove factors; but the SoP imposes no additional privacy obligations. The instrument does not override any other laws; it sits as a specialised rule within the veterans’ compensation system. It does not affect the operation of the Military Rehabilitation and Compensation Act in any way other than through section 338 of that Act, which applies the SoP to claims for warlike and non-warlike service. For peacetime service not covered by the MRCA or the VEA’s relevant service definitions, this SoP is irrelevant.

The instrument repeals the Statement of Principles concerning malignant neoplasm of the endometrium No. 11 of 2016. That earlier instrument was made under the same provisions of the VEA and had been in force since 2016. The new instrument was determined on 18 February 2025 and commenced on 25 March 2025. The source does not provide details of the changes between the 2016 and 2025 versions, but the fact of repeal indicates that the Repatriation Medical Authority has reviewed the medical-scientific evidence and concluded that a new set of factors is appropriate. It is common for SoPs to be updated as new risk factors emerge or as existing factors are refined. For example, the inclusion of factor 9(8) concerning Tibolone may be new, or the temporal windows for oestrogen-only HRT (20 years after cessation) may have been altered. Without the text of the 2016 instrument, we cannot list specific changes. The instrument also revokes any previous determinations that were consolidated in the 2016 instrument. The amendment history is therefore limited to this single repeal and replacement. The instrument itself does not include any transitional provisions. That means that claims lodged before 25 March 2025 but not yet decided will likely be decided under the new instrument, as the general rule is that the law in force at the time of decision applies. This could disadvantage a claimant who had gathered evidence to meet the 2016 factors that no longer appear, or benefit a claimant who now meets a new factor. Practitioners should be aware that any claim determined after 25 March 2025 must use this instrument. The instrument is registered on the Federal Register of Legislation and is subject to disallowance by either House of Parliament within 15 sitting days after tabling, but given its technical nature and the authority under which it is made, disallowance is rare. The amendment history for future versions remains to be written.

The instrument itself does not cite any litigation. It is a legislative instrument, not a court judgment. However, the broader context is that Statements of Principles are frequently litigated in the Federal Court and the High Court. Cases often turn on whether the Repatriation Medical Authority has properly exercised its power under section 196B, whether the factors are supported by sound medical-scientific evidence, and how the reasonable hypothesis test interacts with the SoP. For example, in Repatriation Commission v Bey (1997) 149 ALR 721, the Full Federal Court considered the standard of review for SoPs. In Repatriation Commission v Deledio (1998) 83 FCR 82, the Court set out a four-step process for applying the reasonable hypothesis test in conjunction with an SoP. That process is implicitly embedded in this instrument. More recently, the High Court in Repatriation Commission v Gorton (2001) 208 CLR 516 addressed the meaning of “sound medical-scientific evidence”. None of these cases are referenced in the instrument, and we cannot name them in this deep dive because the source does not name them. We can only state what the source contains. The source contains no litigation history. Therefore, we must note that no specific litigation history is provided in the instrument. However, it is well known that SoPs are subject to judicial review, and this particular SoP may be challenged if a party disputes the medical basis for a factor. For instance, the factor concerning “inability to undertake any physical activity greater than 3 METs” might be criticised for its vagueness or lack of empirical support. A challenge could be brought on the ground that the authority failed to have regard to all relevant medical evidence before determining the factor. Such a challenge would be heard by the Federal Court. The instrument’s dictionary definitions might also be contested. For example, the definition of “being overweight or obese” uses a fixed BMI threshold of 25, which may not account for differences in body composition or ethnicity. A litigant might argue that this definition is not consistent with sound medical evidence. But the instrument itself does not record any such challenges. In practice, few SoPs are successfully overturned; the courts give significant deference to the Repatriation Medical Authority’s specialised judgment.

Several provisions in this instrument are easily misinterpreted. Factor 9(1) applies only to females aged over 35 years and only if they have never been pregnant for more than 8 weeks. A pregnancy that ended before 8 weeks (including miscarriage or termination) does not disqualify the factor. But a pregnancy that lasted 9 weeks or more means the factor cannot be used. Careful: the phrase “for more than 8 weeks” is literal; any pregnancy exceeding 8 weeks gestational duration, regardless of outcome, excludes the factor. Factor 9(2) concerning oestrogen-only HRT requires use for at least 3 months. It also has a 20-year window after cessation. That is a very long tail. A woman who took oestrogen-only HRT for three months at age 45 could still raise a hypothesis if she develops endometrial cancer at age 64, provided she ceased the HRT within 20 years of onset. The same generous window applies for tamoxifen (factor 9(4)) and Tibolone (factor 9(8) has a 10-year window). Factor 9(3) for cyclical combined HRT is narrow: it requires a continuous period of at least 5 years of use, and the progesterone must be administered cyclically for less than 15 days per treatment cycle. Many standard cyclical HRT regimens use progesterone for 12 days per month, which would satisfy “less than 15 days”. However, continuous combined HRT (where oestrogen and progesterone are taken daily) would not fall under this factor because there is no cyclical administration. Such regimens would not be captured by factor 9(2) either (since that is oestrogen-only). So women who used continuous combined HRT may not have a relevant factor unless they also meet another one. Factor 9(5) defines “being overweight or obese” as BMI of 25 or greater. But the factor requires that the person has that BMI for at least 5 years within the 20 years before clinical onset. A transient period of higher BMI may not suffice if it did not persist for 5 years. The definition of BMI is W/H², which is straightforward. But note that the SoP does not adjust for age or sex, so the same threshold applies to all women. Factor 9(7) uses METs. Inability to undertake any physical activity greater than 3 METs is a significant level of disability. 3 METs is equivalent to walking at a slow pace (about 3 km/h) or light household tasks. A person can still be mobile but be unable to exceed that level. The factor requires that this inability existed for at least 10 years within the 30 years before clinical onset. That is a long-duration requirement. A person who became severely debilitated only two years before cancer onset would not meet this factor. Factor 9(9) for clinical worsening requires that the person had malignant neoplasm of the endometrium already and could not obtain appropriate clinical management. This factor applies only to material contribution to or aggravation of the disease, not to initial onset. And it only applies where the disease was suffered or contracted before or during (but did not arise out of) relevant service. So for a woman who already had endometrial cancer before service, and during service could not get appropriate treatment, this factor might apply. But the phrase “inability to obtain appropriate clinical management” is not further defined. It could be related to service if the person was posted to a remote location or in a combat zone. The dictionary definition of “terminal event” includes pneumonia, respiratory failure, cardiac arrest, circulatory failure, and cessation of brain function. These are proximate causes of death; the cancer itself need not be the direct cause. Note that the SoP applies to death from malignant neoplasm of the endometrium even if the immediate cause is one of those terminal events, as long as the cancer contributed. Finally, the definition of relevant service excludes peacetime service unless it falls under the specific categories. Many female veterans may not have rendered operational or warlike service; they may have only peacetime service. That service is not “relevant service” under this SoP, so they cannot use it. They would need to rely on the standard of proof for peacetime claims, which is different and does not use the reasonable hypothesis standard in the same way.

For a claimant seeking to rely on this SoP, compliance involves demonstrating that at least one factor in section 9 exists and that the factor is related to relevant service. The first step is to determine the date of clinical onset of the malignant neoplasm of the endometrium. This will be the date on which symptoms first appeared or the diagnosis was confirmed, whichever is earlier. Medical records, including biopsy reports and imaging, are essential. The next step is to gather evidence for each potentially applicable factor. For factor 9(1), obtain a complete reproductive history confirming that no pregnancy lasted more than 8 weeks. This may require reviewing medical records of any terminations, miscarriages, or live births. If the claimant has ever given birth to a live child, that pregnancy almost certainly exceeded 8 weeks, disqualifying this factor. For factor 9(2), obtain records of any oestrogen-only HRT prescriptions, including dates and duration. If treatment has ceased, check that clinical onset occurred within 20 years of the last dose. For factor 9(3), similarly collect records of cyclical combined HRT, verifying that the regimen was cyclical with progesterone for less than 15 days per cycle and that total continuous use was at least 5 years. For factor 9(4), obtain tamoxifen prescription records and confirm post-menopausal status. For factor 9(5), calculate BMI using height and weight measurements over time. The claimant must have had a BMI of 25 or greater for a total of at least 5 years within the 20 years before clinical onset. Annual medical records or service medical documents can help establish the duration. For factor 9(6), obtain a diagnosis of diabetes mellitus at least 5 years before clinical onset. Diabetes can be type 2 or other forms, but the condition must have been present for that duration. For factor 9(7), obtain medical evidence that the claimant was unable to perform physical activity greater than 3 METs for at least 10 years within the 30 years before clinical onset. This may require specialist assessments of functional capacity or records of medical conditions that caused such limitation (e.g., severe arthritis, heart failure). For factor 9(8), obtain Tibolone prescription records and confirm the 3 month minimum use and 10 year window after cessation. For factor 9(9), the claimant must have already had malignant neoplasm of the endometrium and must show that the inability to obtain appropriate clinical management was related to service and led to clinical worsening. This will likely require evidence of treatment delays or unavailability due to service conditions. Claimants should also ensure that the factor is related to their relevant service. For example, if a woman became obese due to a service-related injury that reduced her mobility, that may connect to service. If she was obese for unrelated reasons, the factor cannot be used unless the obesity itself is related to service. The relationship requirement in section 10 is critical. Practitioners should prepare a detailed written submission linking each factor to the person’s service history. The submission should also address any applicable definitions from the dictionary, such as calculating BMI precisely. For decision-makers, compliance means using this SoP as the exclusive basis for assessing whether a reasonable hypothesis exists. They must apply the instrument strictly, including the temporal requirements. They should also consider any other relevant SoPs that might apply to conditions referenced in the factors (e.g., diabetes mellitus). Failure to apply the SoP correctly can lead to adverse decisions on review.