Statement of Principles concerning malignant neoplasm of the breast (Balance of Probabilities) (No. 85 of 2023)

The central concept is a “factor” as defined in section 9. Each factor is a factual circumstance that, if satisfied and related to service, establishes the connection. The factors are diverse, covering exposure to ionising radiation, use of certain medications, reproductive history, lifestyle factors, and barriers to medical care.

Ionising radiation (factor 1) requires a cumulative equivalent dose of at least 0.5 sievert to the breast at least 10 years before clinical onset. Cumulative equivalent dose is defined in the Schedule 1 Dictionary with a cross-reference to a specific ARPANSA guide dated 2 August 2017. The definition excludes normal background radiation in Australia. Examples given in the note include nuclear weapons tests, diagnostic or therapeutic medical procedures, and aircrew exposure to cosmic radiation. The dose must be calculated as an average over the mass of the breast tissue. This is a significant threshold; 0.5 Sv is a substantial dose, not typically reached through routine medical imaging alone (e.g., a mammogram delivers about 0.4 mSv). Only high-dose exposures such as radiotherapy or proximity to nuclear events would reach this level.

Menopausal hormone therapy (factor 2) is defined as administration of estrogen preparations (often with progestogen) to offset hormone deficiency after surgically induced or natural menopause. The factor requires use for at least 2 years before onset, and if ceased, onset within 5 years of cessation. Combined oral contraceptives (factor 3) are split into two subcategories: 2 to 5 years of continuous use with onset within 10 years of cessation, or at least 5 years of use with onset within 15 years of cessation. In both subcategories, usage must have commenced at least 5 years before onset. Diethylstilbestrol (factor 4) applies to women who took it while pregnant before the onset of their breast cancer; this is a historical exposure factor.

Reproductive history factors include: inability to breast feed for at least 3 cumulative months (factor 5, for parous females only); being nulliparous (never having given birth to a viable infant) for females aged over 35 years at onset (factor 6); being pregnant within 25 years before onset (factor 7); and having a first live birth or first full-term pregnancy after age 30 (factor 8). These factors reflect epidemiological associations but do not require a service connection for the pregnancy itself; the factor merely needs to exist and be related to service.

Lifestyle factors: smoking for females only (factor 9) requires at least 15 pack-years of tobacco products, with onset at least 5 years after commencement and, if ceased, within 30 years of cessation. “One pack-year” is defined as 20 cigarettes per day for one year or 7,300 grams of tobacco. Alcohol consumption for females only (factor 10) requires at least 40 kilograms of alcohol (calculated at 10 g per standard drink) consumed, with onset at least 5 years after commencement and, if ceased, within 40 years of cessation. Physical inactivity (factor 11) applies to both sexes and requires inability to undertake any physical activity greater than 3 METs for at least 10 consecutive years within the 30 years before onset. MET is defined as a unit measuring oxygen consumption, with 1 MET equal to resting metabolic rate.

Obesity (factor 12) applies only to males and postmenopausal females, requiring obesity for at least 5 years within the 20 years before onset. Being obese is defined as either a BMI of 30 or greater, or a waist circumference exceeding 102 cm for males or 88 cm for females. BMI is weight in kilograms divided by height in metres squared.

Two final factors relate to healthcare access: factor 13 applies only to death from breast cancer, for females aged 50 to 69 years, who were prevented from accessing mammographic screening in accordance with contemporary medical standards within the 10 years before onset, provided they did not subsequently have a normal test result or decline the opportunity for appropriate screening. Factor 14 is “inability to obtain appropriate clinical management for malignant neoplasm of the breast” and applies only to material contribution or aggravation of a disease that was suffered or contracted before or during (but did not arise out of) relevant service (section 10(2)).

This SoP directly affects veterans and members of the Australian Defence Force who have rendered “relevant service” as defined in the Dictionary. Relevant service means eligible war service (other than operational service) under the VEA, defence service (other than hazardous service and British nuclear test defence service) under the VEA, and peacetime service under the MRCA. This is a critical distinction: it does not cover operational service (which uses a reasonable hypothesis standard under a different SoP) nor hazardous service or British nuclear test defence service. The SoP applies only to claims where the standard of proof is the balance of probabilities, which typically arises when the service is non-operational.

The practical effect is that veterans with peacetime service, defence service, or eligible war service (e.g., home defence during wartime) who develop breast cancer are affected. The SoP also covers members of the Forces under the VEA and members under the MRCA. Because the disease affects both males and females (the definition explicitly includes males and females), male veterans with breast cancer are also within scope. However, many factors are sex-specific: factors 5 (inability to breast feed), 6 (nulliparity in females over 35), 9 (smoking for females), 10 (alcohol for females), 12 (obesity for males and postmenopausal females only), and 13 (mammographic screening for females aged 50-69) limit the pool of eligible claimants.

Additionally, the SoP affects the decision-makers: the Repatriation Commission, the Military Rehabilitation and Compensation Commission, and the Administrative Appeals Tribunal. They must apply this SoP when assessing claims for malignant neoplasm of the breast under the balance of probabilities standard. The instrument also affects medical practitioners who may be asked to provide evidence about a veteran’s exposure history, reproductive history, or ability to breast feed. Lawyers and advocates representing veterans need to understand the specific definitions and temporal thresholds to build a case.

Family members may be indirectly affected because death from malignant neoplasm of the breast is included; the definition in section 7(5) includes death contributed to by a terminal event, so dependants may claim war widows’ or widowers’ pensions. The SoP also interacts with other SoPs via section 11: if a factor refers to an injury or disease covered by another SoP, that SoP applies. This means a veteran may need to satisfy multiple SoPs if the factor involves, for example, a different cancer or condition.

The SoP does not impose duties on individuals. Instead, it creates an evidentiary framework. The key duty lies on the decision-maker to apply the SoP when determining a claim. A veteran or member has the right to have their claim assessed in accordance with this instrument if their service is relevant service and their disease falls within the definition.

Section 9 states that at least one factor must exist before it can be said, on balance of probabilities, that the disease is connected with the person’s relevant service. This is a necessary condition; if no factor exists, the decision-maker must find no connection (unless other medical evidence is sufficient, but in practice the SoP is intended to be exhaustive for the balance of probabilities standard). The veteran has the right to present evidence that they satisfy a factor. That evidence must be related to service per section 10(1): the factor itself must have been caused or contributed to by the relevant service. For example, if a veteran took menopausal hormone therapy, they must show that the therapy was related to their service (e.g., prescribed by a defence force doctor or taken while serving). If the factor is lifestyle-related (smoking, alcohol, obesity), the veteran must demonstrate that the behaviour or condition was linked to service, which can be difficult for peacetime service unless the service caused or aggravated the behaviour.

Section 10(2) provides a special rule for factor 14 (inability to obtain appropriate clinical management): it applies only to material contribution or aggravation of a disease that existed before or during service but did not arise out of service. This means factor 14 cannot be used to establish initial causation; it only operates where the disease was already present and service-related factors worsened it.

The right to rely on factors involving other SoPs is preserved by section 11. If a factor refers to another injury or disease (e.g., a prior cancer that itself has a SoP), the factors in that other SoP apply. This creates a cascading chain of causation. For instance, if a veteran had a previous cancer treated with radiotherapy (which is a factor for breast cancer via ionising radiation), the radiation factor may itself be linked to service via an earlier SoP for that earlier cancer.

The instrument does not create rights to specific amounts of compensation; those are governed by the VEA and MRCA. The SoP only determines the question of connection. The veteran has the right to seek review of an adverse decision in the AAT, and the SoP will be the applicable standard.

This instrument does not itself create penalties or enforcement mechanisms. It is a legislative instrument that sets rules for decision-making, not a coercive law. However, it operates within the broader veterans’ entitlements framework where penalties for fraud or misrepresentation apply under the VEA and MRCA. For example, a person who knowingly makes a false statement to obtain compensation could face criminal penalties or administrative sanctions such as cancellation of benefits and recovery of overpayments.

The SoP’s enforcement is indirect: if a veteran claims a factor that does not exist, and the decision-maker accepts it, the resulting payment could be an overpayment. The Commission can later recover that overpayment. But the SoP itself does not prescribe any penalty. The enforcement of the SoP lies in the fact that it is binding on decision-makers; a decision that fails to apply the SoP correctly can be set aside on review. The AAT and Federal Court enforce compliance with the SoP through the usual mechanisms of administrative law.

There is also a possibility of the SoP being challenged by way of judicial review on grounds such as procedural fairness (e.g., if the Authority failed to consider relevant medical evidence). However, the instrument recites in section 8 that the Authority has considered the sound medical-scientific evidence. That recital is likely afforded deference by courts. The only way to enforce the SoP against the Authority would be to argue that it is ultra vires the VEA, but that would require showing that the factors are not supported by sound medical-scientific evidence, which is a high bar.

In practice, the main enforcement risk is for the veteran: if they fail to satisfy a factor, their claim is denied. There is no penalty for making a claim that fails, aside from the time and cost. However, if a veteran or their representative deliberately fabricates evidence to meet a factor, they could be prosecuted for fraud under Commonwealth law. The SoP itself does not mention penalties, but the dictionary definition of “one pack-year” and other quantitative criteria create hard thresholds that can be objectively verified, reducing the scope for dispute.

This SoP is made under subsection 196B(3) of the VEA. It operates in the context of the VEA and MRCA. Section 5 specifies that it applies to claims under section 120B VEA (for balance of probabilities claims) and section 339 MRCA (similarly for peacetime service). It does not apply to claims under section 120 VEA (operational service), which uses the reasonable hypothesis standard; a different SoP (made under subsection 196B(2)) would apply for operational service claims for breast cancer.

The SoP also explicitly interacts with other SoPs via section 11. If a factor refers to an injury or disease for which another SoP exists, the factors in that other SoP apply as in force from time to time. This creates a network of causation. For example, factor 1 (ionising radiation) may be satisfied if the veteran received radiotherapy for a previous cancer. That previous cancer may itself be the subject of a SoP, and the veteran would need to satisfy that SoP to establish a link between the radiation and service. This means multiple SoPs may need to be met in sequence.

The instrument repeals the earlier Statement of Principles No. 97 of 2014 (section 4). That prior SoP is no longer in effect for balance of probabilities claims. The new SoP reflects updated medical evidence. The dictionary definitions are tailored to the VEA and MRCA contexts. Terms like “relevant service” are defined to exclude certain categories of service, meaning the SoP does not apply to hazardous service or British nuclear test defence service; those services are covered by separate provisions in the VEA with potentially different standards.

The interaction with the general law of causation is through section 10, which requires the factor to be related to service. This is not a pure medical causation question; it is a question of whether the factor was caused or contributed to by the person’s service. For instance, a veteran who smoked heavily before joining the military would need to show that their smoking was related to service (e.g., started or increased due to service) to rely on factor 9. This is a mixed question of fact and law. The SoP does not override the VEA’s provisions on relationship to service; it simply adds the factor requirement.

The SoP also interacts with the Social Security Act 1991 indirectly: a veteran who is denied compensation may instead qualify for social security benefits, but the SoP does not directly affect that. It also interacts with state workers’ compensation laws if the veteran is employed outside defence, but those are separate schemes.

The only amendment history explicitly provided in the instrument is the repeal of the previous SoP. Section 4 states: “The Statement of Principles concerning malignant neoplasm of the breast No. 97 of 2014 … is repealed.” That earlier instrument was made under both subsections 196B(3) and (8) of the VEA. The new SoP is made only under subsection 196B(3) (balance of probabilities), not under subsection (8) (which deals with reasonableness factors for reasonable hypothesis SoPs). This suggests a simplification: the 2014 instrument may have been a combined SoP covering both standards, while the 2023 instrument is solely for balance of probabilities.

There is no mention of any intermediate amendments between 2014 and 2023. The instrument does not list any other amending instruments. The commencement date is 26 September 2023. Claims made before that date would have been assessed under the 2014 SoP. The new SoP applies to claims on or after commencement.

The dictionary definitions and factors are current as of the date of signing (25 August 2023). The cross-reference to the ARPANSA guide (dated 2 August 2017) is fixed in time. There is no mechanism in the SoP for the Authority to amend it automatically; any future amendment would require a new instrument. The instrument is a legislative instrument registered on the Federal Register of Legislation. It is subject to disallowance by Parliament under the Legislation Act 2003, though this is rare for SoPs.

The Authority is required by the VEA to review SoPs periodically, but the instrument does not indicate when the next review will occur. The replacement of the 2014 SoP after 9 years suggests that the Authority updated the medical evidence, but no details of the evidence are provided in the instrument itself.

The instrument does not refer to any court cases or tribunal decisions. It is a standalone legislative instrument with no recitals of litigation. This does not mean that the SoP has not been litigated; the source simply does not mention any case law. However, it is well known that SoPs under the VEA have been challenged in the Federal Court and the High Court. For example, the validity of the Repatriation Medical Authority’s approach to “sound medical-scientific evidence” has been tested in cases like Repatriation Commission v Gorton (2001) and others. But this specific instrument does not cite or rely on any of those decisions.

The earlier 2014 SoP may have been the subject of litigation, but the source text for the 2023 SoP provides no information about that. The instrument is a fresh determination; it does not incorporate any court rulings by reference. The only external document referenced is the ARPANSA guide for calculating cumulative equivalent dose, which itself may have been considered in litigation, but again not mentioned.

Because this SoP applies only to balance of probabilities claims, and the standard of proof is lower than reasonable hypothesis, litigation may be less frequent. Most veteran appeals concern the application of the factors to the facts, rather than the validity of the SoP itself. The AAT can interpret the SoP’s definitions and decide whether a factor exists. The Federal Court can review legal errors. For example, disputes over whether a person was “prevented from accessing mammographic screening” (factor 13) or what constitutes “inability to obtain appropriate clinical management” (factor 14) would likely be litigated.

Given the source’s silence, the safest statement is that the instrument itself does not record any litigation history. Users should check the Federal Court database for any cases involving this particular SoP number, but that would require external research beyond the source. The note about litigation history is therefore minimal and grounded in the absence of any reference in the text.

Several provisions in this SoP will catch out inexperienced practitioners. First, the definition of “relevant service” excludes operational service, hazardous service, and British nuclear test defence service. A veteran who served in a combat zone (operational service) cannot use this SoP; they must rely on the reasonable hypothesis SoP (likely No. 86 of 2023, if one exists). This is a common error: assuming the same SoP applies to all service.

Second, many factors are sex-specific. Factor 9 (smoking) and factor 10 (alcohol) apply only to females. Male veterans cannot use these factors even if they smoked heavily. Factor 12 (obesity) applies only to males and postmenopausal females; a premenopausal female who is obese cannot rely on it. Factor 5 (inability to breast feed) is for parous females only, and the inability must be cumulative over multiple pregnancies. The term “inability” is not defined, so it may require medical evidence that the person could not breast feed, not just chose not to.

Third, the temporal thresholds are precise and unforgiving. For ionising radiation (factor 1), the dose must be at least 0.5 Sv and occur at least 10 years before clinical onset. If the exposure was 9 years before onset, the factor fails. For menopausal hormone therapy (factor 2), use must be for at least 2 years; if the person used it for 1 year and 11 months, it does not count. The combined oral contraceptive factor (factor 3) has a “continuous period” requirement; intermittent use may not satisfy it. There is no provision for aggregation of interrupted periods.

Fourth, the alcohol factor (factor 10) uses kilograms of alcohol, not standard drinks or years. The note says alcohol consumption is calculated using the Australian Standard of 10 grams per standard drink. So 40 kg = 40,000 grams = 4,000 standard drinks. That is a large amount; a person drinking 10 standard drinks per day would reach 40 kg in about 400 days (a bit over a year). But the factor also requires consumption at least 5 years before onset and within 40 years of cessation. So a female veteran who drank heavily for a short period might satisfy the 40 kg threshold but may struggle to show the drinking was related to service for that specific period.

Fifth, the physical inactivity factor (factor 11) requires inability to undertake any activity greater than 3 METs for at least 10 consecutive years within the 30 years before onset. This is a very high bar. Most people can perform light activities such as slow walking (2-3 METs). “Inability” suggests a medical or service-imposed condition that prevented even minimal exertion. A sedentary lifestyle without a medical reason likely does not qualify. The note defines MET but not what constitutes “inability.” This factor may be difficult to prove.

Sixth, factor 13 (mammographic screening) applies only to death from malignant neoplasm of the breast, not to the disease itself. It also applies only to females aged 50-69 years. The veteran must have been “prevented from accessing mammographic screening in accordance with contemporary medical standards.” The term “prevented” implies an external barrier, such as deployment to an area without screening facilities, not a personal choice. If the person declined screening (subparagraph (b)), they are excluded. Also, if they resumed screening with a normal result at any time before clinical onset, the factor does not apply.

Seventh, factor 14 (inability to obtain appropriate clinical management) applies only to material contribution or aggravation after the disease was already contracted or existed before or during service. It cannot be used to establish initial causation. This is a gotcha for those who try to argue that poor medical care caused the cancer; the factor only covers worsening.

Eighth, the dictionary definitions are binding. For example, “terminal event” is limited to the five listed causes; death from other causes is not covered unless contributed to by one of those five. “Being obese” is defined by BMI or waist circumference; a person may be overweight but not obese according to the definition and thus fail factor 12.

Ninth, the SoP requires that at least one factor must exist. If a veteran has multiple factors that each fall short of the thresholds, they cannot combine them to reach the standard. The factors are not cumulative; each stands alone.

Tenth, the cross-reference to the ARPANSA guide for cumulative equivalent dose means that the calculation methodology is fixed as at 2 August 2017. Any updates to that guide after that date are not incorporated. If ARPANSA changes its method, the SoP would need to be amended. Practitioners must obtain the correct version of the guide.

Compliance with this SoP is not about an individual obeying the instrument; it is about a claimant establishing their case and a decision-maker applying it correctly. For a veteran or their representative, the key steps are: (1) confirm that the person has relevant service as defined (eligible war service other than operational service, defence service other than hazardous or British nuclear test, or peacetime service under MRCA). (2) Obtain a diagnosis of malignant neoplasm of the breast that meets the definition in section 7, including confirmation it is a primary epithelial neoplasm and not one of the excluded types (haematolymphoid, melanoma, mesenchymal). (3) Determine the date of clinical onset of the disease; all temporal thresholds are tied to this date.

(4) Review each factor in section 9 to identify which, if any, apply. Gather evidence to satisfy the specific requirements. For factor 1 (radiation), obtain a dose reconstruction from ARPANSA or a qualified health physicist using the 2017 guide. For medication factors (2, 3, 4), obtain pharmacy records, prescriptions, or medical notes showing continuous use and timing. For reproductive factors (5-8), obtain obstetric history, breastfeeding records, pregnancy tests, and birth dates. For smoking (9) and alcohol (10), obtain self-reported history corroborated by medical notes or service records; note that 15 pack-years is a high threshold and must be calculated as per the definition. For physical inactivity (11), provide medical evidence of a condition that prevented activity above 3 METs for 10 consecutive years; this may require specialist reports. For obesity (12), provide height, weight, and waist circumference measurements at relevant times. For mammographic screening (13), show that the veteran was prevented from accessing screening (e.g., deployed to a location without mammography) and did not subsequently decline or have a normal result. For clinical management (14), show that appropriate management was unavailable and that this materially contributed to aggravation.

(5) Establish that the factor is related to service per section 10(1). This means the factor must have been caused or contributed to by the person’s relevant service. For example, if the veteran smoked due to stress from service, gather evidence of that link. If the veteran was exposed to radiation during service as a medical technician, obtain service records of that role. If the factor is something like being nulliparous (factor 6), it will be difficult to link to service unless the veteran’s service prevented childbearing (e.g., deployed during reproductive years). The decision-maker will assess this.

(6) If the factor refers to another injury or disease that has its own SoP (section 11), the claimant must also satisfy that SoP. For example, if relying on radiation from treatment for a prior condition, the prior condition must be shown to be service-related under its own SoP. This can create a chain of proof.

For decision-makers, compliance means applying the SoP as binding. They must check the applicable standard (balance of probabilities) and not import the reasonable hypothesis standard. They must correctly interpret the dictionary definitions and not broaden them. For example, “inability to breast feed” should be given its ordinary meaning; the note says cumulative over pregnancies, but the decision-maker must determine if the inability was due to a physical or psychological condition. They must also ensure that the factor existed at the relevant time (e.g., obesity for 5 years within 20 years before onset). Temporal relationships are critical.

Record-keeping: claimants should compile a comprehensive chronology of service and medical history, including all exposures, medication use, reproductive events, and lifestyle data. Medical specialists may need to provide opinions on whether factors like inability to breast feed or inability to perform physical activity are present. For ionising radiation, a formal dose calculation per ARPANSA methodology is essential.

Finally, note that the SoP is not retrospective; it applies only to claims determined on or after 26 September 2023. For pre-existing claims, the 2014 SoP governs. A claimant who was denied under the 2014 SoP may seek to reapply if the new SoP provides a factor that was not previously available. However, they must still satisfy the temporal thresholds relative to their clinical onset, which may have occurred years earlier.