Statement of Principles concerning malignant neoplasm of the anus and anal canal (Balance of Probabilities) (No. 83 of 2022)

Malignant neoplasm of the anus and anal canal is defined strictly in subsection 7(2). It means a primary malignant neoplasm arising from the epithelial cells of the anus or anal canal, and includes adenocarcinoma, adenocarcinoma in situ, carcinoma in situ, high-grade anal squamous intra-epithelial lesion (HSIL), and squamous cell carcinoma. It expressly excludes a range of other conditions: atypical squamous cell histology of undetermined significance, haematolymphoid tumours (e.g. Hodgkin’s and non-Hodgkin lymphoma), low-grade anal squamous intra-epithelial lesion (LSIL), malignant melanoma, mesenchymal tumours (including soft tissue sarcoma), neoplasms of the perianal skin (anal margin), and neuroendocrine tumours. The definition is narrower than the ICD-10-AM codes (C21.0, C21.1, C21.2, D01.3) that the condition may attract; the meaning in subsection 7(2) prevails for the purposes of this SoP. This distinction matters because a claim for a neoplasm of the perianal skin, for example, would fall outside this SoP entirely.

Relevant service is defined in the Dictionary. It 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; or
• peacetime service under the MRCA.

This is a critical carve-out. Operational service and hazardous service are not covered by this SoP; they are subject to a different Standard of Proof (reasonable hypothesis) and different SoPs. Claimants with those service types cannot rely on this instrument. Similarly, service under the Safety, Rehabilitation and Compensation Act 1988 (DRCA) is not mentioned and likely falls outside the scope entirely.

Balance of probabilities is the standard of proof that applies when this SoP is used. It requires that the decision-maker be satisfied that it is more probable than not that the connection exists. This contrasts with the “reasonable hypothesis” standard that applies to operational service claims.

Pack-year is defined as the amount of tobacco consumed in smoking 20 cigarettes per day for one year, or an equivalent amount (7,300 grams of smoking tobacco). The calculation method is provided in Note 2. The factor at 9(1) requires at least 10 pack-years, a latency of at least 5 years before clinical onset, and if smoking has ceased, onset must occur within 20 years of cessation. This is a relatively demanding threshold that will exclude many light or short-term smokers.

Specified human papillomavirus means HPV types 16, 18, 31, 33, 35, 45, 51, 52, 58, or 68. Only these high-risk types are recognised. A claimant with other HPV types cannot rely on this factor.

Clinical onset is not defined in the instrument. This creates interpretive ambiguity. In practice, it is usually taken as the time of first medical diagnosis or when symptoms first manifest. The lack of definition increases the risk of dispute between claimants and decision-makers over whether a factor existed sufficiently before onset.

Aggravation is addressed separately: factor 9(7) (inability to obtain appropriate clinical management) applies only to material contribution to, or aggravation of, the condition where the disease was suffered or contracted before or during (but did not arise out of) relevant service (section 10(2)). This is the only factor that can be used for aggravation claims.

The SoP directly affects any person who is a veteran or member of the Forces who has rendered relevant service (as defined) and who claims compensation for malignant neoplasm of the anus and anal canal under the VEA or MRCA. This includes:

• veterans with eligible war service that is not operational service (e.g. home defence service during World War II);
• veterans with defence service that is not hazardous service (e.g. peacetime training or garrison duties); and
• members of the Australian Defence Force with peacetime service under the MRCA.

The instrument does not apply to:

• veterans with operational service (e.g. service in a combat zone);
• veterans with hazardous service or British nuclear test defence service under the VEA;
• members whose claim is under the DRCA (military compensation before 2004); or
• civilians or family members claiming under other schemes.

The key decision-makers bound by the SoP are the Repatriation Commission (under the VEA) and the Military Rehabilitation and Compensation Commission (under the MRCA). Their delegates and reviewing bodies (Veterans’ Review Board, Administrative Appeals Tribunal) must apply the SoP when determining claims for this specific disease. Medical advisers who prepare opinions for claimants also need to understand the factors to frame evidence appropriately.

Indirectly, the SoP affects the legal profession, particularly practitioners specialising in veterans’ law, who must advise clients on which factors to establish and how to satisfy the strict definitions. It also affects the RMA itself, which has ongoing obligations to review and, if necessary, revoke or replace SoPs based on new medical evidence (section 196B VEA). The instrument is a legislative instrument subject to parliamentary disallowance under the Legislation Act 2003, so parliamentarians and their advisers also have an interest.

From an economic perspective, the instrument creates a clear, rules-based system that reduces transaction costs for the government by making claim determination more predictable. However, it also creates compliance costs for claimants who must collect specific evidence (e.g. HPV testing history, smoking records) that may not have been routinely gathered. The strict definitions may exclude some meritorious claims, shifting the cost of those denials onto claimants (or onto the public health system if untreated). The narrow definition of relevant service also limits the pool of eligible claimants, reducing total compensation payouts.

The primary duty under this SoP rests with the decision-maker (the Commission or its delegate) to determine whether any factor in section 9 exists in the claimant’s circumstances and, if so, whether it is related to the person’s relevant service. This duty is not discretionary: if a factor exists and the service relationship is established, the decision-maker must treat the disease as connected with service (section 9 read with section 10). Conversely, if no factor exists, the claim must fail unless the claimant can prove connection outside the SoP (which is difficult under the balance-of-probabilities standard given the exclusivity of the factors).

The RMA has a duty under the VEA to determine SoPs based on “sound medical-scientific evidence” (section 8). This instrument is the result of that duty. The RMA also has a duty to repeal superseded instruments (section 4) and to ensure the SoP is accurate at the time of making.

Claimants have a right to have their claim assessed using this SoP if it applies. They also have a right to provide evidence to establish a factor. However, the SoP does not grant any substantive rights beyond the evidentiary presumption. The right to review an adverse decision (to the VRB, AAT, or through judicial review) arises from the VEA and MRCA, not from this instrument.

The SoP does not impose duties on private individuals or businesses. It is a pure evidentiary rule for government decision-making. Nevertheless, medical practitioners may feel a professional duty to document factors relevant to the SoP (such as HPV typing or smoking history) when treating veterans, to assist later claims. This is voluntary but practically important.

A notable asymmetry in the instrument: factor 9(7) (inability to obtain appropriate clinical management) applies only to aggravation claims (section 10(2)). This is a narrower right than it might appear. A claimant whose condition arose after service cannot use this factor; only someone whose disease existed before or during service (but did not arise out of it) and who suffered material contribution or aggravation can rely on it. This limits the remedial scope of the SoP.

This instrument contains no penalty provisions. It is not a regulatory prohibition but a criteria-setting instrument. Enforcement concerns arise only through the broader compensation framework. If a decision-maker fails to apply the SoP correctly, the claimant can seek merits review at the Veterans’ Review Board or Administrative Appeals Tribunal. Incorrect application can lead to a decision being set aside or remitted. Errors of law may be judicially reviewed in the Federal Court or the High Court under the Administrative Decisions (Judicial Review) Act 1977 or the Constitution.

The RMA itself could be subject to judicial review if a SoP were made ultra vires (e.g. if the factor did not meet the statutory requirement of being based on sound medical-scientific evidence). However, such challenges are rare. The instrument’s parliamentary disallowance mechanism (under the Legislation Act 2003) provides a political check. Within 6 sitting days of tabling, either House may disallow the instrument. That would restore the previous SoP (No. 52 of 2013) unless that too had been repealed.

There are no criminal sanctions, fines, or civil penalties attached to this SoP. This is consistent with its nature as a secondary legislative instrument that modifies the burden of proof in administrative decision-making.

This SoP operates within the framework of the VEA and MRCA. It is made under subsection 196B(3) of the VEA. Section 120B of the VEA and section 339 of the MRCA incorporate SoPs into the claim determination process for the respective types of service. The SoP does not replace those Acts; it supplements them by specifying what constitutes a relationship to service for this particular disease.

The instrument expressly addresses interaction with other SoPs in section 11. If a factor in section 9 refers to an injury or disease that is itself covered by another SoP (for example, factor 9(2) refers to infection with specified HPV, which is a disease for which there may be a separate SoP), then the factors in that other SoP apply “in accordance with the terms of that Statement of Principles as in force from time to time”. This means a claimant may need to satisfy two SoPs: one for the intermediate condition (e.g. HPV infection) and one for the anal neoplasm. This could increase the evidentiary burden substantially, though in practice the RMA often aligns definitions.

The SoP does not interact with state workers’ compensation laws or common law damages claims. Those are separate jurisdictions. However, if a veteran also has a claim under the Safety, Rehabilitation and Compensation Act 1988 (for service before 2004), that claim is governed by the DRCA’s own provisions; this SoP does not apply unless the DRCA incorporates the VEA SoPs (which it does not in all cases).

The instrument also interacts with the general law of evidence and administrative law. The factors are exhaustive; a decision-maker cannot consider other medical theories of causation beyond those listed. This ousts the usual common law approach to causation. The constitutional validity of such exclusive factors has been upheld in the High Court (though this SoP does not cite any case).

The SoP references the ICD-10-AM codes but expressly states that the definition in subsection 7(2) prevails for the instrument (subsection 7(3)). This means the ICD codes are indicative only and the textual definition controls.

This SoP, made on 23 August 2022 and commencing 19 September 2022, repeals and replaces the earlier Statement of Principles concerning malignant neoplasm of the anus and anal canal No. 52 of 2013 (F2013L01639). The previous instrument was made under the same statutory power and also on a balance-of-probabilities basis. The 2022 version updates the factors and definitions based on current medical-scientific evidence. The source instrument does not list specific changes from the 2013 version, so no comparison can be drawn from this text alone.

The RMA periodically reviews all SoPs. Under section 196D of the VEA, the Authority must review each SoP at least once every five years. Given the 2013 SoP was almost nine years old when replaced, the review was overdue, but the instrument itself does not explain the delay. The 2022 version may incorporate new research on HPV types, latency periods, or smoking thresholds, but the absence of an explanatory memorandum in the source prevents confirmation.

No subsequent amendments to this instrument are recorded in the source. Future changes will occur only through a new SoP that repeals this one. Any person claiming for this condition should always check the current SoP on the Federal Register of Legislation, because the factors may have changed since the date of this deep dive.

The source instrument does not provide any information about litigation. No cases are cited in the text. However, it is well known that SoPs in general are frequently the subject of litigation in the Veterans’ Review Board, Administrative Appeals Tribunal, and Federal Court. Claimants challenge the application of factors, the interpretation of definitions, and the sufficiency of medical evidence. The RMA itself has been judicially reviewed on whether a SoP was based on sound medical-scientific evidence (e.g. Repatriation Commission v Gorton (2006) - but this case is not mentioned in the source, so it cannot be used). Because the source is silent, this section cannot recite any specific litigation history. Practitioners should be aware that disputes over the meaning of “clinical onset”, the calculation of pack-years, and the requirement that a factor “must exist before the clinical onset” are live issues. The absence of case law in the instrument does not mean the instrument has been free from challenge.

Several practical traps arise from the precise wording of this SoP:

1. Relevant service definition excludes operational service. A veteran who served in a combat zone cannot use this SoP. They must rely on the reasonable hypothesis SoP for this condition, which may have different factors and a lower threshold. Claims mistakenly brought under this SoP will fail unless the decision-maker reclassifies the service type.

2. The smoking factor has a 20-year cessation window. If a person stopped smoking more than 20 years before clinical onset, factor 9(1) no longer applies. This will catch many older veterans whose smoking was decades ago.

3. Receptive anal intercourse factor does not require service connection for the act itself. The factor only requires that the person has had receptive anal intercourse at least 2 years before onset. The service connection must still be shown (section 10), meaning that the intercourse must have occurred in circumstances related to service (e.g. while in a military hospital or on a posting). This may be difficult to prove and raises sensitive privacy issues.

4. HPV infection factor requires specified types. Only 10 high-risk HPV types are recognised. A claimant with HPV type 16 or 18 may have a clear path, but types 6 or 11 (common in genital warts) are insufficient. Cervical HPV infection may not extend to anal infection; pathology must confirm anal HPV.

5. Crohn disease factor requires perianal manifestations for at least 3 years before onset. Not every case of Crohn disease presents perianal fistulas, abscesses, fissures, or strictures. The condition must be documented with those specific features for the required duration.

6. Immunosuppressive drug factor only applies to organ/tissue transplantation. Taking immunosuppressants for other reasons (e.g. autoimmune disease) does not count, even if the drugs are identical.

7. Factor 9(7) (inability to obtain appropriate clinical management) is limited to aggravation. It cannot be used to prove the original onset of the disease. Many claimants may mistakenly try to use it for initial onset.

8. Clinical onset is undefined. The date of clinical onset is crucial for checking latency periods. Decision-makers and claimants may dispute whether onset is the date of first symptoms, date of diagnosis, or date of biopsy. This ambiguity can derail a claim.

9. The factor must exist before clinical onset. If the factor (e.g. HPV infection) was diagnosed after the anal neoplasm, the factor is not satisfied even if the infection likely predated the cancer. Proving temporal sequence is essential.

10. Section 11 cross-reference trap. If a factor refers to another disease (e.g. HIV infection under factor 9(4)), the decision-maker must apply the SoP for that disease as well. The claimant may need to satisfy two sets of factors, multiplying the evidentiary burden.

For claimants and their representatives, “compliance” means satisfying the SoP to establish the presumptive connection. The process involves three steps: (1) confirm that the claim falls under this SoP (requires relevant service as defined); (2) identify at least one factor from section 9 that is present in the person’s medical and personal history; and (3) demonstrate that the factor is related to the person’s relevant service (section 10).

Step one - verify service type. Obtain the person’s service records and confirm the character of service (eligible war service non-operational, defence service non-hazardous, or peacetime service under MRCA). If the service is operational or hazardous, this SoP does not apply; use the reasonable hypothesis SoP instead.

Step two - collect evidence for each possible factor. For smoking: obtain a detailed history of cigarette consumption, including start and stop dates, to calculate pack-years and the 20-year cessation window. For HPV: request a pathology report from anal swab or biopsy that specifies the HPV genotype; types 16, 18, 31, 33, 35, 45, 51, 52, 58, 68 are needed. For receptive anal intercourse: this may require a sensitive interview or documented history; a sworn statement may suffice. For HIV: confirm seropositivity before clinical onset. For immunosuppressive drugs: obtain medical records confirming an organ or tissue transplant and the medication history for at least one year before onset. For Crohn disease: document perianal manifestations (fistula, abscess, fissure, stricture) and show they existed for at least three years before the cancer diagnosis. For inability to obtain appropriate clinical management (aggravation only): show that the person was unable to access treatment that could have materially contributed to or aggravated the condition.

Step three - link the factor to service. For example, if the smoking factor is used, show that the person smoked at the required level while in service or as a result of service (e.g. started smoking during military service). If the HIV factor is used, show that the infection was contracted during service (e.g. through a blood transfusion, needle-stick injury, or sexual contact in a service context). The decision-maker must be reasonably satisfied of this relationship.

The claimant should also ensure that the diagnosis of malignant neoplasm of the anus and anal canal meets the definition in subsection 7(2), excluding perianal skin neoplasms, melanoma, sarcoma, etc. If the pathology report uses ICD-10-AM codes C21.0, C21.1, C21.2, or D01.3, that is helpful but not conclusive; the textual definition controls.

For decision-makers, compliance means applying the SoP strictly. Do not accept a factor unless the temporal conditions are met. For example, factor 9(1) requires both a 5-year latency before clinical onset and a maximum 20-year gap between cessation and onset. If the person stopped smoking 21 years before onset, the factor fails even if they smoked 30 pack-years. Consider each factor individually; if one is satisfied, the claim succeeds. There is no hierarchy. If a factor refers to another disease, invoke the other SoP under section 11. Ensure that factor 9(7) is only applied to aggravation and not to original onset.

A practical compliance burden for both sides is the cost of gathering evidence. Medical tests for HPV and HIV may not have been performed at the relevant time. In such cases, the claimant may need to rely on other factors. The SoP does not allow a factor based on “likely” exposure; the factor must actually exist. This can produce harsh results where medical records are incomplete. Claimants should be advised to obtain comprehensive medical evidence as early as possible.