Statement of Principles concerning porphyria cutanea tarda (Balance of Probabilities) (No. 70 of 2021)

Porphyria cutanea tarda is defined in section 7(2) of the SoP as a skin disorder resulting from decreased activity of the enzyme uroporphyrinogen decarboxylase in the liver and accumulation of porphyrins in the circulation. Typical clinical manifestations include blistering in sun-exposed areas, hyperpigmentation, and facial hypertrichosis. The ICD-10-AM code E80.1 is assigned to PCT, but the SoP states that the meaning of PCT is that given in the instrument itself, not the ICD code. This is important because ICD codes can change or be interpreted broadly; the instrument’s own definition governs.

The SoP introduces the concept of "relevant service" as 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 deliberate narrowing: it excludes operational and hazardous service. For those categories, a separate SoP under the reasonable hypothesis standard would be used. Therefore, the SoP’s factor sets (9(1)-(21)) only apply where the standard of proof is balance of probabilities and the service is non-operational or non-hazardous.

The factor structure is central. At least one of the listed factors must exist before the condition can be connected to service. The factors are not alternatives in the sense that the decision-maker can choose among them; at least one must be present and related to service. The factors are broken into two groups: onset factors (1-10) and worsening factors (11-21). Worsening factors apply only where the person’s PCT was suffered or contracted before or during (but did not arise out of) the person’s relevant service (section 10(2)). This means worsening can only be claimed if PCT existed pre-service or developed during service from a non-service cause (such as an underlying genetic predisposition). The factor "inability to obtain appropriate clinical management for porphyria cutanea tarda" appears as factor 21 for worsening only, not for onset.

Key definitions in the dictionary include chronic renal failure (glomerular filtration rate less than 15 mL/min/1.73 m2 for at least 3 months, or need for renal replacement therapy, or chronic dialysis), iron overload (accumulation of excess iron confirmed by elevated ferritin or transferrin saturation), specified list of drugs (14 items including carbamazepine, chloroquine, cyclophosphamide, highly active antiretroviral therapy, hydroxychloroquine, imatinib, interferon alpha, iron supplements, oral estrogens, phenobarbital, phenytoin, rifampicin, sulfonylureas, and tamoxifen), and specified list of viral infections (hepatitis B, hepatitis C, and human immunodeficiency virus). These definitions are exhaustive and must be strictly applied.

The SoP directly affects veterans and members of the Forces who have rendered relevant service as defined: eligible war service (non-operational), defence service (non-hazardous), and peacetime service under the MRCA. It does not affect persons with operational or hazardous service for the purposes of balance of probabilities claims, because the SoP only applies to the balance of probabilities standard under sections 120B VEA and 339 MRCA. Operationally deployed personnel and those engaged in hazardous service are likely to rely on the reasonable hypothesis version of the SoP for PCT, which the RMA also issues separately. However, if a person with operational service is making a claim where the standard has shifted to balance of probabilities (for example, because the claim is for aggravation and the disease existed before service), then this SoP could become relevant.

The instrument also affects dependents who claim death benefits. Because the definition of death from PCT includes death contributed to by PCT through a terminal event, a widow or widower may need to establish that PCT materially contributed to the service-related cause of death. That adds an extra layer of proof, but it also potentially broadens the range of acceptable claims if the deceased had PCT and died from a listed terminal event.

Beyond claimants, the SoP imposes obligations on decision-makers in the DVA, the Veterans’ Review Board, and the Administrative Appeals Tribunal. They must apply these factors precisely and must not accept a connection on any ground not listed. They must also apply cross-referenced SoPs under section 11. This creates a compliance burden on the administrative system, as each factor may require medical evidence that meets the definitions. For example, to rely on factor 6 ("having hepatic iron overload at the time of the clinical onset"), the decision-maker must confirm the overload is documented by elevated ferritin or transferrin saturation, not just a clinical suspicion.

Medical professionals providing evidence are also affected. They must understand the specific definitions, particularly for alcohol consumption measured in kilograms and using the Australian Standard of 10 grams per standard drink. The threshold for males is 100 kilograms over 10 years (approximately 10,000 standard drinks, or about 2.74 drinks per day on average) and for females 50 kilograms (about 5,000 standard drinks, or 1.37 drinks per day). A GP who does not record cumulative alcohol intake over a decade may not have adequate evidence, leading to denials or appeals.

Legal practitioners representing claimants must be acutely aware of the distinction between onset and worsening factors, the time windows (e.g., 30 days before clinical onset for drug use, 1 year for hexachlorobenzene ingestion), and the need to satisfy all cross-referenced SoPs. That increases the cost and complexity of preparing a claim, particularly if the factor involves another condition like chronic renal failure or cirrhosis, which have their own detailed SoPs. The economic effect is to raise the effective price of claiming, because the administrative and legal costs of assembling evidence rise with the number of conditions that must be proved.

The SoP itself does not create duties directly. It is a set of diagnostic criteria that the decision-maker must apply. However, it creates a right for claimants to have their PCT claim assessed using these factors. If a claimant can demonstrate that at least one factor exists and is related to their relevant service, then the decision-maker must accept that PCT is connected to service on the balance of probabilities. That is a legal entitlement.

The main duty falls on the decision-maker: to apply the factors exactly as written, including the temporal requirements and definitions. For example, factor 8 requires taking a drug from the specified list within the 30 days before the clinical onset. If a veteran took tamoxifen 35 days before onset, the factor is not met. The decision-maker has no discretion to extend that window. Similarly, factor 9 allows reliance on a drug not on the list if it is associated with onset during therapy and either improvement within 2 months of stopping or tapering, or redevelopment on rechallenge, and the drug was taken for at least 7 days before onset. This is a safety valve for drugs not on the list, but it imposes a strict causation requirement that is often difficult to prove with retrospective medical records.

Section 11 of the SoP imposes an additional duty: if a factor refers to an injury or disease covered by another SoP, the factors in that SoP must also apply. This means the claim is assessed under multiple SoPs simultaneously. For instance, factor 4 is "having cirrhosis of the liver or alcoholic steatohepatitis at the time of the clinical onset of porphyria cutanea tarda." Cirrhosis is itself a condition with its own SoP. The claimant must therefore satisfy the cirrhosis SoP factors in addition to the PCT factor. That multiplies the evidentiary requirements and increases the probability of failure if any one SoP is not satisfied.

The instrument also gives the RMA the authority to determine these factors. Section 8 states the basis: "On the sound medical-scientific evidence available, the Repatriation Medical Authority is of the view that it is more probable than not that porphyria cutanea tarda and death from porphyria cutanea tarda can be related to relevant service." This is the RMA’s statutory opinion, which is not reviewable on its merits; a court can only review it on administrative law grounds such as jurisdictional error or lack of evidence. That limits the ability of claimants to challenge the factor selection itself.

Claimants do have the right to argue that they meet a factor based on the dictionary definitions. For example, chronic renal failure must be proved by a GFR below 15 for 3 months or the need for dialysis or transplantation. A transient reduction would not suffice. The use of defined terms means that lay evidence is usually insufficient; specialist medical reports are essential. The cost of obtaining such reports can be a barrier, especially for veterans on fixed incomes.

The SoP itself does not contain any penalty provisions. It is a criteria-setting instrument, not a penal regulation. Enforcement in the traditional sense does not apply. However, the SoP is enforced indirectly through the claims determination process. If a veteran knowingly provides false information about a factor (e.g., fabricating alcohol consumption records), criminal penalties under the VEA or the Criminal Code could apply. Sections 225 to 229 of the VEA create offences for fraud, false statements, and bribery in relation to claims. The presence of the SoP does not alter those penalties, but it does frame what must be proved, and thus what might be falsified.

The real enforcement mechanism is administrative: the DVA rejects claims that do not satisfy the factors. That rejection can be appealed to the Veterans’ Review Board and then to the Administrative Appeals Tribunal. The AAT conducts merits review, meaning it can substitute its own decision based on the SoP. If the AAT errs in law, judicial review in the Federal Court is available. That court does not remake the merits but can set aside a decision for legal error.

The SoP’s impact on enforcement costs is notable. Because the factors are highly specific (e.g., "consuming a total of at least 100 kilograms of alcohol within the 10 years before the clinical onset"), the DVA must gather evidence on lifetime drinking patterns. This is difficult and expensive. Veterans may not have accurate records of alcohol consumption years earlier. The DVA and claimants must rely on self-reporting, medical records mentioning alcohol use, or collateral evidence from family. This creates uncertainty and potential for disputes. The cost of litigating factual disputes about alcohol intake over a decade can exceed the value of the compensation for PCT, particularly for a skin condition that is often mild and treatable.

The enforcement of the cross-referencing requirement under section 11 also adds complexity. If a decision-maker fails to apply an incorporated SoP, that is an error of law that could be overturned on review. But it also means claimants must be prepared to prove multiple conditions to the same standard. The practical effect is that decisions are more conservative: decision-makers often require explicit medical evidence for each incorporated condition, which lengthens processing times and increases denial rates. The RMA’s own statement in section 8 is not enforceable; it is merely the basis for the factors. No one can directly enforce the RMA’s opinion.

This SoP operates within the VEA and the MRCA. Section 3 of the SoP states it is made under subsection 196B(3) of the VEA. Subsection 196B(3) is the provision that allows the RMA to determine SoPs on the balance of probabilities standard. The SoP applies to claims to which section 120B of the VEA or section 339 of the MRCA applies. Those provisions set out the standard of proof: the claim must be determined to the reasonable satisfaction of the Commission, but the SoP replaces the usual standard with a requirement that at least one factor from the SoP must exist. In effect, the SoP is a code for causation for PCT on the balance of probabilities.

The SoP interacts with other SoPs through section 11. This creates a chain of instruments. For example, if a veteran has cirrhosis and that is relied upon as factor 4 for PCT, then the factor must also satisfy the cirrhosis SoP (which would be, for example, No. XX of 20XX for cirrhosis on the balance of probabilities). The veteran must therefore prove cirrhosis is service-related through its own factors before it can serve as a factor for PCT. This interlocking system means that a veteran with multiple conditions must satisfy multiple SoPs, increasing the likelihood that at least one link fails. This is a deliberate design to ensure consistency across conditions, but it imposes a heavy compliance burden on claimants who often have comorbidities.

The SoP also references the ICD-10-AM classification. Subsection 7(3) says PCT attracts ICD-10-AM code E80.1, but the meaning of PCT is that given in the SoP, not the ICD. This avoids the possibility that future changes to the ICD codes could alter the scope of the SoP. However, it also means that if a veteran has a condition coded as E80.1 but that does not meet the SoP’s definition (e.g., a different porphyria), the SoP will not apply. That precision is a double-edged sword: it prevents scope creep but also may exclude atypical presentations.

The SoP works alongside the VEA’s provisions on standard of proof. Section 120B VEA provides that for non-operational service, the Commission must be satisfied on the balance of probabilities that the condition is related to service. The SoP tells the Commission what must be present to reach that satisfaction. It does not alter the burden of proof, which remains on the claimant to show the factor exists. The interaction is hierarchical: the SoP is subordinate to the VEA but binding in its field.

The MRCA has its own analogous provision (section 339). The SoP applies to both regimes, meaning consistency across the two compensation schemes for PCT claims. However, the definition of "relevant service" under the SoP is tailored to the VEA and MRCA categorisations. Peacetime service under the MRCA is included, but hazardous service and British nuclear test defence service are excluded from "relevant service" under the VEA. This means a veteran with hazardous service who develops PCT cannot use this SoP for a balance of probabilities claim; they must use the reasonable hypothesis version (which may have different factors). The interaction thus creates two tracks: one for non-hazardous service with a lower evidentiary standard but strict factor lists, and one for hazardous service with a looser standard but different factors.

The only amendment history provided in the source is the repeal of the previous SoP. Section 4 states: "The Statement of Principles concerning porphyria cutanea tarda No. 44 of 2012 ... made under subsection 196B(3) of the VEA is repealed." That earlier SoP will have contained its own factor lists, definitions, and commencement date. The current SoP (No. 70 of 2021) commenced on 21 June 2021, replacing the 2012 version. The instrument does not explain the differences between the two, but practitioners should assume that the factors were reviewed based on new medical evidence. The RMA is required to keep SoPs under review and may issue amendments when the underlying evidence changes.

No other amendments are referenced. The SoP has not been amended since its commencement in June 2021. The RMA can amend a SoP by issuing a new instrument that repeals and replaces the old one, as occurred here. There is no provision for partial amendment; SoPs are replaced entirely. Therefore, any future changes to the PCT balance of probabilities SoP will appear as a new instrument with its own number and commencement date. The current instrument remains in force until repealed.

The broader legislative framework has also been subject to amendments. The VEA has been amended many times since its enactment in 1986, and the MRCA since 2004. However, the SoP does not reference those amendments. The key provisions that give the SoP its force, subsection 196B(3) of the VEA and sections 120B and 339, have been in place for years. The SoP is not affected by changes to other parts of the VEA or MRCA unless those provisions are repealed or altered. The RMA’s power to make SoPs under subsection 196B(3) remains unchanged.

Given the frequency of SoP updates, practitioners should verify that they are using the current instrument. The Federal Register of Legislation lists SoPs by number and date. The repealed No. 44 of 2012 is no longer in force; any decisions still based on it would be legally erroneous. The RMA typically updates SoPs every few years as medical evidence evolves. The 2021 version may have refined the alcohol thresholds, added or removed drugs from the specified list, or adjusted definitions based on new research. Without the 2012 text, we cannot compare, but the existence of a new number suggests substantive changes.

The source does not cite any litigation. No cases are mentioned in the instrument itself. That is typical for a Statement of Principles; the RMA does not set out judicial history. However, it is well known in veterans’ law that SoPs are frequently challenged in the Administrative Appeals Tribunal and the Federal Court. Common grounds include whether the RMA correctly applied the "sound medical-scientific evidence" test, whether the factor definitions are lawful, and whether the decision-maker correctly applied the SoP to the facts. The Federal Court in cases such as Repatriation Commission v Deledio (1998) 83 FCR 82 established the framework for applying SoPs, but that case is not cited in this instrument.

For this specific SoP, there is no public record of significant litigation. PCT is a relatively rare condition, and claims may be limited. However, the general principles from challenges to other SoPs apply. Claimants have argued that certain factors are not based on sound medical-scientific evidence, but the Full Federal Court in Repatriation Commission v Gosewinckel (1999) 87 FCR 299 held that the RMA’s decision is unreviewable unless it fails to comply with the Act. The SoP itself is a legislative instrument, and its validity can be challenged only on administrative law grounds, not on the correctness of the medical science.

The AAT routinely applies these SoPs in PCT determinations. Disputes often centre on the interpretation of "clinical onset" versus "clinical worsening", the calculation of alcohol consumption, and whether the veteran has the prerequisite condition (e.g., alcoholic steatohepatitis) as defined. The AAT’s decisions are not published in official law reports, but they appear on AustLII. A search of PCT-related AAT decisions would reveal patterns of reasoning. Typically, the AAT requires precise medical evidence and will not accept self-reporting of alcohol consumption without corroboration.

Given the source’s silence, the most accurate statement is that no specific litigation history is contained in the instrument. Lawyers handling PCT claims should be aware of the general case law on SoPs but cannot rely on any precedent cited in this document. The instrument itself has not been judicially considered, or if it has, that is not part of the public record attaching to this instrument number.

Several features of this SoP are easy to overlook but can be fatal to a claim. The most significant is the distinction between onset and worsening factors in section 9 and the application provision in section 10(2). Worsening factors (11 to 21) apply only "where the person’s porphyria cutanea tarda was suffered or contracted before or during (but did not arise out of) the person’s relevant service." This means if a veteran developed PCT during service and the service caused it, only the onset factors apply. If the PCT existed before service or developed during service but from a non-service cause, then worsening factors might apply. This creates a trap: if the claim characterises the condition as "worsened" but the evidence shows it actually arose out of service, the claim should be assessed under onset factors. Using the wrong factor set can lead to error.

Another gotcha is the alcohol consumption thresholds and the note. The thresholds are 100 kilograms for males and 50 kilograms for females over the 10 years before clinical onset or worsening. The note states that alcohol consumption is calculated using the Australian Standard of 10 grams per standard drink. That means 100 kilograms equals 10,000 standard drinks. Over 10 years (3,652 days excluding leap days), that averages about 2.74 drinks per day. That is not a high threshold; many moderate drinkers would exceed it. However, the burden is on the claimant to prove cumulative consumption over a decade. If medical records do not consistently record alcohol intake, it may be impossible to establish. Even self-reporting may be challenged. The factor does not require alcohol dependence, only cumulative consumption. That is a relatively low bar, but the evidence must still meet the balance of probabilities.

The specified list of drugs includes several common medications: iron supplements, oral estrogens, tamoxifen, and sulfonylureas. Many veterans take iron supplements for anaemia, or tamoxifen for breast cancer. A veteran who took oral estrogens (e.g., hormone replacement therapy) within 30 days before PCT onset can potentially link their condition to service if the estrogen was taken for a service-related condition. But note that the drug must be from the list, and the 30-day window is strict. Any gap beyond 30 days and the factor cannot be used unless factor 9 (drug not on list with improvement on cessation) is satisfied. Factor 9 requires both an association with onset during therapy and improvement within 2 months of stopping or taper, or recurrence on rechallenge, plus at least 7 days of use. That is a high evidentiary bar.

The hexachlorobenzene food contamination factor (10 and 20) is extremely rare and likely relates to historical incidents such as the 1950s Turkish outbreak. It will rarely be applicable in modern Australian veteran claims. Its inclusion is a legacy of medical literature, but it adds little practical value.

The cross-referencing in section 11 is a major trap. If a veteran relies on the factor "having cirrhosis of the liver", the decision-maker must apply the cirrhosis SoP. That SoP will have its own factor list, which may include different requirements (e.g., hepatitis C exposure, alcohol intake thresholds). The veteran might succeed on the PCT factor but fail on the cirrhosis SoP, resulting in a denial. This layered proof increases the likelihood of failure. Legal practitioners must check all incorporated SoPs.

Finally, the definition of "relevant service" is narrow. It excludes operational service and hazardous service. A veteran who served in a combat zone (operational service) who develops PCT cannot use this SoP for a balance of probabilities claim. Instead, the reasonable hypothesis SoP applies, which may have different factors that are less onerous or more onerous. Using the wrong version leads to incorrect application. Practitioners must confirm the claimant’s service type before applying this instrument.

Compliance with this SoP is not a matter of following a set of rules; it is about satisfying the decision-maker that at least one factor exists and is related to service. For veterans and their representatives, the first step is to identify which service category applies. If the veteran had eligible war service (non-operational), defence service (non-hazardous), or peacetime service under the MRCA, this SoP is relevant. If the service is operational or hazardous, do not use this version.

Next, collect evidence to address the most plausible factors. Alcohol consumption (factors 1 or 2 for males/females) is the most common. The veteran should gather any records that show alcohol intake over the 10 years before onset or worsening: medical records, hospital notes, questionnaires, or self-report diaries. The DVA often expects corroboration, such as statements from spouses or evidence of alcohol-related illnesses (e.g., fatty liver). Because the threshold is moderate, many veterans will have consumed enough, but proving cumulative intake is the challenge. A sworn statement detailing typical drinking patterns over the decade may suffice if consistent.

If the veteran has a diagnosis of alcohol use disorder, cirrhosis, chronic renal failure, hepatic iron overload, or a listed viral infection, medical records confirming these conditions at the time of onset or worsening must be obtained. For chronic renal failure, the definition requires either a GFR below 15 for three months, or the need for renal replacement therapy. A single low GFR reading does not suffice. The timing is critical: the condition must exist at the time of clinical onset or worsening, not after. For viral infections, a positive serology for hepatitis B, C, or HIV at the relevant time is needed.

Drug factors require a detailed medication history. The specified list includes 14 drugs. If the veteran was taking any of those within 30 days of onset or worsening, and the medication was related to service (e.g., prescribed for a service-related condition), that factor may apply. The 30-day window is strict; if the drug was taken 31 days before, it does not count. For drugs not on the list, factor 9 or 19 requires proof of a temporal association and improvement on cessation or rechallenge. This is medically intensive and rarely provable without a specialist opinion.

Hexachlorobenzene contamination is niche; if the veteran served in areas with known contamination (e.g., certain agricultural areas in Turkey during the 1950s), they may attempt it, but for most Australian veterans, this factor can be ignored.

If the veteran cannot satisfy any factor for onset, the claim may be framed as worsening of pre-existing PCT. That requires onset factors to be irrelevant (PCT pre-existed or arose from a non-service cause during service) and at least one worsening factor (11-21) to exist. The evidence must show that the PCT was present before or during service but not caused by service. Then a factor such as increased alcohol consumption during service, or a new viral infection, triggered worsening. The temporal windows for worsening factors are similar to those for onset.

If the claim relies on a factor that is a disease (e.g., cirrhosis, chronic renal failure, hepatitis C), the claimant must also satisfy the SoP for that disease. Obtain a copy of the current SoP for that condition and ensure its factors are met. This may require additional medical evidence.

Finally, for death claims, the claim must show that PCT existed and contributed to a terminal event from the list. Documentation of the terminal cause of death and evidence linking PCT to that cause (e.g., PCT leading to liver failure resulting in cardiac arrest) must be provided.

Given the complexity, legal and medical practitioners should work together. The DVA may accept claims on the papers if evidence is strong, but many PCT claims will require a hearing. The cost-benefit analysis is important: PCT is usually manageable with sun avoidance and phlebotomy; the disability rating may be modest. The expense of obtaining specialist reports, forensic alcohol analysis, and possibly appealing may exceed the value of the pension. Claimants should weigh that before embarking on a full claim.