Statement of Principles concerning hepatitis C (Reasonable Hypothesis) (No. 13 of 2018)

Reasonable hypothesis standard. This SoP is expressly stated to be for the “Reasonable Hypothesis” standard, which is the lower evidentiary threshold applicable to claims under section 120A of the VEA. It is distinct from the “balance of probabilities” standard used for other claims. The SoP does not require proof of causation; only that a hypothesis is reasonable and not contrary to proved facts. However, the SoP sets a gatekeeping function: if no factor in section 9 exists, the hypothesis cannot be reasonable.

Hepatitis C. Defined in section 7(2) as infection with the hepatitis C virus resulting in either an acute clinical illness with laboratory confirmation, or a chronic infection of at least six months duration with nucleic acid confirmation. The instrument specifically states that while the condition attracts ICD‑10‑AM codes B17.1 or B18.2, the SoP’s own definition controls, not the coding. Death from hepatitis C includes death from a terminal event (pneumonia, respiratory failure, cardiac arrest, circulatory failure or cessation of brain function) that was contributed to by the person’s hepatitis C.

Relevant service. Defined in the Schedule as operational service, peacekeeping service, hazardous service, or British nuclear test defence service under the VEA, or warlike or non‑warlike service under the MRCA. This is the set of service types that can trigger the SoP. It excludes peacetime service under the VEA that is not operational.

Being exposed to the hepatitis C virus. A key defined term requiring percutaneous (intravenous, intramuscular, subcutaneous or intradermal) or permucosal exposure to a specified body substance derived from a person infected with hepatitis C virus, or a tissue or organ transplant from an infected person. “Specified body substance” means blood, blood products or any body fluid containing blood, or semen or vaginal secretions. This definition is narrower than casual contact or environmental exposure.

Alcohol consumption thresholds. The SoP uses kilograms of pure alcohol, not standard drinks. For females, the threshold is at least 55 kg within the ten years before clinical worsening; for males, 70 kg. The note states that alcohol consumption is calculated using the Australian Standard of ten grams of alcohol per standard alcoholic drink. That equates to 5,500 standard drinks for females and 7,000 for males over ten years, or roughly 10.5 and 13.4 standard drinks per week respectively. The use of weight‑based threshold rather than standard drinks is a potential source of miscalculation.

Pack‑years of cigarettes. The definition in the Schedule calculates one pack‑year as 20 tailor‑made cigarettes per day for one year, or 7,300 cigarettes, equating to 7.3 kg of smoking tobacco. The factor requires at least 15 pack‑years within the 20 years before clinical worsening.

Obesity. Defined as Body Mass Index of 30 or greater, sustained for at least five years before clinical worsening.

Iron overload. Defined as an accumulation of excess iron in tissues and organs confirmed by elevated ferritin or transferrin saturation levels, with a note that causes include haemochromatosis or blood transfusions.

Schistosomiasis. Chronic infection involving the liver before clinical worsening.

The instrument directly affects veterans, members of the Peacekeeping Forces, members of the Forces under the VEA, and members under the MRCA who have relevant service and who suffer from hepatitis C or who die from that condition. It also affects their dependants if a death claim is made. The factors apply to both initial onset of the disease (only factor 9(1) appears able to support an onset claim, because section 10(2) limits factors 9(2) to (4) to material contribution to or aggravation of hepatitis C that was suffered or contracted before or during, but did not arise out of, relevant service) and to worsening of pre‑existing hepatitis C (factors 9(2) to (4)).

Indirectly, the SoP affects decision‑makers within the Department of Veterans’ Affairs and the Military Rehabilitation and Compensation Commission, who must apply it when assessing claims. It also affects medical practitioners who provide evidence for claims, as they must understand the defined terms and the specific criteria. Veterans’ advocates and lawyers must advise clients on whether any factor can be established, and whether that factor is related to service. The SoP also affects the Administrative Appeals Tribunal and the courts if a claim is reviewed, as the instrument constrains the scope of evidence that can be considered to raise a reasonable hypothesis.

Because the SoP is exhaustive in the sense that it lists the minimum factors, claimants who cannot fit within any factor are effectively barred from having a reasonable hypothesis accepted, regardless of other circumstantial evidence. This is a significant limitation on the ability to claim. The instrument also indirectly affects the Repatriation Medical Authority itself, which must periodically review and update SoPs. The revocation of the 2008 SoP means that claims assessed after 29 January 2018 must be determined under this newer version, which may have different thresholds and definitions.

The SoP does not impose duties on individuals. It is an instrument that governs administrative decision‑making. The key duty is on the decision‑maker (the Repatriation Commission or the MRCC) to apply the SoP correctly when determining whether a reasonable hypothesis exists. The decision‑maker must accept that a reasonable hypothesis has been raised if at least one factor in section 9 exists and is related to relevant service, unless the hypothesis is contrary to proved facts.

Claimants have the right to present evidence that a factor exists. They do not have to prove causation, only that the hypothesis is reasonable. The SoP gives claimants a clear set of avenues to pursue: exposure (factor 1), co‑infection with other hepatitis viruses (factor 2), a list of chronic infection‑specific worsening factors (factor 3), or inability to obtain appropriate clinical management (factor 4). Claimants are entitled to have the decision‑maker consider whether the factor is related to service under section 10.

Claimants also have the right to rely on section 11, which incorporates other SoPs if a factor refers to an injury or disease covered by another Statement of Principles. For example, factor 9(3)(a) refers to infection with human immunodeficiency virus. That factor cannot be established unless the claimant also meets the SoP for HIV (if one exists). This cross‑reference right is a double‑edged sword: it may allow a chain of factors, but it also imposes additional evidentiary burdens.

The instrument does not give any right to compensation or treatment; it is merely a step in the claims process. The right to have a claim assessed under the reasonable hypothesis standard is found in the VEA and MRCA, not in this SoP. The SoP constrains that right by prescribing the minimum factors. If no factor exists, the claim cannot succeed under the reasonable hypothesis path; the claimant may then need to rely on the higher “balance of probabilities” standard (if applicable) or on other provisions.

This instrument contains no penalty provisions. It is not a penal instrument; it is a determination of medical‑scientific factors. Enforcement is indirect: a decision‑maker who fails to apply the SoP may have the decision set aside on review. There are no fines or criminal sanctions for non‑compliance with the SoP itself.

However, penalties under the VEA and MRCA may apply to claimants who provide false or misleading information in support of a claim, but that is not within the scope of this SoP. The SoP does not create any statutory offence.

Enforcement of the SoP occurs through the administrative review system. If a claim is rejected because the decision‑maker erred in applying the SoP, the claimant may seek review by the Veterans’ Review Board, the Administrative Appeals Tribunal, or the Federal Court. The Tribunal or court can determine whether the decision‑maker properly applied the factor definitions and the relationship requirement. The SoP is a binding legislative instrument, so it has the force of law. A decision that misapplies the SoP would be legally erroneous.

The Authority itself is subject to no penalty for determining an SoP that is later found to be invalid, though such a finding could lead to revocation or amendment. The practical enforcement of the SoP is thus through the claims and review process, not through any direct enforcement mechanism.

The SoP is made under subsection 196B(2) of the VEA and applies to claims under section 120A of the VEA and section 338 of the MRCA. It does not interact with general workers’ compensation schemes, the National Disability Insurance Scheme, or Medicare. It is specific to the military compensation framework.

Section 11 provides an important interaction with other Statements of Principles. If a factor in section 9 refers to an injury or disease covered by another SoP (for example, human immunodeficiency virus, hepatitis B, obesity, or iron overload), then the factors in that other SoP must also be satisfied. This creates a chain of SoPs: to establish factor 9(3)(a) (HIV infection before worsening), the claimant must also meet the SoP for HIV as it relates to relevant service. This interaction can significantly complicate a claim, as multiple SoPs may need to be satisfied, each with its own set of factors and definitions.

The SoP also interacts with the International Statistical Classification of Diseases (ICD‑10‑AM) Tenth Edition, but only for coding purposes. Section 7(3) makes clear that the SoP’s own definition of hepatitis C prevails over the ICD code. This avoids confusion where a medical certificate uses a broader coding.

The instrument does not interact with state or territory health laws. It is a Commonwealth legislative instrument, so it prevails over inconsistent state laws by virtue of the VEA. It does not create any rights or obligations under the Privacy Act or the Health Records Act, though medical records will be used in assessing claims.

The SoP also interacts with the concept of “terminal event” defined in the Schedule. That definition is used for death claims and includes common causes like pneumonia or cardiac arrest. This means that even if the death certificate lists a terminal event unrelated to hepatitis C, if hepatitis C contributed, the SoP may apply. The interaction is with the usual legal causation rules: contribution is sufficient.

The instrument recites that it revokes the Statement of Principles concerning hepatitis C No. 54 of 2008, which was also made under subsection 196B(2) of the VEA. The earlier SoP was determined in 2008. This SoP, No. 13 of 2018, was made on 22 December 2017 and commenced on 29 January 2018.

The source does not provide the text of the earlier SoP, so differences cannot be identified from this instrument alone. However, the change in commencement date and the new factor list indicates that the Authority updated the medical‑scientific evidence and revised the factors. The 2008 SoP is likely to have had similar factors, but with possible changes to alcohol thresholds, smoking pack‑year requirements, and the definition of exposure.

The instrument does not list any intermediate amendments between 2008 and 2018. It appears that the 2008 SoP remained in force for nearly ten years. The 2018 SoP may itself be subject to future revocation or amendment. The Authority’s practice is to review SoPs periodically in light of emerging medical evidence. No subsequent amendment to this SoP is recorded in the source.

The revocation of the earlier SoP is automatic upon commencement of this one. Claims lodged after 29 January 2018 must be assessed under this SoP. Claims lodged before that date but not finally determined may be subject to transitional provisions in the VEA, but this instrument does not address that. The effective date is clear: 29 January 2018.

The source does not refer to any litigation. The instrument itself is not a court decision. However, it is a legislative instrument that can be challenged on grounds such as jurisdictional error (e.g., the Authority exceeded its power under s196B(2)) or unreasonableness. The Authority’s determinations have been the subject of litigation in the Federal Court and the High Court in other contexts, but no specific case involving this SoP is mentioned in the source.

The reasonable hypothesis standard itself has been litigated extensively under the VEA. The High Court’s decision in Bushell v Repatriation Commission (1992) 175 CLR 408 established the three‑stage test for a reasonable hypothesis, but that case predates this SoP and is not referenced in the source. Without source reference, we cannot use it.

In practice, individual claimants may have challenged decisions made under the 2008 SoP, and those challenges may continue under the 2018 SoP. But the source is silent. Therefore, no specific litigation history can be reported from this instrument. The cautious statement is that the instrument is open to judicial review, but no cases are referenced in the text.

Several traps in the instrument can catch unwary claimants, advocates, and decision‑makers.

Exposure definition is restrictive. Factor 9(1) requires that the exposure be to a specified body substance derived from a person infected with hepatitis C virus. “Derived from a person infected” means the source of the blood or fluid must have been infected. It is not enough to show a potential exposure like a needlestick injury in a medical setting without proof the source was HCV‑positive. For historical claims, that proof may be impossible. The definition also requires percutaneous or permucosal exposure; skin contact with intact skin is not covered.

Only factor 9(1) can support clinical onset. Section 10(2) states that factors 9(2) to (4) apply only to material contribution to, or aggravation of, hepatitis C where the person’s hepatitis C was suffered or contracted before or during (but did not arise out of) relevant service. This means that if a veteran contracted hepatitis C for the first time during service, the only factor that can raise a reasonable hypothesis is factor 9(1) (exposure at least one week before onset). The other factors cannot be used for initial onset. Claimants sometimes try to use alcohol consumption or obesity to explain onset, but those factors are explicitly limited to worsening.

Alcohol consumption measured in kilograms, not drinks. The thresholds are 55 kg for females and 70 kg for males over ten years. Many people are unaware of the conversion. One standard drink contains 10 g of alcohol. So 55 kg = 5,500 standard drinks over ten years, or 1.5 drinks per day on average. That is not a high threshold; many regular drinkers would exceed it. But the calculation must be done in kilograms, not drinks. And the consumption must be “within the ten years before the clinical worsening”, which is a period, not a lifetime cumulative.

Smoking pack‑years calculation. 15 pack‑years within 20 years before worsening. A pack‑year is defined as 20 tailor‑made cigarettes per day for one year, or 7.3 kg of tobacco. This is not the same as the medical definition (often 20 cigarettes per day for one year). The instrument specifies 7,300 cigarettes per pack‑year. If a person smoked roll‑your‑own cigarettes, the conversion to weight must be done.

Interplay with other SoPs. Section 11 means that to establish factors like HIV infection or hepatitis B infection, the claimant must also satisfy the SoP for that condition. That SoP will have its own factors and relationship requirements. This can create a cascade of evidentiary burdens.

“Inability to obtain appropriate clinical management” is limited. Factor 9(4) is a catch‑all, but it applies only to worsening under section 10(2). It also requires that the inability be related to service. For example, if a veteran was posted to a remote area where HCV treatment was unavailable, that might be relevant. But it is not an open‑ended ground; the inability must be due to service circumstances, not personal choice.

Terminal event definition. Death from hepatitis C includes death contributed to by a terminal event. The list includes pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function. If a person dies of a cause not on the list, the instrument does not say it is excluded, but the definition of “terminal event” is limited to those five causes. So if the death is from, say, liver failure directly due to HCV, that would be covered as a direct result, not a terminal event. The definition of “hepatitis C” in section 7(5) simply says includes death from a terminal event contributed to by hepatitis C. So a direct death from HCV cirrhosis would still be captured.

Compliance with this SoP is not about following a set of rules; it is about understanding how to use it in a claim. For a claimant or advocate, the first step is to identify whether the claim involves hepatitis C and whether the reasonable hypothesis standard applies. If the claim is under section 120A of the VEA (operational service) or section 338 of the MRCA (warlike or non‑warlike service), the SoP is relevant. If the claim is under the balance of probabilities standard, this SoP may still be used but is not the sole pathway.

Next, determine whether the claim is for clinical onset or clinical worsening. For onset, the only available factor in section 9 is factor (1): exposure to the hepatitis C virus at least one week before onset. For worsening, any factor in section 9 can apply.

For factor (1), gather evidence of percutaneous or permucosal exposure to a specified body substance from a person infected with HCV. That could be a blood transfusion before 1990, needlestick injury, or sexual contact with an infected partner. The exposure must be documented and the infected status of the source must be proven or at least plausibly established. Medical records, service records, and witness statements may help.

For worsening factors, collect evidence of the specific condition: documentation of infection with hepatitis A, B, D, or E; HIV serology; organ transplant details; rituximab treatment records; alcohol consumption history (in kilograms, not just standard drinks); smoking history in pack‑years; evidence of obesity (BMI of 30 or greater) for at least five years before worsening; iron overload confirmed by ferritin or transferrin saturation; or schistosomiasis with liver involvement.

For alcohol and smoking, careful calculation is critical. Use the formulas in the Schedule: for alcohol, multiply the total number of standard drinks over the ten‑year period by 10 to get grams, then divide by 1,000 to get kilograms. Ensure the consumption occurred within the period immediately before worsening.

For each factor, also establish the relationship to service under section 10. That requires a causal or contributory link between the factor and the person’s relevant service. For example, alcohol consumption may relate to service if it was caused by the stress of operational duties. Smoking may relate if the veteran started or increased smoking due to service conditions. Obesity may relate if service‑related injury reduced mobility.

If the factor refers to another injury or disease (e.g., HIV), section 11 requires compliance with the SoP for that condition. Obtain that SoP and apply its factors.

Finally, if none of the factors can be established, the reasonable hypothesis cannot be raised under this SoP. The claimant may then need to argue that the SoP is invalid or that the claim should be assessed under the balance of probabilities standard. Legal advice should be sought. The SoP itself does not provide an appeal mechanism, but the decision can be reviewed through the Veterans’ Review Board or the Administrative Appeals Tribunal.