Statement of Principles concerning alpha-1 antitrypsin deficiency (Balance of Probabilities) (No. 34 of 2023)

The Statement structures its approach around a series of definitional and causal concepts that determine when alpha-1 antitrypsin deficiency may be considered related to a person’s service for the purposes of the VEA/MRCA claims processes.

Alpha-1 antitrypsin deficiency is defined narrowly for the instrument’s purposes as a genetic disorder of plasma protein metabolism involving reduced serum levels of alpha-1 antitrypsin (s 7(2)). The Statement notes common clinical manifestations, including emphysema and cirrhosis of the liver, but the operative definition focuses on the genetic disorder and reduced serum levels. The Statement also treats death from alpha-1 antitrypsin deficiency as including deaths where a terminal event or condition was contributed to by the deficiency (s 7(3)). The Schedule supplies a list of examples of terminal events (pneumonia, respiratory failure, cardiac arrest, circulatory failure, cessation of brain function) (Schedule 1).

Causation and standard of proof: the RMA records it is of the view, on the sound medical‑scientific evidence available, that it is more probable than not that alpha-1 antitrypsin deficiency and associated death can be related to relevant service (s 8). Operationally, however, the Statement establishes that before a service connection can be accepted on the balance of probabilities, at least one of the prescribed factors in s 9 must exist. That means the RMA uses a two-step approach,first the general scientific view (s 8), then an evidentiary gate constituted by specified factors (s 9).

The two factors that may provide the necessary link are (1) a smoking exposure quantified as at least 5 pack‑years before clinical worsening of the condition; and (2) inability to obtain appropriate clinical management for the condition (s 9). The Schedule defines a pack‑year, sets out examples and converts other tobacco forms to cigarette-equivalents, which is material both to the calculation of the 5 pack-year threshold and to evidentiary assessment (Schedule 1). The Statement limits the application of those factors to material contribution or aggravation where the person’s alpha-1 antitrypsin deficiency was suffered or contracted before or during (but did not arise out of) relevant service (s 10(2)). Finally, where a factor refers to an injury or disease already covered by another Statement, the other Statement’s factors apply in accordance with that Statement as in force from time to time (s 11).

Terminology choices matter. The instrument defines "relevant service" in the Schedule with precise subcategories drawn from the VEA and MRCA regimes: 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 (Schedule 1). The exclusions expressed by the parenthetical qualifiers are part of the definition and therefore affect which service histories will be assessed under this Statement.

Primary subjects: The Statement directly affects persons making claims under the Veterans' Entitlements Act 1986 and the Military Rehabilitation and Compensation Act 2004 where those claims fall within section 120B of the VEA or section 339 of the MRCA (s 5). That typically means veterans and members of the Forces whose disease onset, clinical worsening, or death is asserted to be connected to "relevant service" as defined in the Schedule. The Schedule’s definition of relevant service delimits those service categories that this Statement is designed to cover (Schedule 1).

Decision-makers and administrators: The Repatriation Medical Authority is the instrument-maker under s 196B(3) of the VEA and provides the medical-scientific scaffolding that Department of Veterans’ Affairs decision-makers and any other administrative bodies use when determining causation in applicable claims. The Statement thus affects DVA medical assessors and claims officers who are required to apply Statements of Principles when assessing causation on claims that fall within the specified statutory provisions.

Medical practitioners and evidence providers: While the Statement does not itself prescribe clinical practice, it creates evidential benchmarks that treating clinicians and expert witnesses will be asked to address. For example, the 5 pack-year threshold requires smoking history quantification; the inability to obtain appropriate clinical management will be confronted by records or practitioner statements about access to care. The Schedule’s conversion rules for tobacco types (e.g. 7,300 grams of smoking tobacco as an equivalent to one pack‑year) affect how clinical histories are quantified (Schedule 1).

Indirectly affected parties: Families and estates of deceased persons are affected to the extent that the Statement’s inclusion of death caused or contributed to by alpha-1 antitrypsin deficiency (s 7(3)) informs decisions about entitlement to death-related benefits under the VEA/MRCA processes. The Statement’s cross-reference mechanism (s 11) means that claimants with co-morbid conditions or overlapping injuries/diseases will be routed to the applicable Statement(s) of Principles where relevant factors are addressed.

Excluded or differently treated groups: The Schedule’s framing of relevant service,excluding "operational service" within eligible war service and excluding "hazardous service" and "British nuclear test defence service" within defence service,affects which veterans’ service records fall within this Statement’s operation. That means some categories of service may be outside the intended application of this Statement, and such service histories may be assessed under different Statements or statutory pathways.

Temporal populations: The instrument repeals the prior Statement No. 30 of 2015 (s 4). Consequently, claims that are assessed after the new Statement’s commencement date (23 May 2023) will be assessed under the new Statement. The instrument does not itself state transitional arrangements, but the repeal and commencement mechanism means practitioners must check which Statement was in force at the relevant time for the claim.

This Statement operates primarily as an evidentiary and causation framework rather than as a statute that imposes direct duties or grants stand-alone rights. Nevertheless, it creates clear operational duties for decision-makers and indirect duties for claimants as parts of the statutory claim processes.

Duty on decision-makers to apply the Statement: Where a claim is one to which section 120B of the VEA or section 339 of the MRCA applies, administrative decision-makers must apply Statements of Principles when forming views about whether an injury, disease, or death is connected with service. This Statement provides the medical factors that decision-makers are to apply for alpha-1 antitrypsin deficiency; that is the instrument’s functional duty. The Authority’s recorded view that it is more probable than not that the disease can be related to relevant service (s 8) supplies the medical-scientific premise, but operational determinations depend on whether the prescribed factors (s 9) and relationship-to‑service rules (s 10) are satisfied in the individual case.

Duty to demonstrate at least one factor: The Statement requires that at least one of the factors in s 9 exist before a connection may be accepted on the balance of probabilities. This creates a practical duty on claimants to produce evidence addressing those factors, and a corresponding duty on decision-makers to seek and evaluate such evidence. The two factors are a quantified smoking history of at least 5 pack‑years before clinical worsening, or inability to obtain appropriate clinical management.

Duty to link factors to relevant service: Section 10(1) requires that any factor in s 9 be related to the person’s relevant service. Section 10(2) further constrains the factors in s 9 to situations of material contribution or aggravation where the person’s alpha-1 antitrypsin deficiency was suffered or contracted before or during (but did not arise out of) the person’s relevant service. That places a temporal and causal condition on the applicability of the factors as they operate to establish material contribution or aggravation.

Cross‑Statement application: Section 11 imposes a duty of coordination: if a factor in s 9 refers to an injury or disease already covered by a different Statement of Principles, the factors in that other Statement apply in accordance with its terms. Decision-makers must therefore identify overlap and apply the other Statement as in force when assessing causation.

Rights for claimants within statutory processes: The Statement’s role is to supply the medical framework that must be used in assessing the claim. Practically, a claimant has the right to have their claim assessed against the Statement that is in force for their claim’s timeframe. The Statement does not itself articulate appeal rights, but those rights arise from the governing statutes (VEA and MRCA) and administrative law remedies; they are not restated here.

No penal provisions: The Statement contains no provisions that impose fines, offences, or other penal sanctions. Its legal effect is to inform entitlement determinations within the VEA/MRCA claims architecture rather than to create independent statutory liabilities.

The instrument contains no penal or criminal provisions and does not establish direct enforcement mechanisms of the kind found in regulatory statutes. Its function is to set the medical-scientific criteria used as the basis for determining whether alpha-1 antitrypsin deficiency, or death from it, is connected with relevant service. Enforcement in a conventional regulatory sense therefore does not arise within this instrument.

Operational enforcement is indirect and administrative. The Statement is made under subsection 196B(3) of the Veterans' Entitlements Act 1986 (s 3), and it applies to claims to which s 120B of the VEA or s 339 of the MRCA applies (s 5). Enforcement of the Statement’s effect occurs through the administrative processes provided in the VEA and MRCA: Departmental officers, decision-makers and medical assessors must apply the Statement when forming causation findings in eligible claims. Where decision-makers fail to apply the Statement correctly, remedy would be sought through the statutory review and appeal mechanisms established by the VEA or MRCA and through ordinary administrative law channels; however, the instrument itself does not specify appeal or review procedures.

The Statement empowers the Repatriation Medical Authority to set medical criteria; it does not grant powers to compel medical practitioners to provide particular evidence or to impose sanctions for non‑cooperation. Nor does the Statement prescribe investigatory or compliance inspection powers. Any action to enforce the production of medical evidence or service records will derive from other statutory powers outside this instrument.

The instrument’s repeal of the previous Statement (s 4) is itself an administrative action with legal effect: claims assessed after 23 May 2023 must be considered against the new Statement. The practical implication for enforcement is that decision-makers must ensure they apply the correct Statement that is in force at the relevant time. Failure to do so could be challenged in review processes, but such procedural consequences and remedies are governed by the VEA/MRCA frameworks, not by the Statement text.

This Statement is explicitly crafted to operate within the statutory architecture of the Veterans' Entitlements Act 1986 and the Military Rehabilitation and Compensation Act 2004. The instrument’s authority, application, and cross-reference clauses create a defined relationship with those statutes and with other Statements of Principles made under the same statutory mechanism.

Statutory authority and application: The instrument is made under subsection 196B(3) of the VEA (s 3). Section 5 states it applies to claims to which s 120B of the VEA or s 339 of the MRCA applies. Those references embed the Statement into the decision-making processes of the respective Acts,where those Acts require the application of Statements of Principles to establish causation or service connection, this instrument is the relevant medical standard for alpha-1 antitrypsin deficiency claims that fall within the specified claim provisions.

Interaction with other Statements of Principles: Section 11 provides a mechanism for coordination between Statements. If a factor in s 9 refers to an injury or disease that is itself the subject of another Statement of Principles made under subsection 196B(3) of the VEA, then the factors in that other Statement apply as that Statement is in force. That means overlapping or comorbid conditions are governed by the applicable Statements as they stand at the time of assessment, and decision-makers must apply the other Statements’ criteria in addition to, or instead of, criteria in this instrument where relevant.

Definitions and statutory terms: The Schedule supplies definitions that the Statement uses, including MRCA, VEA, terminal event, one pack-year, and relevant service. The Schedule’s definition of relevant service draws on terminology found in the VEA and MRCA but narrows or excludes certain categories by express parenthetical qualifiers (e.g., eligible war service other than operational service) (Schedule 1). That produces a direct interaction: a person’s actual service descriptor under the VEA or MRCA will determine whether the Statement applies to their claim.

Temporal interaction through repeal and commencement: The instrument repeals the prior Statement No. 30 of 2015 (s 4) and commences on 23 May 2023 (s 2). Practitioners must therefore consider which Statement was in force at the time of the relevant events and at the time of claim lodgement and decision. The instrument does not itself specify transitional provisions beyond the repeal; thus the interaction with earlier Statements is effected by the repeal and the general operation of the VEA’s rules regarding Statements of Principles.

No conflict with criminal or regulatory law in the instrument: This Statement does not create duties that would intersect with criminal law, industrial regulations, or other regulatory regimes. Its sole legal function is to provide the medical factors applied in statutory claims processes under the VEA and MRCA.

The instrument itself contains only limited amendment history within its text: it explicitly repeals the earlier Statement of Principles concerning alpha-1 antitrypsin deficiency No. 30 of 2015 (Federal Register of Legislation No. F2014L01840) (s 4). The current Statement is numbered No. 34 of 2023 and is dated 24 April 2023 on the face of the instrument; it is set to commence on 23 May 2023 (cover sheet; ss 1-2). The Repatriation Medical Authority’s seal and the Chairperson’s name appear on the instrument, evidencing formal execution.

There are no further amendments, schedules of prior amendments, or historical notes contained in the text beyond the direct repeal. The instrument does not include transitional provisions about how claims in progress are to be handled at the moment of repeal and replacement; it simply states the new Statement’s commencement date and repeals the previous instrument. Practitioners therefore must infer that after 23 May 2023 the new Statement is in force and the old Statement is no longer operative, unless other statutory transitional provisions in the VEA or MRCA apply (those are not set out here).

No versioning history or amendment log beyond the 2015 Statement’s repeal appears in the provided text. The instrument contains a Schedule of definitions that operationalise certain terms; future amendments to the Statement would be reflected by new instruments made under subsection 196B(3) but none are recorded within this document.

The instrument contains no record of litigation. It names no judicial decisions, appeals, or tribunal determinations. There are no citations to case law within the text. The Repatriation Medical Authority’s Statement is an administrative instrument serving as medical‑scientific guidance for decision-makers under the VEA and MRCA, and any litigation or tribunal appeals that arise from decisions applying this Statement would be found in external sources, not in this instrument. As a result, the instrument itself provides no litigation history to analyse.

Practitioners seeking to understand how decision-makers’ application of this Statement fares in review or appeal forums will need to consult decisions of relevant administrative tribunals and courts arising after the Statement’s commencement. The Statement’s text does not provide guidance about how particular evidence should be weighed in specific factual scenarios, nor does it record contested interpretations; those issues will be litigated in individual cases and must be sourced from the public record of decisions rather than from this instrument.

Quantification of smoking exposure is precise and can be consequential. The Statement requires at least 5 pack‑years of tobacco smoking before clinical worsening (s 9(1)). The Schedule defines one pack‑year as smoking 20 cigarettes per day for 1 year or an equivalent amount of other tobacco products, and gives concrete conversion metrics (Schedule 1). Notably, the Schedule equates one pack‑year to 7,300 grams of smoking tobacco by weight per year, and says that for pipe tobacco, cigars or combinations, 1 gram of tobacco equals one cigarette (Schedule 1, Note 1). The Schedule also provides calculation examples (10 cigarettes per day for 10 years = 5 pack‑years; 40 cigarettes per day for 10 years = 20 pack‑years). In practice, these precise definitions mean that assessment will turn on historic smoking records, self-reports, and how mixed tobacco usage is converted into pack‑years.

Timing of the smoking threshold matters. The requirement is that the 5 pack‑years must have been accumulated before the clinical worsening of alpha-1 antitrypsin deficiency (s 9(1)). Therefore, the date at which clinical worsening is determined becomes a pivotal evidentiary point. The Statement does not define "clinical worsening" within its text, so decision-makers will need to rely on medical records, practitioner opinions, and accepted clinical markers to fix that date.

"Inability to obtain appropriate clinical management" is an imprecise standard. The second factor in s 9 is inability to obtain appropriate clinical management. The Statement provides no definition of what constitutes "appropriate" management, nor does it specify the types of evidence required to establish inability to obtain care. Practically, that means a claimant will need to produce records or testimony showing attempts to obtain care, barriers encountered, and why the care received (or not received) fell short of an appropriate standard. The absence of a statutory definition invites factual contest and administrative judgement about what is "appropriate", which can create uncertainty for claimants and decision-makers.

Temporal and causal limitation on factor application. Section 10(2) restricts the two factors in s 9 to material contribution to, or aggravation of, alpha-1 antitrypsin deficiency where the condition was suffered or contracted before or during, but did not arise out of, relevant service. That is a specific legal formulation: if the condition "arose out of" service, the s 9 factors are not the relevant mechanism for establishing material contribution or aggravation under this Statement. The distinction between a condition that "arose out of" service and one that was "suffered before or during (but did not arise out of) service" will frequently be contested factually, and the Statement gives no analytical guidance for resolving that contention.

Narrow definition of relevant service may exclude some claims. The Schedule defines relevant service with specific subcategories and express exceptions (e.g., eligible war service other than operational service; defence service other than hazardous service and British nuclear test defence service) (Schedule 1). Claims grounded on operational, hazardous, or British nuclear test defence service could fall outside this Statement’s intended application and may be governed by other Statements or statutory pathways. Practitioners should check the claimant’s service classification carefully against the Schedule.

Cross-reference trap: overlapping Statements. Section 11 says that if a s 9 factor refers to an injury or disease already governed by another Statement, the factors in that other Statement apply as in force from time to time. This can complicate proceedings where a claimant has multiple conditions or exposure histories; the applicable evidence standards may be drawn from a different Statement with different thresholds or timing rules. Decision-makers must identify and apply the correct Statement(s) in force at the relevant time.

No penalties, but administrative consequences. The Statement does not create penalties, but its factors are gatekeepers to entitlement determinations. Failure to demonstrate one of the specified factors, or to show the factor is related to relevant service as required by s 10(1), will likely result in a negative causation finding. That administrative outcome has practical importance for access to benefits under the VEA/MRCA, but the instrument itself does not spell out those consequences.

Death inclusion is broad but bounded. The Statement explicitly includes death from a terminal event or condition contributed to by alpha-1 antitrypsin deficiency (s 7(3)), and the Schedule provides a non-exhaustive list of terminal events. Practitioners should note that the list in the Schedule is presented as examples and the assessment of whether a terminal event was "contributed to" by the deficiency will require medical evidence linking the deficiency to the terminal event.

Prepare to address the statutory gates the Statement establishes: to have alpha-1 antitrypsin deficiency accepted as connected with relevant service under this Statement, a claimant must ensure evidence is assembled that demonstrates at least one of the s 9 factors and that the factor is related to the claimant’s relevant service (ss 9-10). The following practical steps reflect the instrument’s requirements and the definitional detail in the Schedule; they do not create new statutory obligations but are the evidentiary and administrative actions likely to be necessary.

1. Establish the diagnosis and timing of clinical worsening

• Obtain and collate medical records that confirm the diagnosis of alpha-1 antitrypsin deficiency and that document clinical course, including dates of initial diagnosis, dates and markers of clinical worsening, and contemporaneous test results showing reduced serum alpha-1 antitrypsin levels (s 7(2)). The timing of clinical worsening is necessary for assessing whether smoking exposure reached 5 pack‑years before that worsening (s 9(1)).

2. Quantify smoking history against the Schedule’s pack‑year definition

• Produce medical records, primary care notes, hospital records, occupational health records, or sworn statements that quantify tobacco consumption. Use the Schedule’s conversion rules: one pack‑year equals smoking 20 cigarettes per day for one year or the equivalent amount of other tobacco products; one pack‑year is equated to 7,300 grams of smoking tobacco per year and for pipe tobacco or cigars treat 1 gram as equivalent to one cigarette (Schedule 1). Apply the calculation examples provided in the Schedule to illustrate pack‑year computation (Schedule 1, Note 2). If mixed tobacco types were used, convert to cigarette-equivalents per the Schedule.

3. Demonstrate linkage between the factor and relevant service

• For whichever s 9 factor is relied upon, gather evidence linking that factor to the period of relevant service. Section 10(1) requires that the factor must be related to the person’s relevant service. That may include service medical records, postings, evidence of service-related limitations on access to care, contemporaneous smoking records while in service, or sworn statements from fellow service members regarding smoking practices during service.

4. If relying on inability to obtain appropriate clinical management, document attempts to obtain care

• Since s 9(2) uses the phrase inability to obtain appropriate clinical management, compile records of attempts to obtain care, correspondence with medical facilities, referrals, wait times, denials, or resource constraints. Statements from treating clinicians describing limitations in care availability or appropriateness may be persuasive. The Statement does not define "appropriate", so medical opinions explaining what appropriate management would have been and why it was unavailable will be necessary.

5. Identify the correct category of relevant service

• Review service records to determine whether the claimant’s service falls within the Statement’s definition of relevant service (Schedule 1). The Schedule’s choices and exclusions matter: eligible war service other than operational service, defence service other than hazardous or British nuclear test defence service, and peacetime service under the MRCA are the defined categories (Schedule 1). If service falls into excluded categories, another Statement or statutory pathway may be applicable.

6. Check for overlapping Statements and cross‑apply where necessary

• If a s 9 factor refers to another injury or disease that is already the subject of another Statement of Principles, that other Statement’s factors apply per s 11. Practitioners should identify co-morbid conditions and consult any relevant Statements in force to ensure all applicable criteria are addressed.

7. Prepare medico-legal evidence that addresses causation and timing

• Obtain expert medical reports that explicitly engage with the Statement’s requirements: state whether the claimant meets the 5 pack‑year threshold as defined in the Schedule and whether any inability to obtain appropriate clinical management existed; provide a causal opinion linking the factor to material contribution or aggravation and relating the factor to the claimant’s relevant service as required by s 10(1). For death-related claims, ensure the expert links the terminal event (as defined in the Schedule) to the alpha-1 deficiency per s 7(3).

8. Be mindful of dates and the Statement in force

• Ensure that the correct Statement is cited for the claim’s relevant timeframe. The current Statement commenced on 23 May 2023 and repealed the prior Statement (s 2-4). If events, claims or lodgements straddle the repeal and commencement dates, check statutory rules about which Statement applies. The instrument itself contains no transitional rules; practitioners should confirm applicability by reference to the relevant statutory provisions and administrative practice.

9. Anticipate factual contest on "clinical worsening" and "appropriate management"

• These terms are not defined within the instrument. Expect adverse decision-makers to dispute dates of clinical worsening and the adequacy of attempts to obtain care. Prepare contemporaneous documentary evidence, including GP notes, hospital letters, referrals, and any service medical documentation, to lock in timing and access attempts.

10. Record-keeping and witness statements

• Given the Statement’s reliance on historical exposure and access-to-care evidence, thorough documentation and corroborative witness statements (for example, from family members, fellow service members, or treating clinicians) are likely to be critical. Keep precise records of dates, providers, and communications relevant to clinical management attempts and smoking histories.

Following these steps aligns evidence-gathering and procedural preparation with the instrument’s operative requirements: diagnosis and timing of the condition (s 7), existence of at least one factor (s 9), relation of that factor to relevant service (s 10), and correct application of any overlapping Statements (s 11).