Statement of Principles concerning analgesic nephropathy (Balance of Probabilities) (No. 44 of 2025)

This instrument is a Statement of Principles made by the Repatriation Medical Authority under subsection 196B(3) of the Veterans' Entitlements Act 1986 (the VEA) concerning analgesic nephropathy (Balance of Probabilities) (No. 44 of 2025). It formally sets out the medical facts and the causation factors that the Authority has determined, on the available medical‑scientific evidence, to be necessary in order for analgesic nephropathy, or death from analgesic nephropathy, to be regarded as able to be related to a person’s relevant service on the balance of probabilities (see "Basis for determining the factors", section 8). The instrument commences on 19 May 2025 (s2) and expressly repeals the prior Statement of Principles on the same condition (No. 78 of 2016) (s4).

Mechanically, the instrument performs three functions in relation to claims under the VEA and the Military Rehabilitation and Compensation Act 2004 (MRCA). First, it defines the kind of disease to which it relates and the clinical features that constitute that disease for the purposes of the Statement (see "Meaning of analgesic nephropathy", s7(2)). Second, it lists the discrete factors that must exist before, on the balance of probabilities, a connection between the person’s relevant service and the disease or death can be established (s9). Third, it prescribes how those factors must be related to a person’s relevant service and how the instrument interacts with other Statements of Principles (ss10-11). It also incorporates by reference an ICD‑10‑AM code as a label while making explicit that the instrument’s operative definition is the text in s7(2) (s7(3)-(4)).

The instrument applies specifically to claims to which section 120B of the VEA or section 339 of the MRCA applies (s5). It therefore sits inside the statutory scheme for assessing whether a medical condition is connected with service for the purposes of those Acts. The Statement does not itself set out administrative decision‑making procedures, benefit rates, or payment mechanisms; instead it supplies the medical causation framework that decision‑makers will use for those claims.

Key operative elements that change how claims can be established are: a tightly specified medical definition for analgesic nephropathy (s7(2)); two alternative objective phenacetin‑exposure thresholds (s9(1)(a)-(b)); and an alternative, non‑exposure factor concerning inability to obtain appropriate clinical management before clinical worsening (s9(2)). The relationship provisions require that any of these factors must be related to relevant service as defined in the Schedule (s10(1)), and they limit the applicability of the clinical management factor to cases where the disease pre‑existed or was contracted before or during service but did not arise out of service (s10(2)). The instrument also makes explicit that where a listed factor refers to an injury or disease covered by another Statement, the factors in that other Statement apply as that Statement provides (s11).

For practitioners and claims handlers this instrument therefore replaces the earlier 2016 Statement and establishes the specific factual and temporal thresholds by which analgesic nephropathy claims will be assessed under the VEA and MRCA from 19 May 2025 (ss2, 4, 5).

The instrument revolves around a small set of tightly defined concepts that determine its operation. Each concept has a direct role in assessing causation for claims under the VEA and MRCA.

Analgesic nephropathy: The operative meaning is provided in subsection 7(2). The instrument defines it as a bilateral chronic renal disease characterised by papillary necrosis, chronic interstitial nephritis, renal cortical atrophy and capillary sclerosis, and a clinical state of loss of renal function in an individual with a history of consumption of large amounts of analgesic agents, occurring in the absence of another biochemical, anatomical or metabolic cause for renal impairment (s7(2)). The Statement notes that this condition attracts ICD‑10‑AM code N14.0, but it makes clear that for the purposes of the Statement the statutory meaning is the textual definition in s7(2) (s7(3)).

Death from analgesic nephropathy: For claim purposes, the term includes death from a terminal event or condition that was contributed to by the person’s analgesic nephropathy (s7(4)). Terminal event is defined in the Schedule and includes specific proximate/ultimate causes such as pneumonia, respiratory failure, cardiac arrest, circulatory failure and cessation of brain function (Schedule, terminal event).

Factors: Section 9 sets out the discrete causation factors that must exist for the Authority to conclude, on the balance of probabilities, that analgesic nephropathy or death from analgesic nephropathy is connected with a person’s relevant service. Those factors are: substantial phenacetin consumption measured in two alternative ways (either a total intake of at least 1 kilogram of phenacetin before clinical onset, s9(1)(a), or an average of at least 1 gram per day of phenacetin for a continuous period of at least two years immediately preceding clinical onset, s9(1)(b)); and inability to obtain appropriate clinical management for analgesic nephropathy before clinical worsening (s9(2)). The Statement’s Notes identify phenacetin and provide alternative chemical names and examples of compound analgesic medications where phenacetin was a constituent (Notes to s9).

Balance of probabilities and evidentiary basis: The Authority declares that, on the sound medical‑scientific evidence available, it is of the view that it is more probable than not that analgesic nephropathy and death from it can be related to relevant service (s8). The instrument therefore adopts the balance of probabilities standard for causation as the framing premise of the Statement.

Relevant service: The Schedule defines relevant service to include 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 (Schedule, relevant service). The definition limits the classes of service for which the Statement can be used to establish service connection.

This Statement of Principles affects three groups directly, as indicated by its terms: claimants seeking connection of analgesic nephropathy (or death from it) with relevant service under the VEA and MRCA; the administrative decision‑makers who assess those claims under the referenced statutory provisions; and medical advisers and clinicians whose records and expert opinions will be used to show whether the specified factors exist.

Claimants: The instrument applies to a claim to which section 120B of the VEA or section 339 of the MRCA applies (s5). Persons who have served in forms of service captured by the Statement’s definition of relevant service, and who allege analgesic nephropathy or death from it, will be affected because the Statement sets the causation factors that must exist to establish a connection on the balance of probabilities (ss7-9). The Schedule defines relevant service to include eligible war service (other than operational service), defence service (other than hazardous service and British nuclear test defence service) under the VEA, and peacetime service under the MRCA (Schedule, relevant service). Therefore, claimants whose service is outside these categories will not have this Statement applied to their claims under the specified sections.

Decision‑makers and adjudicators: The Repatriation Medical Authority made the Statement under s196B(3) of the VEA (s3). The Statement, by its terms, is the RMA’s view about what medical facts and exposure patterns make it more probable than not that the disease can be related to relevant service (s8). The instrument therefore binds or guides decision‑makers assessing claims under s120B of the VEA or s339 of the MRCA, who must consider whether at least one of the factors in s9 exists and is related to the person’s relevant service (s10(1)). The instrument also cross‑refers to other Statements where factors invoke other injuries or diseases (s11), so decision‑makers must consult other Statements in those circumstances.

Medical and records‑keeping professionals: The definition of analgesic nephropathy requires specific clinical features and a history of consumption of large amounts of analgesic agents, occurring in the absence of other biochemical, anatomical or metabolic causes (s7(2)). The factors in s9 establish objective thresholds based on phenacetin consumption and a factor about inability to obtain appropriate clinical management (s9). Clinicians who provide history, diagnosis, and expert opinions, and health records that document clinical onset, medication intake and management, will affect claims. The instrument’s Notes identify phenacetin by chemical synonyms and list sample compound analgesic medications where phenacetin was a constituent (Notes to s9), so clinical records indicating exposure under those names or products will be relevant.

The Statement sets out duties and rights indirectly through the causation thresholds and procedural relationships it creates for the assessment of claims under the VEA and the MRCA. It does not itself create administrative duties, monetary entitlements, or procedural rights, but it defines the medical criteria that must be met to establish service connection under the referenced statutory provisions.

Duty to establish a relevant factor: For a claim of analgesic nephropathy or death from analgesic nephropathy to be regarded as able to be related to relevant service on the balance of probabilities, at least one of the factors in section 9 must exist (s9). The practical duty, therefore, falls on the claimant and the decision‑making process to show that either the phenacetin consumption thresholds have been met (s9(1)(a)-(b)) or that there was an inability to obtain appropriate clinical management for the condition before it clinically worsened (s9(2)). The Statement does not prescribe who must produce the evidence, but by setting out the factors it defines the factual thresholds that must be satisfied in the claim assessment.

Duty to relate factors to relevant service: Section 10(1) requires that any factor in s9 be related to the person’s relevant service. That establishes an additional linkage duty: evidence must connect the factor to the timeframe or circumstances of the person’s defined relevant service (Schedule, relevant service). The Schedule’s definition narrows relevant service to eligible war service (other than operational), defence service (other than hazardous and British nuclear test defence service) under the VEA, and peacetime service under the MRCA. Consequently, the right to use this Statement to establish service connection depends on the claimant having the appropriate category of service and on evidencing the relationship between the factor and that service.

Limitation on the clinical management factor: Section 10(2) places a substantive limit on the applicability of the clinical management factor in s9(2). That factor applies only to material contribution to, or aggravation of, analgesic nephropathy where the person’s analgesic nephropathy was suffered or contracted before or during (but did not arise out of) the person’s relevant service. Practically, this means that when a claimant’s nephropathy arose out of relevant service, the clinical management factor cannot be relied upon as a factor for material contribution or aggravation. The duty is therefore to identify the temporal relationship between disease onset and service.

Right to have linked Statements applied: Section 11 provides that where a factor in s9 refers to an injury or disease for which a separate Statement has been determined, the factors in that other Statement apply according to its terms. This gives claimants a right, in effect, to the benefits of the other Statement’s medical framework where cross‑references occur. Decision‑makers must apply the other Statement’s factors "as in force from time to time" when the factor invokes another condition.

The Statement contains no provisions that create or prescribe criminal, civil or administrative penalties, fines, or coercive enforcement mechanisms. Its text is exclusively focused on defining a medical condition (analgesic nephropathy), specifying the medical factors that, on the RMA’s view of the medical evidence, can establish a connection to relevant service, and directing how those factors are to be related to service (ss7-11). There is no section in the instrument that establishes sanctions for non‑compliance, nor does it appoint an enforcement agency to impose penalties. The document is an evidentiary and medical framework rather than an enforcement instrument.

Enforcement in the operational sense therefore occurs indirectly, within the statutory claims processes established by the VEA and the MRCA, because the Statement applies to claims to which s120B of the VEA or s339 of the MRCA applies (s5). The instrument requires that at least one of the factors in s9 exist and be related to relevant service (ss9-10), and decision‑makers charged with applying the VEA or MRCA will use this Statement when determining whether service connection is established. How those decision‑makers give effect to the Statement, and what procedural consequences follow from acceptance or rejection of a claim, are determined by the statutory frameworks of the VEA and the MRCA and their procedural rules, not by the Statement text.

Practical enforcement consequences therefore include:

• Acceptance or rejection of claims under s120B of the VEA or s339 of the MRCA based on whether the factors in this Statement are established and related to relevant service (ss5, 9-10). The Statement supplies the medical thresholds that decision‑makers use; the outcome of that decision will trigger statutory consequences in the applicable Acts.

• Cross‑application where factors invoke other conditions: section 11 requires decision‑makers to apply the factors in any other Statement that is referenced, "as in force from time to time". Enforcement therefore may require administrative coordination across multiple Statements of Principles.

• Repeal of the previous Statement: section 4 repeals the 2016 Statement. For cases previously assessed under the old Statement, decision‑makers will need to determine how the new Statement affects existing or pending claims; the instrument itself does not include transitional or grandfathering provisions.

Because the Statement itself does not provide a sanctions apparatus, questions of enforcement, appeal rights or remedies must be resolved by reference to the VEA, the MRCA and the administrative review and judicial review processes that apply to decisions under those statutes. The Statement functions as an authoritative medical input to those processes but does not generate independent enforcement actions.

The Statement operates as a medical‑scientific instrument within the legal architecture provided by the VEA and the MRCA and interfaces with other Statements of Principles and medical classification systems. Its explicit interactions are set out in the operative sections and the Schedule.

Source of authority and application: The instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986 (s3) and applies to claims to which section 120B of the VEA or section 339 of the MRCA applies (s5). This locates the Statement’s legal effect squarely within the claims regimes of those Acts. The Statement does not itself create entitlements or procedural mechanisms; instead, it supplies the medical causation framework that decision‑makers must apply when considering whether a condition is related to relevant service under the referenced provisions.

Interaction with other Statements of Principles: Section 11 creates a specific cross‑reference rule. If a factor in s9 refers to an injury or disease that is the subject of another Statement of Principles made under subsection 196B(3) of the VEA, then "the factors in that Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time." That produces an operational interaction whereby decision‑makers must consult and apply other Statements when a causation factor invokes another condition. This may create iterative or cascade application of Statements; the Statement does not specify procedural sequencing, but it requires consideration of other Statements’ factors.

Use of ICD‑10‑AM: The Statement notes that analgesic nephropathy attracts ICD‑10‑AM code N14.0 but that, for the purposes of the Statement, the relevant meaning is the text in subsection 7(2) (s7(3)). It also specifies the edition and effective date of the ICD‑10‑AM referenced and attributes copyright to the Independent Hospital Pricing Authority (s7(4)). That indicates the instrument uses the ICD code as a classification label but places primacy on the Statement’s textual definition for legal application.

Relationship to the VEA and MRCA definitions of service: The Schedule defines "relevant service" for the Statement and explicitly ties it to categories under the VEA and the MRCA: eligible war service (other than operational service), defence service (other than hazardous service and British nuclear test defence service) under the VEA, or peacetime service under the MRCA (Schedule, relevant service). This definition narrows the universe of service categories for which the Statement may be used to support claims under the referenced sections. The instrument does not alter the underlying statutory definitions in those Acts, but it specifies which parts of the service definitions are applicable for the Statement’s use.

This instrument supersedes a previous Statement of Principles on the same condition and records limited metadata about its making and commencement. The explicit amendment history contained in the instrument is as follows.

Repeal of prior Statement: Section 4 expressly repeals the Statement of Principles concerning analgesic nephropathy No. 78 of 2016 (Federal Register of Legislation No. F2016L01680) that was previously made under subsection 196B(3) of the VEA. The new Statement therefore replaces that earlier instrument in whole. The text does not include transitional provisions for claims commenced before the repeal, nor does it specify whether decisions made under the repealed Statement remain unaffected. The mere repeal is recorded at s4.

Date and commencement: The Statement is dated 15 April 2025 (prefatory material) and the instrument’s commencement date is 19 May 2025 (s2). The instrument therefore took effect on a particular future date following its making.

Authority and statutory basis: The instrument was made under subsection 196B(3) of the Veterans' Entitlements Act 1986 (s3). The reference to this statutory head of power is the only legislative authority cited within the instrument.

Editioning of external references: The instrument cites a particular edition and effective date of the ICD‑10‑AM used for referencing the classification code for analgesic nephropathy. Subsection 7(4) states that the reference is to The International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD‑10‑AM), Tenth Edition, effective date of 1 July 2017, with an ISBN and copyright owner identified. This anchors the instrument to a specific edition of an external classification system.

No internal amendments beyond repeal: The instrument contains no schedule of amendments, no clauses that amend other legislation, and no transitional or savings provisions. Its amendment history as recorded in the text is therefore limited to the repeal of the 2016 Statement and the coming into force information.

Practical consequence for administrators and claimants: Because the instrument replaces an earlier Statement, decision‑makers, claimants and advisers will need to identify whether pending or previously determined claims are affected by the new factors and whether existing evidence meets the new thresholds. The Statement itself does not set out procedural arrangements for that transition. Any change in evidentiary thresholds (for example the phenacetin consumption measures or the framing of the clinical management factor) will be effective from the commencement date set out at s2.

The text of the Statement contains no litigation history, references to judicial decisions, or mention of appeals or challenges to prior Statements. It does not name any cases, does not cite precedent, and does not include summaries of litigation relevant to the condition or to the Statement’s contents. The only historical instrument referenced is the prior Statement of Principles concerning analgesic nephropathy No. 78 of 2016, which is expressly repealed by section 4; the text does not record whether that prior Statement was the subject of litigation.

Because the instrument is made under subsection 196B(3) of the VEA and is an administrative medical‑scientific determination, any litigation that engages this instrument will arise from decisions to which the Statement is applied, and from any administrative review or judicial review of those decisions under the VEA, the MRCA, or general administrative law. The Statement does not identify specific review routes or courts. The absence of litigation references in the Statement text itself means that researchers and practitioners must look beyond the instrument to the case law and review decisions that apply the Statement in practice. That material is not provided in the instrument.

Operational implications of the absence of litigation references: The Statement’s lack of litigation history places on practitioners the task of mapping how decision‑makers and courts have interpreted analogous Statements, phenacetin exposure thresholds, and the concept of inability to obtain appropriate clinical management. The instrument contains a clear declaration that the RMA has formed its view on the sound medical‑scientific evidence available (s8), which will be pertinent in any administrative or judicial review context where the sufficiency of the RMA’s evidentiary base is contested. However, the Statement itself does not set out the evidentiary record or data supporting the RMA’s view, nor does it summarise contested points from litigation.

Consequently, any challenge to an administrative decision that relies on this Statement will require the parties and the reviewing body to examine the decision‑making process under the VEA/MRCA, the application of the Statement to the facts, and the medical evidence relied upon by decision‑makers. The Statement will serve as the RMA’s current authoritative medical framework, but litigants must look to decisions applying the Statement and to any external medical evidence referenced by decision‑makers to build litigation strategies. The instrument itself contains no litigation history or examples.

The Statement contains several specific drafting choices and scope limitations that can generate practical traps for claimants, advisers and decision‑makers if overlooked. These are matters that affect admissibility and sufficiency of evidence, the particular exposures that count, temporal limits, and cross‑reference complexity.

Operative definition overrides ICD label: Although the Statement notes that analgesic nephropathy attracts ICD‑10‑AM code N14.0, it expressly states that "in applying this Statement of Principles the meaning of analgesic nephropathy is that given in subsection (2)" (s7(3)). This means that a medical record or return that uses the ICD code N14.0 is not, by itself, sufficient. Decision‑makers must apply the textual definition at s7(2), which requires the specified pathological features (papillary necrosis, chronic interstitial nephritis, renal cortical atrophy and capillary sclerosis), loss of renal function, a history of consumption of large amounts of analgesic agents, and absence of another biochemical, anatomical or metabolic cause. A report that merely lists an ICD code without addressing each element of the textual definition may be insufficient to satisfy the Statement.

Phenacetin‑specific thresholds: The exposure factors in s9 are specifically framed in terms of phenacetin. The two alternative measures are potentially precise and demanding: either a total of at least 1 kilogram of phenacetin before clinical onset (s9(1)(a)), or an average of at least 1 gram per day of phenacetin for a continuous period of at least two years immediately preceding clinical onset (s9(1)(b)). The Notes identify phenacetin synonyms and list historical compound analgesics in which phenacetin was a constituent. Practically, evidence must address phenacetin exposure specifically, not generic "analgesic" exposure. Records that show use of analgesic medications that did not contain phenacetin, or that do not show phenacetin content by name or synonym, may not meet the thresholds.

Absence of other causes is required: The definition of analgesic nephropathy requires that the renal impairment occurs in the absence of another biochemical, anatomical or metabolic cause for renal impairment (s7(2)). Therefore, clinical records that document alternative causes of chronic renal disease will undermine reliance on the Statement unless those causes are excluded. This places an evidentiary burden on claimants and clinicians to rule out other aetiologies.

Temporal and causal limits on the clinical management factor: Section 9(2) includes "inability to obtain appropriate clinical management for analgesic nephropathy before clinical worsening" as a separate factor. However section 10(2) limits the application of this factor to situations where the person’s analgesic nephropathy was suffered or contracted before or during (but did not arise out of) the person’s relevant service. That means the clinical management factor cannot be used to show material contribution or aggravation where the disease "arose out of" service. Careful attention to timing of onset relative to service is therefore essential. Records that fail to establish that distinction may render s9(2) inapplicable.

Compliance, in the context of this Statement, means assembling the factual and medical evidence required to establish that at least one of the factors in section 9 exists and is related to the person’s relevant service as defined in the Schedule. Because the Statement does not specify procedural steps, compliance requires attention to the Statement’s textual elements and to the procedural rules of the VEA and the MRCA claims processes.

Establish the clinical diagnosis under the Statement’s text: Ensure that medical documentation addresses each element of the instrument’s definition of analgesic nephropathy (s7(2)). Records should describe the bilateral chronic renal disease features specified,papillary necrosis, chronic interstitial nephritis, renal cortical atrophy and capillary sclerosis,and demonstrate loss of renal function. The diagnosis should also address exclusion of other biochemical, anatomical or metabolic causes for renal impairment, because the Statement requires the condition to occur in the absence of such causes.

Quantify phenacetin exposure precisely: If relying on the exposure factors in s9(1)(a)-(b), provide evidence that quantifies phenacetin consumption in terms of total mass and/or average daily intake and duration. The two thresholds are:

• total of at least 1 kg of phenacetin in a phenacetin‑containing analgesic before clinical onset (s9(1)(a)); or

• an average of at least 1 g/day of phenacetin in a phenacetin‑containing analgesic for a continuous period of at least 2 years immediately preceding clinical onset (s9(1)(b)).

Records that can assist include contemporaneous prescriptions, pharmacy dispensing records, purchase receipts, clinician entries, structured medication histories, and reliable patient statements that specify product names and quantities. Because the Statement’s Note provides chemical synonyms for phenacetin and lists example compound analgesics that contained phenacetin, evidence should explicitly identify phenacetin by name or synonym or show that the named product contained phenacetin at a known concentration (Notes to s9).

Document clinical onset and timing relative to service: The phenacetin thresholds specify timing "before clinical onset" and the two‑year period immediately preceding clinical onset (s9(1)). The clinical onset date will therefore be central. Medical records that timestamp symptom onset, laboratory abnormalities, imaging or histopathology are important. For the clinical management factor (s9(2)), it is necessary to demonstrate whether the disease was suffered or contracted before or during relevant service and whether it "did not arise out of" service where that factor is relied upon (s10(2)).