Statement of Principles concerning anosmia (Balance of Probabilities) (No. 20 of 2021)

Core legal and medical concepts are set out as definitions, an operative causation standard, and a closed list approach to causal factors. The principal definitional concept is anosmia. The SoP defines it as an acquired, total and permanent loss of smell due to defect in the olfactory neuroepithelium, olfactory nerves or olfactory neural pathways in the brain (s 7(2)). The instrument expressly notes that loss of smell includes inability to detect, discriminate or identify odours, and it clarifies that the ICD‑10‑AM code is not determinative of meaning for the instrument (s 7(2)-(4)).

“Death from anosmia” is conceptually broadened: anosmia, in relation to a person, includes death from a terminal event or condition that was contributed to by the person’s anosmia (s 7(5)). The Schedule defines “terminal event” as the proximate or ultimate cause of death with non‑exhaustive examples including pneumonia, respiratory failure, cardiac arrest, circulatory failure and cessation of brain function (Schedule 1, terminal event). This makes clear that the SoP contemplates indirect causal chains where anosmia contributes to a terminal outcome.

Causation is governed by a balance of probabilities standard. Section 8 states the Repatriation Medical Authority’s view that it is more probable than not that anosmia can be related to relevant service. Section 9 implements this by listing factors of causation: at least one of those specified factors must exist before it can be said, on the balance of probabilities, that anosmia or death from anosmia is connected with the circumstances of relevant service. Section 10 then requires that any such identified factor must itself be related to the person’s relevant service.

The SoP adopts a closed list model: enumerated factors in section 9 (numbered 1 to 20) specify diseases, exposures, substances and procedures and precise temporal or quantitative thresholds. Examples of temporal windows include development of anosmia within three weeks of commencing implicated drug therapy and persistence after discontinuing therapy (s 9(11)), onset within 30 days after therapeutic radiation where olfactory structures were in the radiation field (s 9(12)), intranasal zinc within 48 hours before clinical onset (s 9(13)), and specific one‑year windows after cessation of certain occupational fumes exposures (s 9(15)-(16)). Quantitative thresholds include cumulative inhalation exposure of at least 5,000 hours for certain fumes (s 9(15)-(16)) and a smoking history of at least 20 pack‑years when smoking has not ceased prior to clinical onset (s 9(18), Schedule 1 one pack‑year).

Several listed factors cross‑refer to other medical conditions covered by other Statements of Principles, and the instrument prescribes application of those other SoPs where relevant (s 11). The Schedule provides the operational definitions and enumerated disease lists referenced in section 9. For example, the specified list of autoimmune diseases includes Behcet disease, granulomatosis with polyangiitis, systemic lupus erythematosus and others (Schedule 1). The specified list of neurotoxic substances for acute poisoning includes ammonia, barbituric acid, chlorine and formaldehyde (Schedule 1).

Finally, the instrument is bounded by its application clause. It applies to claims to which section 120B of the VEA or section 339 of the MRCA applies (s 5). It is also made under VEA s 196B(3) (s 3), which situates it within the statutory architecture governing compensation and rehabilitation entitlement for veterans and members of the forces.

The instrument directly affects claimants under the VEA and the MRCA who assert that anosmia or death from anosmia is connected with relevant service. The application clause is explicit: “This instrument applies to a claim to which section 120B of the VEA or section 339 of the MRCA applies” (s 5). It therefore governs claims brought under those statutory provisions. 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, and peacetime service under the MRCA (Schedule 1, relevant service). For claims purposes, an affected person will typically be a veteran or a member of the Forces whose service meets one of those categories.

Decision‑makers and medical assessors within the Departmental administration are affected indirectly, because the SoP sets the causation criteria they will apply when determining whether anosmia is connected with relevant service. The document is made under the Repatriation Medical Authority’s statutory power (s 3) and records the RMA’s view on causation (s 8), which is the evidentiary hinge for administrative decisions under the VEA/MRCA framework. Where a factor in section 9 refers to a disease or injury that is the subject of another SoP, the interplay with that other SoP will affect both claimants and decision‑makers (s 11).

Medical practitioners, rehabilitation providers and occupational health specialists are affected in practical terms because the SoP sets precise clinical and exposure thresholds that proof must meet. Examples include records showing at least five years of sinusitis or perennial allergic rhinitis before clinical onset (s 9(1)-(2)); laboratory or imaging evidence for chronic renal failure as defined in the Schedule (GFR <15 mL/min/1.73 m2 for at least three months, need for renal replacement therapy, or undergoing chronic dialysis) (Schedule 1, chronic renal failure); documentation of therapeutic radiation fields and timing (s 9(12)); or documentation of intranasal zinc application within 48 hours of onset (s 9(13)). The Schedule’s detailed pack‑year conversions make explicit the form of smoking history evidence required (Schedule 1, one pack‑year).

Parties seeking to bring or defend claims should note who does not fall within the SoP’s reach. The SoP does not itself create penalties, nor does it generate private law causes of action; it is an administrative instrument. It does not define the procedures for lodging or deciding claims under the VEA or MRCA; rather it supplies causation criteria to be applied in such proceedings (s 5). The instrument therefore affects claimants, medical assessors, and administrative decision‑makers in the veterans’ entitlements system, and it shapes what evidence will be material to establishing causation.

The SoP itself does not impose criminal penalties, licensing duties or private civil obligations. Its operative effect is to define what factors must exist for an administrative finding, on the balance of probabilities, that anosmia or death from anosmia is connected with relevant service. Practically, the duties and rights it creates are administrative and evidentiary rather than punitive.

Rights: An affected person who satisfies the SoP’s conditions may, in principle, have the causal nexus required by the Repatriation Medical Authority’s standard for a decision under the VEA or MRCA framework. The SoP’s function is to set out those qualifying factors; when established and linked to relevant service, they constitute, under the SoP, sufficient causal evidence for connection on the balance of probabilities (s 9). The instrument also assures a claimant some predictability by giving defined thresholds and temporal windows , for example, the three week window for drug‑induced anosmia and persistence after discontinuation (s 9(11)), or the 48 hour window for intranasal zinc (s 9(13)).

Duties: The SoP places no express duty on claimants in statutory terms, but it implicitly requires claimants to adduce evidence that the listed factors exist and that they relate to relevant service (s 10). That means claimants will be required to produce medical records, occupational exposure histories, diagnostic test results, or other documentary evidence matching the instrument’s definitions and thresholds. Decision‑makers reviewing claims have the duty to apply the SoP’s factors when assessing causation for anosmia in accordance with the VEA and MRCA provisions to which the instrument applies (s 5, s 8).

Cross‑SoP duty: Section 11 establishes a procedural rule where a factor in section 9 refers to an injury or disease for which another SoP has been determined. In that case the factors in that other SoP apply in accordance with its terms as in force from time to time (s 11). This creates a duty for claim assessors to consult and apply potentially multiple SoPs consistently.

Operational obligations for evidence: The Schedule supplies numerical and definitional thresholds that convert clinical concepts into evidence rules. For example, chronic renal failure is defined by specific GFR levels and treatment states (Schedule 1, chronic renal failure), and pack‑year calculations are specified numerically with conversion to gram weights for non‑cigarette tobacco (Schedule 1, one pack‑year). These definitions create practical obligations to quantify exposure and disease severity when adducing evidence.

Limitations: The instrument does not create an automatic entitlement. It prescribes that at least one of the listed factors must exist and be related to relevant service; absence of any listed factor will mean the SoP does not, on its face, support a finding of causation under its terms. Additionally, where a factor refers to another SoP, claimants must meet the terms of that other SoP as it stands (s 11).

In sum, the SoP establishes administrative rights to have certain kinds of evidence treated as satisfying causation if appropriately linked to service, and it imposes an evidentiary duty on claimants to prove the presence of defined factors and the service link.

The Statement of Principles instrument does not itself create criminal offences, civil penalties, or an enforcement regime. It is a determinative medical‑causation instrument made under subsection 196B(3) of the VEA (s 3) and is applied to entitlement claims under section 120B of the VEA or section 339 of the MRCA (s 5). Its legal operation is administrative: it sets the causation criteria that adjudicators will use in deciding whether anosmia or death from anosmia is connected with relevant service on the balance of probabilities (ss 8-10).

Enforcement therefore proceeds via the administrative decision‑making and review mechanisms contained in the VEA and the MRCA, not via this instrument itself. The instrument provides the factual and medical triggers relevant to entitlement determinations. If a claimant demonstrates a factor listed in section 9 and establishes that the factor is related to relevant service (s 10), the SoP provides the medical basis, on the Repatriation Medical Authority’s view, for a causal connection. Whether that translates into an entitlement, an award of compensation or other statutory outcomes depends on the operation of the relevant provisions of the VEA and MRCA and on the administrative and review processes established under those Acts.

There is therefore no separate penalty provision attached to non‑compliance with the SoP. Administrative consequences flow from the SoP’s application: a failure to demonstrate a listed factor or a service link will be reflected in negative entitlement findings under the VEA/MRCA claims processes. Conversely, establishing a listed factor related to service will inform positive causation findings, which may lead to entitlements if other statutory criteria are satisfied.

Practically, enforcement work rests with decision‑makers and medical assessors who must apply the SoP to individual claims. The instrument contains detailed thresholds, timing windows and definitions which guide evidentiary evaluation, and enforcement in the sense of consistency and predictability depends on correct application by decision‑makers and availability of supporting medical documentation. The endnotes record the instrument’s amendment history and compilation dates (Endnote 3 and 4), but they do not record any sanctioning provisions.

This SoP is situated within the statutory architecture of the VEA and the MRCA. It is made under VEA s 196B(3) (s 3) and expressly applies to claims to which VEA s 120B or MRCA s 339 applies (s 5). Those references make the instrument an administrative tool to be applied in entitlement determinations under the two Acts. The SoP cross‑references and incorporates, by reference, other Statements of Principles where specific factors point to diseases or injuries covered by other SoPs (s 11). Where a section 9 factor refers to an injury or disease that is subject to another SoP, the factors in that other SoP apply according to its terms as in force from time to time (s 11). This creates an inter‑instrument dependency: decision‑makers must consult and apply multiple SoPs to resolve causation issues that cut across defined disease categories.

The instrument also navigates clinical coding regimes. It notes that while anosmia attracts ICD‑10‑AM code R43.0, the meaning of anosmia for the instrument is as given in s 7(2) and not merely the ICD code (s 7(3)-(4)). This sets a legal‑clinical primacy: coding alone does not determine the instrument’s application; the specific clinical definition in s 7(2) controls.

Operational interactions with other statutory provisions are implicit. The SoP sets causation rules that feed into VEA/MRCA decision processes, but the instrument does not rewrite the statutory entitlements, review rights, or procedural mechanisms in those Acts. Whether a claimant receives an entitlement remains subject to the relevant statutory criteria and administrative pathways under the VEA and MRCA that fall outside this document. The SoP therefore interacts as a subordinate instrument used by decision‑makers applying the parent statutes.

Amendment interaction: the instrument itself has been amended. Endnote 3 lists the original registration on 4 January 2021 with commencement 25 January 2021, and an amendment determination registered 26 August 2022 that amended the definition of “one pack‑year” with commencement 19 September 2022. Endnote 4 records that sections 2 and 4 were repealed by the Legislation Act provisions (noted as rep LA s 48D and s 48C respectively). These endnotes show that the SoP exists in a live legislative environment where definitions and components may be updated, affecting how the SoP interoperates with other SoPs and with evidence standards.

Practical interplay points for practitioners: evidence of exposures or conditions that occurred during relevant service must be linked to the definitions in Schedule 1, and where those factors overlap with other SoPs the practitioner must bring those other instruments into play. For example, a factor referring to chronic renal failure must be interpreted using the Schedule definition of chronic renal failure when assessing causation under this SoP.

The compilation includes amendment history and endnotes that record registration and commencement dates for the instrument and an amending determination. The principal entries in the endnotes are as follows.

• The Statement of Principles concerning anosmia (Balance of Probabilities) (No. 20 of 2021) was registered on 4 January 2021 (F2021L00005) and commenced on 25 January 2021 (Endnote 3).

• An amendment, titled Veterans' Entitlements (Statements of Principles,definition of "one pack-year") Amendment Determination 2022 (No. 94 of 2022) (F2022L01128), was registered on 26 August 2022 and commenced on 19 September 2022 (Endnote 3). The compilation notes that the day of commencement of this Amendment Determination is 19 September 2022.

• Endnote 4 (Amendment history) records provision‑level amendments: Section 2 and Section 4 of the instrument were repealed by the Legislation Act provisions (listed as rep LA s 48D and rep LA s 48C respectively). The note also records that Subsection 9(18) note and the Schedule 1 - Dictionary entry for one pack‑year were revised by amendment No. 94 of 2022 (rs No. 94 of 2022). The compilation states that the effect of uncommenced amendments is not shown and directs readers to the Legislation Register for uncommenced amendments.

Operational effect of the 2022 amendment: The amendment to the definition of “one pack‑year” is reflected in Schedule 1 where “one pack‑year” is now defined numerically (the amount of tobacco consumed in smoking 20 cigarettes per day for one year, or equivalent), and Note 1 provides an equivalence in grams , 7,300 grams of smoking tobacco per year , with conversion guidance for pipe tobacco and cigars, and a methodological example in Note 2 for pack‑year calculation. These changes affect how smoking exposure is quantified for the s 9(18) factor requiring at least 20 pack‑years before clinical onset where smoking has not ceased.

The compilation notes further procedural features: the compilation date is 19 September 2022 and the instrument shows the text as amended and in force on that date. It also clarifies that some modifications or uncommenced amendments may not be shown, and that endnotes provide amendment and legislation history (Compilation notes). Users should consult the Legislation Register for any further later amendments or uncommenced changes.

Practitioners should therefore be aware that the SoP is subject to amendment, and that technical definitions, particularly those that convert exposures into quantitative thresholds (for example pack‑years), can be revised by amendment determinations that take immediate effect on commencement dates recorded in the endnotes.

The compilation and the instrument do not record any judicial decisions, appeals or litigation related to this Statement of Principles. The instrument itself contains no case law citations and the endnotes do not list litigation history. The Repatriation Medical Authority’s stated position on causation (s 8) is an administrative view recorded within the SoP and not a judicial determination.

Because the SoP is an administrative instrument that supplies causation criteria in the context of claims under the VEA and MRCA, disputes about its application would arise, if at all, within the administrative decision and review processes provided by those Acts and potentially by judicial review or merits review avenues available under the parent legislation. However, the instrument’s text does not mention or summarise any specific cases, nor does it record outcomes of litigation applying this instrument.

Practitioners should therefore treat litigation history as absent from the instrument and seek case law from other sources if they require precedential material on how tribunals or courts have interpreted Statements of Principles or this SoP in practice. The SoP itself should be treated as the Repatriation Medical Authority’s standing causation determination as of the compilation date; any litigation that subsequently engages its content would be found in external judicial records, not in this instrument.

This SoP contains a number of practical pitfalls for claimants, medical witnesses, practitioners and decision‑makers because it converts clinical concepts into precise temporal, quantitative and list‑based rules. The following points merit particular attention.

1. Clinical onset is repeatedly used but not defined. Section 9 repeatedly requires timing relative to the “clinical onset of anosmia” yet the document does not define “clinical onset”. Practitioners should therefore expect argument over what constitutes clinical onset for anosmia in individual cases and ensure medical evidence either identifies the clinical onset date or provides contemporaneous records that permit a reasoned clinical determination.

2. The instrument is an evidence‑rule, not a diagnosis manual. Although s 7(2) defines anosmia for the instrument, the SoP’s factors operate as triggers for causation only if they are present and linked to relevant service (ss 9, 10). Absent any listed factor, the SoP does not provide a route to causation even where other medical evidence suggests a possible link.

3. Narrow temporal windows and persistence requirements. Several factors impose short windows or persistence requirements that can be decisive. Examples include: therapeutic radiation where the olfactory structures were in field within 30 days before clinical onset (s 9(12)); intranasal zinc within 48 hours before clinical onset (s 9(13)); acute symptomatic poisoning from a listed neurotoxic substance within 30 days before clinical onset (s 9(17)); and drug‑associated anosmia developing within three weeks of commencing therapy and persisting after discontinuation (s 9(11)). Missing or ambiguous timing records can therefore defeat a claim even if plausible causation exists.

4. Quantitative exposure thresholds may be hard to prove retrospectively. The 5,000 hours cumulative exposure threshold for inhalation of fumes from cadmium, nickel, acrylates or methylacrylate (s 9(15)-(16)) requires reliable occupational exposure records. Many veterans and workplaces do not keep precise logged exposure hours, leading to reliance on estimates or expert reconstructions.

5. Smoking criterion depends on continuing smoking status. Section 9(18) requires that “smoking has not ceased prior to the clinical onset of anosmia” and at least 20 pack‑years. If smoking ceased before onset, s 9(18) does not apply. Practitioners must therefore document cessation dates precisely. The Schedule’s pack‑year definition and conversion (Schedule 1) is technical and has been amended; ensure the updated definition is used.

6. Cross‑SoP dependencies. Some factors refer to injuries or diseases covered by other SoPs (s 11). If a factor points to another SoP, the practitioner must identify and apply the other SoP’s factors as in force. Failure to do so may produce inconsistent causation arguments.

7. Definitions may limit the causal scope. For instance, “anosmia” is defined as total and permanent loss. Partial loss (hyposmia) or transient losses are outside the instrument’s defined meaning and thereby outside its coverage unless other provisions apply. The SoP’s ICD‑10‑AM note clarifies coding but does not expand the definition in s 7(2).

8. Death from anosmia requires anosmia to have contributed to a terminal event. Section 7(5) includes death where anosmia contributed to a terminal event as defined in Schedule 1. Practitioners must therefore link anosmia to the terminal event (for example pneumonia or respiratory failure). Mere temporal association with death will not, on the SoP’s face, suffice without evidence of contribution.

9. List limitations for substances and diseases. The specified lists in Schedule 1 are finite. For example, the specified neurotoxic substances are ammonia, barbituric acid, chlorine and formaldehyde (Schedule 1). Exposures to other toxicants are not covered by s 9(17) as written. Similarly, the specified neurological and autoimmune disease lists are enumerated and limited. Evidence pointing to diseases or substances outside those lists will require alternative causation arguments outside the SoP.

10. The instrument is administrative and interacts with VEA/MRCA procedural law. The SoP does not determine entitlement or remedy,only the causation component relevant to adjudicators under the parent Acts. Practitioners must combine the SoP evidence with proof of other statutory elements and procedural rights under the VEA and MRCA.

In short, the SoP’s precision creates evidentiary traps: missing dates, absent exposure records, definitions that circumscribe coverage, and cross‑instrument dependencies can all be decisive. Practitioners should map each claim against the specific section 9 factor they intend to rely on, then reconcile their evidence with the Schedule’s definitions and timing thresholds.

To present a claim that aligns with this SoP, practitioners should structure evidentiary files so that each element of the chosen section 9 factor is established and linked to relevant service as required by section 10. Below is a practical checklist and evidentiary guidance tied directly to the instrument’s terms.

1. Identify the operative factor(s) in section 9. Determine which of the 20 listed factors (s 9(1)-(20)) the claimant’s case will rely on. The SoP requires at least one factor to exist and to be related to relevant service (ss 9, 10).

2. Establish the clinical diagnosis of anosmia as defined in s 7(2). Obtain medical records, specialist ENT or neurology assessments, objective smell tests if available, and imaging or neurophysiological evidence showing defect in olfactory neuroepithelium, olfactory nerves or olfactory neural pathways. Show that loss is acquired, total and permanent per s 7(2), or provide reasoned medical evidence when permanence is asserted.

3. Pin down the clinical onset date. Although the SoP does not define “clinical onset,” the timing is critical for many factors. Secure contemporaneous records showing when the anosmia symptoms began or when the first medical diagnosis was recorded. If onset is contested, provide expert opinion explaining the basis for the onset date.

4. For chronic disease factors, document duration and timing. For s 9(1) and s 9(2) (sinusitis or perennial allergic rhinitis for at least five years before clinical onset), supply continuous treatment records, prescriptions, GP notes, specialist letters, imaging reports, and where available, objective test results that demonstrate chronicity and the five year duration prior to onset.

5. For listed disease factors, rely on diagnostic evidence. For autoimmune diseases (s 9(3)), sarcoidosis (s 9(4)), Paget’s affecting the skull (s 9(5)), neurological diseases (s 9(6)) and others, obtain confirmed diagnostic statements, relevant serology, imaging and clinical notes dated at or before clinical onset. For Paget’s disease specify skull involvement.

6. For chronic renal failure, use Schedule criteria. Document GFR measures over time showing <15 mL/min/1.73 m2 for at least three months, or need for renal replacement therapy, or records of chronic dialysis (Schedule 1, chronic renal failure).

7. For drug‑induced anosmia, meet the temporal and persistence tests (s 9(11)). Show dates of commencing the implicated drug; demonstrate absence of clinical or laboratory evidence of anosmia prior to commencement; and demonstrate persistence of anosmia after drug discontinuation. Exact dates and medication records are critical.

8. For radiation, intranasal agents and procedural causes, document fields and timing. For s 9(12) include radiotherapy treatment plans showing olfactory neuroepithelium or pathways were in field, and dates showing radiation within 30 days before clinical onset. For intranasal zinc (s 9(13)), provide records of use and timing within 48 hours prior to onset. For surgical injury or injury to cribriform plate (Schedule list), supply operative notes and imaging.

9. For occupational or substance exposures, document exposure hours and cessation dates. For fumes exposures to cadmium, nickel, acrylate or methylacrylate (s 9(15)-(16)), assemble workplace records, rosters, employer statements, industrial hygiene reports or expert reconstructions to evidence cumulative exposure of at least 5,000 hours and, where exposure ceased, show clinical onset within one year of cessation. Use the Schedule definition of “fumes” to frame the exposure evidence.

10. For acute poisoning, rely on toxicology and clinical records. For s 9(17) show acute symptomatic poisoning from a listed neurotoxic substance within 30 days before onset. Hospital records, emergency department notes, toxicology results and documented treatment are required.

11. For smoking history, use the Schedule’s pack‑year definition. For s 9(18) where smoking has not ceased, document smoking habits to show at least 20 pack‑years. Use the Schedule’s conversion guidance (20 cigarettes per day for one year = one pack‑year; equivalence in grams is in Note 1; examples in Note 2) and provide workplace or personal histories, GP notes, or other records to establish intensity and duration.

12. For vitamin B12 deficiency or envenomation, supply lab results or bite records. Vitamin B12 deficiency (s 9(19)) requires biochemical evidence at time of clinical onset. For envenomation (s 9(20)), medical records must identify the species where possible or provide treating clinician’s identification and treatment notes.

13. Link factor to relevant service. Section 10 requires the factor to be related to relevant service, which the Schedule defines as certain categories of VEA or MRCA service (Schedule 1, relevant service). Provide service records, deployment details, medical records showing treatment or exposures during service, and contemporaneous military health notes that place the exposure or treatment within the relevant service period.

14. Where a factor refers to another SoP, obtain and apply that SoP. If the factor points to an injury or disease covered by another Statement of Principles, identify that SoP and ensure evidence satisfies its terms in force at the time (s 11).

15. Anticipate timing and persistence issues. Because several factors require narrow windows or persistence after cessation, frame statements by treating clinicians that explicitly address timing, causation and permanence. Expert opinions should connect the listed factor to anosmia pathophysiology and explain the link to service.

16. Structure submissions to decision‑makers. Present a clear tabulated mapping: cite the exact SoP provision (e.g., s 9(13) intranasal zinc), produce the documents proving the element (date, agent, treatment note), show the clinical onset date, and then present the link to service (service record or contemporaneous evidence). For pack‑year or exposure hours, provide calculations and the conversion method per the Schedule.

17. Keep track of amendments. Use the in‑force text at the time of claim. The compilation shows an amendment to one pack‑year that commenced 19 September 2022 (Endnote 3 and 4). Ensure the version applied in a claim is the version current at the time of decision.

18. Prepare for gaps. Where records are incomplete, obtain expert assessments that can reasonably infer dates or exposures, but be prepared to demonstrate the probative basis for such inferences because the SoP sets precise thresholds.

Following this structured approach aligns documentary evidence to the SoP’s precise factors and definitions, and addresses the instrument’s requirement that any established factor be related to relevant service (ss 9, 10).