Statement of Principles concerning Creutzfeldt-Jakob disease (Balance of Probabilities) (No. 81 of 2022)

Primary legal concept: a statutory Statement of Principles under the VEA defining the medical features of Creutzfeldt-Jakob disease and prescribing the set of factors that, on the balance of probabilities, make the disease connected with relevant service (s 3, s 7, s 9). The Statement functions as a determinative medical framework used in claims under s 120B of the VEA or s 339 of the MRCA (s 5).

Disease definition: CJD is defined as a spongiform encephalopathy characterised by accumulation of abnormal prion protein in the brain; the definition expressly includes sporadic (classical) and variant CJD (s 7(2)). Although ICD‑10‑AM code A81.0 is noted as corresponding to CJD, the instrument stipulates that the statutory meaning is the definition in s 7(2) rather than reliance on diagnostic coding alone (s 7(3)-(4)).

Death linkage: the Statement treats death from CJD as including death from a terminal event or condition to which CJD contributed (s 7(5)). The Schedule defines “terminal event” and gives examples (pneumonia, respiratory failure, cardiac arrest, circulatory failure, cessation of brain function), which is relevant when establishing causation for deaths where CJD contributed but the proximate cause was another condition.

Causal factors and timing: s 9 lists the discrete factors. They are expressed as factual exposures, each carrying a minimum latency requirement before clinical onset of CJD:

• receiving treatment involving a specified human tissue or product at least 6 months before clinical onset (s 9(1)); the Schedule enumerates the specified tissues/products (corneal transplant, cadaveric human pituitary hormones, human dura mater as a graft or in radiographic embolisation) (Schedule 1);
• undergoing neurosurgery at least 6 months before clinical onset (s 9(2));
• for variant CJD only, either receiving blood or blood products from a person infected with variant CJD at least 3 years before clinical onset, or consuming beef or a beef product from an area/country with evidence of bovine spongiform encephalopathy (BSE) at the time of consumption, where the consumption occurred at least 3 years before clinical onset (s 9(3)).

Interaction with other Statements: where a factor in s 9 refers to an injury or disease already covered by another Statement of Principles made under subsection 196B(3) of the VEA, that other Statement’s factors apply according to its terms (s 11). This creates a networked structure in which a given exposure may trigger both this Statement and others.

Burden and standard: the instrument frames the inquiry as a balance of probabilities causation test (title and s 8). The RMA expresses the medical-scientific basis for the Statement and asserts a view that it is more probable than not that CJD can be related to relevant service (s 8). Practically, adjudicators will apply these specified factors and timing windows to determine whether the connection to service exists.

Definitions network: the Schedule supplies key operative definitions that narrow or describe the factors: “human tissue or product as specified”, “variant Creutzfeldt-Jakob disease”, “bovine spongiform encephalopathy”, “blood products”, “beef product”, and “relevant service” (Schedule 1). The precise list of tissues and the defined categories of relevant service constrain what exposures and periods qualify.

ICD-10-AM cross-reference: the Statement acknowledges ICD‑10‑AM coding but makes clear that the statutory definition controls. The instrument also records the specific edition and effective date of ICD‑10‑AM and attributes copyright (s 7(3)-(4)).

Primary affected persons: veterans, members of the Forces and members covered under the MRCA who lodge claims under s 120B of the VEA or s 339 of the MRCA (s 5). The Statement is explicitly drafted to apply to any claim to which those claim provisions relate; it is not a general public health instrument.

Claimants and beneficiaries: persons seeking recognition that CJD or death from CJD is connected with their relevant service so as to obtain entitlements and benefits under the VEA or MRCA will be directly affected. The Statement structures the medical proof required for such claims by setting the factors and timing requirements (s 9; s 10). Where the factor involves death from a terminal event that CJD contributed to, dependants or estates making death claims may be affected by the Schedule’s definition of terminal event and by s 7(5).

Decision-makers: the Repatriation Medical Authority is the author of the Statement and will rely on the Statement when making medical determinations; statutory claim decision-makers administering the VEA and MRCA will apply it in adjudicating claims. The instrument itself is made under s 196B(3) of the VEA and therefore forms part of the statutory framework that adjudicators must apply (s 3).

Service providers and record-holders: hospitals, surgeons, blood services, tissue banks, and defence medical services may be indirectly affected because claimants will need records to demonstrate that the specified factors occurred within the relevant time frames and in relation to relevant service. The Schedule limits “human tissue or product as specified” to specific items (corneal transplants, cadaveric human pituitary hormones, human dura mater grafts or use in radiographic embolisation), so holders of records on these procedures will be relevant to evidence collection.

Other Statements of Principles: authors and administrators of other Statements may be affected because s 11 brings into play factors from other Statements where a factor in this instrument refers to an injury or disease already covered by another Statement. This produces cross-Statement application when exposures overlap.

Not affected persons: individuals with CJD exposures or sources not listed in s 9 and the Schedule will not satisfy the statutory factors under this Statement. For example, the Schedule’s narrow list of “human tissue or product as specified” indicates that other tissue types are not captured by the s 9(1) factor unless covered by another Statement (Schedule 1).

Administrative bodies and insurers: while the instrument does not mention insurers or other agencies, administrative staff in Departments handling VEA/MRCA claims, and any tribunal or review body considering decisions under those Acts, will be affected by the need to apply these factors and to verify timing and linkage to relevant service.

Duties created by the Statement: the instrument does not create new criminal offences or civil duties in isolation; rather, it prescribes facts that must be established for a claimant to have CJD or death from CJD accepted as connected with relevant service under existing VEA/MRCA claims processes (s 5, s 9). The practical duty imposed on claimants is evidential: to establish, on the balance of probabilities, that at least one of the enumerated factors existed and that the factor was related to their relevant service (s 9; s 10). The instrument places timing constraints on acceptable evidence: specified treatments or neurosurgery must have occurred at least 6 months before clinical onset (s 9(1)-(2)); variant CJD factors carry a minimum 3 year latency (s 9(3)).

Rights under the instrument: claimants retain the right to rely on these prescribed factors to establish service connection. If a claimant can establish one of the factors in the required relation to relevant service, then, subject to adjudication under the VEA or MRCA claims procedures, the claimant has met the medical-principles threshold set by the RMA for acceptance on a balance of probabilities (s 9; s 8). The Statement also preserves the right to rely on linked Statements of Principles where factors cross-reference to other Statements (s 11).

Decision-maker obligations: while the instrument itself does not spell out procedural duties for decision-makers, its status as a Statement under subsection 196B(3) of the VEA (s 3) indicates it functions as the statutory medical framework decision-makers must apply when determining causation in the specified claim contexts. Therefore, decision-makers must apply these factors and timing requirements when assessing claims for CJD or death from CJD.

Evidentiary implication: the Statement’s definitions determine what counts as qualifying exposures: “human tissue or product as specified” is limited to corneal transplant, cadaveric pituitary hormones, and human dura mater as graft or in radiographic embolisation (Schedule 1). “Variant Creutzfeldt-Jakob disease” is defined in the Schedule and is distinguished by clinical features and pathological findings (Schedule 1). These definitional choices limit and structure the rights of claimants to have particular exposures count as qualifying factors.

Interaction with other Statements: where s 9 factors reference an injury or disease covered by another Statement, s 11 requires that the factors in that other Statement be applied according to its terms. This imposes an obligation on claimants and decision-makers to consult other Statements where relevant exposures are covered elsewhere.

Standard of proof: the Statement is explicit in its title and in s 8 about the balance of probabilities standard. The RMA states that, on the sound medical-scientific evidence available, it is of the view that it is more probable than not that CJD and death from CJD can be related to relevant service. The practical right for claimants therefore is to satisfy that standard using the factors and timing the RMA has specified.

No express administrative appeals or review rights are created by the Statement itself. Those procedural rights remain those provided under the VEA, MRCA and associated administrative review and merits review schemes; the Statement supplies the medical content that will be applied within those procedures.

This Statement of Principles is not a penal instrument and does not create criminal liabilities, monetary penalties, or enforcement mechanisms in itself. It operates as a medical-determinative instrument under the VEA framework that decision-makers use when adjudicating claims for entitlements and compensation. The instrument does not specify sanctions for non-compliance because it is not a regulatory licensing or enforcement statute; it is a criterion-setting instrument. The text contains no sections imposing fines, imprisonment, civil penalties, injunctive powers, or administrative sanctions.

Enforcement in practice occurs within the existing VEA/MRCA claims processes. The Statement’s role is to provide the medical basis for determining whether CJD or death from CJD is connected with relevant service. If a claimant fails to establish the required factors, a claim will be unsuccessful under the statutory schemes; the instrument itself does not prescribe additional enforcement steps. Any adverse claim decision based on application of this Statement will be subject to the review, internal reconsideration, merits review or judicial review avenues available under the VEA and MRCA administrative frameworks; those procedural and review mechanisms are not set out in this instrument.

The Repatriation Medical Authority’s stated view under s 8 that the medical-scientific evidence supports a probable relationship to relevant service is not an enforcement mechanism; it is the evidentiary foundation for the Statement. The instrument also includes an express repeal of the earlier Statement No. 77 of 2014 (s 4), which affects which Statement will be applied in claims after commencement. That repeal is an administrative effect, not a penalty or sanction.

Where the instrument refers to other Statements (s 11), enforcement of the combined medical criteria will be through their application in claims decision-making. If there are disputes over the application or interpretation of these medical criteria, the instrument itself provides no enforcement or disciplinary procedures; disputes must be resolved through the established VEA/MRCA claim review channels.

Decision-makers applying the Statement must adhere to the statutory standard of proof indicated (balance of probabilities). Failure by an administrative decision-maker to apply the Statement correctly could be subject to review under the administrative law avenues contained in the relevant Acts, but those avenues and remedies are external to and not described in this Statement.

Statutory base: the Statement is made under subsection 196B(3) of the VEA (s 3). It therefore functions within the VEA statutory architecture and applies expressly to claims to which s 120B of the VEA or s 339 of the MRCA applies (s 5). The instrument should be read and applied in the context of those substantive claims provisions and the procedural and review frameworks provided by the VEA and MRCA.

Interaction with other Statements of Principles: s 11 establishes a direct interaction rule. If a factor in s 9 refers to an injury or disease already covered by another Statement determined under subsection 196B(3) of the VEA, then the factors in that other Statement apply in accordance with its terms as in force from time to time. This creates an inter-Statement application where exposures overlap. Practically, a decision-maker must identify whether a factor references a matter already governed by another Statement and apply the other Statement’s factors as well.

Diagnostic coding cross-reference: the Statement acknowledges ICD‑10‑AM coding for CJD (s 7(3)). It specifies that while CJD attracts ICD‑10‑AM code A81.0, the statutory meaning for purposes of the Statement is the definition in s 7(2). The instrument further identifies the specific edition of ICD‑10‑AM cited and notes the copyright holder (s 7(4)). This indicates that while diagnostic codes may be used as diagnostic labels, the statutory test is the textual definition within the Statement. Practitioners should apply the Schedule and s 7 definition rather than relying solely on ICD coding.

Definitions of “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, and peacetime service under the MRCA (Schedule 1). That definition narrows the classes of service that can found a claim under this Statement and interacts with the separate statutory definitions and entitlements in the VEA and MRCA. The instrument therefore must be applied in conjunction with the VEA/MRCA definitions of eligibility and service categories.

Overlap with other medical or public health regimes: the instrument makes no direct reference to other public health statutes, occupational disease regimes, workers compensation, or private tort claims. The Statement’s determinations are for the statutory purposes of the VEA/MRCA claims; they do not, of themselves, determine outcomes under other legal regimes. However, the medical findings and records used to support claims under this Statement could be relevant evidence in other forums; the Statement does not address evidentiary weight in those contexts.

Copyright and external standards: by reference to ICD‑10‑AM (s 7(4)), the Statement interacts with an external clinical classification standard, and explicitly notes the edition and copyright. The Statement clarifies it uses the RMA’s own textual disease definition rather than leaving the meaning to ICD coding alone.

Repeal effect: s 4 repeals the earlier Statement No. 77 of 2014. That repeal is an internal statutory interaction changing which Statement is to be applied to relevant claims after commencement. Practitioners handling claims spanning the repeal date will need to consider which version applies to particular claims, consistent with the VEA/MRCA transitional and commencement rules; the instrument itself does not set those transitional rules.

No explicit interaction with criminal law, immigration, or other statutes is set out in the instrument. Any cross-claim or collateral legal effects outside the VEA/MRCA framework are not addressed in the text.

This instrument is identified as the Statement of Principles concerning Creutzfeldt-Jakob disease (Balance of Probabilities) (No. 81 of 2022). It was dated 23 August 2022 (instrument heading) and it commences on 19 September 2022 (s 2). Section 4 expressly repeals the prior Statement of Principles concerning Creutzfeldt-Jakob disease No. 77 of 2014 (Federal Register of Legislation No. F2014L01139), which had been made under subsection 196B(3) of the VEA. No other amendments, supplementations or historical versions are recorded within the text of this instrument.

The instrument therefore replaces the 2014 Statement as the operative Statement of Principles for CJD for claims falling within s 120B of the VEA or s 339 of the MRCA from its commencement date. The instrument does not contain transitional provisions specifying how claims pending at the time of repeal are to be handled; it only effects the repeal. Practitioners must consult the VEA/MRCA commencement or transition rules and relevant administrative guidance outside this Statement to determine the applicable Statement for claims spanning the repeal date.

There is no other internal amendment history recorded in the text. The Schedule and the body of the Statement set out the current operative definitions and factors; any subsequent amendment to these provisions would require a further Statement made under subsection 196B(3) of the VEA and would presumably be published and numbered in the Federal Register of Legislation as a later instrument.

Because the instrument cites a specific edition of ICD‑10‑AM (Tenth Edition, effective date 1 July 2017) and notes the copyright holder (s 7(4)), any future updates or new editions of coding standards will not automatically change the statutory definitions in this instrument. The instrument specifies that for subsection 7(3), a reference to an ICD-10-AM code is a reference to that particular edition. Any legal change to reference a different edition or to change the relationship to ICD coding would require amendment of the Statement.

No amendment history beyond the repeal of the 2014 Statement is provided in the instrument. The text also contains several Notes (for example, on clinical features of CJD and on imported beef contamination) which elucidate the RMA’s reasoning but do not form legislative amendment history.

The instrument itself contains no litigation history. It does not name any judicial decisions, appeals, or determinations that have interpreted or applied prior Statements of Principles within the text. The only historical instrument it expressly repeals is the Statement No. 77 of 2014 (s 4), but the text does not set out any case law or tribunal decisions relating to that Statement.

For practitioners, the absence of a litigation history in the instrument means that the statutory text and the Schedule are the primary source for how the RMA expects causation to be assessed in claims for CJD. If disputes arise about the application or interpretation of these factors, any relevant judicial or tribunal authority that later addresses this Statement will be external to the instrument and must be located through case law research rather than within the Statement text.

Because the instrument is a Statement made under subsection 196B(3) of the VEA, decisions by administrative decision-makers and any subsequent tribunal or court reviews of those decisions may produce case law interpreting the Statement’s terms in future. The instrument does not provide guidance on review mechanisms, remedies, or legal standards beyond the balance of probabilities standard and the RMA’s expressed medical view in s 8. Any litigation that addresses interpretation of terms such as “human tissue or product as specified”, the temporal thresholds in s 9, or the meaning of “related to the relevant service” in s 10, would be developed in external case law and is not reported in this instrument.

Given the lack of recorded litigation in the text, practitioners handling contested claims should anticipate that interpretative questions (for example, the sufficiency of proof that a blood product came from an infected person; or how to prove the provenance of beef or beef product consumed abroad) will require evidentiary argument in the VEA/MRCA adjudicative processes and perhaps future judicial scrutiny. That litigation history, if and when it arises, will be accessible through tribunal and court records rather than through this instrument.

Narrow definitions of qualifying exposures: the Schedule’s definition of “human tissue or product as specified” is limited to corneal transplant, cadaveric human pituitary hormones, and human dura mater as a graft or in radiographic embolisation procedures (Schedule 1). Exposures involving other tissues or products are not captured by s 9(1) unless they are covered by another Statement of Principles invoked under s 11. Claimants should not assume that all tissue transplants or biological treatments qualify; the instrument’s list is specific.

Strict timing windows and clinical onset reference point: the factors in s 9 prescribe minimum latency periods measured against the “clinical onset” of CJD. For treatments and neurosurgery the minimum is 6 months (s 9(1)-(2)). For variant CJD the minimum is 3 years for blood/blood products or beef/beef products (s 9(3)). This means a claimant must establish the date of clinical onset reliably. The instrument does not define “clinical onset” beyond its use; therefore, evidence establishing the onset date will be crucial. The instrument’s timing requirements can operate to exclude exposures that occurred either too soon before onset or after onset.

Variant-only provisions: s 9(3) is expressly limited to variant CJD. The Schedule sets out a clinical and pathological description of variant CJD (Schedule 1). For variant-related factors, the claimant must both show the exposure and meet the variant requirement. A claimant with sporadic (classical) CJD cannot rely on the variant-specific blood or beef factors unless variant CJD is diagnosed.

Burden of provenance proof for beef consumption: s 9(3)(b) requires consumption of beef or beef product from an area or country with evidence of bovine spongiform encephalopathy (BSE) infection in cattle at the time of consumption. The instrument notes that contamination through imported beef has occurred in countries without domestic BSE (s 9 Note 1). Practically, claimants will need to establish where and when beef was consumed, and whether that area/country had evidence of BSE at the relevant time. The Statement does not provide mechanisms to prove provenance; obtaining such proof may be challenging, particularly for remote or historical consumption.

Proof that blood/blood product came from an infected person: s 9(3)(a) requires receipt of blood or blood products from a person infected with variant CJD. The Statement does not specify how infection of the donor is to be proven. That imposes an evidential challenge where donor infection status is unknown or unrecorded. Claimants and decision-makers must confront the practical limits of historical transfusion records and donor screening.

Interaction with other Statements: s 11 requires that if a factor in s 9 refers to an injury/disease covered by another Statement, the factors of that other Statement apply. This can create complexity where exposures overlap multiple Statements; practitioners must identify and apply the relevant Statements and their temporal and substantive requirements.

ICD-10-AM code is not determinative: s 7(3) notes that CJD attracts ICD‑10‑AM code A81.0, but the instrument states the statutory meaning is that in s 7(2). Therefore, a medical record bearing the ICD code alone may not suffice if it does not establish the features described in s 7(2) or the exposure factors in s 9.

Relevant service categories are limited: the Schedule defines “relevant service” narrowly to particular categories (eligible war service other than operational service; defence service other than hazardous service and British nuclear test defence service; peacetime service under MRCA). Claims relying on other kinds of service or on periods excluded by these enumerations may fail to satisfy the link to relevant service required by s 10.

Death causation nuances: s 7(5) extends CJD to include death from a terminal event or condition contributed to by CJD, and Schedule 1 lists examples of terminal events. However, establishing that a terminal event was contributed to by CJD requires medico-legal linkage in evidence; merely listing a terminal event on a death certificate will not, absent evidence that CJD contributed.

No penalties or enforcement details: because the instrument provides medical criteria rather than enforcement mechanisms, practitioners cannot rely on it for procedural remedies; disputes about application must be pursued in the VEA/MRCA decision and review processes, which are external to the Statement.

Repeal of prior Statement: the instrument repeals the 2014 Statement (s 4). Practitioners handling claims that straddle the repeal date should verify which Statement applies to their client’s claim. The instrument does not itself prescribe transitional provisions.

Establish relevant service: confirm that the claimant’s service falls within the “relevant service” categories in the Schedule (eligible war service other than operational service; defence service other than hazardous service and British nuclear test defence service; or peacetime service under the MRCA) (Schedule 1). Where service classification is unclear, obtain the service records used for VEA/MRCA eligibility determinations, because s 10 requires that the factor be related to relevant service.

Document clinical onset: determine and document the clinical onset date of CJD. The timing windows in s 9 measure exposure latency against clinical onset. Collect medical records, clinician notes, imaging, specialist reports, and any diagnostic statements that record symptom onset and progression to support the onset date.

Match exposures to prescribed factors

• Human tissue/product (s 9(1) and Schedule 1): gather records that show receipt of a corneal transplant, cadaveric human pituitary hormones, or human dura mater as a graft or in radiographic embolisation, and confirm that the treatment occurred at least 6 months before clinical onset. Medical/surgical records, transplant registries, pharmacy or hospital dispensing records, and consent forms will be pertinent.
• Neurosurgery (s 9(2)): obtain operative notes, theatre records, anaesthetic records and discharge summaries demonstrating a neurosurgical procedure and its date, showing it was at least 6 months before clinical onset.
• Variant CJD blood/blood product (s 9(3)(a)): retrieve transfusion records, blood bank records, and any available donor identification or screening information that links the recipient’s blood or blood products to a donor. Documentation that the donor was infected with variant CJD will be necessary; where such proof is unavailable, practitioners should identify what contemporaneous records exist and prepare to argue evidential inferences where appropriate.
• Variant CJD beef/beef product (s 9(3)(b)): collect contemporaneous records and a reliable history of consumption, including travel records, work postings, food procurement documentation, and witness statements showing consumption of beef or a beef product in an area or country that had evidence of BSE at the time. Where imported beef may have been the source, gather evidence of imports and supply chains if available.

Link exposure to service (s 10): assemble evidence that the qualifying exposure occurred in relation to the person’s relevant service. For example, show the corneal transplant or neurosurgery took place while the person was serving or within a context connected to service medical care, or show that beef consumption or blood receipt occurred during or in consequence of service postings.

Use other Statements where appropriate (s 11): if any factor in s 9 refers to an injury or disease already covered by another Statement of Principles, obtain and apply that Statement as well. This may add further factors or timing rules that must be satisfied.

Address variant diagnosis: if variant CJD is relied upon, obtain specialist neurology and neuropathology reports confirming variant CJD features as described in the Schedule (younger age at onset, more protracted clinical course, sensory/psychiatric symptoms, marked prion accumulation and florid amyloid plaques). Diagnosis records must align with the Schedule’s definition for the variant-specific factors to apply.

Anticipate evidential weaknesses and prepare supporting materials: where direct proof (for example, donor infection status or exact beef provenance) is hard to obtain, assemble corroborating circumstantial evidence: contemporaneous medical records, witness statements, travel and supply records, service unit logs, and any available registries. Because the Statement prescribes a balance of probabilities standard (title and s 8), a coherent evidentiary narrative tied to the enumerated factors is essential.

Record-keeping and requests: where records are held by third parties (hospitals, blood services, tissue banks, overseas suppliers), prepare written requests for records early, and document the search process in the claim file. For older exposures, explain in the claim why records may be incomplete and produce best-available evidence.

Address death claims: if the claim concerns death from CJD, collect the death certificate, autopsy or coroner’s findings, and medical opinions linking the terminal event listed in the Schedule to CJD (s 7(5) and Schedule 1). Obtain expert medico-legal opinions that explain how CJD contributed to the terminal event where direct textual causation is not apparent.

Engage relevant experts: secure neurology and neuropathology opinions tied to the statutory definitions and to the timing requirements. Experts should address clinical onset dating, the plausibility of the exposure causing CJD given the latency windows, and whether the clinical/pathological features meet the Statement’s definitions (s 7; Schedule 1).

Cross-reference ICD-10-AM thoughtfully: use ICD-10-AM codes as supportive medical documentation, but ensure that clinical narratives demonstrate the features listed in s 7(2), because the statutory meaning is supplied by the instrument and not solely by the ICD code (s 7(3)-(4)).

Prepare submissions on the balance of probabilities basis: frame the case to show that, on the balance of probabilities and applying the RMA’s factors and definitions, the statutory threshold is met (title and s 8). Where a factor falls short, consider whether an alternative factor in s 9 or a linked Statement per s 11 may be relied upon.

Monitor Statements and updates: because s 11 requires using other Statements as in force from time to time, maintain awareness of any subsequent Statements or amendments that may affect overlapping exposures.

Document compliance with procedural rules under the VEA/MRCA: this Statement does not set procedural steps for lodging or reviewing claims. Ensure procedural compliance with the VEA/MRCA claim forms, evidence requirements, time limits and review mechanisms external to this Statement.

In summary, compliance requires targeted evidence collection aimed at the Statement’s specific exposures and timing windows, corroborating the link between the exposure and the person’s defined relevant service, and expert medical opinion tying the facts to the Statement’s definitions and latency requirements.