Statement of Principles concerning tardive dyskinesia (Balance of Probabilities) (No. 79 of 2023)

The instrument’s core medical concept is the RMA‑specified definition of tardive dyskinesia set out in subsection 6(2). TD is characterised as a movement disorder meeting four cumulative criteria drawn from DSM‑5‑TR: abnormal involuntary movements of tongue, jaw, trunk, or extremities associated with medications that block postsynaptic dopamine receptors; persistence for at least four weeks; a required exposure history to the offending agent of at least three continuous months for persons under 60 years or at least one month for persons aged 60 years or older; and onset during medication use or within defined withdrawal windows (within four weeks for oral agents; within eight weeks for long‑acting injectables) (s 6(2)(a)(i)-(iv)). The instrument also lists categorical exclusions, including medication‑induced parkinsonism, acute dystonia and akathisia, dyskinesia due to l‑dopa or bromocriptine, spontaneous dyskinesia, and named neurological diseases (s 6(2)(b)).

A separate but related concept is death from tardive dyskinesia, which the instrument treats as death from a terminal event or condition that was contributed to by the person’s TD (s 6(5)). The Schedule defines "terminal event" by example (pneumonia, respiratory failure, cardiac arrest, circulatory failure, cessation of brain function).

Causation is framed in probabilistic administrative terms. Section 7 states the RMA’s medical‑scientific view that it is "more probable than not" that TD and death from TD can be related to relevant service. Section 8 operationalises that view by prescribing the factors that must exist before a causal link can be accepted on the balance of probabilities. At least one of the enumerated factors in s 8 must be present and, per s 9(1), that factor must be related to the person's defined form of relevant service.

The Schedule’s definition of "relevant service" confines the instrument’s application to the statutory categories: eligible war service (other than operational service) and defence service (other than hazardous service and British nuclear test defence service) under the VEA, and peacetime service under the MRCA (Schedule 1). The instrument also incorporates external classification nomenclature by reference: it notes TD attracts ICD‑10‑AM code G24.01 but instructs that the meaning of TD for this instrument is the DSM‑5‑TR‑derived definition set out in s 6(2), and specifies the version and edition of ICD‑10‑AM referred to (ss 6(3)-(4)).

Finally, the instrument contains a procedural cross‑reference: where a factor in s 8 refers to an injury or disease covered by another Statement of Principles, the factors in that other Statement apply as in force from time to time (s 10). That establishes configurability with the broader RMA framework of Statements of Principles.

The Statement affects three primary groups identifiable in the instrument. First, claimants , veterans, members of the Forces, and other persons who make claims under section 120B of the VEA or section 339 of the MRCA , are affected because the Statement prescribes the medical facts and nexus criteria that may be used to determine whether TD or death from TD is connected to relevant service (s 4). Claimants with a history of exposure to the specific medications listed in s 8(1) and s 8(2), or who can establish inability to obtain appropriate clinical management as in s 8(3), will have that history assessed against these specified criteria.

Second, decision-makers within the Department and statutory decision processes that adjudicate claims under the VEA or MRCA are affected because the Statement is an authorised legislative instrument setting the evidentiary medical standard they must apply insofar as those Acts empower reliance on Statements of Principles (ss 3-4, 7-8). The RMA records its scientific view (s 7) and enumerates the factors that must exist (s 8); decision-makers will use that list to assess nexus on the balance of probabilities.

Third, treating clinicians and medical experts who prepare reports for claims are affected because the Statement prescribes specific medical and temporal criteria that reports should address. The definition and timing thresholds in s 6(2)(a) and the exposure and onset windows in s 8 require clinical documentation of the agent used, the duration of continuous use with the age‑dependent threshold, and the timing of symptom onset relative to medication use or withdrawal. Where death is claimed, clinicians will need to link terminal events defined in the Schedule to the person’s TD per s 6(5).

The Schedule’s statutory definition of "relevant service" narrows the affected population to persons whose service falls within the enumerated categories (Schedule 1). The cross‑reference in s 10 means that where a factor invokes another injury or disease for which a separate Statement exists, the parties affected by that other Statement will be implicated in the analysis.

The instrument does not create criminal sanctions or new funding obligations in its text. It neither designates specific administrative remediations nor prescribes how benefits are to be paid. Its practical effect is to alter evidentiary and medical thresholds used in the adjudication of claims under the VEA and MRCA, thereby affecting the likelihood of successful claim outcomes for persons meeting the stated criteria.

The instrument sets out duties and rights in a narrowly technical sense: it creates binding medical‑evidentiary rules to be applied in claims assessment, and thereby imposes duties on decision-makers to consider the enumerated factors and duty on claimants to adduce evidence capable of establishing those factors where relevant.

Duty on decision-makers: Under the statutory architecture referenced at ss 3-4, the RMA has determined the Statement of Principles, and decision-makers assessing VEA or MRCA claims should apply it when considering whether TD or death from TD is connected with relevant service. Section 8 makes clear that, before connection can be accepted on the balance of probabilities, at least one of the enumerated factors must exist; and s 9(1) requires that any such factor be related to the person’s relevant service. Where a factor refers to another Statement of Principles, s 10 requires that the factors in that other Statement apply in accordance with its terms. These provisions together impose a procedural duty on decision-makers to test the claim against the specific factors and, where invoked, to consult and apply other Statements.

Duty on claimants and medical reporters: The instrument establishes what must be demonstrated medically. For example, to satisfy s 8(1) a claimant must show use of an antipsychotic medication for at least three continuous months if under 60 years, or at least one month if aged 60 or older, and that the symptoms developed during use or within the specified withdrawal windows (s 6(2)(a)(iii)-(iv); s 8(1)). Similarly, s 8(2) lists specific antiemetic drugs and buspirone with the same exposure thresholds. Section 8(3) introduces "inability to obtain appropriate clinical management" as a factor where applicable, but s 9(2) confines its operation to contribution or aggravation where the TD pre‑existed or was present during service but did not arise out of service.

Right to have the Statement applied: For persons making claims under s 120B VEA or s 339 MRCA, the Statement applies by operation of s 4. The instrument thereby gives those claimants a right to have adjudicators test their TD claim against the RMA’s specified factors. The Schedule’s definition of "relevant service" also sets outer limits on who may assert that right.

Limitations and non‑duties: The instrument does not specify a burden of proof beyond the statement that the RMA is of the view that it is "more probable than not" that TD can be related to relevant service (s 7). The practical standard for adjudicators is the balance of probabilities, but the Statement prescribes which factual scenarios will satisfy that standard. The instrument does not, however, create substantive entitlement rights, prescribe benefit quantum, or create criminal or civil penalties. It does not itself define "inability to obtain appropriate clinical management", leaving scope for interpretive work by decision-makers and clinicians.

The Statement contains no express criminal penalties, pecuniary fines, or administrative sanctions. It is not framed as a penal provision. Instead, it is an evidentiary instrument intended to guide the determination of claims under the VEA and MRCA (s 4). Enforcement, to the extent applicable, operates through the administrative claim‑adjudication processes established by the VEA and the MRCA; those statutes themselves provide procedural pathways for decision-making, review and appeal outside of this instrument. The Statement does not prescribe how those review or appeal mechanisms are to be exercised.

Because the Statement prescribes the medical facts and nexus‑factors that decision-makers are to consult, its practical enforcement effect is internal to administrative decision-making. Decision-makers who fail to apply or correctly interpret the Statement when it is applicable may face procedural review under the statutory challenge mechanisms in the VEA or MRCA. However, nothing in this Statement creates new enforcement machinery, investigatory powers, or sanctioning processes against medical practitioners, claimants, or departmental staff.

The instrument does create potential adverse consequences for claim outcomes if its criteria are not met. If a claimant cannot establish at least one factor in s 8 that is related to relevant service (s 9(1)), the claim may not be accepted on the balance of probabilities as connected to service, which in turn may influence entitlement decisions under the VEA or MRCA. That consequence is an administrative outcome rather than a statutory penalty imposed by the Statement itself.

There is also latent implementation risk because the Statement leaves some terms undefined , notably "inability to obtain appropriate clinical management" in s 8(3). That absence increases the likelihood of interpretive disputes and administrative review where parties contest whether failure to obtain care materially contributed to or aggravated TD (see s 9(2) limiting the reach of s 8(3)). Where a factor invokes another Statement of Principles, s 10 directs application of that other Statement’s factors, which means enforcement of the nexus test may require cross‑referencing multiple instruments and consistent administrative application across those instruments.

The instrument’s primary legal interaction is with the Veterans' Entitlements Act 1986 and the Military Rehabilitation and Compensation Act 2004 through express cross‑references. It is made under s 196B(3) of the VEA (s 3) and applies to claims to which s 120B VEA or s 339 MRCA applies (s 4). Those cross‑references place the Statement squarely within the statutory adjudicative architecture for veteran and service‑related claims. The Statement therefore functions as a medical‑evidentiary rule for decision-makers operating under those Acts.

Section 10 expressly addresses interaction with other Statements of Principles. If a factor in s 8 refers to an injury or disease covered by another Statement of Principles determined under s 196B(3) of the VEA, then the factors in that other Statement apply in accordance with the terms of that Statement as in force from time to time (s 10). That creates a multi‑instrument interaction where claims involving comorbid conditions or medication exposures that implicate other RMA Statements will require application of the other Statement’s factors. Decision-makers must therefore be attentive to the current versions of other Statements and ensure consistent cross-application.

The Schedule also incorporates external classification instruments by reference. Subsections 6(3)-(4) say TD attracts ICD‑10‑AM code G24.01, but that for the purposes of this Statement the meaning of TD is the DSM‑5‑TR‑derived definition in s 6(2). The instrument identifies the specific edition and effective date of the ICD‑10‑AM edition used (Tenth Edition, effective date 1 July 2017) (s 6(4)). That means adjudicators and clinicians may use external diagnostic nomenclature when seeking supporting documentation, but must apply the RMA’s definition.

The Statement does not purport to displace other statutory duties or administrative processes under the VEA or MRCA. It does not itself create or alter criminal law, privacy law, professional regulation, or statutory duties of clinicians. Where a factor refers to inability to obtain appropriate clinical management (s 8(3)), actual assessment may engage health‑system regulations, professional responsibility standards, or other administrative law considerations, but those interactions are not specified in the instrument.

Finally, the Schedule defines the statutory categories that constitute "relevant service" for this instrument (Schedule 1). That definition constrains which persons’ service histories can link a s 8 factor to relevant service under s 9(1), thereby interacting with the eligibility schema of the VEA and MRCA.

The instrument itself provides a minimal, explicit amendment and commencement history. It is titled as Statement of Principles concerning tardive dyskinesia (Balance of Probabilities) (No. 79 of 2023) (s 1), dated 25 August 2023, and commences on 26 September 2023 (ss 1-2). Section 3 records the statutory authority under subsection 196B(3) of the VEA for its making. The text contains no express amendments or repeal of earlier Statements of Principles in relation to tardive dyskinesia; it simply asserts the current RMA determination.

There is an embedded mechanism for change: s 10 contemplates that factors in other Statements of Principles "apply in accordance with the terms of that Statement as in force from time to time". That language acknowledges that other Statements may be amended in future and that cross‑references should follow their current terms. The present instrument contains no transitional provision specifying application to claims arising before commencement; it only states the commencement date (s 2) and the statutes under which it applies (s 4).

Beyond the instrument’s own text, no amendment chronology or prior versions are provided in the instrument, and there is no express savings or transitional rule recorded here for earlier determinations relevant to TD. Any subsequent amendment to this Statement would need to be made under the same statutory power (s 196B(3) of the VEA) and would take effect in the manner provided at amendment. The absence of a detailed amendment history in the text means that practitioners should check the authoritative RMA and legislative instrument registers for any later variations or revocations affecting this Statement.

The instrument contains no litigation history. It records only the RMA’s medical‑scientific view and the criteria to be applied in claims adjudication; it does not cite judicial decisions, nor does it record any case law. The Schedule and body of the Statement make no reference to litigation, judicial interpretation, or appeals.

That absence does not preclude litigation arising from application of the Statement. Potential disputes could concern: the interpretation of the temporal thresholds for medication exposure and onset set out in ss 6(2)(a)(iii)-(iv) and s 8(1)-(2); the proper application of the exclusion list in s 6(2)(b); the meaning and proof required for "inability to obtain appropriate clinical management" in s 8(3) read with the limitation in s 9(2); and the application of the "relevant service" definition in Schedule 1 to particular facts. Any such litigation would arise from the application of the VEA or MRCA and the relevant administrative decision‑making processes, not from the Statement itself as a stand‑alone litigable right.

Because the Statement directs decision-makers to other Statements of Principles where a factor refers to another injury or disease (s 10), there is a potential for litigation about inter‑Statement consistency and about which Statement’s factors govern where conditions overlap. The text leaves open whether courts or tribunals would adopt a particular interpretive approach to the RMA’s medical determinations, so litigators should expect that disputes will centre on factual medical evidence, definitional boundaries provided in s 6 and the Schedule, and the evidentiary sufficiency of documentary medical records to establish a s 8 factor related to relevant service as required by s 9(1).

The instrument contains several specific technical traps and interpretive points worth close attention.

1. Precise exposure thresholds and age cut‑offs. The duration thresholds differ by age: "at least 3 continuous months" for persons under 60 years and "at least 1 month" for persons aged 60 years or older is repeated in s 6(2)(a)(iii), s 8(1) and s 8(2). Practitioners must link medication records, prescribing charts and pharmacy dispensing records to the claimant’s age during exposure. Failure to demonstrate continuous months of exposure using clinical records risks non‑acceptance under s 8(1) or s 8(2).

2. Narrow onset windows. The definition requires symptom onset during medication use or within four weeks of withdrawal for oral agents, and within eight weeks for withdrawal from long‑acting injectables (s 6(2)(a)(iv) and s 8(1)). If onset falls outside those windows, the factor is not met under the Statement.

3. Exclusions. Subsection 6(2)(b) lists categories and named diseases that exclude a finding of TD for the purposes of this instrument. The nomenclature is prescriptive: medication‑induced parkinsonism, acute movement disorders, l‑dopa/bromocriptine dyskinesia, spontaneous dyskinesia, Huntington disease, Wilson disease, Sydenham chorea, systemic lupus erythematosus, and heavy metal poisoning are all excluded. A claimant whose movement disorder is attributable to any of those conditions will fall outside the RMA’s TD definition for this Statement.

4. ICD‑10‑AM code is not dispositive. Subsections 6(3)-(4) note that while TD attracts ICD‑10‑AM code G24.01, the meaning for this Statement is the DSM‑5‑TR‑derived definition in s 6(2). Do not assume a medical record coded G24.01 automatically satisfies the Statement; the specific DSM‑5‑TR elements and exposure/onset requirements must be demonstrated.

5. "Inability to obtain appropriate clinical management" is undefined and constrained. Section 8(3) provides a path where inability to obtain appropriate clinical management exists, but s 9(2) limits this factor to contribution or aggravation where TD was suffered or contracted before or during (but did not arise out of) relevant service. The Statement does not define what constitutes "inability" or "appropriate" management, leaving scope for dispute and administrative discretion.

6. Relatedness to relevant service. Any factor relied upon must be related to the person’s relevant service as defined in the Schedule (s 9(1) and Schedule 1). The Schedule constrains relevant service to particular VEA and MRCA categories. Connection must therefore be established not just medically but factually to the claimant’s service category.

7. Cross‑Statement dependencies. If a s 8 factor refers to another injury or disease, that other Statement’s factors apply (s 10). Practitioners must therefore map conditions and medications against the current corpus of RMA Statements to avoid missing a controlling instrument.

8. Commencement and applicability timing. The instrument commenced on 26 September 2023 (s 2). The instrument does not supply express transitional rules for claims arising from earlier events; claimants and decision-makers must be careful about how the Statement is applied to historical records.

9. Death claims require terminal event linkage. For death claims, s 6(5) includes death from a terminal event or condition that was contributed to by the person’s TD, and the Schedule defines terminal events by example. Practitioners must therefore document how TD contributed to the proximate or ultimate cause of death.

10. No prescriptive definition of "continuous" use. The text requires "continuous months" of use, but does not specify permissible interruptions, dosage thresholds, or adherence metrics. Documentation gaps on continuous use will raise evidentiary issues.

For claimants, medical advisers and decision-makers, compliance with this Statement requires targeted factual and medical evidence collection and methodical application of the RMA’s enumerated tests.

Evidence assembly. To meet s 8(1) or s 8(2) a claimant should assemble contemporaneous prescribing and dispensing records, inpatient and outpatient clinical notes, psychiatric treatment records, and aged‑related documentation to evidence the required continuous exposure period (at least three months if under 60, at least one month if 60 or older) and the timing of symptom onset relative to medication use or withdrawal (during use, within four weeks of oral withdrawal, within eight weeks of withdrawal from long‑acting injectable) (s 6(2)(a)(iii)-(iv); s 8(1)-(2)). Pharmacy dispensing logs and hospital medication charts will be particularly important to substantiate "continuous" use.

Differential diagnosis. Because s 6(2)(b) lists specific exclusions, compliance requires clinical documentation excluding medication‑induced parkinsonism, acute dystonia, acute akathisia, l‑dopa/bromocriptine dyskinesia, spontaneous dyskinesia and the listed neurological diseases. Relevant diagnostic tests, neurologist or psychiatrist assessments, and rationale in clinical notes should be included to show the movement disorder meets the DSM‑5‑TR‑derived criteria in s 6(2)(a).

Age and timing. Practitioners must calculate the claimant’s age at the time of medication exposure to apply the correct exposure threshold. Records should show start and stop dates for medication, any switches between oral and injectable formulations, and dates of observed onset of involuntary movements to verify compliance with the onset windows in s 6(2)(a)(iv) and s 8.

Documentation for "inability to obtain appropriate clinical management". Where s 8(3) is to be relied upon, claimants should collect documentary evidence of attempts to obtain care, referrals, wait‑list information, records of denied or unavailable services, and contemporaneous correspondence. Because s 9(2) confines s 8(3) to material contribution or aggravation where TD pre‑existed or existed during service but did not arise out of service, relevant service timelines and pre‑service or in‑service medical records will be necessary.

Death claims. For death from TD, practitioners should compile medical records demonstrating how TD contributed to a terminal event listed in the Schedule (pneumonia, respiratory failure, cardiac arrest, circulatory failure, cessation of brain function) and provide cause-of-death documentation linking TD to that terminal event (s 6(5); Schedule 1).

Cross‑checking other Statements of Principles. If any s 8 factor refers to an injury or disease for which another Statement exists, collect and address the factors required by that other Statement as mandated by s 10. Practitioners should consult the current RMA instrument register to ensure they apply the up‑to‑date requirements of any cross‑referenced Statement.

For decision-makers. Apply the Statement’s factors as the determinative medical yardstick for TD claims under s 120B VEA or s 339 MRCA (s 4). Ensure factual findings as to medication exposure, onset timing, age thresholds, and exclusionary diagnoses are made and recorded in reasons. Where s 8(3) is invoked, record and explain the factual basis for finding "inability to obtain appropriate clinical management" and how that inability materially contributed to or aggravated TD in light of s 9(2).

Record‑keeping and reasons. Because the Statement establishes precise factual thresholds, administrative reasons should explicitly map evidence to the relevant subsection(s) (for example, cite s 8(1) for antipsychotic exposure or s 8(2) for antiemetic/buspirone exposure), state the relevant service category under the Schedule, and, where applicable, explain exclusionary reasoning under s 6(2)(b). Where the ICD‑10‑AM code appears in records, note that s 6(3) instructs that the DSM‑5‑TR criteria in s 6(2) control for this instrument.

Anticipate gaps. The Statement leaves certain terms open for interpretation, notably "continuous" and "inability to obtain appropriate clinical management". When evidence is incomplete, request further medical records or expert opinion targeted to these gaps. Prepare factual findings on continuity of use and contemporaneous medical advice about treatment options and availability.

Timeliness and scope. Be mindful that the Statement commenced on 26 September 2023 (s 2). For claims touching earlier service episodes, document whether the RMA’s criteria as expressed in this instrument apply to the particular claim and whether other Statements or transitional considerations need to be addressed.

Practical checklist. At minimum, assemble: (a) prescription and dispensing records showing continuous exposure dates and formulation; (b) clinical notes describing onset dates and movement character; (c) specialist neurology/psychiatry reports excluding listed conditions in s 6(2)(b); (d) service records showing relevant service category under Schedule 1; (e) evidence of attempts to obtain clinical management where s 8(3) is relied upon; and (f) cause‑of‑death documentation that links TD to a Schedule‑defined terminal event for death claims (s 6(5); Schedule 1).

Applying this Statement precisely to the cited subsections and to related Statements of Principles will reduce interpretive dispute and better position claims and decisions to withstand administrative review.