Voluntary Assisted Dying Regulation 2022

The Regulation introduces or particularises several key concepts that practitioners and suppliers must understand.

Voluntary assisted dying substance - This is the lethal substance prescribed for the purpose of causing death under the Act. The Regulation does not define the substance itself; that is done by reference to the Poisons Standard and the Act. The labelling requirements (section 4) require the approved name or brand name, form, strength, and quantity to be stated.

Coordinating practitioner - The medical practitioner who coordinates the patient’s voluntary assisted dying process under the Act. Section 3 requires this practitioner to complete and sign the prescription, including stating their name, usual practice location, phone number, the date, and the patient’s address. This is an information‑heavy prescription that goes beyond standard pharmaceutical prescribing and forces the practitioner to disclose their practice location and contact details on the document.

Authorised supplier - The entity (usually a pharmacy or hospital) authorised under the Act to supply the substance. Sections 4 and 5 impose duties on the authorised supplier: to attach two labels with specified content, to verify the prescription is less than six months old, to check that no previous supply remains unconsumed and unaccounted for, and to keep the prescription for at least two years after supply. The supplier also must assign a unique identifying number to the prescription.

Authorised disposer and administering practitioner - A person authorised under the Act to dispose of any unused or remaining substance, and the practitioner who administers the substance to the patient if self‑administration is not chosen. Section 7 requires these persons to personally destroy the substance or any unused portion, and defines “destroy” to mean rendering it unusable and unidentifiable by any person. This is an active, personal obligation that cannot be delegated to a third‑party waste service unless that service is itself an authorised person acting under the Act.

Completed request and final request - Terms referenced in section 8 for Board record‑keeping. A completed request is defined under section 117(2) of the Act, and the Board must record for each completed request whether the person died following self‑administration, practitioner administration, or without administration, or whether the request was discontinued. The period between the first request and the final request must also be recorded for each person who made a final request.

Storage box - Section 6 requires the substance to be stored in a box that is not easily penetrable and is lockable with a lock of sturdy construction. The box must be locked at all times except when the substance is being prepared, administered, or disposed of. This is a physical security measure that imposes a direct cost on the person responsible (typically the patient or a carer, but possibly a health facility). The requirement to use a specific type of container is concrete and verifiable; any failure to maintain the lock or use a suitable box could constitute non‑compliance.

Poisons Standard - Referenced in the definition of “approved name” in section 4(5). This links the labelling obligations to the national poisons scheduling framework, meaning any changes to the Poisons Standard that affect the approved name of the substance automatically flow through to the labelling requirement without further amendment to the Regulation.

The Regulation directly affects a narrow cohort of participants in the voluntary assisted dying scheme, but its indirect effects ripple through health services, insurers, and the patients themselves.

Coordinating practitioners are the first affected group. Under section 3, they must issue a prescription that includes more personal information than a standard prescription: their practice address and phone number, plus the patient’s address. This may raise privacy concerns for practitioners who prefer not to have their practice location on a prescription for a lethal substance. The requirement to sign the prescription is also additional to any electronic or digital signing obligations under other laws.

Authorised suppliers (pharmacies, hospital dispensaries, and other entities authorised under the Act) bear the heaviest compliance burden. They must: (a) verify the prescription date and reject any prescription older than six months; (b) check whether a previous supply has already been made and, if so, confirm that the earlier substance has been disposed of or is in the possession of an authorised person before making a second supply; (c) attach two labels with mandatory wording, including a red‑on‑white ‘keep out of reach of children’ warning and a separate label stating the purpose is to cause death; (d) assign a unique identifying number; and (e) retain the prescription for two years. These obligations require administrative systems, staff training, and secure storage of records. The cost of compliance is not reimbursed by the government; it is absorbed by the supplier, which for smaller independent pharmacies may be disproportionate.

Authorised disposers and administering practitioners - often medical practitioners or nurse practitioners - are required under section 7 to personally destroy any unused or remaining substance. This means they cannot simply ask a practice nurse or waste contractor to dispose of the substance unless that person is also an authorised disposer under the Act. The definition of “destroy” (render unusable and unidentifiable) is open to interpretation. A practitioner must have a practical method - such as chemical denaturing or incineration - that meets the standard. Failure to personally destroy the substance could lead to enforcement action. This personal, non‑delegable duty may discourage practitioners from participating in the scheme because it adds a post‑death administrative task and potential liability.

Nurses and nurse practitioners are indirectly affected by section 8, which requires the Board to record the number of nurse practitioners and nurses involved in the provision of voluntary assisted dying. While this is a data‑collection obligation on the Board, it may lead to greater scrutiny of the roles played by nursing staff and could influence employment conditions or insurance premiums.

Patients are affected in that the Regulation governs how they receive and store the substance. They must have a lockable, non‑penetrable box at home (section 6) - a requirement that imposes a tangible cost and may be burdensome for patients with limited mobility or resources. The labelling requirement that the purpose is “to cause death” (section 4(3)(a)) may cause distress to patients and families. The rule against a second supply unless the first is disposed of (section 5(3)-(4)) means a patient who vomits or otherwise does not take the full dose cannot easily obtain a replacement; the practitioner must arrange for disposal of the first substance before a new supply can occur. This creates a practical barrier to successful self‑administration.

The Voluntary Assisted Dying Review Board is required by section 8 to record and keep ten categories of information, including demographic data (sex, age, region), diagnosis, completion status, and involvement of medical and nursing staff. This data‑collection function supports oversight and reporting but imposes administrative costs on the Board and raises privacy considerations for patients and practitioners.

The Regulation imposes specific duties on individuals and entities, but does not grant any rights to patients or practitioners beyond those already provided in the parent Act.

Duty of the coordinating practitioner (section 3): The coordinating practitioner must ensure the prescription contains: the practitioner’s name, usual practice place, phone number, date of issue, and the patient’s address. The prescription must be signed. This duty is non‑delegable; the information must be stated directly on the prescription. Failure to include any of these elements would mean the prescription does not meet the regulatory requirements, and the authorised supplier would be entitled (and arguably obliged) to refuse supply.

Duty of the authorised supplier - labelling (section 4): The authorised supplier must attach two labels. The first label (subsection (2)) must contain nine items of information: supplier’s details, approved or brand name, form and strength, total quantity, the words “keep out of reach of children” in red capital letters on a white background, patient’s name, unique identifying number, date of supply, and expiry date. The second label (subsection (3)) must state that the purpose of the dose is to cause death, that the substance must be stored in accordance with the Act, and that any unused or remaining substance must be disposed of in accordance with the Act. All words (except the red‑on‑white warning) must be in English, in letters at least 1.5mm high, and in a colour that contrasts distinctly with the background. These are objective, measurable standards; non‑compliant labelling could lead to the substance being treated as unauthorised, creating supply delays.

Duty of the authorised supplier - supply restrictions (section 5): The supplier must not supply if the prescription was issued more than six months before the supply date. The supplier also must not supply if a voluntary assisted dying substance has already been supplied for the patient, unless the earlier substance has been disposed of by an authorised disposer or administering practitioner, or is in the possession of such a person. This creates a duty to check both the date and the prior supply history. The supplier must keep the prescription for at least two years after supply. The 2024 amendment to section 5 (SL No. 92 s24) - the precise text of which is not reproduced in the source - likely addressed a technical issue with the prior supply rule, but the core duties remain.

Duty of the person storing the substance (section 6): Any person (typically the patient or a carer) must store the voluntary assisted dying substance in a box that is not easily penetrable and lockable with a lock of sturdy construction. The box must be locked immediately and kept locked except when preparing, administering, or disposing of the substance. This duty is strict and ongoing; momentary failure to lock the box could constitute an offence under the Act.

Duty of the authorised disposer or administering practitioner - disposal (section 7): These persons must personally destroy the voluntary assisted dying substance or any unused or remaining substance. “Destroy” is defined as disposing in a way that renders it unusable and unidentifiable by any person. This is an active, personal, and non‑delegable duty. The person cannot rely on a third‑party waste contractor unless that contractor is also an authorised person under the Act. The definition does not specify methods, leaving practitioners to determine what constitutes “unusable and unidentifiable”. This uncertainty imposes a compliance risk.

Duty of the Voluntary Assisted Dying Review Board (section 8): The Board must record and keep the prescribed information. This is a record‑keeping function, not a discretion. The Board must collect data on assessments (first and consulting), demographic details (sex, age, region), diagnosis, completed requests, mode of death, discontinuations, time between requests, and numbers of involved medical practitioners, nurse practitioners, and nurses. The Board has no power to omit or anonymise this information beyond what the parent Act allows.

Rights: The Regulation does not confer any rights on patients or practitioners. The right to access voluntary assisted dying and the right of practitioners to conscientiously object are matters for the parent Act. The Regulation’s duties are constraints on how the right to access is operationalised.

The Regulation itself does not create offences or penalties. It prescribes requirements for the purpose of specific sections of the Voluntary Assisted Dying Act 2021. Non‑compliance with those requirements would therefore constitute a breach of the parent Act. The parent Act (not reproduced here) is understood to contain its own penalty provisions, including possible criminal offences for unauthorised supply, possession, or disclosure of information. Because the Regulation is a statutory instrument made under the Act, any failure to comply with a prescribed requirement is effectively a failure to comply with the Act itself.

For example, if an authorised supplier supplies a substance without attaching the mandatory labels, they would be in breach of section 71 of the Act for which these labelling requirements are prescribed. The Act would determine the penalty - which could be a fine, imprisonment, or both, depending on the severity. Similarly, a person who fails to store the substance in a lockable, non‑penetrable box (section 6) would be in breach of section 74 of the Act. The Regulation does not specify a separate penalty; it relies on the Act’s enforcement structure.

The Board’s failure to record the prescribed information (section 8) would likely be a breach of its statutory duty under section 117(1)(d) of the Act. This could give rise to administrative law remedies such as mandamus, or internal disciplinary action, but the Regulation is silent on consequences.

Enforcement is likely to be carried out by the relevant health professional regulator (e.g., the Australian Health Practitioner Regulation Agency) for individual practitioners, and by the Department of Health or the Board for systemic issues. Because voluntary assisted dying is a highly sensitive area, any breach is likely to attract significant regulatory and public attention.

The practical effect is that the Regulation’s detailed prescription of duties raises the stakes for compliance. A minor oversight - such as a label font slightly under 1.5mm, or a brief moment when the box is left unlocked - could technically constitute an offence. This creates a chilling effect on practitioner participation, as the compliance burden is high and the margin for error is low.

The Regulation operates as a subordinate instrument under the Voluntary Assisted Dying Act 2021 (the parent Act). It gives effect to specific enabling provisions in sections 67, 71, 73, 74, 79, and 117 of the Act. The parent Act sets the overall framework - eligibility, assessment, requests, practitioner roles, and conscientious objection - while the Regulation fills in the operational detail. Any amendment to the parent Act that changes these enabling sections would require corresponding changes to the Regulation.

Poisons Standard: Section 4(5) of the Regulation incorporates the Poisons Standard (the national scheduling framework for medicines and poisons) by reference for the definition of “approved name”. This means that the label must use the approved name as defined in Part 1 of the Poisons Standard, which is amended periodically by the Therapeutic Goods Administration. The Regulation does not need to be amended each time the Standard changes; the reference automatically updates. However, this creates a risk of incompatibility if the Standard is amended in a way that conflicts with the Regulation’s other labelling requirements.

Health practitioner regulation: Practitioners who participate in voluntary assisted dying are subject to the National Law (Health Practitioner Regulation National Law) and the codes of conduct of their respective boards. The Regulation adds additional obligations on top of those professional standards. A breach of the Regulation could also constitute professional misconduct or unsatisfactory professional performance, leading to disciplinary action by AHPRA or a tribunal.

Drugs and poisons legislation: The storage requirement in section 6 (lockable, non‑penetrable box) interacts with state and territory drugs and poisons regulations that already impose storage standards for scheduled medicines. In Queensland, the Health (Drugs and Poisons) Regulation 1996 (or its successor) may have overlapping or inconsistent requirements for storage of Schedule 8 (controlled) drugs. Voluntary assisted dying substances are likely Schedule 8 or Schedule 4 Appendix D substances. Practitioners and suppliers must satisfy both the voluntary assisted dying storage requirements and the general poisons storage requirements. Where they conflict, the more stringent standard presumably applies.

Coroners Act: The disposal requirement in section 7 (personal destruction of any unused substance) may interact with coronial powers if a death occurs after self‑administration and the substance has not been fully consumed. A coroner may wish to examine the remaining substance as part of an inquest. The Regulation’s requirement to destroy the substance “personally” could conflict with a coroner’s direction to preserve it. The Regulation does not address this potential conflict.

Privacy and health records legislation: The information the Board must record under section 8 includes the sex, age, region, and diagnosis of each person assessed. This is sensitive health information. The Board must handle it in accordance with the Information Privacy Act 2009 (Qld) and the parent Act’s own confidentiality provisions. Practitioners who disclose information on prescriptions (including patient address and practitioner phone number) must also comply with privacy laws.

The Regulation commenced on 1 January 2023. The only amendment noted in the source text is to section 5, made by 2024 SL No. 92 s24. The source does not reproduce the amending instrument, so the precise change is not known from the text alone. However, the presence of the amendment note indicates that the original section 5 was amended. Section 5 deals with other requirements for supplying, including the six‑month prescription validity rule, the prohibition on a second supply unless the first is disposed of, and the obligation to keep the prescription for two years. The amendment may have clarified the circumstances under which a second supply is permitted, or adjusted the record‑keeping period, or addressed a drafting error. Readers should consult the 2024 amending regulation to understand the change.

No other amendments are recorded. The Regulation is a relatively new instrument, and further amendments can be expected as operational experience accumulates and as the parent Act itself is reviewed.

The source text does not mention any litigation or court proceedings involving the Regulation. As a subordinate instrument that came into force on 1 January 2023, there has been limited time for legal challenges. Moreover, the Regulation is procedural and prescriptive; most litigation around voluntary assisted dying in Queensland has concerned the parent Act’s eligibility criteria, conscientious objection provisions, or the interaction with Commonwealth criminal law under section 301.1 of the Criminal Code (using a carriage service to access suicide‑related material).

Because the Regulation does not create rights or restrict eligibility, it is less likely to be directly challenged. However, a practitioner or supplier could theoretically seek judicial review of a decision by the Board or a regulator that relies on the Regulation’s interpretation (e.g., whether a particular storage box satisfies “not easily penetrable” and “sturdy construction”). Any such challenge would require the court to interpret the Regulation’s language. No such cases are reported in the source.

The absence of litigation may also reflect the narrow scope of the instrument: it governs only the logistics of the substance. Those affected (patients, practitioners, suppliers) have limited incentive to litigate because non‑compliance risks serious consequences and the duties are clear enough to leave little room for dispute. The Regulation’s prescriptive nature also reduces ambiguity: a prescription either includes the practitioner’s phone number or it does not; a label is either in red capital letters on a white background or it is not. Objective requirements are less prone to litigation than standards based on reasonableness.

Nevertheless, if a death occurs in circumstances where the substance was not properly stored or disposed of, the Regulation could feature in civil or criminal proceedings as the benchmark for expected conduct. Practitioners should be aware that compliance with the Regulation does not automatically immunise them from liability under the parent Act or the general law; it is a minimum standard, not a safe harbour.

Several provisions in the Regulation contain traps for the unwary.

Prescription validity is only six months (section 5(2)). This is a short window, especially given the time that may elapse between the first assessment, final request, and the actual supply. If the prescription expires, a new one must be obtained, which requires re‑engagement with the coordinating practitioner and potentially a new assessment process. Practitioners should issue prescriptions as close as possible to the expected supply date.

No second supply unless first substance is disposed of or in authorised possession (section 5(3)-(4)). If the patient vomits or cannot self‑administer the entire dose, they cannot simply obtain a new supply. The authorised disposer or administering practitioner must first take possession of the first substance and either dispose of it or hold it. This creates practical problems: the patient may be in distress, and arranging disposal may be delayed. Patients and families should be informed of this rule in advance.

Personal destruction requirement (section 7): The authorised disposer or administering practitioner must personally destroy the substance. They cannot delegate this to a practice nurse, a waste disposal company, or a family member (unless that person is also an authorised person under the Act). The term “personally” is unambiguous. This duty arises even if the substance was not used; for example, if the patient dies naturally before using it. Practitioners must have a plan for destruction, including a method that renders the substance “unusable and unidentifiable”. Methods such as flushing down a sink may not satisfy “unidentifiable” if remnants remain. The safest approach is incineration or chemical denaturing under controlled conditions, but the Regulation does not specify methods.

Labelling specificity (section 4): The words “keep out of reach of children” must be in red capital letters on a white background. The font height for other words must be at least 1.5mm and in a colour that provides a distinct contrast to the background. These are objective requirements that can be measured. A pharmacy that uses a standard label template with insufficient contrast, or uses red letters on a red background, would be non‑compliant. The supplier must also include the unique identifying number on the label, which requires a system to generate and track such numbers.

Storage box must be locked at all times except when in use (section 6(3)). This means the box cannot be left unlocked even for a moment when the patient is not actively preparing or taking the substance. If a carer or family member unlocks the box to retrieve the substance and then steps away to get a glass of water, leaving the box unlocked, that is a breach. The requirement to “immediately lock the box” imposes strict, immediate compliance.

Board data collection (section 8): The Board must record the sex, age, and region of each person assessed in a first assessment, and the disease, illness, or medical condition for those assessed as eligible. There is no provision for withholding this information even if the patient objects. The data is collected for statistical and monitoring purposes, but patients and practitioners should be aware that this information will be recorded and potentially published in de‑identified form.

No grandfathering: The Regulation applies to all prescriptions, supplies, and disposals occurring on or after 1 January 2023. Any substance supplied before that date is not covered, but ongoing storage and disposal after commencement would still need to comply. Practitioners should ensure that pre‑commencement substances are brought into compliance with the storage and labelling rules as soon as possible.

Compliance with the Regulation requires careful attention to documentation, physical processes, and record‑keeping.

For coordinating practitioners: Develop a prescription template that includes all the fields required by section 3: your name, usual practice location, phone number, date of issue, and the patient’s address. Ensure the prescription is signed (wet or electronic signature, whichever is acceptable under the parent Act). Issue the prescription as close as possible to the anticipated supply date to avoid the six‑month expiry. Keep a copy of the prescription for your own records, even though the supplier is required to retain it for two years.

For authorised suppliers (pharmacies, hospitals): Implement a check procedure before dispensing. First, verify the prescription date: if more than six months from the supply date, refuse supply and notify the prescribing practitioner. Second, check your records to see whether a voluntary assisted dying substance has already been supplied for that patient. If it has, confirm that the earlier substance has been disposed of by an authorised disposer or is in the possession of an authorised person (e.g., the administering practitioner). Document this confirmation. Only then may you supply. Prepare two labels as per section 4: one with the nine items of information, and a second with the three statements (purpose is to cause death, storage in accordance with Act, disposal in accordance with Act). Ensure all label text is in English, at least 1.5mm high (except the red “keep out of reach of children” warning), and in a colour that contrasts with the label background. Assign a unique identifying number to the prescription and record it on the label. Retain the prescription for at least two years from the supply date, in a secure location.

For persons storing the substance (patients or carers): Obtain a box that is not easily penetrable (e.g., made of sturdy plastic or metal) and that has a lock of sturdy construction (a simple latch may not suffice; a padlock or combination lock is preferable). Keep the box locked at all times except when you are preparing, administering, or disposing of the substance. Do not leave the box unlocked even momentarily. If you need to store other medicines separately, that is advisable to avoid confusion.

For authorised disposers and administering practitioners: Before destroying any unused or remaining substance, confirm your authority under the Act. You must personally carry out the destruction. Choose a method that renders the substance unusable (i.e., cannot be consumed or injected) and unidentifiable (i.e., cannot be linked to a specific patient or source). Options include dissolving in a denaturing agent, incinerating in a licensed facility, or crushing and mixing with an absorbent material that is then disposed of as clinical waste. Document the destruction - date, method, quantity - and keep a record in the patient’s file. If the patient dies without using the substance, liaise with the family or funeral home to retrieve the substance promptly.

For the Voluntary Assisted Dying Review Board: Establish data‑collection systems to capture the prescribed information under section 8. This includes: number of first assessments and consulting assessments, eligibility outcomes, demographics (sex, age, region), diagnoses, completed requests, mode of death (self‑administration, practitioner administration, or no administration), discontinuations, time interval between first and final request, and counts of involved medical practitioners, nurse practitioners, and nurses. Ensure data security and privacy compliance. Produce annual reports or other statistical outputs as required by the parent Act.

General compliance steps: All parties should review the parent Act to understand the full set of obligations, including those not covered in the Regulation. Maintain training for staff on the specific requirements of the Regulation. Conduct periodic audits of labels, storage boxes, and disposal records. Seek legal advice if any ambiguity arises, particularly around the definition of “destroy” or the interaction with coronial powers. Because the Regulation is relatively new and the amendment history is sparse, practitioners should monitor for further amendments and update procedures accordingly.