Voluntary Assisted Dying Regulations 2022

The central concept embedded in the regulations is that of the “prescribed form”. A prescribed form is not itself contained within the regulations. Instead, each form is determined by the Minister and published in the Gazette from time to time. Regulations 4 through 11 and 14, 15, 17, and 19 each identify a particular form by its statutory definition and then state that the prescribed form is the form so determined and published. This means the precise content of each form can be changed by the Minister without amending the regulations. The practical consequence is that participants in the scheme must consult the Gazette regularly to ensure they are using the current version. There is no single schedule of forms appended to the regulations; the forms exist only in the Gazette and in any subsequent consolidation the Minister may prepare.

The concept of “interpreter” is also crucial. Under the Act, a person requesting or accessing voluntary assisted dying must have an interpreter in certain circumstances, and section 7 of the Act sets out requirements for that interpreter. The regulations prescribe the bodies whose interpreters are acceptable: NAATI and any other body specified by the Minister by Gazette notice (regulation 12). An interpreter who does not come from a prescribed body cannot satisfy the Act’s requirements unless an exemption is granted. The regulations also create a specific exemption for speech pathologists from section 7(b)(iv) of the Act, which relates to the interpreter not being a relative or otherwise involved in the person’s care. This exemption is automatic and unconditional (regulation 13(3)). The more general exemption power is held by the Chief Executive, who may grant a written exemption from the operation of section 7(a) (the requirement to use a prescribed interpreter) on application. That exemption can be conditional or unconditional (regulation 13(1) and (2)).

Another key concept is the “prescribed period” for the determination of a permit application. Regulation 16 sets this at three business days. This applies to the duty of the Chief Executive under section 67(1) of the Act to determine an application for a voluntary assisted dying permit. The short period indicates the legislature’s intention for a swift decision-making process, consistent with the interests of the person seeking voluntary assisted dying.

Secure storage is defined by three specifications in regulation 18: the locked box must be of steel construction, not easily penetrable, and have a lock of sturdy construction. These are qualitative rather than quantitative specifications. There is no reference to particular Australian Standards or locking mechanisms. The terms “easily penetrable” and “sturdy construction” leave some room for interpretation but clearly aim to prevent casual access. The specifications apply to the coordinating medical practitioner, the pharmacist, and any other person who is in lawful possession of the voluntary assisted dying substance under sections 75(b), 76(c) and 78 of the Act respectively.

Finally, the concept of who may seek review of a Tribunal decision is expanded by regulation 20. The Act in section 85(2)(b) allows regulations to prescribe persons who may apply for review. The regulations prescribe two classes: a family member of the person to whom the decision relates, and any other person who the Tribunal is satisfied has a sufficient interest in the matter. The term “family member” is not defined in the regulations, leaving it to the Tribunal to interpret in context. The “sufficient interest” test grants the Tribunal broad discretion to hear from persons with a legitimate stake in the decision, such as a close friend, a guardian, or perhaps a health practitioner involved in the person’s care.

The Voluntary Assisted Dying Regulations 2022 affect multiple categories of persons involved in the voluntary assisted dying process in South Australia. The most directly affected group is the person who is seeking access to voluntary assisted dying. That person must use the prescribed written declaration form (regulation 11) and the prescribed forms when appointing a contact person (regulation 5). If the person chooses to self-administer the lethal substance, they must submit an application for a self administration permit using the prescribed form (regulation 14). If the person chooses practitioner administration, the application form is likewise prescribed (regulation 15). The person also must be able to communicate through an interpreter who belongs to a prescribed body unless an exemption is granted (regulations 12 and 13). The person may have a family member or another person with sufficient interest apply for review of certain decisions before the Tribunal (regulation 20).

Medical practitioners are heavily affected. The coordinating medical practitioner must use the coordinating medical practitioner administration form (regulation 6) and the consulting assessment report form (regulation 4). The consulting medical practitioner must use the first assessment report form (regulation 8). Both practitioners must complete the final review form (regulation 7) before the permit is issued. The coordinating medical practitioner is also responsible for secure storage of the substance before it is transferred to the person or the pharmacist, meeting the specifications in regulation 18, and must use the prescribed labeling form for the substance (regulation 19). If the coordinating medical practitioner is to administer the substance, they must complete the administration form (regulation 6). For dispensing the substance, the dispensing form must be used (regulation 9). For any disposal of the substance, the disposal form must be used (regulation 10).

Pharmacists who dispense the voluntary assisted dying substance are affected by the secure storage specifications (regulation 18) and the labeling requirements (regulation 19). They must store the substance in a steel locked box that is not easily penetrable with a sturdy lock, and affix the prescribed label. The dispensing form (regulation 9) must be completed.

Interpreters are affected because only those who are accredited by NAATI or by another body specified by the Minister in a Gazette notice are recognised under the Act (regulation 12). Interpreters who are not from a prescribed body cannot participate unless the Chief Executive grants an exemption (regulation 13(1)). Speech pathologists are specifically exempted from the requirement in section 7(b)(iv) of the Act, so they may assist a person with communication without being a prescribed interpreter (regulation 13(3)).

The Chief Executive of the relevant department is affected as the authority to grant exemptions from the interpreter requirement under section 7(a) of the Act (regulation 13(1)), and as the decision-maker on permit applications with a prescribed period of three business days (regulation 16). The Minister is affected as the person who determines the content of every prescribed form and publishes it in the Gazette, and who may specify additional bodies for interpreters (regulation 12(b)).

The South Australian Civil and Administrative Tribunal is affected because it must accept review applications from family members and persons with sufficient interest (regulation 20). Finally, any person or entity that comes into possession of the voluntary assisted dying substance - including health services, nursing homes, or transport providers - must comply with the secure storage specifications in regulation 18.

The regulations impose several duties on persons involved in the voluntary assisted dying process. The most pervasive duty is to use the correct prescribed form for each step. A coordinating medical practitioner must use the coordinating medical practitioner administration form when administering the substance (regulation 6). A consulting medical practitioner must use the consulting assessment report form (regulation 4) and the first assessment report form (regulation 8). Both practitioners must use the final review form (regulation 7) before a permit can issue. The person seeking access must use the written declaration form (regulation 11). The duty is not merely administrative; using a non-prescribed form could render the step invalid under the Act, as the form is statutorily required.

A related duty is to stay current with the versions of these forms. Because the Minister determines the forms and publishes them in the Gazette from time to time, the regulations do not prescribe a static form. The user must check the Gazette to identify the current version. There is no duty to use a form that has been superseded; the duty is to use the form that is prescribed at the time of the action.

Another duty concerns the secure storage of the voluntary assisted dying substance. Regulation 18 requires that the locked box be of steel construction, not easily penetrable, and equipped with a lock of sturdy construction. This duty applies to the coordinating medical practitioner under section 75(b), a pharmacist under section 76(c), and any other person authorised to possess the substance under section 78 of the Act. Similarly, regulation 19 imposes a duty to affix the prescribed label to the substance, using the form determined by the Minister. The content of that label is not stated in the regulations; it will be specified in the Gazette form.

The regulations also impose duties on interpreters. An interpreter acting for a person in the voluntary assisted dying process must be from a prescribed body - NAATI or another body specified by the Minister in a Gazette notice (regulation 12) - unless an exemption is granted. This is a duty of compliance: the interpreter must be able to demonstrate accreditation from a recognised body.

The rights created by the regulations are primarily procedural. A person has the right to apply to the Chief Executive for an exemption from the requirement to use a prescribed interpreter (regulation 13(1)). The application must be made in a manner and form determined by the Chief Executive. The exemption may be conditional or unconditional, so the applicant has the right to seek an exemption that suits their circumstances. The Chief Executive must consider the application; there is no time limit prescribed for that decision, but the duty exists.

A person who wishes to have a reviewable decision reconsidered by the Tribunal has the right to apply if they are a family member or if the Tribunal accepts they have a sufficient interest (regulation 20). This expands the class of eligible applicants beyond the person themselves. The right is not absolute; the Tribunal retains discretion to determine sufficiency of interest.

Speech pathologists have a specific right of exemption from the operation of section 7(b)(iv) of the Act (regulation 13(3)). This exemption is automatic; no application is required. A speech pathologist who assists a person in requesting or accessing voluntary assisted dying is simply not caught by that provision, which would otherwise require the interpreter not to be a relative or otherwise connected to the person’s care. This right protects speech pathologists from having to refuse assistance because they do not qualify as a prescribed interpreter.

Finally, all persons affected have the right to rely on the forms as published in the Gazette. If a form is properly gazetted, its use is compliant with the regulations. The regulations provide certainty that following the ministerially determined form is legally sufficient.

The Voluntary Assisted Dying Regulations 2022 do not themselves create any penalty provisions. They are procedural and definitional in nature. Penalties for non-compliance with the requirements of the voluntary assisted dying scheme are found in the principal Act, the Voluntary Assisted Dying Act 2021. However, the regulations provide the enforcement framework by specifying the exact standards that must be met. For example, using a form that is not the prescribed form would likely render the associated step invalid under the Act, potentially making the entire process unlawful. The Act would then apply its own penalties for offences such as contravening a condition of a permit or administering the substance outside the lawful process.

Regulation 18 sets the secure storage specifications. If a person fails to store the voluntary assisted dying substance in a steel locked box that is not easily penetrable with a sturdy lock, they are not complying with the regulations. The Act’s provisions on storage (sections 75(b), 76(c), 78) would be breached, and the Act would provide the enforcement response - likely an offence provision with a maximum penalty. The regulations give a clear, if somewhat qualitative, benchmark for prosecution or enforcement action. Similarly, failing to use the prescribed label under regulation 19 would breach section 76(2) of the Act.

The interpreter requirements in regulations 12 and 13 are also enforceable. Using an interpreter who is not from a prescribed body and who does not hold an exemption could invalidate a step in the process, such as the making of a request for voluntary assisted dying or the witnessing of a declaration. The Act may treat such a step as vitiated, with potential consequences for any subsequent permit or administration. The Chief Executive’s exemption power is the primary mechanism for flexibility. A person who proceeds without an exemption where one was needed would be in breach.

The prescribed period of three business days for determination of a permit application (regulation 16) is a duty on the Chief Executive. Failure to determine within that period may not carry a direct penalty, but it could be grounds for an application to the Tribunal for review or for an order requiring a decision. The regulations do not specify consequences for delay, so enforcement might be through administrative law remedies such as mandamus.

Enforcement of the regulations is ultimately the responsibility of the Chief Executive and the Tribunal. The Chief Executive may investigate non-compliance and may refer matters for prosecution under the Act. The Tribunal may hear applications for review and may set aside decisions that were made on the basis of non-compliant forms or interpreter procedures. The regulations also facilitate enforcement by standardising documentation and procedures, making it easier to identify departures from the lawful process.

It is important to note that the Chief Executive’s power to grant exemptions (regulation 13(1)) serves as a safety valve. Where strict compliance with the interpreter requirement would cause undue hardship or be impracticable, an exemption can be granted, avoiding a technical breach. The exemption may be conditional, so the Chief Executive can impose terms that still safeguard the integrity of the process.

The repeal of the Voluntary Assisted Dying Regulations 2021 by Schedule 1 means that any enforcement action under the old regulations is no longer possible. All current compliance must be measured against the 2022 regulations. The legislative history note shows the regulations came into operation on 29 September 2022, the date section 130 of the Act commenced.

The Voluntary Assisted Dying Regulations 2022 are made under the Voluntary Assisted Dying Act 2021 and are subordinate to it. Every regulation explicitly references a section of the Act. For example, regulation 4 prescribes the consulting assessment report form for the purposes of the definition in section 3 of the Act. Regulation 16 prescribes the period for determination under section 67(1). This direct cross-referencing means the regulations are entirely dependent on the Act for their legal authority and meaning. If the Act is amended, the regulations may need to be updated accordingly.

The regulations also interact with other South Australian legislation, though the text of the regulations does not explicitly reference them. The secure storage specifications in regulation 18 may intersect with the Controlled Substances Act 1984 (SA) or the Controlled Substances (Poisons) Regulations 2011 (SA), which govern the storage of scheduled poisons. The voluntary assisted dying substance is likely a Schedule 8 or Schedule 4 poison. The regulations require a steel locked box with a sturdy lock, but they do not override any additional requirements under poisons legislation. It is probable that both regimes apply cumulatively, meaning storage must comply with both sets of rules. A person storing the substance must meet the regulation 18 specifications as a minimum, but may also need to meet the more detailed requirements of the poisons laws, such as a separate locked room or a register.

The interpreter provisions in regulation 12 interact with the National Accreditation Authority for Translators and Interpreters Limited (NAATI) and its standards. The regulations do not prescribe the level of NAATI accreditation required (e.g., paraprofessional or professional). The Minister may also specify other bodies by Gazette notice, allowing recognition of, for example, a state-based Aboriginal interpreter service. The exemption power in regulation 13(1) interacts with any laws that require an interpreter for medical consent, such as the Consent to Medical Treatment and Palliative Care Act 1995 (SA), but the regulations specifically deal only with the Act’s interpreter requirements.

The tribunal review provisions in regulation 20 interact with the South Australian Civil and Administrative Tribunal Act 2013 (SACAT Act). The regulations prescribe who may apply for review, but the SACAT Act governs the procedures, powers, and time limits for such applications. Regulation 20 does not override the SACAT Act; it supplements it by expanding the class of applicants. The Tribunal’s discretion to determine “sufficient interest” will be exercised in accordance with its general principles.

The repeal of the 2021 regulations by Schedule 1 ensures that only the current regulations are in force. This interacts with the transitional provisions of the Act, if any. The regulations came into operation on the same day as section 130 of the Act, which is the section dealing with regulations. There is no gap: as soon as the Act’s regulation-making power became operative, the 2022 regulations replaced the 2021 version.

The regulations do not interact with the Health Practitioner Regulation National Law (South Australia) directly, but medical practitioners who fail to comply with the regulations may face professional disciplinary action under that law. Unprofessional conduct could include failure to use correct forms or improper storage. The regulations thus provide a benchmark for professional conduct standards.

Finally, the labeling regulation (19) interacts with any relevant poisons scheduling requirements for labeling. The prescribed form determined by the Minister may need to include the information required under the Poisons Standard (the SUSMP). The regulations do not specify the content of the label, so that content must be consistent with both the Act and other applicable laws.

The Voluntary Assisted Dying Regulations 2022 are a principal instrument. They repeal and replace the earlier Voluntary Assisted Dying Regulations 2021, as shown in Schedule 1. The Legislative history records that the 2022 regulations were Gazetted on 29 September 2022 (Gazette 29.9.2022 p6270) and came into operation on that same day by operation of regulation 2, which states commencement on the day on which section 130 of the Voluntary Assisted Dying Act 2021 comes into operation. The Act’s section 130 is the regulation-making power; it commenced on 29 September 2022 when the Act generally commenced. Therefore the regulations and the Act commenced simultaneously.

The regulations themselves have not been amended since their commencement. The legislative history note at the end of the regulations provides only the reference to the principal regulations and a note that for further information see the Index of South Australian Statutes. No amending regulations are listed. This means the content of the regulations as set out in this analysis is the current and only version.

However, because the regulations delegate the determination of forms to the Minister and publication in the Gazette from time to time, forms can change without an amendment to the regulations. The forms under regulations 4 through 11, 14, 15, 17, and 19 can be updated by ministerial determination alone. That is not an amendment to the regulations themselves, but a change in the operational content of the prescribed forms. Users must monitor the Gazette for such changes.

Similarly, regulation 12(b) allows the Minister to specify additional bodies for interpreters by notice in the Gazette. That is also not an amendment to the regulations; it is an exercise of a power under the regulations. Similarly, the Chief Executive’s form for exemption applications under regulation 13(1) can be determined by the Chief Executive without amending the regulations.

The repeal of the 2021 regulations is the only express amendment history. The 2022 regulations are the only ones that have been made under the Act to date. Any future amendments to these regulations would need to be made by further regulations gazetted and laid before Parliament in accordance with the Subordinate Legislation Act 1978 (SA). There is no sunset clause in the regulations themselves, though the Act may be subject to review and potential repeal, which would automatically repeal these regulations.

The Voluntary Assisted Dying Regulations 2022, as presented in the source, contain no reference to any litigation. No court or tribunal decisions are cited, and there is no note of any challenge to the validity of the regulations or any interpretation disputes that have been resolved. This is not surprising given the regulations are procedural and definitional. Litigation is more likely to arise under the principal Act, dealing with eligibility, capacity, or the conduct of medical practitioners, rather than about the form of a particular Gazette notice.

However, the regulations could be the subject of litigation in several scenarios. A person might challenge the validity of a refusal of an interpreter exemption on the ground that the Chief Executive applied the wrong test. The exemption power in regulation 13(1) is discretionary, and a challenge would be by judicial review under the Judicial Review Act 1991 (SA) or through the Tribunal. The Tribunal itself, under regulation 20, may be asked to determine who has a “sufficient interest” to apply for review. That determination could be appealed to the Supreme Court, leading to case law on the interpretation of that phrase.

Another potential area of litigation is the secure storage specifications in regulation 18. The terms “not easily penetrable” and “sturdy construction” are qualitative. A dispute could arise if a person is accused of non-compliance, and the prosecution alleges that the box did not meet the specifications. A court would need to interpret these terms, possibly with expert evidence. Similarly, the labeling requirements in regulation 19 could be litigated if the label did not match the prescribing form.

The prescribed period of three business days for permit determination (regulation 16) could generate litigation if the Chief Executive fails to meet that period. An applicant could apply to the Tribunal or the Supreme Court for an order compelling a decision.

There is also the possibility of constitutional litigation. The voluntary assisted dying scheme generally has been the subject of federal challenges in other states. If the regulations were alleged to be inconsistent with a Commonwealth law (such as the Criminal Code or therapeutic goods legislation), that would be a matter for the High Court. The source does not indicate any such litigation to date.

Because the regulations are relatively new (September 2022), there may be little case law yet. As the scheme matures, litigation may arise on the application of the regulations. Any reported decisions would be found in the South Australian Tribunal statements of reasons or Supreme Court judgments. The regulations themselves remain untouched by judicial interpretation as at the date of this deep dive.

Several aspects of the Voluntary Assisted Dying Regulations 2022 could catch out even an experienced practitioner. The most significant is the reliance on forms that are not set out in the regulations themselves. Every form is “the form determined by the Minister and published in the Gazette from time to time.” A person who relies on a form that has been superseded - perhaps because they kept an older copy from when the scheme began - is using a form that is not legally prescribed. The consequences could be that the step is invalid. The regulations contain no transitional provision allowing use of the old form for a reasonable period. There is also no requirement for the Minister to publish a notice when a form is updated; the new form simply appears in the Gazette. Those who do not subscribe to the Gazette or regularly check it risk non-compliance.

A related trap: the regulations do not define what constitutes “publication in the Gazette”. Electronic publication on the SA legislation website is generally accepted, but the Gazette is a specific publication. If a practitioner accesses the form from a third-party website, it may not be the official version. The safest course is to obtain it from the SA Government Gazette or the official website of the Attorney-General’s Department.

The secure storage specifications in regulation 18 are deceptively brief. They require a steel locked box that is not easily penetrable and has a sturdy lock. No minimum gauge of steel is specified, no locking mechanism standard (e.g., key lock, combination lock, biometric lock) is mandated, and no internal compartment requirements are given. This leaves room for subjective interpretation. A prosecutor and a defendant could disagree on whether a particular box is “easily penetrable”. A box made of thin steel sheeting that can be cut with tin snips might not comply, even though it is steel. Best practice would be to use a safe designed for Schedule 8 poisons, but the regulations do not require that, creating the risk that a simple lockbox may be found inadequate after an incident.

The interpreter exemption in regulation 13(3) for speech pathologists is absolute, but it only relates to section 7(b)(iv) of the Act. That provision prevents an interpreter from being a relative or otherwise involved in the person’s care. A speech pathologist is exempt from that prohibition, but is not automatically an acceptable interpreter for all purposes. They still may need to be from a prescribed body or have an exemption under regulation 13(1) for the purposes of section 7(a). The regulation is narrow; a speech pathologist cannot rely on it to avoid all interpreter requirements.

The prescribed period of three business days for permit determination (regulation 16) is very short. This may be unrealistic for complex cases where the Chief Executive needs additional information. There is no provision for an extension of time. If the Chief Executive fails to determine within three business days, the application has not been refused or granted; it is simply pending. The Act’s provisions on deemed refusal or reasons may then apply, but the regulations do not address this gap. An applicant may be left in limbo.

Regulation 20 allows “any other person who the Tribunal is satisfied has a sufficient interest in the matter” to apply for review. This is a broad and potentially disruptive category. A person who opposes voluntary assisted dying in general could potentially claim a sufficient interest and apply for review of a permit decision. The Tribunal must determine the question on a case-by-case basis. This could lead to delays and additional stress for the person seeking voluntary assisted dying.

Finally, the regulations do not provide any form of model of the compulsory prescriptions, nor do they include a schedule of forms. The entire form system is delegated to the Executive branch. This may reduce parliamentary oversight of the content of forms. A future amendment to a form could effectively change the process without legislative scrutiny.

Complying with the Voluntary Assisted Dying Regulations 2022 requires meticulous attention to the current versions of all prescribed forms, adherence to physical security standards, and proper use of interpreters. The following steps are derived directly from the regulations.

First, identify all forms that will be needed for the particular pathway (self administration or practitioner administration). Obtain the current versions of each form from the South Australian Government Gazette. The relevant forms are: consulting assessment report form, contact person appointment form, coordinating medical practitioner administration form, final review form, first assessment report form, voluntary assisted dying substance dispensing form, voluntary assisted dying substance disposal form, written declaration, application for self administration permit, application for practitioner administration permit, voluntary assisted dying permit (to be issued by the Chief Executive), and labeling form for the substance. Check the Gazette on a regular basis - at least monthly - to see if any form has been updated. Maintain a register of form versions used for each person, including the Gazette number and date.

Second, ensure that all persons involved in the process use only the current prescribed forms. The coordinating medical practitioner must complete the coordinating medical practitioner administration form when administering the substance (regulation 6). The consulting medical practitioner must use the consulting assessment report form and the first assessment report form (regulations 4 and 8). Both must complete the final review form (regulation 7). The person must use the written declaration form (regulation 11). For permits, the application forms under regulations 14 or 15 must be submitted. The dispensing form (regulation 9) must be used by the pharmacist or coordinating medical practitioner when dispensing the substance. The disposal form (regulation 10) must be used for any disposal.

Third, comply with interpreter requirements. Use only interpreters who are accredited by NAATI or by any other body specified by the Minister in a Gazette notice (regulation 12). If it is not possible to obtain such an interpreter, apply to the Chief Executive for an exemption under regulation 13(1). The application must be in the manner and form determined by the Chief Executive. Be aware that a speech pathologist is automatically exempt from the requirement in section 7(b)(iv) of the Act, but this does not mean they can replace a prescribed interpreter for all purposes. Record the interpreter’s accreditation details and the date of the exemption, if any.

Fourth, secure storage. Obtain a locked box that meets the specifications of regulation 18: made of steel, not easily penetrable, and with a lock of sturdy construction. A heavy-duty steel safe with a key lock or combination lock would satisfy this. Place the voluntary assisted dying substance in that box whenever it is in your possession. Ensure that any other person who receives the substance (such as the pharmacist or the person themselves if self-administering) also has a compliant box. Affix the prescribed label to the substance container using the current form (regulation 19).

Fifth, observe the three business day period for permit determination (regulation 16). Submit the application promptly and monitor the Chief Executive’s decision. If a decision is not made within three business days, follow up with the department and consider seeking legal advice about the status of the application.

Sixth, if a reviewable decision is made, be aware that family members and persons with sufficient interest may apply for review to the Tribunal (regulation 20). If you are a medical practitioner or health service, inform the person and their family about this right.

Seventh, maintain records of all forms used, interpreter accreditation, storage details, and any exemptions granted. These records may be needed to demonstrate compliance in the event of an audit or investigation.

Finally, review any changes to the regulations or any new Gazettes. The Minister may specify additional interpreter bodies, and the forms may change. Stay current through the SA legislation website and the Gazette. The regulations themselves are unlikely to be amended frequently, but the forms determined under them may change without notice.