VOLUNTARY ASSISTED DYING ACT 2017 (VIC) AND REGULATIONS
After considered and prolonged debate, the Victorian Parliament passed the Voluntary Assisted Dying Act 2017 (Vic) (Act), to come into force on 19 June 2019. The Voluntary Assisted Dying Regulations 2018 (Vic) (Regulations) including prescribed forms for the voluntary assisted dying scheme (VAD Scheme) have recently been passed to come into force on the same date.
The Act provides for access to voluntary assisted dying for adults with decision-making capacity who are suffering from an incurable disease that is expected to cause death in six months or less (or 12 months in the case of a neurodegenerative disease), where their suffering cannot otherwise be alleviated in a way that is acceptable to the person. In practice, this means the person can gain access to a lethal dose of medication (called ”voluntary assisted dying substance” in the Act) that will cause death when ingested, or for a person to have such a substance administered to them by a medical practitioner upon request, where the person is unable to self-administer.
Persons exercising a power or performing a function or duty under the Act must have regard to a number of principles, including the equal value of all human life, the need to respect a person’s autonomy, a person’s right to receive appropriate information to make informed decisions about their care, the importance of a person receiving care that maximises quality of life and minimises suffering, the value of openly discussing death and dying and related individual preferences [section 5 of Act].
The Act also provides for an extensive regime of oversight by the Voluntary Assisted Dying Review Board (Board). Insofar as registered health practitioners, including medical practitioners, are intended to participate in the VAD Scheme, the Act provides for registered health practitioners to refuse to participate in any part of the VAD Scheme, where the practitioner has a conscientious objection to voluntary assisted dying.
This update provides:
- an overview of key elements of the VAD Scheme under the Act and Regulations; and
- some points for health service organisations and registered health practitioners to consider in moving towards implementation, based on guidance from the Department of Health and Human Services (DHHS).
Key Elements of the VAD Scheme
Who is eligible to access voluntary assisted dying?
Individuals are eligible to access voluntary assisted dying [section 9 of Act] if they:
- are aged 18 years or older;
- are an Australian citizen or permanent resident;
- have been residing in Victoria for no less than 12 months;
- have decision-making capacity;
- suffer from a disease, illness or condition that is incurable, and is expected to cause death within no more than six months (or 12 months in the case of a neurodegenerative disease), as certified by two experienced medical practitioners; and
- are suffering in a manner that cannot be relieved in a way that is tolerable to the person.
Health Practitioners may not initiate discussion
Registered health practitioners must not directly or indirectly initiate discussion around voluntary assisted dying [section 8 of Act]. Any violation of this prohibition constitutes unprofessional conduct under the Health Practitioner Regulation National Law (National Law). Health practitioners may, however, provide information about the VAD Scheme where the patient requests it.
The steps in the VAD Scheme
If a person wishes to access voluntary assisted dying, they must follow the following steps [section 6 of Act]:
- the person must make a first request to a medical practitioner, who (subject to having the required qualifications as set out below) becomes the co-ordinating medical practitioner if accepting the request;
- the person must have been assessed by the co-ordinating medical practitioner and an additional consulting medical practitioner as eligible (based on the criteria set out above);
- having been so assessed, the person may if desired make a written declaration to seek to access voluntary assisted dying [section 34 of Act]. The declaration must specify that the person makes the declaration voluntary and without coercion, and understands its effects. The declaration may be made with the assistance of an appropriately qualified interpreter and may be signed by a different person on the direction of the person making it. Such a declaration must be signed in front of two witnesses and the co-ordinating medical practitioner. Persons who may benefit from the death of the relevant person, and persons providing healthcare or residential care to the person, are not eligible as witnesses, and no more than one witness may be a family member [section 35 of Act];
- the person must then make a final request to the co-ordinating medical practitioner;
- the person must appoint an adult contact person who has the obligation to return any remaining voluntary assisted dying substance to the dispensing pharmacy following the person’s death, or where the person becomes unable to self-administer the substance [section 39 Act];
- the coordinating medical practitioner must certify in a final review form that the process required under the Act has been complied with, which then allows the coordinating medical practitioner to apply for a voluntary assisted dying permit [section 43 Act] in the form prescribed in the Regulations. The Secretary must decide on the outcome of such an application in 3 business days [reg 7]; and
- the person must be the subject of a voluntary assisted dying permit for self-administration or practitioner administration, in the form prescribed by the Regulations.
The details of access to and handling of the voluntary assisted dying substance are set out in the relevant part below.
To assist persons seeking access to voluntary assisted dying to navigate the required steps, it is intended to provide additional support through dedicated “care navigators”. Initially, Peter McCallum Cancer Centre in Melbourne will be hosting two care navigators for 12 months to test and refine the roles and responsibilities for these positions. Recommendations about a Statewide care navigator service model and access pathways will then be developed based on the learnings.
A person seeking access to voluntary assisted dying, or their agent, may apply to VCAT for review of a decision in relation to residency status or lack of decision-making capacity [section 68 of Act].
Medical practitioners must hold specialty registration, or be a vocationally registered general practitioner, to be able to act as co-ordinating or consulting medical practitioner [section 10 of Act]. Co-ordinating medical practitioners must also have completed mandatory training as approved by the Secretary, details of which are not yet available [section 17 of Act].
Registered health practitioners who have a conscientious objection to voluntary assisted dying have a broad right to refuse to participate in any aspect of the VAD Scheme [section 7 of Act]. They do not have an obligation to refer patients to a practitioner who does not have such objections.
“Conscientious objection” is not defined, and we would anticipate that this would be a subjective rather than objective standard, in accordance with the principle that “all persons, including health practitioners, have the right to be shown respect for their culture, beliefs, values and personal characteristics.” [section 5(1)(j) of Act.]
The Act and Regulations provide comprehensive requirements for any dealings with the medication intended to cause death in the VAD Scheme, referred to as “voluntary assisted dying substance” (Substance). The Substances to be prescribed by the co-ordinating Medical Practitioner will be based on a best practice medication protocol that has been developed by a working group of the Voluntary Assisted Dying Implementation Taskforce with appropriate expert advice. To minimise any risk of abuse or misuse, the content of the medication protocol will not be made publicly available. It will only be provided to medical practitioners who have completed the required training, and therefore have a legitimate need to know its contents, on condition of confidentiality.
Statewide Pharmacy Service
DHHS has provided guidance (“Voluntary Assisted Dying Statewide Pharmacy Service”) indicating that a single Statewide pharmacy service located at the Alfred Hospital in Melbourne (Service) will import, compound, store, pack and dispense medications for voluntary assisted dying. The Service will be notified by DHHS of the medical practitioners who have completed relevant requirements and are permitted to prescribe the Substances.
The Service will dispense the prescribed medication to the patient or medical practitioner. For patients in rural areas, the Service will deliver the Substance as required. The Service will also receive any returned Substance or retrieve it from rural locations as required.
The Service will be overseen by the Voluntary Assisted Dying Review Board.
Information that must be provided
Where a person has obtained the relevant permits, and receives a prescription, the co-ordinating medical practitioner must instruct the person:
- in how to administer the Substance;
- that they are not under any obligation to self-administer the Substance;
- that they must arrange for the return of any unused prescriptions for the Substance to the practitioner;
- that any unused Substance must be returned to the pharmacy by the person (or the contact person following the death of the person); and
- that they must continue to store the Substance in the locked box it was dispensed in (prescribed to be constructed of steel, not easily penetrable, and with a lock of sturdy construction) [section 57 of Act].
The pharmacist dispensing the Substance must provide the same information [section 58 of Act] and must record and notify (using the prescribed form, which is not yet available) within 7 days details of what Substance was dispensed, and compliance with the requirements to provide information, and labelling requirements.
The Substance must be labelled as prescribed in the Regulations, including the clear warning that “If ingested, this substance will cause death” [section 59 of Act, also Regulations, regulation 9, form 5].
The person to or for whom the Substance has been dispensed must continue to store it in the locked box it was dispensed in, and return it if deciding to not, or becoming unable to, self-administer [section 61 of Act]. If the person lives for longer than the expected 6 or 12 months, they are not obligated to return the substance. If any unused Substance remains upon the death of the person, the contact person must return it to the dispensing pharmacy.
If a person is or becomes unable to self-administer the Substance, the co-ordinating medical practitioner may, in the course of the process as set out above, apply for a practitioner administration permit.
Administering the Substance under a practitioner administration permit
Where a practitioner administration permit has been granted in relation to a person, the co-ordinating medical practitioner may, subject to specific conditions, supply and administer the Substance to the patient [section 46 of Act].
Where the person the subject of the practitioner administration permit has decision-making capacity and an enduring intent to access voluntary assisted dying, the person may in the presence of a witness make an administration request (including verbally, by gesture or by other means of communication) to the co-ordinating medical practitioner to administer the Substance [section 64 of Act].
If the co-ordinating medical practitioner is satisfied as to the person’s capacity and enduring intent, and that the person in making the request is acting voluntarily and free from coercion, the co-ordinating medical practitioner may administer the Substance immediately following the administration request.
The witness must be independent of the coordinating medical practitioner and must certify in the prescribed form in writing that the person at the time of the request appeared to have capacity and act without coercion, and had an enduring intent, and that the co-ordinating medical practitioner administered the Substance [section 65 of Act].
Following administration of the Substance, the co-ordinating medical practitioner must on the same form as the witness certify that the person was incapable of self-administering the Substance, that the person had capacity, acted without coercion, and had the relevant intent. A copy of the form must be provided to the Board within 7 days.
Notification obligations for medical practitioners after the death of a person
A medical practitioner who was responsible for a person’s care before death, or examines the body of a deceased person after death, must notify the Registrar and the Coroner of their reasonable belief or knowledge of any of the following:
- the person was the subject of a voluntary assisted dying permit, and did self-administer the Substance; or
- the person was the subject of a voluntary assisted dying permit, and did not self-administer the Substance; or
- the person was the subject of a practitioner administration permit, and was administered the Substance in accordance with the permit;
and the disease, illness or medical condition that was the grounds for the person to access the VAD Scheme [section 67 of Act]. This obligation is in addition to notification obligations under the Births, Deaths and Marriages Registration Act 1996 (Vic).
Protection from liability when acting in accordance with the Act
Registered health practitioners who act in good faith, without negligence, and in accordance with the Act are not guilty of any offence or unprofessional conduct or professional misconduct and are not subject to any civil liability in relation to such actions [section 80 of Act].
This freedom from liability includes the circumstances where registered health practitioners are present and do not administer life-saving or life-sustaining treatment where they have a reasonable belief that a person is dying after being administered or self-administering a Substance (unless the person requests such treatment) [section 81 of Act].
However, the Act does establish several offences for non-compliance [sections 83-91 of Act].
Mandatory reporting for practitioners and employers
Registered health practitioners or their employers (or entities contracting with practitioners for services) are required to notify the Australian Health Practitioner Regulation Agency (AHPRA) as soon as possible where they form a belief on reasonable grounds that a health practitioner in providing health or professional care services acts in a manner that is not compliant with the Act by initiating a discussion about or suggesting voluntary assisted dying, or offering to provide access to voluntary assisted dying other than in accordance with the Act [sections 75 and 76 of Act]. For practitioners, failure to comply with the notification obligation will constitute unprofessional conduct under the National Law. Other persons may make a notification to AHPRA under such circumstances.
The role of the Board
The Board as established under the Act and initially appointed for 6 years consists of currently 13 members from backgrounds including the judiciary, various areas of medicine and nursing, pharmacy, and consumer representation. It has broad powers to monitor and assess the operation of the VAD Scheme, refer resulting issues to the relevant authorities, and consult on the operation of the VAD Scheme [section 93 of Act].
Preparing for implementation of the VAD Scheme
The Act and Regulations come into force on 19 June 2019. DHHS has provided and continues to provide further additional resources to assist individual healthcare providers and healthcare organisations in working towards implementation of the VAD Scheme.
DHHS will make further resources under different projects of the Implementation Taskforce available in future. Some of the resources have been prepared in collaboration with the Victorian Healthcare Association.
Considerations for health service organisations
Health service organisations should consider how they might be involved in the VAD scheme in view of the services they provide. They should consult with stakeholders, including registered health practitioners employed by or otherwise practising at the health service organisation, to reach a view about whether the health service organisation will or will not participate in the VAD Scheme. They should also aim to bring relevant information material to the attention of their staff.
While the Act addresses conscientious objection by individual practitioners, the Second Reading Speech and DHHS materials clearly indicate an expectation that organisations will, as a whole, be able to refuse to participate in the VAD Scheme. The Second Reading speech for the Bill underlying the Act articulates the expectation in relation to organisations as follows: “While some organisations may opt not to provide voluntary assisted dying, it is expected that they will continue to support all of their patients by providing access to high-quality healthcare services.”
Based on the outcome of the decision, health service organisations will then need to decide how to respond to patient requests to access voluntary assisted dying. If refusing to participate in the VAD Scheme, organisations are not obligated to refer patients, but they should not inhibit a person’s access to voluntary assisted dying and should inform the patient of the refusal as soon as possible.
If deciding to provide health services related to voluntary assisted dying, health service organisations should consider organisational implications, including how they will accommodate conscientious objectors, and how they will support staff participating in access to voluntary assisted dying, both procedurally and in relation to staff mental and emotional health needs.
Implementation by health service organisations
The Victorian Healthcare Association has developed the “Voluntary assisted dying safety and quality guidance for health services” which include an overview of the application of the Australian Safety and Quality Framework for Health Care (2010) and Aged Care Quality standards to health service implementation of voluntary assisted dying, as well as an implementation checklist.
It has also developed the “Voluntary assisted dying model of care pathways for health services” (VAD Pathways Guidance), which is intended to assist health services in developing and implementing a care pathway for voluntary assisted dying that is appropriate for the relevant entity’s resources, and the services that they can and are willing to provide.
Specific high-level pathways are:
- Pathway A – Single Service: Such as eg tertiary metropolitan health services that will have the resources and staff to provide all voluntary assisted dying support in their own networks;
- Pathway B – Partnership Services: Such as eg rural or regional or smaller, and multi-purpose services that provide services to persons nearing the end of their life. These services may facilitate the assessment process, but will need to partner with other services or suitably qualified general practitioners to access specialist services as necessary; and
- Pathway C – Information and support services: This includes services that choose to not participate in the VAD scheme, as well as health services that do not provide care to persons nearing the end of their life. Such services will need to provide relevant information and possibly referrals where patients seek this.
Individual health practitioners
Individual registered health practitioners should consider how the VAD Scheme will impact them in view of the work they do, and the likely position of organisations where they practice. If they expect to be asked to participate in aspects of the VAD Scheme, they should consider if they hold any conscientious objection, and what if any aspect of the scheme they wish to refuse to participate in based on these objections. The VAD Pathways Guidance also addresses conscientious objection in the context of the professional obligations of different registered health practitioners.
If medical practitioners meeting the specialist registration or vocational registration requirement expect to be called upon to participate, and are not conscientious objectors, they should seek to undergo the mandatory training once available.
The VAD Scheme provides regulated and transparent access for patients with decision-making capacity to die peacefully and painlessly at a time of their own choosing when they are nearing death, and where their suffering cannot be relieved in a manner that is acceptable to them. It also provides a framework for appropriately qualified medical practitioners to provide care in accordance with the patient’s wishes, in a way that is compatible with the practitioner’s professional obligations.
Where a registered health practitioner holds a conscientious objection to patients choosing the time and manner of their own death, or to the practitioner playing any part in this, the VAD Scheme ensures that the practitioner is not required to participate or facilitate the patient making and enacting such a choice.