• If a person has decision-making capacity, they can consent to or refuse the COVID-19 vaccine.
• If they don’t have capacity, and there is no advance care directive, their medical treatment decision maker can consent to or refuse the vaccine.
  • The consent or refusal must be based on the person’s values and preferences.
  • If the person's values and preferences can’t be determined, the decision must be based on what best promotes their personal and social wellbeing.
• If there is no medical treatment decision maker, a health practitioner, such as the person’s GP, needs to decide if the vaccine administration is ‘significant’ or ‘routine’ treatment.
  • If it is routine treatment, the health practitioner can make the decision but must record the details in their notes.
  • If it is significant treatment, for example if the injection will cause the person distress or there is a risk of significant side effects, the health practitioner must request the Public Advocate to make the decision (by completing the s.63 for COVID-19 vaccine online form). 

Guideline

The administration of the COVID-19 vaccine is considered to be medical treatment under the Medical Treatment Planning and Decisions Act 2016 (MTPDA) as it will be:

• treatment by a ‘health practitioner’, expected to be a doctor or registered nurse

• for the purpose of preventing disease

• in the form of a prescription pharmaceutical.

As such, how a decision is made to consent or refuse the vaccine is the same process as is for any other medical treatment decision. Note that:

• it is not mandatory to have the COVID-19 vaccine (and therefore it is not a public health decision)

• it is a legal right of the patient or the medical treatment decision maker to refuse the vaccine if it aligns with the patient’s preferences and values; or if they cannot be established, if this were to promote the patient’s personal and social wellbeing

• the vaccine is expected to be administered via an injection, in two doses

• where a guardianship order is in place, the order will only have effect if it has an authority for medical treatment. Guardians need to ensure they have the appropriate authority before providing consent.

Consent process

1. If the patient has decision-making capacity to make decisions then they can consent or refuse of their own volition.
2. If the patient is assessed to lack decision-making capacity, then their medical treatment decision maker will make the decision to consent or refuse the vaccine (regardless of whether the vaccine is deemed to be significant or routine medical treatment) but, in doing so, must take note of any advance care directives in place and of the patient’s values and preferences (as per the MTPDA).
3. If the patient lacks decision-making capacity and has no medical treatment decision maker then, at this point, the treating health practitioner must determine whether the vaccine is deemed to be significant treatment or routine treatment (as defined by the Act; further guidance for the health practitioner is available in the ‘Significant treatment clinical guidelines for the Medical Treatment Planning and Decisions Act 2016’, published by the Department of Health and Human Services:
   1. if the health practitioner deems the vaccine to be routine treatment, they can proceed without consent, but must document their actions in the patient’s medical records
   2. if the health practitioner deems the vaccine to be significant treatment, then they will need to submit a s.63 form to OPA. For the health practitioner to consider if it is significant treatment it must be because there is a significant degree of bodily intrusion, significant risks, significant side effects, or significant distress of the patient.
4. If a medical treatment decision maker has refused significant treatment and the health practitioner reasonably believes the patient’s preferences and values are not known or unable to be known or inferred, the health practitioner may submit a s.62 notice to OPA. OPA must then consider whether an application to VCAT is necessary. Note that it may well be legitimate that the medical treatment decision maker refuses the treatment, given the criteria in s.61 of the MTPDA.

Other considerations

• It is understood that the vaccine will be provided to aged care and disability facilities by a specialist care team who will also monitor for side effects. As such, the usual contact that the medical treatment decision maker has with GPs may not be relevant in the vaccine rollout.

• Hospitals are expected to use their own resources for the administration of the vaccine.

• Known risks/side effects of the vaccine:

• Common: fatigue, fever, headache, aching limbs/muscle weakness, which should subside over a few days

• Rare but documented: allergic reactions and anaphylaxis.

If you are the medical treatment decision maker making a decision on behalf of the patient, be aware that if you have consented to the treatment but, on the day, the patient is unable to cooperate with the person administering the vaccine, the vaccine may not be administered.

In making your decision consider:

• what are the patient’s values about COVID-19

• what are the patient’s preferences and values about a COVID-19 vaccine

• what are the patient’s preferences and values about vaccinations in general

• what are the patient’s preferences and values about injections (for example, if the patient has a fear of needles, they may be about the form of administration of the vaccine, rather than its purpose and effect)

• has the patient consented or refused other vaccinations in the past; has the patient suffered any side effects to vaccinations in the past; if a previous vaccination has been administered as routine treatment (and, therefore, the patient’s consent was not required), was the patient accepting of this/opposed to this

• what are the patient’s preferences and values about their health and medical treatment in general and how this might inform their thoughts about the vaccine.