What happens when a patient cannot consent to a COVID-19 vaccine?

This article was co-authored by Scott Walker, Paralegal.

For most people, getting their COVID-19 vaccine will be as simple as booking an appointment and presenting for a ‘jab’, but for those who lack capacity to consent to the vaccine, who can be among the most vulnerable to COVID-19, the process is less straightforward. The law in this area involves a careful balancing of the patient’s right to autonomy and self-determination with the right to life and the highest attainable standard of health. While the issue of capacity to consent to medical treatment is far from novel, some recent UK cases relating to COVID-19 vaccine refusal highlight what may be taken into account by a court in such cases.

Recent case illustrations

In each of the following cases, the Court of Protection of England and Wales was called to determine whether a care home resident who lacked capacity to consent should receive the COVID-19 vaccine in the face of objections from their relatives. In each case, the Court held that it was in the person’s best interests to receive the vaccination and ordered that it be given.

Re E v London Borough of Hammersmith and Fulham

Mrs E was 80-years-old with a diagnosis of dementia and schizophrenia, who had been living in a care home in London since the end of March 2020. Mrs E’s son, W, objected to his mother receiving the COVID-19 vaccine. The local authority responsible for the care home applied to the Court for a declaration pursuant to s 15 of the Mental Capacity Act 2005 (UK) that it would be lawful and in Mrs E’s best interests to receive the vaccine at the next possible date.

W was concerned about: the vaccine’s efficacy; the speed at which it had been authorised; whether it had been adequately tested on the cohort to which his mother belongs; and whether Mrs E’s true wishes and feelings had been canvassed. The Court determined that these views were more likely to be W’s own views and not in accordance with Mrs E’s approach to life or medical treatment.

In order to ascertain Mrs E’s past and present wishes and feelings and her beliefs and values, the Court gave weight to Mrs E’s previous adherence to public health advice on vaccinations, including regular influenza vaccines and a vaccination for swine flu. Further, Mrs E was documented as having articulated trust in health advice, telling her GP that she wanted ‘whatever is best for me’.

Considering the risk presented by COVID-19 to Mrs E without the vaccine, the Court summarised the following points:

• Mrs E was in her 80s
• Mrs E was living in a care home
• The care home in which Mrs E lived had recent confirmed positive cases of COVID-19
• Mrs E had type 2 diabetes
• Mrs E lacked the capacity to understand the nature and transmission of COVID-19 and, as a person living with dementia, was challenged in complying with social distancing
• The COVID-19 vaccine reduces the risk of death or serious adverse outcomes from COVID-19 ‘dramatically’.

The Court ordered that it was in Mrs E’s best interests to receive the vaccine because of the unacceptable risk to her health and life posed by the threat of COVID-19. Further, in light of the COVID-19 outbreak currently at the care home, the Court ordered that Mrs E should receive the vaccine as soon as practically possible.

SD v Royal Borough of Kensington and Chelsea

V was a woman in her early 70s who had been living in a care home in the south-west of England. V had been living with Korsakoff’s syndrome for over a decade. V’s daughter, SD, sought a declaration from the Court that it would not be lawful or not in V’s best interests to administer V with a COVID-19 vaccination or any other vaccine. SD’s evidence was that her mother was too diffident to medical advice and the medical profession generally and therefore unquestioningly followed their advice. Further, SD told the Court that she was concerned about the efficacy and testing of the COVID-19 vaccine and considered that it would pose an unacceptable risk to her mother.

In considering V’s wishes, the Court had regard to her previous compliance with public health vaccine campaigns. Further, V had evinced an eagerness to receive the COVID-19 vaccine and had willingly lined up with other residents to receive the vaccine before being told SD objected to her receiving it. The Court considered that because of V’s age and her short-term memory problems, which made following social distancing measures and hygiene requirements difficult, there was an unacceptable risk of death or serious harm to health posed by COVID-19 without a vaccine.

The Court determined that the risk to V’s life and health were unacceptably high if she did not have the vaccine, therefore it was in her best interests to have it. In so doing, the Court reminded the parties that it was V’s interests and voice that the Court should hear and not the views and voices of others, including family members, however well-intentioned they were.

NHS Tameside & Glossop CCG v CR

CR was a 31-year-old man living with disabilities, autism and epilepsy. He had been living in a care home since early January 2021 for assessment related to his disability. CR’s father, SR, objected to him receiving the vaccination, for a number of reasons which included:

• CR’s background health issues
• CR’s worry that some people had died after having the vaccine
• CR’s concern that the period of testing for the vaccine was too short and that it had not been done sufficiently
• SR’s concern that a previous vaccine had caused CR’s autism.

In considering CR’s best interests, the Court was mindful that although CR was not an elderly person, he lived with significant disabilities and health conditions which rendered him a clinically vulnerable person to COVID-19. Further, the risk of infection whilst living in a care home was unacceptably high, engaging CR’s right to life. The Court took into account the fact that CR had a history of phobia to hospitals and health interventions, but still had previously undergone blood tests and had received vaccinations in the past. Weighing all of these matters, the Court granted a declaration that it was lawful for the local authority to vaccinate CR, provided that they did not require physical restraint to do so.

The requirement for informed consent

In Australian as well as UK law, an adult with decision-making capacity has the right to consent and withhold consent to medical treatment. According to this principle, a competent adult has the right to refuse medical treatment ‘for religious reasons, for rational or irrational reasons, or for no reason at all’. Where informed consent is not obtained, a practitioner who provides medical treatment without consent may commit a criminal offence or be liable in a civil claim for negligence.

Valid, informed consent requires the following:

• the capacity to make treatment decisions
• the consent must be free and voluntary
• the consent must cover the act to be performed.

In order to have decision-making capacity, it is generally accepted that the person must be able to:

• take in and retain information about their treatment
• weigh that information, balancing the risks posed by the treatment with their own needs.

What happens in Victoria if a person does not have decision-making capacity?

Where a person does not have decision-making capacity in Victoria, there is a hierarchy of persons who can consent to medical treatment on behalf of a person. The hierarchy is as follows:

• a medical treatment decision-maker appointed by the person
• a guardian appointed by the Victorian Civil and Administrative Appeals Tribunal (‘VCAT’), with authority to make medical decisions
• the first of the following persons who is in a ‘close and continuing relationship’, who is ‘reasonably available’ and who is ‘willing and able’ to make medical treatment decisions:
  • the person’s spouse or domestic partner
  • the person’s primary carer
  • the person’s adult child
  • the person’s parent
  • the person’s adult sibling

Under the Medical Treatment Planning and Decisions Act 2016 (Vic), a person who has decision-making capacity may also make an advance care directive. This is either an ‘instructional directive’ or a ‘values directive’ in relation to their future care should they become unable to exercise decision-making capacity in the future. An instructional directive is an express statement in an advance care directive of a person’s medical treatment decision which takes effect as if the person consented to or refused consent to medical treatment. A practitioner can refuse to comply with an instructional directive if: the circumstances have changed whereby the directive is no longer consistent with the person’s preferences and values; and applying to VCAT for a formal order would lead to a significant deterioration in the person’s condition.

A values directive is a statement in an advance care directive of a person’s preferences and values regarding medical treatment decisions to be made on their behalf. It may take the form of a statement of medical treatment outcomes which the person considers to be acceptable. A values directive is non-binding.

Additionally, the Supreme Court of Victoria has ‘parens patriae jurisdiction’, whereby the Court has power to make decisions in the best interests of persons unable to take care of themselves, including infants and those of ‘unsound mind’. This power enables the Court to authorise the provision of medical treatment, or to provide consent to the treatment on behalf of an adult who lacks decision-making capacity. However, because of the statutory decision-makers considered above, the parens patriae power is rarely resorted to for adults.

What happens if there is no medical treatment decision-maker?

If there is no advance care directive and no medical treatment decision-maker, a practitioner may administer routine treatment without consent. If the treatment is ‘significant treatment’, the treatment may only be administered with the consent of the Public Advocate. Significant treatment means treatment that involves a significant degree of bodily intrusion, a significant risk to the person, significant side effects, or significant distress to the person. Routine treatment is all other treatment. It is for the practitioner to decide whether the treatment is routine or significant treatment.

Key takeouts for medical practitioners

• If a patient is unable to consent to receive the COVID-19 vaccine, a practitioner must first ascertain whether there is a valid advance care directive in place which relates to the administration of vaccinations. If it is an instructional directive, this must be followed unless it appears no longer consistent with the person’s preferences because circumstances have changed.
• If a patient is unable to consent to receive the COVID-19 vaccine, a practitioner must consider whether there is an appropriate medical treatment decision-maker who is ready and available to act. If so, there is a strict hierarchy about who is empowered to make the decision.
• If there is no medical treatment decision-maker and no advance directive, the practitioner can provide the COVID-19 vaccination without consent if the practitioner determines that the vaccine is routine treatment. If the vaccine is determined as significant treatment, then the practitioner must apply to the Office of the Public Advocate for consent, who may seek a VCAT hearing.
• In determining whether to give consent for the vaccine, VCAT or the Supreme Court exercising parens patriae power, may consider the following factors:
  • It is not mandatory to have the COVID-19 vaccine
  • It is a legal right of the patient or the medical treatment decision-maker to refuse medical treatment if it aligns with the patient’s preferences and values
  • The known risks/side effects of the COVID-19 vaccine
  • The patient’s values about the COVID-19 vaccine and vaccinations in general
  • The patient’s preferences and values about their health and medical treatment in general and how this might inform their thoughts about the vaccine.

If a practitioner has any concerns in relation to a patient’s capacity to consent or a medical decision maker’s refusal to provide consent to the COVID-19 vaccine, advice should be sought from the practitioner’s medical indemnity insurer.

This article was originally published in AMA Victoria's blog, Stethoscope

Read other items in the Australian Healthcare Brief - July 2021