TBC

QUEENSLAND CIVIL AND
ADMINISTRATIVE TRIBUNAL

CITATION:

TBC [2024] QCAT 590

PARTIES:

In an application about matters concerning TBC

APPLICATION NO/S: GAA13567-24

MATTER TYPE:

Guardianship and administration matters for adults

DELIVERED ON:

17 December 2024 (ex tempore)

HEARING DATE:

17 December 2024

HEARD AT:

Brisbane

DECISION OF:

Senior Member Browne, Presiding
Member Dr Pinkerton

ORDERS:

1.     The Tribunal approves the participation in the following experimental health care for TBC:

(a)     Phase II Trial of BTK and immune Checkpoint Inhibitor in CNS Lymphoma.

2.     The approval remains current for two (2) years.

CATCHWORDS:

HEALTH LAW – GUARDIANSHIP, MANAGEMENT AND ADMINISTRATION OF PROPERTY OF PERSONS WITH IMPAIRED CAPACITY – OTHER – whether there are ‘special circumstances' under s 131 of the Guardianship and Administration Act 2000 (Qld) – whether the adult has capacity to make decisions about participating in experimental health care – where the adult does not have capacity for experimental health care – whether the Tribunal should approve the adult’s participation in experimental health care – where the Tribunal approved the adult’s participation in experimental health care – where the Tribunal considered the meaning of ‘experimental’ – whether the Tribunal is satisfied the health care is ‘special health care’

HUMAN RIGHTS – HUMAN RIGHTS LEGISLATION – where the Tribunal identified human rights affected by the decision – where the Tribunal considered the decision was compatible with human rights – where the Tribunal considered limits to human rights were reasonable and justified – where the Tribunal considered the right to be recognised as a person before the law – where the Tribunal considered the right of equal protection of the law without discrimination – where the Tribunal considered the right to life and the right not to be arbitrarily deprived of life – where the Tribunal considered rights to privacy and reputation – where the Tribunal considered the right to a fair and public hearing

Guardianship and Administration Act 2000 (Qld), 11B, s 68, s 72, s 125 , s 131, sch 2, sch 4

Human Rights Act 2019 (Qld), s 13, s 16, s 25, s 31, s 58

Powers of Attorney Act 1998 (Qld), 62, s 63, sch 2

APPEARANCES & REPRESENTATION:

Adult:

J Abraham of Aged and Disability Advocacy Law, by videoconference

Applicant:

Dr F Zhao, by videoconference

Statutory health attorneys:

MPE and NQG, by videoconference

REASONS FOR DECISION

Senior Member Browne: These are the Tribunal’s reasons in relation to the matter of GAA13567-24, concerning TBC, on the 17^th of December 2024. The Tribunal today is constituted by Senior Member Browne presiding, together with Member Pinkerton.
Dr Frances Zhao has applied to the Tribunal for approval of special health care that includes experimental health care for TBC. The application is urgent because TBC has a disease called relapsed primary central nervous system lymphoma. The condition is unfit for standard therapy.
The central nervous system includes the brain and spinal cord. The type of lymphoma is caused by a growth of abnormal B cells that are a type of immune cell that may help to fight infection. If the disease is left untreated it will result in TBC’s death.
The Tribunal is satisfied that special circumstances exist in this matter such that it is necessary, for the purposes of section 131 of the Guardianship and Administration Act 2000 (Qld) ('GA Act’), for the Tribunal to act quickly, and to decide the application on the information before it without receiving further information. The Tribunal also abridges the time for giving notice of the hearing to enable the matter to proceed today.
Dr Zhao seeks the Tribunal’s approval to use a treatment identified as Phase II Trial of BTK, an immune Checkpoint Inhibitor in CNS Lymphoma. The proposed treatment is said to be experimental health care that requires the participant’s consent. There is a question about TBC’s ability to give informed consent to participate in the health care because of the disease affecting the central nervous system that includes the brain.
This brings us to the underlying reason for the application, that is, for the Tribunal to give consent for TBC’s participation in the experimental health care. It is helpful to set out the law and the Tribunal’s power to give consent for a person to participate in experimental health care that is as provided under section 72 of the GA Act.
The starting position is section 68 of the GA Act, which gives the Tribunal the power to consent to special health care, including participation in special medical research or experimental health care.
Relevantly, under section 72 of the GA Act, the Tribunal may consent, for an adult with impaired capacity for the special health matter concerned, to the adult’s participation in special medical research or experimental health care relating to a condition the adult has, or to which the adult has a significant risk of being exposed, only if the Tribunal is satisfied as to the following matters:
(a) the special medical research or experimental health care is approved by an ethics committee;
(b) the risk and inconvenience to the adult and the adult’s quality of life is small;
(c) the special medical research or experimental health care may result in significant benefit to the adult;
(d) the potential benefit can not be achieved in another way.
Importantly, special medical research or experimental health care does not include psychological research or approved clinical research. The words, ‘special medical research’, or ‘experimental health care’ are further defined under schedule 2 of the GA Act.
The first issue to be considered by the Tribunal today is whether TBC has capacity, as defined under schedule 4 of the GA Act, to make decisions about special health care matters, including participating in experimental health care. The treatment described as Phase II trial of BTK, an immune Checkpoint Inhibitor in CNS Lymphoma, is detailed in a document filed, together with the application titled Participant Information Sheet.
The treatment involves a combination of drugs called Zanubrutinib and Tislelizumab. Zanubrutinib was approved for use in Australia by the Therapeutic Goods Administration (‘TGA’) in October 2021 for the treatment of two different types of lymphoma: namely, Mantle cell lymphoma and Waldenström’s macroglobulinemia. Put simply, Zanubrutinib is approved by the TGA for two types of lymphoma, but not CNS lymphoma. Tislelizumab has not been approved by the TGA for use in Australia.
The study is designed to determine the effectiveness of combination treatment in CNS lymphoma. The proposed treatment involving Zanubrutinib and Tislelizumab are described as experimental drugs and treatment that may or may not have any direct medical benefit to the participant.
The words ‘experimental’ are not defined under the GA Act. The Oxford Dictionary defines ‘experimental’ as, ‘based on or making use of experiment, used in experiments, based on experience, not on authority or conjecture’. The Macquarie Dictionary defines ‘experimental’ as, ‘relating to, derived from, or founded on experiment; based on or derived from experience; empirical; of the nature of an experiment; tentative; functioning as an experiment or used as a means of experimentation’.
On a fair reading of the Participant Information Sheet as a whole, it is clear the treatment is experimental health care intended to treat a condition called central nervous system non-Hodgkin lymphoma.
The treatment requires the participant, in this case, TBC’s consent. The Tribunal is satisfied the treatment is special health care and it is necessary to consider whether TBC has capacity to give his consent to his participation in the treatment that is experimental health care for the purposes of section 72 of the GA Act.
The decision about whether to give consent to participation in the treatment involves reading and understanding the participation sheet.
There are possible risks and disadvantages of taking part in the program that are reported to be mild, and in some patients, they may respond to treatment, but in some other cases there may be serious side-effects that require urgent treatment. Some of the side-effects may be life-threatening or fatal. The side-effects are detailed in the Participant Information Sheet and include other indicators associated with taking medications or from eating certain foods.
The patient needs to be able to understand at least the very common side-effects of both drugs and they are listed in the document and the implications of the side-effects of the toxicity. These are complex decisions and there are many complex medical terms used in the document that would be incomprehensible to a lay person and would require face-to-face explanation by a clinician.
There is a need for ongoing scans and other medical procedures, in addition to the treatment itself. The treatment requires the participant to take oral medication and, in some instances, intravenous treatment.
The treatment is detailed for enrolled patients in the participant document. The patient would receive a lead-in of Zanubrutinib monotherapy at 320 milligrams orally once daily for four weeks, with response assessment during the fourth week. From cycle 2 patients will commence on Tislelizumab, at 200 milligrams IV every three weeks, in combination with ongoing Zanubrutinib. At week 12, response assessment will be performed and then at 12 weekly intervals thereafter.
There is also an issue about confidentiality in the collection of samples belonging to TBC. The Participant Information Sheet details the collection of samples and provides that destruction of the samples will happen if requested. Further, information collected will be shared with others, such as researchers. This also raises a question of who may have access to the information and whether there is other testing involved, for example, genetic testing, that may affect members of TBC’s family. Relevantly, a patient may elect to withdraw from the treatment at any time and request the destruction of samples.
The Tribunal finds that consent for participation in the treatment is complex because it involves a consideration of the treatment itself in terms of what is involved by the participant, taking medication and presenting for other testing, in circumstances where the treatment is experimental and there are side-effects that are minor, or in other cases very serious.
Capacity
Relevant to determining TBC’s capacity is the General Principles found in section 11B and, amongst other things, TBC’s right to make decisions should be restricted and interfered with to the least possible extent. Further, an adult with impaired capacity has a right to adequate and appropriate support for decision-making. The Tribunal is also required to seek and take into account to the greatest extent practicable the views, wishes and preferences expressed and demonstrated by TBC.
TBC attended the hearing before the Tribunal by Teams from hospital. Also attending were his daughters. TBC says that he is fine with ‘it’ stating, ‘This is a trial. I could get better or somebody will get better. If I get worse, the doctor will stop. It could be better for someone else’.
The Tribunal has considered the Occupational Therapy Assessment prepared by Ms Sarah Gale on the 5^th of December 2024. The report details cognitive decline in the context of relapsed lymphoma and previous subdural haemorrhage. TBC is reported as having demonstrated reduced insight into reason for his admission and is frequently making statements referencing when he gets home. A recent Montreal Cognitive Assessment score of 12 out of 24, compared with a score of 24 out of 30 on the 12^th of July 2024, is indicative of declining cognitive function.
The Tribunal accepts the cognitive assessment performed recently and detailed in Ms Gale’s report. The Tribunal finds that TBC does not have capacity to understand the nature and effect of decisions about the experimental health care. TBC has functional and cognitive deficits in the context of relapsed lymphoma and previous subdural haemorrhage that impacts on his ability to weigh up possible risks and benefits. This includes understanding the side-effects of the proposed treatment that is experimental health care and to give his consent to participation in the treatment.
TBC’s family agree with the assessment that indicates cognitive decline and his daughters report that although there is a slight improvement, their father’s memory and decision-making, including basic conversation, is not the same.
The presumption of capacity to give consent to the experimental health care, involving a combination of drugs called Zanubrutinib and Tislelizumab, is rebutted.
Should the Tribunal approve TBC’s participation in the experimental health care?
The next issue to be considered is whether the Tribunal should approve TBC’s participation in the experimental health care relating to the identified condition, and if so, for what period of time should the approval be given. It is noncontroversial that TBC has a condition, primary CNS lymphoma, which recurred after standard treatment. Further, standard treatment for this condition is not deemed to be appropriate.
In considering whether to give approval under section 72 of the GA Act, the views of the statutory health attorney is a relevant matter for the purposes of section 68A. To understand the difference between a health care matter for which a statutory health attorney may give consent and a special health care matter for which the Tribunal may give its consent, it is necessary to consider the meaning of a statutory health attorney and health care.
The Powers of Attorney Act 1998 (Qld) ('POA Act’) authorises a statutory health attorney for an adult’s health matter to make any decision about the health matter that the adult could lawfully make if the adult had capacity for the matter. This is under section 62 of the POA Act. The priority of an attorney’s power is decided by the GA Act under section 66. Further, section 63 of the POA Act provides a listed order of the people readily available and culturally appropriate to exercise power for the matter.
Under the POA Act, a health matter is a matter relating to health care, other than special health care of the principal or adult. Health care is defined under schedule 2, section 5, of the POA Act and means, amongst other things, as ‘care or treatment of, or a service or a procedure for the principal or adult–
(a) to diagnose, maintain or treat the principal’s physical or mental condition; and
(b) carried out by or under the direction or supervision of a health provider.
Relevant to the present application before the Tribunal is the meaning of ‘special health care’ under schedule 2, section 7, of the POA Act which is mirrored under the GA Act in schedule 2, section 7.
Special health care of an adult is health care which includes, amongst other things, participation by the adult in special medical research or experimental health care.
Under schedule 2, section 12 of the GA Act, special medical research or experimental health care for an adult means:
(a) medical research or experimental health care relating to a condition the adult has or to which the adult has a significant risk of being exposed; or
(b) medical research or experimental health care intended to gain knowledge that can be used in the diagnosis, maintenance or treatment of a condition the adult has or has had.
Special medical research or experimental health care does not include psychological research or approved clinical research.
In the present matter the proposed treatment is not QCAT approved clinical research.
Turning now to the views of the statutory health attorney, TBC and his family. TBC’s daughters, MPE and NQG, have been acting as his statutory health attorneys. They say there are side-effects and do not really have another option, and there is no other treatment. They would give their consent for participation in the treatment.
The Tribunal has also considered the views of TBC’s representative, Mr Abraham, appointed under section 125 of the Act. As detailed in his written submission filed on the 12^th of December 2024, TBC is a 60 year old man. He was born in Fiji and in accordance with his Hindu faith he maintains specific dietary requirements that must be observed. He migrated to Australia in 1987 and is the father of two children from his first marriage. He was formerly employed at BHP Billiton in the capacity of machine operator. Prior to his recent hospital admission, he lived alone in his residence in Brisbane.
In terms of TBC’s memory, his short-term memory is reported to be affected and he experiences periods of low mood, particularly noting his hospital admission that caused him distress. TBC is also reported to be frustrated with having multiple treatments and various changes he has undergone throughout his medical journey.
In relation to the proposed treatment, TBC is reported to rely on his doctors and his interest in pursuing a second medical opinion. He is reported to have apprehension regarding his brain tumour diagnosis, and he has expressed specific concern about wanting to exert pressure on his brain.
In the hearing the Tribunal clarified with Mr Abraham, TBC’s current views about the treatment. TBC is reported to be deferring to medical opinions of doctors and the views of his daughters.
Turning back to the considerations previously outlined by the Tribunal under section 72 of the GA Act, we will now consider those matters in turn with reference to section 72(1) as stated above.
The experimental health care is approved by an ethics committee from Monash Health, dated the 21^st of September 2022. This means the study is of sufficient scientific merit and issues concerning patient information, consent, data, privacy, and confidentiality have all been addressed. Further, the Tribunal heard in the hearing that the treatment has received approval from Metro South Human Research Ethics Committee.
Although the risk and inconvenience to TBC and his quality of life is not small, when considering the possible adverse side-effects, the risks associated with the condition alone are significant and will result in death. There will be inconvenience to TBC’s quality of life because he will be required to take medication and present for regular testing, including receiving intravenous injections. Some of this testing, however, forms part of the usual treatment administered for TBC’s condition.
The evidence shows that relapsed primary CNS lymphoma is a very aggressive disease and without treatment, prognosis would be limited to weeks, therefore commencing treatment as soon as possible is vital for patients.
On balance, the Tribunal is satisfied that the potential benefits from the treatment outweigh the potential adverse side-effects. This is because TBC’s condition is serious and as can be seen from recent cognitive testing, is progressive, despite some moderate recent improvement while on steroids.
On balance, the Tribunal is satisfied the experimental health care could result in some benefit to TBC, such that his life could be extended. The benefits may include stabilisation of any cognitive decline as a result of the condition.
The Tribunal is satisfied that the potential benefit from the proposed treatment or experimental health care cannot be achieved in another way. This is because TBC has a serious condition that, if left untreated, will result in his death. The condition is progressive and TBC will experience further cognitive decline and his quality of life will be limited, as a result of an increased need for assistance and support in all areas of his life.
The Tribunal has considered the issue of confidentiality and the collection of samples belonging to TBC. The collection of samples has been approved by the Ethics Committee at Monash University. On balance, we are satisfied that any risk associated with the sharing of samples and data is mitigated by the ethics approval that details the handling of samples and data. Further, the Participant Information Sheet details the collection of samples and provides destruction of the samples will happen if requested.
How long should the approval be given?

The treatment requires taking the medication for up to two years. After that, if the patient benefits from treatment, then there will be a discussion at the end of two years requiring ongoing treatment. The Tribunal is satisfied that approval should be given today and that an approval for two years is the least restrictive order.
Human rights
In exercising the powers under the Act the Tribunal is acting in an administrative capacity and is a public entity for the purposes of section 58 of the Human Rights Act 2019 (Qld) ('HR Act’). The Tribunal is therefore required to make a decision in a way that is compatible with human rights and in making a decision must give proper consideration to relevant human rights. The Tribunal has considered relevant human rights under the HR Act and the requirement under section 48 to interpret all statutory provisions, to the extent possible, that is consistent with their purpose and that is compatible with human rights.
The following human rights are limited and engaged by the making of the Tribunal’s order, that is, to approve the experimental health care.
The right to be recognised as a person before the law and is entitled to equal protection of the law without discrimination under section 15 will be limited and engaged because the Tribunal is making a decision about whether to give consent for participation in experimental health care. This is a decision that should be made by the participant, in this case, TBC. The Tribunal has found that TBC does not have capacity to make decisions about participation in the proposed treatment because of his cognitive deficits. The Tribunal has, however, taken into account TBC’s views, wishes and interests through him directly and through a section 125 representative and the views of his family, including the statutory health attorneys, who are his two daughters.
TBC’s right to life and the right not to be arbitrarily deprived of life under section 16 is limited and engaged because the proposed treatment has risks, including the risk of death. The Tribunal has, however, accepted the medical evidence about TBC’s condition that is life-threatening. TBC has relapsed CNS lymphoma and he is deemed unfit for standard therapy. The proposed treatment may achieve a response and improvement to his quality of life. Further, it was clarified in the hearing that participation would in no way inhibit the involvement of the palliative care service when deemed appropriate.
The right to privacy and not to have the reputation unlawfully attacked will be impacted under section 25 because TBC’s personal and sensitive information will be shared with others. Participation in the treatment will require testing and samples to be taken. The samples may be used and shared with others and TBC’s personal information shared. TBC can request the samples be destroyed and the treatment has ethics committee approval.
The right to a fair and public hearing under section 31 is limited and engaged because the Tribunal is deciding this matter quickly and with limited time for TBC to seek his own advice about the proposed treatment. The Tribunal has taken into account his views and wishes through the appointment of a section 125 representative. The Tribunal’s also heard from TBC himself and has also considered the views of his family, including his statutory health attorney and the views of his treating team.
The rights identified are limited by the operation of the GA Act, which provides for the appointment of substituted decision-makers to make decisions for a person who is found to have impaired decision-making capacity for a relevant matter. Also, the Tribunal has the power to approve the participation in experimental health care. The Act seeks to strike a balance between the right of an adult with impaired capacity to the greatest possible degree of autonomy in decision-making and the adult’s right to adequate and appropriate support for decision-making. The GA Act acknowledges the right of a person with impaired capacity to make decisions should be restricted and interfered with to the least possible extent. Further, the General Principles under the GA Act that reflect relevant rights of a person with impaired decision-making capacity must be applied by a person or other entity that performs a function or exercises a power under the GA Act. The Tribunal is satisfied that the limits imposed on TBC’s human rights by the making of this order or giving this approval today is reasonable and justified in accordance with section 13 of the HR Act. The Tribunal has applied the GA Act, including the General Principles, and is satisfied that the consent or the order is necessary and the least restrictive, based on the information before the Tribunal.
Orders
The orders will be:
1.The Tribunal approves the participation in the following experimental health care for TBC:
(a) Phase II trial of BTK, an immune Checkpoint Inhibitor in CNS lymphoma.
2. This approval remains current for two (2) years.

[2024] QCAT 590

17 December 2024 (ex tempore)