Shehabi v Attorney General

Shehabi v Attorney General - [2017] NSWCATGD 30 - NSWCATGD 2017 case summary — Zoe

[3]

Statutory framework

Part 5 of the Act governs the conduct of clinical trials involving persons with a decision-making disability. Part 5 applies to patients who are aged 16 years or over and who are incapable of giving consent to the carrying out of medical or dental treatment: s 34(1) of the Act.
Section 33(2) of the Act states that for the purposes of Pt 5, a person is regarded as being incapable of giving consent to the carrying out of medical treatment if the person: (a) is incapable of understanding the general nature and effect of the proposed treatment, or (b) is incapable of indicating whether or not he or she consents or does not consent to the treatment being carried out.
"Medical treatment" is defined in s 33(1) of the Act to include: "medical treatment (including any medical or surgical procedure, operation or examination and any prophylactic, palliative or rehabilitative care) normally carried out by or under the supervision of a medical practitioner ... (and, in the case of treatment in the course of a clinical trial, is taken to include the giving of placebos to some of the participants in the trial)...[subject to a number of exceptions which are not relevant for present purposes]".
"Clinical trial" is defined in s 33(1) of the Act to mean "a trial of drugs or techniques that necessarily involves the carrying out of medical or dental treatment on the participants in the trial".
The Tribunal may approve a clinical trial as a trial in which patients who are unable to give a valid consent to their own treatment may take part: s 45AA(1) of the Act. Before doing so, the Tribunal must be satisfied as to each of the criteria set out in s 45AA(2) of the Act. Section 45AA states: 45AA Tribunal may approve clinical trials (1) The Tribunal may approve, in accordance with this section, a clinical trial as a trial in which patients to whom this Part applies may participate. (2) The Tribunal may give an approval under this section only if it is satisfied that: (a) the drugs or techniques being tested in the clinical trial are intended to cure or alleviate a particular condition from which the patients suffer, and (b) the trial will not involve any known substantial risk to the patients (or, if there are existing treatments for the condition concerned, will not involve material risks greater than the risks associated with those treatments), and (c) the development of the drugs or techniques has reached a stage at which safety and ethical considerations make it appropriate that the drugs or techniques be available to patients who suffer from that condition even if those patients are not able to consent to taking part in the trial, and (d) having regard to the potential benefits (as well as the potential risks) of participation in the trial, it is in the best interests of patients who suffer from that condition that they take part in the trial, and (e) the trial has been approved by a relevant ethics committee and complies with any relevant guidelines issued by the National Health and Medical Research Council. (3) The fact that a clinical trial will or may involve the giving of placebos to some of the participants in the trial does not prevent the Tribunal from being satisfied that it is in the best interests of patients that they take part in the trial. (4) The Tribunal's approval of a clinical trial under this section does not operate as a consent to the participation in the trial of any particular patient to whom this Part applies. The appropriate consent must be obtained under Division 3 or 4 before any medical or dental treatment in the course of the trial is carried out on the patient. (5) In this section: "ethics committee" means: (a) for so long as there is any relevant Institutional Ethics Committee registered by the Australian Health Ethics Committee established under the National Health and Medical Research Council Act 1992 of the Commonwealth--an Institutional Ethics Committee so registered, or (b) in the absence of such a committee, an ethics committee established by: (i) a local health district or a public hospital, or (ii) a university, being an ethics committee concerned, wholly or partly, with medical research, or (iii) the National Health and Medical Research Council.
If satisfied of the matters specified in s 45AA(2) of the Act, the Tribunal may make one of the following orders listed in s 45AB of the Act, providing it is satisfied that the proposed form for granting consent provides "sufficient information to enable the persons responsible to decide whether or not it is appropriate that the patients should take part in the trial". Section 45AB of the Act states: 45AB Consent for participation in clinical trials in individual cases (1) If the Tribunal is satisfied as to the matters specified in section 45AA (2) in relation to a clinical trial, it may, by order, determine: (a) that the function of giving or withholding consent for the carrying out of medical or dental treatment on patients in the course of the trial is to be exercised by the persons responsible for the patients (in which case Division 3 applies), or (b) that the Tribunal is to exercise that function itself (in which case Division 4 applies). (2) Before making a determination referred to in subsection (1) (a), the Tribunal must be satisfied that the form for granting consent and the information available about the trial provide sufficient information to enable the persons responsible to decide whether or not it is appropriate that the patients should take part in the trial.
As explained by the Appeal Panel in Shehabi v Attorney General (NSW) [2016] NSWCATAP 137 at [67], ss 45AA and 45AB of the Act establish a three-step process for obtaining consent to medical treatment as part of a clinical trial for patients to whom Pt 5 of the Act applies: (1) First, the Tribunal must determine whether to approve the trial, under s 45AA but that approval does not operate, by itself, as consent to the participation in the trial by any particular patient. (2) Secondly, if the Tribunal is satisfied in accordance with s 45AA(2) that the clinical trial should be approved, the Tribunal then has to determine whether consent to treatment as part of that trial should be given by the "person responsible" or by the Tribunal. (3) Thirdly, depending on whether the consent is to be obtained from the person responsible or the Tribunal, consent must then be obtained under s 40 or under ss 42 to 45, respectively, for the medical treatment in the course of the trial to be carried out on the patient.
In exercising the power conferred by Pt 5 of the Act to approve a clinical trial, the Tribunal must observe the "general principles" listed in s 4 of the Act: 4 General principles It is the duty of everyone exercising functions under this Act with respect to persons who have disabilities to observe the following principles: (a) the welfare and interests of such persons should be given paramount consideration, (b) the freedom of decision and freedom of action of such persons should be restricted as little as possible, (c) such persons should be encouraged, as far as possible, to live a normal life in the community, (d) the views of such persons in relation to the exercise of those functions should be taken into consideration, (e) the importance of preserving the family relationships and the cultural and linguistic environments of such persons should be recognised, (f) such persons should be encouraged, as far as possible, to be self-reliant in matters relating to their personal, domestic and financial affairs, (g) such persons should be protected from neglect, abuse and exploitation, (h) the community should be encouraged to apply and promote these principles.

[6]

Will the Trial involve any known substantial risk to the patients (or, if there are existing treatments for the condition concerned, will not involve material risks greater than the risks associated with those treatments)?

The Trial is a Phase 3 trial, that is, as the name suggests, a clinical trial that has undergone two previous trials: a Phase 1 trial evaluates the safety of the trial drug on a small group of people (e.g. to determine a safe dosage range and identify side effects); a Phase 2 trial is used to determine efficacy (that is, whether the drug works as intended) and to further evaluate the safety of the trial drug. (National Health and Medical Research Council, "Phases of clinical trials" https://www.australianclinicaltrials.gov.au/what-clinical-trial/phases-clinical-trials accessed 3 March 2017.
According to the Protocol, reported studies involving adults and children with intractable epilepsy reveal that doses of up to 800 mg CBD per day have been well tolerated in adults and up to 22 mg/kg/day in children. The Protocol states that the sponsor reviews all safety information on an ongoing basis and is not aware of any safety issues arising from the dosing used to date.
As conceded by Dr Lawson, CBD is an "experimental agent" and its safety and efficacy is not yet fully known. However, in his opinion there are "no known substantial risks to patients" from the use of the drug. He describes the known side effects - mild drowsiness, diarrhoea and weight loss - as "minor and reversible". He states that the only other known problem with the drug is liver abnormality, which generally settles within a short period and does not result in any permanent damage. Under the Protocol, the liver function of participants must be monitored regularly.
Dr Lawson explained that the pharmacological therapies currently available for TSC-associated epilepsy are not optimal. According to the Protocol, internationally the drug of first choice for the treatment of infantile spasms secondary to TSC is Vigabatrin (VGB). Although, VGC is generally well tolerated, long-term treatment is associated with irreversible peripheral visual field defects, the risk of which increases with increasing dose and cumulative exposure. In Australia, oral corticosteroids (prednisone/prednisolone) are also used to treat infantile spasms, but with limited success.
Dr Lawson's opinion that there are no known substantial risks from CBD is supported and uncontradicted. We are satisfied that the Trial will not involve any known substantial risks to patients.

[11]

Should the Tribunal leave the issue of consent to "persons responsible"?

Section 45AB of the Act states: (1) If the Tribunal is satisfied as to the matters specified in section 45AA (2) in relation to a clinical trial, it may, by order, determine: (a) that the function of giving or withholding consent for the carrying out of medical or dental treatment on patients in the course of the trial is to be exercised by the persons responsible for the patients (in which case Division 3 applies), or (b) that the Tribunal is to exercise that function itself (in which case Division 4 applies). (2) Before making a determination referred to in subsection (1) (a), the Tribunal must be satisfied that the form for granting consent and the information available about the trial provide sufficient information to enable the persons responsible to decide whether or not it is appropriate that the patients should take part in the trial.
Section 45AB of the Act requires us to decide whether the function of giving or withholding consent for the carrying out of medical treatment on patients in the course of the Trial should be exercised by the "persons responsible" for the relevant patients, or the Tribunal. The Act provides no express guidance on the factors to take into account in making this determination.
The Applicant seeks the function of giving or withholding consent to be exercised by the "persons responsible" for the patients. See s 33A of the Act for the definition of "person responsible".
According to Dr Lawson, the participants in the Trial at the NSW site will be drawn from the 150 patients who attend the TSC clinic at Sydney Children's Hospital. In our view, in the circumstances of this Application, where it is likely that each of the proposed participants will have a person responsible with whom they are in close regular contact, it is preferable that the function of giving and withholding consent be exercised by the person responsible, not the Tribunal.
However, before a final decision can be made about whether the Tribunal or the relevant "person responsible" should be given the function of giving or withholding consent to participating in the Trial, s 45AB(2) directs that we be satisfied that the form for granting consent, and the information available about the Trial proposed to be provided to the persons responsible, provide sufficient information to enable the persons responsible to decide whether or not it is appropriate that the patients should take part in the Trial.

At a glance

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Judgment (14 paragraphs)

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Legislation Cited (1)

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