The Guardianship and Administration Amendment (Medical Research) Bill 2020 (the Bill) was introduced into the WA Legislative Assembly by Mr R.H. Cook, the Minister for Health, on 1 April 2020 and passed Parliament on 2 April 2020. The Bill was assented to on 6 April 2020 and is now the Guardianship and Administration Amendment (Medical Research) Act 2020 (WA) (No 14) (the Amending Act). The legislation is part of the WA Government's response to COVID-19 and seeks to ensure that people falling under the guardianship laws are not left behind, particularly with respect to new treatments and developments relating to COVID-19.
The new laws are intended to ensure that all Western Australians have the opportunity to participate in world leading research and experimental treatments targeted at combating COVID-19. The current WA legislation enables an "enduring guardian", a "guardian" or "a person responsible" to make a decision regarding medical treatment. The current laws do not extend to participation in medical research - effectively denying critically ill, or otherwise incapacitated COVID-19 patients, access to cutting edge treatments which are on trial throughout the world.
The Amending Act enables all Western Australians to access the drugs and treatments that are being tested in other countries to give them the best possible chance of recovery.
The Amending Act amends the Guardianship and Administration Act 1990 to provide the authorisation and appropriate safeguards enabling "enduring guardians", "guardians" and "next of kin" to consent to medical research for people under legal incapacity. As well, where the situation is urgent and it is not practicable to obtain consent within an appropriate timeframe, the Amending Act permits a researcher to carry out research approved by a Human Research Ethics Committee (HREC), in situations where an independent medical practitioner has determined that:
The Amending Act, according to the WA Attorney General:
Definition of medical research: Section 5 of the Amending Act inserts a new section 3AA into the Guardianship and Administration Act, which defines, for the purposes of the Guardianship and Administration Act, what medical research is and what medical research may include. Generally, "medical research" means research conducted with or about individuals, or their data or tissue, in the field of medicine or health; and includes an activity undertaken for the purposes of that research. Section 3AA(2) sets out a list of types of research that constitute medical research but is not intended to be limited to that list - any other types of medical research must be prescribed in regulations.
New medical research part inserted: Section 12 of the Amending Act inserts the new Part 9E into the Guardianship and Administration Act, a new section 110ZP sets out who is a research decision-maker for a research candidate, by providing a hierarchy of relationships or roles between a person and a research candidate. This section sets out what is referred to in section 110ZP(4) as a substitute decision maker for a research candidate, and the order of priority that will be applied in determining who is a substitute decision-maker.
Section 110ZR authorises a research decision-maker to make a research decision for a research candidate in relation to a candidate’s participation in medical research, provided certain conditions are satisfied. Section 110ZS authorises urgent medical research without consent of a research decision-maker in certain limited circumstances.
Certain research prohibited: The substance of section 110ZT(2) and (3) is that under no circumstances can consent be given for a research candidate to participate in medical research that is a procedure for sterilisation of the research candidate or for electroconvulsive therapy to be performed on the candidate.
Considerations by independent medical practitioner: Section 110ZV sets out what an independent medical practitioner must consider when required to make a determination about whether a person is likely to regain the ability to make reasonable judgments within the timeframe for the research approved by the HREC. This determination is used to inform medical research with consent of a research decision-maker, or medical research without consent. Section 110ZW sets out what an independent medical practitioner must assess if required to make a determination about risks to the research candidate if the research candidate participates in the medical research, in relation to carrying out medical research with consent of a research decision-maker, or medical research without consent.
In section 110ZX the term "take research action" is introduced and means ". . . to commence or continue any medical research in relation to a research candidate, or to not commence or to discontinue medical research in relation to a research candidate".
Section 110ZY(1) provides that if a researcher does not carry out medical research in relation to a research candidate, in accordance with a research decision or urgent research decision, and the result is such that the candidate’s condition worsens in severity or worsens the prognosis for the candidate, the researcher is taken to have acted in accordance with a valid decision.
Administrative review: Section 6 of the Amending Act amends section 13 of the Guardianship and Administration Act to expand the jurisdiction of the WA State Administrative Tribunal to ensure that the Tribunal has jurisdiction over matters in the newly inserted Part 9E dealing with medical research. Part 9E in section 110ZZ provides that if the State Administrative Tribunal is of the opinion that a person has an interest in a decision made under Part 9E, the person may apply to the State Administrative Tribunal for a review of a decision. A new section 110ZZA provides that the review process will engage the various powers of the State Administrative Tribunal contained in the State Administrative Tribunal Act 2004, and will not engage some parts of the State Administrative Tribunal Act 2004, including section 20; subject to subsection (4) — sections 21, 22 and 23; sections 26(e) and 31; section 29(3)(c)(ii); section 29(5)(b). The State Administrative Tribunal may review a decision about whether research is in the best interests of a candidate, or whether a candidate is able to make reasonable judgments about undertaking the research. If the Tribunal considers that a review is warranted, it may effectively set aside a decision made by a research decision-maker or a researcher.
Reporting on operation: Division 6 of Part 9E sets out a requirement for researchers to report medical research conducted under new Part 9E of the Guardianship and Administration Act 1990 to the Health Minister, and for the Health Minister to report to Parliament on medical research carried out under new Part 9E. Division 7 of Part 9E contains a review provision that provides that the operation and effectiveness of Part 9E must be reviewed as soon as practicable after one year from the date that Part 9E comes into operation. After the first one-year review, the operation and effectiveness of Part 9E must be reviewed every three years.
In his Media Release the Minister for Health indicated that the Amending Act was intended to help the medical community in the fight against COVID-19 saying:
The Health Minister further indicated in his Media Release that without the Amending Act not all Western Australians would be able to be tested for new treatments for diseases like COVID-19:
AMA (WA) President Dr Andrew Miller in a Media Release has stated that the AMA (WA) welcomed the legislation and stated that:
The Amending Act has largely commenced operation on 7 April 2020 with the exception of sections 13 and 15 of the Amending Act which commence four years after the date of assent.
TimeBase is an independent, privately owned Australian legal publisher specialising in the online delivery of accurate, comprehensive and innovative legislation research tools including LawOne and unique Point-in-Time Products. Nothing on this website should be construed as legal advice and does not substitute for the advice of competent legal counsel.
Guardianship and Administration Amendment (Medical Research) Act 2020 (14 of 2020) (WA), Bill and 2nd Reading Speech and explanatory material as reported in the TimeBase LawOne Service.
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