Time Limits — Statement by Leader of the House
HON SUE ELLERY (South Metropolitan — Leader of the House) [11.37 am]: I advise the house that the maximum time limits for each stage of the Guardianship and Administration Amendment (Medical Research) Bill 2020 will be: second reading, 180 minutes; Committee of the Whole, 180 minutes; adoption of report, five minutes; and third reading, 45 minutes.
Resumed from 1 April.
Comments and speeches by various members
HON ALISON XAMON (North Metropolitan) [2.05 pm]: I rise as the lead speaker for the Greens on the Guardianship and Administration Amendment (Medical Research) Bill 2020. I note from the outset that although the bill has been presented as an urgent COVID-19 bill, its substance has been the subject of quite a bit of discussion since 2015; indeed, much of what lies within the content of the bill has already been subject to quite a lot of feedback and discussion. Therefore, it is disappointing that we have found ourselves in these circumstances in which we have been given such a constricted time frame in which to debate what is quite an important bill, and that has not enabled those of us who have a responsibility to ensure that the legislation that we pass is sound to undertake the level of detailed scrutiny that we would ordinarily apply. Of course, along with everybody else, I only received draft 14 of the bill on Monday this week, noting that we are many drafts down the track, and was offered a briefing less than two hours later. I did not have a chance to open the email to look at the bill before I received that briefing because I do not spend my days sitting around waiting to receive stuff. I was already frantically trying to address a range of other commitments in that time frame. I am disappointed that I was not able to give such important legislation the level of detailed attention that I would ordinarily give it before a briefing. Nevertheless, I note that there has been considerable effort to respond to the many questions that have arisen as a result. I hope that we can find some comfort in what is incorporated in the bill.
Effectively, the bill addresses an identified issue in the Guardianship and Administration Act 1990 to ensure that people who are legally incapacitated and, therefore, unable to consent to medical research, can potentially participate in medical research under certain circumstances. As has already been articulated, that raises a lot of serious ethical questions, and it is beholden on us to make sure that we develop a sound framework to address those concerns. As has already been said, this bill does not simply deal with the immediate emergency of COVID-19. The bill is of a general and enduring application, so it is neither just COVID-19 related nor for just 12 months like some of the other urgent COVID-19-related legislation that we have debated this week. Of course, it is applicable to the COVID-19 situation but, essentially, as I said, it implements recommendations that arose from a 2015 statutory review, so it has been around for a while.
That review was conducted by the Department of the Attorney General under the former government. The report lists a lot of consultation that occurred at that time, but, being a statutory review, the report covers a lot of ground. Specific reference is made to consent to medical research, and it goes into quite a bit of detail about how a potential future amendment should operate. This bill will apply when a person is incapable of making reasonable judgements about participating in medical research. That, of course, can occur for a number of reasons. The incapacity might be permanent, such as people who have longstanding brain injuries or cognitive impairment, or it might be temporary, such as someone who is heavily sedated, unconscious, or in a coma. Currently at law, no-one else can make that decision for them. That means that they simply cannot participate in medical research, and that is final— that is the end of it. As an advocate for people who have mental impairments, consumer organisations that I have had a lot of dealings with have raised concerns with me about the capacity of adult loved ones to avail themselves of potential treatments if they require them. This is a longstanding concern, particularly for parents of adult children with disability. They feel as though, when they deal with the health system, their children never receive the same level of care that other people get. From the conversations that I have had very briefly over the course of the last 24 hours, I know that there are people who are advocating very strongly to ensure that no-one is denied the best opportunity to get well in a range of circumstances simply because they have a permanent disability.
The concern now is that COVID-19 is a new disease; therefore, there is no existing standard treatment for it. Even though the issue has been around for a while, it has come to our attention as something that needs to be addressed now. The government has provided a number of examples in which the lack of an alternative consent process has been a problem in the past. The sorts of things that were raised with me were issues around cardiac arrest, with the typical outcome being death when the heartbeat stops, and the possibility of using experimental treatments. Other issues were illicit drug use, major trauma and sudden septic shock. Of course, there is the longstanding problem of dementia and the capacity to consent to treatment. Dementia is an interesting issue. I have always been concerned that people are quite happy to let people with dementia just slip away through lack of treatment. I remain really concerned about that from another side. I am certainly very interested in ways that those who have dementia can get the best possible treatment that might be available to them.
The bill defines medical research broadly. The explanatory memorandum states that it is modelled on the Victorian legislation and that medical research means research conducted with or about individuals, or their data or tissue, in the field of medicine or health. It includes, but is not limited to, pharmaceuticals or placebos. I want to make a comment about the placebo issue, because I note that the original 2015 report stated that the use of placebos is not in the best interests of an unconscious patient. It clearly has no benefit, so I am curious to know why that would potentially be in there. I will follow that up, unless the minister can answer that in the course of the second reading reply. Medical research also includes equipment or devices; health care; comparisons between health care; sample taking; observation and visual examinations; measurements and surveys; collecting, using and disclosing information; and anything else that is prescribed by regulation. We still do not really know the full extent of what will ultimately be determined to be medical research. It does not include analysing data about individuals or publishing personal information. Regulations can also prescribe what is not medical research. That will be interesting to see.
In the briefing, the briefers were at pains to explain that there is a continuum between research and standard treatment. The bill currently bans two types of medical research, with a maximum penalty of two years’ imprisonment or a fine of $10 000. One of those is sterilisation—except as incidental to a different procedure—which is already currently banned. The other is electroconvulsive therapy. I note that that is a new ban under the bill, which is good, because ECT is very clearly monitored and prescribed, as is appropriate, by the Mental Health Act. It is a controversial treatment and we already have an act that completely governs how it can be utilised.
The bill sets out two processes that will permit medical research to proceed with a person who lacks capacity to decide for themselves. For the purpose of this debate I am going to use the term “patients” rather than “research candidates”, as the bill refers to them. I do not think that is very helpful. If anything, it will raise hackles about what the bill actually is. If someone is a patient, that is much clearer than if someone is simply a research candidate. One process is a consent process in which consent is given by another person on behalf of the patient. That is a process that I feel very comfortable with, and others in this chamber have indicated they feel quite comfortable with it. I will go into that a bit more in a moment. The second process is the controversial one, which has raised people’s concerns. That is the non-consent process, in which the patient requires urgent treatment to save their life, prevent serious damage to health, or prevent them from suffering or continuing to suffer significant pain or distress. However, I note that excludes psychiatric treatment.
The consent process involves someone else making a decision on the patient’s behalf. That person is called the research decision-maker. Appropriately, the bill lists a hierarchy of research decision-makers. The obvious first one is the person’s enduring guardian, assuming they have one, who is reasonably available and authorised and willing to make that decision. If they are not available, the second person in the hierarchy is the patient’s guardian, if they have one. Again, they have to be reasonably available and authorised and willing to make that decision. If there are neither of those, the next in the hierarchy is a series of other adults, who must be reasonably available, have full legal capacity, and be willing to make that decision. That list starts with the patient’s partner or spouse, provided that they live with the patient or have a close personal relationship with them, as defined. Next is the patient’s adult child. Otherwise, it reverts to the patient’s parent or adult sibling, providing that they have a close personal relationship, as defined. That is when it starts to get a bit tricky, because one person’s idea of a close relationship may not be somebody else’s. Failing all of those, the next in the hierarchy is the patient’s adult primary carer. That is provided that the person is not, effectively, employed or paid as that carer unless they are receiving a carer’s allowance or a similar benefit. Failing that, the final person in the hierarchy is any adult who has a close personal relationship with the patient, as defined. I note that some members who have contributed have indicated concern particularly with this latter one. I do not share those concerns and I will explain why. Firstly, they are the last in a hierarchy of a range of people who will potentially be able to make decisions on behalf of an unconscious patient. I also know from my background in working with people who have severe and enduring mental illness that a lot of those people, unfortunately, tend to be estranged from their families and often do not have close partners who would be able to step into those roles. Very often, they rely heavily on close friends, who effectively become the family for those purposes. I note that under provisions in the Mental Health Act, we can acknowledge people who play those particular roles in people’s lives. It still has to be demonstrated; someone cannot just turn up and say, “Hey, I’m Facebook friends with this person, so I get to make decisions about their treatment.” It recognises that some people do not have those ready relationships. It is about ensuring that at least somebody who is close to the person and is trusted within their life is in a position to consent to treatment or, alternatively, is in a position to say no to treatment. That is the other part of it that we are recognising. Bearing in mind the hierarchy, at any given point someone can say, no, they do not consent to treatment being pursued.
It is important that when there are two or more people at the same level in the hierarchy, the decision needs to be made jointly, failing which, the responsibility for making a decision will flow to the next person in the hierarchy. That is good. I had a conversation with someone during the lunchbreak about whether their parents would ever agree on something, and they agreed that they would not, so that responsibility would flow on to the next person. It is important that we do not allow those impasses to prevent a decision from being made. The bill provides that medical research must not proceed unless and until someone in that hierarchy is found who, at the end of the day, is willing to make a decision and whose decision is to consent to, not refuse, the research proceeding. That person’s ability to consent is fettered. They cannot consent to any medical research that has not been approved by a human research ethics committee established in accordance with the national statement. They must not consent unless an independent medical practitioner, as defined, has assessed, in the manner set out in the bill, the following things and has provided them with that assessment and the reasons for it in writing, if practicable, before the medical research commences: the patient is unlikely to become able to make their own decision within the time frame of that research and the patient’s participation in the medical research is in their best interests, or at least is not adverse to their interests, and an example would be placebos. This assessment must take into account the patient’s wishes, so far as they are ascertainable, as the paramount consideration. Other matters that must also be taken into account are the likely consequences for the patient of participating or not participating, any alternative treatments available, and any other prescribed matters. I will be curious to know what some of those prescribed matters would be.
There must be a comparison of the risks to the patient from the medical research or standard treatment, or from doing nothing if there is no standard treatment available. They cannot consent unless they personally decide, having regard to the assessment of the independent medical practitioner, that the medical research is ultimately in the patient’s best interests or at least is not adverse to their interests, and either the research is non-invasive to the patient or, if it is invasive, the research has no known substantial risk to the patient; or, if it does and an existing treatment is available, those risks are not greater than those of the existing treatment; or, if they are and there is no available existing treatment, those risks are not greater than those of not doing the research. They must not consent if this would be inconsistent with the patient’s current advance health directive. I ask the minister to please confirm that this process will prevent the trumping of the patient’s wishes, as long as they are known, because of the two safeguards— that is, the advance health directives and the paramountcy of the patient’s wishes and the best interests assessment made by the independent medical practitioner. It will prevent the trumping of the research decision-maker’s decision by a researcher or a medical practitioner because the final responsibility for making the decision lies with the research decision-maker, not with the researcher or a medical practitioner. It will prevent consent being given by a research decision-maker who does not have the patient’s best interests at heart. Some of the examples that were raised in previous contributions talked about issues of family violence, as well as elder abuse—for example, hoping for an inheritance if the patient dies. This is something that was mentioned by the committee that looked into the prevalence of elder abuse. It found that it was a huge issue within the community, and consent can be given only if it is in accordance with the three assessments by the independent medical practitioner, including the assessment that the consent is in the patient’s best interests.
I feel quite comfortable with that consent process. I feel as though there are a lot of safeguards in there. Putting it very simply, I like the fact that these changes will allow my husband to make decisions in my best interests— because I feel confident he would—on not only conventional treatment, but also experimental treatment, if he is put in the situation of trying to make sure that I am kept alive and that I am going to be okay. Therefore, I recognise that that process will potentially enable a great number of people to receive treatment, who would otherwise have the treatment denied to them because it cannot be agreed to by anyone, and that will be at the behest of the people who love them.
I will now go to the second process, the non-consent process in the bill. This is the one that has created so much concern and the one that a lot of people are talking about wanting to have further examination of, to look at some sort of sunset clause provision. This bill is being expedited in a way that a bill of this substance would ordinarily not be. The non-consent process in the bill will apply only to urgent situations, but under that process, the medical research must not proceed unless a number of factors apply. The research will need to have been approved, like in the previous process, by a human research ethics committee that is established in accordance with the national statement. The patient must need urgent medical treatment, meaning, as I said earlier, to save their life or to prevent serious damage to their health or to prevent them suffering or continuing to suffer significant pain or distress, but, again, not including psychiatric treatment, sterilisation or electroconvulsive therapy. Another factor will be that the patient cannot make a reasonable judgement for themselves about whether to participate, and no pre-existing research decision has been made by the other consent process. Another factor will be that it is not practicable for the researcher to use the consent process and it is unlikely to be practicable to get consent via that process in the time frame for the research to happen. Other factors will be that insofar as the researcher is aware, or ought to reasonably be aware, there is no inconsistent advance health directive of the patient against the research proceeding, and an independent medical practitioner has made the same three assessments as I mentioned earlier.
But I ask the minister to confirm that this process will prevent the researcher from, again, trumping the independent medical practitioner’s assessment, because the research cannot proceed, except in accordance with the assessment of the independent medical practitioner. If all the conditions that I have just said are met and the medical research proceeds, the lead researcher will still be obliged under the bill to continue taking reasonable steps to locate and obtain the consent of a research decision-maker using the consent process that I described a few moments ago. In this way, I recognise that the urgent non-consent process is potentially an interim process, because they may not end up finding a research decision-maker. I understand that it is intended to last only until that other consent process can be used. I ask the Leader of the House to confirm whether that is the case.
When and if the patient regains the ability to decide for themselves or a research decision-maker is located and they decide to refuse consent, the lead researcher must discontinue the research as soon as it is safe to do so and must not recommence it unless they are able to obtain consent. What happens if the proper process in the bill is not followed? What are the consequences for researchers who do not comply with the process in the bill? Will they lose the protections in the bill that take them to have made valid decisions and to have acted as though the patient had full legal capacity and had consented to the medical research? There are not any penalties in the bill, or the act, except for a breach of the bans on sterilisation and electroconvulsive therapy. The consequence of noncompliance is the risk of professional disciplinary proceedings arising from a formal complaint against the researcher.
Proposed section 110ZZ will permit a person who is interested in the decision to apply to the State Administrative Tribunal for a review. This provides a review process, for example, to a person who has a close relationship with a patient and cares about their wellbeing but who is not the person that the hierarchy in the bill designates to be the research decision-maker.
As always, I am delighted to see a review clause. I am pleased that the review period is one year. This is appropriate, considering the very grave and complex nature of this bill, and also the truncated time for parliamentary scrutiny of it. I thank the Attorney General for bringing that review period forward. I also want to thank the Minister for Health for his written undertaking to the Greens, the Liberals and the Nationals—that I know of—to refer the legislation for review to the Education and Health Standing Committee of the Legislative Assembly following its passage. Ideally, of course, as has been said, parliamentary committees review legislation before it is passed, not after—that is the normal way we do things. I acknowledge that we are living in extraordinary times during this pandemic. I at least appreciate that the minister has agreed to refer it to that Legislative Assembly committee. I also indicate that I will be supporting its referral to the Legislative Council Standing Committee on Legislation. I think that is a very wise and necessary move considering the seriousness of this legislation and the truncated time in which we have had the opportunity to appropriately assess it.
I understand we may be considering a sunset clause of sorts in relation to proposed section 110SZ, which relates to urgent medical research without consent. That should receive serious consideration and potentially support. I want to see the wording of the final amendment. I think that is the bit that probably creates the most disquiet for people. Otherwise, in relation to the other provisions that enable people that I know who love me to be able to make a whole range of decisions on my behalf, and for other people to have decisions made on their behalf that will potentially have the capacity to save their lives or prevent them from unnecessary further harm, they are sound and quite consistent with the intent and the purpose of the Guardianship and Administration Act as a whole. I am disappointed that it took this crisis for this legislation to come on when it did. I would have preferred this to have been brought on much earlier. I am also aware that we have been waiting quite some time for a lot of other reform of the guardianship act.
With those words, I look forward to hearing the Leader of the House’s response and will have further questions when we go into Committee of the Whole.
Comments and speeches by various members
Hon SUE ELLERY:
I commend the bill to the house.
Question put and a division taken with the following result —
Question thus passed.
Bill read a second time
Comments and speeches by various members
Progress reported and leave granted to sit again, on motion by Hon Sue Ellery (Leader of the House).