Terminally Ill Adults (End of Life) Bill (Twenty-fifth sitting)

Sojan Joseph Excerpts

Committee stage
Tuesday 18th March 2025 Public Bill Committees

[The Minister for Care (Stephen Kinnock)]

It is a pleasure to serve under your chairship, Sir Roger. Before I speak to amendments 497 and 498, on which the Government have worked with my hon. Friend the Member for Spen Valley, let me address amendments 462 and 463.

Amendment 462 would amend clause 18 to require the co-ordinating doctor to explain to the person that they do not have to proceed and self-administer the approved substance, and that they may still cancel their declaration. Although it is not specified, it is presumed that the amendment refers to the second declaration that the person will have made. The Committee may wish to note that there is already a requirement in clause 18(4)(b) that,

“at the time the approved substance is provided”,

the co-ordinating doctor must be satisfied that the person

“has a clear, settled and informed wish to end their own life”.

The purpose of amendment 463 is to limit what the co-ordinating doctor is permitted to do in relation to providing the person with an approved substance under clause 18. As the clause stands, subsection (6) sets out the activities that the co-ordinating doctor is permitted to carry out in respect of an approved substance provided to the person under subsection (2). It states that the co-ordinating doctor may

“(a) prepare that substance for self-administration by that person,

(b) prepare a medical device which will enable that person to self-administer the substance, and

(c) assist that person to ingest or otherwise self-administer the substance.”

Additionally, subsection (7) provides that

“the decision to self-administer the approved substance and the final act of doing so must be taken by the person to whom the substance has been provided.”

Amendment 463 would remove subsection (6)(c), which would result in the co-ordinating doctor being unable to assist the person

“to ingest or otherwise self-administer”

the approved substance. The co-ordinating doctor would still be permitted to prepare that substance for self-administration and to prepare a medical device to enable the person to self-administer the substance. This could mean that a co-ordinating doctor may not be able to provide assistance such as helping the person to sit up to help with swallowing, or explaining how the medical device for self-administering the substance works. This could result in practical difficulties in self-administration of the substance and/or place the co-ordinating doctor in a difficult position.

[Sojan Joseph (Ashford) (Lab)]

Does the Minister think that it is confusing for health professionals when we say that they can assist the patient to sit up or hold a cup of water or put the medication into their mouth? Is it not confusing for medical professionals that we are giving contradictory statements?

[Stephen Kinnock]

One of the fundamental principles of the Bill, which my hon. Friend the Member for Spen Valley has prioritised, is self-administration. It is not for me as a Minister to opine on that; it is simply there in the Bill. Once that fundamental principle is established, it is about defining what “assistance” means, compared with what “self-administration” means. As I was setting out, I think “assistance” can mean things like helping the patient to sit up; it does not mean actually administering the substance to the patient. It is about the dividing line between assistance and self-administration—hence the term “assisted dying”, I suppose, which is very different from the doctor actually administering the substance.

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[Stephen Kinnock]

I thank my hon. Friend, who speaks with considerable clinical expertise. It is about exactly that difference between self-administration and administration. If we cleave to those two principles, that is the basis on which we will achieve the stated aim of my hon. Friend the Member for Spen Valley.

[Sojan Joseph]

Does the Minister agree that assisting a person to ingest is different from assisting a person to self-administer?

[Stephen Kinnock]

In order to ingest, there has to be self-administration. The self-administration is the precondition for ingesting the substance. That is my reading. I hope that that satisfies my hon. Friend.

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[Danny Kruger]

I am grateful to the hon. Lady. Let me let me look that up later. I am happy to exchange data, because this is clearly something we should be trying to get right.

Nevertheless, I want to try to explain why I am suggesting that we have a problem with the drugs that are used in assisted dying and that it has been suggested we use here. Let me continue the quote from Dr Zivot:

“When one watches an execution, it’s not clear that this is happening”—

meaning that it looks like a peaceful, painless death. He continues:

“There is not much to see. Executions, like, I imagine, medical assistance in dying, are a rather bloodless event; not much can be seen outwardly. But the autopsies revealed a very disturbing and surprising finding.”

He makes the point that that is particularly disturbing, given that assisted dying often uses a paralysing drug, which induces the impression of peace and calm in the patient, when in fact something else might be going on below the surface.

To conclude my quote from Dr Zivot, he says:

“To claim that this is a death that is peaceful, well, it can be nothing else because now a person is unable to move in any way, but whether or not they have any conscious experience of what is happening is unknown…it should be clear to the Canadian public that the kind of death that they will experience…will be something other than the way it is represented. It could be exceedingly painful and more akin to drowning.”

I cannot judge whether Dr Zivot is right, but we should be very wary of any claims that there is a simple answer to the question surrounding lethal drugs. To the point made by the hon. Lady, and I think by the hon. Member for Stroud, there is no evidence in the many reports from Dignitas, which has a regime very similar to the one we are imagining here—I will certainly look at the evidence mentioned made by the hon. Lady—that contradicts the concerns raised by Dr Zivot.

[Sojan Joseph]

Does this not show that clinical documentation is very important? We debated the issue in Committee earlier, when we talked about professionals being required to complete all relevant documentation. Maybe we are missing certain data because these things are not clearly documented in other places. Should we not take from that the learning that if we go ahead with this proposal, we should have proper documentation and make it clear to the clinician what they should and should not document?

[Danny Kruger]

I entirely agree that there is great concern about the lack of evidence in countries on which we are constantly relying for evidence of why this proposal is safe. I have suggested that, from the quite limited evidence we have, that it may not be safe. The hon. Gentleman is absolutely right that if we are to proceed, we need to be extremely strict about data collection.

To the hon. Gentleman’s point about making it clear to clinicians what drugs they are permitted to use, we also need to have a proper regime of clearing and approving those drugs. In earlier clauses, we debated the imperative on the NHS, the Medicines and Healthcare products Regulatory Agency and the Department of Health to properly authorise the specifics of what drugs will be used. It is not clear at the moment what those would be, and I very much agree that we need to be clearer on that.

I finish with a reference to an earlier debate, in which it was suggested, on the basis of the Australian example, that there is no evidence of complications. The hon. Member for Stroud talked about horrible stories from the United States and Canada. He also referred to Australia, where there is apparently no evidence of problems. In fact, I understand that of the six states, only Western Australia records complications, and it does so in relation only to practitioner administration—when the doctor administers the drug—which we do not propose to do here. It does not record complications in relation to self-administration, which is what the Bill proposes. In Western Australia, complications have been reported in 4.3% of cases involving practitioner administration. Again, we are dealing with the great mystery and enigma of how death happens with assisted suicide, and it is certainly unclear what we should do about it.

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[Sojan Joseph]

We repeatedly talk about doctors, but nurses, healthcare assistants and other professionals will definitely be involved in a hospital environment. The Bill does not talk about other professionals. Furthermore, within a hospital environment, NHS wards may be bays without individual bedrooms. Does the hon. Lady think we need to be clearer on the procedures that will happen in those areas?

[Sarah Olney]

I am grateful for the hon. Gentleman’s professional experience, which is extremely helpful. He is absolutely right. Following the point made by the hon. Member for Banbury, we cannot define the circumstances in which a patient will find themselves when this is taking place. That is why it is incumbent on us to make sure we provide very clear guidance on precisely what Parliament intends.

As Dr Rebecca Jones told us in written evidence:

“As the death may take many hours, I’m uncertain of the practicalities of”

doctors remaining with the patient

“for many doctors…have competing demands on their time.”

In written evidence, Dr Chris Ainsworth asked how this will work in cases where death takes several days, as has happened in Oregon, while Dr Trevor Stammers wrote:

“If the doctor is required to be present until the patient’s death, this may require hours of practitioners’ time to fulfil and is unlikely to be adhered to in many cases if the dying process is protracted.”

Dr Rachel Fisher said in her written evidence that for Australian doctors, who are not required to be present at the final act, each assisted death requires around 60 hours of professional time. For British doctors, we will need to add the time it takes for the self-administration to result in death. Dr Fisher also raised the real impact on doctors, writing,

“imagine the practicalities of those who must deliver it. The GP, motivated by a deep desire to preserve life and relieve suffering arrives at the home of the patient with a cocktail of powerful drugs. What if the patient has symptoms? Who will collect their child from nursery or school if the patient takes a long time to die? How will they know when to decide the death was unsuccessful? Will there be counselling for GPs observing and feeling complicit in a potentially drawn out and symptomatic death?”

Finally, Dr Paul Shaw asked in his written evidence:

“How will this service be funded? What support will be required from the NHS when things go wrong or death takes longer than expected? Will this be a 0900-1700hrs service? What will be the out of hours arrangements?”

A lot of the written evidence touches on the practicalities of a doctor being required to remain with the patient until they die. Amendment 429, in the name of the hon. Member for Bexleyheath and Crayford, seeks to clarify whether “being with the patient” requires the doctor to be physically present in the room.

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[Sojan Joseph]

Does my hon. Friend think that 10% is a high number? Does he also think that if we informed patients about the side-effects of those medications from the beginning, the number of patients opting out would probably be higher?

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[Dr Opher]

I almost agreed with the hon. Gentleman earlier, when he asked at one point, should we not just leave this to doctors?

One of the key things the hon. Gentleman said is that the doctor administers the drug. This is self-administered, first of all, so that is a very clear line. However, also, in a case of terminal care—this is what I am trying to get across to the Committee—we know the patient is dying, and therefore if they are becoming worse we simply do things to make them comfortable, and we do not try to revive them, because they are dying. It is important that we realise that this is a very different medical situation from normal care, and that it actually needs very different skills as a doctor. Here, a doctor is not trying to prolong life, but trying to make a death as comfortable as possible.

That is why I support the Bill—because I think it will enhance a comfortable death. I wanted to make it clear that that is normal practice now in terminal care: we do not revive a patient with a terminal diagnosis who is in terminal care, but we make them comfortable.

[Sojan Joseph]

This is a very good discussion, and with a clinician as well—maybe my hon. Friend can help here. Are we leaving the Bill to professionals to administer, who might be confused and not clear about what they should be doing? In normal current practice, when somebody has a poor prognosis and is very fragile; we use “do not resuscitate” or “do not attempt CPR” decisions. Why do we not build that into the Bill—that everyone who is going through this process should have a DNR or DNACPR in place?

[Dr Opher]

I thank my hon. Friend for his experience in a clinical setting. I would remind everybody that in the Bill we are trying to help people die in a comfortable way, and I do not feel it is the Bill’s job to define exactly how we treat nausea or abdominal obstruction and so on. What we would like to do here is ensure that a patient has a pain-free death, and a death that they are in control of.

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[Sojan Joseph]

We had some discussion earlier about how we will potentially be assisting dying in people’s own homes—that was not previously known to us; we thought it would be always in clinical settings—so medication will be transported from where it is stored as a controlled drug, in a hospital setting, to the patient’s home. Does the hon. Gentleman think that it is important that we have clear guidance as to how we store this medication?

[Danny Kruger]

I entirely agree. The regulations need to specify not only what drugs may be approved, but, as the hon. Gentleman suggests, how they should be stored and transported. I would expect that to be part of the package of regulations under the Bill.

As I have stated, I do not accept that we are talking about healthcare here; nevertheless, we are using products that are comparable to health products. The MHRA would need to significantly adapt its work in order to identify the most effective drug to cause what we currently perceive as harm—namely, the death of a patient. I recognise that that would be a significant change of remit and work for the MHRA, but we need to do it. One of the reasons that we need regulation of approved substances is to help ensure that falsified versions of the drug—drugs that do not have a licence for use in assisted dying—cannot enter the market. Such drugs may not be effective and could cause distress to those ending their lives and their families. I would be grateful if the Minister could clarify whether, in his view, clause 20 is sufficient to establish the necessary regulatory regime, or whether further legislation will be needed.

We had evidence from Greg Lawton, and other pharmacists, who wrote to the Committee to suggest that the approved substances would not legally come within the definition of a “medicinal product”, so medicines law, the protections associated with medicines and the MHRA licensing process might not apply. If that is the case, what do we do about it? We need a new licensing regime to ensure that the MHRA is able to properly regulate the substances, or, potentially, another regulatory agency would need to be established to do the job.

The Committee needs to make sure that there is a process that applies to approved substances used for assisted dying. It is not necessarily the case that a product licensed for treating a medical condition could not be used to bring about death—it is not the case that we cannot use any drug that is currently used for genuine health treatment—but it would not be being used as a medicine, so medicines law may not apply to its use for that purpose. There is an ambiguity, and I would be grateful for clarity on it.

The amendments that I am supporting would ensure that the MHRA had approved the drug for the specific purpose of ending someone’s life, and that there was scientific consensus that the drug would be effective for that purpose. The MHRA, in the marketing authorisation for the approved substance, would define the dosage of the drug required to bring about death. It would also ensure that specific considerations and warnings were placed in the product licence.

For example, some patients have allergies to certain drugs. If they decide to end their own life, that should be brought about as a result of the effect of the drug, not an unintended allergic reaction to it. Some patients would not be able to take drugs orally and might need to have the drug administered through a tube into the stomach, so different formulations would need to be available. Some drugs may need to be administered by injection. Patients may be unable to do the injection themselves, as we have discussed. Even if the patient is physically capable, injection techniques require proper training, and that needs to be considered when licensing drugs for assisted dying if the patient is responsible for self-administration.

There will be further considerations when deciding what drugs can be used. Patients will have a right to know what to expect. If they take the drug orally, how long will they have to wait before they die? Will they lose consciousness first? If so, how long will that take? Could there be some side effects or reactions after taking the drug, such as seizures or choking, that the family or carers will have to deal with? Can the drug be taken at home—that relates to the point that the hon. Member for Ashford made—or must it be used in a clinical setting? We have suggested that it could be used at home, so questions about transportation arise. Is a combination of drugs required? If so, in what order should they be taken? What happens if the patient passes out before taking the entire concoction of drugs? Has the drug formulation been optimised for the purpose of assisted dying, so that it reaches maximum blood levels as quickly as possible?

All these sorts of questions are appropriate for medical regulators. The MHRA could ensure that the patient information leaflet, and the warnings associated with it, given with the drug when it is prescribed prompt doctors to think about what drugs are most suitable for the patient and to provide information to the patient about what to expect.

Parliament must have oversight. It must bear responsibility for the kinds of deaths that it approves. Both Houses of Parliament should approve the statutory instrument. To inform that decision, the Secretary of State should provide all relevant information on the likely time to death, and on complications and side effects. When the state is creating a regime that will end lives, there must be maximum transparency and accountability, yet the Bill provides that this will be done by a negative statutory instrument. In other words, Parliament will get a say on the regulations only if the Leader of the Opposition prays against them—that is the process for a negative SI. That is the only circumstance under which the Government would make time for a debate and a vote on a negative SI. Given that this is an issue of conscience, I find it inconceivable that the Leader of the Opposition would want to take a position on it and so pray against it to trigger a proper debate. I think it is highly likely that Parliament would never get a say on this crucial issue because of the use of the negative procedure.

That situation has been recognised repeatedly as being unacceptable. When Lord Falconer introduced his Assisted Dying Bill to the House of Lords in 2014, it too provided for a negative SI power on this matter. The highly respected House of Lords Delegated Powers and Regulatory Reform Committee—we do not have an equivalent Committee in the Commons, but it sits over Parliament—said that it did not consider either the power or the procedure in the Falconer Bill to be appropriate, yet that is the procedure that we are being presented with here.

In 2021, when Baroness Meacher introduced her Assisted Dying Bill to the House of Lords, the Delegated Powers and Regulatory Reform Committee again issued a report, in which it said:

“In the interests of clarity and transparency on such important issues of public policy, the matters that are in due course to be dealt with under clause 4(7) by negative regulations should in our view be spelled out in detail on the face of the Bill from the outset. Accordingly, the Bill should contain a definitive list of medicines, and details of the manner and conditions under which such medicines are to be dispensed, stored, transported, used and destroyed. The power to amend such matters should be a matter for regulations subject to the affirmative procedure.”

We then come to Lord Falconer’s 2024 Assisted Dying for Terminally Ill Adults Bill, which he withdrew following the introduction of this Bill by the hon. Member for Spen Valley. That Bill in part took on that feedback from the Lords Committee. Although it did not provide a list of medicines, it did at least provide that the power to specify the drugs would be through the affirmative procedure.

The Hansard Society, which is non-partisan and neutral on assisted dying, has issued a critical report on this power. It says:

“MPs may wish to enquire why Kim Leadbeater has chosen not to adopt the scrutiny procedure set out in the 2024 bill, but has preferred that proposed in the 2014 and 2021 incarnations of the bill, despite the advice to the contrary of the Delegated Powers Committee.”

I would be grateful to learn from the hon. Lady why she has chosen this procedure.

It might be objected that the list that I am requesting might need to be modified quickly and that the affirmative procedure—having a parliamentary vote—would be an obstacle to doing that. The Hansard Society anticipated that objection. It said that

“this could be addressed by making provision for the use of the ‘made affirmative’ procedure in urgent cases where the Secretary of State wishes to remove a substance from the approved list and is of the opinion that it is necessary to do so immediately in order to prevent adverse medical events or failed assisted deaths. This would mean Ministers could act expeditiously but Parliament would have to debate and approve – albeit retrospectively – the change in the list. Whilst not perfect it would provide more opportunity for oversight than that offered by the negative scrutiny procedure.”

It seems to me that there is no justification for this vital matter to be regulated under the negative procedure. Too much power and responsibility is being given to Ministers subsequent to the passage of the Bill— if that is what happens. My amendment 467 would ensure that Parliament has a meaningful say, through the affirmative procedure, and that a report is published as part of that process setting out the expected efficacy of the drugs that will be used. I hope that the Committee will support it.