(1 week, 4 days ago)
Lords ChamberMy Lords, for the purposes of the point I am making, I am going to proceed on the assumption that was put forward by the sponsors that the drugs used for an assisted death are to be treated as a healthcare intervention, although I do not accept that this assumption is correct. If that assumption is made then the legal and ethical standards governing informed consent must apply in full. I added my name to Amendment 55, which would require that the patient understands fully the physiological effects of the lethal drugs used for assisted suicide and their possible complications.
The General Medical Council provides guidance on decision-making and consent to medical professionals. It requires that a clinician must be satisfied that a patient has given valid consent before an intervention unless there are certain legal exceptions, which would not apply to assisted dying. The guidance is explicit about what informed consent requires. Patients must be given clear, accurate, up-to-date and evidence-based information. For every option, clinicians must explain the potential benefits; the risks, including side effects and complications; the uncertainties involved; and the likelihood of success. Where there is uncertainty about outcomes or the quality or limits of the evidence, the clinician has a duty to be open about that uncertainty. Informed consent is not compatible with ambiguity being concealed, minimised or glossed over.
Who provides this important information for the consent process? The MHRA regulates medicines in the United Kingdom by assessing their safety, quality and efficacy before licensing, and by monitoring harms after licensing through the Yellow Card scheme. I intend to return to this in a later group. The GMC is explicit that a clinician should propose or prescribe a medicine or treatment only when they have sufficient and reliable information. This includes agreeing with the patient by giving a clear explanation of the benefits, the risks, the common and serious adverse effects, and what to do if problems arise.
On the drug protocol, there is currently no internationally agreed prescribing protocol for assisted dying. There is a wide range of drug types, combinations and doses being used, with significant variation even within individual countries. Protocols include varying combinations of barbiturates, benzodiazepines, opioids, cardiotoxic agents and neuromuscular blockers. Under the current Bill, the intention appears to be that the drugs to be used for assisted dying would be prescribed off-licence. An unlicensed drug is one used outside the terms of its licensed indication. Under existing GMC guidance, prescribing an off-licence drug requires a clinician to
“be satisfied that there is sufficient evidence … to demonstrate its safety and efficacy”.
However, there is no systematised clinical research, no standardised reporting and marked variability in practice. The pharmacokinetic and pharmacodynamic data available for these drugs individually come from therapeutic use, which is quite different from the very high doses or combinations required to induce death.
The Government’s impact assessment refers to an experimental drug regime from Oregon, one of the few jurisdictions that has published the outcomes of orally ingested approved substances. These drug combinations are not the product of conventional clinical trials but a form of human experimentation that was introduced without prior scientific evaluation and bypassing conventional regulatory frameworks. A combination of four drugs was chosen out of necessity because of restricted access to barbiturates, rather than good evidence of safety and efficacy. Subsequently, a fifth drug has been added in an attempt to reduce the median time to death. Rather than the quick and pain-free death advertised by the sponsors and campaigners, what has been documented are significant adverse effects, as reported by the noble Baroness, Lady Lawlor.
The drugs generally regarded as most effective in assisted suicide are barbiturates, particularly high-dose pentobarbital and, less commonly, secobarbital. These were the agents used in Oregon before restrictions on their export to the USA because of their use in capital punishment. This restriction forced assisted suicide providers to look for alternatives. The barbiturates cause death by reducing brain activity, leading to loss of consciousness and respiratory arrest. They are the same agents used in veterinary euthanasia in the United Kingdom, where they are subject to very strict veterinary regulatory requirements. However, these substances are not licensed for human use in the United Kingdom. They are class B controlled drugs under the Misuse of Drugs Act, meaning that they cannot be prescribed, imported or possessed without Home Office authorisation. The assertions made in the other place and in the Government’s impact assessment that appropriate drugs are already licensed and available for off-licence use appear to be incorrect. I would welcome the noble and learned Lord’s response to this.
Despite this, the proposed approach does not involve licensing by the MHRA, nor appraisal or guidance by NICE, and no clinical trials are required. Instead, the Bill grants the Secretary of State the power to specify the drugs and procedures by regulation, including their manufacture, supply and storage, thereby bypassing the established regulatory frameworks that apply to every other drug.
I could describe what the consent process might look like. When a drug is prescribed for you, you get a leaflet which sets it all out. It tells you what the indication is, what the likely success is and what the most common complications are. One in 10 is very common, and these are the kinds of side effects, complications or adverse effects described by the noble Baroness. Imagine saying to the patient that outcomes are variable, and many complications have been reported, suggesting that one in 10 people who take this combination of drugs may experience vomiting, seizures or may regain consciousness. One in 10 is very common. You would also have to say that there is no guidance or certainty about what support would be provided to you if you experienced these very common adverse effects.
That is what the obtaining of informed consent would look like under the current Bill. That would not be acceptable to any regulator or professional body, or, I suggest, to any patient who had the capacity to consent.
My Lords, I support Amendment 39A, tabled by my noble friend Lord Blencathra. I am pleased to see my noble friend Lord Wolfson at the Dispatch Box, because although I support the amendment, it is more that it enables us to raise important principles, not necessarily the details.
I am grateful to the noble Baroness, Lady Hollins, for outlining informed consent and mentioning that the patient has to have sufficient and reliable information. The noble and learned Lord’s Bill says that there should be a
“clear, settled and informed wish”.
This is another occasion where I fear that the Bill is legislating for an analogue age. Much of the principle around informed consent comes from a situation where the patient is gaining much, if not most, of their information from the clinician or support staff. That is not the case today. We know that people have access to many more sources of information.
I ask the Minister and the sponsor of the Bill: what is the situation in regard to reliable information or an informed wish if in front of the clinician is a young person who basically has just been watching on a doom loop information that is false? We have the problem now—there may be an issue around the development of the law on informed consent here—of people having a lot of misinformation or false information. From the wording of the amendment, it is not clear what the duty would be on the clinician if they are aware that the person has an informed wish but it has been informed by false information.
(3 weeks, 4 days ago)
Lords ChamberMy Lords, I have added my name to several of my noble friend’s amendments and I would like to congratulate him on finding a solution that could allow the Bill to meet one of the sponsors’ original aspirations. The impact of Amendments 25 and 120 are many. One that may be attractive to the Committee would be that it would considerably shorten the Bill, as several clauses would be removed and hours of debate would probably become unnecessary.
The Bill states that it will
“allow adults who are terminally ill … to request and be provided with assistance to end their own life”
and refers to eligibility for
“lawful assistance to voluntarily end their own life”.
The Oxford Concise Medical Dictionary defines suicide as
“deliberately causing one’s own death”
and assisting suicide as
“the act of helping a patient to commit suicide by giving them the means … to do so”.
The Office for National Statistics similarly defines suicides as
“deaths resulting from intentional self-harm for persons aged 10 and over”.
Clause 32 on the criminal liability for providing assistance explicitly references the Suicide Act 1961, providing that assistance carried out in accordance with this Bill will be exempt from that Act’s offence of assisting suicide. This reinforces that the subject of the legislation under consideration is assisted suicide.
I am aware that many people would prefer the term “assisted dying” because of the stigma associated with the term “suicide”. The Bill rather contradicts itself by adopting the term “assisted dying” while attempting to modify these other statutory provisions that concern assisted suicide. That creates both conceptual and legal ambiguity. If Parliament is being asked to authorise assisted suicide, then it follows that such decisions fall within the proper domain of the courts. For that reason, among others, I support my noble Lord, Lord Carlile’s amendment that would replace the assisted dying review panel with a court-supervised process.
Amendment 120 appropriately moves decision-making from the medical to the legal sphere. Assisted dying is not a medical treatment; it is an act with profound societal implications, and it therefore requires, I suggest, judicial rather than clinical oversight. For that reason, I believe that it does not belong in the National Health Service. Under the proposed model, doctors would continue to provide expert medical evidence confirming diagnosis and prognosis, but the final authorisation would rest with a judge. That judicial scrutiny provides a stronger safeguard against errors, and enhances transparency and public confidence in the system by placing responsibility for these irreversible decisions in the courts, where I believe they properly belong.
Concerns about capacity in the courts, or potential delay and cost, do not outweigh the need for robust safeguards when decisions of life and death are involved. The appropriate response is to streamline court processes, not to lower the level of scrutiny. The same issues of capacity in taking on a new stream of work would, of course, apply in the NHS. A judge would provide a more independent assessment of an individual application than a panel, which is likely to comprise people who have chosen to do that work and have no track record of dealing with issues such as undue influence. It is regrettable that the other place abandoned judicial oversight in favour of an assisted dying review panel and commissioner, thus seriously weakening the safeguards that were originally envisaged. The assisted dying review panel is not, in its current form, fit for purpose. Its composition does not provide sufficient safeguards for vulnerable individuals, and there is insufficient clarity on how it includes expertise in palliative care, safeguarding and decision-making capacity. A court model would be preferable; without it, the panel would need to be substantially strengthened.
I also strongly believe that, without guaranteed access to a comprehensive multi-disciplinary specialist assessment of palliative, psychological and social care needs, neither judicial scrutiny nor an expert panel would be able reliably to identify inappropriate requests for an assisted death. Those preliminary assessments are the most essential safeguards to ensure that treatable sources of distress, or modifiable psychosocial factors, are considered before an informed decision can be made, both by the individual concerned and by the decision-makers. We will debate specialist multi-disciplinary assessments in the next group of amendments, and I look forward to returning to that.
I also support the amendments tabled by my noble friend Lord Carlile that seek to broaden the scope of safeguards referred to in Clause 1. At present, the Bill limits those safeguards to Clauses 8 to 30, which cover only the procedural steps. My noble friend’s amendments would extend the safeguard requirements to the whole of the Bill, ensuring that every substantive provision—not just the procedural elements—must be complied with before assistance to die can be lawfully provided.
I also support my noble friend’s Amendment 69 to strengthen the definition of “a terminal illness”. The amendment clarifies that a terminal illness must be
“an inevitably progressive disease which cannot be halted”.
The inclusion of “halted” is important; it ensures that eligibility is limited to conditions for which the disease trajectory cannot be stabilised or slowed through available interventions.
My Lords, I will speak briefly to two of the amendments in this group. I am grateful to the noble Lord, Lord Carlile, for meeting me in relation to his proposals under Amendment 120.
This group also contains related Amendment 116, which would introduce the capacity test that the noble Lord expects the court to use. Within that amendment, in the clear and settled intention part of that capacity test, is the introduction of the phrase “undue influence or coercion”. That test is different from the rest of the Bill, which uses “dishonesty, coercion or pressure”. I am sure that the noble Lord is aware, as he has outlined, that undue influence has a particular meaning in civil law and is presumed within certain relationships.