Baroness Hollins (CB)

My 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.