The UK Assisted Dying Bill and its implications for pharmaceutical companies

The Terminally Ill Adults (End of Life) Bill, introduced as a private members’ bill by Kim Leadbeater MP on 11 November 2024 (Leadbeater Bill), has been a dominant subject of discussion in the UK media in the last weeks. The main purpose of the Leadbeater Bill is to decriminalise in England and Wales the provision of assistance by a doctor to a terminally ill person to end their own life. Decriminalisation will be subject to compliance with certain safeguarding procedures intended to ensure that the terminally ill person has a clear, settled and informed wish to end their own life, has the capacity to make that decision, and has not been subject to pressure or coercion in reaching that decision.

It is currently a criminal offence in England and Wales under the Suicide Act 1961 to encourage or assist another person to attempt suicide. This offence is punishable by a term of up to 14 years in prison.

MPs will vote for the first time on the Leadbeater Bill on Friday 29 November, when it goes for second reading in the House of Commons. MPs have been given a free vote on the Bill, meaning that MPs can vote in accordance with their conscience and the vote will not be whipped along party lines. As such it is unclear whether or not the Bill will pass the second reading vote. While the vote is only to determine whether the Leadbeater Bill can proceed to committee stage, the Bill could be permanently blocked from proceeding if a majority of MPs choose to vote against it.

Quite rightly, the discussion around the Leadbeater Bill has focused on profound and weighty subjects such as the autonomy and dignity of terminally ill people, the sanctity of human life, the subtle and not so subtle ways in which a person might be pressured or coerced into ending their own life, whether ending a life should be part of the role of a caregiver, and the effectiveness of safeguards involving the expert assessment of professionals such as doctors and High Court judges. This article is not intended to address those vital matters, which have been the subject of much more considered analysis elsewhere by more qualified commentators. This article is only intended to address one small component of the assisted dying regime proposed in the Leadbeater Bill which has so far not attracted very much attention in public discussion: the substances which a doctor will be allowed to provide to assist a terminally ill person to end their own life. These substances are referred to in the Leadbeater Bill as “Approved Substances”.

Approved Substances

An Approved Substance is defined in the Leadbeater Bill as “a drug or other substance specified by the Secretary of State [for Health and Social Care] in regulations for the purposes of the Act.” The Secretary of State is also empowered to make regulations concerning the prescribing, dispensing, transportation, storage, handling and disposal of Approved Substances.

In other words, the Leadbeater Bill does not make concrete proposals regarding the products which will be authorised for use in assisted dying as Approved Substances, nor does it make any proposals regarding the regulation of the supply chain for Approved Substances. This is deferred to secondary legislation to be prepared by the Secretary of State. As the Leadbeater Bill is a private member’s bill which has been prepared without government support, it is unsurprising that many of the specifics of implementation are left for future legislation following consideration by the appropriate government department.

Realistically, the Approved Substances designated by the Secretary of State will be medicinal products: either licensed medicinal products to be used “off-label”, or unlicensed medicinal products to be supplied as “specials”. As noted by a 2022 House of Commons research paper, there are no medicinal products authorised for use in assisted dying by a medicines regulator, even in European countries such as the Netherlands and Belgium where assisted dying is lawful.  Further, medicinal products used in assisted dying are invariably used at very high dosages, far higher than the approved dosages for ordinary clinical use.

Based on research cited in that House of Commons paper, certain classes of medicinal product are commonly used in assisted dying in those jurisdictions where it is lawful, such as:

• Sedatives and hypnotics, including benzodiazepines such as lorazepam and barbiturates such as thiopental
• Opioids, such as morphine and fentanyl
• Cardiotoxic agents, such as potassium chloride and propranolol
• Antiemetics, such as haloperidol and ondansetron
• Neuromuscular blockers, such as atracurium and cisatracurium

Given that use of these classes of product appears to represent standard medical practice in assisted dying (to the extent that such exists), it is highly likely that products in some or all of these classes will be designated as Approved Substances, if the Leadbeater Bill enters into law.

The assisted dying regime proposed in the Leadbeater Bill poses challenges for suppliers of licensed and unlicensed medicinal products designated as Approved Substances, and also for marketing authorisation (MA) holders of licensed medicinal products designated as Approved Substances.

Supply of medicinal products for use in assisted dying

The basic issue with the Leadbeater Bill for suppliers of Approved Substances is that it is unclear whether they will commit an offence under the Suicide Act 1961, if they supply an Approved Substance for the purpose of assisted dying.

Commission of an offence 
It is an offence under Section 2 of the Suicide Act 1961 for a person to intentionally encourage or assist the suicide or attempted suicide of another person. Clearly, if a person supplies an Approved Substance, knowing that it will be used in an attempt at suicide, there is a risk that that person commits an offence. As noted above, such an offence is punishable by up to 14 years in prison.

A supplier of an Approved Substance which is high up the supply chain, well-removed from the doctor who will provide assistance to a terminally ill person, is at less risk of committing an offence. For instance, where a wholesale dealer of a licensed opioid medicinal product supplies that product to a pharmacy, and the pharmacy then dispenses that product in order to fill a prescription for “off-label” use in assisted dying by a doctor in accordance with the Leadbeater Bill, it is hard to see that an offence is committed by the wholesale dealer. The wholesale dealer had no knowledge that its product would be used for assisted dying.² As such, it did not provide assistance intentionally.

However, the risk of a supplier of an Approved Substance acquiring knowledge that its product will be used in assisted dying increases the further down that supplier sits in the supply chain. The risk is particularly pronounced for a supplier of an unlicensed “special” medicinal product. “Specials” can only be supplied in response to an unsolicited order by a person with direct responsibility for the care of a patient, where that patient’s special needs cannot be met with a licensed medicine. Given that the dosage of a licensed medicine is generally far less than a reliably lethal dose, it is very likely that “specials” will be a common way of obtaining very high dosage presentations of Approved Substances for use in assisted dying.

The fact that a particular product has been designated as an Approved Substance, together with an order from a doctor for a very high dosage presentation, is likely sufficient to fix a “specials” supplier with knowledge that the product it supplies will be used for assisted dying. On top of that, a “specials” supplier in the UK is required to obtain evidence that the special needs of the patient cannot be met with a licensed medicine. As a result, an order to a “specials” supplier for an Approved Substance for use in assisted dying will likely state on its face that the Approved Substance is intended to be used for assisted dying and that licensed medicines are not appropriate for this purpose. Filling such an order will constitute knowing and intentional assistance for an attempt at suicide. In such circumstances, it is very hard to see how a “specials” supplier of an Approved Substance could avoid committing a prima facie offence under the Suicide Act 1961.

Availability of a defence
Section 24 of the Leadbeater Bill (Criminal liability for providing assistance) creates a defence to the offence of encouraging or assisting suicide where the defendant:

1. provides assistance to a terminally ill person, reasonably believing they are acting in accordance with the Leadbeater Bill; and
2. takes all reasonable precautions and exercises all due diligence to avoid the commission of the offence.

On its face, a company which supplies an Approved Substance for use in accordance with the Leadbeater Bill ought to be able to avail itself of this defence. However, there are some problems with this in the current drafting.

First, Section 24 of the Leadbeater Bill is found under the heading “Protections for health professionals”, which could be read to limit the availability of this defence to such professionals. Excluding pharmacists, companies which supply medicinal products are not generally considered health professionals. While headings are not determinative of meaning, courts can use them to interpret the meaning of ambiguous legislation.³

Second, the Leadbeater Bill does not create obligations for companies which supply Approved Substances. It is left to the Secretary of State to create such obligations in secondary legislation. As such, it will be very hard for a company to clearly demonstrate that it is acting in accordance with the Leadbeater Bill, when the Leadbeater Bill simply does not apply to it. This also creates further ambiguity around whether the defence is really intended to apply to companies supplying Approved Substances.

Third, in the absence of any positive obligations under the Leadbeater Bill with which to demonstrate compliance, what “reasonable precautions” and “due diligence” ought to be taken by a supplier of Approved Substances to avoid committing an offence? It is possible to think of some sensible steps that could be taken: for instance, a company could seek to verify that the doctor requesting the supply of an Approved Substance is duly authorised to assist a terminally ill person to end their life. A company could also request copies of the declarations made by the terminally ill person that they wish to end their life and a copy of the declaration issued by the High Court confirming that the requirements of the Leadbeater Bill have been met.

However, unless prescriptive obligations are set down in secondary legislation or formal guidance is issued, companies supplying Approved Substances will not have any certainty that they are able to avoid committing an offence under the Suicide Act 1961. It would be best if the defence created by Section 24 of the Leadbeater Bill were expressly drafted to cover companies in the supply chain for Approved Substances.

Pharmacovigilance for licensed medicinal products

The key issue with the Leadbeater Bill is whether it provides clear protection from criminal liability for companies in the supply chain for Approved Substances, especially for suppliers of unlicensed “specials”. However, there are also challenges for MA holders of licensed medicines which are designated as Approved Substances, particularly in relation to pharmacovigilance (PV).

An MA holder is obliged to conduct PV in order to monitor safety signals relating to its medicinal product and to continually assess the risk/benefit balance of that product. The essence of PV is the obligation to proactively monitor available information sources for reports of adverse reactions to the medicinal product, to investigate and evaluate such reports, and to take appropriate measures to minimise and prevent risks associated with use of the medicinal product. Such measures can include steps such as adding new safety warnings to the Patient Information Leaflet, reducing pack size to reduce the likelihood of overdose, varying the MA to limit the indications or populations in which the medicinal product is authorised for use, or even restricting the circumstances under which the product can be prescribed. An MA holder must also report adverse reactions and the outcome of its evaluation of such reactions to regulators such as the MHRA. Regulators can also impose risk minimisation measures or even suspend or withdraw the MA if the risk/benefit balance is no longer positive.

Under the Human Medicines Regulations, “adverse reaction” means a response to a medicinal product that is noxious and unintended.⁴ Clearly, the death of a patient as a result of administration of a medicinal product is “noxious”. It is ambiguous whether such death in the context of assisted dying is “unintended”. Clearly such death is the intention of the terminally ill person and the doctor providing assistance to them. However, the better view is that such death is not an “intended” response to the medicinal product, as this is not a response intended by the MA holder and is not part of the licensed indications for the medicinal product. Death resulting from use of a medicinal product for assisted dying will likely be regarded as an “adverse reaction”.

Further, any undesirable reactions which are suffered by a terminally ill person following administration of a licensed medicinal product for the purpose of assisted dying should be regarded as adverse reactions. For instance, research has reported a wide variety of undesirable reactions by patients administered with high dosages of substances commonly used for assisted dying, such as burning, nausea, vomiting, regurgitation, seizures, and prolonged loss of consciousness without death.⁵ While the context of use is unusual, these are classic examples of adverse reactions which should be addressed under PV.

As such, MA holders of licensed medicinal products which are designated as Approved Substances will need to think seriously about how to address reports of use of their product in assisted dying when undertaking PV. Such uses will be “off-label”. Further, given that the purpose will be to end life rather than to treat disease, there is a good argument that such uses should be regarded as positive misuse, meaning “intentional and inappropriate use not in accordance with the terms of the marketing authorisation”. MA holders will need to think carefully about how such unusual reports will fit into their PV systems, and whether risk minimisation measures should be taken in response. It would be valuable to have guidance from the MHRA on how to address adverse reaction reports arising from use of medicinal products in assisted dying.

It is also unclear how regulators worldwide will respond to receiving PV reports of licensed medicinal products being used for the purpose of assisted dying. Some overseas regulators may take the pragmatic view that use of a licensed medicinal product in accordance with the legal regime for assisted dying in England and Wales does not constitute a risk for use of the product in their jurisdiction. Other regulators may not take such a view. For instance, a regulator may see a risk in the medicinal product becoming known as a “suicide drug”, and impose risk minimisation measures accordingly.

As plenty of other countries around the world have already legalised assisted dying, these are not entirely new issues and there is surely regulatory experience to draw on. Nonetheless, thought is required.  

Postscript on Scotland

The Leadbeater Bill will not apply in Scotland. In fact, encouraging or assisting suicide is not a specific criminal offence in Scotland, but such conduct is effectively criminalised under other offences, such as manslaughter and assault. As such, parallel legislation to legalise assisted dying is currently under consideration by the Scottish parliament, having been introduced by Liam McArthur MSP (McArthur Bill).

This article does not directly address the McArthur Bill, but the issues which it addresses are equally applicable to the parallel Scottish legislation as to the Leadbeater Bill. The McArthur Bill also proposes a regime for “Approved Substances” for use in assisted dying, and the establishment of this regime will depend on cooperation with the UK Parliament in Westminster, as the regulation of medicines and poisons is a matter outside of the competence of the Scottish Parliament under the Scotland Act 1998. Assuming that both the Leadbeater Bill and the McArthur Bill become law, it would make sense to adopt a single approach to the regulation of products as “Approved Substances” across Great Britain.⁶

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1. https://researchbriefings.files.parliament.uk/documents/POST-PB-0047/POST-PB-0047.pdf
2. Any supplier of a medicinal product which has been designated an Approved Substance must be aware that the product may be used in assisted dying, which must increase the risk that in certain circumstances supply would be deemed “intentional assistance”.
3. R v Montila & Ors [2004] UKHL 50
4. Regulation 8(1), Human Medicines Regulations 2012
5. Worthington A, Finlay I, Regnard C. Efficacy and safety of drugs used for 'assisted dying'. Br Med Bull. 2022 Jul 9;142(1):15-22. https://pmc.ncbi.nlm.nih.gov/articles/PMC9270985/ 
6. There are not currently any legislative proposals in Northern Ireland to introduce an assisted dying regime.