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A barrister and pharmacist has warned that Kim Leadbeater’s private members’ bill on assisted dying does not offer pharmacists iron-clad protection against criminal action or being placed under obligation to play a role in assisting a terminally ill patient to end their own life.

In written evidence to the House of Commons public bill committee in January, Manchester-based barrister Greg Lawton, a pharmacist who previously worked with Boots, identified a number of concerns with the Leadbeater bill as currently written.

He said that while the bill would give a health secretary the power to legislate on the ‘dispensing’ of approved substances used in assisted suicide, it does not in itself provide a legal mechanism for the sale or supply of these substances to doctors, and it is not clear what legal mechanism is being relied upon. 

In Mr Lawton’s view, this means that while there is a conscience clause applicable to some, the bill as written “would not prevent pharmacists being placed under a duty to supply drugs used for ending a patient’s life… [there could be a] regulatory duty or a contractual duty imposed by an employer.”  

Speaking to P3pharmacy, Mr Lawton said: “There has been strikingly little consideration given to the drug supply process - in the bill itself, its explanatory notes, the associated briefing papers, in oral evidence to parliament or in parliamentary debate.

“You’d expect pharmacy would play a role in the sale or supply.” 

Potential for criminal liability

In his submission to parliamentarians, Mr Lawton wrote that because there is no express mechanism for the sale or supply of the approved substances, pharmacists or pharmacy owners who made sales or supplies to doctors would likely be found to be acting outside the bill if it was considered by the courts.

He told P3pharmacy: “Since  it was a private member’s bill and the matter has not been the subject of parliamentary debate or discourse in papers associated with the bill, in my view no parliamentary intention can be inferred by courts that those voting in favour of the bill intended the secretary of state to have the power to make regulations about sale or supply. To make such inference would effectively confer extensive powers on the secretary of state.”

He added that it may be “particularly unlikely” the court would make such an inference now parliament has been advised that dispensing and sale/supply are not equivalent terms.

Citing clause 24 of Leadbeater’s bill which states that “a person is not guilty of an offence by virtue of providing assistance to a person in accordance with this act,” Mr Lawton argued that because in his view the sale and supply of the drug would not be carried out in accordance with the act, the clause “would not remove criminal liability in relation to such sale or supply”. 

“This means that they would likely commit the offence of assisting or encouraging suicide under s.2(1)(a) of the Suicide Act 1961,” he said.  

‘Approved substances’ are 'not medicines'

Mr Lawton also said there are serious questions around how the approved substances would sit within current legislation that the bill’s proponents have so far failed to answer. 

In his view, any substance supplied with a view to ending a terminally ill patient’s life cannot be understood as a medicine as defined by the Human Medicines Regulations 2012 – and so could not be sold, supplied, or distributed via wholesale for the purposes of assisting suicide under that legislation. 

This is because, taking into account wider provisions in the Human Medicines Regulations 2012 which assist with interpretation, the genesis of the regulations and existing case law, the drugs would fit neither of the two definitions used in the regulations: a substance that prevents or treats disease in human beings, or one that restores, corrects or modifies a physiological function. 

This raises numerous questions, he said, including what legal vehicles could be used to sell or supply the drugs to a doctor who is providing it.

He wrote: “Would a supply by a pharmacist to such a doctor be authorized under the Misuse of Drugs Regulations 2001? 

“How would the quality and efficacy of the drug be guaranteed, if it does not go through the process of obtaining a marketing authorization? 

“Would this depend on the specific drug(s) used?”

Mr Lawton told P3pharmacy: “If it isn’t a medicinal product then any sale or supply would be completely outside of the framework in medicines legislation that’s provided for the supply of medicinal products. 

“Supervision regulations in medicines legislation, for example, wouldn’t apply, and it would not be categorized as a prescription only medicine or a P or GSL – it would be completely separate to that.” 

And he said that even if the bill were changed so that a health secretary were able to legislate for the sale or supply of these drugs, this could create substantial legislative work:

“He or she may need to write extensive regulations to secure a process which resulted in the assembly, sale, supply etc. of the drug with the same safety precautions and other legal provisions as apply in relation to medicinal products.

“This could potentially involve the Secretary of State mirroring in regulations, to the extent within his or her powers, substantial sections of what is, in respect of medicinal products, primary legislation.”