Summary
This editorial highlights the UK’s drug regulatory double standards. Drugs for assisted suicide would bypass standard regulation despite limited evidence, while psychedelics face significant barriers despite promising evidence internationally. I argue that drugs for assisted suicide should meet the same regulatory standards, and psychedelics should be rescheduled to enable further clinical research.
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Both psychedelic therapy and assisted suicide are gaining support in the UK. Recent focus around psychedelic therapy has been on generating evidence of safety and efficacy but, despite the growing body of promising evidence, regulatory barriers remain, restricting further research.
On the other hand, current debates around assisted suicide have predominantly focused on ethics and eligibility with little focus on the drugs that would be used or the lack of high-quality evidence internationally on their safety and efficacy. Under recently proposed legislation, regulatory hurdles applied to psychedelic therapy would be side-stepped for assisted suicide.
UK’s drug regulatory framework
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that drugs entering the UK market are safe and effective. The licensing process involves a rigorous review of evidence submitted by the pharmaceutical company seeking market authorisation. If an application involves a substance scheduled under the Misuse of Drugs Regulations 2001, the company must also obtain a domestic licence from the Home Office.
For off-patent medicines, where there may be few financial incentives for pharmaceutical companies, the UK government can offer research support through the National Institute for Health and Care Research (NIHR).
Once market authorisation is granted, the National Institute for Health and Care Excellence (NICE) conducts a health technology assessment (HTA) to evaluate the clinical efficacy and cost-effectiveness of the substance.
If a pharmaceutical company wants to repurpose a drug that’s already licensed in the UK for use in assisted suicide the company will need to apply for a new market authorisation. This is because assisted suicide would constitute a novel indication in which death is the primary intended outcome. It would also involve doses far exceeding established therapeutic ranges, thereby requiring new risk-benefit evaluation.
Since the drugs for use in assisted suicide are likely to be off-patent, there would be little incentive for pharmaceutical companies to pursue this, so government support through NIHR funding would be required. Following MHRA approval, the drug would be subject to an HTA by NICE.
What is being proposed under the Terminally Ill Adults (End of Life) Bill
Under the recently proposed legislation, the authority to determine the most appropriate substance for assisted suicide would rest with the Secretary of State. This approach effectively bypasses the regulatory oversight process described above, thus raising significant patient safety concerns.
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