Question to the Home Office:

To ask the Secretary of State for the Home Department, what assessment her Department has made of the adequacy of the evidence supporting the continued placement of psilocybin in Schedule 1 of the Misuse of Drugs Regulations 2001.

Psilocybin is controlled under the Misuse of Drugs Act 1971 (‘the 1971 Act’) and placed in Schedule 1 to the Misuse of Drugs Regulations 2001 (‘the 2001 Regulations’). Drugs are typically placed in Schedule 1 when they have no established medical use in the UK. Drugs that have an established medical use are typically placed in another schedule to enable prescribing.

The Government recognises that studies into the potential use of psilocybin as part of the treatment for mental health conditions, including publicly-funded research, have been or are being conducted in the UK. These studies have included the clinical use of psilocybin in treatment-resistant depression. However, medicines based on psilocybin have to date not been assessed on the basis of their safety, quality and efficacy and granted a marketing authorisation (a product licence) by the Medicines and Healthcare products Regulatory Authority (MHRA).

The MHRA supports the safe and scientifically sound conduct of trials in this area and provides regulatory and scientific advice to companies at all stages of developing medicines. Should a company apply for a marketing authorisation, it will ultimately be a decision for the MHRA whether to license a psilocybin-based medicine as a therapy. Reconsideration of scheduling under the 1971 Act would ordinarily follow such an assessment by the MHRA.

The Government responded to recommendations from the Advisory Council on the Misuse of Drugs (ACMD) on how best to reduce barriers to clinical research with Schedule 1 drugs, such as psilocybin, in July 2025. The Home Office is working with the Department for Health and Social Care to take forward that response with a view to making it easier to research with Schedule 1 drugs.

Ministers are under a duty to consider advice from the ACMD prior to making regulations under the 1971 Act, for example if the Government were minded to reschedule a drug to enable it to be prescribed. The Government has no current plans to commission the ACMD to assess the scheduling of psilocybin, or to otherwise make psilocybin available for administration or prescribing outside of clinical trials, in advance of marketing authorisation.