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Psilocybin: Health Hazards

Question for Home Office

UIN 53823, tabled on 23 September 2021

To ask the Secretary of State for the Home Department, pursuant to the Answer of 7 June 2021 to Question 7725, on Psilocybin: Health Hazards, for what reason her Department has not commissioned a review into the scheduling status of psilocybin in the context of no recent analysis of the evidence for that drug's harm having been commissioned or published by the Government to support the compound being a Class A and a Schedule 1 drug and recent evidence of that drug's clinical and experimental potential.

Answered on

18 October 2021

There is an established process for the development of medicines, which enables medicines (including those containing Schedule 1 drugs such as psilocybin) to be developed, evaluated in clinical trials and licensed based on an assessment of their safety, quality and efficacy.

The Government recognises that a number of studies into the potential use of psilocybin as part of the treatment for mental health conditions have been or are being conducted in the UK. However, medicines based on psilocybin have not yet been licensed by the Medicines and Healthcare Products Regulatory Authority (MHRA) which would address safety, quality and efficacy concerns. Ministers could seek advice from the ACMD about the rescheduling of psilocybin-based products on the basis of evidence of the therapeutic use of unlicensed medicines, but we would ordinarily do this only in consultation with the Department for Health and Social Care and the MHRA.

The MHRA continues to support the safe and scientifically sound conduct of trials in this area and also to provide regulatory and scientific advice to companies at all stages of developing medicines. Should a company apply for a marketing authorisation (a product licence), it will ultimately be a decision for the MHRA whether to license a psilocybin-based medicine as a therapy.

If a psilocybin-based medicine is made available following an assessment of its quality, safety and efficacy by the MHRA, the Home Office will seek and then consider advice provided by the Advisory Council on the Misuse of Drugs (ACMD) on its scheduling under the Misuse of Drugs Regulations 2001 as soon as possible. Such advice is a statutory requirement and will be considered before any decision is taken on scheduling under the 2001 Regulations.

Answered by

Home Office
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