Question to the Home Office:

To ask the Secretary of State for the Home Department, what assessment her Department has made of the potential merits of rescheduling psylocibin to allow for research into its potential merits in the treatment of mental health issues.

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 there is 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 have been or are being conducted in the UK. 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 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 (a product licence), 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.

Research into Schedule 1 drugs, including psilocybin, proceeds in the UK under Home Office licence. On 16 July, the Government responded to recommendations from the Advisory Council on the Misuse of Drugs (ACMD) on how best to reduce barriers to research with Schedule 1 drugs. The Government intends to trial an approach whereby a domestic controlled drug licence is not required in universities, university colleges and hospitals, nor for clinical studies with relevant approval from the Health Research Authority or MHRA. These measures will support the Government’s aim of facilitating access to Schedule 1 controlled drugs for legitimate research into potential uses in healthcare, while minimising the risk of harm, diversion and misuse.

Ministers are under a duty to consider advice from the ACMD prior to making regulations under the Misuse of 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.