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.

Ministers are under a duty to consider advice from the Advisory Council on the Misuse of Drugs (ACMD) prior to making regulations under the 1971 Act. The Government has no current plans to commission the ACMD to review the scheduling of psilocybin.

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). Reconsideration of scheduling under the 1971 Act would ordinarily follow such an assessment by the MHRA.

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.

No recent representations on the potential clinical use of psilocybin to treatpsychiatric illness have been made to the Home Office by the AdvisoryCouncil on the Misuse of Drugs, Royal College of Psychiatrists or theDepartment of Health and Social Care.

The Government recognises that studies into the potential use of psilocybinas part of the treatment for mental health conditions have been or are being conducted in the UK under Home Office licence.

On 16 July, the Government responded to recommendations from theAdvisory Council on the Misuse of Drugs (ACMD) on how best to reducebarriers to clinical research with Schedule 1 drugs, such as psilocybin.

The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department and regulates medicine, medical devices, and blood components for transfusion in the United Kingdom, with responsibility for ensuring medicines meet appropriate standards of safety, quality, and efficacy.

Clinical trials are underway in the UK to investigate psilocybin's use for various mental health conditions, with the open trials being in phases 1, 2, and 3, including depression, anxiety, post-traumatic stress disorder, and addiction. The MHRA is aware and is supporting the trials in this area to determine benefit versus risk. The MHRA is ready to review any data submitted to ensure an assessment of the quality, safety, and efficacy is completed rapidly upon submission.

The National Institute for Health and Care Research (NIHR) Clinician Scientist Fellowship titled ‘A Feasibility RCT of Single-Dose Psilocybin in Unipolar Depressive Disorder Resistant to Standard Treatments’ is shown on the NIHR Funding and Awards website as concluding in February 2024. The progress of this award was significantly delayed by the COVID-19 pandemic. The results are therefore not yet available and are due to be released in 2026.

The main aim of this award is to investigate the feasibility of conducting a trial in this patient group and to contribute towards the design of a more definitive study. The award has resulted in the creation of the Psychoactive Trials Group at King’s College London, which is one of the world’s most experienced clinical research teams in this emerging area of treatment.

The Department recognises that the use of psychedelic-assisted psychotherapies, such as psilocybin, to treat mental illness is gaining attention both within the medical and scientific communities, as well as across the public more broadly. However, there is no proven medical use for psilocybin in the United Kingdom, and no such substance has yet been licensed as safe and effective in the treatment of mental health conditions. The National Institute for Health and Care Research (NIHR) is supporting psilocybin research via the NIHR King’s Clinical Research Facility, the NIHR Oxford Health Clinical Research Facility, and the NIHR Maudsley Biomedical Research Centre, where researchers are developing and evaluating the efficacy and safety of psilocybin therapies.

There are no current plans to reschedule psilocybin under the Misuse of Drugs Act 1971, also known as the Act.

There is an established process for the development of medicines, overseen by the Medicines and Healthcare products Regulatory Agency (MHRA). This enables medicines, including those containing Schedule 1 controlled drugs under the Act, such as psilocybin, to be developed, evaluated in clinical trials, and licensed, based on an assessment of their safety, quality, and efficacy, before being made available to patients in the United Kingdom. Should an application be submitted for a marketing authorisation, for a product licence, it will ultimately be a decision for the MHRA whether to license psilocybin as a therapy. There are no psilocybin-based medicines with a marketing authorisation in the UK.

If a manufacturer is successful in being granted a marketing authorisation by the MHRA for a medicine containing psilocybin, the Home Office is committed to reviewing its scheduling under the Act, subject to advice from the Advisory Council on the Misuse of Drugs on the appropriate scheduling and safeguards for the medicine.

The National Institute for Health and Care Research (NIHR) is supporting psilocybin research via the NIHR King’s Clinical Research Facility, the NIHR Oxford Health Clinical Research Facility, and the NIHR Maudsley Biomedical Research Centre, where researchers are developing and evaluating the efficacy and safety of psilocybin therapies.

I completely sympathise and understand why people suffering from distressing conditions will want to seek the best possible treatment available, and I thank the hon. Lady for raising the issue. We are committed to ensuring that the UK is a world-leading

jurisdiction for pharmaceutical, clinical and other medical research, and we have asked the Advisory Council on the Misuse of Drugs to review barriers to legitimate medical research involving controlled drugs such as psilocybin. I am pleased to tell the hon. Lady that our response to the council’s recommendations will be published as soon as possible.

The UK used to be a world leader in psilocybin research but, despite the calls of the Home Affairs Committee, leading researchers, charities, veterans’ organisations and the Royal College of Psychiatrists, we have shamefully fallen behind on breakthrough treatments for conditions such as post-traumatic stress disorder and depression, causing misery to millions of people in our country. Can the Prime Minister explain why this policy remains the responsibility of a Home Office that cannot give it the attention it deserves, and why it is okay that American, Canadian and Australian patients can access treatment that British patients cannot?

The Department commissions research through the National Institute for Health and Care Research (NIHR), who have invested £1.1 million in a randomised controlled trial to examine if it is feasible, safe and effective to use psilocybin to treat people with treatment-resistant depression. The NIHR is supporting psilocybin research via the NIHR King’s Clinical Research Facility and the NIHR Maudsley Biomedical Research Centre, where researchers are developing and evaluating the efficacy and safety of psilocybin therapy for use in the National Health Service and other healthcare settings. The NIHR welcomes funding applications for research into any aspect of human health, including the use of psilocybin in the treatment of severe depression and other chronic conditions.

Before any new medicine can be used to treat patients, it must go through a strictly monitored development process. Manufacturers of medicines are expected to conduct research and clinical trials, and medicines must undergo scrutiny by the Medicines and Healthcare Products Regulatory Agency which will assess the safety, quality and efficacy of a product before a marketing authorisation (licence) may be granted. For a licence to be granted for a medicine the MHRA must receive a full marketing application from the applicant. In addition, the National Institute for Health and Care Excellence (NICE) evaluates all new medicines for clinical and cost effectiveness and makes recommendations about routine funding and use on the NHS. This is the foundation of NHS decisions about routine access and funding of medicines.

I routinely meet with Welsh Government Ministers to discuss a variety of issues. In addition, my officials regularly engage with Welsh Government officials regarding R&D support for Welsh businesses and universities, including health-based R&D.

The UK Government is investing £39.8 billion on R&D between 2022 and 2025, the largest amount ever. This will contribute to the Prime Minister’s ambition to cement the UK as a science and technology superpower by 2030, in which businesses and universities in Wales will play a key role.

I have recently visited all of the universities in Wales and I have also visited many businesses within the Welsh Life Sciences and MedTech sectors. I have greatly appreciated seeing the innovative technologies that are contributing to the Welsh R&D landscape because of excellent research and collaboration between academia and industry.

Drug policy and the associated legislation regarding its use and possession is reserved. I have not had any discussions with the Scottish Government regarding research into psilocybin.

Support for businesses and universities in Northern Ireland to conduct research is a devolved matter for the Northern Ireland Department for the Economy.

However, the Government is committed to supporting economic growth and driving transformational investment in Northern Ireland. In conjunction with Invest Northern Ireland and local partners, the UK Government will host the Northern Ireland Investment Summit in Belfast in September to showcase Northern Ireland’s internationally renowned sectors, including advanced manufacturing, software and technology, financial & professional services and emerging life & health sciences sector.

No assessment has been made by the Department for Work and Pensions of the potential impact of psilocybin on the health, or ability to work, of disabled people and people with long-term health conditions.

The National Institute for Health and Care Research (NIHR), funded by the Department of Health and Social Care, welcomes funding applications for research into any aspect of human health. This includes the potential impact of psilocybin on the health and ability to work of people with long-term health conditions. Applications are subject to peer review and judged in open competition, with awards being made on the basis of the importance of the topic to patients and health and care services, value for money and scientific quality.

The Department commissions research through the National Institute for Health and Care Research (NIHR), who have invested £1.1 million in a randomised controlled trial to examine if it is feasible, safe and effective to use psilocybin to treat people with treatment-resistant depression. NIHR welcomes funding applications for research into any aspect of human health, including the use of psilocybin in the treatment of depression, addiction and other chronic conditions. Applications are subject to peer review and judged in open competition, with awards made on the basis of the importance of the topic to patients and health and care services, value for money and scientific quality.

NIHR infrastructure is supporting psilocybin research via the NIHR King’s Clinical Research Facility and the NIHR Maudsley Biomedical Research Centre where researchers are developing and evaluating the efficacy and safety of psilocybin therapy for use in the National Health Service and other healthcare settings.

The meeting referred to in Hansard was on reducing barriers to research into controlled drugs, rather than on the rescheduling of psilocybin. It took place on 28 April 2023.

The Home Office has no plans to publish minutes of this meeting, which was intended to support the provision of advice to Ministers.