UK Government supports ACMD plan to enable research with schedule 1 medicines such as psilocybin and MDMA

By Jody Chu, James Bunn and Prof Jo Neill

Despite the resurgence of research into the clinical efficacy and mechanism of action of psychedelic drugs such as such as psilocybin, LSD, DMT, and MDMA they are currently in Schedule 1 of the Misuse of Drugs regulations 2001. This means that researchers must apply for a controlled drugs licence from the Home Office to possess, supply, or administer these substances, even when ethical and regulatory approvals are already in place. This places significant barriers to research, in terms of cost, delays, bureaucracy and stigma and some researchers in the UK will not conduct this research because of these barriers (Howard et at al. 2021) This work is essential to advance clinical and preclinical knowledge about these much needed treatments for mental and physical health, especially within universities and hospitals. For several years Drug Science, the University of Manchester, and others have been calling for reforms such as have occurred in other countries [e.g. Australia]. In response, in 2023 the Advisory Council on the Misuse of Drugs (ACMD) published the “Consideration of Barriers to Research Part 2” report: a set of recommendations to ease these barriers.  

On 16 July 2025, the government issued its formal response, the key element of which is to enable research with Schedule 1 drugs without the requirement for a controlled drugs licence. They will then evaluate this through a pilot scheme. Certain exemptions are not enabled yet, including import and export of these substances (ie this will still require a specific controlled drugs licence) and pharmaceutical industry requirements for working with Schedule 1 drugs will not change.

This is a significant advance in policy that Drug Science welcomes, please do refer to these new recommendations below and contact your Home Office representative to find out how to proceed in your specific situation.

Please keep supporting us to pursue our goal of enhancing access to these important medicines in the UK. For more details of the ACMD report and the Government response, please read on...

Government Response to ACMD “Consideration of Barriers to Research Part 2: Schedule 1 Controlled Drugs” Recommendations

What did the ACMD recommend?

ACMD Recommendations

1.     Exempt Research Institutions from Licensing

The ACMD recommended that universities and hospitals be exempt from requiring a Home Office licence to possess, supply, or administer Schedule 1 substances for research purposes. This would bring Schedule 1 substances in line with how Schedule 2 drugs are currently handled under existing regulations.

2.     Exempt Clinical Trials with MHRA/HRA/REC Approval

Where researchers have already secured approval from the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA), or the Research Ethics Committee (REC) they should not also need a Home Office licence to administer Schedule 1 substances to human participants.

3.     Exemption for Licensed Suppliers

Organisations already authorised to supply Schedule 2–5 substances to hospitals or universities should also be permitted to supply Schedule 1 substances for research without needing a separate licence.

4.     Licensing System Reform

The Home Office’s domestic and import/export licensing system should be improved to make the process easier for first-time or infrequent applicants, with clearer guidance and greater transparency.

5.     Evaluate Policy Impact

A structured framework should be developed to evaluate whether any policy changes made are effectively reducing barriers to research.

How did the government respond?

Home Office Response

Recommendations 1 & 2: Agreed in principle

The government expressed support for exempting research institutions and approved clinical trials from Schedule 1 licensing but stressed that operational feasibility must first be evaluated.

From an outsider’s perspective, it is difficult to fully assess the implications of the Home Office’s response to the recommendations. The key question is what "agreed in principle" actually means in this context. The Home Office indicated it would accept the Advisory Council on the Misuse of Drugs’ recommendation—provided it aligns with their proposed pilot scheme. This scheme will assess the practical implementation of the policy and examine its real-world effects. The response also underscored the importance of maintaining compliance with international drug control obligations and ensuring cross-departmental coordination.

Currently, Drug Science does not know how the pilot scheme will measure success. As such, when it comes to Recommendations 1 and 2, the devil is in the details—only time will reveal how this unfolds. We expect this licensing change to have a net positive impact and would welcome collaborating with the Home Office to evaluate the scheme’s effectiveness.

Recommendation 3: Rejected for now

This proposal was not accepted in its current form. The government raised concerns regarding definitional ambiguity, specifically questioning whether the recommendation pertained to supply or manufacturing. They are currently seeking further clarification from the Advisory Council on the Misuse of Drugs.

Beyond this, limited additional information has been provided, other than an indication that the government would be willing to revisit this issue within a cross-government working group at a later date.  Drug Science strongly urges the Home Office to assess this matter with a broad group of stakeholders.

The Drug Science Medical Psychedelics Working Group comprises a diverse range of professionals experienced in working with scheduled substances. We hope the Home Office adopts a similar approach when addressing this recommendation in the future, or they are welcome to contact us.

Recommendation 4: Accepted


The Home Office agreed and stated that reforms to the licensing system are already underway. Updates to guidance and improvements in application processing are ongoing, with reference to recent hemp licensing reforms.

While Drug Science supports this decision, it's worth noting the Home Office has a reputation for being remarkably slow in reviewing licensing applications. The very hemp reforms they cite significantly lagged behind the growth of the hemp industry in the UK. We would have preferred to see some sort of timeline associated with this acceptance to ensure timely implementation.

Recommendation 5: Accepted


The government endorsed the development of an impact assessment framework and confirmed this will be incorporated into the proposed pilot schemes and future policy design. This will help determine whether proposed reforms are functioning as intended.

What’s next?

A new cross-government working group will be established to oversee implementation of the accepted recommendations. The ACMD will remain involved in shaping the pilot schemes and addressing unresolved issues such as supplier licensing. While the government’s language signals a willingness to reform, practical progress will hinge on interdepartmental coordination and the outcomes of pilot programmes.