Correspondence

Government response to the ACMD's report on barriers to research: part 2 (accessible)

Published 16 July 2025

Professor Owen Bowden-Jones, Chair, Advisory Council on the Misuse of Drugs (ACMD)

Professor Roger Knaggs Chair of the Barriers to Research Working Group, ACMD

By email only ACDM@homeoffice.gov.uk

16 July 2025

Dear Owen and Roger,

The government response to the ACMD advice on Barriers to Research Part 2: Schedule 1 Controlled Drugs

We would like to thank the ACMD, especially the Barriers to Research Working Group for all their work on this report. We recognise that this has been an extremely complex area which has been ongoing for several years and we appreciate the ACMD’s commitment and patience in ensuring that we continue to progress this matter. Your report and its recommendations raise awareness of the potential to reduce bureaucracy in research which could make a significant difference to our nation’s public health and contribute to our wider missions within the National Health Service and beyond.

Protecting the public from the harmful consequences of drug misuse is part of our mission to keep our streets safe, but we are mindful of the need to ensure properly regulated access to controlled drugs where appropriate. The Home Office and Department of Health and Social Care (DHSC) have worked together to consider the ACMD advice and respond to these recommendations, and we are united in wishing to facilitate the progress of clinical trials involving controlled drugs, while minimising any risk to public safety from drug misuse.

The issue of research using controlled drugs is not limited to Home Office licensing and we are therefore establishing a cross-government approach to ensure that we continue to consider ways of improving research using controlled drugs in the round.

As part of that, a new cross-government officials working group will focus on any new issues involving research with controlled drugs while also monitoring the changes following your recommendations. This will provide the opportunity to carefully consider the practical implications, procedural design and delivery of the reforms, and ensure that there is a forum to review existing or new barriers to research, and discuss any future reforms arising from your work.

1. Responses to immediate ACMD recommendations:

Recommendation 1

The ACMD recommends that research using Schedule 1 Controlled Drugs in universities and hospitals be exempt from the need to apply for a Home Office domestic licence and instead to operate in accordance with the requirements of Schedule 2 Controlled Drugs.

The government agrees with this recommendation in principle subject to operational feasibility. If the recommendation proves feasible, we aim to implement this via a pilot scheme to assess the benefits and potential consequences.

The purpose of this recommendation is to mirror current provisions under the Misuse of Drugs Regulations 2001 (MDR 2001) which apply to substances listed in other schedules of those regulations, as follows:

• Under Regulation 8(2)(f) ‘a person who is in charge of a laboratory the recognised activities of which consist in, or include, the conduct of scientific education or research and which is attached to a university, university college or such a hospital as aforesaid or to any other institution approved for the purpose under this sub-paragraph by the SoS’ will not require a HO licence for the supply of a Schedule 2 drug.

• Under Regulation 10(1)(a) a person listed under 8(2)(f) MDR 2001 does not need a HO licence for the possession of a Schedule 2 drug; and

• Under Regulation 7 MDR 2001, there are provisions which remove the need for an administration licence for Schedule 2-5 drugs.

These provisions would exempt universities and hospitals from the requirement to seek a Home Office licence to possess, supply or administer a Schedule 1 drug through any stages of the research process (whether ‘in vitro’ or ‘in vivo’). As is currently the case for Schedule 2 drugs, this recommendation does not extend the exemption to produce, import or export a Schedule 1 drug without the necessary Home Office licence. Additionally, this does not extend to other entities conducting research with Schedule 1 drugs, such as pharmaceutical companies, who will continue to require a Home Office licence to possess or supply a Schedule 1 drug for ‘in vitro’ research and an administration licence during ‘in vivo’ testing.

While we are supportive of this proposal, we note that there are potential implications of withdrawing the checks currently provided by the Home Office licensing regime, in line with ACMD advice, ‘further consideration will be required regarding the practical implementation of any of these options within the current regulations, which may present further benefits, limitations or risks’.

We therefore agree to this recommendation “in principle”, as there are delivery considerations which will need to be resolved prior to implementation. This will include putting in place necessary governance arrangements and guidance, ensuring continued compliance with our international obligations, and creating a monitoring process to establish the practical impact of these changes. The Home Office will continue to work closely with other departments to consider these issues.

Recommendation 2

The ACMD recommends that clinical studies using Schedule 1 Controlled Drugs with relevant HRA and MHRA approvals be exempt from the need to apply for a HO domestic licence and instead to operate in accordance with the requirements of Schedule 2 Controlled Drugs.

The government agrees with this recommendation in principle. In the first instance, we would like to create an exemption under the MDR 2001 to remove the requirement for a Home Office licence for administration of Schedule 1 drugs for those with MHRA/HRA/REC approval. We intend to measure the impact of this prior to considering any further amendments.

This recommendation seeks to exempt any organisation from a Home Office licence to possess, supply, administer a Schedule 1 drug provided they have received the relevant HRA and MHRA approval for clinical trials. We understand that in practice this will also apply to the Research Ethics Committee (REC) which sits within the HRA. It does not seek to provide any further exemptions for the import/export of a Schedule 1 drug, nor does this recommendation refer to the Animal (Scientific Procedures) Act 1986 (ASPA) licensing requirements.

Any pre-clinical research (e.g. ‘in vitro’ testing) requires a Home Office licence to possess and supply a Schedule 1 drug. This licence will continue through all stages of the research process (including ‘in vivo’ testing). Under the MDR 2001, there is an exemption for the administration of Schedule 2-5 drugs as they are intended for medicinal purposes and therefore available for administration by healthcare professionals. However, a Schedule 1 Home Office administration licence is required following the relevant MHRA/HRA/REC approval for clinical trials involving humans.

We accept that, in practice, the removal of a Schedule 1 Home Office administration licence could facilitate the research process and remove some of the administrative burdens on companies seeking to conduct human in vivo testing following receipt of the MHRA/HRA/REC approval. This would remove unnecessary duplication as clinical trials are already supervised.

As is the case with Recommendation 1, there will be some operational delivery considerations. We will use the cross-government working group to consider this in further detail.

There is a need to strike the right balance in ensuring that we alleviate some existing requirements while ensuring that no additional administrative burdens are introduced. We need the process to be streamlined and efficient with any necessary safeguards in place, and ensure compliance with our international obligations. As with Recommendation 1, we will also need to create a monitoring process to assess the practical impact of these changes.

Recommendation 3

The ACMD recommends that organisations that are already exempt from the need to apply for a Home Office domestic licence for the purpose of supplying a university or hospital with Schedule 2–5 Controlled Drugs, be exempt from the need to apply for a Home Office domestic licence for the purpose of supplying a university or hospital with a Schedule 1 Controlled Drug for research purposes.

The government cannot accept this recommendation as currently presented in the ACMD report, which focuses on the production or manufacturing of a controlled drug for research purposes, rather than the supply. There is ambiguity in the recommendation as to the type of research to which the proposed exemption would apply. The need to clarify this would be essential to understanding the implications of the proposed change for regulators and for the HO controlled drugs licensing function. This will therefore be discussed within the cross-government working group, and the ACMD will be asked for further clarification regarding this recommendation if required.

Recommendation 4

The ACMD recommends the HO review the domestic and import/export licence application systems to consider if there are any further options to improve applicant understanding and experience, recognising some applicants are first-time applicants or use the system infrequently.

The government accepts this recommendation. The Home Office is already taking steps to improve the overall applicant experience of our licensing service and to improve timeliness of decision making across all domestic controlled drugs licences. Recent reforms to hemp licensing are one example of this, providing greater flexibility for farmers growing this crop. The Home Office will ensure that guidance on domestic and import/export licences is up to date. The latest version of the domestic licence guidance was updated in November 2023 and is available on the gov.uk website. We will continue to look for opportunities to communicate about the process for applying for a licence to support legitimate businesses and researchers in their work.

Recommendation 5 (Option 5)

The ACMD recommends the HO design a framework for the assessment and evaluate the impact of any policy changes to reduce barriers to research associated with Schedule 1 Controlled Drugs. The government accepts this recommendation. As set out in recommendation 1 and 2, we believe that, once the practical requirements and amendments have been established, it is right to assess whether these changes have had the desired impact.

2. Additional (longer term) options proposed by the ACMD

We are grateful for the additional options the ACMD has recommended for longer-term consideration and reform, which we will explore further at official level in our new working group and may need to discuss in more depth with you in due course. Here are some initial and brief observations on these options as they stand:

On establishing more general terms or definitions of products for exemption, we think it would be difficult at present to ensure sufficient legal certainty while also preventing the risks of loopholes. We agree with the ACMD that there is no ‘one size fits all’ approach and it is my hope that the pilot scheme will provide further insight on whether the changes have removed barriers to research.

On reviewing the Misuse of Drugs (Safe Custody) Regulations 1973, we agree there may be merit in that work, but we are also aware that it would be a time consuming and resource-intensive exercise, so it is an option we will keep in mind, while not committing to a full review at this stage.

On allowing industry organisations greater flexibility to add a Schedule 1 permit to their existing domestic licence, we can see the objective behind this proposal, but we are concerned about the greater risk it would introduce in relation to oversight of controlled drugs. We do not therefore intend to take this option forward at this stage, but we will suggest that the working group add it to their list of issues to examine.

Finally, on establishing a consultation process with academia and industry before implementing new generic controls, we agree that consultation is an important part of establishing the case for any legislative changes, whether for generic or specific controls. This also needs to be balanced against the need for urgency where such controls are intended to address threats to public safety and we will continue to assess what we can do to improve our consultation process with that in mind.

We greatly appreciate all the ACMD’s suggestions on these longer-term options, which will remain a focus in our further discussions regarding this issue.

3. Next steps

Officials will continue to work closely across government to consider the process for implementing the recommendations agreed in Section 1 of this letter. We invite the Barriers to Research Working Group to meet the new cross-government working group to discuss the implementation of these recommendations. Any changes to the 2001 Regulations will of course require prior consultation with the ACMD.

As always, we are very grateful for the work of the ACMD in supporting 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. We look forward to seeing the benefits that these latest proposals will deliver.

Yours sincerely

Rt Hon Dame Diana Johnson DBE MP
Minister of State for Policing and Crime Prevention

Baroness Merron
Parliamentary Under-Secretary of State for Patient Safety, Women’s Health and Mental Health