Consideration of barriers to research part 2: schedule 1 controlled drugs (accessible version)
Updated 6 February 2024
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ACMD Chair: Professor Owen Bowden-Jones
ACMD Barriers to Research Secretary: Matthew Brace
1st Floor (NE), Peel Building
2 Marsham Street
London
SW1P 4DF
Rt Hon Chris Philp MP
Minister of State for Crime, Policing and Fire
2 Marsham Street
London
SW1P 4DF
22 December 2023
Dear Minister,
RE: ACMD Consideration of Barriers to Research Part 2: Schedule 1 Controlled Drugs
We are pleased to enclose the Advisory Council on the Misuse of Drugs (ACMD) Barriers to Research Part 2 report which has considered barriers to research for all Schedule 1 controlled drugs.
This follows ACMD advice on reducing barriers to research for controlled drugs in research and healthcare (ACMD, 2017) and further advice on reducing barriers to research for synthetic cannabinoid receptor agonists (SCRAs) (ACMD, 2021).
A dedicated ACMD working group was established, which conducted a public evidence gathering exercise on barriers to research for Schedule 1 controlled drugs. Responses were received from a range of stakeholders, including university researchers, pharmaceutical companies, scientific societies, non-profit organisations, UK contract research organisations (CROs) and individual stakeholders.
The ACMD then sought information on current procedures and regulations from several Government departments and agencies, including the Home Office, Department for Health and Social Care (DHSC), Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA). The reported barriers discussed in the Home Affairs Committee ‘Drugs’ report (Home Affairs Committee, 2023) were also considered.
The ACMD formulated several options to reduce barriers to research across four broad areas involved in the exploration and development of potentially therapeutic drugs: theoretical (‘blue skies’) research, discovery research, development activities and clinical studies. These options were based on our understanding of these barriers and developed following discussions with the research community and review of international approaches. The ACMD is also grateful to Home Office officials who provided ideas to consider as part of the report.
Considering the breadth and complexity of research, the ACMD has concluded that there is unlikely to be a single ‘one-size-fits-all’ solution applicable to all settings.
The ACMD has recommended several non-mutually-exclusive options, which could provide solutions for specific areas of research. However, further work is required to address other areas of research and the ACMD has proposed several ‘further options’ which could reduce barriers for these areas in the long-term. The ACMD has concluded that the Home Office is best placed to consider if and how these options could be practically implemented within the legislative framework.
Spectrum of drug research activity
The ACMD has examined the four broad areas involved in the exploration and development of potentially therapeutic drugs conducted in ‘academia’ (research in universities and hospitals) and ‘industry’ (research in pharmaceutical companies, CROs or other private sector companies – these companies can vary significantly in size and range of activities undertaken). Further details on each of these areas can be found below.
Theoretical (‘blue skies’) research
Research to enhance understanding of the chemical and biological properties of a compound and its mechanisms of action.
Discovery research
Research involving testing compounds against a biological target to assess viability for further drug development. Discovery research can involve screening large numbers of compounds (several thousands to several million) to assess their biological affinity and efficacy.
Development activities
Research to assess the intended biological effects and to establish the optimal dose, administration route, toxicity and safety of a drug before clinical studies. Development activities can include in vitro studies (testing the efficacy and safety of a drug in individual cells or tissue cultures) and in vivo studies (testing the efficacy and safety of a drug in a living organism).
Clinical studies
Research conducted to examine the biological effects of drugs in humans. This includes research to assess the cognitive and behavioural effects of drugs and how they are absorbed, distributed and eliminated. Phase 1, 2 and 3 clinical studies examine the efficacy, optimum dose and formulation of a drug when developing new medicines.
The research stages and time required for the development of new medicines are described in Figure 1 below. Discovery research and development activities occur prior to clinical studies during the development of a new medicine. Theoretical research can occur at any time during this process.
Figure 1: Research stages and time required for the development of new medicines. Note theoretical research can occur at any point during the development of a new medicine [adapted from a figure submitted to the ACMD as part of the public evidence collection].
In the UK, research in academia often relies on funding from UK Research and Innovation (UKRI) grants, charities (for example, Wellcome Trust, British Heart Foundation, Cancer Research UK) or industry. Research grants are typically awarded over a fixed period (one to five years) for a particular project or programme of work.
Requirements under the Misuse of Drugs Regulations 2001
Legitimate use of controlled drugs is enabled through scheduling under the Misuse of Drugs Regulations 2001, which regulates their availability according to their medicinal value and perceived risk of misuse. Controlled drugs are placed in one of five schedules, where Schedule 1 has the greatest restrictions on activities and Schedule 5 the fewest.
All research in the UK involving Schedule 1 controlled drugs requires a Home Office domestic licence. Research using Schedule 2, 3, 4 & 5 controlled drugs also require a Home Office domestic licence; aside from research in universities and hospitals which are exempt under Regulation 8(2)(f) of the Misuse of Drugs Regulations 2001. A Home Office domestic licence is required by industry to possess, manufacture, produce or supply controlled drugs.
A Home Office import/export licence is required to import or export controlled drugs in the UK. The controlled drug licence requirements for research in academia and industry are summarised in Table 1 below.
Table 1: controlled drug licence requirements
| Controlled drug licence requirements | |||||
|---|---|---|---|---|---|
| Schedule 1 | Schedule 2 | Schedule 3 | Schedule 4 | Schedule 5 | |
| Academia | Domestic licence required | Exempt from domestic licence | Exempt from domestic licence | Exempt from domestic licence | Exempt from domestic licence |
| Import/export licence required | Import/export licence required | Import/export licence required | Import/export licence required | Import/export licence required | |
| Industry | Domestic licence required | Domestic licence required | Domestic licence required | Domestic licence required | Domestic licence required |
| Import/export licence required | Import/export licence required | Import/export licence required | Import/export licence required | Import/export licence required |
Storage of controlled drugs
The storage of controlled drugs may also be subject to legislative requirements under the Misuse of Drugs (Safe Custody) Regulations 1973. This includes Schedule 1 & 2 controlled drugs and some Schedule 3 controlled drugs. These regulations specify requirements for safes, cabinets and rooms when storing controlled drugs.
Generic controls within the Misuse of Drugs Act 1971
In the Misuse of Drugs Act 1971, compounds can be controlled either by (i) name or (ii) a description of a core chemical structure and a range of modifications (hereafter referred to as ‘generic controls’), which provides broad coverage to cover multiple chemicals.
During discovery research, large numbers of compounds may be stored in molecular libraries. Generic controls may therefore inadvertently control compounds in these libraries with as-yet unrealised therapeutic potential or other uses.
Generic controls have been developed and previously recommended by the ACMD to capture groups of compounds that are closely related in structure to potentially harmful ‘designer drugs’ that are often created to circumvent those in the Misuse of Drugs Act 1971.
When formulating generic controls, the ACMD gathers evidence from contacts in the research community, including CROs, to consider whether this definition could control compounds in active or future research or currently licensed medicines.
Exempt product definition
The ‘exempt product definition’ in the Misuse of Drugs Regulations 2001 permits an ‘exempt product’ (a preparation or other product containing a controlled drug, where the quantity of controlled drug is under 1 mg in a non-recoverable form not designed for use in a human or animal) to be exempted from the Home Office domestic and import/export licence requirements. The intention of the exempt product definition was to exempt diagnostic test kits that contained extremely low amounts of controlled drugs for quality control purposes. The exempt product definition has also been utilised in the context of theoretical and discovery research.
The ACMD has recently provided advice on the exempt product definition in relation to consumer cannabidiol (CBD) products (ACMD, 2021) and barriers to research for SCRAs (ACMD, 2021).
Additional approvals
Research in the UK may also require additional approvals which are summarised in Table 2 below.
Table 2: Additional approvals potentially required for research
(ASPA – Animals (Scientific Procedures) Act 1986; HRA – Health Research Authority; MHRA – Medicines and Healthcare products Regulatory Agency)
Development activities
Development activities using animals may require licences under the Animals (Scientific Procedures) Act 1986 (ASPA).
Clinical studies
Clinical studies may require clinical trials authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) and parallel approvals from the Health Research Authority (HRA) and a Research Ethics Committee (REC). MHRA approval considers matters including patient safety and scientific validity of a proposed trial. RECs consider aspects such as the site where research is being conducted and the professional qualifications of those involved. The HRA is responsible for RECs and provides ethics approval in respect of NHS Trusts, and when NHS patients are involved.
This parallel approval process of the MHRA, RECs and HRA is considered as a ‘combined review’ and submitted on the integrated research application system (IRAS).
Reported barriers to research using Schedule 1 controlled drugs
The reported barriers from the ACMD evidence gathering exercise, Home Affairs Committee report and other stakeholders in the research community for theoretical research, discovery research and development activities were very similar and are therefore combined below.
Theoretical research, discovery research and development activities
Time
The time taken to apply for, acquire and renew a domestic licence was reported as a significant barrier to research using Schedule 1 compounds by academia and industry. Responses considered that, even for those familiar with the process, a significant amount of time was required to administer an application for or renewal of a licence. For those unfamiliar with the licensing system, there was also a significant learning curve necessary to understand the intricacies of the process.
The 3-month validity period for import/export licences was reported as a barrier to research by both academia and industry. Responses highlighted that the validity period of this licence was not sufficient to organise cross-border shipments and associated paperwork. Furthermore, any delays could result in the licence expiring, thus requiring a completely new application.
The time taken from application to approval and receipt of a domestic licence was reported as a barrier to research by academia. This process was reported to take around one year, causing delays to commencing research. Therefore, research using Schedule 1 controlled drugs was not compatible with many research grants, which were typically awarded for a fixed duration (often three years). Responses suggested this had posed barriers to ‘pilot studies’ which typically run over short timescales and the results of which are used to support funding applications for future work.
Industry reported that although the proportion of research that utilised controlled drugs was small, it required a disproportionate amount of time to manage.
Cost
The cost of the Home Office domestic licence, the required Disclosure and Barring Service (DBS) checks and installation of storage fulfilling safe custody requirements were often considered substantial in comparison to the size of a typical research grant and therefore reported as a barrier to research. Additionally, as licences are site-specific and research could take place across multiple locations, it could be prohibitively expensive to obtain a domestic licence for each location.
The additional financial cost of the domestic licence included both the direct costs of obtaining and holding a licence and the staff costs associated with the time to manage the application and renewal, both of which were reported as barriers to research by academia.
Academia also reported that, as there were only a small number of suppliers willing to synthesise Schedule 1 controlled drugs in the UK, the cost associated with procurement of Schedule 1 compounds for research was a barrier. There was also a high cost associated with both the initial licence, then additional fees for yearly renewal and inspector visits. Responses suggested research using Schedule 1 controlled drugs therefore often required additional support and funding from industry partners.
Understanding of controlled drug licensing process and permissions
Lack of understanding of the Home Office licensing process and permissions permitted to researchers under the domestic licence were reported as barriers to research by both academia and industry. Also, although information was available in the public domain and on the Home Office website, academia reported this was unclear and they still needed to approach licensing authorities directly for clarification. Uncertainty regarding whether compounds were exempted under the exempt product definition was also reported as a barrier to research by industry.
Stigma
By virtue of their scheduling status, Schedule 1 controlled drugs have no current approved therapeutic use, but they may also have potential benefits that were yet to be realised or exploited further. However, this does not mean the drug is any more harmful than controlled drugs in Schedule 2 but may deter future exploration of compounds for their potentially unrealised therapeutic benefits.
Clinical studies
The time and cost barriers reported by academia and industry relevant to theoretical research, discovery research and development activities also pertain to clinical studies.
Understanding of controlled drug licensing process and permissions
Uncertainty regarding the sequencing of other relevant approvals was reported as a barrier by academia. For example, uncertainty as to whether the Home Office domestic licence was required before approvals from the HRA and MHRA.
Options to reduce barriers to research
The ACMD has considered several options to reduce barriers to research for Schedule 1 controlled drugs and discussed what we understand to be the potential advantages and limitations of each option. The ACMD recognises further consideration will be required by the Home Office and other government departments regarding the practical implementation of any of these options within the current legislative framework, which may present further benefits, limitations or risks. Table 3 describes these options in more detail. How these options apply to the four stages of research are outlined in Table 4.
The main options considered, which are not mutually exclusive, were:
1. Research using Schedule 1 controlled drugs in universities and hospitals to 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.
2. Clinical studies using Schedule 1 controlled drugs with relevant HRA and MHRA approval to 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.
3. ‘Approved research organisations’ to be exempt from the need to apply for a Home Office domestic licence for research using Schedule 1 controlled drugs and instead to operate in accordance with the requirements of Schedule 2 controlled drugs.
4. ‘Approved research’ using Schedule 1 controlled drugs to 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.
5. ‘Approved animal research’ using Schedule 1 controlled drugs to 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.
6. Reschedule individual controlled drugs from Schedule 1 to Schedule 2.
7. Increasing the ‘de minimis limit’ in the exempt product definition.
Table 3: Main options considered by the ACMD to reduce barriers to research
| Option | Effect | Potential Benefits | Potential Limitations |
|---|---|---|---|
| 1. Research using Schedule 1 controlled drugs in universities and hospitals to 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 | This option would extend the existing exemption from the Home Office domestic licence for universities and hospitals using Schedule 2–5 controlled drugs to Schedule 1 controlled drugs. For universities and hospitals, this option would apply for all stages of research, including theoretical research, discovery research, development activities and clinical studies. |
This option would benefit hospitals and universities. As Schedule 1 compounds are not MHRA-approved medicinal products, patient access outside a clinical study would be restricted. Once a product containing the Schedule 1 controlled drug is licensed by the MHRA as a medicine, it can then go through the normal rescheduling process under the Misuse of Drugs Regulations 2001 and prescription and administration rights outside of a clinical trial are automatically restored. The ACMD does not consider there to be an increased risk of diversion of Schedule 1 controlled drugs in these settings if they were subject to the same restrictions and safeguards of existing Schedule 2 controlled drugs. |
This option would not benefit industry. Many UK hospitals and universities may not have the capabilities to formulate Schedule 1 controlled drugs on-site for research. They therefore may rely on other organisations to produce Schedule 1 controlled drugs for research. Certain organisations have legislative rights under the Misuse of Drugs Regulations 2001 to produce Schedule 2 controlled drugs without a Home Office domestic licence. For the purpose of supplying a university or hospital with a Schedule 1 controlled drug, these organisations could be exempt from the need to apply for a Home Office domestic licence. |
| 2. Clinical studies using Schedule 1 controlled drugs with relevant HRA and MHRA approval to 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 | This option would allow clinical studies in humans using Schedule 1 controlled drugs, that have already received ethical approval from the HRA and study approval from the MHRA, to be exempt from the need to apply for a Home Office domestic licence. | This option would benefit both academia and industry. It would particularly reduce barriers to research in academia, where the reported cost, time and uncertainty barriers associated with the Home Office domestic licence were greatest. |
This option would not reduce barriers to research for theoretical research, discovery research or development activities. Further consideration may be required to ensure clinical trial approvals are sufficiently definitive on the dates, location and drugs involved. |
| 3. ‘Approved research organisations’ to be exempt from the need to apply for a Home Office domestic licence for research using Schedule 1 controlled drugs and instead to operate in accordance with the requirements of Schedule 2 controlled drugs | This option would allow ‘approved research organisations’ (definition to be outlined) to be exempt from the need to apply for a domestic licence for research using Schedule 1 controlled drugs. ‘Approved research organisations’ could include organisations in both academia and industry. | This option would reduce the reported barriers to research across all stages of research, including theoretical research, discovery research, development activities and clinical studies. ‘Approved scientific research’ is defined within the Psychoactive Substances Act 2016 and this definition could be adapted to develop the definition of an ‘approved research organisation’. The ACMD also understands that other countries, for example Germany, have provided exemptions for ‘the state of the art in science and technology for commercial, industrial or scientific purposes’ with no reports of increased diversion or misuse. This option would mean responsibility for preventing misuse or diversion of the controlled drugs would rest with the institution or organisation. In the context of Schedule 1 controlled drugs, the ACMD has concluded that if an appropriate definition could be developed, this would provide wide-ranging benefits to both academia and industry. |
This option could create a scenario where research in industry using Schedule 2–5 controlled drugs requires a Home Office domestic licence; but research using Schedule 1 controlled drugs does not. To mitigate this, ‘approved research organisations’ could first have to apply for and hold a Schedule 2 licence. The ACMD has previously recommended the Home Office to develop a definition of a ‘research organisation’ to reduce barriers to research for SCRAs (ACMD, 2021). The Government response to this advice suggested it was not practical to set out a wide-ranging definition of an ‘approved research organisation’ in the manner proposed. The ACMD recognises it may be challenging to develop an appropriate definition of a ‘research organisation’ that has sufficient legal certainty to prevent the risk of loopholes. |
| 4. ‘Approved research’ using Schedule 1 controlled drugs to 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 | This option would allow ‘approved research’ (definition to be outlined) to be exempt from the need to apply for a domestic licence for research using Schedule 1 controlled drugs. This option would reduce the reported barriers to research across all stages of research in both academia and industry. | ‘Approved scientific research’ is defined within the Psychoactive Substances Act 2016 and this definition could be adapted to develop the definition of ‘approved research’. The ACMD also understands that other countries, for example Germany, have provided exemptions for ‘the state of the art in science and technology for commercial, industrial or scientific purposes’ with no reports of increased diversion or misuse. | The ACMD recognises it may be challenging to define ‘approved research’ with sufficient legal certainty in the current regulations without the risk of loopholes. |
| 5. ‘Approved animal research’ using Schedule 1 controlled drugs to 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 | This option would allow ‘approved animal research’ (definition to be outlined) to be exempt from the need to apply for a domestic licence for research using Schedule 1 controlled drugs. This option would only reduce barriers to research associated with animal research as part of development activities and would benefit both academia and industry. | ‘Approved scientific research’ is defined within the Psychoactive Substances Act 2016 and this definition could be adapted to develop the definition of ‘approved animal research’. The ACMD also understand other countries, for example Germany, have provided exemptions for ‘the state of the art in science and technology for commercial, industrial or scientific purposes’ with no reports of increased diversion or misuse. | The ACMD recognises it may be challenging to define ‘approved animal research’ with sufficient legal certainty in the current regulations without the risk of loopholes. |
| 6. Reschedule individual controlled drugs from Schedule 1 to Schedule 2 | Certain Schedule 1 controlled drugs could be rescheduled to Schedule 2 with additional statutory limits restricting access to scientific and clinical studies, thus avoiding the risks of inappropriate prescribing and diversion. | This option would not interfere with the MHRA’s ability to regulate and make decisions on which drugs classify as medicinal products. This option would principally reduce barriers to research to theoretical research, discovery research, development activities and clinical studies in academia. |
There may be insufficient evidence and research available to justify an ACMD decision or government commission to consider rescheduling individual compounds. There may also be insufficient evidence or research available to support the decision to reschedule individual controlled drugs from Schedule 1 to Schedule 2. Rescheduling individual compounds to Schedule 2 would not reduce the licensing burden on industry, as they still require a licence to perform research using Schedule 2 controlled drugs. ACMD advice would be required for each individual controlled drug, which could be resource intensive and time consuming. |
| 7. Increasing the ‘de minimis limit’ in the exempt product definition | Increasing the exempt product definition de minimis limit would increase the quantity of controlled drug in an ‘exempt product’. The ACMD has previously recommended increasing the ‘de minimis limit’ to 100 mg for ‘research organisations’ specific to SCRAs to facilitate theoretical and discovery research. |
This would simplify requirements for small quantities of controlled drugs being used in research. | In the absence of a definition for a ‘research organisation’, the varying potencies of controlled drugs mean that a single ‘de minimis’ amount may be inappropriate for all controlled drugs. |
Table 4: Application of proposed options to areas of research
| Theoretical research | Discovery research | Development activities | Clinical studies | |
|---|---|---|---|---|
| Academia | Option 1 | Option 1 | Option 1 | Option 1 |
| Option 2 | ||||
| Option 3 | Option 3 | Option 3 | Option 3 | |
| Option 4 | Option 4 | Option 4 | Option 4 | |
| Option 5 | ||||
| Option 6 | Option 6 | Option 6 | Option 6 | |
| Option 7 | Option 7 | Option 7 | Option 7 | |
| Industry | Option 2 | |||
| Option 3 | Option 3 | Option 3 | Option 3 | |
| Option 4 | Option 4 | Option 4 | Option 4 | |
| Option 5 | ||||
| Option 6 | Option 6 | Option 6 | Option 6 | |
| Option 7 | Option 7 | Option 7 | Option 7 |
Conclusions
The ACMD has made the following conclusions:
The requirement to obtain a Home Office domestic licence was reported as a significant barrier to research using Schedule 1 controlled drugs across all stages of research in academia. As research in academia was exempt from this licence for Schedule 2–5 controlled drugs, the most significant reported barriers were the additional time and cost associated with acquiring and renewing the domestic licence, in addition to other barriers associated with uncertainty, misunderstanding of the process and stigma.
There were barriers associated with all stages of research using Schedule 1 controlled drugs in industry. These barriers were similar to those reported for using Schedule 2–5 controlled drugs.
Considering the breadth and complexity of the research supply chain, there is unlikely to be a single ‘one-size-fits-all’ solution applicable to academia and industry. Several non-mutually exclusive options could provide solutions for specific areas of research. However, 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.
There are several options, which, in combination, could provide benefits to theoretical research, discovery research, development activities and clinical studies in academia, and clinical studies in industry.
Irrespective of suggested exemptions from the Home Office Domestic licence as part of these options, other requirements for Schedule 1 substances specified within the Misuse of Drugs Regulations 2001 would remain, for example those relevant to record keeping and registers and those in the Misuse of Drugs (Safe Custody) Regulations 1973 regarding safe storage requirements.
Further options could provide more wide-ranging solutions to reduce barriers to research for Schedule 1 controlled drugs. However, these may require further consideration regarding their practical implementation within the current regulations.
Recommendations
Recommendation 1 (Option 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.
Lead– Home Office
Measure of outcome– Change to the Misuse of Drugs Regulations 2001
Recommendation 2 (Option 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 Home Office domestic licence and instead to operate in accordance with the requirements of Schedule 2 controlled drugs.
Lead– Home Office
Measure of outcome– Change to the Misuse of Drugs Regulations 2001
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.
Lead– Home Office
Measure of outcome– Change to the Misuse of Drugs Regulations 2001
Recommendation 4
The ACMD recommends the Home Office review the domestic and import/export licence application system to consider if there are any further options to improve applicant understanding and experience, recognising some applicants are first-time customers or use the system infrequently.
Lead– Home Office
Measure of outcome– review of Home Office licence application system, improved understanding of the process and reduced queries
Recommendation 5
The ACMD recommends the Home Office should 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.
Lead– Home Office
Measure of outcome– Framework for the assessment of the impact of any changes; formal evaluation of actions three years after implementation
Further options (longer term)
The ACMD also proposes the following options could provide further solutions to reduce barriers to research using Schedule 1 controlled drugs. However, the ACMD has concluded the Home Office, with other government departments and agencies, is best placed to consider if and how these further options could be implemented within the legislative framework. Following this consideration, the ACMD understands further engagement with government may be required:
-
‘Approved research organisations’ to be exempt from the need to apply for a Home Office domestic licence for research using Schedule 1 controlled drugs (Option 3).
-
‘Approved research’ using Schedule 1 controlled drugs to be exempt from the need to apply for a Home Office domestic licence. It may be beneficial to review international approaches where similar exemptions have been utilised (Option 4).
-
‘Approved animal research’ using Schedule 1 controlled drugs to be exempt from the need to apply for a Home Office domestic licence (Option 5).
-
Extend the exempt product definition to include products used for ‘scientific research’.
-
Review the Misuse of Drugs (Safe Custody) Regulations 1973 to consider if there are any further options to reduce barriers to research, for example, safe storage requirements for research quantities of Schedule 1 drugs.
-
Allow industry organisations with an existing Home Office domestic licence to flexibly add an additional ‘Schedule 1’ permit rather than reapply for a new licence.
-
Establish a clear consultation process with academia and industry before implementing generic controls to understand potential unintended consequences of recommended controls.
We look forward to discussing our recommendations with you in due course.
Yours sincerely,
Professor Owen Bowden-Jones Chair of the ACMD
Professor Roger Knaggs Chair of the ACMD Barriers to Research Working Group
References
ACMD (2017) Legitimate Use of controlled drugs: Research and Healthcare. London, Home Office, Advisory Council on the Misuse of Drugs. Available from: https://www.gov.uk/government/publications/legitimate-use-of-controlled-drugs-research-and-healthcare [accessed 18 October 2023]
ACMD (2021) Considerations of Barriers to Research- Part 1: Synthetic Cannabinoid Receptor Agonists (SCRA). London, Home Office, Advisory Council on the Misuse of Drugs. Available from: https://www.gov.uk/government/publications/consideration-of-barriers-to-research-part-1 [accessed 18 October 2023]
Home Affairs Committee (2023) Drugs. London, House of Commons. Available from: https://committees.parliament.uk/publications/41147/documents/203039/default/ [accessed 18 October 2023]
Annex A: Quantitative responses to the ACMD’s call for evidence
| Question |
Academia |
Industry |
|||||
|---|---|---|---|---|---|---|---|
| University |
Think tank |
Professional body |
Pharmaceutical |
CRO |
Reference Material Producer |
||
| Number of responses |
5 |
1 |
2 |
4 |
3 |
2 |
|
| Q4: Barriers from named compounds |
4 (80% yes) |
1 (100% yes) |
1 (50% yes) |
4 (100% yes) |
1 (33% yes) |
2 (100% yes) |
|
| Q4: Barriers from generic controls |
3 (60% yes) |
1 (100% yes) |
2 (100% yes) |
4 (100% yes) |
2 (66% yes) |
2 (100% yes) |
|
| Q5: Type of barrier imposed |
Regulatory Financial Time Other None |
5 (100% yes) 4 (80% yes) 5 (100% yes) 3 (60% yes) 0 (0% yes) |
0 (0% yes) 0 (0% yes) 0 (0% yes) 0 (0% yes) 1 (100% yes) |
2 (100% yes) 1 (50% yes) 2 (100% yes) 0 (0% yes) 0 (0% yes) |
4 (100% yes) 4 (100% yes) 4 (100% yes) 2 (50% yes) 0 (0% yes) |
2 (66% yes) 3 (100% yes) 3 (100% yes) 0 (0% yes) 0 (0% yes) |
2 (100% yes) 2 (100% yes) 2 (100% yes) 1 (66% yes) 0 (0% yes) |
| Q6: Barriers have an impact on type/extent of research carried out |
5 (100% yes) |
0 (0% yes) |
2 (100% yes) |
4 (100% yes) |
3 (100% yes) |
2 (100% yes) |
|
| Q7: Organisation has applied for a controlled drugs licence |
4 (80% yes) |
0 (0% yes) |
1 (50% yes) |
4 (100% yes) |
2 (66% yes) |
1 (50% yes) |
|
| Q8: Organisation has applied for an import/export licence |
2 (40% yes) |
0 (0% yes) |
0 (0% yes) |
2 (50% yes) |
1 (33% yes) |
1 (50% yes) |
|
| Q9: Organisation has made use of the ‘Exempt product’ definition in the MDR 2001 |
0 (0% yes) |
0 (0% yes) |
0 (0% yes) |
3 (75% yes) |
2 (66% yes) |
1 (50% yes) |
|
Annex B: Case studies from public evidence gathering
This annex presents case studies provided in the public evidence gathering exercise. This is qualitative evidence demonstrating typical problems confronted.
Case study 1
“Research intensive institutions are more comfortable holding a licence separately and supporting researchers with their work on controlled drugs. However, those universities with less focus on research may not have the infrastructure or expertise to support this, tending to push the requirements onto individual researchers which then becomes a burden….this is because the process is hard to navigate, puts an unrealistic burden on individual researchers, is not cost-effective and takes too long to organise. I was not able to apply for a Schedule 1 Licence until I had grant funding in place to pay the costs – likely to be £3000 inspection/application fee and £1500 per annum. This is absolutely prohibitive for most academics. As our work is funded by a Pharma company we can pay this fee, but most academics do not have that luxury.”
Case study 2
“The procedures for managing scheduled drugs including purchasing, storage etc are similar for both Schedule I and II but the regulatory burden in terms of licensing and associated paperwork is much greater for Schedule I. There is a cost associated with Schedule I that must be met by the institution which does not exist for Schedule II. These additional financial costs include both the direct costs of obtaining and holding a licence and the staff costs associated with the time to manage the paperwork. The time frame for starting studies with Schedule I compounds was about 12 months despite having institutional support and prior knowledge and expertise in holding Home Office licences. These time scales are not compatible with state of the art research and development and in enabling researchers to respond to the very dynamic nature of discovery research.”
Case study 3
“It cost us over £3000 for one CD licence for a preclinical study. It cost us £3133.00 to obtain the licence to possess controlled drugs and it now costs £326 each year to maintain it. If a visit from a controlled drugs licensing inspector is required for renewal of the licence then a fee of £1,371 needs to be paid. We also had to buy lockable fridge-freezer, for storage in the CD designated room, costing £600. This is absolutely prohibitive for most academics.”
Case study 4
“As the current regulatory processes have set the barriers too high to research Schedule 1 drugs, we observe that potential clients who are interested in conducting clinical trials are disincentivised to do so due to the concerns about regulatory compliance. The regulatory barriers limit the number of businesses undertaking manufacture, R&D and clinical trials using these drugs, which is reflected by the fact that most of our clients are international and not UK-based.
Due to the onerous nature and associated costs of applying for a Schedule 1 licence, only the very highest priority clinical research questions and well-funded research projects concerning compounds in this schedule have the opportunity to be pursued, and consequently many research questions that would help us develop a fuller understanding of these compounds’ potential safety and optimal use in different therapeutic settings remain unanswered.
Research questions with significant academic and medical value but without the very high commercial potential have to be deprioritised due to the financial restrictions placed on this research by Schedule 1 licensing, which in turn disincentivises researchers from engaging in projects that focus on these compounds.”
Case study 5
“Although the proportion of our research that utilises controlled drugs is small it can nonetheless require a disproportionate amount of time to manage.”
Case study 6
“Stigma which makes the animal research more difficult. Home Office approval (Animals Scientific procedures Act 1986) to use psilocybin had to be applied for and extra work and meetings with the named Veterinary Surgeon (NVS)”
Annex C: ACMD membership at time of publication
| Members | |
|---|---|
| Dr Kostas Agath | Consultant psychiatrist (addictions), Change Grow Live |
| Professor Judith Aldridge | Professor of Criminology, University of Manchester |
| Professor Owen Bowden-Jones | Chair of the Advisory Council on the Misuse of Drugs. Consultant psychiatrist, Central North West London NHS Foundation Trust and Honorary Professor, University College London |
| Professor Anne Campbell | Lecturer in Social Work, Queens University Belfast |
| Dr Emily Finch | Clinical Director of the Addictions Clinical Academic Group and Consultant Psychiatrist, South London and Maudsley NHS Trust |
| Mr Mohammed Fessal | Chief Pharmacist, Change Grow Live |
| Mr Lawrence Gibbons | Head of Drug Threat (Intelligence Directorate, Commodities), National Crime Agency |
| Dr Carole Hunter | Lead Pharmacist, Alcohol and Drug Recovery Services NHS Greater Glasgow and Clyde and Doping Control Officer, UK Antidoping |
| Dr Hilary Hamnett | Associate Professor in Forensic Science, University of Lincoln and Forensic Toxicologist |
| Professor Graeme Henderson | Professor of Pharmacology, University of Bristol |
| Professor Roger Knaggs | Associate Professor in Clinical Pharmacy Practice, University of Nottingham |
| Professor Tim Millar | Professor of Substance Use and Addictions, University of Manchester |
| Dr Ann Sullivan | Consultant Physician in HIV and Sexual Health and National Co-lead for HIV Surveillance, Office for Health Improvement and Disparities |
| Mr Harry Shapiro | Director, DrugWise |
| Dr Paul Stokes | Reader in Mood Disorders and Psychopharmacology, King’s College London and Honorary Consultant Psychiatrist, South London and Maudsley NHS Foundation Trust |
| Dr Richard Stevenson | Emergency Medicine Consultant, Glasgow Royal Infirmary |
| Professor David Taylor | Director of Pharmacy and Pathology, South London and Maudsley NHS Foundation Trust; Professor of Psychopharmacology, King’s College, London; Honorary Professor and Head of Pharmaceutical Sciences Clinical Academic Group, King’s Health Partners |
| Professor Simon Thomas | Emeritus Professor of Clinical Pharmacology and Therapeutics, Newcastle University |
| Dr Derek Tracy | Consultant Psychiatrist and Medical Director, West London NHS Trust; Senior Lecturer, King’s College London and Visiting Senior Lecturer, University College London |
| Dr David Wood | Consultant Physician and Clinical Toxicologist, Guys and St Thomas’ NHS Foundation Trust and Honorary Reader in Clinical Toxicology, King’s College London |
| Ms Rosalie Weetman | Public Health Lead (Alcohol, Drugs and Tobacco), Derbyshire County Council |
Annex D: ACMD barriers to research II working group membership
| Members | |
|---|---|
| Professor Judith Aldridge | Professor of Criminology, University of Manchester |
| Professor Graeme Henderson | Professor of Pharmacology, University of Bristol |
| Professor Roger Knaggs | Associate Professor in Clinical Pharmacy Practice, University of Nottingham |
| Dr Ann Sullivan | Consultant Physician in HIV and Sexual Health and National Co-lead for HIV Surveillance, Office for Health Improvement and Disparities |
| Dr Paul Stokes | Reader in Mood Disorders and Psychopharmacology, King’s College London and Honorary Consultant Psychiatrist, South London and Maudsley NHS Foundation Trust |
| Professor David Taylor | Director of Pharmacy and Pathology, South London and Maudsley NHS Foundation Trust; Professor of Psychopharmacology, King’s College, London; Honorary Professor and Head of Pharmaceutical Sciences Clinical Academic Group, King’s Health Partners |
| Professor Simon Thomas | Emeritus Professor of Clinical Pharmacology and Therapeutics, Newcastle University |
| Mr Ric Treble | Retired Laboratory of the Government Chemist (LGC) expert |