Correspondence

001/2024: The Misuse of Drugs Act 1971 (Amendment) Order 2024 and The Misuse of Drugs and Misuse of Drugs (Designation) (England and Wales and Scotland) (Amendment and Revocation) Regulations 2024

Published 20 March 2024

Changes to the Misuse of Drugs Act 1971 (“the 1971 Act”) to control 20 substances under that Act, schedule those substances and reschedule two further substances under the Misuse of Drugs Regulations 2001 (SI 2001/3998) (“the 2001 Regulations”) and, where appropriate, designate those substances under the Misuse of Drugs (Designation) (England, Wales and Scotland) Order 2015 (SI 2015/704) (“the 2015 Order”).

Introduction

This circular draws attention to the contents of the below Statutory Instruments which will come into force at 00.01 on 20 March 2024:

• The Misuse of Drugs Act 1971 (Amendment) Order 2024 (SI 2024/190) (“the 2024 Order”)

• The Misuse of Drugs and Misuse of Drugs (Designation) (England and Wales and Scotland) (Amendment and Revocation) Regulations 2024 (SI 2024/248) (“the 2024 Regulations”)

The 2024 Order amends the 1971 Act to control 15 substances as Class A drugs, four substances as Class B drugs and one substance as a Class C drug.

The 2024 Regulations complement the 2024 Order by amending the 2001 Regulations and the 2015 Order to:

• add 19 substances controlled by the 2024 Order to Schedule 1 to the 2001 Regulations and Schedule 1 to the 2015 Order, owing to their lack of known medicinal value in the UK;

• add one substance (remimazolam) controlled by the 2024 Order to Part 1 of Schedule 4 to the 2001 Regulations to enable access for legitimate use in healthcare as a medicine; and

• move two existing Class A drugs under the 1971 Act (clonitazene and etonitazene) from Schedule 2 to Schedule 1 to the 2001 Regulations and designate them under the 2015 Order, as they have no known medicinal value in the UK.

The 2024 Regulations also revoke the Misuse of Drugs and Misuse of Drugs (Designation) (England and Wales and Scotland) (Amendment) Regulations 2024 (SI 2024/239). The 2024 Regulations come into force, for the purpose of that revocation, at 00.01 on 19 March 2024. The effect is to revoke SI 2024/248 before it would otherwise have come into force.

The SIs are available at www.legislation.gov.uk, at the following links:

• The Misuse of Drugs Act 1971 (Amendment) Order 2024 (legislation.gov.uk); and

• The Misuse of Drugs and Misuse of Drugs (Designation) (England and Wales and Scotland) (Amendment and Revocation) Regulations 2024 (legislation.gov.uk).

SIs are also published by the Stationery Office. Telephone orders and general enquiries: 0330 202 5070.

Background

The 1971 Act controls drugs that are ‘dangerous or otherwise harmful’ when misused, under a three-tier system of classification (Class A, B and C). This framework sets criminal penalties with reference to the harm a drug has, or is capable of having, when misused and the type of illegal activity undertaken in regard to that drug.

The 2001 Regulations enable lawful access to controlled drugs under the 1971 Act for legitimate uses, such as in healthcare. Drugs that are controlled under the 1971 Act are placed in Schedules 1 to 5 to the 2001 Regulations, with drugs in Schedule 1 being subject to the highest restrictions on legitimate use. The Schedule into which a drug is placed primarily dictates the circumstances in which it is lawful to import, export, produce, supply, administer and possess the drug. The 2001 Regulations also impose requirements about the form of prescriptions, record-keeping, labelling, destruction, disposal and safe custody with respect to controlled drugs.

Controlled drugs in Schedule 1 to the 2001 Regulations can only be accessed for legitimate purposes under a Home Office controlled drug licence, issued by the Drugs and Firearms Licensing Unit (DFLU). Controlled drugs are designated under the 2015 Order where, in the opinion of the Secretary of State, it is in the public interest for production, supply and possession of that drug to be either wholly unlawful or unlawful except for research or other special purposes, or for medicinal use of the drug to be unlawful except under licence.

All amendments made by these instruments follow consultation with the ACMD, as is statutorily required by sections 7(7) and 31(3) of the 1971 Act.

The Misuse of Drugs Act 1971 (Amendment) Order 2024

2-benzyl benzimidazole and piperidine benzimidazolone opioids

Three synthetic opioids – isotonitazene, metonitazene and brorphine – were controlled internationally under the United Nations Single Convention on Narcotic Drugs 1961, to which the UK is a signatory. Isotonitazene was added in June 2021, followed by metonitazene and brorphine in March 2022. Following this, the Government requested advice from the ACMD on appropriate control under the 1971 Act and associated Regulations. In addition to the review of these substances, the ACMD’s report also considered other 2-benzyl benzimidazole (also known as ‘nitazenes’) and piperidinyl benzimidazolone (also known as ‘brorphine-like’) opioids that have been detected in the UK or elsewhere.

The ACMD published its report and three addendums between 18 July 2022 and 15 December 2023. The ACMD assessed there to be serious associated acute health risks with these synthetic opioids, such as respiratory depression, which in overdose can lead to death. It reported the involvement of nitazenes in a number of drug-related deaths and near-fatal overdoses in the UK and elsewhere and deemed that their availability presents a significant potential threat to public health.

The ACMD recommended control of 15 synthetic opioids, 14 of which are nitazenes, as Class A drugs under the 1971 Act, Schedule 1 to the 2001 Regulations and the 2015 Order. The Government accepted this recommendation. The report, three subsequent addendums and Government responses are available at the following link: ACMD advice on 2-benzyl benzimidazole and piperidine benzimidazolone opioids - GOV.UK (www.gov.uk).

The 2024 Order therefore controls the following 15 synthetic opioids as Class A drugs under the 1971 Act:

• brorphine;

• butonitazene;

• ethyleneoxynitazene;

• etodesnitazene (etazene);

• flunitazene;

• isotonitazene;

• metodesnitazene (metazene);

• metonitazene;

• protonitazene;

• N-Desethyl etonitazene;

• N-Desethylisotonitazene;

• N-Desethyl protonitazene;

• N-Piperidinyl-etonitazene (etonitazepipne);

• N-Pyrrolidino-etonitazene (etonitazepyne);

• N-Pyrrolidino protonitazene.

Possession of a Class A drug carries a maximum penalty of up to 7 years in prison, an unlimited fine or both, whilst production and supply carries a maximum penalty of up to life imprisonment, an unlimited fine or both.

Diphenidine, ephenidine and methoxyphenidine

Diphenidine, a stimulant, was added to Schedule 2 of the United Nations Convention on Psychotropic Substances 1971 (“the 1971 Convention) in April 2021, following which the UK Government requested advice from the ACMD on appropriate control under the 1971 Act and associated Regulations. The ACMD provided its report on 25 May 2023, which also reviewed the harms of several similar substances. The report noted the involvement of diphenidine and a similar substance, methoxyphenidine, in a number of drug-related deaths worldwide, including in the UK. Effects of diphenidine, ephenidine and methoxyphenidine include tachycardia, hallucinations, confusion and paranoia, and acute toxicity is reported to be similar to ketamine, which is already a Class B drug under the 1971 Act.

The ACMD recommended that three substances – diphenidine, ephenidine and methoxyphenidine – are controlled as Class B drugs under the 1971 Act and Schedule 1 to the 2001 Regulations and the 2015 Order. The Government accepted this recommendation. The report and Government response are available at the following links: ACMD review of the evidence on the use and harms of diphenidine - GOV.UK (www.gov.uk) and The use and harms of diphenidine - GOV.UK (www.gov.uk).

The 2024 Order therefore controls the following substances as Class B drugs under the 1971 Act:

• diphenidine;

• ephenidine;

• methoxyphenidine.

Possession of a Class B drug carries a maximum penalty of up to 5 years in prison, an unlimited fine or both, whilst production and supply carries a maximum penalty of up to 14 years in prison, an unlimited fine or both.

Cumyl-PeGaClone

Cumyl-PeGaClone, a type of synthetic cannabinoid receptor agonist (SCRA), was added to Schedule 2 of the 1971 Convention in April 2021, following which the UK Government requested advice from the ACMD on appropriate control under the 1971 Act and associated Regulations. The ACMD report published on 25 May 2023 noted the use of SCRA can produce important adverse health effects including confusion, anxiety, and psychosis. These effects may cause hospitalisation and in severe cases death may occur.

SCRA are currently controlled under an existing generic definition for SCRA under the 1971 Act and associated Regulations but, owing to its structure, cumyl-PeGaClone falls outside of that definition. The ACMD therefore recommended that the Government consult relevant stakeholders on modification to this definition. The Government has agreed to consult as soon as possible but, to meet our international obligations under the 1971 Convention more quickly, has opted to control cumyl-PeGaClone individually as a Class B drug (in line with other SCRA) under the 1971 Act in the interim.

The ACMD report and Government response are available at the following links: ACMD review of the evidence on the use and harms of Cumyl-PeGaClone - GOV.UK (www.gov.uk) and The use and harms of Cumyl-PeGaClone - GOV.UK (www.gov.uk).

The 2024 Order therefore controls cumyl-PeGaClone as a Class B drug under the 1971 Act.

Possession of a Class B drug carries a maximum penalty of up to 5 years in prison, an unlimited fine or both, whilst production and supply carries a maximum penalty of up to 14 years in prison, an unlimited fine or both.

Remimazolam

Remimazolam is a type of benzodiazepine. It is the active ingredient in a product, which was given marketing authorisation (a medicines licence) by the Medicines and Healthcare products Regulatory Agency (MHRA) in 2021. The product was approved for use in adults for procedural sedation, which is required for a wide range of medical endoscopic procedures, imaging techniques and in minor surgical procedures.

Following its approval, the MHRA provided a written dossier and oral presentation to the ACMD to inform its review of the potential harms of remimazolam. The ACMD provided its report on 2 December 2022, which assessed the harms of remimazolam to be commensurate with other benzodiazepine drugs already controlled under Class C of the 1971 Act.

The ACMD recommended control of remimazolam as a Class C drug under the 1971 Act and Part 1 of Schedule 4 to the 2001 Regulations. The Government accepted this recommendation. The report and Government response is available at the following link: ACMD advice on the classification and schedule of Remimazolam - GOV.UK (www.gov.uk).

The 2024 Order therefore controls remimazolam as a Class C drug under the 1971 Act.

Possession of a Class C drug) carries a maximum penalty of up to 2 years in prison, an unlimited fine or both, whilst production and supply carries a maximum penalty of up to 14 years in prison, an unlimited fine or both.

The Misuse of Drugs and Misuse of Drugs (Designation) (England and Wales and Scotland) (Amendment and Revocation) Regulations 2024

The 2024 Regulations compliment the 2024 Order by ensuring that all 20 substances controlled under the 1971 Act by that Order are scheduled under the 2001 Regulations to regulate legitimate access (as appropriate) and, where appropriate, designated by the 2015 Order to restrict access to those substances unless it is required for research or other special purposes under a Home Office licence. The 2024 Regulations also reschedule two existing Class A drugs under the 1971 Act (clonitazene and etonitazene) from Schedule 2 to Schedule 1 of the 2001 Regulations, and designate them under the 2015 Order.

The 2024 Regulations also revoke the Misuse of Drugs and Misuse of Drugs (Designation) (England and Wales and Scotland) (Amendment) Regulations 2024 (SI 2024/239).

Synthetic opioids, cumyl-PeGaClone, diphenidine, ephenidine and methoxyphenidine

Following consultation with the ACMD, the 2024 Regulations place 19 of the 20 substances controlled by the 2024 Order in Schedule 1 to the 2001 Regulations. They also designate those substances under the 2015 Order as they have no known medicinal value in the UK. The substances are as follows:

• brorphine;

• butonitazene;

• cumyl-PeGaClone;

• diphenidine;

• ephenidine;

• ethyleneoxynitazene;

• etodesnitazene (etazene);

• flunitazene;

• isotonitazene;

• methoxyphenidine;

• metodesnitazene (metazene);

• metonitazene;

• protonitazene;

• N-Desethyl etonitazene;

• N-Desethylisotonitazene;

• N-Desethyl protonitazene;

• N-Piperidinyl-etonitazene (etonitazepipne);

• N-Pyrrolidino-etonitazene (etonitazepyne);

• N-Pyrrolidino protonitazene.

Consequently, these substances can only be accessed for research, or other special purposes, under a Home Office controlled drug licence issued by the DFLU. It is therefore only possible for an authority to lawfully import, export, produce, possess, supply and administer these substances under the aforementioned licence.

Remimazolam

The remaining substance controlled under the 1971 Act by the 2024 Order is remimazolam. The 2024 Regulations place remimazolam in Part 1 of Schedule 4 to the 2001 Regulations, owing to its known medicinal value in the UK as the active ingredient in a medicine given marketing authorisation (a medicines licence) from the MHRA. Remimazolam can be accessed for use in healthcare settings, subject to requirements in the 2001 Regulations related to record-keeping, preservation of documents, furnishing of information and destruction.

Clonitazene and etonitazene

The ACMD report of 18 July 2022 also provided advice on two synthetic opioids, clonitazene and etonitazene, already controlled as Class A drugs under the 1971 Act. The report is available at the following link: ACMD advice on 2-benzyl benzimidazole and piperidine benzimidazolone opioids - GOV.UK (www.gov.uk).

When clonitazene and etonitazene were controlled under the 1971 Act, they were also added to Schedule 2 to the 2001 Regulations. In their 2022 report, the ACMD consulted the MHRA about legitimate medicinal use of clonitazene and etonitazene, alongside the other synthetic opioids being considered for control. The MHRA confirmed that neither drug has been marketed in the UK as a medicine, imported for legitimate purposes or been involved in a clinical trial where the applicant has applied to the MHRA.

The ACMD recommended clonitazene and etonitazene be moved from Schedule 2 to Schedule 1 to the 2001 Regulations and designated under the 2015 Order, which the Government accepted.

The 2024 Regulations therefore move clonitazene and etonitazene from Schedule 2 to Schedule 1 to the 2001 Regulations and designate them under the 2015 Order, owing to their lack of known medicinal value in the UK. This means they can only be accessed for research, or other special purposes, under a Home Office licence issued by the DFLU.

Revocation

The 2024 Regulations also revoke the Misuse of Drugs and Misuse of Drugs (Designation) (England and Wales and Scotland) (Amendment) Regulations 2024 (S.I. 2024/239). The revocation takes effect at 00.01 on the 19 March 2024, before S.I. 2024/239 would have otherwise come into force. As such, S.I. 2024/239 has no effect.