Correspondence

Circular 009/2019: third generation synthetic cannabinoids update

Published 15 November 2019

Introduction

This circular draws attention to the content of the Statutory Instruments (SIs) – SI 2019/1323 and SI 2019/1362. The new provisions, The Misuse of Drugs Act 1971 (Amendment) Order 2019 and The Misuse of Drugs and Misuse of Drugs (Designation) (Amendment) (England, Wales and Scotland) Regulations 2019, both come into force today (15 November 2019).

Links to the two SIs, together with the associated explanatory memorandums can be found beneath the Annex to this document.

Summary

Synthetic cannabinoids are a group of compounds that mimic the effects of cannabis, which are commonly referred to as ‘Spice’ and ‘Mamba’.

‘Third generation’ synthetic cannabinoids were originally controlled through a generic definition in December 2016, following advice from the Advisory Council on the Misuse of Drugs (ACMD). Such compounds were controlled as Class B drugs under the Misuse of Drugs Act 1971 (‘the 1971 Act’), Schedule 1 of the drugs under the Misuse of Drugs Regulations 2001 (‘the 2001 Regulations’) and designated under the Misuse of Drugs Designation Order 2015 (‘the 2015 Order’).

Due to the broad nature of the generic definition some compounds were unintentionally captured under this definition, inadvertently subjecting them to strict controls. Following advice from the ACMD, these SIs amend the generic definition of ‘third generation’ synthetic cannabinoids to reduce the scope of the generic definition and excludes compounds which were unintentionally captured, removing them from control as Class B drugs under the 1971 Act, Schedule 1 of the 2001 Regulations and designation under the 2015 Order. However, this amendment is a technical amendment and does not revoke the generic definition of synthetic cannabinoids, thus retaining control over harmful compounds and those known to be, or likely to be misused such as those commonly referred to as ‘Spice’ and ‘Mamba’.

Background

The 1971 Act controls drugs that are ‘dangerous or otherwise harmful’. Schedule 2 to the 1971 Act specifies these drugs and divides them into three classes; A, B and C, with different sentences being issued for offences, dependent on the class of drug involved. The classification is predicated on an assessment of their respective harms and in accordance with recommendations made by the ACMD.

The 2001 Regulations provide access to controlled drugs for legitimate purposes (including industrial purposes) under the 1971 Act.

The Schedule into which a drug is placed is based on an assessment of its medicinal or therapeutic usefulness, the need for legitimate access as well as its potential for harm when misused. The Schedule primarily dictates the extent to which it is lawful to import, export, produce, possess, supply and administer and imposes prescribing, record keeping and safe custody requirements. Schedule 1 drugs are subject to the greatest level of restrictions and only available with a Home Office licence.

Synthetic cannabinoids

The ACMD, first published advice in 2014 on the ‘third generation’ of synthetic cannabinoids. This followed the control of the ‘first generation’ of synthetic cannabinoids in 2009 and the ‘second generation’ in 2013. ‘Third generation’ reflects substances which were outside the scope of control under the first and second generation of synthetic cannabinoids, but had subsequently entered the market and became widely available. They are known under many of the same brand names as previous generations, such as ‘Spice’ and ‘Black Mamba’. The ACMD recommended that ‘third generation’ synthetic cannabinoids should be captured under a ‘generic definition’, as Class B drugs under the 1971 Act. The ACMD also recommended that these compounds were placed under Schedule 1 of the 2001 Regulations and designated under the 2015 Order. Controlled drugs are designated where the Secretary of State is of the opinion that 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 a licence.

This advice was based on the associated harms of the synthetic cannabinoids and the widespread availability. Whilst noting that there were limited data available on the patterns of acute harm associated with the use of synthetic cannabinoid receptor agonists, a 2012 ACMD report suggested that certain synthetic cannabinoids had psychoactive effects. Anecdotal user reports suggested that certain synthetic cannabinoids can produce severe adverse effects such as increased heart rate, panic attacks and convulsions were also cited in that report.

On 14 December 2016, the third generation of synthetic cannabinoids (as defined in Annex D) were permanently controlled as Class B drugs under to the 1971 Act and associated Regulations.

Effects of the 2016 amendments

Following the control of ‘third generation’ synthetic cannabinoids in 2016 it was noted that due to the broad nature of the generic definition, some compounds were unintentionally captured, inadvertently subjecting them to the strictest level of control. Concerns were raised by the research community that the definition captured compounds used in scientific research which should not have been controlled. As Schedule 1 drugs under the 2001 Regulations and designated under the 2015 Order, organisations were required to obtain a Home Office licence to conduct scientific research on such compounds.

New amendment

The ACMD provided advice in December 2017 (Annex B) recommending that the generic definition of ‘third generation’ synthetic cannabinoids be amended to reduce the scope, removing compounds from the definition which were not intended for control. That revised definition specifies which univalent substituents are included in the generic definition (rather than referring to “univalent substituents” generally). The reduced scope continues to exclude all of the licensed medicines and the two Class A drugs currently excluded by name and excludes many materials of potential pharmaceutical interest.

These SIs amend the definition of ‘third generation’ synthetic cannabinoids in the 1971 Act and associated secondary legislation, to ensure that compounds which were unintentionally controlled are no longer captured by the generic definition.

The amended definition is seen in Annex E.

Impact of these changes

This amendment does not revoke the generic definition of synthetic cannabinoids. Compounds which are known to be, or likely to be, misused and harmful remain under strict controls. Synthetic cannabinoids, such as ‘Spice’ will remain as Class B drugs in the UK.

Police forces and Border Force should be aware that penalty codes have not been affected. The Order removes a number of compounds from the generic definition which were unintentionally controlled, and consequently permits research on these excluded compounds without the requirement for a Home Office licence. The practical impact of the change is limited to the pharmaceutical and healthcare research sector as such compounds are used in legitimate research. Those compounds remaining under the generic definition are still controlled as Class B drugs under the 1971, Schedule 1 drugs under the 2001 Regulations and designated under the 2015 Designation Order. Companies wishing to conduct research on these controlled compounds are still be required to obtain a Schedule 1 Home Office licence.

For further detail on the technical amendment to the generic definition of ‘third generation’ synthetic cannabinoids; please see Annex D and E.

Annex A

For more information contact: Emma Nichols, Drugs Legislation Team, Drugs and Alcohol Unit Email: emma.nichols5@homeoffice.gov.uk

Annex B

ACMD advice on amending the generic definition

Annex C

Government’s response to the ACMD

Annex D

December 2016, ‘third generation’ synthetic cannabinoid definition:

Misuse of Drugs Act 1971 - paragraph 1(ca) of Part 2 of Schedule 2

any compound (not being clonitazene, etonitazene, acemetacin, atorvastatin, bazedoxifene, indometacin, losartan, olmesartan, proglumetacin, telmisartan, viminol, zafirlukast or a compound for the time being specified in sub-paragraph (c) above) structurally related to 1-pentyl-3-(1-naphthoyl)indole (JWH-018), in that the four sub-structures, that is to say the indole ring, the pentyl substituent, the methanone linking group and the naphthyl ring, are linked together in a similar manner, whether or not any of the sub-structures have been modified, and whether or not substituted in any of the linked sub-structures with one or more univalent substituents and, where any of the sub-structures have been modified, the modifications of the sub-structures are limited to any of the following, that is to say—

(i) replacement of the indole ring with indane, indene, indazole, pyrrole, pyrazole, imidazole, benzimidazole, pyrrolo[2,3-b]pyridine, pyrrolo[3,2c]pyridine or pyrazolo[3,4-b]pyridine;

(ii) replacement of the pentyl substituent with alkyl, alkenyl, benzyl, cycloalkylmethyl, cycloalkylethyl, (N-methylpiperidin-2-yl)methyl, 2-(4morpholinyl)ethyl or (tetrahydropyran-4-yl)methyl;

(iii) replacement of the methanone linking group with an ethanone, carboxamide, carboxylate, methylene bridge or methine group;

(iv) replacement of the 1-naphthyl ring with 2-naphthyl, phenyl, benzyl, adamantyl, cycloalkyl, cycloalkylmethyl, cycloalkylethyl, bicyclo[2.2.1]heptanyl, 1,2,3,4-tetrahydronaphthyl, quinolinyl, isoquinolinyl, 1-amino-1-oxopropan-2-yl, 1-hydroxy-1-oxopropan-2-yl, piperidinyl, morpholinyl, pyrrolidinyl, tetrahydropyranyl or piperazinyl

Misuse of Drugs Regulations 2001 – paragraph 1 (ld) of Schedule 1

any compound (not being clonitazene, etonitazene, acemetacin, atorvastatin, bazedoxifene, indometacin, losartan, olmesartan, proglumetacin, telmisartan, viminol, zafirlukast or a compound for the time being specified in sub-paragraphs (h) to (lc) above) structurally related to 1-pentyl-3-(1-naphthoyl)indole (JWH-018), in that the four sub-structures, that is to say the indole ring, the pentyl substituent, the methanone linking group and the naphthyl ring, are linked together in a similar manner, whether or not any of the sub-structures have been modified, and whether or not substituted in any of the linked sub-structures with one or more univalent substituents and, where any of the sub-structures have been modified, the modifications of the sub-structures are limited to any of the following, that is to say—

(i) replacement of the indole ring with indane, indene, indazole, pyrrole, pyrazole, imidazole, benzimidazole, pyrrolo[2,3-b]pyridine, pyrrolo[3,2-c]pyridine or pyrazolo[3,4-b]pyridine;

(ii) replacement of the pentyl substituent with alkyl, alkenyl, benzyl, cycloalkylmethyl, cycloalkylethyl, (N-methylpiperidin-2-yl)methyl, 2(4-morpholinyl)ethyl or (tetrahydropyran-4-yl)methyl;

(iii) replacement of the methanone linking group with an ethanone, carboxamide, carboxylate, methylene bridge or methine group;

(iv) replacement of the 1-naphthyl ring with 2-naphthyl, phenyl, benzyl, adamantyl, cycloalkyl, cycloalkylmethyl, cycloalkylethyl, bicyclo[2.2.1]heptanyl, 1,2,3,4-tetrahydronaphthyl, quinolinyl, isoquinolinyl, 1-amino-1-oxopropan-2-yl, 1-hydroxy-1-oxopropan-2yl, piperidinyl, morpholinyl, pyrrolidinyl, tetrahydropyranyl or piperazinyl.

Misuse of Drugs (Designation) (England, Wales and Scotland) Order 2015 – paragraph 1(sa) of Schedule 1

any compound (not being clonitazene, etonitazene, acemetacin, atorvastatin, bazedoxifene, indometacin, losartan, olmesartan, proglumetacin, telmisartan, viminol, zafirlukast or a compound for the time being specified in sub-paragraphs (h) to (s) above) structurally related to 1-pentyl-3-(1-naphthoyl)indole (JWH-018), in that the four sub-structures, that is to say the indole ring, the pentyl substituent, the methanone linking group and the naphthyl ring, are linked together in a similar manner, whether or not any of the sub-structures have been modified, and whether or not substituted in any of the linked sub-structures with one or more univalent substituents and, where any of the sub-structures have been modified, the modifications of the sub-structures are limited to any of the following, that is to say—

(i) replacement of the indole ring with indane, indene, indazole, pyrrole, pyrazole, imidazole, benzimidazole, pyrrolo[2,3-b]pyridine, pyrrolo[3,2-c]pyridine or pyrazolo[3,4-b]pyridine;

(ii) replacement of the pentyl substituent with alkyl, alkenyl, benzyl, cycloalkylmethyl, cycloalkylethyl, (N-methylpiperidin-2-yl)methyl, 2(4-morpholinyl)ethyl or (tetrahydropyran-4-yl)methyl;

(iii) replacement of the methanone linking group with an ethanone, carboxamide, carboxylate, methylene bridge or methine group;

(iv) replacement of the 1-naphthyl ring with 2-naphthyl, phenyl, benzyl, adamantyl, cycloalkyl, cycloalkylmethyl, cycloalkylethyl, bicyclo[2.2.1]heptanyl, 1,2,3,4-tetrahydronaphthyl, quinolinyl, isoquinolinyl, 1-amino-1-oxopropan-2-yl, 1-hydroxy-1-oxopropan-2yl, piperidinyl, morpholinyl, pyrrolidinyl, tetrahydropyranyl or piperazinyl.

Annex E:

Amended definition in November 2019:

Misuse of Drugs Act 1971 - paragraph 1(ca) of Part 2 of Schedule 2

any compound (not being a compound for the time being specified in sub-paragraph (c) above) structurally related to 1-pentyl-3-(1-naphthoyl)indole (JWH-018), in that the four sub-structures, that is to say the indole ring, the pentyl substituent, the methanone linking group and the naphthyl ring, are linked together in a similar manner, whether or not any of the sub-structures have been modified, and whether or not substituted in any of the linked sub-structures with a benzyl or phenyl group and whether or not such compound is further substituted to any extent with alkyl, alkenyl, alkoxy, halide, haloalkyl or cyano substituents and, where any of the sub-structures have been modified, the modifications of the sub-structures are limited to any of the following, that is to say—

(i) replacement of the indole ring with indane, indene, indazole, pyrrole, pyrazole, imidazole, benzimidazole, pyrrolo[2,3-b]pyridine, pyrrolo[3,2c]pyridine or pyrazolo[3,4-b]pyridine;

(ii) replacement of the pentyl substituent with alkyl, alkenyl, benzyl, cycloalkylmethyl, cycloalkylethyl, (N-methylpiperidin-2-yl)methyl, 2-(4morpholinyl)ethyl or (tetrahydropyran-4-yl)methyl;

(iii) replacement of the methanone linking group with an ethanone, carboxamide, carboxylate, methylene bridge or methine group;

(iv) replacement of the 1-naphthyl ring with 2-naphthyl, phenyl, benzyl, adamantyl, cycloalkyl, cycloalkylmethyl, cycloalkylethyl, bicyclo[2.2.1]heptanyl, 1,2,3,4-tetrahydronaphthyl, quinolinyl, isoquinolinyl, 1-amino-1-oxopropan-2-yl, 1-hydroxy-1-oxopropan-2-yl, piperidinyl, morpholinyl, pyrrolidinyl, tetrahydropyranyl or piperazinyl.

Misuse of Drugs Regulations 2001 – paragraph 1 (ld) of Schedule 1

Any compound (not being a compound for the time being specified in sub-paragraphs (h) to (lc) above) structurally related to 1-pentyl-3-(1-naphthoyl)indole (JWH-018), in that the four sub-structures, that is to say the indole ring, the pentyl substituent, the methanone linking group and the naphthyl ring, are linked together in a similar manner, whether or not any of the sub-structures have been modified, and whether or not substituted in any of the linked sub-structures with a benzyl or phenyl group and whether or not such compound is further substituted to any extent with alkyl, alkenyl, alkoxy, halide, haloalkyl or cyano substituents and, where any of the sub-structures have been modified, the modifications of the sub-structures are limited to any of the following, that is to say—

(i) replacement of the indole ring with indane, indene, indazole, pyrrole, pyrazole, imidazole, benzimidazole, pyrrolo[2,3-b]pyridine, pyrrolo[3,2-c]pyridine or pyrazolo[3,4-b]pyridine;

(ii) replacement of the pentyl substituent with alkyl, alkenyl, benzyl, cycloalkylmethyl, cycloalkylethyl, (N-methylpiperidin-2-yl)methyl, 2(4-morpholinyl)ethyl or (tetrahydropyran-4-yl)methyl;

(iii) replacement of the methanone linking group with an ethanone, carboxamide, carboxylate, methylene bridge or methine group;

(iv) replacement of the 1-naphthyl ring with 2-naphthyl, phenyl, benzyl, adamantyl, cycloalkyl, cycloalkylmethyl, cycloalkylethyl, bicyclo[2.2.1]heptanyl, 1,2,3,4-tetrahydronaphthyl, quinolinyl, isoquinolinyl, 1-amino-1-oxopropan-2-yl, 1-hydroxy-1-oxopropan-2yl, piperidinyl, morpholinyl, pyrrolidinyl, tetrahydropyranyl or piperazinyl.

Misuse of Drugs (Designation) (England, Wales and Scotland) Order 2015 – paragraph 1(sa) of Schedule 1

Any compound (not being a compound for the time being specified in sub-paragraphs (h) to (s) above) structurally related to 1-pentyl-3-(1-naphthoyl)indole (JWH-018), in that the four sub-structures, that is to say the indole ring, the pentyl substituent, the methanone linking group and the naphthyl ring, are linked together in a similar manner, whether or not any of the sub-structures have been modified, and whether or not substituted in any of the linked sub-structures with a benzyl or phenyl group and whether or not such compound is further substituted to any extent with alkyl, alkenyl, alkoxy, halide, haloalkyl or cyano substituents and, where any of the sub-structures have been modified, the modifications of the sub-structures are limited to any of the following, that is to say—

(i) replacement of the indole ring with indane, indene, indazole, pyrrole, pyrazole, imidazole, benzimidazole, pyrrolo[2,3-b]pyridine, pyrrolo[3,2-c]pyridine or pyrazolo[3,4-b]pyridine;

(ii) replacement of the pentyl substituent with alkyl, alkenyl, benzyl, cycloalkylmethyl, cycloalkylethyl, (N-methylpiperidin-2-yl)methyl, 2(4-morpholinyl)ethyl or (tetrahydropyran-4-yl)methyl;

(iii) replacement of the methanone linking group with an ethanone, carboxamide, carboxylate, methylene bridge or methine group;

(iv) replacement of the 1-naphthyl ring with 2-naphthyl, phenyl, benzyl, adamantyl, cycloalkyl, cycloalkylmethyl, cycloalkylethyl, bicyclo[2.2.1]heptanyl, 1,2,3,4-tetrahydronaphthyl, quinolinyl, isoquinolinyl, 1-amino-1-oxopropan-2-yl, 1-hydroxy-1-oxopropan-2yl, piperidinyl, morpholinyl, pyrrolidinyl, tetrahydropyranyl or piperazinyl.

Annex F

On 14 December 2016, the third generation of synthetic cannabinoids (as defined in Annex D) were permanently controlled as Class B drugs under to the 1971 Act and associated Regulations.

The Home Office circular for the 2016 controls is available on GOV.UK.

For more information and further guidance please go to:

• ACMD 2012 report on synthetic cannabinoids

• ACMD 2014 advice in respect of the ‘third generation’ synthetic cannabinoids, along with a number of addenda

• Misuse of Drugs Act 1971

• Misuse of Drugs Regulations 2001 ‘2001 Regulations’

• Misuse of Drugs (Designation) Order 2015 ‘2015 Designation Order’

SI references for ‘third generation’ synthetic cannabinoids:

• The Misuse of Drugs Act 1971 (Amendment) Order 2019 [SI 2019/1323]

• The Misuse of Drugs and Misuse of Drugs (Designation) (Amendment) (England, Wales and Scotland) Regulations 2019 [SI 2019/1362]