Considerations on COM(2023)2 - EU position on the scheduling of substances under the Single Convention on Narcotic Drugs of 1961

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dossier COM(2023)2 - EU position on the scheduling of substances under the Single Convention on Narcotic Drugs of 1961.
document COM(2023)2 EN
date March  9, 2023
 
(1) The United Nations (UN) Single Convention on Narcotic Drugs of 1961, as amended by the 1972 Protocol 12 ('the Convention on Narcotic Drugs') entered into force on 8 August 1975.

(2) Pursuant to Article 3 of the Convention on Narcotic Drugs, the Commission on Narcotic Drugs may decide to add substances to the Schedules of that Convention. It can make changes in the Schedules only in accordance with the recommendations of the World Health Organisation (WHO), but it can also decide not to make the changes recommended by the WHO.

(3) The United Nations (UN) Convention on Psychotropic Substances of 1971 ('the Convention on Psychotropic Substances') 13 entered into force on 16 August 1976.

(4) Pursuant to Article 2 of the Convention on Psychotropic Substances, the Commission on Narcotic Drugs may decide to add substances to the Schedules of that Convention or to remove them, on the basis of the recommendations of the WHO. It has broad discretionary powers to take into account economic, social, legal, administrative and other factors, but may not act arbitrarily.

(5) Changes to the Schedules of both Conventions have direct repercussions on the scope of application of Union law in the area of drug control. Council Framework Decision 2004/757/JHA 14 applies to substances listed in the Schedules to these Conventions. Thus any change to the Schedules annexed to the Conventions directly affects common Union rules and alters their scope, in accordance with Article 3(2) of the Treaty on the Functioning of the European Union.

(6) The Commission on Narcotic Drugs, during its sixty-six session scheduled for 13 to 17 March 2023 in Vienna, is to adopt decisions on the adding of seven new substances to the Schedules of the above Conventions.

(7) The Union is not a party to the Convention on Narcotic Drugs and the Convention on Psychotropic Substances. It has an observer status with no voting rights in the Commission on Narcotic Drugs where twelve Member States are to be members with the right to vote in March 2023 15 . It is therefore necessary for the Council to authorise the Member States to express the position of the Union on the scheduling of substances under the Convention on Narcotic Drugs and the Convention on Psychotropic Substances since the decisions on the addition of new substances to the Schedules of the Conventions fall under the exclusive competence of the Union.

(8) The WHO recommended to add four new substances to Schedule I of the Convention on Narcotic Drugs, and three new substances to Schedule II of the Convention on Psychotropic Substances 16 .

(9) All substances reviewed by the WHO Expert Committee on Drug Dependence (‘the Expert Committee’) and recommended for scheduling by the WHO are monitored by the European Monitoring Centre for Drugs and Drug Addiction as a new psychoactive substance under the terms of Regulation (EC) No 1920/2006 of the European Parliament and of the Council 17 .

(10) According to the assessment of the Expert Committee on Drug Dependence, ADB-BUTINACA (IUPAC name: N-[1-(aminocarbonyl)-2,2-dimethylpropyl]-1-butyl-1H-indazole-3-carboxamide) is an indazole-derived synthetic cannabinoid, the S-enantiomer being the active compound (CAS No.: 2682867-55-4). ADB-BUTINACA has no therapeutic uses nor has it received a marketing authorisation as medicinal product. There is sufficient evidence that ADB-BUTINACA is being or is likely to be abused and may constitute a public health and social problem warranting the placing of the substance under international control. Thus, the WHO recommends that ADB-BUTINACA be placed in Schedule II of the Convention on Psychotropic Substances.

(11) ADB-BUTINACA has been detected in 26 Member States and is controlled in at least five Member States. ADB-BUTINACA is subject to intensive monitoring by the European Monitoring Centre for Drugs and Drug Addiction. It has been the subject of a public health-related alert issued by the European Union Early Warning System. ADB-BUTINACA is also mentioned in two additional public health-related alerts. It has been associated with serious adverse events, including 14 deaths reported by two Member States.

(12) Therefore, the Member States should take the position to add ADB-BUTINACA to Schedule II of the Convention on Psychotropic Substances.

(13) According to the assessment of the Expert Committee, protonitazene (IUPAC name: N,N-diethyl-5-nitro-2-[(4-propoxyphenyl)methyl]-1-H-benzimidazole-1-ethanamine) is a benzimidazole opioid. Protonitazene was first synthetized as an alternative to morphine but there is no approved therapeutic use of protonitazene. There is sufficient evidence that protonitazene is being or is likely to be abused and may constitute a public health and social problem warranting the placing of the substance under international control. Thus, the WHO recommends that protonitazene be placed in Schedule I of the Convention on Narcotic Drugs.

(14) Protonitazene has been detected in two Member States and is controlled in at least three Member States. Protonitazene is subject to intensive monitoring by the European Monitoring Centre for Drugs and Drug Addiction. No information on serious adverse events involving protonitazene has been reported to the EMCDDA.

(15) Therefore, the Member States should take the position to add protonitazene to the Schedule I of the Convention on Narcotic Drugs.

(16) According to the assessment of the Expert Committee, etazene (IUPAC name: 2-[(4-ethoxyphenyl)methyl]-N,N-diethyl-1H-benzimidazole-1-ethanamine) is a benzimidazole-derived synthetic opioid with a chemical structure and pharmacological similar to drugs scheduled under Schedule I (under the 1961 United Nations Conventions) such as clonitazene, etonitazene and isotonitazene. Etazene was studied for its analgesic properties but there is no known medical use of etazene. There is sufficient evidence that etazene is being or is likely to be abused and may constitute a public health and social problem warranting the placing of the substance under international control. Thus, the WHO recommends that Etazene be placed in Schedule I of the Convention on Narcotic Drugs.

(17) Etazene has been detected in eight Member States and is controlled in at least five Member States. Etazene is subject to intensive monitoring by the European Monitoring Centre for Drugs and Drug Addiction. It has been associated with serious adverse events, including four deaths, reported by two Member States.

(18) Therefore, the Member States should take the position to add etazene to the Schedule I of the Convention on Narcotic Drugs.

(19) According to the assessment of the Expert Committee, etonitazepyne (IUPAC name: 2-[(4-ethoxyphenyl)methyl]-5-nitro-1-(2-pyrrolidin-1-ylethyl)-1H-benzoimidazole) is a benzimidazole-derived synthetic opioid with a chemical structure and pharmacological similar to drugs scheduled under Schedule I (under the 1961 United Nations Conventions) such as etonitazene. Etonitazepyne was studied for its analgesic properties but there is no known medical use of etonitazepyne. There is sufficient evidence that etonitazepyne is being or is likely to be abused and may constitute a public health and social problem warranting the placing of the substance under international control. Thus, the WHO recommends that etonitazepyne be placed in Schedule I of the Convention on Narcotic Drugs.

(20) Etonitazepyne has been detected in six Member States and is controlled in at least two Member States. Similar to other new opioids, etonitazepyne may be sold as a replacement to controlled opioids, and has been the subject of a public health-related alert issued by the European Union Early Warning System. Etonitazepyne is subject to intensive monitoring by the European Monitoring Centre for Drugs and Drug Addiction. A death with confirmed exposure to etonitazepyne has been reported by one country.

(21) Therefore, the Member States should take the position to add etonitazepyne to the Schedule I of the Convention on Narcotic Drugs.

(22) According to the assessment of the Expert Committee, 2-methyl-AP-237 (IUPAC name: 1-{2-methyl-4-[(2E)-3-phenylprop-2-en-1-yl]piperazin-1-yl}butan-1-one) is a synthetic opioid typically classed as a 1-cinnamylpiperazine. There is no known therapeutic use for 2-methyl-AP-237, nor has it received a marketing authorisation as medicinal product. There is sufficient evidence that 2-methyl-AP-237 is being or is likely to be abused and may constitute a public health and social problem warranting the placing of the substance under international control. Thus, the WHO recommends that 2-methyl-AP-237 be placed in Schedule I of the Convention on Narcotic Drugs.

(23) 2-Methyl-AP-237 has been detected in six Member States and is controlled in at least four Member States. It has been associated with serious adverse events, including a death.

(24) Therefore, the the Member States should take the position to add 2-methyl-AP-237 to the Schedule I of the Convention on Narcotic Drugs.

(25) According to the assessment of the Expert Committee, alpha-PiHP (α-PiHP, IUPAC name: 4-methyl-1-phenyl-2-(pyrrolidin-1-yl)pentan-1-one) is a synthetic cathinone. There is no known therapeutic use for alpha-PiHP, nor has it received a marketing authorisation as medicinal product. There is sufficient evidence that alpha-PiHP is being or is likely to be abused and may constitute a public health and social problem warranting the placing of the substance under international control. Thus, the WHO recommends that alpha-PiHP be placed in Schedule II of the Convention on Psychotropic Substances.

(26) Alpha-PiHP has been detected in 18 Member States and is controlled in at least seven Member States. Alpha-PiHP is mentioned in a public health-related alert issued by the European Union Early Warning System. It has been associated with serious adverse events, including four deaths, reported by one Member State and detected in biological samples linked to serious adverse events, reported by four Member States.

(27) Therefore, the the Member States should take the position to add alpha-PiHP to the Schedule II of the Convention on Psychotropic Substances.

(28) According to the assessment of the Expert Committee, 3-methylmethcathinone (3-MMC, IUPAC name: 2-(methylamino)-1-(3-methylphenyl)propan-1-one) is a synthetic cathinone and a positional isomer of the internationally controlled 4-methylmethcathinone (4-MMC, mephedrone, Schedule II of the Convention on Psychotropic Substances). 3-MMC was critically reviewed in 2016, but it was decided to request another critical review, to be considered at a subsequent meeting, pending the availability of more information. Some patent applications including the use of 3-MMC were found but no current clinical trials were identified on therapeutic use of 3-MMC. 3-MMC also has no recognised human or veterinary medical use in the Union.

(29) The risks of 3-MMC have been assessed by the scientific committee of the European Monitoring Centre for Drugs and Drug Addiction and 3-MMC has already been included in the definition of ‘drug’ under Framework Decision 2004/757/JHA by Commission Delegated Directive (EU) 2022/1326 18 . 3-MMC is subject to intensive monitoring by the European Monitoring Centre for Drugs and Drug Addiction. At the time of risk assessment, in November 2021, 3-MMC had been detected in 23 Member States. A total of 27 deaths with confirmed exposure to 3-MMC had been reported by five Member States and 14 acute non-fatal poisonings with confirmed exposure to 3-MMC had been reported by four Member States.

(30) Therefore, the Member States should take the position to add 3-MMC to the Schedule II of the Convention on Psychotropic Substances.

(31) It is appropriate to establish the position to be taken on the Union’s behalf in the Commission on Narcotic Drugs, as the decisions on the different scheduling decisions as regards the nine substances will be capable of decisively influencing the content of Union law, namely Framework Decision 2004/757/JHA.

(32) The Union's position is to be expressed by the Member States that are members of the Commission on Narcotic Drugs, acting jointly.

(33) Denmark is bound by Framework Decision 2004/757/JHA and is therefore taking part in the adoption and application of this Decision.

(34) Ireland is bound by Framework Decision 2004/757/JHA and is therefore taking part in the adoption and application of this Decision.