Considerations on COM(2019)631 - EU position in the Commission on Narcotic Drugs on the scheduling of substances under the Single Convention on Narcotic Drugs and Convention on Psychotropic Substances - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2019)631 - EU position in the Commission on Narcotic Drugs on the scheduling of substances under the Single Convention on Narcotic ... |
|---|---|
| document | COM(2019)631  |
| date | December 13, 2019 |
(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 UN Convention on Psychotropic Substances of 1971 ('the Convention on Psychotropic Substances') 15 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 16 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 (TFEU).
(6) The Commission on Narcotic Drugs, during its sixty-third session tentatively scheduled for 2 to 6 March 2020 in Vienna, is to adopt decisions on the adding of 12 new substances to the Schedules of the UN Conventions.
(7) The Union is not a party to the relevant UN Conventions. It has an observer status in the Commission on Narcotic Drugs where thirteen Member States are to be members with the right to vote in March 2020 17 . 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 two new substances to Schedule I of the Convention on Narcotic Drugs, one new substance to Schedule I, seven new substances to Schedule II and two new substances to Schedule IV of the Convention on Psychotropic Substances 18 .
(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 ('EMCDDA') as a new psychoactive substance under the terms of Regulation (EC) No 1920/2006 of the European Parliament and of the Council 19 . None of the substances has been subject to an initial report nor to a risk assessment at Union level.
(10) According to the assessment of the Expert Committee, crotonylfentanyl (chemical name: N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]-2-butenamide) is a synthetic opioid and is structurally similar to fentanyl, a controlled substance widely used in medicine for general anaesthesia during surgery and for pain management. Crotonylfentanyl has no therapeutic uses nor has it received a marketing authorisation as medicinal product. There is sufficient evidence that crotonylfentanyl 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 crotonylfentanyl be placed in Schedule I of the Convention on Narcotic Drugs.
(11) Crotonylfentanyl has been identified only in autumn 2019 for the first time in the EU (in the Netherlands). No deaths or acute intoxications have been associated with the substance yet.
(12) The Member States should take the position to add crotonylfentanyl to Schedule I of the Convention on Narcotic Drugs.
(13) According to the assessment of the Expert Committee, valerylfentanyl (also referred to as fentanyl pentanamide analogue; chemical name: N-phenyl-N-[1-(2-phenylethyl)-4-piperidyl]pentanamide) is a synthetic opioid. Valerylfentanyl has no therapeutic uses nor has it received a marketing authorisation as medicinal product. There is sufficient evidence that valerylfentanyl 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 valerylfentanyl be placed in Schedule I of the Convention on Narcotic Drugs.
(14) Valerylfentanyl has been detected in four Member States and is controlled in at least four Member States. No deaths or acute intoxications have been associated with the substance yet.
(15) Therefore, the Member States should take the position to add valerylfentanyl to Schedule I of the Convention on Narcotic Drugs.
(16) According to the assessment of the Expert Committee, DOC (also referred to as 2,5-Dimethoxy-4-chloroamfetamine; chemical name: 1-(4-chloro-2,5-dimethoxyphenyl)propan-2-amine) is a phenethylamine. DOC has no therapeutic uses nor has it received a marketing authorisation as medicinal product. There is sufficient evidence that DOC 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 DOC be placed in Schedule I of the Convention on Psychotropic Substances.
(17) DOC has been detected in 27 Member States and is controlled in at least twelve Member States. It has been associated with at least one death and four acute intoxications.
(18) Therefore, the Member States should take the position to add DOC to Schedule I of the Convention on Psychotropic Substances.
(19) According to the assessment of the Expert Committee, AB-FUBINACA (also referred to as FUB-AMB; chemical name: N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) is a synthetic cannabinoid. AB-FUBINACA has no therapeutic uses nor has it received a marketing authorisation as medicinal product. There is sufficient evidence that AB-FUBINACA 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 AB-FUBINACA be placed in Schedule II of the Convention on Psychotropic Substances.
(20) AB-FUBINACA has been detected in 24 Member States and is controlled in at least 13 Member States. It has been associated with at least 20 deaths and 19 acute intoxications.
(21) Therefore, the Member States should take the position to add AB-FUBINACA to Schedule II of the Convention on Psychotropic Substances.
(22) According to the assessment of the Expert Committee, 5F-AMB-PINACA (also referred to as 5F-AMB, 5F-MMB-PINACA, 5-fluoro AMB, 5-fluoro AMP or 5F-AMP; chemical name: Methyl 2-({[1-(5-fluoropentyl)-1H-indazol-3-yl]carbonyl}amino)-3-methylbutanoate) is a synthetic cannabinoid. 5F-AMB-PINACA has no therapeutic uses nor has it received a marketing authorisation as medicinal product. There is sufficient evidence that 5F-AMB-PINACA 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 5F-AMB-PINACA be placed in Schedule II of the Convention on Psychotropic Substances.
(23) 5F-AMB-PINACA has been detected in 17 Member States and is controlled in at least eight Member States. It has been associated with at least two deaths and three acute intoxications.
(24) Therefore, the Member States should take the position to add 5F-AMB-PINACA to Schedule II of the Convention on Psychotropic Substances.
(25) According to the assessment of the Expert Committee, 5F-MDMB-PICA (also referred to as 5F-MDMB-2201 or MDMB-2201; chemical name: methyl 2-[[1-(5-fluoropentyl)indole-3-carbonyl]amino]-3,3-dimethyl-butanoate) is a synthetic cannabinoid. 5F-MDMB-PICA has no therapeutic uses nor has it received a marketing authorisation as medicinal product. There is sufficient evidence that 5F-MDMB-PICA 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 5F-MDMB-PICA be placed in Schedule II of the Convention on Psychotropic Substances.
(26) 5F-MDMB-PICA has been detected in 22 Member States and is controlled in at least three Member States. It has been associated with at least eight deaths and one acute intoxication.
(27) Therefore, the Member States should take the position to add 5F-MDMB-PICA to Schedule II of the Convention on Psychotropic Substances.
(28) According to the assessment of the Expert Committee, 4-F-MDMB-BINACA (also referred to as 4F-ADB, 4F-MDMB-BINACA or 4F-MDMB-BUTINACA; chemical name: methyl 2-(1-(4-fluorobutyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) is a synthetic cannabinoid. 4-F-MDMB-BINACA has no therapeutic uses nor has it received a marketing authorisation as medicinal product. There is sufficient evidence that 4-F-MDMB-BINACA 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 4-F-MDMB-BINACA be placed in Schedule II of the Convention on Psychotropic Substances.
(29) 4-F-MDMB-BINACA has been detected in 14 Member States and is controlled in at least one Member State. It has been associated with at least one acute intoxication. 4-F-MDMB-BINACA was the subject of a EU Early Warning System Briefing in April 2019.
(30) Therefore, the Member States should take the position to add 4-F-MDMB-BINACA to Schedule II of the Convention on Psychotropic Substances.
(31) According to the assessment of the Expert Committee, 4-CMC (also referred to as 4-chloromethcathinone or clephedrone; chemical name: 1-(4-chlorophenyl)-2-(methylamino)propan-1-one) is a synthetic cathinone, which is structurally related to mephedrone 20 , which is scheduled under the Convention on Psychotropic Substances. 4-CMC has no therapeutic uses nor has it received a marketing authorisation as medicinal product. There is sufficient evidence that 4-CMC 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 4-CMC be placed in Schedule II of the Convention on Psychotropic Substances.
(32) 4-CMC has been detected in 24 Member States and is controlled in at least eight Member States. It has been associated with at least four deaths and three acute intoxications.
(33) Therefore, the Member States should take the position to add 4-CMC to Schedule II of the Convention on Psychotropic Substances.
(34) According to the assessment of the Expert Committee, N-ethylhexedrone (also referred to as NEH, Hexen, Ethyl-Hex, Ethyl-hexedrone or HEX-EN; chemical name: 2-(ethylamino)-1-phenylhexan-1-one) is a synthetic cathinone. N-ethylhexedrone has no therapeutic uses nor has it received a marketing authorisation as medicinal product. There is sufficient evidence that N-ethylhexedrone 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 N-ethylhexedrone be placed in Schedule II of the Convention on Psychotropic Substances.
(35) N-ethylhexedrone has been detected in 23 Member States and is controlled in at least six Member States. It has been associated with at least 31 deaths and nine acute intoxications.
(36) Therefore, the Member States should take the position to add N-ethylhexedrone to Schedule II of the Convention on Psychotropic Substances.
(37) According to the assessment of the Expert Committee, alpha-PHP (also referred to as PV-7, α-PHP, α-pyrrolidinohexanophenone; chemical name: 1-phenyl-2-(pyrrolidin-1-yl)hexan-1-one) is a synthetic cathinone. It is a higher homologue of alpha-PVP, 21 which is scheduled under the Convention on Psychotropic Substances. Alpha-PHP has no therapeutic uses nor has it received a marketing authorisation as medicinal product. There is sufficient evidence that alpha-PHP 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-PHP be placed in Schedule II of the Convention on Psychotropic Substances.
(38) Alpha-PHP has been detected in 21 Member States and is controlled in at least seven Member States. It has been associated with at least 27 deaths and two acute intoxications.
(39) Therefore, the Member States should take the position to add alpha-PHP to Schedule II of the Convention on Psychotropic Substances.
(40) According to the assessment of the Expert Committee, flualprazolam (also referred to as Ro 11-5073/000; chemical name: 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine) is a benzodiazepine. Flualprazolam has no therapeutic uses nor has it received a marketing authorisation as medicinal product. There is sufficient evidence that flualprazolam 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 flualprazolam be placed in Schedule IV of the Convention on Psychotropic Substances.
(41) Flualprazolam has been detected in eight Member States and is controlled in at least two Member State. It has been associated with at least 26 deaths. Flualprazolam was the subject of an Union Early Warning System Advisory in March 2019.
(42) Therefore, the Member States should take the position to add flualprazolam to Schedule IV of the Convention on Psychotropic Substances.
(43) According to the assessment of the Expert Committee, etizolam (also referred to as Y-7131 or Depas; chemical name: 4-(2-chlorophenyl)-2-ethyl-9-methyl-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine) is a benzodiazepine-type substance. Etizolam has been reviewed by the Expert Committee on three occasions, most recently in 2017. There is sufficient evidence that etizolam 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 etizolam be placed in Schedule IV of the Convention on Psychotropic Substances.
(44) Etizolam has been detected in 21 Member States and is controlled in at least seven Member States. It has been associated with 43 deaths 22 . While etizolam is an authorised medicine 23 in several countries (Japan, Italy, India), it is thought that most of the substance that is sold on the drug market in Europe is not from diverted medicines but purchased as a powder in bulk quantities from chemical companies based outside of Europe. It is then imported into the Union using express mail and cargo services and then typically pressed into tablets and sold either as etizolam or passed off as fake diazepam and alprazolam. Etizolam is often sold as ‘street valium’. The number of Union spontaneous cases reported to EudraVigilance (EV) for etizolam that can be identified through the Standardised MedDRA Query ‘Drug abuse, dependence and withdrawal’ is small. 24 In 2017, etizolam was the most commonly seized benzodiazepine reported to the Union Early Warning System both by number of cases and by amount. Etizolam was the subject of an Union Early Warning System Briefing in March 2019.
(45) Therefore, the Member States should take the position to add etizolam to Schedule IV of the Convention on Psychotropic Substances.
(46) 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 12 substances will be capable of decisively influencing the content of Union law, namely Framework Decision 2004/757/JHA.
(47) The Union's position is to be expressed by the Member States that are members of the Commission on Narcotic Drugs, acting jointly.
(48) Denmark is bound by Framework Decision 2004/757/JHA as applicable until 21 November 2018 and is therefore taking part in the adoption and application of this Decision.
(49) Ireland is bound by Framework Decision 2004/757/JHA and is therefore taking part in the adoption and application of this Decision.
(50) The United Kingdom is not bound by Framework Decision 2004/757 JHA and is therefore not taking part in the adoption of this Decision, and is not bound by it or subject to its application.