Considerations on COM(2018)862 - EU position in the Commission on Narcotic Drugs on the scheduling of substances under the Single Convention on Narcotic Drugs and the Convention on Psychotropic Substances - Main contents
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| dossier | COM(2018)862 - EU position in the Commission on Narcotic Drugs on the scheduling of substances under the Single Convention on Narcotic ... |
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| document | COM(2018)862  |
| date | January 7, 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)16 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/JHA17 applies to substances listed in the Schedules to the Convention on Narcotic Drugs and the Convention on Psychotropic Substances. Thus any change to the Schedules annexed to those 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).
15 16 17
United Nations Treaty Series, vol. 978, No. 14152.
United Nations Treaty Series, vol. 1019, No. 14956.
Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on
the constituent elements of criminal acts and penalties in the field of illicit drug trafficking (OJ L 335,
11.11.2004, p. 8).
(6) The Commission on Narcotic Drugs, during its sixty-second session of 18 to 22 March 2019 in Vienna, is to adopt decisions on the adding of 10 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 currently eleven Member States are members with the right to vote. 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 five new substances to Schedule I of the Convention on Narcotic Drugs and five new substances to Schedule II of the Convention on
Psychotropic Substances.18
(9) According to the assessment of the WHO Expert Committee on Drug Dependence (the ‘Expert Committee’), ADB-FUBINACA (chemical name: N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) is a synthetic cannabinoid receptor agonist that shows similar effects to Tetrahydrocannabinol (THC), which is responsible for the major psychoactive effects of cannabis. ADB-FUBINACA has no therapeutic uses nor has it received a marketing authorisation as medicinal product. There is sufficient evidence that ADB-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 ADB-FUBINACA be placed in Schedule II of the Convention on Psychotropic Substances.
(10) ADB-FUBINACA is 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 ADB-FUBINACA has been detected in 19 Member States and is controlled in at least ten Member States. It has been associated with at least two deaths and four acute intoxications, and has been the subject of a public health-related alert issued to the European Union Early Warning System.
(11) Therefore, the Member States should take the position to add ADB-FUBINACA to Schedule II of the Convention on Psychotropic Substances.
(12) According to the assessment of the Expert Committee, FUB-AMB (also referred to as MMB-FUBINACA or AMB-FUBINACA; chemical name: methyl (2S)-2-[[1-[(4-fluorophenyl)methyl]indazole-3-carbonyl]amino]-3-methylbutanoate; methyl-2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamide)-3-methylbutanoate) is a synthetic cannabinoid receptor agonist that shows similar effects to THC, which is responsible for the major psychoactive effects of cannabis. FUB-AMB has no therapeutic uses nor has it received a marketing authorisation as medicinal product. There is sufficient evidence that FUB-AMB 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 FUB-AMB be placed in Schedule II of the Convention on Psychotropic Substances.
Oral statement at the reconvened 61st session of the Commission on Narcotic Drugs on 7 December
2018.
Regulation (EC) No 1920/2006 of the European Parliament and of the Council of 12 December 2006 on
the European Monitoring Centre for Drugs and Drug Addiction (OJ L 376, 27.12.2006, p. 1).
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(13) FUB-AMB is monitored by the EMCDDA as a new psychoactive substance under the
terms of Regulation (EC) No 1920/2006. FUB-AMB has been detected in 23 Member States and is controlled in at least four Member States. It has been associated with at
least two deaths and two acute intoxications.
(14) Therefore, the Member States should take the position to add FUB-AMB to Schedule II of the Convention on Psychotropic Substances.
(15) According to the assessment of the Expert Committee, ADB-CHMINACA (chemical name: N-[(2S)-1-amino-3,3-dimethyl-1-oxobutan-2-yl]-1-(cyclohexylmethyl)indazole-3-carboxamide; N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide) is a synthetic cannabinoid receptor agonist that shows similar effects to THC, which is responsible for the major psychoactive effects of cannabis. ADB-CHMINACA has no therapeutic uses nor has it received a marketing authorisation as medicinal product. There is sufficient evidence that ADB-CHMINACA 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-CHMINACA be placed in Schedule II of the Convention on Psychotropic Substances.
(16) ADB-CHMINACA has already been subjected to control measures at Union level by Council Implementing Decision (EU) 2018/747.20
(17) Therefore, the Member States should take the position to add ADB-CHMINACA to Schedule II of the Convention on Psychotropic Substances.
(18) According to the assessment of the Expert Committee, CUMYL-4CN-BINACA (chemical name: 1-(4-cyanobutyl)-N-(1-methyl-1-phenylethyl)-1H-indazole-3-carboxamide) is a synthetic cannabinoid receptor agonist that shows similar effects to THC, which is responsible for the major psychoactive effects of cannabis. CUMYL-4CN-BINACA has no therapeutic uses nor has it received a marketing authorisation as medicinal product. There is sufficient evidence that CUMYL-4CN-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 CUMYL-4CN-BINACA be placed in Schedule II of the Convention on Psychotropic Substances.
(19) CUMYL-4CN-BINACA has already been subjected to control measures at Union level by Council Implementing Decision (EU) 2018/748.21
(20) Therefore, the Member States should take the position to add CUMYL-4CN-BINACA to Schedule II of the Convention on Psychotropic Substances.
(21) According to the assessment of the the Expert Committee, cyclopropylfentanyl (chemical name: N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]cyclopropanecarboxamide) 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. Cyclopropylfentanyl has no recorded therapeutic use and its use has resulted in fatalities. There is sufficient evidence that
Council Implementing Decision (EU) 2018/747 of 14 May 2018 on subjecting the new psychoactive substance N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
carboxamide (ADB-CHMINACA) to control measures (OJ L 125, 22.5.2018, p. 8).
Council Implementing Decision (EU) 2018/748 of 14 May 2018 on subjecting the new psychoactive substance 1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxamide (CUMYL-4CN-
BINACA) to control measures (OJ L 125, 22.5.2018, p. 10).
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cyclopropylfentanyl 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 cyclopropylfentanyl be placed in Schedule I of the Convention on Narcotic Drugs.
(22) Cyclopropylfentanyl has already been subjected to control measures at Union level by Council Implementing Decision (EU) 2018/1463.22
(23) Therefore, the Member States should take the position to add cyclopropylfentanyl to Schedule I of the Convention on Narcotic Drugs.
(24) According to the assessment of the Expert Committee, methoxyacetylfentanyl (chemical name: 2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) 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. Methoxyacetylfentanyl has no recorded therapeutic use and its use has resulted in fatalities. There is sufficient evidence that methoxyacetylfentanyl 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 methoxyacetylfentanyl be placed in Schedule I of the Convention on Narcotic Drugs.
(25) Methoxyacetylfentanyl has already been subjected to control measures at Union level by Council Implementing Decision (EU) 2018/1463.
(26) Therefore, the Member States should take the position to add methoxyacetylfentanyl to Schedule I of the Convention on Narcotic Drugs.
(27) According to the assessment of the Expert Committee, ortho-fluorofentanyl (chemical name: N-(2-fluorophenyl)-N-[1-(2-phenylethyl)-4-piperidinyl]-propanamide) 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. Ortho-fluorofentanyl has no recorded therapeutic use and its use has resulted in fatalities. There is sufficient evidence that ortho-fluorofentanyl 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 ortho-fluorofentanyl be placed in Schedule I of the Convention on Narcotic Drugs.
(28) Ortho-fluorofentanyl is monitored by the EMCDDA as a new psychoactive substance under the terms of Regulation (EC) No 1920/2006. Ortho-fluorofentanyl has been detected in five Member States and is controlled in at least four Member States. It has been associated with at least four deaths and two acute intoxications.
(29) Therefore, the Member States should take the position to add ortho-fluorofentanyl to Schedule I of the Convention on Narcotic Drugs.
(30) According to the assessment of the Expert Committee, p-fluoro-butyrylfentanyl (also known as 4-fluoro-butyrfentanyl or 4F-BF; chemical name: N-(4-fluorophenyl)-N-[1-(2-phenylethyl)piperidin-4-yl]butanamide) 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. p-Fluoro-butyrylfentanyl could be converted to its isomer p-fluoro-isobutyrylfentanyl, which is listed in Schedule I of
Council Implementing Decision (EU) 2018/1463 of 28 September 2018 on subjecting the new psychoactive substances N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]cyclopropanecarboxamide
(cyclopropylfentanyl) and 2-methoxy-N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]acetamide
(methoxyacetylfentanyl) to control measures, OJ L 245, 1.10.2018, p. 9.
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the Convention on Narcotic Drugs. p-Fluoro-butyrylfentanyl has no recorded therapeutic use and its use has resulted in fatalities. There is sufficient evidence that p-fluoro-butyrylfentanyl 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 p-fluoro-butyrylfentanyl be placed in Schedule I of the Convention on Narcotic Drugs.
(31) p-Fluoro-butyrylfentanyl is monitored by the EMCDDA as a new psychoactive substance under the terms of Regulation (EC) No 1920/2006 (under the name 4-fluoro-butyrfentanyl / 4F-B). p-Fluoro-butyrylfentanyl has been detected in seven Member States and is controlled in at least seven Member States. It is being sold openly on the market. It has been associated with at least three deaths.
(32) Therefore, the Member States should take the position to add p-fluoro-butyrylfentanyl to Schedule I of the Convention on Narcotic Drugs.
(33) According to the assessment of the Expert Committee, p-methoxy-butyrylfentanyl (chemical name: N-(4-methoxyphenyl)-N-[1-(2-phenylethyl)piperidin-4-yl]butanamide) 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. p-Methoxy-butyrylfentanyl has no recorded therapeutic use and its use has resulted in fatalities. There is sufficient evidence that p-methoxy-butyrylfentanyl 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 p-methoxy-butyrylfentanyl be placed in Schedule I of the Convention on Narcotic Drugs.
(34) p-Methoxy-butyrylfentanyl is monitored by the EMCDDA as a new psychoactive substance under the terms of Regulation (EC) No 1920/2006 (under the name 4-methoxybutyrfentanyl / 4-MeO-BF). p-Methoxy-butyrylfentanyl has been detected in two Member States and is controlled in at least four Member States. It is being sold openly on the market. It has been associated with at least two deaths.
(35) Therefore, the Member States should take the position to add p-methoxy-butyrylfentanyl to Schedule I of the Convention on Narcotic Drugs.
(36) According to the assessment of the Expert Committee, N-ethylnorpentylone (chemical name: 1-(2H-1,3-benzodioxol-5-yl)-2-(ethylamino)pentan-1-one) is a synthetic cathinone. N-Ethylnorpentylone has no therapeutic uses nor has it received a marketing authorisation as medicinal product. Seizures indicate that N-ethylnorpentylone is available in powder, crystal, capsule, and tablet forms. Examples exist where this drug has been surreptitiously sold as ‘ecstasy’/MDMA23. There is sufficient evidence that N-ethylnorpentylone 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-ethylnorpentylone be placed in Schedule II of the Convention on Psychotropic Substances.
(37) N-Ethylnorpentylone is monitored by the EMCDDA as a new psychoactive substance under the terms of Regulation (EC) No 1920/2006 (under the name Ephylone). N-Ethylnorpentylone has been detected in 24 Member States and is controlled in at lest six Member States. It is being sold openly on the market as well as in mixtures with MDMA, cocaine and ketamine. It has been associated with at least seven deaths and seven acute intoxications.
MDMA stands for 3,4-Methylenedioxymethamphetamine,
stands for 3,4-Methylenedioxymethamphetamine, commonly known as ecstasy.
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(38) Therefore, the Member States should take the position to add N-ethylnorpentylone to Schedule II of the Convention on Psychotropic Substances.
(39) 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 10 substances will be capable of decisively influencing the content of Union law, namely Framework Decision 2004/757/JHA.
(40) The Union's position is to be expressed by the Member States that are members of the Commission on Narcotic Drugs, acting jointly.
(41) Denmark is bound by Framework Decision 2004/757/JHA and is therefore taking part in the adoption and application of this Decision.
(42) Ireland is bound by Framework Decision 2004/757/JHA, as amended, and is therefore taking part in the adoption and application of this Decision.
(43) The United Kingdom is not bound by Framework Decision 2004/757 JHA, as amended, and is therefore not taking part in the adoption of this Decision, and is not bound by it or subject to its application.