Considerations on COM(2019)624 - EU position in the sixty-third session of the Commission on Narcotic Drugs on the scheduling of substances under the conventions on narcotic drugs and psychotropic substances - Main contents
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| dossier | COM(2019)624 - EU position in the sixty-third session of the Commission on Narcotic Drugs on the scheduling of substances under the ... |
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| document | COM(2019)624  |
| date | December 12, 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 of 2 to 6 March 2020 in Vienna, is to adopt decisions concerning cannabis and cannabis-related substances which are already under control on the basis of the Convention on Narcotic Drugs or the Convention on Psychotropic Substances.
(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 international scheduling of substances under the Conventions fall under the exclusive competence of the Union.
(8) The WHO submitted on 24 January 2019 18 six recommendations issued following the critical review carried out at the 41st meeting of its Expert Committee on Drug Dependence (the ‘WHO Expert Committee’)concerning cannabis and cannabis-related substances. These recommendations do not aim at authorising the recreational use of cannabis or cannabis-related substances.
(9) According to the assessment of the WHO Expert Committee, cannabis and cannabis resin are not particularly liable to produce ill-effects similar to the effects of the other substances in Schedule IV of the Convention on Narcotic Drugs. In addition, preparations of cannabis have shown therapeutic potential for treatment of pain and other medical conditions such as epilepsy and spasticity associated with multiple sclerosis.
(10) The WHO considered that cannabis and cannabis resin should be scheduled at a level of control that will prevent harm caused by cannabis use and at the same time will not act as a barrier to access and to research and development of cannabis-related preparations for medical use. Thus, the WHO concluded that the inclusion of cannabis and cannabis resin in Schedule IV is not consistent with the criteria for a drug to be placed in Schedule IV.
(11) That recommendation implies no change in the international control level of cannabis and cannabis resin as they will continue to be included in Schedule I of the Convention on Narcotic Drugs. It duly takes into account scientific developments in the field since the first introduction of cannabis and cannabis resin into the Convention on Narcotic Drugs. The deletion of cannabis and cannabis resin from Schedule IV of the Convention on Narcotic Drugs would be beneficial to the advancement of collective knowledge of both the therapeutic utility as well as any associated harms of cannabis.
(12) Therefore, the Member States should take the position to delete cannabis and cannabis resin from Schedule IV of the Convention on Narcotic Drugs.
(13) According to the assessment of the WHO Expert Committee, delta-9-tetrahydrocannabinol and its active stereoisomer dronabinol, especially in high purity illicitly derived forms, can produce ill-effects, dependence, and abuse potential that is at least as great as for cannabis, which is placed in Schedule I of the Convention on Narcotic Drugs. A substance liable to similar abuse and productive of similar ill-effects as that of a substance already scheduled within the Convention on Narcotic Drugs would normally be scheduled in the same way as that substance. As delta-9- tetrahydrocannabinol is liable to similar abuse as cannabis and has similar ill effects, it meets the criteria for inclusion in Schedule I of the Convention on Narcotic Drugs.
(14) Moreover, the WHO understood that placing delta-9- tetrahydrocannabinol under the same Convention and in the same schedule as cannabis, i.e. Schedule I of the Convention on Narcotic Drugs, would greatly facilitate the implementation of the control measures of the Conventions in Member States. Thus, the WHO recommended that delta-9- tetrahydrocannabinol and its active stereoisomer dronabinol be placed in Schedule I of the Convention on Narcotic Drugs and, if this recommendation is adopted, to be deleted from Schedule II of the Convention on Psychotropic Substances.
(15) That recommendation implies no change in the international control level of delta-9-tetrahydrocannabinol and its active stereoisomer dronabinol. It could also facilitate the implementation of the control measures in Member States.
(16) Therefore, the Member States should take the position to add delta-9-tetrahydrocannabinol and its active stereoisomer dronabinol to Schedule I of the Convention on Narcotic Drugs and, if that recommendation is adopted, to delete them from Schedule II of the Convention on Psychotropic Substances. Alternatively, the recommendation should not be put to vote and further assessment by the WHO should be requested.
(17) According to the assessment of the WHO Expert Committee, tetrahydrocannabinol (isomers of delta-9-tetrahydrocannabinol), which is placed in Schedule I of the Convention on Psychotropic Substances, does not have abuse and ill effects similar to those associated with delta-9-tetrahydrocannabinol but, due to the chemical similarity of each of the six isomers to delta-9-tetrahydrocannabinol, it is very difficult to differentiate any of these six isomers from delta-9-tetrahydrocannabinol using standard methods of chemical analysis. Moreover, placing these six isomers under the same Convention and in the same Schedule as delta-9-tetrahydrocannabinol, i.e. Schedule I of the Convention on Narcotic Drugs, would facilitate the implementation of international control of delta-9-tetrahydrocannabinol, as well as assist Member States in the implementation of control measures at country level. Thus, the WHO recommended that tetrahydrocannabinol (isomers of delta-9-tetrahydrocannabinol) is added to Schedule I of the Convention on Narcotic Drugs subject to adoption of the recommendation by the Commission on Narcotic Drugs (CND) to add dronabinol and its stereoisomers (delta-9-tetrahydrocannabinol) to Schedule I of the Convention on Narcotic Drugs, and, if that recommendation is adopted, to be deleted from Schedule I of the Convention on Psychotropic Substances.
(18) That recommendation implies no change in the international control level of tetrahydrocannabinol (isomers of delta-9-tetrahydrocannabinol). It could also facilitate the implementation of the control measures in Member States.
(19) Therefore, the Member States should take the position to add tetrahydrocannabinol (isomers of delta-9-tetrahydrocannabinol) to Schedule I of the Convention on Narcotic Drugs subject to the CND’s adoption of the recommendation to add dronabinol and its stereoisomers (delta-9-tetrahydrocannabinol) to Schedule I of the Convention on Narcotic Drugs, and, if that recommendation is adopted, to delete it from Schedule I of the Convention on Psychotropic Substances. Alternatively, the recommendation should not be put to vote and further assessment by WHO should be requested.
(20) According to the assessment of the WHO Expert Committee, the variability in psychoactive properties of extracts and tinctures of cannabis, as cited in the Convention on Narcotic Drugs, is due principally to varying concentrations of delta-9-tetrahydrocannabinol contained in these extracts and tinctures. Some extracts and tinctures of cannabis without psychoactive properties and including predominantly cannabidiol have promising therapeutic applications. The fact that diverse preparations with a variable concentration of delta-9-tetrahydrocannabinol are controlled within the same entry “Extract and Tinctures” and the same schedule, is a challenge for responsible authorities that implement control measures in the individual countries. Moreover, the definition of preparations under the Convention on Narcotic Drugs may cover all products that are ‘extracts and tinctures’ of cannabis as “preparations” of cannabis and also, if the Committee`s recommendation to move dronabinol to Schedule I of the Convention on Narcotic Drugs was followed, as “preparations” of dronabinol and its stereoisomers. Thus, the WHO recommended that extracts and tinctures should be deleted from Schedule I of the Convention on Narcotic Drugs.
(21) However, notwithstanding the clarifications provided by the WHO after the issuance of that recommendation, there is no apparent public health justification for it and it is difficult to assess fully its implications, including in terms of comprehensiveness of the international control system.
(22) Therefore, the Member States should take the position that the recommendation should not be put to vote and further assessment by WHO should be requested.
(23) According to the assessment of the WHO Expert Committee, cannabidiol is found in cannabis and cannabis resin but does not have psychoactive properties and has no potential for abuse and no potential to produce dependence. It does not have significant ill-effects. Moreover, cannabidiol has been shown to be effective in the management of certain treatment-resistant, childhood-onset epilepsy disorders.
(24) The WHO noted that medicines without psychoactive effects that are produced as preparations of the cannabis plant will contain trace amounts of delta-9-tetrahydrocannabinol and acknowledged that chemical analysis of delta-9-tetrahydrocannabinol to an accuracy of 0.15 % may be difficult for some Member States. Thus, the WHO recommended that a footnote be added to Schedule I of the Convention on Narcotic Drugs to read: “Preparations containing predominantly cannabidiol and not more than 0,2 % of delta-9-tetrahydrocannabinol are not under international control.”
(25) However, that recommendation would lower current control level for these preparations, the establishment of any THC limit for preparations containing predominantly cannabidiol is not supported by scientific evidence, and the wording of the recommendation does not exclude possible divergent interpretations concerning the way of calculating such limit. The differentiated treatment of cannabidiol compared to other cannabinoids is not justified and is not in line with the existing structure of the Schedules of the Conventions.
(26) Therefore, the Member States should take the position that the recommendation should not be put to vote and further assessment by WHO should be requested.
(27) According to the assessment of the WHO Expert Committee, medicines containing delta-9-tetrahydrocannabinol are not associated with problems of abuse and dependence and they are not diverted for the purpose of non-medical use. Moreover, the WHO recognised that such preparations are formulated in a way that they are not likely to be abused and there is no evidence of actual abuse or ill effects to an extent that would justify the current level of control associated with Schedule I of the Convention on Narcotic Drugs or the level of control associated with Schedule II of the Convention on Psychotropic Substances. Thus, the WHO recommended that “preparations produced either by chemical synthesis or as preparation of cannabis, that are compounded as pharmaceutical preparations with one or more other ingredients and in such a way that delta-9-tetrahydrocannabinol cannot be recovered by readily available means or in a yield which would constitute a risk to public health” to be added to Schedule III of the Convention on Narcotic Drugs.
(28) However, that recommendation could imply additional regulatory burden on Member States. Moreover, the wording of the recommendation concerning “pharmaceutical” preparations is not based on any defined term under the Convention on Narcotic Drugs and may not be compatible with the EU terminology as provided by Directive 2001/83 of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use 19 .
(29) Therefore, the Member States should take the position to vote against the recommendation to add “preparations produced either by chemical synthesis or as preparation of cannabis, that are compounded as pharmaceutical preparations with one or more other ingredients and in such a way that delta-9-tetrahydrocannabinol (dronabinol) cannot be recovered by readily available means or in a yield which would constitute a risk to public health” to Schedule III of the Convention on Narcotic Drugs. Alternatively, that recommendation should not be put to vote and further assessment by WHO should be requested.
(30) 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 cannabis and cannabis-related substances will be capable of decisively influencing the content of Union law, namely Framework Decision 2004/757/JHA.
(31) The Union's position is to be expressed by the Member States that are members of the Commission on Narcotic Drugs, acting jointly.
(32) 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.
(33) Ireland is bound by Framework Decision 2004/757/JHA and is therefore taking part in the adoption and application of this Decision.
(34) 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.