Council Decision (EU) 2021/3 of 23 November 2020 on the position to be taken, on behalf of the European Union, at the reconvened sixty-third session of the Commission on Narcotic Drugs, on the scheduling of cannabis and cannabis-related substances under the Single Convention on Narcotic Drugs of 1961, as amended by the 1972 Protocol, and the Convention on Psychotropic Substances of 1971

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 83(1), in conjunction with Article 218(9) thereof,

Having regard to the proposal from the European Commission,

Whereas:

1. The United Nations (UN) Single Convention on Narcotic Drugs of 1961, as amended by the 1972 Protocol (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 (CND) may decide to add substances to the Schedules of that Convention. It can make changes to the Schedules only in accordance with the recommendations of the World Health Organization (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’) entered into force on 16 August 1976.

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

5. Changes to the Schedules of the Convention on Narcotic Drugs and of the Convention on Psychotropic Substances have direct repercussions on the scope of application of Union law in the area of drug control. Council Framework Decision 2004/757/JHA⁽¹⁾ applies to substances listed in the Schedules of those Conventions. Therefore, any change to the Schedules of those Conventions is directly incorporated into common Union rules.

6. The CND, at its reconvened sixty-third session, which is scheduled to take place from 2 to 4 December 2020 in Vienna, is to adopt decisions concerning cannabis and cannabis-related substances, which are already being controlled on the basis of the Convention on Narcotic Drugs or the Convention on Psychotropic Substances.

7. The Union is not a party to the Convention on Narcotic Drugs or the Convention on Psychotropic Substances. It has an observer status in the CND, where 12 Member States are members with the right to vote at its reconvened sixty-third session. It is therefore necessary for the Council to authorise those 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 decisions on the international scheduling of substances under those Conventions fall within the competence of the Union.

8. On 24 January 2019, the WHO issued six recommendations following the critical review at the 41st meeting of its Expert Committee on Drug Dependence (the ‘WHO Expert Committee’) concerning cannabis and cannabis-related substances. Those recommendations do not aim to authorise 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, oral preparations of cannabis have shown therapeutic potential for the 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. Therefore, the WHO concluded that the inclusion of cannabis and cannabis resin in Schedule IV of the Convention on Narcotic Drugs is not consistent with the criteria for a drug to be included in that Schedule.

11. That recommendation implies no change in the level of international control of cannabis and cannabis resin. It duly takes into account scientific developments in the field since the first inclusion of cannabis and cannabis resin in the Convention on Narcotic Drugs. The deletion of cannabis and cannabis resin from Schedule IV of the Convention on Narcotic Drugs could be beneficial to the advancement of collective knowledge of the therapeutic utility as well as any associated harms of cannabis.

12. Therefore, the position of the Union should be 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 included 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 in 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. The WHO understood that including delta-9-tetrahydrocannabinol under the same Convention and in the same schedule as cannabis, namely, Schedule I of the Convention on Narcotic Drugs, would greatly facilitate the implementation of the control measures of the Convention on Narcotic Drugs and the Convention on Psychotropic Substances in Member States. Therefore, the WHO recommended that delta-9-tetrahydrocannabinol and its active stereoisomer dronabinol be included in Schedule I of the Convention on Narcotic Drugs and, if that recommendation is adopted, be deleted from Schedule II of the Convention on Psychotropic Substances.

15. That recommendation implies no change in the level of international control 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 position of the Union should be 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.

17. According to the assessment of the WHO Expert Committee, tetrahydrocannabinol (isomers of delta-9-tetrahydrocannabinol), which is included 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 of delta-9-tetrahydrocannabinol, it is very difficult to differentiate any of those six isomers from delta-9-tetrahydrocannabinol using standard methods of chemical analysis. Moreover, including those six isomers under the same Convention and in the same Schedule as delta-9-tetrahydrocannabinol, namely, Schedule I of the Convention on Narcotic Drugs, would facilitate the implementation of international control of delta-9-tetrahydrocannabinol, and would assist Member States in the implementation of control measures at national level. Therefore, the WHO recommended that tetrahydrocannabinol (isomers of delta-9-tetrahydrocannabinol) be added to Schedule I of the Convention on Narcotic Drugs, subject to the adoption by the CND 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, be deleted from Schedule I of the Convention on Psychotropic Substances.

18. That recommendation implies no change in the level of international control of tetrahydrocannabinol (isomers of delta-9-tetrahydrocannabinol). It is in line with principles of better regulation and could facilitate the implementation of the control measures in Member States.

19. Therefore, the position of the Union should be to add tetrahydrocannabinol (isomers of delta-9-tetrahydrocannabinol) to Schedule I of the Convention on Narcotic Drugs, subject to the adoption by the CND 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 them from Schedule I of the Convention on Psychotropic Substances.

20. In order to ensure the coherence of the scheduling of delta-9-tetrahydrocannabinol and its active stereoisomer dronabinol as well as of tetrahydrocannabinol (isomers of delta-9-tetrahydrocannabinol), and to avoid the risk that any of those substances are scheduled under the Convention on Narcotic Drugs as well as under the Convention on Psychotropic Substances, it should be possible for the Member States that are members of the CND to express the position of the Union regarding the scheduling of those substances in a joint vote.

21. According to the assessment of the WHO Expert Committee, the variability in psychoactive properties of extracts and tinctures of cannabis, as laid down in the Convention on Narcotic Drugs, is due principally to varying concentrations of delta-9-tetrahydrocannabinol contained in those 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 are included in the same schedule, is a challenge for responsible authorities that implement control measures in 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 recommendation of the WHO Expert Committee to move dronabinol to Schedule I of the Convention on Narcotic Drugs were followed, as ‘preparations’ of dronabinol and its stereoisomers. Therefore, the WHO recommended that extracts and tinctures of cannabis be deleted from Schedule I of the Convention on Narcotic Drugs.

22. The information provided by the WHO after the issuance of that recommendation and the analysis of the impact of that recommendation by the International Narcotics Control Board (INCB) clarify that that recommendation does not entail any change in the level of international control of extracts and tinctures of cannabis and that that recommendation is not expected to have any impact on the control or reporting obligations of Member States. In addition, the deletion of extracts and tinctures of cannabis from Schedule I of the Convention on Narcotic Drugs would bring about greater certainty in the control of products derived without the use of a solvent but by application of heat and pressure.

23. Therefore, the position of the Union should be to vote for the recommendation to delete extracts and tinctures of cannabis from Schedule I of the Convention on Narcotic Drugs.

24. 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.

25. 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. Therefore, the WHO recommended that a footnote be added to the entry for cannabis and cannabis resin in Schedule I of the Convention on Narcotic Drugs, to read ‘Preparations containing predominantly cannabidiol and not more than 0.2 percent of delta-9-tetrahydrocannabinol are not under international control.’.

26. However, that recommendation would lower the current control level for those preparations. Moreover, the establishment of that limit of 0,2 percent of delta-9-tetrahydrocannabinol is not sufficiently supported by scientific evidence, the wording of that recommendation does not exclude possible divergent interpretations concerning the way of calculating that limit of 0,2 percent of delta-9-tetrahydrocannabinol, and the technical implementation of that recommendation will be difficult for reasons of technical and administrative capacity. The differentiated treatment of cannabidiol compared to other cannabinoids is not in line with the existing structure of the Schedules of the Convention on Narcotic Drugs and the Convention on Psychotropic Substances. That recommendation, as it has been drafted, does not offer the necessary legal certainty.

27. Therefore, the position of the Union should be to vote against the recommendation to add a footnote concerning ‘preparations containing predominantly cannabidiol and not more than 0.2 percent of delta-9-tetrahydrocannabinol’ to the entry for cannabis and cannabis resin in Schedule I of the Convention on Narcotic Drugs.

28. However, the Union would welcome further consultation with all relevant stakeholders on a recommendation on the appropriate level of international control for cannabis preparations with a low delta-9-tetrahydrocannabinol content, while ensuring the protection of public health and welfare, taking into consideration the existing structure of the international drug control system for cannabis as well as the technical and administrative capacity that is needed for the implementation of such recommendation.

29. 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. Therefore, 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, be added to Schedule III of the Convention on Narcotic Drugs.

30. However, the wording of that recommendation concerning pharmaceutical preparations is not based on any defined term in the Convention on Narcotic Drugs. Moreover, that recommendation could bring about additional regulatory burden on Member States, which would need to define the concepts used in that recommendation to ensure its uniform application and would have to ascertain whether the condition of not being recoverable by readily available means is or is not fulfilled for each product.

31. Therefore, the position of the Union should be 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.

32. It is appropriate to establish the position to be taken on the Union’s behalf in the CND with regard to changes to the scheduling of cannabis and cannabis-related substances, as the decisions on scheduling as regards the above-mentioned cannabis and cannabis-related substances will directly affect the content of Union law, namely, Framework Decision 2004/757/JHA.

33. The position of the Union is to be expressed by the Member States that are members of the CND, acting jointly in the interest of the Union.

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

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

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