United Nations Commission on Narcotic Drugs (CND) has called a session on the 3rd and 4th of December in Vienna when further decisions on scheduling of cannabis and cannabis-related substances are expected.
The decisions are expected to be based on the collection of formal recommendations issued by the World Health Organization (WHO) in January 2019. Among the rest, the recommendations acknowledge cannabis’ medical therapeutic properties and express a need to remove the term ‘extracts and tinctures of cannabis’ from the International Drug Control Conventions (IDCC). The International Drug Control Conventions (IDCC) that refer to this subject are the 1961 Single Convention on Narcotic Drugs, amended by the 1972 Protocol (C61) and its complementary treaty, the 1971 Convention on Psychotropic Substances (C71).
In the recommendations conducted by the Expert Committee on Drug Dependence (ECDD), the WHO emphasized a need for several scheduling changes, first of which refers to cannabis and cannabis resin. As cannabis and cannabis resin are presently included in Schedule I and Schedule IV of the 1961 Single Convention on Narcotic Drugs, along with the substances that are particularly liable to abuse and produce ill-effects, and substances that are associated with a significant risk of death and have little or no therapeutic use. In their 5.1 recommendation, the WHOs 41st Committee has recommended cannabis and cannabis resin to be deleted from Schedule IV and placed in Schedule I or Schedule II of the 1961 Single Convention on Narcotic Drugs.
The 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, the report observed. In line with 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, research, and development of cannabis-related preparation for medical use.
The recommendation 5.2 refers to delta-9- tetrahydrocannabinol (Δ 9 – THC) and its active stereoisomer dronabinol, which was included in the 1971 Convention on Psychotropic Substances. In a synthetic form, they had been considered as a pharmaceutical preparation, and Δ 9 – THC today also refers to the main psychoactive component of cannabis and the principal compound in illicit cannabis-derived psychoactive products. Some of these products contain Δ9 -THC at concentrations as high as 90%, the report stated. The WHOs Committee recommends the inclusion of Δ 9 – THC in Schedule I of the 1961 Single Convention on Narcotic Drugs. They believe that placing Δ 9 -THC under the same Convention and in the same schedule as cannabis would greatly facilitate the implementation of the control measures of the Conventions.
The recommendation 5.3 refers to tetrahydrocannabinol (THC). There are currently six isomers of tetrahydrocannabinol (THC) listed in the Schedule I of the 1971 Convention on Psychotropic Substances. These six isomers are chemically similar to delta-9- tetrahydrocannabinol (Δ 9 -THC), which is currently listed in Schedule II of the 1971 Convention on Psychotropic Substances, but which the Committee has recommended deleting from this Schedule and including in Schedule I of the 1961 Single Convention on Narcotic Drugs. While these six isomers are chemically similar to Δ 9 -THC, the Committee has found very limited or no evidence concerning the potential for abuse or acute intoxicating effects of these isomers. There are no reports that the THC isomers listed in Schedule I of the 1971 Convention induce physical dependence or that they are being abused and could constitute a public health or social problem. The Committee recommended placing these six isomers under the same Convention and in the same Schedule as Δ 9 -THC, as it would facilitate the implementation of international control of Δ 9 -THC, and assist member states in the implementation of control measures at country level.
As indicated in the Guidance on the WHO review of psychoactive substances for international control, to facilitate efficient administration of the international control system, it is not advisable to place a substance under more than one Convention, so all of the substances in question should be erased from the 1971 Convention on Psychotropic Substances, the Committee emphasized.
Extracts and Tinctures
The 5.4 recommendation refers to a subject of interest for the medical cannabis industry – extracts and tinctures of cannabis. The preparations produced by the application of solvents to cannabis are currently placed in Schedule I of the 1961 Single Convention on Narcotic Drugs. These include both medical preparations such as that containing an approximately equal mixture of delta-9-tetrahydrocannabinol (dronabinol; Δ 9 -THC) and cannabidiol and non-medical preparations with high concentrations of Δ 9 -THC such as butane hash oil. While the medical extracts and tinctures are administered orally, those produced and used illicitly are normally inhaled following heating and vaporization. In its report, the Committee recognized that the term Extracts and Tinctures of Cannabis, as cited in the 1961 Single Convention on Narcotic Drugs, encompasses the preparations with psychoactive properties as well as those without. The Committee also recognized that the psychoactive properties of these preparations vary depending on concentrations of Δ 9 -THC, which is currently scheduled in the 1971 Convention on Psychotropic Substances. Some extracts and tinctures of cannabis without psychoactive properties and including predominantly cannabidiol have promising therapeutic applications, the Committee points out in this recommendation.
The fact that diverse preparations with a variable concentration of delta-9 THC are controlled within the same entry “Extract and Tinctures” and the same schedule presents a challenge for the authorities that implement control measures, the Committee concludes. As per the 1961 Single Convention on Narcotic Drugs, preparations are defined as mixtures, solid, or liquid containing a substance in Schedule I or II and are generally subject to the same measures of control as that substance. By this definition, the 1961 Single 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 1961 Single Convention on Narcotic Drugs was followed, as “preparations” of dronabinol and its stereoisomers. Accordingly, the Committee recommended deleting Extracts and Tinctures of Cannabis from Schedule I of the 1961 Single Convention on Narcotic Drugs.
A Footnote for CBD
Cannabidiol (CBD) alone is considered in the recommendation 5.5. of the Committee’s report. At its previous 40th meeting, the ECDD recommended that preparations considered to be pure cannabidiol should not be scheduled within the International Drug Control Conventions. CBD 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, the ECDD states in their report. At the same time, CBD has been shown to be effective in the management of certain treatment-resistant, childhood-onset epilepsy disorders, as they point out.
The ECDD noted that medicines without psychoactive effects produced as preparations of the cannabis plant will contain trace amounts of delta-9-tetrahydrocannabinol (Δ9-THC; dronabinol). The cannabidiol preparation approved for the treatment of childhood-onset epilepsy, Epidiolex, contains not more than 0.15% Δ9-THC by weight and has no effects indicative of a potential for abuse or dependence. In keeping with the recommendation that preparations considered pure cannabidiol not be controlled and recognizing that trace levels of Δ9-THC may be found in such preparations, such as the concentration of 0.15% in Epidiolex, while acknowledging that chemical analysis of Δ9-THC to an accuracy of 0.15% may be difficult for some member states, the Committee recommended that a footnote be added to Schedule I of the 1961 Single 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.”
Medicines Containing Δ9-THC
The last recommendation in this report refers to pharmaceutical preparations of cannabis and dronabinol (Δ9-THC). There are currently two main types of registered medicines that contain Δ9-THC. One type is a preparation of cannabis that contains both the psychoactive Δ9-THC and the nonpsychoactive cannabidiol in approximately equal concentrations, e.g. Sativex. This is used for the treatment of spasticity in multiple sclerosis. A second type contains only Δ9-THC as the active compound and is used for the treatment of anorexia associated with weight loss in patients with AIDS, and for nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional anti-vomiting treatments. Currently approved medicines with Δ9-THC as the only active compound use synthetically produced Δ9-THC, e.g. Marinol, Syndros. It is possible in the future that medicines with equivalent amounts of Δ9-THC could be prepared from cannabis, the Committee expects.
There is no difference in the therapeutic effects or adverse effects of synthetic Δ9-THC compared to Δ9-THC from the cannabis plant, the report founds. These medicines are all taken orally and are approved for use in a number of countries. The evidence concerning the use of these Δ9-THC containing medicines is that they are not associated with problems of abuse and dependence and they are not diverted for the purpose of non-medical use. The Committee 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 1961 Single Convention on Narcotic Drugs for cannabis based preparations such as Sativex and the level of control associated with Schedule II of the 1971 Convention on Psychotropic Substances, for preparations using synthetic delta-9 THC e.g. Marinol and Syndros.
In order not to impede access to these medicines and in reference to Article 3.4 of the 1961 Single Convention on Narcotic Drugs, the Committee recommended that preparations containing delta-9- tetrahydrocannabinol (dronabinol), produced either by chemical synthesis or as a preparation of cannabis, and which are compounded as pharmaceutical preparations with one or more other ingredients 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, be added to Schedule III of the 1961 Convention on Narcotic Drugs.
These ECDDs recommendations will be presented to the 187 Member States at the United Nations Office on Drugs and Crime (UNODC) headquarters in Vienna with high expectations coming from the industry expecting a more clarified legal framework. However, an analysis of the ECDD’s report, conducted by the UN’s International Narcotics Control Board (INCB), shows there is still some space for improvement. The analysis, a copy of which was obtained by Marihuana Business Daily, points out several potential flows in ECDD’s report.
The INCB did not position itself in favor of or against any of the recommendations but concluded some of them might not have the desired impact. Also, they emphasized the importance of more accurate definitions. If recommendation 5.1 was adopted, control measures at the international level will not change, neither would the periodic reporting requirements of the member states, the Board points out. Furthermore, recommendations 5.2 and 5.3 would result in a number of additional control measures, the INCB concludes. In recommendation 5.4, the presence of extracts and tinctures of cannabis in Schedule I could be considered a repetition that the recommendation aims to correct, and it would not have a meaningful practical implication, the Board said.
When it comes to the 5.5 recommendation, The INCB has found that, while CBD is not specifically listed in the international drug control treaties, CBD “that is produced from an extract of cannabis is included in the 1961 Convention.” The main issue with this recommendation relates to its practical implementation at the national level, they point out. In most countries, chemical analysis down to the threshold indicated in the recommendation might not be possible. Also, they identified a lack of access to appropriate identification techniques for the required level of accuracy. Even where achievable, the INCB believes it might not be ”considered a good use of resources.” Furthermore, the Board expressed a concern over cannabis cultivated for the extraction of CBD. They consider CBD would need to be monitored under the provisions of the 1961 Single Convention on Narcotic Drugs because it does not meet the definition of industrial purposes.
INCB President Cornelis P. de Joncheere has said in previous meetings that “if the cultivation of cannabis … is for the production of the flowering top, then it should be considered under control regardless of the THC or CBD content.”