In journalism and media industry for more than twenty years, worked for a number of media companies. Business editing, research and PR specialist. Covering industry and science news for Ilesol Pharmaceuticals.
Today, during its 63rd session, the United Nations Commission on Narcotic Drugs (CND) accepted the World Health Organization (WHO) recommendation to remove cannabis and cannabis resin from Schedule IV of the 1961 Single Convention on Narcotic Drugs.
On Wednesday, in a virtual meeting based in Vienna, the CND voted on six formal recommendations issued by the WHO in January 2019. The recommendations intended to bring long-awaited changes to the International Drug Control Conventions. Among those, recommendation 5.1 is seen as the most significant for the industry.
With 27 votes in favor, 25 against, and one abstained (Ukraine), the recommendation was adopted. Australia, Austria, Belgium, Canada, Colombia, Croatia, Czech Republic, Ecuador, El Salvador, France, Germany, India, Italy, Jamaica, Mexico, Morocco, Nepal, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, Thailand, UK, USA, and Uruguay voted in favor of the recommendation. Hungary was the only country of the European Union that voted against this recommendation.
By deleting cannabis and cannabis resin from Schedule IV of the 1961 Single Convention on Narcotic Drugs, the CND now prompted a cascade of positive effects for the cannabis industry, opened the way for further national legalizations, and gave a boost to cannabis research, the industry media hopes.
Cannabis and cannabis resin were so far included in Schedule I and Schedule IV of the 1961 Single Convention on Narcotic Drugs, 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. Being listed in both Schedule I and Schedule IV of the Convention, cannabis was subjected to the most strict control, which presented an obstacle in scientific research.
Other recommendations referred to erasing THC and dronabinol from Schedule II of the 1971 Convention and listing them under Schedule I of the 1961 Convention, which would facilitate the implementation of the control measures. With 23 votes in favor, 28 against, and two abstentions, the CND rejected the recommendations. The preparations containing dronabinol were recommended to be added to Schedule III of the 1961 Convention. This recommendation was also rejected in today’s session.
CBD industry has been closely following the destiny of two WHO’s recommendations – 5.4 and 5.5. The 5.4 recommendation refers to the extracts and tinctures of cannabis. The WHO recommended them to be deleted from Schedule I of the 1961 Single Convention on Narcotic Drugs.
The extracts and tinctures of cannabis are the preparations produced by the application of solvents to cannabis include both medical preparations containing an approximately equal mixture of THC and CBD, and non-medical preparations with high concentrations of THC. 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 WHO’s Expert Committee on Drug Dependence (ECDD) noted 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 THC, which was scheduled in the 1971 Convention on Psychotropic Substances. Some extracts and tinctures of cannabis without psychoactive properties and including predominantly CBD have promising therapeutic applications, the Committee pointed out. This recommendation, like all the other WHO’s recommendations to the CND, refer only to CBD products considered to be medicinal, and not to food, cosmetics, or other products containing CBD.
The fact that diverse preparations with a variable concentration of THC are controlled within the same entry “Extract and Tinctures” and the same schedule presented a challenge for the authorities that implement control measures, the Committee concluded. 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.
With 24 in favor, 27 against, and two abstentions, the CND rejected the recommendation. The countries in favor were Australia, Austria, Belgium, Canada, Chile, Colombia, Croatia, Czech Republic, Ecuador, El Salvador, France, Germany, Italy, Mexico, Morrocco, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, UK, USA, Uruguay. Again, Hungary was the only European country that voted against it.
Prior to the session, some countries suggested that CBD should be included in the scheduling. However, the WHO’s expert committee concluded that pure CBD should not be scheduled within the International Drug Conventions. Instead, in the recommendation 5.5 of their report, the Committee recommended a footnote added to Schedule I of the 1961 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.”
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, the Committee concluded. It does not have significant ill-effects, and, at the same time, it has been shown to be effective in the management of certain treatment-resistant, childhood-onset epilepsy disorders.
The Committee recommended that preparations considered pure CBD should not be controlled and recognized that trace levels of Δ9THC may be found in such preparations, such as the concentration of 0.15% in Epidiolex. The chemical analysis of Δ9-THC to an accuracy of 0.15% may be difficult for some member states, it acknowledged.
With 6 in favor, 43 against, and four abstentions, the recommendation was rejected. Only Australia, Canada, Ecuador, Peru, South Africa, Thailand voted in favor of the 5.5 recommendation.
At the first topical CND meeting in June, the 5.5 recommendation had almost no support. The member countries that expressed their reservations were the USA, Canada, Brazil, and Kyrgyzstan. The US underlined it would prefer that member states “decide for themselves what an appropriate threshold (of THC) should be.”
Although it voted in favor at today’s CND session, during the first meeting Canada called the WHO to reformulate the proposal because of its inconsistency with the 1961 treaty. In their opinion, it specified “what is not subject to control rather than indicating what is subject to control.” Along with the USA, it called for the reexamination of the THC threshold. Brazil was worried about several issues, including the possibility of THC products bearing fake CBD labels to disguise international control.
Other countries also expressed their reservations. Japan was worried about the potential application to nonmedical products, Singapore said “preparations containing THC should not be excluded from international control, regardless of the amount”, while Indonesia remarked that the WHO made a “hasty” decision by saying that CBD preparations with minimum THC aren’t liable to abuse. Turkey criticized the “predominantly CBD preparations” definition as ambiguous, and questioned the current ambiguity surrounding “cannabis cultivation for nonmedical CBD.”
In their analyses, the UN’s International Narcotics Control Board (INCB) previously concluded that the presence of extracts and tinctures of cannabis in Schedule I could be considered a repetition that the recommendation 5.4 aims to correct, and it would not have a meaningful practical implication.
When it comes to the 5.5 recommendation, the INCB has found that the main issue relates to its practical implementation at the national level. 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 said it might not be ”considered a good use of resources.” The Board expressed a concern over cannabis cultivated for the extraction of CBD and considered 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.
The European Union common stand on the recommendations by WHO’s Committee was discussed by the members of the Horizontal Working Party on Drugs (HDG) at their informal videoconference on 29 October 2020. The Council of the European Union approved it on the 18th of November. While supporting the need for scientific progress prior to the vote, the EU countries stressed out that the recommendations should not be seen as a step towards the liberalization of the use of cannabis.
In this light, the removal of cannabis and cannabis resin from Schedule IV of the 1961 Single Convention on Narcotic Drugs could be seen more as a symbolic win for the cannabis industry than a foundation for high hopes. Nevertheless, it represents a step forward in the regulation of medical cannabis products in international law.