Key questions about the transfer of THC to the 1961 Single Convention

Martin Jelsma / TNI – 20 August 2020   The key issue at stake at the 2nd ‘Topical meeting’ of the CND about the WHO cannabis recommendations (24-25 August), is the proposed transfer of Δ9-THC (dronabinol) and other tetrahydrocannabinols from the 1971 Convention on Psychotropic Substances to Schedule I of the 1961 Single Convention on Narcotic Drugs.    Initially many saw this as simply correcting an historical error and simplifying control and reporting requirements, because it seems incomprehensible that cannabis and its main psychoactive compound are not controlled under the same treaty, as is the case with opium/morphine or coca leaf/cocaine. But closer inspection of the recommended transfer reveals a number of important  differences in the control regimes of the two treaties, resulting in inconsistencies that are not so easy to resolve. The answers provided thus far by WHO, INCB and UNODC to the long list of questions raised by Member States are unsatisfying, often contradictory, and have increased confusion rather than resolved ambiguities.    The WHO can hardly be blamed for the shortcomings of the treaty system as it stands. It is the result of negotiated compromises between Member States decades ago, and the current legal framework in which the WHO and its Expert Committee on Drug Dependence (ECDD, Expert Committee) is  obliged to operate. Still, the experts could have indicated more clearly the complicated dilemmas they faced when elaborating this complex and interrelated set of recommendations. The WHO does bear a degree of historical responsibility for the original inclusion of cannabis and resin in Schedules I and IV of the 1961 Convention, and of THC in Schedule I of the 1971 Convention, the most stringent schedules of the treaties. In both cases the plenipotentiary conferences adopted the inclusion based on lists provided by the WHO that were produced without any critical review. That omission was addressed by the Expert Committee in the case of dronabinol/Δ9-THC in subsequent reviews that resulted in its de-scheduling to Schedule II, but the current review process represents the first opportunity to also correct the historical errors made in the original classification of cannabis itself.    As explained in more detail below, the inconvenient truth that becomes ever more obvious after the WHO’s recent questionable decision to recommend keeping cannabis in Schedule I, is that the 1961 Single Convention has proven to be too blunt an instrument to deal with today’s wide spectrum of cannabis-related substances on the rapidly expanding and diversifying licit and illicit markets. The 1961 Convention does not allow for making distinctions between plant material and extracted compounds, or between levels of potency. By comparison, the 1971 Convention  leaves considerably more discretion to parties to exempt designated preparations from specific control provisions. The proposed WHO solutions to contain the potential damage of a transfer of THC to the 1961 Convention,  the footnote (5.5) and Schedule III exemptions (5.6), are band-aids that do not seem to adhere firmly on the treaty’s rigid skeleton. Moreover, the full sets of conditionalities between the different recommendations are not made explicit, allowing for scenarios of partial adoption of the WHO recommendations that would entail unintended negative consequences, including the risk of decreased access to cannabis-based medicines.   Unless the upcoming topical meetings bring more clarity around these concerns, or the ECDD is willing to adapt certain recommendations to address them, our advice under current circumstances is not to approve the transfer of THC from the 1971 to the 1961 Convention. Consequently, as we regard them to be interrelated, also the proposed footnote and Schedule III exemption (recommendations 5.5 and 5.6) should not be adopted at this stage, at least not in their current wording. A worst-case scenario could be that the transfer (5.2 and 5.3) is adopted, but the exemption (5.6) is rejected. In our view, these are the main problems:    1) Ratifying that cannabis remains in Schedule I   As argued previously, the reason the ECDD gives for keeping cannabis and resin in Schedule I is questionable given its finding that “the Committee did not consider that cannabis is associated with the same level of risk to health of most of the other drugs that have been placed in Schedule I”. But because it does not represent a change in the schedules, the recommendation does not require a confirmation by vote of the CND. However, if Member States adopt the transfer of THC from the 1971 Convention to Schedule I of the 1961 Convention, they will implicitly be voting yes on keeping cannabis in Schedule I as well, because the only reason for the transfer of THC to Schedule I is its ‘similarity’ to cannabis. Member States should be well aware of the fact that voting to approve recommendation 5.2.1 means expressing consent with the proposal to keep cannabis under the stringent control measures of Schedule I, alongside heroin and cocaine. For many countries this seems to be contrary to the direction of recent or ongoing developments in their national cannabis policies that are implementing or exploring moving cannabis out of the most restrictive schedule to facilitate medical access and research, or—in a growing number of cases—even moving towards a legally regulated cannabis market.   An argument could even be made that WHO’s recommendation ‘5.0’ to keep cannabis in Schedule I should first be submitted to a vote because—as the ECDD has underscored several times—“cannabis has never been subject to a formal pre-review or critical review” before. So, even though it would not be a change in the schedules, this is the first time the inclusion of cannabis in Schedule I would be based on a WHO recommendation made in accordance with the required treaty procedure.    2) Contradiction with previous dronabinol/Δ9-THC reviews   After the initial de-scheduling of dronabinol/Δ9-THC within the 1971 treaty from Schedule I to II, which was adopted by a two-thirds majority of the CND in 1991, the ECDD recommended to de-schedule it further down to Schedule IV (in 2002, not passed on to CND) or III (first in 2006, with no action taken by the CND, and again in 2012, rejected by CND vote in 2014). Accepting the previous WHO recommendations for Schedule III or IV would have meant that medical prescriptions for Δ9-THC preparations would no longer have been obligatory, record keeping and reporting to the INCB would be minimal, and no prior import and export authorizations would be required. Adding Δ9-THC to Schedule I of the 1961 Convention would, therefore, mean imposing significantly stricter controls and more stringent reporting obligations than those that currently exist under its current placement in Schedule II of the 1971 Convention, thus moving the international control level in the opposite direction than that contemplated by the WHO’s previous recommendations.    As the INCB made clear in its answers to Member State questions, “the endorsement of this recommendation by the Commission, will result in a number of additional control measures required for States under the 1961 Convention” (p. 44). “Instead of assessments which are required for drugs in Schedules II, III and IV of the 1971 Convention, pursuant some ECOSOC resolutions, Governments will need to submit estimates, pursuant to article 19 of the 1961 Convention. The mandate to submit estimates is stricter than for assessments, as it is a treaty mandate. Submitted estimates are subject to confirmation by the Board and Governments must furnish estimates annually (instead of three-year intervals under the assessment system)” (p.31).    3) Discretion regarding exemptions for preparations    Different combinations of vote outcomes on 5.2 (the transfer of THC from the 1971 to the 1961 Convention) and 5.6 (certain pharmaceutical preparations containing Δ9-THC included in Schedule III of the 1961 Convention) could have far-reaching consequences for the availability of medicines containing THC. A major difference between the control regimes of the 1961 and 1971 Conventions is how preparations containing narcotic drugs or psychotropic substances can be exempted from specific control provisions. Under Article 3 the 1971 Convention on ‘Special provisions regarding the control of preparations’, a Party may decide itself to exempt certain preparations containing substances on Schedules II, III and IV (e.g. including dronabinol which is currently in Schedule II) from any or all of the control measures (except from a few requirements around licenses, administration and export to countries that have imposed an import ban).    Only if other Parties, or the WHO itself, have reasons to believe that an announced exemption constitutes a ‘public health and social problem’ for other Parties, will the exemption be reviewed by the WHO, which can recommend that the CND either partially or fully terminate the exemption. This leaves considerable flexibility for countries to decide which medicinal preparations are allowed under what conditions on the domestic market, including the ability to establish national quantity thresholds for the substances those preparations contain. In contrast, the 1961 Convention leaves individual Parties much less flexibility in this regard: preparations can only be exempted from a few control measures if they are explicitly mentioned in Schedule III, and those exemptions apply equally to all Parties. Thus the transfer of THC to Schedule I of the 1961 treaty will further constrain Member States room for manoeuvre regarding future developments in medical access.   4) Access to medicinal cannabis preparations currently on the market   “In order not to impede access” to medicines such as Sativex®, Marinol® and Syndros®, the proposed transfer of THC to the 1961 Convention is accompanied by recommendation 5.6 to exempt such  THC-containing ‘pharmaceutical preparations’ from some treaty provisions by adding them to Schedule III, because according to the ECDD’s 41st report, “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” (p. 55). “This lower level of control will increase international access to pharmaceutical preparations of dronabinol”, according to the WHO presentation at the CND Intersessional Meeting, 24 June 2019.   By introducing the new term ‘pharmaceutical preparations’ (a term not used in the treaties, the schedules or the Commentaries) and by only referring to examples with registered trademarks, the exemptions only seem to be meant for certain products of the pharmaceutical industry. Replying to Member States’ questions, the WHO offered a broader interpretation: “Based on conventional usage of the term, pharmaceutical preparations are those that are used for defined medical purposes and therefore that are in dosage forms appropriate for such medical use. These pharmaceutical preparations encompass the ones requiring pre-market approval and the ones produced extemporaneously according to a prescription and to agreed good manufacturing practices.” Additionally, in an attempt to preserve some flexibility for Member States, the WHO explained that it “was considered that individual Member States will have their own criteria for assessing whether a product is for medical use and as addressed in their national legislation” (E/CN.7/2020/CRP.4, WHO, p. 76).   This broader interpretation would include the customized compounded prescription medications that are tailor-made for patients by a pharmacist (‘magistral formulas’) including those compounded directly from herbal cannabis, an established practice in countries such as Germany and Colombia. However, confusion still prevails about how to interpret the wording of recommendation 5.6, and many countries have asked for further clarification, to allow for development of a better common understanding of its meaning and implications. For example, one of the crucial control measures from which Schedule III preparations are exempted, according to the 1961 Convention (Article 2), is the requirement of “medical prescriptions for the supply or dispensation of drugs to individuals” (Article 30-2). In this context limiting the proposed exemption to medications “produced extemporaneously according to a prescription” appears confused and contradictory. The restrictions imposed by the proposed wording of 5.6 seem to exclude more traditional cannabis-based medicines, an important issue for many countries in Africa, the Caribbean and Asia. Would the new legislation allowing traditional medical cannabis practices in Thailand, for example, be legitimate under the international control regime if these WHO cannabis recommendations were to be adopted? To what extent does the current package of cannabis recommendations reflect the renewed importance the WHO is giving to promoting traditional medicines in the WHO Traditional Medicine Strategy 2014–2023?    If the ECDD is not willing to revisit the recommendation and to consider a less restrictive wording, Member States considering voting in favour of its adoption—and especially those countries where traditional medicinal cannabis practices are widespread—may wish  to accompany a positive vote with an interpretive statement to put on record a broader interpretation of the recommendation than the WHO has thus far provided. Even more worrisome is the scenario in which the transfer of THC to 1961 is adopted, but the proposed inclusion in Schedule III to facilitate certain exemptions is rejected. This scenario is actually quite likely because—as explained above—there are legitimate concerns about its current restrictive wording. The consequence would be that any medicine containing THC (including Sativex, Marinol and Syndros) would have to be treated with the same strict control requirements currently in place for morphine. Individual countries would not have the option to apply less strict national controls, as many countries with medical cannabis legislation currently have for such preparations. Despite the intention of the WHO clearly being to off-set the potential negative impact of the recommended transfer of THC from the 1971 to the 1961 Convention, no conditionality is mentioned between the transfer and recommendation 5.6, even though accepting the one without the other could have significant negative consequences for access to medical cannabis preparations.    5) Consequences for cannabis leaves and hemp cultivation   Another fundamental distinction in the control logic of the 1961 and 1971 treaties is the completely different treatment of plant source material versus isolated active compounds. Plants and cultivation were deliberately kept out of the control regime of the 1971 Convention. For example, cathine and cathinone are included in the 1971 schedules, but there is no mention of the khat plant containing those alkaloids; the same with mescaline and peyote cactus, or psilocybin and mushrooms. In fact, when discussing the option to place THC under control of the 1971 Convention, one of the arguments used by the UK delegation was to keep plants and cultivation out of the 1971 Convention altogether, because otherwise cannabis cultivation would be controlled under both treaties.   The 1961 Convention, conversely, was based on the premise that the raw plant materials were the precursors for the principal narcotic substances brought under its control and therefore needed to be placed under the same level of control as their extracted psychoactive compounds. Hence the irrationality of equally strict treatment of the coca leaf and cocaine (strongly contested by Bolivia), or opium and morphine/heroin, and hence the need for special exemptions for poppy and cannabis seeds, or the cultivation of the coca leaf for a flavouring agent (Coca Cola®). During the drafting of the 1961 convention the principal active compound of cannabis was not yet unambiguously identified (though THC was discussed), and therefore the more generic ‘extracts and tinctures’ of cannabis was included in the schedules instead, and special exemptions were made for the cultivation of cannabis for industrial and horticultural purposes.    In this context, it is still not fully clear what it means for the plants and its various active compounds to now transfer THC from the 1971 Convention to the more stringent control logic of the 1961 Convention. For example, during the 1961 treaty negotiations India lobbied hard to keep cannabis leaves out of the definition of the ‘flowering or fruiting tops’ of cannabis as the parts of the plant brought under control of the treaty, so that they would not be obligated to crack down on the widespread bhang culture, a drink made from the cannabis leaves, a cultural practice still legal in several Indian states today. But the leaves do contain THC—albeit in much smaller amounts compared to the ‘flowering or fruiting tops’—raising the question of what the addition of THC to Schedule I of the 1961 Convention would mean for the control of cannabis leaves.    Similar controversies have arisen around the cultivation of cannabis for industrial purposes or hemp cultivation for the extraction of CBD. Several jurisdictions have exempted certain ‘hemp’ varieties of the cannabis plant with low THC content from drug control altogether. The U.S. Hemp Bill, for example, operates on the basis of the ‘source rule’, which means that anything derived from a legal source (in this case hemp with <0.3% of THC) is considered legal: the source of the material dictates its legality.    The Single Convention, however, contrary to popular misconceptions in this regard, does not make any distinctions between ‘cannabis’ and ‘hemp’ varieties of the cannabis plant. The special provision under Article 28, paragraph 2, that “This Convention shall not apply to the cultivation of the cannabis plant exclusively for industrial purposes (fibre and seed) or horticultural purposes”, is not based on any exemption for ‘hemp’. The only thing that legally matters in terms of the treaty is the purpose for which cannabis is cultivated, no matter which variety is grown. As the 1961 Commentary about the special provision on cannabis cultivation spells out, “this régime applies only to the cultivation of the cannabis plant for the production of cannabis and cannabis resin. Cultivation of the plant for any other purpose, and not only for the purposes mentioned in paragraph 2, is consequently exempted from the control régime”.    So again, what would the transfer of THC to Schedule I of the Single Convention in this context mean for the control of cannabis cultivation, if the percentage of THC content is irrelevant according to the control logic of the treaty? Is there a risk that it jeopardizes the legal justification for ‘source rule’-based national legislation such as the U.S. Hemp Bill or the Swiss allowance on the market of low-THC cannabis products (<1%) derived from hemp? The questionable treaty interpretation of the INCB—an interpretation apparently now also followed by the European Commission—is a troubling sign in this regard. The INCB Secretariat claims in its June 15th 2020 paper “Analysis of the impact of the WHO recommendations on cannabis and cannabis-related products on the control requirements of the international drug control system” that:    “The cultivation of cannabis for the extraction of CBD would need to be monitored under the provisions of the 1961 Convention because it does not meet the definition of “industrial purposes” (fibre and seed) of article 28 paragraph 2. Also, cannabis cultivated for the extraction of CBD would have some delta-9-THC content, however small, and this would have to be controlled in accordance with its scheduling. What happens to the delta-9-THC needs to be accounted for and reported to the INCB.” (p. 7)   In the paper, the INCB also claims that treaty requirements include “the cultivation of cannabis plant rich in CBD and the use of the leaves if delta-9-THC is present” (p. 8) and that “National legislation and regulations for the cultivation of cannabis would need to be reviewed and changed in order to differentiate cultivation for the extraction of CBD and or delta-9-THC and for industrial purposes as described in the 1961 Convention” (p. 10). This narrow treaty interpretation of the INCB needs to be contested, otherwise the least countries can expect is more criticism and scrutiny from the INCB of their national policies on these issues.   6) Procedural concerns about the transfer and the voting   The only precedent for a discussion about the transfer of a substance from the 1971 to the 1961 Convention was the WHO review of buprenorphine in 2006, an opiate in Schedule III of the 1971 Convention that is much used in opioid substitution therapy—similar to methadone which is placed in Schedule I of the 1961 Convention—and that is also included in the WHO List of Essential Medicines. The ECDD’s 34th report mentioned in 2006 that additional documents presented to the Committee “dealt primarily with the possible effects of rescheduling buprenorphine from the 1971 Convention to the 1961 Convention”, that “there were divergent views on the legal situation related to the transfer of substances between Conventions”, and that the majority of its members considered “that the Expert Committee on Drug Dependence is not properly constituted to discuss legal issues related to international treaties”:   “The Committee was informed that this question had been discussed during the 115th meeting of the WHO Executive Board. It was indicated during the discussion that the transfer of substances from one convention to the other would result in problems with implementation of the conventions in national laws. A concern was expressed that transfer could consequently give rise to rescheduling at the national level, which would have the unintended effect of restricting access to buprenorphine for use in opioid agonist therapy. Of the 56 countries that responded to the WHO questionnaire, 14 stated that such a rescheduling would result in impeded access to treatment.” (p. 7)   As a result, the ECDD decided not to recommend any change in the scheduling of buprenorphine. Interestingly, at the very same meeting, the ECDD also discussed the outcomes of its updated critical review of dronabinol/THC, recommending that it “should be rescheduled from Schedule II to Schedule III of the 1971 Convention”, without even mentioning the option of a transfer to the 1961 Convention. More generally, the ECDD did draw attention to the fact that the existing guidelines “do not give guidance on the transfer of a substance from the 1961 to the 1971 Convention or vice versa”:     “A transfer of a substance from one Convention to the other would demand that the United Nations Commission on Narcotic Drugs take a simultaneous decision on deletion of a substance from one Convention and adding it to the appropriate schedule of another Convention. A procedure for making a deletion from the schedules of the 1971 Convention is included in article 2 para. 6 of the Convention and requires a new assessment by WHO. A similar provision is included in the 1961 Convention article 3 para. 6(b). No provision is included, however, to indicate that these decisions are to be taken simultaneously.” (p. 7)   The Guidance on the WHO review of psychoactive substances for international control was subsequently updated in 2010 and, in response to the request for more guidance on the issue, specified that:   “A recommendation to delete a substance from one Convention with a simultaneous recommendation to add the same substance to another Convention may affect administration of the international scheme of regulation. Like all recommendations, consideration of such changes in control may be undertaken in light of new information to justify such a change. Any proposal to move a substance from one convention to another should be made only if specific new control measures are necessary in order to decrease the extent or likelihood of abuse or the use of the substance in illicit drug manufacturing, and will not unduly limit availability for legitimate medical and scientific purposes.” (Paragraph 45)    Referring to this new guidance in answer to questions raised about what ‘specific new control measures’ were necessary in this case, the rationale given for the transfer of THC is based on the higher prevalence on the market of high-potency THC products; “Those with the highest concentration are butane hash oil and propane hash oil, which may contain from 50 to 90% of the active ingredient, Δ9-THC,” according to the ECDD 41st report (p. 50). The argument then circles back to recommendation ‘5.0’ and the ‘similarity principle’:    “In derived forms of such high purity, Δ9-THC produces ill-effects, dependence and abuse potential that is at least as great as that produced by cannabis, which is placed in Schedule I of the 1961 Single Convention on Narcotic Drugs. A substance liable to similar abuse and productive of similar ill-effects to those of a substance already scheduled within the 1961 Single Convention on Narcotic Drugs would normally be scheduled in the same way as that substance. It was further recognized that cocaine, the principal active compound in coca is placed together with coca leaf in Schedule I of the 1961 Single Convention on Narcotic Drugs. Futhermore, morphine, the principal active compound in opium, is placed with opium in the same Schedule. Placing Δ9-THC, the principal active compound in cannabis, in the same Schedule as cannabis would be consistent with this approach.” (p. 46)   No reference is made to the other criteria mentioned in the updated Guidance (no doubt added on the basis of the buprenorphine precedent), that any proposal to move a substance from one convention to another should be made only if it “will not unduly limit availability for legitimate medical and scientific purposes”. No alternative options have been presented that might have more effectively addressed the main concern expressed by the ECDD regarding high-potency THC products without unduly limiting access to cannabis-based medicines (either pharmaceutical preparations or traditional medicines). For example, instead of introducing new categories in the form of the footnote  (a maximum THC threshold for CBD products) or exemptions for ill-defined ‘pharmaceutical preparations’, why not propose a new category for such high-potency THC products (for example >50%) for Schedule I, and move other cannabis-related substances to Schedule II of the 1961 Convention? At the very least, the ECDD could usefully have made more explicit the conditionalities between the different recommendations in order to reduce the risk that certain combinations of voting outcomes would actually reduce access to cannabis-based medicines—something we can reasonably assume to be the opposite of their intention.