23 June 2020 – Martin Jelsma (TNI)
The WHO Expert Committee on Drug Dependence (ECDD) released in January 2019 the outcomes of the critical review of cannabis, recommending a series of changes in the scheduling of cannabis-related substances under the UN drug control conventions. The 1961 Single Convention on Narcotic Drugs placed cannabis and resin (hashish) in its strictest schedules I and IV (the latter reserved for narcotic drugs with ‘particularly dangerous properties’ and little or no therapeutic value) and cannabis ‘extracts and tictures’ in Schedule I. Bringing cannabis under the strict controls of the Single Convention has been controversial from the start, driven in the 1950s by a colonial and racist bias –including by the WHO secretariat at the time- and the decision was made without any proper scientific assessment. A decade later, also on dubious grounds, a number of tetrahydrocannabinol substances, including dronabinol or delta-9-THC (the main psychoactive compound of cannabis) were included in the strictest Schedule I of the 1971 Convention on Psychotropic Substances. Since then, the WHO Expert Committee on Drug Dependence (ECDD) has recommended several times to ease international control of delta-9-THC by downgrading it to the less strict schedules II, III or even IV of the 1971 Convention, where it currently resides in Schedule II. Questioning the classification of cannabis itself alongside cocaine and heroin under the 1961 Convention, however, was considered politically too sensitive, so this is the first-ever WHO review of the scheduling of cannabis itself.
The CND decided in March to postpone the vote on all WHO cannabis recommendations to the reconvened session in December 2020 and to continue its considerations this year ‘in order to clarify the implications and consequences of, as well as the reasoning for, these recommendations’. Three ‘topical meetings’ to discuss ‘economic, social, legal, administrative and other factors’ are scheduled for 24-25 June (focused on cannabis extracts and CBD), 24-25 August (focused on transferring control of THC preparations from the 1971 to the 1961 Convention), and 16-17 September (focused on deletion of cannabis from Schedule IV while keeping it in Schedule I).
Recommendations 5.1 (deletion from Schedule IV) and 5.4 (delete ‘extracts and tinctures’ from Schedule I), are merely meant to recognize the medicinal value of cannabis and to clarify that CBD is not under international control by removing an outdated term. Those two recommendations can be approved by a simple majority of CND Member States present at the time of voting. However, with regard to the other recommendations there are still valid reasons for further deliberations and to question their reasoning, wording and implications, without undermining the WHO-ECDD mandate which is determinative with regard to medical and scientific matters. Changes in the schedules of the 1971 Convention require a two-third majority, a minimum of 36 of the total of 53 CND Member States.
The main arguments are:
1) The WHO decision not to recommend deleting cannabis from Schedule I of the 1961 Convention as well (but only from Schedule IV), is questionable and seems to have been influenced by political considerations that it would trigger too much controversy and would never pass a CND majority vote. The ECDD assessment that it ‘did not consider that cannabis is associated with the same level of risk to health as that posed by most of the other drugs placed in Schedule I’, however, seems to support a recommendation to move it to the lighter Schedule II. The main reason the ECDD gives to keep cannabis in Schedule I is that ‘it noted the high rates of public health problems arising from cannabis use and the global extent of such problems’. ‘High rates’ or the ‘global extent’ of cannabis-related health problems, however, are not a sufficient criterion for the similarity principle, the basic threshold test for recommending whether cannabis should be placed in Schedule I (e.g., on a par with morphine and cocaine) or II (e.g., on a par with codeine). ‘Substances which are comparatively less dangerous and widely used in medical practice may therefore often be proposed for inclusion in Schedule II’, according to the Commentary on the Single Convention (p. 90). A major difference is that Schedule II leaves more discretion to Parties to decide about prescription requirements for the drugs included in the schedule and their preparations. Moving cannabis from Schedule I to II would thus allow more policy options to regulate and improve access to cannabis-based traditional and herbal medicines, something actively promoted in the WHO Traditional Medicine Strategy 2014–2023 for other types of herbal medicines. WHO Director-General, Dr Margaret Chan, stated in 2013 that ‘traditional medicines, of proven quality, safety, and efficacy, contribute to the goal of ensuring that all people have access to care. For many millions of people, herbal medicines, traditional treatments, and traditional practitioners are the main source of health care, and sometimes the only source of care. This is care that is close to homes, accessible and affordable. It is also culturally acceptable and trusted by large numbers of people. The affordability of most traditional medicines makes them all the more attractive at a time of soaring health-care costs and nearly universal austerity.’ This definitely also applies to the widespread traditional medicinal cannabis practices across Asia and Africa.
2) The decision to keep cannabis in Schedule I also influences the proposed transfer of THCs from the 1971 to the 1961 Convention (recommendations 5.2 and 5.3). Because cannabis remains in Schedule I, argues the ECDD, dronabinol (delta-9-THC) has to be added to the same schedule. This risks reducing the flexibility of Member States to adjust their policies on medical cannabis preparations to domestic circumstances and could negatively affect certain practices currently in place in a number of countries. Those practices have developed based on the previous WHO recommendation to de-schedule dronabinol (delta-9-THC) within the 1971 treaty from Schedule I to II, which was adopted by a two-third majority of the CND in 1991. Subsequently the ECDD recommended to de-schedule it even further down to Schedule IV (in 2002, not passed on to CND) or III (first in 2006, with no action taken by the CND at all, and again in 2012, rejected by vote in 2014). Accepting the previous WHO recommendations for Schedule III or IV would have meant that medical prescriptions would no longer have been obligatory. Moving delta-9-THC to Schedule I of the 1961 Convention now would in fact mean stricter control and more stringent reporting obligations to the INCB compared to its current placement in Schedule II of the 1971 Convention.
3) The ECDD, aware of the consequences of moving THC to Schedule I of the 1961 Convention, intends to address the issue with recommendation 5.6, to add certain THC preparations ‘compounded as pharmaceutical preparations … in such a way that delta-9-tetrahydrocannabinol (dronabinol) cannot be recovered by readily available means’ to Schedule III of the 1961 Convention, granting them exemption from several control measures required for Schedule I, including the requirement of medical prescription. Questions have been raised about the wording ‘pharmaceutical preparations’, introducing a term which does not appear anywhere in the conventions. Combined with the examples mentioned in the ECDD report, the wording used could easily be read to only refer to ‘preparations like Sativex and Marinol produced by the pharmaceutical industry’, and to exclude the wide array of herbal cannabis preparations with similar medicinal properties. In answers from Member States, the WHO did clarify that 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’ (written answer by WHO, circulated on 2 July 2019). And that the ‘limitation to “pharmaceutical” preparations is meant to ensure that only preparations with an acceptable public health risk-profile would enjoy the flexibility of Schedule III’ (written answer by WHO, circulated on 4 October 2019). Still, the confusion could relatively easily be resolved by another wording of the recommendation, avoiding a term that is not used in the conventions.
4) When asked whether this recommendation for Schedule III depended on the adoption of the proposed transfer of THC from the 1971 to the 1961 Convention, the WHO denied the existence of any conditionality, answering that it ‘is still relevant if the recommendation to move dronabinol (delta-9-THC) to the 1961 Convention is not supported, as the medications may contain dronabinol derived from the cannabis plant and therefore qualify as preparations of cannabis.’This would seem to increase rather than resolve the confusion about whether THC preparations are controlled under the 1961 or 1971 Convention, one of the main arguments for the proposed transfer. Moreover, the consequence of a scenario in which the transfer of THC to 1961 is adopted, but the inclusion in Schedule III of certain ‘pharmaceutical preparations’ is rejected, would be that any medicine with THC (including Sativex, Marinol and Syndros) would have to be treated with the same strict control requirements currently in place for morphine.
5) In the previous case where a transfer from one Convention to the other was considered, namely to move buprenorphine from 1971 to 1961, there was an equally strong argument that it would in principle improve the consistency of the treaty system, given the fact that buprenorphine is an opiate and would therefore better be placed alongside other opioids under the 1961 Convention. However, the argument was made (by France, among other MS) that moving it now to 1961 would negatively impact on access and availability. The ECDD therefore advised to keep it in 1971, a position supported by the WHO’s Office of the Legal Council on the basis of the legal principle of Lex posterior supra lex anterior. A convincing explanation for the inconsistencies between these and previous ECDD recommendations on dronabinol itself and on buprenorphine, has not yet been provided.
6) While negotiating the 1971 Convention, the drafters were well aware that cannabis was already controlled under the Single Convention and that delta-9-THC was its main psychoactive compound. Still a conscious decision was made to add THC to the new treaty. An attempt to resolve the resulting ambiguities between the two treaties, based on the Lex posterior principle, should therefore first consider whether it can be resolved within the most recent treaty. That would have led to a completely different –and in many ways preferable- picture. The 1971 Convention deliberately did not place plants under international control, only their extracted alkaloids. Clear examples are the khat plant, ‘magic’ mushrooms or ayahuasca: only their respective psychoactive compounds cathinone/cathine, psilocybine and DMT are placed under control of the 1971 Convention. Dealing with cannabis-related substances under the regime of the 1971 Convention could have avoided many of the structural problems encountered by placing it under the Single Convention, including the condemnation of centuries-old cultural traditions and the prohibition of ceremonial uses in the Rastafari and certain Islam and Hindu religions.
7) In the answers to previous questions raised, the WHO consistently refers to the ‘relatively new phenomenon’ of high potent butane hash oil as the main justification for transferring THC to the Single Convention. For the ECDD these high-THC substances appear to have been their main concern regarding the potential harmfulness of cannabis-related substances, their principal justification for the transfer of THCs from 1971 to Schedule I of the 1961 Convention, and ultimately for keeping cannabis and resin in Schedule I as well. An important question to raise is whether other possible solutions have been considered by the ECDD to address their single foremost cannabis-related health concern. For example, to introduce somehow a category of such high-THC preparations that would remain in Schedule I, allowing ‘cannabis and cannabis resin’ to be moved to Schedule II.
8) Many questions have been raised about recommendation 5.5 to add a footnote to Schedule I of the 1961 Convention that establishes that CBD preparations with less than 0.2 per cent of THC are not under international control. The need to include a specific threshold and the choice for 0.2 per cent has been subject to questioning by several member states. In the answers, regular references are made to the precedent of a similar footnote about dextromethorphan and dextrorphan. In those cases, however, the footnote simply states that those substances ‘are not under international control’ without mentioning any percentage. Apparently, that was originally the idea from the ECDD for CBD as well: the 0.2 per cent was only inserted after receiving ‘requests from Member States to indicate what maximum percentage was considered appropriate and to ensure that the currently registered CBD medication was exempted from control’ (written answers by WHO circulated on 30 July 2019). The medication referred to, Epidiolex, the brand name of the first CBD medicine approved by the FDA in the U.S. in 2018, contains <0.15 per cent residual THC. That was taken as the standard, while ‘the Expert Committee recognised the difficulty in measurement to this high degree of accuracy (0.15%) and therefore adopted 0.2% as a more reliable measure that would allow Member States to control’. The confusion only increased when the WHO further clarified that ‘it is important to specify the delta-9-THC content relative to the entire plant content by weight which includes CBD and other cannabis compounds’ (written answer by WHO circulated on 30 July 2019), even though that is not made explicit in the wording of the footnote. Many other Member States, however, are already allowing CBD products, including whole-plant hemp extracts, on their markets using higher THC thresholds of 0.3 up to 1 per cent. In the case of the ‘pharmaceutical preparations’ in Schedule III the WHO considered that ‘Member States could make their own specifications as to permitted delta-9-THC dosage levels’ (written answer by WHO, circulated on 4 October 2019). Why not leave the same discretion to Member States in the case of CBD preparations and simply add a footnote –similar to dextromethorphan and dextrorphan- saying that ‘cannabidiol (CBD) is not under international control’?
9) The conditionalities of the recommendations are not sufficiently spelled out. The only explicit conditionality mentioned in the recommendations, is that the deletion of THC from the 1971 schedules is subject to the CND’s adoption of the recommendation to add them to Schedule I of the 1961 Convention. The argument used, based on the WHO guidance, is that ‘to facilitate efficient administration of the international control system, it is not advisable to place a substance under more than one Convention’. That argument, however, works equally in the other direction: the vote to adopt the inclusion in 1961 therefore needs to be subject to the deletion from 1971 as well, even though this is not spelled out in the WHO recommendations. But it is also questionable whether recommendations 5.5 (the footnote) and 5.6 ('pharmaceutical preparations') could be implemented in case the transfer of THC from the 1971 to the 1961 Convention would not be adopted. Certain combinations of voting outcomes could result in a situation that would clearly contravene the intention of the WHO. Especially the risk of THC preparations being controlled by both Conventions and the termination of the possibility of control exemptions for preparations would be outcomes with negative unintended consequences for the administrative system maintained by the INCB and for patients’ access to medical cannabis. These outcomes would be contrary to the aims of the WHO recommendations.
All these arguments do not in any way question the scientific assessment itself about the health risks and therapeutic usefulness of the cannabis-related substances undertaken by the WHO in the critical reviews. The upcoming 43rd ECDD meeting, scheduled for 12-16 October 2020, would provide an opportunity to address a number of the social, legal, economic and administrative concerns raised by Member States during the series of ‘topical meetings’ and to table an amended set of WHO recommendations in time for the vote at the reconvened CND session on 3-4 December that could have a better chance of adoption. This would require a specific request from Member States to the WHO to revisit some of the recommendations and add it to their agenda for the October meeting. Otherwise, it would be prudent to only approve now recommendations 5.1 and 5.4 and defer consideration of the other ones to a later date, after an updated WHO review taking into account some of the ambiguities and inconsistencies.