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UN Commission on Narcotic Drugs Memo - Changes in the scope of international control of medical Cannabis and cannabinoids

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Memo for State Parties. Changes in the scope of international control of medical Cannabis and cannabinoids. 4th inter-sessional meeting, 62nd Commission on Narcotic Drugs, June 24th, 2019.
Memo
Changes in the scope of international control
of medical Cannabis and cannabinoids.
4th intersessional meeting | 62nd Commission on Narcotic Drugs | June 24th, 2019
Authors: Kenzi Riboulet-Zemouli (kenzi@zemou.li) and Michael Krawitz (miguet@november.org).
Background.
An international consensus reaffirmed in the outcome document of the 2016 special
session of the UN General Assembly on the world drug problem (UNGASS 2016) and in the
March 2019 Ministerial Declaration recognizes the numerous public health dimensions of
the world drug problem, as well as its centrality in the international drug control system.
Balanced and scientific evidence-based policies are also recognized as keystone to drug   
control measures that efficiently address these public health-concerns.
In the context of the access to, and availability of controlled drugs for medical purposes (a
major goal of the 1961 and 1971 treaties, even present in their respective preambula), there
is no doubt that “Addressing the discrepancy in the availability of narcotic drugs and     
psychotropic substances for medical and scientific purposes is one of the obligations of
Governments in complying with the international drug control conventions” (Werner Sipp,   
former President of the International Narcotics Control Board, Special Report: Availability of    
Internationally Controlled Drugs: Ensuring Adequate Access for Medical and Scientific
Purpose, INCB 2015), and the 1961 Convention is clear that “‘Drug’ means any of the
substances in Schedules I and II” (1961 Convention, Article 1(1)j). It is therefore undoubtedly  
that, already today, the Convention obliges countries to ensure the availability of Cannabis,  
cannabis resin, as well as extracts and tinctures of cannabis for medical and scientific
purposes.
In the UNGASS 2016 outcome document, the international community expressed deep
concern regarding the “low or nonexistent” availability of internationally controlled drugs for
medical purposes (UNGASS 2016 outcome document, Preamble, Paragraph 5), and made a    
“strong commitment to improving access” (ibid., Item 2, Introductory Paragraph). As
proposed way forward, the outcome document called for “informed and coordinated    
scheduling decisions” (ibid., Paragraph 2(g)) while reaffirming the treaty-mandated role of    
the World Health Organization (ibid., Preamble, Paragraph 16).
In the 2019 Ministerial Declaration, the international community committed “to
strengthening the work of the Commission on Narcotic Drugs with the World Health   
Organization [...] to continue to facilitate informed scheduling decisions on the most      
persistent, prevalent and harmful substances [...] while ensuring their availability for medical
and scientific purposes”. Keeping balance restrictions aimed at minimizing abuse, and  
regulations aimed at ensuring availability, is hard, and is subject to variability depending on
specific contexts. The Conventions established via the World Health Organization (WHO) an
independent assessment system with this specific purpose of arbitrating complex  
scheduling decisions.
The WHO is mandated under the drug control Conventions to “find” if a “substance is liable
to [...] abuse and productive of [...] ill effects [...] or is convertible into a drug” (1961    
Convention, Article 3(3)iii) The whole process of placement or changes in the scope of
control of a drug relies on this mandate given to the WHO. Within WHO, it is an independent
Expert Committee on Drug Dependence (ECDD) which is tasked with the very assessments,
defined as “grounded in considerations of public health and with the best evidence-based
approach” and aimed at “develop[ping] scheduling recommendations guided by […] the need
to reduce the risk to public health, including the risk of abuse and ensuring medical
availability” (Guidance on the WHO review of psychoactive substances for international  
control, WHO Geneva 2010).
Understanding the outcome.
65 years ago, the last time an opinion was expressed by the WHO Expert Committee about
medical cannabis, the conclusion was that “there should be extension of the effort towards
the abolition of cannabis from all legitimate medical practice” (WHO, Expert Committee on    
Drugs Liable to produce Addiction, Fifth Report. Technical Report Series No 95. WHO, Geneva,    
1954). This year’s results are the first milestone since 1954, and present an important
number of new approaches, that can be summarized as follows:
- The potential for medical applications is acknowledged, and the legitimacy of cannabis in    
medical practice is recognized;
-International law is simplified and made considerably clearer;
- All cannabis products and substances are placed at the same level of control, harmonizing    
cannabis with common practice applying to the scheduling of coca and opium derivatives
in the 1961 Convention;
-Sovereignty of Member States is preserved through flexibility of criteria when choosing    
which medicinal preparations should be controlled under Schedule I policies, and which
should be controlled under the lighter subset of obligations provided by Schedule III. The
outcome only specifies that the preparations which “[contain]
delta-9-tetrahydrocannabinol”, be “compounded as pharmaceutical preparations with one
or more other ingredients” and prepared “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”. This definition can be understood narrowly as referring
only to the type of preparations such as Nabiximols (Sativex®) as approved by the national
clinical trials assessment system, but can also be understood as referring to various
regulated Cannabis products (for instance as herbal medicines or phytotherapeutical
materials);
- Countries are encouraged, but not obliged, to provide access to an increased variety of        
medicinal formulations. This non-obligation is central in the ECDD recommendation as well
as constituting a core principle of the 3 Conventions contemplating the possibility for State      
Parties to “adopt more strict or severe measures of control than those provided” if in their       
opinion “such measures are desirable or necessary for the protection of the public health
and welfare” (1971 Convention, Article 23). In the 1961 Convention, Article 39 even  
explicitely states that “a Party shall not be, or be deemed to be, precluded [...] from
requiring that preparations in Schedule III [...] be subject to all or such of the measures of
control applicable to drugs in Schedule I as in its opinion is necessary or desirable for the  
protection of the public health or welfare”;
- Notice the core controls over the production and manufacture of the Cannabis plant    
(Articles 22, 23 and 28 of the 1961 Convention) are not affected by these    
recommendations;
- The Experts refused to introduce an artificial distinction between cannabinoids produced    
in laboratory (synthetic cannabinoids) and those derived from the plant  
(phytocannabinoids). They declare that “there is no difference between the therapeutic
effects or adverse effects of synthetic Δ9-THC and Δ9-THC produced from cannabis” – a
chemical indistinguishability which is also true for Cannabidiol and other compounds. Such
a stance avoids embedding inconsistency into policy that would make it impossible to
enforce. 
Mandates.
Article 3(3)iii of the 1961 Convention mandates the CND to take its scheduling decisions “in
accordance with the recommendation of the World Health Organization” and the 1971      
Convention adds that “assessments [from WHO] shall be determinative as to medical and
scientific matters” (1971 Convention, Article 2(5)). The overall role of WHO’s mandate is to    
ensure that the placement of drugs in a particular Schedule is grounded in considerations
of public health and utilizes the highest standards of contemporary scientific information
available. It is also there to bring a tangible and objective analysis of the issue and to advise,
from the perspective of science, decision-making.
The methodology and framework to implement this mandate is detailed in an internal
procedure regularly updated by the Executive Board of WHO (Guidance).
Ten years ago in 2009, the Commission on Narcotic Drugs asked for “an updated report on
cannabis by the Expert Committee” (CND Resolution 52/5). This constituted a direct  
mandate for the WHO to beginning the review process of cannabis.
In 2014, in its annual report, the INCB “invite[d] WHO, in view of its mandate under the 1961
Convention, to evaluate the potential medical utility of cannabis and the extent to which
cannabis poses dangers to human health” (INCB, Report for 2013, Chapter IV. INCB 2014).    
According to the WHO procedure (Guidance, §15(3)) this constituted a second direct    
mandate for beginning a review.
In 2015, during the 37th meeting of the ECDD, the Experts “requested the Secretariat to begin        
collecting data towards a pre-review of cannabis, cannabis resin, extracts and tincture of
cannabis at a future meeting.'' This constituted a third direct mandate for beginning a review    
(see Guidance, §15(2)).
In May 2016, a Party to the Conventions declared that “WHO should urgently consider
rescheduling cannabis and products derived from it” during the 69th World Health Assembly
(WHO, Sixty-ninth World Health Assembly, Summary Records of Committees, Committee A  
thirteenth meeting, Agenda Item 12.6. P. 248). This was the fourth direct mandate received.
In October 2016, a Non-State Actor in official relation with the WHO (in addition to hundreds
of scholars from all continents) requested the leadership of WHO to start the process of
assessing cannabis. This constituted a fifth direct mandate for beginning a review    
(Guidance, §15(3)).
Even after the process had started, a sixth call appeared in the 2018 report from the      
Caribbean Community (CARICOM) Secretariat that considered of importance “the status of
cannabis in the international arena” described as presenting “a significant obstacle in
effecting change to the legal regime on cannabis given its classification [...] under
international instruments.” The report concluded that “the Commission is unanimous in its
view that the current classification for [...] should be changed.”
The CND as a whole, Parties to the Conventions individually, regional groups of Countries,
the INCB, NGOs in consultative status, as well as a worldwide range of scholars have been
asking for this review for a decade now. But the WHO did not answer these mandates earlier,
arguing that “so far, material to formally review the status of Cannabis as a scheduled
substance [was] insufficient”. In this context, the start of the process in 2016 can hardly be    
considered as an initiative of the WHO but is rather clearly on the one hand a global and    
multisectorial ask, and on the other hand a lawful mandate for updating the basis of    
knowledge on cannabis globally.
... The same goes with molecules structurally identical to naturally occurring phytocannabinoids such as dronabinol or cannabidiol (CBD is the INN of (-)-CBD, whether natural or synthetic) that are designed in vitro without involving initial plant material (Adam Ametovski and Lupton, 2019; Mechoulam and Gaoni, 1965;Petrzilka et al., 1967;Razdan et al., 1974;Trost and Dogra, 2007). Analytically indistinguishable, fully synthesised in vitro phytocannabinoids and naturally obtained in vivo phytocannabinoids were not distinguished by the ECDD which considers them in all points pharmacologically identical (ECDD, 2019: 54-55; Riboulet-Zemouli and Krawitz, 2019). ...
Article
Full-text available
Objective: Identify a coherent nomenclature of products containing cannabinoids (whether derived from Cannabis sativa L. or not). Design: Research undertaken in parallel to the three-year assessment of Cannabis derivatives by the World Health Organisation. The scope is limited to Cannabis products intended for human incorporation (internal and topical con- sumption). Primarily embedded in pharmacognosy, the study incorporates a wide range of scholarly and grey literature, folk knowledge, archives, pharmacopœias, international law, field pharmacy, clinical and herbal medicine data, under a philosophical scrutiny. Generic and Cannabis-specific nomenclatural frames are compared to determine the extent to which they coincide or conflict. Results: All lexica reviewed use weak, ambiguous, or inconsistent terms. There is insufficient scientific basis for terms and concepts related to Cannabis at all levels. No sound classification exists: current models conflict by adopting idiosyncratic, partial, outdated, or utilitarian schemes to arrange the extraordinarily numerous and diverse derivatives of the C. sativa plant. In law and policy, no clear or unequivocal boundary between herbal and non-herbal drugs, nor natural and synthetic cannabinoids was found; current nomenclatures used need updates. In science, the botanical Cannabis lexicon overlooks parthenocarpy, and wide disagreement remains as to the taxonomy and systematics of the plant; chemical research should address differences in kinds between synthetic cannabinoids; pharmacopœias include little information related to Cannabis, and disagree on broader classes of herbal medicines, virtually failing to embrace many known Cannabis medicines. Since existing products and compounds fail to be categorised in an evidence-based manner, confusions will likely increase as novel cannabinoid compounds, genetic and biotechnological modifications surge. Conclusions: The lack of clarity is comprehensive: for patients, physicians, and regulators. The study proposes an update of terms at several levels. It points at gaps in morphological descriptions in botany and pharmacognosy and a need for a metaphysical address of cannabinoids. Methods of obtention are identified as a common criterion to distinguish products; the way forward suggests a mutually exclusive nomenclatural pattern based on the smallest common denominator of obtention methods. In the context of a swelling number of Cannabis products being consumed (be it via medical prescription, adult-use, ‘hemp’ foodstuff and cosmetics, or other purposes), this study can assist research, contribute to transparent labelling of products, consumer safety and awareness, pharmacovigilance, medical standards of care, and an update of prevention and harm reduction approaches. It can also better inform regulatory policies surrounding C. sativa, its derivatives, and other cannabinoid-containing products. Original article available at: https://journals.sagepub.com/doi/full/10.1177/2050324520945797
Article
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To read the accepted manuscript, go to: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4055389 ––– Background: “Cannabis” and “cannabis resin” are derived from the Cannabis plant, used as herbal medications, in traditional medicine and as active pharmaceutical ingredients. Since 1961, they have been listed in Schedule IV, the most restrictive category of the single convention on narcotic drugs. The process to scientifically review and reschedule them was launched by the World Health Organisation (WHO) on 2 December 2016; it survived a number of hindrances until finally being submitted to a delayed and sui generis vote by the UN Commission on Narcotic Drugs on 2 December 2020, withdrawing “cannabis” and “cannabis resin” from Schedule IV. | Design/methodology/approach: To evaluate WHO’s scheduling recommendations, the process leading to the Commission vote and subsequent implications at global, national and patient/clinician levels. Narrative account of the four-year proceedings; review of the practical implications of both rejected and accepted recommendations. | Findings: The process was historically unprecedented, of political relevance to both medical Cannabis and evidence-based scheduling generally. Procedural barriers hampered the appropriate involvement of civil society stakeholders. The landscape resulting from accepted and rejected recommendations allow countries to continue creating decentralised, non-uniform systems for access to and availability of “cannabis” and “cannabis resin” for medical purposes. | Originality/value: Perspective of accredited observers; highlight of institutional issues and the lay of the land; contrast of stakeholders’ interpretations and engagement.
Technical Report
Full-text available
On 21 April 2021, the herbal medicines “cannabis” and “cannabis resin” definitively ceased to appear in Schedule IV of the 1961 Single Convention on narcotic drugs (C61), where they had been listed since the entry into force of that treaty in 1964. The process to scientifically review and reschedule Cannabis-related controlled drugs had been launched by the World Health Organization (WHO) on 2 December 2016 and went through a number of hindrances until it finally got submitted to a unique voting process on 2 December 2020 at the United Nations Commission on narcotic drugs (CND). This report reviews the scientific assessments of Cannabis-related controlled drugs and cannabidiol (CBD) by the WHO’s Expert Committee on Drug Dependence (ECDD) and subsequent political discussions at CND that culminated with the 2 December 2020 vote, changing the scheduling of “cannabis” and “cannabis resin” under the C61. A digest of the four years of proceedings (2015-2021) is presented, showcasing elements that provide an understanding about the length and complexity of the processes involved. The report introduces previously-unpublished minutes, complements of information, details on stakeholders and their role, and highlights a number of bureaucratic and diplomatic issues; it compares the efforts undertaken by WHO and CND in terms of method, transparency, and involvement (or not) of interested parties, beyond governments. [ Suggested citation: Riboulet-Zemouli, K., Krawitz, M.A., and Ghehiouèche, F. (2021). History, science, and politics of international cannabis scheduling, 2015–2021. Vienna: FAAAT editions. ISBN: 979-10-97087-50-0 ]
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