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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 nonexistent” 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.