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ECDD40
Procedural, methodological
and terminological bias.
Joint Civil Society Contribution to the
40th Meeting of the WHO
Expert Committee on Drug Dependence.
Geneva. May 31
st
, 2018.
Acknowledgments.
This document is an official contribution to the work of the 40th Meeting of the Expert
Committee on Drug Dependence of the World Health Organization.
It has been written between May 25th and May 29th, due to the late publishing of the pre and
Critical review report documents by the World Health Organization. Some minor errors might
have subsisted, due to the extremely limited timeline. We hope that future Meetings will make
documentation available on an earlier basis, according to established rules of proceedings.
This contribution has been endorsed by 68 civil society organizations from 29 countries in all
continents (see the full list page 30) as of May 30th.
An updated list will be made available on faaat.net/ecdd40
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Core authors.
Contributing authors.
Michael KRAWITZ.
Kenzi RIBOULET ZEMOULI.
Corresponding author:
kenzi@faaat.net
Boris BAŇAS, Ing.
Bernhard BEITZKE, Sc.D.
David BORDEN.
José-Carlos BOUSO, Ph.D.
Farid GHEHIOUÈCHE.
Amy L. KING.
Alejandra OUTOMURO, MD.
Òscar PARÉS FRANQUERO.
Jean-Jacques 'Sonny' PERSEIL, Ph.D.
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Index.
Foreword. 5
Part I
Exploring the history of Cannabis
international control. 6
Indian Hemp, Public Hygiene, and the Dangerous & Habit-Forming Drugs. 7
Part II
Criticisms of the Pre-reviews of Cannabis
and Cannabis
-related products. 12
Cannabis
& Cannabis
resin. 13
a) Bias in the scientific part of the pre-review report. 13
b) Bias arising from the data collection process. 15
c) The case of tobacco: Double standard of substance scheduling. 16
Extracts and tinctures of Cannabis
. 17
a) Bias in the scientific part of the pre-review report. 17
b) Issues of taxonomy. 19
c) Bias arising from the data collection process. 21
Delta-9-tetrahydrocannabinol. 23
Part III
Getting critical on cannabidiol. 25
Critical review of CBD: Irrelevant assessment, inexistent methodology, binding outcome. 26
General comments on cannabidiol and the relevance of a review. 26
Concluding words. 28
Abbreviations used in the document. 29
List of Civil Society organizations endorsing this contribution.30
Who are we? (About FAAAT think & do tank)30
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Foreword.
The goal of the ECDD is to issue the highest standard of evidence-based recommendations, grounded
in science, robust risk-assessment methodologies, and emerging from a broad collection of all available
data regarding a product, a plant or a substance. Its purpose is to enable a science-based
decision-making process on a major global health issue: the need to balance the decision of applying
restrictive measures of control, with the need to protect and enhance the right of everyone to the
enjoyment of Health.
Keeping in mind the high standards expected and the important consequences of the policy decisions
informed by the Committee's discussions, great care should be taken when undertaking such a crucial
series of assessments, especially about products so widely used.
Oversight, plagiarism, gross negligences, terminology issues, mistaken references, erroneous
translations, mismatched data aggregated, and in fine bias, is evident in the preparation process of the
reviews you are about to undertake. Moreover, some authors of the reports over which you will base
your assessment, have omitted or misrelated important pieces of evidence.
This contribution examines, in detail, the bias and oversights that are likely to undermine your work –
after presenting a brief historical overview of the previous WHO Expert Committee’s influence on the
placement of Cannabis
in the international Treaty system.
In light of the bias and errors pointed out in this contribution, three possible pathways forward appear:
- end the review process,
- continue the process despite ethical concerns, bias and over strong objection,
- slowdown to ensure deliberative process, comprehensiveness and thoroughness.
The last option is our preference. Our perspective is that the Expert Committee, whose role is to
systematically recommend appropriate international scheduling (which apparents to the discipline of
systematics ) would benefit from first updating the description, identification and nomenclature of all the
1
Cannabis
-related products and substances so that they match observed realities and the lege artis
scientific research. In other words, as logic suggests, the Committee should start reviewing the
taxonomy of Cannabis
-related products and substances before addressing systematics.
2
1 The discipline of Systematics
consists in establishing classification systems and hierarchical arrangement of taxa.
2 The word "taxa", plural of "taxon", refers to the discipline of Taxonomy
, which is an exercise of nomenclature and
means giving names to different clearly-defined categories, each name being a different taxon.
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Part
I.
Exploring the history of
Cannabis
international control.
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01. Historically the first international treaties and arrangements mainly concerned war and commerce.
Global health and international law intersected in the drug control system on the occasion of series of
war motivated by business issues in the trade of opium, that came up with the adoption of the first
drug control treaties (mainly about opium) in the early 1900's .
3
02. Initially created only to establish common rules for fairness in the trade of opium, the agreements
soon gravitated towards thematics of health – in that time called "hygiene" – and started to
acknowledge health outcomes in drug policies.
Indian Hemp, Public Hygiene, and the
Dangerous & Habit-Forming Drugs.
03. The Cannabis plant was genuinely included in the 1925 International Opium Convention, on the
peasant insistence of a small number of countries. The control measures then only required
countries to provide some documentation when trading internationally and to pledge to refrain from
exporting to countries that had forbidden its use .
4
04. It has been written that the League of Nations (LoN) undertook a review of Cannabis in 1935 but it
appears that this was not the case. Contrary to what has been previously written in official WHO
documents or in other indispensable research on the origins of international drug policies, the
so-called assessment of Cannabis
made in 1935 by League of Nations never took place.
05. The archives have indeed partly disappeared during the second world war (WWII) however
something happened at the Office International d'Hygiène Publique (International Office of Public
Hygiene, OIHP)
, a sui generis international body led by French and Italian Foreign Affairs
departments, to which the LoN had delegated a technical and consultative mandate on health issues.
In a meeting of their sub-Committee of Experts in Pharmacology held in Bern on 4th and 5th March
1935 (see Images 1 and 2, page 8), they reviewed 5 particular "preparations containing extract or
tincture of Indian hemp" in a preparation including other powerful compounds such as strychnine.
06. October of the same year, 1935, the LoN Health Committee noted the review (Image 3) and
recommended to countries that preparations partly made with "extracts and tinctures" of Cannabis be
subject to the same control measures as the pure "extracts and tinctures". By then only "extracts and
tinctures" were internationally controlled where the "preparations" were not. However, that
recommendation was restricted to countries voluntarily applying it, and external and topical
preparations were exempted.
07. The myth of an assessment of Cannabis under the LoN has justified the WHO shirking its
responsibilities in the face of draconian measures of control, relying on a supposed previous ruling to
avoid making decisions on a difficult subject matter.
3E. Rodriguez, 2015. À l'origine des lois d'interdiction des drogues : Le Sommet International de Shanghai 1909 Ou
l’irruption de la société civile dans les relations diplomatiques et les politiques internationales
, Paris, 2010, Université
Paris 3 Sorbonne Nouvelle.
4To learn more about the international discussions on Cannabis prior to the 1925 Convention, see The rise and
decline of cannabis prohibition, D. Bewley-Taylor, T. Blickman and M. Jelsma, Amsterdam, 2014.
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Image 1
Excerpt from the
1935 review of
"preparations
containing extract
or tincture of Indian
hemp" by the
Committee of
Experts in
Pharmacology of
the Office
International
d'Hygiène Publique.
Image 2
List of preparations
concerned by the
“1935 review”.
Image 3
Excerpt from the
Circular Letter from
the Secretary
General of the
League of Nations
acknowledging the
outcome of the
Experts meeting.
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08. Shortly after its creation the United Nations system initiated a process to merge all existing
international arrangements into a Single Convention to control the then-so-called “dangerous
drugs”. The Single Convention on Narcotic drugs would be adopted in 1961 and enter into force in
1964. The first draft of this new Treaty , issued in 1950, proposed several options for narrow policy
5
frameworks allowing medical cannabis use, while seeking to discontinue policies that allowed
non-medical uses.
09. WHO started to take interest in the subject in 1952, through its then-so-called Expert Committee on
Drugs Liable to Produce Addiction. At its 3rd Meeting, the "question of justification of the use of
cannabis preparations for medical purposes was discussed by the committee. It was of the opinion that
cannabis preparations are practically obsolete
. So far as it can see, there is no justification for the
medical use of cannabis preparations.
" However, no review of literature was made, and preparatory
6
documents of the meeting mentioned in the minutes of the Meeting are minimal.
10. At its 4th meeting in 1953 the Committee "was pleased to note that the elimination of cannabis
7
preparations had already begun by national action, following the opinion expressed in its [3
rd meeting] that
'
there is no justification for the medical use of cannabis preparations.' The committee [...] was of the
opinion that the definitions for cannabis and its preparations should be revised on the basis of the presence
of active principles.
"
11. The year 1954 is the occasion for the Committee to reiterate its allegations, relying this time on no
more information than "feelings" sent by South African police authorities: "The committee considered
the report of the Inter-Departmental Committee on the Abuse of Dagga, informing it of (1) the existence in
the Union of South Africa of widespread addiction to cannabis, always by smoking, (2) the feeling among
the South African police of a relationship between cannabis addiction and crime, (3) evidence of permanent
deterioration as the result of the addiction, and (4) evidence that, as in other parts of the world, cannabis
abuse is very likely to be a forerunner of addiction to opiates. [...] The committee was of the opinion that
cannabis abuse comes definitely under the terms of its definition of addiction, that the abuse of cannabis is
still a serious problem in many parts of the world, and that not only can there be no abatement in control
procedures but there should also be extension of the effort towards the abolition of cannabis from all
legitimate medical practice.
"
8
Image 4
Excerpt from the 5
th
report of the Expert Committee on Drugs Liable to Produce Addiction.
5 E/CN.7/AC.3/3
6 WHO Technical Report Series nº57, 1952.
7 WHO Technical Report Series nº76, 1954.
8 WHO Technical Report Series nº95, 1955.
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12. Historically, these three reports constitute a critical tipping point. In those meeting minutes we have
been able to identify that members of the Committee clearly acknowledge their ignorance of the
mechanisms of action of Cannabis on the human body (Δ9-THC wouldn’t be isolated until 1964, and
even later the endocannabinoid system). Yet without evidence they issued and reissued outcomes
that have gone down in history unchallenged until now.
13. In 1953, the CND created the concept of a Schedule IV which would consist of drugs aimed at being
completely prohibited. In 1955 and 1958 the Commission finished confirming the inclusion under
9 10
this new schedule "Cannabis and cannabis resin, extracts and tinctures of cannabis, or any other
substances containing the pharmacologically active principle of the cannabis resin (subject to the special
regime [for traditional medicine]).
" No review or scientific assessment was ever mandated prior to that
inclusion. However, on the insisting remarks of several countries provision was made in the draft
Convention to balance the "prohibition of the medical use of cannabis drugs"
giving exception to "certain
systems of indigenous medicine.
"
14. In 1958, the CND "noted that some Governments had reported that there still existed an appreciable use of
cannabis drugs in medical practice
". However, countries decided to maintain their "view [...] shared by
the WHO Expert Committee on Drugs Liable to Produce Addiction that cannabis drugs no longer served
any useful purpose. The Commission decided, therefore, that
the new treaty [...] should provide for a
régirne of prohibition
. It should also be made clear in the new treaty that
the use of cannabis would be
prohibited for all purposes, medical and non-medical alike
, except that of scientific research.
"
15. Your predecessors in this Committee therefore have directly served as a justification for the
strictest possible global policy for medical uses of the Cannabis plant and its derivatives and
thereby have made scientific research into Cannabis
unnecessarily burdensome.
16. In 1960, as the Plenipotentiary Conference was about to begin – to adopt the final text of the Single
Convention – the UN premiered what is now a Treaty-mandated role of the ECDD: to assess
substances for the purpose of defining the suitable international control. The first-ever assessment
for the purpose of international scheduling was exercised for Cannabis
, after the United Nations
"invited the World Health Organization to prepare [...] a report on the use of cannabis for the extraction of
useful drugs, particularly of the antibiotic type [...] to make this report available to the [...] Plenipotentiary
Conference [...] with a view to a
possible modification of the provisions of the Single Convention in
order to permit the use of cannabis for the extraction of useful drugs
.
" That year, the Expert
11
Committee met at its 11th Meeting, but although acknowledging promising research on antibiotic
properties of Cannabis
, recalled for the third time that "the opinion expressed in [the 3
rd meeting]
remains unchanged. Cannabis and its preparations are practically obsolete and there is no justification for
their medical use.
"
12
9 E/2768/Rev.1
10 E/3133
11 E/CONF.34/5
12 WHO Technical Report Series nº211, 1961.
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17. In the spring of 1961 the Plenipotentiary Conference adopted, in New-York, the Single Convention on
Narcotic drugs with an exemption from Schedule IV for the extracts and tinctures of Cannabis – It is
our opinion that this was intended to leave the door open for future identification of the active
principles of the plant that would lead to isolating drugs extracted from the Cannabis plant.
18. The 5th and 11th Meeting of the Expert Committee provided direct input to the Single Convention (still
in force), considered to be the last and only assessments made of this drug. Because of that, six
decades later, robust scientific evidence is still minimal, even for a substance consistently
documented as having great therapeutic potential. Schedule IV has effectively stifled gold standard
research into Cannabis
and cannabinoids medical applications.
19. The extreme policy that prohibition represents – justified by this Committee – has proven to be an
almost impassable fence for research, and an intolerable barrier to medical access. Hence the
emergency for this Committee to:
invoke the Right to a Remedy and Reparation for Victims of Gross Human Rights Violations ,
13
by enforcing the Right of everyone to share in scientific advancement and its benefits, and the
Right to enjoy the benefits of scientific progress and its applications , , , ,
14 15 16 17
in order to enhance the Right of everyone to the enjoyment of the highest attainable standard of
physical and mental health and wellbeing .
18
13 Basic Principles and Guidelines on the Right to a Remedy and Reparation for Victims of Gross Violations of
International Human Rights Law and Serious Violations of International Humanitarian Law, included in UNGA
Resolution 60/147.
14 Article 27 of the Universal Declaration of Human Rights.
15 Article 15 of the International Covenant on Economic, Social and Cultural Rights.
16 Preamble of the Declaration on Social Progress and Development, included in UNGA Resolution 2542 (XXIV).
17 3rd report of the UN Special Rapporteur in the field of cultural rights, included in A/HRC/20/26.
18 Preamble of the Constitution of the World Health Organization, included in WHO Basic Documents, 45th edition.
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Part
II.
Criticism of the
Pre-review of Cannabis
and
Cannabis
-related products.
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Cannabis
& Cannabis
resin.
20. Cannabis sativa L. is the most widely used controlled drug worldwide. It is cultivated all over the
planet, and is largely present in traditional as well as contemporary cultures on the 5 continents. The
history of its documented medical uses dates back to 3000 B.C, and in addition to its numerous listed
medical uses (supervised or self-medicated), the tales about the state of wellness and pleasure
Cannabis provokes, as well as the state of mind it induces are witnessed in the arts in all time
periods and in all regions.
21. Global prohibitionist policies strongly promoted after WWII (in a mindset of overflowing optimism
and boundless perspectives of the world community), seem to have resulted in that the exact opposite
of their stated goals. Research, access to quality phytopharmaceuticals, galenical or
cannabinoid-based medicines, and ceremonial or religious uses are at their lowest while so-called
recreational use has never been so high. Misuse, harms and problematic use have reached historical
peaks, illicit trade skyrockets, violence and crime generated by the illicit trade keep increasing, and
public expenditure in law enforcement exploded – while budgets for prevention, treatment and harm
reduction programs languish.
22. The suggested Cannabis and Cannabis resin Pre-Review Report edited by the NGO Drug Science and
19
provided to the 38th ECDD Meeting, makes explicit the fact that recommendations made by the
Committee at its 3rd, 4th, 5th and 11th meetings (see above, §10-16) are still in force, for not having been
revoked or updated.
23. After the adoption of the Single Convention, the Committee continued to reiterate its calls for
abolishing medical uses of the Cannabis plant and its derivatives, although never undertaking any
formal step to confirm their claims.
a) Bias in the scientific part of the pre-review report.
24. The 1st section on Chemistry, otherwise original, is undermined by the fact that two entire pages (pp.
23-24) reproduce in extenso a report published by the UNODC in 2010 . Of interest to us is the lack
20
of quotation marks, although nothing has been changed compared to the original document.
25. The document, addresses risks of contamination and adulteration in "street marijuana" (this is biased
language) but neglects to address the wide-spread adulteration of Cannabis resin traded in the illicit
market, although this information is largely documented by the UNODC (from 1953 to present) or by
21
the EMCDDA .
22
26. The adulteration of Cannabis resin, mostly due to the legal status and the lack of safety &
manufacturing standards, is a major health issue in countries where the use of hashish is prevalent. A
19 Curran H.V., Wiffen P, Nutt D.J., Scholten W., Cannabis and Cannabis resin Pre-Review Report, document prepared
for the WHO ECDD38
. DrugScience, London, 2016.
20 United Nations Office on Drugs and Crime, Laboratory and Scientific Section, Recommended methods for the
identification and analysis of cannabis and cannabis products
, 2009, pp. 16-17.
21 UNODC Bulletin on Narcotic Drugs, The Surprising Extinction of the Charas Traffic
, New-York, 1953.
22 European Monitoring Centre for Drugs and Drug Addiction, EMCDDA INSIGHTS nº12 - Cannabis production and
markets in Europe
, Luxembourg, 2012.
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2015 document commissioned by the EMCDDA stressed that "THC contents are to be considered
23
with caution for it is unclear if a resin showing a 16 % THC content is or is not an end product with
half the adulterant amount of a resin showing an 8 % THC content." The author confirms that "hashish
is very often adulterated with a range of inert or active substances [...] Users and cannabis watchers often
mention the presence, sometimes in large quantities, of soil, henna, paraffin wax, bee wax, rosin, glue,
flour, liquorice, milk powder, coffee, used motor oil, animal excrement, or even medical drugs
", and further
details the results of the 2001 British chemical-anthropological Cannabis Resin Impurities Survey
Project (CRISP) which found that resin seized "often showed very high levels of impurities, sometimes up
to 80% of the final product.
"
27. The Pharmacology section of the report is weak in describing pharmacokinetic and
pharmacodynamics of the plant by limiting the scope to only 2 cannabinoids. The Chemistry section
of the report, on the other hand, specified that their are 120 phytocannabinoids recorded to date
although being minor compared to Δ9-THC and CBD, and they "may affect pharmacology of cannabis
via two basic mechanisms: (1) the pure constituent may have pharmacological effects and/or (2) the
constituent may interact with Δ
9
-THC and alter its effects (e.g. entourage effect)
". Yet the importance of
the substance and its consumption worldwide would have seemed to justify an approach to this
section more focused on the multiplicity of cannabinoids and their well published "entourage" or
cross-cutting pharmacological effects.
28. The section on Therapeutic use is strangely built with its opening sentence addressing non-medical
use as well as some biased language, specifically the use of "clients" instead of "patients".
29. Lastly, the section on Epidemiology presents a balanced and complete panorama of the topic. Minor
oversights are to be noted though such as data relating to self-medication (under part 2.5.3) in
contradiction with data observed in the Netherlands over 13 years, showing a stabilization of use by
medical Cannabis patients , or with the results of a survey completed by 953 participants from 31
24
countries showing the positive influence of regulated medical access over patterns of use among
patients . Important studies about the medical conditions people use Cannabis
for are missing .
25 26
30. More broadly, tools to measure epidemiology of illicit drugs are subject to numerous bias that
ought to be more explicitly stated in the document. Data from self reports, healthcare statistics,
anonymous surveys looking at groups or populations that use Cannabis
, many not formally engaged
in any health care system or not represented in official census, each carry unique characteristics that
require special care to avoid bias. The existence of laws and policies that include mandatory drug
treatment as a punishment or as an alternative to penal measures, can also create an important
statistical bias.
31. Reported data that discriminates use according to gender is lacking an acknowledgment of the social
gender conditions that are (a) an important barrier to access to healthcare systems, and (b) a factor
of biased declaration to health surveys , . These gender conditions vary according to regions and
27 28
23 P.A Chouvy, The supply of hashish to Europe Background paper commissioned by the EMCDDA for the 2016 EU Drug
Markets Report
, Lisbon, 2016.
24 B. de Hoop B, E.R Heerdink & A. Hazekamp, Medicinal Cannabis on Prescription in The Netherlands: Statistics for
2003-2016
, Cannabis Cannabinoid Research, 2018.
25 A. Hazelkamp, M.A. Ware, K.R. Müller-Vahl, D. Abrams and F. Grotenhermen, The Medicinal Use of Cannabis and
Cannabinoids-An International Cross-Sectional Survey on Administration Forms
. Journal of psychoactive drugs, 2013.
26 R. Borràs, P. Modamio, C.F. Lastra, & E.L. Mariño, Medicinal use of Cannabis in Spain
, Alternative Therapies In
Health And Medicine, 2011.
27 WHO Commission on Social Determinants of Health, Women and Gender Equity Knowledge Network. Unequal,
Unfair, Ineffective and Inefficient. Gender Inequity in Health: Why it exists and how we can change it
. 2007.
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social contexts. Similarly, the access to illicit retail of Cannabis is more prone to male than to female,
in particular young women, thus virtually inflating the data on problematic use of young males. Also
factors of genetic predispositions should be balanced according to what modern research has shown
- including one study referenced in the report, but which conclusions are only partially cited .
29 30
b) Bias arising from the data collection process.
32. The Pre-review report document on which you, as scientists and independent Experts, will base your
discussions is composed of two parts of equal importance:
a. A scientific part covering toxicology, chemistry, pharmacology, epidemiology and
therapeutic use of the plant or substance under review,
b. A country Questionaire part where epidemiological, statistical, empirical and field data is
provided by Ministers of Health of all countries to complement the scientific data
presented. This is also the opportunity for Member States to submit comments and
feedback, or to highlight country specific situations that systematic reviews might
overlook.
33. Significant bias has undermined the ability of countries to provide relevant and accurate data. In
particular, this problem concerns the Terms of reference for the data collection, often differing vastly
between authors of the scientific part
, and authors of the country Questionnaire part
. Below are
highlighted some major differences in the definition and framing of substances about which data has
been collected.
34. Category name: the Single Convention defines the herbal part of the substance that is placed under
control as “cannabis”, and uses the term “cannabis plant” to refer to the plant Cannabis sativa L.,
including parts that are not placed under control (e.g. leaves, seeds…). Therefore, the use of “cannabis
plant” to refer to “cannabis” is in contradiction with the language used internationally since 1961 and
adds confusion. The logic of treaty language would recommend the use of the term "crude Cannabis
"
to designate the dried flowering and fruiting tops of the Cannabis plant from which the resin has
not been extracted.
35. Definition: The terms of reference for countries data collection make absolutely no mention of
"Cannabis resin", while for crude Cannabis
, a weak definition is provided. It is incomprehensible that
acopy-paste of the same terms of reference has not been done to avoid the collection of erroneous
data. Consequently, it is likely that many countries will not have submitted national data on Cannabis
resin, the most frequently used product in the illicit market in many countries.
36. Countries are provided at least with some examples of terminologies commonly used for cannabis,
although some extremely geographically relevant denominations like "ganja" are missing.
28 V. Govender and L. Penn-Kekana, Gender biases and discrimination: a review of health care interpersonal
interactions. Background paper prepared for the Women and Gender Equity Knowledge Network of the WHO
Commission on Social Determinants of Health
. 2007.
29 G. Maté, Addiction: Childhood Trauma, Stress and the Biology of Addiction. Journal of Restorative Medicine,
2012.
30 K.J.H. Verweij, B.P. Zietsch, M.T. Lynskey, S.E. Medland, M.C. Neale, N.G. Martin, D.I. Boomsma and J.M. Vink,
Genetic and environmental influences on cannabis use initiation and problematic use: a meta-analysis of twin studies
.
Society for the Study of Addictions, 2010.
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c) The case of tobacco:
Double standard of substance scheduling.
37. Finally, it is to be noted that in 1999, in the outcome of the pre-review of tobacco undertaken at its 31st
meeting, the ECDD acknowledged that "smoking tobacco is dependence-producing, causes serious
public health problems and has no therapeutic use." But the Experts declared as well that "existing
international drug control measures for narcotic drugs and psychotropic substances appear to be
unsuitable for controlling tobacco, a dependence-producing natural substance widely used for
non-medical purposes at the time of adoption of the relevant conventions. Even though new
information indicates health risks greater than those previously known, tobacco would not meet the
criteria for scheduling under the existing international drug control treaties."
38. WHO records more than 7 million deaths due to tobacco each year , but the morbidity-mortality of
31
Cannabis
is extraordinarily low – hence the lack of WHO records on Cannabis
-related deaths.
39. For the ECDD, not adopting a similar approach for Cannabis as the one adopted at its 31st meeting
for tobacco would represent an unacceptable double standard for substance scheduling.
Table 1
Terms of reference used to contract
authors of the report
(December 2017)
Terms of reference used to collect
data among Countries
(March 2018)
Comments
Introduction
& context
"Cannabis plant and Cannabis Resin"
"cannabis plant and cannabis resin"
§34
Definition
"• Cannabis as defined by the International Drug
Control Conventions as “the flowering tops of the
cannabis plant from which the resin has not been
extracted”. The term “cannabis” generally refers
to a dried preparation of the flowering tops or
other parts of the cannabis plant.
• Cannabis resin which is defined as “the
separated resin, whether crude or purified,
obtained from the cannabis plant”. It is normally
in solid form and is sometimes known as hashish."
"The dried flower/ leaf of the cannabis
sativa plant.
Examples: marijuana, weed, pot,
hashish, and kief"
§35
Examples
provided
No example provided for herbal cannabis.
Only 1 example is provided for resin ("
hashish").
4 examples are provided for crude
cannabis. Although no definition of
resin is provided, there is one example
("
hashish") merged with examples of
crude cannabis.
§36
31 See Key facts on tobacco
, World Health Organization, 2018. www.who.int/news-room/fact-sheets/detail/tobacco
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Extracts and tinctures of Cannabis
.
40. Placed under a different control regime (Schedule I) than the plant and resin material of Cannabis
(Schedule I & IV), the different types of extractions of the Cannabis plant and the preparations based
upon them offer the most complex panorama for a thorough scientific assessment that avoids bias.
a) Bias in the scientific part of the pre-review report.
41. Authors of the Chemistry section are misleading the Experts when defining "Cannabis extracts" in the
footnote 1, on page 7. No systematic overview on the composition of the various products discussed is
made and no percentages (max., min., typical values) of the main constituents in the various extracts
are provided – except for BHO (the most problematic and least representative of these products).
Chemists and experienced readers might wonder: what products are they talking about?
42. Moreover, the Chemical Abstract Service (CAS) registry number provided seems irrelevant for many
of the extracts included in this category that already have separate CAS registry numbers. Defining
"cannabis extracts and tinctures" by their CAS registry number is too broad, and gives rise to
important ambiguities and room for biased interpretation. Indeed, such definition comprises solvent
extracts, expressions (pressed products), distillation and hydro-distillation, as well as all physically
modified derivatives, including purified extracts (e.g. purified by chromatographic techniques).
Words to balance such a broad definition would have been desirable, as well as the mention of other
CAS registry number known:
a. Cannabis sativa
seed oil: 8016-24-8,
b. Haschish oil: 8001-45-4,
c. Cannabis sativa
extract: 89958-21-4
43. The Pharmacology section of the pre-review report, although being generally thorough, is
undermined by a lack of precision when it comes to providing definitions (such as to "dabbing") or to
address important trends in consumption patterns (such as the use of microdosing Cannabis extracts
in harm reduction, or in tobacco cessation). Other data that balance the presented research outcomes
seem to be missing.
44. Furthermore, although several mentions of "edibles" (ingested preparations made out of Cannabis
extracts) are made, a definition and a specific description of their pharmacological effects are absent .
Yet the author in her report on "Cannabis plant and cannabis resin", states that the pharmacology of
edibles is addressed in the Pharmacology section of "Extracts and tinctures".
45. Finally, the author of the pharmacology section notes that "users who smoke or vape products with
higher Δ9-THC contents than their regular product tend to up-titrate, resulting in greater overall
exposure." However, more detailed scrutiny into the published literature shows ample evidence to
the contrary ,.
32 33
32 "The concerns that have been expressed about a possible rise in cannabis potency often assume that users will
necessarily consume more THC, but the evidence for this is equivocal. If the potency of cannabis products has
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46. Severe points of concern arise from the pre-review report section on Toxicology. The first is the
strange framing of the different sub-taxa of the category (addressed below in §51-58), which includes
"cannabis resin" (yet explicitly excluded from the terms of reference provided to the author), and
agglomerates into "concentrates" what other authors divided into up to 5 categories.
47. It is also astonishing to read concerns about "disastrous fires and explosions" in a report about the
toxicology of drugs. Beside the irrelevance of the matter in such a document, it is fair to say that
explosions due to home artisanal production of cannabis concentrates are certainly more likely to be
associated with the lack of a regulated and standardized legal retail market than the toxicology of
Cannabis
extracts per se
.
48. The section on Therapeutic use has deficiencies too: two full parts of the document (namely "Extent
of therapeutic use" and "epidemiology of medical use") address only Nabiximols. Yet, other extracts
and tinctures of Cannabis are available on the pharmaceutical market (such as in Germany,
Netherlands, Australia, some States of the USA, Malta, Canada...), although often only marketed
legally as magistral products in compounding pharmacies.
49. Lastly the section on Epidemiology invents new terminology, "BCO" (for "Butane cannabis oil") where
common language, and all other authors, use the term "BHO" (for "Butane hash oil" or "Butane honey
oil").
50. The most disconcerting part of this last epidemiological section, comes from what is missing:
a. The part 1 on "industrial use" only addresses Nabiximols, while other legal industrial
uses are well known, for pharmaceutical (see above §46 on toxicology) as well as for other
very different purposes (e.g. essential oils and hemp seed oils),
b. When compared to the report on Therapeutic use (4th Section, part 3.1 "Extent of
therapeutic use") 19 countries, where Sativex is marketed, are missing from the list in
the Epidemiology report;
c. Section 3 is aimed at reviewing thoroughly the "nature and magnitude of public health
problems related to misuse, abuse, and dependence." However, it only reports burn
injuries - where one might have expected an update on data concerning the extent of
shown a marked increase, then it might be expected that the typical user would need to consume less on a weight
basis to achieve the desired effect. Given a choice, users preferred cigarettes with a higher THC content (Chait and
Burke, 1994; Kelly et al., 1997). Ashton (1998) also argued that users would not titrate the dose of THC from cannabis
in contrast to tobacco smokers. However, Heishman et al. (1989) found that those smoking cigarettes with a higher
THC content tended to have a lower inhalation rate than control subjects. Yet little research has been conducted,
particularly in Europe, to answer a crucial question: do those smoking high potency cannabis have higher blood
levels of THC? However, even if the strength of some forms of cannabis has increased, and even assuming that, as
a consequence, users do have higher blood levels of THC, then it cannot be concluded that this will translate into a
greater harm to the individual. Experience with alcohol suggests that the health consequences are not simply
related to the alcohol concentration of what is consumed, but rather it is the total quantity of alcohol consumed
that is important. As Hall et al. (2001) note, age of onset of use and frequency of use are likely to be more influential
than changes in potency in determining consumption levels." in EMCDDA, EMCDDA MONOGRAPHS - A cannabis
reader: global issues and local experiences. Perspectives on cannabis controversies, treatment and regulation in Europe
,
Brussels, 2008, pp. 255-256.
33 "Not only is high-potency cannabis considered suitable as a medicinal product, but an assessment carried out by
the Dutch Coordination Centre for the Assessment and Monitoring of New Drugs concluded that (illicit)
higher-potency cannabis products did not pose any additional risk than those present for cannabis products as a
whole, either to the individual, to society, to public order or criminality (W. Best, personal communication, 2004).",
ibid
, p. 256.
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dependence and problematic use. Further this extraordinary focus on burn injuries is a
bias that deserves further examination:
i. Authors indistinctly use the words "legalization", or "medical liberalization", as
synonyms, and do not distinguish the huge difference between the terms,
ii. There is no mention about the important reporting bias that could explain the
increase of burn injuries related to home-made Cannabis extraction either caused
by an unclear retail market liable to bring inexperienced persons to experiment
with extraction techniques in inadequate conditions or actual burn accidents
mischaracterized because the illegal status as a matter of minimizing legal
sanction.
d. Part 4 proposes that the researchers "did not yield any articles related to licit production,
consumptions and international trade of cannabis extracts and tinctures". A basic search
in a web browser, however, shows dozens of results, such as the 2017 annual report of
the UN International Narcotics Control Board stating that globally, "[the] licit use of
cannabis has been increasing considerably since 2000. Before 2000, licit use was restricted to
scientific research [...] In 2000, total licit production was 1.4 tons; by 2016 it had increased to
211.3 tons
" Experts might have been interested in knowing that this international agency
34
explained that "The United Kingdom [where Sativex® is manufactured] continued to be the
main exporter of cannabis (2.1 tons, or 67.7 per cent of the total)
" and that "the large majority
of the stocks were held by the United Kingdom (93.1 tons, or 78.2 per cent).
" Much other data is
easily available, from highly reliable sources.
e. Similar to part 4, part 5 ignores the immense amount of information available about the
illicit manufacture and traffic of the different extracts or tinctures included. The authors
only acknowledge the "negligible role" of the "seizures of tinctures" – although it is
broadly recognized that seizures are the among least representative metrics of illicit
markets – and totally omits oils, concentrates, and other extracts.
b) Issues of taxonomy.
51. The category "extracts and tinctures" encompasses many different products and preparations of the
Cannabis plant (gathered according to their manufacturing processes, and not at all according to
their chemical composition, pharmacology or toxicological effects which would be the state of the
art) therefore making it tough to frame.
52. The category is known under different names, according to the emitter:
a. "Cannabis extracts and tinctures" as per the Single Convention on narcotic drugs;
b. "Extracts and tinctures of cannabis" as per the language used by the WHO;
c. "Extracts or preparations" of Cannabis
, as per the wording proposed by the 39th ECDD.
34 Technical Report of the International Narcotics Control Board for 2017 "Narcotic Drugs Estimated World
Requirements for 2018 Statistics for 2016", particularly pp. 43-48. Read online at:
www.incb.org/incb/en/narcotic-drugs/Technical_Reports/2017/narcotic-drugs-technical-report-2017.html
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53. The vast variety of products included in this category implies that special attention should be
focused on the taxonomy of these different products, before undertaking any analysis of the content.
54. The UN system has developed tools, such as the World Trade Organization's harmonized tariff
system, which could be of some help to discuss these issues. WTO already clearly differentiates:
a. Hemp seed oil (1515.90) among "Other fixed vegetable fats and oils",
b. Hemp essential oil (3301.90) among "Other Essential oils", and
c. Cannabis flower/Cannabis
extract (1302.19) among "Other Vegetable saps and extracts".
55. As well, the criterion excluding "Cannabis resin" from the scope of this pre-review – although that
product is obviously fitting the criteria to be considered as an "extract" – should be discussed.
56. Taking advantage of the distinct taxonomy proposals made by the authors of the 5 different sections
of the pre-review report (see Table 2, below), the most refined, precise and inclusive categories and
taxa should be defined by the Expert Committee itself to enable the possibility of undertaking
Critical reviews based on evidence accordingly.
57. Beyond the core taxonomy issue, demonstrated by the incoherence between the authors of the 5
sections, civil society stakeholders (including affected populations and people who use Cannabis
,
independent and academic researchers, members and former-members of relevant governments
administrations and international institutions) have suggested to extend the taxonomy of this
category beyond its current boundaries. With a view to enabling the Expert Committee to issue final
scheduling recommendations that best fits the Treaty, correlates with the evidence and could be
acceptable by Countries as well as by civil sectors and non-State actors. The following considerations
have been suggested:
a. Adopt the taxa used in Section 1 (Chemistry) of the report, and extend it for the purpose
of the assessment, to all disciplines reviewed;
b. Include "Cannabis resin" in this category, under the taxon "Extracts of Cannabis";
c. Consider creating a taxon that would comprise all Extracts or preparations of the
Cannabis
plant known to be part of traditional or indigenous uses;
d. Create a sub-taxon under "Extracts of Cannabis", that would comprise all Extracts or
preparations of the Cannabis plant with a minimal THC profile (or Extracts or
preparations of the Cannabis plant with almost no THC). Precise quantities and limits
could be determined either by the Committee or at the discretion of Countries;
Note: In the report on Chemistry (Section 1) however, the sub-item "Cannabis oils" is controversial, as
it includes so-called "Rick Simpson Oil" and "medical cannabis oil", merged with "hemp seed oil" (the
latter is directly exempted from the Convention's control measures) and "essential oil", a steam
distillate of the freshly-cut Cannabis plants which in no way fits any criterion that would justify
international scrutiny. In 2009, the UN Office on Drugs and Crime (UNODC) wrote that "the essential
oil does not contain THC
" .
35
35 United Nations Office on Drugs and Crime, Laboratory and Scientific Section, Recommended methods for the
identification and analysis of cannabis and cannabis products
, 2009, page 19.
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e. Products and preparations included under this sub-item should be reviewed separately
one from another;
f. Essential oils and Cannabis sativa Semen Oleum should be completely excluded from
further reviews in this category, and might be considered for inclusion under a newly
created sub-taxon "Extracts and preparations Cannabis with a minor THC profile" that
would keep the door open for continuing the exemption from the Treaty's control
measures, exemption presently into force for these products.
58. Such an update in the taxonomy of this category appears as a mandatory preliminary step prior to
any further step in the assessment process.
c) Bias arising from the data collection process.
59. Besides, there are concerns about the comprehensiveness of data collection: table 3 (below) illustrates
important differences between the Terms of reference provided to the scientific community
(through the core authors of the report) versus to Countries (through the questionnaires sent to all
Ministers of Health). This is a inconsistency with serious implications.
60. While the assessment has to be made on the basis of all existing data, including non-medical use and
so-called "recreational" use, the Questionnaire sent to countries is incomplete, requesting only
"approved medical uses". This is directly contrary to the Guidance document, which governs the
ECDD proceedings and states that all possible uses and all data must be included in the review
reports, either regarding medical, scientific, recreational or religious uses.
61. In the definition, the difference between the substances and products about which information is
requested, to authors and to countries, is tremendous. A main consideration is the inclusion under
this category of products made out of Cannabis
, but that are clearly exempted from the scope of the
international drug control system . This concerns in particular:
36
a. the aqueous extract Bhang, or "hemp teas", legally commercialized in some countries, and
prepared using the leaves (exempted from international control) of the Cannabis
plant,
b. Cannabis sativa Semen Oleum, the so-called "hemp seed oil", sometimes also called "hemp
oil", made out of the seeds/achenes of the Cannabis
plant, exempted from international
control, and that contains an insignificant amount of Δ9-THC.
62. Finally, although Countries are provided with 10 more examples of products and names to be
included, some examples such as "Hemp seed oil" have inexplicably disappeared in the terms of
reference headed to Ministers of Health.
63. Given the wide diversity of products and uses included in the category "extracts and tinctures",
feedback from countries especially including their national health data collection services appears to
be indispensable as a complement to the scientific part to ensure thoroughness of the data corpus.
36 See Article 28 (2) of the Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol.
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Table 2
Differences of taxonomy between the 5 sections of the
pre-review report on "Extracts and tinctures of cannabis"
Section 1,
CHEMISTRY
Section 2,
PHARMACOLOGY
Section 3,
TOXICOLOGY
Section 4,
THERAPEUTIC USE
Section 5,
EPIDEMIOLOGY
Cannabis tinctures
Cannabis tinctures
"Cannabis extracts,
tinctures, oils and
tea."
"Cannabis Sativa
Extract."
Extracts and
tinctures
Cannabis extracts
Cannabis oils
Cannabis oils
Aqueous extracts
Aqueous extracts
Hemp seed oil
"Hemp seed, Evening
Primrose Oils."
"Nabiximols / CBD in
preparation with
other
cannabis-related
ingredients."
Nabiximols
Nabiximols
Nabiximols
Nabiximols
"Oral-mucosal
cannabinoid extract"
Cannabis resin
Table 3
Terms of reference used to
contract authors of the report
(December 2017)
Terms of reference used to collect data among
Countries
(March 2018)
Comments
Introduction
& context
/
"approved medical use of extracts and tinctures"
§60
Definition
"• Cannabis extracts: this term
refers to a plant extract mixture
from the leaves and flowers of
Cannabis sativa
• Cannabis tinctures: this term
refers to specific alcohol
extractions of the flowering tops or
other parts of Cannabis sativa.
• Cannabis oils e.g. Butane Hash
Oil, Hemp Seed Oil
• Aqueous extracts e.g. marijuana
tea
• Nabiximols (e.g. Sativex®)"
"The term 'extracts and tinctures' refers to
substances that have been extracted from the
Cannabis sativa plant. This term does not include
synthetic preparations.
Examples:
• Liquid concentrate (e.g. hash oil, hemp oil, butane
honey oil, etc)
• CBD oil
• Solid concentrate (e.g. shatter, budder)
• Edibles (e.g. prepared food products)
• Liquids (e.g. marijuana tea;)
• Tinctures (e.g. concentrated amounts ingested
orally or taken under the tongue)
• Topical ointments (lotions, salves, balms, etc)
• Nabiximols (e.g. Sativex®)
• Epidiolex
• Arvisol"
§61
Examples
provided
4 examples provided for so-called
oils ("
Butane Hash Oil, Hemp Seed
Oil"), aqueous extracts ("
marijuana
tea"), and for one pharmaceutical
preparation ("
Nabiximols").
14 examples provided in the definition.
§62
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Delta-9-tetrahydrocannabinol.
64. Δ9-THC is the key active compound justifying the international scrutiny and control over the whole
Cannabis plant. Crude cannabis, resin, extracts, tinctures and other preparations, systematically refer
to Δ9-THC – hence the importance of thoroughness and comprehensiveness of its assessment.
65. The substance has previously been reviewed by the Expert Committee at its 17th, 21st, 26th, 27th, 31st, 32nd,
33rd and 34th meetings. Consensus has never been found on the name and the scope of the molecules,
isomers and stereochemical variants to be included or not in the present category. International
control was first applied to Δ9-THC and its 6 isomers under the name "tetrahydrocannabinols", later
addressed as "dronabinol", a sole-stereochemical variant of the molecule, and finally until today, open
to the 4 stereochemical variants of Δ9-THC.
66. Since as many as 8 meetings of the ECDD have reviewed the substance (among which three were
Critical reviews), previous Critical review meeting documents and outcomes would have been
expected to be more central in this new review working document.
67. The Section 2 on Pharmacology misses a more refined acknowledgement of the numerous scientific
discoveries about cannabinoids and the endocannabinoid system (ECS). The absolute lack of
information concerning the endocannabinoid system (two lines in total) is particularly surprising.
No mention is made of the mechanism of action of anandamide and 2-AG as well as of FAAH and
monoacylglycerol lipase. No mention is made in the references of key researchers such as Prof.
Raphael Mechoulam leading the team that isolated Δ9-THC and premieered ECS research. Beyond
these details the document also cites very few references, especially recent, while the Pharmacology
section of the 2006 Critical review document edited for the 34th ECDD meeting provided far more
evidence .
37
68. The same pre-review document from 2006 presents numerous elements whose inclusion in the
present Section would have been welcomed such as, inter alia, the figure in Image 6 below.
69. The Pharmacology section of the report ignores important emerging evidence indicating that the
two-cannabinoid receptor theory might be incorrect. Beyond CB1 and CB2, the activation of some
other receptors (e.g. GPR55) by cannabinoids suggests that they may have a role in the wide ranging
neuro-modulatory effects of the endocannabinoid system .
38
70. Cannabinoids, and Δ9-THC in particular, not only have important brain-related activity, they also
have notable gastrointestinal activity. Not mentioned in the Pharmacology section.
71. Much more complete is the section of the report on Therapeutic use. However, it underestimates
important pre-clinical research, as well as preliminary and anecdotal evidence of the therapeutic
potential of Δ9-THC (e.g. ongoing studies related to the anti-tumor activity of Δ9-THC in several
cancer models).
37 WHO ECDD34, Assessment of dronabinol and its stereo-isomers. Available on:
www.who.int/medicines/areas/quality_safety/4.2DronabinolCritReview.pdf
38 Reviewed in Pertwee et al., 2010; Stella, 2010
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72. Finally, the Epidemiology section is sparse, as parts 2, 3, 4 and 5 are almost non existant. To follow on
the comparison, the 2006 review document prepared for the 34th ECDD meeting, presented more
than ½ page of information about both parts 3 (nature and magnitude of the public health problems)
and 4 (licit production, consumption, and international trade).
73. Contrarily to the other products and substances under review, the preparation process for the
assessment of Δ9-THC has less bias. It is regretable however that the definition provided to countries
is shorter and more synoptic. Again, copying and pasting the same terms of reference should have
been considered (see table 4 below).
Image 6
Excerpt from the 2006 Critical review document on Dronabinol.
Table 4
Terms of reference used to contract
authors of the report
(December 2017)
Terms of reference used to collect
data among Countries
(March 2018)
Introduction
& context
Delta-9- tetrahydrocannabinol (THC)
Delta-9- tetrahydrocannabinol (THC)
Definition
• Pure delta-9-tetrahydrocannabinol that is obtained
either directly from the cannabis plant or synthesised.
• The stereochemical variants of
delta-9-tetrahydrocannabinol:
- (-)-trans-delta-9-tetrahydrocannabinol (also
known as dronabinol)
,
- (+)-trans-delta-9-tetrahydrocannabinol,
- (-)-cis-delta-9-tetrahydrocannabinol,
- (+)-cis-delta-9-tetrahydrocannabinol.
Pure delta-9-tetrahydrocannabinol that is
obtained either directly from the cannabis
plant or synthesised.
This definition also includes the following
stereochemical variants of THC:
-dronabinol (Marinol; Syndros)
Examples
provided
No example provided.
2 examples provided in the definition
("
Marinol; Syndros")
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Part
III.
Getting critical on cannabidiol.
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The Critical review of cannabidiol:
Irrelevant assessment, inexistent methodology,
but binding outcome.
74. The numerous bias referred to in Part II of this contribution seriously undermine the ability of the
Committee to issue serious pre-review outcomes for Cannabis
, resin, extracts, tinctures, THC and its
isomers. However, the pre-review being a preliminary step, these can always be corrected or caught
up. When it comes to Critical Review, however, the process has a much broader impact: Critical
review outcomes are binding recommendation for international scheduling, ultimately notified to all
countries by a Note Verbale
of the UN Secretary-General.
75. Decisions made in a Critical Review meeting therefore have direct and permanent consequences on
the broad international drug control system, and through it affect millions of people.
a) General comments on cannabidiol and the relevance of a review.
76. A Critical review of "Extracts or preparations containing almost exclusively cannabidiol" was
convened by decision of the Experts of the 39th ECDD, in November 2017.
77. A first confusion emerges from the indistinct use of the terms "extracts", "tinctures" and
"preparations", associated together as if they were synonyms. An interesting approach would be to
take inspiration in the WTO Harmonized Tariff System, where "Vegetable saps and extracts" are up to
80% purified (HS 1302.19), being considered as "chemical mono-constituent" over this percentage of
purification (HS 2907.29).
78. Secondly, and most importantly, the WHO has reformulated the terminology of the review. All the
preparation process was undertaken in the perspective of a Critical review of CBD instead of
products "containing almost exclusively" CBD. Requests for data sent to Ministers of Health, besides
not reproducing the terminology recommended by the ECDD, vary importantly between languages:
a. "
Extracts and tinctures containing cannabidiol
(CBD)"
(English version),
b. "
Cannabidiol
(CBD)"
(French version: "Les questions ont trait au cannabidiol (CBD)"),
c. "
Extracts and preparations that contain cannabidiol (CBD)" (Spanish version: "Extractos
y preparaciones que contienen cannabidiol (CBD)").
79. The ECDD explicitly called for a Critical review, not of CBD, but of these among the extracts of
Cannabis that are rich in CBD. The difference is extremely substantial. "CBD", in clear terms Pure
Cannabidiol (whether produced synthetically or by isolation from Cannabis plant), has been clearly
excluded from the scope of control of the Conventions, excluding any narcotic-related harms or
effects.
80. In parallel, it is admitted that almost all extract or tinctures of Cannabis will contain some CBD.
Therefore, the "extracts or tinctures containing CBD" corresponds to almost all of the extracts from
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the Cannabis plant. But these extracts are already under review under a different category (“Extracts
and tinctures of cannabis”, see above). The terminological precision made by the 39th ECDD was also
meant to avoid a data collection that would aggregate all sorts of extracts of the Cannabis plant,
regardless of the fact that preparations may contain other cannabinoids that importantly modify the
effect of CBD.
81. Pure CBD has never been agreed by the Experts to be critically reviewed during the 40th ECDD. The
lack of respect by WHO administration exemplified by the request of the Experts to collect data on
"Extracts or preparations containing almost exclusively cannabidiol" will have a direct impact on the
ability of the meeting to result in an assessment and outcome based on evidence. Such an error
constitutes an unacceptable bypass of the work and decisions of the Experts, but also a violation of
their independence.
82. Please note, pure Cannabidiol is legally used in an important number of industrial products (e.g.
cosmetics ingredient), particularly in EU. The broad scope of the category under Critical review could
have important and unexpected effects on such products.
83. The Experts of the 40th ECDD should refrain from undertaking a Critical review of "pure CBD" in such
conditions. The Experts might prefer wording that sets precise boundaries to include and exclude in
a clear manner certain products irrelevant to the 1961 and 1971 Conventions.
84. Based upon the wishes of the 39th ECDD, CBD should be clearly and definitely excluded from the
scope of the 40th ECDD's mandate. Moreover, for procedural, practical and clarification reasons, the
Experts could consider creating a sub-taxon of "extracts and tinctures with almost no THC" that
should be exempted from the scope of the Treaty's control measures (thus solving as well the
problem of "hemp seed oil" and "essential oil" included under the category "Extracts and tinctures of
cannabis", see above §57).
Table 5
Terms of reference used to contract
authors of the report
(December 2017)
Terms of reference used to collect
data among Countries
(March 2018)
Comments
Introduction
& context
"Extracts or preparations containing almost
exclusively CBD (cannabidiol;
(1’R,2’R)-5’-Methyl-4-pentyl-2’-(prop-1-en-2-yl)-1
’,2’,3’,4’- tetrahydro-[1,1’-biphenyl]-2,6-diol)".
In the English version:
"Extracts and tinctures containing
cannabidiol (CBD)"
In the French version:
"Cannabidiol (CBD)"
§77-80
Definition
CBD is defined as "
cannabidiol" and as
"
(1’R,2’R)-5’-Methyl-4-pentyl-2’-(prop-1-en-2-yl)-
1’,2’,3’,4’- tetrahydro-[1,1’-biphenyl]-2,6-diol".
No definition provided.
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Concluding words.
Adopted two weeks ago, the 13th general programme of work for 2019–2023 addresses (at least in its §37,
43 and 62) and the Report by the Director-General titled "Addressing the global shortage of, and access
to, medicines and vaccines", join the concerns expressed by the UNGASS 2016 about the lack of
availability and access to medicines , which undermines the goal "1 billion more people enjoying better
39
health and well-being".
In May 2016, a report of the WHO Secretariat presented during the 69th World Health Assembly (WHA)
40
"highlighted the importance of moving towards a more balanced and comprehensive approach in
global drug policies that highlights public health and development outcomes, consistent with the
original purpose of the three international drug control conventions to promote the health and
welfare of humankind". It was also recalled that "the enjoyment of the highest attainable standard of
health is a fundamental right of every human being [...] and that WHO is the directing and coordinating
authority for health within the United Nations system", noting that "WHO is one of [the] four treaty
bodies [of the drug control conventions]."
One month before, the United Nations in a special General Assembly (UNGASS) dedicated to drug
policies, reaffirmed the same desire to refocus global drug policies around health outcomes, in up to six
occasions , and especially made a call for "informed and coordinated scheduling decisions" , while
41 42
recalling the need for "scientific evidence-based review and scheduling of the most prevalent, persistent
and harmful substances" with the aim to clear existing debate for the purpose of focus on the rapid
43
emergence of new psychoactive substances (NPS).
In the same UNGASS outcome document, a deep concern is expressed regarding the "low or
non-existent" availability of internationally controlled drugs for medical purposes as well as a "strong
44
commitment to improving access" to those substances . The link between the scheduling status of
45
medicines, and their lack of availability, is not a coincidence.
In light of these elements, a renewed and more accurate scheduling of substances appears not only as
an essential issue towards a comprehensive availability of scheduled substances for medical purposes
, but also as a mandate given to the WHO ECDD by the international community to start issuing
46
scheduling recommendations driven by public health, more than moral, considerations.
We are confident that the Experts will correct this situation and undertake the necessary steps to fully
appreciate the substantially increased scientific Cannabis
-related
knowledge-base.
39 WHO/A71/4, General programme of work 2019–2023, "Promote health, keep the world safe, serve the vulnerable".
40 WHO/A69/12
41 General Assembly resolution A/S-30/1, annex "Our joint commitment to effectively addressing and countering the
world drug problem
", 2016. 6th and 19th paragraphs of the introduction, preliminar paragraph and paragraph 1 (d) of
item 1, 2nd preliminar paragraph and paragraph (y) of item 5.
42 A/S-30/1, annex, item 2, paragraph (g).
43 A/S-30/1, annex, item 5, 2nd preliminar paragraph.
44 A/S-30/1, annex, introduction, 5th paragraph.
45 A/S-30/1, annex, item 2, preliminar paragraph.
46 To learn more, check the contribution to the post-UNGASS process by the NGO FAAAT think & do tank "One
proposed reading of the UNGASS 2016 outcome document: reassessing substances
", available on
www.unodc.org/postungass2016/en/contributions/ngos/faat-think-and-do-tank.html
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Abbreviations
CAS Chemical Abstract Service
CBD Cannabidiol
CND Commission on Narcotic Drugs
CRISP Cannabis Resin Impurities Survey Project
ECS Endocannabinoid System
EMP WHO Essential Medicines and health Products department
ECDD Expert Committee on Drug Dependence
EMCDDA European Monitoring Centre for Drugs and Drug Addiction
Guidance Guidance on the WHO review of psychoactive substances for international control
HCV Hepatitis C Virus
HIV Humane Immunodeficiency Virus
INCB International Narcotics Control Board
INNs International Non-proprietary Names
LoN League of Nations
NGO Non-Governmental Organizations
NPS New Psychoactive Substances
OIHP Office International d'Hygiène Publique (International Office of Public Hygiene)
Single Convention See
1961 Convention
THC Tetrahydrocannabinol
UN United Nations
UNGA United Nations General Assembly
UNGASS United Nations General Assembly Special Session
UNODC United Nations Office on Drugs and Crime
UN-SG United Nations Secretary-General
Vienna Convention See
1971 Convention
WHA World Health Assembly
WHO World Health Organization
WHO-DG Director-General of the World Health Organization
WTO World Trade Organization
WWII IInd World War
1961 Convention 1961 Single Convention on Narcotic drugs, as amended buy the 1972 Protocol
1971 Convention 1971 Convention on Psychotropic Substances
Δ9-THC Delta-9-tetrahydrocannabinol
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Endorsements.
KOPAC (CZ)
,
Latino America Reforma (CHL)
,
La María Guanaca (SLV)
,
Legalizače (CZ)
,
Legalize (NL)
,
Madawa Addiction and Health Care
Organisation (AFG)
,
MamaCoca (COL)
,
Multidisciplinary Association for
Psychedelic Research (USA)
,
Museum of Sacred, Magical and
Medicinal Plants (PER)
,
NORML France (FRA)
,
Patients Out of Time (USA)
,
Pazienti impazienti Cannabis (ITA)
,
Por Grace A.C (MEX)
,
Regulación Responsable (SPA)
,
Spanish Observatory for Medicinal
Cannabis (SPA)
,
Students for Sensible Drug Policy
(INT)
,
Students for Sensible Drug Policy
Ireland (IRL)
,
Swiss Safe Access for Cannabinoids
(CH)
,
Unión de Productores de Aceites y
Cremas de Cannabis (URY)
,
Users’ Voice (UK)
,
Verbond voor Opheffing van het
Cannabisverbod (NL)
,
Veterans Ending The Stigma (USA)
,
Veterans for Medical Cannabis Access
(USA)
,
Virginians Against Drug Violence
(USA)
,
Zimbabwe Civil Liberties & Drug
Network (ZWE)
.
Acción Semilla (BOL)
,
Ale Yarok (ISR)
,
Americans for Safe Access (USA)
,
Asociación Civil Rosarina de Estudios
Culturales (ARG)
,
Australian Medical Cannabis Council
(AUS)
,
Austrian Cannabis Network (ÖT)
,
Auto Support des Usager.e.s de
Drogues (FRA)
,
Canadian Students for Sensible Drug
Policy (CAN)
,
Cannabis Sans Frontières (FRA)
,
Cannabis War is Over campaign (CZ)
,
Caribbean Collective for Justice (TT)
,
Caribbean Drug & Alcohol Research
Institute (LCA)
,
Center of Excellence in Harm
Reduction and Dependency (AFG)
,
Collectif Thémis (FRA)
,
Criminal Justice Policy Foundation
(USA)
,
Dosemociones (SPA)
,
DRCNet Foundation (USA)
,
DrugScience (UK)
,
ECHO Citoyen (FRA)
,
ENCOD (BEL)
,
Estudiantes por una Política Sensata de
Drogas (BOL)
,
Estudiantes por una Política Sensata de
Drogas (MEX)
,
Ethio-Afro Diaspora Unity Millennium
Council (JAM)
,
European Industrial Hemp Association
(INT)
,
FAAAT think & do tank (INT)
,
Federación de Asociaciones
Cannabicas (SPA)
,
Federación Nacional de
Cannabicultores (URY)
,
Federation of Cannabis Users
Associations of Aragón (SPA)
,
Federation of Cannabis Users
Associations of Euskadi (SPA)
,
Fields of Green for All (ZAF)
,
Foundation of Cannabis Unified
Standards (USA)
,
Fundación Renovatio (SPA)
,
Groupement Romand d'Étude des
Addictions (CH)
,
Grüne Hilfe Netzwerk (DEU)
,
Hanf Institute (ÖT)
,
Hanfparade (DEU)
,
Help Not Handcuffs (USA)
,
Help Not Harm (IRL)
,
Hemp Industries Association (USA)
,
Iglesia Evangélica Protestante de El
Salvador (SLV)
,
International Center for
Ethnobotanical Education, Research
and Service (INT)
,
International Medical Cannabis
Patients Coalition (INT)
,
Knowmad Institute (DEU)
,
About FAAAT think & do tank
FAAAT think & do tank (For Alternative Approaches to Addiction - Think & do tank) is a transnational non-governmental,
non-partisan and non-profit organization working on the issue of addiction, controlled drugs, and plants, products or substances
liable to produce harmful effects.
Based in Paris and Barcelona, and active in Geneva,New-York, and Vienna, FAAAT think & do tank centralizes the collaboration
of a global network of experts to provide meaningful inputs in the international processes related to drug policies and strategies.
Genuinely focused on methodologies of substance assessment for international control, our teams have started, since 2014, to
follow the processes related to the review of Cannabis and its related substances, both at the United Nations level (Vienna-based
UN agencies) and in Geneva at the WHO level.
Our vision. Transparent and measurable drug policies framed by fundamental rights, grounded on
sustainable development, and enforcing empowerment, social justice, and health.
Our mission. Research rigorous and ethical policy alternatives, and take action through social
engineering, collective action and advocacy for ground-up democratic reformers at all level.
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