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The
CRIMSON
DIGEST
Volume 1
FAAAT think & do tank • The Crimson Digest (Vol. 1) 1/45
Acknowledgments.
Written and edited by Kenzi Riboulet Zemouli.
Co-authored by Michael Krawitz and Farid Ghehiouèche.
The authors would like to thank Arné Verhoef and Amy King for constructive criticism and proofreading.
The authors thank the support from the European Industrial Hemp Association, Hempoint, CBDepot,
Harmony Ltd, Don E. Wirtshafter’s Cannabis Museum, Revista Cañamo and Sensi Seeds.
Copyright © FAAAT 2018
ISBN 979-10-97087-06-7 | EAN 9791097087067
This report is published under a Creative Commons “Attribution Non-Commercial Share Alike” licence. It may
be reproduced in part or in full for free and without permission for non-commercial use, on the understanding
that the authors and FAAAT think & do tank are credited and a link to the website (www.faaat.net/cannabis)
is provided. See: creativecommons.org/about/licenses
The views expressed in this report are those of the authors, not necessarily those of other contributors,
supporters of FAAAT, or project funders.
For more information, please contact FAAAT think & do tank at info@faaat.net.
FAAAT think & do tank is a registered non-profit in Paris Prefecture (France), referenced by Official Gazette
(148e année, Nº12, 19 mars 2016, Nº1540, page 93) with SIREN number 822213013.
FAAAT think & do tank • The Crimson Digest (Vol. 1) 2/45
INDEX
FOREWORD 4
INTRODUCTION 5
Chapter 1. The Schedules 10
1.1 International drug control Conventions 10
1.2 An annex to the Conventions: their Schedules 10
1.3 Schedules of the 1961 Convention 12
1.4 Schedules of the 1971 Convention 13
1.5 Treaty obligations. 14
Chapter 2. The review process 16
2.1 Launch 16
2.2 Preparation, documentation and data collection process 17
2.3 The Expert Committee meetings 17
2.4 Assessment criteria 18
2.5 Post-review process at WHO 19
2.6 Detailed flow chart of the review process 19
Chapter 3. The Experts 23
3.1 Role and mandate of the ECDD 23
3.2 History 23
3.3 Nomination, rules and functioning 24
3.4 Members of the Committee 25
Chapter 4. After the ECDD: Vote & legal consequences. 27
4.1 The voting process 27
4.2 53 Countries with right to vote 28
4.3 Negotiations within regional groups 30
4.4 Sovereignty breach in the European Union 30
4.5 Barriers at the Commission on Narcotic Drugs 32
4.6 After the vote: entry into force 32
Chapter 5. Timeline & history of Cannabis in the Schedules 33
5.1 From 2016 to 2018 34
5.2 From 1925 to 1961 35
5.3 From 1952 to 2018: detailed timeline. 37
FAAAT think & do tank • The Crimson Digest (Vol. 1) 3/45
FOREWORD
In 2014, Michael Krawitz, Farid Ghehiouèche and Kenzi Riboulet Zemouli started to cooperate in an effort to
diminish the strict controls surrounding cannabis (and sometimes the associated prohibition) imposed to
all countries by an international agreement dating back to 1961, with its roots in early 20th Century
geopolitical arrangements where moral considerations of the time trumpsed evidence.
Our focus was the problematic scheduling status of cannabis. The international community had just
outrageously broken its own rules to avoid changing the scheduling of THC, but times were changing, and
so were the officials and personnel of international institutions. The UNGASS 2016 was on the horizon and
1
Uruguay had just demonstrated to the whole world that it is possible to regulate the cannabis market even
by voting a downgraded legalization bill.
Our actions were tridirectional: past, present and future. We started a comprehensive review of the archives
and historical steps leading to the scheduling status of cannabis; we started mainstreaming the topic
among United Nations stakeholders, decision-makers, researchers, civil society and the global cannabis
community; and we launched a series of actions to ensure that the start of a process aimed at updating the
scheduling status of cannabis would begin as soon as possible.
Part of our work was rendered in documents edited and published online on www.faaat.net/cannabis, in
particular, the Crimson papers – A series of information documents on the general functioning of the
international drug scheduling processes – and the Crimson fact sheets – briefings detailing the ongoing
and expected changes in this domain.
The Crimson Digest that you are reading is an extended and updated collection of these Crimson papers
and fact sheets, complemented with materials that were kept restricted at the time.
NB: For the purpose of this document, cannabis means the ‘drug’, the actual substance placed under
control and Cannabis means ‘the Cannabis sativa L. plant’.
1UNGASS 2016 was a Special Session of the United Nations General Assembly dedicated to the "world drug problem",
where an important update of the international political consensus on drug policies happened.
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INTRODUCTION
In November 2016, the World Health Organization (WHO) launched a process of scientific assessment of
the uses (medical or otherwise) and potential harms of the plant Cannabis sativa L. and its derivatives. The
final outcome of the WHO will be recommendations to place cannabis and its derivatives in the appropriate
"Schedules" of the International Drug Control Conventions. These schedules list all controlled drugs by their
perceived level of harm and directly impact the international laws and regulations to be applied to the said
drug.
Part of the work of the authors consisted of promoting a neutral, comprehensive and independent
assessment, one that recognizes and acknowledges both traditional knowledge and contemporary
research on Cannabis (the plant) and cannabis (the "drug").
Challenging and changing the current position of Cannabis/cannabis within the International Conventions'
Schedules (which until now bound countries to prohibit its use and eradicate the cultivation thereof) will
have profound effects worldwide, increasing room and opportunities for scientific research, but also
increasing medical access and supply. More broadly, it will ease off pressure against cannabis policy
reforms at the country level, and allow cannabis policies to be integrated into and linked with national
policies on health, human rights, education, economy, and rural or sustainable development.
* * *
The international obligations to prohibit cannabis – derived from the drug control Treaties which consider
cannabis as one of the drugs with the highest potential of harm and the least medical usefulness – have
not evolved since 1961. This undue scheduling was slowly constructed with an obscure process that
started in 1925, and ended in 1961 with the inclusion of cannabis and its derivatives at the highest possible
level of restrictive State control measures.
Unlike every other drug submitted to international restrictions, cannabis was never scientifically assessed
between 1925 and 1961, when it was included at first in the international schedules of the treaties. Neither
has it been reassessed after the identification in 1964 of tetrahydrocannabinol (THC), the main active
compound of cannabis. Moreover since 1964, even though dozens of new clinical applications were
evidenced by research, no further scientific reviews of the plant and its compounds were undertaken.
Since then, almost every single country has followed this scheduling, placing cannabis and
cannabis-derived medicines and health products under the strictest of national regulations, blocking
availability and denying access for medical patients and researchers, making legal production, trade, or
quality certifications almost impossible, whilst de facto creating a near-total prohibition of cannabis,
generating countless collateral harms in the process.
While the current classification of cannabis in the Treaties is, almost unbelievably, from an outdated and
obscure evidentiary process conducted before 1961, no scientific, evidence-based process has been
conducted to assess cannabis and classify it in the appropriate Schedule since that date.
It is essential to recognize the extreme complexity of international drug policy related to plant and
substance scheduling, its primary and central role in the prohibition regime, and its impact on day-to-day
practices and local policies.
The process of scientific assessment by the Expert Committee on Drug Dependence (ECDD), the only one
able to change the status of cannabis within the Treaties schedules, is supposed to be a routine internal
FAAAT think & do tank • The Crimson Digest (Vol. 1) 5/45
process of the World Health Organization. However, it has been repeatedly blocked since the adoption of
the Single Convention on narcotic drugs in 1961, while it could (and should) have happened long ago.
●Until 2014 (Details in Chapter 5)
A review process for THC had been started at the WHO, thought to help secure access to some basic
cannabis medicines, but also as a first step to evaluate the response of the countries. The countries
brutally stopped this process through the UN Commission on Narcotic Drugs (CND), and the WHO did not
react, letting the process come to a stop. It was at this moment that our team started to gather energy for
a new start for the WHO assessment process – this time not only for THC but for the whole plant.
●November 2015 - ECDD37
We first started attending the ECDD meetings during their 37th session. On this occasion, we pointed out
that one the experts was, in fact, the same lone witness previously presenting for the United States against
rescheduling in the country's federal court, Professor Bertha Madras – an Expert that the WHO had hired on
the ECDD. Through an oral statement delivered by Michael Krawitz, we asked the committee to look into
possible conflicts of interest due to the relationship of this researcher with the United States government.
Although the statement delivered by Krawitz to the ECDD was censored on the WHO website (the part of
his statement that dealt with Professor Madras removed), when the ECDD reconvened the following year
Professor Bertha Madras was no longer in the committee.
●April 2016 - UNGASS2016
The supreme organ of the United Nations, its General Assembly, held a Special Session focused on drugs
(called UNGASS 2016, for United Nations General Assembly Special Session). In the outcome document,
the countries agreed on the need for renewing and balancing approaches to the international scheduling
system, basing it on scientific evidence, and reaffirmed the role of the WHO. They also resolved to
“[support] scientific evidence-based review and scheduling of the most prevalent, persistent and harmful
substances” and called for “informed and coordinated scheduling decisions.”
●May 2016 - WHA69
Shortly after UNGASS, the 69th World Health Assembly, supreme organ of the WHO, took place in Geneva.
FAAAT’s goal there was to emphasize the new favourable landscape brought by the UNGASS outcome
document, as well as to convince the maximum number of stakeholders to provide increased support,
including financially, to the department of WHO in charge of the ECDD and the review process. We also
wrote and distributed a “Civil Society Declaration” on behalf of the IMCPC (International Medical Cannabis
Patients Coalition) and a “Memo for Member States” recalling the UNGASS outcome as well as the basics
of the review process, and the arguments supporting the need to undertake such a review for cannabis and
cannabinoids.
This Memo, had been constructed over the previous months, thanks to research and discussions with
experts and some Countries’ Drug-control authorities. Eventually, these discussions had a supplementary
beneficial outcome for the process: one of the countries we had been in discussions with (Czech republic)
orally expressed (in a World Health Assembly session) their concerns regarding the lack of a recent review
of literature concerning the medical applications of cannabis and cannabinoids on the part of the WHO,
and demanded that the WHO undertakes a review process concerning cannabis in order to update
knowledge and enlighten countries’ decisions on the matter.
Importantly, our stay in Geneva also provided us time for extensive research in the archives and library of
the United Nations.
●Fall 2016
We gathered support, evidence and Treaty-binding elements inciting the WHO to start the review, we
recalled the direct request by the Czech republic made in May [1], and combined it to previous declarations
of the UN Commission on Narcotic Drugs (CND) [2] and the International Narcotics Control Board (INCB)
[3] in the same direction. We included all these elements in a letter which was sent to the then
Director-General, Dr. Margaret Chan, by hundreds of scientists and political figures from all continents.
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Among the signatories of this letter was an NGO “in consultative status with the WHO” [4] which, according
to WHO’s rules, is one of the parties that can request a review of a substance by the ECDD.
●November 2016 - ECDD38
On three occasions before the 38th ECDD meeting in November 2016, the WHO eluded the review of
cannabis by organizing pointless "update" meetings without procedural value in the scheduling process. In
November 2016 however, cornered by the four direct mandates for a review (Country, CND, INCB,
consultative NGO - underlined with brackets in the paragraphs above), the WHO finally decided to begin the
review process for cannabis, under different components. They announced that the process would start
with the Pre-review of cannabidiol (CBD), and convened an extraordinary ECDD meeting specifically to
Pre-review all other products of the Cannabis plant:
- cannabis (buds) and cannabis resin,
- extracts and tinctures of cannabis,
- Δ9THC,
- Isomers of THC.
●November 2017 - ECDD39
At its 39th session, the Committee undertook the Pre-review of CBD. We joined efforts with the European
Industrial Hemp Association (EIHA) to present a mutual statement, both orally and in an extended written
version (which can be found on faaat.net/publications).
Our conclusion stated that “CBD is a safe to use substance that is beneficial to human health and public
welfare and has numerous applications in industry and nutrition, cosmetics as well as health and wellbeing
products, besides its promising benefits in diverse indications such as reducing anxiety or helping people to
quit smoking” and that recommending the scheduling of CBD “would severely restrict its availability for the
non-problematic consumers of CBD and CBD-related products, as well as undermining safe access for many
patients who already profit from CBD’s manifold health-related and homeostasis-supporting effects.” In our
understanding and conclusions, “Cannabidiol did not fit any of the requirements or criteria for inclusion in
the international drug control Schedules.”
We urged the ECDD “to clearly recommend the exclusion of Cannabidiol from the scope of the international
control measures, and reaffirm its unbelonging to the lists of internationally controlled substances.”
●December 2017 - Outcome of ECDD39
One month after the meeting, the outcome was presented during a CND session. Our call had been heard
by the Experts, who recognized that “CBD is not specifically listed in the Schedules” and that “there is no
evidence that CBD as a substance is liable to similar abuse and produces similar ill-effects to substances in
the 1961 or 1971 Conventions.” The outcome, however, assimilated CBD-rich extracts of cannabis as
“extracts and tinctures of cannabis”, already placed under Schedule I of the 1961 Convention.
●June 2018 - ECDD40
The 40th meeting of the ECDD (this extraordinary reunion, decided in November 2016, and focusing solely
on Cannabis) pre-reviewed cannabis, cannabis resin, extracts and tinctures of cannabis, THC and the
isomers of THC. They also did the Critical-review (final step) of CBD, which in the meantime had been
renamed as “pure CBD.” The outcome of the CBD Critical-review was clear enough: “pure CBD should not
be scheduled” reaffirming the outcome from the 39th ECDD (See Chapter 5.3).
●November 2018 - ECDD41
The ECDD, at its 41st session, is Critically reviewing cannabis, cannabis resin, extracts and tinctures of
cannabis, THC and the isomers of THC. The outcome of this 41st meeting Critical reviews is a definitive
and final recommendation proposing the adequate Schedule under which each of these item should be
placed.
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One of our first tasks has been to clear and highlight the reality of the hidden historical processes and
political influences that led to the current international scheduling of cannabis. That process started in
1925 with the inclusion of so-called “Indian hemp” in the by-then “anti-opium” treaties. The WHO and
numerous academics have been pretending that a scientific assessment had taken place in 1935, one
which supported the inclusion of cannabis in this Treaties – although the minutes were missing.
After extensive research in the archives and history of international cannabis control, the minutes from the
1935 meeting that was alleged to be the scientific basis of the inclusion of cannabis among the other
"dangerous drugs", were still impossible to find. Instead, most of the archives have mysteriously
disappeared.
The ones we could find, however, were hiding key elements that unravel the official story.
It was in fact after the second world war, between 1950 and 1961, that cannabis was placed under a status
of exceptionality by the diplomats preparing the draft 1961 Single Convention. They created the concept of
lists arranging drugs according to their perceived level of harm, and introduced the Schedule IV listing
drugs aimed at being completely prohibited – substances considered highly liable to create use disorders
and dependence, with particularly dangerous properties, and little or no therapeutic values.
The WHO started to take an 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 the literature was made and preparatory documents of the
2
meeting mentioned in the minutes of the Meeting are minimal. The following year, WHO Experts were
"pleased to note that the elimination of cannabis preparations had already begun by national action". In 1954
the Committee delivered its final sentence, relying this time on no more information than "the feeling
among the South African police of a relationship between cannabis addiction and crime" and "evidence
that, as in other parts of the world, cannabis abuse is likely to be a forerunner of addiction to opiates."
It is apparent that members of the Committee clearly acknowledged 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
unchallenged in history – until now: Their 1954 opinion 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" was the last time WHO emitted a statement regarding the uses of Cannabis…
3
until 2018.
2 WHO Technical Report Series nº57, 1952.
3 WHO Technical Report Series nº95, 1955.
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In 2015, the WHO edited an infographic resuming their Treaty-mandated roles on drug-related matters.
It is perhaps the best starting point to this section.
FAAAT think & do tank • The Crimson Digest (Vol. 1) 9/45
Chapter 1. The Schedules
As annex to the three international Treaties framing the drug laws and policies that countries can
implement (or not), there are a set of lists called the Schedules.
They include the whole panoply of products and substances that recent human history has placed "under
control", the unduly designated "illegal drugs".
Highly inconsequential and irrelevant in the eyes of any scientist, the Schedules and their methodology of
inclusion/withdrawal are like a drill core sample: they actually reflect the layers of an unspoken history of
geopolitical struggles that have characterized the 20th Century.
Before 1961, every substance needed its own international multilateral agreement to be placed under
control. Each country could choose to endorse it or not.
In 1961 a new Treaty compiled all the previous international agreements on drugs: the Single Convention. It
brought an incredible simplification tool, the Schedules, that allow countries to add or withdraw drugs from
the scope of international control and to automatically apply the related control measures to all Nations
that are signatories to the latter Convention, without the need for renegotiating a Treaty.
However, though the Schedules make the work of governments easier, it is a complex landscape which
needs to be debriefed for ordinary people.
1.1 International drug control Conventions
The so-called International Drug Control System relies on three Treaties:
●The 1961 Convention (Single Convention on Narcotic Drugs of 1961 as amended by the 1972
Protocol), which mostly deals with plants or pharmaceutical preparations, but also some
molecules. It recovers the many Treaties on opium and other drugs prior to World War II.
●The 1971 Convention (Convention on Psychotropic Substances of 1971). This particular one only
addresses psychoactive substances and drugs from a molecular chemical perspective.
●The 1988 Convention (United Nations Convention against Illicit Traffic in Narcotic Drugs and
Psychotropic Substances of 1988) reinforces the previous two and, as its name eludes, scales-up
international cooperation on the repression of traffic (and production/cultivation) of products,
substances and plants listed under the 1961 and 1971 Conventions.
It is critical to recall that the reading and implementation of these 3 Conventions is fully framed by general
international law, and in particular by the Human, Cultural, Civil, and Political Rights instruments and
Treaties, as well as the Charter of the United Nations.
Measures of the drug Treaties that would go against the UN Charter on fundamental rights should be
considered null and void.
1.2 An annex to the Conventions: their Schedules
Besides the plants and substances directly placed under control in the Articles of the 1961 Convention
(coca leaf, poppy and opium, cannabis and the Cannabis plant), and in order to create a rapid process of
legal response to the eventual appearance or discovery of new substances, the international community
created a mechanism that permits the CND (Commission on Narcotic Drugs of the United Nations, the
FAAAT think & do tank • The Crimson Digest (Vol. 1) 10/45
central legislative body on international drug control topics) to add or withdraw substances from the scope
of control established by the Convention.
With the notable exception of ethanol and nicotine (the active compounds of alcohol and tobacco,
respectively) most psychoactive products or substances are included in the Schedules of the 1961 or 1971
Conventions. Other non-psychoactive products, used as ingredients for the production of synthetic drugs,
are scheduled under the 1988 Convention against trafficking in drugs.
Except drugs genuinely included in the Treaties (mostly opium poppy, coca leaf, Cannabis and their
derivatives) every drug has to be scientifically assessed by independent Experts reporting to the World
Health Organization, in order to be placed in, changed, or withdrawn from a Schedule.
The 1961 Convention on narcotic drugs created four lists - four Schedules - that are each linked to
different, specific control measures. These Schedules list the drugs according to their therapeutic value
and their potential for "abuse" and "creating ill-effects".
The 1961 Convention is essentially structured around Schedule I, which constitutes the standard regime of
the Treaty. Some of the drugs included in Schedule I, considered as the most dangerous, are placed in the
complementary Schedule IV – also called the Prohibition Schedule.
Plants, drugs or substances placed under Schedule II of the 1961 Convention are submitted to the same
measures of control as the ones prevailing for schedule I, with some exemptions and a lighter subset of
policy obligations. Finally, drugs in Schedule III are pharmaceutical preparations containing drugs included
in the other schedules of the 1961 Convention, but with a much lighter control régime applied.
The 1961 Convention includes in its schedules pharmaceutical preparations, plants, raw drugs, precursors,
as well as chemicals, while the 1971 Convention only includes molecular compounds. However, the 1971
Convention on psychotropic substances followed this model and created four other (different) Schedules,
based on a more rigorous frame.
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1.3 Schedules of the 1961 Convention
Schedule III is a lighter subset of the schedules I and II. It exempts from control measures some
drug-based preparations that are considered less of a danger than the raw drug they contain (for instance,
while codeine is placed under schedule II, medicines containing less than 2.5% of codeine are placed under
Schedule III and therefore exempted from control measures applying to Schedule II).
Schedule IV is a stricter subset of schedule I, that specifies extra control measures. Any substance
included in Schedule I can also be added to Schedule IV, if it is considered "particularly liable to abuse and
to produce ill-effects and if such liability is not offset by substantial therapeutic advantages not possessed
by substances other than drugs in Schedule IV".
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1.4 Schedules of the 1971 Convention
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1.5 Treaty obligations.
Treaties and Conventions establish rules that signee countries commit to respect. In the present case,
there are two kinds of rules implied by the Treaties:
●Body rules, general rules specified in the articles of the Conventions,
●Schedule rules, also in the Articles but applying only to substances in a specific Schedule.
To provide a general overview of the obligations derived from the Schedules of the drug-control
Conventions, key measures of control imposed by the 1961 Convention have been summarized below.
Of course, beyond the obligations linked to the Schedule in which each substance or product is placed, the
Treaties also consider other measures, such as the obligation to eradicate “within 25 years” the cultivation
of Cannabis and other "narcotic" plants.
The Schedule IV or Prohibition Schedule, includes plants, drugs, substances or preparations that are
considered as having "particularly dangerous properties" in comparison to all other drugs. The worst of the
worst. The measures implied by Schedule IV forces countries (although it is not mandatory) to apply
stringent regulations, leading up to the complete prohibition.
An open reading of the Convention does not compel mandatory prohibition. It is indeed specified that a
country "shall, if in its opinion the prevailing conditions in its country render it the most appropriate means of
protecting the public health and welfare, prohibit the production, manufacture, export and import of, trade in,
possession or use of any such drug except for amounts which may be necessary for medical and scientific
research only." A compromise reached during the process of writing of the 1961 Convention, this article
indirectly leaves it up to the countries, and their own judgement, whether to enforce prohibition as the
means to protect public health or not. Applying prohibition or not, the chosen policy has to be considered
sincere and "bona fide" (in good faith). Such a decision made insincerely would be considered a violation of
the Treaty.
The text of the Convention already shapes a policy framework for each drug (in this case, prohibition).
However, as there is an exception for "medical and scientific research only", some minor production, trade
and use of the drug can be conducted. This is why there are complementary measures of control related to
the Schedules.
Mandatory control measures of the 1961 Convention
Schedules to
which
the measure
applies
Limitation to medical and scientific purposes
The production, manufacture, export, import, distribution of, trade, use and possession have to be
limited exclusively to medical and scientific purposes.
IV
I
II
III
System of licences
Governmental licensing is required for participation in any phase of the trade (manufacture, trade,
distribution). Licensed persons and enterprises as well as all the modalities of the business are
controlled.
IV
I
II
III
System of authorisations for import/export
A governmental authorisations is required for each individual international transaction (import and
export).
IV
I
II
Exceptions on licences
Governmental licensing is required for manufacturers of these preparations: a periodical permit specifies the kinds
III
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and amounts of drugs which they are allowed to manufacture.
Governmental licensing is required for the establishments and premises in which trade or distribution takes place.
Control and inspection
Governments must quite generally control all persons and enterprises carrying on, or engaged in the
manufacture, trade or distribution.
IV
I
II
III
Estimates for the International Narcotics Control Board (INCB)
Governments have to provide to INCB estimates of:
- the quantities of drugs to be consumed for medical and scientific purposes;
- quantities of drugs to be utilized for the manufacture of other drugs, of preparations in Schedule
III, and of substances not covered by this Convention;
- stocks of drugs to which the estimates relate;
- quantities of drugs necessary for addition to special stocks;
- the number of industrial establishments which will manufacture synthetic drugs and the
quantities of synthetic drugs to be manufactured by each of these establishments;
Afterwards, quantities in manufacture and importation, trade and distribution are limited in accordance
with the estimates.
IV
I
II
III
Exception on retail trade stocks
No obligation to prevent the accumulation of drugs in the possession of retail trade distributors, including in
excess of the quantities required for the normal conduct of business.
II
III
Exception on estimates
Estimates are not directly required for drugs in this Schedule, although indirectly, the general estimates of the drug
requirements (see above) must include information about the quantities of drugs to be utilized for the compounding
of these Schedule III preparations.
III
Reports to the INCB
Governments have to provide to INCB annual statistical returns on:
- production or manufacture of drugs;
- utilization of drugs for the manufacture of other drugs or preparations;
- consumption of drugs;
- seizures of drugs;
- stocks of drugs;
- area of cultivation;
- imports and exports of drugs (quarterly reports).
IV
I
II
Medical prescription
A medical prescription is required for the supply or dispensation of drugs to individuals.
Does not apply to such drugs that certain individuals may lawfully obtain, use, dispense or administer
in connexion with their duly authorized therapeutic functions.
Only authorized persons engaged in the drug trade and distribution, (such as manufacturers, wholesale
and retail traders, medical practitioners and scientists) are entitled to acquire the drugs necessary for
the performance of their legal business functions, professions or occupations.
IV
I
Exception on medical prescriptions
No obligation of medical prescriptions for the supply or dispensation to individuals
No obligation to use the official prescription forms in the shape of counterfoil books issued by authorities.
The label under which these drugs are offered for sale in the retail trade must not show the exact content by
weight or percentage.
II
III
Records
All participants in the trade have to keep detailed records of any transaction done. The obligation
however does not applies for medical practitioners (physicians, surgeons, veterinarians and dentists).
IV
I
II
III
Exception on records
Pharmacists (retail traders) are not obligated to maintain records of their retail sales of these drugs, unless if
they compound or prepare it themselves (with some minor variations).
II
III
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Chapter 2. The review process
The World Health Organization (WHO) is mandated by international law to review, assess and recommend
appropriate levels of control to apply to each drug already included in the lists of the international
Conventions, or those susceptible to enter. The process to generate such a public health benefit-risk
assessment of drugs, plants, products or substances liable to produce harms or dependence, is called
"scientific assessment" or "review of substances for international control". Officially, the purpose of this
"abuse liability assessment" is to "evaluate substances for international control" and "provide scheduling
advice".
The WHO defines its role regarding the three drug control Conventions as follows: "WHO is the only treaty
body with a mandate to carry out medical and scientific assessment of substances. According to the
Convention on Psychotropic Substances (Article 2, paragraph 5), the CND, taking into account the
information received from WHO “whose assessment shall be determinative as to medical and scientific
matters, and bearing in mind the economic, social, legal, administrative and other factors it may consider
relevant” makes a scheduling decision with regard to the substance.
The role of the WHO, through the Expert Committee on Drug Dependence (ECDD), is to evaluate the impact of
psychoactive substances on public health by evaluating their dependence producing properties and potential
harm to health, as well as considering their potential medical benefits and therapeutic applications. The
ECDD then makes recommendations for the scheduling (or de-scheduling) of substances according to
international drug conventions. These recommendations are communicated to the Secretary-General of the
United Nations, and are subject to a vote by the United Nations Commission on Narcotic Drugs (CND)."
The ECDD assessment process is precisely defined by the rules and procedures of the WHO – known for
being complex and with room for interpretation. The mechanism goes through all the existing data and
knowledge about a medicine (a product with known or supposed therapeutical properties, may it be a plant,
a substance or a complex preparation) determining the due policies and regulations that should apply to it.
The WHO entrusts this work to a group of independent Experts specially called for the occasion. This
group, the Expert Committee on Drug Dependence (or ECDD), analyzes the information submitted to them
by different stakeholders (see flow-chart of the evaluation procedure under Chapter 2.5), and assesses the
therapeutic effects, health-related or social harms that can be associated with the particular product.
The outcome of this global public health risk-benefit balance, is a recommendation to the United Nations to
concretely amend the Treaties' Schedules and include, withdraw or move drugs amongst these.
2.1 Launch
A proposal to review a drug, plant or substance, already present in the Schedules of the 1961 or 1971
Conventions or not, can come from different stakeholders, namely:
●One or several of the Experts of the ECDD themselves,
●WHO officials,
●The United Nations Office on Drugs and Crime (UNODC),
●The International Narcotics Control Board (INCB),
●Observers (necessarily NGOs in an official status of relations with the WHO),
●The UN Commission on Narcotic Drugs (CND),
●The government of any member country of the Conventions (called “Party to the Convention”).
Once one of these stakeholders presents a request for a review, the WHO should start collecting data and
add the suggested drug to the agenda of the next meeting.
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2.2 Preparation, documentation and data collection process
The preparation process consists of gathering all relevant data concerning the plant, product or substance
under review. It is prepared by civil servants of the WHO, employing three methods of data collection:
●Routine data collection by the Secretariat,
●Questionnaires sent to countries to collect field information and data from national drug agencies,
●Sub-contraction of an Expert or advisor to write a scientific report
Along the review process, several different documents are edited – and not always published. Only the last
of these, in the list below, proposes the definitive views on the product reviewed.
●Pre-review report, presented to ECDD [Uploaded in PDF version on who.int],
●Outcome report of the pre-review meeting [Edited and published in the WHO Technical Report
Series],
●Working-report on the questionnaires [Confidential],
●Working-report on the scientific data part [Confidential],
●Preliminary critical-review report for peer-review [Confidential],
●Critical-review report, presented to ECDD [Uploaded in PDF version on who.int],
●Outcome report of the critical-review meeting, including the final Scheduling recommendations
[Edited and published in the WHO Technical Report Series].
2.3 The Expert Committee meetings
The review process is composed of two meetings of the Experts. Each of these reviews has its own
preparation process.
●Pre-review. The purpose of this review is for the Experts to determine whether the data submitted
to them justifies that attention should be increased on the substance, and that a thorough
evaluation (Critical review) should be made on the basis of comprehensive data.
●Critical review. It is the central duty of the Experts. The outcome is definitive and has legal
consequences globally: if the United Nation adopts these recommendations, they become an
amendment of the Treaty’s schedules.
The closed-doors meetings gather all the Experts, plus some external advisers usually appointed among
experts of relevant international institutions (often the UNODC, the INCB and the European monitoring
center on drug addiction).
At every meeting, the WHO tries to better the possibility of involvement and inputs from civil society: there
is now an opening session where civil society representatives and researchers can present their views and
directly address the Experts.
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2.4 Assessment criteria
The criteria for the Experts to recommend a "change in the scope of drug control" (i.e the placement under
control of a drug, plant or substance, its change of Schedule, or its withdrawal from the lists) follows a
strict and formal, although illogical, assessment index, simplified in the chart below.
Essentially, these criteria can be summarized to the following:
●Similarity to substances already controlled under either the 1961 or 1971 Convention, or both;
●Degree of therapeutic usefulness;
●"Extent of abuse" or "degree of likelihood to abuse", or its liability to provoke addiction;
●Possible broader impact on public health and on creating social problems.
TREATY
PRINCIPLE
ASSESSMENT
CRITERION
If the substance, plant or preparation under review is either...
1
SIMILARITY
"liable to similar abuse, and productive of similar ill-effects
as the substances in Schedules I or II" of the 1961 Convention
OR
2
CONVERTIBILITY
"convertible into a substance already in Schedules I or II" of the 1961 Convention
OR
3
"of such a kind as to make it, by the ease of the process and by the yield,
practicable and profitable for a clandestine manufacturer to transform the
substance in question into controlled drugs",
...if it is, then it should be scheduled under the 1961 Convention.
...if it is not, but there is "sufficient evidence that the substance is being or is
likely to be abused so as to constitute a public health and social problem", and
the substance has...
4
DEPENDENCE
(AND "HIGH")
a "capacity to produce a state of dependence"
AND
capacity to produce a "central nervous system stimulation or depression,
resulting in hallucinations"
OR
capacity to produce a "disturbances" in "motor function" / "thinking" / "behaviour"
/ "perception" / "mood"
OR
5
SIMILARITY
if found that substance has no capacity to produce dependence nor a stimulation
or depression of the central nervous system, but "has the capacity to produce
similar abuse and similar ill-effects as a substance in Schedule I, II, III or IV" of
the 1971 Convention
...then it should be scheduled under the 1971 Convention.
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Luckily enough, the WHO has issued internal guidelines precising these elements. However, besides efforts
made to strengthen the procedure, the last Guidance for the Experts to recommend a level of control for
drugs dates back to 2010 . They would benefit from an in-depth revision, and should take advantage of a
4
civil society consultation where different academic proposals and methodologies could be shared.
2.5 Post-review process at WHO
Once a meeting has finished, the ECDD Secretariat takes care of editing the outcome of the discussions, to
shape it in the form of an outcome report. It is then cleared by the internal WHO administration and
ultimately endorsed by the Director-General of the WHO. The WHO has had a tendency to use this period
between the end of the Experts meeting and the release of the report to amend and sometimes undermine
opinions from the Experts.
The WHO DG takes then two steps:
●Transmission of the content of the recommendations to the Secretary-General of the United
Nations, for the emission of a Note Verbale to all countries, an official letter announcing the result
of the ECDD meeting and announcing the votes to come at the CND.
●Transmission of the report to the Executive Board of WHO for adoption and final publication in
press by the WHO Technical Report Series.
Every year in March, the CND meets and discusses the recommendations of the Expert Committee on Drug
Dependence. The Commission has a 2-years rotating membership of 53 countries. It is these countries that
have the right to vote on the scheduling recommendations of the ECDD.
2.6 Detailed flow chart of the review process
The next pages present a detailed flow-chart of the Pre-review and Critical review processes.
The opportunities for involvement of different stakeholders (Countries, UN agencies, civil society) has been
underlined, and the legend below can guide this lecture:
4 Guidance on the WHO review of psychoactive substances for international control, WHO, Geneva, 2010.
http://www.who.int/medicines/areas/quality_safety/GLS_WHORev_PsychoactSubst_IntC_2010.pdf
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Chapter 3. The Experts
3.1 Role and mandate of the ECDD
The ECDD (Expert Committee on Drug Dependence) of the World Health Organization is the only
international body responsible for conducting scientific and medical evaluations of all
dependence-producing plants or substances.
The ECDD releases recommendations concerning the level of international control to be applied, under the
1961 or the 1971 international Conventions on drugs, and submits it to the Commission on Narcotic Drugs
(CND) of the United Nations, the central legislative organ on drugs at international level.
The ECDD is a technical body, aimed at being independent from countries and political pressure.
The CND, one of the sub-commissions of the UN ECOSOC (Economic and Social Council), is a legislative
body where Parties to the international Conventions (member countries) gather to vote on the
recommendations of the ECDD.
Theoretically, no psychoactive substance can be scheduled internationally without first being evaluated by
this expert committee. All decisions from the CND to add or withdraw a drug from the schedules needs to
be backed by such a recommendation.
The review procedure, or abuse liability assessment, consists of a pre-review and a critical review ⇒Read
the Crimson Paper #3 to learn more about the pre & critical review.
Although they have no obligation to follow the ECDD recommendations, the treaties clearly imply that the
recommendations shall be followed by votes from the CND.
Outcomes from the ECDD meetings are issued in a report, published by the World Health Organization in its
Technical Report Series collection.
3.2 History
Although the name of the ECDD hasn't changed since 1969, it has previously had different names:
●1966-1969: Expert Committee on Dependence-Producing Drugs.
●1964-1966: Expert Committee on Addiction-Producing Drugs.
●1950-1964: Expert Committee on Drugs Liable to Produce Addiction.
●1949: Expert Committee on Habit-Forming Drugs established.
Before the second world war, the League of Nations used a so-called "Committee of experts in
pharmacology", the ancestor of the ECDD. Caught in a struggle between two concurrent ancestors of the
WHO (the Health Committee of the League of Nations, and the International Office for Public Hygiene), this
committee was issuing pseudo-scientific reviews of substances and recommendations for the
consideration of the League of Nations' General Assembly to place several substances under control. At
that time the Schedules were non-existent, each new substance required a specific multilateral agreement
to be ratified by every country individually, in order to fall under the international controls of the existing
Treaties.
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3.3 Nomination, rules and functioning
The ECDD is composed of independent experts, academics and researchers from all over the planet,
following the general rules of procedure of the WHO for the choice of independent experts working groups
(WHO's Regulations on Expert Advisory Panels and Committees):
Each meeting of the ECDD requires a renewal of its members, chosen by the WHO among a list of eminent
specialists in medicine, pharmacology, behavioural or biological disciplines, but also members of public
health administrations, etc. Mechanisms exist to prevent conflicts of interest.
The WHO, under its department of "Essential Medicines and Health Products", convenes, prepares,
organizes and monitors the meetings of the Experts. The so-called "ECDD Secretariat" is in charge of this
work. The Secretariat also compiles data and provides it to the Experts.
After years of absence of clear formal procedures, the WHO adopted in 2010 a document titled "Guidance
on the WHO Review of Psychoactive Substances for International Control" that precises the procedures to
5
be followed by the ECDD members to undertake the abuse liability evaluation within a clearer and more
accurately defined evidence-based process, centered around matters of public health.
However, previously to the very Experts' review, the process and criterion followed by the Secretariat for the
choice and selection of the relevance of data to be presented to the ECDD keeps following an undefined
procedure. That can possibly represent an important way of undermining the independence of the work of
the ECDD, by impeding access to parts of the collected data.
Apart from an introductory "open session" in which duly accredited observers can have short formal
exchanges with the Experts, all meetings and deliberations of the ECDD are confidential, and indeed made
public only after a clearing from the hierarchy of the WHO – another possible way of undermining the voice
of the Experts.
For more detailed information, we recommend the reading of a very complete article detailing the history,
6
process and details about the ECDD, as well as a NGO paper from 2014 .
7
5 See footnote 4, page 18
6 E. Danenberg, W.K. Scholten et al., Drug and alcohol dependence (#13, 2013, pp. 175–181)
7 C. Hallam, D. Bewley-Taylor and M. Jelsma, TNI-IDPC series No. 25, 2014
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3.4 Members of the Committee
37th ECDD
Nov. 2015
UPDATE
38th ECDD
Nov. 2016
UPDATE
39th ECDD
Nov. 2017
P-R CBD
40th ECDD
June 2018
C-R CBD
P-R CANNABIS
41st ECDD
November 2018
C-R CANNABIS
Junishi Kitanaka
♂
JAPAN
/
/
Sutisa Nudmamud Thanoi
♀
THAILAND
/
/
Katie Gysling
♀
CHILE
/
/
Lin Lu
/
♂
CHINA
/
/
Sandra Comer
/
♀
USA
/
Hye Jin Cha
/
♀
SOUTH KOREA
Simon Elliott
♂
UK
Raka Jain
♀
INDIA
Pamela Kaduri
♀
TANZANIA
Jason White
♂
AUSTRALIA
Afarin Rahimi-Movaghar
♀
IRAN
Ifeoma Toyin Ekwere
♀
NIGERIA
Patrick M. Beardsley
♂
USA
Bruna Brands
♀
CANADA
Bertha Madras
♀
USA
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Junishi Kitanaka
Pharmacology / Molecular neurobiology.
Specialist of methamphetamine use and
addiction.
Ex-NIDA advisor. Currently Associate Professor,
Hyogo College of Medicine
Sutisa
Nudmamud Thanoi
Psychiatry + Pharmacy + Medical &
Cognitive Neurosciences + Medicinal Plants
and Herbs + Depression
Department of Anatomy, Naresuan University
Katie Gysling
Biochemistry + Pharmacology + Interaction
between stress & addiction
Pontificia Universidad Católica de Chile
Lin Lu
Neurobiological mechanisms + clinical
intervention measures of psychiatric
disorders
National Institute of Drug Dependence of
Beijing University
Sandra Comer
Neurobiology + Psychiatry
Columbia University + New York State
Psychiatric Institute
Hye Jin Cha
Government official + Specialist of New
psychoactive substances and Synthetic
cannabinoids
National Institute of Food and Drug Safety
Evaluation, Ministry of Food and Drug Safety
Simon Elliott
Biochemistry + Forensic Toxicologist +
Biochemical Toxicology
Consultant + Managing Director of Forensics
Ltd (Alere Forensics) + Advisor of EMCDDA and
WHO on NPS
Raka Jain
Chemistry + Toxicology +
Neuro-psychopharmacology (Behavioral,
Biochemical, Molecular studies) + Abuse
liability & abuse patterns + tobacco
cessation
National Drug Dependence Treatment Centre +
Department of Psychiatry, All-India Institute of
Medical Sciences + In Charge of De-addiction
centres.
Pamela Kaduri
Addiction Psychiatrist
(MD, Mmed, MscCH) Addiction Psychiatrist at
the Department of Psychiatry and Mental
Health
Jason White
Pharmacology + Neurosciences + Behaviour
analysis & management of alcohol and drug
problems
Afarin
Rahimi-Movaghar
Psychiatry + policy-making on substance
use & mental health
Head of the Iranian National Centre for
Addiction Studies + Tehran University of
Medical Sciences + regular advisor for WHO &
UNODC
Ifeoma Toyin Ekwere
Pain medicine + Anaesthesia + Intensive
care
Senior Consultant Anaesthesiologist
Patrick M. Beardsley
Pharmacology + Toxicology
Researcher, Virginia Commonwealth University
Bruna Brands
Pharmacology
Office of Drug Science & Surveillance (Health
Canada) + Director of the Collaborative
Program in Addiction Studies (Univ. Toronto)
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Chapter 4. After the ECDD: Vote
& legal consequences.
The recommendations of the WHO do not enter into force by themselves. To be turned into a Treaty
amendment, they have to be endorsed by the United Nations, through its functional commission for
drug-related matters: the Commission on Narcotic Drugs (CND).
The United Nations Office on Drugs and Crime (UNODC) gives a clear overview of the “scheduling
procedures” on its website . “The CND exercises its mandated treaty-based scheduling functions under
8
agenda item entitled "Implementation of the international drug control treaties: Changes in the scope of
control of substances". Under that agenda item the Commission considers proposals to add substances to
the schedules/tables or to transfer or delete substances from the schedules/tables.”
4.1 The voting process
“In the case of changes in the scope of control of substances under the 1961 and the 1971 Conventions, the
Commission decides whether a substance is to be placed under international control. Under the 1961
Convention, it can either accept the recommendation of the WHO concerning changes in the scope of control
of substances or abstain from extending control at all. The CND cannot decide to add a substance or
preparation to a schedule of the 1961 Convention if WHO has not recommended to do it.”
“Under the 1971 Convention, the Commission has more discretion. It may decide - contrary to a
recommendation of WHO - to add a substance to a schedule of the 1971 Convention or refuse to do so, to
add a substance to a different schedule than recommended, or to remove a substance from the schedule in
which it is listed or refuse to do so. However, the CND has to take into account the assessment from the
WHO, which shall be determinative as to medical and scientific matters, and to bear in mind the economic,
social, legal, administrative and other factors communicated to it by the Parties. The Commission may also
decide to seek further information from the WHO or from other appropriate sources.”
The voting processes are very similar for the 1961 and 1971 Conventions. The only difference is in the
quorum for the vote:
●In the case of the 1961 Convention, “a single majority of the members of the Commission present
and voting is sufficient for decisions to add, transfer or delete substances to or from the schedules
annexed to the 1961 Convention”
●Under the 1971 Convention however, “a two-thirds majority of the members of the Commission is
required for such decisions”.
Although this is contested, it has already happened that the Commission decided by consensus not to vote
on recommendations concerning scheduling changes. This is what happened in 2014 with THC (see
historical timeline below).
8 See unodc.org/unodc/fr/commissions/CND/Mandate_Functions/Mandate-and-Functions_Scheduling.html
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4.2 53 Countries with right to vote
Afghanistan
Iraq
Algeria
Iran
Argentina
Israel
Australia
Italy
Austria
Japan
Belarus
Kenya
Belgium
Kyrgyzstan
Brazil
Mauritania
Burkina Faso
Mexico
Cameroon
Netherlands
Canada
Norway
Chile
Pakistan
China
Peru
Colombia
Qatar
Côte d'Ivoire
South Korea
Croatia
Russia
Cuba
Slovak Republic
Czech Republic
South Africa
Democratic Republic of Congo
Spain
Ecuador
Sudan
El Salvador
Switzerland
France
Thailand
Germany
Togo
Guatemala
Tur
key
Hungary
Uganda
India
USA
Uruguay
(Legend next page)
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Access to prescription cannabis in its
phytopharmaceutical form is possible,
in all or part of the territory.
AG
Countries members of the
African Group
Access to prescription cannabis in the form
of extracts or tinctures is possible,
in all or part of the territory.
APG
Countries members of the
Asia-Pacific Group
Access to prescription CBD preparations
or CBD-rich extracts is possible,
in all or part of the territory.
EEG
Countries members of the
Eastern European Group
Access to non-medical CBD preparations
or CBD-rich extracts is possible,
in all or part of the territory.
WEOG
Countries members of the
Western European and Others Group
Abdc.
Countries members of the
European Union
GRULAC
Countries members of the
Latin American and Caribbean Group
Abdc.
Countries members of the
Organization of American States.
Abdc.
Countries where some
non-illicit access to recreational
cannabis is regulated.
Map of the five regional groups of Countries within the United Nations.
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4.3 Negotiations within regional groups
As we can see in the chart above, countries are identified by their regional groups. As the regional groups
are pivotal elements of the broad United Nations system, arrangements and agreements are ordinarily
made between countries of these groups. Therefore, other considerations or negotiations, unrelated to the
topic of substance scheduling, can influence the decision of countries of the different regional groups to
align with the common position or not.
It is an important element to consider in the voting process that should be explicitly addressed by civil
society stakeholders, to avoid their country’s decision on the vote being a negotiation tool for other topics
within the regional groups.
4.4 Sovereignty breach in the European Union
During the last few decades, member countries of the European Union have been previously agreeing on
common approaches to adopt during the discussions and negotiations at CND. A joint position was always
sought for substance scheduling issues (and the vote that goes with it - as all other decisions at CND are
taken by consensus). In early March 2017, the European Commission and the Council of the European
Union decided that, on voting matters, the joint position of EU member states should be mandatory, and
that the vote of EU Member States on substance scheduling at CND should be previously authorized by the
Council.
Obviously, this “imperative mandate” to vote jointly interferes with the fact that some member states
belong to the UN regional group WEOG, and others to the regional group EEG (see above p. 28, under 4.2).
The Horizontal Working Party on Drugs of the European Union, much better known as Horizontal Drug
Group (HDG) is a preparatory body of the Council of the European Union, established in 1997 to coordinate
EU Member States’ internal action on drug-related matters, and their position in the international
landscape.
The HDG, integrated by top public servants from national drug-control agencies, meets on a monthly basis
in Brussels to prepare all relevant legislation and political documents adopted by the Council (EU drugs
strategies, action plans, or EU common statements on drug-related aspects for international fora, such as
the CND). They are also in charge of the cooperation with EMCDDA (European Monitoring Centre on
Drugs and Drug Addiction), Europol (European Law Enforcement Agency), with international organisations,
and with non-EU countries.
Originally, at the end of 2016, the Legal Service of the European Commission announced that the Treaties
9
allowed for an imperative mandate of all EU Member States for the votes on substance scheduling at the
CND – meaning that all the countries will agree to vote the same way prior to the actual vote, and be
obliged by such agreement to vote the same as the rest. This imperative mandate decided in the HDG has
already been functioning without a problem for decisions concerning the scheduling of ‘precursors’ under
the 1988 Convention (a very different process not addressed in this report).
9Proposal for a Council Decision on the position to be adopted, on behalf of the European Union, in the sixtieth
session of the Commission on Narcotic Drugs on the scheduling of substances under the Single Convention on
Narcotic Drugs of 1961 as amended by the 1972 Protocol and the Convention on Psychotropic Substances of 1971.
Explanatory Memorandum by the Commission. Brussels, 6th February 2017, included in 2017/0026 (NLE)
http://data.consilium.europa.eu/doc/document/ST-5912-2017-INIT/en/pdf
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“It is necessary that Member States prepare the meeting of the CND when it is called to decide on the
scheduling of substances by reaching a common position in the Council. Such position, due to the limitations
intrinsic to the observer status of the Union should be expressed by the Member States that are currently
members of the CND, acting jointly in the interest in the Union within the CND. The Union, who is not a party
to the 1961 UN Convention and to the 1971 UN Convention would not vote in the CND. To this end, the
Commission is proposing a position to be adopted, on behalf of the European Union…”
“The legal basis for this proposal is Article 83(1) in conjunction with Article 218(9) of the Treaty on the
Functioning of the European Union (TFEU).
“Article 83(1) TFEU identifies illicit drug trafficking as one of the crimes with a particular cross-border
dimension and empowers the European Parliament and the Council to establish minimum rules concerning
the definition of offences and sanctions in the area of illicit drug trafficking.
Article 218(9) TFEU applies regardless of whether the Union is a member of the body or a party to the
agreement at issue. The CND is "a body set up by an agreement" within the meaning of this Article, given that
it is body that has been given specific tasks under the 1961 UN Convention and the 1971 UN Convention.
The CND's scheduling-decisions are "acts having legal effects'' within the meaning of Article 218(9) TFEU.
According to the 1961 UN Convention and the 1971 UN Convention, decisions of the CND automatically
become binding, unless a party has submitted the decision for review to ECOSOC within the applicable
time-limit. The decisions of ECOSOC on the matter are final. The CND's scheduling decisions also have legal
effects in the EU legal order by virtue of Union law, namely Framework Decision 2004/757/JHA. Changes to
the schedules of the 1961 UN Convention and the 1971 UN Convention have direct repercussions for the
scope of application of this EU legal instrument.”
This imperative mandate, however, already did not apply to the United Kingdom due to technicals details
linked to the adoption of the Lisbon Treaty, with no link to their status of negotiation to leave the European
Union.
The HDG discussed that decision, “delegations expressed their views” – and disagreed with it.
“A number of delegations questioned the possibility/necessity to adopt a Council decision on this matter in
preparation for the forthcoming 60th CND session. Delegations questioned the EU competence in this area,
the appropriateness of the proposed procedure as well as the short timeframe for the procedure”
It was decided to refer to the COREPER II (2nd Committee of the Permanent Representatives of the
Governments of the EU Member States), a preparatory and advisory body of the Council that clears the
claims or disputes. The COREPER and the Council’s Legal Service, however, backed the proposal of the
Commission:
“The Union’s competence is exclusive in so far as it relates strictly to the scheduling of substances, and
therefore Member States are only able to exercise their voting prerogative at the CND once it has been
authorised by the Union, through a Council decision based on Article 218(9) TFEU.”
It is worth noting at this point that both HDG and COREPER take their decisions with a ⅔majority of the
votes.
Finally, the dispute was resolved a few days before the beginning of the CND session, with a precision that
the imperative mandate was concerned only with the decision to vote on substance scheduling, and not the
general position of Countries within the CND discussions.
The HDG therefore agreed to expand for narcotic drugs (1961 Convention) and psychotropic substances
(1971 Convention) the imperative mandate voting process that was already in force for their precursors
(1988 Convention).
As the EU Commission and Council noted themselves, the European Union is not a member of the
Conventions - just an observer entity. Therefore, the EU does not have right to vote. Even though, as it is
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explained in the Commission’s explanatory memorandum, the CND scheduling decisions automatically
apply to the EU, the decisions on substance scheduling are fully part of the sovereignty of States that have
individually ratified the Treaties.
This is however highly questionable, and seems to hamper the sovereignty of EU Member States on the
topic of substance scheduling.
4.5 Barriers at the Commission on Narcotic Drugs
As we have seen earlier, the CND can eventually decide not to vote on the recommendations. Such a step is
extraordinary, and happened to date only for THC (dronabinol) in 2014, after the WHO has recommended
on several occasions lowering the scheduling of this substance.
"At its 1277th meeting, on 14 March 2007, the Commission on Narcotic Drugs decided by consensus:
(a) Not to vote on the recommendation of the World Health Organization to transfer dronabinol and its
stereoisomers from Schedule II to Schedule III of the Convention on Psychotropic Substances of 1971;
(b) To request the World Health Organization, in consultation with the International Narcotics Control Board,
as appropriate, to undertake, for consideration by the Commission, a review of dronabinol and its
stereoisomers when additional information became available."
The decision by consensus (with all countries present) bypasses the limited mandate of only 53 countries
to vote on the recommendations, and is a way for countries that are not voting members of the CND to
overlap the mandate of “the 53” planned in the Treaty.
Another possible barrier at the CND level is its secretariat, that could eventually tend to diminish the
importance of the voting process (by scheduling it at the end of the meeting agenda, for instance).
4.6 After the vote: entry into force
It is possible for a Country to formally object to the UN Economic and Social Council (ECOSOC) about a
vote made at the CND. In this case (which is quite unlikely to happen) the ECOSOC can confirm, alter or
reverse the decision of the CND, and “the decision of the Council shall be final”.
If no objection is made, decisions become effective immediately (or after 180 days in the case of the 1971
Convention).
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Chapter 5. Timeline & history of
Cannabis in the Schedules
Basically, nothing has changed since 1961 for Cannabis, and since 1991 for THC. Before that however, the
uncertainty of the global community regarding the controls to apply was palpable:
1925 Geneva Treaty
1961 Convention
1971 Convention
THE WHO TAKES OVER THE LEAGUE OF NATIONS’ MANDATE
OF THE PRE-2nd WORLD WAR DRUG TREATIES.
1947
Indian hemp
Extracts of Indian hemp
1948
---
1960
ADOPTION OF THE
1961 SINGLE CONVENTION
1961
Herbal Cannabis
Schedule I
Schedule IV
Cannabis resin
Schedule I
Schedule IV
Extracts of Cannabis
Schedule I
Tinctures of Cannabis
Schedule I
1962
---
1970
ADOPTION OF THE
1971 CONVENTION
1971
All isomers
of THC
Schedule I
1972
---
1977
Only Δ6a(10a), Δ6a(7), Δ7,
Δ8, Δ9, Δ10 and Δ9(11) THC
Schedule I
1978
---
1990
Δ6a(10a), Δ6a(7), Δ7,
Δ8, Δ10 and Δ9(11) THC
Schedule I
Only
Δ9 THC
Schedule II
1991
---
2018
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5.1 From 2016 to 2018
Since 2016 however, and the launch of the review process, things are moving:
However, to better understand how this review process is now possible - and why it took so long to start it,
it is necessary to have a look at history. The journey between the inclusion in the lists and the reviews has
been a long, as shown in the chart above.
Interestingly enough, the Experts of the ECDD have proposed, on several occasions, to undertake scientific
assessments of tobacco or alcohol, noting that the harms generated by the use of these substances made
relevant their consideration for inclusion in the schedules.
In both cases, either the Experts or the WHO officials noted that the current legal framework - basically any
other legal framework than the one of the Treaties - would better address the public health problems
related to these substances, instead of an actual inclusion in the lists of narcotic or psychotropic drugs.
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5.2 From 1925 to 1961
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 a series of wars
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 .
10
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.
The Cannabis plant was genuinely included in the 1925 International Opium Convention, on the pedant
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 .
11
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.
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 preparations that
included other powerful compounds such as strychnine.
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.
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.
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 frameworks allowing medical
12
cannabis use, while seeking to discontinue policies that allowed non-medical uses.
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
10 E. 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.
11 To 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.
12 E/CN.7/AC.3/3
FAAAT think & do tank • The Crimson Digest (Vol. 1) 35/45
cannabis preparations." However, no review of literature was made, and preparatory documents of the
13
meeting mentioned in the minutes of the Meeting are minimal.
At its 4th meeting in 1953 the Committee "was pleased to note that the elimination of cannabis
14
preparations had already begun by national action, following the opinion expressed in its [3rd 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."
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."
15
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.
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 this
16 17
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."
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 régime 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."
Therefore the predecessors of the ECDD 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.
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
13 WHO Technical Report Series nº57, 1952.
14 WHO Technical Report Series nº76, 1954.
15 WHO Technical Report Series nº95, 1955.
16 E/2768/Rev.1
17 E/3133
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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 Committee met at its 11th Meeting, but although
18
acknowledging promising research on antibiotic properties of Cannabis, recalled for the third time that "the
opinion expressed in [the 3rd meeting] remains unchanged. Cannabis and its preparations are practically
obsolete and there is no justification for their medical use."
19
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.
The 5th and 11th Meeting of the Expert Committee repeatedly provided direct input to the Single Convention
on cannabis (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 an important therapeutic potential. Schedule IV has effectively stifled gold
standard research into Cannabis and cannabinoids medical applications.
5.3 From 1952 to 2018: detailed timeline.
Date
Body
Reference
Action taken related to Cannabis
1952
3rd ECDD:
ECDD03
TRS_57
Update of Cannabis as "Cannabis sativa L."
"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."
1953
ECDD04
TRS_76
Update of Cannabis as "Cannabis sativa L."
"The committee was pleased to note that the elimination of cannabis preparations had
already begun by national action, following the opinion expressed in its [ECDD03] report
that 'there is no justification for the medical use of cannabis preparations.' The
committee expressed its agreement with the action taken by the Commission on
Narcotic Drugs at its eighth session to the effect that the term 'Indian hemp' should be
replaced by the term 'cannabis', as proposed by the representative of the World Health
Organization. Furthermore, it was of the opinion that the definitions for cannabis and its
preparations should be revised on the basis of the presence of active principles."
1954
ECDD05
TRS_95
Update of Cannabis under the item "Situation concerning Cannabis sativa"
"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
18 E/CONF.34/5
19 WHO Technical Report Series nº211, 1961.
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forerunner of addiction to opiates.
The committee was pleased to note the steps taken by the Government of the Union of
South Africa to assess and control the cannabis situation in the Union. The committee
was also pleased to note information on improvement in the cannabis situation in India.
Evidence from India, however, confirmed the development of permanent deterioration as
the result of the abuse of cannabis. 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."
1959
ECDD 10
TRS 188
Opinion about Schedule IV: Total prohibition should not be mandatory, and Treaty
should impose the less restrictions as possible to physicians.
1960
ECDD11
TRS_211
Update about "Antibiotic Substances from Cannabis"
"The Committee considered the information available regarding substances with
antibacterial activity which can be extracted from Cannabis sativa. The Committee
concluded that at present the case has not been proved in favour of making cannabis
available for the extraction of useful drugs, particularly of the antibiotic type.
As regards the question of the therapeutic usefulness of cannabis, the opinion
expressed in [ECDD03] remains unchanged. Cannabis and its preparations are
practically obsolete and there is no justification for their medical use. This conclusion
does not affect the Committee's opinion as expressed in its tenth report.2 The
prohibition or restriction of the medical use of a drug representing a particularly high
danger to the community should continue to be recommended by the international
organs concerned, but should not be mandatory."
1961
Pleni-
potentiaries
Conference
Treaty
Adoption of the 1961 Convention on narcotic drugs.
The WHO's ECDD receives a more direct mandate from the Convention to recommend
scheduling of narcotic drugs.
1964
ECDD13
TRS_273
Definition of the "drug-dependence of cannabis type"
"Drug dependence of cannabis type is described as a state arising from repeated
administration of cannabis or cannabis substances, which in some areas is almost
exclusively periodic, in others more continuous. Its characteristics include:
(1) a desire (or need) for repeated administration of the drug on account of its
subjective effects, including the feeling of enhanced capabilities;
(2) little or no tendency to increase the dose, since there is little or no development of
tolerance;
(3) a psychic dependence on the effects of the drug related to subjective and individual
appreciation of those effects;
(4) absence of physical dependence so that there is no definite and characteristic
abstinence syndrome when the drug is discontinued."
1965
ECDD14
TRS_312
Update of "Cannabis"
"As pointed out previously, medical need for cannabis as such no longer exists. It is
becoming increasingly apparent that tetrahydrocannabinol is its most important
constituent from the point of view of pharmacodynamic effects, and
tetrahydrocannabinol or related substances, whether naturally or synthetically produced,
may eventually be shown to have medical applications. Research on cannabis will be
facilitated if all investigators will calibrate their methods and results using the same
uniform sample. Such a sample has been prepared by the Narcotics Laboratory of the
United Nations."
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1968
ECDD16
TRS_407
Update of "Cannabis*"
With the precision "Ganga, hashish, kif, maconha, marihuana and 'pot' are but a few of
the names commonly used in referring to cannabis."
"As pointed out by previous WHO Expert Committees concerned with drug dependence,
medical need for cannabis as such no longer exists.
However, the non-medical use of this substance persists and has been increasing in a
number of countries. In some countries, there are considerable differences of opinion
about questions of dependence liability, the acute and chronic effects on the individual
user and the community, and the type and nature of the controls to be applied.
This Committee strongly reaffirms the opinions expressed in previous reports 1 that
cannabis is a drug of dependence, producing public health and social problems, and that
its control must be continued.
It was generally recognized that more basic data on the acute and chronic effects of
cannabis on the individual and society are needed to permit accurate assessment of the
degree of hazard to public health. It was also noted that tetrahydrocannabinols, which
are important constituents of cannabis, have been isolated in pure form and completely
synthesized. The availability of these compounds will make it possible to intensify basic
research into such matters as tolerance, dependence potential, abuse liability, and
specific acute and chronic toxic effects."
1970
ECDD17
TRS_437
Recommendation to schedule "tetrahydrocannabinols"
Tasked with drafting the future 1971 Convention, the ECDD recommended to place
under control "tetrahydrocannabinols, all isomers" in the "Group (a)", the strictest
schedule (later adopted by Member States as Schedule I of the 1971 Convention),
without even the possibility of medical prescription.
Inherited from the 1931 Convention "Group 1" Schedule, the ECDD proposed "Group (a)"
was aiming to reune "drugs recommended for control because their liability to abuse
constitutes an especially serious risk to public health and because they have very
limited, if any, therapeutic usefulness."
Recommendation to schedule "cannabidiol" as a precursor.
Parallelly, ECDD proposes a supplementary 5th Schedule for the 1971 Convention, that
would list the substances precursor (easily convertible into scheduled drugs), a
concept foreshadowed in the 1931 Convention. Although they assumed the difficulty
to define criteria for inclusion would not allow them to create such a Schedule of
precursors, they still decided to review the case of 3 substances, among which
"cannabidiol, a precursor of the tetrahydrocannabinols used only in their preparation".
The ECDD recommended that CBD should fall under similar control measures as those
planned for THC:
"The Committee recommended that [cannabidiol] be controlled and suggested that the
broad controls be the same as those suggested for drugs in group (a), except that
(1) they should be available to licensed persons only on the basis of a non-refillable
order, and
(2) records should be kept of all transactions from the production or manufacture of the
precursors up to and including the initial disposal of any non-controlled products