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Letter to the International Narcotics Control Board regarding their future Guidelines on cannabis for medical and scientific purposes, dated 21 September 2020

Authors:

Abstract

The INCB is preparing a "guidelines/manual of good practices on the international drug control requirements for the cultivation, manufacture and utilization of cannabis for medical and scientific purposes" that "will support Member States in complying with the 1961 Single Convention." 1Since the establishment of such guidelines/manual represents a giant step on a topic rarely addressed so in-depth in the 52 years of activity of the Board, we sent a letter to INCB Board Members in order to provide insight into critical elements that such guidelines/manual should provide, particularly regarding the traditional, indigenous, and human rights aspect of cannabis as a medicinal plant.
Letter to INCB Board Members from 21 September 2020.
From:
Michael KRAWITZ,
Kenzi RIBOULET-ZEMOULI
To:
Members of the INCB
International Narcotics Control Board,
Vienna International Centre,
P.O. Box 500, A-1400 Vienna, Austria.
Barcelona, September 21st, 2020
Dear INCB member,
We hope this letter finds you well amidst particularly difficult times.
The INCB is preparing a “guidelines/manual of good practices on the international drug
control requirements for the cultivation, manufacture and utilization of cannabis for medical and
scientific purposes” that “will support Member States in complying with the 1961 Single
Convention.”
1
Since the establishment of such guidelines/manual represents a giant step on a topic
rarely addressed so in-depth in the 52 years of activity of the Board, we volunteer to provide
insight into critical elements that such guidelines/manual should provide.
Cannabis sativa
L.-based medicines are diverse, numerous, and complex. This is
however not necessarily problematic since these medicines correspond to pre-existing legal and
regulatory pharmaceutical and clinical systems which apply to most situations. The diversity and
complexity of these medicines are also reflected in a range of regulatory models, the three main
lanes of which being:
1. Standard regulations for pharmaceutical medicines (e.g.
, dronabinol, cannabidiol ,
2
nabiximols),
2. Standard regulations for phytopharmaceutical (herbal) medicines,
3. Sui generis regulations/protections for traditional pharmaceutical and
non-pharmaceutical medicines.
WHO finds that 82% of the world’s population uses some form of “lane 2.” herbal drugs and/or
“lane 3.” traditional drugs. ,
3 4
1 See UN Careers, cache page for the Job Opening “20 - United Nations Office on Drugs and Crime -
140183 - Consultant” https://careers.un.org/lbw/jobdetail.aspx?id=140183&Lang=en-US
2The medication identified with International Nonproprietary Name “cannabidiol / cannabidiolum”
is not an internationally controlled medicine.
3 Morris W, Gomes S & Allen M (2012), International Classification of Traditional Medicine. Global
Advances in Health and Medicine 2012;1(4):38–41.
4 See: World Health Assembly Resolutions on traditional & complementary medicine nº56.31
(2003), nº62.13 (2009), nº67.18 (2014), and nº69.39 (2016), as well as WHO Executive Board report
EB120/36 (2006).
* * *
Countries always have a system in place for “lane 1.”, and either have coexisting lanes 2. and 3.,
or only one of each (see WHO global report on traditional and complementary medicine 2019).
These are echoed, mainly, by these two clinical approaches and regulations:
A. Standard clinical healthcare regulations,
B. Sui generis
regulations for traditional healers or practitioners.
On “lane 1.”: It is likely that the Board will provide comprehensive guidelines regarding the
lanes 1. and A., however, these only concern a handful of medical products subject to
international control (e.g., dronabinol, nabiximols, other pharmaceutical compound-based
medications).
* * *
On “lane 2.”: Medical products available such as Bedrocan® or Bedrobinol® in the
Netherlands and many similar products in other countries provide access to medicines consisting
of prepared Cannabis flowering and fruiting tops (e.g.
, Germany, Israel, many States of the
USA). These are sometimes present in Pharmacopeias as such (e.g.
, German and Swiss
Pharmacopeia, American Herbal Pharmacopeia) as “Cannabis sativa flos
.”
Other corresponding products present or likely to be presented in Pharmacopeias as
herbal drugs are Cannabis sativa oleoresinæ or plantarum medicinalium extracta (see Ph.Eur.
5
monograph nº0765; corresponds in the Single Convention to “preparation of cannabis resin” or
“preparation of dronabinol” in the event WHO recommendations are adopted), but also tincturæ
,
teas and instant teas (plantæ ad ptisanam
, see Ph.Eur. monographs nº1435 and nº2620), etc.
It would be unfortunate if these products should be forcibly controlled and ruled under
inappropriate laws and regulations. They correspond to the “lane 2.” stated above of “standard
phytopharmaceutical medicines regulations” and should be regulated accordingly. This implies a
change in the focus of pre-conceived notions of the pharmaceutical system that do not
encompass the well-established specificities of herbal drugs. Europe’s drug agency (EMCDDA)
explains that, even beyond Europe:
6
“most pharmaceutical regulatory systems allow the use of herbal medicines that do not meet the
same requirements as those for pharmaceutical medicines [...] For example, manufacturers of
traditional herbal medicines with well-established uses are not usually required to provide
evidence of efficacy and safety from clinical trials. Instead, they are required only to show
evidence of product quality and consistency to ensure that consumers receive standardised doses
of herbal products that are free from contaminants or adulterants.”
5The concept of “herbal drugs” or “medicinal plants” is largely encompassed in Pharmacopeias
worldwide (Brazilian, British, Chinese, European, French, German, Indian, Japanese, Swiss,
Pharmacopeia). They sometimes merge single compound-based medicines and herbal medical
products, but most often provide for a separate volume for such medications.
6 See p. 21 in: EMCDDA (2018), Medical use of cannabis and cannabinoids: Questions and answers
for policymaking. Lisbon: EMCDDA.
www.emcdda.europa.eu/system/files/publications/10171/20185584_TD0618186ENN_PDF.pdf
In its General Guidelines for Methodologies on Research and Evaluation of Traditional
Medicine , WHO explains:
7
“methods such as randomization and use of a placebo may not always be possible as they may
involve ethical issues as well as technical problems. For example, it may be not possible to have
a placebo control if the herbal medicine has a strong or prominent smell or taste, as is the case for
products containing certain essential oils. In addition, patients who have been treated previously
with the herbal medicine under investigation that has a characteristic organoleptic property,
cannot be randomized into control groups.”
There is no justification for the INCB guidelines to overly restrict the model of assessment,
certification, and acceptance for herbal medicines, or to expand that of single compounds to
herbal drugs. INCB should refer Member States to applicable guidelines and manuals, such as:
- 2000: General Guidelines for Methodologies on Research and Evaluation of Traditional
Medicine7,
- 2011: Quality control for herbal materials ,
8
- 2018: WHO Expert Committee on Specifications for Pharmaceutical Preparations, 52nd
report , containing:
9
- Guidelines on good herbal processing (Annex 1),
- Guidelines on good manufacturing practices for herbal drugs (Annex 2),
- Good pharmacopoeial practices for herbal drugs monographs (Annex 7).
7 WHO (2000), General Guidelines for Methodologies on Research and Evaluation of Traditional
Medicine. Document WHO/EDM/TRM/2000.1
https://apps.who.int/iris/bitstream/handle/10665/66783/WHO_EDM_TRM_2000.1.pdf
8https://apps.who.int/iris/handle/10665/44479
9https://apps.who.int/iris/bitstream/handle/10665/272452/9789241210195-eng.pdf
Natural biodiversity Cannabis sativa
and associated traditional knowledge
National policies on traditional
& complementary medicine
Source: WHO global report on traditional and complementary medicine 2019. ©
World Health Organization 2019, All rights reserved.
Countries with endemic varieties of Cannabis sativa
, and
documented traditional knowledge, traditional cultural
expressions & folklore, before 1961.
Countries with documented traditional knowledge,
traditional cultural expressions & folklore, before 1961.
No data available.
Yes
No
No data available
n/a
On “lane 3.”: Traditional and complementary medicine (according to the terminology used by
WHO ) or indigenous systems of medicine (according to the words of the Commentary11) are
10
fully legitimate under the Single Convention at the same level as “lane 1.” In practice, the
11
INCB recalls in its report for 2001 (§208) a widely-documented and researched fact: “Cannabis
has been used in traditional medicine in some countries for centuries” and explains that
“Countries where traditional use of cannabis existed were allowed a 25-year moratorium to
phase out the use of cannabis for purposes other than medical and scientific purposes, in
accordance with 1961 Conv. Art. 49.” The “traditional use” mentioned does not concern
traditional medicine, which is a subset of medical purposes (thus allowed by, and controlled and
regulated under, the Single Convention)
Additionally, the United Nations Declaration on the Rights of Indigenous People
12
(UNDRIP) lays out “the minimum standards for the survival, dignity and well-being of the
indigenous peoples of the world” (Article 43). The UNDRIP is clear in that "Indigenous peoples
have the right to their traditional medicines and to maintain their health practices, including the
conservation of their vital medicinal plants” (Article 24), and that “indigenous peoples have the
right to be actively involved in developing and determining health, housing and other economic
and social programmes affecting them and, as far as possible, to administer such programmes
through their own institutions” (Article 23).
Article 8’s “Indigenous peoples and individuals have the right not to be subjected to
forced assimilation or destruction of their culture” suggests traditional medical systems should
not be assimilated within the conventional medicine system (e.g.
, “lane 1.” or “lane 2.”), and
specific policies and measures should be sought for that purpose.
In practice, this implies that expensive, overly-restrictive, and burdensome regulations
or administrative red tape should be avoided, simplified or adapted to allow indigenous peoples
to develop and sustain their traditional medical systems in countries where conventional medical
use is allowed.
The discontinuation of the traditional use of Cannabis in medicine, in some countries, is
not an excuse to ignore these issues. Indeed, “Indigenous peoples have the right to practise and
revitalize their cultural traditions and customs. This includes the right to maintain, protect and
develop the past, present and future manifestations of their cultures” (Article 11-1).
* * *
Link between “lane 1.” and “lane 3.”: Finally, the UNDRIP also specifies that “Indigenous
peoples have the right to maintain, control, protect and develop their cultural heritage, traditional
knowledge and traditional cultural expressions, as well as the manifestations of their sciences,
technologies and cultures, including human and genetic resources, seeds, medicines, knowledge
10 WHO defines traditional and complementary medicine as “the sum total of the knowledge, skill
and practices based on the theories, beliefs and experiences indigenous to different cultures
(whether explicable or not) used in the maintenance of health as well as in the prevention,
diagnosis, improvement or treatment of physical and mental illness.” See also the recent WHO
global report on traditional and complementary medicine published in 2019:
https://apps.who.int/iris/handle/10665/312342
11 “‘medical purposes’ does not necessarily have the same meaning at all times and under all     
circumstances [...] not only ‘western medicine’, but also legitimate systems of indigenous medicine
such as those which exist in China, India and Pakistan, may be taken into account in this
connexion.” (Commentary on the Single Convention, p.111, §12).
12 UNDRIP https://undocs.org/en/A/RES/61/295
of the properties of fauna and flora, oral traditions, literatures [...] They also have the right to
maintain, control, protect and develop their intellectual property over such cultural heritage,
traditional knowledge, and traditional cultural expressions.”
This triggers critical legal questions that the INCB should, at least, suggest Member
States pay attention to especially those Member States representing developing countries.
Contemporary Cannabis
medicines are developed from two sensitive materials:
-natural and genetic resources (the plants, derived from traditional varieties), without
which the development of Cannabis
pharmaceuticals is impossible, and
- the traditional medical knowledge over these resources (including oral knowledge or
ancient texts) which serves as a quintessential indication for pharmaceutical research
and development.
Both are subject to international laws and norms in particular the Convention on Biological
Diversity and its Nagoya Protocol (of prime relevance), FAO’s “Plant Treaty” , the Paris
13 14
Convention on the Protection of Industrial Property, the WTO TRIPS Agreement as well as a
15
series of other treaties administered by the World Intellectual Property Organization.
Non-compliance with these instruments constitute gross violation of international law and of the
rights of indigenous peoples and local communities to which Cannabis is a traditional and
complementary medicine. INCB should consider including these elements not only as
considerations for traditional medical knowledge or plant genetics holders but also for the
Western pharmaceutical research and development sector.
"Indigenous peoples have the right to the recognition, observance and enforcement of
treaties, agreements and other constructive arrangements concluded with States or their
successors and to have States honour and respect such treaties, agreements and other
constructive arrangements" (UNDRIP, Article 37-1)
The UNDRIP calls on the INCB: “The organs and specialized agencies of the United
Nations system and other intergovernmental organizations shall contribute to the full
realization of the provisions of this Declaration through the mobilization, inter alia, of
financial cooperation and technical assistance. Ways and means of ensuring participation of
indigenous peoples on issues affecting them shall be established.” (Article 41).
* * *
Porosity between “lane 1.” and “lane 3.”: There is a porosity between “Western” herbal drug
medicine and other traditional medicines, and Cannabis bridges both “lanes” because of its
formulations and because of the way it is used and perceived by patients and physicians. “The
preference among some patients for the medical use of herbal preparations of the whole
cannabis plant rather than pharmaceutical products has strong similarities to the reasons people
give for using traditional herbal medicines” . Moreover, “the fact that field-based academic
16
research in cannabis-producing countries has most often been limited in time, scope, and depth,
13Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits
Arising from their Utilization to the Convention on Biological Diversity. Signed in 2010, entered into
force in 2014, see: https://www.cbd.int/abs/
14International Treaty on Plant Genetic Resources for Food and Agriculture. Signed in 2001, entered
into force in 2004, see: http://www.fao.org/plant-treaty/en/
15Agreement on Trade-Related Aspects of Intellectual Property Rights.www.wto.org/trips
16 Joseph Brand & Zhao (2017), Cannabis in Chinese Medicine: Are Some Traditional Indications
Referenced in Ancient Literature Related to Cannabinoids? Front Pharmacol. 2017;8:108.
DOI:10.3389/fphar.2017.00108 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5345167/
explains why a large number academics and journalists alike write rather inaccurately not only
about the Cannabis plant but also about the many traditional [...] cannabis end products” .
17
* * *
On personal cultivation: INCB declares that “personal cultivation of cannabis for medical
purposes is inconsistent with the 1961 Convention for several reasons: it heightens the risk of
diversion and it presents health risks.” However, self-cultivation of cannabis for medical
18
purposes is only dependent on the Conventions, it is also dependent on international human
rights law in particular the right to privacy.
Countries that authorize self-cultivation do it under their constitutional principles
(reflected in international human rights law) of right to privacy and right to the free development
of personality. It is clearly established (see 1988 Convention and UN Charter) that
constitutional, fundamental rights are above and supersede the requirements of the Conventions
in case of conflict. Even refusing to incorporate the elements laid out in the 1988 Convention
legal analysis of international law echoes this superiority of human rights principles (in this
19
case, the human rights contained in constitutional texts) above and over any conflicting
provision mandated under the drug control Conventions.
Constitutional human rights protect the right of people to cultivate cannabis for their
personal use in a private context. This principle is not exclusive of medical use hence whatever
the purpose is of the self-cultivation (and regardless of the status of control of such purpose
under the Conventions) conventional obligations are not relevant in the case of self-cultivation.
* * *
On security requirements: INCB has repeatedly requested governments to scale-up minimum
security requirements for licensed cannabis production or manufacturing facilities. While the
need for safe workspace makes no doubt, the controls required under the Conventions are those
of monitoring, licensing, tracking, and scrutinizing the production. An analysis of the licensing
system in one Member State that implemented medical cannabis access policies noted that
overly-restrictive security requirements constitute a barrier to access to legally-regulated settings
for small-scale traditional farmers:
“farmers have been asked to set up a high perimeter fences and to install security cameras for
continuous monitoring. The costs for acquiring these are forbidding, the installation requires
significant inputs of labour, will then impede the free movement of farmers across the terrain not
to speak of blighting the landscape. Community members were caustic in their criticism of this
requirement, which they did not see as being needed given the circumstances of their location.
[These farmers] are situated in locations that are not easy to access among tight knit communities
with a long history of ganja cultivation. Strong community support, the difficulty of access to the
growing areas, and a severe approach to criminal justice mitigate the risks of praedial larceny
[=theft of agricultural produce] and diversion to criminal markets.”
20
17 Chouvy (2019), Cannabis cultivation in the world: heritages, trends and challenges, EchoGeo
2019;48. DOI:10.4000/echogeo.17591 https://journals.openedition.org/echogeo/17591
18www.incb.org/documents/Publications/AnnualReports/AR2018/LAUNCH/Highlights.pdf
19 English summary of International law and cannabis II. Regulation of cannabis cultivation and trade
for recreational use: positive human rights obligations versus UN Narcotic Drugs Conventions:
www.ru.nl/publish/pages/797876/internationaal_recht_en_cannabis_ii_-_english_summary.pdf
20 Klein A & Hanson VJ (2020), Ganja Licensing in Jamaica Learning lessons and setting standards.
University of the West Indies/Interdisciplinary Centre for Cannabis Research.
iccresearch.org/sites/default/files/Ganja%20Licensing%20in%20Jamaica%20-%20April2020.pdf
The Conventions do not impose specific security requirements, but an a priori and a posteriori
oversight of the national agency in charge of cannabis licensing and regulations. The details of
security requirements should be left up to Member States, depending on the particular conditions
of their territories and populations.
* * *
Conclusion: In recent reports the Board has recalled that international drug control is fully part
of international law and therefore falls under the Charter of the United Nations and the general
principles of international law beyond the three drug control legal instruments. Therefore, the
“international drug control requirements for the cultivation, manufacture and utilization
of cannabis for medical and scientific purposes” are not only those of the Single
Convention but also those of the international Human Rights instruments, the Convention on
Biological Diversity and its protocols, the FAO Plant Treaty, etc. Addressing only the
requirements of the drug control treaties with no mention of other key obligations of Member
States would not constitute “guidelines” but fundamental research, which is interesting, but not
the role of INCB.
Member States have obligations to respect, protect, promote, and progressively unfold
the “right to the enjoyment of the highest attainable standard of physical and mental health”
which includes the right for patients to access the medicines that both patient and caregiver
agree to use (a right expressly recognized by the Single Convention for the case of cannabis and
other controlled medicines). Any external injunction hampering the freedom of patients and
medical caregivers to select, access, prescribe, and use the medicine they deem useful for
therapy constitutes a violation of the right to health as contemplated in Article 25 of the
Universal Declaration of Human Rights and Article 12 of the International Covenant on
Economic, Social and Cultural Rights. This should be central to these proposed guidelines.
To achieve this, the guidelines should avoid recommending the creation of new layers of
sui generis
regulations for cannabis medicines, but rather rely on the different existing “lanes.”
The INCB should also remember its own words:
“civil society organizations have diverse perspectives on the means and modalities for the
implementation of the drug control conventions in their local communities. Nonetheless, without
the assistance of dedicated organizations, the aims of the conventions to prevent substance abuse
and provide treatment and rehabilitation will be hard to achieve. The Board therefore wishes to
reaffirm in this Alert the important role of civil society, as outlined in the outcome document of
the UN General Assembly Special Session (UNGASS) in 2016 and the 2019 Ministerial
Declaration. The INCB clarified at the time of UNGASS that the principle of a balanced
approach to elaborating drug policy means facilitating greater participation and cooperation
between all relevant stakeholders, including civil society groups”
21
* * *
21 INCB (2019), The role of civil society in the development and implementation of drug policies on
prevention, treatment and social reintegration. Document NºE/INCB/2019/Alert.16.
https://www.incb.org/documents/News/Alerts/Alert16_CES_Essay_civil_society_Dec_2019.pdf
We suggest the INCB revise the process for the edition of the planned guidelines, and:
-Extend the deadline, to take into account the pandemic and the following elements,
- Include references to existing guidelines for herbal & traditional medicines,
- Involve other UN agencies (at least WHO, Secretariat of the Convention on Biological
Diversity, WIPO & FAO),
- Engage in open-ended dialogues, and consult with civil society (patients, doctors,
scientists, indigenous peoples and other communities concerned),
- Share the above information with the Consultant in charge of drafting the report,
- Submit the draft report to a transparent and open process of “Public Comments.”
We remain at your disposal to assist in this direction. Our unequivocal commitment to human
rights, our strong not-for-profit approach, our commitment to multilateralism, and our absence of
conflicts of interest with either side of the debate can help the Board ensure the ultimate delivery of
guidelines that strengthen access and availability of medicine while efficiently countering the
potential risks associated with the inappropriate prescription and misuse of controlled drugs.
Sincerely,
Michael Krawitz,
Kenzi Riboulet-Zemouli
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