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Voluntary contribution to INCB
Guidelines on Medical Cannabis
– due diligence, good faith, & technical concerns.
Kenzi Riboulet-Zemouli & Michael Krawitz
24 February 2021 | Licence CC BY-SA
Ceiling of the UN Human Rights and Alliance of Civilizations Room, Geneva.
Photo: Tom Page / flickr
The authors wish to thank the many reviews, corrections and assistance provided by five experts.
Suggested citation: Riboulet-Zemouli, K. and Krawitz, M. (2021). Voluntary contribution to INCB
Guidelines on Medical Cannabis – due diligence, good faith, & technical concerns. Vienna: FAAAT
editions. ISBN ebook: 979-10-97087-09-8. Available at: faaat.net/incb
2
Tables and Figures
Table 1. Non-exhaustive list of human rights affected by the modalities of
international control over Cannabis for medical and scientific purposes. 8-9
Table 2. International entities with a mandate related to Cannabis for
medical purposes. 11
Table 3. Tentative timeline of the INCB Cannabis Initiative. 24
Figure 1. Growth in the number of Member States with national or state
level laws or regulations for T&CM, 1999–2018. 18
Figure 2. WHO Member States with a national or state level laws or
regulations for T&CM, 2018. 18
Figure 3. Are cannabidiol and cannabidiol products under international
treaty control? Flexibilities and options for legal interpretation. 22
Figure 4. Participation in the 1st Expert Group Meeting. 25
Figure 5. Participation in the 2nd Expert Group Meeting. 25
Introduction 3
Acronyms 4
1. Human rights approach: “more than an added value” 6
2. UN-system human rights due diligence and Cannabis, in practice 10
2.1. Human rights, the environment, and biological diversity 12
2.2. Human rights of indigenous peoples, peasants, and rural communities 13
2.3. INCB and T&CM: an amnesia 16
2.4. Freedom of religion and belief 19
3. Home cultivation and self-medication 19
4. Cannabidiol: from stance to insistence 21
5. (Lack of) civil society participation 23
6. Other technical issues 26
Conclusion 27
Annex: Letter addressed to INCB Board Members in September 2020. 29
3
Introduction
In March 2020, the International Narcotics Control Board (INCB) launched a “Cannabis
Initiative” with the purpose of issuing “guidelines/manual of good practices on the
international drug control requirements for the cultivation, manufacture and utilization of
cannabis for medical and scientific purposes” and to “support Member States in complying
with the 1961 Single Convention on Narcotic Drugs as amended by the 1972 Protocol, on
requirements for cultivation, manufacture and utilization of cannabis for medical and
scientific purposes.”
1
The INCB states:
“Objective of the Guidelines:
1. Improve implementation of the international drug conventions
2. Comply with the regulatory control and monitoring requirements of the licit trade
3. Monitor cannabis-related activities in national settings
4. Meet reporting obligations in accurate and timely manner”
The development of the guidelines has flown under the radar (Chapter 5). A consultant was
hired , and a series of stakeholders meetings held, during a pandemic. The important
2 3
discussions on the WHO’s recommendations for changes in the scope of control of cannabis
and cannabis-related substances eclipsed INCB’s work in 2020. In 2021 the agenda of
Member States’ Vienna delegations will be centered around two major upcoming events (UN
Crime Congress in March, and General Assembly special session on corruption, in April ).
4
The draft Guidelines raise a series of questions: they contain a number of issues (Chapter 6)
among which an overlap the mandate of the World Health Organization (WHO) and that of
State Parties (Chapters 3 & 4) they favour certain formulations against others, they disregard
the latest developments in scientific research and clinical applications taking place in Member
States, they ignore the hundreds of years of history of use in medicine and the particularities
that this entails, compared to other medications (Chapter 2).
The drug control conventions do not operate in a vacuum: They operate within the rule of law
that is framed, internationally, by the UN Charter and human rights instruments. INCB’s
Guidelines on medical cannabis must acknowledge this and invite governments to ensure full
compliance with international law not only within drug control (Chapter 1).
1 United Nations careers. (2020). Job Opening, Number: 20-United Nations Office on Drugs and
Crime-140183-Consultant. careers.un.org/lbw/jobdetail.aspx?id=140183&Lang=en-US
2 Ibid. See also Chapter 5
3 INCB. (2021, January 22). INCB holds Expert Group Meeting on control and monitoring requirements of cannabis
and cannabis-related substances (UNIS/NAR/1430).
www.incb.org/incb/en/news/press-releases/2021/incb-holds-expert-group-meeting-on-control-and-monitoring-req
uirements-of-cannabis-and-cannabis-related-substances.html
4 UNGA. (2020, June 2). Resolution 74/276. www.undocs.org/en/A/RES/74/276
4
Inter-governmental organizations (IGOs), in performing their mandate, have the duty to show
“due diligence” with respect to the full international legal order, not just the treaty under
which they are mandated. Omission or failure to do so can mislead countries to breach their
compliance with other instruments of international law, particularly those which supersede
certain dispositions of drug control, such as international human rights law (IHRL).
For Cannabis sativa, this is true for fundamental human rights (right to health, to science, to
privacy), but also for unforeseen economic, social and cultural rights (related to indigenous
peoples and local communities, the environment, the trade in biological, genetic material, and
plant resources, the involvement of traditional medical knowledge, etc.) (Chapter 2). The areas
of work the INCB disregards are primarily those that concern developing countries, and in
particular indigenous peoples, rural, and other vulnerable communities.
Acronyms
Δ9-THC delta-9-tetrahydrocannabinol
API Active Pharmaceutical Ingredients
CBD Convention on Biological Diversity*
CEDAW Convention on the Elimination of All
Forms of Discrimination against
Women
EMCDDA European Monitoring Center on Drugs
and Drug Addiction
EU European Union
FAO Food and Agriculture Organization of
the United Nations
HRC Human Rights Council
ICJ International Court of Justice
IGO Inter-governmental organizations
ILC International Law Commission
IHRL International Human Rights Law
INCB International Narcotics Control Board
IPLC Indigenous Peoples and Local
Communities
ICCPR International Covenant on Civil and
Political Rights
ICESCR International Covenant on Economic,
Social and Cultural Rights
ICERD International Convention on the
Elimination of All Forms of Racial
Discrimination
OHCHR Office of the United Nations High
Commissioner for Human Rights
Plant Treaty International Treaty on Plant Genetic
Resources for Food and Agriculture
T&CM Traditional & Complementary Medicine
UDHR Universal Declaration of Human Rights
UNDRIP United Nations Declaration on the
Rights of Indigenous Peoples
UNDROP United Nations Declaration on the
Rights of Peasants and Other People
Working in Rural Areas
UNEP UN Environment Programme
UNGA United Nations General Assembly
UNGASS UNGA Special Session
UNODC United Nations
UNPFII United Nations Permanent Forum on
Indigenous Issues
WHO World Health Organization
WIPO World Intellectual Property
Organization
* The acronym “CBD” is not used for “cannabidiol”
The INCB should exercise due diligence –just like it has done with regards to death penalty.
The Board should also be open to inputs from civil society and academics, and not only
government officials and the largest private sector companies –similar to the consultations
organized by the INCB on a number of other subjects during the previous years.
5
“Everyone is entitled to asocial and international order in which the rights and
freedoms set forth in this Declaration can be fully realized.”
– Universal Declaration of Human Rights, Article 28.
“The United Nations shall promote [...] universal respect for, and observance of,
human rights and fundamental freedoms for all”
– United Nations Charter, Article 55.
“International organizations [...] are bound by any obligations incumbent upon
them under general rules of international law”
– International Court of Justice (Advisory Opinion of 20 December 1980).
“Unnecessary suffering resulting from a lack of appropriate medication due to inaction
and excessive administrative requirements is a situation that shames us all”
– International Narcotics Control Board (Preface of the 2015 ‘availability report’).
6
1. Human rights approach: “more than an added value”
“Placing human rights at the centre of drug control” is broadly recognized as a goal and task
5
of the international community. In 2010, UNODC Executive Director commented:
“Such an approach represents more than ‘added value’; it is a legal obligation. [...] That the
fight against drugs, crime and terrorism must conform to human rights is clear. The challenge
is to understand how these policies may be pursued in a manner that not only respects and
protects human rights, but also contributes towards their positive fulfilment.”
6
The international community is composed of a series of public stakeholders: the States -
parties to the treaties, but also international or inter-governmental organisations (IGOs) as
well as non-State actors which include non-governmental organizations, academia and
researchers both independent and in publicly or privately supported institutes.
When seeking to pursue human rights-compliant drug policies, not only States, but also IGOs
and civil society are subject to the same rule of law in the international order, lying in human
rights, development, peace and security. UNODC explains:
“The normative foundation of the United Nations' work on the rule of law is the Charter of the
United Nations and the body of international law, including international human rights law [...].
Responses to drugs, crime and terrorism that are based on the rule of law must therefore also
incorporate human rights law and principles.”
7
These norms are to be known, considered and implemented by all stakeholders. At the
international level this translates into the need to respect, or at least not adversely impact
areas of work of other IGOs, but also State obligations beyond drug control.
IGOs have legal personalities , and can be held accountable. Although IGOs are not per se
8
parties to the human rights instruments, this does not allow them to disregard international
human rights law (IHRL) in fulfilling their mandate. The International Court of Justice (ICJ)
recalls that “there is nothing in the character of international organizations to justify their
being considered as some form of ‘super-State.’ International organizations are subjects of
international law and, as such, are bound by any obligations incumbent upon them under
general rules of international law.” This is confirmed by the International Law Commission
9
(ILC), which clearly places a responsibility over IGOs to ensure they do not induce or
10
encourage a State to commit an act in violation of international law.
5 UNODC. (2010). Drug control, crime prevention and criminal justice: A Human Rights perspective. Note by the
Executive Director (E/CN.7/2010/CRP.6–E/CN.15/2010/CRP.1).
unodc.org/documents/commissions/CND/CND_Sessions/CND_53/CRPs/E-CN7-2010-CRP6_V1051605_E.pdf
6 Ibid. p. 3
7 UNODC. (n.d.). UNODC mandates and human rights foundations.
www.unodc.org/unodc/en/Human-rights/unodc-mandates---more.html
8 ICJ. (1949). Reparations for Injuries suffered in the Service of the United Nations, Advisory Opinion of 11 April 1949.
www.icj-cij.org/public/files/case-related/4/1837.pdf
9 ICJ. (1980). Interpretation of the Agreement of 25 March 1951 between the WHO and Egypt, Advisory Opinion of 20
December 1980. www.icj-cij.org/public/files/case-related/65/065-19801220-ADV-01-00-BI.pdf
10 In its Articles on the responsibility of international organizations, the ILC included a Chapter on the “Responsibility
of an international organization in connection with the act of a State or another international organization” which, in
particular in its Article 15 on the “Direction and control exercised over the commission of an internationally wrongful
act” and Article 17. See: ILC. (2011).
7
Photo: Richard Burlton / unsplash
This is called due diligence.,The need for due diligence within and among IGOs is an
11 12
important field of study for academics It has also explicitly been outlined in 2011 by UN
13
Secretary General in its UN Human Rights Due Diligence Policy specifically focused on
14
peacekeeping missions. Nonetheless it offers insights for IGO’s approach to due diligence:
“This endeavour is congruent with the growing attention that issues of ‘shared responsibility’
receive today. Traditionally, the law of international responsibility was focussed very much on
the relationships between pairs of two states—a wrongdoing state and an injured state.
Whether and if so how a third state—let alone an [IGO]—would impact on the commission of a
wrongful act was considered to be a marginal issue. This is no longer the case. Especially for
states and [IGOs] which proclaim in a solemn manner their attachment to ideals of the
international rule of law, it would fall significantly short of this rhetoric if they pretended that it
was none of their business how their support to another actor would be used for the
furtherance of wrongful conduct. This is especially true for the UN.”
15
IGOs (including the INCB) have a legal responsibility to show due diligence with respect to
the international legal order while performing their treaty mandates. Omission or failure to do
so –negligence– can lead States to breach compliance in other areas of international law
and/or hinder the work of other IGOs.
11 Interestingly, the concept of due diligence can be related to that of bona fide (good faith) present in the
international drug control Conventions. With the difference, as we have seen, that due diligence applies also to
IGOs between themselves, and with regard to States.
12 “Due diligence comes from Latin diligentia which can be translated as care or circumspection. The opposite of
(due) diligence is negligence. [...] Diligence is a qualifier of behaviour as shown in its adverbial use: an actor can
behave diligently –or negligently. Due diligence thus is no free-standing obligation but a modality attached to a duty
of care for someone or something else (including the duty to prevent and mitigate harm). One might call it an
ancillary obligation if one wants to use the language of obligation at all.” Peters A., Krieger H. & Kreuzer L. (2020).
Due Diligence in the International Legal Order: Dissecting the Leitmotif of Current Accountability Debates. In:
Krieger, H. Peters, A. & Kreuzer, L. Due Diligence in the International Legal Order (pp.1–19). Oxford, UK: Oxford
University Press. books.google.es/books?hl=es&lr=&id=tmkLEAAAQBAJ
13 In 2020, a new Chair on “International Law of Institutions” opened at the College de France, with its first course
titled “Diligence and Negligence in International Law” and addressing specifically the roles and responsibilities of
IGOs. See: Collège de France. (2020). Samantha Besson, International Law of Institutions, 2020-2021 lecture
"Diligence and Negligence in International Law".
www.college-de-france.fr/site/en-samantha-besson/course-2020-2021.htm; see also Samantha Besson. (2020).
Due Diligence and Extraterritorial Human Rights Obligations – Mind the Gap! ESIL Reflections, 9, 1.
hal.archives-ouvertes.fr/hal-02918960/document
14 United Nations Secretary-General. (2013). Identical letters dated 25 February 2013 from the Secretary-General
addressed to the President of the General Assembly and to the President of the Security Council: "Human rights due
diligence policy on United Nations support to non-United Nations security forces" (A/67/775–S/2013/110).
undocs.org/en/A/67/775
15 Helmut, P. A. (2015). The UN Human Rights Due Diligence Policy: An Effective Mechanism against Complicity of
Peacekeeping Forces? Journal of Conflict and Security Law, 20, 1, pp.61–73.
8
Table 1.
Non-exhaustive list of human rights affected by the modalities of international
control over
Cannabis
for medical and scientific purposes.
Right
Included in:
Examples
involving
Cannabis
Human Rights
declarations
International legal
instruments
Right to highest
standards of
health
UNDRIP Art. 21, 23, 24
UNDROP Art. 4(2), 23(1)
UDHR Art. 25(1)
ICESCR Art. 12
ICERD Art. 5(e)(iv)
Lack of access and
availability besides
ease of cultivation
Right to traditional
medicines
UNDRIP Art. 24
UNDROP Art. 23(2)
ICCPR Art. 1, 47
ICESCR Art. 1(2), 11, 15, 25
ICERD Art. 5(e)
CBD Art. 8(j), 10, 15
Plant Treaty Art. 9
Access to medicinal
plant based
products restricted
Biopiracy
Undue appropriation
of traditional
medical knowledge,
or agricultural
know-hows
Right to seeds,
plants and genetic
resources
UNDRIP Art. 31
UNDROP Art. 19
Right to prior and
informed consent
UNDRIP Art. 11, 19, 28, 29
Rights to natural
and cultural
heritage
UNDRIP Art. 8, 11, 29, 31
UNDROP Art. 5, 18, 26
Right to benefit
from science
UNDROP Art. 2(6)(c), 25
ICESCR Art. 15
Findings about
medical
applications not
reflected in broader
patient access
Research hampered
by strict treaty
controls
Right to privacy
American Convention on
Human Rights Art. 11
Arab Charter on Human Rights
Art. 16, 21, 31
ASEAN Human Rights
Declaration Art. 21
European Convention on
Human Rights Art. 8
UDHR Art. 12
ICCPR Art. 17
Interference with
self medication and
home cultivation
Invasion of private
property and
consensual
transactions
Right to
participation in
policy-making
UNDRIP Art. 18, 23
UNDROP Art. 2(3), 10, 11, 15(4)
Sustainable Development
Agenda, Goal 17
UDHR Art. 21
ICCPR Art. 25
ICESCR Art. 8
ICEAR Art. 5(c)
CEDAW Art. 7, 8
Only large
companies are
consulted, and not
peasants, IPLC,
patients or
healthcare workers
9
Table 1.
Continued.
Scholars ,and IGOs themselves, ,including the INCB agree that an enforcement of
16 17 18 19 20
international drug control requirements without consideration of other aspects of IHRL can
lead to breaches. When considering the cultivation, trade and use of Cannabis sativa L. for
medical and scientific purposes for its Guidelines it is quintessentially important for the INCB
to consider the package of IHRL that relate to health, well-being and access to medicine and
health services.
21
It is also important to consider that Cannabis sativa is a plant with environmental,
biodiversity, traditional, cultural, and indigenous ties –all elements constitutive of relevant
IHRL dispositions on their own (see Table 1).
Although the role of the INCB is not to comprehensively assess and balance the international
obligations of States with regards to Cannabis, the Board should exercise due diligence to
ensure, at least, that its Guidelines do not support States in, or promote them to ignore or
breach other dispositions of international law that can supercede drug control.
16 Piet Hein van Kempen and Masha Fedorova. (2016). International law and cannabis II. Regulation of cannabis
cultivation and trade for recreational use: positive human rights obligations versus UN Narcotic Drugs Conventions
[Executive summary]. Nijmegen: Radboud University.
www.ru.nl/publish/pages/797876/internationaal_recht_en_cannabis_ii_-_english_summary.pdf
17 Piet Hein van Kempen and Masha Fedorova. (2016). Internationaal recht en cannabis II: Regulering van
cannabisteelt en-handel voor recreatief gebruik: positieve mensenrechtenverplichtingen versus VN-drugsverdragen.
Alphen aan den Rijn: Wolters Kluwer. www.ru.nl/publish/pages/797876/internationaal_recht_en_cannabis_ii.pdf
18 United Nations Development Programme. (2019).
19 UNODC. (2012). UNODC and the promotion and protection of human rights; position paper.
unodc.org/documents/justice-and-prison-reform/UNODC_Human_rights_position_paper_2012.pdf
20 “There are a number of unintended consequences that can flow from a variety of factors, including the unbalanced
implementation of national and international drug control measures.” §38 in INCB. (2016). Report of the International
Narcotics Control Board for 2015 (E/INCB/2015/1).
21 See for instance: OHCHR. (2021). Claiming Human Rights > Definitions of the right to health [online].
www.claiminghumanrights.org/health_definition.html
Right
Included in:
Examples
involving
Cannabis
Human Rights
declarations
International legal
instruments
Right to non-
discrimination
UNDRIP Art. 2, 46(3)
UNDROP Art. 4
UN Declaration on the Right to
Development Art. 6
Sustainable Development
Agenda Goal 10
ICCPR Art. 2(1), 26
ICESCR Art. 2(2)
ICEAR Arts. 2, 5
CEDAW Art. 2
Persistence of
colonial policy and
practice w.r.t.
pre-colonial plants,
products &
practices.
Access to legal
schemes not
possible for small
stakeholders
Right of religion
and belief
UNDRIP Art. 11, 12, 24, 35
UNDROP Art. 8
UDHR Art. 18
ICCPR Art. 18
ICERD Art. 5(d)(vii)
Rastafari
(Caribbean), Sadhus
(Himalayas), etc.
10
On Cannabis and drug policies, the Committee on Economic, Social and Cultural Rights
(CESCR) recently provided insights about Cannabis, recalling that:
22
“given the potential health benefits of these controlled substances, the [drug control]
restrictions should also be weighed up in relation to States parties’ obligations under article 12
of the Covenant [on Economic, Social and Cultural Rights].”
The CESCR also clarifies the dynamic nature of the “precautionary principle” noting that:
“The precautionary principle should not hinder and prevent scientific progress, which is
beneficial for humanity. Nonetheless, it should be able to address available risks for human
health and the environment, inter alia. Thus, in controversial cases, participation and
transparency become crucial because the risks and potential of some technical advances or
some scientific research should be made public in order to enable society, through informed,
transparent and participatory public deliberation, to decide whether or not the risks are
acceptable.”
23
These elements should be kept in mind while discussing matters pertaining to the intersection
of Cannabis control with economic, social and cultural rights.
2. UN-system human rights due diligence and
Cannabis
, in practice
INCB seems to be developing its Guidelines in a vacuum –contrary to UNODC’s Human
Rights recommendations. This could therefore lead States to, if not direct them towards,
24
breaching their obligations under IHRL. There are many human rights that can be hindered by
wrongful or poorly advised drug control policies (non-exhaustive list in Table 1).
25
In the case of the millenia-old medicinal plant Cannabis sativa, a series of supplementary
rights are at stake –individual, collective, and nation-wide rights. The most specific and
emblematic case is possibly that of indigenous peoples, who have been using Cannabis as
part of their traditional pharmacopoeia –as the INCB recognized two decades ago: “Cannabis
has been used in traditional medicine in some countries for centuries.”
26
INCB should exercise due diligence with regards to a number of areas of international law that
correlate directly to the international trade in Cannabis for medical and scientific purposes.
UNODC suggests to assess IGOs’ programs in liaison with the Office of the High
22 See § 68, in: CESCR. (2020). General comment No. 25 (2020) on science and economic, social and cultural rights
(article 15 (1) (b), (2), (3) and (4) of the International Covenant on Economic, Social and Cultural Rights).
undocs.org/E/C.12/GC/25
23 Ibid. § 57.
24 “No treaty, however special its subject-matter, applies in a normative vacuum, as both general international law
(including customary international law) and particular concurrent international obligations affect its interpretation
and application” See §9 in: UNODC. (2010). “Whilst the maintenance of effective working relationships with
government counterparts is important, technical assistance cannot be delivered in a vacuum that is divorced from the
wider human rights and rule of law context. Protection of human rights need not involve public denunciation of
abuses. Rather, through constructive and open dialogue with government counterparts, human rights protection may
be achieved alongside the delivery of technical assistance. Indeed, effective support for the rule of law requires both
the willingness to partner and the willingness to be clear and bold on international human rights law and standards.
From a practical perspective, human rights protection issues are most usually to be addressed in coordination with
OHCHR and the UN Resident Coordinator system.” in: UNODC. (2012).
25 United Nations Development Programme. (2019). International Guidelines on Human Rights and Drug Policy.
www.humanrights-drugpolicy.org
26 See §208, p.34, in: INCB. (2002). Report of the International Narcotics Control Board for 2001 (E/INCB/2001/1).
www.incb.org/documents/Publications/AnnualReports/AR2001/AR_01_English.pdf
11
Commissioner for Human Rights (OHCHR), but the INCB should also seek insights from a
27
number of other IGOs dealing with the issues at stake (see Table 2 below).
Table 2.
International entities with a mandate related to
Cannabis
for medical purposes
27 UNODC. (2012).
Office of the United Nations High Commissioner for Human Rights
– OHCHR (Geneva, Switzerland)
International
Human Rights Law
United Nations Human Rights Bodies including:
Charter-based (Human Rights Council)
Treaty-based (Committee on Economic, Social and Cultural Rights)
Other (Expert Mechanism on the Rights of Indigenous Peoples)
Secretariat of the
United Nations Permanent Forum on Indigenous Issues
– UNPFII (New York, United States of America)
Secretariat of the
Convention on Biological Diversity
– CBD (Montreal, Canada)
Convention on
Biological Diversity
Nagoya Protocol
United Nations Environment Programme
– UNEP (Nairobi, Kenya)
Food and Agriculture Organization of the United Nations
– FAO (Rome, Italy)
International Treaty on
Plant Genetic Resources
for Food and Agriculture
Essential medicines and health products section (EMP) of the
World Health Organization
– WHO (Geneva, Switzerland)
Intellectual Property
agreements related to
traditional medicine,
traditional knowledge and
cultural expressions
Traditional and Complementary Medicine (T&CM) unit of the
World Health Organization
– WHO (Geneva, Switzerland)
Traditional Knowledge unit of the
World Intellectual Property Organization
– WIPO (Geneva, Switzerland)
12
2.1.
Human rights, the environment, and biological diversity
As early as 1972, the Stockholm Declaration linked the environment to human rights:
“The protection and improvement of the human environment is a major issue which affects the
well-being of peoples and economic development throughout the world [...]. Both aspects of
[human]'s environment, the natural and the [human]-made, are essential to his well-being and
to the enjoyment of basic human rights –even the right to life itself.”
28
The human rights obligations (including non-discrimination obligations) relating to “the
enjoyment of a safe, clean, healthy and sustainable environment,” have been addressed by the
Human Rights Council (HRC) on several occasions. , Resolution 37/8 recognizes that:
29 30
“unsustainable management and use of natural resources, [...] loss of biodiversity and the
decline in services provided by ecosystems may interfere with the enjoyment of a safe, clean,
healthy and sustainable environment, and that environmental damage can have negative
implications, both direct and indirect, for the effective enjoyment of all human rights”
31
A series of normative instruments relevant to Cannabis appeared after the 1992 Rio Earth
Conference, strengthening this approach, in particular in what relates to biodiversity. The
Convention on Biological Diversity and its Nagoya Protocol on Access and Benefit-sharing of
genetic resources (respectively 193 and 129 States Parties as of February 2021) are good
examples of international dispositions on environmental rights directly related to Cannabis.
The World Intellectual Property Organization (WIPO) recalls that “traditional medical
knowledge, such as the medicinal use of herbs, is often associated with genetic resources [...]
subject to access and benefit-sharing regulations under international agreements.” In
32
addition, “some genetic resources are linked to traditional knowledge and traditional practices
through their use and conservation by indigenous peoples and local communities, often over
generations.”
33
In this respect, another relevant instrument is FAO’s International Treaty on Plant Genetic
Resources for Food and Agriculture (or “Plant Treaty,” 148 State Parties early 2021) that
recognizes “farmers’ rights.” Local communities, farmers, peasants, and indigenous
34
peoples have used, conserved, bred, maintained, and preserved the biological diversity of
Cannabis plants within local ecosystems, over generations. This entails rights: not only to
continue preservation but also to moral recognition and to avoid misappropriation of genetic
28 UN. (1973). Report of the United Nations Conference on the Human Environment, Stockholm, 5-16 June 1972.
undocs.org/en/A/CONF.48/14/Rev.1
29 See resolutions 7/23, 10/4, 16/11, 18/22, 19/10, 28/11, 31/8, 34/20, 37/8, 40/11 (non-exhaustive).
30 Former Special Rapporteur John Knox expressed more clearly that “the full enjoyment of human rights [...]
depends on biodiversity, and the degradation and loss of biodiversity undermine the ability of human beings to
enjoy their human rights.” See: Human Rights Council. (2017). Report of the Special Rapporteur on the issue of
human rights obligations relating to the enjoyment of a safe, clean, healthy and sustainable environment
(A/HRC/34/49). undocs.org/A/HRC/34/49
31 UN Human Rights Council. (2018). Human rights and the environment : resolution adopted by the Human Rights
Council on 22 March 2018 at its 37th session (A/HRC/RES/37/8).
ap.ohchr.org/documents/dpage_e.aspx?si=A/HRC/RES/37/8
32 WIPO. (2015a). Intellectual Property and Traditional Medical Knowledge (Background Brief No. 6).
www.wipo.int/edocs/pubdocs/en/wipo_pub_tk_6.pdf
33 WIPO. (2019). Intellectual Property and Genetic Resources (Background Brief No. 10).
www.wipo.int/edocs/pubdocs/en/wipo_pub_tk_10.pdf
34 The Treaty’s Article 9 recognizes “the enormous contribution that the local and indigenous communities and
farmers of all regions of the world, particularly those in the centres of origin and crop diversity, have made and will
continue to make for the conservation and development of plant genetic resources which constitute the basis of food
and agriculture production throughout the world.” Food and Agriculture Organization of the UN. (2009). International
Treaty on Plant Genetic Resources for Food and Agriculture. www.fao.org/3/a-i0510e.pdf
13
resources protected by and for these communities. This also entails protection from drug
control-led eradication programmes.
35
The Nagoya Protocol includes in its Article 4(3) a call for due diligence, stating that the
Protocol “shall be implemented in a mutually supportive manner with other international
instruments,” and calling on IGOs to be “supportive of and do not run counter to the objectives
of the Convention and this Protocol.”
36
Plant Treaty and Nagoya Protocol echoe the World Summit outcome (General Assembly
Resolution 60/1) which called “upon all parts of the United Nations to promote human rights
37
and fundamental freedoms in accordance with their mandates” (§119), supporting “the further
mainstreaming of human rights throughout the United Nations system” (§126), while
“recognizing the need for more efficient environmental activities in the United Nations system,
with enhanced coordination, improved policy advice and guidance, [...] better treaty
compliance, while respecting the legal autonomy of the treaties” to support a “stronger
system-wide coherence” (§169).
2.2.
Human rights of indigenous peoples, peasants, and rural communities
The call for due diligence with regards to human rights contained in the World Summit
outcome was reinforced by a mandate to "make progress in the advancement of the human
rights of the world’s indigenous peoples at the local, national, regional and international
levels, including through consultation and collaboration with them" (§127).
38
The UN Declaration on the Rights of Indigenous People (UNDRIP) lays out “the minimum
standards for the survival, dignity and well-being of the indigenous peoples of the world”
39
(Article 43) and declares that indigenous peoples have, among others:
- the right to their traditional medicines and to maintain their health practices, including
the conservation of their vital medicinal plants (Art. 24);
- the right not to be subjected to forced assimilation or destruction of their culture (Art.
8);
- 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 (Art. 23);
- the right to maintain, control, protect and develop their cultural heritage, traditional
knowledge and cultural expressions, and the manifestations of their sciences,
technologies and cultures (including genetic resources, seeds, medicines, knowledge
of the properties of fauna and flora, oral traditions, literatures) and to maintain,
control, protect and develop intellectual property over their heritage (Art. 31).
35 See also the concerns of the Committee on Economic, Social and Cultural Rights about the use of “aerial
spraying of cannabis crops to control the illicit cultivation of cannabis” in CESCE. (2018). Concluding observations
on the initial report of South Africa. https://undocs.org/E/C.12/ZAF/CO/1
36 Secretariat of the Convention on Biological Diversity. (2011). Nagoya Protocol on Access to Genetic Resources
and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity :
text and annex. Montreal: Secretariat of the Convention on Biological Diversity.
www.cbd.int/abs/doc/protocol/nagoya-protocol-en.pdf
37 UNGA. (2005). Resolution 60/1. undocs.org/A/RES/60/1
38 ibid.
39 UNGA. (2007, September 13). Resolution 61/295, United Nations Declaration on the Rights of Indigenous Peoples.
undocs.org/en/A/RES/61/295
14
The eradication or discontinuation of traditional cultivation and/or medical uses of Cannabis
–caused by prohibition itself– does not negate the right of indigenous peoples to “practise
and revitalize” their cultures, traditions, and customs (Art. 11): this “includes the right to
maintain, protect and develop the past, present and future manifestations of their cultures.”
Interestingly, the due diligence of IGOs and the UN system is directly called for in UNDRIP’s
Article 41:
“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”
Indigenous peoples and local communities (IPLC) have played an indispensable role in
preserving Cannabis plant biodiversity over generations. Without them, in 2021, humans may
not be able to explore the hundreds of cultivars and the different ratios and contents in
“diverse phytochemicals in cannabis, including both minor cannabinoids and terpenes,” that
the US National Institutes of Health say “have shown promise.”
40
Like the UNDRIP suggests, in addition to environmental specificities, INCB Guidelines ought to
pay attention to the IPLC’s traditional cultures and knowledge associated with the Cannabis
plant, which are often a set of medical skills, practices and know-hows derived from the
collective guardianship and conservation of traditional knowledge. Contemporary Cannabis
medicines are derived from if not built upon this corpus of traditional medical knowledge,
which entails intellectual property rights on its own also mapped by a series of international,
regional, and other sui generis systems. ,
41 42
The Nagoya Protocol insists on the “interrelationship between genetic resources and
traditional knowledge, their inseparable nature for indigenous and local communities” in
relation with “the importance of the traditional knowledge for the conservation of biological
diversity and the sustainable use of its components, and for the sustainable livelihoods of
these communities.”
In the case of medicines, the Global strategy and plan of action on public health, innovation and
intellectual property is a major guideline to diligently address any policy related to access to
43
medicines integrating intellectual property components. The current global strategy of WHO
for Traditional and Complementary Medicine confirms that:
“As T&CM becomes more popular, it is important to balance the need to protect the intellectual
property rights of indigenous peoples and local communities and their health care heritage
while ensuring access to T&CM and fostering research, development and innovation. Any
actions should follow the global strategy and plan of action on public health, innovation and
intellectual property.”
44
40 National Institutes of Health. (2019). NIH to investigate minor cannabinoids and terpenes for potential
pain-relieving properties [online].
www.nih.gov/news-events/news-releases/nih-investigate-minor-cannabinoids-terpenes-potential-pain-relieving-pro
perties
41 WIPO. (2015a).
42 WIPO. (2015b). Traditional Knowledge and Intellectual Property (Background Brief No. 1).
www.wipo.int/edocs/pubdocs/en/wipo_pub_tk_1.pdf
43 WHO. (2011). Global strategy and plan of action on public health, innovation and intellectual property.
www.who.int/phi/publications/Global_Strategy_Plan_Action.pdf
44 WHO. (2013). WHO traditional medicine strategy: 2014-2023.
who.int/medicines/publications/traditional/trm_strategy14_23/en
15
Cannabis plants in front of Dhaulagiri summit, Nepal.
Photo: Arne Hückelheim / Wikimedia.
Analysing its duties and responsibilities with regards to IHRL, in 2012, UNODC found that:
“A human rights based approach implies a conscious and systematic integration of human
rights and human rights principles in all aspects of programming work. In particular, a human
rights based approach should include a focus in programming on the promotion of equality and
nondiscrimination, ensuring the participation and inclusion of disadvantaged groups, and
strengthening of state accountability concerning its human rights obligations.”
45
And indeed, beyond indigenous peoples, specially covered by the UNDRIP, other local, rural,
but also disadvantaged and marginalized communities have similar ties with the Cannabis
plant as those of indigenous peoples. These communities are well defined in the Declaration
46
on the Rights Of Peasants and other people working in rural areas (UNDROP) adopted in
47
2018 which recalls in its preamble the right of peoples to exercise “full and complete
sovereignty over all their natural wealth and resources.” The UNDROP recalls the centrality of
human rights in its Article 2(4), and, in its Article 27, echoes UNDRIP’s Article 41 by calling on
UN system entities and IGOs to contribute to its full realization:
“Ways and means of ensuring the participation of peasants and other people working in rural
areas on issues affecting them shall be considered. The United Nations [...] and other
intergovernmental organizations [...] shall promote respect for and the full application of the
present Declaration and follow up on its effectiveness.”
UNDRIP and UNDROP do not create new rights: they explain how fundamental rights included
in the core IHRL instruments unfold for these specific populations.
48
45 UNODC. (2012).
46 A “peasant” is defined as a “person who engages, alone, or in association with others or as a community, in
small-scale agricultural production for subsistence and/or for the market, and who relies significantly, though not
necessarily exclusively, on family or household labour and other non-monetized ways of organizing labour, and who
has a special dependency on and attachment to the land”
47 UNGA. (2018, December 17). Resolution 73/165, United Nations Declaration on the Rights of Peasants and Other
People Working in Rural Areas. undocs.org/en/A/RES/73/165
48 As UNPFII explains: “UN Declarations are generally not legally binding; however, they represent the dynamic
development of international legal norms and reflect the commitment of states to move in certain directions,
abiding by certain principles.” See: www.un.org/esa/socdev/unpfii/documents/FAQsindigenousdeclaration.pdf
16
2.3. INCB and T&CM: an amnesia
Back in 2001, the INCB acknowledged Cannabis as a traditional medicine. In its report for
49
2003 and for 2014, the Board addressed “the use of cannabis for medical purposes.”
50 51
Nonetheless, more recently, the INCB has stopped referring to “cannabis” for medical
purposes, preferring the terms “therapeutic use of cannabinoids” and “medicinal
52
cannabinoids,” The bias against herbal and traditional medicines became clear in the report
53
for 2018, where INCB chose to refer “only to cannabinoids that have been extracted from the
54
plant or synthesized” (§4) and declared (§14), with no supporting argument:
“attempts to market and promote the medical use of cannabis products as ‘herbal medicines’
are inconsistent with the classification of cannabis and its derivatives under the 1961 and
1971 Conventions”
The 2021 draft Guidelines refers to cannabis medicines as “novel” medicines [15 February
draft, p.11]. But Sativex (commercialized since 2010, UK), delta-9-THC (since 2008, Austria;
since 1986, USA), Canasol (since 1987, Jamaica), Bedrocan (since 2003, Netherlands) or
Sarpagandha Ghan Vati (ayurveda formulation currently commercialized in India, known for
several hundreds years), are all but novel. INCB members should know this.
It is not impossible for INCB to express a preference for certain types of preparations (even if
it is doubtful that it is part of their mandate). Yet, they should not do so by ignoring or
disqualifying the mere existence of Cannabis botanical formulations. Among many surprising
statements in the report for 2018, the INCB explains (§21):
“A large variety of preparations containing cannabinoids are used in various regions of the
world to provide different dosage forms and concentrations of active and psychoactive
ingredients by different routes of administration. They are used in the belief that they will
alleviate a wide range of symptoms, often in the absence of high-quality evidence that they are
safe and effective. In many cases, it is unclear what cannabinoids these products contain
(active principles and dosage), what the best route of administration is or what their adverse
side effects may be.”
This kind of statement is surprising, since it seems to correspond to the definition of
“traditional medicine” provided by the WHO:
“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”
55
49 See §208, in: INCB. (2002).
50 See p. 24 in: INCB. (2004). Report of the International Narcotics Control Board for 2003 (E/INCB/2003/1).
www.incb.org/documents/Publications/AnnualReports/AR2003/AR_03_English.pdf
51 See pp. 35–36 in: INCB. (2015).
52 See pp. 49-50 in: INCB. (2018). Report of the International Narcotics Control Board for 2017 (E/INCB/2017/1).
53 INCB. (2019). Report of the International Narcotics Control Board for 2018 (E/INCB/2018/1).
www.incb.org/documents/Publications/AnnualReports/AR2018/Annual_Report/Annual_Report_2018_E_.pdf
54 ibid.
55 WHO. (2013).
17
The European Monitoring Center on Drugs and Drug Addiction (EMCDDA) rightly notes in this
regard:
“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.”
56
INCB’s bias is reflected in the draft Guidelines, which introduce an artificial distinction
between formulations: the draft has been developed on the basis that “cannabis and cannabis
resin [...] are described as raw materials” [15 February draft, p.6] while “Cannabis extracts and
tinctures [...] are described as Active Pharmaceutical Ingredients (API)” [p.7]. It is only
suggested that “in some circumstances, cannabis is also considered an API when it is directly
administered for medical purposes” [p.7].
However, this notion is not present in the Conventions where, like in real life, “cannabis” and
“cannabis resin” are both a starting material and an API –not only “in some circumstances.”
The draft also insists on the need for “cannabis” herbal material to be comminuted (i.e. cut,
powdered, or granulated) although no such requirement exists in the Convention.
The drug control Conventions do not restrict their scope to certain formulations of Cannabis.
To the contrary: there is a voluntarily broad definition of medical practice. The Commentary
57
on the Single Convention (p. 111) mentions that “the term ‘medical purposes’ has not been
uniformly interpreted by Governments” and specifies that “medicine”:
“does not necessarily have exactly the same meaning at all time and under all circumstances.
Its interpretation must depend on the stage of medical science at the particular time in
question; and not only modern medicine, sometimes also referred to as ‘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.”
Far from being ancient or something of the past, T&CM are increasingly incorporated into
national health systems and regulations, as shown in the figures below.
56 EMCDDA. (2018). Medical use of cannabis and cannabinoids: Questions and answers for policymaking.
www.emcdda.europa.eu/system/files/publications/10171/20185584_TD0618186ENN_PDF.pdf
57 UN. (1973). Commentary on the Single Convention on Narcotic Drugs, 1961.
18
Figure 1.
Growth in the number of Member States with national or state level
laws or regulations for T&CM, 1999–2018.
Source:
WHO, 2019 (p.18).
58
Figure 2.
WHO Member States with national or state level laws or
regulations for T&CM, 2018.
Source:
WHO, 2019 (p.19).
59
58 WHO. (2019). WHO global report on traditional and complementary medicine 2019. www.who.int/traditional-
complementary-integrative-medicine/WhoGlobalReportOnTraditionalAndComplementaryMedicine2019.pdf
59 ibid.
19
2.4. Freedom of religion and belief
There are also concerns regarding the need for INCB to balance drug control with human
rights particularly towards the well-established religious and spiritual uses of the Cannabis
plant throughout the world –most famously by Sadhus in the Himalayan region, or people of
Rastafarian faith in the Caribbean and among the Caribbean diaspora.
Frontally attacking the freedom of religion and belief of people of Rastafari belief, the Board
stated that “regulatory developments in Jamaica are not in accordance with the 1961
Convention, which limits the use of cannabis to medical and scientific purposes,” and
60
encouraged Jamaican authorities to revisit the piece of legislation allowing for the use of
Cannabis products by rastafari peoples.
61
The World Summit outcome (§119) called “upon all parts of the United Nations to promote
human rights and fundamental freedoms” –including freedom of religion and belief – and
62
recalled (§130) that “the promotion and protection of the rights of persons belonging to
national or ethnic, religious and linguistic minorities contribute to political and social stability
and peace and enrich the cultural diversity and heritage of society."
63
3. Home cultivation and self-medication
The Board “repeatedly stated that personal cultivation of cannabis for medical purposes is
inconsistent with the 1961 Convention as amended because, inter alia, it heightens the risk of
diversion.” The arguments of the Board are that:
64
“Personal cultivation of cannabis to be used for medical purposes does not allow Governments
to exercise the supervision required by the 1961 Convention over the production, manufacture,
export, import and distribution of, trade in and use and possession of cannabis, the
establishment of estimates of medical usage, the furnishing of related statistical returns or the
implementation of the provisions of article 28 of that Convention. In addition to the risks of
diversion, allowing private individuals to cultivate cannabis for personal medical consumption
may present additional health risks, in that the dosages and levels of THC consumed may be
different from those medically prescribed. The production of very high THC concentrates and
extracts for ‘medical use’ heightens the Board’s concerns about the risks of diversion for
non-medical use.”
65
This opposition of the Board to activities that relate to privacy is significative of the tendency
to “overemphasise the importance of preventing non-medical use, while not paying attention
60 INCB. (2017). Report of the International Narcotics Control Board for 2016 (E/INCB/2016/1).
www.incb.org/documents/Publications/AnnualReports/AR2016/English/AR2016_E_ebook.pdf
61 Klein, Axel, and Hanson, Vicki J. (2020). Ganja Licensing in Jamaica: Learning lessons and setting standards.
http://iccresearch.org/sites/default/files/Ganja%20Licensing%20in%20Jamaica%20-%20April2020.pdf
62 “Freedom of religion or belief is guaranteed by article 18 of the Universal Declaration of Human Rights, article 18 of
the International Covenant on Civil and Political Rights and the Declaration on the Elimination of All Forms of
Intolerance and of Discrimination Based on Religion or Belief” see:
www.ohchr.org/en/issues/freedomreligion/pages/standards.aspx
63 UNGA. (2005).
64 See § 12 in: INCB. (2019).
65 See § 12 in: INCB. (2019).
20
to the importance of medical use” in a context where “the burden of disease from pain is at
least 37 times larger than the burden of disease from substance use disorder.”
66
It should not be within the prerogative of INCB to comment on, and even less condemn,
personal, home-bound private activities such as the cultivation of Cannabis for one’s
personal medical use. Worth noting, this right might extend to self medication, as Jessica
Flanigan explains in Pharmaceutical Freedom: Why Patients Have a Right to Self-Medicate
published at Oxford University in 2017.
67
In case the Board wishes to express an opinion on activities that relate to the private sphere it
should diligently explain the existence of conflicting obligations and propose alternative
solutions short of a prohibition of these activities.
This is particularly true since there are “flexibilities in the UN drug control conventions to
decriminalise the possession, purchase, or cultivation of controlled substances for personal
consumption.” And it became even clearer after a series of groundbreaking cases in the
68
highest courts of South Africa, Georgia, Mexico, and Italy ,which confirmed that “under
69 70 71 72 73
international law, States must give priority to their human rights obligations over and above
any conflicting obligations under the UN Drugs Conventions.” The EMCDDA issued a press
74
release on “Cannabis control and the right to privacy,” explaining:
75
“In 2018 the highest courts in countries across three continents have asserted that state
intervention in the private life of their citizens who wish to (grow and) use cannabis is not
always justified. [...]
The Georgian court noted the increasing application of human rights law in modern legal
standards, and the South African court ruled that such state interference is not justified ‘in open
and democratic societies’.
In the 1988 UN Convention against trafficking, Article 3(2) states that a country should
criminalise possession and cultivation for personal use ‘subject to its constitutional
principles’. The court in Mexico stated that it upheld the constitutional principle of free
development of personality and considered it was still in line with the Convention.”
Most State Parties include the right to privacy among their “constitutional principles,” also
present, inter alia, in Article 12 of the Universal Declaration on Human Rights and Article 17 of
the International Covenant on Civil and Political Rights, as well as a number of regional
instruments (see Table 1). Due diligence would be welcome, in this domain too.
66 Scholten, W. (2020). Access to Controlled Medications: Barriers, Measuring Adequacy of Consumption, and
Current Developments. Journal of Illicit Economies and Development. jied.lse.ac.uk/articles/10.31389/jied.59
67 See also: Roberts. (2020). How to Regulate the Right to Self-Medicate. doi.org/10.1007/s10730-020-09415-7
68 p. 14 in: United Nations Development Programme. (2019).
69 Constitutional Court of South Africa. (2018). Case CCT 108/17. www.saflii.org.za/za/cases/ZACC/2018/30.pdf
70 Constitutional Court of Georgia. (2018). Judgement №1/3/1282 dated July 30, 2018 on the case of “Citizens of
Georgia – Zurab Japaridze and Vakhtang Megrelishvili v. the Parliament of Georgia"
www.constcourt.ge/uploads/documents/5e6111b70798e.pdf and www.constcourt.ge/en/judicial-acts?legal=1949
71 Suprema Corte de Justicia de la Nación. (2018). Comunicado de prensa: Reitera primera sala inconstitucionalidad
de la prohibición absoluta del consumo recreativo de marihuana e integra jurisprudencia.
www.internet2.scjn.gob.mx/red2/comunicados/noticia.asp?id=5785
72 Corte Cassazione Penale, Sezioni Unite. (2019). Informazione Provvisoria n. 27.
www.giurisprudenzapenale.com/2019/12/27/la-decisione-delle-sezioni-unite-sulla-rilevanza-penale-della-coltivazio
ne-modiche-quantita-cannabis-informazione-provvisoria/
73 The New York Times. (2019). Growing a Little Marijuana at Home Is Not a Crime, Italy’s Top Court Says.
www.nytimes.com/2019/12/27/world/europe/italy-marijuana-growing-cannabis.html
74 Piet Hein van Kempen and Masha Fedorova. (2016).
75 EMCDDA. (2019). Press release: Cannabis control and the right to privacy.
www.emcdda.europa.eu/news/2019/cannabis-control-and-the-right-to-privacy_en
21
4. Cannabidiol: from stance to insistence
The phytocannabinoid compound cannabidiol is a molecule which was not, is not, and will
76
not be listed per se in the Schedules of the international drug control Conventions. Since drugs
under international control are defined as the substances being listed in the Schedules,
cannabidiol should not be considered internationally controlled. Indeed, some governments
consider cannabidiol this way, and do not require narcotic or psychotropic drug control
requirements for this substance.
This should be clearly explained to State Parties by the INCB, whose role is only to monitor
substances listed in the Schedules.
Nonetheless, it is true that cannabidiol products are complex. Some governments are
concerned that these products are not always composed only of the “pure” cannabidiol
molecule, and can also contain minor amounts of Δ9-THC, which is a controlled substance
(listed in the Schedules). This leads these governments to consider cannabidiol products
under control, because of their trace-amounts of Δ9-THC.
Other governments may consider cannabidiol products under control, viewing it as “cannabis
resin,” a substance which is also per se under international control (listed in the Schedules).
For instance, European Union (EU) Member States follow a recent judgment of the EU Court of
Justice which “concluded that cannabidiol is not a ‘drug’ within the meaning of the United
Nations Single Convention on Narcotic Drugs” and the United States have declared that “it is
77
not our position that cannabidiol should be or is under the control of the international drug
conventions.”
78
There are broad divergences.
In addition to these diverging views about the substance itself, actual cannabidiol products
are produced, marketed, and used for a series of different motives and purposes. Not all of
these purposes can be assimilated to medical uses. This leads some governments to
consider that cannabidiol products are “industrial hemp” products, therefore exempt from
international drug control requirements. ,
79 80
Figure 3, next page, shows how a cannabidiol product might be viewed as falling under
international control, or not, depending on the particular interpretation adopted. The red dots
indicate the opportunities to choose different interpretations.
76 Note: in this document, the acronym "CBD" is only used to refer to the “Convention on Biological Diversity,” and
not to refer to the molecule "cannabidiol"
77 Delegation of the European Union to the United Nations (Vienna). (2020). Conference Room Paper: Judgment of
the Court of Justice of the European Union in case C-663/18 (“Commercialisation du cannabidiol (CBD)”)
(ECLI:EU:C:2020:938).
unodc.org/documents/commissions/CND_CCPCJ_joint/2020_Reconvened_Statements/ECN72020_CRP23_V2007
192.pdf
78 Secretariat to the Commission on Narcotic Drugs. (2020). Statements following the voting on the WHO scheduling
recommendations on cannabis and cannabis-related substances (E/CN.7/2020/CRP.24).
unodc.org/documents/commissions/CND/CND_Sessions/CND_63Reconvened/ECN72020_CRP24_V2007524.pdf
79 Riboulet-Zemouli, K. (2019). Scope and definition of the exemption covering “hemp” in the international drug
control Conventions. A total exemption – by purpose [online] www.researchgate.net/publication/336617754
80 Riboulet-Zemouli, K. (2020). CBD as a ‘narcotic’? Food for thought. Barcelona: FAAAT editions.
www.researchgate.net/publication/343768923_CBD_as_a_'narcotic'_Food_for_thought
22
Figure 3. Are cannabidiol and cannabidiol products under international treaty control? Flexibilities and options for legal interpretation.
23
The INCB has long held one of the most restrictive interpretations of the treaty in relation to
cannabidiol: considering it systematically under control. However, it is but one of numerous
points of view.
In this case, there is no direct breach of IHRL involved but it undermines the sovereignty and
freedom of States to interpret the treaties according to their needs and priorities.
Just like for the preference of the INCB for “medical cannabinoids” over all Cannabis-based
and Cannabis-related medicines, their particular interpretation of international control over
cannabidiol is not per se problematic. What is concerning is the insistence of the Board on this
particular interpretation with no reservation or contextualization. It would rather be expected
for the Board, in good faith,to present the array of possible choices offered to Member
States, while explaining its favoured interpretation.
For State Parties to take efficient and justified decisions in good faith they need to receive
honest, unbiased advice. The Board should not withhold information about the flexible
interpretative options regarding the status of cannabidiol under international law. It should
not present the most restrictive reading of the treaties as the norm.
5. (Lack of) civil society participation
In previous works and reports, the INCB has organized consultations with civil society
stakeholders, in particular relying on the two worldwide NGO Committees on Drugs.
81
Following UNODC, the INCB should recognize “the need to promote strong partnerships with
civil society organizations in dealing with the complex issues of drug abuse” and “the active
involvement of [...] NGOs, community groups, labour unions, indigenous groups, charitable
organizations, faith-based organizations, professional associations and foundations.”
82
The right to participate in public life and in policy-making is enshrined in core IHRL treaties
(see Table 1) and more specifically in the UNDROP (Article Art. 2(3), 10, 11, 15(4)) and UNDRIP
(Art. 18, 23). However, for its Guidelines, the INCB consulted almost entirely large companies
–but no peasants, IPLC, patients, or healthcare workers were involved or even consulted for
these guidelines.
There is a huge disparity in the efforts put forward to prevent “diversion and abuse” of
Cannabis medicines compared to efforts to promote access to these substances for
therapeutic uses and for the science of drugs, drug use and dependence. Often it has been the
role of non governmental organizations to champion these important facets.
By having a process without the benefit of civil society participation –and not only the private
sector, but also NGOs, researchers, affected populations, IPLC, etc.– the INCB deprives itself
of first hand information not easily accessible to large companies or governments: an on the
ground perspective of how Cannabis is being cultivated and used right now as a medicine, of
how that use relates to a rich botanical and cultural history, of how and when human rights are
at stake.
81 Vienna NGO Committee (vngoc.org) and New-York NGO Committee (nyngoc.org). See also: Fordham, A. (2020).
The Meaningful Participation of ‘Stakeholders’ in Global Drug Policy Debates—A Policy Comment. International
Development Policy, 12. https://journals.openedition.org/poldev/3861
82 UNODC. (2021). UNODC Engagement with Civil Society on Drugs and Crime [online]
www.unodc.org/unodc/en/ngos/cst.html
24
Table 3.
Tentative timeline of the INCB Cannabis Initiative.
* See detail in figure 4. ** See detail in figure 5.
Date
Event
Purpose
Stakeholders
November 2019
Informal Consultation on the
Supply of Cannabis raw materials
and Demand for cannabinoids
Identification of knowledge gaps.
Governments (“Competent
national authorities”)
“Private industry of major
cultivators and producers of
cannabis”
March 2020
Initiation of the activities of the
INCB Cannabis Initiative
Launch of the project with Member
States
INCB Board Members.
INCB Staff.
Governments.
20 August 2020
Job Opening for a Consultant to
prepare guidelines/manual of good
practices on the international drug
control requirements for Cannabis
“The consultant is expected to
deliver the following outputs:
Outline of the guidelines; Annotated
draft; First draft”
INCB Board Members.
INCB Staff.
Fall 2020
Outline for the Guidelines and
annotated draft
Delivered by the Consultant
Consultant.
2 December 2020
Reconvened 63rd Commission on
narcotic Drugs
Majority vote in favour of removing
“cannabis and cannabis resin” from
1961 Convention, Schedule IV
Governments (diplomatic
embassies in Vienna)
December 2020
1st Draft Guidelines
Delivered by the Consultant
Consultant.
From 18 to 21
January 2021
1st Expert Group Meeting “on the
Control and Monitoring
Requirements of Cannabis and
Cannabis-related”
Consultations with selected
stakeholders (private sector
stakeholders with profile of
analysts, former or current drug
authority members, former INCB
staff, etc.)
INCB Board Members & Staff.
Consultant.
A selection by INCB of ± 16
government and private sector
stakeholders*
January-
February 2021
2nd Draft Guidelines
Revision of the Draft
INCB Board Members & Staff.
Consultant.
23
February 2021
2nd Expert Group Meeting (part 1)
Joint Consultations with Competent
National Authorities and the Private
Sector
INCB Board Members & Staff.
Consultant.
± 80 government and private
sector stakeholders selected by
Governments**
24 and 25
February 2021
2nd Expert Group Meeting (part 2)
Consultations Competent National
Authorities
INCB Board Members & Staff.
Consultant.
± 70 Government
stakeholders**
February-
March 2021
3rd Draft Guidelines
Revision of the Draft
INCB Board Members & Staff.
Consultant.
24 March 2021
Intergovernmental Meeting with
Permanent Missions
“Gathering knowledge and
exchanging information”
Governments (diplomatic
embassies in Vienna)
Between 12 and 16
April 2021
64th Commission on Narcotic
Drugs, Side event “Way Forward in
the Control and Monitoring of
Cannabis and Cannabis-related
Substances”
Expose the development of INCB
Guidelines on the International Drug
control Requirements on Cannabis
for Medical and Scientific Purposes
Public
November 2021
(estimation)
132th Session of the Board
Approval of Draft Guidelines by
INCB Board Members
INCB Board Members & Staff.
March 2021
(estimation)
65th Commission on Narcotic
Drugs
Acknowledgement or acceptance of
the Guidelines by the Commission
Governments (diplomatic
embassies in Vienna)
25
There are also concerns regarding the participants to the two series of meetings, since a
number of them have been identified as having potential conflicts of interests. For instance,
the consultant hired for the redaction of the draft Guidelines (national of New-Zealand) is well
known for its work for, and professional relation with, an important Dutch cannabis
pharmaceutical company. Several attendees to the two “informal consultations”/”Expert
Group Meetings” are also listed as patent holders, or holders of plant variety protection
rights, in direct relation (and therefore potential conflict) with the topics discussed.
Figure 4.
Participation in the 1
st Expert Group Meeting, INCB Cannabis Initiative.
A: Approximate composition of the meeting (n=51). B: Geographic distribution of participants from Governments
(private sector and IGOs excluded) (n=10). C: Geographic distribution of participants from the private sector
(Governments and IGOs excluded) (n=6). *The Consultant from the private sector hired by INCB is included among
“INCB & UNODC Staff.” **Department of Political Affairs. ***Majoritarily includes representatives from “cannabis
companies” with profiles of analysts, former or current drug authority members, former INCB staff, etc.
Figure 5.
Participation in the 2
nd Expert Group Meeting, INCB Cannabis Initiative.
A: Approximate composition of the meeting (n=104). B: Geographic distribution of participants from Governments
and Regional Organizations (private sector and INCB/UNODC excluded) (n=75). C: Geographic distribution of
participants from the private sector (Governments and IGOs excluded) (n=8). *The Consultant from the private
sector hired by INCB is included among “INCB & UNODC Staff.” **Government-owned enterprises which unfold in the
legal market in competition with other companies have been listed among “private sector.”
26
6. Other technical issues
In addition to the important concerns expressed in this document, the draft Guidelines
includes a series of technical issues that will need to be addressed.
The first problem is a tendency to simplify the complexity of the Cannabis plant –starting
with the oversimplifying comparison with poppy and opium [15 February draft, p.4]. The
differences between opioids and cannabinoids, in terms of potential harms and clinical
approaches, are also fundamental –but not captured in the draft. The INCB plants to
harmonize control requirements for Cannabis on the basis of opium, poppy, poppy straw, and
concentrate of poppy straw, although these are very different from Cannabis products:
botanically, pharmaceutically, and in terms of drug control.
The Guidelines describe “the plant, Cannabis sativa L.” as a “substance under control” [p.6].
Although some provisions of the Convention do apply to the plants, they are not, and cannot
be considered “under control” insofar as the Cannabis plant is not listed in the Schedules.
The Guidelines attempt to introduce terms of questionable appropriateness. This is for
instance the case with the word “utilisation for medical and scientific purposes" that INCB
uses as a synonym of “use.” If there are several instances where the word “utilisation" is used
in international law, its meaning does not always correlate to the “use" understood as
“consumption." For instance, “utilisation" is defined as “to conduct research and development
on the genetic and/or biochemical composition of genetic resources, including through the
application of biotechnology" in the Nagoya Protocol, and similarly in other instruments. Such
definitions do not include “use” as present in the drug control treaties.
The INCB presents as universal a standard that is only limited to a small number of
jurisdictions, namely that “‘hemp’ [is] currently defined as cultivars containing < 0.2% THC
w/w” [15 February draft, p.9]. Many jurisdictions rely on different definitions or thresholds.
In some instances, the Guidelines suggest as a standard the installation of “high fences and
secondary perimeter of control” to “limit the risks of intrusion with double controls for entering
the facilities.” These sort of measures, besides their onerous cost, are not required under the
Convention and might not be needed in all circumstances. Furthermore, it has been suggested
that over-protection and disproportional security measures over licit Cannabis crops in
economies transitioning away from prohibition can disrupt local security or even generate
violence and criminality. As a report on Jamaican security requirements mentions:
“farmers are struggling to meet the requirements imposed. What they would question further is
if the particular circumstances of their situation should not be taken into account. Could for
instance community cohesion or geographical isolation not be listed as security factors in lieu
of standardised requirements for hard fences and security cameras?”
83
Many other “good practices” are pushed for without it being related to drug control
requirements. The overall feeling is that the draft Guidelines are de facto increasing control
measures and reporting requirements over Cannabis and its derivatives –a move that seems
in direct opposition to the decision of the international community to lower the status of
control of “cannabis and cannabis resin” on 2 December 2020.
84
83 Klein and Hanson. (2020).
84 FAAAT. (2020). Press release — History made today: UN recognizes medical cannabis.
https://faaat.net/blog/press-release-united-nations-recognize-medical-cannabis-december-2020/
27
Conclusion
The INCB regularly proclaims that “due respect for universal human rights, human duties and
the rule of law is important for effective implementation of the international drug control
conventions.” It stressed on several occasions that “it is clear that the human rights
85
conventions form an important cluster of binding international legislation that needs to be
taken into consideration while implementing any international treaty.”
86
It is therefore positive to note that, following the 2016 UNGASS, the INCB has already exerted
due diligence with regards to IHRL for example by encouraging Member States “to consider
87
the abolition of the death penalty for drug-related offences,” even though this “remains the
prerogative of States parties.” In doing so, the INCB recalled “relevant international
conventions and protocols and resolutions of the General Assembly, the Economic and Social
Council and other United Nations bodies on the application of the death penalty.”
88
There is no reason why the INCB would not act in a similar fashion with respect to the series
of rights outlined in this contribution, particularly those protected in the “nine core human
rights conventions.” It would fall short if the INCB pretended to ignore their omission to
89
mention overlapping provisions of international law can be used for the furtherance of
wrongful conduct against indigenous peoples, farmers, peasants, but also patients, and their
rights. These are topics of primary concern for developing countries.
When recommending traceability systems on seeds and reproductive materials, labeling,
cultivation practices, documentation regarding the seeds and starting material, restrictive
licensing schemes, and so many other elements contained in its Draft guidelines 15 February,
the Board is entering into fields that require an effort of due diligence.
Back in September 2020, the authors of this document shared their concerns with the
members of the Board (see Annex). This document now adds that the issues raised are not
peripheral, ceremonial, or facultative: they entail diligent scrutiny and accountability.
85 See §35 in INCB. (2008). Report of the International Narcotics Control Board for 2007 (E/INCB/2007/1).
www.incb.org/documents/Publications/AnnualReports/AR2007/AR_07_English.pdf
86 See §35 in INCB. (2015). Report of the International Narcotics Control Board for 2014 (E/INCB/2014/1).
www.incb.org/documents/Publications/AnnualReports/AR2014/English/AR_2014.pdf
87 See §34 in: Fordham, A. (2020).
88 See §315 in INCB. (2017). Report of the International Narcotics Control Board for 2016 (E/INCB/2016/1).
www.incb.org/documents/Publications/AnnualReports/AR2016/English/AR2016_E_ebook.pdf
89 §37 in INCB. (2015).
90 ILC. (2011). Draft articles on the responsibility of international organizations. Yearbook of the International Law
Commission, vol. II, Part Two. legal.un.org/ilc/texts/instruments/english/draft_articles/9_11_2011.pdf
91 Ibid. Article 17
We call on the INCB to have its actions follow its words, according to the motto of its 2015
report on access to controlled medicines: “indispensable, adequately available and not
unduly restricted” and suggest adding and human rights compliant.
Failure of the Board to take appropriate steps, even though they are “the prerogative of
States parties,” could be qualified as negligence since it might be seen as “the [direction] of
a State [...] in the commission of an internationally wrongful act," something which could
90
eventually “[incurs] international responsibility” if the IGO “does so with knowledge of the
91
circumstances of the internationally wrongful act.”
28
29
Annex: Copy of the Letter addressed to INCB Board Members, 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.”
92
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 ,
93
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. ,
94 95
92 See UN Careers, cache page for the Job Opening “20 - United Nations Office on Drugs and Crime -
140183 - Consultant” careers.un.org/lbw/jobdetail.aspx?id=140183&Lang=en-US
93 The medication identified with International Nonproprietary Name “cannabidiol / cannabidiolum” is
not an internationally controlled medicine.
94 Morris W, Gomes S & Allen M (2012), International Classification of Traditional Medicine. Global
Advances in Health and Medicine 2012;1(4):38–41.
95 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).
30
* * *
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. monograph
96
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,
97
even beyond Europe:
“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.”
In its General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine ,
98
WHO explains:
96 The 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.
97 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
98 WHO (2000), General Guidelines for Methodologies on Research and Evaluation of Traditional
Medicine. Document WHO/EDM/TRM/2000.1
apps.who.int/iris/bitstream/handle/10665/66783/WHO_EDM_TRM_2000.1.pdf
31
“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 ,
99
- 2018: WHO Expert Committee on Specifications for Pharmaceutical Preparations, 52nd
report , containing:
100
- 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).
99 apps.who.int/iris/handle/10665/44479
100 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
32
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 fully
101
legitimate under the Single Convention at the same level as “lane 1.” In practice, the INCB
102
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
103
(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 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.”
101 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: apps.who.int/iris/handle/10665/312342
102 “‘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).
103 UNDRIP undocs.org/en/A/RES/61/295
33
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 Convention on
104 105
the Protection of Industrial Property, the WTO TRIPS Agreement as well as a series of other
106
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 research in
107
cannabis-producing countries has most often been limited in time, scope, and depth, 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” .
108
* * *
104 Nagoya 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: www.cbd.int/abs/
105 International Treaty on Plant Genetic Resources for Food and Agriculture. Signed in 2001, entered into
force in 2004, see: www.fao.org/plant-treaty/en/
106 Agreement on Trade-Related Aspects of Intellectual Property Rights. www.wto.org/trips
107 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 www.ncbi.nlm.nih.gov/pmc/articles/PMC5345167/
108 Chouvy (2019), Cannabis cultivation in the world: heritages, trends and challenges, EchoGeo 2019;48.
DOI:10.4000/echogeo.17591 journals.openedition.org/echogeo/17591
34
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 purposes is only
109
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 case, the human rights
110
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.”
111
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.
* * *
109 www.incb.org/documents/Publications/AnnualReports/AR2018/LAUNCH/Highlights.pdf
110 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
111 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
35
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”
112
* * *
112 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.
www.incb.org/documents/News/Alerts/Alert16_CES_Essay_civil_society_Dec_2019.pdf
36
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
