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INCB [Medical] Cannabis Control Initiative’s 2022 Questionnaire for Civil Society
In 2020, the International Narcotics Control Board (INCB) launched an opaque “Cannabis Control Initiative” whose scope,
boundaries, and purposes were unclear. The initiative raised important concerns among world citizens, in particular organisations
representing patients using Cannabis medicines and doctors of healthcare practitioners prescribing them, or helping patients in the
management and improvement of their health in a context involving Cannabis or cannabinoids. Late 2020, the INCB announced that the
output from the Cannabis Control Initiative would be an “international Guidelines” addressing a broad range of details of the medical
cannabis landscape.
In early 2021, a written contribution was shared, outlining important concerns stemming from leaked versions of the hundred
pages-long first drafts of the Cannabis Control Initiative’s “Guidelines.” In December 2021, 182 NGOs from over 50 countries wrote to
the INCB, the UN Secretary-General and Commission on Narcotic Drugs to ask for transparency and accountability in INCB processes
generally, and for the Cannabis Control Initiative in particular. Secretary-General spokesperson echoed civil society’s concerns, recalling
that, in principle, transparency should indeed be the rule in all international bodies.
Answering these concerns, on 22 February 2022, the INCB released a Questionnaire for civil society organisations to
provide inputs to its Cannabis Control Initiative. The move is positive, since experts and affected populations are able to provide
their views –which are known to be of insightful help to the work of international organisations. But, because there is still no draft of the
“Guidelines” made publicly available, the possibility to provide useful comments is limited.
It seems, however, that there has been a reduction in the scope of INCB Cannabis Control Initiative’s output: compared to the
originally-intended “Guidelines” which addressed many aspects of the plant, many purposes, and a long list of cannabinoids, INCB’s
Initiative seems today to be limited to “reporting and monitoring standards” solely on the medical and scientific purposes, and only on
Cannabis products directly and explicitly listed in the Schedules of the international drug control conventions.
If that was the case, it would be a positive move to celebrate, provided that it would account for due diligence with regards to the
obligations of countries under other international treaties (for instance on plants or on human rights) and to their sovereignty, as well as
a respect for the margin of manoeuvre that countries agreed on when accessing the Conventions. An “INCB Cannabis Control Initiative”
which would be limited to harmonising statistical entries for reporting requirements would be an extremely useful tool to facilitate
international trade in licit Cannabis botanical medicines and compounded derivatives, and may be able to provide much needed public
health data to follow the adequacy of access to Cannabis and cannabinoids medicines throughout the world.
All info and updates on the INCB Cannabis Initiative: kenzi.zemou.li/incb-monitor
The introductory text and questions provided in the questionnaire are reproduced in the frame below, and have been archived here.
QUESTIONNAIRE FOR CIVIL SOCIETY ORGANISATIONS
The present questionnaire has been prepared by the International Narcotics Control Board (INCB) with the intention to hear the opinions of the civil society organizations on
the work that the Board has been undertaking to assist Member States in reaching a consensus on reporting and monitoring standards of cannabis and cannabis-related
substances for medical and scientific purposes.
Since the vote on the WHO recommendations on the scheduling of cannabis and cannabis-related substances that took place at the reconvened session of the 63rd Commission
on Narcotic Drugs in December 2020, the Board has been working together with Member States to harmonize international drug control and reporting requirements for the
cultivation, manufacture, utilization, trade, and consumption of cannabis and cannabis-related substances for medical and scientific purposes.
In this context, the Board invites civil society organizations to provide their views by filling out the following questionnaire. The Board would like to clarify that the initiative is
limited to the specific areas of the international drug control treaties related to reporting and monitoring of controlled substances for medical and scientific purposes.
The Board would be grateful if the form could be filled out at your earliest convenience before 23 March 2022. Should you have any questions, please do not hesitate to get in
touch with [email] or [email]. Many thanks for cooperating with INCB in this important matter.
Questions: 1.Name of the civil society organization; 2.Country; 3.Email address; 4.Name and position of contact person; 5.What is the nature of your organization’s activity?
Please check all that apply: Primary Prevention Treatment and/or Rehabilitation, Public Health, Human Rights, Education/ Training, Development, Social Justice, Advocacy/
Public Policy, Academia/ Research, Other; 6.If other please specify: (Max.500 words); 7.What is the mission and objectives of your organization? (Max.500 words); 8.What is
the primary geographical reach of your organization? Local level (your own town, province or state where applicable), National level, Regional level (operating in more than 2
countries in your continent), Global level; 9.Does your organization have inputs or suggestions in relation to the control and reporting requirements applicable to the
cultivation of cannabis for medical and scientific purposes? No, Yes; 10.If "yes" please elaborate (Max.500 words); 11.Does your organization have inputs or suggestions in
relation to the control and reporting requirements applicable to the manufacturing of preparations of cannabis and cannabis-derived substances for medical and scientific
purposes? No, Yes; 12.If "yes", please elaborate: (Max.500 words); 13.Does your organization have inputs or suggestions in relation to the control and reporting requirements
applicable to the trade of cannabis and cannabis-derived substances for medical and scientific purposes? No, Yes; 14.If "yes" please elaborate: (Max.500 words); 15.Does your
organization have inputs or suggestions in relation to the control and reporting requirements applicable to the consumption of cannabis and cannabis-derived substances for
medical and scientific purposes? No, Yes; 16.If "yes" please elaborate: (Max.500 words); 17.Please leave below any further comments you might have (Max.500 words).
It seems that the INCB is now making a difference between control and reporting requirements applicable to: cultivation, manufacturing, trade, and
consumption; and classifies products as: “cannabis,” “preparations of cannabis and cannabis-derived substances,” and “cannabis and cannabis-derived
substances.”
Representation of the scope of the INCB Cannabis Control Initiative: an harmonisation of the control and reporting requirements applicable to:
cultivation…
…of cannabis…
…for medical and scientific purposes
manufacturing…
…of preparations of cannabis and cannabis-derived substances…
trade…
…of cannabis and cannabis-derived substances…
consumption…
Inputs and suggestions by FAAAT think & do tank to the INCB
Cannabis Control Initiative Questionnaire for Civil Society
faaat.net – kenzi.zemou.li/incb-monitor
Control and reporting requirements applicable to the cultivation of cannabis for medical
and scientific purposes
Inputs:
1. Cultivation reporting requirements should not be attached to any sort of qualitative assessment of the crops. Only
quantitative data should be collected, reliant upon the same metrics used for other crops under control.
2. A challenge which could be foreseen is the possible confusion of crops grown for the various other than medical and
scientific purposes, which need not to be reported in the same way as crops grown for medical and scientific purposes.
This is true for so-called “hemp” cultivation but also for the cultivation for the non-medical industry, as well as cultivation
for personal- and private-bound purposes.
To prevent confusions and misreporting, it may be useful to include a disclaimer in INCB’s reporting Forms which would
recall that only crops grown for medical and scientific purposes should be included in the reporting.
3. There is an important challenge related to the reporting requirements applicable to the cultivation of cannabis for
medical and scientific purposes. Indeed, while the distinction between “medical and scientific purposes” and other
purposes (which are debated) may be more or less clear in international law and regulatory practice, it is often not the
case in the field.
From immemorial times, the very same crops of Cannabis sativa have been grown to be used for multiple purposes. This is
obviously an agricultural practice widespread in many developing countries where Cannabis is a traditional crop. No parts
are leftover, from the stalk to the seeds and resinous glands, all parts are often harvested and used for a variety of distinct
purposes: medicine, ritual/spiritual uses, oils, food, feed, bedding, building materials… Beyond traditional and rural
practices, multi-purpose crops have also been relied upon in the modern Western pharmaceutical sector. As early as 1908,
the U.S. pharmaceutical company Parke-Davis (nowadays part of Pfizer) how it used local northern-American varieties to
obtain both hemp seeds and pharmacopeial-grade cannabis extracts (see
https://archive.org/details/parke-davis-1908-cannabis-americana; the company continued producing and exporting
these extracts until the late 1960s). Nowadays, multi-purpose Cannabis crops are encouraged by agricultural guidances
and desired by farmers, to improve economic sustainability by diversifying sources of revenue.
Suggestions:
In light of the reporting requirements as established by Articles 23 and 28, and considering the elements outlined in the
Commentary on this issue (§2 p. 312 & §§10-11 p. 314, in particular, which address these issues but, by mentioning
“elsewhere” in §11, fail to provide guidance for multi-purpose crops), the INCB seem to have two possible interpretations
on the table with regards to multi-purpose cannabis crops:
a) Considering that reporting on cultivation of multipurpose crops is not required.
Indeed, in this view, the purpose for which the crops are cultivated –“multi-purpose”– is different that medical
and scientific purpose, and hence not requiring reporting on such crops. The monitoring which would happen in
any case with regards to the reporting of “production” and “manufacture” would allow, by differential calculation,
an actual monitoring of the products without having to add burden of reporting for governments, and regulatory
burdens for farmers which were so far not ruled by drug control regulations (added burden having been shown,
even in previous INCB reports, to play against the adequate availability of medicines);
b) Considering that reporting on cultivation of multipurpose crops is required.
This approach would adopt the view that multi-purpose does nonetheless include “medical and scientific
purposes” and for this reason call for control. In case this solution was to be preferred, it would be highly
desirable, however, to provide for two reporting fields: one for crops exclusively grown for the production of
medicines, and one for crops from which medicines are obtained, however among other products for other
purposes. Not only is this distinction methodologically sound, in order to produce data reflecting the reality of the
ground, but it may also allow a differential processing of the data as well as adapted reporting requirements that
may be fit to the distinct characteristic of multi-purpose crops, and of medicinal- and research-only crops,
respectively. This would, however, entail an important additional burden of data collection for farmers, and
reporting for national competent authorities, which may not be the preferred solution.
Control and reporting requirements applicable to the manufacturing of preparations of
cannabis and cannabis-derived substances for medical and scientific purposes.
It seems needed to clarify terms.
1. Research shows that the term “manufacture” in the Single Convention corresponds, for cannabis, to a large number of
activities, and the term is somehow confusing; see table 2 in “‘Cannabis’ ontologies I: Conceptual issues with Cannabis
and cannabinoids terminology” (https://journals.sagepub.com/doi/full/10.1177/2050324520945797) and a simplified
graphical version (page 21 in: https://www.researchgate.net/publication/352284842).
Although the draft “reporting and monitoring standards of cannabis and cannabis-related substances for medical and
scientific purposes” are not available and it is consequently difficult to comment on something secret, the language used
in this very questionnaire suggests that the INCB has chosen to simplify the use of terms by:
a) relying on “production” for the obtention of “cannabis” or “resin” from the “plant” on the one hand;
b) relying on “manufacture” for either the obtention of “extracts and tinctures” or the obtention of “preparations”
from either “cannabis” or “resin”, on the other hand.
This seems to be an interesting decision, from a practical perspective. However, it would deserve to be explained and
made clearer. Indeed, the Single Convention eventually uses the term “manufacture” for the obtention of “extracts and
tinctures” directly from the plant, or for the obtention of the same products from other substances not listed as a drug.
2. Another point relates to the terms “preparations of cannabis and cannabis-derived substances.” What is this
encompassing? Are “extracts and tinctures” included in this or not? What about “resin”? How does this reflect the
distinction between “crude” and “refined” resin in the Convention?
And, w.r.t. real-life products, would herbal preparations be included? To take an example: would the granulates Bediol®
and the prepared & conditioned Cannabis tops Bedrobinol® both be included in that same category?
Are we talking about (1) “preparations of cannabis” and (2) “preparations of cannabis-derived substances”, or are we
talking about (1) “preparations of cannabis” and (2) “cannabis-derived substances”? In that latter case, what is the
difference between a “preparation of cannabis” and a “cannabis-derived substance”?
Another question would be: at what point does a “preparation of cannabis”/“cannabis-derived substance” under the 1961
Convention cease to be such, and becomes “dronabinol” or a “preparation of dronabinol” under the 1971 Convention? The
different praxis outlined in the side-event organised by the INCB in the margins of the 65th Commission on narcotic drugs
(but also during the discussions in 2019 and 2020 on the WHO recommendations) show important differences in this
regard: what concrete solution is proposed by the INCB?
3. On the complexity of distinguishing between the diversity of Cannabis derived products, we would like to suggest you
to consult the Appendix III. “Review of extraction methods used with Cannabis” in the supplemental materials of the
above-mentioned article (https://journals.sagepub.com/doi/suppl/10.1177/2050324520945797). Part II of this research,
supported by our organisation, goes more in-depth into these product specificities: ahead of its publication, preliminary
findings could enlighten the work of the INCB –should the Board desire to have such an input. Researchers affiliated with
our organisation remain open to sharing knowledge.
Control and reporting requirements applicable to the trade of cannabis and
cannabis-derived substances for medical and scientific purposes.
Similar terminological concerns: what does "cannabis and cannabis-derived substances" entail?
The current state of reporting standards for cannabis cultivation is not particularly problematic in and of itself as it is
currently. The same issues as outlined in the following answers are at stake.
Control and reporting requirements applicable to the consumption of cannabis and
cannabis-derived substances for medical and scientific purposes.
1. The definition relied upon for "consumption" should be clarified: indeed, different meanings exist in the Convention, as
the Commentary informs.
2. Overall, the questions of manufacture, trade, and consumption (in the meaning of the Convention) point back at a
fundamentally insoluble equation: it is impossible to reconcile (1) the categories of Cannabis products present in the
Conventions: cannabis, cannabis resin, extracts & tinctures of cannabis, dronabinol, (2) the IDS codes in use, and (3) the
Cannabis products of real life.
The equation is almost insoluble, because there are constants that cannot be touched (treaty categories) and which
unfortunately are conflicting and overlapping categories. And there are variables that vary a lot (real life products: the
diversity of Cannabis medicines, many of whom are traditional or compound medicines, is already immense; research
and development in Cannabis cultivation, biotechnology, and in cannabinoid medicine makes it more complex every day).
The only tool in hand are IDS codes,1but what to do: more IDS codes to get closer to real life products, risking confusion
and misreporting by Member States, or lesser IDS codes to ensure comprehensive, although less detailed reporting?
The question seems to be easily resolved by the scope of the mandate of the Board –which is not that of WHO. The INCB
is not collecting data on detailed products of the other drugs or products under international control, except when these
are explicitly listed in the Schedules or otherwise in the Conventions (this can be the case for specific preparations of some
drugs, but also for poppy straw or other plant products). There are no such specified distinctions in the Conventions or the
Schedules: State Parties voted against the inclusion of further specific language proposed by the WHO. Such language
would have facilitated the task of the Board; yet, it must be recognized that State Parties opposed the further detailing of
Cannabis medicines in the Schedules of the 1961 Convention, and such detail is not present in the text –beyond
“cannabis,” “cannabis resin,” “extracts & tinctures of cannabis,” and “dronabinol”/”tetrahydrocannabinols.”
Everything seems to suggest that the option that INCB should follow is therefore to stick to treaty language and adapt IDS
reporting codes to such language, without going beyond. A suggestion to move forwards would be to stick with current
IDS codes and rely on the second proposal of the German delegation, namely:
- NC 001 “CANNABIS” for herbal cannabis,
- NC 008 “CANNABIS RESIN, EXTRACTS and TINCTURES” for all Cannabis derived medicines except purified/isolated
delta-9-THC,
- PD 010 “DRONABINOL” for pure isolated delta-9-THC, whether natural or synthetic.
Further comments.
Members of our non-profit organisation are experts in the field, and we remain ready to assist or help in any way possible
the development of the minimal reporting standards. We are open to any form of engagement, and are convinced that
effective collaboration between all interested parties is of utmost necessity in such a complex field, where the health, and
wellbeing of millions of patients is at stake. Improving the soundness of the terms and concepts used for reporting is a
public interest endeavour. Ultimately, mastering sound and evidence-based reporting standards will improve the quality
and reliability of public health statistical monitoring over a medicine that many patients view as essential –if not vital.
The task is welcome. But, so far, its potential outcome and contents have generated fears, and a generally negative
scrutiny. It may not have been the case had the process not been kept outside of public sight. The need to precise that “the
initiative is limited to the specific areas of the international drug control treaties related to reporting and monitoring of
controlled substances for medical and scientific purposes” shows at which point the public is not aware of the exact scope
of the “initiative” and of what should be commented upon. Attempting to brute-force the release of an international
document making precedent, but that would not have received text-based inputs, comments, improvements, or review,
would be deemed to receive widespread rejection by patients and doctors –almost 200 NGOs representing them
expressed their concerns in this exact matter, four months ago (see: https://kenzi.zemou.li/incb-monitor#letter).
Conversely, a release of the reporting standards which would have benefited from enlightened improvements from all
interested parties, particularly expert ones, may become a central tool and reinforce the recognition of INCB’s work.
During the informal dialogue with civil society held on 17 March 2022 in the margins of the Commission on narcotic
drugs, INCB president made a detailed list of all the documentation that the INCB is mandated to keep confidential. It is
our great satisfaction that the draft documentation for non-binding harmonisation of reporting requirements was not
mentioned among the documentation that ought to be kept away from public view. We look forward to providing further
inputs based on a draft of the reporting standards.
1IDS codes = International Drug System codes.