Side event: Way Forward in the Control and Monitoring of Cannabis and Cannabis-Related Substances

Organised by the International Narcotics Control Board with the support of Finland, Germany, Japan, and Thailand, and the European Union

Way Forward in the Control and Monitoring of Cannabis and Cannabis-Related Substances

Organized by the International Narcotics Control Board with the support of Finland, Germany, Japan, and Thailand, and the European Union

Discussion moderated by Ms. Juliana Erthal-Williamson, Drug Control Officer, ICCI Coordinator, INCB

Mr. Cornelis P. de Joncheere, President of INCB: In 2020, the Board launched its International Cannabis Control initiatives, or ICCI, and we’re very grateful for the financial support of the Government of Japan, that makes this possible. The initiative aims at providing guidance and assistance to member states in the area of control, monitoring and reporting on cannabis and cannabis related substances. Following the December 2020 vote by the CND, on the WHO recommendations, and in response to requests from member states for more guidance on their control and reporting on cannabis,  the Board has accelerated this process of developing the guidelines to assist competent national authorities in this area. INCB organised an expert group meeting in January of this year, and an informal consultation in February with major cannabis producing countries. Furthermore, in March 2021, one month ago an inter inter governmental meeting with member states on the guidelines took place. The meeting was the first in a series of consultations with member states that are planned for this year by the board. Meetings are the platform for member states to provide inputs, and share practices and comment on the draft guidelines. Representatives of the African Union, the European Union, the Organisation of American States, WHO and UNODC are also contributing to the process, and consultations with civil society will be done through questionnaires and online meetings. The aim is to provide the international community with a final draft by December of this year, for the member states, and to be considered, possibly in the context of a resolution at the 65th session of the Commission in 2022 to draft guidelines, aimed at strengthening the capacity of competent national authorities and decision makers to implement the requirements of the conventions, as they relate to cannabis related substances and derived products for medical and scientific purposes to comply with the regulatory control and monitoring requirements of the licit trade in narcotic drugs and psychotropic substances in national settings, and to be able to participate in international trade in line with those requirements if countries wish to do so. And thirdly, to meet the reporting obligations in an accurate and timely manner. Shared understanding of control and reporting requirements, among Member States is required to avoid gaps in the monitoring process, to avoid discrepancies in reporting, and to ensure compliance with the international drug control framework. The draft guidelines will provide guidance towards that shared understanding in the discussions. Over the last month, we’ve made a lot of progress, but it’s also clear that there are still issues to be ironed out. For instance, with regard to the status of cannabidiol, CBD, on what is ‘industrial use’; the scientific questions around cannabis; and also on the legal interpretation of the relevant articles of the convention. The Board is committed to work with member states and resolve these issues one by one. So we all have a shared understanding on what is to be reported and how. This side event provides another opportunity for interacting with member states, with delegates, with interested parties, and to get your input into this process, and we look forward to a fruitful discussion this morning, And to a continuation of this important initiative. Thank you very much for your attention and for your active participation.

Mr. Hideo Eno, Director for Counter Narcotics of the Ministry of Health, Labour and Welfare, Japan: This year we marked the 60th anniversary of the 1961 single convention on Narcotic Drugs and also the 50th anniversary of the 1971 convention for time. New findings backed by scientific evidence supporting the medical use of cannabis and cannabis related substances has emerged, resulting in numerous discussions, and an intense review, as well as changes in its level of risk. These significant changes have led to increasing complexities in reporting, due to the differences in views on the legal aspects, and on the interpretation of the conventions, especially since more countries have engaged in the production of cannabis. Given the circumstances, competent authorities seek a common understanding on reporting and control requirements. I would like to express my heartfelt appreciation on behalf of the Government of Japan to the INCB for addressing this complex and promoting the exchange of ideas, experiences and best practices with various stakeholders, by offering its guidance through the INCB Cannabis Control initiative, being presented here today. Note that the circumstances surrounding cannabis and cannabis related substances have changed significantly over the past 60 years due to technology and progress in research and development. At the same time, increased disparities in the interpretation and implementation of the Convention is a serious concern. I believe that the INCB initiative, by advancing guidelines on the international drug control requirements for the cultivation, manufacture and utilisation of cannabis for the medical and scientific scientific purposes will provide member states with solutions to improve compliance of the treaties and help governments fulfil their control, and reporting obligations on cannabis and cannabis related substances that we read to further harmonisation. It is also quite feasible to imagine that these guidelines will also lead to the prevention of illicit  activities, such as cultivation, manufacture, smuggling, trafficking, diversion, and abuse, as well as promote its proper use, in line with the international drug control conventions. Japan is proud to support this lofty initiative and looks forward to the final product, which we hope is a collection of best practices, offered by the expert group meeting that took place earlier this year. You have Japan’s support

Mr. Hendrik Greve, Head of Legal Trade in Narcotics and Psychotropic Substances II, Federal Institute for Drugs and Medical Devices, Germany: Okay, thank you, Juliana and hello to everyone I repeat the first sentences, first of all I would like to thank the INCB for inviting us to contribute, actively to this important side event, and to share our view on monitoring the medical use of cannabis and cannabis related substances. We begin with a brief time travel, regarding the medical use of cannabis and cannabis related substances in Germany. The timeline displays the respective milestones in 1998, the psychoactive principle of cannabis, Dronabinol, became prescribed bubble in Germany, and in 2005 medical cannabis and extract preparations became available for patients as a lastline therapy based on exceptional individual licences, as a result of a court decision. In 2011, the cannabis based medicine Sativex received marketing authorization, as finished medicine a product; and the 2017, the National narcotic drugs act has been amended so that medical cannabis and extract preparations became precribable, and moreover reimbursable by health insurance, and became part of a Monitoring Survey. In the same year, 2017, the National cannabis agency was established and the first tender was published regarding the cultivation of medical grade cannabis. Up to now, 2021, the medical demand for medical grade cannabis is still covered by imports but the first harvests are expected for this year. Let’s have a look to the international control of cannabis and cannabis related substances. As you may know cannabis and its psychoactive principles delta-9-THC belong together but unfortunately they are controlled internationally by two different regimes; namely, the single convention on aquatic drugs of 1961 and the Convention on psychotropic substances of 1971, respectively. On the one hand, the single convention of 1961 covers cannabis, its extracts and tinctures, the resin and its preparations; but on the other hand, the convention on psychotropic substances of 1971 include Delta-9-THC, including Dronabinol, and six more isomers of THC. Therefore, the international control covers more and more products which turned out to be increasingly used for medical and scientific purposes; for instance, dried flowers, extracts as intermediate extract preparations, as prescription medicines, and moreover, as finished medicinal product with marketing authorization. Apart from that, we have dronabinol from synthetic or semi synthetic or even from natural sources as API, active pharmaceutical ingredient. And we have other THC isomers, such as delta-8-THC, which becomes more and more interesting for the international community. This situation poses challenges for the competent national authority. The challenges, belong to, among others, fulfilling our estimating assessing and reporting obligations in regard to total quantities, concerning cultivation and production, international trade, manufacturer consumption for medical and scientific purposes and stocks. The most crucial question in this regard is how to display and account for cannabis and cannabis related substances in their respective import and export authorizations and the INCB forms. We can refer a cannabis based product, either to cannabis and the 1961 convention (we a conversion factor) or refer to the Delta-9-THC content and the 71 convention. At present, one can find quite inconsistent practices among Member States, leading in losing compliance of the current guidance. To solve this issue, we have to keep our overall goals in this context in mind at all times. This is to avoid discrepancies between importing and exporting countries to a (…) products into the legal supply chain and to provide reliable, consistent and transparent data to the INCB all these efforts I essential to ensure availability of governmental monitored cannabis and cannabis related substances for medical and scientific purposes while preventing the diversion and abuse. Coming to the results. Please allow me to create some confusion at this point in order to emphasise the complexity of this topic. As you can see, the displayed word cloud encompasses four different levels, difference stated by sizes and colours. The main level is represented by the biggest size and dark red colour, displaying the international drug control conventions, the competent national authorities and the new guidelines by INCB; followed by the white the light green, and finally small shapes. Our expectations on the new INCB guidelines relate to harmonisation of practices, seamless transition in control and reporting cannabis versus delta-9-THC and to reflect on the essentials. In this context, any double reporting of cannabis versus delta-nine-THC needs to be excluded and details such as the use of conversion factors, along with the distinguishing between Dronabinol of natural versus synthetic origin, have to be clarified. Moreover, the impact on the INCB forms, and on the respective important export authorizations is of interest. In this context, it needs to be clarified. Which IDS, international grant system code has to be used for which kind of cannabis based product. The whole system is dependent on the international drug control conventions, whose schedules are continuously under revision of the WHO and the CND and whose regulations are continuously expanded by ECOSOC and CND resolutions. Apart from that compliance and active contribution by the competent national authority is essential for the success of this process, diverse aspects may have impact on the performance of the competent national parties, such as capacity and networking regional differences and national legislation. And last but not least, new products, which newly come on the market. In result, we highly appreciate and welcomed the development of new guidance by the INCB in order to achieve satisfying solutions for all stakeholders for this complex and important topic. Thank you very much for your attention.

Ms. Stacy Harper-Avilla, Chief of the UN Reporting and Quota Section, Diversion Control Division, Drug Enforcement Administration: Good morning, good evening, good afternoon to the panellists and gas, the United States, thanks to INCB in Japan for co-hosting this event and allowing the US to serve as a panellist. The United States welcomes the INCB his efforts to accelerate international harmonisation of the necessary terminology for monitoring and reporting, and to facilitate the worldwide exchange and coordination of scientific and medical information on cannabis and cannabinoids. As member states allow or increase medical and scientific research, utilising cannabis, the import and export of cannabis and cannabinoids will naturally grow more prevalent, and more complex. For example, the global research community will need to share sample materials across international lines to replicate, verify and build upon research results. As this research leads to the development of new medicines cannabinoids will be increasingly available on the legitimate market and complex international supply chains may develop that could involve cultivation in one country, refinement and production in another, and consumption in yet another. In these cases, it is critical that the import and export and countries involved, share a common understanding of terms for data collection and reporting purposes. The three drug control conventions envision the creation of domestic regulatory systems that allow for the industrial, medical and scientific use of drugs, such as cannabis; while effectively preventing their diversion. However, the conventions left many of the details of these regulatory systems up to the discretion of the member states. In 2018, spurred by growing public interest in the industrial uses of the cannabis plant, the US enacted the Agricultural Improvement Act, to promote the cultivation and use of the cannabis plant for industrial and agricultural purposes. This legislation provided a clear delineation between cannabis for industrial or agricultural purposes and cannabis that was at risk for diversion and illicit use by setting a limit of 0.3% delta-nine-THC or less in the plant and final products produced from the plant material cannabis was 0.3% Delta-nine-THC or less was classified in this legislation as hemp, to provide a clear distinction to both the industry and the interested public. As a result of this legislation, hemp and hemp derivatives, containing 0.3% Delta-nine-THC or less are not controlled, under the, the US Controlled Substances Act. In addition to clearly define and what qualifies as cultivation for industrial purposes, this delineation between hemp and cannabis allows for increased scientific and medical research of hemp derivatives, in particular the substance cannabidiol, or CBD. In the US, CBD extracted from hemp and containing less than 0.3% Delta-nine-THC is classified as a hemp derivative and therefore not a controlled substance. The control status of CBD derived from hemp is based on domestic scientific research, and is aligned with the recent WHO recommendation that preparations considered to be pure CBD, should not be under international control. In addition to its industrial uses cannabis and cannabis derived substances such as CBD, have been under a scientific review to develop treatment medications. This research is promising. And we believe that member states should take action to increase access to cannabis for research purposes in line with their treaty obligations. For example, in 2018, epidiolex was approved by the US Food and Drug Administration for the treatment of two specific forms of severe childhood seizures. Epidiolex, developed in the United Kingdom is a drug product containing CBD, which was originally produced from cannabis, and contains extremely low levels of Delta-nine-THC. As the country that participated in global clinical trials during the development of this drug, prior to its 2018 domestic approval, the US held discussions over several years with both the UK and the INCB to identify how the Controlled Substances contained in the drug product should be considered for import-export permits and annual reporting purposes, and how the import of dosage forms to support clinical trials should be reported. This drug product raises the question of whether the controlled substance in question, which was a cannabis extract, cannabidiol, or delta-nine-THC, due to its residual trace amounts should be reported. Further, would reporting it as both cannabis extract and delta-nine-THC inflate the actual quantities imported and or utilised for scientific and medical purposes. For the US, domestically, this drug product is considered to be pure CBD, rather than a cannabis extract. The US believes it is important for international trade, global research efforts, and data collection and reporting purposes, to clarify, when a drug product derived from cannabis ceases to be considered a cannabis extract and becomes classified only as CBD, or THC. The US believes that this is one of the most important issues, which the cannabis guidelines can clarify, not only for this approved drug product, but for all, for other products still in the research and development phases in various countries, US looks forward to continued work with our international colleagues to further refine the terms and frame the report and parameters within the guidelines to facilitate international trade for industrial, medical and scientific purposes and INCB reporting of the relevant data. Thank you for your time this morning.

Mr. Justice Tettey, Chief of the Laboratory and Scientific Section of UNODC: Thank you, Juliana, let me first say it’s been a pleasure collaborating with the INCB on this initiative. And UNODC would like to thank you for allowing us to contribute to the discussions on the development of these guidelines. I would like to focus on the analytical challenges we face as we move forward. Cannabis products are the most widely trafficked drugs worldwide, with practically every country affected. Yet very few countries are prepared for the analytical challenges it brings both from a regulatory and a law enforcement angle. Hendrik who spoke before me mentioned a range of products we find on the market. And this ranges from products such as CBD, with trace amounts of THC, through herbal cannabis, to the more potent cannabis resin. From the analytical point of view, how low should our measures go. Hendrik also mentioned important points: the prominence of the cannabinoid Delta-8-THC on cannabis markets. Let’s not forget, this is a minor component in herbal cannabis, which we normally don’t worry about, but this can be easily made from cannabidiol. Now the question for the analysis: can we separate these various components of cannabis, and be able to report on them. Quite often, we assume that analytical data between laboratories are comparable. This will be ideal for a wide range of purposes including monitoring, cultivation, providing estimates to regulatory authorities, and even understanding economics markets in general. But in real life, legislation in a number of countries, does not require detailed analysis of the THC content of different products. The forensic question under a lot of legislations is often, whether cannabis is present or not. Never how much is present. Where such analyses are carried out, they could involve the use of a variety of approaches and experimental designs, and this can reduce the comparability of results, and also impact on useful procedures like providing estimates to INCB. On the technological side, the analysis of cannabis products is fairly complicated by the relatively restricted availability of well defined reference materials of THC and other cannabinoids. The experience from the UNODC international collaborative exercises, a proficiency scheme we run for national drug testing laboratories has shown, that disparities in THC content by different laboratories for the same sample of cannabis could be significant. It brings up questions: How can labs provide comparable analytical data to support the INCB system of estimates? How can we reliably differentiate between the different components, including the isomers Delta-eight and delta-nine, with the former becoming so relevant? How can analytical science support the choice of even the cultivars we use in the cultivation of cannabis for industrial purposes and for the production of CBD, whilst reducing the risk of diversion of the THC containing parts in this plants? There are challenges, and with all these challenges ahead of us, we really welcome the efforts of INCB to get these guidelines in place. From UNODC, we’ve been supporting over 300 laboratories in 85 countries worldwide, to be able to analyse cannabis, and related substances, accurately, and to be able to produce comparable data. As we go along, UNODC is ready to make available to INCB resources such as our Manuals on the analysis of cannabis and cannabis products. I’ll share this in the chatroom for those who are interested in looking at the document. Reference standards collection will also support countries to be able to analyse products accurately, and to be able to differentiate between the different components of cannabis. And finally, our proficiency tests for national laboratories, will be made available to anyone who wants to join this forum, to make sure that you’re able to generate data, which will once again be comparable between countries. We look forward to supporting the elaboration of these guidelines, and also to ensure that analytical science is at the core of regulatory and law enforcement efforts.


Q&A

Ms. Juliana Erthal-Williamson, Drug Control Officer, ICCI Coordinator, INCB: One of the first issues that were raised by participants who pre-registered was the terminology; so could you please tell us why in the title of the guidelines we use the term utilisation, instead of ‘use’, or ‘users’ and where it is defined.
Stefano Berterame, Chief of Narcotics Control and Estimates Section, INCB: Thank you, Juliana and thanks to the speakers, it was very interesting to hear from the experts from the national authority as well as from the UNODC. As you can see the matter is very complex and we are in an effort to try to work with member states to get some clarification regarding the question: ‘Why it was in the document with the draft guidelines the term we use was utilisation and not use, or user?’. We are trying to refer as much as possible to the terminology that is used in the conventions, and in the conventions, the ‘utilisation’ is referring to ‘the use of a drug to manufacture another drug’; so if you’re taking cannabis to extract the cannabinoids, then that would be ‘utilisation’ from the point of view of the convention. Also when the convention describe the therapeutic use of medical, scientific use, they talk about consumption and ‘consumption’ is considered when a drug is distributed to the retail, being pharmacies or hospitals, and then it’s considered to be consumed at that point. So these are the two terms that we prefer to use making reference to what is in the convention. Thanks.

Ms. Juliana Erthal-Williamson, Drug Control Officer, ICCI Coordinator, INCB: What is the process or processes that INCB has developed to consult and consider scientific literature and other relevant pieces of evidence?
Stefano Berterame, Chief of Narcotics Control and Estimates Section, INCB: Thank you. So first of all, I think we need to clarify that the effort of the INCB is in support of the decision of the member states regarding scheduling; and, as you know, the determination for the scheduling is based on scientific analysis by the [WHO] expert committee on drug dependence. So, for the NCB, the process of review of scientific literature or relevant piece of evidence is only related to the development or clarification of the control mechanism, so we are not doing a reassessment of the medical use of cannabis, because that is being done already by WHO, and it has been already considered by member states. However in this process we had been able to carry out a review of literature, and also  engaged a consultant who conducted extensive review of literature engage with experts in the field of the manufacturing utilisation of cannabis and cannabis related substances. As was mentioned also by the President in his opening we had an Expert Group Meeting that took place in January, 2021, and we continue to work with the Member States through an intergovernmental consultations, but also from scientific community and NGOs and as it was mentioned also by the president; there is foreseeing the possibility to consult with civil society, to see what is their point of view on the on this particular aspect.

Ms. Juliana Erthal-Williamson, Drug Control Officer, ICCI Coordinator, INCB: Thank you, Stefan also to reinforce that we welcome submissions of papers, some of you have already submitted papers, documents, any kind of supporting material that you may find relevant; we’re welcome to receive them and take them into consideration. We like to think of these consultations that the President mentioned as a platform that the INCB has launched for broad consultations in the context of the production of these guidelines; so thank you in advance for your contributions and thank you for the ones who have already sent us material. Definitely the next question is about control of cannabidiol, CBD: is CBD extracted from cannabis plant controlled internationally under the 1961 drug convention, and if so how should member states report on the quantity of CBD.
Stefano Berterame, Chief of Narcotics Control and Estimates Section, INCB: Thank you, Juliana and I think this is something that was already discussed by some of the presenters. And I think in particular, the representative of the United States pointed out that there is the need to clarify when an extract, and, and when it becomes pure CBD from the legal point of view so that kind of border need to be considered because, as it’s been one of the major issue of concern is that cannabidiol is not explicitly scheduled as a substance in the convention. However, it is extracted from the cannabis plant, and therefore could be considered control under the 61 convention as an extract of cannabis. As you all know the there was a discussion in the Commission of Narcotic Drugs based on the recommendation of WHO; then, some of the recommendations of WHO would have tried to address this problem but unfortunately they were not accepted or adopted by the Member States. Anyway, from the point of view of the board we think the member states are mandated to report on the production, utilisation and trade, stock, and consumption of extracts of cannabis containing CBD. However when considering CBD as a pure substance, it would be possible to understand it as a non scheduled substance as CBD is not listed in any schedule. This is something that we think needs to be discussed further with member states, and the INCB is making every effort to facilitate the discussion in the intergovernmental meetings on the guidelines, and we hope that in the context of the debate, it would be possible to identify a common ground on reporting. The issue I think that remains is some of the preparation CBD continues to contain traces of THC and therefore it is important for country to be aware of what is the use of this CBD. And one of the concerns that we have if you have a very big production of CBD extracts, then it will be possible through manufacturing process to extract and separate the CBD from the THC, and there may be, you know, the possibility to have a big amount of THC being produced that needs to be reported nevertheless. So this is one of the concerns that we have and also I think Justice Tettay from you UNODC mentioned earlier, the possibility of converting from CBD to Delta-eight-THC which is also an issue that needs to be addressed. So, This is something that we think together with member states and experts we will try to see what is possible to conclude, as in a common understanding on reporting and control.

Ms. Juliana Erthal-Williamson, Drug Control Officer, ICCI Coordinator, INCB: Are there any initiative actions for the regulations of cannabis / hemp derived edibles and consumer products such as dietary supplements skincare products etc?
Stefano Berterame, Chief of Narcotics Control and Estimates Section, INCB: Thank you, Juliana. I think this brings also back some of the issue related to CBD used as a cannabis derivatives for certain preparations. First of all, in the convention, there is no mention of hemp, per se, but only of the cannabis plant, meaning any plant of the genus cannabis, so this is what is in the conventions, from the legal point of view. So the as you know the convention require that control substances, including cannabis and cannabis related substances and I underlined controlled substances, we use exclusively for medical and scientific purposes. So the use of cannabis related substances for purposes other than those is not in line with the convention. However, if the references to products or dietary supplements that contain CBD; if CBD is not considered to be controlled, then there would be something that would need to be left to the national authorities to determine the level of control that needs to be applied to this preparations, or product. If the, the preparations contain substances that are under control, from the point of view of the International Convention national authorities needs to control them, and they need to be prescribed, with proper medical prescription for related health condition. So, if, let’s say THC, for example, that is clearly controlked is used in a preparation, that needs to be used for medical and scientific purposes. Not for skincare products; this is what the convention requires. If it was instead of, let’s say a skincare product or dietary supplement containing CBD, that would not seem to, you know, fall into the control of the international conventions; however, are still a product that may have an impact on the health of those who are taking them and we would expect that the national authorities medical authority would put in place, regulation on the assumption of the administration of these substances.

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