Side event: International Standards for Reporting Cannabis and Cannabis-related Substances for Medical Purposes

18 March 2022 at 8:00 AM- 8:50 AM Vienna Time (CET)

Organised by the INCB Narcotic Control and Estimates Section with the support of Argentina, Australia, Costa Rica, Israel, Germany, Japan, the Netherlands, Paraguay, Portugal, South Africa, Spain, Switzerland, the United Kingdom, the United States, and the African Union Commission, the European Union and the UNODC Laboratory and Scientific Service.

 INCB_Flyer_-_International_Standards_Cannabis_10.03.2022

Juliana Erthal-Williamson, Drug Control Officer, ICCI Coordinator, International Narcotics Control Board (Moderator)

Ms. Jagjit Pavadia, President of the INCB: Since the CND voted on the WHO recommendations on cannabis and cannabis-related substances, INCB has been working with member states on their implementation, including on legal and technical issues related to compliance, with monitoring obligations set in the 1961 and 1971 conventions. The INCB has worked with competent authorities and civil society organisations including convening expert working groups, intergovernmental meetings, and a questionnaire circulated through VNGOC. The intergovernmental meetings were a platform for member states to address common harms and harmonise standards for reporting. The participation of regional mechanisms and the UNODC has been critical. The minimum common standards are being developed, and consistent with the international drug conventions in relation to cannabis. These developments are necessary given the growing focus on cannabis, which raise more issues on reporting and monitoring by competent national authorities. INCB has sought civil society input on the standards, including through distributing a questionnaire through VNGOC. Coming to a common approach will enable member states to submit accurate information, and enable the INCB to ensure compliance, and access to substances for medical purposes. The Board understands that it will take continual effort to reach consensus and believe the right spirit is there.

Mr. Ryuichi Komuta, Japan, Senior Coordinator for Drug Control, Compliance and Narcotics Division, Ministry of Health, Labour and Welfare: We commend the Board for their excellent work on the minimum common standard on reporting on cannabis-related substances for medical and scientific purposes. Evidence has been emerging on the medical purposes of cannabis-related substances, with changes in perceptions about the risks of its use. We are convinced that a common understanding amongst member states is necessary to address the current circumstances. I would like to express our sincere appreciation to the INCB for providing the minimum consensus needed to tackle this issues, and enable exchange of views and best practices. We believe the expected standards will clarify the reporting required of member states. We anticipate that implementation of the convention will clarify the interpretation of the standards. It is an important initiative for Japan and will ensure implementation will be in line with the three drug control conventions and the 2019 Ministerial Declaration. The government of Japan has contributed to supporting the INCB’s efforts, therefore we look forward to the final outcomes. Japan will continue to support proper implementation of the conventions.

Juliana: We are appreciative to the support provided by Japan.

Mr. Andrew B. Thompson, USA, Narcotics Science Advisor, U.S. Department of State: This process started with a CND resolution that identified some ambiguities and difficulties by member states on cultivation of cannabis for medical purposes. These ambiguities could lead to inaccurate reporting that could lead to diversion and undermine effectiveness of international drug control. The controls applicable to opium are very different to those applicable to cocaine, and for cannabis, the controls are different for different parts of the plant and the purposes they are used for. We therefore need to be careful about the precise requirements of the treaties. For example, we have been reporting on THC produced natural under 1961 convention and synthetically under 1971 convention, but this was not correct as they should both be reported under the 1971 convention. Providing clear and detailed guidance on reporting is important. While its true that extracts of cannabis are controlled under the 1961 convention, it is our view that no information will be lost by calculating products produced through extraction processes. The INCB can decide best way to proceed. Other important issues that arise don’t relate to reporting but to ambiguities in the treaty, e.g. on ‘industrial purposes’ there is no explicit definition. On ‘systems of control’ that parties are required to establish for licit cannabis cultivation, there is no further explanation. Some questions remain on how best to achieve the aims of the convention while preventing diversion. These ambiguous parts of the treaties are for member states to interpret. We are not asking the INCB to interpret the treaties for us. It is ultimately the role of the member states to interpret how the conventions apply to them. It is not for the INCB to adjudicate on this. However the INCB has provided an important forum to discuss these issues and discrepancies. Effective and uniform monitoring is vital to ensuring drug control.

Mr. Conor Crean, UNODC, Scientific Affairs Officer, Laboratory and Science Section: I would like to provide information on the specific tools for laboratories. We provide a range of services to laboratories around the world, in Vienna and in the field, analytical instrumentation and toolkits. Since the 1980s, 40 manuals have been produced to help improve standards of forensic drug laboratories. There is guidance on how to implement quality management systems, and on emerging psychoactive substances such as synthetic cannabinoids. We also update the manuals we produce. For example our manual on cannabis in 1987 was updated in 2009 to incorporate new developments on cannabis cultivation and products, e.g. with increased THC. Cannabis products with cannabidiol and low levels are THC are now on the market. There is a need to detect their isomers. There is a need for more detailed analysis. I will give an overview of some of the information in the cannabis manual, e.g. through botanical means, which entails looking at its isomers, biosynthesis and levels of THC. There are different analytical things and preliminary tests that have been added to the manual, e.g. to distinguish between cannabis for industrial and medical purposes. The UN Toolkit on Synthetic Drugs provides the breadth of analytical tools from the UNODC.

Mr. Hendrik Greve, Germany, Head of Trade in Narcotics II and International Affairs, Federal Opium Agency, BfArM: There is a diversity of cannabis and cannabis substances availability in Germany (shown on Table in PPT Slide). Most products are used for medical purposes, while some are used for research. Some are produced domestically. Considering the diversity of the products, it is worth looking at the lifespan of cannabis and cannabis substances, starting with cultivation then production, manufacture, export/import, manufacture and consumption. On manufacture, dried cannabis flowers can be used to create intermediate products – extract products include dronabinol for medical purposes. There was a proposal for reporting manufacture as a total quantity in kg in accordance with the 1961 convention, and the total quantity of Delta 9 – THC, in accordance with the 1971 convention. However the WHO recommendations in 2020 on cannabis were to be incorporated for reporting. We therefore propose an alternative format of reporting whereby reference is made to 1961 Convention IDS Code: NC 008CAS No. 6465-30-1 (yellow list, INCB) for Delta 9 – THC, and for dronabinol (green list, INCB).

Ms. Daphney Mokgadi Fafudi, South Africa, Manager: Regulatory Compliance, SAHPRA: We appreciate the INCB’s support since 2018, where numerous engagements in understanding the expectations of the conventions were addressed in relation to medical cannabis. The use and production of medical cannabis is regulated by a specific Act. We have participated in several consultations and meetings with the INCB to develop guidelines. We ensure that medical and scientific cannabis is regulated. Extraction is treated as manufacturing, so licenses are required, as for research and export. There is not much delta 9 related cannabis substances that fall under the 1961 convention. There is a huge interest in the export market, and we have exported to Australia, Canada, USA, Portugal, Israel, Switzerland, Macedonia, Macedonia, Germany and the UK, among others. We issue licenses to facilities that are ready, and conduct inspections. We are aligned with our alliance partners on how we conduct inspections and issue licenses. South Africa is committed to ensuring regulatory frameworks in alignment with the conventions.

 Ms. Angharad Thomas (Head of Drugs and Firearms Licensing Unit) and Katie Walton, Home Office, UK: The UK has a long and proud history in providing regulatory systems to enable cannabis research and production for medical purposes, mostly extracts. This supports bona fide companies, and research institutes to conduct trials. The Home Office is responsible for setting regulations, and works with the Ministry of Health and the Medicines and Healthcare Agency. Definitions are interesting, e.g. dronabinol where in the UK only synthetic dronabinol is defined as dronabinol and everything else is defined as delta 9 THC. We work closely with the Medicines and Healthcare Agency on accessibility to unlicensed cannabis products, which have been available since 2018 where there has been a lot of interest. However ambition and expertise do not always align. There are ongoing efforts to remain compliance with the 1961 Convention and reporting requirements. We undertake regular site visits, to monitor manufacturing processes. They can be complex. We consider ourselves to be a credible regulator and provide supports and advice to other related jurisdictions on regulation. We support formulation of an informal network of regulators, especially on how regimes are practically delivered.

Ms. Andrea Eng, New Zealand, Manager, Regulatory Practice and Analysis, Ministry of Health: The New Zealand cannabis scheme has been in place for 2 years and put in place to increase access to medicinal cannabis products. It involves a licensing regime to set up a domestic industry and setting standards for products to comply with. We have a domestic industry that is becoming established, some locally produced CND products and some imported products containing THC. The government is committed to the long term sustainability of the industry so has allowed cannabis and products to be exported. Companies are beginning to produce high quality, raw material products. We are starting to engage with international regulators and coming across challenges and opportunities. We want to minimise the potential for diversion of products and raw materials going overseas. As our domestic communities start to engage with overseas regulators, there are criticisms that our standards are too high and there are questions whether it is possible for them to meet the standards of the importing country without having met NZ standards. We support the establishment of an informal network to share information about regulatory requirements, as suggested by the UK, and points of contact to approach with inquiries. Meetings with counterparts in other countries have been very useful. There are different regulatory schemes and requirements around the world so those exchanges have been important.

Juliana: the INCB will see how we can support some of the processes suggested. We will now turn to address some of the questions. The representative of Israel was not able to join but we can share his presentation (and of other speakers) for those who have registered.

Stefano Berterame, Secretary ad interim, INCB: We will quickly address some questions submitted beforehand. For the question on the draft Guidelines, they were used at an early stage in a discussion platform with member states, and then the focus has narrowed considerably to the requirements for reporting and monitoring. These standards are still being discussed with member states, and quite technical. The INCB has asked civil society for their general views, and where inputs are relevant and appropriate, we will take them into account. There was another question about import requirements for the EU in terms of moisture; the standard is currently not more than 10% moisture for certain cannabis products. On another question about reporting estimates of amounts needed, the conventions talk about estimates in terms of quarters – as long as the estimate amount requested is in line, they are generally accepted. On the question from FAAAT about whether recreational use is allow under the conventions, I believe this is outside the scope of this event because the discussion today is only about medical cannabis. On the question from Kenzi of FAAAT about a legal provision in the treaty, is it also not under the scope of this event. On another question, the standard of countries reporting to the INCB is to report quantities in kgs.

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