Agenda item 2: Proposed scheduling recommendations by WHO
Chair: Good morning, we have a slight change in the agenda. We are starting with agenda item 2 which is regarding the proposed scheduling recommendations by WHO – no objections. Assistant Secretary General of United Nations Office of Rule of Law and Security, you have the floor.
Alexandre Zouev Alexandre Zouev, Assistant Secretary-General for Rule of Law and Security Institutions: UNODC has been an executive partner of my office, we share good practices on a regular basis, with the inclusion of UNPOL. We operate in regional and global context. We have supported UNODC on operations “open road” with MS such as Zambia, Senegal, etc., a cross-border mechanism addressing cross border trafficking. Two years ago, our entities signed a partnership including the prevention of violent extremism, we cultivate regular exchanges on policy, development, assessment, training – this will continue be our growing are of focus. In particular UNODC chairs the counter terrorism group of UN and it co-chairs the resource mobilization group as well as border management and law enforcement groups. We encourage this collaboration. Serious organized crime is often a product and contributor to conflict in vulnerable states. As a nature of this threats and capacity gaps, we see a need for different skillsets, one is to follow the money. The future will likely bring increased demand, to respond effectively it will be necessary to capitalize on partners inside and outside the UN systems. UNODC and office of counter-terrorism evolves a closed collaboration with various regional and functional groups. Inter-agency mechanism that addresses the rule of law is called a global focal point, a practical field bringing together key actors like OHCR, ONWOMEN, UNODC among others. Thank you for your attention.
Chair: MS were asked to submit their questions to WHO, regarding recommendations to the 61 and 71 conventions regarding Cannabis. We will begin by an introductory presentation then proceed to the questions and answers. There will be a possibility to address questions to INCB after WHO today. Non-state actors, UN entities and NGOs are allowed to make statements afterwards. Now, secretary of ECDD, Gilled Forte, you have the floor.
Gilles Forte, WHO: The body that carries out the assessment is comprised of independent experts selected via a thorough process with a geographical and gender balance. The committee also has observers from INCB and UNODC. The work is guided by a guide developed by MS in 2010. The rationale for reviewing cannabis and related products is to respond to resolutions so WHO has a mandate to review Cannabis including dronabinol. A number of countries requested WHO to collect and analyze evidence as more and more countries are embarking on unregulated medical use. Cannabis has never been a subject to review since its original placement in the schedule. So this process is operating under a stepwise approach since 2014. There has been a progressing in the collection of information and review. Information is central for the work of ECDD and an important objective is that to makes sure that the committee works with appropriate amounts of such so proper decisions are made. Robust information is central to the ECDD review process, we reviewed hundreds of scientific publications that were peer-reviewed. We also take into account MS’s data. Every year we issue a survey about the substances that we review. We do have other sources of data, Early Warning Advisory System of UNODC&INCB, EMCDDA, Uppsala Monitoring Centre on adverse medicines reactions (WHO), Global Surveillance and Monitoring System on Substandard and Falsified Medicines (WHO).
Because the importance and sensitivity of this topic, we paid careful attention of how it is carried out and issued an open call for authors in 2017 in line with UN procurement procedures. We received 31 applications. The consultation process’ reports were posted on our website, comments were received from MS, CSO, private groups and scientific orgs. We held open sessions, consultations with UNODC, INCB regularly, we briefed MS in Geneva and the WHO Executive Board.
The rationale for issuing recommendations on scheduling: We seek to prevent harms and to ensure controlled substances are available when and where they are needed for medical and scientific purposes. We aim to ensure a coherent international control that considers contemporary information. The levels of control should be considered as minimum requirements, it is at the MS discretion to implement locally relevant measures.
Cannabis and cannabis resin: Currently schedule 1 and 4 of 1961 convention. Recommendation: Delete from schedule 4. The rationale is that Cannabis is not similar to other schedule 4 substances, it has proven medically useful.
Dronabinol (delta-9-thc): Currently schedule 2 of 1971 convention. Recommendation: add to schedule 1 of 1961 convention, delete from the 1971 convention. Rationale: delta-9-thc was not known to be the main active component at the time of original scheduling and so placing cannabis and its active component in the same convention schedule makes sense.
Isomers of THC: Currently in the schedule 1 of 1971 convention. Recommendation: add to schedule 1 of 1961 convention and delete from 1971 convention. Rationale: these are not easily differentiated from delta-9-thc, placing them will facilitate international control.
Extracts and tinctures: Currently in schedule 1 of 1961 convention. Recommendation: delete from scheduling. Rationale: it was concluded originally because the original active component was not known but it is covered now as per previous recommendations.
Cannabidiol preparations: Currently schedule 1 and 4 of 1961 convention. Recommendation: Footnote to schedule 1 of 1961. Rationale: childhood epilepsy, not psychoactive, no evidence for dependence or abuse. However, trace amounts of THC can be detected, the proposed change will allow pharmaceutical preparation.
Dronabinol preparation: Currently schedule 2 of 1971 convention. Recommendation: add to schedule 3 of the 1961 convention. Rationale: not liable for abuse when taken orally, lower level of control will increase access to pharmaceutical preparations while protecting from harm.
Chair: Item 2b – we have received questions by state parties and on the alphabetic sequence. I invite the WHO to provide the answers in writing after this session that are in the general interest.
WHO: We are grateful for your questions, we will not respond to them question by question but we prepared a comprehensive response. It is a dense text but you can follow our paper on the screen.
Cannabis has never been subject to a formal review since its original placement within the conventions. CND 52/5 requested the WHO to provide an updated report.
In recent years more robust scientific research has been conducted regarding cannabis and preparations. This clearly identified delta-9-THC to be the main psychoactive compound. We considered this new evidence as the basis for our review. Our recommendations seek to prevent harms and to make sure availability for scientific and medical use. […]
WHO will continue to engage and closely collaborate with all relevant parties, MS, UN agencies, etc to address questions, concerns, comments with regards to our recommendations. We received a question regarding industrial use (hemp) and in food products. These issues are not within the mandate of ECDD, however WHO is prepared to address these issues in other forms. WHO acknowledges the challenges MS in enforcing balanced policies.
Chair: floor is open for questions
European Union on behalf of its MS: It is an honour to speak on behalf of the European Union and its Member States. Mr. Chair, Excellencies, Ladies and Gentlemen, The European Union and its Member States would like to thank you, Mr. Chair, and to thank the World Health Organisation for the opportunity of today’s exchange on the WHO’s proposed scheduling recommendations on cannabis and cannabis-related substances. A full understanding by all Member States, of the precise scope and content of the recommendations, is the only way to enable a future vote by the Commission on Narcotic Drugs, based on facts and evidence. Mr. Chair, please allow us to make a few important remarks in the framework of today’s discussion. First of all, the EU and its Member States would like to reiterate their commitment to the effective implementation of the UN Drug Conventions. We welcome the broad consensus of the international community that the Conventions and the relevant international human rights instruments are the cornerstone of the international drug control At the same time, we strongly support the important role played by the WHO Expert Committee on Drug Dependence in the international drug control system. We also acknowledge that the recommendations of the ECDD are based on the available scientific, medical and public health evidence and comply with the criteria established in the conventions. Moreover, building on experience, the European Union and its Member States would like to emphasise that drug policies based upon an integrated, balanced and – importantly – on an evidence-based approach, including the risks for users or patients, prove to be the most effective way to address the world drug situation.
The European Union’s drug policy is based on such an approach. It is therefore of utmost importance for the EU to properly evaluate the impact of the recommendations put forward by the World Health Organisation on scheduling of substances, ahead of the decisions to be taken by the Commission on Narcotic Drugs. The short time that had elapsed between the presentation on 24 January of this year of the scheduling recommendations, and the 62ndsession of the Commission on Narcotic Drugs in March, had not allowed for a proper assessment. Therefore, we welcome the opportunity to put forward questions to the World Health Organisation on these The EU and its Member States have specific questions, that we have submitted in writing to the UNODC ahead of our meeting today.
On a more procedural level, it is key for us all to understand what the follow-up of today’s meeting will be. In particular, may we ask the World Health Organisation what their intention is as regards the recommendations: in particular, will the recommendations’ wording be further specified and/or completed with additional information following the requested clarifications, in order to facilitate the process towards a future vote? In this regard, the EU and its Member States believe that the future vote should take place once the impact of the cannabis and cannabis-related substances re-scheduling recommendations has been assessed. Chair, Excellencies, Ladies and Gentlemen, The European Union and its Member States are looking forward to receiving additional information on these aspects, and regarding the questions that we have submitted in writing. We have no doubt that the discussions today and in the weeks and months to come, will help to provide clarity on the consequences of the WHO recommendations, before a future vote is held in the CND.
Mexico: We reiterate our full support for the WHO and ECDD’s role, we welcome CND’s opportunity to consider this vast scientific analysis – it is rather a duty to update the conventions. I will submit our questions in writing as well: Do medical and scientific communities have the same tools now as when the conventions were crafted? Is the knowledge about different components the same? Could you confirm if the original concept of cannabis as a single substance is still viable? Is there now a better understanding of the different components well beyond the differentiations captured in the conventions as well as their different characteristics? Is there a different consideration regarding the poppy seed similar to cannabis plant – will this prevail in the recommendations?
Jamaica: The way forward is clearly outlined; we thank the WHO’s work. We covered the Geneva portfolio and had a 360 view on the process and appreciate the transparent and inclusive process adopted by the ECDD. We know all MS were given an opportunity to give input. We regret the delay in the submission to CND but we understand that time was needed to give best recommendations as possible We are of the view that these are the first step in the right direction. International convention can be a barrier to access, they play a dual obligation on governments. To prevent abuse has gained larger importance that access to medical use. We conducted extensive research and continue to be faced with obstacles due to the current placement of cannabis within the current scheduling, therefore we fully support the recommendations of the ECDD that will aid our scientific efforts. We are mindful that implementations will impact the way in which medical practitioners work therefore successful rescheduling will contain re-education and training. Wat are the plans of UNODC, INCB to assist MS in implementation. What is the timeline?
Canada: the ECDD follows the guidance in the conventions as well as the WHO executive boards guidance – could we have a summary of that guidance and how it complements the conventions?
Russia: Cannabis related issues are more and more visible on the CND agenda, according to the World Drug Report, it is the most abused substance worldwide it is most used among youth, increased potency and increased number of people seeking treatment. Some MS chose to legalize non-medical use in violation of their commitment to the conventions. It is a volatile environment, WHO comes up with recommendations – we should be particularly diligent, why after 60 years we are unexpectedly get a proposal to reschedule, what has drastically changed? Th ultimate question is how the international drug control system will be impacted? Will rescheduling allow larger medical access? This doesn’t seem logical. The market has expanded and more and more cannabis medications are visible, nothing in the conventions seems to prevent that. The WHO has repeatedly recognized the therapeutic evidence is weak and not sufficient to support a change, they are never used as a first line medication and can almost always be replaced by a legal substance. As for a harmful effect, WHO is only about to launch an assessment. We intend to conduct our own national research and will share it. Without those results, it is premature to implement these recommendations. The political implications are also something to consider. Even minor changes will be considered by the general public as a blessing for the way towards full legalizations. The number of questions submitted show that we need more clarity on the issue. The CND is now not in a position to take an informed decision.
USA: We take note of the work of the ECCD. We have submitted a number of questions as we are charting a way forward for international scheduling. It is our global responsibility to get it right, we can not rush this. We are in some ways, hampered because the original convention was drafted with limited knowledge. We have to be mindful that we share a universal commitment to the scheduling process and address our overarching concern about the welfare of mankind – prevent abuse but assure access for medical purposes. Does the ECDD has the flexibility to react to the interest of governments in regard to modifying the recommendations to be more specific and stir it in a different direction? Several recommendations are based on findings of others, but this is not written into the recommendation – what would happen if the underlying recommendation is not adopted?
Uruguay: We understand the recommendations are positive step towards a right direction. We request the recommendations to be approved as soon as possible.
Pakistan: We need more detailed assessments as a number of MS have contestations. What was the criteria to include cannabis in schedule 4? What are the findings have compelled WHO to delete Cannabis from schedule 4? Removal will increase the repercussion of legalization? Scientific use is more important the threat of risk? What re the remaining areas that need to be explored to see way forward clearly? This is the most abused rug worldwide, in our view stricter control is needed. We think the removal will increase the threats of Cannabis – it will mark a shift and a further weakening of international control. It may send out negative signals and might be perceived as a promotion of legalization.
China: We have submitted our questions already and hope fir written answers. I would like to echo Russia, Pakistan and US – we need more scientific evidence, this should not be rushed.
WHO: In response to Canada, the guidance document is called “the blue book” internally, it is a 25 page document adopted in 2010. The role of this document is to give procedural guidance and operationalize the rules set out in the conventions. It ensures that WHO review process is on public health and scientific principles and provides clarity to the procedure as a whole – includes a lot of things that Mr. Forte has outlined earlier this morning. It can be found on our website.
Concerning the potential to clarify and refine the recommendations – at this moment, there is no process in place or plan to revisit the recommendations.
Regarding the change in knowledge, in response to Mexico, it is correct that there has been a vast change in our understanding of the plant and substances. There was no attempt at the time of the original scheduling to medically asses Cannabis so there was no information available then. The research on harm and potential for abuse has developed majorly since.
With respect to the question of the EU, this is our first opportunity to engage but we understand that there will be an additional intersessional this year when we can continue. We will share documentation of today’s exchange. We are happy to continue this discussion – we see it as a process where we clarify the rationale and way forward.
Responding to USA and Pakistan, we will address them in the following section.
Chair: Some question were addressing INCB and UNODC, we will give them an opportunity to respond later on so we proceed with our agenda. WHO, please provide answers regarding 5.1.
WHO: Cannabis and Cannabis Resin are currently in 1 and 4 of 1961, we recommend to only have it in 1 based on similarity issues. The drugs in schedule 2 are considered to be weak opioids. We considered the liability to abuse and decided that Cannabis and resin were more similar to schedule 1 as schedule 2. That evidence is outlined in our report. The main points address the effects on mental state, potential for abuse, lethality, impairment of cognitive functions.
Only a small subset of drugs in schedule 1 are also in 4, apart from cannabis these are opioids without therapeutic use, for example the latest addition was carfentanyl. Cannabis did not produce similar ill-effects. In 1961, Cannabis was included as no therapeutic potential was recognized. Today, national regulatory authorities in a number of countries approve cannabis-based medication. We considered that Cannabis was not similar to other substances in schedule 4 and decided it is not appropriate to keep it there. The impact of this will vary from country to country.
In response to Canada’s submitted question (How does the committee reconcile its recommendation to maintain cannabis under Schedule 1 with the fact that the committee did not consider that cannabis is associated with the same level of risk as most other drugs that are in schedule1) it is important to consider that we noted the high rates of public health problems arising from cannabis use and the global extent of such problems.
There would be no weakening of the international control if Cannabis would only be included in schedule 1. The levels of international control are a minimum requirement.
Chair: Floor is open to comments but please focus on follow-up to 5.1.
Mexico: Regarding from the scientific advancement of the past 60 years – if so is the case, why do we refer to Cannabis as a whole if its only one constituency? Why is delta-9-thc is similar to some other substance where mortality and etc risk is completely different? If the committee did not consider it to be dangerous as much as other schedule 4 substances, why is it recommended that cannabis and resin remains in that schedule? Seems to me as a contradiction. If toxicity and mortality is an issue, what are the other public health problems arising from cannabis use? What is the metric for these other health problems? What would be the difference between these and those arising from the use of other legal such as sugar, caffeine or even work? WHO determined burnout as an occupational hazard and now it is a medical condition – just to reflect on the medical understanding?
Russia: ECDD repeatedly reviewed the health risks of Cannabis and concluded that scientific evidence is insufficient to arrive to a rescheduling decision. What has changed? The evidence for medical efficacy is weak and insufficient. What is the rationale? Cannabis use has a number of adverse effects, safety has never been well documented, medical use is not proved to be safe and beneficial enough. Problems related to other drugs have reached epidemical proportions but no one recommended rescheduling those.
WHO: One of the reasons it is considered as a plant is the 1961 specifically including Cannabis. The second issue is why it is still included in schedule 1 is because it was more similar to substances there with regard to abuse. In this regard it is not just the plant, it is also preparations. The committee was aware of preparations illicitly that have a very high concentration of THC, so we were mindful of those as a recent phenomenon. Nevertheless, we considered it to be different from substances in schedule 2 as previously outlined. Regarding public health problems, the evidence is outlined in our report in more details. The main concerns were abuse and dependence based on epidemiological studies that established that 1 in 10 users do develop a problem. We were also concerned about driving under the influence of Cannabis that increases the number of traffic accidents. We cannot compare this to other types of disorders and unscheduled substances.
Russia, I suggest to take a look at the critical reviews that is a key document in arriving to our decision with regards to empirical research. With regard to the timing, there have been a number of developments as well as the resolutions influenced WHO to conduct the review, including medical use, number of research and increasing potency. With regard to clinical use, this is not our main reason for recommending the removal, the main reason is that it is not similar to the substances it is currently scheduled with. A number of cannabis medications have been approved in some countries which means a recognized medical use.
Canada: We have similar concerns as Mexico – can similarity be seen with Cannabis and alcohol and tobacco. We understand it is not within your mandate yet is an important question. You already answered this question but we do think this is an important comparison especially because you mentioned driving.
Singapore: Did Cannabis resin have similar considerations?
Nigeria: We conducted a survey at home and launched the report in January. It revealed 14million people used drugs and the most used one was Cannabis. Each time our military takes Boko Haram camps, we find a lot of Cannabis and are we are worried […] We raised this issue already at CND. One of the major reasons for the recommendations is the recently uncovered therapeutic use. The INCB noted that therapeutic use of cannabis is not usually the first line of treatment. The growing abuse is also recognized by ECDD. People tend to move away from the technical discussion in fear of giving flexible control to this substance. You noted that schedule 4 means additional measures – don’t ECDD think additional measures are necessary in light of this growing abuse? How do you reconcile the incompatibility between your own conclusions and the reports of the INCB?
WHO: To Singapore; yes but we now recognize a wide range of preparations. Addressing Nigeria, I would make the point that medical use was not the principal reason for removal but that it was not similar to the other substances t was scheduled with in schedule 4. This criterion of similarity was most important. With regard to clinical use, it is true that a number of indications are not first line but have been showed to have several level of interventions – first line doesn’t work for everybody and different types of interventions need to be available. It is still clinically important to have second and third line of medical response. About additional measures, they can still be put in place by MS if they feel necessary in their local context.
UK: We align with the EU. Mr. Forte made a pertinent point that by removing Cannabis from schedule 4, we are not weakening the international control although reading the media reports, I understand the concerns. Are there any communications outside CND to clarify the recommendations that this is not aimed at weakening the international drug control system?
USA: As a follow-up to Mexico’s question, you responded that the scheduling must be as per the treaty – is this a result of a legal opinion? This seems as a pivotal issue.
Russia: We looked at the 41st technical report and found limited list of references, none of them published in international peer-reviewed journals to support rescheduling. We are looking forward to seeing your list of literature.
WHO: With respect to the question from the UK, indeed it is important for us to communicate properly. Misleading statements are visible so we are working on a communication strategy and translatable material. We count on your support for that.
Responding to the US, there is a commentary in the convention regarding the deletion of Cannabis. This is not our recommendation at this time, but we did consider new evidence. The control can only be changed through an amendment and not via recommendations.
Slovenia: THC is in the first group as per this recommendation, but we know that other plants also contain THC other than Cannabis. Will these plants be then scheduled in the future?
WHO: I find it strange that you refer to other plants. Those should be controlled with regard to THC itself.
With respect to Russia, could you please submit a written request so we understand what exactly you are looking for?
5.2.1 and 5.2.2 regarding Dronabinol.
WHO: (pic) Dronabinol does not refer to the medicinal form or chemically produced. Earlier recommendations to the CND were recommendations were based on the understanding that delta-9-thc is a pure substance existing only in this medicinal form. However, particularly in the past 10 years, there has been increasing use of illicit substance prepared from the cannabis plant. These contain a range of purities and active THC up to 90% purity.
It is also the case for morphine and cocaine. (pic)
Mexico: I have several questions on this one. If delta-9-thc was already recognized as the only narcotic agent, why did the international regime never updated? What is the rationale for ECDD to compare active and naturally occurring dronabidol to chemical version? Is it even scientifically sound? Does delta-9.thc at concentrations as high as 90% is not naturally produced is it scientifically sound to address this with manipulated versions? Are you familiar with the work of CB therapeutics? Could you elaborate on the MS request re who what and why listing dronabinol and delta-9-thc could greatly facilitate the implementation of control measures bearing in mind that ECDD undoubtedly confirms it is not comparable to other substances’’ dangers? Is that not a contradiction?
WHO: Th knowledge about delta-9-thc in 71 was identified but the evidence at that time was nto convincing enough so there was still a little ambiguity. Dronabidol can be chemically synthetized but there is difference in the effects. With regard to high potency THC preparations, such as hash-oil, this requires human intervention for high concentrate. Why would we consider this together? Because if a drug is included in a schedule then the preparations are also included. There is no specification of the preparations, this is a general coverage. In terms of illicit preparations of high concentrates, it can be regulated under other conventions. We have a situation where preparations vary from relatively low to almost pure THC. Therefore, some ambiguity whether they should be controlled exists. Hence the moving Dronabidol. With regard to companies, there is a large number of companies that carry out their own research, we don’t usually look at these unless they are published in peer-reviewed scientific papers as they might have certain interests in mind.
USA: Conventions exclude leaves when they are not attached to the plant. So if we remove delta-9-thc from the 79 convention, do we not run the risk of causing contradictions within the treaty itself?
Canada: The ECDD previously recommended different rescheduling. So what changed? Our impression is that the market has changed and higher potency has appeared.
WHO: Canada, yes.
With regard to USA, if this are followed and Dronabidol is included in 61 that the plant can be controlled because of the presence of THC. It was certainly the understanding of the committee but we might require more legal expertise on advising.
5.3.1 and 5.3.2 – source of THC
WHO: Isomers are recinnebded to be included in schedule 1 don’t usually occure naturally. (pic)
5.4 – extracts and tincture
WHO: We were not seeking to decrease the level of control. Should the recommendation be adopted, nothing of such will occur. These are usually subject to the same control as the actual substance. There are 4 types: extract, eg butane hash-oil, tincture (using alcohol as solvent), products derived with heat and pressure. There are potential extracts that don’t result in psychoactive effects. THCA and little THC will continue to be controlled. Preparations are controlled using whatever method.
5.5 – cannabidiol preparations
WHO: It can be obtained from the plant so it is controlled under 1 and 4. This shows no potential for abuse or dependence, any ill-effect is minimal, it is not similar to other substances it is currently scheduled with. It is not considered psychoactive, so we recommend that it should not be controlled. The option of a footnote is adopted after consultation with UNODC. When produced from the plant, it will contain trace amounts of THC and other cannabinoids – we recommend it should be 0.2% THC (by weight). It was specified as WHO requested MS to indicate the max percentage was approved in currently registered CBD medications and it will not produce significant effects. Preparations will include pre-marketing authorization and also could include magistral authorization. MS can control CBD containing food products using their own legislation. We concluded that CBDV and etc should be considered separately.
Russia: Even though CBD has no potential for abuse, it is a precursor that might be easily converted to THC by acid and heat. Don’t you think this should be as controlled as the psychoactive substance then?
Mexico: How did the ECDD come to the range of 0.2%? Could it not be somewhat arbitrary to set a certain percentage?
Canada: We have the same question as Mexico regarding the percentage. You addressed some of our questions already but one of our concerns arises from foods that contain CBD…non pharmaceutical preparations are difficult to control. You said precise percentage might be determined by MS? Could we look over that text again?
WHO: Regarding Russia’s question, this method is difficult and risky, it is not generally used. It has uncertain yield and many byproducts, is expensive so seems unlikely that anyone would engage in that as opposed to plant production.
Regarding the percentage, we were guided by evidence from clinical trials that used 0.5% then some MS suggested 0.2% would be more reasonable. This is the principal justification.
With regards to non-pharmaceutical preparations, we concluded it should be predominantly CBD but we recognize plant derivates will include others, so 100% pure is not really possible so we thought in consultation with INCB MS can decide this for themselves. We did end up however suggesting 0.2%.
Slovenia: Do you accept that CBD could have also negative side effects on the liver and other organs? We still don’t know all about CBD but in reality, everyday use is popular – was this lucky that people use it in low doses?
USA: Looking at the percentage, in epidalex our records indicate 0.01% so 54mg of THC could be within that suggested percentage. We also know that MS that cultivate cannabis for industrial purposes, we adopted a percentage below that while others allow as much as 1%. So if MS can deliberate that in consultation with INCB, could we clarify that a little? They don’t have a role within the scheduling process, that is unique to WHO and MS. This gets to a potential inconsistency because 61 exempts industrial/horticultural cultivation of Cannabis.
WHO: Addressing Slovenia, there are some recognized side-effects as is the case with any medicine. I would agree that we don’t have extensive information. Obviously the toxicology data was such that certain MS approved it for clinical use and we will see how it unfolds with other states’ regulatory systems. Compared to many medicines, CBD’s side effects are relatively minor, but we will see further information as it is more widely used.
USA mentioned their approved dronabidol containing medicine. IF you take CBD and THC before its diluted then that is the percentage which we are referring and that is indicated in the patent. After dilution, lower percentage can be witnessed. As for hemp, there are different percentages within and we recognized that this was excluded from control. The percentages in the hemp plant were not relevant to this issue. With regards to delta-9-thc, we didn’t see any such implications that cannabis for industrial purposes would be excluded, but we will require further legal advise.
Singapore: We seek clarification on the interpretation, can we take the 0.2% THC as controlled?
WHO: Yes, it would be a footnote to the 61 convention’s schedule.
UK: I would like to revisit USA’s statement regarding epidiolex. The finished product on a weight-to-volume basis is indeed 0.01%. This coincides 20 times less than the recommended amount, I just think this is important to note.
WHO: Yes, as extracted it concludes other substances, THC among others. Pharmaceutical manufacturers dilute the drug with whatever additives of their choice and the percentage refers to the concentration after the process. Different manufacturers put different additives so it is difficult to regulate.
5.6 – pharmaceutical preparations
WHO: Preparations are exempted from some of the requirements for control, however they are still subject to significant level of control as per articles 31, 31, 19, 20 of the 1960 Schedule 2. Pre-market approval and prescription as well as good manufacturing practices will be necessary. We found evidence that the preparation is not connected to harmful effects. Under schedule 3, dosage will vary based on conditions and the patient’s history.
Thailand: Pharmaceutical preparations to be added to schedule 3 of 1961 is Dronabinol an active ingredient? Regarding the preparation, do you specify the percentages as with opium or morphine?
Mexico: Could you reconfirm that there is no difference in the therapeutic and ill effects of synthetic and naturally occurring molecules? Would be then safe to assume new versions of synthetics should be addressed differently? Could you elaborate what would be covered by the term “pharmaceutical preparations”?
WHO: Whether Dronabinol is the only active substance – it could be the presence of CBD but the control refers to the level of Dronabinol only. The reason why a percent was not specified because it would not be recoverable. In terms of other drugs in the schedule, the drugs are recoverable. With regards to synthetic substances, there are more powerful versions that act in a similar way and a number of those have been recommended for scheduling as synthetic cannabinoids and indeed have been controlled but delta-9-THC is the same substance, it is not possible to get a more powerful version. The pharma preparation referenced preparation for medical use.
USA: Earlier the emergence of highly concentrated Dronabinol was cited as the basis for rescheduling. Could you cite the evidence for increased risks in MS associated with health problems? The WHO used another authorized medicine in the USA of Dronabinol, it’s used as an example that it should be in schedule 3 – this level implies that it has little to no potential for abuse. This just seems […] whereas 5mg in a concentrated form is indicated as for schedule 3.
Singapore: Are preparations here intended to be confined for therapeutic use that have been tested for safety and medical efficacy?
Nigeria: I would like to follow-up on my earlier question: I was looking at the criteria and high rate of abuse and the impact on our society. The response was that the recommendation was because of the similarity principle. I would like to refer to the provisions, paragraph 3 article 3 of the single convention – this relates to substances not already in schedules. If a substance is liable for similar abuse and ill-effects as in schedule 1 or 2, it shall communicate its findings, then WHO will decide. My concern is in paragraph 5 of this article which provides that if WHO finds that a drug in schedule 1 has particular ill-effects and it is not balanced by particular medical effects, the Commission may place that drug in schedule 4. I need some clarification on understanding this. It talks about the criteria not just in terms of similarity but also in therapeutic use when it can measure above the ill-effects. There are not enough information regarding the therapeutic use when you compare it to the negative impacts. I refer to the INCB report here too.
WHO: I start with the USA, some of the high-THC preparations are treated somewhat differently than the medical preparations with high concentrations. The administration is different in these cases so liability to abuse and to produce ill-effects are significantly different too. With regard to medical preparations, it would be up to individual MS, granted it is by a recognized pharmaceutical entity using good manufacturing practices, etc. The passage read out by Nigeria was very much the guideline for our Committee. There is only a small number of substances under schedule 1 that are also included in 4 of the same convention. With regard to similarity, what I was referring to is that for a substance to be included there, it would need to have the same liability to produce ill-effects.
USA: Preparations containing delta-9-THC, if this is not included in the 1961 Convention is it possible to define a preparation that is not contained? So this goes back, that if a previous recommendation is not enacted, how does this play out? Predominantly CBD containing medicines […] so there seems to be a contradiction about the rescheduling.
WHO: If Dronabinol is not moved, schedule 3 would still apply as the cannabis plant is included in the 1961 Convention. Cannabidiol: it was our understanding that the exclusion of the preparations would override schedule 3. I can not speak from a legal point of view.
Chair: Thank you WHO.
WHO: Responses will be provided in writing. We look forward to continue this discussion.
Secretary: We have asked the conference management to collect questions in written form.
Stefano Berterame, Secretariat of INCB: I work with the team that deals with the issues exactly related to cannabis. We are aware of the process that lead the ECDD to the recommendations, we have been present at the meetings, although not at the closed sessions. We had some initial discussion but decided to review thoroughly the implications of the recommendations. We are not given any role about scheduling but we will provide some clarification on our view-point and address the MS’s questions.
5.1: ECDD recommend to be deleted from schedule 4, that would affect stricter control measures on the national level however control measures on international level would not change. These would be subject to schedule 1 measures. Statistics and estimates are mandatory for governments and we would continue to monitor and analyze developments.
5.2: Dronabinol’s addition and deletion will result in some changes. Instead of assessment, governments will need to submit estimates pursuant of the 61 conventions. These are subject to confirmation of the board. If cannabis and active principles are controlled under same conventions will facilitate reporting as same measures will apply to the substances. This will facilitate the work of the board to monitor and analyze.
5.3: Addition to the 61 and deletion from 71 means number of additional control measures would need to be added.
5.4: The lack of definition does not facilitate the control. With the event of last years, the use of such broad category may no longer be adequate ensure control. This could allow the control of preparation however. This requires a clearer definition of this category to be agreed by MS.
5.5.: The main concern of INCB is about practical implementation, as was pointed out, chemical analysis might not be possible or feasible. This would also give rise on cannabis control regarding CBD extraction. As a way of reference, reporting similar to poppy would be need.
Romania has asked about import/export, if the recommendation is endorsed, this would not be subject to international control. The wording of the recommendation might result in confusion among national authorities. 1960 limits industrial cultivation for fibers and seeds, this would be complicated too. Cannabis cultivated for CBD will have THC content and it will have to be controlled.
5.6: It is not clear to INCB which preparation this would apply to. Certain control needs will be eliminated. Manufacture would be monitored and governments will need to report on statistics. It will reduce control over CBD and THC. Additional guidance will need to be provided for a common understanding.
Canada: Could we ask that MS also receive a copy of INCB’s intervention?
Russia: We believe INCB plays an important role in scheduling. Which are the main criteria for a substance to be included in the schedule 4 of the single conventions, is similarity one of them? We believe conventions talk about convention when we talk about a substance for schedule 1 or 2, according to paragraph 5 of article 3, the main criteria should be liability to abuse and that is not offset by therapeutic uses. Rescheduling one substance from a convention to an other – is there a precedence of such move? Does ECDD have a mandate of such?
Slovenia: What would be the reaction of INCB is an industrial cannabis has for example 2% THC. Where is the limit?
USA: Practical impact on our work if these were to be adopted. Regarding 5.4, we didn’t understand the rationale. Could you give us more information whether you do get data on that and whether it is useful? What was meant by this “no longer being adequate”? Regarding fibers and seeds, the conventions didn’t say it was limited to so I know this is a question to some treaty interpretation. Difficulties have been reported in enforcing rules of substances being scheduled in different conventions. We have cannabis and resin scheduled now. Does the inclusion also trigger the estimate system? If we are adding delta-THC to the estimate system when we know that drafters of the convention didn’t think if that, do we amend the convention in a way?
Secretariat of the INCB: We will make the text available, yes. Regarding Russia’s questions, I need to refer to UNODC legal services as we have no function in the scheduling. Regarding Slovenia, I do not believe WHO indicated a percentage in the plant, they referred to percentage in preparations. In the case of industrial cannabis, the convention does not prescribe level of THC in the plant. Cultivation for industrial purposes is not subject to control, I think at the time they referred to hemp even if there is no reference for it in the convention. I gave you the example of poppy and extraction for medicines, we will consider this at our next meeting in November.
To answer the USA, the definition was put forward because there was no knowledge of the active principles so it captured something more general. We don’t get a lot of estimates in this regard so MS have been evidently battling with this. If other cannabinoids are introduced that are not explicitly listed, they eventually need to be looked at. The definition could be used to capture the number of possible cannabinoids. Regarding reporting across conventions, it has indeed caused some confusion. The problem about resin is that in the absence of THC scheduling, MS convert back to cannabis because THC was not on the list so couldn’t be explicitly monitored by our system. Adding THC to the system would facilitate the estimates. Similarly, there is a clear process, for opium. The recommendations of the ECDD therefore are helpful in this regard.
USA: The transfer from 1971 to 1961 will entail more work for our specialized staff. Do you think this will be a tremendous burden on MS? What impact will that have on INCB? Do you have sufficient resources for the work?
Secretariat of the INCB: We are following the conventions the same as opium, there needs not to be a new body but more capacity, a licensing system and ensure that there is safe storage of harvest, a degree of control. So there are a number of steps needed on the national level that may require some human resources expansion. At the level of INCB, we have a good system in place for opium. It requires a lot of work and if a similar mechanism is required, we do need a small expansion in human resources.
Chair: UNODC you have the floor, John Brandolino.
UNODC: We haven’t prepared an intervention as today served for WHO and INCB to discuss the possible rescheduling and its implications. There was one question specifically directed to us by Jamaica as to how we plan to support MS to implement these recommendations. We generally, as with all types of all assistance, we relate it to our mandates and support MS implement their obligations. It’s difficult to say now exactly what that would look like.
Russia addressed some legal issues – there are some questions today that seem to be legal but they are really towards INCB and WHO about their independent processes and how they believe the conventions instructed them to move forward. If you have general legal questions, we are happy to liaise in a more general fashion.
Russia: Thank you for the explanations. We too believe WHO and ECDD should provide more information on the similarity criterion. Is there a precedence of rescheduling from one convention to the other and what role the ECDD plays in this regard? We believe the UNODC should have a historical overview.
UNODC: Just to clarify the similarity principle, this is not an explicit factor but it is known by colleagues of the laboratory sections and was also used previously, thought from a legal point of view, this might not be sufficient. There are other arguments as well and should be used if required by the conventions. Regarding precedence, WHO has the role of making recommendations and the 71 doesn’t address relationships with other conventions.
USA: A suggestion to the UNODC, particularly the legal team, when we switch a substance from one convention to the other, does that have an impact on MS’s obligation in regards to penal laws? When it comes to “traditional uses”, there are some contradictions between 71 and 61, it would be useful to get UNODC’s unbiased opinion on how that will affect MS?
UNODC: Your suggestions are well noted and we can continue off-line to see where this will go.
Agenda item 1: Follow-up to the 62nd session of CND and its Ministerial Segment
Chair: Now onto the next agenda item, follow-up to the 62nd session of CND. We are committed to foster a broad and transparent inclusive discussion and make sure the follow-up is done n a single track. Our plan was prepared and shared with the extended bureau. Ambassador Okeke has held informals – in the name of the commission, I thank you for this and invite you to share the status.
Ambassador Okeke: Implementation of all our international drug policy commitments following the 2019 Ministerial Declaration.
Peru: If MS would like to add topics, how is that going to be? This morning some delegations said they prefer not touching this document, that’s my only doubt.
Secretary: Additional topics can be brought before the extended bureau. The Commission will work on further fine-tuning the work plan. It should start with concrete proposals through the regional groups.
Chair: With this addition, are we agreeable? No objections, it is so decided. Now EU would like to deliver a statement on behalf of its MS.
European Union and MS & friends: The European Union and its Member States would like to thank you for organizing this intersessional meeting in which we can prepare the follow-up to the 62nd session of the CND, including on the Ministerial We welcome the March Ministerial Segment, where we unanimously reaffirmed our political will to strengthen our actions at the national, regional and international levels to accelerate the implementation of our joint commitments to address and counter the world drug problem. Accelerating the implementation of our joint commitments is precisely what we should now focus on, in order to have effective results by 2030. Building on experience, the European Union and its Member States emphasise that drug policies based upon an integrated, balanced and evidence- based approach prove to be the most effective for addressing the world drug situation. This approach underpins our EU Drugs Strategy 2013-2020 and its accompanying Actions. It is therefore essential to accelerate the implementation of the UNGASS Outcome Document “Our joint commitment to effectively addressing the world drug problem”. With its seven chapters, UNGASS puts a focus on inter alia drug supply reduction, new challenges and threats – and, at the same time, on prevention, public health related measures, development aspects and the human rights dimension of the world drug situation. It is the most comprehensive international drug policy document – a milestone – and a progressive step towards the improvement of the current situation on international drug policy.
For the EU and its Member States, it is clear that the way forward to accelerate the implementation of our joint commitments requires the following next steps. Firstly, we support the multiyear workplan proposed by you, Mr. Chair, and we thank Ambassador Okeke for her commitment in facilitating its adoption. The workplan provides a pragmatic basis for discussions among experts and practitioners on international drug policy with a view to effectively address and counter the world drug problem. Secondly, if we are to accelerate the implementation of our joint commitments, it is key to further enhance cooperation between the United Nations Office on Drugs and Crime and other relevant UN entities and regional and international organisations. In this regard, the EU and its Member States take note of the work done by the UN system coordination Task Team on the Implementation of the UN System Common Position on drug-related matters. Thirdly, a solid evidence base on all aspects of the drug problem is needed notably to inform policy actions and be able to measure results. We have all made considerable efforts to meet that objective. For instance, the European Drug Report 2019 recently published by the European Monitoring Centre for Drugs and Drug Addiction, is based on sound and reliable data, which examines relevant aspects related to drug supply, drug use prevalence and trends, drug-related harms, and therefore provides a comprehensive analysis of patterns emerging across the EU. Nonetheless, implementing our joint commitments requires the strengthening of the data collection system at international level. We welcome the organization of the expert consultation meeting in this area in the months to come.
To ensure the success of this process, it is important to focus our efforts on three main areas, in particular:
- the Annual Report Questionnaire should be updated, strengthened and streamlined to enable reporting on the new aspects of the drug policy introduced by the UNGASS Outcome Document;
- the cooperation between UNODC and other UN entities as well as other relevant stakeholders should be strengthened in order to create streamlined, coherent, relevant mechanisms; and
- a targeted capacity building programme should be developed, helping low return rate countries and regions to improve and increase data collection, analysis and
Distinguished Chair, Allow me to recall that 2030 is also the year by which we have committed to achieve the Sustainable Development Goals of the 2030 Agenda. As we know, these efforts and our work on drug policies are complementary and mutually reinforcing. In line with SDG 3, the implementation of UNGASS would of course strengthen the prevention and treatment of drug abuse. But it would also enable to contribute to ending epidemics such as AIDS, tuberculosis and malaria, to combat diseases such as hepatitis and water-borne diseases, to reduce by one third premature mortality from non-communicable diseases, and provide access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines. In line with SDG 16, the implementation of UNGASS would contribute to significantly reducing violence and related death rates, and to combatting organised crime. It is therefore key for us to keep the achievement of the relevant SDGs as an overarching consideration when advancing our work on drug. To conclude, the international community needs to step up its responses to cope with the challenges at stake. And we want to assure you that the EU and its Member States will continue working relentlessly at the national, regional and international levels to accelerate the implementation of our joint commitments to address the world drug situation, thus stepping up the implementation of the operational recommendations of the UNGASS Outcome Document, to achieve substantial results by 2030.
Jamie Bridge, VNGOC: Thank you for allowing me to speak today as the Chair of the Vienna NGO Committee on Drugs, and on behalf of our network of around 200 organisations around the world. The VNGOC is dedicated to ensuring the strongest possible civil society engagement here at the CND and elsewhere across the UN system. When we reflect back on the Ministerial Segment and the CND meeting in March – there is a lot to be proud of in terms of the civil society presence and the inputs that we made. Through the Civil Society Task Force, working with the New York Committee and UNODC, we were able to support NGOs to attend, speak and participate – whether they could physically be here in Vienna or not.
Now, as you are discussing how best to follow and build on this year’s Ministerial Declaration, I would like to take this opportunity to remind you all that – like the UNGASS document before it – the 2019 Declaration underscores the important role played by civil society and others in implementing our joint commitments. The Declaration also commits the CND to fostering broad, transparent and inclusive discussions involving all relevant stakeholders – including civil society. With this in mind, we welcome the proposed multi-year work plan for the CND, encompassing thematic autumn intersessionals over the coming years. The idea to use the ‘stock-taking’ section of the Ministerial Declaration to frame the coming discussions is a good one, as this is possibly the most honest and wide-reaching articulation of the problems that we have failed to fix over the last decade.
The CND thematic intersessionals last autumn were a positive model for civil society engagement. The work plan from last June invited the Civil Society Task Force to select panel speakers, and we were able to coordinate more than 50 presentations and video submissions from a wide range of different organisations, regions and perspectives. We made these selections through open calls, and received more than 200 applications – which demonstrates the commitment and the demand from NGOs to be a part of these discussions. NGOs and affected populations have a crucial role to play as we collectively address the challenges identified in the Ministerial Declaration. So, for this coming autumn and beyond, we assume that the good practice model from 2018 will be maintained. The Vienna NGO Committee looks forward to continuing to work with the CND Chair and Secretariat, and we also commit to continuing to select speakers through open calls, and to being inclusive of a broad range of views and organisations. Working together, the challenges can be met, the problems can be fixed, and the harms can be mitigated. But not without civil society – whether here in the VIC, advocating and lobbying for change at the local level, or on the ground delivering services and saving lives. Thank you for your kind attention and your continued support.
Katherine Pettus, International Association for Hospice and Palliative Care: The International Association for Hospice and Palliative Care is a non-governmental organization in consultative status with ECOSOC and a non-state actor in official relations with the World Health Organisation. We are pleased to report to you that we have been collaborating actively with our membership who provide services to patients in all your countries, with academia, the INCB, UNODC, CICAD, and the World Health Organisation to improve availability and access to internationally controlled essential medicines for the relief of pain and symptoms. We do this through educational workshops that convene all stakeholders, including doctors, nurses, pharmacists, competent authorities, and policymakers, to work on constructive strategies in the context of balanced drug policies.
Balanced drug policies are those that follow the Single Convention mandate to allow adequate access to substances containing “narcotic drugs” for medical use, while preventing diversion and non-medical use. Countries with adequate access to internationally controlled essential medicines for the relief of severe pain and symptoms, and low rates of non-medical use, can claim to have balanced drug policies. According to INCB, 80% of the world population, mainly in low- and lower middle-income countries, consume only 14% of the morphine globally available for pain management, although morphine is the most affordable of all the opioids. This, of course, reduces its attractiveness to industry, making adequate government procurement of morphine, often in collaboration with regional partners to reduce costs, a necessity. According to former INCB President Sumyai, ”if morphine availability increased in low- and middle-income countries, it would significantly reduce the gap between the need for pain treatment and its accessibility in low- and middle-income countries.”. Our experts look forward to assisting the WHO in the work of updating the 2011 Ensuring Balance Guidelines to reduce this gap, and to working with all stakeholders in your countries to improve access for all patients in need. I thank you.
Agenda item 3. Contributions to the work of the Economic and Social Council
Chair: Agenda item 3. Contributions to the work of the Economic and Social Council. The theme for this year’s High-Level Political Forum: Empowering people and ensuring inclusiveness and equality.
Agenda item 4. AOB
Chair: Is there any other issue needing to be addressed? I open the floor.
USA: Thank you and all the participants today. We have many more questions, it would be prudent to recognize this is a work in progress and we would like to continue this at the next intersessional.
Chair: Yes, thank you. Thank you to the speakers. We will meet on the 5th intersessional, likely on the 30th of September. Meeting adjourned.