Home » Side event: The new regulatory models of psychoactive substances in the grey zone – A new challenge or an opportunity?

Side event: The new regulatory models of psychoactive substances in the grey zone – A new challenge or an opportunity?

Organized by Czechia with the support of Canada, Colombia, Mexico, Switzerland, the United States, the International Drug Policy Consortium and the Transnational Institute

Jindrich Voboril – Czech Republic: Why is Czechia organising this event? The Czech Republic is a country with only 10,000,000 people in Central Europe, in the centre of the European Union. We had a history of totalitarianism before 1989 —before the revolution and collapse of the system brough large changes. Drug policy was one of the many millions of things that we needed to decide where to go with the transformation. it wasn’t the largest problem at the time, because we lived behind the Iron Curtain, but the country was on the verge of collapse: so we needed a policy that was rational, economic and cheap. We opted to not focus on repression because it was expensive. The idea of a drug free world and abstinence-based policies didn’t seem to be working enough, and even bringing unwanted consequences. The new ideas coming up in policies, around minimising harms and risks, were emerging. The Czech Republic wanted to be based on the realistic possibilities of minimising harms and risks. Our strategy is not guided by a society free of drugs but rather harm reduction. The current government decided to regulate products in relation to their risks. Alcohol, gambling, tobacco, and illicit drugs. Regulating certain substances that pose lesser risks. So we’re looking into cannabis and kratom. Plant-based substances. I’m going to ask questions to panellists and we’re going to debate. So, my first question for our US colleagues is about kratom. How does the US regulate kratom in the US? Is there any regulatory system? Which substances? What criteria?

Edward Greg Hawkins – United States: This is a very complicated question. One way to outline it is to understand how the US system works in terms of drug / food regulation, etc. Will give you a brief outline on that now. IN the US, the FDA regulates drugs, foods, dietary supplements —all under the Food, Drugs and XXX Act. We don’t consider new drugs in the market to be in a grey area because if they have CNS properties, they have to be regulated. With foods and dietary ingredients, like kratom, there’s a specific safety guideline. If it doesn’t fall within safety requirements and they are added to products, they’re considered to be unsafe. We can issue a warning letter, we can seize the product or we can also issue an import order on a product. We’ve done that with kratom. We’ve issued warning letters, import alerts seizing it from other countries, and seized it from interstate commerce.

Viktor Mravcik – Czech Republic: Why do you think substances need regulation? As an author of the bill currently going to parliament related to that. I’m cited as the author of this bill, but i invented this idea to regulate substances distinct from the Narcotic and Psychotropic substances, and distinct from food —a group of us around my colleague prepared regulation on that. It’s not adopted yet. Why? Our drug policy has always been balanced, harm reduction based. There’s a window of opportunity in the current government, which in defining its programme, talked about the importance of balance and regulation of substances must be based on the proportional risks of the substances —their harmfulness. There’s a window of opportunity that we’re trying to fill with our initiative: 1) Decriminalisationa nd depenalisation of drug policy toward controlled substances; 2) regulation of cannabis for adult use; 3) Initiatives toward legal substances (alcohol and tobacco) to make the regulation of all products with addictive potential consistent. 4) Introduction to regulatory framework for substances that are not under international control as a product with psychoactive potential for human consumption (distinct from foods, medicines or narcotic/psychotropic substances). This is an idea to establish a whole regulatory framework for the whole group of substances —which are many as you know (the psychoactive ones but not controlled). There is a clear regulatory gap —a vacuum, as we call it. Between the strict regulation of controlled substances, in principle set by UN Conventions (PRohibition of non-medical use) and non-regulation. There’s nothing in between. It creates a problem because there’s a dilemma, and all countries have that. How to regulate these substances? You either go toward strict responses, or a no response. 

Martin Jelsma – TNI: This is a very interesting attempt, what Czechia is doing to fill this regulatory vacuum. If you look at how similar plants are treated at the moment in the UN system, there are clear structural inconsistencies in the way they’re treated. It has to do with the different logics applied in the different COnventions, with regard to plants, raw materials, extracts, preparations, convertible substances, etc. Examples of these inconsisntencies: Coca leaf and cocaine compounds are in the same schedule. They’re treated exactly the same. Khat is an interesting example where the plant material is not scheduled but two of the main compounds are scheduled through the 1971 conventions and a third compound is scheduled under the 1981 as a precursor. Ephedra, which has thousands of years of medicinal use, is not scheduled as a plant, and the main compound, ephedrine, is also not scheduled as a narcotic or psychotropic substance. It’s on the WHO list of essential medicines. But it is included as a precursor for methamphetamine under the 1988 Convention. Very inconsistent differences. Because the COnventions emerge from a time of colonial Western presumed superiority. There wasn’t a review of the 1971 Convention, which is almost a copy-paste of the US CSA. They only included active compounds instead of plant material. In the scheduling and review material they have often applied the principles of similarity and convertibility. If something is similar to a scheduled substance it has to be placed under the same schedule. It perpetuates the inconsistencies in this system. WHO has tried to address these inconsistencies and INCB is doing a good job at trying to look at a system that is science based. The limitations in the review process became clear in the complicated cannabis review process, which covered plants and materials in the 1961 convention, then cannabinoids in the 1981 convention. There was a study oif khat in 1965, concluding that the problems connected with khat should be considered in the same light as problems associated with amphetamines because of the similarity of some of their effect but, luckily at the time, amphetamines were not scheduled, it only came in the 1971 convention. But then the 1971 convention did not include plants! Kratom was recently reviewed in 2021 and identified certain health issues with intensive use but the ECDDA concluded that there is insufficient evidence to recommend a critical review, so it stayed out of the two conventions.

Jindrich: Kratom is used by about 4% of young adults —almost 2% of the population under 65. It’s a significant number for a small country. What is the current debate, evidence and new knowledge about kratom?

Edward: There needs to be a balance between safety and population use. We see the same with, for instance, CBD. In the US, the FDA has some tools in place to look at safety. They’re not perfect because we cannot regulate things in ways that satisfy people who use them, and we don’t have enough safety studies. With regard to CBD in 2023, FDA asked the legislator to generate new regulatory tools to work for CBD. Potentially could work with kratom. What those are is the reason why we’re here.

Jindrich: The EU is like a country of many countries. I hope something rational will come from it. Would it be possible to hear now about the regulatory model we’re going for? The EU is an open market, so what would happen if they banned substances that we regulate. What happens if it gets internationally scheduled? With kratom, we had an evaluation concluding there was no need to schedule, but 7 countries in the EU did ban it.

Viktor: On the risks. The substances will be marketed for human consumption so we want controls on toxicity, on the chemical microbiological contaminants, with regard to other questions of safety. But the most interesting question is psychoactivity per se. The features that justify the ban of substances apart from medical use. We’re proposing a new regulation arguing that it’s not just that- Substances can be marketed for human consumption even if they’re psychoactive. Psychoactivity is not enough to “prohibit” a substance. Based on the knowledge that this thinking of substances in terms of either abstinence or abuse is a bifurcation philosophy. There’s all sorts of patterns of use in the middle. The majority of substances can manage their use of psychoactive substances. So the question is building a framework that controls the risks best. So, we challenge this paradigm of banning psychoactivity outside of the medical sphere. This is about principles of regulation: Psychoactivity per se is not reason enough for prohibition. The objective and measurement against the success is reduction of health and social negative consequences. Criminal law should be the last resort for the regulation of human behaviour. Regulating supply should be based on the harmfulness of substances. There should be different regimes for different substances and the product as such needs to be controlled —regulating the risk profile of the product. Criteria will be set for the potency of the product, the product will be marketed in a unique packaging. Regulating also the volume of the substance in a package. Protection of minors from the supply of substances. Adequate information to users on the effects and risks of the product, risk, recommended dosing. Prevention and harm reduction and treatment should all be strengthened. Stricter regulation of marketing and advertising —a total ban at the place of sale. Newly established legal markets should be protected from illicit markets for the same product. Taxation and pricing police, where taxation supports prevention, harm reduction and treatment measures. Monitoring and evaluation. And correcting its parameters whenever possible.

Martin: The proposal in Czechia can be applied with relative ease in non-controlled substances. So what would it happen if a substance gets scheduled at the UN level? I mentioned the khat and kratom review. WHO is now starting a review of the coca leaf. Test case of to what extent the system has a mechanism to correct some of its inconsistencies for substances already on the schedule. It’s easier to add the substance to a schedule. It would make sense to put the coca leaf at the same level as kratom. But you run into international challenges. The existence of different control regimes for the same substance —and kratom is an example (there’s several national bans but in other places it can be freely marketed). But a few of those examples of coexistence exist and they’re relatively peaceful. This idea that everything has to be scheduled, controlled, in the same way, across the planet, is an idea to abandon. There are many examples already of the same substances being subjected to differences in control level at the national level. I’d invite Czechia to consider the coca leaf being added to the same schedule. It will be easier if the WHO critical review leads to the de-scheduling of the coca leaf and removal from the 1961 convention. But pushing for more consistency at the national level helps inform debate at the international level.

Jindrich: What’s the role of civil society on this whole thing? It’s so technical and depends so much on administrative, international bodies. Is there space? 

Martin: I think so. To gather realities from the field of examples of problems and histories and cultures of non problematic use of several of these substances. This happened in the context o the WHO process. There were voices from fisher villages in Myanmar about what kratom meant for them —it was a stimulant used in the hardships of everyday work. To help gather evidence from the ground is something civil society can do very well.

Question: Is this legislative approach also about cannabis?

Viktor: Yes. There is another separate initiative to regulate cannabis for adult use, separate from this initiative. I would stop here because it’s a different story. But with regard to psychomodulatory regulation, we’re considering, on the first phase, to schedule within this framework not only kratom but also low thc cannabis and cannabis products. They’re not regulated elsewhere and they’re in this regulatory vacuum.

Question: We love research on academic and business level. The federal government gets in our way to do this research.

Edward: There’s regulations in place. There’s research on kratom ongoing. We’re doing science and the research. You have to be a registrant to do research on substances of concern. BUt also how specifically are we getting on your way?

Question: A veteran doing research at the University of Irvine is being torpedoed. Veterans are more likely to die of suicide. And yet we’re treated this way.

Edward: I cannot talk about specific cases. There’s regulations and we follow them.

LEAP US: We know prohibition and criminalisation kills people. You touched upon briefly the problem with schedule 1 in the United States. Because the word science keeps coming up, schedule 1 is a highly unscientific category. Can we get rid of schedule 1? 2nd question: how can we all support the same approach that the Czech republic is trying to implement.

ONDPC: Echo Greg that we appreciate being part of this discussion. It shines a light on an area of concern. What you have here today from the US are from FDA, Executive Branch, DEA. A lot of people on the ground will be able to talk to you during the week. And to the VAC. Just for the room, the legislative branch has the ability, when it comes to the CSA, to make the laws. We in the Executive Branch cannot discuss the removal of Schedule 1 because we don’t have the authority —we have a parliamentary and regulatory process. Which is why it’s so interesting. What to do with substances that don’t meet the criteria for regulations in place. IN the US, it means doing deeper research on the history and context of some of the scheduling actions taken internationally and domestically. That was then. Now new substances emerge that we need to do research on. The research community and civil society are incredibly important to find out whether these substances indeed fall under the regulatory system. 

Kitty Chopaka, based in Thailand: What about traditional producers? All production happens in SEA. In regulating, have you engaged producers and how products could be made to fit the regulation of end users.

Jindrich: Important because we’re debating how to pass the bill. How to secure the product that will fit within the Czech regulations, such as safety. Dr Mravcik was talking about contaminants, for instance. Thailand has some kind of regulation for kratom production for human consumption. We’re in discussions with the Thai government on this —we had a seminar with producers present. Still unclear, however. It could be a bilateral treaty! Many questions.


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