Side event: The shortcomings and side effects of substance scheduling

Organised by the HIV Legal Network with the support of Canada, the Netherlands, the Centre on Drug Policy Evaluation, the International Drug Policy Consortium, the Transform Drug Policy Foundation and the Transnational Institute

[youtube https://www.youtube.com/watch?v=qpTrauKAi98&w=560&h=315]

Steve Rolles, Transform Drug Policy Foundation. It goes without saying that we are expressing our solidarity with Ukraine. Our event is live streamed on YouTube and will be available to view afterwards. There will be a short Q&A at the end of the event, so put your questions for the speakers in the chat or Q&A. Substance scheduling is a central function of the Commission on Narcotic Drugs and a longstanding pillar of international and national drug policies. Despite the continued reliance on scheduling, there is an ongoing debate as to whether scheduling substances is beneficial or detrimental in preventing drug-related harms. the scheduling of substances and resulting law enforcement involvement is routinely followed by the emergence of new substances often posing greater harms from consumption, as has been observed in the case of the steadily increasing rate of overdoses around the world caused by highly potent opioids in the unregulated drug market. Scheduling substances also impedes access for medical and scientific purposes. This side event will examine the limitations and consequences of substance scheduling as well as consider alternatives for preventing drug-related harms.

Martin Jelsma, Transnational Institute. I will provide a scene setting and historical overview of the scheduling system. We need to realise that many drugs in the system have never been subject to a scientific review. This was copied and pasted from the pre-war treaties and was tainted with prejudices. Many of those plants and extracted products have never been reviewed by WHO. And similar drugs to those or those that could easily be transformed into them would also be scheduled later on, based on the principles of the treaties. The recent WHO review of cannabis was truly historical. The basic point I want to make here is that as long as the original drugs have not been assessed, the principle of similarity and convertibility risk to perpetuate bias in the system. This is also related to the need for decolonisation. Substances included in Schedule I were pasted. The list was used as a basis for the 1971 convention, and then it adopted also a similarity principle and warranted similar controls, perpetuating issues with the scientific basis of these levels of control. The term ‘psychotropic substances’ also lack a scientific basis. The ECDD called the attention to the ambiguity between the definitions of psychotropic and narcotic drugs, as it causes problems related to stimulants. The INCB, in an evaluation of the effectiveness of the scheduling, also expressed concerns on the inconsistencies. Precursors that could be easily converted from substances included in the 1971 convention were not included in the convention. This was done in the 1988 Convention. To show inconsistencies: ephedrine is controlled as a precursor under the 1988 convention, but there is no control for the actual plant. The active component of khat, ayahuasca is included in schedule I of the Single Convention, but the plant itself is not. On the contrary, coca leaf and cocaine are in the same schedules of the Single Convention, but if we were to follow the same principles of the other substances, there would not have been a need to place such strict controls on coca leaves. One last flaw: the WHO is mandated to recommend substances included in the 1961 and 1971 conventions and the CND accepts or rejects the recommendation. Both treaties make clear that the recommendations are determinative and that in no case the CND can extend control on other substances not recommended. But the UNODC guidance on scheduling claims that under the 1971 convention the CND may decide to schedule a substance without the advice of the WHO. This could set a very dangerous precedent. Further blurring about this mandate is further done on precursors, especially this week’s US resolution on designer precursors. The rise in new substances has led to pressure to issue blanket bans on any substance similar to an already scheduled substance. To conclude: the consistency of scheduling criteria are critical for the international drug control system, ensuring also access for medical and scientific purposes. WHO has played a fundamental role for this, especially in the case of ketamine, tramadol, khat and kratom. The WHO’s role should be strengthened, and perhaps it should be useful to transfer the scheduling decision form the CND to the WHO. The ECDD is limited in its options because of the legal architecture of the international drug control system. The cannabis review has shown these failings and weaknesses. A group of likeminded countries could start to highlight the key features of a more modernised treaty system with differences between more and less harmful drugs, allowing more flexibility with controls at national level, among others.

Nazlee Maghsoudi, Centre on Drug Policy Evaluation. Thank you for joining our side event. I appreciate the opportunity to speak. I represent the Centre on Drug Policy Evaluation, an organization based in Canada that supports the development of evidence- and rights-based drug policies around the globe. I will specifically focus on our experience of implementing and operating the first and only drug checking service in Toronto, Ontario. Opioid overdoses continue to increase in Canada and elsewhere, and have been exacerbated by the COVID-19 pandemic. In recognition that the primary cause of increased fatalities is the rise of highly-potent synthetic opioids, like fentanyl, in the unregulated drug supply, drug checking has been adopted across Canada as an overdose prevention response. Launched in October 2019, Toronto’s drug checking service offers people who use drugs timely and detailed information on the contents of their drugs, helping them to make more informed decisions, while also uncovering the makeup of the unregulated drug supply. Drug checking in Toronto has detected new psychoactive substances that cause health harms in the unregulated drug supply, including several substances that have been recently internationally scheduled and were already scheduled in Canada. Highly-potent synthetic opioids that greatly increase the risk of overdose continue to present in expected opioid samples checked by Toronto’s drug checking service. I will focus on a couple pertinent trends related to this drug class, although there are many other examples. First, isotonitazene, a high-potency synthetic opioid considered to be up to 5 times stronger than fentanyl, which was added to schedule I of the 1961 Convention by the CND at last April’s session and was already scheduled in Canada. Toronto’s drug checking service detected isotonitazene for the first time later that same month in April 2021, specifically in samples expected to be fentanyl and alongside fentanyl, heroin, and etizolam (a benzodiazepine-related drug). When isotonitazene is used in combination with other opioids or other central nervous system or respiratory depressants, like benzodiazepine-related drugs, the risk of dangerous suppression of vitals is increased (e.g., slowing down of breathing, blood pressure, heart rate). This is often the case since over 60% of opioid samples checked by Toronto’s drug checking service have contained more than one type of opioid or an opioid and a benzodiazepine-related drug. My second example is a less recent international scheduling decision, namely, carfentanil, a synthetic opioid approximately 100 times stronger than fentanyl and typically used by veterinarians on very large animals and not for human consumption. The CND internationally controlled carfentanil under schedules I and IV of the 1961 Convention in 2018. Fentanyl and fentanyl analogues, including carfentanil, have been scheduled in Canada since 1996. Last month, carfentanil presented in expected fentanyl samples for the first time since September 2021. We have seen the reemergence of carfentanil in our unregulated opioid supply before, causing an increase in overdoses. Carfentanil availability has continued unabated globally and causing deaths in several countries, illustrating that controlling substances has not prevented their emergence or reemergence in the unregulated drug supply. It is important to recall that the unregulated opioid supply moved towards carfentanil after other less potent opioids were criminally controlled. In 2016, one fentanyl analogue and two fentanyl precursors were scheduled by the CND. Carfentanil was subsequently detected in Toronto’s drug market and has remained despite itself being scheduled internationally two years later. The emergence of both these highly-potent synthetic opioids, reflects a phenomenon seen again and again in global drug markets, that scheduling is followed by a move towards more highly-potent – and thus more easily trafficable – comparable substances. This phenomenon has been described as the “Iron Law of Prohibition” and applies across drug classes: “as law enforcement becomes more intense, the potency of prohibited substances increases.” Other theories are also relevant to consider here, such as the balloon effect, which states that supply side interventions without appropriate sequencing have historically increased drug-related harms. It’s a phenomenon to describe the ways that trying to intervene in one part of a drug market can impact things elsewhere, for the way that squeezing one part of a balloon causes other parts to expand. It applies across many examples in drug policy, such as crackdowns on drug production spreading production to neighboring areas, or drops in the availability of a drug leading to increases in the use of other drugs. In brief, the problem is trying to control supply in a global economy where demand has not been reduced only incentivizes new supply routes or new drugs to bring to the market. Per the Iron Law of Prohibition, those new drugs are often more harmful. I should also mention the displacement/replacement effect, a term used by UNODC is recent years, which indicates that the scheduling of substances and resulting law enforcement involvement is routinely followed by the emergence of new substances. Such new substances often pose greater harms from consumption. Scheduling has therefore been unable to control the rise of these highly-potent synthetic opioids, much like the so-called “cat and mouse” game or “whack-a-mole” experienced with many new psychoactive substances. NPS themselves are emblematic of the increased health harms caused by a reliance on scheduling and law enforcement crackdowns, as these are substitutes for the illegal drugs they are replicating but with more health harms. Such is the case with synthetic opioids, with rising overdose events and fatalities being the most apparent harm, but other harms are also evident, like the unavailability of other less potent opioids on the unregulated market leading to increased tolerances, which are then not able to be easily managed with available opioid agonist therapies. We must carefully examine the ramifications of supply reduction interventions before implementing them and consider whether other interventions, such as health and harm reduction services, are better equipped to reduce drug-related harms. Balance has thus far not been achieved as supply side interventions have rarely been accompanied with necessary health interventions, including for new psychoactive substances. Resources dedicated to law enforcement could more usefully be redirected towards tailored health interventions, developed in collaboration with people who use drugs and civil society, to prevent health harms caused by the drugs in question. Expanding low threshold access to pharmaceutical-grade alternatives to the toxic unregulated drug supply, or “safer supply” as we refer to it in Canada, is a critical response to the poisoned drug supply. We must acknowledge what the evidence has come to bear: scheduling drugs and pursuant law enforcement approaches have not been effective in deterring demand or preventing supply, and almost always have so-called “unintended consequences” on the most marginalized populations. We must act upon where efforts are most needed and most effective – by prioritizing and investing in evidence- and rights-based policy and health interventions, that focus on harm reduction. It is beyond time to rethink and reimagine how the global drug control system can best uphold our collective obligation to protect the health and welfare of humankind.

Maria-Goretti Loglo, International Drug Policy Consortium. Greetings everyone and thanks for giving me the opportunity to share light on how scheduling does and would restrict access to substances, with a focus on tramadol, for medical and scientific purposes, in doing so i will like to share some study we undertook in 2018 in some selected African countries (Benin, Niger Cote D’ ivoire, Benin, Nigeria, Ghana, Namibia and Botswana), basically exploring the impact of scheduling on patients and the work of medical practitioners. And also understand the non-medical use of the drug.

In 2018, there was media outcry by many countries by West Africa countries of the non-medical use of tramadol, coupled with the proposal by the Egyptian to add tramadol to the list of internationally controlled substances. The main objective of the study was to get an understanding of the “tramadol issue in West Africa” and how it was framed and perceived and how international control will impact health care delivery. So, what we wanted to do was to understand how: Tramadol was being used in medical practice – so we interviewed doctors, pharmacists, and informal medicine sellers; Tramadol used without medical prescription – talking to over 100 people who self-identified as non-medical tramadol users; The perception of the authorities, so we interviewed members of control agencies; Discourse analysis of the media – looked at newspaper and electronic media accounts. Before I proceed to share the findings of the study permit me to give you ,permit me to highlight on some of the practical realities on the ground that are usually overlooked or glossed over when it comes to the use of opioid  especially in the case of my region. 

What we first need to acknowledge is the fact that, In West Africa, Access to opioid medications is very challenging. Millions of people in Africa still can’t access the clinical benefits of effective pain medication and enjoy the freedom from unnecessary suffering. Tramadol is currently the most effective alternative pain medication. Even though pain alleviation is a central pillar of the World Health Organization (WHO’s) enhanced public health approach for developing palliative care services, what we also need to appreciate that,tramadol fills a critical gap in treating pain across Africa. it’s also important for us to understand the real situation on the ground in west Africa, what many have failed to acknowledge is the fact that, the structure of medical care provision across the region are still struggling from decades of neglect and sharp spending cuts. Existing services focus on preventing infectious diseases and improving the life expectancy of children and mothers and are struggling to meet the growing burden of non-communicable diseases. In the region there are currently Sharp increases in the case load of cancer and HIV are leaving large numbers of people in need of regular medical attention. Urgent need for palliative care – for helping people with chronic pain. In most countries this is being done with different opiate products – but in West Africa we import minute amounts of morphine. They can be accessed at only a very small number of hospitals. Countries find it difficult to import internationally controlled substances because they need authorization from the INCB before they can find a reputable pharmaceutical exporter. Growing social inequality means that large sections of rural folks but also of the urban poor are sorely neglected. These populations rely on the informal sector especially the rural poor. The truth of the matter is that, Most Africans obtain their medications from markets, chemist shops and wandering traders because they are those readily available to respond to the needs of the people especially in areas where the structures are non-existing. The fact is that, people need to treat pain, but currently readily available services and pain medications are not available for patients, hence the reason many will rely on street Vendors for their supply. What this means is that the majority of the so-called “Tramadol” being used illicitly in Africa does not come from the medical supply chains at all. Cheap, generic pills labelled “Tramadol”, manufactured in labs in India and China are pouring through West Africa’s weakly governed borders, and creating a booming street trade. So, any international move to restrict medical Tramadol will have no real impact on this market. Now, amid these crises, the worrying non-medical consumption of products labelled as “tramadol” has generated a debate with many governments (led by Egypt,) calling for it to be added to the list of internationally controlled substances. The problem of Tramadol in Africa is less about drug enforcement and more about medicine fraud. It is also important to understand the motivation behind the vast majority using especially young working group patronising tramadol, from our study POVERTY, unemployment was a major driving force to the use of tramadol among young population, pleasure was the least. It is important to stress that the reaction of countries regarding opioids by de facto criminalizing and increasing restrictions comes at a high cost. It affects patients and the work of health professionals. It is critical to be more nuanced and factual while responding to the current situation because an addition of the most accessible pain medication in Africa will lead to significant damages to the very palliative care system in Africa. What this will essentially do will fail to address the reality of the issue and is unlikely to solve the problem. Attempts to place prescription pain medications like tramadol under international control will only worsen the current situation of non availability of pain management medications in the region. The rural poor will continue to suffer in pain. Repressive responses can only succeed in creating temporary shortages without eliminating supply. They fall particularly hard on the poor who are often brutalised by law enforcement. Our entire understanding of what is happening in Africa might be based on faulty evidence and assumptions.

From our study, we found from our interviews with non-medical users and from our visits to markets and purchases of samples was that none of the tramadol that is circulating in West Africa was from health care settings. It was not leaky pharmacies or hospitals who were supplying tramadol – but it was market traders, Most people buy their medicines in markets, and most of these medicines are generic medicines – but many are what the WHO has defined as “substandard/spurious/falsely-labelled/falsified/counterfeit medical products” (SSFFC). In conclusion will like to reiterate the findings of our study while engaging the various stakeholders in our study – that the push by some countries to ban or placing tramadol under international control, unfortunately such decisions will reinforce the current “opiophobia”. By increasing the international restriction on Tramadol, we will significantly undermine the ability to provide pain relief to African patients. Any attempts to place tramadol under the list of internationally controlled substances will equal to prioritizing restrictive control to the detriment of ensuring adequate availability of an access to effective pain medications. Thereby violating the rights of people who need them. What we are simply doing is letting administrative convenience determine the direction of policy-making, , this will simply maintain and exacerbate the harms being caused by our current drug policies – arriving at a cure before having the diagnosis, and using the criminal justice system to address a public health problem.

What the CND should be focussing on is how to provide people with a legitimate, affordable and effective alternative. They should be helping to make morphine more widely available. They should be assisting the department of health in making a realistic assessment of importation needs. And they should assist the medical authorities in reducing the obstacles to prescribing and dispensing morphine.

Steve. Thank you so much. it’s useful to hear from you and Nazlee on some of the impacts of the scheduling system in terms of its failure to prevent some of the drivers of the opioid epidemic and to provide pain medication for those in need.

Wim Best, independent expert. I already disagree with some of the speakers. It’s not the conventions that give us obstacles, nor the scheduling system. Oxicolon is already scheduled since 1994. There was a scheduled drug prescribed in the USA, people misused and this resulted in scheduling, then people moved on to heroin, and then to fentanyl. Looking at carfentanyl, it’s been available since the 1960s in veterinary practice. Now we’re focusing on other products. Scheduling morphine or tramadol, if you look at the conventions, it’s not the conventions that give you an obstacle but national laws. In Eastern Europe it was national legislation that didn’t allow pharmacies or doctors to prescribe the product. There you have your problems. If you review your laws, it will be more valuable than discussing the drug conventions. These were created in the 1960s. 60 years later, people still think that drugs are dangerous. In the Netherlands there are more deaths due to traffic accidents than drug use. politicians are more dangerous than drugs. If we rethink the conventions, then we should probably get new ones. Now it’s only about shifting THC, including precursors or not. This is not the issue. It’s about how we deal with drugs and how we prevent people from dying from drugs. And this is because of the social and economic system: COVID, lack of employment, education, lack of healthcare. People are driven to drugs that are not yet under control. Most of the products are already regulated in the USA, so it’s not really different from narcotics control. Don’t focus so much on scheduling and the conventions, talk about national laws. I checked the conventions before the session and there is no obstacle in the conventions: you can prescribe, dispense morphine. It’s not about the INCB, countries can always increase the levels they need without any problem. I don’t see obstacles there. What we need is not better conventions, but better politicians.

Steve. I will go straight to the Q&A: don’t domestic national laws significantly reflect the conventions?

Wim. They reflect the conventions, but the conventions are not that straight. They don’t say that you are not allowed to only prescribe morphine by doctors. In Switzerland it’s regulated by the government but it is adequately prescribed. In the Netherlands, cannabis and heroin are available for patients. We also allow NPS and substances like LSD for scientific purposes in clinical trials. So it’s not the conventions, it’s just national level policies and politicians saying that drugs are dangerous. If you take carfentanyl, when you go back to the details of pharmaceutics, it’s less dangerous than fentanyl but you have to take less as it’s more potent.

Steve. I take your point, thanks for your comments. We won’t have time for more questions, so let me conclude. It’s been a fascinating insight into this strange world of drug scheduling which can feel quite technocratic, but it’s essential to the global drug control system. We can see that the system has evolved in an ad hoc historical process, and it’s not meeting the needs of many member states that are having unintended consequences, beyond the non-scientific scheduling, but also structural issues on how the scheduling system interacts with other treaties. We have a dysfunctional, dated system that is not achieving its goals. And it does need repairing. Perhaps the problems reflect the wider issues with the UN drug control system, which have been discussed by Nazlee and Maria (safer supply, access to medicines, etc.). There were interesting comments from Wim that it’s not just about the conventions, but in many cases it’s the political environment that filters through national laws: politicians are more dangerous than drugs. If the system is to be reformed, it will require political will. This begins with an acknowledgement that the system as it currently exists is not fit for purpose.

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