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Psychedelics researchers and advocacy institutions from around the world are joining forces to launch the International Therapeutic Psilocybin Rescheduling Initiative, meant to reschedule psilocybin under United Nations law.
The convention divides psychoactive drugs into four different schedules, according to their touted toxicity and potential for abuse. Psilocybin was inscribed in Schedule I, the highest level of control, reserved for dangerous drugs with no therapeutic value, which pose an especially serious risk to public health.
“This is for a drug that was never reviewed in the first place,” says Koddermann. “It was just put in there because there is an assumption that it had no therapeutic value and that it was highly risky in terms of abuse and dependance.” The compound remains in Schedule I to this day, although since 1971 –and increasingly since the turn of the century– that psilocybin can have beneficial effects to mental health when administered in the right context under professional supervision.reported that just one session with the compound was able to significantly reduce symptoms of depression in at least one quarter of participants with treatment-resistant depression, maintaining its efficacy three months after administration.“Most of the domestic regimes in terms of how psilocybin is scheduled and controlled, are driven by countries’ obligations under the 1971 convention,” said Koddermann in an interview. This means that all over the world, psilocybin can only be used in very specific scientific and medical contexts, and is subject to highly strict regulation. “The 71’ Convention specifies the types of controls that governments are obliged to put in place under the treaty,” says Koddermann. These controls include licensing regimes that only allow government entities to do research on the compound. As well as safe custody controls, which limit the amount of psilocybin that can be accessed and used. “So there's all these various controls that show up in domestic regimes and create this additional level of cost and complexity. And so either the research becomes costly and is slowed down or in some cases it doesn't take place,” says Koddermann. Enzo Tagliazucchi is a physicist and neuroscientist researching the effects of psychedelics in the human brain. His lab at University of Buenos Aires in Argentina performs basic neuroimaging studies on volunteers under the effects of psilocybin or LSD. However, the lab has yet been unable to receive legal authorization from the country’s health authority to legally provide psilocybin to patients, due to its Schedule 1 status. “We have the experiments designed, we have people willing to fund the studies, we have psilocybin providers ready, but getting the permission to import the substance and begin working with the drug here in Argentina is becoming truly elusive. And that’s paralyzing all of our research, sadly. It’s very frustrating,” says Tagliazucchi. In addition to creating a permissive legal environment for governments to remove restrictions on psilocybin, rescheduling it under the 1971 convention would give further scientific validation to the therapeutic potential of the drug. Koddermann thinks that if the initiative is successful, it would put some additional pressure on many governments to act and maybe have other governments take a second look at their psilocybin legislation. Mind Medicine Australia, an Australian charity working to expand access to psychedelic medicines is part of the coalition behind the rescheduling initiative, alongside The Beckley Foundation, the Multidisciplinary Association for Psychedelic Studies and other institutions from The Netherlands, Mexico and Sweden.by the Australian government. Part of the justification behind the decision not to amend the country’s Therapeutic Goods Regulation was that psilocybin is in Schedule 1 of the United Nations Convention on Psychotropic Substances of 1971.To get psilocybin into schedule 2, 3 or 4 of the 1971 Convention, which would remove much of the restrictions currently in place, the first step is to get a review by the World Health organization’s Expert Committee on Drug Dependance. “The ECDD is made up of independent scientific and medical experts and is tasked under the convention with reviewing compounds for scheduling or rescheduling,” says Koddermann. Koddermann says there are three pathways for pursuing getting the committee to review psilocybin. The first one involves a state party-initiated review. “Any of the one hundred and seventy five state parties to the treaty can initiate a review of any scheduled substance, and they do that by notification to the UN Secretary General. And so we've identified a number of governments for priority engagement that we think are potential initiators of review,” says Koddermann. These countries were chosen for their previous approach to medicinal cannabis legislation, their general approach to drug policy reform, their funding of mental health treatment services and whether or not they host psychedelic research within their borders. Canada, Israel, The UK, The Czech Republic, The Netherlands, Portugal, New Zealand, Germany, Switzerland, Norway and Luxembourg are some of the countries that could lead the way in initiating a review. Only one country needs to ask for a review for the process to begin taking place. Koddermann thinks in some cases, asking for a review can be in the best interest of governments, too.They just changed the special access program , they're being lobbied to change how psilocybin is scheduled and regulated in Canada. To them, rather than dealing with the domestic politics of it and potential criticism from opposition parties –who may not be quite as enlightened on drug policy–, they could throw it over to the WHO, request a formal review and wait for the WHO to make a recommendation.” But the WHO can also initiate a review independently. That’s the second possible pathway for the initiative to succeed.Lastly, any of the members of the Expert Committee on Drug Dependance can initiate a pre-review that can eventually lead to a review if the evidence is backing. “A pre-review essentially looks at the same thing that a formal critical review would look at. So pharmacology, toxicology, pharmacokinetics, pharmacodynamics, the degree to which there's an illicit market, so on and so forth. It's essentially the same process,” says Koddermann. Technically, the UN Commission on Narcotic Drugs could also request a review, but the initiative thinks that's not a viable starting point.gave the recommendation to reclassify cannabis , which was categorized alongside cocaine and heroin as a dangerous substance with no medicinal benefit and a high potential for abuse in the 1961 Single Convention on Narcotic Drugs. In December 2020, the Commission on Narcotic Drugs accepted the recommendation and changed the drug’s scheduled status. In the case of Cannabis, the WHO relied on findings showing that the plant has therapeutic potential in order to justify their recommendation to reschedule. “I think it's fair to say that research into psilocybin is a lot more advanced than medical cannabis, and it's only getting stronger given how many companies are undertaking research and how many dedicated centers you have, and obviously highly reputable institutions conducting this research,” says Koddermann. For him, if the initiative can get the WHO to perform a review, the existing evidence for psilocybin’s therapeutic potential is already enough to guarantee a recommendation to reschedule the substance.Koddermann says the second part of the process is the toughest one, but “a problem he’d like to have.” Presuming the group is able to get the WHO’s Expert Committee on Drug Dependance to make a recommendation to reschedule psilocybin, it’s the UN Commission on Narcotic Drugs who has to enact that change. “They're bound by the ECDD’s medical and scientific assessment, so they can't come to their own conclusions around therapeutic potential or around abuse liability. But they can take a number of other factors: legal, administrative, social, economic, into account in making their decision as to whether to accept the recommendation or not.” Koddermann thinks that in any case, just getting a recommendation out of the WHO would be a huge win for advancing the credibility of psilocybin-assisted therapies and psychedelic therapies in general.