The government should lower regulatory hurdles impeding psilocybin assisted psychotherapy research.
Psychedelic plant and fungi constituents—such as mescaline, ibogaine, ayahuasca, and psilocybin—have long been an essential part of Indigenous and traditional medicine and culture. Following the synthesis of LSD by Albert Hoffman in 1938, early clinical studies showed the therapeutic potential of psychedelics for a range of conditions, including life-chronic pain and the anxiety and depression that occur with a life-threatening diagnosis.
This burgeoning research, however, ended abruptly in 1971 when the United Nations introduced the Convention on Psychotropic Substances, in large part because of lobbying by the U.S. government. This treaty formed the basis of subsequent national legislation, such as the U.S. Controlled Substances Act and the United Kingdom’s Misuse of Drugs Act 1971. In the United Kingdom, drugs were placed into “Schedules” ranked from 1—most controlled—to 5—least controlled—based on the perceived harm they could cause to individuals and society. Despite subsequent research confirming that psychedelics carry significantly less risk of harm than legal substances, such as alcohol, these drugs were placed on and remain in Schedule 1—with significant implications for medical and scientific research.
Schedule 1 status does not prevent research with psychedelics. Indeed, this has been the defense used by successive British governments as an excuse for not changing their Schedule 1 status. But it does create prohibitive financial and bureaucratic barriers that disable research. In the United Kingdom, researchers who want to work with Schedule 1 substances must complete an extensive application for a license from the Home Office—the government department responsible for U.K. drug policy—and have their facilities inspected by Home Office personnel, incurring extra work, expense, and delay. A controlled drugs register is used to record details of Schedule 1 substances, and these drugs must be kept under lock and key, with only a limited number of researchers authorized to handle and dispose of them. Often this happens in the same laboratories that store Schedule 2 substances—including heroin, cocaine, and ketamine—which are not subject to the same controls.
For medical researchers wishing to conduct clinical trials, the process is even more complicated and expensive, with separate licenses required for each location where these substances are stored and handled. Coupled with the lengthy process for gaining Home Office approval, which ranges from 6 months to a year, and the comparatively short timeframes of many research grants, this regulatory environment has effectively limited research on psychedelics to all but the largest higher education institutions and pharmaceutical companies. Worryingly, in a recent study, we found that many researchers working in smaller institutions will not even attempt to conduct research with Schedule 1 substances due to these barriers.
Despite this regulatory landscape, some remarkable progress has been made in developing medicines based on psychedelic substances. Most recent clinical studies show that psilocybin—the active compound in “magic” mushrooms—in combination with psychotherapy, has great promise as a potential treatment for severe depression, addiction, and post-traumatic stress disorder (PTSD), among other conditions. Psilocybin assisted psychotherapy (PAP), has shown greater than 70 percent long-term efficacy in small-scale trials in the treatment of depression.
Nonetheless, these encouraging results have not been enough to convince the U.K. government to relax regulations and enable the larger trials required to develop psychedelics into an approved medicine. Paradoxically, the stance taken by the Home Office is that they will only review the Schedule 1 status of psychedelics when a medicine makes it to market, ignoring the fact that Schedule 1 status makes this process far longer and more expensive than if psychedelics had the same research exemptions as Schedule 2 substances, which require no license to conduct research. This is not just an academic problem—we have found that those who would benefit from PAP, including military veterans, have been forced either to illegally self-medicate or seek help in countries where PAP is not illegal, such as the Netherlands and Peru.
There are optimistic signs, however, that British policymakers are listening to members of the research community who encounter these barriers. A recent report authored by Members of Parliament (MPs), and drawing on evidence from scientists, clinicians, and other experts recommended the “urgent” rescheduling of psychedelics to enable larger-scale research and trials. The Home Office responded by commissioning a report from its advisory body on drugs, published in December 2023, which laid out a range of options to help remove the barriers to research. And the Parliamentary Office for Science and Technology (POST) recently published overviews of the evidence for PAP in treating severe depression and anxiety disorders, with more POST articles planned on PAP for other psychiatric conditions. Most heartening of all has been to see certain MPs, some drawing on personal experience of trauma, speak passionately in Parliament in favor of enabling patient access to psilocybin.
The wheels of change are turning around the world, albeit slowly—creating a risk that the United Kingdom will be left behind as other countries forge ahead with more evidence-based drug laws. Indeed, there have been significant developments in psychedelics policies in the United States, at both the state and federal level, including decriminalization of possession in many jurisdictions and provision of research funding. Most notably, the U.S. Department of Defense has funded projects with active-duty service personnel investigating PAP for PTSD and traumatic brain injury. And the U.S. Food and Drug Administration has announced a priority review of the first psychedelic new drug indication—MDMA-assisted therapy for PTSD. Oregon and Colorado have legalized psychedelic assisted therapy, with Colorado set to launch treatment in 2025.
Elsewhere, in 2023, Australia became the first country in the world to recognize MDMA and psilocybin as medicines. Much debate and discussion on psychedelic assisted therapy has also been seen in the European Parliament. The snail’s pace of U.K. progress in this area is inexplicable in view of the enormous financial, scientific, and—most importantly—patient benefit potential, especially for people who do not respond to current treatment approaches.
Psychedelic assisted therapy is proving to be a much-needed alternative approach to the treatment of severe mental health conditions, and more research is warranted to enable safe and affordable patient access. The U.K. government’s resistance to removing psychedelics from Schedule 1 of the Misuse of Drugs Act is a barrier to this. It is high time it frees up researchers and clinicians to unlock the medical potential of psychedelics.
Joanna Neill is a psychopharmacology professor and researcher at the University of Manchester.
This essay is part of a six-part series entitled, Global Perspectives on Psychedelics Regulation.
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