The International Therapeutic Psilocybin Rescheduling Initiative (ITPRI) has launched today to push for the rescheduling of psilocybin across the globe.

For more than 50 years psilocybin has been placed under Schedule 1 of the 1971 UN Convention on Psychotropic Substances in most countries across the world.

Now, the new ITPRI global coalition initiative will be working to promote and secure the rescheduling of psilocybin under the Act.

The 1971 UN Convention on Psychotropic Substances Act is aimed at dangerous drugs which create a serious risk to public health and which have a therapeutic value of little to none. This limits their scientific and medical use much more strictly than other Schedules. 

In recent years, however, evidence of the therapeutic potential of psilocybin has been emerging for mental health conditions including depression and anxiety, as well as end-of-life distress and addiction.

According to professor David Nutt, head of Imperial College London’s Centre for Psychedelic Research and founder of ITPRI partner Drug Science: “Psilocybin’s Schedule I status has severely limited – and continues to limit – neuroscience research and the development of treatments for patients.”

As a result of psilocybin being classed in Schedule I, researchers face numerous regulatory hurdles to study the compounds, which add significantly to the cost, complexity, and duration of research and can negatively impact ethical approvals, funding and collaboration.

The need for a scheduling review

The ITPRI will be working with governments and institutions across the globe through engagement, education and mobilisation to advocate for a more sensible policy that enables scientific and health research into psilocybin.

Speaking to Psychedelic Health, Christopher Koddermann, ITPRI co-founder and chair of the board of directors, commented: “We think this is the right time to pursue this. 

“The goals of the 1971 convention are to balance two things: to “combat abuse” is the term they use, and, to ensure that scientific and medical availability is not unduly restrictive. 

“It is pretty clear that they have got that balance wrong when it comes to psychedelics. The decision to schedule psilocybin, and frankly, other psychedelics in Schedule 1 is a result of largely political factors. 

“They did not do any assessment in terms of therapeutic potential. They did not do any assessment in terms of non-medical use and dependence, and they have never done it – it has never been done at the international level. 

“So, we are stuck with a scheduling decision that was made in the early 1970s and it has never been really looked at.”

The potential for new mental health treatments

There are currently hundreds of millions of people across the globe living with mental health conditions, and there has been no innovation in treatments since the advent of SSRIs – which do not work for many. This situation has also been exasperated by the COVID-19 crisis.

“There has been a huge focus on mental illness as a result of COVID due to what it has done in the US and the UK, and elsewhere, in terms of the rates of depression, anxiety and other mental health conditions,” said Koddermann.

WHO statistics show that mental health conditions are the leading cause of disability-adjusted life years lost, accounting for 37 per cent of healthy life years lost from non-communicable diseases.

Researchers have suggested that psychedelics could help to provide desperately needed new treatments for mental health conditions.

Willem Scholten, ITPRI Advisory Board member and former Secretary to the World Health Organization (WHO) Expert Committee on Drug Dependence (ECDD),  the body responsible for international drug control scheduling recommendations, commented: “Rescheduling procedures under the 1971 Convention offer a potentially game-changing opportunity to advance further research and accelerate the approval of treatments for patients.”

Pursuing change for science and health

The ITRPI will pursue the schedule change, basing its objectives on research from a number of leading universities and institutes.

Its ultimate goal is to accelerate research and foster the availability of psilocybin-assisted therapies for those suffering from mental illness and substance use disorder.

Partner organisations in the effort include leading psychedelic research, drug reform and human rights organisations such as The Beckley Foundation, Drug Science, the Multidisciplinary Association for Psychedelic Studies (MAPS), Mind Medicine Australia, Nierika AC, the Open Foundation and the Osmond Foundation.

“In 2010, the WHO Executive Board adopted guidance for the ECDD as it undertakes reviews. One of the things that guidance states is that recommendations for inclusion in Schedule 1 should only be made when criteria are fully met with respect to both therapeutic usefulness and public health,” said Koddermann.

“In other words, you do not put a compound in Schedule 1 unless you have both — especially serious risk to public health, and very limited if any, therapeutic usefulness. 

“Anybody who is involved in psychedelic research and science would tell you that psilocybin doesn’t tick either box, let alone both boxes. So, it is clearly prime for rescheduling.

“Presuming the ECDD look the evidence in an impartial manner and follow the science, one could anticipate a recommendation out of the ECDD to change the Schedule.”

Scheduling decisions are made by the UN Commission on Narcotic Drugs (CND), and formal scheduling reviews may be initiated either by the WHO or by notification by any State party to the 1971 treaty. The ECDD is tasked with making scheduling recommendations based on a medical and scientific review of the compound in question.

If a review of psilocybin is undertaken by the WHO and scheduling recommendation is provided, the CND may decide to add, transfer or remove the substance from Schedule 1. This must be by a vote of a two-thirds majority. However, the CND must accept the findings of the WHO and is not able to base its decision on other medical or scientific views.

The ITPRI has highlighted that a recent precedent exists for such a review and rescheduling of drugs under the UN drug treaties, as, in 2020, the CND voted to accept a WHO recommendation to remove cannabis and cannabis resin from Schedule IV of the 1961 Single Convention on Narcotic Drugs. 

To achieve its aim in securing the rescheduling of psilocybin, the ITPRI will be pursuing three parallel routes including a WHO-initiated scheduling review, a state party-initiated scheduling review and an ECDD pre-review leading to a formal critical review.

Koddermann concluded: “Given today’s scientific understanding of psilocybin’s high potential therapeutic value and low risk of dependence, a change of its status as a Schedule I drug is long overdue.”

For more information, please visit www.reschedulepsilocybin.org.