The Plan to Reschedule Psilocybin at the UN

One of the biggest barriers to global drug policy reform is countries’ need to adhere to international drug control regimes, also known as the UN conventions on drugs. While there have been a lot of advocacy efforts to change their national implementation, a coalition of drug policy reform named International Therapeutic Psilocybin Rescheduling Initiative (ITPRI) has been set up to push for greater change at the UN level.

Founded just at the start of 2022, TalkingDrugs came across ITPRI mostly through the collaboration of its international partners: big names like the Beckley Foundation, Drug Science, and MAPS are all ITPRI partners, alongside Nierika AC, Heroic Hearts UK, Open Foundation, Osmond Foundation, Mind Medicine Australia and a patient advocacy group soon to be announced. All these partners have coalesced into an organisation focused on one singular goal: the rescheduling of psilocybin from the 1971 UN Convention.

We spoke with Chris Koddermann, one of the co-founders of ITPRI. Originally from Canada but now based in Switzerland, he has worked in several government and public affairs roles throughout his career, and has now established his own company public affairs company. Calling from his family home, Chris spoke on why he got involved with this project in the first place, and how ITPRI plans to reach its objective of rescheduling psilocybin. The interview has been edited for clarity and brevity.

Could you tell me a bit about your background and how you got involved with ITPRI?

Koddermann: I'm a lawyer by training but spent the early part of my career working in Canadian politics. So I was a political and policy advisor to several different liberal governments in Canada. I then spent a number of years in the corporate sector, doing government affairs, public policy/communications type roles, some of which involved a fairly international focus. And then I got tired of working for big companies and set up my own public affairs consultancy about three years ago, and that's how I make my living, doing government affairs type work, with a significant focus on Geneva based UN permanent missions, WHO, international institutions etc.

My interest in the psychedelic space, and sort of the genesis of ITPRI, you know, I had read Tom Wolfe's Electric Kool Aid Acid Test when I was like 14, therefore becoming aware of Ken Kesey's involvement in the CIA studies in the early 1960s. And through it I became aware of some of the early research that had gone on. Then I had experiences with a number of these compounds in my 20s and developed an appreciation for the power of these drugs. And so I was kind of primed when I started reading a number of years ago about the resurgence in the research into various therapeutic applications of psilocybin, LSD and various other compounds, and had also been similarly following the long saga around the rescheduling of cannabis.

It was clear that nobody is pursuing the rescheduling of psilocybin or any of these other compounds that were being studied for therapeutic purposes. There's lots of writing on the topic and the inappropriateness of this current scheduling regime, and so on and so forth. And so I really saw an opportunity to launch an initiative with a coalition of partners to try and get psilocybin out of Schedule 1, which is really the problem. You know, I think the issue isn't that it's scheduled in the first place, although one could argue about that. It's the fact that it's in Schedule 1. And that schedule really creates a whole layer of obligations on governments in terms of domestic controls that really sort of gum up the system when it comes to advancing the science and the research.

Have you considered through ITPRI or any other kind of advocacy efforts to work on the decriminalisation of psilocybin? Or is the target to start shifting psilocybin from at least from Schedule 1 into any other schedule?

Koddermann: We're really focused on rescheduling under the 1971 UN Convention. Our focus is on trying to help accelerate research and approval of therapies. I think that there are lots of excellent groups like the Global Commission on Drug Policy, the International Drug Policy Consortium, and Ethan Nadelmann's former group in the US [Drug Policy Alliance] who are doing great work on drug policy reform issues. I agree that we need to move away from a criminal law model to a public health model. But our focus is really on the international scheduling and the obligations that it creates. What we can do to bring the greatest benefit is not try and pursue something that's not realistic in terms of total de-scheduling, but pursue something that is realistic and get it rescheduled.

I'm really curious about the engagement part of this work. Could you tell me a bit more about your plan?

Koddermann: So there's two stages to rescheduling. The first stage is getting a review initiated, whereby the WHO Expert Committee on Drug Dependence is tasked with doing a medical and scientific assessment of psilocybin, looking at what are the risks to public health in terms of abuse liability, and its therapeutic value. They weigh those two factors to determine whether it belongs in Schedule 1, or belongs elsewhere. Schedule 1 is for drugs that present an especially serious risk to public health, in terms of their abuse liability, and have very little if any therapeutic value. And in order to be in Schedule 1, a drug is supposed to tick both boxes. Psilocybin clearly doesn't fit either box, right? So you need to get a review initiated, so that the WHO Expert Committee on Drug Dependence can do that assessment, and make that determination.

The ECDD’s criteria for scheduling recommendations. Source: WHO ECDD 1970

There's essentially four paths to get that review initiated. Any state party to the treaty, that is any government that is signed and ratified the treaty, can ask for a review. The WHO itself can ask for a review, and members of the Expert Committee on Drug Dependence who are independent to the WHO, or international bodies that participate in their meetings like the International Narcotics Control Board, can ask for a pre-review. A pre-review looks at the same things as a review, but for purposes of determining whether a formal review is warranted. So those are the three pathways that we're focused on. There's a fourth path, that's through the UN Commission on Narcotic Drugs and is really not a viable starting point.

We will be engaging with a number of governments that we've identified as priority targets for initiating a state-initiated review. And we've identified those governments by looking at a number of factors. So: what is their approach been to drug policy reform and harm reduction? What's been their approach to implementing medicinal cannabis regimes? How important have they prioritized the funding and availability of mental health services? And then lastly, is there any psychedelic research going on in a particular jurisdiction? So we're going to focus on countries that tick some of or many of those boxes. That includes places like Canada, Switzerland, the UK, New Zealand, Portugal, Czech Republic, Jamaica, Israel, Norway, the Netherlands, Luxembourg, and I'm sure I'm forgetting somebody. So a bunch of governments that we'll be engaging with in order to try and convince them to notify the UN that they want to review an issue.

So it's very traditional lobbying - reaching out, meeting, making the case, showing the evidence and the science... I think it's also going to be important to involve some of the leading researchers, folks like David Nutt from Drug Science, but also involve patients so that there's a patient voice in the discussion, which I think is going to be key to success. It's one thing to present the science and evidence, but it's another thing for people who are in decisionmaking positions to hear from people have benefited from psilocybin assisted therapy, whether those be veterans or folks who have struggled with depression or other mental health issues.

What kind of outputs are going to be coming from ITPRI that will be made publicly available?

Koddermann: One of the key things that we're planning on doing is creating what's called a "critical reviews style" report. So when the WHO Expert Committee in Drug Dependence is tasked with reviewing a drug for rescheduling or for scheduling when not presently scheduled, one of the base working documents they use is called a "critical review report". Essentially it looks at the drug and it outlines its pharmacology, toxicology, pharmacokinetics, pharmacodynamics, illicit use, previous efforts at international control, so on and so forth. And we have on our advisory board, a gentleman by the name of John Van Amsterdam, who actually has previously been hired by the WHO to author these documents for scheduling procedures.

I wanted to ask you about some funding concerns, and what are the expectations for the sources of funding that are going to be coming for this initiative.

Koddermann: Yeah, I mean, listen, I think in an ideal world, I would love to fund this purely based on philanthropic donations. And certainly there are a number of folks who have been active in the psychedelic space, particularly in the US, that are funding much of the research and some of the centres that have been established and whatnot. I had reached out to them early on and I'll be reaching out to again, to see if we can get some of that philanthropic funding. I think that's the cleanest route. I don't think we're going to be able to raise sufficient funds through small individual donations.

I think, you know, it complicates things a little bit in the sense that when you're lobbying folks and you have corporate partnerships, then, you know, that complicates the story in terms of the motivations and the benefits, but I don't think that that necessarily has to be an impediment to doing effective lobbying. And there are, you know, a number of for-profits in this space that are doing excellent work. And the vast majority are doing it in an ethical way, with a desire to benefit patient populations.

Some of the concerns that come with funding is that the new regulatory system that then is proposed is something that remains maybe not as exclusive as before, but still an exclusionary system.

Koddermann: No, because I think, irrespective of who's funding us, that's not going to change the outcome we're seeking. So we're not trying to change the treaty itself so that it's a different model. We're simply trying to move psilocybin out of Schedule 1. Partners who may be funding us, like for-profit partners, or philanthropists who get involved must clearly understand what our objective is. It's a pretty clear objective, get it out of Schedule 1, and that's not going to change irrespective of who's involved in the process.

Frankly, I think getting psilocybin out of Schedule 1 is to the benefit of the not-for-profit sector, and academic institutions who have to deal with rules that complicate and slow down their research and make it much more expensive. But I also think it's a benefit to the commercial folks, because it will provide an additional layer of legitimacy to the pursuit of psychedelic medicine as you would get, hopefully, a recommendation out of the WHO saying these drugs have a low abuse liability and they have either moderate to great therapeutic potential or moderate therapeutic potential, or whatever the case may be, but certainly a recognition of the therapeutic potential of these drugs.

Is psilocybin going to be the last step? Is this the endgame of ITPRI, or will it be focused on more psychedelics?

Koddermann: At this point, we're focused on psilocybin. I think it's the one that is most advanced in terms of the science and evidence, maybe with the exception of MDMA for PTSD, where, you know, the guys at MAPS are getting very close to the finish line. But I think, aside from those efforts, most of the research has been on psilocybin, I think it's the easiest case to make from a therapeutic benefit perspective. I think it's also the easiest case to make from an abuse liability perspective.

I think if we succeed with psilocybin, we'll certainly be taking a look at what, if anything, is next. The P in ITPRI can easily be changed from psilocybin to psychedelics. But let's start where we are. This is going to take time and a lot of effort, and it's not going to be quick. We'll see how the science evolves with respect to other compounds. I think it's still early days, when it comes to a lot of the research on LSD and in various other compounds. I think it's still fairly early days compared to where psilocybin is. So maybe the research just needs to also catch up.