Approval Is Not Access: A Postcard From Psychedelic Europe
Haarlem, the Netherlands, June 4, 2026 — My ICPR adventure started six years ago, in a cramped attic. The pandemic had forced the organizers first to delay and then move the entire event online. I became one of three disembodied voices of God, hosting one of the three parallel tracks of psychedelic research from a borrowed attic in one of the organizers’ homes, stooping under the rafters between sessions; how things have changed since then.
The Interdisciplinary Conference on Psychedelic Research now shines its purple beacon from the Philharmonie in Haarlem, the cozier, smaller cousin of Amsterdam that sits a half-hour west of the capital. Outside, on the Thursday morning, it was gray and drizzling, the kind of low Dutch sky that makes a warm hall and a strong coffee feel like a small mercy. Inside, several hundred researchers, clinicians, lawyers, anthropologists, and the occasional underground practitioner filled three halls with the hum of people who do not get to talk shop very often. A full hall under a leaking sky turned out to be a decent portrait of the field right now. Real warmth and momentum inside. Weather of uncertainty outside.
I came to ICPR wearing two hats, and I should declare them. I run Blossom, where I spend my days tracking psychedelic research, and I had a twenty-minute slot of my own on the program, on the least glamorous topic on the program: whether Europe’s health systems are anywhere near ready to pay for these treatments once they are approved.
Approval, it turns out, is not the same thing as access. And the people who usually push hardest to close that gap, the drug developers, were the ones who barely showed up. Those two facts are the same story. It is the story I want to tell.
A Field Taking Its Own Temperature
Joost Breeksema, executive director of the OPEN Foundation, kicked off the conference, and he did not set the tone with a victory lap.
His framing was about patience. The OPEN Foundation’s guiding question, he said, “has never been how to grow this field faster but really figuring out what it needs to grow sustainably.” Breeksema talked about Europe’s “moderate temperament,” ethical and institutionally cautious, not easily swept up by hype, and he admitted the caution has been frustrating to watch against the speed of clinical development in the U.S.. Then he said the line I underlined: “Most of the real challenges that we have faced over the past years have arisen when we tried to move faster than the speed of trust.”
That is a different register from the psychedelic conference of a few years ago, when the mood was closer to a countdown. Breeksema was not selling an arrival. He was describing a long road and asking the room to respect the distance.
Breeksema had reason to advocate for patience. Rewind to the previous ICPR, in 2024. Days before that conference opened, the U.S. Food and Drug Administration handed a complete response letter to Lykos Therapeutics (the MDMA-assisted therapy developer that began as the nonprofit MAPS’s commercial arm and has since renamed itself, again, to Resilient Pharmaceuticals). The letter is the regulatory term for a rejection of the MDMA-assisted therapy for PTSD developed by Lykos. The most advanced psychedelic therapy program in the world had just been told to run another Phase 3 trial (the large, final-stage study regulators require before approval). That same year, the Dutch State Committee on MDMA had urged the government to build a regulatory framework for medical MDMA as fast as possible, both positive and negative, arriving together.
That whiplash has become the field’s resting heart rate. Francisca Silva of PAREA, a European psychedelic-policy organization, put it well when I intercepted her for a hallway interview. The story of the last two years, she said, has been “a positive and a negative again,” and the tone in Haarlem had shifted. Not many people in the conference hallways were talking about the U.S. company COMPASS Pathways, the field’s best-funded psilocybin developer, and the FDA anymore.
“They are dead to us,” I said, half joking. “People are focusing more on what can we do here, what can we do now,” Silva replied.
Before we get to the road Europe is now trying to build, though, there was a more immediate thing to make sense of. For a conference about an industry on the cusp, this one had a conspicuous hole in the middle of it.
I See No PR
During ICPR, there were no industry-sponsored talks. No big drug developer presenting pivotal results for the first time. A handful of badges carried a developer’s name, but there was no PR machine, no booth war, no breathless “data readout.” For a field that spent the late 2010s being narrated by companies developing drugs for psychedelic therapies, the silence of those organizations was the loudest thing in the room.
ICPR stands for the Interdisciplinary Conference on Psychedelic Research. Say the letters out loud, in the right frame of mind, and you get the joke the weekend kept making to me. I saw no public relations efforts by companies describing their progress.
The conference had become almost defiantly interdisciplinary: history, law, ethics, anthropology, women’s health, Indigenous knowledge, neuroscience, and a great deal of clinical and policy work, with the commercial layer peeled away. I found this genuinely refreshing and slightly worrying, and I think both reactions are correct.
Refreshing, because the program was richer for it. Across three halls you could move from the constitutional law of drug prohibition in South Africa to the neuroscience of consciousness to a panel on psychedelics in active war zones, and the transitions felt earned rather than scattered.
Worrying, because of what the absence of drug development companies is a signal of. Drug developers are not only hype machines. They are also the entities with the capital, the regulatory staff, and the commercial urgency to do the slow, expensive, thankless work that turns an approval by the FDA into a treatment a patient can actually receive. After the 2024 rejection of Lykos’s proposed MDMA-assisted therapy, a lot of that money and urgency cooled. So a field that has gone quiet on the commercial layer is also a field where the road to access risks stalling, not because the science failed, but because almost no one is paid to build it.
And the few people still dissecting the industry in public were mostly warning the rest of us off our own best press. Josh Hardman, who writes the closely read Psychedelic Alpha newsletter, gave one of the talks that looked the industry in the face, and his read was sober. The political opening in the U.S., where a friendlier administration has floated faster review timelines, is a genuine tailwind, he allowed, but tying these drugs to a political moment also ties their fate to that moment’s reversal. Hardman was wary of the hype cycle running ahead of the evidence again, pointing to the way a striking but thin “80% cure” figure for ibogaine in opioid use disorder had detached from its modest underlying data. Set a bar that high, he warned, and you are setting the field up to fail.
So the developers were not in the room, and the one person dissecting them was warning against believing our own press. That is a strange place for a field that keeps being told it is on the cusp.
Josh Hardman presenting at ICPR 2026 on the current state of the psychedelic industry. (Photo courtesy of Josh Hardman)
Approval Is Not Access
This is where my own bias becomes useful, so I will use it.
I spend my time on the question of what happens after the science works, and my talk in Haarlem had a single, deliberately unsexy thesis: approval does not equate access. A European license is only the first gate. After that, a treatment still has to clear a national health-technology assessment (the evaluation that decides whether a system considers it worth paying for in insurance coverage), secure an actual payment route for the entire episode of care rather than just the drug, and then meet the workforce and clinic infrastructure needed to deliver it.
The reaction I got afterward told me something. Several people came up, surprised, not by the conclusion but by the volume of work that still lies between a successful trial and a treated patient. The trial is the part everyone watches. The two-plus years of administrative plumbing that follow are the part that determines whether anyone is ever treated. In my own talk, I tried to put a number on it. Even if every step lined up without delay, the earliest a country like the Netherlands could have a fully reimbursed psychedelic-assisted treatment running was around 2029, and that was the optimistic case. The room did not feel as if it were bracing for 2029.
Here is the uncomfortable comparison I leaned on. Esketamine, sold as Spravato, is the closest thing we have to a precedent: a novel, in-clinic, monitored psychiatric treatment that actually made it through FDA approval. And in England and Wales, the National Institute for Health and Care Excellence (NICE), the body that decides what the NHS, the UK’s public health service, will fund, has declined to recommend it, and even refused to look at it again. The same drug is funded in Scotland and in around twenty other European countries. Approval did not equal access. It did not even equal access within one country.
Now make it harder. Spravato fits into roughly a two-hour appointment. Almost every classic psychedelic does not. Psilocybin, MDMA, and LSD sessions run four, six, eight, even twelve hours, with two trained therapists in the room. Only the short-acting compounds, DMT and 5-MeO-DMT, look anything like a normal clinical slot. So the question is not abstract. How do you fit a multi-hour, two-therapist, preparation-and-integration treatment into a billing code, a training pipeline, an accreditation standard, and a clinic schedule that were all built for pills and brief consultations? Mostly, we have not figured this out.
There is a human version of this gap, and it had its own session. A patient-led panel featuring Leonie Schneider, Ian Roullier, and Caroline Lilley, with the trial participant Hannah Harvey, described what it feels like when the clinical structure simply ends. Harvey’s line, read aloud, stuck with me: when the trial finished, it felt to her “a bit like being gently or not so gently dropped back into the real world,” with no follow-up contact allowed. We talk about access as a question of getting people in. They were describing the opposite failure: getting people in, changing their lives, and then letting go of their hand at the worst possible moment.
Which sharpens a question that the developers’ absence already raised. If the system is this unready, who is all of it even for?
The 51% Blind Spot
Grace Blest-Hopley, who runs Hystelica, a venture focused on women’s health and psychedelics, gave the keynote that named one answer, and it was the talk people kept referencing for the rest of the weekend.
Her title was “The 51% blind spot.” The argument: women are 51% of the population and carry a disproportionate share of the mental-health burden these treatments are aimed at, yet psychedelic science has been built largely on men. That choice, she argued, has shaped what questions get asked, what outcomes get measured, and whose suffering gets prioritized. It echoed a point Breeksema had made in his opening about the field centering male experience almost by default.
What made the talk land was that it did not stop at the gap. It complicated the science itself. Hormonal fluctuation across the menstrual cycle may change both how a psychedelic feels and how risky it is, and we do not have the data to say when in the cycle it is safest or most effective to dose. A screening done three weeks before a session may not describe the person who actually shows up. Dose into the wrong window, into something like premenstrual dysphoric disorder (PMDD, a severe, mood-disrupting form of premenstrual illness), and you may do harm instead of good. Most existing trials, Blest-Hopley noted, have not run gender analysis that means anything.
This is the honest-broker version of a promise. The opportunity is real and specific. So is the homework, and it is not just bureaucratic. Even the basic pharmacology has an asterisk on it for half the population.
Which brings me back to the question the absent developers left hanging. If the science still carries this much homework, and no company is rushing to file for approval of its therapy in Europe, who is going to build the road to access? In Haarlem, a few people had stopped waiting for an answer and started pouring the concrete themselves.
Building the Road Before the Cars Arrive
The conventional route to a European market runs through the European Medicines Agency (EMA), the EU’s central drug regulator. In this process, a developer of a proposed drug therapy assembles a full dossier and seeks approval for the whole therapeutic plan at once. That is the road with no traffic on it right now.
The alternative, quietly underway in at least three countries, is to register a treatment at the national level first, through a relatively lightweight country-specific path, and let approval in one place create pressure and precedent for the next.
These efforts are early-stage and uneven, and I want to be careful not to oversell them. The most public is in Germany, where the DiMension trial is pursuing exactly this kind of national-registration approach and is openly fundraising to do it. Tellingly, no drug company is behind it: the trial is run by a consortium of the MIND Foundation, the German federal innovation agency SPRIN-D, the non-profit Usona Institute, and the Central Institute for Mental Health in Mannheim, testing psilocybin with psychotherapy for treatment-resistant depression in what is set to be the largest psychedelic trial yet.
There is comparable work underway in the Netherlands, at varying stages and mostly behind the scenes, and a registered Phase 3 trial of psilocybin for alcohol use disorder with depressive symptoms in France. None of this is a finished pathway. But it is a meaningful change of posture: Europeans deciding to build the road themselves rather than wait for someone to drive in.
The country furthest down that road is the Czech Republic, and it makes a useful test case for the whole argument. In August 2025, Czech lawmakers passed an amendment to the country’s Addictive Substances Act that, from January 1, 2026, allows the medical use of psilocybin for serious and treatment-resistant depression, including cancer-related depression. It is the first full national framework of its kind in the EU. Read the fine print, and you see the shape of the real thing: psychiatrist-led, only in facilities approved by the health ministry, sessions of around six hours with two qualified therapists, mandatory psychotherapy, a ceiling of 75 milligrams a month.
And then the gap reappears, in the same country, in real time. The law took effect at the start of this year, but the National Institute of Mental Health (NÚDZ) expects actual treatment to begin only in the second half of 2026, with only a few dozen patients per year to start. Approval on paper is not yet treatment in a clinic.
Gray Hairs and the Ketamine Question
Reimbursement is the hinge. On the ketamine-clinics panel, the Czech clinicians described ketamine as only partly covered by insurance. About 60% of the combined drug-and-therapy cost is reimbursed, with patients paying the rest themselves. Psilocybin therapy coverage is still being worked out even though the law is live. This is my entire talk, compressed into one country: you can get the statute and still be a long way from a system that pays for the care and a patient who receives it.
If you want to know what the boring middle actually feels like, ask someone running a clinic.
A panel of European ketamine and psychedelic clinic founders promoted as “A decade of clinical insights” was the most useful hour of the weekend for me, because it was the least visionary. The recurring phrase was about gray hair. There is no playbook, one founder said. The legal and regulatory work is a slog. Waiting lists are long. And a recurring worry was that, under time pressure, ketamine gets stripped of everything that might make it work. One founder had a phrase for the bad version: ketamine “in the toilet.” A patient left alone on a drip for an hour, with none of the preparation, support, and integration (the therapeutic container) that the careful version depends on.
There is one clear bright spot. Lowan Stewart, of the Axon Clinic in Norway, described how Norway in August 2025 became the first country in the world to approve nationwide public reimbursement for generic racemic ketamine (the cheap, original form of the drug, not the far more expensive patented Spravato nasal-spray version) in treatment-resistant depression, delivered within specialist services and paired with psychotherapy. It is a real precedent for a publicly funded, psychedelic-adjacent treatment at a national scale, and it is already drawing pharmaceutical pushback, which tells you something about whose model it threatens.
But funding a treatment and knowing it works are different achievements, and the most bracing session of the weekend was about the second one.
The Dutch picture sets it up. Ketamine is reimbursed here for specific cases, and I think the cost-effectiveness argument can be made to close any resistance to insurance coverage. But “can be made to close” is carrying weight in that sentence. We still do not know cleanly under which conditions it works, for whom, and how much of the effect is the drug versus the expectation of the drug.
That question got its own session. A symposium on negative trials, the kind of results the field used to bury, put three failures on stage and treated them as data rather than embarrassment. Jurriaan Strous presented a ketamine trial for acute suicidality that was stopped early for futility, and made the uncomfortable point that the blinding had actually worked: when patients could not tell whether they had received ketamine or an active placebo, the effect did not separate.
Strous has a name for the usual problem, “expectancy stacking,” where everyone’s hope piles onto the active arm of the clinical research. Lea Mertens of Maastricht presented a psilocybin trial for treatment-resistant depression that missed its primary endpoint (the main result it was built to test), and argued, reasonably, that one statistical result should not get to label an entire study a failure. Eline Haijen-Bongers presented a trial of repeated low-dose LSD for adult ADHD that did not beat placebo, in which 80% of participants correctly guessed they had received the drug.
Put those together and you get the question that lies under the whole enterprise. When the blinding required for the research is successful, how much of the resulting effect is due to the molecule, how much to the container, how much to the therapy, and does a single dose ever do what the brochures imply? Even a clearly positive trial does not fully escape this.
Paul Liknaitzky, who leads the Clinical Psychedelic Lab at Monash in Melbourne, presented what he fairly called a highly successful MDMA-assisted therapy trial for PTSD in veterans and first responders, with around a third of participants in full remission. For chronic, treatment-resistant PTSD this is a genuinely strong result. He was also straight about the other end of the distribution: about a third did not respond at all. He noted that more dosing sessions did not reliably help. Promise and asterisk, in the same dataset.
The Question No One Asks
Here is the part I have not seen anyone put on a slide.
Not everyone wants to take a psychedelic.
At a psychedelic conference this sounds almost heretical, partly because everyone in the building does want to, and a fair number will prove it at the afterparty. But step outside the field and the picture changes. In ordinary mental-health care, a lot of people are not looking for an intense, hours-long, ego-dissolving experience. A temporary loss of the everyday sense of self is not desirable for everyone, even if it is safe, even if it is free, even if it is down the street. The substance is not what they came for.
I heard this most plainly not in a talk but in the hallways. Several people working with psychedelics in the Netherlands (where psilocybin-containing truffles are legal) told me a version of the same thing: there are now more people trained and ready to offer this work than there are people asking for it. More capacity than demand, at least for now. That is an impression, not a measurement. I would want real numbers before building a policy on it. But it points at a quieter question the field mostly skips.
That inverts the usual access conversation, which assumes a queue of patients held back only by the system. The question underneath is one of sequencing. If someone has other options, which do they try first, and where does a six-hour psychedelic session sit in that order? Treating psychedelics as one tool among several, rather than the obvious destination, is a more honest starting point than the one the field usually uses.
I do not think this undercuts the promise. I think it sharpens it. A treatment can be genuinely effective and still reach far fewer people than the enthusiasm implies, because effectiveness and demand are different things. The field has spent much more time measuring the first.
The Closing Panel
By the final afternoon, the program gathered itself into a closing panel that, almost by accident, held all of these threads at once. Joost Breeksema moderated a stage that pulled the weekend’s recurring faces back together, Joanna Kempner, Grace Blest-Hopley, and Josh Hardman among them, alongside the Indigenous leader Adana Omagua Kambeba.
Two notes from it stayed with me. One panelist described the European mood as “still optimism, but without the hype,” which is about the most accurate summary of the weekend I can offer. Another, reflecting on the cost of success, warned that something gets lost when an interdisciplinary project hardens into a field and starts becoming self-referential, talking mostly to itself.
And then the sharpest discomfort of the three days, raised from the stage by Adana Omagua Kambeba and others: where are the guardians of these medicines? Two years ago there had been a single Indigenous representative at ICPR; this year a handful. For a field that exists, in large part, because of Indigenous knowledge, that imbalance is not a footnote. It is the moral version of the same gap that runs through everything else here, the distance between what we say the work is for and who actually gets to be in the room.
The ICPR closing panel that ended on a critical note. (Photo by Floris Wolswijk)
Rain, FOMO, and Two More Years
The conference ended where psychedelic conferences tend to end, with an afterparty. It was held out at Ruigoord, the old artists’ village, and by every account it was warm and loud and gezellig inside, that Dutch word for cozy that English never quite manages, while the rain that had opened the conference kept drumming on the roof. The people who had spent three days dissecting set, setting, and statistical power were enjoying themselves, and a few of them, no doubt, were quietly putting their own subject matter to the test.
I went home instead, which is its own small data point about a field that is growing up: the conference now has an after-hours life I am too domesticated to keep up with. I will admit the FOMO, the specific ache of scrolling the next morning’s photos from a party you left early. I will also admit the obvious fix, which is to come back in two years.
The promise of psychedelic medicine is real, and on a long enough horizon it probably arrives. But the date is further out than the mood in that hall implied, and the work between now and then is administrative, clinical, and cultural at least as much as it is pharmacological. The drug developers stayed home this year, and in their absence the unglamorous questions — about money, about workforce, about demand, about who these medicines are really for — finally had the floor. The catch is that those are also the questions that need the developers’ capital and urgency to answer.
Maybe that is its own reason for hope: a field finally willing to sit with its hardest questions, even without the people who usually wave them away. But the empty seats were their own kind of weather. Warmth and momentum inside, and outside, still, the long gray business of turning a promise into something a patient can actually reach.