After almost three decades of psychopharmacological research—and having treated thousands of psychiatric patients with psychotropic drugs like antidepressants and antipsychotics—Dr. Gerhard Gründer became critical of this approach.
“At a certain point, I thought, we have to do something different,” the professor of psychiatry and head of molecular neuroimaging at the Central Institute of Mental Health (CIMH) in Mannheim, Germany, told Filter.
“That’s when I started to become interested in psychedelics.”
At a time when many countries face mental health crises and access to effective therapies is limited, psychedelics represent an exciting new frontier. And after decades of prohibition, a number of European nations are now taking steps toward increasing access to these treatments.
A growing body of scientific research is pointing to psilocybin, in particular, as a promising therapeutic for depression, along with other mental health conditions, in patients who have not responded to conventional treatments.
“We had some patients who had taken 20 different antidepressants without success, and we have seen some amazing improvements.”
Gründer began researching psychedelic-assisted therapies in 2021. He led the EPIsoDE study, which concluded in 2024 and is said to be the largest academic clinical trial of its kind, investigating the effects of psilocybin in combination with psychotherapy in 144 patients with treatment-resistant depression (TRD).
According to Gründer, the findings, which are yet to be published, show that around a third of participants experienced significant benefits.
“We had some patients who had taken 20 different antidepressants without success, and we have seen some amazing improvements. We had patients who were still in remission two years after the single dose,” he said. “I believe if we had the opportunity to treat patients with a second or third dose, we could really change the trajectory for them and increase the number who responded.”
This study, along with the growing, wider evidence base, played a critical role in the approval of Germany’s first compassionate use program for psychedelic therapies in mental illness—the first of its kind in the European Union.
On July 11, the Federal Institute for Drugs and Medical Devices (BfArM) gave the go-ahead for two medical facilities—the CIMH in Mannheim and the OVID Clinic in Berlin—to offer psilocybin in exceptional cases to adults with TRD, under the direction of Gründer, who made the application.
While no drugs containing psilocybin have been authorized for medical use in the EU, Germany’s Expanded Access Program permits the use of as-yet-unapproved therapies in patients suffering from serious or life-threatening illnesses.
Now that this first milestone has been reached, other German research and medical institutions are expected to join the program.
To be eligible, patients must meet strict criteria, such as not responding to treatment with approved drugs and being unsuitable for clinical trials. Even so, with around 5.3 million people in Germany living with depression—and around a third of cases thought to be treatment-resistant—demand is expected to exceed supply.
While the program currently allows for up to 200 patients, there are already over 100 on the waiting list, and the two facilities will only have the capacity to treat around 50 people in the first year.
Now that this first milestone has been reached, however, other German research and medical institutions are expected to join the program.
“I think within the next 12 months, we will have more sites in Germany that can treat patients,” Gründer said. “Then we might see up to 500 patients, but this is still a small number compared to the demand.”
Building the Real-World Evidence Base
Compassionate use programs “cannot replace approval” of psychedelic medicines such as psilocybin, Gründer said, and there is still work to do to integrate these therapies into the standard treatment of mental illness. However, the developments in Germany are likely to pave the way for further advances.
“I think our program will inspire other clinicians and researchers to start such a program in their country,” Gründer said. “I’m sure 12 months from now, we will have several more such programs in Europe.”
Switzerland, which is not an EU member, implemented a framework for the therapeutic use of psilocybin, MDMA and LSD in certain conditions in 2014. But the fact that prescribers there are only required to report adverse events means that over the last decade, no data on patient outcomes have been collected. Germany’s program will collect and share data on patient outcomes, as well as any potential adverse effects.
“This is a great opportunity to gather real-world evidence for this drug, in this indication, to provide to the public and the authorities,” Gründer said.
“Different countries must come together and compile the evidence that we gain through these programs,” he continued. “We get more evidence every year, and this will lead to more compassionate use programs in different indications, and probably with other psychedelics, like LSD.”
“With Germany being the European powerhouse, we can hope that these developments will have a knock-on effect.”
His European colleagues agree. Professor David Nutt, a leading neuropsychopharmacologist and chair of the British charity Drug Science, told Filter that the program would “massively accelerate work with these important drugs.”
Dr. Anne Schlag, the charity’s acting CEO and head of research, said the real-world data it provides could be instrumental in informing future policy change.
“With Germany being the European powerhouse, we can hope that these developments will have a knock-on effect in terms of legitimizing psychedelic medicine more widely in Europe,” Schlag told Filter.
“The collection of real-world data will be essential for this, and German researchers now have a unique opportunity to systematically collect, analyze and share high-quality data, and to impact future policymaking.”
Policy Shifts in the UK
The United Kingdom, while no longer a member of the EU, has in the past followed in Germany’s footsteps in drug policy reform—notably legalizing medical cannabis in 2018, a year after German lawmakers did the same.
In August, the government’s Home Office accepted proposals put forward by the Advisory Council for the Misuse of Drugs to remove the requirement for a license to research Schedule 1 drugs such as psilocybin and MDMA.
According to James Bunn, a legal and regulatory consultant in the psychedelic sector, while it’s not clear yet what wider impact this will have, the move should make it easier to conduct vital research.
“This reform should not only reduce bureaucratic burdens but also expand the range of institutions able to study Schedule 1 drugs, ultimately enriching the evidence base for future regulatory decisions,” Bunn told Filter. He believes this shift will be buoyed by Germany’s new “progressive policies,” which could have a “de-stigmatizing effect.”
“For the UK to keep pace, it must move beyond its existing ‘Early Access to Medicines Scheme,’ which is ill-suited for psilocybin, and establish a new framework to mirror Germany’s,” he said, though exactly what this would look like is still an “open question.”
Davis believes the first psychedelic drugs are “on the cusp” of UK market authorization. “We’re quite confident that the changes abroad are going to lend weight to our own campaign.”
“We’ve got a limited amount of time to put the infrastructure and regulation in place to fill the vacuum that psychedelics will find themselves in,” Timmy Davis, CEBDP’s director of psychedelic policy and regulation, and policy director for the public-facing campaign Psilocybin Access Rights, told Filter.
Davis believes the first psychedelic drugs are “on the cusp” of market authorization in the UK, but he’s skeptical that the country will see any regulatory change before then.
“Now that the government has facilitated research, I don’t think it will reschedule until a drug reaches market authorization, which I would imagine will be another three years,” he said. “Then, post-market authorization, we are almost certainly looking at a considerable period where it will only be available on private prescription.”
“That doesn’t mean we aren’t continuing to push and have these conversations in Parliament,” he said. “We’re quite confident that the changes abroad are going to lend weight to our own campaign.”
Czech Republic to Legalize Psilocybin Therapy in 2026
In the meantime, in the Czech Republic, an amendment to legalize psilocybin therapy has recently passed through the entire legislative process.
The new law, expected to take effect from 2026, will allow physicians with psychiatric or psychotherapeutic qualifications to administer psilocybin to patients with certain conditions, in the context of psychedelic-assisted psychotherapy.
“This is a huge breakthrough for mental health care,” Dr. Rita Kočárová, a psychologist, psychotherapist and leading psychedelics expert in the Czech Republic, told Filter. “This change paves the way for a new form of legal support for people suffering from depression, anxiety, addiction and other mental health issues.”
As a researcher at the country’s National Institute of Mental Health, Kočárová has investigated the therapeutic potential of psilocybin, ayahuasca, 5-MeO-DMT, and other psychedelics. She was the principal investigator of a nationwide study mapping the phenomenon of psychedelic use, supported by the Technology Agency of the Czech Republic. The clinical and epidemiological research has been “essential“ for this major political change, she said.
“I hope we will be able to build a sustainable, credible and ethical system of care that can serve as a model for Europe and beyond.”
However, the details of the legal framework—including which conditions will qualify, and how and by whom the treatment will be provided—are still being discussed.
As founder of the international initiative Beyond Psychedelics, the professional educational institutions Beyond Academy and Beyond Institute, and the Czech Psychedelic Society, Kočárová is working closely with colleagues to support the Ministry of Health in setting regulations that are “open enough” to provide access, while ensuring a high standard of care.
“Ideally, this would be carried out by well-qualified experts in multidisciplinary teams, which I believe are the backbone of truly beneficial care,” she said.
“Simply providing access is not enough; what truly matters is the quality of training, integration into mental health care and clear professional standards,” she continued. “In the Czech Republic, we have already set up professional training programs combining medical safety, psychotherapeutic depth and human-centered care.”
If they get it right, it could be a blueprint for other countries to follow.
“I hope that, through collaboration between regulatory bodies and psychedelic experts, we will be able to build a sustainable, credible and ethical system of care that can serve as a model for Europe and beyond,” Kočárová said.
The Beginning of European Acceptance
Opinions are mixed on whether, and when, other European states will explore the rescheduling of psychedelic drugs. But Josh Hardman, CEO of the consulting company Psychedelic Alpha, told Filter that discussions around other compassionate use programs and “legal carve-outs” are already underway in some countries.
“Europeans often have to wait longer to access innovative medicines than their American counterparts, especially for more complex or novel treatments,” he said. “I think that these moves in the Czech Republic and Germany reflect, to some extent, a concern that Europeans might have to wait quite some time before psychedelic therapies are available and reimbursable in many member states. I would not be surprised if other European countries followed suit in the coming years.”
“This is for the pursuit of better mental health and well-being for millions.”
In 2024, the EU announced it would fund its first-ever multi-site clinical study into psychedelic-assisted therapy, with a consortium of 19 European organizations investing €6.5 million to explore whether psilocybin therapy can help reduce psychological and existential distress in patients with progressive incurable illnesses.
Meanwhile, an EU citizen’s initiative, led by PsychedliCARE, is attempting to collect 1 million signatures in 2025 to request that the European Commission take action to “foster equitable, timely, affordable, safe and legal access to innovative psychedelic-assisted therapies.” It marks the first time a movement of such scale has called on European leaders to address the issue.
Kočárová believes that with research growing at an “accelerating rate,” and public initiatives starting to catch up, we are at the beginning of an era of broader acceptance of psychedelic medicine in Europe.
“As in the Czech Republic and other countries, it is only a matter of time before other substances, contexts, and changes are sensibly and safely regulated and made available to those who need them, as well as to those who can benefit from them in other ways,” Kočárová said. “This is for the pursuit of better mental health and well-being for millions.”
Image (cropped) by Zelch Csaba via Pexels
