Germany has become the first European Union member state to permit the controlled therapeutic use of psilocybin, the psychoactive compound found in magic mushrooms, for patients battling severe, treatment-resistant depression, according to Euronews.
The country’s Federal Institute for Drugs and Medical Devices (BfArM) approved the landmark compassionate use programme following an application by the Central Institute of Mental Health (CIMH), marking a significant shift in Europe’s approach to psychedelic medicine.
Under the scheme, psychiatrists at two designated clinics, CIMH Mannheim and Berlin’s OVID Clinic, may administer pharmaceutical-grade psilocybin to adults who have exhausted conventional treatments without success.
Access will be strictly limited to “justified exceptional cases” under what Dr. Gerhard Gründer, Head of Molecular Neuroimaging at CIMH, describes as “very strict” rules.
The programme utilises Filament Health’s botanical psilocybin candidate, PEX010, administered within comprehensive psychiatric care protocols. Crucially, unlike systems requiring regulatory approval per patient, qualified psychiatrists at the two designated sites hold authority to determine patient eligibility.
“This decision cannot be made by any formal regulatory or governmental authority,” Gründer said.
This eliminates a significant administrative bottleneck hindering similar initiatives elsewhere. Furthermore, protocols allow for repeat dosing if patients show no initial response or require maintenance, offering flexibility absent in many clinical trials.
The programme anticipates serving approximately 50 patients in its first year due to resource constraints, though regulatory permission allows for higher numbers. Treatment costs, excluding the donated drug, will be covered by statutory health insurance as part of integrated psychiatric care, a critical accessibility factor.
While depression is widespread, CIMH notes 20-30% of sufferers experience treatment-resistant forms, finding little relief from standard antidepressants. Emerging research suggests psilocybin may help foster links between different regions of the brain, helping people “let go of excessive self-focus and rumination.”
Earlier in July 2025, the Czech Republic legalised medical psilocybin for conditions including depression. Concurrently, the first EU-funded psychedelic medicine trial investigates psilocybin’s potential against anxiety and depression in progressive neurological conditions like multiple sclerosis and ALS.
Dr. Gründer cautions that demand will vastly outstrip initial capacity, citing Switzerland’s experience where exceptional authorisations for psilocybin, MDMA, and LSD reached nearly 700 in 2024, with psilocybin being the most sought-after.
