Germany Pioneers Compassionate Psilocybin Access for Treatment-Resistant Depression in EU First
- Jody Chu and James Bunn
- Aug 5
- 3 min read
By Jody Chu and James Bunn
Germany has recently taken a landmark step by introducing compassionate access to psilocybin for patients with treatment-resistant depression (TRD), marking the first such programme in the European Union. This initiative allows eligible patients to receive psilocybin treatment outside of clinical trials under a legal framework designed for compassionate use.
Founder of Drug Science - Prof David Nutt says "It is pleasing to see such a rational development in the provision of proven therapy to people who have failed conventional treatments. I see no reason why the UK should not follow suit."
Compassionate access is a programme that permits patients with severe or life-threatening conditions—for whom standard treatments have failed and clinical trial participation is not feasible—to receive unapproved substances still in development.
In Germany, authorised by the Federal Institute for Drugs and Medical Devices (BfArM), the Central Institute of Mental Health (CIMH) in Mannheim and the OVID Clinic in Berlin are now licensed to offer psilocybin therapy to eligible patients. Led by Gerhard Gründer in collaboration with Filament Health, which will supply its psilocybin candidate, these two clinics are currently the only sites approved to provide psilocybin under this framework.
How the Programme Works
The programme emerged from years of clinical research demonstrating psilocybin’s potential for TRD, following Germany’s participation in major Phase 2 and Phase 3 studies, including the EPIsoDE trial. Approximately 20-30% of people diagnosed with depression are affected by TRD. Recognising that some patients could not access ongoing trials but faced urgent unmet medical needs, clinicians sought a pathway for legal treatment outside the traditional drug approval system. While similar psilocybin compassionate access programmes exist in Canada, Israel, and Switzerland, Germany sets itself apart by granting licensed psychiatrists the discretion to offer psilocybin on a case-by-case basis, as well as exempting approval for repeat treatments.
Eligibility & Treatment Protocol
Under the German model, patients must:
Have failed at least two standard antidepressant therapies.
Be ineligible for relevant clinical trials.
Psychiatrists at CIMH or OVID assess eligibility, oversee preparation, and supervise each dosing session. Psilocybin is administered in a controlled setting with two trained healthcare professionals, including a physician, followed by integration therapy to support psychological processing and minimise risks.
The Psilocybin-based medical product being provided is specifically Filament Health’s botanical formulation PEX010.
Crucially, the compassionate use framework operates outside the formal drug approval process and does not grant psilocybin market authorisation. Instead, it allows temporary, exceptional access under medical supervision. To improve accessibility for patients, the psilocybin itself is supplied free of charge by Filament Health, while overall treatment costs are typically covered by the patient’s health insurance. Early estimates suggest the programme can accommodate roughly 50 patients in its first year due to resource and staffing constraints, though demand is expected to be significantly higher.
Key Considerations
The compassionate use framework operates outside formal drug approval and does not grant psilocybin market authorisation.
Filament Health supplies psilocybin free of charge, while treatment costs are typically covered by health insurance.
Due to staffing constraints, the programme may only accommodate around 50 patients in its first year, though demand is expected to be far higher.
Implications for Psychiatry & Drug Policy
Immediate Relief for TRD Patients – Provides an option for those with no alternatives while awaiting potential European Medicines Agency approval in coming years.
Real-World Data Collection – Offers insights into psilocybin’s safety and efficacy in clinical settings.
Foundation for Future Integration – Establishes clinical protocols, training pathways, and ethical guidelines for psychedelic therapies beyond trials.
By balancing compassionate access with strict oversight, Germany has created a model that offers hope while maintaining scientific rigour—a cautious yet significant step toward broader medical acceptance of psilocybin.
