Berlin / Mannheim – August 2025 – Germany has taken a historic step in mental health care, becoming the first European Union nation to authorise medical access to psilocybin for adults with treatment-resistant depression (TRD).
The Federal Institute for Drugs and Medical Devices (BfArM) has approved a compassionate use program that allows two specialised clinics — the Central Institute of Mental Health (CIMH) in Mannheim and the OVID Clinic in Berlin — to administer psilocybin under strict medical supervision.
Who Can Access the Program?
The scheme targets adults who have failed to respond to at least two standard antidepressant treatments and who cannot participate in ongoing clinical trials.
Eligible patients will undergo a thorough medical evaluation. Psilocybin sessions will be conducted in a safe, structured environment, with preparation meetings, dosing under the supervision of two professionals (including one physician), and post-treatment integration therapy.
Medication and Supply
Filament Health’s botanical psilocybin candidate (PEX010) will be supplied to the program. Initial treatment is expected to be free of charge for patients, with insurance coverage potentially available in the future.
Why This Matters
- Bridging a treatment gap: Around 20–30% of depression patients do not respond to existing therapies.
- Regulatory milestone: This is the first EU-approved compassionate psilocybin access program, potentially influencing other European nations.
- Data for future policy: The program will gather real-world evidence to guide future medical approvals.
“In selected individual cases, the therapeutic use of psilocybin as part of a Compassionate Use Program can be a medically and ethically justifiable option, provided it is carried out under strictly controlled conditions and with careful medical supervision,” said Prof. Dr. Gerhard Gründer of the CIMH.
Looking Ahead
While the program will initially be small-scale, experts anticipate significant demand. Germany’s model may set a precedent for other EU countries exploring psychedelic-assisted therapies.