Germany’s Pioneering Psilocybin Program: A New Hope for Depression Treatment

Germany has launched the EU’s first regulated psilocybin program, offering hope for those with severe depression but facing hurdles in scale and reach.

In July 2025, Germany became the first European Union country to legalise psilocybin access for adults with treatment-resistant depression (TRD) through a compassionate use program. Approved by the Federal Institute for Drugs and Medical Devices (BfArM), the initiative allows two clinics, the Central Institute of Mental Health (CIMH) in Mannheim and OVID Clinic Berlin, to provide Filament Health’s psilocybin product, PEX010, within a broader mental health treatment plan. Data from Psychedelic Alpha (2025) provides early insights into the program’s structure, patient access, and challenges.

Image Credits: NCCIH

Program Structure and Patient Access

The program targets adults with TRD, meaning they’ve tried at least two antidepressants without relief. Unlike programs in Canada or Switzerland, where regulators approve each case, German psychiatrists at CIMH and OVID decide eligibility, speeding up access (Psychedelic Alpha, 2025). Gerhard Gründer, the program’s lead, noted that doctors can offer additional doses if needed, a flexibility not always available elsewhere.

Each session is overseen by two healthcare professionals, including a doctor, to ensure safety, with strict protocols in place. The program is limited to 50 patients in its first year due to resource constraints, though more could be treated if capacity grows. Psilocybin is provided free by Filament Health, and treatment costs are covered by health insurance, making it more affordable than similar programs globally.

Global Comparison of Psilocybin Access

Germany’s program contrasts with others worldwide. In Switzerland, outside the EU, 322 patients accessed psilocybin in 2024, but each case requires individual approval. Canada’s Special Access Program has seen declining approvals due to heavy paperwork, limiting uptake. Australia’s program served fewer than 100 patients over 18 months, and New Zealand has only one approved prescriber. The U.S. has minimal access, with just one MDMA program for 50 patients since 2019. Germany’s clinician-led model and insurance coverage sets it apart for efficiency and affordability.

Safety and Monitoring

Safety is a priority, with strict protocols ensuring patient wellbeing. Two professionals monitor each session, and the program includes data collection, such as brain scans at CIMH and mental health questionnaires, to track outcomes. This research aims to build evidence on psilocybin’s effectiveness for depression, with results shared globally to support future studies. No adverse events have been reported yet, suggesting a strong safety framework.

Image Credits: Nessa Esparza

Challenges in Scaling Up

The program’s small scale is its biggest hurdle. Limited to two clinics, it may struggle to meet demand, especially if interest grows as Gründer expects. Expanding to other clinics is possible but requires meeting strict standards. For now, the program focuses solely on depression, though conditions like anxiety could be considered if supported by ongoing clinical trials. Resource constraints and the need for trained staff could slow growth.

Leadership and Expertise

CIMH and OVID are well-positioned to lead. Gründer, OVID’s medical director, ran Germany’s first major psilocybin study for depression, funded by the government. OVID offers ketamine therapy, and its partner, the MIND Foundation, trains therapists in psychedelic care. CIMH is a leading mental health research centre. Filament Health, the psilocybin supplier, has supported 230 patients in Canada and provides PEX010 free in Germany, unlike other firms like Compass Pathways, which focus on trials rather than compassionate use.

Future Outlook

Germany’s program is a bold step for psychedelic therapy, offering a model for the EU. Quarterly data updates from CIMH and OVID, will be tracked by Psychedelic Alpha, and provide ongoing insights into its impact. Advocates hope it will inspire broader access, but scaling up without compromising safety or affordability remains a challenge. Regulatory changes and increased funding could help make psilocybin therapy available to more people struggling with severe depression.