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Germany Opens the EU's First Compassionate-Use Psilocybin Program

Germany's federal drug regulator, BfArM, approved what's reportedly the EU's first compassionate-use program for psilocybin in treatment-resistant depression — inpatient-only, at two sites in Mannheim and Berlin, using a botanical psilocybin candidate alongside psychotherapy. Capacity is small, roughly 50 patients in the first year, and compassionate use isn't approval — it's a narrow, case-by-case pathway for patients who've exhausted other options. Still, it's a real crack in the EU's otherwise cautious regulatory posture.

Read at Central Institute of Mental Health, Mannheim