Germany has become the first country in the European Union to allow legal access to a psychedelic, under certain conditions, prior to regulatory approval.
Through a newly established compassionate use program—which has received the blessing of the country’s drug regulator, the Federal Institute for Drugs and Medical Devices (BfArM)—two facilities are now able to offer psilocybin to adults with treatment-resistant depression (TRD).
Those two clinics, the Central Institute of Mental Health (CIMH, also known as ZI Mannheim) and the OVID Clinic Berlin, expect demand will far outpace capacity. There, psychiatrists will admit qualified patients to receive Filament Health’s botanical psilocybin candidate, PEX010, in the context of a broader psychiatric care protocol.
