Germany has become the first country in the European Union to allow legal access to psilocybin — a psychedelic substance found in so-called “magic mushrooms” — even before its regulatory approval. This historic achievement was made possible through the creation of a compassionate use program, approved by the Federal Institute for Drugs and Medical Devices (BfArM), the country's regulatory body.

According to a report by journalist Josh Hardman, published on Thursday (31) on the Psychedelic Alpha platform, the program will allow two authorized institutions — the Central Institute of Mental Health (CIMH/ZI Mannheim) and the OVID Clinic in Berlin — to offer the substance to adults with treatment-resistant depression (TRD). The treatment will use the botanical compound PEX010, developed by the Canadian company Filament Health.

Furthermore, in an interview with the platform, psychiatrist Gerhard Gründer, who spearheaded the program's request and implementation, explained that Germany has adopted an innovative model by allowing psychiatrists themselves to decide on patient inclusion, without the need for case-by-case authorization from government authorities.

“This decision cannot be made by any formal regulatory or governmental authority,” Gründer stated. “Our protocol allows us to repeat the treatment in case of non-response to the first dose or to maintain the treatment's effect.”

 

Dosage sessions will adhere to strict safety rules, with the mandatory presence of two trained healthcare professionals, including a physician. The program also includes continuous patient monitoring and the collection of clinical and scientific data — including psychometric scales and brain imaging studies, mainly at the CIMH.

The treatment will be free of charge for patients, covered by the healthcare system, as it will be included in a broader psychiatric care plan.

With this move, Germany joins Canada and Switzerland, countries that already allow compassionate use of psychedelics under specific criteria. However, the German model stands out for its streamlined process and greater medical autonomy, which could accelerate patient access and serve as a reference for other European Union countries.

 Source: Psychedelic Alpha
Article by Josh Hardman
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