Germany has become the first member state of the European Union to permit the prescription usage of psilocybin mushrooms in exceptional cases.
On Aug. 1, the country’s Federal Institute for Drugs and Medical Devices officially authorized two state facilities to administer the psychedelic drug to patients with treatment-resistant depression (TRD). Namely, OVID Clinic Berlin and the Central Institute of Mental Health (CIMH) in the city of Mannheim.
“The intention is to help patients access new resources, shift rigid cognitive patterns, gain new insights, and reduce depressive symptoms when no other treatment has worked,” said OVID Clinic Berlin in a social media post.
Similar to the Special Access Program in Canada and a comparable framework in Switzerland, select individuals in Germany will be enabled to legally access the psychoactive substance through a compassionate use scheme. However, it will differ from Canada in that German psychiatrists will be responsible deciding if a patient should receive psilocybin rather than a government agency (Health Canada).
It is estimated that approximately 25 per cent of Germans suffering from TRD find orthodox treatments to be of no use. As a body evidence continues to grow showing the therapeutic value of the psychedelic compound for mental health in certain cases, Germany has decided to cut red tape for those in dire need. It will be administered in conjunction with psychotherapy.
Canada’s Filament Health Corp (OTCMKTS: FLHLF) (FRA: 7QS) will be a key supplier for the country’s access scheme. The company will be providing its psilocybin drug PEX010.
“This is an enormously important step that expands our scope for action,” said Dr. Gerhard Gründer, a German professor and psychiatrist from the CIMH. He was significantly responsible for preparing the extensive paperwork associated with attaining the necessary government approval.
“In selected individual cases, the therapeutic use of psilocybin as part of a Compassionate Use Program can be a medically and ethically justifiable option,” he added, “provided it is carried out under strictly controlled conditions and with careful medical supervision.”
Although Germany is the first EU country to take this course of action, it is not the first in Europe. In June, the Czech Republic’s lower house of government agreed to permit psilocybin therapy beginning in 2026. Opposition to the new legal measure is not expected in the nation’s Senate.
The news also follows the first EU-backed research trial on psychedelic therapies commencing in 2024. Psilocybin has been a key focus for the “PsyPal” initiative with a focus on treating conditions like multiple sclerosis, Parkinson’s, Chronic Obstructive Pulmonary Disease and ALS.
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