In an unprecedented move for EU healthcare, Germany has become the first EU country—and one of very few in the world—to approve the compassionate use of psychedelic therapy for patients suffering from treatment-resistant depression.
The approval, granted by Germany's Federal Institute for Drugs and Medical Devices (BfArM), allows the Central Institute of Mental Health (CIMH) in Mannheim and the OVID Clinic in Berlin to offer psilocybin therapy in select individual cases. Psilocybin will be provided by the Canadian company Filament Health, involved in Canada’s Special Access Programme.
Although limited, this initiative can offer relief to German patients who have not benefitted from conventional treatments. Treatment-resistant depression affects approximately 20-30% of people diagnosed with depression, highlighting an urgent need for innovative therapeutic solutions.
“We do not treat patients with psilocybin in isolation, but always as part of a multi-professional and integrative therapeutic approach that takes into account the psyche, body, and life context in equal measure,” says Dr. med. Andrea Jungaberle, Chief Physician at OVID Clinic Berlin, specialist in anesthesiology and medical psychotherapist. “With our many years of clinical experience in psychedelic-assisted psychotherapy, we can offer patients new therapeutic approaches in a safe and professionally supervised setting.”
With several hundred clinical trials involving psychedelic compounds currently ongoing worldwide, approvals for broader clinical use are expected within the next few years. However, compassionate use programs offer a critical interim step, making these treatments accessible to patients who cannot wait.
Furthermore, such naturalistic settings can complement traditional clinical trials, offering valuable real-world data that can help inform regulators and payers. They provide essential insights into how treatments can be effectively integrated into healthcare systems, build readiness among healthcare professionals, and guide the development of infrastructure required for future rollout at scale.
Importantly, the use of psychedelic therapy, combined with structured psychotherapy, may support a more recovery-oriented model of mental healthcare, addressing root causes of distress rather than focusing solely on symptom management.
Germany’s compassionate use approval follows the recent signing by Czech President Petr Pavel of legislation allowing medical use of psilocybin, further highlighting a broader European shift toward innovative treatments for mental health.
PAREA welcomes these steps toward greater patient access and will continue monitoring developments closely, advocating for evidence-based, patient-centred policy changes across Europe.
