In a bold move for European mental health care, Germany has become the first country in the EU to approve psilocybin therapy for patients with treatment-resistant depression outside of clinical trials!
This decision, made under a compassionate use framework, marks a significant step forward in the responsible integration of psychedelic-assisted therapies into mainstream medicine.
Addressing Unmet Needs in Depression Treatment
Depression remains one of the most prevalent mental health conditions in Germany and worldwide. While many patients benefit from existing treatments, many individuals with major depressive disorder do not respond adequately to standard antidepressant therapies and are classified as having treatment-resistant depression. For these patients, the lack of effective options can be devastating, underscoring the urgent need for innovative approaches.
Multiple clinical studies have demonstrated psilocybin’s promise in alleviating symptoms of treatment-resistant depression, with some patients experiencing rapid and sustained improvements. Until now, access to psilocybin therapy in Europe has been limited to clinical trials or, in rare cases, special authorizations in countries like Switzerland.
Germany’s Compassionate Use Program: Structure and Safeguard
The new program, approved by the Federal Institute for Drugs and Medical Devices (BfArM), allows psilocybin therapy to be administered at two specialized centers: the Central Institute for Mental Health (CIMH) in Mannheim and the OVID Clinic Berlin. Both institutions are recognized leaders in the field of psychedelic-assisted psychotherapy, with experienced teams led by Prof. Dr. Gerhard Gründer and Dr. Andrea Jungaberle, respectively.
Key Features of the Program
- Strict Eligibility Criteria: The program is exclusively for adult patients who have not responded to at least two standard antidepressants at adequate doses and durations. Patients must also demonstrate that participation in a clinical trial is not possible.
- Medically Supervised Setting: Psilocybin therapy is delivered in a highly structured environment, with intensive preparation, administration, and aftercare. Each dosing session is monitored by two trained healthcare professionals, including at least one physician, to ensure patient safety.
- Repeat Dosing and Flexibility: The protocol allows for repeat dosing in cases of non-response or to maintain therapeutic effects, providing a degree of flexibility not always seen in clinical trials.
- Insurance Coverage and Accessibility: Psilocybin is provided free of charge by Filament Health, a Canadian company specializing in natural psychedelic medicines. The overall treatment is integrated into psychiatric care and is expected to be covered by German health insurance, reducing financial barriers for patients.
- Data Collection and Research: The program emphasizes rigorous data collection, including psychometric assessments and, at CIMH, neuroimaging studies. This real-world evidence will complement ongoing clinical trials and inform future policy and practice.
A Patient-Centered, Decentralized Approach
One of the most innovative aspects of Germany’s program is its decentralized decision-making process. Unlike similar schemes in Switzerland and Canada, where each patient requires regulatory approval, Germany empowers licensed psychiatrists at the participating sites to determine eligibility. This streamlines access and reduces bureaucratic delays, while maintaining high medical and ethical standards.
Stakeholders and Collaborative Efforts
The program is the result of collaboration among several key stakeholders:
- Federal Institute for Drugs and Medical Devices (BfArM): The national regulator overseeing the program’s compliance and safety.
- CIMH Mannheim and OVID Clinic Berlin: The two authorized treatment centers, both with deep expertise in psychedelic therapies.
- Filament Health: The supplier of the naturally derived psilocybin drug candidate (PEX010), supporting the program’s rollout.
- MIND Foundation: Affiliated with the OVID Clinic, the MIND Foundation promotes responsible psychedelic integration and provides training for therapists through its Augmented Psychotherapy Training (APT) program.
Europe and the Global Context: How Does Germany Compare?
Germany’s decision places it at the forefront of psychedelic medicine in Europe. While Switzerland has allowed compassionate use of psychedelics since 2014, its system requires case-by-case regulatory approval, which can be slow and administratively burdensome. In 2024, Swiss authorities granted 322 psilocybin authorizations, but demand continues to outpace supply.
Canada’s Special Access Program also permits exceptional use of psilocybin, but approval rates have declined, and patients often face significant costs and logistical hurdles. Australia and New Zealand have established pre-approval pathways, but patient numbers remain small and access is limited.
Germany’s approach stands out for its streamlined access, integration into standard psychiatric care, and commitment to generating real-world data. By covering treatment costs through health insurance and providing the drug free of charge, Germany is setting a new standard for accessibility and patient-centered care.
Challenges and Future Directions
Despite its promise, the program faces challenges. For example, capacity is limited: No more than 100 patients are expected to be treated in the first year. However, the framework allows for future expansion if resources permit. Demand is anticipated to far exceed supply, reflecting the urgent need for new depression treatments.
Full regulatory approval for psilocybin in Germany and the EU is still several years away. However, the compassionate use program is expected to provide valuable real-world evidence to support future policy decisions and the broader integration of psychedelic therapies into mental health care.
By fostering collaboration among clinicians, researchers, regulators, and patient advocates, Germany is not only expanding access for those in urgent need but also contributing to the global evidence base for psychedelic medicine. As the field continues to evolve, Germany’s experience will offer valuable lessons for other countries seeking to balance innovation, safety, and accessibility in the treatment of mental health conditions.
Author: Gustaf Palm
