Germany allows individual-patient psilocybin therapy for severe treatment-resistant depression via the §13 Medicines Act compassionate-use pathway — and the CIMH is Europe's center of gravity.
Section 13 of Germany's Arzneimittelgesetz (Medicines Act, AMG) allows a licensed physician to prescribe an unapproved medicinal product to a specific, named patient when no authorised alternative treatment exists. This individual-patient pathway — often called "Einzelheilversuch" or compassionate use — does not require the drug to hold marketing authorisation in Germany or the EU.
For controlled substances like psilocybin, §13 AMG works alongside the Betäubungsmittelgesetz (BtMG), Germany's narcotics law. A physician who wants to prescribe a Schedule I narcotic must also obtain a separate exemption from BfArM, the Federal Institute for Drugs and Medical Devices. Without that exemption, even a well-intentioned §13 AMG prescription would violate narcotics law.
This is the legal structure Germany used to create Europe's first psilocybin compassionate use programme. BfArM granted a programme-level authorisation in July 2025, removing the need for each physician to file an individual BtMG exemption request for every patient.
On July 11, 2025, BfArM approved the first formal psilocybin Compassionate Use Programme (CUP) in the European Union. The approval names two sites as authorised treatment locations: the Central Institute of Mental Health (CIMH) in Mannheim and the OVID Clinic in Berlin.
The approval covers adults with treatment-resistant depression. It specifies Filament Health's botanical psilocybin product PEX010 as the approved substance, at a standard dose of 25 mg per session. Physicians at the two named clinics can now make treatment decisions for individual patients without submitting a separate BtMG exemption application for each person — a significant step down from the prior ad hoc process.
The programme was the direct result of CIMH's years of clinical research, including the EPIsoDE phase 2b trial, and advocacy by the MIND Foundation and OVID's clinical team. The Lancet Psychiatry published a framework paper in 2025 outlining the rationale for compassionate use pending formal approval.
Eligible patients must be adults with a confirmed diagnosis of treatment-resistant depression who have failed at least two adequate antidepressant courses — meaning sufficient dose and duration for each. Patients must also show that joining an active clinical trial is not a realistic option.
There is no self-referral route. A patient's psychiatrist or GP must initiate the process by contacting one of the two authorised clinics directly. CIMH handles public and statutory-insurance patients; OVID Clinic Berlin operates as a private day clinic and accepts patients with private insurance or those who can demonstrate private-pay capacity.
The programme is small by design. The clinical teams at both sites estimated no more than 50 patients would be admitted in the first year, reflecting staff capacity for the required two-clinician supervision protocol. Patients on waiting lists for clinical trials should ask their treating physician whether compassionate use is the faster route for their situation.
The Central Institute of Mental Health (Zentralinstitut für Seelische Gesundheit, ZI or CIMH) in Mannheim is the academic engine behind Germany's psilocybin programme. CIMH is a public research hospital affiliated with Heidelberg University and one of Germany's leading psychiatric research centers.
Between June 2021 and February 2024, CIMH and Charité — Universitätsmedizin Berlin co-ran the EPIsoDE trial: a phase 2b, triple-blind, active-placebo-controlled study of psilocybin in 144 adults with treatment-resistant depression. Principal investigator was Lea J. Mertens, with Prof. Gerhard Gründer overseeing the CIMH programme. Results were published in JAMA Psychiatry in March 2026.
The trial found that 17% of patients on a single 25 mg psilocybin dose responded (versus 10.6% on active placebo) — a numerically higher response that did not reach statistical significance. The authors noted that expectancy effects in open-label psychedelic trials make blinding difficult and may have compressed the treatment-placebo gap. A 12-month follow-up study, also published by the ZI Mannheim team, showed durable antidepressant signal for patients who did respond.
Patients who are accepted into the programme receive psilocybin in a structured day-clinic or inpatient setting, not at home. A standard dosing session uses 25 mg of PEX010, Filament Health's botanical psilocybin product, which is supplied free of charge to approved sites.
Every session requires at least two trained clinicians present, including one physician. Sessions are embedded in a broader psychiatric care protocol that includes preparation visits before the dosing day and integration support afterward. The psychotherapy component is individualized — there is no single mandated therapy model, but clinics follow a preparation-dosing-integration framework consistent with the EPIsoDE trial protocol.
At CIMH Mannheim, treatment falls under normal inpatient cost-sharing rules for statutory insurance (gesetzliche Krankenversicherung, GKV). At OVID Clinic Berlin, treatment is billed as a day-clinic stay, which private insurance typically covers. In both cases, the psilocybin molecule itself is not the billed item — it is provided free by the manufacturer, so there is no psilocybin line item on a German insurance claim.
Germany and Switzerland are the two European countries with the most developed pathways for clinical psilocybin access, but they work very differently. The table below compares the key features of each programme.
| Feature | Germany (§13 AMG / BfArM CUP) | Switzerland (Art. 8 Heilmittelgesetz / FOPH) |
|---|---|---|
| Legal basis | §13 Arzneimittelgesetz + BfArM Compassionate Use Programme | Article 8 of the Swiss Heilmittelgesetz (Medicines Act) |
| Per-patient federal approval | No — approved clinics make the call; no individual BtMG application per patient | Yes — FOPH must approve each individual patient application |
| Programme start | July 2025 (formal CUP); earlier individual-use under §13 AMG possible but rare | 2014 (LSD and psilocybin); expanded over time |
| Authorized sites | 2 (CIMH Mannheim, OVID Clinic Berlin) | ~100 authorized physicians across multiple cantons (as of 2024) |
| Substances covered | Psilocybin only (PEX010) | Psilocybin, MDMA, LSD — 348 psilocybin patients in 2024 |
| Condition scope | Treatment-resistant depression only | Wider — TRD, PTSD, end-of-life distress, addiction and others |
| Cost to patient | Medication free; treatment billed via insurance (GKV or private) | Varies by canton and insurance; often out-of-pocket for therapy component |
| Verdict | Faster to access for eligible TRD patients; fewer sites | More conditions covered; more sites; longer track record |
When Germany fits better: if you are a German resident with treatment-resistant depression, statutory health insurance, and no access to a clinical trial. The medication is free and inpatient billing reduces out-of-pocket cost compared to private Swiss programmes. When Switzerland fits better: if your condition is PTSD, end-of-life anxiety, or an addiction — or if you want more geographic choice and a longer-established system with more physicians. See our Switzerland psychedelic compassionate use guide for a full breakdown.
Psilocybin is listed in Anlage I of the Betäubungsmittelgesetz (BtMG), Germany's narcotics law. Anlage I substances are "non-trafficable" — meaning possession, purchase, sale, and import are prohibited without explicit federal authorisation. This is the strictest scheduling tier in German law, equivalent to Schedule I in many other systems.
Outside the compassionate use programme, no personal-use exemption exists. Germany's 2024 cannabis reform (CanG) did not extend to psychedelics. Possession of any amount of psilocybin by a person not enrolled in an approved clinical or compassionate-use programme remains a criminal offence under BtMG §29.
The compassionate use programme works because BfArM can grant an Anlage-I exemption to a specific institution for a specific therapeutic application. This is the same mechanism that allows Schedule I drugs to be used in clinical trials in Germany. The exemption covers the two named clinics; it does not extend to patients or any other facility.
Germany's programme is still in its first year, and its immediate ceiling is the two-site capacity limit of roughly 50 patients annually. The most likely expansion path is adding authorized sites — any licensed psychiatric facility could, in principle, apply to BfArM for inclusion in the existing CUP framework, rather than requiring a new programme approval from scratch.
Formal EU-wide approval of psilocybin as a medicine would remove the need for the §13 AMG pathway entirely. The European Medicines Agency (EMA) has not received a marketing authorisation application for psilocybin as of mid-2026; that step depends on phase 3 trial data, which no company has yet filed with EMA. Germany's programme bridges the gap while that data matures.
The EPIsoDE trial's mixed results — not statistically significant but numerically positive — mean Germany's psychiatric community is watching future phase 3 data carefully before advocating for a wider rollout. For live tracking of legislative moves across Europe and the US, see our psychedelic legalization tracker.
Psilocybin remains a Schedule I narcotic under Germany's Betäubungsmittelgesetz (BtMG), making recreational possession and use illegal. However, since July 2025, adults with treatment-resistant depression can access psilocybin through an official compassionate use programme approved by BfArM at two authorized clinics — the CIMH in Mannheim and the OVID Clinic in Berlin.
Section 13 of the German Medicines Act (Arzneimittelgesetz, AMG) allows a physician to prescribe an unapproved medicine to a named patient when no licensed alternative exists. For psilocybin, the physician must also obtain a BfArM exemption from the BtMG narcotics controls. The July 2025 compassionate use programme approval by BfArM streamlined this process for authorized clinics, removing the need for individual patient-by-patient federal applications.
Adult patients qualify if they have treatment-resistant depression — meaning they have failed at least two adequate courses of standard antidepressants — and if participation in an ongoing clinical trial is not possible. Patients must be assessed and treated at one of the two authorized sites: CIMH Mannheim or OVID Clinic Berlin.
The Central Institute of Mental Health (Zentralinstitut für Seelische Gesundheit, CIMH or ZI) in Mannheim is a public psychiatric research center affiliated with Heidelberg University. Between 2021 and 2024 it co-led the EPIsoDE phase 2b randomised trial — 144 adults with treatment-resistant depression — published in JAMA Psychiatry in March 2026. Principal investigator was Lea J. Mertens; the programme director is Prof. Gerhard Gründer.
Switzerland's Article 8 exceptional-use pathway requires the federal health authority (FOPH) to approve each individual patient application. Germany's compassionate use programme lets authorised psychiatrists at approved clinics decide whether a patient qualifies — no individual federal sign-off is needed per patient. Switzerland has had a running pathway since 2014 and had 348 psilocybin patients authorised in 2024 alone, covering more conditions including PTSD and end-of-life distress.
Psilocybin medication is supplied free of charge by Filament Health under the programme. At CIMH Mannheim (a public hospital), inpatient treatment falls under standard statutory insurance copay rules. At OVID Clinic Berlin (a private day clinic), costs are typically covered by private insurance as a day-clinic stay. Patients without private insurance should confirm coverage with CIMH before starting.
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