Germany compassionate-use psilocybin programme

Domain VII · Transpersonal, psychedelic & altered states · Gerhard Gründer · 2025 · Mannheim, Germany

What it is

This is a regulated access programme, not a therapy model. The Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) accepted a compassionate-use notification filed by Prof. Gerhard Gründer (ZI). Adults with treatment-resistant depression (TRD) can then receive an unlicensed botanical…

Format

• Costs: the drug itself must be supplied free of charge (§ 21 Abs. 2 Nr. 3 AMG). The treatment around it, meaning screening, the monitored session day and therapy, is not covered by that rule. No tariff or reimbursement decision has been published. The reports differ by date and site:

Who practises it, and how they are trained or regulated

• Staffing and training: the rule of two trained healthcare professionals per session, including a physician, appears only in secondary sources, which cite no source for it. The ZI/DGPFT press release, OVID's press release and OVID's programme page do not mention it. Treat it as reported, not as a published programme rule. A November 2025 report on the OVID site says eligibility is first checked over several…
• Version followed: the German psilocybin compassionate-use programme (Härtefallprogramm) for treatment-resistant depression, run by the Zentralinstitut für Seelische Gesundheit (ZI / CIMH), Mannheim, and the OVID Clinic day clinic, Berlin. The ZI says treatment has been possible since 11 July 2025; the public announcement was on 31 July 2025. The legal frame is § 21 Abs. 2 AMG and the…
• This is a regulated access programme, not a therapy model. The Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) accepted a compassionate-use notification filed by Prof. Gerhard Gründer (ZI). Adults with treatment-resistant depression (TRD) can then receive an unlicensed botanical psilocybin product, PEX010, supplied free by Filament Health. Patients are treated individually, in justified exceptional…

Questions to explore with your client

• What drew you to it, and what are you hoping it will change?
• Is there physical contact? Was it explained beforehand, and do you feel free to say no or stop at any point?
• Does it involve any substance, plant preparation, remedy or supplement? Has your doctor or prescriber been told, especially about any medication you take?
• Does it involve fasting, a special diet or 'detox'? Have you discussed this with your doctor?
• Is it a group, retreat or community? How do they respond if someone wants to leave or raises a concern?
• Who runs it, and what training or registration do they hold?
• What actually happens in a session or meeting, and how often?
• What does it cost, and is there pressure to commit to more?
• How do you feel afterwards, in the hours and days that follow?
• Does it fit with, or clash with, the work we do here?

What practitioners of it watch for

• any deterioration, and new perceptual symptoms. Working when: you have a clear, shared picture of change over time.
• clients minimising symptoms to stay in the programme. Working when: the event is reported, assessed and followed up.
• waiting passively for the effect to return, or chasing a repeat. Working when: the client keeps practising the new behaviours.
• the client stopping current treatment while waiting, and despair if rejected. Working when: the client keeps engaging with current care.
• consent driven by desperation or by pressure from family. Working when: the client can explain the risks and alternatives in their own words.

When to involve someone else

• New or worsening physical symptoms, or advice to stop or change prescribed medication: involve the client's doctor or prescriber.
• Signs of coercion, isolation from family and friends, escalating costs or secrecy: discuss openly and consider safeguarding.
• A crisis or thoughts of suicide: follow your crisis protocol. In the US, call or text 988; in the UK and Ireland, Samaritans on 116 123.

Drawn automatically from the guide's own sections. Stay curious: neither endorse nor dismiss what the client values, and check anything that matters against the full guide and its sources. Not medical advice.