Germany compassionate-use psilocybin programme

1. Introduction

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 Arzneimittel-Härtefall-Verordnung (AMHV, 14 July 2010, amended 2022). Where the frame of the session itself is thinly published, this guide uses the EPIsoDE trial (ZI/Charité, 2021–2024) as the published reference model and label it as such. Psilocybin's narcotics-law status and the extra BtMG permit the programme needs come from the Federal Government's 2021 answer to the Bundestag. Eligibility, setting, licence holder and one exclusion come from OVID's own programme page and the ZI/OVID press releases. The one-year limit and the re-notification route come from the AMHV text itself (§ 5). The renewed BfArM listing (18.06.2026–17.06.2027) is known second-hand, from Psychedelic Brief's reading of the register on 17.08.2026, supported by PsyAccess [uncertain]. Still [uncertain]: how many patients have been treated, the programme's full exclusion list, the two-person staffing rule (stated only in secondary sources), any training requirement, and cost coverage, for which only reports and interviews exist.

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 cases, inside psychiatric care, with psychotherapeutic preparation and follow-up. [source: ZI news 31.07.2025; PTAheute 02.09.2025; Filament press release 31.07.2025]

The published idea of how change happens is that the psilocybin experience, embedded in psychotherapy, can loosen rigid patterns of thought and open the way to new insights and new behaviour, which reduces depressive symptoms. Integration afterwards is treated as the decisive phase. [source: ZI news 31.07.2025; tipBerlin 2026] Gründer stresses that the programme "cannot replace approval". [source: ZI news 31.07.2025]

Legal and regulatory status (as of the sources' dates)

• Germany: psilocybin is not an authorised medicine. A Härtefallprogramm under § 21 Abs. 2 AMG lets an unlicensed medicine be given free of charge to patients with a serious illness that approved medicines cannot treat satisfactorily. [source: PTAheute 2025] Under the AMHV, the "verantwortliche Person" (the person who initiates, organises and finances the programme) notifies the federal higher authority. The programme may start once the notification has been confirmed complete and no objection has been raised. The authority can object later, which stops the programme. If the authority objects, the programme may not start or continue. A programme ends at the latest one year after the confirmed notification is received (earlier if it is stopped or the medicine becomes available on the market); continuing beyond that needs a fresh notification, which the regulation allows. Suspected serious adverse reactions must be reported electronically within 15 days at most, and a safety report is due after the programme ends. [source: AMHV §§ 3–6, gesetze-im-internet.de] Narcotics law: psilocybin and psilocin are listed in Anlage I BtMG as non-marketable narcotics (nicht verkehrsfähige Betäubungsmittel). The Federal Government has stated that a Härtefallprogramm is possible in principle for such a substance, but that the permit conditions of § 3 Abs. 2 BtMG must also be met. That section lets the BfArM grant an exceptional permit for scientific purposes or other purposes in the public interest. [source: BT-Drs. 19/30322, 04.06.2021] OVID states that the substances fall under the BtMG and are used only in controlled trials or in this programme. It also states that the licence is held by Prof. Gründer, and that Dr. Andrea Jungaberle holds it in Berlin by delegation from him. [source: OVID programme page 2026] Whether the programme holds its own § 3 permit, and what it covers, is not published. [uncertain] Use outside these settings remains illegal. [source: OVID programme page 2026; BT-Drs. 19/30322]
• Timeline and BfArM listing: treatment has been possible since 11.07.2025, so under AMHV § 5 the first term ended at the latest on 11.07.2026, and continuation required a fresh notification. [source: ZI news 31.07.2025; AMHV § 5] On 17.08.2026 the register showed a single current term, 18.06.2026 to 17.06.2027. The notifying party is ZI Mannheim, Department of Molecular Neuroimaging, with Prof. Dr. Gerhard Gründer as the responsible person. It is the only one of the 28 listed programmes not run by a company. The register does not name treatment sites. Gründer told Psychedelic Brief that the programme had been extended by one year. [source: Psychedelic Brief no. 10, 18.08.2026; PsyAccess 02.08.2026 ("current listing runs to 17 June 2027")] The renewed term is reported second-hand; confirm it on the BfArM list of Härtefallprogramme before advising. [uncertain] Patient numbers conflict, and none is official. Filament's July 2025 press release spoke of one patient. OPEN Foundation (2025) said up to 100. Drug Science (05.08.2025) estimated about 50 in year one, citing no source. ZI and OVID publish no number, only that demand will far exceed capacity. [source: DGPFT/ZI press release 31.07.2025; OVID press release 31.07.2025] In a June 2026 interview, the ZI reportedly had about 700 people on its interest list. [source: Psychedelic Alpha 16.06.2026, as summarised by Psychedelic Brief; uncertain] tipBerlin (July 2026) reports that import difficulties delayed the start, that the first OVID patient began in April 2026, and that only a few people had been treated. Treat "a small number treated so far, far more waiting" as the only defensible summary. [uncertain]
• EU: there is no EMA authorisation. Phase III trials are ongoing. [source: Drug Science 2025; Berlin Science Week 2025]
• Other jurisdictions: Drug Science names comparable compassionate or special access routes in Canada, Israel and Switzerland. The status in the US, the UK and other EU states was not verified for this guide. [uncertain]

2. Framework

[source: ZI news 2025; OPEN Foundation 2025; Drug Science 2025; tipBerlin 2026; AMHV; for the trial reference model: ZI EPIsoDE news 2022/2026]

Exclusion criteria: the programme has not published a full list. OVID's page names one firm exclusion: people with psychiatric pre-conditions, especially a tendency to psychosis, should not take psilocybin. [source: OVID programme page 2026] OVID's press release says a comprehensive medical and therapeutic pre-selection is required. [source: OVID press release 31.07.2025] Any further programme exclusions are [uncertain]. The published EPIsoDE trial excluded:

• a family history of psychosis and/or bipolar disorder
• schizophrenia or other psychotic disorders
• borderline personality disorder
• substance use disorder
• serious physical or neurological illness that rules out a psychedelic
• pregnancy or breastfeeding

Treat these as the likely reference set, not as the programme's confirmed list. [source: idw 15.11.2022; inference: synthesis]

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. [source: Drug Science 05.08.2025; OPEN Foundation 2025] 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. [uncertain] A November 2025 report on the OVID site says eligibility is first checked over several conversations and that patients are accompanied throughout by therapists and physicians, without giving numbers. [source: Business Punk, 7 Nov 2025; secondary] What is published: Gründer leads the programme and holds the licence; at OVID, Dr. Andrea Jungaberle holds it by delegation. The teams cite many years of experience from psychedelic research studies, psychotherapy and psychiatry. [source: OVID programme page; ZI/DGPFT press release 2025] No training requirement for programme staff is published. [uncertain] OVID's press release mentions the MIND Foundation's Augmented Psychotherapy Training, whose eighth course began in November 2025, without saying it is required. [source: OVID press release 31.07.2025] EPIsoDE relied on a therapy manual, specific training and regular supervision, with two therapists in the room. [source: ZI 19.03.2026]

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. [source: Psychedelic Brief 18.08.2026] The reports differ by date and site:

• Drug Science (2025) said treatment costs are typically covered by health insurance, citing no source.
• ZI Mannheim: Lea Mertens said in June 2026 that inpatient treatment is covered, with only the standard daily inpatient co-payment, and that approval for outpatient delivery was pending. [source: Psychedelic Alpha interview via Psychedelic Brief; uncertain]
• OVID Berlin: tipBerlin (July 2026) reports that, as a private clinic, OVID can take people with statutory insurance (GKV) only as self-payers, at about €3,000 per week. Privately insured patients generally pay nothing extra. Jungaberle reported a fast-track agreement with Germany's largest private insurer. [source: tipBerlin 29.07.2026; Psychedelic Brief 2026]

No routine statutory-insurance (GKV) reimbursement decision has been published. [source: Psychedelic Brief 18.08.2026] Check the current terms with the site. [uncertain]

3. Guiding principles

[source per line where given; otherwise synthesis]

• Exception, not standard care. Hardship use is for justified individual cases. Practical meaning: refer only after approved treatments have been properly tried, and never present it as a routine option. [source: ZI 2025; AMHV § 2]
• Individual risk-benefit judgement by the site psychiatrist. Practical meaning: your role is to supply good information; you do not decide eligibility. [source: ZI 2025; Drug Science]
• Embedded in psychiatric care. Practical meaning: keep the client's psychiatrist or GP in the loop. Changes to medication are medical decisions only. [source: OPEN Foundation; synthesis]
• Two-person team with a physician present. Practical meaning: the client is never alone with one person during the session, and medical monitoring is the physician's job. [source: OPEN; Drug Science]
• Set and setting. A quiet, pleasant room, music, eye mask, lying down. Practical meaning: preparation explains this frame so that nothing on the day surprises the client. [source: ZI 2026; tipBerlin]
• Inward focus with minimal talk. The experience happens largely in the patient's own inner world, under supervision. Practical meaning: processing in words belongs to integration, not to the session. [source: tipBerlin]
• Intention-setting. Jungaberle frames a good intention as finding out what matters most to the person, so they can shape their life better. Practical meaning: help clients turn "get rid of depression" into a values-based question. [source: tipBerlin, paraphrased]
• Integration is decisive. Practical meaning: plan the integration support before the session, not after it. [source: tipBerlin; ZI 2026]
• Informed, voluntary consent in German. Practical meaning: the client must understand that the drug is unlicensed, the risks, and the alternatives. Consent is taken by the participating physician. [source: AMHV § 3(2)]
• Safety reporting. Suspected serious adverse reactions must be reported without delay, within 15 days at most, by the responsible person. Practical meaning: report any adverse event you observe to the treating site promptly. [source: AMHV § 6]
• Honesty about scarcity and limits. Practical meaning: tell the client plainly about capacity, cost and the chance of not being accepted. [source: ZI 2025; tipBerlin; synthesis]
• The outside therapist supports and never facilitates. Practical meaning: give no substance advice. If a client turns to illegal use, your role is harm reduction and integration. [synthesis]

4. Intervention inventory

Scope: the sites have not published a session-by-session manual for this programme. Items 4.5–4.10 describe the components the programme sources name (preparation, set and setting, the two-person session team, integration, follow-up). Items 4.1–4.4 and 4.11–4.13 describe what an outside psychotherapist does when referring and supporting a client; those steps are mostly [synthesis] built around the published criteria. All example wording is illustrative.

4.1 Pre-referral suitability conversation

• Purpose / when: a client with long-standing depression asks about "the psilocybin programme". Check whether a referral makes sense before raising hopes. [criteria source: ZI 2025; OPEN; Drug Science; steps: synthesis]
• Steps:
  1. Confirm the client is an adult with a diagnosed depressive episode that has persisted despite treatment.
  2. List every antidepressant tried, with duration, adherence and whether the trial was adequate. The published threshold is at least two failed adequate trials.
  3. List the psychotherapies tried, by type and length. Ask about augmentation strategies and other approved treatments already discussed with a psychiatrist.
  4. Ask whether the client has looked into, or been turned down for, a psilocybin trial. Being unable to join a trial is a programme criterion.
  5. Screen for features that trials have used as exclusions: a personal or family history of psychosis or bipolar disorder, borderline personality disorder, substance use disorder, serious physical or neurological illness, pregnancy or breastfeeding. Explain that the site makes the final decision.
  6. Review current suicidality with a standard risk assessment, and the client's support and stability.
• Example language (illustrative): "Before we look at the programme, let's map everything you've tried. The clinic will ask for exactly this, and it tells us whether you're likely to qualify."
• Watch for: idealisation ("this is my last chance"), under-reporting of past psychotic or manic symptoms, and active suicidality that needs addressing now, whatever happens with the programme. Working when: you and the client have a clear, factual picture and realistic expectations.

4.2 Preparing the referral or self-referral

• Purpose / when: the client wants to apply. [source: ZI 2025 for the contact route; synthesis for content]
• Steps:
  1. Explain the route. For ZI, the patient emails the site, includes consent to data storage and full contact details, and gives a brief case summary. For OVID, the patient contacts the clinic, which runs screening conversations, a medical examination and insurer applications.
  2. With written consent, prepare a short clinical summary: diagnosis, course, treatments tried (medicines, durations, response), psychotherapy history, comorbidities, current risk and current prescriber.
  3. Ask the treating psychiatrist or GP for a medication history and medical findings.
  4. Agree who the site should contact, and get a release of information.
• Example language (illustrative): "I'll write a one-page summary of your treatment history. You decide whether to attach it to your email to the clinic."
• Watch for: sending clinical data without explicit consent. Working when: the site can judge eligibility without needing to come back for basic information.

4.3 Expectation and capacity counselling

• Purpose / when: before the client applies, and again if they are declined. [source: ZI 2025 (demand far exceeds capacity; time-limited; not a substitute for approval); tipBerlin 2026 (costs, few treated); synthesis]
• Steps:
  1. Explain that this is an exceptional-case programme with very limited places, and that rejection is likely and not personal.
  2. Explain costs as reported. At ZI, inpatient treatment is reportedly covered apart from the usual daily co-payment. At OVID, GKV patients currently self-pay (about €3,000 per week, per tipBerlin), while privately insured patients generally pay nothing extra. Ask the site for current terms.
  3. Explain that a treatment course at OVID is a six-to-eight-week day-clinic programme with daily psychotherapy, and that ZI treats as an inpatient with outpatient preparation and follow-up.
  4. Agree a parallel plan that continues regular treatment whatever the outcome.
• Example language (illustrative): "Let's apply and keep working on your current plan at the same time. If a place comes up, it'll build on what we're already doing."
• Watch for: the client stopping current treatment while waiting, and despair if rejected. Working when: the client keeps engaging with current care.

4.4 Supporting informed consent

• Purpose / when: the client has been offered a place. Consent itself is taken by the participating physician, after explanation and with patient information in German. [source: AMHV § 3(2)]
• Steps:
  1. Go through the site's patient information with the client and help them list their questions. Do not interpret medical content yourself.
  2. Make sure the client understands four things: the drug is unlicensed; the programme does not mean approval; there are known short-term effects on the day; participation is voluntary and can be withdrawn.
  3. Note the effects that EPIsoDE commonly reported on session days: emotional lability, vivid inner imagery, headache and raised blood pressure, mostly settling within days. Note also its rare serious reactions: a marked blood-pressure rise and a prolonged perceptual disturbance. Suggest the client ask the physician how the site handles these. [source: ZI 19.03.2026]
• Example language (illustrative): "Write down anything you want the doctor to explain. The point is that you say yes knowing what you're agreeing to."
• Watch for: consent driven by desperation or by pressure from family. Working when: the client can explain the risks and alternatives in their own words.

4.5 Preparation sessions: alliance and intention work (programme component)

• Purpose / when: before the substance session, delivered by the site team. Clarify what the person hopes to gain. [source: ZI 2025 (therapeutic preparation); tipBerlin 2026 (intentions); EPIsoDE: preparatory sessions before each session]
• Steps:
  1. Explore the person's hopes, fears and current life situation.
  2. Shape an intention. Jungaberle describes a good one as finding out what matters most, so the person can shape their life better. [paraphrased]
  3. Rehearse attitudes for difficult moments, such as staying with what comes up and using the staff present. [synthesis]
  4. Agree practicalities and the plan for after the session.
• Outside therapist's role [synthesis]: reinforce the intention work in your own sessions without contradicting the site's preparation, and share relevant history with consent.
• Example language (illustrative): "If the depression lifted a little, what would you most want to turn towards in your life?"
• Watch for: intentions that are only about symptoms, and outcome pressure. Working when: the client can name a values-based intention and feels prepared for difficult material.

4.6 Orientation to set and setting (programme component)

• Purpose / when: at preparation, so the client knows the frame of the day. [source: tipBerlin 2026; ZI 19.03.2026]
• Content to explain:
  • a quiet, pleasant room set up for the purpose
  • lying down, eye mask, headphones with a music playlist
  • a full day at the site
  • two trained staff present, at least one a physician
  • talk kept to essentials, so the experience happens largely inside the person, under supervision
  • inpatient stay at ZI, day clinic at OVID
• Example language (illustrative): "On the day you'll mostly be lying with eyeshades and music. Two staff stay with you the whole time, and one of them is a doctor."
• Watch for: worry about losing control, and claustrophobia with the eye mask. Pass these to the site team. Working when: the client can describe the day accurately.

4.7 Session-day conduct by the two-person team (programme component)

• Purpose: safety and non-directive support during the experience. [source: OPEN; Drug Science (two trained professionals including a physician); ZI 2026 (EPIsoDE: two therapists in the room, manual, training, supervision); tipBerlin (minimal talk)]
• What is published:
  • two trained professionals are present throughout, at least one a physician
  • the physician carries medical monitoring and management of acute medical events
  • verbal contact is minimal
  • the patient stays with the inner experience
• Not published in the programme sources: the programme's touch policy and its specific responses to acute distress. [uncertain]
• Outside therapist's role: none during the session. Do not attend unless the site invites you. [synthesis]
• Watch for (site staff): the safety events EPIsoDE reported, such as raised blood pressure and lability. Working when: the session ends with the patient settled and medically cleared.

4.8 Integration sessions (programme component)

• Purpose / when: after the session, to process the experience and connect it with everyday life. tipBerlin calls this the decisive phase. [source: ZI 2025 (outpatient follow-up); ZI 2026 (integration sessions); tipBerlin (daily therapy at OVID in various formats)]
• Steps (programme outline; detail [synthesis]):
  1. Invite an open account of the experience without interpreting too early.
  2. Identify what felt meaningful, including emotions, memories, images and insights.
  3. Link these to the intention and to the person's values.
  4. Translate them into concrete behavioural steps and test them in daily life.
  5. Revisit difficult content and normalise residual emotional lability.
• Example language (illustrative): "Tell me what stayed with you most, in any order." Then: "What would it look like this week to act on that?"
• Watch for: grandiosity, impulsive life decisions, new or persisting perceptual changes, a drop in mood after an initial lift, and suicidality. Working when: the client reports changes in behaviour, not only insight, and symptom scores improve.

4.9 Integration group / community (reference model)

• Purpose: longer-term integration with peers. [source: idw 17.06.2026 (EPIsoDE offered a monthly integration group, which many attended); Berlin Science Week 2025 (a MIND/OVID event on community in integration)]
• Steps [synthesis]: ask the site whether it runs an integration group. If it does not, consider a professionally led group that does not promote substance use.
• Example language (illustrative): "Would it help to hear how others have made sense of similar experiences?"
• Watch for: groups that encourage further use outside medical settings. Working when: the client gains support and perspective without pressure to repeat the experience.

4.10 Outcome and safety monitoring (programme component)

• Purpose: the sites collect psychometric data, and CIMH also does neuroimaging. The responsible person must document serious suspected adverse reactions and report them. [source: OPEN Foundation; AMHV § 6]
• Outside therapist steps [synthesis]:
  1. Use a validated depression measure at baseline, before the session and at regular intervals after it. Choose a licensed or public-domain instrument and do not reproduce its items for clients.
  2. Monitor suicidality at every contact in the first weeks after the session.
  3. With consent, share results with the site.
• Example language (illustrative): "I'd like to track how you're doing with the same short questionnaire every couple of weeks."
• Watch for: any deterioration, and new perceptual symptoms. Working when: you have a clear, shared picture of change over time.

4.11 Adverse-event recognition and reporting pathway

• Purpose / when: the client reports something unusual after treatment. [source: AMHV § 6; ZI 19.03.2026 (types of events in EPIsoDE); steps: synthesis]
• Steps:
  1. Ask about physical symptoms and about the psychological effects reported in EPIsoDE: emotional lability, persisting or recurring perceptual changes, new anxiety, mood crash, sleep disturbance, and suicidal thoughts.
  2. Assess urgency. For emergencies use the usual routes: emergency services or psychiatric crisis care.
  3. Tell the treating site without delay, with consent. The responsible person must report serious suspected reactions within 15 days at most.
  4. Arrange a medical review through the client's physician.
  5. Document what you observed and what you did.
• Example language (illustrative): "This needs the clinic's doctors to hear about it today. Shall we call them together now?"
• Watch for: clients minimising symptoms to stay in the programme. Working when: the event is reported, assessed and followed up.

4.12 Continuing integration in outside psychotherapy

• Purpose / when: after the site's integration phase ends, the client returns to you. [synthesis, building on the programme's integration emphasis]
• Steps:
  1. Ask for the site's discharge summary, with consent.
  2. Revisit the intention and the insights the client brought back, and turn them into goals for your own modality (for example behavioural activation, value-based action or relational work).
  3. Watch whether gains hold up over months. EPIsoDE followed patients up at 6 and 12 months.
  4. Coordinate with the psychiatrist about restarting or changing medication. That is a medical decision.
• Example language (illustrative): "Which of the things you saw in that session do you want us to keep working on here?"
• Watch for: waiting passively for the effect to return, or chasing a repeat. Working when: the client keeps practising the new behaviours.

4.13 Harm reduction for clients outside the programme

• Purpose / when: a client is ineligible or not accepted and mentions retreats, abroad, or illegal use. [synthesis; no programme source]
• Steps:
  1. Stay non-judgemental. State clearly that you cannot help them obtain substances or arrange use.
  2. Explain in general terms why the programme screens so carefully: psychosis and bipolar risk, cardiovascular effects such as raised blood pressure, interactions with psychiatric medication, and the lack of medical staff in unregulated settings.
  3. Advise the client to discuss any medication questions with their physician. Never advise stopping medication.
  4. Make a safety plan, including crisis contacts.
  5. Offer integration support after any experience, whatever its source.
  6. Point to legal routes: trials and the programme's re-opening.
• Example language (illustrative): "I can't help you get it or plan it. I can help you think through the risks, and I'm here afterwards whatever you decide."
• Watch for: active suicidality combined with risky plans. That needs urgent risk management. Working when: the client takes the safety information on board and stays in contact.

5. Handling problems

Most of this section is [synthesis]. Programme sources address only eligibility, capacity, the session frame and AE reporting.

• Rejected or wait-listed client in despair. Normalise it: demand far exceeds capacity [source: ZI 2025]. Do a risk assessment. Revisit approved TRD options with the psychiatrist. Keep therapy goals that do not depend on psilocybin. [synthesis]
• Client stops current treatment while waiting. Name the pattern. Remind the client that eligibility depends on proper approved treatment and that the programme is "not a substitute" for care. Involve the prescriber. [source: ZI 2025; synthesis]
• Cost barrier (GKV patients at OVID). Give accurate information [source: tipBerlin 2026]. Tell the client that ZI inpatient treatment is reportedly covered apart from the daily co-payment [source: Psychedelic Brief 2026, citing a June 2026 interview], and ask both sites about current terms. Do not encourage debt-driven decisions. [synthesis] No official reimbursement decision is published. [uncertain]
• Ambivalence or fear before the session. Explore it in preparation and pass it to the site team. A delay or withdrawal is a legitimate outcome. [synthesis]
• Overwhelm or a difficult experience on the day. This is handled by the two-person team, and medical issues by the physician [source: OPEN; Drug Science]. Afterwards, the outside therapist helps the client tell the story, contain it, and normalise emotional lability, which settled within days in most EPIsoDE patients [source: ZI 2026]. Refer back to the site if distress persists. [synthesis]
• Destabilisation or suicidality after the session. Do a standard suicide risk assessment and safety plan, involve crisis services if needed, and inform the site so it can review and report. Lethal-means counselling covers safe storage and removal only. [synthesis; AMHV § 6 for reporting]
• Persisting perceptual changes. EPIsoDE recorded one prolonged perceptual disturbance [source: ZI 2026]. Refer for medical and psychiatric review via the site, reassure without minimising, and use grounding. [synthesis]
• Non-response or early relapse. Review integration work and maintenance strategies with the client. Further treatment is the site's decision (repeat treatment is reportedly possible without new approval [source: OPEN; Drug Science; uncertain]). Avoid framing it as failure. [synthesis]
• Grandiosity or impulsive life decisions after the session. Suggest a waiting period before major decisions. Screen for hypomania and inform the psychiatrist. [synthesis]
• Rupture with the outside therapist. This can happen if the client feels you are discouraging referral or competing with the site team. Acknowledge it, clarify the roles (you are referrer and continuity, the site delivers treatment), and repair the alliance. [synthesis]
• Role confusion or conflicting messages between therapists. With consent, hold one coordination contact. Agree who leads integration and when the client hands back to you. [synthesis]
• Pressure from family or partner. Assess for voluntary consent and see the client alone. [synthesis; AMHV consent requirement]
• Client moves to illegal or retreat use. Use 4.13 (harm reduction). Never facilitate, and document your advice. [synthesis]
• Confidentiality and data. Share data with the site only with explicit written consent. ZI asks applicants to consent to data storage [source: ZI 2025]. [synthesis]
• Programme closure or non-renewal. An AMHV programme ends at the latest one year after its confirmed notification unless it is notified afresh, and an objection by the authority stops it [source: AMHV §§ 4–5]. The first term ran from 11.07.2025, and the current listing is reported to run to 17.06.2027 [source: ZI news 2025; Psychedelic Brief 2026; PsyAccess 2026; uncertain]. Prepare clients whose treatment would fall after mid-2027 for possible non-renewal, with a plan B. [synthesis]

Sources

Pages consulted:

• Compassionate Use Program for psilocybin possible for the first time in Germany (ZI Mannheim, 31.07.2025)
• Psilocybin-Therapie erstmals in Deutschland möglich (PTAheute, 02.09.2025)
• Arzneimittel-Härtefall-Verordnung (AMHV), full text as amended 6 July 2022 (gesetze-im-internet.de, Federal Ministry of Justice)
• Germany's compassionate psilocybin programme (Drug Science, 05.08.2025)
• OPEN Foundation: Germany's landmark compassionate use program for psilocybin (06.08.2025)
• Filament Health: first-ever compassionate use approval for psilocybin in the EU (31.07.2025)
• tipBerlin: Psilocybin-Therapie gegen Depression (29.07.2026)
• Business Punk: Trip auf Rezept (7 Nov 2025; secondary)
• Berliner Zeitung: Berliner Klinik darf Stoff aus Zauberpilzen einsetzen (10.10.2025)
• Berlin Science Week: Compassionate Use Psilocybin, current and future developments (2025)
• idw: EPIsoDE psilocybin depression study (15.11.2022)
• ZI: Psilocybin combined with psychotherapy shows significant efficacy in TRD (19.03.2026)
• idw: Psilocybin with psychotherapy, antidepressant effects over 12 months (17.06.2026)

Cited by author, year and title: Mertens LJ, Koslowski M, Betzler F, et al. (2026). Efficacy and safety of psilocybin in treatment-resistant major depression: the EPIsoDE randomized clinical trial. JAMA Psychiatry, doi:10.1001/jamapsychiatry.2026.0132. Arzneimittelgesetz (AMG) § 21 Abs. 2, cited via PTAheute and Psychedelic Brief. The BfArM listing details come from Psychedelic Brief's reading of the register on 17.08.2026 [uncertain]. The Psychedelic Alpha interview with Mertens and Jungaberle (16.06.2026) is cited only as summarised by Psychedelic Brief [uncertain].

Further sources:

• Antwort der Bundesregierung: Medizinische Forschung mit Psilocybin und anderen psychedelischen Wirkstoffen in Deutschland, BT-Drs. 19/30322 (04.06.2021)
• OVID Clinics Berlin: Psilocybin-Therapie Berlin (programme page, 2026)
• OVID Clinic Berlin press release: Medizinischer Meilenstein: Psilocybin-Therapie erstmals in Deutschland außerhalb von Studien möglich (press1, 31.07.2025)
• ZI/DGPFT press release: Arzneimittel-Härtefallprogramm für Psilocybin erstmals in Deutschland möglich (31.07.2025, PDF)
• BfArM: Liste der Arzneimittel-Härtefallprogramme (compUse-tabelle)
• Psychedelic Brief, issue 10: A clinician, not a company, runs Germany's psilocybin compassionate use programme (18.08.2026)
• PsyAccess: Psilocybin-Therapie: Was die Evidenz zeigt (updated 02.08.2026)