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Psyche Insights Weekly · Issue #2

Psilocybin stays in Schedule 1, Germany's compassionate use programme gets numbers, and a 5-MeO-DMT spray lands in JAMA

· Published by Psyche Vibes Ltd, London

Independent, evidence-first news on psychedelic-assisted therapy research, regulation and business, with the UK and Europe first. This is information, not medical advice. We do not promote using any controlled substance outside lawful clinical settings.

This week the UK government closed the door on an early psilocybin review, and a report from this month's TAIP conference in Tallinn gave us the clearest picture yet of how Europe's legal access routes are working in practice. Every claim below links to its source, and our live approval tracker is updated.

🇬🇧 UK: no early review of psilocybin

  • The Home Office says no to an ACMD review before a licence. Sir Julian Lewis asked the Home Secretary to commission the Advisory Council on the Misuse of Drugs to review the evidence behind psilocybin's Schedule 1 status. In a written answer on 27 October, the Home Office said psilocybin remains in Schedule 1, noted that no psilocybin medicine has yet been granted an MHRA marketing authorisation, and said "the Government has no current plans to commission the ACMD to assess the scheduling of psilocybin in advance of marketing authorisation" (UK Parliament written answer 37245). It added that reconsidering the scheduling "would ordinarily follow" an MHRA assessment, so any change comes after a licence, not before. We have updated our UK legal guide.
  • The NHS is building delivery capacity anyway. At the TAIP conference in Tallinn (8–9 October), Imperial's David Erritzoe presented CIM-KeT, a model of ketamine-assisted psychotherapy adapted for the NHS. Around it sits CIPPRes: a research centre at Hammersmith Hospital, a clinic at St Charles Hospital (Central and North West London NHS Foundation Trust), an NHS consortium spanning 17 trusts, and a conference in Oxford in March 2027. The stated aim is to prepare public services for possible future psychedelic therapies (Psychedelic Alpha, 23 Oct).

🇪🇺 Europe: the legal routes, in numbers

  • Germany: first numbers from the compassionate use programme. Germany's psilocybin compassionate use programme for treatment-resistant depression was approved on 11 July 2025 and runs at ZI Mannheim and OVID Clinic Berlin. At TAIP, Prof. Gerhard Gründer said the first patient was treated in Berlin on 1 April 2026, and that both sites expect to have treated around 20 patients each by the end of the year. The psilocybin is supplied free of charge, but statutory insurance does not pay for the dosing day, which is one reason Mannheim hopes to try a group model from early 2027. The programme was extended for a year in June 2026 (Psychedelic Alpha; BfArM list, current period 18 June 2026 to 17 June 2027).
  • Don't expect EU approvals soon. Gründer argued that German health technology assessment will want at least one trial against standard care before recognising added benefit, and predicted: "We won't have [licensed] psychedelics over the next couple of years, in Europe" (Psychedelic Alpha). ZI Mannheim's own estimate is approval in Germany within three to five years if current Phase 3 trials succeed (ZI Mannheim).
  • Switzerland: 775 patients in 2025. Under its limited medical use programme, around 100 physicians treated 775 patients across 15 sites last year: 410 with psilocybin, 231 with MDMA and 134 with LSD, mostly for depression and PTSD (Psychedelic Alpha).
  • Norway widens ketamine access. In August, Norway became the second country after France (March) to approve ketamine for acute suicidal crisis across diagnoses, following a favourable health technology assessment. Implementation protocols are still being written (same source).
  • New guide: our explainer on Germany's programme, in English and German, covers the law, who qualifies and the trials with German sites.

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Psyche Insights is an independent publication by Psyche Vibes Ltd, 71-75 Shelton Street, Covent Garden, London WC2H 9JQ. Nothing here is medical, legal or investment advice. If you're struggling, speak to your GP or call Samaritans on 116 123 (UK). Sponsorships are always labelled. Spotted an error? Email [email protected] and we'll correct it publicly.