Implementing psychedelic-assisted therapy: History and characteristics of the Swiss limited medical use program

Psychoactive compounds such as psilocybin, lysergic acid diethylamide (LSD) and 3,4-methylenedioxymethamphetamine (MDMA) are being evaluated as medical treatments for psychiatric disorders, with psilocybin, LSD and MDMA in Phase III trials for major depressive disorder, generalized anxiety disorder and post-traumatic stress disorder respectively. Market approvals remain uncertain in Europe and are not expected broadly before 2028 in the United States; in the meantime, several countries have created special access or limited use schemes to allow clinical use of these agents outside formal marketing approvals. This paper describes the history, legal framework, provider characteristics, activity and early outcome reporting of the Swiss limited medical use programme for psychedelic-assisted therapy (PAT), which began in 2014 and expanded to include psilocybin in 2021. The authors aim to characterise how the Swiss programme operates, who provides PAT, what indications are treated and what early outcome and safety data are available, and to compare key features of the Swiss scheme with recent programs in Canada and Australia. The intent is to inform clinicians, regulators and other stakeholders considering similar restricted access programmes.

Liechti and colleagues present a descriptive, programme-level report based on regulatory and professional registries and on a voluntary outcome registry. The principal data sources were the Federal Office of Public Health (FOPH) registry, which records authorizations for limited medical use (mandatory), and an outcome/quality-assessment registry maintained by University Hospital Basel (UHB) in collaboration with the Swiss interest group IG-PAT (voluntary). The authors report programme activity from its start in 2014 through 2024, with particular emphasis on counts of authorised physicians, authorised patients and substance use in 2024. Where available, the paper summarises information submitted with FOPH authorisations (patient demographics, diagnosis, pharmacy source, financing) and the content of the UHB outcome questionnaires (session format, concomitant medications, doses used, acute subjective effects, Clinical Global Impression ratings and adverse events). Training and professional-society activities were described from society records and programme documentation. The authors note that outcome data were incomplete because contribution to the UHB registry is voluntary and the regulator’s registry does not provide outcome data to professionals; where sample sizes for outcomes are reported, these are explicitly small.

Programme scale and activity: By 2024 the FOPH had issued 723 individual treatment authorizations for PAT: 245 for MDMA, 130 for LSD and 348 for psilocybin. Approximately 100 physicians held authorisations in 2024, and there were an estimated 1,660 psychedelic/MDMA-assisted treatment sessions that year. Patients were typically treated 2–4 times with the authorised substance within a 12-month authorisation period. Provider and setting: Around 80 private practices and 15 institutional providers (including four university hospitals) offered PAT in 2024. Most providers were psychiatrists, but other medical specialities also participated. The median number of patients treated per physician was two (mean = 7, range 1–72). Treatments were delivered either as outpatient single-patient sessions or as group sessions, with preparatory and integration visits varying by setting. Legally, the term PAT in Switzerland refers to the use of the controlled substance to treat a medical condition and does not mandate a specific form of psychotherapy. Regulatory and training requirements: Authorisations are issued per patient, per substance, for 12 months and require written informed consent, documentation of the patient’s clinical situation and, for physicians’ first applications, evidence of education and continuous training, professional society membership and clinical exchange with experienced providers. Serious adverse events must be reported to the FOPH within seven working days. Costs and financing: A full day of PAT was estimated to cost CHF 3,000–4,000; however, patients were typically charged CHF 800–2,000 per day. Substance costs ranged from CHF 100–450. Mandatory health insurance generally does not reimburse the substance or supervision on treatment days; some preparatory and follow-up visits may be covered. Funding sources included out-of-pocket payment, foundations or social assistance; some clinics subsidised care. Professional societies and education: Several Swiss societies support formation, supervision and quality efforts (SÄPT, SSMP, ASPT, Alaya Foundation) and collaborate within IG-PAT. Training offerings range from short courses to a SÄPT three-year programme (24 professionals per intake). The FOPH recognises society-organised training as part of authorisation requirements, though training standards are not uniformly regulated. Registries and available outcome data: The mandatory FOPH registry captures authorisations and basic patient demographics and diagnoses; UHB’s voluntary outcome registry collects additional clinical details. For the present report only a limited set of outcome feedback reports were available (LSD n = 22, MDMA n = 59, psilocybin n = 21). Median doses reported were 150 μg for LSD (range 100–200 μg), 125 mg for MDMA (range 75–200 mg), and 25 mg for psilocybin (range 10–40 mg). Group therapy was more common than individual therapy in the available sample. The median number of substance sessions per patient was three (range 1–6) within 12 months. Clinical effects and harms (from limited sample): Therapists’ median rating of any acute drug effect was 8 on a 0–10 scale, with ‘good’ effects rated median 6–8 and ‘bad’ effects 3–5.5. Median baseline Clinical Global Impression (CGI) severity was 6/7, indicating high disorder severity; median CGI global improvement ratings at treatment end were 1–2 (consistent with much improvement), and median CGI therapeutic efficacy was rated 2 on a 1–4 scale (clear improvement). Reported adverse effects included headache, nausea, palpitations, sleep disturbances, anxiety, psychological destabilisation and flashbacks; suicidal thoughts were uncommon and no suicidality was reported in the available feedback.

Liechti and colleagues interpret the Swiss limited medical use programme as a pragmatic, bottom-up implementation developed over more than a decade, facilitated by a legal framework that has allowed exceptional medical use of controlled substances since 1951. The programme evolved in parallel with clinical research in Switzerland, which provided supply chains and pharmacological data that informed early dosing and safety practices. Growth has been gradual: by 2024 the programme comprised roughly 100 authorised physicians treating under 1,000 patients annually. The authors contrast the Swiss model with Canadian and Australian special access systems. Notable differences include Switzerland’s allowance of LSD use, broader indication scope (not limited to specific diagnoses), and less restrictive provider requirements—medical doctors outside psychiatry may prescribe and physicians may treat without a required two-person dyad or prior ethics approval. Canada and Australia, in contrast, have narrower indication and prescriber restrictions. The Swiss model therefore appears more permissive in several respects. Several limitations and uncertainties are acknowledged. Outcome data are incomplete: although the FOPH registry is mandatory for authorisations, it does not currently make outcome data accessible to professionals, and participation in the UHB outcome registry is voluntary. Consequently, the therapeutic outcomes and safety profile reported here derive from a small subset of patients. The authors also recognise that the programme’s relative permissiveness carries the risk that PAT could be applied to indications that later prove ineffective when higher-quality evidence becomes available. In terms of implications, the authors view limited access programmes as useful interim mechanisms until licensed products and formal market approvals become widely available, estimated not earlier than 2028. Such schemes can support clinician training, early clinical experience and potentially lower-cost access compared with future licensed products. The paper argues for the value of comprehensive, standardised outcome collection across patients and countries to improve oversight, quality assurance and knowledge generation. At a policy level, the authors note opportunities such as regulatory sandboxes in forthcoming European pharmaceutical legislation as possible ways to pilot harmonised approaches, while recognising existing fragmentation of early access arrangements across EU member states.

The Swiss limited medical use programme for psychedelic-assisted therapy is presented as a longstanding, pragmatic model that expanded from 2014 and now allows MDMA, LSD and psilocybin to be used under individual authorisations. The authors conclude that the programme’s bottom-up development, its integration with research infrastructure and its professional-society networks offer practical lessons for stakeholders designing restricted access pathways elsewhere. They emphasise the need for comprehensive and standardised outcome registries to monitor effectiveness and safety, and caution that continued programme evaluation is required to ensure appropriate indication use as more robust evidence and marketed products emerge.