Psilocybin Approved as of January 1. What Does This Mean in Practice?

Why the State Allows Psilocybin Therapy

The prevalence of mental disorders in the Czech Republic is increasing; between 2010 and 2021, it rose by 22%. Depression is among the most common causes of work incapacity, and in a significant proportion of patients, standard treatments fail or are poorly tolerated.

In patients with treatment-resistant depression or severe depression in the context of oncological or other incurable diseases, clinical data accumulated over recent years have shown that psilocybin can provide rapid relief where other approaches have failed.

Previous legislation allowed these effects to be studied but not applied in practice, creating a difficult-to-justify discrepancy between the legal framework and scientific evidence. The new legal regulation seeks to correct this discrepancy and enable strictly regulated, professionally supervised use in a narrow group of patients, with the aim of reducing suffering, decreasing long-term disability, and limiting the chronic burden that severe depression places not only on individuals but also on the healthcare and social systems.

What Changes as of 2026

Psilocybin remains classified in legislation as an addictive and psychotropic substance. There is no general legalization or unrestricted therapeutic use. What is newly permitted is the prescription and administration of an individually prepared medicinal product containing psilocybin exclusively for therapeutic purposes, under conditions defined by law.

Who May Indicate and Administer Psilocybin

Psilocybin may be prescribed and administered only by a physician with specialist certification in psychiatry, or with additional specialized certification in medical psychotherapy.

Administration is permitted:

• in psychiatric hospitals and institutions directly administered by the Ministry of Health,
• at psychiatric outpatient, day-care, or inpatient departments that are part of hospitals under the direct authority of the Ministry of Health.

The process includes:

• prescription on a special controlled prescription form (blue stripe),
• maintenance of detailed medical documentation,
• special post-administration supervision performed by the physician who administered psilocybin.

If three consecutive administrations do not lead to demonstrable clinical improvement, further treatment is contraindicated.

Psilocybin as Part of Assisted Psychotherapy

The core principle of the entire concept is that psilocybin is not approved as a standalone pharmacological intervention, but exclusively as part of psilocybin-assisted psychotherapy.

The therapeutic process has three phases:

1. Preparation –⁠ patient education, work with expectations, and establishment of a therapeutic relationship.
2. The session itself –⁠ administration of the substance in a safe environment in the presence of a trained team.
3. Integration –⁠ subsequent work with the experience and its incorporation into ongoing psychotherapy.

Repeated psilocybin sessions are prescribed according to the patient’s clinical condition when the therapeutic effect begins to wane.

Indications

Therapeutic use of psilocybin is reserved for patients with treatment-resistant depressive disorder and depressive states associated with existential distress in oncology patients and those in palliative care. It is considered only when standard approaches have failed. Indication is always subject to careful clinical assessment and exclusion of contraindications, such as psychotic disorders and the risk of psychological decompensation.

How It Differs from Conventional Antidepressants

Unlike SSRIs, the effect of psilocybin is based on an acute change in the functional organization of brain networks. Agonism at 5-HT_2A receptors leads to a temporary disruption of rigid patterns of brain activity typically described in depressive disorders. This state is often compared to a “reset” of pathologically fixed neural circuits, particularly within the default mode network, which is associated with rumination and rigid self-referential processing.

While conventional antidepressants aim for gradual mood normalization through long-term administration, psilocybin induces a short-term but intense neurobiological and psychological change, followed by a longer-lasting clinical effect driven by increased neuroplasticity and therapeutic processing of the experience. This may allow patients to step outside entrenched cognitive and emotional patterns.

The main advantage is the rapid onset of effect and the absence of a need for chronic medication. A limitation is that the effect cannot be separated from the individual psychological response of the patient.

What Physicians Outside Specialized Centers Should Know

Most physicians will encounter psilocybin primarily through patient inquiries. In this situation, it is important to:

• clearly explain that this is a regulated medical procedure,
• highlight the difference between therapeutic use and self-medication,
• maintain professional neutrality without implicit recommendation.

Knowledge of the basic framework allows the physician to respond in an informed manner and, if appropriate, guide the patient correctly without exceeding their professional competencies.

Conclusion

The favorable safety profile of psilocybin, with low somatic toxicity and minimal risk of addiction when used under professional supervision, is another reason for its inclusion among therapeutic options in psychiatric care. Its introduction represents a test of the healthcare system’s ability to work with innovative approaches in a safe and transparent manner.

Editorial Team, Medscope.pro

Sources:

1. Explanatory memorandum: Draft government regulation on the conditions for prescribing, dispensing, and using individually prepared medicinal products containing psilocybin for therapeutic use (No. 2025-0225-002-TVO). Available at: www.odok.gov.cz/portal/veklep/material/KORNDLNJR6SC/

2. Recommended guideline of the PS-ČNPS for psilocybin-assisted psychotherapy for therapeutic use. Bulletin No. 21/2025. Ministry of Health of the Czech Republic.

3. Psychiatric Society of the Czech Medical Association J. E. Purkyně. Section of Psychedelic-Assisted Therapy. Available at: www.psychiatrie.cz/sekce/sekce-psychedeliky-asistovana-terapie