The word psychedelic itself (from the ancient Greek psychê – mind, soul, + dêlos – to reveal, to show) was coined to express the idea of a substance that reveals hidden aspects of the mind. The modern history of hallucinogens (an umbrella term for substances that produce a psychedelic effect) is associated with Albert Hofmann, who accidentally took LSD in 1943 and recognized its powerful potential to alter human consciousness. This discovery increased interest in other psychedelic substances in the following years.[1]

What psychedelics have in common is that they cause profound changes in consciousness and perception,[2] i.e. acute changes in cognitive, perceptual and emotional functions,[3] which can have a long-term effect on the nature of experience and psychological function.[4] One of the ways psychedelics work in the brain is by increasing suggestibility, which has positive impacts on the therapy in which psychedelics are used.

But what about the legal framework and use of these breakthrough therapies in our country?

Our legal system for prescribing and treating psychedelics is currently very strict. In the case of prescribing medicinal products that contain a narcotic and psychotropic substance, it is necessary that this is prescribed on a prescription with a blue stripe for a specific patient issued in paper form according to the provisions of Section 81f in accordance with the Act on Addictive Substances.[5] The prescription and further handling of medicinal products that contain a narcotic or psychotropic substance, beyond the scope of Act No. 378/2007 Coll., on medicinal products and amendments to certain related acts (the Act on Medicinal Products), is further elaborated by the Act on Addictive Substances. According to Section 5, par. 2, let. c) of the Act on Addictive Substances, a doctor may prescribe, when providing health services, preparations containing addictive substances listed in Annex No. 1, 2, 5, 6 or 7 of the Government Regulation on the List of Addictive Substances and medicinal products containing the specified substance of Category 1. These substances may also be used for therapeutic purposes by doctors and other healthcare professionals in inpatient and outpatient care facilities and in facilities providing residential social services, in accordance with letter d) of the same provision.

The amendment to the Criminal Code is also related to a significant amendment to the Act on Addictive Substances and the Act on Pharmaceuticals for the purposes of this article. This legislative change allows, from January 1, 2026, the administration of medicinal psilocybin individually prepared for defined therapeutic purposes in healthcare facilities. The legislator directly introduced a provision on psilocybin for medicinal use in the new Section 33l of the Act on Addictive Substances, which contains the conditions for the administration of psilocybin. The conditions include the requirement for special supervision by a doctor, specialization of the doctor in the field of psychiatry or special specialized competence in the additional field of medical psychotherapy, or the maintenance and archiving of documentation.

The conditions of the legal provisions on the administration of psilocybin are further specified in Government Regulation No. 552/2025 Coll., on the conditions for the prescription, dispensing and use of individually prepared medicinal products containing psilocybin for therapeutic use. One of the conditions for the prescription and administration of psilocybin is the ineffectiveness or documented intolerance of treatment with registered medicinal products. According to the explanatory report to Government Regulation No. 552/2025 Coll., the primary goal is to relieve the patient in an adverse psychological state when other treatment does not work. The law and the regulation also assume the existence of a uniform recommendatory professional procedure for psilocybin-assisted psychotherapy for therapeutic use.

Psilocybin for medicinal purposes was included in Annex No. 5 of Government Regulation No. 463/2013 Coll., on lists of addictive substances with the amendment to the Criminal Code and related regulations. Its handling is possible only on the basis of a handling permit from the Ministry of Health, or for this reason it is necessary to ensure that medicinal products containing it are dispensed in pharmacies only on prescription or on a request form marked with a blue stripe running from the lower left corner to the upper right corner. In contrast, ketamine, which is also used in therapy, and for a longer time than psilocybin, has a different regime. Ketamine is used as part of the so-called off -label medication, which is enshrined in Section 8 (4) of the Act on Medicinal Products. The essence is the use of a medicinal product for other medicinal purposes or in a manner other than that specified and approved. The conditions for such use are that the medicinal product with the necessary therapeutic properties is not distributed or is not in circulation, and the intended use of the medicinal product is sufficiently justified by scientific knowledge.[6]

And which patients can be given psilocybin or other psychedelics? It is possible for patients who suffer from:

-        depressive disorder associated with oncological disease,

-        clinically significant depressive disorder without psychotic symptoms, or

-        sudden worsening of another serious neuropsychiatric or mental disorder seriously threatening the patient's life, provided that such use of psilocybin for therapeutic purposes is sufficiently justified by scientific knowledge.

However, these are not the only conditions that can be treated with psilocybin or other psychedelics. Psilocybin is being studied for a number of neuropsychiatric disorders, such as obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), and chronic pain syndromes of various etiologies, as well as for the treatment of addictions and eating disorders.

Psychedelic-assisted therapy has three phases. The first is preparation, which involves learning about the effects of the substance and its side effects, taking a history, establishing a relationship and building trust, and practicing relaxation techniques. This is followed by the actual session under the influence of the substance, in a safe environment with a trained therapist (or two), who does not interfere with the experience but creates a safe and supportive framework. After this psychedelic experience, the patient is given space and help to process the experience,[7] the so-called integration phase, which is crucial for processing the experiences and their meaningful integration into the patient's life.

The Czech Republic is not far behind and is also exploring the potential of psychedelics for treatment. In 2019, the first clinic specializing in psychedelic-assisted psychotherapy was founded in our country, the company Psychedelická klinika, sro, which then began offering ketamine-assisted psychotherapy for the treatment of depressive illness in 2020, and has added other indications such as anxiety disorders and OCD, eating disorders, or PTSD.

Australia is even further along in psychedelic therapy, as from July 1, 2023, doctors there (psychiatrists with special authorisation) can prescribe MDMA (3,4-methylenedioxymethamphetamine, known as ecstasy) and psilocybin for the treatment of post-traumatic stress disorder and treatment-resistant depression.[8] Australian Medicines Agency Therapeutic Goods took this step after a nearly three-year process that included extensive consultation with experts.

By amending the Criminal Code and the Act on Addictive Substances and related regulations, legislators have made it clear that the Czech Republic is on the path to innovative and often more effective and faster methods of treating serious mental illnesses. In my opinion, this is a good step forward for patients who are not helped by classic treatment with antidepressants and other drugs, or are not as effective and often have a long onset of effect. For example, for patients with terminal cancer, a faster onset of effect and relief is desirable, as they often do not have much time left.

[1] Tylš , F. The phenomenon of psychedelia: subjective descriptions of experiences from experimental psilocybin intoxication supplemented by researchers' perspectives . Prague: Dybbuk, 2017. pp. 16 – 17 .

[2] Páleníček , T . Psychedelics , problem children of psychopharmacology III – Psychedelics and psychedelic- assisted therapy in practice . Psychiatry: Journal for modern psychiatry. 2023, 27. p. 21.

[3] Bravermanová , A., Tylš , F. and Horáček, J. 2021. Psychedelic- assisted psychotherapy – an experimental strategy in the treatment of anxiety-depressive symptomatology in seriously ill patients . Palliative medicine 2021 (2), p. 31. Also see Chomynová , P., Kočárová, R., Kňažek , F., Plevková, M., Bláhová, B., Valeš, K., Mravčík , V. Use of psychedelics in the Czech Republic: Results of recent population surveys . Central European Journal of Public Health . 2022; 30 (3). p. 144.

[4] Villines , Z. What to know about psychedelic therapy [online]. 30. 6. 2021 [cited 2023-07-20]. Available here.

[5] Provisions of Section 80(1)(c) of the Pharmaceuticals Act.

[6] Šustek, P., Holčapek , T., Šolc, M. Recommendations for the so-called off ‑-label use of medicinal products for patients with COVID-19 . Anesthesiology and Intensive Care Medicine [online]. 2020, 31(3), p. 120 [cited 2023-07-27].

[7] Bravermanová , A., Tylš , F. and Horáček, J. 2021. Psychedelic- assisted psychotherapy – an experimental strategy in the treatment of anxiety-depressive symptomatology in seriously ill patients . Palliative medicine. 2, 2 (Czech. 2021), p. 32.

[8] Hunt, K. Australia ushers in a new era of psychedelic medicine [online]. [cited. 2023-07-31]. Available here.

Source: epravo.cz