The Legal Perspective on Psilocybin for Medical Use in Czechia: A Key Milestone and the Case for Broader Consideration Beyond the Clinical Setting

Abstract

Czechia has recently approved the medical use of psilocybin, marking a pivotal shift in the country’s drug policy landscape. This development paves the way for regulated therapeutic applications of psilocybin within clinical settings, while simultaneously prompting a timely discussion on the potential uses of psychedelics beyond strictly medical contexts. This commentary first outlines the legal status of psilocybin for therapeutic use in Czechia and situates this reform within broader international policy trends. Drawing on the publication How to Regulate Psychedelics and qualitative findings from a ketamine-assisted therapy program conducted as part of the Czech Destigmatizing the Therapeutic Use of Psychedelics in Psychiatry project, it then examines the regulation of non-clinical psychedelic use, while also highlighting the persistent legal ambiguity surrounding the Czech offence of “spreading toxicomania.” The commentary advocates for a rational, evidence-based regulatory approach, arguing that while the medicalization of psilocybin constitutes a significant legal milestone, the framework will remain incomplete without clear pathways for non-clinical use to ensure safety and legal clarity.

1. Introduction

The recent legal reform permitting the medical use of psilocybin in Czechia represents a historic development in national drug policy. This reform should be viewed as a milestone rather than a conclusion, opening a space for deeper legal and policy debates—not only concerning the integration of psychedelics into clinical treatment but also regarding the regulation of their broader non-clinical use.

This commentary focuses on the legal dimensions of the Czech reform and advances a two-fold argument. First, the medicalization of psilocybin constitutes a significant achievement, establishing the legal and institutional foundations for safe, supervised therapeutic practice. Second, without addressing the unresolved challenges surrounding non-clinical use, the Czech regulatory framework remains incomplete and unable to accommodate the full spectrum of contemporary psychedelic practices. The commentary advocates for a rational, evidence-based approach to psychedelic regulation that extends beyond clinical settings.

The article unfolds in six sections. Section 1 outlines the Czech legal framework enabling psilocybin-assisted psychotherapy, detailing conditions of use, facility requirements, and relevant secondary legislation. Section 2 situates the reform in comparative perspective, contrasting narrowly medical models with broader supported-use approaches. Section 3 examines the doctrinal rationale and regulatory implications of the reform. Section 4, Section 5 and Section 6 move beyond the formal law: Section 4 presents and analyzes perspectives from participants in ketamine-assisted therapy regarding the legal use of psychedelics in clinical and non-clinical contexts; Section 5 reviews non-clinical regulatory models and their potential implementation; and Section 6 considers the Czech offence of “spreading toxicomania” and its implications for harm reduction activities and psychedelic sitting.

In summary, the commentary emphasizes that while the medicalization of psilocybin establishes essential legal and institutional foundations for therapeutic practice, unresolved questions surrounding non-clinical use must be addressed to ensure a comprehensive regulatory framework. It closes with recommendations for policy and further research.

2. Legal Framework for Medical Psilocybin Use

A newly enacted legal amendment introduces the concept of “psilocybin for medical use”, thereby distinguishing it from conventional psilocybin, which remains classified as a Schedule I psychotropic substance under the country’s strictest control regime according to the international legislation set by international drug conventions. The objective of this legal distinction is to enable the administration of psilocybin as part of assisted psychotherapy, under tightly regulated conditions.

2.1. Conditions for Use and Professional Competence

According to the new Czech legislation, psilocybin for medical use is to be prepared as an individually compounded medicinal product. Its preparation, prescription, distribution, dispensing, and administration will follow existing regulations governing compounded medications, while also adhering to new requirements set forth in § 35a of the Czech Act on Addictive Substances. Administration will be limited to patients aged 18 and older, and only in cases that meet specific clinical justifications. The entire therapeutic process must comply with a “clinical guideline specifically developed for psilocybin-assisted psychotherapy”, as stated in the new law.

Only physicians with specialized qualifications in psychiatry, or those with additional subspecialty certification in medical psychotherapy, will be authorized to administer the substance. Dispensation will require a special type of prescription known as a “blue stripe requisition,” and only the administering physician will be permitted to obtain the compound. However, a broader group of medical professionals may be authorized to prescribe it, depending on future governmental regulation—potentially including for example physicians in palliative care.

2.2. Authorized Settings: Facility Standards, Indications, and Implementing Regulation

Psilocybin administration will only be permitted within health care facilities that meet stringent regulatory criteria. Facilities under the direct jurisdiction of the Ministry of Health—such as psychiatric hospitals, psychiatric departments of general hospitals, and similar institutions—will be able to administer psilocybin without additional approval. All other health facilities will be required to obtain a special authorization from the Ministry, contingent upon compliance with specifically defined conditions.

The range of diagnoses for which psilocybin may be prescribed will be narrowly defined through a government regulation. This secondary legislation will also regulate other critical aspects of administration, such as dosage limits, physician qualification requirements, and the mandatory duration of medical supervision, which may vary depending on the administered dose. In this context, it should be emphasized that the implementing government regulation remains to be issued.

2.3. Comparative Point of Reference: The Australian Authorized Prescriber Model

The Czech legal reform was notably inspired by regulatory models from abroad, particularly the Australian framework for therapeutic use of MDMA and psilocybin. Since 2023, Australia has permitted the controlled therapeutic use of these substances—MDMA for post-traumatic stress disorder and psilocybin for treatment-resistant depression. Under this model, only psychiatrists who receive prior approval from a Human Research Ethics Committee and authorization through the Therapeutic Goods Administration via the Authorized Prescriber Scheme are permitted to prescribe these substances [1].

In this context, MDMA and psilocybin for medical use were reclassified from the most strictly controlled schedule of illegal psychoactive substances to a category permitting clinical application. However, the general forms of these substances remain prohibited—the change applies exclusively to the so-called “medical” MDMA and psilocybin, which are intended for therapeutic administration under highly regulated treatment conditions [2].

This development does not constitute a general legalization of these substances nor a fundamental transformation of their legal status. A similar approach has now been adopted by Czech legislation, although currently limited to psilocybin.

3. Comparative International and European Context

The Czech step should be placed within the international context. Recently, changes have been occurring primarily in the United States, more precisely in certain states.

3.1. Medical and Supported Adult-Use U.S. Models

The Czech framework aligns partly with regulatory models such as that of the U.S. state of New Mexico, which recently in 2025 allowed the medical use of psilocybin strictly for individuals diagnosed with specific mental health conditions, such as treatment-resistant depression or post-traumatic stress disorder (PTSD). This therapy must take place in clinical settings and under the supervision of licensed healthcare professionals [3]. Both the Czech and the New Mexico models converge in restricting psilocybin use exclusively to medical and psychotherapeutic purposes, without any provision for open or recreational access. The key divergence lies in the substance itself: the Czech framework is designed around synthetic psilocybin, prepared as an individually compounded medicinal product, whereas the New Mexico framework prioritizes natural psilocybin, explicitly excluding synthetic analogues from its program.

By contrast, Oregon became the first U.S. state to adopt a broader model with the passage of Measure 109 in 2020, which came into effect in 2023. This legislation allows adults aged 21 and over to consume psilocybin at licensed service centers under the guidance of trained facilitators. The program is not diagnosis-based—participants are not required to suffer from a mental health disorder, and facilitators are explicitly prohibited from providing healthcare services. This model is referred to as “supported adult use,” rather than medical treatment [4].

A similar path has been followed by Colorado, where Proposition 122, passed in 2022, decriminalized the personal use of psilocybin and other naturally occurring psychedelics. The measure also established a framework for the development of licensed “healing centers”. Here, too, participation does not require a formal diagnosis—prospective clients are only required to undergo a screening process [5].

Whereas New Mexico, like Czechia, emphasizes tightly regulated clinical use for narrowly defined indications, Oregon and Colorado are implementing broader access models oriented more toward psychological well-being and personal development, without requiring medical referral. We can therefore see that developments worldwide are not limited solely to the clinical context.

3.2. Emerging EU-Level Debate

In the European context, it is also worth noting the emergence of the Psychedelicare citizens’ initiative, an official instrument of participatory democracy within the EU, which advocates for the introduction of psychedelic-assisted therapy as a recognized treatment for mental health disorders across the European Union. This initiative responds to the escalating mental health crisis and the limitations of conventional therapeutic modalities. It builds upon a growing body of scientific evidence demonstrating the therapeutic potential of psychedelic substances [6].

Psychedelicare aims to initiate a public debate during a one-year campaign in 2025 and to collect one million signatures from citizens across at least seven EU Member States. Only upon reaching this threshold will the initiative be able to formally request the European Commission to consider drafting concrete legislative proposals.

4. Rationale and Implications of the Czech Reform

Back in Czechia, the proposed legal framework draws clear inspiration from the regulation of medical cannabis, which has been permitted in Czechia since 2013. In this regard, the country remains ahead of many others, having implemented medical cannabis laws even before corresponding international changes—such as the reclassification of cannabis to a less restrictive schedule by the United Nations in 2020. The experience gained from medical cannabis regulation has served as a model for the development of psilocybin-based treatment.

4.1. Doctrinal Fit: Scheduling, “Medical Psilocybin” as a Category, and UN Compatibility

From the perspective of legal compatibility, the proposal does not conflict with the United Nations Convention on Psychotropic Substances nor with Directive 2001/83/EC of the European Union. Psilocybin remains listed under Schedule No. 4 of the Government’s implementing decree to the Czech Act on Addictive Substances. However, “psilocybin for medical use” will now be listed under Schedule No. 5 of the same decree, thereby permitting its regulated use for therapeutic purposes without altering the classification of conventional psilocybin.

4.2. Policy Drivers and Evidence Base

The incentive for the legal reform stems from scientific studies demonstrating the efficacy of psilocybin particularly in patients suffering from treatment-resistant depression, where conventional pharmacological interventions have failed [7,8,9]. There is also emerging interest in its potential application in palliative care, where psilocybin may help alleviate anxiety related to the end-of-life experience [10,11,12].

Simultaneously, the proposal reflects the current Czech government’s policy statement, which commits to ensuring that the regulation of psychoactive substances corresponds proportionately to their risk profile and therapeutic potential.

This legislative change is essentially the outcome of proposals long advocated by the Czech professional psychedelic community and this point has been consistently emphasized over time [13]. For instance, I have argued that an effective legal pathway for enabling the medical use of psychedelics could mirror the Czech approach to medical cannabis. That is, by creating a special category such as “psilocybin for medical use” analogous to “cannabis for medical use,” it would be possible to allow access to psilocybin-based treatment within a controlled framework, while leaving the ‘classical’ psilocybin on Schedule No. 4 of the Czech Government Regulation on addictive substances. This mirrors the current regime under which cannabis for medical use appears on Schedule No. 1, while non-medical cannabis remains on Schedule No. 3 [14].

The key to the solution and optimal legal route for enabling psychedelic-assisted psychotherapy (PAP) is to formally designate psychedelics as medicinal products. These would be medicinal preparations containing controlled substances, with clearly defined conditions for their use—namely, in the context of PAP. However, the precondition would be to establish a “special” substance for therapeutic use—for example, medical psilocybin—following the precedent set by Australia. Such a medical psilocybin could be transferred from Schedule No. 4 of Government Regulation No. 463/2013 Coll., to a more permissive schedule enabling medical application, such as Schedule No. 7 (which already includes ketamine) or Schedule No. 1 for narcotic substances, where medical cannabis is currently listed. This would enable psilocybin to be used as a medicinal product administered directly to the patient in a clinical setting, rather than dispensed by prescription. Specifically, it would allow for the preparation and administration of individualized human medicinal preparations containing a controlled substance, provided by a licensed psychiatric healthcare provider [15].

In the past, I have also addressed the legal avenues for conducting psychedelic-assisted psychotherapy in Czechia, particularly through the legal doctrine of permissible risk as a justification for excluding criminal liability [15]. Although this interpretation is no longer necessary in the case of psilocybin-assisted therapy due to recent legislative shifts, I believe it remains relevant for enabling legal and non-punishable MDMA-assisted therapy, as well as for the use of psychedelics in supervised self-experiential training of therapists—in Czechia, courses and training programs for psychedelic-assisted therapy are also being developed, which, taking into account international best practice experiences, should include personal experience with the substance.

In this regard, it is essential to highlight that psychedelic therapy receives considerable public endorsement in Czechia. According to a recent survey by the Psyres Foundation for Psychedelic Research, conducted by the research agency Simply5, 68% of Czechs would support the use of psychedelics in treatment if recommended by a physician and consented to by the patient. Despite the fact that most of the population has no personal experience with these substances and 72% have never heard any information about them, public interest is rising—over half of the population expresses a desire for at least basic knowledge of their effects and risks. The greatest perceived potential of psychedelic therapy lies in palliative care, the treatment of neurodegenerative disorders, and conditions where conventional treatments have failed [16].

It should be noted that, within the scope of the inquiry, psychedelic treatment was framed as an innovative therapy for mental health disorders, which indicates that the Czech public perceives mental health as a crucial issue and expresses a positive stance toward various solutions.

In the following section, I would like to highlight another Czech psychedelic initiative—a destigmatization project—through which I intend to present its findings, particularly the experiences of patients undergoing psychedelic-assisted therapy with ketamine. Although the substance in question was ketamine, it was administered within a structured therapeutic framework, closely resembling the protocols anticipated for future clinical applications of psilocybin. Notably, participants also shared their perspectives on the potential legalization of psychedelics for both medical and non-medical purposes, offering valuable insights for ongoing discussions around psychedelic policy and regulation.

5. The Perspective of Participants in Ketamine-Assisted Therapy in Czechia

Several clinical studies involving psychedelics are currently underway in Czechia, led by the National Institute of Mental Health. In Prague, the psychedelic clinic Psyon operates, while in Brno, a new center called New Elysium was recently established—both offering ketamine-assisted therapy. Since ketamine is an approved pharmaceutical, it can be used off-label to treat depression and other mental health conditions. Czechia is also home to the Psyres Foundation, which supports psychedelic research, and the Czech Psychedelic Society, an organization dedicated to public education and outreach.

One notable initiative in this context is the project “Destigmatizing the Therapeutic Use of Psychedelics in Psychiatry and Their Application in Czechia for the Reintegration of People on Long-Term Sick Leave Back into Life,” carried out by the Third Faculty of Medicine at Charles University. Running from 1 May 2023, to 31 July 2024, the project aimed to reduce stigma surrounding psychedelics among people with mental illness, professionals, and policymakers; to pilot innovative applications of psychedelic therapy; to explore new forms of stakeholder collaboration; and to lay the groundwork for systemic change in how psychedelics are used in mental healthcare in Czechia [17].

A key component of the project involved interviews with participants in ketamine-assisted psychotherapy, who provided insights not only on the clinical use of psychedelics but also on their non-clinical, sometimes ritual, applications. For this reason, I consider it relevant to introduce this perspective into the field, even though it does not concern psilocybin per se. [18].

5.1. Psychedelics in the Therapeutic Context: Support for Clinical Integration and Access Barriers

The vast majority of respondents expressed unequivocal support for the use of psychedelics in medical treatment. Many explicitly stated their belief that psychedelic therapy should be integrated into standard clinical practice. For example, participant DPT-16 asserted, “Psychedelic therapy should be part of routine care,” while another stated, “Psychedelic therapy should be a legal option for those who wish to heal.” One interviewee remarked, “Personally, I would recommend legalizing psychedelic therapy. I think it’s an effective way for a person to help themselves” [18].

Participants frequently emphasized the therapeutic potential of psychedelics, especially in cases where traditional treatment methods had failed. Their arguments often drew on personal experience or a deeper engagement with mental health care. Some referenced ketamine’s existing legal status—DPT-04, for example, noted that “ketamine is already legally available and should be offered based on individual indications.”

Financial and access barriers were also a recurring theme. Several participants criticized the lack of insurance coverage for ketamine therapy, arguing that it should be offered as a standard treatment option, as one respondent (DPT-14) noted: “It’s a standard medication—why shouldn’t insurance cover it?” [18].

Overall, the prevailing narrative underscores the desirability of legal access to psychedelic therapy—not only to improve availability but also for its demonstrated effectiveness. Many participants linked the therapeutic potential of these substances to the need for their integration into formal healthcare systems.

5.2. Psychedelics Outside the Therapeutic Context: Divergent Views on Non-Clinical, Ritual, and Recreational Use

In contrast, views on non-clinical, ritual, or recreational use of psychedelics were more heterogeneous. A substantial subset of participants adopted a liberal stance, supporting not only therapeutic use but also other forms of consumption. Participants DPT-01, DPT-06, DPT-08, and DPT-10, for example, explicitly endorsed the legalization of “psychedelic therapy, rituals, and recreation.” Others emphasized the personal or spiritual significance of these experiences: “I would absolutely support it, especially if it brings positive outcomes—that would be fantastic” (DPT-17), or, “Ritual use of psychedelics should be legal and accessible to those who find meaning in it” (summary of DPT-17) [18].

Positive personal experiences—often with LSD or MDMA—were a common basis for openness toward broader legalization. Some respondents rejected the classification of psychedelics as “drugs” or inherently dangerous: “I don’t agree that it’s a drug or a dangerous substance” (DPT-21), instead describing psychedelics as tools for self-exploration and personal growth beyond the clinical setting. Individual autonomy was another recurring theme: “I don’t see why an adult shouldn’t be able to take a psychedelic outside a therapeutic setting,” said one respondent. Another added: “Non-clinical use—like rituals or recreation—makes sense to me. It’s a matter of freedom” [18].

On the other hand, some participants expressed caution or outright disapproval. Skepticism was most often directed toward recreational or religious use, citing potential risks if legalized. For example, DPT-14 stated that they would not recommend psychedelic use outside medical supervision, while DPT-15 added that legalization “wouldn’t be a good idea.” The strongest opposition came from DPT-29, who said, “Ritual or religious use of psychedelics shouldn’t be allowed in Czechia. It’s nonsensical and increases risk for users” [18].

Concerns frequently centered on potential misuse, especially in connection with unqualified facilitators: “I support legalization for both therapeutic and recreational use,” said DPT-25, “but I’m concerned about abuse by charlatans” in ritual settings. Explicit rejection of legalization—whether for therapeutic or non-therapeutic use—was relatively rare in the sample. Negative views were typically rooted in personal concern or lack of information: “I wouldn’t legalize psychedelics; I think they’re dangerous,” said one participant. Another admitted: “I have no experience with them, but I’m mostly against it. I worry about misuse.” Some respondents took a neutral stance, deferring the decision to the professional community (e.g., DPT-19) or highlighting the need for broader education and awareness [18].

Synthetizing key themes, the interviews reveal two dominant narratives. First, there is strong consensus on the clinical benefits of psychedelics and the need to integrate them into formal healthcare systems. Participants consistently highlighted their therapeutic efficacy, practical accessibility, and the moral imperative of making such interventions available to those in need. Second, perspectives on non-clinical use were more nuanced, ranging from enthusiastic support grounded in personal and spiritual experiences to cautious skepticism emphasizing safety and responsible oversight. Across both domains, participants stressed the importance of informed, regulated, and safe practices, suggesting that systemic integration should be accompanied by education, professional guidance, and consideration of ethical and legal frameworks.

In sum, participants in ketamine-assisted therapy in Czechia overwhelmingly advocate for the legitimization and clinical integration of psychedelic therapy while expressing diverse, often conditional, views on non-clinical use. Their insights underscore both the promise of psychedelics in mental healthcare and the challenges of expanding access responsibly beyond strictly medical contexts.

On the other hand, public opinion on non-medical psychedelic use remains ambivalent. Consequently, any consideration of the use of psychedelics in non-clinical settings must be accompanied by comprehensive education and outreach. This includes ensuring broad access to accurate information, providing avenues for professional support and integration of challenging experiences, and fostering destigmatization in the public eye. It is equally important to educate society about the differentiation between various substances, their effects, and potential risks. Only a well-informed society can responsibly embrace a responsible psychedelic-friendly approach.

Ultimately, individuals should retain the autonomy to decide whether or not to use psychedelics, much as they choose whether to consume legal substances, alcohol or tobacco. In this context, the principle of cognitive liberty—understood as a fundamental human right to control one’s own mental processes, consciousness, and thought patterns—becomes particularly salient [19]. Cognitive liberty frames the ethical foundation for personal choice in the domain of psychedelic use while balancing the need for safety, education, and public health considerations.

In the following section, I will turn to the question of the possible regulation of non-medical psychedelic use, exploring models ranging from decriminalization to controlled licensing schemes.

6. Non-Clinical Use of Psychedelics

While psychedelic-assisted therapy is emerging as a promising tool in the treatment of mental illness, in my opinion, attention must also be paid to non-clinical forms of use—whether recreational, self-exploratory, or spiritual. At this point, it is crucial to reiterate that the decriminalization of psychedelics is primarily concerned with their therapeutic use in safe, controlled settings under professional supervision. This is fundamentally different from the full legalization of psychedelics for recreational purposes. I have addressed this theme in earlier work as well pointing out that the aim of decriminalizing therapeutic psychedelic use is to create a legal framework enabling professionals—many of whom are currently constrained by the legislative situation—to provide treatment responsibly and effectively. That said, non-therapeutic models of use cannot be ignored. The potential of these substances extends beyond clinical settings and can also be realized in the context of responsible psychonautics, personal development, or even self-medication [20].

Moreover, recently, the Czech Psychedelic Society translated into Czech the document How to Regulate Psychedelics which addresses key topics related to the safe, ethical, and effective regulation of psychedelic substances out of clinical context. The original was produced by the UK-based think tank Transform Drug Policy Foundation and offers practical recommendations and inspiration for policymakers, experts, and also the general public [21].

The publication offers a comprehensive and critically informed framework for the regulation of psychedelic substances outside clinical contexts. Written in response to a growing international debate on the legal and ethical status of psychedelics, the document advances a regulatory vision grounded in public health, harm reduction, human rights, and cultural sensitivity. It challenges the dominant prohibitionist paradigm and calls for evidence-based and socially equitable alternatives that take into account the complexity and diversity of psychedelic use.

At the core of the publication lies the argument that the principal policy question concerning psychedelics is not whether these substances should be prohibited or permitted, but rather how they can be effectively and responsibly regulated. The authors reject the false binary between prohibition and medicalization, pointing instead to the need for a nuanced regulatory architecture that encompasses therapeutic, spiritual, personal growth, and recreational uses. They emphasize that while medical research has played a critical role in de-stigmatizing psychedelics and driving reform, the exclusive framing of psychedelics as clinical tools risks marginalizing other forms of legitimate use and reinforcing outdated hierarchies of legitimacy. In this context, the document highlights the importance of protecting non-medical uses, particularly ceremonial, religious, and Indigenous practices that long predate Western biomedical interest in these substances [22].

Accordingly, I consider it highly relevant in light of current discussions and the broader movement toward acknowledging the therapeutic potential of psychedelics. Moreover, I would like to acknowledge and highlight the practical dimension of the publication, as it offers four specific regulatory models for the non-clinical use of psychedelics, each reflecting a different degree of formality, institutional oversight, and commercial involvement.

The first model concerns private use, home cultivation, foraging, and non-commercial sharing, which the authors propose should be fully decriminalized. This includes the collection and cultivation of naturally occurring psychedelics for personal use, as well as their non-commercial distribution within community settings. Framed as a “grow, gather, gift” model, it reflects a vision of responsible autonomy and collective care rooted in mutual aid rather than profit.

The second model involves non-profit, membership-based associations dedicated to the cultivation and distribution of psychedelics, particularly natural substances such as psilocybin mushrooms. Drawing inspiration from cannabis social clubs, these associations would function on the basis of a closed-loop system in which members produce and consume psychedelics without commercial transactions. The model further allows for the provision of guided psychedelic experiences within the association, subject to appropriate safety, ethical, and professional standards.

The third model entails licensed production and regulated retail distribution of psychedelic substances, tailored to both natural and synthetic compounds. Under this framework, commercial entities may manufacture and sell psychedelics through specialized outlets, with oversight provided by a dedicated regulatory agency. The authors envisage a tightly controlled market, including quality assurance protocols, age verification, dose regulation, standardized packaging, and restrictions on marketing. In this model, psychedelics would be legally available to adults through authorized vendors, who are trained to provide risk information and basic guidance. Online sales would be permitted, provided they include appropriate verification mechanisms.

The fourth model envisions regulated commercial use with trained facilitators, whereby individuals can purchase access to psychedelic experiences administered in a structured and supervised setting. This service-based model would require facilitators to undergo accredited training, demonstrate personal experience with psychedelics, and adhere to professional and ethical guidelines. Moreover, the authors propose the establishment of a self-regulatory body—such as a professional guild or chamber of psychedelic guides—responsible for setting standards, certifying practitioners, and ensuring accountability. Importantly, the model also allows for the inclusion of traditional Indigenous practitioners as licensed facilitators, thereby fostering epistemic plurality and intercultural dialogue in the emerging field of psychedelic practice.

In presenting these four regulatory models, the publication also addresses broader legal and geopolitical considerations. It acknowledges the constraints imposed by the 1971 UN Convention on Psychotropic Substances, which lists LSD, psilocybin, DMT, and mescaline as Schedule I substances, but notes that the natural sources of these compounds—unlike coca leaves, cannabis, or opium poppies—are not internationally scheduled. This legal distinction offers a degree of flexibility that can be leveraged by national governments seeking to establish regulated markets for natural psychedelics. While acknowledging the risk of international criticism, the authors point to existing examples of legal natural psychedelic markets that have not yet been subject to formal censure by the International Narcotics Control Board.

Last but not least, throughout the document, particular attention is paid to ethical imperatives and the principle of social justice. The authors stress the need to prevent monopolization of psychedelic markets, particularly by corporate actors, and to safeguard access for marginalized and historically excluded communities. They emphasize that regulation must not reproduce the exclusions and harms of the prohibitionist system it seeks to replace. Instead, a just regulatory model should be inclusive, redistributive, and culturally sensitive, incorporating reparative measures and community-based initiatives. The authors also warn against psychedelic exceptionalism—the tendency to advocate for psychedelics on the basis of their perceived superiority to other drugs—and argue that all psychoactive substances deserve regulation according to their relative risks and benefits, not according to their cultural capital.

In sum, How to Regulate Psychedelics offers a sophisticated and practically oriented roadmap for psychedelic policy reform, which is why I consider it a highly significant document. It provides policymakers, researchers, and advocates with a set of actionable models that take seriously the ethical, social, and legal dimensions of psychedelic regulation.

In the Czech context, the first model of home cultivation, particularly focusing on psilocybin mushrooms, could be analogous to the recent reform of the Czech Criminal code, which also decriminalized the cultivation of three cannabis plants for personal use and the possession of up to 100 g of dried cannabis at home or 25 g in public. The second model, involving community cultivation and sharing within a non-profit club, is likewise conceivable, analogous to the cannabis clubs that operate successfully in some countries—such as Uruguay, Malta, or Catalonia, among others. The model of supervised use would require the establishment of professional standards, good practice procedures, and financial frameworks, as it involves a therapeutic setting similar to the clinical context but without the requirement of a mental health diagnosis. Such models already exist—pioneered in Oregon and subsequently adopted by other states—and their implementation is ongoing, albeit not without challenges. The final model, retail distribution, could draw inspiration from the forthcoming regulation of kratom as a psychomodulatory substance—a special category for psychoactive substances with low health and societal risk within the Czech legal framework (For further information on psychomodulatory substances in Czechia, see Mravčík et al., Int. J. Drug Policy 2024, 133, 104603 [23]).

A fundamental complication remains the legal status of psychedelics under international conventions. However, when it comes to plants or fungi containing prohibited substances, these conventions allow for a pro-natural psychedelic interpretation. A notable example is the legal status of ayahuasca, which can be criminalized as a beverage containing DMT, as illustrated by the Czech case in which two neo-shamans were sentenced to eight years in prison for conducting ceremonies that caused no harm [24], or by the more lenient approach of Spanish courts, which emphasized that ayahuasca, as a complex plant preparation, is neither individually listed nor explicitly prohibited under any national or international legal provision [25].

Overall, the document How to Regulate Psychedelics provides a sophisticated and practically oriented roadmap for psychedelic policy reform. It offers concrete models that take into account the ethical, social, and legal dimensions of regulation, making it a valuable resource for policymakers, researchers, and advocates alike.

In my opinion, by shifting the focus from prohibition to governance, and from pathology to agency, the report contributes meaningfully to the emerging discourse on post-prohibition drug policy and the responsible integration of psychedelics into contemporary society. While the path forward is well defined, meaningful progress will require genuine political will.

I acknowledge that the regulation of non-medical psychedelic use may seem controversial. Still, it is both timely and necessary to base such regulation on evidence of risk and harm, rather than on entrenched stigma. An approach centered on prevention, user support, and public health protection—commonly known as harm reduction—is increasingly recognized as a more effective alternative to repressive drug policies. Responsible regulation can enhance public safety, improve public awareness, and strengthen the quality of available services. Moreover, legalization and taxation could generate revenue for prevention, research, and education. Beyond these practical benefits, regulation also creates an opportunity for destigmatization and a shift in the public discourse surrounding psychedelics and their users [21].

This represents a paradigm shift—one that demands not only expertise but also a willingness to rethink established approaches to psychoactive substances. A meaningful public debate should not be limited to the question of whether to regulate, but must focus on how, for whom, and under what conditions such regulation should be designed. Psychedelics hold potential not only in therapeutic contexts but also in fostering personal growth and expanding consciousness. Viewing them solely as a threat closes the door to a more nuanced understanding of their broader significance. This publication seeks to encourage open dialogue, offer fresh perspectives, and contribute to a more informed public debate about the role of psychedelics in society.

7. The Offence of “Spreading Toxicomania” (Section 287): Doctrinal Boundaries and Practical Implications

In the context of non-medical use, it is also necessary to draw attention to a Czech legal-cultural peculiarity—the criminal offense of spreading toxicomania (or drug addiction). While it lacks a direct equivalent in most foreign legal systems, it encompasses a broad set of behaviors that facilitate or encourage drug use—extending beyond mere sale or distribution.

7.1. Legal Definition and Interpretation

The criminal offense of spreading toxicomania is codified in Section 287 of the Czech Criminal Code and aims to protect society from the potential harms associated with the misuse of psychoactive substances other than alcohol. The statutory elements of the offense encompass inducing another person to misuse a substance, supporting such misuse, inciting it, or otherwise facilitating its distribution. “Inducing” includes prompting the decision to use the substance or endorsing its misuse; “supporting” may involve providing the substance itself, a suitable environment, or psychological assistance; “inciting” refers to actions intended to create a disposition or intention in others to misuse substances; and “spreading” covers any conduct aimed at promoting substance misuse, irrespective of whether the target of such conduct is actually influenced. Some harm reduction activities—such as the distribution of medical supplies, educational outreach, or counseling—should not be regarded as supporting substance misuse. However, the statutory provision is interpreted restrictively, excluding practices such as testing substance purity at music, cultural, or other events, or the psychedelic sitting (see Section 7.2 for details) [26]. Historically, this provision has been applied to criminalize for instance to operators of growshops and publishers of books containing cannabis-based recipes. Notably, the Editor-in-Chief of the magazine Legalizace (Legalization) was prosecuted under this provision for publishing articles on cannabis and its effects that could potentially encourage others to cultivate the plants containing THC. In 2025, this case reached the Constitutional Court, which ultimately rejected the lower court’s decision and reaffirmed the protection of freedom of expression even regarding controversial statements and messages [27].

In practice, Section 287 has proven legally ambiguous and controversial, complicating its application and increasing the risk of misuse. Contemporary scholarly and expert critique highlights its nonsensical character and calls for reform, ideally its repeal, whereas law enforcement authorities continue to uphold it as a useful instrument of repression. Political will, however, has so far favored maintaining the status quo.

7.2. Harm Reduction and Psychedelic Sitting: A Teleological Reading

The reason for highlighting this criminal offense is that it poses a significant barrier to the effective delivery of harm reduction services; in the context of psychedelics, this particularly concerns psychedelic sitting—the practice of accompanying and supporting someone during a psychedelic experience. Sitting is a key harm reduction measure—and not only harm reduction, but rather benefit maximization, since the presence of a sitter helps ensure an optimal setting for the psychedelic experience. Representing the Czech Psychedelic Society, I took part in expert working groups convened in 2023 and 2024 by the Secretariat of the Government Council for Drug Policy Coordination, where I raised the issue of psychedelic sitting in relation to Section 287 of the Czech Criminal Code, which defines this offence.

In these discussions, proposals were put forward to amend the law, limiting criminal liability for spreading toxicomania only to cases involving minors. This limitation was also debated during the recent major reform of Czech criminal law, which included also the proposal for the medical use of psilocybin. Unfortunately, the proposed revision of the provision on the spreading of toxicomania was not passed by the legislature. As a result, legal uncertainty around psychedelic sitting persists.

Nevertheless, the Czech Psychedelic Society has published a legal analysis of the issue, which argues that the essence of psychedelic sitting lies in the presence of a sober individual (the sitter) who supervises and supports another person undergoing a psychedelic experience. The sitter creates a safe and stable setting, which is crucial for navigating often intense and emotionally challenging experiences. Sitters may also offer factual information about the substance, provide preparation and integration support, and mitigate potential risks. Sitting is thus a preventive harm reduction intervention. From a rational and purposive interpretation of the offence of spreading toxicomania—particularly given the lack of social harm involved it should not constitute a criminal offence. As legal commentary notes, the purpose of this offence “is not to criminalize conduct aimed at reducing the negative psychological, health-related, and social consequences of drug use”. Furthermore, the protected legal interest—the protection of the society from the abuse of addictive substances—appears only minimally threatened in the case of psychedelic sitting. Because it actively contributes to safer use, sitting should be considered a harm reduction service and, as such, should not be criminalized under Section 287 [28].

In summary, I argue for the interpretation that the psychedelic sitting is not the type of conduct that criminal law—especially in its role as ultima ratio—should aim to punish. In this regard, I have also previously emphasized the problematic nature of this offence pointing out that there should also be a legal possibility to use psychedelic substances safely, consciously, and responsibly for the purpose of self-medication, self-development, improving psychological well-being, etc., even in the absence of acute clinical need. Given the lack of significant social harms associated with psychedelics, their use should not fall under the domain of criminal law as a means of protecting society. From this perspective, criminalization is disproportionate and illegitimate [20]. Until the legislative status of psychedelics is aligned with principles of rational drug policy, the practice of sitting should be explicitly exempted from actions that fall under the criminal offence of spreading toxicomania, similar to the exemptions currently granted to harm reduction services [26].

Unfortunately, such interpretation from authorities is absent. As a result, Czechia has become a country where psilocybin-assisted therapy is legally available, yet the status of other psychedelic care services and harm reduction activities remains uncertain. Moreover, there is a notable lack of discussion regarding the regulation of non-clinical models of psychedelic use.

8. Conclusions: Towards a Rational Regulatory Pathway

The medicalization of psilocybin in Czechia represents a significant milestone in drug policy, yet it should be understood not as an endpoint but rather as the beginning of a broader and necessary debate about the future direction of regulation. This commentary advances a dual claim. First, medicalization, while crucial, is only one step on the pathway toward an adequate and sustainable framework. Second, without addressing the offence of spreading toxicomania (Section 287 of the Czech Criminal Code) and without creating clear, legally secure avenues for non-clinical use, the regulatory system will remain incomplete and internally inconsistent.

As long as non-clinical forms of use remain stigmatized or legally ambiguous, the full potential of psychedelics—whether therapeutic, spiritual, or self-exploratory—cannot be realized legally, nor therefore safely or responsibly. A multidimensional and evidence-based approach, grounded in harm reduction, social justice, and public health principles, is therefore required. By fostering informed public discourse and inclusive policymaking, Czechia has the opportunity to help shape a post-prohibition paradigm that reflects contemporary scientific understanding as well as the diverse contexts of use. These uses cannot be reduced to the simplistic category of so-called recreational use, given the wide range of non-clinical purposes and settings in which psychedelics are engaged.

Based on the conclusions above, the following key policy and research recommendations are proposed:

• Policy recommendations:

Recognize non-clinical models: Explore regulatory pathways beyond the clinical setting, drawing on international examples (e.g., Oregon and Colorado service models, cannabis social clubs) to provide safe and legal contexts for non-clinical use and to integrate cultural and spiritual practices into the regulatory framework.

Support public engagement and destigmatization: Promote open debate and awareness campaigns to shift discourse from prohibition to smart regulation grounded in evidence and human rights.

• Research recommendations:

Monitor the rollout of medical psilocybin: Evaluate barriers to patient access, including cost and insurance coverage, as well as clinical outcomes.

Investigate real-world non-clinical practices: Study ritual use, psychonautic experiences, self-medication, etc., to build an evidence base for proportionate and informed regulation.

Analyze the legislative framework: Assess the legal and regulatory implications for both medical and non-medical psilocybin/psychedelics use to inform future policy development.