Policy Brief – Implementation Priorities for Oversight of the Regulated Market in Psychomodulatory Substances

Introduction

The regulation of psychomodulatory substances has represented, as of January 1, 2025, a major shift in Czech drug policy toward the protection of public health and the rationalization of the market. The amendment to Act No. 167/1998 Coll. established a legal framework for the existence of a regulated market for selected psychomodulatory substances, including kratom, and defined the core competencies of supervisory authorities. However, this step alone does not guarantee a functional and trustworthy system unless it is complemented by thoughtful implementation, sufficient supervisory capacity, and effective consumer protection tools.

The aim of this policy brief is to formulate practical recommendations for oversight, control, and protection of the regulated PML market based on expert outputs from a professional conference. The text develops these outputs into operational measures in the areas of quality control, consumer information, monitoring of use, and combating the black market.

Current State of Oversight and Institutional Roles

Oversight of the regulated PML market is currently divided among several institutions whose roles need to be better coordinated and strengthened. The Czech Agriculture and Food Inspection Authority (SZPI) plays a key role in supervising compliance by license holders, particularly in the areas of labeling, composition, quality, and reporting obligations. SZPI also has the authority to withdraw products from the market when legal requirements are breached.

The Ministry of Health (MoH) is responsible for protecting the regulated market from the entry of unlicensed entities and for overseeing compliance with licensing conditions. For long-term system stability, it is essential that the MoH actively acts as the guarantor of regulation and does not shift responsibility solely onto supervisory authorities without adequate methodological and financial support.

The Customs Administration plays a crucial role in monitoring imports and combating the illegal market. Without systematic control of import flows and targeted enforcement against unlicensed imports of risky substances, the regulated market will remain vulnerable to cheaper, unregulated competition, undermining both consumer protection and the economic sustainability of legal operators.

Safe Sales and an Informed Consumer

A fundamental prerequisite for protecting public health is the transition from formal legality to genuinely safe sales practices. The regulated market must not replicate grey-zone practices where consumers are left without information or responsibility. A sustainable business model for PML must be based on active communication of risks, dosing, and contraindications, rather than the maximization of short-term profits.

Mandatory training for PML vendors should be considered a key harm reduction tool. Vendors are in direct contact with consumers, and their ability to clearly and accurately communicate safe-use information is essential. Unlike alcohol, there is no intergenerational transfer of experience, and parents are often unable to adequately explain the risks of PML use.

Standardized consumer information should take the form of a package leaflet similar to those used for medicinal products. This tool should include clear information on recommended dosage, method of use, possible adverse effects, interactions, and how and where to report adverse effects. A unified structure will also facilitate control and reduce the risk of misleading claims.

Vigilance, Reporting, and Data Use

The introduction of a PML vigilance system (adverse effects reporting) is essential for the timely identification of risks and adaptive regulation. Inspiration should be drawn from pharmacovigilance principles, complemented by elements of nutrivigilance, enabling users themselves to report adverse effects.

At the same time, it is worth considering whether to extend existing tools for ongoing safety monitoring of food supplements or to adopt a system similar to that used for medicines in pharmacovigilance. This approach is particularly useful for systematically collecting information on when a product should not be used, how it may interact with other substances, and what serious adverse effects may occur—including those resulting from overload of liver enzymes responsible for metabolizing bioactive substances, including medicines.

Monitoring of usage patterns should be continuous and modeled on gambling regulation. Systematic evaluation of data on sales, adverse effect reports, and consumer behavior will enable early identification of problematic trends and evidence-based adjustments to regulatory measures, rather than ad hoc responses.

Quality, Testing, and Laboratory Capacity

Current requirements for PML quality testing need to be revised with regard to actual risks, available scientific knowledge, and the capacities of accredited laboratories. For example, mandatory testing for aflatoxins significantly increases the cost of accredited analyses, while the established limits are exceptionally low and do not correspond to available data on real risk. The obligation to initiate analysis of a PML sample in an accredited laboratory within 24 hours of sampling creates practical complications for both producers and laboratories without improving the reliability or accuracy of sampling and analytical processes.

Attention should also be paid to the chemical profiles of substances. In the case of kratom, monitoring the ratio of mitragynine to 7-hydroxymitragynine is essential, as it directly affects the product’s effects and risk profile.

Responsibility for overall quality remains with the manufacturer and distributor. When introducing a new raw material supplier, non-targeted analytical testing should be a mandatory part of risk management, allowing detection of unexpected contaminants or deviations in composition.

Protection of the Regulated Market and Combating the Illegal Market

Without active suppression of the illegal market, the regulated system cannot be sustained in the long term. The state must clearly declare and practically enforce the priority of protecting the regulated market; otherwise, legal operators are placed at a competitive disadvantage relative to unregulated sellers.

Ethical codes of professional associations can play a complementary, but not substitutive, role to state regulation. Initiatives committing members to interpret legal ambiguities in favor of health protection and the regulated market are beneficial, but they do not replace the need for systematic law enforcement.

Fiscal Instruments as a Condition for Sustainable Regulation

The introduction of an excise tax on psychomodulatory substances is a key prerequisite for long-term functional and credible regulation. The current model, based primarily on licensing fees, does not provide a sufficiently flexible or proportional source of funding and creates barriers to entry for smaller entities. This may lead to undesirable market concentration and weaken resilience against illegal competition.

An excise tax allows public revenues to be linked to actual sales volume and the risk profile of individual substances. Unlike fixed fees, it better reflects market dynamics and enables differentiated approaches based on the level of risk, form of distribution, or concentration of active ingredients. It also represents a transparent instrument understandable to both regulators and the public.

A crucial element is the partial allocation of excise tax revenues back into the regulatory and public health protection system. Without stable funding, it is not possible to ensure high-quality risk assessment, sufficient laboratory capacity, systematic oversight, or a functional vigilance system. Funding for these areas should not depend on annual budget negotiations but be embedded directly in the regulatory framework.

Part of the revenues should be specifically allocated to expert risk assessment, monitoring of use, and preventive activities. This includes supporting institutions involved in PML evaluation, developing systems for data collection and analysis on usage and adverse effects, and financing prevention and educational programs focused on safe use and addiction services. Such a model aligns with the principle of internalizing social risks and strengthens the legitimacy of regulation in the eyes of the public.

Conclusion and Recommendations

• Introduce mandatory training for PML vendors as a standard licensing condition
• Implement standardized package leaflets for consumers modeled on medicinal products
• Establish a functional PML vigilance system based on pharmacovigilance principles
• Revise laboratory testing requirements with a focus on relevant risks
• Strengthen monitoring of usage patterns and systematic evaluation of regulation
• Actively protect the regulated market by combating the illegal market and grey economy
• Introduce an excise tax on PML and systematically allocate part of the revenues to control, risk assessment, and prevention