Position on the Introduction of Regulated Over-the-Counter Dispensing of Medical Cannabis in the Czech Republic

The current medical cannabis system does not reflect the real needs of an ageing society. According to estimates by the National Monitoring Centre, approximately 720,000 to 790,000 people have used cannabis purely for health reasons, while the number of patients who are actually prescribed medical cannabis is on the order of only a few thousand per year. This fundamental mismatch between need and the healthcare system’s absorptive capacity shows that the current model is unable to meet existing demand through a legal and controlled pathway. The result is that some patients shift into self-medication outside medical supervision and outside the regulated distribution channel.

Introducing an over-the-counter dispensing regime represents a regulated shift of existing demand into a safer framework. It involves creating a clearly structured, health-oriented access pathway. The aim is to reduce barriers for patients with chronic conditions, especially older people, while preserving state oversight of quality, distribution, and safe use.

The proposed model retains safety safeguards through a differentiated approach based on THC content. Products up to 1% THC are available without registration; products with THC content above 1% up to 7% are subject to registration with a general practitioner. Registration does not constitute a standard prescription regime, but functions as a safety filter enabling a basic health assessment and risk prevention for vulnerable groups. In clinical practice, an eVoucher (ePoukaz) could be used to issue such registration. This dual-track model corresponds to the risk level of individual products and preserves the principle of proportionality.

Distribution exclusively through pharmacies ensures quality control and professional counselling. Over-the-counter medical cannabis is to be dispensed only in pharmacies, upon identity verification and compliance with monthly quantity limits. Mail-order dispensing is not permitted. The pharmacist provides mandatory counselling on proper use, risks, and interactions. This creates a healthcare framework that is significantly safer than the current self-medication via illegal or unregulated sources.

Standardised counselling and patient information leaflets are key to minimising risks. Mandatory pharmacy counselling should always include a definition of the range of conditions for which the regime is intended, basic contraindications, and possible interactions with central nervous system depressants, alcohol, and other substances. The patient should also receive from a doctor or pharmacist dosing recommendations based on the principle of gradual titration, a warning about impairment of the ability to drive and operate machinery, and warnings for pregnant and breastfeeding women and for people with a history of psychotic disorders. The patient information leaflet should include a uniform warning box, a brief dosing schedule, a list of the most common adverse effects, and clear instructions on when to seek medical advice. Non-combustion routes of administration should be preferred, and differences in onset and duration of effect should be clearly communicated.

Institutional responsibility in the transitional period is fully enforceable under the Ministry of Health. The system is guaranteed by the Ministry of Health and the State Institute for Drug Control (SÚKL), which under the Act on Addictive Substances performs the tasks of the state agency for cannabis for medical use. The absence of a separate specialised agency is not currently an obstacle to launching the system, because control, record-keeping, and methodological tools already exist within the healthcare system. The possible creation of a specialised institution may be a long-term goal, not a condition for implementation.

Monitoring and evaluation of impacts must be part of the system from the outset. The Ministry of Health should continuously track dispensing volumes, repeat purchases, reports of adverse effects, and any signals of misuse. The data should serve to adjust methodologies, limits, and counselling based on real-world developments. The goal is adaptive, data-driven regulation with ongoing evaluation.

An over-the-counter dispensing regime represents a realistic response to the structural tension between patient needs and healthcare capacity. In the context of an ageing population and high prevalence and incidence of chronic pain, sleep disorders, and other long-term conditions, it is not sustainable to leave hundreds of thousands of people outside the regulated system. Introducing regulated over-the-counter dispensing of medical cannabis creates an environment in which the state maintains control over quality, safety, and record-keeping, while enabling patients to access a more available and predictable pathway, without imposing additional financial burdens on the healthcare system.

Recommendations

• Introduce a regulated over-the-counter dispensing regime for medical cannabis, differentiated as follows: up to 1% THC without registration, and 1% to 7% THC with registration by a general practitioner.
• Maintain dispensing exclusively in pharmacies, with identity verification and defined quantity limits.
• Introduce mandatory standardised counselling and a uniform patient information leaflet with clear warnings and dosing rules.
• Ensure continuous monitoring of dispensing and adverse effects under the leadership of the Ministry of Health.
• Regularly evaluate data and adjust methodology based on observed impacts of the system.