Czech Republic is on the verge of significant changes in the sale and marketing of psychomodulatory substances, specifically kratom and CBD cannabis. After a long and stormy debate, the government has decided not to proceed with a complete ban, but instead to introduce strict measures that will significantly limit their availability on the market, as it has so far been possible to buy these so-called psychomodulatory substances without restrictions, for example in vending machines or e-shops.
Czech government’s draft law amending the Czch Act No. 167/1998 Coll., on Addictive Substances, as amended, and other related laws (the “Draft”) is intended to significantly restrict the more or less free sale of kratom and CBD cannabis.
The Draft consists of several parts which contain extensive amendments of:
- Substance Abuse Act;
- Advertising Regulation Act;
- Act on the operation of radio and television broadcasting;
- Criminal Code;
- Act on on-demand audiovisual media services;
- Health Protection from Substance Abuse Act; and
- Video Sharing Platforms Services Act.
Czech Ministry of Health had previously proposed the inclusion of kratom and CBD cannabis on the list of banned substances due to the desirability of limiting accessibility to children, but the government did not approve a blanket ban, so a group of MPs from across the political spectrum quickly prepared the text of the now approved Draft, which passed its first reading in the Chamber of Deputies on 26 September 2023 and is moving forward in the legislative process.
You can read about the current legal regulation, conditions, and rules for testing, packaging, and sale of psychoactive substances under the Draft, including the expected impact on sellers and consumers of these substances in the following article.
Psychomodulants in general and current legal regulation
The term ‘psychomodulants’ is usually used to refer to substances or drugs that affect the central nervous system (CNS) to modify or modulate mental function or behaviour. These substances can have a variety of effects, including improving mood, reducing anxiety, improving cognitive abilities, or alleviating symptoms of psychiatric disorders. Psychomodulants include several different classes of drugs and substances, such as antidepressants, anxiolytics, nootropics, or antipsychotics.
Psychomodulants are not included in the list of internationally banned substances, so the way they are regulated is entirely up to the individual states. In all EU member states where they have not been banned, they remain in a kind of ‘grey area’, being labelled, for example, as decorative items, toys, etc.
The Draft now operates with two categories, namely:
- psychomodulatory substances, which it defines as “substances with psychoactive effects that pose a low risk of negative health or social effects on individuals and society and are also listed in the Annex to the government regulation on the list of psychomodulatory substances, and products made from them” (see Section 2(1)(l) of the Draft);
- new psychoactive substances, which it defines as “substances for which psychoactive effects or health risks cannot be ruled out in the light of current scientific knowledge and which are also listed in the Annex to the government regulation on the list of new psychoactive substances, and products thereof” (see Section 2(1)(v) of the Draft).
As is clear from the definition itself, the list of substances that will be subject to sales restrictions, as well as other related rules, are set out in the relevant government regulations. The reason for the government to regulate in this way is to enable the State to react quickly and effectively to any new psychoactive substances that appear on the market. According to minister Bartos, this is intended to be an innovative and functional regulation for this group of substances.
New obligations for retailers
Although the Draft does not introduce a complete ban on the sale of kratom and CBD cannabis, it sets out a relatively large number of new obligations that sellers will have to meet and comply with. What are the most important of these?
Registration and Fees – Under the Draft, sellers of psychomodulatory substances in general will be required to register in a special Register of Persons Handling Psychomodulatory Substances to be administered by the Office of the government of the Czech Republic. However, this entails a considerable amount of administration and also a financial burden for potential sellers, as annual fees of CZK 100,000.- will be set.
Strict rules on packaging and labelling – Another important aspect of the new regulation is the strict rules on the packaging and labelling of these products. Sellers will have to comply with mandatory texts and health warnings on packaging similar to those found on tobacco products. The mandatory information that must be included on the outer packaging under the Draft includes the literal indication “Psychomodulatory substance”, the name, subtype, and form of the psychomodulant, information on the recommended dosage, and other information listed in Section 33d(1) of the Draft. The exact manner in which these particulars are to be provided will then be laid down in implementing legislation.
Laboratory tests and certification – Manufacturers and sellers of psychomodulatory substances will have to undergo laboratory tests and obtain certification of the concentration of active substances in their products. This measure aims to ensure the quality and safety of these products.
Restrictions on sales to minors – Shops that offer these substances will have to clearly indicate that no one under the age of 18 can enter. It will also be required to separate the supply of psychomodulants from other products, which will also apply to e-shops.
The administrative authority for psychomodulatory substances will be the Office of the government of the Czech Republic.
What will no longer be possible?
The new regulation introduces several fundamental prohibitions, such as:
- sales will only be permitted in specialised outlets dedicated to the sale of these substances and related products;
- the sale of psychomodulants to persons under the age of 18 will be banned across the board;
- vending machine sales will be prohibited;
- e-shops will have to verify the age of their customers;
- it will not be possible to provide free gifts or samples of these substances;
- e-shops will be banned from cross-border sales;
- it will be strictly forbidden to use customers’ personal data for purposes other than the delivery of the purchased goods;
- exports will be possible only under the authorisation regime.
Another very significant change is the categorical and blanket ban on advertising psychomodulants in all forms of media, including print and online media, radio, radio, social media, leaflets and billboards. Sponsorship of events or celebrities in the field of these substances will also be banned, similar to the current regulation of cigarette advertising.
Criminal law
The criminal law aspect is also important because as the nature of psychomodulatory substances and new psychoactive substances described in the introduction of the article suggests, they are addictive substances.
The Draft thus includes them in the list of addictive substances in Section 130 of Act No.40/2009 Coll., the Criminal Code, as amended (the “Criminal Code”) and introduces a new offence of unauthorised sale, offering for sale and other business with psychomodulatory substances or new psychoactive substances (new provision of Section 251a of the Criminal Code).
Furthermore, according to the Draft, there is a change in the existing legal regulation of the crime of Proliferation of toxic addiction under Section 287 of the Criminal Code, where the facts in paragraph 1 are changed so that, in addition to other addictive substances and alcohol, it will be a crime to entice another to abuse psychomodulatory substances.
Different views on regulation
In general, kratom is seen as a controversial substance in the EU and regulation can range from free sale to a categorical ban on marketing.
It should be noted that the trend across EU member states is towards stricter regulation or outright bans. In addition to Slovakia, which has equated kratom with heroin and made its possession and distribution illegal, other countries that have banned kratom completely include Germany, France, Sweden and Poland.
In the Czech Republic, both the minister of health and the national drug coordinator agree in principle that it is better to go down the route of comprehensive legal regulation in this area than to ban the sale of kratom altogether.
The proposal to introduce new categories of substances fills a wide gap between the two current extreme alternatives, i.e. between unregulated availability on the one hand and substance prohibition with strict criminal enforcement on the other.
Conclusion
The new regulation of the sale of kratom and CBD cannabis in the Czech Republic marks a major step towards greater transparency, safety and protection of minors. While many may see these measures as strict, they are proving necessary in response to the growing popularity of these psychomodulatory substances.
It seems that the Czech Republic will choose the path of regulation and control instead of a blanket ban, despite the EU trend, which more or less reflects an understanding of the need for a rational approach to these substances.
Producers, sellers and consumers of kratom and CBD cannabis will now face new challenges and obligations but let us bear in mind that the aim of these measures is to protect public health while keeping the market for these substances in line with regulation. We will see further developments in this area in the coming years and it will be interesting to see how these changes affect the availability, consumption and prices of kratom and CBD cannabis in the Czech Republic.
One thing is certain: retailers and consumers will have to adapt to the new rules and it is hoped that this new regulation will bring greater protection and certainty for all parties involved.
We will continue to monitor the legislative process of the Draft for You.
If you have any questions about psychoactive and psychomodulatory substances and their regulation, or about food law in general, please do not hesitate to contact us.
Mgr. Tereza Dvořáková, attorney at law – dvorakova@plegal.cz
Rachel Kouklíková, legal assistant – kouklikova@plegal.cz
Mgr. Jakub Málek, managing partner – malek@plegal.cz
17. 10. 2023