Passage of the Act on Psychomodulatory Substances

6.5.2024

On May 3, 2024, the so-called Act on Psychomodulatory Substances was passed by the Chamber of Deputies in the 3rd reading within the legislative process, amending the Addictive Substances Act, the Health Protection from the Harmful Effects of Addictive Substances Act, the Advertising Regulation Act, the Criminal Code and a number of other laws (herinafter referred to as the "Act on Psychomodulatory Substances"), which fundamentally changes the world of psychoactive substances and their handling.

(pictured is the ARROWS technical cannabis team)

What changes does the Act on Psychomodulatory Substances introduce?

The Act on Psychomodulatory Substances introduces 3 groups of substances: a) addictive substances, b) psychomodulatory substances and c) psychoactive substances.

According to the wording of the act, psychomodulatory substances are new psychoactive substances and other substances with psychoactive effects that do not pose a serious risk to public health or a risk of serious social impacts on individuals and society and are also listed in the Government Regulation on the list of psychomodulatory substances, and products thereof.

Psychoactive substances are those new psychoactive substances for which, in the light of current scientific knowledge, serious health and social risks cannot be ruled out and which are at the same time listed in the Government Regulation on the list of classified psychoactive substances and their products. The handling of such a substance is restricted strictly for research purposes, on the basis of a licence granted by the Ministry of Health.

The inclusion of substances on the list of addictive, psychomodulatory or psychoactive substances will therefore be decided by listing them on the list of substances by the Government in close cooperation with the Ministry of Health, the State Institute of Health and the Office of the Government of the Czech Republic.

The procedure should be set up in a way that if a new substance appears on the market that is not regulated or controlled in any way, even in terms of international law, its effects on human health are unknown, but it may pose a health or social risk, it should be placed on either the list of addictive substances or the list of psychoactive substances. In particular, the pharmacological and toxicological properties of the substance, the degree and nature of psychoactivity, the potential of the substance to cause dependence and other aspects defined by the act are assessed.

If a substance has been listed on the list of classified psychoactive substances, the Ministry of Health, in cooperation with the State Institute of Health and the Office of the Government, shall carry out a risk assessment of the scheduled psychoactive substance and, upon completion of the risk assessment, but no later than 2 years after the placement of the substance on the list of scheduled psychoactive substances, shall propose to the Government (a) placement of that substance on the list of psychomodulatory substances, (b) placement of that substance on the list of addictive substances, (c) that the substance shall remain on the list of classified psychoactive substances, or (d) that the substance shall be removed from the list.

Regulation of psychomodulatory substances

According to the act, the psychomodulatory substances can only be handled on the basis of a permit issued by the Ministry of Health.

The psychomodulatory substances and the products containing such substances can be marketed under strictly regulated conditions under the Act on Psychomodulatory substances:

In properly labelled unit packs so that the quantities in the pack and the concentrations of the active substances are limited;
It must not contain foreign substances (chemical and microbiological limits);
They must be labelled so that the consumer receives all relevant information, including health and safety warnings;
Sales are only permitted in shops specialising in the sale of these substances and related products;
Sale to minors is prohibited;
Sales in a health care facility and related premises, school or events intended for persons under 18 years of age are prohibited;
Vending machines are prohibited;
Exports should only be possible under the authorisation régime.

At the same time, the possibility of advertising psychomodulatory substances will be strictly limited, with the only form of advertising allowed being in shops specialising in the sale of psychomodulatory substances.

The act also imposes requirements on the availability of psychomodulatory substances. The online shop through which Psychomodulants will be sold must be dedicated exclusively to the sale of psychomodulants and psychomodulant-related goods. At the same time, the seller must provide age verification at the time of purchase, at the time of delivery and at the same time the goods must be delivered only into the customer's own hands.

What now?

Now The Act on Psychomodulatory Substances must be passed by the Senate and then signed by the President. At the same time, it must be approved by the European Commission as part of the notification process in accordance with Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 on the procedure for the provision of information in the field of technical regulations and regulations for information society services, as such national legislation will affect the internal market of the European Union.

This act is expected to come into force and take effect on 1 January 2025, however, as the act still needs to be passed by the Senate and the European Commission, this is only an estimate. The notification process by the European Commission may take up to 6 months, however, according to the statements of the relevant MPs, the Minister of Health should arrange an expedited discussion with the European Commission.

Currently, the government regulation No. 463/2013 Coll., on the lists of addictive substances, is in force, according to which HHC, HHC-O and THCP fall under Schedule 4 psychotropic substances. The effective date of classification of these substances as addictive is set until 1 January 2025, or until The Act on Psychomodulatory Substances comes into force. Thus, with The Act on Psychomodulatory Substances coming into force, these substances should no longer be classified as addictive substances under the Addictive Substances Act and should most likely be classified as psychomodulatory substances. The handling of these substances should therefore be legal again, but under the conditions stipulated by the act.

As of the date of publication of this article, the draft implementing legislation, in particular the government regulation on the lists of psychomodulatory and psychoactive substances, has not yet been published and therefore it is not possible to say with certainty what substances will be included in these lists. However, the most talked about substances in this context are HHC and kratom, which are most likely to be classified as the psychomodulatory substances.

At the same time, an amendment to Government Decree No. 463/2013 Coll., on the lists of addictive substances, which is to add additional substances such as HHCP to the list No. 4 of psychotropic substances, is currently under discussion. You can read about this forthcoming amendment in the following article.