Draft:Psychomodulatory substances

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Psychomodulatory substances (PMS) (Czech: psychomodulační látky (PML)) is a term referring to a potential new category of psychoactive substances in the Czech Republic for the control and regulation of which a special legislation has been in the making since 2021.

Psychomodulatory substances are defined as psychoactive substances with low health and societal risk (i.e., in principle with a known and acceptable safety profile) that can be, as a distinct product category, marketed for human consumption. Their regulation is independent of other legislative frameworks and categories of substances or products, such as controlled substances ("illegal drugs"), pharmaceuticals, or food and dietary supplements.

Regulation as an alternative to prohibition

Since the late 1980s, prohibition, with its strict enforcement through the instruments of criminal law (criminalization), including user behavior and handling for personal use, has become the dominant concept for the regulation of psychoactive substances at the international and national levels worldwide, leading to the so-called war on drugs with the militarization of drug policies. The efficacy of such punitive prohibition in controlling psychoactive substances has been repeatedly questioned and often called a policy failure; prohibition is a source of harm in areas of health, societal, human rights, security or economy. Yet the prohibition regime is difficult to repeal, change or reform, because it is a system designed to exclude any intervention or alternatives.

The regulation of psychomodulatory substances fills the gap between the currently existing extreme alternatives - prohibition and criminalization on the one hand and unregulated unrestricted availability on the other - which are associated with the highest health and overall societal harms (the model of availability regulation and its impact on societal harms is also referred to as the U-curve). In this regulatory vacuum, it is not possible, for example, to restrict the availability of the product to children and minors, to ensure adequate consumer information (e.g. psychoactive substances are offered as collectibles, bath salts, etc.), and notably, the absence of adequate regulation is a source of moral dilemma, where politicians and decision-makers trying to regulate supply face the choice of either not intervening at all or subjecting the psychoactive substance to an unreasonably strict prohibition regime.

Legislative framework for psychomodulatory substances in the Czech Republic

Psychomodulatory substances are primarily a (potential) legislative category, the aim of which is to establish adequate and modern regulation of psychoactive substances. So far, the only existing option for controlling psychoactive substances is prohibition, i.e. banning their use outside of a medical or a research context. This prohibition regime has been in place worldwide since 1961 and is the result of the three international drug conventions of 1961, 1971 and 1988, which concern hundreds of psychoactive substances ("narcotic drugs and psychotropic substances") contained in the annexes to the 1961 and 1971 Conventions. However, the prohibition regime does not apply to, for example, alcoholic beverages or tobacco products, even though these are psychoactive substances and products with a higher health and overall social harmfulness than the narcotic drugs and psychotropic substances that are subject to prohibition. In the Czech legal system, the prohibition regime is established by Act No. 167/1998 Coll., on Additive Substances, and the related Government Regulation No. 463/2013 Coll., on Lists of Addictive Substances, and Government Decree No. 455/2009 Coll., establishing which plants and mushrooms are considered to contain a narcotic or a psychotropic substance for the purposes of the Criminal Code.

The regulation of psychomodulatory substances circumvents the prohibition regime because it concerns psychoactive substances that are not controlled as narcotic drugs or psychotropic substances by international drug conventions or European regulations, i.e. they are not on the lists of controlled narcotic drugs and psychotropic substances ('illegal drugs'). These are therefore mainly substances referred to as new psychoactive substances (NPS). The legislative framework for psychomodulatory substances is based on Article 1b of Council Framework Decision 2004/757/JHA, which allows EU Member States to control new psychoactive substances at their discretion if they are not subject to EU control.

Parameters of the Czech regulatory framework for psychomodulatory substances

The handling of psychomodulatory substances in terms of import, export, manufacture, sale (introducing on the market to final consumers) will be subject to licensing. The sale will be subject to strict conditions: these substances can only be marketed in unit packaging with health and safety warnings, the quantity in the pack and the concentration of active substances will be limited, the content of foreign substances will be controlled (chemical and microbiological limits) and the user will be provided with information on health risks and recommended dosage. Sales will only be allowed in specialized stores, sales to minors and sales through vending machines will be prohibited. Minors will not be allowed inside the specialized stores. For online sales, there will be a double age verification (e.g. via bank identity or ID check) both at the time of order and at the time of delivery of the products (only by registered mail, with identity check). Advertising of psychomodulatory substances will be prohibited. The new regulation will also make it possible to react quickly to a new substance before assessing its harmfulness and to prevent its uncontrolled distribution and availability by creating a list of so-called scheduled psychoactive substances, the introduction to market (sale) of which will be prohibited, but the illicit handling of which will not be subject to disproportionately severe penalties as for narcotic drugs and psychotropic substances.

The regulated market for psychomodulatory substances should in the first phase cover kratom and then low delta-9-tetrahydrocannabinol technical cannabis products intended for recreational use.

The regulation of psychomodulatory substances corresponds to the principles of so-called smart regulation (rational regulation) of psychoactive substances, which have been proposed as the principles of modern psychoactive substance regulation:

• the psychoactivity of a substance per se is not a sufficient reason to ban it, as people can maintain control over their use (also related to the principle of cognitive liberty)
• the primary objective and measure of the regulatory framework must be to reduce the harms associated with the existence of the substance/product (harm reduction principle)
• the extent of regulation must be proportionate to the harmfulness of the substance/product
• the riskiness of the product and its sale, including advertising, must be regulated
• adult users have the right to adequate information about the psychoactive substance
• the availability of prevention and treatment services for those who have lost control of their substance use needs to be ensured
• consumption taxation and other economic instruments are a means of regulating consumption and a source of funds for prevention and treatment
• criminal law should be a tool of last resort to regulate human behavior, people should not be punished for acts of low social risk,
• children and minors should be protected from the supply of addictive products
• the legal market should be protected from the development of dangerous illegal supply

The process of preparing the Czech regulation of psychomodulatory substances

• In November/December 2021, the regulatory framework is conceived of, the new category acquires its name (psychomodulatory substances, Czech psychomodulační látky) and the first draft of a law is created.
• Since mid-2022, the preparation of the Bill has been under the responsibility of a working group under the Government Council for Addiction Policy Coordination and the National Drug Coordinator, and since autumn 2022 it has been the subject of a broad interdepartmental discussion and bilateral negotiations with key ministries and institutions (Ministry of Health, Ministry of Agriculture, State Agricultural and Food Inspectorate, Ministry of Finance, National Anti-Drug Centre of the Police of the Czech Republic, etc.).
• The proposal to regulate psychomodulatory substances has also been discussed several times at the governmental level, in particular in relation to kratom or cannabis with low tetrahydrocannabinol content or semi-synthetic cannabinoids (e.g. HHC, THCP), which are not internationally controlled as narcotic and psychotropic substances but which cannot be classified as food due to their psychoactive effect. During the negotiations of the new regulation, it was agreed to go down the route of a Parliamentary Bill proposal due to the urgency of the need to regulate these substances.
• At the request of the Minister of Health, the Government discussed additions to the lists to Government Regulation No. 463/2013 Coll., on Lists of Addictive Substances (i.e. narcotic and psychotropic substances) on 12th July 2023 and did not approve the Minister's proposal to add the substances ADB-BUTINACA, hexahydrocannabinol (HHC), 7-hydroxymitragynine, kratom, mitragynine and tetrahydrocannabiphorol (THCP) to the list of controlled narcotic drugs and psychotropic substances, stating that a new regulatory framework is being prepared for these substances.
• In the last phase (July/August 2023) before submission as a Parliamentary Bill proposal, the draft was intensively finalized by the team of the Government Council for Addiction Policy Coordination in cooperation with the Inspectorate for Narcotic Drugs and Psychotropic Substances and the Department of Legislation of the Ministry of Health.
• A group of MPs, members of the Health Committee of the Chamber of Deputies of the Parliament of the Czech Republic (Zdenka Němečková Crkvenjaš, Tom Philipp, Věra Adámková, Michaela Šebelová, Martina Ochodnická, Klára Kocmanová, David Kasal) submitted the draft Bill to the Chamber on 31st July 2023. The draft law was circulated to MPs as press 504/0 on 1st August 2023.
• The Government discussed the draft on 30th August 2023 and adopted a favorable opinion on it despite a number of comments (press 504/1, registered under No. OVA 751/23).
• The first reading in the Chamber of Deputies took place on 26th September 2023 at its 76th session (Resolution No 772). The Bill was referred to the Health Committee as a guarantee committee. At the request of the Minister of Health, the time limit for consideration by the Committee was extended by 20 days, making it 90 days.
• In view of the comments made by the Government and MPs during the debate at the first reading, it was agreed that a comprehensive amendment to the version discussed at the first reading would be submitted by the second reading. Between October 2023 and March 2024, a series of negotiations were held in various configurations between the MP-patrons, the Government Council for Addiction Policy Coordination, the National Drug Coordinator, the Ministry of Health, the Ministry of Agriculture, the Czech Agriculture and Food Inspection Authority, the Ministry of Finance, the Government Legislation Department of the Office of the Government of the Czech Republic, with the aim of preparing a consensus comprehensive amending proposal. The problem areas on which full consensus was not reached were: what authorities should be responsible for the new regulation and for the process of listing substances (the Ministry of Health versus the Office of the Government), the export of psychomodulatory substances (prohibit versus allow under strict conditions) and the earmarking of fees for particular causes (not designating any particular use for funds versus fees as revenue assigned for addiction prevention and treatment programs).
• On 7th and 14th February 2024, the Government discussed the issue of the unregulated presence of the semi-synthetic cannabinoid HHC and decided to add it (along with THCP and HHC-O) to the list of controlled substances, despite the fact that a Psychomodulatory Substances Bill is pending in the Chamber of the Deputies of the Parliament (thus not resisting the pressure of the regulatory dilemma - see above). The decision to list them as narcotic drugs and psychotropic substances was adopted by the Government (Resolution No. 112/2024, Decree No. 52/2024), however, at the suggestion of the Minister for Legislation, the ban was time-limited until 31st December 2024.
• The meeting of the Health Committee of the Chamber of Deputies regarding the press 504/0, at which the comprehensive amending proposal was approved (press 504/2), took place on 9th April 2024. The comprehensive amendment was approved in the version promoted by the Ministry of Health, i.e. under the authority of the Ministry of Health, with a ban on the export of psychomodulatory substances and with the fees as a revenue of the state budget without purposive assigning.
• At the 98th session of the Chamber of Deputies on 16th April, the press 504/0 was discussed at the second reading. In it, the proposal to return the Bill to the Health Committee for consideration was rejected, a comprehensive amendment in the wording was approved by the Health Committee on 9th April 2024, and 6 other amendments were recorded (press 504/3). In addition, a proposal to reduce the time for consideration by the guarantee committee (the Health Committee) from 14 to 7 days was approved.
• The Health Committee issued a resolution of the guarantee committee, which was delivered to deputies as parliamentary press 504/4 and press 504/5 on 25th April 2024.
• The third reading of the Bill happened on 3rd May 2024 and was approved (Resolution No. 992).
• The Bill will be submitted to the Senate and if passed needs to also be approved and signed by the President.
• On 17th May 2024, the European Commission received a notification as part of the process in accordance with Directive (EU) 2015/1535 of the European Parliament and of the Council of 9th September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services, and is currently pending approval. This directive aims to prevent creating barriers in the internal market; EU Member States notify their legislative projects regarding products and Information Society services to the Commission which analyses these projects in the light of EU legislation. Member States participate on the equal foot with the Commission in this procedure and they can also issue their opinions on the notified drafts.

About the origin of the term "psychomodulační látka" (psychomodulatory substance)

The author of the Czech term psychomodulační látka (English: psychomodulatory substance) is Viktor Mravčík, a Czech epidemiologist in the field of addiction. He and other members of a small implementation team (Petr Pleva, Jana Michailidu, later Matyáš Lucký, Lucia Kiššová) first on their own initiative, and later as part of the decriminalization and regulatory initiatives of the National Drug Coordinator Jindřich Vobořil, prepared the new legal framework and guided it through the tasking and legislative process. The term psychomodulační (psychomodulatory) was to refer to the existence of a psychoactive effect, i.e. the ability to influence (modulate) mental processes, but at the same time it was to be a new neutral term that distinguished the new category of substances from current categories with existing legal or professional definitions and meanings (such as addictive, psychoactive, narcotic, psychotropic, etc.).