Psychedelics Regulation in the UK and EU: Germany
KFN+ Law Office
1) Psychoactive Substances Legislation
The basic regulation of narcotics in Germany is the Narcotics Act (BtMG). According to article 1 BtMG, narcotics are all substances and preparations listed in Annexes 1-3 to this law.
Concerning the relevant penalties, article 29 para. 1 no. 1BtMG establishes the following:
A custodial sentence not exceeding five years or a monetary penalty shall be imposed on any person who
- Cultivates, manufactures, trades in, imports, exports, sells, delivers, otherwise puts into circulation, acquires or otherwise procures narcotics.
Moreover, a permission of the Federal Institute for Drugs and Medical Devices (BfArM) is required for the cultivation, manufacturing, trade, importing of narcotics without trading with them, export, delivering, selling or otherwise bringing narcotics into circulation (article 3 para. 1 BtMG). This permission can only be granted in exceptional cases for scientific or other purposes of public interest (article 3 para. 2 BtMG).
Another important piece of legislation is the Neu-psychoaktive-Stoffe-Gesetz (new psychoactive substance Act). With the second Ordinance amending the Annex to the NpSG of June 6th, 2021 (BGBl. I, 2231), which came into force on July 3rd, 2021, the substance groups of the New Psychoactive Substances Act (NpSG)were revised and adapted to the current state of knowledge. In addition, two new substance groups were added to the annex: arylcyclohexylamine-derived compounds and benzimidazole- derived compounds. Thus, the NpSG now contains a total of seven substance groups.
2) Analogue Compounds Legislation
The emergence and proliferation of new chemical variants of psychoactive substances (new psychoactive substances - NPS) posed a threat to public health in the opinion of the regulator. A punishable ban on the use and transferal of NPS is the aim of the new regulation. It is intended to combat the spread of these substances and protect the health of the population and individuals. The Act to Combat the Proliferation of New Psychoactive Substances, which came into force on November 26th, 2016, supplements the single-substance approach of the Narcotics Act (BtMG) with a substance group regulation, in order to counter NPS more effectively in legal terms, and to combat the proliferation and availability of these substances.
This substance group regulation is intended to break the race between the emergence of ever new chemical variants of known substances and the prohibition regulations in narcotics law that need to be adapted. Furthermore, the regulator seeks to send a clear message to dealers and consumers; these substances are prohibited and hazardous to health.
Up to now, NPS have been included in the annexes of the BtMG as individual substances (listed) and thus prohibited and subject to penalties. The substances to be newly subordinated often show only minor changes in chemical structures to substances already subject to the BtMG. Since the new substance is close in structure and effect to the substance already subject to the BtMG, the possibility of abuse under the conditions of supposed "legality" has been exploited, and the criminal provisions of the BtMG have been circumvented.
The NpSG is an independent law with a new approach. By banning entire groups of substances, the government believes that the health risks posed by NPS, especially for adolescents and young adults, can be countered more effectively and with greater foresight. This implies that it is no longer possible, as it was before, to circumvent bans by making small chemical changes and to place the corresponding substances on the market.
Depending on the development of the market, the government can amend the substance groups in the regulations of the NpSG, by either expanding or restricting them. Substances that prove to be particularly psychoactive and dangerous to health in a special way, as well as substances that are misused to a large extent, will continue to be included in the annexes of the BtMG. In these cases, the stricter regulations of the BtMG take precedence over those of the NpSG.
Similarly, recognized uses for commercial, industrial or scientific purposes are exempt from the prohibition (article 3(2)). Furthermore, the NpSG does not apply to medicinal products and narcotics (article 1(2)). In this respect, however, the handling of such substances must be subject to the approval required in each case according to the purpose pursued.
The law closes the regulatory and criminal gap created by a ruling of the European Court of Justice (ECJ) in July 2014 on the Medicines Act. The ECJ ruled that the handling of NPS not yet subject to the BtMG may no longer - as was previously the practice in Germany - be prosecuted and punished under pharmaceutical law.