Insights / 01-02-2022

Netherlands

 
Karin Verzijden
Axon

1) Psychoactive Substances Legislation

Psychoactive substances can be and are often regulated under the Dutch Opium Act (https://wetten.overheid.nl/BWBR0001941/2021-07-01) and underlying regulations (including the Opium Decree and Opium Regulation). Substances that are regulated are included in List I and II of the Dutch Opium Act.

If a psychoactive substance is regulated under the Dutch Opium Act, it implies that the substance is prohibited (e.g. to sell, produce, distribute and possess), unless an exception or exemption applies.

If a psychoactive substance is the active substance in an authorized medicinal product or is used in (approved) research, the Dutch Opium Act and underlying regulations remain to be applicable, in combination with the relevant act (such as the Dutch Medicines Act or the Medical Research involving Human Subjects Act).

If a specific compound is not listed, and also not authorised as a medicinal product, the product cannot be sold as a medicinal product (and no claims should be made about the effect of the compound, in order to avoid that the product qualifies as a non-authorised -and thus prohibited- medicinal product).

2) Analogue Compound Legislation

Currently, there is no general legislation that covers analogue compounds. However, in practice, this leads to situations that are perceived as undesirable, as compounds with a different chemical structure are not always regulated as part of the existing legislation.

Therefore, a legislative proposal was published for public consultation in March 2020 to amend the Dutch Opium Act. In the proposal, it was included that groups of substances could be added to a new list in the Opium Act (List Ia), with the aim to avoid the situation wherein the chemical structure of a substance is (slightly) changed and is after that change no longer a regulated substance.

This proposal is not yet adopted due to the political situation in the Netherlands: there is not yet a new formal government after the elections and in March 2021. The Dutch Parliament was informed that no changes would occur until at least spring 2022 (and the Dutch Parliament has not yet voted with regard to this proposal): https://www.parlementairemonitor.nl/9353000/1/j9vvij5epmj1ey0/vlhrnrig0rxo

If the proposal is adopted in the future, it will become possible to regulate groups of substances and it will be possible to act fast if a specific substance must be regulated without delay. However, as of today, there is not yet a specific regulation with regard to analogue compounds. Thus, the legal status of a product shall depend on whether or not the specific analogue compound will be included on the lists of the Dutch Opium Act.