26 September 2017 - Authored by:Eveline Van Keymeulen
A long-awaited Royal Decree on controlled substances (Royal Decree) entered into force on 26 September 2017. The Royal Decree: (i) addresses the issue of “new psychoactive substances” by modifying the “black list” approach previously in place; (ii) creates a new framework for the use of the substances gamma-butyrolactone (GBL) and 1,4-butanediol (1,4-BD); and (iii) implements certain international guidelines from, for example, the World Health Organization and the United Nations.
The Royal Decree:
- Prohibits controlled substances on the basis of their common chemical structure instead of their inclusion by name in a so-called “black list” to avoid manufacturers slightly modifying the names of drugs to circumvent a match with a blacklisted drug.
- Restricts access for private individuals by introducing a licence for private property for the substances GBL and 1,4-BD,which are primarily used on a large scale for different production purposes (for example, as solvent for gluing) though can also be converted into the psychotropic substance GHB or so-called “liquid XTC”.
- Introduces an exemption to the export authorisation requirement for psychotropic substances in case of humanitarian urgency by only requiring an a posteriori notification to the Federal Agency for Medicines and Health Products (FAMHP).
Other changes include an update of the structure of the substances list and the implementation and modification of criminal sanctions. The Royal Decree will likely limit the administrative burden for the pharmaceutical industry, which is a regular user of some of these substances, for example by introducing the licence for private property.
A prior version of this post was originally published by the same author in Practical Law – Life Sciences, September 2017 Issue (Thomson Reuters).