10 July 2014: CJEU judgment in case D (C-358/13)
Mr. D. sold in his shop ("G.- All about hemp") small bags of herbs with added synthetic cannabinoids as air fresheners, not meant for human consumption. There was no information on the bags as to either fixed quantities of any active substances or dosage guidance. Mr D. was, however, supposedly aware that his customers used these bags as a substitute for marijuana and was sentenced to prison due to introducing 'unsafe medicinal products' on the market. Synthetic cannabinoids has been classified as an unsafe medicinal product in German law, where its potential negative side effects were taken into account. The question referred to the CJEU is whether this product could be considered to be a 'medicinal product' as defined by the Directive 2001/83 on the Community code relating to medicinal products for human use, which the German law was implementing. What is the issue here?
The definition of a medicinal product in Article 1(2) of the Directive requires it to treat or prevent diseases in human beings or to have a beneficial effect on their physiological functions (according to the settled case law - Par. 33-38). The synthetic marijuana has not been proven to bring any benefit to human health but is only confirmed to modify physiological functions in humans (not necessarily for the better), and is being used to induce a state of intoxication, which as such is considered harmful to human health (in an objective manner). (Par. 26) If the definition of a medicinal product is limited only to such products that are supposed to contribute to consumer's immediate or long-term well-being the synthetic cannabinoids may not, therefore, be classified as such. The CJEU concludes that such products as mentioned in this case may not be seen as a medicinal product and are, consequently, not subject to the rules governing the introduction of medicinal products to the market. Even if it means that selling such products may, therefore, not bring about any criminal sanctions, this does not undermine this conclusion, pursuant to the CJEU. (Par. 48)