The Court of Justice of the European Union ("CJEU") found in a judgment of 10 July 2014 (joined cases C-358/13 and C-181/14) that according to EU law, mixtures of herbs containing synthetic cannabinoids cannot be regarded as medicinal products under the definition of Article 1 (2) b of Directive 2001/83, that defines medicinal products as "any substance or combination of substances which may be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making diagnosis". The reasoning of the Court states that synthetic cannabinoids merely have the effect of modifying physiological functions but are not such as to have any beneficial effects, either immediately or in the long term, on human health and are consumed solely to induce a state of intoxication and are, as such, harmful to human health.
Background of the case
The CJEU's decision is rendered in response to questions raised by the German Supreme Court in the framework of a national case based on the following facts.
Between 2010 and 2012 two individuals, Mr. D and Mr. G, sold in Germany herbs mixed with synthetic cannabinoids. Synthetic cannabinoids are "new psychoactive substances", which are generally similar to those of the substance they copy without being exactly the same, which enables them in certain cases – at least in the short term – to circumvent narcotics legislation.
The German authorities brought criminal charges against Mr. D and Mr. G, based on a breach of the German Medicines Act given that, at the material time, the German Act on narcotic drugs did not cover synthetic cannabinoids. Both vendors were sentenced before the lower courts.
On appeal however, the German Supreme Court held that the vendors' criminal liability under the German Medicines Act essentially depended on whether synthetic cannabinoids can be regarded as "medicinal products" covered by Article 1 (2) (b) of the Directive 2001/83. The sale of mixtures containing synthetic cannabinoids used as a marijuana substitute could give rise to criminal law proceedings on the ground of unlawful sale of unsafe medicinal products, unless said substance does not qualify as a medicinal product –in which case no criminal sanctions could be applied under German law. The question was subsequently referred to the CJEU.
Opinion of Advocate-General Bot
In his opinion on the case, Advocate-General Bot held that based on the wording and objectives pursued by Directive 2001/83 as well as the existing EU case-law, substances and mixtures such as synthetic cannabinoids should be excluded from the legal definition of a "medicinal product" based on Article 1 (2) b of Directive 2001/83 in the absence of any therapeutic benefit.
More specifically, he considered that subparagraphs (a) and (b) of Article 1 (2) of Directive 2001/83 must be read in conjunction, and that hence the criterion related to the capacity to restore and correct human physiological functions referred to in Article 1 (2) b of Directive 2001/83 cannot be interpreted independently of its context and the medical application for which the substance is intended. The Advocate-General stated that it is not sufficient for the substances to be capable of modifying physiological functions, even more so where those substances are consumed purely for recreational purposes and may be particularly harmful to human health.
In addition, while acknowledging that Member States may be confronted with a legal vacuum in their fight against psychoactive substances, the AG considered that the rules governing medicines do not provide the appropriate tools in that respect. The AG noted that "Only repressive measures based on the control of narcotic drugs will enable, through the objectives of public safety, public policy and public health pursued by such measures, a response to be given with the requisite speed to the appearance on the market of substances whose effects are similar to those of narcotic drugs on account of, inter alia, their derived chemical composition and acute toxicity", thus rejecting any attempt at 'twisting' the definition of medicinal product in order to achieve that goal.
The Judgment of the Court
The CJEU followed the Advocate-General's opinion ruling that the term "medicinal product" does not include products, such as mixtures of herbs containing synthetic cannabinoids, which have the effect of modifying physiological functions, but do not have any immediate or long-term beneficial effects on human health and are, contrarily, solely consumed to induce a state of intoxication and are as such harmful to human health.
This conclusion is based on a combined interpretation of Article 1 (2) a and Article 1 (2) b of Directive 2001/83, which require the existence of a "beneficial effect" for human health in order for a product to qualify as a medicinal product. That interpretation relies inter alia on the fact that the definition refers to a "medical diagnosis", of which the purpose is to identify a disease or illness so that it may be treated in good time.
The word "modify" must therefore, according to the Court, be interpreted as encompassing substances which are capable of having a beneficial effect on the functioning of the human organism and as a consequence on human health. Therefore, the term medicinal product in Article 1(2) b of Directive 2001/83 must be interpreted as not covering substances whose effects consist in a mere modification of physiological functions and which are not such as to entail immediate or long-term beneficial effects for human health.
This article is part of the International Life Sciences Update for October 2014