CJEU: A product must have a beneficial effect to be a medical product

In a judgment of 10 July 2014 (joined cases C-358/13 and C-181/14), the Court of Justice of the European Union (CJEU) concluded that, according to EU law, mixtures of herbs containing synthetic cannabinoids cannot be regarded as medicinal products under the definition given in Article 1 (2) b of Directive 2001/83. The term medicinal product should be interpreted as excluding substances whose effects only involve a modification of physiological functions and do not entail immediate or long-term benefits to human health.

Background to the case

The merits of the case at the CJEU were as follows. Two men in Germany marketed synthetic cannabinoids designed to induce a state of intoxication in humans. The two men subsequently became the subject of criminal proceedings so that the authorities could put a stop to their marketing activities. However, at the time it was not possible to impose criminal sanctions for marketing these new psychoactive substances as they were not yet defined as narcotics according to German law. The men were therefore charged under medical products legislation for selling unsafe medical products. However, the national court was unsure how to interpret Article 1 (2) (b) of Directive 2001/83 and referred the question to the CJEU.

Definition of a medical product

Article 1 (2) (b) of Directive 2001/83 states that a product is a medical product under the Directive if it is a substance or combination of substances that may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis. One of the questions for the court was therefore how to interpret the word “modify”.

The judgment of the Court of Justice

From settled case law it is clear that not only the wording of the provisions should be considered, but also the context in which it occurs. From the context it was clear that the Directive aims to attain a high level of human health protection. The word “modify” should therefore, according to the court, be interpreted as not covering substances whose effects merely modify physiological functions and do not entail immediate or long-term benefits to human health.

It was concluded that the products in question in the case before the court were purely for recreational purposes and harmful to human health. The court stated that Article 1 (2) (b) of Directive 2001/83 should be interpreted as excluding substances which produce effects that merely modify physiological functions but do not have any beneficial effects on human health, are consumed solely to induce a state of in-toxication and are harmful to human health. The products in question were therefore not deemed to be medical products under the Directive.

The impact of the judgment

In this case, the products concerned fell outside criminal law sanctions. The actions of the German authorities are understandable, applying legislation to medicinal products in order to more effectively control and punish the marketing of these new psychoactive substances. However, a satisfactory outcome will not be achieved by applying the rules on medicinal products.

Advocate General Bot of the CJEU was clear in his opinion that the definition of a medical product is not to be used in this respect and stated 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 sub-stances whose effects are similar to those of narcotic drugs on account of, inter alia, their derived chemical composition and acute toxicity.”

This case therefore clarifies that the rules governing medicines are not the appropriate tools to protect public health from the dangers posed to the general population by drugs such as synthetic cannabinoids. The legal system must find another approach to help control such products.

It is also clear that 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.