On 10 July 2014, the Court of Justice of the European Union (CJEU) gave its judgment in a case involving “legal highs” that a substance which only influences physiological functions without any beneficial effects on human health, shall not be considered as a medicinal product within the meaning of Article 1(2)(b) of Directive 2001/83/EC (decision of the CJEU, dated 10 July 2014, joined cases C-358/13 and C-181/14 (criminal proceedings against Markus D. and G.)). The CJEU thus clarifies the scope of the definition of medicinal products under EU laws and overrules diverging case law at Member State level. This decision is potentially relevant for the regulatory classification of other borderline products.

This CJEU decision answered a request for a preliminary ruling issued by the German Federal Supreme Court on whether a product containing herbs and synthetic cannabinoids must be classified as a medicinal product. The product in question was sold in small bags and did not contain fixed quantities of active substances or any indications on the active substance or dosage guidance. However, it was proved in pre-experimental studies that these substances had a physiological effect, but did not have any desired health effects. The sellers declared those products to be “air fresheners” whose content was not suitable for human consumption.

During criminal proceedings at first-instance in Germany, the “legal highs” were classified as medicinal products and the sellers were convicted of selling unsafe medicinal products. The sellers appealed against this judgment and the German Federal Supreme Court then doubted that these substances should properly be considered as medicinal products in accordance with the definition in Article 1(2) of Directive 2001/83/EC:

“2. Medicinal product:

(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or

(b) Any substance or combination of substances which 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.”

The German Federal Supreme Court stated that due to the substance’s lack of health effects only the criterion “modifying the physiological functions” could be relevant to its classification as a medicinal product. In this regard, the court found that it is not clear whether the wording of the EU Directive also includes products which simply modify physiological functions without any beneficial health effect or whether it limits the definition to products with health effects. Therefore, the court suspended the procedure and referred the following question to the CJEU:

“Can substances which influence physiological functions be considered as medicinal products even though they do not have any beneficial effects on human health or are even hazardous to health?”

The CJEU opposed this (possible) interpretation and ruled that a substance which merely influences physiological functions without any beneficial effects on human health cannot be considered as a medicinal product under Directive 2001/83/EC:

  • First, the judges made clear that the definitions of medicinal products by function and medicinal products by presentation have to be seen in context and must not be read in a manner that would bring the two elements into conflict.
  • They further acknowledged that the wording “to modify the physiological functions” does not explicitly address whether a positive or negative effect is meant. However, they referred to the legislature’s intention to include substances having a beneficial effect on humans which should also apply to medicinal products by function.
  • According to their view, such intention would also become clear as the wording “to modify” is used in connection with the further terms “restore” and “correct” physiological functions which imply beneficial effects.
  • In addition, such interpretation would correspond with recital 7 of Directive 2001/83/EC which refers to the basic concept of harmfulness and therapeutic efficacy of medicinal products and thus also suggests their positive impact on human health.

This decision resulted from a case involving “legal highs” and has now led to further clarification on the definition of medicinal products. The Court’s findings will also be relevant for other borderline products (e.g., e-cigarettes) and should therefore be carefully analyzed by practitioners. However, the situation is still not fully clear. Oral contraceptives or abortifacients arguably do not have a beneficial health effect, but were classified by the CJEU as belonging to a special regime under Directive 2001/83/EC. In addition, the concept of “beneficial effects” is fairly vague and leaves room for interpretation. For example, if one follows the Court’s reasoning, a pharmacologically active weight loss product intended for persons with normal weight but wanting the reach “model standard” may fall outside the definition of a medicinal product.