Introduction

On July 10 2014 the European Court of Justice (ECJ) (Joined Cases C-358/13 and C-181/14) found that according to EU law, mixtures of herbs containing synthetic cannabinoids cannot be regarded as medicinal products under Article 1(2)b of EU Directive 2001/83/EC. The directive 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."

Synthetic cannabinoids are new psychoactive substances which are generally similar to the substance that they copy without being exactly the same. In certain cases this enables them to circumvent narcotics legislation, at least in the short term.

The court's reasoning states that synthetic cannabinoids merely modify physiological functions but with no beneficial effects on human health, either immediately or in the long term, and that they are consumed solely to induce a state of intoxication and as such are harmful to human health.

The ECJ's decision was rendered in response to questions raised by the German Supreme Court.

Opinion

Based on the wording and objectives pursued by the directive and existing EU case law, Advocate General Bot held that substances and mixtures such as synthetic cannabinoids should be excluded from the legal definition of a 'medicinal product' based on Article 1(2)(b) in the absence of any therapeutic benefit.

More specifically, Bot considered that Article 1(2)(a) and Article 1(2)(b) must be read in conjunction, and that the criterion related to the capacity to restore and correct human physiological functions referred to in Article 1(2)b cannot be interpreted independently of its context and the medical application for which the substance is intended. Bot stated that it is insufficient 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, Bot considered that the rules governing medicines do not provide the appropriate tools in that respect. He 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."

This rejected any attempt at manipulating the definition of 'medicinal product' to achieve that goal.

Decision

The ECJ followed Bot's opinion and ruled that the term 'medicinal product' does not include products (eg, mixtures of herbs containing synthetic cannabinoids) which have the effect of modifying physiological functions but with no immediate or long-term beneficial effects on human health, and which are contrarily, consumed solely to induce a state of intoxication and as such are harmful to human health.

This conclusion is based on a combined interpretation of Article 1(2)a and Article 1(2)b, which require the existence of a beneficial effect on human health in order for a product to qualify as a medicinal product. This interpretation relies, among other things, on the fact that the definition refers to a 'medical diagnosis', the purpose of which is to identify a disease or illness so that it may be treated in good time.

According to the court, the word 'modify' must therefore be interpreted as encompassing substances that are capable of having a beneficial effect on the functioning of the human organism and consequently on human health. Therefore, the term 'medicinal product' in Article 1(2)b must be interpreted as not covering substances whose effects consist of a mere modification of physiological functions and which entail no immediate or long-term beneficial effects for human health.

Maria-Paz Martens & Nicolas Carbonnelle 

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