Case C-358/13, D. – legal highs [judgment 2014, ECLI:EU:C:2014:2060]

Is a substance capable of creating a ‘legal high’, a ‘medicinal product’ under the EU’s medicinal products Directive 2001/83, as amended by Directive 2004/27?

Facts
Mr D. runs a shop in Germany called ‘G. – All About Hemp’ [G. – Alles rund um Hanf]. His customers could also buy tiny packages of ‘air freshener’ which, when smoked with tobacco, could induce a high.

The German authorities ran some tests on this ‘air freshener’. The results established the presence of synthetic cannabinoids. More specifically, the air freshener was shown to contain the ‘non classical’ aminoalkylindoles of JWH-210 and RCS-4. These are important in two respects. First, they are not like the ‘classical cannabinoids’, which are structurally related to an active ingredient found in marijuana and known as THC. And second, whereas THC stimulates the immune system and is administered to cystic fibrosis sufferers, the development of synthetic cannabinoids had been stopped at an early stage of development because of the serious side-effects that were expected from the substances’ psychoactive effects.

The German authorities decided to prosecute Mr D not under the German Drugs Act [Betäubungsmittelgesetz] but under the German Medicines Act [Arzneimittelgesetzes]. The prosecution claimed that Mr D already knew from an earlier investigation into these ‘herbal mixtures’ that the authorities had taken the view that these were a danger to public health and had been classified as a ‘dubious’ risky drug for the purposes of the German Medicines Act. Equally, the packages sold by Mr D had been labelled as ‘air freshener’. The packages indicated that their content was not suitable for human consumption. And the packaging said nothing about either the type or quantity of active ingredient in the ‘air freshener’, or indeed the correct dosage.

At first instance, Mr D was found guilty. He was given a suspended prison sentence of 1 year and 9 months. But Mr D appealed on the basis of the court’s assessment of the evidence, and its concomitant finding that synthetic cannabinoids had a ‘dubious’ risky effect. He also challenged the court’s finding that he knew about this.

The German Supreme Court, bound as it was to recognise the factual findings made by the court at first instance, noted that these goods were bought not for any health-improving reasons but solely for the purposes of getting high.

Consequently, the Supreme Court noted that it would only be a criminal offence under German law if a particular substance would be deemed to fall within the definition of a ‘medicine’, as defined in Article 2(1) of the German Medicines Act.

The Supreme Court recalled that the wording of Article 2(1) of the German Medicines Act had been fundamentally changed in order to implement Article 1(2) of the EU’s Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27.

In particular, Article 1(2)(b) of the Directive defines a ‘medicinal product’ as:

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 Supreme Court identified the key issue. Could a substance which causes a high be said to ‘modify physiological function’?

German law provided no clear answer to that question. According to one strand of German criminal and administrative case law, plus a group of legal commentators, a medicinal product could only qualify as such if a substance actually improved physiological function. Support for such an interpretation was to be found in the positive aims and goals inherent in the very words of ‘restore’ (and ‘improve’, as mentioned in the German Act). Equally, systematically interpreting the words ‘medicinal product’ in the context of EU and German legislation, would suggest that a medicinal product was something that could combat illness. It surely would not have been the intention of the legislature to have included within that definition substances which would actually encourage a risk to human health. Consequently, the term ‘medicinal product’ should be interpreted narrowly.

However, the Supreme Court noted that there was another body of case law, and attendent legal commentary, which advocated the opposite approach. That is to say, the definition of medicinal product should be understood as including any substance which modified ‘physiological function’ irrespective of whether there was a beneficial therapeutic effect or a negative one (in the sense that it caused harmful effects). The determining factor should be whether the pharmacological effect of the substance caused a change which was foreign to the normal processes occurring in the human body. Defining a medicinal product in this way would therefore cover substances or preparations that were used to create a high.

The German Supreme Court recognised that the latter approach had been used by the German Supreme Court itself in order to bring some substances within the scope of the legal definition of a ‘medicine’. These substances included not only designer drugs like methylmetaqualone but also chemical solutions such as gamma-butyrolacton.

The difficulty with maintaining that approach, however, was that line of Supreme Court case law hinged on the old definition of what constituted a medicine. Of course, the definition had been radically altered when, in 2009, the German legislature had redefined the term as part of Germany’s implementation of the EU Directives.

Consequently, the German Supreme Court faced a twin problem. The German Supreme Court could not rely on the old German law definition of ‘medicine’, and the concept of a ‘medicinal product’ would itself be an autonomous concept under EU law.

Therefore, the President of the German Supreme Court and four other Supreme Court judges realised that they were obliged to make a reference to the CJEU.

Questions Referred
An unofficial translation of the questions asked by the German Supreme Court reads:

Must Article 1(2)(b) of Directive 2001/83, as amended by Directive 2004/27 of 31 March 2004, be interpreted as including any substance or combination of substances which merely modify physiological functions – and thus do not restore or improve them – will only be considered to be a medicinal product if they are therapeutically useful or in any event exert a positive influence on the body’s functions?
If so, then does any substance or combination of substances which are taken solely for their – ‘high-creating’ – psychoactive effect and thereby presenting a risk to human health, fall outside of the Directive’s concept of a ‘medicinal product’?