Criminal proceedings against Markus D. (C-358/13) and G. (C-181/14).

• Jurisdiction: European Union
• Court: Court of Justice (European Union)
• Date: 12 June 2014

OPINION OF ADVOCATE GENERAL

BOT

delivered on 12 June 2014 (1)

Joined Cases C‑358/13 and C‑181/14

Criminal proceedings

v

D. (C‑358/13),

G. (C‑181/14)

(Requests for a preliminary ruling from the Bundesgerichtshof (Germany))

(Medicinal products for human use — Directive 2001/83/EC — Scope — Interpretation of the concept of ‘medicinal product by function’ — Scope of the criterion relating to the capacity to modify physiological functions — Product based on herbs and synthetic cannabinoids marketed solely for recreational purposes — Absence of medical or therapeutic benefits — Included)

1. Can a combination of substances based on herbs and synthetic cannabinoids designed to induce a state of intoxication in human beings comparable to that resulting from the consumption of cannabis fall within the definition of ‘medicinal product’ within the meaning of Article 1(2)(b) of Directive 2001/83/EC? (2)

2. In other words, can the definition of ‘medicinal product’ in that provision cover a substance or a combination of substances which, while it is capable of modifying human physiological functions, is not designed to prevent or cure disease, where it is administered to human beings solely for recreational purposes?

3. These are, in essence, the questions referred to the Court by the Bundesgerichtshof (Federal Court of Justice, Germany).

4. Those questions form part of two sets of criminal proceedings instigated by the Generalbundesanwalt beim Bundesgerichtshof (Procurator General attached to the Bundesgerichtshof, ‘the Generalbundesanwalt’) against two individuals, Mr D. and Mr G., who, between 2010 and 2012, marketed herb mixtures to which various synthetic cannabinoids were added which were designed to mimic the effects of cannabis when smoked.

5. At the time of the facts in the main proceedings, it was not possible under German legislation relating to combating narcotic drugs to impose criminal law sanctions in respect of the marketing of these new psychoactive substances. In the absence of express legislative provision, the national courts therefore applied the legislation on medicinal products, taking the view that the sale of a product such as that in question fell within the definition of placing an unsafe medicinal product on the market and, on that basis, constituted an offence.

6. Pursuant to that legislation, the Landgericht Lüneburg (Regional Court, Lüneburg, Germany) — in Case C‑358/13 — sentenced Mr D. to one year and nine months imprisonment which was suspended, on the basis that he had marketed mixtures of herbs and synthetic cannabinoids in the form of air fresheners and deodorants in his shop, ‘G. Alles rund um Hanf’. Under the same legislation, the Landgericht Itzehoe (Regional Court, Itzehoe, Germany) — in Case C‑181/14 — sentenced Mr G. to four and a half years imprisonment and fined him EUR 200 000 for having sold those products through his online shop, initially alone and, subsequently, with another person.

7. It is in the context of the appeals on a point of law lodged by Mr D. and Mr G. that the Bundesgerichtshof has raised the question of how these mixtures of herbs and synthetic cannabinoids are to be classified under EU law. As the Bundesgerichtshof points out in its orders for reference, these individuals can be found to be criminally liable only in so far as the measure or preparation in question may be classified as a ‘medicinal product’ within the meaning of Article 1(2)(b) of Directive 2001/83.

8. According to that provision, the term ‘medicinal product’ must be regarded as covering ‘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’. (3)

9. In the main proceedings, it is not disputed that the consumption of synthetic cannabinoids contained in these mixtures of herbs triggers a modification of physiological functions in human beings by exerting a pharmacological action, particularly through their nerve receptors.

10. The Bundesgerichtshof therefore asks whether, notwithstanding the risks which the combination of substances in question poses to human health, the capacity of that combination to modify physiological functions is sufficient for it to be classified as a ‘medicinal product’ within the meaning of Article 1(2)(b) of Directive 2001/83, or whether it is also necessary for the administration of that combination to be of therapeutic benefit for human beings.

11. As the Bundesgerichtshof entertains doubts as to the correct interpretation of Article 1(2)(b) of Directive 2001/83, it has decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

‘(1) Is Article 1(2)(b) of Directive 2001/83 … to be interpreted as meaning that substances or combinations of substances within the meaning of that provision which merely modify — that is, do not restore or correct — human physiological functions are to be regarded as medicinal products only if they are of therapeutic benefit or at any rate bring about a modification of physiological functions along positive lines?

(2) Consequently, do substances or combinations of substances which are consumed solely for their — intoxication-inducing — psychoactive effects, and in the process also have an effect which at least poses a risk to health, fall under the definition of “medicinal product” contained in … [D]irective [2001/83]?’

12. In their observations, the Generalbundesanwalt and the German, Czech, Estonian, Italian, Finnish and Norwegian Governments submit that the definition of ‘medicinal product’ in Article 1(2)(b) of Directive 2001/83 covers all substances or combinations of substances capable of modifying human physiological functions, including where such substances or combinations of substances are not of any therapeutic benefit. Consequently, they consider that substances or combinations of substances which are consumed solely for their intoxication-inducing psychoactive effects and which are, on any view, harmful to health, may fall within that definition.

13. The Hungarian and United Kingdom Governments disagree with that interpretation, arguing that a product which is consumed solely for its psychoactive effects and not for any therapeutic purpose must be excluded from the definition of medicinal product. Similarly, the European Commission considers that the criterion relating to the capacity to modify physiological functions laid down in Article 1(2)(b) of Directive 2001/83 is not, in itself, decisive for the purpose of classifying a product as ‘medicinal’. In this respect, it submits that ‘medicinal products by function’ covered by that provision must perform an action which goes beyond triggering a chemical or biological process in the human body, a process which must be evaluated in the light of the medical or therapeutic purpose of the product concerned.

14. In this Opinion, I shall explain the reasons for my view that the definition of ‘medicinal product’ in Article 1(2)(b) of Directive 2001/83 is not intended to cover combinations of substances such as those in question, the consumption of which admittedly leads to a modification of human physiological functions but the administration of which, purely for recreational purposes, is not intended either to prevent or cure disease.

I – Legal framework

A – EU law

15. Under Article 1(2) of Directive 2001/83, the definition of ‘medicinal product’ covers:

‘…

(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.’

B – German legislation

16. The term ‘medicinal product’ is defined in Article 2(1) of the Law relating to trade in medicinal products (Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz)). (4)

17. Article 2(2) of the AMG defines medicinal products as substances or preparations consisting of substances:

‘… which may be used in or on or administered to human beings or animals either with a view to:

(a) restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action; or

(b) making a medical diagnosis.’

18. Article 5 of the AMG prohibits the placing on the market or the use in or on human beings of unsafe medicinal products. Unsafe medicinal products are ‘medicinal products in respect of which there are, given the current state of scientific knowledge, reasonable grounds for considering that, should they be used in accordance with their intended purpose, they will produce harmful effects which go beyond what is regarded as acceptable given the current state of medical knowledge’.

19. Article 95(1)(1) of the AMG provides that any person who, in breach of Article 5(1) of that law, places a medicinal product on the market or uses...