Brussels, 13/06/2014 (Agence Europe) - In conclusions in jkoint cases C-358/13 and C-181/14 on Thursday 12 June, Advocate General Yves Bot at the European Court of Justice said that products consisting of aromatic herbs and synthetically-produced cannabinoids and which are sold exclusively for recreational purposes are not medicinal products because, in order to be classified as a medicinal product, a substance or combination of substances must be intended to prevent or treat an illness.
The cases were about a mixture of herbs and synthetically-produced cannabinoids that are like cannabis when smoked. When these products were put on the market from 2010 to 2012, the German law on combating narcotics did not allow prosecution for the sale of those substances. The German authorities therefore sentenced two people to prison on the basis of the law relating to medicines, concluding that they had marketed a “dubious medicinal product”. The German federal court asked the European Court of Justice to decide whether the products can be described as medicines.
Bot said no because EU Directive 2004/27/EC on medicines for human beings does not cover the mixture in question. The directive defines the concept of “medicinal product by function” 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” and while the mixture in question modifies physiological functions, it is used for recreation rather than treatment.
Bot says the directive aims to ensure the free movement of safe and effective products and does not apply to a combination of substances intended, in reality, to be excluded from the market because it lacks any medical benefit and presents risks to human health. A Court press release states: “Although it is understandable that confronted with a legal vacuum, Germany sought to apply legislation relating to medicinal products in order to be better able to control and prevent the marketing of those new substances, Advocate General Bot concludes that such an aim is not however capable of warranting a broad interpretation, indeed a distortion, of the concept of 'medicinal product'. He considers, consequently, that only enforcement measures based on the control of narcotics are suitable in order to respond to the appearance of psychoactive substances on the market. In that regard and in the interests of clarity, he recommends that the legal basis of texts currently being drafted be clearly linked with the area of freedom, security and justice”. (MD)