The Danish Health and Medicines Authority - in accordance with its administrative practice - submitted that the e-cigarettes in question containing a certain amount of nicotine were to be considered pharmaceutical products "per effect", cf. Section 2(1)(b) of the Danish Medicines Act (corresponds to Article 1(2) second paragraph of directive 2001/83).
However, the Danish Health and Medicines Authority "conceded" that the pres-ence of nicotine is not - in itself - sufficient to classify an e-cigarette as a medicinal product, although the Danish Health and Medicines Authority stated that e-cigarettes with as little as 0.5 mg nicotine had been classified as medicinal prod-ucts.
Making reference to the 20 mg threshold in the new tobacco products directive (di-rective 2014/14/EU), the retailer held that the e-cigarettes in question were not to be considered medicinal products, simply because the nicotine contents were be-low 20 mg and thus not sufficient to provide for a pharmacological effect.
Following an expert witness statement, the High Court held that the quantities of nicotine present in the product were sufficient to impart a pharmacological effect and thus sided with the Danish Health and Medicines Authority.
As an interesting point, the retailer had requested that the High Court lodge a pre-liminary reference to the ECJ, as the retailer held that the Danish authorities had misinterpreted directive 2001/83. The High Court of Western Denmark dismissed this request with reference to the acte clair doctrine (i.e. that the relevant provi-sions of EU law are sufficiently clear). One could argue, however, that the applica-bility of the acte clair doctrine could be discussed, as a number of European coun-tries do not consider e-cigarettes (containing nicotine) to be pharmaceutical prod-ucts.