article | 17 May 2016

E-cigarettes are not medicinal products in Sweden

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The Swedish Supreme Administrative Court ruled in a judgment of 17 February 2016 (Case No. 1385-15) that what are known as e-cigarettes containing nicotine are not considered medicinal products. The court is thereby making a different assessment than the lower Swedish courts.


In October 2013 the Swedish Medical Products Agency prohibited a company from selling e-cigarettes since, according to the Agency, they had such a feature as to be considered medicinal products by function.

The Medical Products Agency set forth inter alia the following as grounds for its decision: The products have a relatively high content of nicotine, which is a pharmacologically active substance with a well-established medical use, particularly for smoking withdrawal. There are a number of approved medicinal products that contain nicotine in various pharmaceutical forms. The current products are medicinal products that are not authorised for sale and not covered by any recognition. They may therefore not be sold under the Medicinal Products Act.

At the same time, the Medical Products Agency ruled that the decision should apply immediately and be subject to a periodic penalty of SEK 700,000.

In Sweden what constitutes a drug is regulated in the Medicinal Products Act, which in turn is based on EU Directive 2001/83/EC.


Assessment of the Supreme Administrative Court

The Supreme Administrative Court starts by noting that a prerequisite for a product that contains a substance having a physiological effect to be designated as a medicinal product by function is that the competent authority, with due diligence, has made an assessment in the case of the individual product, taking into account inter alia the properties of the product according to current scientific knowledge (see Hecht-Pharma, C-140/07, EU:C:2009:5, paragraph 40).

According to established case law of the CJEU, this assessment in each case shall take into account all the properties of the product, including in particular its composition, its pharmacological, immunological and metabolic properties according to current scientific knowledge, the manner in which it is used, its spread, how known it is to consumers and the risks that may be associated with use of the product (see e.g. Laboratoires Lyocentre, C-109/12, EU:C:2013:626, paragraph 42).

It is further evident from case law that to be classified as a medicinal product by function, the product should have a composition – that also includes the dosage of its active substances – which in normal use is likely to significantly restore, correct or modify physiological functions in humans (see e.g. Chemische Fabrik Kreussler & Co., C-308/11, EU:C:2012:548, paragraph 35).

The fact that a product contains a substance that affects the functions of the body is not sufficient for it to be included in the function-based definition of medicinal products. In addition, the product must have the function of preventing or treating disease (see the Commission v. Germany, paragraph 64, cf. Hecht-Pharma, paragraph 35). The term medicinal product thus does not cover substances which only restore, correct or modify physiological functions. It is also necessary that they are likely to cause immediate or indirect beneficial effects on human health (see consolidated actions Markus D. and G., C-358/13 and C-181/14, EU:C:2014:2060, paragraphs 36–38).

When motivating its decision the Medical Products Agency stressed that the products contain nicotine, which is a pharmacologically active substance with a well-established medicinal use, particularly in medicinal products used in smoking withdrawal.

The Medical Products Agency cited several studies that support the claim that e-cigarettes with nicotine concentrations comparable to those in the products in question have a pharmacological effect which may significantly affect bodily functions, and that such products can be used to treat tobacco dependence.

The Supreme Administrative Court found that the studies cited did not permit any definite conclusions regarding the effects and significance of e-cigarettes in smoking withdrawal. In several of the studies it was also stressed that further research is needed in this field. The scientific findings that were reported in the case thus did not adequately prove that the use of the products had such a beneficial effect on human health as is required for them to be classified as medicinal products.

Further the Court noted that the assessment shall also take into account inter alia how the product is used and spread. The Court studied a report from the European Commission, Special Eurobarometer 429, in which around 28,000 EU citizens were interviewed about the use of tobacco and e-cigarettes. The report shows inter alia that of the Swedish participants, only two percent had tried to quit smoking using e-cigarettes. At the same time, it was evident that for a majority of respondents, smoking withdrawal was the most common reason for why they started using e-cigarettes. A large percentage of them, however, felt that the product had no effect on their smoking in the long term.

Further the Court found that the e-cigarettes at issue had been said to be designed as a stimulant healthier than tobacco cigarettes. They were thus designed to imitate regular tobacco cigarettes. The products were not provided with specific instructions on how they should be used for the user to reduce their smoking and addiction to nicotine.

The Medical Products Agency thus had no grounds for its decision and marketing ban has therefore been lifted.


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Life Sciences

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