19. November 2013
A court in Germany ruled in September that as e-cigarettes are not designed for therapeutic purposes, they are not medicinal products. However, permission was granted to appeal the ruling.
German law: E-cigarettes are not medicinal products
In reaching its decision that electronic cigarettes are not medicinal products the Higher Administrative Court of North Rhine-Westphalia (OVG) reasoned that e-cigarettes are not designed for therapeutic purposes. Instead, they contain nicotine-based fluids (or liquids) which are turned into vapours and inhaled. The liquids do not lead to smokers permanently giving up smoking.
Case 1: Pharmaceutical products
A lady from Wuppertal, Germany was prohibited from selling e-cigarettes by the city authorities. The reason given was that e-cigarettes are unauthorised pharmaceutical products.
The OVG ruled against the city authorities and came to the conclusion that there were no grounds to prohibit the sale of e-cigarettes on the basis that they are unauthorised pharmaceutical products, as e-cigarettes are not pharmaceutical products. As a result, there is no possibility to authorise them as pharmaceutical products.
Case 2: Unauthorised distribution
In the second case, North Rhine-Westphalia’s Ministry of Health issued a warning that liquids containing nicotine were pharmaceutical products. Consequently, their unauthorised distribution would give rise to criminal liability.
A producer of liquids of this kind sued for an injunction, which was granted by the OVG.
Case 3: Medicinal products
The third case concerned two producers of nicotine-rich liquids and e-cigarettes. They brought a claim arguing that the liquids are not pharmaceutical products and that the e-cigarettes through which the vaporisation and inhalation occurs are not medicinal products.
The court ruled in the producers’ favour.
The court’s reasoning can be summarised as follows:
Medicinal products are those products which are presented as having properties for treating or preventing disease in human beings.
The court ruled that liquids containing nicotine do not fall under this definition, as they are not presented for sale as being suitable for treating or preventing disease in human beings.
Medicinal products can also be those products which are 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 make a medical diagnosis.
The OVG referred to the case law of the European Court of Justice, stating that the circumstances of each case must be decided on their own merits. The question to answer is whether a product functions as a medicinal product. The factors to consider include: the composition, method of use, ingredients, consumers’ familiarity with the product, and the risks of using the product.
The court applied these factors and came to the conclusion that as liquids containing nicotine do not have a therapeutic effect, they are not medicinal products.
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Categories: Medical Law