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Legal Rulings/Opinions

Legal Rulings/Opinions

Germany
Higher Administrative Court of North Rhine-Westphalia
Case numbers: 13 A 2448/12, 13 A 2541/12 and 13 A 1100/12
September 17th, 2013

The court upheld three previous decisions that electronic cigarette products containing nicotine were not medicines, unless presented as such. A translation of the actual decision was not available at the time of writing, however the following translated excerpt from the Administrative Court's press release provides a clear indication of the courts thinking:

In support of the three judgments, the Supreme Administrative Court has essentially decided that nicotine-containing liquids are not a medicinal product by presentation because they are not indicated or recommended as a means to cure, mitigate or prevent disease. But also the liquids are not a medicinal product by function. According to settled case law of the European Court had to decide whether a product is a medicinal product by function, are taken on a case by case basis, taking all the features of the product are considered, i.e. composition, methods of use, volume of distribution, brand awareness among consumers and risks of use. The application of these criteria leads to the conclusion that nicotine-containing liquids are not medicinal products.

 

Estonia
Tartu Administrative Court NB: Needs document upload and hyperlink? Or insertion of doc? How will this work?
Case number: 3-12-2345
March 2013

 

The Court found that the State Agency of Medicine had incorrectlycompared E-Lites’ products with medicinal NRT products withoutexplaining why tobacco cigarettes are excluded from medicinal

regulation:

 

It is not clear why the pharmacological effects of the manufactured liquid nicotine on the body are different from the effect of the nicotine in anormal cigarette or whether any pharmacological effect manifests itself ina normal cigarette. [...] In the contested decisions, there is no answer to the claim raised by the complainant that there is no science-based evidence and examples of why particularly E-Lites products or their properties negatively affect public health and influence human physiology

more than do conventional cigarettes. [...] If the effects produced by E-Lites cigarettes are unique to medicinal products only, then the question arises as to why the normal cigarettes do not have the same effect unique to a medicinal product. In this case, the desired nicotine is received from an e-cigarette instead of a tobacco cigarette; nicotine addiction is satisfied, not cured.” (paragraph 27)

 

The Judge further expanded on the concept of ‘quitting smoking’ as a medicinal process:

 

E-Lites products are an alternative for regular smoking, their use is more harmless to health, safer and cleaner and in this regard, it appears that there is no dispute. The court agrees with the complainant that according to the respondent's approach, all the nicotine-containing products, thus in this case also the normal cigarettes should be defined as a medicinal product on the basis of the effect of nicotine. This, however, does not exclude the possibility that a past smoker cannot use e-cigarettes as a smoking cessation tool. Quitting smoking is possible for some people and in some cases even without any special equipment or without any mediation of a medicinal product. It is not excluded that, if desired, symptoms of withdrawal can also be alleviated with the help of a normal

cigarette, which is not to say that it is a medicinal product. [...]

 

...people who have given up smoking tobacco cigarettes in favor of e-cigarettes for health reasons do not use nicotine as a medicinal product, but as a drug which is less detrimental to the health instead of a more hazardous cigarette.” (paragraphs 28 and 29)

 

The judge went on to give her ruling on the amounts of nicotine in the products:

 

Regarding the quantity of nicotine, the respondent has noted, when defining the product as a  medicinal product, that the active dose of a single e-cigarette capsule exceeds the dose necessary for treatment or alleviation of a condition and that in the products' user information, consumers have not been warned of the dangers that may arise from using the product or the risk associated with using the product are not generally known to the consumers. The fact that one of the e-cigarette capsules contains the amount of the active agent which is equivalent to an average of 40 normal cigarettes is not disputed. But there is a serious and logical explanation of the complainant that administration of the active ingredient of a capsule does not take place at the same time, it is used in analogy to conventional cigarettes according to each smoker's needs. Although the amount of nicotine in one conventional cigarette is significantly smaller than in the e-cigarette capsule, there is nothing to prevent a smoker from smoking conventional cigarettes more than one cigarette at a time, as in case of conventional cigarettes, the smoker usually has a whole pack, not just one cigarette.” (paragraph 30)

 

On how the products are used by consumers, the Judge observed the following:

 

Also should be taken into account the fact that e-cigarettes are sold to adults and they are used by people who already have a nicotine addiction. This part is not disputed by the respondent. Thus, a smoker of an e-cigarette has a strong habit and experience and is able to assess their needs. Since e-cigarettes do not contain harmful substances (tar, tobacco), it can be concluded that the use of e-cigarettes as compared to the use of tobacco products is more harmless and safer to public health. Thus the complainant has pointed out on the basis of several studies that the transition from conventional cigarettes to electronic cigarettes because of the elimination of combustion by-products are likely to be at least 99% safer and healthier than continuation of smoking of conventional cigarettes.” (paragraph 31)

 

In conclusion, the Judge stated:

 

The court is of the opinion that it is a feel-good substance with the intention of replacing tobacco cigarettes and allows the consumption ofnicotine without the harmful effect of tobacco smoke and tar. Upon definition of the product as a medicinal product within the meaning of Directive 2001/83/EC should be taken into account all the characteristics of the product - the composition, pharmacology, disposition and the extent of use of the product, awareness of the consumers of the product and the risks which may be associated with using the product. The court agrees with the complainant that the respondent has not taken into account all these circumstances in the decision of definition of the product as a medicinal product, or has done so inadequately. The complainant has also referred to the decision of European Court of Justice in Case No. C-140/07 (Hecht-Pharma vs Lüneberg ) in which the court has decided when interpreting Directive 2001/83/EC, Article 2, paragraph 2, that the directive does not apply to the product, for which there is no scientific evidence that it is a medicinal product by function, but for which it cannot be excluded. It is therefore not legitimate to define the product as a medicinal product in any doubt. Regarding E-Lites products, taking into account the specific characteristics and features of these products, there is no such scientific studies.” (paragraph 31)

 

The Estonian State Agency of Medicines was ordered to pay costs.