Yesterday, at the same time as I was preparing an article on the Swedish transposition of the EU TPD, the Supreme Administrative Court of Sweden overturned a long-standing ban on e-cigarettes in the country and ruled that the vaping products could not be considered as medicine.
The arguments that were put forward before the court deserve a couple of lines in our columns since most of the argumentation was elaborated against the e-cigarette in order to cancel a ban on the sale of vaping products.
In this case, the Swedish vape shop The Trade Team saw its activities drastically reduced on October 4, 2013 after the Swedish Medical Products Agency (MPA) declared illegal the sale of nicotine vaping products (e-cigarettes and e-liquids) that it considered as medicines.
The MPA in its decision considered that the vaping products named in their list constituted medicinal products of the function-based definition of the Medicines Act. MPA said in justification for its decision that the products contain nicotine which is a pharmacologically active substance with well established medical use, particularly a drug used for smoking cessation.
The arguments of the MPA in favor of the medicines were that:
- the products have a relatively high content of nicotine,
- the nicotine is a pharmacologically active substance having a well established medicinal use, especially smoking cessation,
- the list of approved nicotine products is released by the MPA and did not read the e-juices, making them illegal for sale without prescription.
In addition to the ban commercial activities of the Swedish vape shop, the MPA fined it 700,000 SEK (€74,000).
The vape shop took the case to the Administrative Court that changed MPA’s decision so that the ban would only cover the
products listed in the decision and not the “other products with essentially the same content.” Followed a suite of recourses with always the central question: Do vaping products constitute medicinal products? And more precisely what falls under the definition of a “drug by function”. To comply with the EU Medicines Directive, minor editorial changes occurred in the new Swedish Medicines Act §1 that entered into force on January 1, 2016, in replacement of the former Act of 1992, and changed the deal by slightly modifying the definition of a “drug” and especially of a “drug by function”.
Even if the vape shop is now in bankrupt, it is a huge win for consumer-driven tobacco harm reduction and freedom of choice, writes Argvargen, wondering how Prof Stan Glantz and other ANTZ advocates would bear the responsibility of the cancellation of a ban on e-cigarettes.
The ironical paradox
The arguments that MPA put forward to prohibit e-cigarette business were in favor of the e-cigarette as an efficient tool for smoking withdrawal (i.e. referring to the Cochrane review). In contrast, the vape shop alluded to a recreational use or the lack of direct therapeutic benefit.
The Supreme Administrative Court found that the cited studies did not allow any conclusions regarding the effects of e-cigarettes and their importance in smoking cessation. Several of the studies also suggest that further research is needed in this area. The scientific findings that have been reported in the case thus provides not enough support to the use of the vaping products with such a beneficial effect on human health, which is a prerequisite for they should be classified as medicines.
After the Eurobarometer 429 special survey on the use of the e-cigarette, the Court found that the use of the device in Sweden did not demonstrate sufficient efficiency for smoking cessation and that its use was rather as a “healthier stimulant than tobacco cigarettes“.
The vape shop showed that the design of an e-cigarette resembles that of a tobacco cigarette, even reproducing smoking-like vapor. In its concept, the e-cigarette differs from the traditional forms of NRT, gums and patches, that are considered as medicinal products for smoking cessation and therefore, it shouldn’t be considered as such. Finally, e-cigarette is supplied without any instruction on the way it may be used by patients to reduce smoking and nicotine addiction, which is another proof that vaping products are not medicines, stricto sensu.