Court agrees plaintiff: The e-cigarette is not a medicine
The North Rhine-Westphalian Ministry of Health had to accept a defeat at the Higher Administrative Court in Münster. The Ministry can no longer warn against e-cigarettes in the previous form. The electronic cigarettes are not medicinal products, as the judges ruled. The ruling can also have far-reaching consequences for other state health ministries and authorities.
Supporters and opponents have been arguing for a long time about the health risks of electronic cigarettes, also known as e-cigarettes for short. By an injunction, the NRW Higher Administrative Court in Münster has now prohibited the Ministry of Health in North Rhine-Westphalia from warning about the electric glow sticks. A few months ago (December 2011), the Minister of Health, Barbara Steffens (Greens), referred to possible negative health aspects for users in the press and at the same time warned against consumption. The Ministry may no longer make certain statements.
According to the law, e-cigarettes are not medicinal products
NRW Minister of Health Barbara Steffens is no longer allowed to warn of e-cigarettes, at least not in the form in which she partly did in the past. In a statement at the time, Steffens said, "Everything that is currently on the market is not approved and has not been tested." Some of the liquids have high levels of nicotine and should therefore be classified as "medicinal products". In the course of this, she had spoken out in favor of a ban and speculated that trading in “unauthorized medicinal products” was punishable by law. However, contrary to the Minister's assumption, the senior administrative judges believe that e-cigarettes and cartridges containing nicotine cannot be classified under the Medicines or Medical Devices Act. A further proceeding of the legal dispute is excluded, since it is an unassailable judgment (file number: 13 B 127/12). The Cologne Administrative Court already made it clear that the e-cigarette is not a medicine.
The judges in Münster found in their judgment that the nicotine liquids for e-cigarettes do not meet the legal requirements for classification as a medicinal product. Although many consumers report that conventional cigarettes have been weaned through consumption, the hoped-for abstinence is not in the foreground. In addition, the electronic cigarettes and accessories "have no therapeutic or preventive purpose for a drug," said the judges in the reasoning. "With regard to the media coverage of the marketability of the e-cigarette, there is a strong argument that the disputed statements by the ministry acted as a ban." For this reason, "the legal assessment of the ministry should not only be checked for its justification, but rather the court had to make its own legal assessment based on the standards of the Medicinal Products Act and the Medical Devices Act. ”The statements made in the press release by the Ministry and the position represented in the decree were therefore illegal.
Plaintiff an e-cigarette producer and trader
A businessman who runs a company that produces and sells e-cigarettes filed the complaint. The Left Party leader Gregor Gysi acted as a lawyer. In the first instance, the request for an injunction was still refused, in the second the plaintiff was successful.
After the end of the trial, a spokesman for the State Department of Health said after an initial review of the verdict, "neither a revocation nor a correction to previous statements has been imposed." The spokesman left open how the Ministry would decide in the future and how the judgment as a whole would be evaluated.
Ulrich Lau, spokesman for the higher administrative court, emphasized that the judgment only applies to the two parties to the proceedings. It is conceivable, however, that other health ministries and authorities agree with the legal opinion of the court.
Health warnings are still not prohibited
It is not expressly forbidden that the NRW Minister of Health can continue to comment on the possibly negative health aspects of the e-cigarette, as Laut explained. The minister just must not continue to claim that the e-cigarette is a drug that is subject to authorization. Such a position gives the appearance of a ban. According to the OVG, the liquids offered are not covered by the Medicines Act, since they are not primarily used to “wean nicotine consumption or to alleviate nicotine addiction”. The judgment is binding and applies immediately to the North Rhine-Westphalian Ministry. Since it was a preliminary legal protection procedure, there was no possibility of calling a higher authority than the OVG.
According to the manufacturers, around 2 million people in Germany consume the electronic cigarette. Consumers also refer to the use of “vaping”. The e-cigarette consists of a battery with electronics, air sensor, a tank and a chamber for vaping. A liquid is placed in this chamber that contains flavored liquid with or without nicotine. To inhale, the "steamer" presses a small button on the device. But there are also brands in which the mechanism is automatically started when pulling. From the outside, the device looks very similar to that of a conventional cigarette.
No long-term scientific experience values yet
From a scientific point of view, what health risks actually exist and what long-term consequences are imminent is not yet sufficiently researched. There are some smaller comparative studies, some of which have achieved positive results, but the long-term experience is missing due to the relative novelty of the product. The same argument is repeatedly used by supporters. They say: "There is no study to prove that the e-cigarette is more harmful than a smoldering stick". The industry therefore hopes that electronic smoking devices will soon be classified as luxury foods so that the products can be sold not only in special shops or pharmacies, but also in the supermarket.
The Federal Center for Health Education continues to warn of the dangers of e-cigarettes after the judgment. Consumption is "associated with health risks," said a spokesman. The cartridges used contain “the addictive nicotine as well as other harmful substances”. (sb)
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