Die IG-ED schickt den Text der Pressemitteilung des OVG Münster vom 17.09.2013 an alle Abgeordneten der Europäischen Parlaments. Dabei liegen uns diesmal vor allem die nicht-deutschsprachigen Politiker am Herzen, um auch ihnen die Aussage dieser für uns sehr erfreulichen Pressemitteilung nahezubringen - daher schreiben wir ausnahmsweise nur in englische Sprache.
Three German Court Decisions: E-Cigarette is no Pharmaceutical Product
Ladies and Gentlemen,
today we would like to inform you of a press release of the Higher Administrative Court in Muenster, North Rhine-Westphalia (Germany).
In three cases the court decided that e-cigarettes are no pharmaceutical products. The court even refers to EU jurisdiction! As consumers we share their view and welcome the court's decision.
Not only still seeking for common sense but also assuming that you will try to avoid unnecessary lawsuits on EU level we ask you to take these adjudications into consideration when you vote on the Tobacco Product Directive #2 in October.
Thank you very much!
Sincerely
IG-ED e. V.
Translation of the court's original German press release:
The E-Cigarette is no Pharmaceutical Product
September 17, 2013
The 13th Senate of the Higher Administrative Court today decided in three cases that nicotine-containing fluids (so-called liquids) which are vaporised and inhaled using e-cigarettes, are no pharmaceuticals; accordingly e-cigarettes themselves are no medical devices.
In the first case the suit was filed by a woman operating a store for e-cigarettes and liquids in Wuppertal where the public health department of the city previously had prohibited the sales of nicotine containing liquids claiming that they were non-approved pharmaceutical products. The administrative court in Duesseldorf dismissed her case in first instance. In the appeals procedure, the Higher Administrative Court granted the appeal.
The subject of the second case was a press release issued by the Ministry of Health of North Rhine-Westphalia on 16th December 2011, which advised against the distribution of nicotine containing liquids claiming again they are unapproved pharmaceutical products the distribution of which is liable to persecution. Again, the Administrative Court of Duesseldorf had rejected action for an injunction of a manufacturer of such liquids against this statement, although the High Administrative Court had instructed the state of NRW in a previous urgent procedure by interim order to refrain from this statement: Such liquids are no medicinal products (see press release the OVG NRW of 23 April 2012). Again, the Higher Administrative Court upheld the application in the main proceedings.
In the third case, two companies manufacturing and/or selling e-cigarettes and liquids containing nicotine sued. They wanted a court decision against the Federal Institute for Drugs and Medical Products (BfArM) stating that the liquids are no medicines and that the e-cigarettes necessary for vaporising them are no medicinal products. This suit had already been confirmed by the Cologne Administrative Court. The Higher Administrative Court confirmed this judgment in the appeals procedure.
As reasons for the three judgments the Higher Administrative Court essentially stated: Nicotine containing liquids are no pharmaceuticals by presentation, because they are not indicated or recommended (presented) as a means of healing, alleviation or prevention of a disease. Neither are the liquids a pharmaceutical by function. According to the permanent jurisdiction of the European Court of Justice the decision if a product is a pharmaceutical by function must be made from case to case, where all characteristics of the product must be considered, as are composition, modalities of use, degree of extension, degree of popularity, and risks of use. Applying these criteria lead to the conclusion that nicotine containing liquids are no medicine. Medicines typically would have a therapeutical ability and a therapeutical purpose. Both requirements are not fulfilled in the case of nicotine containing liquids. So these liquids are neither suitable nor determined to achieve a permanent smoking cessation. This is assumed by the Federal Centre for Health Education (BZgA) as well as the German Cancer Research Centre (DKFZ) and the latest scientific studies.
In all three cases the Higher Administrative Court allowed for revision to the Federal Administration Court.
File Reference: 13 A 2448/12, 13 A 2541/12 and 13 A 1100/12
Original link (German language):
http://www.ovg.nrw.de/presse/pressemitteilungen/27_130917/index.php
3 Gedanken zu „E-Liquids sind keine Medikamente: Info über OVG-Urteile geht an alle Europaparlamentarier“
Super Maßnahme und guter Brief!
Aber heißt es nicht korrekt “medicinal products” anstatt “pharmaceutical products”?
Falls der Brief noch nicht raus ist, könnte man das noch korrigieren.
Sehr gutes Anschreiben!
Nur eine klitzekleine Sache: Gut wäre gewesen, wenn darauf hingewiesen worden wäre, dass das OVG Münster aufgrund des Arzneimittelrechts und damit auf der angepassten EU-Arzneimitteldirektive von 2012 geurteilt hat.
Diese wird ja wohl nicht demnächst geänder, oder?
Wenn die neue TPR so durchkommt, hätten wir den wunderbaren Fall, dass die TPR ein Arzneimittel definiert, was nach der Arzneimittelrichtlinie keines ist 🙂
Hm wir haben doch lange genug über den Text diskutiert, Du Vereinsmitglied. 😉