Triple German Court Ruling Today - ecigs NOT medicinal

[Matt Gluggles]

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LATEST NEWS

A Court Ruling has just been announced today (17th September) for three cases. ( local, regional and national court cases) - in Germany.

In all 3 cases, the Courts ruled that nicotine in e-liquid is NOT medicinal.

The court ruling can be read here (German language)
www.ovg.nrw.de/presse/pressemitteilungen/27_130917/index.php

If you put that into Google Translate, you get this:

The 13th Senate of the Higher Administrative Court today ruled in three cases that nicotine-containing liquids (so-called liquids) that are vaporized and inhaled by using e- cigarettes, no drugs are , accordingly, the e -cigarettes are not medical devices themselves .

In the first case, a woman had complained that a store for cigarettes and e- liquids operates in Wuppertal and had the health department of the city of Wuppertal prohibits the sale of nicotine liquids on the grounds that it states that it is not authorized medicines . The administrative court in Dusseldorf dismissed its application in the first instance . On appeal, the Supreme Administrative Court granted the application .

Subject of the second method was a press release from the Ministry of Health of North Rhine -Westphalia on 16 December 2011 , in which it was warned of the distribution of nicotine to keep liquids because they are drugs whose distribution is punishable without approval. Again, the Administrative Court of Dusseldorf had rejected the claim of a manufacturer of such liquids to cease this statement , although the Supreme Administrative Court had given in a previous fast-track the state of North Rhine -Westphalia by interim order , to refrain from this statement : Such liquids are not medicinal products (see press release the OVG NRW of 23 April 2012). Again, the Supreme Administrative Court upheld the action in the main proceedings .

In the third case, two companies that nicotine-containing cigarettes and e- liquids complained manufacture or distribute . They wanted to leave to the Federal Institute for Drugs and Medical Devices judicial notice that no liquids and medicines necessary for the evaporation of e- cigarettes are not medical devices . That action, the Cologne Administrative Court had already upheld. The Supreme Administrative Court upheld this ruling on appeal.

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 ( presented ) would . 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 , ie, 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 . Drugs typically have a therapeutic fitness and a therapeutic purpose . Both conditions are not met in nicotine- hold liquids . Thus, these liquids are neither suitable nor intended to achieve a lasting cessation . Walked away from both the Federal Centre for Health Education as well as the German Cancer Research Center and the latest scientific studies.

The Higher Administrative Court has approved in all three cases, an appeal to the Federal Administrative Court.

Case number : 13 A 2448/12 , 13 A 2541/12 and 13 A 1100/12

This needs forwarding to ALL your MEP's, the MHRA and Linda McAven.



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[Greigster]

Great find Matt Gluggles, thanks for posting.

[Deleted]

Great news Matt Gluggles thanks for the heads up ... celebration drinkypoos for deffo!

[ckc]

Not medicinal by function. Thanks Matt Gluggles that's what the MHRA are aiming for.

[skyjay]

Thanks 4 the news......just hope our idiot mps read it

[OneDay]

This is another weapon in our armoury. Good find!

[kibbster]

That's more court rulings in our favour, in fact there's none that have gone against us!
MHRA will try their luck anyway but at least we can be pretty sure they'll get a bitch slapping when it goes to court.

[djs]

Ich werde nach Deutschland, schnell bewegen.

[Ron]

Ich werde mitkommen

[OneDay]

To ensure that your MEP sees this information, use the simple tool at www.writetothem.com/ to contact all your local MEPs.

I have copied the ruling into a message to all of mine and it only takes a few minutes.

[Chrissie]

Brilliant news

[demonvape666]

This is fantastic news and good old Germany they know how to be efficient and to the point, but we have to suffer the british political bull shit and waffle as they pretend to know what they are talking about "revolution! " is what's needed lol;)

Sent from my GT-I9300 using proboards

[Jen]

Great stuff

If you're going to be using it for official MP purposes, here's my very quick translation of it so it's at least in vaguely decent English:

E-cigarettes are not medicines
17 September 2013
The 13th Senate of the Higher Administrative Court today ruled in three cases that liquids containing nicotine (so-called ‘e-liquids’), which are vaporised and inhaled using e-cigarettes, are not medicines; accordingly, e-cigarettes themselves are not medical devices.

In the first case, a suit was filed by a woman who runs a shop providing e-cigarettes and e-liquids in Wuppertal and who had been prohibited from selling liquids containing nicotine by the health department of the city of Wuppertal on the grounds that they are non-authorised medicines. The Düsseldorf Administrative Court dismissed her application in the first instance. On appeal, the Higher Administrative Court granted the application.

The subject of the second suit was a press release by the Health Department of the state of North Rhine Westphalia of 16 December 2011, warning against selling liquids containing nicotine as they are medicines, whose unauthorised sale is punishable. Here, too, the Düsseldorf Administrative Court had rejected the application, made by a manufacturer of such liquids, to desist from making this statement even though the Higher Administrative Court had ordered the cessation of this statement in a previous emergency procedure in the state of North Rhine-Westphalia via interim order: such liquids are not medicine, they said (see press release by NRW SAC of 23 April 2012). Here, too, the Higher Administrative Court upheld the application in principal proceedings.

In the third case, two businesses that manufacture and/or sell e-cigarettes and liquids containing nicotine filed a suit. They sought a court order against the Federal Institute for Drugs and Medical Products stating that the liquids were not medicines and the e-cigarettes necessary for vaporising them were not medical products. This suit had already been upheld by the Cologne Administrative Court. The Higher Administrative Court upheld this ruling on appeal.

The Higher Administrative Court gave the following essential grounds for the three rulings: Liquids containing nicotine are not medicines by presentation, as they are not labelled or recommended (presented) as means for curing, mitigating or preventing illnesses. These liquids are also not medicines by function. According to settled case law of the European Court, the decision of whether a product is a medicine by function must be made on a case by case basis, taking into account all the features of the product, i.e. composition, methods of use, volume of distribution, awareness amongst users and risks of use. The application of these criteria leads to the conclusion that liquids containing nicotine are not medicines. Medicines are typically suitable for therapeutic use and have a therapeutic purpose. Liquids containing nicotine meet neither of these conditions. Consequently, these liquids are neither suitable nor intended to achieve lasting smoking cessation, they said. The Federal Centre for Health Education and the German Cancer Research Centre and the latest scientific studies all worked on this assumption.

The Higher Administrative Court permitted an appeal to the Federal Administrative Court in all three cases.
Document numbesr: 13 A 2448/12, 13 A 2541/12 and 13 A 1100/12

[dragon]

"Consequently, these liquids are neither suitable not intended to achieve lasting smoking cessation, they said."

I sure hope that proof that e-cigs help people give up the stinkies, doesn't get them classed as medicine Anyone fancy a cig?

[Jen]

In my layman's understanding of the applicable law (which isn't great), the German system at least has two types of medicine: by presentation, and by function. Presentation means it's labelled and marketed as a medicine, function means it acts as a medicine.

So you may be right and the latter could be a bit of a minefield!