What do the Germans know that we don’t?

Agnieszka Slusarczyk, a German lawyer wrote about the courts in Germany ruling in September, that as e-cigarettes are not designed for therapeutic purposes, they are not medicinal products.

So what is it that the Germans know that our UK Government doesn’t? Why are e cigarettes not a medicine in one EU country, yet just up the road and over the Channel, they are being considered as such?

The Higher Administrative Court of North Rhine-Westphalia (OVG) reasoned that e-cigarettes are not designed for therapeutic purposes; instead, they contain nicotine-based fluids (or liquids) which are turned into vapour and inhaled.

This premise has been challenged four times, and each time it was overturned.  This is something that the UK gov’ should bear in mind, as they were not considered medicine by function or presentation, a fact that has been verified by our own MHRA. Unbelievably, the MHRA admit that electronic cigarettes are not medicinal, so one still wonders why they are carrying on with this? Why are they continuing with a regulation that actually defies logic?

Agnieszka, using EU law, (that the UK is subject to as well) states:

1. Presentation

Medicinal products are those products that are presented as having properties for treating or preventing disease in human beings.

The court ruled that liquids containing nicotine do not fall under this definition, as they are not presented for sale as being suitable for treating or preventing disease in human beings.

2. Function

Medicinal products can also be those products that are used in, or administered to, human beings, either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to make a medical diagnosis.

The OVG referred to the case law of the European Court of Justice, stating that the circumstances of each case must be decided on their own merits. The question to answer is whether a product functions as a medicinal product. The factors to consider include: the composition, method of use, ingredients, consumers’ familiarity with the product, and the risks of using the product.

The court applied these factors and came to the conclusion that as liquids containing nicotine do not have a therapeutic effect, they are not medicinal products.

Jane Ellison, Jeremy Hunt and Jeremy Mean, please understand this.

 

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