Electronic Cigarette Industry Trade Association
Tel : 01639 710 558
Email : firstname.lastname@example.org
On the proposal for a directive of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products.
“Article 18 of the proposal prohibits nicotine-containing products (NCP) such as e-cigarettes containing a certain nicotine level if they are not authorised pursuant to Directive 2001/83/EC (the Medicinal Products Directive). It is, however, quite unclear if these products (which are much less harmful than tobacco products) even fall under the scope of the Medicinal Products Directive. For products which do not fall under the Directive, this would effectively constitute a ban. Banning products which are less harmful than tobacco products and which can be a means of smoking cessation is certainly not in line with the public health aims of the proposal.
Finally, the Commission’s proposal contains a large number of provisions delegating powers to the Commission. However, pursuant to Article 290 TFEU, a delegation of powers is only possible with regard to non-essential elements of the legislative proposal. Some of the proposed provisions providing for delegated acts do not fulfil this requirement.”1
Additionally, in footnotes to the first paragraph above, the JURI Committee’s Opinion was expanded as follows:
“Relying on the strict jurisprudence of the CJEU, several national courts have already held that e-cigarettes cannot be qualified as a medicinal product by function under the Medicinal Products Directive, see e.g. Oberverwaltungsgericht Nordrhein-Westfalen, 24 April 2012, 16 L 2043/11.”
"Article 18 [now Article 20] also lacks a valid legal base as it is in no way aimed at improving the conditions for the establishment and functioning of the internal market. Pursuant to the Commission, the provision will allow NCP to move freely across borders as they would benefit from the mutual recognition procedure under the Medicinal Products Directive (Impact Assessment, page 8). However, this is already the case without Article 18 [now Article 20], as any NCP which qualifies as a medicinal product is already now subject to the Medicinal Products Directive. The only effect Article 18 [now Article 20] has is that it prohibits the placing on the market of NCP that are not authorised pursuant to the Medicinal Products Directive."2
The JURI Committee recommended that Article 18 (now 20) be deleted in its entirety.
The JURI Committee's legal Opinions were largely disregarded in the final text of the revised TPD, despite the European Parliament's having voted strongly against the reclassification of electronic cigarettes as medicinal products in October 2013.
© ECITA 2016. All rights reserved