Electronic Cigarette Industry Trade Association
Tel : 01639 710 558
Email : firstname.lastname@example.org
Case No. 5262-13
The Administrative Court decides that the contested Decision will not apply until further notice. This appeal decision applies until the Administrative Court orders otherwise, or until the Administrative Court itself gives final judgment. The Administrative Court grants leave to MPA to comment on the appeal by November 1, 2013 latest, the administrative court annex is 1.
The Medical Products Agency decided on 4 October 2013 to prohibit The Trade Team in Vintrie AB from selling the products Disposable Kit 1 - Supercig, Disposable Kit 2 - Healthcig, Disposable E-cigarette, e-cigar 1800, e-cigar 1200, e-cigar 701, e-juice 10 ml (all 37 flavors and all nicotine concentrations), E-juice 30ml (all 37 flavors and all nicotine concentrations), E-juice 100 ml (all 37 flavors and all nicotine concentrations) - these are listed in the table in the Decision - and other products with substantially duplicated content. The Agency decreed that the Decision would take effect immediately and imposed a penalty payment of one million SEK for each violation. The Decision stated that the company must submit a written declaration that the sale of the products had ceased no later than two weeks from the time the company received the Decision.
The MPA justified its Decision on the following grounds: all of the products named in the Decision contain nicotine inhaled in concentrations of 6, 12, 18 and 24 mg/ml. Nicotine is a pharmacologically active substance which acts on nicotinic cholinergic receptors in the nervous system. Nicotine may thus be supplied to people with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action. Nicotine also has a well-established medicinal use. The products have a relatively high dose of nicotine. The products should be classified as medicinal product by function under §1 of the Medicines Act. Since the products are not authorized for sale as a medicine, nor covered by any recognition under §5 of the same Act, they must not be sold.
The Trade Team in Vintrie AB (“the Company”) appeals the Decision and claims, insofar as it is currently relevant, that the Decision does not apply until further notice. In support of its claim for interim relief from sanctions, the Company pleads the following: the products do not fulfill the criteria to be classified as drugs. The effect must be significant. There are more factors than the content of nicotine in itself that determine a product's effect, such as concentration, other constituent substances, the amount of product used, the product formulation and its use. Such considerations are missing in the Decision. Also missing is consideration of the concentration of the products which would have a significant effect on body functions. It is important to distinguish between dose and daily dose. The Decision is contrary to the EU Court of Justice rulings on the classification of products as medicinal by function. The decision is also contrary to the decision of the EU Parliament of October 8, 2013, when it was decided that in the new Tobacco Products Directive, e-cigarettes will not be classified as drugs but as [related to] tobacco products.
MPA denies approval of the application for interim relief, supporting its position in the following: the Decision is in accordance with applicable law and is designed to protect the public from dangerous products, i.e. generally to protect public health. The said Directive is being negotiated at EU level and has not been decided yet, let alone come into force. The decision is not of such a nature that it cannot be overturned.
According to practice, the prerequisites for interim relief generally require that there is a fairly high probability that the decision will be changed in substance. The threshold has, however, been lower, if the case is of such a nature that an individual is likely to have significant disadvantages if the decision comes into force
immediately and there is no conflicting interest that strongly suggests that the Decision must apply immediately. Interim relief has since been held to be notified as soon as the outcome of the case appears to be uncertain (RAW 1990 ref 82).
The Administrative Court, which will hear the case finally later, finds reason to order the interim relief against the contested Decision. This assessment is made against the following background: the decision on the ban on sale is very interfering. The contested Decision’s effects are such that it may be assumed not to be possible for the company to get full compensation if the appeal is approved. MPA argues that the Decision is intended to protect the general public from dangerous products, i.e. to protect public health. It has been the case, however, that the MPA has not provided compelling reasons for considering that the Decision must be imposed immediately with regard to safety or consumer interests. In such a spirit, it is customarily sufficient to allow interim relief when the outcome is uncertain, as it may be considered at this time. The conditions for granting interim relief are thus fulfilled. The appeal should therefore be valid indefinitely, pending the Administrative Court’s ordaining otherwise, or at most until the case is decided.
HOW TO APPEAL, see Appendix (DV 3109/1A)
The decision was made after a presentation by Kristina Lorentzson.
MANAGEMENT LAW RULING Case No.
IN UPPSALA 2013-10-18 5262-13
Announced in Uppsala Unit 2
The Trade Team in Vintrie AB, 556885-4797
Counsel: Lawyers Lennart Arvidson and Helena Nilsson
203 20 Malmö
The Medical Products Agency (“MPA”)
751 03 Uppsala
APPEALED AGAINST DECISION
MPA decision of October 4, 2013,
Prohibitions under penalty under the Medicines Act (1992:859) to sell product; now the case of inhibition.
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