Pillbox 38 (UK) Limited, trading as Totally Wicked v Secretary of State for Health.
Date: 2016-05-04
15


In that regard, it should be recalled that it is solely for the national court before which the dispute has been brought, and which must assume responsibility for the subsequent judicial decision, to determine in the light of the particular circumstances of the case both the need for a preliminary ruling in order to enable it to deliver judgment and the relevance of the questions which it submits to the Court. Consequently, where the questions submitted concern the interpretation or the validity of a rule of EU law, the Court is in principle bound to give a ruling (judgment in Gauweiler and Others, C‑62/14, EU:C:2015:400, paragraph 24).
16


It follows that questions concerning EU law enjoy a presumption of relevance. The Court may refuse to give a ruling on a question referred by a national court only where it is quite obvious that the interpretation, or the determination of validity, of a rule of EU law that is sought bears no relation to the facts of the main action or its purpose, where the problem is hypothetical, or where the Court does not have before it the factual or legal material necessary to give a useful answer to the questions submitted to it (judgment in Gauweiler and Others, C‑62/14, EU:C:2015:400, paragraph 25).
17


As regards, first, the genuine nature of the dispute in the main proceedings, it should be noted that the claim for judicial review of the ‘intention and/or obligation’ of the United Kingdom Government to implement Directive 2014/40, which Pillbox has brought before the referring court, has been held admissible by the latter, even though, when those claims were brought, the period prescribed for implementation of the directive had not yet expired and no national implementation measures had been adopted. There is, moreover, disagreement between Pillbox and the Secretary of State for Health as to whether or not the abovementioned claim is well founded. Given that the referring court has been asked to resolve that disagreement, it is not obvious that the dispute in the main proceedings is not genuine (see, by analogy, judgment in British American Tobacco (Investments) and Imperial Tobacco, C‑491/01, EU:C:2002:741, paragraphs 36 and 38).
19


Moreover, the opportunity open to individuals to plead the invalidity of an EU act of general application before national courts is not conditional upon that act actually having been the subject of implementing measures adopted pursuant to national law. In that respect, it is sufficient if the national court is called upon to hear a genuine dispute in which the question of the validity of such an act is raised indirectly. That condition is fulfilled in the case of the main proceedings, as is apparent from paragraph 17 of the present judgment (see, by analogy, judgments in British American Tobacco (Investments) and Imperial Tobacco, C‑491/01, EU:C:2002:741, paragraph 40, and Gauweiler and Others, C‑62/14, EU:C:2015:400, paragraph 29).
24


As regards, moreover, the obligation on the referring court to set out the reasons that led it to raise the question of the validity of Article 20 of Directive 2014/40, it does indeed follow from the spirit of cooperation which must prevail in the operation of the preliminary reference procedure that it is essential that the national court sets out in its order for reference the precise reasons why it considers a reply to its questions concerning the interpretation or validity of certain provisions of EU law to be necessary to enable it to give judgment (see to that effect, inter alia, judgments in Bertini and Others, 98/85, 162/85 and 258/85, EU:C:1986:246, paragraph 6; ABNA and Others, C‑453/03, C‑11/04, C‑12/04 and C‑194/04, EU:C:2005:741, paragraph 46; and IATA and ELFAA, C‑344/04, EU:C:2006:10, paragraph 31).
25


It is therefore important that the national court should set out, in particular, the precise reasons which led it to question the validity of certain provisions of EU law and set out the grounds of invalidity which, consequently, appear to it capable of being upheld (see to that effect, inter alia, judgment in Greenpeace France and Others, C‑6/99, EU:C:2000:148, paragraph 55, and order in Adiamix, C‑368/12, EU:C:2013:257, paragraph 22). Such a requirement also arises under Article 94(c) of the Rules of Procedure of the Court.
26


Furthermore, according to the settled case-law of the Court, the information provided in orders for reference not only enables the Court to give useful answers but also serves to ensure that the governments of the Member States and other interested persons are given an opportunity to submit observations in accordance with Article 23 of the Statute of the Court of Justice of the European Union. It is for the Court to ensure that that opportunity is safeguarded, given that, under Article 23, only the orders for reference are notified to the interested parties, accompanied by a translation in the official language of each Member State, but excluding any case file that may be sent to the Court by the national court (see, inter alia, judgments in Holdijk and Others, 141/81 to 143/81, EU:C:1982:122, paragraph 6; Lehtonen and Castors Braine, C‑176/96, EU:C:2000:201, paragraph 23; and order in Adiamix, C‑368/12, EU:C:2013:257, paragraph 24).
35


The Court has consistently held that the principle of equal treatment requires that comparable situations must not be treated differently and different situations must not be treated in the same way unless such treatment is objectively justified (see, inter alia, judgment in P and S, C‑579/13, EU:C:2015:369, paragraph 41).
36


It should, in that regard, be noted that electronic cigarettes display different objective characteristics from those of tobacco products.
42


Accordingly, it must be held that electronic cigarettes are not in the same situation as tobacco products for the purposes of the case-law cited in paragraph 35 of the present judgment.
48


It should be borne in mind at the outset that, according to the settled case-law of the Court, the principle of proportionality, which is one of the general principles of EU law, requires that acts of the EU institutions be appropriate for attaining the legitimate objectives pursued by the legislation at issue and do not exceed the limits of what is necessary in order to achieve those objectives; when there is a choice between several appropriate measures, recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims pursued (see, to that effect, judgments in British American Tobacco (Investments) and Imperial Tobacco, C‑491/01, EU:C:2002:741, paragraph 122; ERG and Others, C‑379/08 and C‑380/08, EU:C:2010:127, paragraph 86; and Gauweiler and Others, C‑62/14, EU:C:2015:400, paragraphs 67 and 91).
49


With regard to judicial review of the conditions referred to in the previous paragraph of the present judgment, the EU legislature must be allowed broad discretion in an area such as that at issue in the main proceedings, which entails political, economic and social choices on its part, and in which it is called upon to undertake complex assessments. Consequently, the legality of a measure adopted in that area can be affected only if the measure is manifestly inappropriate having regard to the objective which the competent institutions are seeking to pursue (see, to that effect, judgment in British American Tobacco (Investments) and Imperial Tobacco, C‑491/01, EU:C:2002:741, paragraph 123).
55


Under such circumstances, the EU legislature had to take account of the precautionary principle, according to which, where there is uncertainty as to the existence or extent of risks to human health, protective measures may be taken without having to wait until the reality and seriousness of those risks become fully apparent. Where it proves to be impossible to determine with certainty the existence or extent of the alleged risk because of the insufficiency, inconclusiveness or imprecision of the results of studies conducted, but the likelihood of real harm to public health persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures (judgment in Neptune Distribution, C‑157/14, EU:C:2015:823, paragraphs 81 and 82).
58


However, taking into account the growing market for electronic cigarettes and refill containers, noted in both recital 43 of Directive 2014/40 and in the ENDS report, the national rules relating to the conditions which those products must satisfy are in themselves liable, in the absence of harmonisation at Union level, to constitute obstacles to the free movement of goods (see, by analogy, judgment in British American Tobacco (Investments) and Imperial Tobacco, C‑491/01, EU:C:2002:741, paragraph 64).
64


In the third place, it is admittedly true that the measures chosen by the EU legislature pursuant to Article 20 of Directive 2014/40 were not included among those which had been initially intended by the Commission in its 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 (COM(2012) 788 final) and were therefore not the subject of the impact assessment accompanying that proposal and referred to in paragraph 57 of the present judgment.
65


However, the Court has already held in this regard that such an impact assessment is not binding on either the Parliament or the Council (judgment in Afton Chemical, C‑343/09, EU:C:2010:419, paragraph 57). Consequently, the EU legislature remains free to adopt measures other than those which were the subject of that impact assessment. Therefore, the mere fact that it adopted a different and, as the case may be, more onerous measure than the measures envisaged by the Commission in the impact assessment referred to in paragraph 57 of the present judgment is not such as to demonstrate that it manifestly exceeded the limits of what was necessary in order to achieve the stated objective.
66


Moreover, during the legislative process, the Parliament, the Council and the Commission took account of the available scientific evidence and the opinions of the interested parties. It is common ground that a number of consultations and meetings were organised at a late stage in that process precisely in order to collect the necessary information on the options available to the EU legislature. Thus, the Commission in particular conducted, on 25 November 2013, further discussions with associations representing the tobacco industry, in particular the Tobacco Vapor Electronic Cigarette Association (TVECA) and the Electronic Cigarette Industry Trade Association (ECITA). In addition, the Parliament’s Committee on the Environment, Public Health and Food Safety held, on 19 March 2013, an open meeting with representatives of the industry concerned and also, on 7 May 2013, a workshop on electronic cigarettes with the participation of experts from the WHO, national authorities, scientists and consumer associations.
78


In addition, it is open to the EU legislature to have recourse to a general legal framework which is, if necessary, to be made more precise at a later date. In the present case, it is precisely the Commission which must adopt, pursuant to Article 20(13) of Directive 2014/40, implementing acts laying down, inter alia, a common format for the notification provided for in paragraph 2 of that article.
101


The fact that that provision does not prescribe any specific method or process for the purposes of the fulfilment of that requirement does not mean, however, that it infringes the principle of legal certainty.
In the absence of any legislation in this connection at Union level, it is for the Member States or, depending on the circumstances, for the manufacturers themselves to choose a reliable method capable of ensuring compliance with that requirement.
116


The fact that tobacco products have been able to benefit for many years from advertising campaigns cannot under any circumstances constitute a reason requiring the EU legislature to allow such campaigns also for electronic cigarettes. On the contrary, as soon as it became aware of serious scientific information alleging the existence of potential risks to human health to which a relatively new product on the market might give rise, the EU legislature was required to act in accordance with the precautionary principle in the second sentence of Article 35 of the Charter, Article 9 TFEU and Articles 114(3) TFEU and 168(1) TFEU which require it to ensure a high level of protection of human health in the definition and implementation of all Union policies and activities.
123


The Court has already held that an EU measure adopted on the basis of Article 114 TFEU may incorporate provisions seeking to ensure that requirements aimed at improving the conditions for the functioning of the internal market are not circumvented (see, to that effect, judgments in Germany v Parliament and Council, C‑376/98, EU:C:2000:544, paragraph 100, and British American Tobacco (Investments) and Imperial Tobacco, C‑491/01, EU:C:2002:741, paragraph 82).
130


It is apparent, in this respect, from the Court’s case-law that the statement of reasons for a measure of general application may be limited to indicating the general situation which led to its adoption, on the one hand, and the general objectives which it intends to achieve, on the other (see, inter alia, judgment in Inuit Tapiriit Kanatami and Others v Commission, C‑398/13 P, EU:C:2015:535, paragraph 29).
139


In respect of, in the second place, the alleged lack of clarity regarding the contours of the obligation to provide information on the ‘preferences of various consumer groups’ referred to in Article 20(7)(ii) of Directive 2014/40, it is already apparent from paragraphs 78 and 101 of the present judgment that it is not necessary for a legislative act to itself provide details of a technical nature, such as, inter alia, the definition of the methodology which it is necessary to apply in order to collect any such data and, moreover, in the absence of any legislation in this connection at Union level, it is for the Member States to choose a reliable method for the enforcement of the relevant obligations.
144


The principle of subsidiarity is set out in Article 5(3) TEU, under which the European Union, in areas which do not fall within its exclusive competence, is to act only if and in so far as the objectives of the proposed action cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale or effects of the proposed action, be better achieved at EU level. Furthermore, Article 5 of Protocol (No 2) lays down guidelines for the purpose of determining whether those conditions are met (judgment in Estonia v Parliament and Council, C‑508/13, EU:C:2015:403, paragraph 44).
149


Since the present case concerns an area — the improvement of the functioning of the internal market — which is not among those in respect of which the European Union has exclusive competence, it must be determined whether the objective of Directive 2014/40 could be better achieved at EU level (see, to that effect, judgment in British American Tobacco (Investments) and Imperial Tobacco, C‑491/01, EU:C:2002:741, paragraphs 179 and 180).
155


The protection afforded by Article 16 of the Charter covers the freedom to exercise an economic or commercial activity, the freedom of contract and free competition, as is apparent from the explanations relating to that article, which, in accordance with the third subparagraph of Article 6(1) TEU and Article 52(7) of the Charter, have to be taken into consideration for the interpretation of the Charter (judgment in Sky Österreich, C‑283/11, EU:C:2013:28, paragraph 42).
157


However, in accordance with the case-law of the Court, the freedom to conduct a business does not constitute an unfettered prerogative, but must be examined in the light of its function in society (see, to that effect, judgment in Sky Österreich, C‑283/11, EU:C:2013:28, paragraph 45).
158


The freedom to conduct a business may thus be subject to a broad range of interventions on the part of public authorities which may limit the exercise of economic activity in the public interest (judgment in Sky Österreich, C‑283/11, EU:C:2013:28, paragraph 46).
159


That circumstance is reflected, inter alia, in the way in which Article 52(1) of the Charter requires the principle of proportionality to be implemented (judgment in Sky Österreich, C‑283/11, EU:C:2013:28, paragraph 47).
160


In accordance with Article 52(1) of the Charter, any limitation on the exercise of the rights and freedoms recognised by the Charter must be provided for by law and respect the essence of those rights and freedoms and, in compliance with the principle of proportionality, must be necessary and actually meet objectives of general interest recognised by the European Union or the need to protect the rights and freedoms of others (judgment in Sky Österreich, C‑283/11, EU:C:2013:28, paragraph 48).