On 4 May the European Court of Justice (ECJ) has rendered three important judgments in the field of tobacco control, each confirming the validity of the EU Tobacco Products Directive. This blog discusses the findings in one of these judgments, (Case C-477/14 Pillbox 38 v The Secretary of State for Health) concerning the newly introduced rules regulating the use of electronic cigarettes. It focuses on the risk regulatory aspects of this judgment, namely the findings regarding the health risks of e-cigarettes, scientific uncertainty, and the use of the precautionary principle by the EU legislature. The Court’s reasoning confirms that EU courts grant the EU institutions broad discretion to assess politically and scientifically complex situations while emphasizing the importance of procedural safeguards. It also leaves us with certain open questions regarding the legal nature and effects of the precautionary principle in the EU.

The three cases (two preliminary ruling requests and one annulment procedure) were initiated by two tobacco companies (Philipp Morris and Pillbox 38) and Poland, and constituted a sort of a general legal onslaught on the validity of the Directive adopted in 2014. Pillbox 38 concerned the validity of Article 20 of the Directive, which introduced new rules governing electronic e-cigarettes. In this case the Court had to address the question, to use AG Kokott’s words, ‘how, having due regard to the precautionary principle, to counter the possible health risks of e-cigarettes as a novel and still relatively little known product.’

Before the High Court of Justice of England and Wales, Pillbox 38 (UK) Ltd, a manufacturer of e-cigarettes, has claimed that the Directive infringes the principles of proportionality, legal certainty, free competition, and subsidiarity, as well as Articles 16 and 17 of the Charter of Fundamental Rights of the EU. In assessing these claims the ECJ dealt with several aspects of Article 20. The latter introduces a notification requirement for e-cigarettes, establishes the maximum nicotine dose and certain requirements regarding packaging, as well as restricts the advertising of e-cigarettes.


E-cigarettes different from conventional cigarettes

A first important finding of the Court was that e-cigarettes display several objective characteristics, which make them different from conventional tobacco products. Most importantly, ‘unlike tobacco products’ e-cigarettes are relatively new products, whose risks to human health still need to be clarified.’ This justified submitting e-cigarettes to a separate legal regime than conventional cigarettes without infringing the principle of equal treatment.


The principle of proportionality and precaution

Pillbox argued that e-cigarettes are less harmful or even beneficial for public health, because they can substitute for conventional tobacco products or support the cessation of tobacco use. Subjecting them to specific rules under Article 20, therefore, was disproportionate. In response, the Court first established the appropriate standard of review. Following established case law, it stated that ‘the EU legislature must be allowed broad discretion in an area (…), which entails political, economic, and social choices on its part, and in which it is called upon to undertake complex assessments.’ Therefore, the legality of the measure can only be assessed to the extent that it is manifestly inappropriate having regard to the objective which the competent institutions are seeking to pursue.

The Court then turned to the question of available evidence regarding the health risks of consuming e-cigarettes. That evidence was highly disputed by the parties. The EU institutions countered Pillbox’s arguments by stating that e-cigarettes may create a nicotine addiction and lead to nicotine poisoning prompted by over-consumption or inadequate handling. Moreover, they may become the point of entry to smoking for non-smokers, since they trivialize the action of smoking and increase its attractiveness. Without pronouncing itself on the substance of the science-based arguments on both sides, the Court searched for answers in an international expert opinion, namely an expert report of the World Health Organization. The latter finds that e-cigarettes represent ‘an evolving frontier, filled with promise and threat for tobacco control.’ While acknowledging the inconclusiveness of existing scientific evidence, the report also identifies certain health risks in particular for children, adolescents, pregnant women and women of reproductive age. And it also points to the limited evidence regarding the benefits of e-cigarettes as tobacco cessation help. Likewise, the available evidence does not affirm or reject the ‘gateway’ effects associated with e-cigarettes. In other words, neither of the scientific studies presented to the Court could sufficiently substantiate the claims made by either of the parties. Rather, the need for additional studies was acknowledged.


Precautionary principle as obligation to act?

Under these circumstances, the Court concluded that ‘the EU legislature had to take account of the precautionary principle, according to which, where there is uncertainty as to the existence 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 risks 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 materialize, the precautionary principle justifies the adoption of restrictive measures.’ It should be noted that the precautionary principle was not assessed as a self-standing plea (eg the compliance of the EU institutions with the precautionary principle), but rather as a part of the proportionality test, which followed the logic of the pleas raised by Pillbox.


Lack of impact assessment irrelevant

Pillbox supported its claim of disproportionality by pointing out the measure chosen by the EU legislature in Article 20 was not included in the Commission’s initial proposal, and was therefore not subject to an impact assessment accompanying that proposal. Pointing to its judgment in Afton, the Court re-affirmed that an impact assessment is not binding on either the Parliament or the Council. The EU legislature remains free to adopt measures other than those, which were the subject of that impact assessment. The choice of a different regulatory option does not as such demonstrate a manifest error of assessment. However, the Court added to that argument by pointing out that during the legislative process, the EU institutions took account of the available scientific evidence and the opinions of the interested parties by carrying out consultations. This in turn supported the finding that Article 20 of the Directive does not infringe the principle of proportionality by establishing a special regime for e-cigarettes.


Maximum nicotine level

The threshold chosen by the EU legislature for the maximum nicotine dose in the refill container of an e-cigarette (20 mg/ml) was also scientifically controversial between the parties. At this point the Court relied on the finding that the EU legislature nevertheless relied on ‘objective evidence’ when adopting this limit. It referred to the WHO expert opinion, un-contradicted statements by the EU institutions regarding the maximum levels of e-cigarettes already sold on the market, and a letter of Pillbox to the European Parliament, which acknowledged the appropriateness of the 20 mg/ml level. This led to the conclusion that the EU legislature balanced the various interests by taking several factors into account and without exceeding the limits of its broad discretion.



The judgment confirms previous approaches to EU judicial review of science-based regulation and the precautionary principle (eg Pfizer, Gowan, Acino, and most recently Neptune Distribution). In a line of established case law the Court shows deference to the exercise of both executive and legislative discretion in situations involving the balancing of both public interests and complex scientific assessments. This broad discretion is granted even in cases involving potential violations of fundamental rights of the claimants. While respecting discretion, the Court also tries to ensure a certain level of control, which is however reduced to the duty to respect procedural safeguards (see here). As was the case here, the availability of international expert opinions pointing to the existence of health risks as well as the fact that the EU institutions have taken all relevant aspects and considerations into account is seen as an important indicator of the legality of both administrative and legislative measures based on contested scientific evidence. The Court’s test developed to ensure compliance with the precautionary principle also builds on existing case law. As such it also remains subject to ongoing criticism regarding its vagueness and ambiguity. Is it ever possible to determine with certainty the existence or extent of health and environmental risks in technologically driven economy? How to measure the likelihood of real harm to public health should the risk realize? And, does and can the Court actually engage with those questions? In other words, more often than not, the developed formula ultimately does not allow for a meaningful substantive judicial review, which is why the Court rightly emphasizes the importance of procedural safeguards and the duty to consider all relevant aspects and concerns. Lastly, it is interesting to note that in this case the Court formulates the precautionary principle as triggering an obligation to act on the part of the EU legislature (‘had to take into account’) in situations of scientific uncertainty. In other words, the principle is not only seen as justifying restrictive measures, but as requiring them in such situations. This question relating to the legal nature of the precautionary principle is controversial (see here). The scarcity of explanation of the Court’s reasoning as well as the fact that in the same paragraph the Court speaks about the precautionary principle as ‘justifying’ restrictive measures, unfortunately does not add much clarity to this controversy (but see the judgment in Sweden v Commission).


Dr. Maria Weimer is a senior research fellow at the Amsterdam Centre for European Law and Governance (ACELG).

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