Just this week, after overcoming one hurdle after another, a British marketer of e-liquids, Totally Wicked, presented its case and the case for science-based regulation of nicotine products before the EU Court of Justice (CJEU). The chances of success: slim, given the Byzantine nature of the EU's regulatory process. But if anything might arouse the ire of the EU Court, the TPD's Article 20, with its bizarrely anti-science regulations crafted in secret, might be it.
The EU’s 5-year process of revising the Tobacco Products Directive (TPD) has resulted in a nearly-unmitigated disaster. Eschewing at every opportunity science-based (or even rational) policy, a conflicted, unaccountable bunch of commissioners working with zero transparency or accountability, crafted a destructive, corrupt framework for dealing with tobacco. Those of us devoted to public health, specifically interested in reducing the dreadful toll of smoking, disgusted with this measure foisted on an unsuspecting populace, hoped some entity with credibility and resources would tackle the TPD legally.
Article 20 of the TPD deals with e-cigarettes and vapor products. The inclusion of e-cigarettes, which do not contain tobacco, in the TPD is controversial. In the text of the TPD, the EU states that e-cigarettes "can develop into a gateway to nicotine addiction and ultimately traditional tobacco consumption, as they mimic and normalize the action of smoking." However, there is little evidence for this gateway effect. A recent report by Public Health England notes that "very few" nonsmokers become regular e-cigarette users. The authors of the report concluded that "The gateway theory is ill defined and we suggest its use be abandoned."
Clive Bates, formerly director of Action on Smoking and Health, has described Article 20 as "a catalogue of poorly designed, disproportionate and discriminatory measures that will achieve nothing useful but do a great deal of harm." Given that non-smokers have so far shown little interest in e-cigarettes, critics argue that discouraging vaping amounts to encouraging smoking and that some of the EU’s new regulations will damage health by raising prices and reducing the appeal of products which, if smokers switched to them, would save lives.
The legal challenge launched by Totally Wicked is based on the grounds that Article 20 is "a disproportionate impediment to the free movement of goods" and "fails to comply with the general EU principle of equality."
Everyone agrees that smoking is the most important, catastrophic — yet preventable — cause of disease and death in the western world: while 100 million lives were lost to tobacco in the last century, reliable estimates predict one billion cut short in the 21st. The lethal use of tobacco derives almost entirely from the smoking of cigarettes.
The ostensible goal of the TPD revision was to reduce the toll of smoking, an especially important issue in Europe, where about 30 percent of the population smokes, and where almost 700,000 die each year from it.
How did the current TPD version come to be so miserably wrong? The perverse requirements of the extraordinarily lengthy section dealing with electronic cigarettes and vapor products, now known as Article 20, are more stringent than those applied to cigarettes. The byzantine process of making legislative and regulatory policy in the EU cannot be understood, or even described, in an opinion piece of reasonable length. Suffice it to say that the three-headed lawmaking organs — the Commission (EC), the Council of Nations (ECN), and the Parliament (EP) — simply evaded (or when necessary, ignored) the legal framework mandated by the treaties which created the EU; many of the proposed regulations fly directly in the face of both the substance and the spirit of these pillars of the EU.
Saying it could have been worse is unacceptable as an explanation of the irresponsible measure facing European smokers and vapers now: as it stands, the measure must be implemented by the EU’s 28 member nations by next May 20th.
Some cause for optimism remains: the Totally Wicked litigation commenced over two years ago, and has succeeded in gaining leave to proceed from two separate preliminary rulings in the U.K. And the blatant deficiencies of Article 20 would require a very dark willful blindness on the part of the CJEU to be ignored. Anyone who wishes that Europe's bleak smoking-related history might be at least improved should join me in wishing good fortune to the plaintiffs in this matter.
A decision is not expected until next winter.