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UK electronic cigarette company formally challenges Tobacco Products Directive

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electronic-cigaretteTotally Wicked, the UK’s leading electronic cigarette manufacturer has launched a legal challenge to the European Union’s recently adopted Tobacco Products Directive on the grounds that Article 20 of the Directive breaches established EU law.

Specifically, that Article 20 represents a disproportionate impediment to the free movement of goods and the free provision of services, places electronic cigarettes at an unjustified competitive disadvantage to tobacco products, fails to comply with the general EU principle of equality, and breaches the fundamental rights of electronic cigarette manufacturers.

Totally Wicked has obtained permission from the UK's Administrative Court to bring a judicial review action challenging the above, following an Order made by Mr Justice Supperstone on 31July 2014.  Permission was obtained after issuing court proceedings against the Secretary of State for Health, which asked the UK court to refer the lawfulness of Article 20 for a “preliminary ruling” by the Court of Justice of the EU (CJEU) in Luxembourg.

Significantly, having considered Totally Wicked's claim and supporting evidence, the Secretary of State for Health has accepted that it would be appropriate for the issues raised by Totally Wicked to be referred to the CJEU for a ruling. Whilst maintaining that Article 20 is lawful, the secretary of state has not objected to Totally Wicked pursuing a claim and has consented to a reference to CJEU being made.

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A hearing will now take place in London on the 6th of October 2014, where an Administrative Court judge will determine whether a reference should be made and if so, the terms of the questions being referred. Totally Wicked's lawyers are liaising with the Treasury Solicitor, acting for the Secretary of State, to try and agree draft terms of reference with a view to this being approved by the court in October.

The parties, and Mr Justice Supperstone, have agreed that the matter should be dealt with urgently given the proposed implementation date of May 2016.

If the matter is referred to CJEU, it is expected a hearing to take place in 2015 to determine whether Article 20 breaches EU law.

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Totally Wicked Managing Director Fraser Cropper said: "Many of the regulations contained within Article 20 of the Tobacco Products Directive would result is electronic cigarettes being subjected to a stricter regulatory regime than some tobacco products.  Not only is Article 20 therefore disproportionate, we believe it is also contrary to established EU law.  It is for these reasons that we have taken the significant step to challenge formally the Directive in the courts and we are delighted with the progress made to date.

"For nearly 30 million people in the EU, electronic cigarettes have and continue to provide a viable alternative to smoking tobacco cigarettes.  They have enabled those using them to leave smoking behind, either on a full or part-time basis.  Electronic cigarettes have the potential to be one of the great transformational products of the 21st century.  This Directive, if implemented in its current form, will severely hamper this potential and force many people back to smoking tobacco cigarettes.

"For the sake of electronic cigarette users and potential users, it is vital that our industry is allowed to mature within a proportionate regulatory framework, which supports appropriate controls and safety requirements, and necessary social responsibility and continues to provide consumer choice to maximise the enormous potential of these products.  Article 20 of this Directive patently will not deliver this environment.”

Totally Wicked is represented by Addleshaw Goddard LLP and Kieron Beal QC of Blackstone Chambers.

In December 2012 the European Commission brought forward proposals to amend the Tobacco Products Directive (TPD).  These proposals sought to bring electronic cigarettes within the scope of the Directive for the first time.  Final agreement on the amended TPD was reached between the European Commission, Parliament and Council in December 2013.  Member states have until May 2016 to implement the TPD.

Article 20 of the TPD deals specifically with the regulation of electronic cigarettes.

To read the TPD in full click here.

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Vaping flavour bans prove own goal for public health advocates

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The Canadian federal government recently published draft regulations to ban almost all e-cigarette flavours across the nation, with only tobacco and mint/menthol flavours left untouched. The proposal would also see most flavouring ingredients, including all sugars and sweeteners, banned from use in vaping products, writes Louis Auge.

The bill’s intended purpose is to protect public health by making vaping less appealing to young people. The available evidence, however, suggests that not only could the measure fall short of the mark, it could actually cause more problems than it solves, prompting both young people and adults to take up smoking conventional cigarettes, a far more harmful practice than vaping. Indeed, a recent study by the Yale School of Public Health (YSPH) suggested that, after a San Francisco ballot measure banned flavoured vape liquids in 2018, smoking rates increased in the city’s school district after years of steady decline.

Even after adjusting for other tobacco policies, the study found that San Francisco high school students’ odds of smoking conventional cigarettes doubled in the wake of the ban on flavoured vapes. Other studies, meanwhile, have illustrated how flavours are instrumental in prompting adult users to abandon conventional cigarettes—one 2020 study found that adults who used flavoured e-cigarettes were more likely to quit smoking than those who used unflavoured (or tobacco-flavoured) e-cigarettes.

Even more staggering is the fact that Canada’s own assessment of the proposed ban on e-cigarette flavours admits that the measure would likely cause some adults to smoke more. Some consumers aged 20 and over who currently use flavoured vaping products, Health Canada acknowledged, would not substitute the flavours they prefer with tobacco- or mint-flavoured e-cigarettes, and instead would choose to purchase more conventional cigarettes.

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The startling admission from Canadian authorities really brings home the fact that flavour bans will almost certainly lead to a proportion of users abandoning their vaping devices to take up conventional cigarettes instead—with potentially ruinous public health consequences. It should be a stark warning for countries across the Atlantic, given that several European governments, including Finland and Estonia, have already banned vaping flavours—or are working furiously to push through similar legislation.

The Netherlands is one such example, where health secretary Paul Blokhuis announced last summer that he planned to ban all non-tobacco vape flavours in the country. A public consultation on the issue drew in a record number of responses and yielded a near-unanimous consensus: an overwhelming 98% of respondents were opposed to the ban. Nevertheless, Blokhuis’ measures could take effect as early as next year.

The move is a paradox in the making for the otherwise liberal country, with the Netherlands concurrently pushing major stop-smoking campaigns like STOPtober to get tobacco users to put out their cigarettes for good. By banning flavoured e-cigarettes, the Netherlands risks

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jeopardising this progress and sending smokers away from vaping—a practice which is, according to research commissioned by Public Health England, roughly 95% less harmful than smoking combustible tobacco.

That these flavour bans threaten to push smokers back to combustible tobacco products could spell disaster for the EU’s efforts to have a tobacco-free generation by 2040. Despite considerable effort on the part of public health authorities, progress toward this goal has been less than promising: 23% of the overall population still use conventional cigarettes, and almost a third of young Europeans smoke. Europe now has less than 20 years, then, to help nearly 90 million smokers give up the habit.

Failure to achieve this objective could have serious public health consequences. Across Europe, more than 700,000 deaths annually, and a quarter of all cancers, are currently attributed to smoking; unsurprisingly, the bloc is keen to eliminate “the single largest avoidable health risk” via all means possible. As such, the Tobacco Products Directive has been active for a half-decade, and utilises a range of tools to dissuade smokers including health warnings, a track and trace system, and educational campaigns.

All of these measures, however, have not driven smoking rates down sufficiently, and top European officials have acknowledged that significant additional measures will be necessary to achieve the dream of a smoke-free generation. As studies have shown and Health Canada has now admitted, banning the very flavours which make e-cigarettes an attractive option for smokers who are seeking to reduce their health risks yet are unwilling or unable to quit nicotine altogether would likely push many consumers to buy more cigarettes. If this halted— or even reversed— the decline in smoking rates across Europe, the flavour bans could prove to be a dramatic own goal for public health, setting the EU’s efforts to curb smoking back years.

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Plain packaging not the panacea policymakers have been looking for

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A new study by researchers from LUISS Business School and Deloitte in Rome analyses the effectiveness of plain packaging for tobacco products in the UK and France and comes to a sobering conclusion.

EU Reporter wanted to find out more and sat down with the researchers.


EU Reporter: Thank you for agreeing to this interview. This is the second analysis by your group on the effectiveness of plain packaging. The first time you looked at Australia. This time, you focused on the UK and France, two countries that implemented plain packaging to curb cigarette consumption three years ago. Can you summarise how you approached the analysis and the methodology used for the report?

Professor Oriani: Thank you for having me. Our analysis is based on cigarette consumption statistics that span more than three years of full implementation of plain packaging in the UK and France. So far, ours is the only study that we are aware of that has used data from such a long time period.

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We used three methods to assess whether the introduction of plain packaging had a significant impact on cigarette consumption in both countries.

Firstly, we performed a structural break analysis to test whether the introduction of plain packaging led to a change in the cigarette consumption trend.

We then performed a structural model estimation, to confirm if plain packaging can be associated with a reduction in cigarette consumption after alternative influencing factors, such as price, are controlled for.

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Finally, we estimated a difference-in-differences regression equation for cigarette consumption that allowed us to assess the differential impact of plain packaging in France and the UK with respect to comparable countries that have not introduced plain packaging.

EU Reporter: What were the main findings of the research?

Professor Oriani: We found that the introduction of plain packaging has had no impact on cigarette consumption trends in the UK or France.

The estimation of the structural model showed that after controlling for alternative influencing factors , plain packaging has had no statistically significant impact on cigarette consumption in both countries. Finally, the difference-in-differences regression shows that plain packaging has had zero effect in the UK, while it is associated with a statistically significant increase in per capita cigarette consumption of 5% in France, which is contrary to the intended goals of the regulation.

EU Reporter: That is very interesting. So, the evidence does not suggest that plain packaging reduces cigarette consumption?

Professor Oriani: Taken together, the data show that there is no evidence that plain packaging reduces cigarette consumption at any levels. None of the different models used showed a reduction in consumption of cigarettes because of plain packaging in the UK and France.

And indeed our research found some evidence of an increase in cigarette consumption in France, suggesting that plain packaging may have had a counterproductive effect on smoking levels.

We also have to keep in mind those smokers that switched to alternative products, such as e-cigarettes or heated tobacco products. Our analysis does not include them. The fact that we found that plain packaging had no effect even without taking account of the shift to alternative nicotine products, reinforces our results that plain packaging is ineffective.

EU Reporter: I mentioned your first study earlier. Can you compare the results of the Australian study on plain packaging to the results from the UK and French studies? What conclusions can we draw from such a comparison?

Professor Oriani: The results in this report are consistent with those presented in our previous study on the impact plain packaging has had on cigarette consumption in Australia. We used the same methodology and came to the conclusion in one of our models that plain packaging is associated with a statistically significant increase in cigarette consumption there, as well.

This shows that there is no indication that plain packaging reduces cigarette consumption. Also, there is some evidence that plain packaging may result in higher smoking levels, which is something we should try to avoid.

EU Reporter: As an expert, how do you recommend European policymakers approach the topic of plain packaging?

Professor Oriani: As the most in-depth and comprehensive study on plain packaging in the UK and France to date, our research can help inform European policymakers when considering which types of tobacco control measures to introduce. This and our previous studies do not confirm the hypothesis that plain packaging is an effective policy measure to reduce cigarette consumption. European decision-makers evaluating plain packaging should consider this to ensure they have a full picture of the potentially counterproductive impact and costs of plain packaging.

The study can be accessed here

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World No Tobacco Day 2021:

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“Tobacco use is the single largest avoidable health risk. It is the leading cause of preventable cancer, with 27% of all cancers attributed to tobacco. With Europe's Beating Cancer Plan, we are proposing bold and ambitious actions on prevention to reduce the use of tobacco. We have set a very clear objective - to create a smoke-free generation in Europe, where less than 5% of people use tobacco by 2040. This would be significant change compared to the around 25% today. And reducing the use of tobacco is crucial to reach this goal. With no tobacco use, nine out ten cases of lung cancer could be avoided.

"Many, if not the majority, of smokers have attempted to quit at some point in their lives. The latest Eurobarometer[1] figures speak for themselves: if we manage to support smokers trying to quit to follow this through successfully, we could already halve the smoking prevalence. On the other hand, three out of four smokers who quit, or tried to stop, did not use any help.

"The COVID-19 crisis has highlighted the vulnerability of smokers, who have up to a 50% higher risk of developing severe disease and death from the virus, a fact that has triggered millions of them to want to quit tobacco. But quitting can be difficult. We can do more to help, and this is precisely what this year's World Tobacco Day is about – committing to quitting.

"We need to increase the motivation to leave smoking behind. Stopping smoking is a win-win situation at all ages, always. We need to step up our game and ensure that EU tobacco legislation is enforced more strictly, especially as regards sales to minors and campaigns on giving up smoking. It also needs to keep pace with new developments, be sufficiently up to date to address the endless flow of new tobacco products entering the market. This is particularly important to protect younger people.

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"My message is simple: quitting is saving your life: every moment is good to quit, even if you have been smoking forever.”

[1] Eurobarometer 506. Attitudes of Europeans towards tobacco and electronic cigarettes. 2021

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