A Hard Sell
The EU continues to view harm reduction with suspicion.
By Stefanie Rossel
The European Commission’s 2021 application report on the EU Tobacco Products Directive (TPD), which was published on May 20, 2021, had been highly anticipated as its objective was to clarify which parts of the TPD the commission deemed necessary to amend.
Considering the Commission’s goal to create a “tobacco-free generation” by 2040, where less than 5 percent of EU citizens use tobacco, tobacco harm reduction (THR) advocates had been hoping the report would reconsider its opposition to their cherished concept.
TPD Article 28 required the Commission to review the directive in the light of scientific and technical developments five years after the legislation had entered into force. It was obliged to pay special attention to e-cigarettes.
The application report would also guide the EU position toward safer nicotine products at the upcoming Conference of the Parties (COP9) of the World Health Organization Framework Convention on Tobacco Control (FCTC). As COP9 had to be postponed to November 2021 due to the Covid-19 pandemic, the commission found itself in the unusual situation that its stance might point the way for COP9 rather than the other way around.
In the event, the Commission preferred to be the well-behaved pupil, mirroring the WHO’s hostile stance toward THR and what has been termed the organization’s war on nicotine. “As scientific consensus has yet to be reached, the precautionary principle prevails and the TPD takes a careful approach in regulating these products,” the application report states. “The WHO further concluded that no firm evidence exists on the safety of e-cigarettes, but there is increasing evidence of harm.”
That the commission was unwilling to consider the relative risks of alternative nicotine products compared to that of combustible cigarettes already became clear when the EU Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) released its preliminary opinion in 2020. Critics called the report “fundamentally flawed,” having, among other things, effectively ignored scientific literature published after April 2019, most of which supports the argument that vaping actively helps facilitate THR. Mandated to focus only on health impacts of e-cigarettes compared to nonsmoking, the SCHEER’s final opinion leaves the users of vape products without guidance and clear information about the level of risk of these products compared to traditional cigarettes, as scientists wrote in a letter to the EU Commissioner of Health and Food Safety, Stella Kyriakides.
Disregarding ample feedback from the scientific community and other stakeholders, the final opinion turned out to be a nearly verbatim version of the preliminary opinion. “The SCHEER opinion underlined [the] health consequences [of e-cigarettes] and the important role they play in smoking initiation,” its authors stated. “This opinion supports the careful and precautionary approach taken so far. However, it should be explored whether some provisions could be further developed or clarified, such as tank size or labeling requirements; use of flavors; use of nicotine-free liquids; and advertising provisions. Insofar as e-cigarettes are smoking cessation aids, their regulation should follow the pharmaceutical legislation.”
Damian Sweeney, a partner in the European Tobacco Harm Reduction Advocates (ETHRA), an advocacy group formed by consumers, says that the EU misuses the precautionary principle to justify imposing harsher regulations. “This could mean flavor bans and restrictions on open systems, which would severely limit the appeal of vaping and would be extremely detrimental to public health,” he says. “The danger is that they will throttle the one game-changing measure that really does seem to be working and could scale up dramatically and quickly with the right regulatory, fiscal and communications environments.”
Learning from others
Altogether, the application report is positive about the TPD, claiming it has put in place comprehensive EU tobacco control policy rules, “notably through enlarged combined health warnings, a track-and- trace system, a ban on characterizing flavors, the creation of an ingredients database and the regulation of electronic cigarettes.” Most importantly, the Commission states that the TPD has overachieved its aim to reduce tobacco consumption among those aged 15 and over by 2 percent within five years of its transposition. Smoking prevalence across the EU, the report says, had declined from 26 percent in 2014 to 23 percent in 2020. “Of course, it didn’t attribute any of this to the rise of low-risk alternatives, even though that has had an obvious effect,” says Sweeney. “While any reduction in smoking is to be welcomed, we think that the gains in smoking cessation could have been far greater were it not for the excessive restrictions which the TPD imposes on vaping products, such as nicotine and volume limits or marketing restrictions. A positive effect of the TPD is that it has prevented member states from banning vaping outright.”
According to Sweeney, declines in smoking prevalence accelerate where safer nicotine products are widely available, accessible and affordable. “The EU data shows that Sweden has almost reached smoke-free status, with a smoking prevalence of just 7 percent,” he says. “This is the lowest smoking prevalence in the EU by a significant margin and it’s largely thanks to the use of snus. The U.K., where tobacco harm reduction is widely supported and promoted by public health, experienced the sharpest decline in smoking prevalence since 2006 (minus 21 percentage points). Ireland has one of the highest rates of adult vaping in the EU, which led to a 6 percent fall in smoking prevalence in three years—a drop which was unheard of before vaping became popular.”
Despite the U.K.’s departure from the EU, Sweeney says the country will continue to play an important role in tobacco control policy at the international level. “The U.K. is a world leader in tobacco harm reduction, with a smoking prevalence 9 percent lower than the EU average, so they are clearly doing something right that the rest of the EU can learn from. Researchers from the U.K. are still involved in pan-European tobacco control initiatives and the high-quality research and experience they bring will be invaluable in informing future policy.”
While the EU Parliament lost important voices for tobacco harm reduction with the departure of Britain, Sweeney believes the move creates opportunities as well. “Leaving the EU means that the U.K. is now in a position to diverge from the TPD; to remove the arbitrary restrictions on vaping products, which are a barrier to switching; and to lift the ban on snus. The main consumer organization in the U.K., the New Nicotine Alliance, has put forward proposals that would take advantage of Brexit to help the government meet its ambitious smoke-free 2030 target. If the government adopted these proposals, it would set an example for the EU by showing what could be achieved with a comprehensive approach to tobacco harm reduction.”
Proof, not anecdotes
To achieve an EU smoking incidence of less than 5 percent by 2040, the application report urges improvements in TPD enforcement at the national level and better consideration of new market developments, such as novel tobacco products.
The 5 percent goal is at the heart of the EU’s Beating Cancer Plan (BCP), which the EU presented in February this year (see “Beating Harm Reduction,” Tobacco Reporter, April 2021). The BCP identified tobacco as the top avoidable key risk factor. However, this plan, too, failed to distinguish between combustible and noncombustible products. It did not recognize low-risk alternatives, such as vape products and smokeless tobacco, as substitutes for the more harmful combustible products.
The European Parliament’s BECA committee drew similar conclusions. Its draft report, presented for discussion on July 15, calls for an increase in minimum excise duties for all tobacco products and a ban on flavorings in all tobacco products. At press time, it remained unclear whether these requirements would apply to safer nicotine products. “Taken literally in EU law, this would apply to heated-tobacco products and smokeless tobacco, including snus,” says Sweeney. “Most countries have cigarette taxes that are above the minimum, so this would tend to close the gap between very dangerous and much safer products and therefore reduce switching and increase smoking compared to not doing it,” he explains.
“However, several countries have moved to increase taxes on vaping products, most notably Germany. So, we may see this language evolve. The danger is that we will see the fiscal incentive to switch weakened and more smoking as a result. The MEPs need to realize that taxation has direct consequences for behavior and therefore for health,” says Sweeney.
Ahead of the July meeting, ETHRA had written to all BECA members to outline the important role THR can play in achieving the goal of reducing cancer in Europe. Judging from members’ reactions to the draft report presentation, Sweeney is cautiously optimistic. “THR is facing a difficult future in Europe, there can be no doubt about that, but I don’t think it’s the end—far from it. Ultimately, political opinions don’t change the lived experience or underlying science. There is support for THR within the European Parliament and several MEPs have asked very important parliamentary questions on the role harm reduction can and should play in the Cancer Plan. […] So, some MEPs clearly do understand the concept and importance of harm reduction strategies.”
According to Sweeney, the fact that the science of THR and the lived experience of consumers of safer nicotine products have been largely ignored should be used as a rallying call to consumers and advocates alike. “We need to contact our elected representatives to share our experiences and let them know that harm reduction will be key to successfully preventing cancer. As consumers who have successfully quit smoking using safer nicotine products, we are not anecdotes, we are proof that THR works. There are millions of us, and we shouldn’t be ignored.”
