The European Union wants its tobacco and nicotine policy to be guided by science.
That, as well as the goal to make Europe “smoke-free” by 2024, is highly laudable and the right standard.
But as the Union moves toward major revisions of its tobacco control framework,another question is being asked: which science, and which scientists, is the EU willing to hear?
That question is underscored by a formal letter from a respected group called the Platform for Tobacco Harm Reduction (PRDT) to DG SANTE, the health directorate in the European Commission.
PRDT is an initiative born out of the shared concerns of a group of Spanish doctors, scientists, and healthcare professionals.They say they seek to promote “evidence-based” policies that lessen the physical and social consequences of smoking.
The purpose of the letter, says PRDT, is to highlight what they call “the limitations” of the current formats of the EC’s Call for Evidence and the Open Public Consultation, which, according to the Platform, “do not allow for the submission of the extensive scientific evidence available on smoke-free products.”
The letter concerns the completion of the consultation process related to two key EU laws: the Tobacco Products Directive and the Tobacco Advertising Directive.
It says that “given the complexity and breadth of the evidence base, these formats are too restrictive to enable a thorough and scientifically robust assessment of the issues at stake.”
The letter, dated 16 June, calls for a “more appropriate consultation channel, better suited to detailed scientific input, so that the available evidence on smoke-free products, comparative risk, harm reduction, and public health can be properly considered” in the Commission’s ongoing work.
The scientists say they appreciate the fact that interested stakeholders are being given further opportunities to contribute to the consultation.
It goes on, “However, we would respectfully like to raise a serious concern regarding the format of these consultation channels and their suitability for the type of scientific input that this file requires.
“While these instruments formally provide an opportunity for input, in practice they are too limited to allow meaningful scientific engagement.”
The letter says that “a 4,000-character submission, even when accompanied by a single document capped at 1 MB, is plainly insufficient to reflect the complexity, breadth and nuance of the available evidence on novel nicotine products and comparative risk.”
It continues, “Likewise, a questionnaire-based public consultation with a restricted set of predefined questions and answer options leaves little room for fully evidence-based scientific positions.”
The letter says that, in its current form, the consultation framework “risks reducing a complex scientific and public health debate to an overly simplified exercise that does not allow for adequate presentation of the relevant evidence and, in the case of the questionnaire, may at times appear one-directional.”
“For these reasons, we would respectfully request that our group be given the opportunity to participate in the targeted stakeholder consultation, which we understand forms part of the broader impact assessment process.”
The letter said, “We believe that such a format would be considerably better suited to a thorough and scientifically robust exchange on the evidence relating to combustible and non-combustible nicotine products, comparative risk, harm reduction, youth protection, and the overall public health implications of future regulation.”
“Given the scientific and public health significance of this file, we believe it would be difficult to justify relying predominantly on consultation formats that do not allow stakeholders with relevant expertise to present the evidence in an adequate and methodologically sound manner.”
It concludes by stating that the Platform is “available to provide evidence-based input and would welcome the opportunity to contribute constructively to the next phase of the Commission’s work.”
The EC, for its part, says that EU rules on tobacco control have contributed to a significant decline in smoking and tobacco-related deaths across the EU. At the same time, its evaluation, it says, highlights “growing challenges” linked to the rapid emergence of novel tobacco and nicotine products, particularly among young people.
Since 2012, smoking rates in the EU have fallen from 28% to 24% of the population, with an even sharper decline among young people. Tobacco-related deaths have also decreased substantially, reflecting the positive impact of stricter rules on product regulation, advertising bans and health warnings.
A Commission source there are “no safe levels” of tobacco or nicotine consumption, including from smoke-free nicotine products. It says evidence suggests that the growing popularity of novel products “may act as a gateway to nicotine addiction and, in some cases, traditional smoking.”
“Nicotine is a toxic and highly addictive substance and the growing appeal of these products, in particular among young people, is a worrisome trend.”
The EC source said that, according to the World Health Organization (WHO), more than 14 million adolescents aged 13-15 years are currently using e-cigarettes globally and those aged 13-15 years are nine times more likely than adults to use electronic cigarettes.
The Scientific Committee on Health, Environmental and Emerging Risks, for example, underlined the negative health effects associated with e-cigarettes, including damaging the cardiovascular and respiratory systems, tumorigenic effects and negative impact of foetal brain development in pregnant women, added the source.
“Notably, switching from cigarette smoking to e-cigarette does not significantly change the extent of the negative effect on the cardiovascular system. Besides the intrinsic public health risk these products represent, they also have the potential of leading to nicotine addiction and act as a gateway towards conventional smoking.”
Work is ongoing in line with the EU cardiovascular health plan -the Safe Hearts Plan- that stated the Commission intends to propose, in 2026, a revision of the legislative framework on tobacco control.
“In terms of next steps, the Commission will now carry out an impact assessment in view of further policy actions.”
