Feedback from: Institute for Rational Addiction Policies on TPD and TAD

Public Health TP

The Institute for Rational Addiction Policies (IRAP) acknowledges this Call for Evidence on the revision of the Tobacco Products Directive and Tobacco Advertising Directive. However, we have significant concerns about the analytical foundations of this revision and urge the Commission to address them before advancing to impact assessment.

IRAP approaches this revision from a public health perspective, with the objective of reducing tobacco-related disease, preventing youth nicotine uptake, supporting cessation, and minimising harms among adults who continue to use nicotine.

Addressing the evaluation’s methodological limitations

IRAP regrets the absence of a counterfactual scenario in the evaluation report. Without modelling what would have occurred under alternative regulatory approaches, observed changes in smoking prevalence cannot be specifically attributed to the TPD framework. The evaluation itself concedes that "no data was available to clearly quantify the specific impact of all these factors." Furthermore, approximately 40% of the prevalence decline is attributed to taxation policy, yet conclusions on TPD effectiveness are drawn without separating the relative contribution of different instruments. The revision must rest on a more rigorous evidence base, including a full counterfactual analysis prior to impact assessment.

Taking evidence-based approaches into account

IRAP calls on the Commission to reorient the TPD revision around a policy framework that is "rational, realistic and based on prevention and harm reduction" (Statement by the Czech Republic on the Council Recommendation on smoke-and aerosol-free environments).

This dual foundation, the protection of non-smokers and youth on one hand, and risk minimisation for adult smokers on the other, is the most credible path toward meaningfully reducing tobacco-related mortality in Europe, where 535,000 deaths were recorded in 2023 alone and the Cancer Plan's 2025 target has not been met.

IRAP recognises that no tobacco or nicotine product is risk-free, and that the best health outcome remains complete cessation of smoking and, where possible, nicotine use.

The Czech Republic offers a relevant example that should be assessed as part of the broader evidence base: it treats harm reduction as one of the main pillars of tobacco policy, explicitly applied to adults who cannot or do not wish to quit. This framing should be adopted at EU level. The revised TPD should establish two explicit and complementary primary objectives: first, to protect children and adolescents from tobacco use and exposure to tobacco and related products; and second, to facilitate, where supported by independent evidence and appropriate safeguards, the transition of adult smokers who would otherwise continue smoking to lower-risk alternatives when they are unable or unwilling to quit entirely. These objectives are mutually reinforcing, and both are necessary for an effective public health framework.

Central to the Czech approach is the recognition that emerging tobacco and nicotine products may pose lower health risks than traditional combustible tobacco. The Commission should ensure that the revised TPD incorporates risk-proportionate regulation. That is, a regulatory framework calibrated to the relative social and health risk of different product categories, rather than one that treats all tobacco and nicotine products as equivalent. Recent statements by the European Commissioner for Health Oliver Varhelyi equating the risks of every products is therefore concerning. Risk-based regulation does not mean weakening protections. Such an approach must include strict age verification, robust enforcement, restrictions on youth-oriented marketing, and measures addressing flavours, packaging and product design that may appeal to children and adolescents. It means directing the most restrictive measures where the evidence shows the greatest harm, while allowing reduced-risk alternatives, where supported by independent evidence, to be considered within cessation or substitution pathways for adult smokers who would otherwise continue smoking. Strict regulation to prevent youth access to all products must remain a core component of this framework.

The experience of Member States such as Czechia should be better taken into account. The Commission's evaluation characterises divergent national approaches primarily as an internal market problem, but these differences represent a body of real-world evidence that should inform, not be overridden by, harmonisation efforts. Such experience should be evaluated against clear public health indicators, including youth uptake, smoking prevalence, cessation outcomes, illicit market dynamics and health inequalities.

Towards a comprehensive understanding and regulation of addiction

Dr. Pavel Bem, National Drug Policy Coordinator of the Czech Republic, argued before the European Parliament's Committee on Public Health that the regulatory lessons learned from licit substances, including tobacco, have direct relevance to the governance of other psychoactive substances. Effective addiction policy, whether applied to tobacco, alcohol, or illicit drugs, shares a common architecture: it must be evidence-based, proportionate, attentive to human rights, and oriented toward reducing harm rather than relying primarily on prohibition or punitive enforcement. As Dr. Bem observed, repressive approaches consistently generate unintended consequences, including illicit markets, increased stigma, and diminished public health outcomes. Good regulation, by contrast, protects public health.

The TPD revision offers an opportunity to embed this integrated, evidence-led logic into EUlevel policy. IRAP recommends that the Commission pair any TPD revision with an EU-cofinanced package of cessation support and risk minimization interventions, including stopsmoking services and training for healthcare professionals, and that it adopts measurable indicators for youth uptake, initiation, cessation, substitution among continuing adult smokers, abstinence rates, dual use and relapse. A structured, inclusive consultation process, drawing on public health experts, cessation specialists, healthcare professionals, people with lived experience of tobacco use, and Member States with relevant regulátory experience, is equally essential.

The policy process should be protected from conflicts of interest and undue commercial influence, in line with the need for independent evidence and transparent decision-making.