Position on the Evaluation of the EU Tobacco Control Framework

IRAP acknowledges the publication by the European Commission of the evaluation report on the Tobacco Product Directive (TPD). IRAP considers that the evaluation is primarily based on a precautionary regulatory approach that may not fully reflect the available evidence, does not sufficiently consider risk minimisation as a public health strategy, and may lead to policy outcomes that are not optimally aligned with the objective of achieving a Tobacco-Free Europe by 2040. IRAP calls on the Commission to further refine its analytical framework before advancing to impact assessment.

1. Limitations of the Evaluation Framework

The Commission did not include a counterfactual scenario in its evaluation, making it difficult to assess what would have happened under an alternative regulatory approach. The evaluation therefore cannot demonstrate that the observed decline in smoking prevalence is attributable to the current TPD framework rather than to other factors. The document itself notes that “no data was available to clearly quantify the specific impact of all these factors.”

In addition, approximately 40% of the smoking prevalence decline is attributed to taxation policy, yet the evaluation draws conclusions about the effectiveness of the TPD and TAD without fully disentangling the relative contribution of different policy measures.

The consultation process may also present limitations in terms of representativeness. A consultation that may not fully capture the diversity of perspectives, including lived experiences, cannot be considered fully comprehensive.

2. Limitations of the Current Policy Approach

The evaluation does not clearly present harm reduction as a distinct policy objective. The framework is assessed primarily against the goal of reducing tobacco and nicotine use, placing primary emphasis on prevention of initiation and cessation outcomes. While abstinence is the ideal outcome, a singular focus on abstinence may limit the consideration of approaches that support smokers who are unable or unwilling to quit. The evaluation records 535,000 tobacco-related deaths in 2023, notes that tobacco use in Europe remains among the highest across WHO regions, acknowledges that the Cancer Plan’s 2025 target has not been met, and yet primarily proposes further regulatory measures without sufficient consideration of how different approaches may affect behavioural change among smokers.

3. Limited Consideration of Member State Experience

The evaluation repeatedly identifies divergent national approaches to novel products as an internal market issue requiring EU harmonisation. The evaluation does not sufficiently consider that Member States have adopted differing approaches that may provide useful policy insights, which could be further assessed before additional legislative action.

The role of different product categories and regulatory approaches, including in Sweden, in contributing to variations in smoking prevalence across Member States is not fully explored, with outcomes often attributed primarily to tobacco control measures. However, comparable tobacco control frameworks have produced varying results across countries.

In addition, the Czech Republic has implemented a differentiated regulatory approach to certain nicotine products, which is not reflected in the evaluation. It would be valuable for the revision of the TPD to also consider regulatory approaches that take into account differences in risk across product categories, with the objective of reducing overall harm associated with combustible tobacco use.

Recommendations

•   Order a full counterfactual analysis before the impact assessment, including the modelling of alternative regulatory scenarios, such as those that may incorporate harm reduction considerations.

• In light of the increased appeal of illicit and under-regulated electronic cigarettes, strong and evidence-based measures should be implemented to address the use of smokeless products by underage people.

•   Rebalance the consultation process for the TPD revision: ensure structured input from a broad range of stakeholders, including public health experts, cessation specialists, and individuals with lived experience of tobacco use, as well as Member States with relevant regulatory experience.

•   Integrate harm reduction as a complementary policy consideration in the TPD revision, alongside youth protection, with measurable indicators for smoking substitution and cessation outcomes, in addition to abstinence.

•   Pair any TPD revision with an EU-co-financed package of evidence-based cessation and harm reduction interventions, including stop-smoking services and healthcare professional training.