Brussels, 27 May 2025
Tobacco Europe has reached out to Commissioner Olivér Várhelyi to request further clarity on the upcoming Implementation Dialogues, as outlined in his mission letter from President von der Leyen.
These dialogues — set to take place at least twice a year — aim to ensure alignment between EU policy implementation and the realities experienced on the ground by stakeholders. The mission letter also refers to the preparation of an Annual Progress Report on Enforcement, highlighting the need for structured and inclusive stakeholder engagement.
Tobacco Europe would like to understand how the Commissioner intends to proceed with the organisation of these dialogues — including timelines, stakeholder engagement processes, and expected outcomes.
Please find the letter here Request from Tobacco Europe to Commissioner Varhelyi
Brussels, November 11, 2024
End of October, Tobacco Europe wrote to Mrs Juhansone, Secretary General, to ask whether the ongoing evaluation of the Tobacco Control Acquis, including the Tobacco Products Directive (TPD) and the Tobacco Advertising Directive (TAD), had been selected among the evaluations to be scrutinised by the Regulatory Scrutiny Board (RSB) this year or in 2025.
In her answer from November 29, Mrs Juhansone confirmed that the Evaluation of the legislative framework for tobacco control has been selected for scrutiny in 2025. Tobacco Europe welcomes such confirmation and hope this will ensure the quality of the evaluation and the soundness of any regulatory decisions stemming from it.
Find the full document here: SG response Tobacco Europe letter fin
Find Tobacco Europe’s letter here: Tobacco Europe letter to Secretary General on Evaluations
Brussels, October 14 2024
Tobacco Europe wrote this day to the Ombudsman to draw attention on a potential conflict of interest that involves Open Evidence, the leading party in the consortium contracted by the European Commission for services concerning EU actions in tobacco control, including the ongoing revision of the Tobacco control acquis.
This letter follows TE’s previous correspondence shared with the Ombudsman on 13th March, which already highlighted our concerns regarding both Open Evidence and ENSP (under investigation).
As detailed in the attached letter, Tobacco Europe and its members are worried about potential breaches of confidentiality, professional misconduct, and conflicts of interest, which could compromise the impartiality and objectivity required for the contractual work. This is why we urge the Ombudsman to thoroughly investigate these concerns and take appropriate actions towards the Commission to ensure the integrity and impartiality of the contracted work and that the proper measures are put in place to prevent such misconducts.
The full document can be found here: Tobacco Europe letter to the Ombudsman on Open Evidence 14.10.24
Brussels, 10 September 2024
Download the letter here: TE letter on SfE to Commissioner Schinas 10.09.24
Tobacco Europe wrote to Commissioner Schinas regarding the revision of the Recommendation on Smoke-free Environments. Indeed, as the proposal may be addressed on the 17th of September, Tobacco Europe would like to bring the Commissioner’s attention to several important elements highlighted in the letter attached, and below:
Dear Commissioner Margaritis Schinas,
Tobacco Europe has been following the ongoing discussions regarding the revision of the Recommendation on Smoke-free Environments. We understand it may be addressed on the 17th of September, and we greatly appreciate the chance to engage with you on this topic.
While we assume the publication of a proposal will not be on the agenda due to the ongoing consultation process, we would like to seek your clarity. As you may be aware, the Commission had committed to publishing a ‘synopsis report’ summarizing the input from stakeholders at the conclusion of the consultation. However, to date, this report remains unpublished and thus we are led to assume the consultation is still ongoing:
At the end of the consultation process, a synopsis report summarising all consultation activities will be published.
We believe the timely publication of the report, well in advance of any proposal and in line with the process the Commission outlined to stakeholders, is crucial for transparency and ensuring the input of over 200 entities, including the Tobacco Europe members, is adequately considered. If there is intention to withhold it, we would greatly appreciate your help in reconsidering this, in the spirit of openness the Commission champions and its duty to justify such decisions.
We also trust you agree public scrutiny is essential. Without an evaluation or impact assessment performed, the consultation is the main source of primary and timely data for this revision. Unfortunately, some studies the Commission relies on are outdated (some of which date from the 1990s!), which raises concerns about the evidence-base related to today (please see the Annex our remarks on the revision process).
We are aware DG SANTE is navigating complex challenges, including the management and verification of conflict-of-interest allegations involving the contractor supporting this revision consultation. As stakeholders, we are not privy to this process, but we trust your experience and help to ensure it proceeds with the integrity expected by all parties.
Particularly, we would appreciate your consideration of whether it aligns with the principles of Better Regulation to base policy decisions on deliverables authored by contractors subject to unresolved conflict of interest allegations. Unfortunately, it is unclear to us whether due diligence and thorough reviews were conducted on those deliverables. Furthermore, the Commission previously mentioned the need for “further work” and additional “evidence gathering.” We are left uncertain whether those observations, or the delay in the publication of the consultation report, are linked to the conflict-of-interest concerns in any way.
In the UK, similar discussions have sparked significant public debate, which we believe serves as a valuable lesson. We hope the Commission will rely on comprehensive, transparent, and up-to-date data to base any decisions.
Tobacco Europe members remain fully committed to participating in the consultation process. With the publication of the ‘Draghi report’ emphasizing the regulatory burden of businesses and the definition of Commissioner portfolios, we believe that crucial aspects, such as competitiveness, which were not sufficiently addressed in previous questionnaires, should now be given proper attention.
Thank you very much for your attention to these matters,
Yours Sincerely,
Nathalie Darge
ANNEX – General comments on the process
It is unclear whether an evaluation of the revised Recommendation was ever performed in line with the Commission’s Better Regulation guidelines. A formal evaluation should have been made but to our knowledge, it seems the Commission limited itself to Implementation Reports.
The Commission developed the 2021 Rand report based on both a questionnaire and desktop research on the implementation of the 2009 Council Recommendation on smoke-free environments.
This report was meant to be the basis in 2022 for a Commission proposal in 2023.
The Commission is considering the 2021 RAND report on the Tobacco Advertising Directive and Smokefree environments as an “evaluative study”. However, this report does not follow the evaluation structure imposed by the Better Regulation Principles. In addition, the Commission has so far refrained from carrying out an impact assessment (IA), claiming that the initiative “does not substantially change the scope of the 2009 Recommendation” and the IA carried out in 2008 and published in 2009 remains valid. We find this perturbing as:
- The Commission itself has acknowledged on two occasions, the scientific challenges of such an update, particularly Commissioner Kyriakides who called it “a particularly challenging task” and whose services have stated “it requires further work and evidence gathering”;
- The 2009 IA cites studies dating back to the 1990s and is itself over 15 years old;
- The IA does not assess the impact of restrictions in outdoor and quasi-outdoor spaces, such as terraces of restaurants and bars. At the time, the Commission’s goal was to improve indoor air quality. Its findings are irrelevant to the Commission’s current goals;
- The IA included a subsidiarity test to justify EU action against smoke exposure. No such test has been conducted for this initiative. The 2023 Progress Report on the implementation of the FCTC shows a 95% implementation rate for its Article 8 (protection from exposure to tobacco smoke). This is the highest for any Article and suggests very limited need for EU intervention;
- The 2009 IA examined the impact of five alternative policy options.3 This time no alternative options are being considered, nor there is any input from the Regulatory Scrutiny Board, which provided substantial input at the time;
- The IA fails to address the specific impact on small and medium-sizedenterprises (SMEs). This omission is troubling given President Ursula Von der Leyen’s emphasis on SMEs being the “heart of our economy” in her candidacy speech
- The 2009 IA did not cover emerging products. Whereas the Commission justifies the update on the need to keep pace with “technological change and technological development”, the legal basis for the Recommendation (Articles 153, 168, and 292 TFEU) does not support such a rationale.
According to the latest Eurobarometer 539 survey4, more than half of respondents reported that vaping and heated tobacco products helped them reduce or quit smoking. Therefore, these conclusions must be considered by the Commission. TE believes that extending the scope of Smoke-Free environments to outdoor spaces would send the wrong message to consumers who wish to quit smoking by using potentially reduced risk alternatives, as these would be treated the same as combustible tobacco products.
Therefore, we believe that the Commission should carry out an Impact Assessment to inform the proposal, by carrying out a new analysis of evidence and ensuring a consultation with relevant stakeholders.
Conclusion
Tobacco Europe encourages the Commission to act in accordance with the principles of Better Regulations and first develop an Impact Assessment prior to considering any changes to the review of the Council’s “Recommendation on smoke-free environments (2009/C 296/02)”.
Tobacco Europe believes that measures to restrict smoking and vaping in outdoor public places such as the outdoor terraces of bars and restaurants are not supported by any scientific evidence.
Considering the lack of scientifically based evidence and of consistency used in the assessment methodology, Tobacco Europe does not support the extension of the Recommendation to emerging products nor the extension of its current scope to additional outdoor spaces.
All in all, in a liberal society, the state’s responsibility is to regulate for safety, not to make choices on behalf of their citizens, nor to tell them how to live their lives. We view that nanny state interference should not prevail, but rather uphold the respect of individual autonomy and personal responsibility.
Brussels, August 6 2024
In this letter, DG SANTE replies to Tobacco Europe’s letter of May 8, and reiterates its position on the fact that there is no conflict of interest involving Open Evidence.
Find the full letter here: Reply_to_Ares(2024)3420053_Tobacco Europe_V2_clean
Brussels, July 28 2023
Find the full document here: Tobacco Europe_evaluation_Ares(2023)4270427_R1-A2
Subject: Procedural shortfalls identified in the public consultation on the evaluation of the legislative framework for tobacco control
Brussels, 31 August 2023
DG SANTE influence on think tanks based in Brussels
Brussels, 20 June 2023
Ombudsman’s inquiry on tobacco interaction with the European Commission.
Brussels, June 19 2023
Find the full document here: Tobacco Europe Letter on Procedural Shortfalls Public Consultation
