Brussels 20 February 2026
Since its entry into force in 2005, the WHO Framework Convention on Tobacco Control (FCTC) has provided the global framework for tobacco control policies.
In recent years, Article 5.3 has sparked increasing debate in the European policy environment going beyond its original intent. Some interpretations suggest that it requires the systematic exclusion of the tobacco industry from any interaction with policymakers, regardless of the policy area.
Tobacco Europe believes that this trend warrants clarification.
Article 5.3 was designed “[...] to protect [public health] policies from commercial or vested interests of the tobacco industry [...]”. It is not intended to justify the blanket exclusion of lawful economic operators from regulatory discussions that directly affect them. Nor does it extend to unrelated policy areas such as environmental legislation, customs enforcement, taxation, financial regulation or other non-health matters This interpretation was further clarified by the Court of Justice of the European Union in February 2022, in its judgment in Case C-160/20 concerning emission measurement methods. The Court stated:
“It is clear from the very wording of that provision that it does not prohibit all participation of the tobacco industry in the establishment and implementation of rules on tobacco control but is intended solely to prevent the tobacco control policies of the parties to the convention from being influenced by that industry’s interests.”
This confirms that Article 5.3 aims to prevent undue influence in public health policies, not to prohibit engagement, information exchange or dialogue , and especially not to extend its scope to unrelated areas of policymaking.
Tobacco Europe believes that a correct interpretation of Article 5.3 provides an opportunity to strengthen transparency, accountability and integrity in decision-making. These objectives are fully aligned with EU and OECD principles of Better Regulation, which emphasise openness, stakeholder consultation and evidence-based policymaking.
Ensuring transparency does not require exclusion. On the contrary, structured and accountable dialogue with all affected stakeholders supports more robust, balanced and legally sound policymaking.
Tobacco Europe and its members operate legally within the European Union. They are subject to extensive regulation and are directly impacted by legislative and regulatory initiatives across multiple policy fields. As such, they are legitimate, transparent and accountable stakeholders in European policymaking and should be able to engage with the European institutions.
Brussels, 3 February 2026
Tobacco Europe contributed to the Call for Evidence on Better Regulation.
Find more information on our position here: TE response COM call for evidence better regulation 26.02.03
Brussels, 24 October
On 22 October 2025, the World Health Organization (WHO) published a news release entitled “Tobacco industry targets WHO FCTC COP and MOP negotiations: Parties urged to stay vigilant” (available here).
In this communication, the WHO Secretariat of the Framework Convention on Tobacco Control (FCTC) alleged that the tobacco industry was attempting to “interfere” with upcoming negotiations ahead of the Tenth Conference of the Parties (COP11) in Geneva, including by “placing sympathetic actors in delegations” and “spreading misleading research.”
These accusations were later reported by media outlets, among which Politico in its Morning Health Care newsletter on 23 October.
Tobacco Europe firmly rejects these unfounded allegations and the characterisation of the industry’s engagement. The statement below reiterates our organisation’s commitment to transparency, evidence-based policymaking, and respect for democratic processes.
Read our full statement here: Tobacco-Europe-Statement-on-COP11-lobby.pdf (1201 downloads )
Brussels, February 6
Following Tobacco Europe’s complaint lodged in March 2024, the Ombudsman has finally issued a decision on the 4th of February and informed us that they were closing the inquiry as the “the Ombudsman found that no further inquiries are justified in this case”.
While deciding that there is no cause for a financial conflict of interest, the Ombudsman’s findings confirm what Tobacco Europe has long argued: the Commission failed to acknowledge ENSP’s vested interests and concealed the bias in the legislative process involving the Tobacco Products Directive currently under evaluation.
The Ombudsman herself stated:
“It is regrettable that the Commission did not acknowledge ENSP’s interest in tobacco control in its exchanges with the complainant and then failed to explain how it assessed this interest in view of the ENSP’s role under the framework contract.”
This case highlights a deeper issue: the Commission’s selective interpretation of conflict-of-interest rules. While industry links are heavily scrutinized, ideological and institutional biases within NGOs remain unchecked. To the point where the Ombudsman reminds the Commission NGOs must be subject to the same conflict of interest standards:
“It is relevant to recall that the Commission must make a conflict of interest assessment in relation to all bidders in a procurement procedure, including non-governmental organisations” (emphasis added).
The Ombudsman’s decision serves as a wake-up call—EU-funded NGOs must be subject to the same transparency and accountability standards as all other stakeholders.
Find attached to this article the decision of the Ombudsman, and Tobacco Europe’s reactive statement to it.
TE Reactive Statement Ombudsman_ENSP_OE Final clean 05 02
DECISION_202400517_20250204_104705
Brussels, December 3rd, 2024
Today, the EPSCO Council adopted the Smoke and Aerosols Free Environments Recommendation.
Tobacco Europe regrets the Council's decision to include emerging products within the scope of this Recommendation. This inclusion, in our view, lacks a solid scientific foundation and fails to account for the specificities of these products.
Moreover, we find the extension of restrictions to open and semi-open spaces, such as hospitality terraces, to be disproportionate and unsupported by evidence of public harm.
It is important to remember that this Recommendation remains non-binding for Member States, allowing each to determine the measures best suited to their national contexts.
We encourage policymakers to continue engaging in a balanced dialogue and to base their decisions on thorough scientific analysis and proportionality.
Brussels, 20 September 2024
Tobacco Europe thanks the Ombudsman’s inquiry team for the diligent work carried out regarding the potential conflict of interest with ENSP in the framework contract on tobacco control policy, and welcomes the opportunity to provide comments to the Report on the meeting of the European Ombudsman inquiry team with representatives of the European Commission on how it handled these alleged conflicts.
All comments provided by Tobacco Europe can be found in the document here: Tobacco Europe's comments to Ombudsman Report meeting 20.09.24
Brussels, 17 September 2024
Download the statement here: 24.09.17 Tobacco Europe's statement to the Publication of the Smoke- and Aerosol-Free Environments’ recommendation
On September 17, the outgoing Commission put forward a proposal for the revision of the non-legislative Council Recommendation on Smoke-Free Environments, just days after publishing the ‘Draghi’ Report to revamp European competitiveness.
Tobacco Europe considers that the inclusion of emerging products within the scope of the Recommendation lacks scientific basis and views the extension to open and semi-open areas (such as hospitality terraces) as disproportionate.
Tobacco Europe wrote to the Commission expressing concerns about the process. No evaluation was performed in line with the Better Regulation guidelines. No new impact assessment was conducted relying instead on the 2008 one, which did not cover emerging products and focused only on indoor spaces.
Additionally, the Commission had committed to publishing a ‘synopsis report’ summarizing stakeholders input at the conclusion of the consultation. Instead, it released the report simultaneously with the proposal denying us and +200 stakeholders the opportunity to assess how the input was considered ahead of the proposal.
Tobacco Europe wished the outgoing Commission had acted in transparency and in accordance with the principles of Better Regulations.
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, July 23rd
Background: On 13 March, Tobacco Europe lodged a complaint with the Ombudsman concerning the evaluation process of the legislative framework for tobacco control, highlighting specific concerns about both: the European Network for Smoking and Tobacco Prevention (ENSP) and Open Evidence, both contractors involved in the framework contract on tobacco control policy.
Following our submission, the Ombudsman initiated an investigation on 25 April, focusing on how the European Commission addressed alleged conflicts of interest within a framework contract on tobacco control policy, specifically on ENSP.
Update: In June, Tobacco Europe received confirmation from the Ombudsman that a meeting with the Commission on this case would be held on 28 June. A draft report will be prepared, and shared with Tobacco Europe for any additional comments. Such report will serve as the basis for the Ombudsman to formulate a position on the matter. Although the timeline remains unclear, we anticipate receiving feedback by end of July.
Concerning our complaint to DG SANTE sent on both 13 March and 8 May on the potential conflict of interest involving Open Evidence, the leading consultant in the consortium contracted by the Commission for services concerning EU actions in tobacco control, including the ongoing revision of the Tobacco control acquis, DG SANTE has failed to reply within the stipulated time frame as outlined under the European Code of Good Administrative Behaviour, which mandates that institutions respond to correspondence from citizens and organizations within a reasonable time frame, typically set at 15 working days. It notably stipulates that a decision on every request or complaint to the institution is taken within a reasonable time-limit, without delay, and in any case no later than two months from the date of receipt.
In parallel, Tobacco Europe observes that a numerous of other conflict of interests have popped up recently, impacting various industries and for which the Commission and the Ombudsman have been taking taking a clear stance, notably in pharma, big techs, as well as another case involving a consultancy specialised in competition law, in which the element of professional conflict of interest was considered.
Tobacco Europe will continue providing regular updates on this matter.
Tobacco Europe is surprised by the claims made by Minister Vandenbroucke on Monday 29 January during the exchange with the ENVI Committee, holding the industry responsible for the delay of the proposal’s publication.
Tobacco Europe, as legitimate and transparent stakeholder, effectively took part in the European Commission’s consultation process, namely the Call for Evidence in July 2022, the Targeted Consultation in March 2023 and finally the Targeted Stakeholders’ Workshop in April 2023.On the latter, Tobacco Europe never received minutes from the consultant and therefore is not aware of the feedback transmitted to the Commission. As Tobacco Europe, we have always acted in a transparent manner; hence, we cannot agree with Minister Vandenbroucke’s remarks, nor we are aware of any official statement concerning possible delays from the Commission.
We reiterate our interest and commitment to engaging transparently and publicly in decision-making processes affecting our members’ businesses.
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.
