The European Commission has made commitments offered by Sanofi legally binding under EU antitrust rules. The commitments relate to the Commission's preliminary competition concerns relating to Sanofi's alleged disparagement campaigns in Germany and France against Fluad, the only enhanced flu vaccine for vulnerable patients that competes with Sanofi's Efluelda.
To address the Commission's preliminary concerns, Sanofi offered to engage in proactive communication to rectify and undo the possible effects of the potentially misleading messages shared regarding Fluad, as well as to refrain from any communication portraying Fluad negatively or casting doubt about its performance.
The Commission's preliminary concerns
Sanofi, headquartered in France, is active in the research, development, and manufacturing of innovative prescription medicines, vaccines, and healthcare solutions. One of the vaccines offered by Sanofi is an enhanced flu vaccine, which is specifically designed to provide greater protection against flu for people over 60.
In the EU, this vaccine is marketed under the brand name 'Efluelda' and competes with the only other enhanced flu vaccine currently marketed in the EU, by the company CSL Seqirus under the brand name 'Fluad'.
The Commission preliminarily found that Sanofi may be dominant in the market for enhanced flu vaccines in Germany and France. The Commission is concerned that, from 2024 until at least autumn 2025, Sanofi may have pursued a misleading communication campaign targeted at healthcare professionals (HCPs). This communication campaign was conducted in Germany and, with a lower degree of intensity, in France and consisted of:
- suggesting that the evidentiary basis for Fluad is weaker than that for Efluelda, in contradiction to the findings of the European Centre for Disease Control and national immunisation technical advisory groups in Germany and France;
- misrepresenting national vaccination recommendations;
- suggesting that the national vaccination recommendations for Fluad in Germany remains subject to unresolved scientific objections from medical professional societies.
By doing so, Sanofi may have restricted competition on the markets for enhanced flu vaccines in Germany and France, in breach of Article 102 of the Treaty on the Functioning of the EU (TFEU), which prohibits the abuse of a dominant position that may affect trade and prevent or restrict competition within the Single Market.
The commitments
To address the Commission's preliminary concerns, Sanofi offered commitments.
For one part, Sanofi will, until March 2030:
- not use statements in its promotional materials directed at HCPs in Germany and France that: (i) criticise, cast doubt upon or contradict national vaccination recommendations; (ii) highlight negatively Fluad or unduly suggest that Sanofi's vaccine Efluelda is safer or more effective; (iii) suggest or imply that the evidence base supporting Fluad is weaker than the one supporting Efluelda;
- not use such statements when providing input to so-called Key Opinion Leaders (KOLs) for their interactions with HCPs in France and Germany concerning the flu vaccines at stake; and
- in Germany specifically, include, in most of its promotional material related to Efluelda, a sufficiently comprehensive and legible reference to the most recent national vaccination recommendations.
In addition, to correct and remedy the potential effects of its past messages that may have been disparaging, Sanofi will:
- publish, for 24 months, a statement on its German and French websites, acknowledging and clarifying that the applicable national vaccination recommendations treat Fluad and Efluelda as equivalent in protecting elderly people against the flu, both having a robust evidence base; and
- send such statement to HCPs and KOLs in Germany who had been previously targeted by Sanofi's disparagement campaign against Fluad.
Between July and August 2026 , the Commission market-tested those commitments. In light of the outcome of this market test, Sanofi adjusted the initial proposal, notably by extending its proactive outreach to also cover KOLs in Germany who had been previously targeted by Sanofi's alleged disparagement campaign against Fluad.
The Commission concluded that the commitments proposed by Sanofi will address its competition concerns related to the potential disparagement of Fluad. It has therefore decided to make them legally binding on Sanofi.
The implementation of the commitments will be monitored by a monitoring trustee who will report regularly to the Commission.
Background
On 26 June 2026 , the Commission opened a formal antitrust investigation to assess whether Sanofi's alleged disparagement campaign against Fluad violates EU competition rules. On the same date, the Commission adopted a Preliminary Assessment summarising the main facts of the case and identifying its preliminary competition concerns.
On 8 July 2026 , the Commission launched a market test on the commitments offered by Sanofi, which ran until 21 August 2026.
Article 102 TFEU prohibits the abuse of a dominant position that may affect trade and prevent or restrict competition within the Single Market. The implementation of Article Article 102 TFEU is defined in Regulation 1/2003 .
Article 9(1) of Regulation 1/2003 enables companies investigated by the Commission to offer commitments in order to address the Commission's concerns and empowers the Commission to make such commitments binding on the companies. Article 27(4) of Regulation 1/2003 requires that, before adopting such decision, the Commission shall provide interested third parties with an opportunity to comment on the offered commitments ("the market test").
If the market test indicates that the commitments are a satisfactory way of addressing the Commission's competition concerns, the Commission may adopt a decision making them legally binding on the company concerned. Such a decision would not conclude that there is an infringement of EU antitrust rules, but would legally bind that company to respect the commitments it has offered.
If the company does not honour such commitments, the Commission may impose a fine of up to 10% of its worldwide annual turnover, without having to find an infringement of EU antitrust rules, or a periodic penalty payment of 5% per day of its daily turnover for every day of non-compliance.
