# EU Commission Makes Sanofi Commitments Binding > The EU Commission has made Sanofi’s commitments on flu vaccine communications binding until March 2030 without finding an antitrust violation. Source: https://www.mtrlegal.com/en/eu-commission-makes-sanofi-commitments-binding/ · Language: en · Updated: 2026-10-26 --- ## EU Commission Makes Sanofi Commitments Binding On 14 October 2026, the European Commission made commitments offered by Sanofi legally binding under EU antitrust rules. The proceedings concerned preliminary competition concerns regarding alleged communications campaigns in Germany and France said to have targeted the Fluad influenza vaccine. According to the Commission, Fluad is the only enhanced influenza vaccine for particularly vulnerable patients that competes with Sanofi’s Efluelda vaccine. The commitment decision does not establish that Sanofi infringed competition law. After the proceedings were initiated, Sanofi rejected the allegations and pledged its cooperation. ## Preliminary Concerns Regarding Possible Disparagement ### Communications Addressed to Healthcare Professionals According to the Commission’s preliminary assessment, Sanofi is alleged to have conducted a communications campaign since 2024 that was primarily directed at healthcare professionals in Germany and France. The Commission expressed concerns that potentially misleading or disparaging statements about Fluad may have been disseminated in the process. The representations challenged by the Commission included the assertion that Germany’s national vaccination recommendation for Fluad remained subject to unresolved scientific objections from medical associations. Competition Commissioner Teresa Ribera stated that practices of this kind could restrict the freedom of choice of doctors and patients. This constitutes the Commission’s preliminary assessment and not a final finding of an infringement of antitrust law. Sanofi is presumed innocent unless and until such a finding is made. ### Investigations in Germany and France In September 2025, the Commission conducted inspections at Sanofi’s premises in Germany and France. At the time, the company confirmed the visit by Commission representatives and stated that it complied with the applicable rules and would cooperate fully with the authority. Formal proceedings were opened on 26 June 2026. At the same time, the Commission submitted its preliminary assessment of the competition concerns. There was no statutory deadline for completing the investigation. ## Proceedings Under Article 102 TFEU The Commission is conducting the proceedings under case reference AT.40998 “Sanofi Efluelda”. [The case register](https://competition-cases.ec.europa.eu/cases/AT.40998) identifies Article 102 TFEU (Treaty on the Functioning of the European Union) and Article 54 of the EEA Agreement (Agreement on the European Economic Area) as the legal bases. These provisions prohibit the abuse of a dominant market position where trade between Member States or within the European Economic Area may be affected. Sanofi submitted proposed commitments to the Commission on 3 July 2026. The subsequent market test under Article 27(4) of Regulation (EC) No 1/2003 was published in the Official Journal of the European Union on 10 July 2026. Third parties were able to submit comments until 21 August 2026. The Commission adopted [its commitment decision](https://ec.europa.eu/commission/presscorner/detail/en/ip_26_2154) on 14 October 2026. The decision made the measures offered by Sanofi binding without the authority determining whether there had been an infringement of Article 102 TFEU or Article 54 of the EEA Agreement. ## Substance and Monitoring of the Commitments ### Clarification of the German Vaccination Recommendation The measures that have become binding include a statement on Sanofi’s German website. It must remain accessible for two years and clarify that the Ständige Impfkommission (STIKO, German Standing Committee on Vaccination) recommends Fluad and Efluelda equally for older people. In addition, Sanofi has committed to including a clause referring to [the commitments](https://www.mtrlegal.com/wiki/verpflichtungszusagen/) in new agreements with so-called key opinion leaders. This will also incorporate the requirements into future contractual relationships with the relevant opinion leaders. The key elements of the commitments therefore include, in particular: - publishing and making available for two years the clarification regarding the recommendation of the Ständige Impfkommission, - referring to the commitments in new agreements with key opinion leaders, - complying with the commitments until March 2030, and - continuous monitoring of their implementation by a monitoring trustee. ### Monitoring Until March 2030 The commitments will remain in force until March 2030. Their implementation will be monitored by an independent monitoring trustee who will report regularly to the European Commission. A breach of the binding commitments may be sanctioned without the Commission first having to prove an infringement of the underlying antitrust rules. Possible sanctions include a fine of up to ten per cent of worldwide annual turnover or a daily penalty payment of up to five per cent of average daily turnover. ## Significance of the Commitment Decision Commitment decisions enable the European Commission to address competition concerns through binding behavioural commitments without making a final determination as to whether an antitrust infringement actually occurred. By offering such commitments, the company concerned does not therefore necessarily admit to an infringement of the law. In the present case, the allegations made against Sanofi remain at the stage of a preliminary assessment. The decisive point is that the measures offered have become binding as a result of the Commission’s decision and that compliance with them will be monitored until March 2030. CSL Seqirus, the supplier of Fluad, welcomed the Commission’s decision. The proceedings demonstrate that statements about competing products may also fall within the scope of Article 102 TFEU if they are made by a dominant undertaking and are capable of restricting competition. Companies and investors dealing with comparable issues concerning market communications, product presentation or regulatory oversight can contact MTR Legal and obtain [legal advice on competition law](https://www.mtrlegal.com/rechtsberatung/wettbewerbsrecht/).