Commission opens investigation into possible anticompetitive conduct by Sanofi regarding the promotion of a flu vaccine for vulnerable patients

The European Commission has opened a formal antitrust investigation to assess whether Sanofi has breached EU competition rules by carrying out a communication campaign that disparages the only rival flu vaccine recommended for vulnerable patients with risk factors.

Sanofi, headquartered in France, is a multinational company active in the research, development, and manufacturing of innovative prescription medicines, vaccines, and healthcare solutions. One of the vaccines currently offered by Sanofi is an enhanced flu vaccine, which is specifically designed to provide greater protection against influenza for people over 60.

In the EU, this vaccine is marketed under the brand name 'Efluelda' and competes with another enhanced flu vaccine marketed by the company CSL Seqirus under the brand name 'Fluad'.

The Commission is concerned that Sanofi pursued a misleading communication campaign to disparage Fluad by portraying it as inferior to Efluelda, going against national vaccination recommendations in several Member States. The campaign primarily targeted healthcare professionals in Germany and France.

In both of these markets, the Commission considers that Sanofi holds a dominant position. In particular, the Commission preliminarily is concerned with the following messaging:

• Claims suggesting that the evidentiary basis for Fluad is weaker than that for Efluelda, contradicting the findings of the European Centre for Disease Control and national immunisation technical advisory groups in Germany and France.
• Misleading and/or inaccurate representations of national vaccination recommendations.
• Claims, in Germany, suggesting that the national vaccination recommendation for Fluad remains subject to unresolved scientific objections from medical professional societies.

If proven, the practices under investigation may breach EU competition rules that prohibit the abuse of a dominant position (Article 102 of the Treaty on the Functioning of the European Union ('TFEU')).

The opening of a formal investigation does not prejudge its outcome.

In parallel to the opening of proceedings, the Commission has adopted a Preliminary Assessment summarising the main facts of the case and identifying its competition concerns. To address the Commission's concerns, Sanofi may now submit commitments.

Background

The Commission carried out unannounced inspections at the premises of Sanofi in September 2025.

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 this provision is defined in Regulation 1/2003.

A Preliminary Assessment summarises the main facts of the case and identifies the competition concerns of the Commission. To meet these concerns, the addressee of the Preliminary Assessment may offer commitments in line with Article 9(1) of Regulation 1/2003, which allows the Commission to conclude antitrust proceedings by accepting commitments offered by a company. Such a decision does not reach a conclusion as to whether there is an infringement of EU antitrust rules, but legally binds the company to respect the commitments submitted.

Article 11(6) of Regulation 1/2003 provides that the opening of proceedings by the Commission relieves the competition authorities of the Member States of their competence to apply EU competition rules to the practices concerned. Article 16(1) further provides that national courts must avoid adopting decisions which would conflict with a decision contemplated by the Commission in proceedings it has initiated.

There is no legal deadline for bringing an antitrust investigation to an end. The duration of an antitrust investigation depends on a number of factors, including the complexity of the case, the extent to which the companies concerned cooperate with the Commission and the parties' exercise of the rights of defense.

For more information

More information on the investigation will be available on the Commission's competition website, in the public case register under the case number AT.40998. For more information on the Commission's competition law enforcement in pharmaceutical and health service markets, see here.