Lyon: The vaccine plants ringing this city ship influenza doses to health systems that buy on the advice of national immunisation committees. The European Commission now suspects that one manufacturer tried to move that advice with words rather than data, and the remedy on the table reveals how Brussels reads a modern abuse case.
Regulators opened the formal investigation into Sanofi on 26 June. They published the company’s proposed commitments on 7 July. Eleven days separated the start of a dominance case from a draft settlement, a pace that suggests Sanofi walked into the room with an offer already written.
The theory of harm stays narrow. The Commission takes the preliminary view that Sanofi holds a dominant position in enhanced flu vaccines in Germany and France, a segment built for older patients whose immune response to standard formulations fades with age. Since 2024, the Commission says, indications point to a communication campaign aimed at healthcare professionals that cast doubt on a competing product, Fluad, while pushing Sanofi’s own Efluelda.
Two allegations carry the case. Sanofi allegedly suggested that the evidence behind Fluad was thinner than the evidence behind Efluelda, an assertion that contradicts the European Centre for Disease Prevention and Control and the national immunisation technical advisory groups in both countries. Sanofi also allegedly told professionals that German vaccination recommendations for Fluad still faced unresolved scientific objections from medical societies. Neither claim, on the Commission’s reading, survives contact with the public record.
The commitments run until March 2030. Sanofi would publish a statement on its German website acknowledging that the advisory groups treat the two products as equivalent. It would stop portraying Fluad negatively and stop implying that Efluelda is safer or more effective, unless the claim rests on approved product characteristics or on head-to-head trials meeting defined criteria. The Commission is market-testing those undertakings before it makes them binding.
Disparagement as an abuse of dominance grew up in national courtrooms, mostly French and Italian, in disputes over off-label use of cheaper medicines. Applying it at Union level tells pharmaceutical companies that the sales conversation now sits inside competition law. That reach cuts both ways. Firms hold a legitimate interest in arguing about clinical evidence, and immunisation policy improves when manufacturers contest each other’s data openly. A rule that punishes misleading claims must not silence contested ones.
The settlement route also buys Sanofi something valuable. A commitments decision closes the file without a finding of infringement, so no fine follows and no national court gets a ready-made hook for damages. Health insurers in Germany and France who paid for a vaccine mix shaped by the disputed campaign therefore gain a public correction and little else.
Third parties can still change the outcome during the market test. Competitors and payers may argue that a website statement and a set of speech restrictions cannot undo two seasons of procurement decisions, and that only a full infringement decision would deter the next campaign. The Commission must weigh that against the appeal of a fast fix in a market where the next flu season starts in weeks.
