Seqirus is the marketing authorisation holder (MAH) of Fluad®, an MF59-adjuvanted influenza vaccine, while Sanofi is the MAH of Efluelda®, a high-dose influenza vaccine. Although the evidence for the efficacy of these vaccines differed, the European Centre for Disease Prevention and Control (ECDC) and the German Standing Committee on Vaccination (STIKO) each confirmed in 2024 that both products presented the same level of evidentiary certainty.

Since October 2024, Germany’s STIKO has recommended annual vaccination with either Efluelda® or Fluad® for persons aged 60 and above, with no preference for one over the other.  In France, the Haute Autorité de Santé (HAS) similarly treats the two vaccines as equivalent and recommends both preferentially over standard-dose vaccines for persons aged 65 and over.

Sanofi came in the Commission’s crosshairs (see, Van Bael & Bellis Life Sciences News and Insights of 2 October 2025, 29 June 2026, and 9 July 2026) because it made three types of possibly misleading and/or disparaging statements in its dealings with healthcare professionals (HCPs):

• Disparaging the evidence base of Fluad®, by suggesting that Fluad® was supported by weaker evidence than Efluelda®, contrary to the assessments of the ECDC, STIKO and HAS.
• Misrepresenting national vaccine recommendations, by incorrectly suggesting that Efluelda® was the only enhanced influenza vaccine recommended for the elderly, when Fluad® had been recommended on equal terms.
• Undermining the STIKO recommendation, by suggesting that STIKO’s recommendation of Fluad® remained subject to unresolved scientific objections, even though STIKO had reviewed and discarded those objections before adopting its recommendation.

The Commission was of the opinion that making these statements could give rise to an abuse of dominant position in breach of Article 102 of the Treaty on the Functioning of the European Union. In order to undo the possibly negative market impact of its statements, Sanofi has now agreed to abide by several behavioural principles while avoiding an adverse finding of infringement and the associated legal responsibility. Sanofi will:

• not use statements in its promotional materials directed at HCPs or in its communications with key opinion leaders (KOLs) that: (i) criticise, cast doubt upon or contradict national vaccination recommendations; (ii) highlight negatively Fluad® or suggest that Efluelda® is safer or more effective; and (iii) imply that the evidence supporting Fluad® is weaker than that underpinning Efluelda®;
• publish a statement acknowledging that the applicable national vaccination recommendations treat Fluad® and Efluelda® as equivalent in protecting elderly people against influenza and send such a statement to both HCPs and KOLs in Germany;
• accept the oversight of a monitoring trustee who will report to the Commission on a regular basis.

The case against Sanofi continues a trend which at the European level began with the Commission’s decisions concerning disparagement of competitors in the Vifor case (see, Van Bael & Bellis Life Sciences News and Insights of 22 July 2024) and the Teva case (see, Van Bael & Bellis Life Sciences News and Insights of 31 October 2024). At national level, mainly in France, there has been for years an established administrative practice of tackling such conduct.

During her press conference, Teresa Ribera, the Commissioner in charge of competition policy, prided herself on the “very fast and effective outcome, with immediate effects for healthcare systems, within a year of [the Commission’s dawn raid] carried out in October 2025” (see, attached “opening remarks”). Ms. Ribera added that competition policy forms an important part of the Commission’s efforts to bolster the pharmaceutical sector as a “strategic sector for Europe”.