The European Commission (“Commission”) has made legally binding the commitments offered by Sanofi to address its preliminary competition concerns regarding Sanofi’s alleged disparagement of Fluad, a competing enhanced flu vaccine for vulnerable patients, in Germany and France. The Commission’s concerns relate to potentially misleading communications directed at healthcare professionals, which may have undermined the competitive position of Fluad against Sanofi’s own enhanced flu vaccine, Efluelda.
According to the Commission’s preliminary assessment, between 2024 and autumn 2025, Sanofi may have conducted communication campaigns suggesting that Fluad had a weaker evidentiary basis than Efluelda, misrepresenting national vaccination recommendations and implying that unresolved scientific objections remained regarding the recommendations for Fluad in Germany. The Commission considered that such conduct may have restricted competition in the markets for enhanced flu vaccines in Germany and France, potentially infringing Article 102 of the Treaty on the Functioning of the European Union (“TFEU”), which prohibits the abuse of a dominant position.
To address these concerns, Sanofi has committed, until March 2030, to refrain from using promotional statements in Germany and France that criticize or cast doubt on national vaccination recommendations, portray Fluad negatively, unduly suggest that Efluelda is safer or more effective, or imply that the scientific evidence supporting Fluad is weaker. These commitments also cover communications with key opinion leaders (“KOLs”). In Germany, Sanofi will additionally include sufficiently comprehensive and legible references to the latest national vaccination recommendations in most of its Efluelda promotional materials.
To remedy the potential effects of its past communications, Sanofi will publish a statement on its German and French websites for 24 months, clarifying that the applicable national vaccination recommendations consider Fluad and Efluelda equivalent in protecting elderly people against influenza and that both vaccines have a robust evidentiary basis. Sanofi will also send this statement to healthcare professionals and KOLs in Germany who were previously targeted by the alleged disparagement campaign.
Following a market test conducted between July and August 2026, Sanofi revised its initial proposal, including by extending its proactive communication commitments to KOLs in Germany. The Commission concluded that the commitments adequately address its preliminary competition concerns and made them legally binding on Sanofi. Their implementation will be monitored by a monitoring trustee, who will report regularly to the Commission.
(European Commission – 14.10.2026)
NAZALI TAX & LEGAL