In its ongoing investigation of Sanofi for the alleged disparagement of a rival vaccine (see, Van Bael & Bellis Life Sciences News and Insights of 29 June 2026), the European Commission (Commission) published a communication on 8 July 2026 summarising its preliminary assessment that Sanofi may have abused its dominant position (the Communication).  The Commission also published commitments proposed by Sanofi (the Commitments) to seek to resolve the case.  Interested parties have until 21 August 2026 to provide comments on the proposed Commitments.  If ultimately accepted by the Commission, the Commitments will become binding on Sanofi and the Commission will close its investigation.

For companies operating in the pharmaceutical sector, this case demonstrates the significant risks that can arise if a company adopts a communication campaign that is found (even at a preliminary stage) to be misleading and capable of discrediting a competing product.  While Sanofi would avoid any fine if the Commission accepts the Commitments, it would nevertheless have to conduct a communication campaign to resolve the alleged misleading statements.  Sanofi would also be subject to ongoing commitments and monitoring by an external trustee of its external communications for the next four influenza seasons.

Factual Background

The influenza vaccines.  Sanofi’s Efluelda® is a high-dose influenza vaccine, which competes with Seqirus’s Fluad®, an MF59-adjuvanted influenza vaccine.

The different types of evidence.  The types of evidence supporting the efficacy of each of these vaccines differed (e.g., randomised controlled trial data v. real-world evidence).  Nevertheless, the European Centre for Disease Prevention and Control (ECDC) and the German Standing Committee on Vaccination (STIKO) confirmed in 2024 that both products had the same level of certainty of evidence.

Equivalent national recommendations.  Since October 2024, 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’s Alleged Misleading Communications

According to the Commission’s Communication, Sanofi may have spread misleading messages to healthcare professionals (HCPs) that were capable of harming competition from Fluad and were not supported by any legitimate business justification.  The Commission identified three categories of potentially problematic messaging:

• Disparaging Fluad’s evidence base, 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, when STIKO had reviewed and discarded those objections before adopting its recommendation.The Commitments Offered by SanofiWithout admitting any wrongdoing or agreeing with the Commission’s findings, Sanofi has offered the following commitments, which would apply for the next four influenza vaccine seasons (until 31 March 2030):
  • Corrective public communications.  Sanofi will publish corrective communications on its German and French websites for 24 months, acknowledging the ECDC’s, STIKO’s and HAS’s assessments and clarifying that both Efluelda and Fluad have been assessed as having equally robust evidence bases and are recommended on equal footing.  In Germany, Sanofi will also send these communications directly to HCPs who were the subject of previous campaigns.
  • Compliance obligations for future messaging.  Throughout the commitment period, Sanofi’s marketing and promotional communications in Germany and France will: (i) include a reference (in Germany) to the applicable STIKO recommendation in force; (ii) not criticise, cast doubt on or contradict recommendations issued by any national immunisation technical advisory group (NITAG); (iii) not negatively highlight Fluad or suggest Efluelda is safer or more effective unless supported by the relevant summary of product characteristics (SmPC) or qualifying head-to-head studies; and (iv) not suggest that Fluad’s evidence base is weaker, including through selective presentation of scientific studies.  These restrictions extend to Sanofi’s interactions with key opinion leaders (KOLs) and require Sanofi to include a clause referencing the Commitments in new KOL contracts.
  • • External Monitoring Trustee & Internal Compliance Mechanisms.  Sanofi will establish an internal review mechanism, conduct annual compliance training, and appoint a Monitoring Trustee (at Sanofi’s expense) to oversee implementation.  Seqirus may raise alleged breaches of the Commitments directly with the Monitoring Trustee, who will issue formal recommendations in case of disagreement.

    While Sanofi’s commitments are broadly similar to those implemented in the Commission’s prior case against Vifor, several elements of Sanofi’s commitments are significantly lighter.  For example, Sanofi’s commitment period is limited to 4 influenza seasons (until 31 March 2030), compared to Vifor’s 10-year commitment period.  Sanofi has also not committed to conduct the multi-wave mail and e-mail campaigns, medical journal publications, and in-person communications that are included in Vifor’s commitments, or committed to allow competitors to use Sanofi’s corrective communication.  Sanofi’s commitments do, however, contain an additional obligation to reference the Commitments in Sanofi’s new KOL contracts.

Key Takeaways

Ongoing Competition Law Scrutiny of Communication Practices in the Pharmaceutical Sector.  This investigation of 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 is already an established administrative practice of tackling such practices.

Expansion of Types of Communications That May Constitute an Abuse.  Beyond statements addressing Fluad, the Commission’s preliminary assessment raises concerns about Sanofi’s communications that only address Efluelda, such as statements implying that Efluelda was the only vaccine recommended for the elderly.  This indicates that even a communication that solely mentions a company’s own product could potentially constitute an abuse if it is misleading and unfairly harms a competing product.

Importance of Providing Training and Guidance for All Relevant Teams (Sales Force, Medical Science Liaisons (MSLs), Market Access, …).  The Commitments indicate that the allegedly misleading statements were not confined to Sanofi’s sales field force.  The compliance obligations and training requirements extend equally to MSLs and market access teams, reflecting the Commission’s view that potentially problematic communications can originate from any team that interacts with HCPs, KOLs, payors or other stakeholders.  Competition law compliance programs should therefore not focus exclusively on sales and marketing functions, but should instead cover all staff that communicate externally about the products of the company or its competitors.