In an attempt to close the antitrust investigation launched by the European Commission for alleged anti-competitive practices in promoting its influenza vaccine Efluelda, Sanofi has presented a series of commitments proposing to change its communication towards the competing vaccine Fluad, produced by CSL Seqirus. Brussels, which suspects that the French group discredited the rival product among healthcare professionals in Germany and France, has indeed launched a public consultation on the measures offered by the company before deciding whether to make them binding.
THE COMMITMENTS PRESENTED BY SANOFI
Sanofi’s proposal comes just weeks after the formal procedure was initiated by the European Commission and includes a series of obligations intended to remain in effect until March 2030. Among these are the publication, for two years, of statements on the company’s French and German websites acknowledging that Efluelda and the competing vaccine Fluad, produced by CSL Seqirus, have been assessed by national technical-scientific authorities as equivalent options for vaccinating the elderly. In Germany, moreover, Sanofi has committed to disseminate this communication also to healthcare professionals and to recall for four years the recommendations of the national technical group in promotional materials dedicated to enhanced influenza vaccines.
The company has also committed not to disseminate communications that could question national vaccination recommendations, not to portray Fluad negatively, nor to suggest that Efluelda is safer or more effective, unless such claims are supported by documents approved by regulatory authorities or by direct comparative studies compliant with pre-established criteria. The same principles must be respected in activities carried out with so-called Key Opinion Leaders (i.e., specialists and experts who conduct training and discussions with other healthcare professionals), whose new contracts will include an explicit reference to the commitments made. The implementation of the measures will be verified by an external supervisor appointed to monitor compliance, who will report periodically to the European Commission. Brussels will collect feedback from interested parties until August 21 before deciding whether to make the commitments legally binding.
BRUSSELS’ ALLEGATIONS
According to the European Commission’s preliminary assessment, Sanofi may have abused its dominant position in the French and German markets for enhanced influenza vaccines through a communication campaign directed at healthcare professionals.
In particular, Brussels believes that, starting from 2024, the company may have presented Fluad as supported by less solid scientific evidence compared to Efluelda, contrary to the assessments of the European Centre for Disease Prevention and Control (ECDC) and the national technical groups for immunization in France and Germany. The allegations also include an alleged inaccurate representation of national vaccination recommendations and the claim that in Germany the competing vaccine was still subject to unresolved scientific objections.
Such behaviors, according to the Commission, could have restricted competition in violation of Article 102 of the Treaty on the Functioning of the European Union.
THE INVESTIGATION OPENED IN JUNE
The formal investigation was announced by the European Commission on June 26, after unannounced inspections were carried out at Sanofi’s premises in the previous September. The procedure concerns exclusively the promotion of the Efluelda vaccine against the competitor Fluad and focuses on the markets of Germany and France, where Brussels believes the French group holds a dominant position.
At the announcement of the inquiry’s opening, Sanofi had denied all allegations, stating it had always operated in full compliance with applicable rules, including competition laws. The company also described the Commission’s initiative as a procedural step without implications on the final outcome of the investigation, reaffirming its commitment to competition and patient access to innovative vaccines.
SANOFI’S POSITION
Presenting the commitments to the Commission, Sanofi clarified that their adoption does not constitute an admission of liability. The company stated it is cooperating with Brussels to enable a swift conclusion of the procedure, reaffirming its belief that it has acted and continues to act in full compliance with European and national legislation, including competition provisions.
