EU seeks advice on Sanofi's response to mismarketing claim
The EU is asking for feedback on measures proposed by Sanofi to address concerns about a marketing campaign for a flu vaccine that may have disparaged the only rival product in the market.
Last month, the European Commission opened an investigation into promotional activities for Sanofi's enhanced flu vaccine Efluelda, which is used to protect vulnerable patients with risk factors for severe flu aged over 60, and competes in that setting with CSL Seqirus' Fluad shot.
In a preliminary finding, the Commission said there are concerns about claims in Sanofi's campaign suggesting that the evidence for Fluad's efficacy was weaker, contradicting the findings of the European Centre for Disease Control (ECDC) and national immunisation technical advisory groups (NITAGs) in Germany and France.
It also said Sanofi may have issued misleading information on national vaccination recommendations, as well as making the erroneous claim that in Germany, the national recommendation for CSL Seqirus' product "remains subject to unresolved scientific objections from medical professional societies."
In reparation, Sanofi has offered to publish a statement on its French and German websites, for a period of two years, that will acknowledge the ECDC and NITAG positions that both Efluelda and Fluad "have a robust evidence base" and are both equivalent for use in elderly people over standard flu vaccines.
It has also committed to including a "prominent citation" of the current German NITAG recommendation in marketing and promotional material for enhanced flu vaccines in Germany, for the next four years.
In addition, Sanofi has pledged to refrain from "criticising, casting doubt on or contradicting the applicable national vaccine recommendations" on enhanced flu vaccines and portraying Fluad and its efficacy negatively.
The commitments would remain in force until March 2030, and a trustee would report regularly to the Commission to monitor compliance with the commitments.
Feedback on the proposals will be accepted until 21st August, said the Commission.
The investigation follows unannounced inspections of Sanofi offices in France and Germany last September, which the EU said took place because of concerns that Sanofi had violated EU antitrust rules that prohibit abuses of a dominant market position. Under EU law, companies can be fined up to 10% of their global turnover if it is proved they have committed anticompetitive actions.
Photo by Laurin Steffens on Unsplash
