On the heels of a European Commission probe into whether Sanofi “disparaged” one of its flu vaccine rivals in the marketing of its own shot, the EC is lining up a “market test” to solicit feedback on new promotional commitments offered up by the French pharma.
The comment-seeking period and probe tie back to Sanofi’s marketing for its flu shot for adults ages 60 and over, which is marketed as Elfuelda in the European Union, where its only competition is the rival enhanced influenza vaccine Fluad from CSL Seqirus.
In announcing the formal investigation in late June, the EC noted that it was concerned Sanofi may have engaged in a “misleading communication campaign” that portrayed Fluad as inferior to its respective vaccine, running afoul of national vaccine recommendations in several EU member states.
The campaign mainly targeted healthcare professionals in Germany and France, according to the EC, which also noted that Sanofi’s Elfuelda appeared to hold a dominant position in those markets.
Now, after Sanofi put forward proposed pledges about what it will and won’t say regarding its rival’s vaccine, the EC is inviting the public to weigh in on those commitments by Aug. 21. The EC has the power to make the commitments binding on Sanofi until March 2030, which would put the probe to bed without concluding infringement of antitrust rules by the company, following a mandatory comment period for “interested third parties,” according to a July 7 release.
In the full text submitted (PDF) by Sanofi to the EC, the French drugmaker stressed that its commitments “do not constitute an acknowledgement that Sanofi agrees with the concerns expressed by the Commission nor an acknowledgement that Sanofi or any of its affiliates have infringed EU competition law.”
Digging into Sanofi’s proposed pledges, the company has said that it will publish a statement on its German website for two years that Europe’s National Immunisation Technical Advisory Group (NITAG) in Germany recommends both Efluelda and Fluad “equally for elderly people,” plus a similar statement on its French website, according to the EC.
Sanofi has also promised to send its German statement to local healthcare professionals and to include, for four years, a “prominent citation” of the current German NITAG vaccine recommendation in all German marketing and promotional materials for enhanced flu shots.
The company has also pledged to avoid “criticizing, casting doubt on or contradicting the applicable national vaccine recommendations issued by the relevant NITAG” and to refrain from “portraying Fluad negatively,” in addition to suggesting that its shot Efluelda is safer or more effective.
That could change in the future based on evolving health authority guidance or the results of a head-to-head trial, the EC clarified.
Crucially, Sanofi has also committed to refrain from such comments when providing input to key opinion leaders ahead of interactions with healthcare professionals in Germany and France.
Should the commitments pass the public comment period and become legally binding, the EC noted that it could impose a fine of up to 10% of its worldwide annual turnover on Sanofi if the company doesn’t honor its pledge. Alternately, the company could face a period penalty payment of 5% per day of its daily turnover for every day in which it’s in noncompliance, the EC added.
At the time the EC unveiled its probe last month, Sanofi told Fierce in a statement that it was “confident that it has acted, and continues to act, in full compliance with all applicable laws and regulations, including competition law.”