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Jump to Key Points BRUSSELS, Oct 14 (Reuters) - French pharmaceutical company Sanofi has staved off a potential hefty fine after European Union antitrust regulators on Wednesday said they had accepted its offer to stop disparaging a rival flu vaccine.
The European Commission opened an investigation in June into whether Sanofi disparaged a vaccine called "Fluad" made by CSL Seqirus, primarily in France and Germany, which competes with its "Efluelda" flu vaccine.
In its initial response, the French drugmaker said it was confident it complied with all applicable laws, but subsequently proposed a series of measures to address the EU competition enforcer's concerns to avert potential charges and a fine of as much as 10% of its global annual turnover.
"To their credit, Sanofi has engaged helpfully with the Commission since the beginning of our investigation. And it is this engagement that has allowed us to reach a very fast and effective outcome," EU antitrust chief Teresa Ribera told a press conference, announcing the approval of Sanofi's proposed actions.
- EU antitrust probe: Sanofi avoided potential fine via commitments.
- Issue involved disparaging CSL Seqirus Fluad vs Sanofi Efluelda.
- Sanofi barred from negative HCP promo in France/Germany through 2030.
- No claims allowed that national recommendations favor Sanofi vaccine safety.
- Sanofi must clarify Fluad = Efluelda in elderly flu protection by 2 years.
The Commission said Sanofi will not use promotional materials aimed at healthcare professionals in Germany and France to criticise national vaccination recommendations nor highlight negatively the rival vaccine or that its own product is safer. This pledge is valid until 2030.
CSL Seqirus welcomed the EU decision.
"The Commission's decision reinforces the importance of accurate, evidence-based vaccine communications that reflect independent scientific assessments and national vaccine recommendations," the company said in an emailed statement.
Under the agreement with the EU regulators, Sanofi will also publish in the next two years a statement on its German and French websites acknowledging and clarifying that the applicable national vaccination recommendations treat Fluad and Efluelda as equivalent in protecting elderly people against the flu.
(Reporting by Foo Yun Chee; Editing by Makini Brice and Tomasz Janowski)
