Say what you like about the competition! No fines for Sanofi in EC disparagement case

On 26 June, the European Commission (EC) announced the opening of a competition law investigation into allegations of a campaign of denigration by Sanofi against a competing flu vaccine. Less than two weeks later, on 8 July, it effectively announced its intention to close the case without penalties or an infringement finding while seeking feedback on commitments from Sanofi. 

Why this rush to inaction: is this a novel legal theory? Is it a borderline case? Is the infringement trivial or was the consumer harm limited? Has the EC extracted wide ranging and burdensome commitments? Not obviously.

It is now well established in the life sciences sector that false or misleading statements about competitor products can violate competition law (see our 2025 article here). This is, in fact, the third case of this type pursued by the EC in this area (after Vifor and Copaxone, both in 2024) and there have been many more at the national level. The clearest infringements involve:

• a dominant undertaking;
• false or objectively misleading statements about product safety or efficacy;
• made to healthcare professionals (HCP);
• as part of an orchestrated campaign.

This case appears to tick all of those boxes. According to the EC, Sanofi was one of only two suppliers of enhanced flu vaccines recommended for vulnerable patients with risk factors (including people over 60). It apparently pursued a communications campaign aimed at HCPs suggesting that the only competing vaccine:

• was less effective (“weaker”); and
• remained subject to unresolved scientific objections.

These suggestions contradicted the findings of competent regulatory bodies, including the European Centre for Disease Control and national immunisation technical advisory groups in Germany and France. Sanofi also appears to have misrepresented national vaccine recommendations, including by suggesting that it was the only seasonal flu vaccine designed or recommended for the elderly. 

In principle, this is a serious infringement of competition law. As long ago as 2017, in F. Hoffmann-La Roche (Case C-179/16), the ECJ agreed with its Advocate General that such behaviour is “by its very nature, harmful to the proper functioning of normal competition”. In France, the national competition authority has imposed a fine of over €440m in relation to similar behaviour. That isn’t surprising: this kind of infringement is generally accepted to harm national healthcare systems and patients. In fact, in this case, the EC expressly describes the relevant patient group as “vulnerable”.

Nor are the commitments that the EC is extracting from Sanofi particularly onerous. The core commitments are to:

• publish corrective statements regarding the regulatory status of the competitor product on its German and French websites for two years; and
• include a “prominent citation” of the regulatory position in its German marketing and promotional material; and
• refrain from further disparaging statements about the competitor vaccine for four years (in France and Germany).

This amounts to little more than a promise to obey the law in future – and that only in France and Germany (the EC suggests that Sanofi’s behaviour was not limited to these two jurisdictions). The EC might argue that swift action was required to prevent further harm in those jurisdictions, but then why not impose interim measures (something that is currently all the rage)?

Perhaps most surprisingly, this appears to be a pattern of behaviour. The EC also imposed no fine in Vifor, the only other pure disparagement case it has taken (although that was the first case of its kind at the EU level and the corrective commitments imposed were significantly more extensive – including 10 years’ of supervision by a trustee). Admittedly, it imposed a €462m fine on Teva in the Copaxone case, but there the disparagement formed part of a wider infringement that the EC appears to have regarded as more serious.

So, can suppliers of medicines now ignore competition law risk and say what they like about the competition? Well, that probably wouldn’t be wise. The EC may have taken its foot off the gas in terms of its enforcement of this issue, but there is no suggestion that national competition authorities (NCAs) in Europe have, and NCA fines can be very high. The €440m fine imposed by the French authority mentioned above, was upheld by the French Supreme Court in July last year, and the Italian authority has previously imposed fines of €190m in a single case. Then there is the issue of litigation. Insurers and reimbursement authorities in France and Germany may now bring actions for damages if Sanofi does not offer to settle first (assuming the competing product was less expensive). Further, misleading advertising is often separately actionable under unfair commercial practices laws or industry codes of conduct etc. Lastly, there is the adverse publicity – not least from law firm blog posts. And of course the EC may change its mind and pursue substantial financial penalties (but don’t hold your breath).