1. Introduction

The European Commission (‘Commission’) has been intensifying its scrutiny of abuse of a dominant position through ‘disparagement’ since 2022. Disparagement occurs when an undertaking makes incorrect or misleading statements about a competitor, with the aim of hindering that competitor’s access to the market or undermining its market position. The Commission appears to focus in particular on the pharmaceutical sector. Following earlier investigations into Vifor Pharmaceuticals (‘Vifor’) and Teva Pharmaceuticals (‘Teva’), the Commission has recently also opened an investigation into alleged disparagement by Sanofi, likewise a pharmaceutical company. As a result, all of the Commission’s disparagement cases to date concern pharmaceutical undertakings. These investigations demonstrate that companies – and pharmaceutical companies in particular – must exercise great care in their communications regarding competitors’ products.

2. What is at stake?

Sanofi is active in the pharmaceutical sector and is engaged in the development of innovative medicines. One of these medicines is the influenza vaccine ‘Efluelda’. The company CSL Sequirus offers a competing vaccine called ‘Fluad’. According to the Commission, Sanofi conducted a misleading marketing campaign in which it portrayed ‘Fluad’ as inferior to its own ‘Efluelda’. In doing so, Sanofi acted contrary to various national vaccination recommendations, particularly in Germany and France. Specifically, Sanofi is alleged to have:

• argued that the underlying evidence for Fluad is weaker than for Efluelda. This is contrary to the findings of the European Centre for Disease Prevention and Control (ECDC) and national advisory groups in Germany and France, which have assessed the underlying evidence for Fluad as comparable to that of Efluelda;
• provided a misleading or inaccurate representation of national vaccination recommendations. For instance, Sanofi is alleged to have wrongly suggested that Efluelda was the only vaccine recommended or developed for elderly influenza patients, whereas in reality Fluad was also developed for this patient group and was recommended; and
• suggested that the German national vaccination recommendation for Fluad was still subject to unresolved scientific objections from professional associations of medical practitioners, whereas these objections had been examined and dismissed prior to the vaccination recommendation.

Because Sanofi holds a dominant position in both Germany and France, the opened an investigation. Following the investigations into Vifor and Teva, the (then) European Commissioner Margrethe Vestager stated: “With these consecutive actions, we send a clear message to dominant pharmaceutical companies that we will not tolerate the use of disparagement campaigns to foreclose competing medicines”. The investigation into Sanofi demonstrates that pharmaceutical companies remain under close scrutiny under the current European Commissioner Teresa Ribera.

3. Earlier disparagement cases

The investigation into Sanofi does not stand in isolation. In recent years, the Commission also investigated Vifor and Teva for abuse of their dominant position through disparagement.

In the Vifor case, the Commission opened an investigation in June 2022 – as did the British competition authority CMA a year and a half later – into the dissemination of misleading information regarding the safety of the competing iron deficiency medicine Monofer, with the aim of favouring its own medicine Ferinject. In order to address the Commission’s concerns, Vifor offered commitments in April 2024, including a corrective communication campaign, a ten-year prohibition on external communications not based on the approved product information for Monofer or on a clinical comparative study, and the implementation of internal compliance measures. The Commission accepted these commitments in July 2024, without definitively establishing that an infringement of Article 102 TFEU had occurred.

While Vifor got away with commitments, Teva was fined. The Commission opened an investigation into Teva in March 2021, which had allegedly impeded the market entry of a competing multiple sclerosis medicine through disparagement and the misuse of patent procedures. According to the Commission, Teva conducted a targeted campaign to discourage healthcare professionals and healthcare institutions from using the competing medicine, including by disseminating misleading information about its safety, efficacy and therapeutic equivalence. The price tag: a fine of EUR 462.6 million.

In addition to the Commission’s enforcement activities, disparagement has long been on the radar of national competition authorities. For example, the French, Belgian and Danish competition authorities have previously imposed fines for disparagement.

4. Disparagement test

Where is the line between legitimate promotion of one’s own product and abusive disparagement of a competitor? Actively promoting one’s own product – if one is not careful – can quickly cross the line into disparagement.

According to the Commission, disparagement exists where the following elements are present:

• Objectively misleading information capable of discrediting a competing product: this concerns not only factually incorrect information. Information that is in itself accurate but is presented in an incomplete manner with the aim of manipulating public perception may also be regarded as misleading;
• Capability to produce exclusionary effects: it is not required that the intended result has actually been achieved. In the Teva case, the Commission pointed out that the commercial success of medicines depends heavily on decisions by pricing and reimbursement authorities and the prescribing practices of healthcare professionals. Because Teva directed its disparagement campaign precisely at these parties, the Commission considered it capable of diverting demand away from the competing product; and
• Lack of objective justification: a justification must be substantiated with evidence that the conduct was objectively necessary to achieve a legitimate aim, and that no less restrictive means existed to achieve that aim.

5. What does this mean in practice?

The Sanofi case underscores that the Commission regards disparagement as a serious enforcement priority. For companies active in the pharmaceutical sector, this means the following:

• Be aware of a possible dominant position in your market. This applies particularly in the pharmaceutical sector, where many parties hold a dominant position as a result of (now expired) patents;
• There are competition law limits to what a dominant undertaking may say about competing products. Therefore, ensure that every statement regarding a competing product is factually substantiated and complete, so as to prevent misleading conduct;
• For non-dominant competitors, the increased regulatory focus of European authorities on the pharmaceutical industry presents opportunities: a complaint to a competition authority or a civil damages claim through a stand-alone action can be an effective means of correcting misleading statements by dominant parties.