At the end of September, the European Commission carried out a dawn raid at Sanofi, which is also active in the vaccine market. The inspection was accompanied by representatives of national competition authorities. The raid fits into the increasingly hard-line enforcement policy pursued by European competition authorities in the pharmaceutical sector in recent years — a trend that may also be followed by the Hungarian Competition Authority (GVH).
The Sanofi Case
A dawn raid is an unannounced on-site inspection aimed at enabling authorities to collect evidence as quickly and as undistortedly as possible in relation to a suspected competition law infringement. In the present case, the European Commission sought to find evidence at Sanofi that the pharmaceutical giant had abused its dominant market position by attempting to discredit competing seasonal influenza vaccines.
Anti-competitive disparagement is a specific form of abuse of dominance. Through such conduct, a dominant undertaking presents a competitor, or its product or service, in an unjustifiably negative light by means of misleading or unfounded statements. The objective is to strengthen the undertaking’s own market position by weakening that of its rival.
Background to the Proceedings
Neither the targeted scrutiny of the pharmaceutical industry nor the focused analysis of disparagement campaigns is new in the enforcement practice of European competition authorities. In their interpretation, the pharmaceutical sector is particularly sensitive, as effective competition is essential to ensuring the broad availability and affordability of medicines. Between 2018 and 2022, European competition authorities adopted a total of 26 antitrust decisions in pharmaceutical cases, resulting in fines exceeding EUR 780 million, as well as numerous binding commitments.
The European Commission has previously imposed fines for anti-competitive disparagement. In October 2024, for example, the Commission imposed a sanction of EUR 462.6 million on TEVA. According to the decision, TEVA conducted an active disparagement campaign against the generic competitor of its own product, Synthon GA, in which it systematically disseminated objectively misleading information regarding the essential characteristics of the competing product, calling into question its safety, efficacy and therapeutic equivalence to TEVA’s products. In another case, the Commission examined the conduct of VIFOR Pharma, which involved the dissemination of misleading information regarding the safety of the medicinal product Monofer.
Where Does Hungarian Competition Law Practice Stand?
Similarly to the European Commission, the Hungarian Competition Authority (GVH) has also been visibly active in the pharmaceutical and dietary supplements markets. In recent years, numerous competition supervision proceedings have been launched concerning market sharing, price fixing, misleading health and therapeutic claims, or unfair commercial practices. In 2017, for example, the GVH fined SANDOZ Hungária Kereskedelmi Kft. a total of HUF 105 million for misleading advertisements implying therapeutic effects. In 2021, it initiated proceedings concerning alleged anti-competitive agreements between the largest domestic pharmaceutical wholesalers and cooperating pharmacies, and this September alone three investigations were launched into the lawfulness of communications relating to food products and dietary supplements. This enforcement momentum is not expected to diminish in the future.
What Is the Message of the Sanofi Case?
Although a dawn raid does not necessarily result in an adverse decision, it — beyond its deterrent effect in itself — indicates that the competition authority already has a well-founded suspicion of a potential infringement. The recent raid, together with the decisions of competition authorities in previous years, serves as a warning that in the pharmaceutical industry, competition law compliance is not merely a formal requirement but a key element of corporate risk management. In other words, undertakings in a dominant position must exercise heightened care not only in drafting their contracts, but also when shaping their external communications.
Regardless of whether an undertaking holds a dominant market position, it is essential to establish a well-defined and effective competition law compliance system. Such a system can regulate day-to-day business conduct and also prepare the organization for the handling of potential authority investigations and interventions.