When determining “dominance,” the European Commission first defines the relevant market, then examines market share. This is a complex procedure in the pharma industry: the market is determined jointly by the therapeutic area, active substance, method of administration, and prescribing habits. The critical threshold lies around 40% market share: below this, the EC rarely finds dominance, whereas above 50%, case law establishes a presumption of a dominant position. In the pharma industry, barriers to entry are high so that dominance may be established even below 40%.
Market leadership alone does not constitute an infringement. A dominant company may compete on price, quality and innovation, provided it does so fairly. The problem arises when it uses its market power to exclude competitors or hinder their market entry. Competition law reflects this by stating that a dominant undertaking bears a “special responsibility” to protect competition.
Classic forms of abuse include predatory pricing, exclusivity rebates, unjustified refusal to supply, or strategic manipulation of the patent system. However, in the pharma industry, forms of abuse can go beyond these categories. In October 2024, the EC adopted a landmark decision: it found that Teva had abused its dominant position on the glatiramer acetate (Copaxone) market in several EU member states and imposed a fine of EUR 462.6 million on the company.
The decision established two infringements: first, the abusive use of patent strategy: Teva used so-called “divisional” patents to delay the market entry of generic competitors. The second infringement, which is the true novelty, was that the EC found Teva systematically disseminated misleading information about a competing product, calling into question its safety, efficacy and therapeutic equivalence. The EC also established that Teva deliberately built channels and mechanisms to disseminate these messages.
In contrast to the EC’s earlier practice, where misleading conduct directed at authorities constituted abuse, the novelty in the Teva case was that communication discrediting a competitor’s product, lacking scientific basis, was directed at healthcare professionals. The essence of Teva’s communication was not that it praised its own product, but that it systematically painted a negative and false picture of the competitor, to discourage doctors from prescribing the generic alternative.
In cases of abuse of dominance, the EC may impose a fine of up to 10% of worldwide turnover; for a company of this size, this could mean fines in the billions of euros. A fine is only the beginning: a finding of infringement opens the door to damages claims, and national competition authorities may also initiate proceedings.
Therefore, if a company approaches a 40% market share in a given therapeutic area, it should fundamentally rethink its communication about competitors. Every claim made to healthcare professionals about a competing product must be objectively verifiable, supported by published scientific data. What cannot be substantiated is better left unsaid on any platform.
However, reviewing marketing materials alone is not enough. In the Teva case, the EC specifically examined the “dissemination mechanisms,” meaning sales force training, medical representative scripts and informal channels. If the company message anywhere systematically paints a negative picture of a competitor, it poses a risk. In a dominant position, the company’s special responsibility extends to everyday commercial communication.
Any statement by a market leader in the pharma industry concerning its competitors may pose a competition law risk, which is why it is critical to involve compliance already at the planning stage of communication.
With any further questions, reach out to Wolf Theiss, the 2026 LMG Life Sciences Awards EMEA Hungary Law Firm of the Year recipient.
This article was first published in the Budapest Business Journal print issue of September 4, 2026.
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