Of Disparagement and Other Demons: Trends in EU Competition Law Enforcement in the Pharmaceutical Sector
Disparagement practices (spreading misleading information to undermine competitors’ products) as an anti-competitive practice in the pharmaceutical sector is not a new topic in EU competition law. However, this practice has not been an enforcement priority at the EU level for many years. Recently, disparagement cases at the EU level were prioritized, and the European Commission has been active in this area. This blog post explores the recent trends in EU competition law enforcement in the pharmaceutical sector, focusing on the Teva case and the potential role of AI in the future of pharmaceutical competition.
EU Competition law enforcement in the pharmaceutical sector has evolved significantly in the last 20 years. Different factors have impacted this evolution; the pharmaceutical sector inquiry of 2008, the COVID-19 pandemic and other global crises, and the new era of digital advances were significant turning points that also impacted the enforcement trends in policy and practice. One of these changes was having a multi-layer enforcement agenda, which included combating a diverse range of anti-competitive practices besides the traditional ones (such as pay-for-delay agreements) in this sector.
One recent trend is a series of “disparagement” cases, which, although they have precedent at the national level, such as the Sanofi-Aventis case in France (2013), are pretty new at the EU level. Disparagement activities often aim to spread misleading information about a rival’s products to protect the company’s market position. The complex interplay of competition law, consumer protection, and intellectual property rights creates a unique legal landscape for this practice. Disparagement campaigns are composed of different elements, and companies often try to persuade patients, health providers, and other stakeholders that the rival’s product (which is usually a generic or biosimilar version of the original one) is not safe, not ineffective or simply not a substitute for the branded product. These elements could be a complex set of divisional games, patent system abuse, product hopping, and other exclusionary conducts that aim to focus on one thing: the rival’s product is not a substitute for ours. Two significant turning points came in 2024 when the European Commission took intense action against companies accused of spreading false claims about their rivals’ medicines. The first decision was against Vifor in July 2024, in which the Commission accepted commitments from this pharmaceutical company to address potential anti-competitive disparagement against the iron deficiency product of a competitor.
In the recent case of Teva, the Commission fined this pharmaceutical company 462.6 million euros for abuse of dominance. According to the Commission, Teva used a complex, primarily patent-based strategy to create barriers to entry for the rival product of Copaxane, a drug used to treat multiple sclerosis (MS). MS is a brain and spinal cord disease where damage to nerve coatings disrupts signals, causing problems with movement, speech, sensation, and vision. Teva’s strategy included some “divisional games” to extend the patent protection of Copaxane, which initially expired in 2015. A disparagement campaign with the target audience of patients, healthcare providers, Member States’ health authorities, and regulators was also part of this anti-competitive practice and strategy. More than one million people in Europe live with multiple sclerosis, and Teva’s strategies directly impact their care and treatment options. The core issue is that disparagement, by distorting information about healthcare products, can also interfere with doctors’ professional decisions and jeopardize patient safety.
The pandemic-related problems and post-pandemic needs and concerns have spotlighted the pharmaceutical sector, which is now more central to public health than ever. Disparagements and other anti-competitive practices in the pharmaceutical industry can hinder fair competition and limit patients’ access to affordable and safe medicine. This goal is central to the European Commission’s post-pandemic policies and agenda (including the pharmaceutical strategy for Europe). As I’ve explained in a recently published paper, the Commission’s focus now is ensuring equitable access to essential medicines as part of the competition law enforcement. This shift reflects a more inclusive agenda that puts patients (and patients’ rights) at the center of regulatory and competition policies.
The Commission’s enforcement priorities, policies, and practices have evolved significantly since the 2008 sector inquiry, which reflects a new era of new societal challenges and crises (such as public health crises, wars, and technological advancements); this requires more effort to future-proof the enforcement and policies. Instead of a historical focus on pay-for-delay agreements, the agenda is now more diverse. Excessive pricing, cartels, disparagements, and product hopping are new trends in pharmaceutical antitrust, and EU competition authorities are actively investigating several pharmaceutical companies, as mentioned in the Commission’s recent report on the enforcement of EU competition law in this sector.
Will AI make disparagement more sophisticated? The dark side of innovation
One subject that was less known to the public and is now a hot topic is the use of artificial intelligence (AI) in the pharmaceutical sector. In the case of disparagement, the challenge becomes particularly acute when considering how AI could analyze vast amounts of healthcare data to create targeted disparagement campaigns that appear scientifically sound yet contain subtle misleading elements.
The rise of AI has made it even harder for competition authorities to tackle disparagement. They now have to deal with what is being said and how advanced technologies are used to spread misleading information. Can competition authorities tackle the context of harmful communications against competitors and the complex way of creating and sharing them?
Using AI in the pharmaceutical industry and applying the EU AI Act in this sector when deploying AI in the discovery, design, production, and development of pharmaceuticals, which has yet to be discovered, is still new and unknown. In the past two years, pharmaceutical companies have come into agreement with AI companies (such as the recent agreement between OpenAI and Moderna), and some of these agreements raise questions about their potential anti-competitive aspects.
Conclusion
The Teva case marks a crucial shift in EU pharmaceutical competition enforcement, moving beyond traditional competition concerns in this sector. Yet, as pharmaceutical companies forge new partnerships with AI undertakings, competition authorities will shortly face a complex challenge—how to detect, investigate, and prevent AI-powered disparagement campaigns that could manipulate medical decisions on an unprecedented scale.
Dr Mina Hosseini is an experienced researcher, lecturer, Marie Curie alumna, lawyer, consultant, and mentor with research interests in Health Law, Competition Law, Pharmaceutical Policy, and AI in Healthcare. She holds a PhD in Competition Law, an LLM in Economic Law from Beheshti University (Tehran), an LLB in Law from Shiraz University, and a Level 6 Project Management Certificate (with Distinction) From QQI Ireland. As a Marie Skłodowska-Curie Fellow at UCD Sutherland School of Law (2022-2024), she led COMPHACRISIS, a project examining EU Competition law enforcement in the pharmaceutical sector before, during, and after the COVID-19 pandemic. Before joining UCD, she held several positions, including Assistant Professor and lecturer at the Tehran University of Science and Culture (2018-2022), Consultant and Researcher at the Niroo Research Institute in Tehran (2014-2018), and Attorney at Law at Iranian Central Bar (2008-2020).
This research is part of the COMPHACRISIS project, which has received funding from the European Union’s Horizon Europe MSCA programme (grant agreement no 101061575). The views and opinions expressed are, however, those of the author only and do not necessarily reflect those of the European Union or the European Research Executive Agency.