The Spanish Markets and Competition Commission is expanding antitrust enforcement in pharma. We explore what this means in practice for companies operating in Spain.

Introduction

Spain's pharmaceutical sector has become a laboratory for some of the most ambitious antitrust enforcement theories in Europe. Over the past five years, the Spanish Markets and Competition Commission (CNMC) has stepped up its enforcement activity with novel theories of harm, deep scrutiny of digital distribution and even the first merger prohibition in its history.

The central challenge for competition enforcement is preserving the balance between rewarding innovation through exclusivity and ensuring that exclusivity is not artificially extended at the expense of affordable medicines. This is a balance that appears simple, yet is difficult to implement in practice.

Taken together, these developments reflect a broader shift. The CNMC is reshaping the competitive rulebook in Spain’s pharmaceutical sector: expanding the scope of potential infringements and their practical consequences, with direct implications for how companies innovate, litigate, contract and share data.

Antitrust enforcement trends

Can innovative theories of harm safeguard innovation?

The pharmaceutical sector has become a testing ground for novel theories of harm, including new categories of exclusionary abuse and a renewed focus on exploitative practices that had long remained dormant at EU level.

The CNMC has been one of the national competition authorities particularly proactive in aligning with the European Commission in the application of these theories of harm:

• In the Merck Sharp and Dohme (MSD) case, the CNMC applied an abusive litigation theory of harm in the pharmaceutical sector for the first time, acting in parallel with the European Commission, which had just raised similar charges in its Statement of Objections to Teva in the Copaxone case.

• In the Leadiant case, the CNMC followed the European Commission's excessive pricing theory of harm developed in Aspen one year before. This case is also relevant as it involved three parallel investigations in Spain, Italy and the Netherlands.  

At EU level, other exclusionary theories continue to develop, including disparagement (closely linked to abusive litigation, as seen in Vifor and Teva Copaxone) and, more recently, a potential abuse based on the exclusionary discontinuation of a pipeline product intended to be commercialised in the European Economic Area by a third party (Zoetis). These cases confirm that the boundaries of abusive conduct remain in flux.

Additionally, in Spain the CNMC is vested with specific powers to pursue acts of unfair competition where these affect the market and the public interest. Disparagement is one such category that may fall within this scope.

Conduct that falls within the legitimate exercise of patent or litigation rights may nevertheless be characterised as abusive. This lack of certainty may have a chilling effect on innovation and must not be underestimated.

Closer scrutiny of distribution, digital platforms and data use

Recent ongoing CNMC investigations highlight an increasingly proactive approach to digital tools and data flows in the pharmaceutical distribution chain.

First, in November 2024, the CNMC opened infringement proceedings against the General Council of Official Pharmacists’ Associations and several regional bodies. The case concerns a potential collective recommendation to use digital logistics applications developed by the professional body itself. According to the CNMC, such recommendations may have hindered the development of competing platforms offering similar services to pharmacies.

Second, in April 2025, the CNMC initiated formal proceedings against Sandoz, Bexal, Alliance Healthcare and Bluetab. The investigation concerns an alleged exchange of commercially sensitive information relating to pharmacy orders of generic medicines, including data from pharmacies outside the “Club Sandoz” programme, without their consent or knowledge. The authority considers that such exchanges may infringe competition law.

These cases signal a clear enforcement priority: the competitive risks associated with digital infrastructure and data sharing in pharmaceutical distribution.

More broadly, these cases illustrate the CNMC’s willingness to intervene at the level of market infrastructure. Compliance programmes must evolve beyond traditional pricing practices to cover the design, governance and use of digital platforms and cross-business data flows.

The CNMC has also developed the BRAVA tool (Bid Rigging Algorithm for Vigilance in Antitrust), which uses artificial intelligence to analyse public procurement data and detect patterns indicative of collusion in tendering processes.

A shift towards more interventionist merger control analysis has been reflected in the pharmaceutical sector

The CNMC’s Decision in C/1501/24 CURIUM/IRAB has also marked a turning point in Spanish merger control, showing a clear willingness to intervene in structurally fragile markets such as radiopharmaceuticals. While the CNMC had already been moving towards more conditional clearances, this was its first ever prohibition decision.

The case concerned Curium’s proposed acquisition of IRAB, both active in the supply of PET radiopharmaceuticals and related manufacturing services: in practical terms, a three-to-two merger. The CNMC’s analysis highlighted the regional dimension of these markets, driven by the short shelf life of radioactive products, which severely limits transport.

Against this backdrop, the CNMC found that the transaction would significantly increase concentration in an already oligopolistic market. High barriers to entry compounded concerns, notably the investment required for cyclotrons (a particle accelerator used to produce radioisotopes for PET imaging) and regulatory constraints. The disappearance of IRAB as an independent contract manufacturer raised fears of reduced competitive pressure, foreclosure risks and ultimately higher prices or reduced choice for hospitals.

The CNMC found the commitments offered insufficient and prohibited the transaction. This outcome reflects a more interventionist stance: the CNMC is prepared to prevent structural changes before competitive harm materialises. The CNMC did not consider a structural remedy capable of creating a credible third player to be viable, nor did it regard the target’s independent administration as a feasible alternative.

This Decision signals the CNMC's willingness to intervene decisively when mergers threaten to eliminate key competitive constraints in niche healthcare markets. It reinforces the importance of early, realistic remedy assessments and careful attention to local market dynamics.

For a deeper look at the competitive dynamics and M&A complexities specific to this market, see our our analysis here.

Practical implications: why this matters for companies?

Taken together, these developments mark a clear shift: antitrust risk in Spain is no longer confined to traditional pricing or market-sharing conduct. Pharmaceutical companies must now manage exposure across litigation strategy, digital infrastructure, data governance and transaction planning.

In addition to financial penalties (including fines on individual directors), three consequences deserve particular attention:

• Debarment risk: Since 2025, the CNMC has been applying bans on contracting with public authorities, turning antitrust findings into immediate commercial restrictions (Icon, Travel Agencies, UFD Contadores, Distribución de Hidrocarburos and Eléctrica de Alfoz).

• Tender Exclusion: Companies may be excluded from public procurement processes, where the contracting authority identifies indicia of collusive conduct, confirmed by the CNMC through a specific fast-track procedure.

• Private enforcement exposure: Spain has become one of Europe's leading jurisdictions for antitrust damages claims, driven by extended limitation periods, court-validated estimation methods, mass claim assignments and the growing role of litigation funders.

For pharmaceutical companies, the practical implication is clear: antitrust compliance can no longer be treated as a reactive, standalone function. It must be integrated into core business decisions, including how products are brought to market, how data is shared and how transactions are structured.