CMS Expert Guide to Competition Law Enforcement in the Pharmaceutical Sector in CEE


The pharmaceutical or, more generally, the healthcare market is of vital socio-economic importance. Its functioning directly affects patient health. As a result, the pharmaceutical market is heavily regulated and closely monitored by European and national authorities. This supervision concerns not only standard regulatory issues like marketing, clinical trials and the promotion of medicinal products, but also competition law.

There is no doubt that in recent years, the pharmaceutical market has been closely scrutinised vis-à-vis competition law. As stated in this guide, in 2019 the European Commission (“the Commission”) published a Report on Competition Enforcement in the Pharmaceutical Sector (2009-2017) (the “Report”), in which it describes the current enforcement of competition law, as well as the most common infringements in the pharmaceutical market. According to the Report, the Commission and national competition authorities (the “NCAs”) pay close attention to competition law in the pharmaceutical market. The main aim in this context is to ensure increased competition and strive for innovation, product accessibility and fair prices.

This approach by the Commission is unlikely to change. On 25 November 2020, the Commission issued a communication entitled Pharmaceutical Strategy for Europe. According to this document, over the coming years the Commission will focus on maintaining a strong, fair, competitive and green healthcare industry. To do so, the Commission will continue to:

  1. review mergers between pharmaceutical companies; and
  2. strategies that may hinder the entry or expansion of generic and biosimilar products.

The Commission is expected to propose some legislative amendments. According to the Pharmaceutical Strategy for Europe, in 2022 there will be a review of pharmaceutical legislation and steps taken to address market competition considerations.

Given this growing scrutiny on the pharmaceutical market, we have prepared an overview of the competition issues that have been identified in the sector.

Our Expert Guide includes a summary of the Report and brief description of competition law enforcement in eight CEE jurisdictions (Bulgaria, Czech Republic, Hungary, Poland, Romania, Russia, Slovakia and Ukraine).