Pharmaceuticals – New European Commission Report on Competition Law Enforcement (2018-2022)
On 26 January 2024, the European Commission (the Commission) published a report summarizing recent competition law enforcement in the pharmaceutical sector during 2018-2022 (the Report). The Report covers EU antitrust and merger control activities by the Commission and national competition authorities (the European authorities), and follows a similar previous report for the period 2009-2017 (Van Bael & Bellis Life Sciences News & Insights, 29 January 2019).
The Report notes that competition law enforcement in the pharmaceutical sector remains a matter of high priority, with 30 ongoing investigations in the pharmaceutical sector alone. Cases occurring during the period 2018-2022 concerned a range of anticompetitive practices, including abuse of dominance (50%); cartels / horizontal agreements (39%); and vertical agreements (11%).
On IP matters, the Report discusses the Commission’s preliminary findings in the Teva/Copaxone case, concerning an alleged misuse of the patent system by filing multiple divisional patents, as well as national cases on abusive behaviour in IP litigation. The report also discusses the confirmation by the Court of Justice of the potential illegality of pay-for-delay patent settlement agreements (although some proceedings are still pending).
Concerning commercialization matters, the report summarizes the recent significant increase in enforcement concerning excessive pricing, as well as abusive rebates and predatory pricing (thus highlighting the importance of price competition). The report also covers the ongoing line of cases concerning disparagement at both national and EU levels.
With respect to mergers, the Report notes that, during 2018-2022, the Commission raised competition issues in five transactions related to the pharmaceutical sector, leading parties to either offer suitable remedies to address the competition concerns or abort the deals. The Report also highlights that the Commission is now actively monitoring deals in the pharmaceutical sector to identify transactions that fall below the relevant notification thresholds but should still be scrutinized to ensure that they do not harm effective competition in the EU internal market.
Finally, the Report also discusses other forms of competition law guidance provided by competition authorities to companies. For example, during the COVID-19 pandemic, European authorities provided guidance that pharmaceutical companies could cooperate in exceptional circumstances to avoid supply shortages. European authorities also issued comfort letters and guidance to companies to foster compliance with competition law.
The Commission issued the following documentation:
- European Commission press release of 26 January 2024;
- Report from the Commission to the Council and the European Parliament – Update on Competition Enforcement in the Pharmaceutical Sector (2018-2022) – European competition authorities working together for affordable and innovative medicines);
- List of antitrust enforcement decisions in the pharmaceutical sector;
- Market monitoring and advocacy actions in the pharmaceutical sector undertaken by the European competition authorities in the period 2018-2022.