The evolution of EU competition law and policy in the pharmaceutical sector: long-lasting impacts of a pandemic

Abstract This article investigates the evolution of the European Union (EU) competition law and policy enforcement in the pharmaceuticals sector, focusing on the impact of the coronavirus disease 2019 (COVID-19) crisis as a turning point. Before COVID-19, EU competition authorities’ goals and priorities focused on pay-for-delay agreements between originators and generic pharmaceutical undertakings. During COVID-19, the European Commission developed soft laws (such as temporary frameworks and comfort letters) enabling undertakings to cooperate to increase access to essential health products and COVID-19 vaccines. In the post-pandemic era, initiatives like the Pharmaceutical Strategy for Europe, the Single Market Emergency Instrument (SMEI), the Health Emergency Response Authority (HERA), the compulsory licensing proposal and the upcoming changes in the pharmaceutical regulations reflect a patient-centred approach and diverse agenda. This article underscores the move towards a more inclusive EU competition law and policy framework in the pharmaceutical sector as part of this evolution.