Abstract Background COVID-19 has highlighted the importance of preparedness and response systems when faced with a pandemic. The rapid spread of the disease throughout Europe raised questions about the capacity of the European Union (EU) and its Member States to combat serious cross-border threats to health. This article provides an overview of institutional arrangements for pandemic preparedness before the COVID-19 pandemic and outlines the changes proposed by the European Health Union (EHU) framework. Methods A systematic review of relevant EU law, EU policy documents and the scientific literature was conducted. EUR-lex, PubMed, Web of Science core collection and Google Scholar databases were searched for relevant records published after the year 2000. The proposed new regulatory framework was extracted from the EHU legislative package. The results were organized according to the Public Health Emergency Preparedness Logic Model. Results The main EU bodies involved in preparedness and response are the European Centre for Disease Prevention and Control (ECDC), the European Commission and the Health Security Committee (HSC). The proposed changes of the EHU focus on strengthening the auditing capabilities of the ECDC, increasing the scope of EU action in managing medical countermeasures, and further formalizing the HSC. Conclusions The proposal takes bold steps to address technical and political issues of preparedness and response; whereas, on the latter point, it is likely that amendments to the proposal will not address long-standing challenges in preparing for and coordinating national responses to a future EU-wide pandemic.