The crowded global health landscape has been joined by the European Union Health Emergency Preparedness and Response Authority (HERA). HERA will assume four broad areas of responsibility: horizon scanning for major health threats; research and development; support for capacity to manufacture drugs, vaccines, and equipment; and procuring and stockpiling key medical countermeasures. In this Health Reform Monitor article, we outline the reform process and describe HERA's structure and responsibilities, explore issues that arise from the creation of this new organisation, and suggest options for collaboration with existing bodies in Europe and beyond. The COVID-19 pandemic and other infectious disease outbreaks have shown the need to treat health as a cross-border issue, and there is now a broad consensus that greater direction and coordination at the European level is needed. This ambition has been matched with a considerable increase in EU funding to tackle cross-border health threats, and HERA can be used to deploy this funding in an effective manner. Yet this is contingent upon clearly defining its role and responsibilities vis-à-vis existing agencies to reduce redundancies.