CoR Plenary (April 2022)

HERA anticipates threats and potential health crises, through intelligence gathering and building the necessary response capacities.

Q&A on HERA

The outbreak of the coronavirus pandemic exposed the weaknesses in the EU's preparedness and planning capacities as well as its lack of funding, with much of the EU's initial response being on an ad-hoc basis. Coordination and cooperation between EU Member States was initially often difficult, and took time to get established and start functioning in a structured way. The EU's Health Emergency Preparedness and Response Authority (HERA) was established by a Commission decision of 16 September 2021, as part of the European health union initiative that also includes legislative proposals reinforcing the roles and mandates of the European Centre for Disease Prevention and Control and the European Medicines Agency. Set up within the European Commission and endowed with €6 billion from the EU's long-term budget, the 2021-2027 multiannual financial framework, HERA is expected to strengthen EU health security coordination during the preparedness phase, shorten crisis response times, and reinforce the EU's overall health emergency preparedness and response architecture. While the creation of HERA has been welcomed by European stakeholders active in research, innovation and healthcare, they stress their preference for inclusive governance, and the need to harness the activities so that they reflect the public good dimension of HERA investments. Since HERA is a European Commission entity and not an EU agency, the European Parliament's role, and in particular that of its relevant committees, in assessing and monitoring HERA's effectiveness and efficiency has yet to be defined.

This Briefing forms part of an EPRS series which offers a synthesis of the pre-legislative state-of-play and advance consultation on a range of key European Commission priorities during the latter’s five-year term in office. It seeks to summarise the state of affairs in the relevant policy field, examine how existing policy is working on the ground, and identify best practice and ideas for the future on the part of governmental organisations at all levels of European system of multilevel governance. This analysis of the positions of partner organisations at EU, national, regional and local levels suggests that they would like the following main considerations to be reflected in discussion of the legislative proposal to establish an emergency framework for a European Health Emergency Preparedness and Response Authority (HERA).

In the early phases of the COVID-19 pandemic, amid shortages for essential medicines, reagents, and equipment, the European Commission struggled to develop a coordinated and comprehensive European response. The EC now seeks to strengthen its role in preparedness planning and response through, among other measures, the establishment of the European Union Health Emergency Preparedness and Response Authority (HERA). While the remit and scope of HERA is yet to be formally agreed, it is envisaged to play a similar role to the US Biomedical Advanced Research and Development Authority (BARDA) and be responsible for:
• horizon scanning of major threats to health and potential medical countermeasures,
• funding research and development,
• supporting manufacturing capacity, and
• stockpiling of essential medical supplies, and equipment.
The proposed focus is broad, and HERA will be expected to operate among a multiplicity of agents already responsible for preparedness planning and response in Europe. To stimulate debate and discussion, we consider potential functions of HERA and how they may complement the roles and responsibilities of pre-existing EC agencies and institutions.