European Health Emergency Preparedness and Response Authority (HERA)

The COVID-19 pandemic demonstrated the need for coordinated EU level action to respond to health emergencies. It revealed gaps in foresight, including demand/supply dimensions, preparedness and response tools. A European HERA is a central element for strengthening the European Health Union with better EU preparedness and response to serious cross-border health threats, by enabling rapid availability, access and distribution of needed countermeasures.

As part of the European Health Union package, the aim of the proposal is to establish a HERA, which will support the EU’s preparedness and response to serious cross-border health threats through an EU-level countermeasure management system. This would aim to enable rapid access, availability, development and deployment of medical countermeasures.

To this end, the proposal envisages that EU action will be taken to secure medical countermeasures, particularly with respect to: health threat assessment, prioritisation of countermeasures, monitoring of the demand and supply chain, real-time intelligence, security of supplies and optimised investments that identify threats and market failures.

In view of such policy objectives, the proposal considers three policy options outlined in the document to represent that official functions of HERA:

Policy option 1 – EU coordination for threat assessment and knowledge generation

This option recommends a more coordinated EU-wide approach for knowledge anticipation, generation and distribution, through horizon scanning of novel technologies, threat assessments and prioritisation, demand and supply analysis, market intelligence, threat and capacity forecasting and public-private collaboration.

Policy option 2 – A stand-alone authority

Under this option, HERA would be a permanent structure, with varying degrees of operational roles and infrastructure.

Sub-option 2.1: Operational Authority

In this case, HERA would have integrated EU stockpiling and distribution mechanisms and would focus on the development of technologies and medical countermeasures to address market failures and provide technical support for safety and efficacy issues. This option would require tailored emergency reserve access, procurement and financing instruments, together with data integration into logistical infrastructure for storage and distribution. It would also closely work with private and public entities through EU instruments such as Horizon 2020.

Sub-option 2.2: Operation and Infrastructure Authority

In addition to the tasks outlined in sub-option 2.1, HERA would also establish dedicated EU centralized and scalable manufacturing and innovation capacities for the sufficient development of crisis-relevant products in health emergencies or market failures. The objective of such an option is that through HERA, the most advanced technologies are available in the EU market to combat the health crisis in question.

Policy option 3 – Full end-to-end Authority and streamlining of EU initiatives on countermeasures

In addition to the responsibilities outlined in sub-option 2.2, HERA would also be tasked with streamlining existing EU financial and operation instruments (such as Horizon 2020 and rescEU), with the aim of serving as a single entry-point for all initiatives related to medical countermeasures for cross-border health threats. The Authority would also be active in the field of medical countermeasures amongst EU Agencies.

This roadmap was open for feedback until 24 February. Following this, an impact assessment will be conducted alongside the legislative proposal, which is foreseen to be adopted towards the end of 2021.

The Commission will additionally launch a 12-week public consultation in the second half of March 2021 and conduct targeted consultations for the most relevant stakeholder groups.