Reply to European Commission’s Inception Impact Assessment on a European Health Emergency Preparedness and Response Authority (HERA)

European Health Response: Getting together to better prepare

AESGP welcomes the European Commission’s efforts to strengthen the EU’s preparedness and response for serious cross-border threats to health, as an integral part of the EU Health Union.

AESGP supports the proposed Better Regulation approach which integrates an impact assessment to accompany the legislative proposal for the establishment of the European Health Emergency Preparedness and Response Authority (HERA). In this early phase of this initiative, AESGP would like to share some views regarding the objectives and policy scenarios described in the Inception Impact Assessment.

As preconized in the impact assessment, such an Authority is set to take a whole value chain approach, from threat assessment to conceptualisation to deployment in case of need. The purpose will be to support Member States’ response capacities and access and ensuing availability and releasing of countermeasures to prepare for and address human cross-border health threats.

It is paramount that the EU efforts to strengthen its preparedness and response in terms of medical countermeasures for serious cross-border threats are assessed in the broader context of the other EU Strategic initiatives (e.g. Pharmaceutical Strategy for Europe) as well as ongoing efforts to establish the necessary infrastructure to make the existing regulatory frameworks successful (e.g. Regulation on Medical Devices) so as to avoid unnecessary duplication of initiatives, to guarantee a proportional and adequate effort allocation, and to create the necessary synergies with other policies and stakeholders.

AESGP is determined to further contribute to the discussions on COVID-19 recovery and resilience to prepare and manage future health threats and is looking forward to the dialogue with the Commission, European Parliament, Member States and European Medicines Regulators on the proposed actions.


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