EUHealthGov with Sebastiano Lustig: The role of HERA in the EU Health Security Framework
EUHealthGov held its fifth Practitioner Perspective on 13 March 2025. We were delighted to host Sebastiano Lustig, Policy Coordinator for prevention, preparedness and response planning for medical countermeasures at the European Health Emergency preparedness and Response Authority (HERA). What follows is a summary of some of the key points addressed in the presentation. A recording is also available here.
While the EU health security architecture predates COVID-19, the lessons learned from the pandemic, especially on the importance of coordination, have led this framework to be restructured and strengthened. Successful coordination during COVID, visible notably in mechanisms like joint procurement served as good examples to build on. However, the pandemic response was generally marked by a lack of coordination, which exposed fragmentation and vulnerabilities in supply chain of medical countermeasures (MCM). The new EU Health Security Framework aims to address this and represents the first pillar of the broader project to build a European Health Union announced by Commission President von der Leyen in 2020. The health security pillar includes the new Regulation on cross border health threats (replacing the 2013 Decision of the same name), strengthened mandates of the ECDC and EMA, and the creation of HERA. HERA deals specifically with MCMs, its mission is to strengthen the EU’s capacity to respond to future pandemics of other health threats, mainly by ensuring the provision of critical medical countermeasures.
HERA’s work takes a so-called ‘end-to-end’ approach, covering each stage of the MCM from threat assessment (in partnership with the ECDC) through to stockpiling and everything in between. This approach was illustrated using the pandemic influenza case study, also pointing out that, at the R&D stage, HERA recently established a structure for coordinating clinical trials. The coordination role of HERA was also emphasised when outlining its interaction and collaboration with other EU institutions (in particular but not limited to the ECDC and EMA), industry and civil society stakeholder, and international actors to promote global health cooperation.
HERA operates in two phases: preparedness and crisis. The activities and mechanisms of the crisis phase are set out in a separate emergency framework regulation. In addition to emergency measures aimed at accelerating the availability of crisis-relevant MCMs, the activation of the crisis phase triggers the set-up of a Health Crisis Board, composed of Commission officials, high-level member states representatives, and is the only structure within the EU health security framework that is co-chaired by the Council.
Finally, the audience’s attention was drawn to two next steps: first, the upcoming release of a new strategy to support MCM against public health threats. Second, the assessment of national preparedness and response plan, a task undertaken by the ECDC, with the support of HERA.
You can watch the recording of the presentation here.