Sandra Gallina, Director-General of the of the Directorate-General for Health and Food Safety [1], notes in her editorial that the EU Health Security Framework was reinforced "to make use of the lessons learned and, recognise the limitations of our collective response to the pandemic at EU level". Thus, to learn from experiences and to further strengthen the EU's preparedness and resilience towards cross-border health threats and other crises, a reinforced EU Health Security Framework was initiated [1]. Together, the European Medicines Agency (EMA), the European Health Emergency Preparedness and Response Authority (HERA) and the European Centre for Disease Prevention and Control (ECDC) are in the forefront to protect the health of the Europeans.
The mandates for both EMA and ECDC have recently been reinforced [2,3], while HERA [4] was established in 2021 to further strengthen Europe's capacity to prevent, detect and respond rapidly to cross-border health crises. EMA's new role will enable it to improve access to medicines and medical devices between EU countries. ECDC's strengthened mandate further enhances the Centre's capacity to provide the robust and independent scientific expertise needed to support prevention, preparedness and response planning to prevent and control serious cross-border health threats.
What can be expected in the future?
Maarit Kokki and ECDC Director Andrea Ammon [3] describe in their editorial how ECDC plans to operate under its new mandate. The EU Health Task Force (EUTHF), to be established and coordinated by ECDC, is one example of what to expect from the agency: in disease outbreak situations, the EUTHF will provide hands-on support to EU countries and third countries. Moreover, to give assistance in their preparedness and response planning. Ann Enhanced Emergency Capacity will be created consisting of EUTHF public health experts from EU/EEA countries as well as ECDC experts and fellows from the ECDC fellowship programme. During their deployment, experts will support outbreak investigations or preparedness and response activities.
EMA's Executive Director Emer Cooke [2] explains in her editorial how the extended mandate has enabled to implement tools that will help manage medicine shortages in future public health emergencies. For example, a new executive body, the Medicine Shortages and Safety Steering Group (MSSG), has been set up to respond broadly to medicine supply problems caused by public health emergencies or other major events. It will also coordinate rapid action across the EU where necessary.
The role of HERA as another building block of the EU Health Emergency Framework is outlined by its Director-General Pierre Delsaux [4]. During a public health crisis, the Emergency Framework Regulation allows HERA to enter a crisis mode, which can be triggered by e.g., a declaration of a public health emergency at EU level. In this mode, HERA can take required actions that ensure adequate and timely access to and provision of medical countermeasures relevant to emergencies in Europe. If and when the emergency framework is not activated, HERA works in preparedness mode together with EU countries, ECDC and EMA as well as international partners on activities such as intelligence gathering and threat assessment and promoting advanced research and development of medical countermeasures, to only name a few.
Protecting the health of Europeans through close collaboration
Although the organisations have their separate tasks, the framework is built for close and efficient collaboration. Emer Cooke [2] describes how ECDC will provide epidemiological data to EMA to help forecasting the needs of medicines and to gather specific data from countries and supply-chain stakeholders. These forecasts will be important for HERA to build EU manufacturing capacities and stockpiles. In addition, to launch emergency procurements and emergency deployment of medical countermeasures such as vaccines.
One example where all the new tools were applied, is the 2022 mpox (formerly monkeypox) outbreak mainly affecting the community of men who have sex with men (MSM) in Europe: ECDC Epidemic Intelligence picked up the signals of an outbreak, with next steps including contacting EMA, who would then act as an advisor for HERA. Here, the role of EMA was to help identifying the available both authorised and unauthorised treatments as well as vaccines for mpox.
A common insight from the editorials is the need for multi-sectoral collaboration and cross border coordination in order to effectively face future health threats. In addition, authors note it is imperative that lessons learned are not only listed but also acted on. Kokki and Ammon [3] state that "to ensure this, continuous political will and sustained investment in public health at national and at EU level are needed".
As the key players of the EU Health Security Framework, ECDC, EMA and HERA will together contribute to better preparedness for and to respond quickly to future cross-border health threats in the EU as well as build resilience to overcome these new challenges together.
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