HERA is designed to be a flexible structure and will be adapted as required. Its particularity is the governance change when in preparadeness phase and when in crisis phase. While respecting the institutional competences of the Commission and of the Member States and without prejudice to the institutional prerogative of the Commission, HERA will be assisted by the HERA Board.
The Board will bring together European Commission expertise and senior Member States representatives. The Board will contribute to the preparation of multiannual strategic planning, which will help set HERA’s objectives and shape the strategic direction of both EU and national health preparedness and response actions.
In this way, HERA will further strengthen the close relationship between EU countries and the European Commission. The Board will also play a key role in outreach beyond the Member States, including with the health, research and industry communities.
HERA’s interactions and networks
HERA and EU Agencies
HERA will work closely with the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) and complement their work both in preparedness and crisis times. ECDC has a specific mandate in the area of communicable disease threats but no mandate in the area of other health threats, nor on the procurement, development or production of medical countermeasures.
HERA will have a stronger anticipatory, forward-looking and response-focused dimension in terms of threat assessments and foresight. On the other hand, EMA’s scientific advice on the safety, effectiveness and high-quality of medical products will be a key input to the work of HERA’s much broader work on development and production capacities, stockpiling and deployment mechanisms for vaccines, therapeutics and diagnostics.
Working with other EU institutions, agencies and bodies as observers
Representatives of EU agencies and bodies are invited to participate as observers. The Board will also make sure to avoid overlaps with other key structures, such as the Health Security Committee, the Vaccine Steering Board and relevant committees involved in the management of EU programmes, with close contacts needed.
The European Parliament is also invited to designate an observer in the HERA Board. The European Commission will also ensure a regular exchange with the European Parliament about the work of HERA.
Working with national & regional authorities and other stakeholders
Of critical importance will be HERA’s work with national authorities. A network will be set up of existing and developing national or regional agencies in EU Member States responsible for carrying out tasks related to the availability and accessibility of relevant medical countermeasures in case of an health emergency. The network will provide for close day-by-day exchanges, building common analysis and understanding, reinforcing joint priorities and feeding into the work of the HERA Board. This should be fully in place in the course of 2022.
A HERA Advisory Forum will ensure increasingly close cooperation between HERA and competent bodies in EU countries on the planning and implementation of scientific, health and industrial activities of HERA. There will be a strong dimension of cooperation with external stakeholders such as industry, academia and civil society representatives to ensure constant exchanges on coordination and convergence of preparedness priorities. As sub group of the Advisory Forum, a Joint Industrial Cooperation Forum will be setup, including industry representatives.
Working with epidemiologists
To ground its work on scientific evidence and translate into coherent communication, HERA will establish a set of close working arrangements with the future European Chief Epidemiologist and the future group of leading national epidemiologists, as set by the "Drawing the early lessons from the COVID-19 pandemic" communication.