HERA has the particularity to have 2 operating modes. During the preparedness phase HERA will work closely with Member States to analyse, identify, and priorities possible health threats. This will be the basis for strategic coordination for the development of medical countermeasures, and the industrial capacity to produce and supply those countermeasures.

During the crisis phase, HERA will rely on its anticipatory overall management system and deploy it in the context of an emergency framework activated by the Council on a proposal of the Commission where that is appropriate to the economic situation.

HERA operations during the preparedness phase

HERA will work closely with EU countries to analyse, identify, and prioritise possible health threats. This will be the basis for strategic coordination for the development of medical countermeasures, and the industrial capacity to produce and supply those countermeasures.

The key actions in preparedness phase will be

Threat assessments and intelligence gathering

Key actions:

• Threat detection: Establish state of the art, real-time data and intelligence on threats, relevant countermeasures, and enabling technologies, through a full partnership with Member States expertise and enhanced collaboration with industry, international actors and institutions, as well as with EU agencies.
• Threat modelling: Strengthen real-time analytics and develop accurate models to forecast the course of an outbreak.
• Threat prioritisation: By early 2022, identify and act on at least 3 specific high impact threats and address the possible gaps in terms of the availability and accessibility of related medical countermeasures.
• Threat awareness: Produce an annual ‘State of Preparedness report’ to be discussed among EU leaders to ensure that preparedness remains on top of the political agenda.
• Wastewater surveillance: such surveillance emerged during the COVID-19 pandemic as a critical tool to facilitate and complement the tracking of coronavirus and variants across all EU countries. Building on the many activities conducted by the Commission in this context, HERA has the specific task to strengthen environmental monitoring including wastewater-based surveillance and establish efficient data-sharing mechanisms to ensure relevant information on pathogens with pandemic and/or epidemic potential is widely and regularly available. In 2023, under the EU4Health programme, HERA launched two actions, namely:
  • a joint action aimed at strengthening national capacities for pathogen prioritisation, sampling and integration of wastewater data in surveillance for public health decision making
  • the establishment of a sentinel system to allow for the testing of samples through centralised partner laboratories for a number of serious cross-border health threats in collaboration with JRC
• Epidemic surveillance: Extend support programmes set up under HERA Incubator to strengthen the detection and identification of variants in the EU.
  • HERA Incubator: The support programmes set as part of this incubator include, for a total budget of €135 million:
    • a whole genome sequencing support framework contract
    • a national infrastructure support programme
    • a capacity building support programme
    • a support programme and data network related to detection of SARS-CoV-2 variants in wastewater.

Promoting advanced R&D of medical countermeasures and related technologies

Key actions:

• Create a common strategic EU research and innovation agenda for pandemic preparedness to help guide both EU and national funding and link with the planned Important Project of Common European Interest (IPCEI) Health.
• Build on the EU Pandemic Preparedness Partnership to pool fragmented pandemic preparedness research capacities across the EU and ensure shared responsibility and funding between the European Commission, Member States and associated countries.
• Further develop the European COVID-19 Data Platform to encourage breakthrough discoveries and accelerate the development of health solutions.
• Work with EMA to create a long-term and large-scale EU platform for multi-centre clinical trials and corresponding data platforms.

Addressing market challenges and failures and boosting EU’s open strategic autonomy

Key actions:

• Identify critical production facilities by systematically mapping and monitoring supply chains, manufacturing capacities and ever-warm production sites.
• Identify bottlenecks within and outside the EU and market failures that could limit production capacity of medical countermeasures and raw materials during a health crisis, including through collecting feedback from industry via the Joint Industrial Cooperation Forum.
• Work with industry to address bottlenecks and supply chain dependencies within and outside the EU.
• Set up new industrial partnerships and organise pan-European matchmaking events across the EU.
• Establish close linkages with and build on the outcomes of relevant programmes and initiatives such as IPCEI Health and EU FAB. A first step will be to devote some €120 million to a call for EU FAB in early 2022.

HERA operations during the crisis phase

HERA’s task will be to ensure that the EU and Member States are ready to act in the face of a cross-border crisis. A key part of HERA’s role in the crisis phase will be to ensure the effective deployment of all the preparations taken in advance.

In the crisis phase, HERA would shift into a different operational mode. To be able to work effectively, this must include swift decision-making and emergency measures. As announced in the Communication on the early lessons from the COVID-19 pandemic of 15 June 2021, the proposal for a Council Regulation accompanying this Communication lays down a framework of emergency measures. If a public health emergency is recognised at EU level, the Council, upon the proposal of the Commission, may adopt a regulation activating the emergency framework where that is appropriate to the economic situation.

The Council activation of the emergency framework will also specify which of the following emergency measures, appropriate to the economic situation, should be implemented:

• The establishment of a Health Crisis Board to coordinate urgent action in response to the crisis. The Health Crisis Board will be composed of the European Commission and one representative from each Member State; other institutions and agencies should also be closely involved
• A mechanism for monitoring crisis-relevant countermeasures
• The procurement, purchase and manufacturing of crisis-relevant medical countermeasures and raw materials
• The activation of EU-FAB facilities to make available reserved surge manufacturing capacities
• The activation of emergency research and innovation plans and the use of Union wide clinical trial networks and data sharing platforms
• The establishment of an inventory of crisis-relevant medical countermeasures production facilities and measures to ensure their aiming at increasing their production availability and supply in the EU
• The activation of emergency funding