HERA strives consistently to improve the common preparedness and response capabilities of the EU in anticipation of future health crises. Most of our everyday operations take place well before an emergency is declared in the preparedness phase, in which we cooperate closely with Member States to analyse, identify, and prioritise possible cross-border health threats. This work forms the basis for strategic coordination for the development of medical countermeasures, such as medicines, vaccines, masks, and gloves, as well as for the monitoring of the industrial capacity to produce and supply those countermeasures.
The preparedness phase consists of many different targeted actions that cross several policy areas, ensuring that we can build towards a preparedness that is both robust and comprehensive.
Threat assessments and intelligence gathering
Threat assessment and intelligence gathering are at the heart of HERA's operations. Detecting biological and other health threats soon after they emerge, evaluating their impacts, and identifying potential countermeasures are a vital first step before informed counteraction may be taken, and we are consistently scanning the horizon for actionable data.
While in preparedness phase, HERA carries out the following targeted actions for intelligence gathering and threat assessment:
- Threat assessment and MCM prioritisation: Identifying and acting on high impact threats and addressing gaps in terms of the availability and accessibility of related medical countermeasures.
- Systematic review, assessment, and reporting on ongoing health events: identifying and weighing policy alternatives to select appropriate MCM preparedness and response options.
- Strengthening surveillance, laboratory and diagnostic capacities for the early detection and characterisation of health threats: strengthening sequencing capacities and wastewater surveillance, supporting the development of diagnostics and open-source epidemic intelligence, and establishing efficient data-sharing mechanisms.
Promoting advanced R&D of medical countermeasures and related technologies
A vital part of HERA's mission is to promote the research and development of innovative, safe, and affordable medical countermeasures (MCM) for EU citizens. We strive to ensure that, even outside an active health emergency, preparedness remains at the front of the health agenda and our researchers and industry have access to adequate support and resources – ensuring that, when a crisis hits, the right response capacities are in place and ready to be implemented.
While in preparedness phase, HERA's activities focus on the following measures to promote research and development of innovative medical countermeasures:
- A common strategic EU research and innovation agenda for pandemic preparedness: providing a coherent framework for long-term pandemic preparedness research and helping guide both EU and national funding towards vital innovations.
- Mapping the availability of medical countermeasures: developing the ATHINA IT system for detecting potential health threats and monitoring vulnerabilities in the supply of MCMs.
- Improving readiness for clinical trials: working with other Commission services and the European Medicines Agency on the creation of a framework for coordinating and funding emergency clinical trials.
- Investing in the development of innovative medical countermeasures: supporting research and development of new medical countermeasures and the scaling-up of innovative solutions in health and life sciences through the HERA Invest financing mechanism.
Addressing market challenges and failures and boosting EU's open strategic autonomy
Pinpointing market challenges inside the health industry and taking action to redress failures before they develop into vulnerabilities are a key concern that drives much what HERA does. We strive to ensure that critical medical countermeasures are available when and where they need to be by planning ahead of health emergencies and take measures to secure and enhance the EU's capacity for self-sufficiency and independence in regard to the supply of vital medicines, vaccines, and diagnostics.
While in preparedness phase, HERA's activities include the following actions for addressing market challenges and failures:
- Identifying critical production facilities: systematically mapping and monitoring supply chains, manufacturing capacities and ever-warm production sites.
- Identifying bottlenecks and market failures: flagging structural weaknesses in the market within and outside the EU 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.
- Working with industry: cooperating to address bottlenecks and supply chain dependencies within and outside the EU and shoring up vulnerabilities.
- Building closer partnerships: setting up new industrial partnerships and organising pan-European matchmaking events across the EU, as well as establishing closer linkages with and build further on the outcomes of relevant programmes and initiatives such as IPCEI Health and EU FAB.
Procurement and stockpiling
HERA coordinates both the procurement and stockpiling of medical countermeasures on the EU level, making sure that critical products such as medicines, vaccines, and personal protective equipment are ready in the event of a health emergency. Through different procurement mechanisms, including by acting as a central purchasing body for Member States, and establishing strategic reserves across the EU, we help ensure that the relevant medical countermeasures are available to citizens on an equal, timely, and cost-effective basis.
In the preparedness phase, HERA's focus is on the following actions to support procurement and stockpiling:
- Identifying needs and promoting joint procurement at EU level: pinpointing Member States' needs for key medical countermeasures and facilitating joint procurement to fill gaps in an efficient and coordinated manner.
- Tackling challenges related to transportation, storage and distribution: carrying out systematic mapping of logistical requirements and challenges related to stockpiling to address key risks.
- Developing a common EU strategy for stockpiles and supplies: assessing existing stockpiling capacity on both the EU and national levels and developing a common strategy to ensure effective geographical coverage and timely deployment of critical medical countermeasures across the Union.
- Providing operational recommendations to the Union Civil Protection Mechanism: providing operational support and recommendations on medical countermeasures, their stockpiling and deployment to the Union Civil Protection Mechanism (UCPM).
