In response to the devastating impact of the COVID-19 pandemic, the EU has drawn a revived focus on how to better prepare for future pandemic crises. In March 2021, the European Commission launched an online public consultation on the Health Emergency Preparedness and Response Authority (HERA). The purpose of the consultation is to gather knowledge that will help to improve Europe’s capacity and readiness to respond to cross-border health threats and emergencies. Key to this is EU capacities around medical countermeasures, such as vaccines, personal protective equipment and medical devices.
The STAMINA project has joined forces with some of its partner projects from the PREPARE cluster to provide joint feedback for the HERA consultation. The cluster consists of a network of projects whose aim is to improve preparedness and response for emergency situations in Europe. Our response combines expertise from researchers and end-users from STAMINA, EUR3KA, CO-VERSATILE and PERISCOPE. Each project was able to spot different challenges, meaning the collaboration has resulted in a balanced and robust response.
The feedback was structured around key questions asked around how HERA should be structured and what should be its priorities. As a whole, the PREPARE cluster agreed that current capacities need further development and more equal distribution – including foresight mechanisms, data sharing, quality assurance, real-time data gathering – and HERA could help.
As a whole, the cluster agreed that:
What types of medical countermeasures HERA should prioritize depends on the type of threat and underlying preparedness and response gaps at the national and EU levels. Nevertheless, important countermeasures are: a) ensuring sufficient reserves of medical equipment and consumables; b) research and implementation of new types of antibiotics and alternatives, in the context of proven diminution of the efficiency of the already existing ones; c) patenting, testing and production of vaccines to reduce the risks associated with communicable diseases.
These instruments should not be under the control or favour any single agency. However, they could be used by HERA to facilitate the coordinated application of the European-wide Public Health Policy and the preparedness and response plan to situations that threaten the health of European citizens
To do so, the cluster made the case that HERA needs to:
· Address resource sharing, coordination and understanding the complexities of benefit and burden sharing across the MS.
· Mitigate the fragmented and unevenly spread research and manufacturing capabilities within the EU.
· Enhance suboptimal modelling capacities and monitoring instruments (particularly anticipatory and cross-border) across the EU.
· Improve market intelligence to anticipate problems, particularly ones with differential effects.
· Acknowledge the potential need for alternative financing mechanisms (e.g. public-private partnerships, European-national co-investment).
· Facilitate the distribution of equipment based on regional needs and the management of problems in the production and delivery of medical equipment.
Insights from this project cluster point to the need for HERA to develop dialogues with existing systems – rather than subsume them within its umbrella – in order to establish joint procurement agreements, fabrication networks, it can build a strong capacity to trigger such EU-level coordination activities while maintaining economies of scale. However, the cluster made the case that national differences need to be considered and a balance between EU and MS autonomy is necessary, particularly concerning flexible surge manufacturing. Benefits outside of health (e.g. environmental, administrative) are contingent upon raise awareness of different risks and challenges across the EU.
They also pointed that HERA needs mechanisms for feedback and data stewardship. HERA needs to work closely with other EU agencies and stakeholders at national level but also with other emerging initiatives such as the WEF Manufacturing Global Response. The interplay with European Medicines Agency (EMA) and European Centre for Disease Control and Prevention is of particular importance.
HERA should act as an intermediary as well as broker of information and knowledge. This role could entail a) communication, collective planning and cooperation for unitary preparedness policies and measures, b) sharing medical data and statistics, c) organizing scientific events to monitor and evaluate threats and procedures. The aim would be to support MS to work closely and equally together in the fields of research, health crisis planning, global repurposing production network development, ongoing education and exchange of expertise and ideas.
Finally, this would be strengthened with a legislative framework to clearly determine the role and duties of HERA.
In parallel to the public consultation, the Commission is also holding talks with the Member States and stakeholders. Feedback to the consultation will be considered before the EC finalise a legislative proposal.
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