Abstract

COVID-19 has shown that coordinated action at EU level is necessary to effectively respond to health emergencies. While during the pandemic the EU reacted to issues as they arose, the creation of HERA is a first step to putting Europe on the front foot in addressing global health threats.
This paper outlines EFPIA and VE’s views and recommendations on a number of elements included in the Commission’s Decision establishing the Health Emergency Preparedness and Response Authority (HERA)] and in the Proposal for a Council Regulation on a framework of measures for ensuring the supply of crisis relevant medical countermeasures in the event of a public health emergency at Union leveP. EFPIA and VE, their national associations and member companies, look forward to working with HERA and all stakeholders towards the shared goal of a safer, healthier and more resilient Europe.

GENERAL PRINCIPLES
Based on the lessons learned from COVID-19 crisis management, points which we believe require particular attention during planning and implementation of preparedness, as well as response activities by HERA, include:

• a lean approach to decision-making, with clear delineation of responsibilities of different institutions and agencies, avoiding overlapping remits, and duplicative or contradictory measures;
• scenario planning and technology screening, in dialogue with developers of medical countermeasures;
• supply and deployment tools which leverage global supply capabilities and do not create unintended vulnerabilities in the supply chain;
• a clear legal framework and contracting terms, to improve predictability, and therefore encourage industry’s participation;
• a no-fault compensation system which provides the right level of protection and compensation in case of injuries related to medical countermeasures procured and deployed via HERA, to enhance public trust;
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