Establishment of the Health Emergency Preparedness and Response Authority

A joint EFPIA and Vaccines Europe white paper

The COVID-19 pandemic has shown that Europe needs a robust preparedness system to face current and future health emergencies. The announcement of the creation of a European Health Emergency and Preparedness Response Authority (HERA) is a step in the right direction. For it to be successful, EFPIA and Vaccines Europe believe that its scope, mandate, and operational structure should be set up in a way that is ambitious and, at the same time, sustainable.

With regards to its scope, EFPIA and Vaccines Europe believe that this new authority should be both reactive (current pandemics) and proactive (future threats) by aligning its focus with the European Commission’s Serious Cross-Border Health Threats Regulation proposal. HERA should start by focusing on the most pressing challenges in addressing crossborder health threats, and expand its scope and focus areas depending on capacity and budget. Additionally, HERA should act only where market and other existing incentives cannot ensure better results and base its actions on trust and shared expectations between industry and HERA. HERA’s priorities should be set by assessing the likelihood of outbreaks, the best approach and technology to deal with them, and determining if HERA is the most appropriate instrument.

In terms of its mandate, EFPIA and Vaccines Europe believe that HERA plays a coordinating role, linking all the activity stages in the research and development process: risk assessment, early development, late development, regulatory pathways, manufacturing, purchasing, and stockpiling. In addition to this coordinating capacity, the new authority should also provide funds to bridge the existing gaps between early stage research and bringing a drug, vaccine, or therapeutic solution to market.

Finally, with regards to its operational structure, EFPIA and Vaccines Europe believe that the success of the new authority will be based on its leadership and independence, capabilities, strong partnership with industry, and fit for purpose instruments. Therefore, HERA will need differentiated instruments, appropriate funding, and an adequate intellectual property framework based on license variety, flexibility, industry ownership, and a predictable process in case of failure to commercialise a biopharmaceutical product. Instruments such as liability safeguards for emergency authorisations and measures should be set to ensure timely and flexible response to health threats. Moreover, No-Fault Compensation (NFC) systems to compensate adverse effects should be implemented in all Member States, backed by an EU-funded compensation mechanism.

With this White Paper, EFPIA and Vaccines Europe are looking forward to contributing to the European Commission’s process to set up a flexible, collaborative, and agile HERA, which is able to deliver on the European Union’s ambitions.