HERA and the EU’s disease and biothreat preparedness

The current COVID-19 pandemic demonstrates the ability of an infectious disease to disrupt our societies and economies, terrify our citizens, overwhelm health systems and cause elevated levels of serious disease and mortality. It also revealed that the European Union was largely unprepared to deal with this pandemic and the response was reactive rather than based on well prepared plans.

Among key issues encountered were the lack of adequate availability of stockpiled medical countermeasures, such as personal protective equipment, and robust distribution and supply chains. Lack of coordination between member states during the pandemic regarding cross-border movement of medical countermeasures, protective equipment, medical equipment and testing capacity also hampered the response.

The lessons learnt from this pandemic give the EU the opportunity to be better prepared against future pandemics and other biothreats, such as emerging diseases and deliberate release of biological agents by bioterrorists or rogue state actors. Unfortunately, some of these continuing threats have the potential to be more devastating than COVID-19. The spread of emerging diseases is also being driven by climate change, as more extreme events such as flooding and global warming make our citizens more vulnerable to new and existing diseases. For example, some insects that carry pathogens can move further into European territories as migration patterns are altered due to temperature changes.

Key lessons learnt are a requirement for more coordination and focus on preparedness and response at the EU level, ensuring adequate reserves of medical countermeasures are available for known and future threats, robust deployment mechanisms are established, and supply chains are strengthened. In addition, there needs to be a recognition of the need to closely cooperate and engage with industry as part of future preparedness so that relationships based on trust are established ahead of future emergencies which will improve cooperation in crisis mode.

The European Health Emergency Preparedness and Response Authority (HERA) has been established by the European Commission in response to the pandemic to implement the lessons learnt. It will focus, coordinate and drive the extensive capabilities and expertise of EU members states, EU agencies, Centres of Excellence, the Commission Directorates-General and industry in preparing and responding to cross-border health emergencies, such as pandemics and other biothreats in the future.

It will provide an EU ‘end-to-end’ preparedness and response capability by ensuring that health threats are thoroughly assessed, medical countermeasures, such as vaccines and therapies, are developed, procured and stockpiled in response to these threats. In parallel, autonomous manufacturing and supply chains will be established to provide robust distribution and deployment mechanisms to enable equitable availability across all member states.

Key to the success of HERA will be the cooperation of the member states, as well as utilising and strengthening the expertise and capabilities of some of the EU institutions, such as the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA). EU legislation is currently being negotiated to strengthen the scope and capabilities of both organisations so that they become pivotal to HERA’s instruments against future biothreats.

The ECDC is being strengthened to enhance surveillance and epidemiological capabilities to provide early warning and risk-managing recommendations to guide HERA on threat assessment and any gaps in available medical countermeasures. It will also reinforce the contribution to the EU’s international cooperation and development, as well as EU commitment to global health security preparedness, especially via the Health Task Force which can be deployed to the crisis-affected areas.

The EMA will remain the centralised regulatory authority for approval of medicines within the EU and will be independent of HERA. It will be key in ensuring that streamlined regulatory processes are in place for the approval of medical countermeasures for stockpiling purposes and to be employed during health emergencies. However, one of the lessons learnt from the pandemic is that even when a vaccine is approved at EU level, member states still have their own regulatory authorities which may impose additional requirements, such as restrictions for certain age groups. This led to divergence in the use of an EMA-approved vaccine across some member states, and this is an area where HERA can assist in harmonising the regulatory process. Another point to consider is that HERA and the EMA need to interrogate the global landscape for approved products when assessing the availability of medical countermeasures as they may be suitable for approval and procurement in the EU without the need to invest considerable resources to develop and manufacture within the EU.

The establishment of HERA by the Commission is a very positive step in helping the EU to better prepare and respond to future pandemics, emerging disease and bioterror threats. It provides an opportunity to reshape the enormous expertise, resources and capabilities in EU public and private sectors to meet the challenges of future biothreats. HERA could also present itself as the platform for the EU’s ‘voice’ in leading the global effort against biothreats going forward.

We need to be mindful that this is a long-term commitment requiring ongoing cooperation and investment. Political and national memories can be short, but infectious disease and bioterrorists do not respect politics or borders.