A new EU agency will monitor production and raw material capacity, address weaknesses in supply chains and protect Europe from health crises.

UM – 02/2021

Hera is the queen of the Gods, wife of Zeus and also his older sister – she is the most important of the goddesses in Greek mythology, watching over marriage and childbirth. The new Crisis Prevention and Response Agency of the same name, which the European Commission intends to set up, is also intended to take on important protective functions in the event of health emergencies or threats.

More protection against health threats

HERA (European Health Emergency Response Authority) aims to complement national health strategies and equip the European Union (EU) for both better preparedness and faster response to health emergencies. European Commission President, Ursula von der Leyen sees HERA as a European "ecosystem" that focuses on cooperation between reliable public institutions and innovative private-sector companies. However, the scope of HERA remains to be seen at this point.

HERA can become a public institution

The possible scenarios, proposed by the European Commission in an impact assessment range from "maintaining the status quo" to an operational authority with far-reaching powers of intervention, under whose umbrella all relevant initiatives relating to prevention, response and defence against health threats as well as the design, development, production and implementation of appropriate countermeasures are to be brought together. Feedback and a public consultation - the latter starting in mid-March - will allow comments on the design of HERA and its prospects.

The USA as a role model

The US American BARDA (Biomedical Advanced Research and Development Authority) is regarded as a role model, and a look at its self-image gives an indication of where the journey could also lead in Europe. To be prepared for crises and respond appropriately, BARDA supports the development of medical countermeasures such as vaccines, drugs, and diagnostics from research and advanced development to U.S. Food and Drug Administration approval as well as inclusion in the National Strategic Reserve. BARDA's support includes funding, technical assistance and core services ranging from a network of clinical research organisations to innovation centres in advanced development and manufacturing to a fill-finish manufacturing network. It supports a broad portfolio of medical countermeasures; its products have received a total of 57 FDA approvals, licences or clearances. Core here too – "successful public-private partnerships with industry to share risks, increase efficiency and accelerate developments".

If the American example is followed, extensive operational tasks will be placed in the hands of HERA. This will raise questions of delimitation as the European Centre for Disease Prevention and Control (ECDC) is also to be strengthened and given new tasks (see proposed Regulation COM(2020) 726 final).

Initially, the focus is on antimicrobial resistance

A legislative proposal to establish HERA has been announced for the end of this year. Notwithstanding the above, preparatory activities to address the health threats posed by antimicrobial resistance will be undertaken in advance, appropriate partnerships will be initiated and, where appropriate, blueprints for the future work of the agency will be created. In this context, it should be referred to the European Action Plan on Antimicrobial Resistance under the "One Health" concept of June 2017 (COM(2017) 339 final) and the Council Conclusions of June 2019 (10366/19).