HERA
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).