iStockphoto/Johnny GreigHERA is limited in scope
The new European crisis authority bears little resemblance to its American model.
UM – 09/2021
The crisis authority adopted by the European Commission (EC) on
September 14 falls short of the previous announcements and expectations.
Nevertheless: "HERA will be implemented to enable the European Union (EU) to deal earlier
and better with future health threats" stated the President of the European
Commission, Ursula von der Leyen, when announcing the decision a day later as
part of her annual “State of the Union” address.
No autonomous authority ...
HERA is the new EU authority for crisis
preparedness and response to public health emergencies. - It is to become a
central administrative unit within the EC, bringing together the competences
and responsibilities that are currently widely dispersed. HERA will not become
an independent authority like the EMA (European Medicines Agency) or the ECDC (Centre
for Disease Prevention and Control). However, it should cooperate closely with
both agencies and ensure the "development, production, procurement and
distribution of medicinal products" in the event of a crisis, which is
beyond the other agencies’ competence frameworks. It will also work closely
with the authorities in Member States whose competence and responsibility is
health protection, analysing health threats of their origin - biological,
chemical or other - and jointly developing strategies with them.
... but it’s part of a "mission"
HERA is due to be launched in the spring of
next year with a six-year budget of six billion euros. Perhaps it was with this
comparatively manageable amount in mind that von der Leyen proposed in her
speech a new crisis preparedness and resilience mission for the EU, which, when
added to 24 billion euros from other EU budget items for health emergencies and
20 billion euros from EU countries' plans to improve national pandemic
preparedness, totals up to 50 billion euros.
HERA in standby times
In quiet times, its tasks will include
threat assessment and knowledge gathering, supporting R&D into crisis
measures, ensuring sufficient production capacities for crisis-relevant
technologies, procuring and stockpiling the necessary medicinal products and
supporting Member States in preparing for a crisis.
HERA in times of crisis
HERA will be called upon to organise and
coordinate countermeasures during acute cross-border threat phases. Procuring,
purchasing and producing suitable medicinal products will be at the forefront
as well as developing production capacities, targeted research and innovation
promotions as well as financing. The crisis unit should be able to ensure quick
decisions and rapid action. HERA will be led by a director general appointed by
the EC, assisted by a coordinated committee of commissioners co-chaired by
vice-president Margaritis Schinas and health commissioner Stella Kyriakides.
The Member States will be represented by their senior representatives on the
HERA board. Technical networking with the Member States will take place in the
HERA advisory forum. Cooperation with industry will also be sought.
International cooperation
HERA will also have an international
component. Supply chains for raw materials, materials and pharmaceutical
products will be increasingly organised globally, which means that disruptions
will be felt worldwide. HERA will aim to work closely with its global partners
and EU neighbours in order to address any bottlenecks in supply chains, remove
unnecessary restrictions and barriers to the international movement of goods
and help increase global production capacities for crisis-relevant medicinal
products. Part of its mandate will be supporting low-income countries in
particular, as well as building up expertise and crisis capacities. The
authority also intends to support access to EU-funded or EU-procured medical
countermeasures and regional and local production capacities in third-world
countries.