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.