HERA: the ‘EU Health Hero’ after all?

By Daniel Costa

Last week the European Commission (EC) came one step closer to building its cherished ‘EU Health Union’. Indeed, the proposal for the creation of a European equivalent to the US Biomedical Advanced Research and Development Authority (BARDA) had been in the works for some time. Now the new EU Health Emergency Preparedness and Response Authority (HERA) is here to stay. The question is whether it will be able to fix the EU’s shortfalls in case of a future pandemic and be the EU’s ‘health hero’ going forwards.

As we all know, the COVID-19 exposed Europe’s need for a strategy to protect it against supply chain interruptions, notably for medical equipment, but also pharmaceuticals. Since the start of the pandemic, the EC has boosted investment into many areas, such as vaccine development and stockpiling. All of this has been to prepare Europe for future health treats under the ‘European Health Union’ package. A core proposal, and the ‘biggest’ of the package, was the creation of HERA itself. But instead of being a giant leap in terms of EU health policy, the proposal seems to fall short of expectations.

HERA won’t be a standalone agency like the European Centre for Disease Prevention and Control (ECDC) or the European Medicine Agency (EMA). It will be an ‘administrative unit’ within the Commission; something that MEPs have not taken lightly. The reason for this, according to the communication, is that establishing HERA within the EC would allow for a swift mobilisation by early 2022 and allow it to benefit from the full range of tools and expertise available to the EC from the outset. This constitution of HERA also won’t require dramatic changes to legislation as the commission has enacted Article 122 of the Treaty on the Functioning of the European Union (TFEU), which excludes the European Parliament from having any say on the structure.

The original idea for creating HERA was to tackle the limits that both the ECDC and EMA have in their mandates. It is expected to develop better EU health security coordination (before and during crises), boost the development, production, stockpiling, and distribution of medicines, and strengthen the global health emergency response architecture. To deliver on such goals, the EC provided the authority with an indicative budget of €6 billion from the EU’s current multiannual budget, part of which will come from the EU’s €750 billion coronavirus fund, NextGenerationEU.

In principle, HERA’s work will depend on if it is preparing for a crisis or tackling one. Before a health crisis, in the “preparedness phase”, HERA will work closely with other EU and national health agencies, and international partners to improve the EU’s readiness for health emergencies. It will carry threat assessments and, by early 2022, identify and act on at least three high-impact threats and address possible gaps in medical countermeasures. Should another health emergency be declared, HERA would switch to emergency operations, and be able to make decisions fast, activate emergency funding, and launch mechanisms for monitoring, new targeted development, procurement, and purchase of medical countermeasures and raw materials.

The core of the HERA will be constituted by its Board. The Board will bring together EC expertise and senior member states representatives, as well as industry representatives, all contributing to joint preparation of multiannual strategic planning. Such an organisation is similar to the EU’s vaccination steering committee. The Board won’t go to the European Parliament for approval and will be appointed instead.

All these changes to the ‘ideal HERA’ were due to the pressure of the EU Council, i.e. EU member states, in an attempt to guard their national competencies in health. If member states were already resisting the idea of having the ECDC give them nonbinding recommendations, it would have been difficult to see the creation of a standalone agency that could designate their health systems as ‘unsuitable’ for the next pandemic.

By ceding to member states, the EC now has infuriated the Parliament, the main advocate for the proposal, which has now been reduced to an observer seat at the Board. The left-leaning Socialists & Democrats (S&D) Group quickly produced a response to the announcement and called for greater ambitions. The Renew Europe Group’s MEP Nils Torvalds outright rejected the unilateral move with the invocation of Article 122.

In the end, HERA seems to be another example of the complications that the European project faces daily. The needs of the Union are somewhat put at risk due to member states’ national concerns- even though not so long ago they paid lip service to give more health competencies to the EU. Looking towards the future, how game-changing will the “health preparedness and resilience mission” announced by the EC President in her State of the Union a few days ago be? Currently, its prospects do not seem to be very revolutionary. The mission itself might stumble in the same way HERA has. One thing is probably certain, though: MEPs most likely won’t be impressed with how the EU Health Union is starting to look.

To learn more about HERA or EU health policy, get in touch with us at Brussels@Instinctif.com.