LEAKED: The EU’s new body to prevent the next pandemic

The announcement of the EU's new Health Emergency preparedness and Response Authority (HERA) is expected to be one of the highlights of the State of the Union address which Commission President Ursula von der Leyen will deliver before the European Parliament on Wednesday (15 September). [European Parliament]

Leaked documents seen by EURACTIV reveal the structure of the European Commission’s proposed new authority to prepare against future health crises by developing “medical countermeasures.”

Tasks and powers of the new Health Emergency preparedness and Response Authority (HERA) will be detailed in a decision to be discussed today (14 September) at a meeting of the 27-strong College of Commissioners.

It will then formally be adopted on Thursday (16 September), when the proposal is expected to be unveiled.

Already announced in February, the HERA will become a key actor in strengthening Europe’s ability to prevent, detect, and rapidly respond to cross-border health emergencies.

“COVID-19 will not be the world’s last public health emergency, nor will it necessarily be the worst,” the EU executive writes in the communication seen by EURACTIV, underlining the importance of improving preparedness to address “ongoing and increasing risks, not only of pandemics but also of threats such as bioterrorism.”

The announcement of HERA, which will become fully operational by early 2022 after a short transitional phase, is expected to be one of the main highlights of the State of the Union address which Commission President Ursula von der Leyen will deliver before the European Parliament on Wednesday (15 September).

The new authority will be essentially tasked with “the development, manufacturing, procurement, and equitable distribution of key medical countermeasures.”

Vaccines, antibiotics, medical equipment, chemical antidotes, therapeutics, diagnostic tests and personal protective equipment (PPE), such as gloves and masks, are listed as “medical countermeasures” in the Commission’s proposal.

Its main missions will be to strengthen coordination between the EU and member states in both preparedness and crisis response, as well as addressing vulnerabilities and strategic dependencies within the EU related to the development, production, procurement, stockpiling and distribution of medical countermeasures.

Commission slows down on returning drug manufacturing to Europe

Despite widespread hopes for a quick shift towards ‘strategic autonomy’, the European Commission has made clear it needs another two years of reflection before coming up with proposals to reduce the risk of shortages caused by over-reliance on third-country medicine production.

HERA will have two different operational modes depending on whether addressing preparedness or crisis times.

In the “preparedness phase”, the new agency will steer investment and action in strengthening prevention, preparedness and readiness for new public health emergencies. When the emergency phase is activated, a Health Crisis Board is put in place to coordinate urgent action in response to crises.

The emergency phase will also include a mechanism for monitoring crisis-relevant countermeasures, emergency funding and the establishment of an inventory of crisis-relevant medical countermeasures.

Structure and funding

The HERA will not be an EU agency like the European Centre for Disease Prevention and Control (ECDC) or the European Medicine Agency (EMA) but rather “a structure within the European Commission.”

As such, it “will benefit from the full range of financial, regulatory, technical and organisational tools and expertise available to the Commission, from the outset,” the leaked documents read.

HERA’s “swift operationalisation” in early 2022 is made possible by the flexibility gained from using the Commission’s existing powers, tools and programmes, which does not require complicated changes in the legislative framework.

However, the authority will be in close contact with the ECDC and EMA, the EU’s two main  health agencies and an annex to the decision shows the importance of coordination to avoid overlapping.

“HERA operations require a significant and sustainable budget,” the Commission communication reads.

The Commission already provided the new agency 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.

The core of the HERA will be constituted by its Board that will bring together Commission expertise and senior member states representatives, both contributing to joint preparation of multiannual strategic planning.

Representatives of EU agencies and bodies will be invited to participate as observers to the Board, the document reads.

The legal basis of the proposal has already triggered criticisms from Green MEP Tilly Metz, who complained that the European Parliament will be cut off from the negotiations on setting up the new agency.

“All key areas where HERA will intervene are within the competence of the European parliament so why should only the Council have a say on that?” Metz told EURACTIV.

She warned that MEPs might not be welcome in these talks due to their recent call for having transparent mechanisms for tracking public funds and secure a public health driven agenda.

Von der Leyen: we must ensure that this is the last pandemic

European Commission President, Ursula von der Leyen, has urged world leaders to work together to tackle the COVID-19 pandemic to avoid future health crises ahead of the publication of a declaration demanding more coordinated action on health policy.

[Edited by Frédéric Simon]

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