The structure of the European Commission’s proposed new authority to prepare for future health crises by developing “medical countermeasures” has been revealed by leaked documents.
The new Health Emergency Preparedness and Response Authority’s (HERA) tasks and powers will be detailed in a decision to be discussed today (14 September) at a meeting of the College of Commissioners’ 27 members.
It will then be formally adopted on Thursday, September 16, when the proposal is expected to be unveiled. The HERA, which was announced in February, will play a key role in strengthening Europe’s ability to prevent, detect, and respond quickly to cross-border health emergencies.
“COVID-19 will not be the world’s last public health emergency, nor will it necessarily be the worst, hence the importance of improving preparedness to address ongoing and increasing risks, not only of pandemics but also of threats such as bioterrorism,” the EU executive writes in the communication.
The announcement of HERA, which will be fully operational by early 2022 after a short transition period, is expected to be one of the main highlights of Commission President Ursula von der Leyen’s State of the Union address to the European Parliament on Wednesday (15 September).
The new authority will primarily be responsible for “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) like gloves and masks are all listed as “medical countermeasures” in the Commission’s proposal.
Its primary missions will be to improve coordination between the EU and member states in both preparedness and crisis response, as well as to address vulnerabilities and strategic dependencies within the EU in the development, production, procurement, stockpiling, and distribution of medical countermeasures.
HERA will operate in two modes, depending on whether it is dealing with preparedness or crisis situations.
The new agency will direct investment and action in strengthening prevention, preparedness, and readiness for new public health emergencies during the “preparedness phase.” When the emergency phase is activated, a Health Crisis Board is formed to coordinate immediate crisis response.
The emergency phase will also include a mechanism for monitoring crisis-relevant countermeasures, emergency funding, and the creation of a crisis-relevant medical countermeasures inventory.
The HERA will be a structure within the European Commission rather than an EU agency like the European Centre for Disease Prevention and Control (ECDC) or the European Medicines Agency (EMA).
As a result, it will “benefit from the full range of financial, regulatory, technical, and organizational tools and expertise available to the Commission from the start,” according to the leaked documents.
HERA’s “rapid operationalization” in early 2022 is made possible by the flexibility gained by utilizing the Commission’s existing powers, tools, and programs, which do not necessitate complicated legislative changes.
The authority will, however, maintain close contact with the ECDC and EMA, the EU’s two main health agencies, and an annex to the decision emphasizes the importance of coordination to avoid overlapping.
“HERA operations necessitate a significant and sustainable budget,” according to the Commission communication.
The Commission has already provided the new agency with an indicative budget of €6 billion from the EU’s current multiannual budget, a portion of which will come from NextGenerationEU, the EU’s €750 billion coronavirus fund.
The HERA’s core will be its Board, which will bring together Commission expertise and senior member state representatives, both of whom will contribute to the joint preparation of multiannual strategic planning.
The document states that representatives from EU agencies and bodies will be invited to participate as observers to the Board.
The proposal’s legal basis has already sparked criticism from Green MEP Tilly Metz, who claims that the European Parliament will be excluded from the negotiations to establish the new agency.