In response to the Covid-19 pandemic and in anticipation of future health crises, the EU will establish a Health Emergency Preparedness and Response Authority (HERA) modelled on the United States’ BARDA. This is what the European Commission announced last November (see EUROPE 12600/24).
In the coming days, we will know a little more about the form this authority will take: the president of the institution, Ursula von der Leyen, is expected to address the subject during her State of the Union speech on Wednesday 15 September, before presenting her proposal publicly by the end of the week.
However, a draft version of this proposal, of which EUROPE has obtained a copy, already suggests that HERA will take more the form of a “framework of measures”: a framework that would aim “to ensure the supply of crisis-relevant medical countermeasures in the event of a public health emergency”.
This is a far cry from the “authority coordinating the EU’s health agencies and supervising the supply of medicines from development to manufacture” that was expected by, for example, the European Parliament.
The draft version of the Regulation - an “EU Council Regulation” to be precise - states that in the event of a public health emergency affecting two or more Member States, the EU Council could, after a proposal from the European Commission, decide to activate this “framework of measures”.
The measures in question, the form and purpose of which are also detailed, include: the convening of a “ Health Crisis Board”, measures for the monitoring and procurement of medical countermeasures, the activation of emergency research and innovation plans, emergency funding, and the establishment of an inventory of medical countermeasure production and production facilities.
And these measures, the document states, could only be activated if they are “appropriate to the economic situation”.
“Concern and disappointment”
The proposal to be presented by the European Commission this week, if it is faithful to the draft document described here, may disappoint some.
First of all, the European Parliament is not involved in the project at all - neither at the legislative level nor in the long term.
Within the institution, on the eve of the State of the Union speech, some expressed “concern and disappointment” at the outline of this initiative, which had been “scaled down”.
Nathalie Colin-Oesterlé (EPP, France), who is involved with the issue of drug shortages, recalled that “setting up a European agency of the same type as BARDA” will require “public authorities, industrialists and researchers [to] work together, hand in hand”. She added: “Let’s hope that the Commission’s first draft is up to the challenge”.
EUROPE will continue to follow this story.
To consult the draft rules: https://bit.ly/3tHg8tH (Original version in French by Agathe Cherki)