On Thursday 16 September, the European Commission unveiled the contours of the new and long-awaited “European Health Emergency preparedness and Response Authority” (HERA), presented by Vice-President Margarítis Schinás as “the missing block” in the configuration of the European Health Union.
The Authority - which is expected to be fully operational by early 2022 - will be tasked with complementing the work of existing European health agencies and ensuring that the EU and the EU27 are ready to act on all fronts in the event of a cross-border health crisis.
To do this, HERA will operate in two different modes. A preparedness mode and an emergency mode.
Crisis preparedness
In the absence of an immediate health emergency, HERA will operate in a “preparedness phase”: it will be responsible for gathering intelligence, assessing potential threats, supporting research and innovation, or ensuring that sites are available to produce sufficient medical countermeasures if needed.
To support and maintain this large-scale production - even when demand is not as strong as in times of crisis - and to ensure rapid access to production sites at all times, the Commission explains that it will set up a programme called “EU FAB”.
The latter will aim to reduce the time needed between development and industrial scale-up. A tender for the programme’s facilities will be launched in early 2022.
Emergency response
The second mode, the “crisis phase”, will only be activated when a public health emergency is recognised at EU level, and “where appropriate to the economic situation”, the Commission says.
The provisions on HERA provide that once a public health emergency has been recognised, the Commission may propose to the EU Council that special measures be put in place.
These measures are detailed by the Commission in a proposal for a Regulation, unveiled today and likely to evolve, since it will still have to be validated by the EU Council.
The special measures proposed by the Commission include: - a Health Crisis Board; - a monitoring mechanism for crisis-related countermeasures; - the procurement, purchase and manufacture of crisis-relevant medical countermeasures and raw materials; - the activation of “EU FAB” facilities; - activation of emergency research and innovation plans.
€6 billion over 6 years
How will all this be funded? The Commission plans to provide its new service with a budget of six billion euros for the period 2022-2027.
The six billion will be taken from the budgets allocated to the EU4Health, rescEU, Horizon Europe and Next Generation EU programmes. The idea is therefore that part of the budget available under each of these programmes should be managed by HERA.
And these six billion will be part of a much larger budget for health, the Commission promises. This increases to “almost 30 billion, if we take into account investments made in health security, preparedness and response through other EU programmes”, according to Commissioner Stella Kyriakides.
Beyond the 30 billion, the Commission estimates that a significant proportion of national budgets will be devoted to health countermeasures and assures that HERA will mobilise private funds.
“All these initiatives taken together will support the new European mission of preparedness and resilience, which will represent an investment of around 50 billion”, the Commissioner stressed.
A “service” rather than an “authority”
HERA will therefore not be an independent authority, but an internal Commission entity, with its own staff and “independent of the Health Directorate-General”, according to an institutional source.
It will be more of a Commission service. A decision that Mr Schinás justified by explaining that “setting up a fully-fledged agency takes time and, by definition, health emergencies do not wait”.
The Commission confirms that creating a new agency would have required the more time-consuming procedure of interinstitutional negotiations and would have been difficult from a budgetary point of view. As no budget has been envisaged for HERA, it is only by creating an internal structure that funds can be mobilised through the programmes, the Commission assured..
And the European Parliament?
While the EU27 will be closely involved in the service - in the ‘HERA Management Board’ in “preparation” mode and in the ‘Crisis Board’ - the European Parliament will simply be invited to appoint an observer to the Management Board.
This decision is causing some concern within the institution, despite assurances from the two Commissioners that it is not a question of excluding MEPs.
So why did the Commission “opt for using article 122 [of the TFEU] and discuss the proposal only with the EU Council?”, asked Tilly Metz (Greens/EFA, Luxembourg) on Twitter.
The explanation given by the Commission is that this article is the only legal basis in the Treaties that allows such a project to be set up in the field of health.
The news, however, is not going down well. The S&D and Renew Europe groups were quick to respond, calling for the Parliament to have a say as well.
“In times of crisis, the Commission, the EU Council and the Parliament have demonstrated how fast and effective they were able to react and adopt strong measures”, argued Véronique-Trillet Lenoir (Renew Europe). “The Parliament should have a seat at the negotiating table”, insisted Jytte Guteland (S&D, Sweden).
MEPs will try to make their voices heard when they discuss the issue with Ms Kyriakides on 27 September in the ENVI Committee.
See the HERA communication: https://bit.ly/39ega2Y
See the EU Council Regulation: https://bit.ly/3lzgBKG (Original version in French by Agathe Cherki)