The Council of the EU reached a political agreement on Monday 20 December on the Regulation for the joint management of medical countermeasures in the event of a cross-border health crisis (see EUROPE 12832/19).
The text will, among other things, establish a European Health Crisis Board. It will meet in the event of a public health emergency to coordinate the implementation of joint mechanisms for the inventory, supply, manufacture and purchase of medical countermeasures, the launch of emergency research and pharmaceutical trial plans and the raising of exceptional funding.
More specifically, the Committee will “assist and provide guidance” to the European Commission on the implementation of the various measures.
It will be composed of one member of the Commission and one representative of each Member State and will be co-chaired by the Commission and the representative of the State holding the rotating Presidency of the EU Council.
This question of governance was the main source of concern for the EU27. Several delegations had requested, at the beginning of December, that the text be reworked, in particular with a view to obtaining more guarantees as to the involvement of the Member States in the decision-making process (see EUROPE 12848/4). Changes in this direction have therefore been initiated by the Slovenian Presidency of the Council.
Unblocking the text
The text on the table at the beginning of December, for example, gave the Commission the possibility to act, in certain exceptional cases, without seeking the prior opinion of the Health Crisis Board.
This possibility, however, no longer appears in the text negotiated on Monday, which now requires the Commission to consult the Committee “in a timely manner, whenever possible before taking action” and to take “the utmost account” of its recommendations.
In addition, the text details the procedure for the various measures. With regard to the purchase of medical countermeasures, it provides, for example, that the EU27 mandate the Commission to act as a central purchasing body.
In addition to the issue of governance, some delegations were opposed to closing the negotiations on this regulation while discussions continued on a second regulation - this one on the comprehensive European response to transboundary health threats (see EUROPE 12845/21).
On this point, reluctant delegations were assured that “technical adjustments” could be made later to the settlement reached on Monday depending on the progress of the trilogues on the second settlement, an EU source told EUROPE. Only one political trilogue has so far taken place on this dossier (see EUROPE 12836/19). No further meetings have yet been scheduled.
The regulation on the management of countermeasures should therefore be formally adopted in the first months of 2022.
It will therefore be one of the key components of HERA (see EUROPE 12792/24) - and it will also regulate another component: the future network of “continuous” production capacities for vaccines and medicines (see EUROPE 12793/8).
To consult it: https://bit.ly/3FgSw3Z (Original version in French by Agathe Cherki)