The Council of the European Union and the European Parliament reached a political agreement, on Thursday 23 June, to strengthen European preparedness and response to serious cross-border health threats.
The draft regulation in this respect is part of a package of three pieces of legislation which also includes the strengthening of the mandate of the European Medicines Agency and the European Centre for Disease Prevention and Control (see EUROPE 12704/2).
The negotiations had already been well prepared by the French Presidency and the last discussions of this last trilogue focused on grouped purchases, one of the important European tools in this fight against health threats.
These contracts should follow a two-stage procedure with an initial expression of interest from Member States to the European Commission. The future regulation should also introduce the possibility for the Union to have an exclusivity clause for group purchasing contracts for medicines or countermeasures.
The regulation strengthens the health response and provides for the development of a European plan for prevention and preparedness for health crises and pandemics. This plan will be developed by the European Commission and approved by the Health Security Committee. The compromise sets out rules for a strengthened and integrated epidemiological surveillance system at EU level and better data collection tools.
The compromise provides for enhanced surveillance of emerging pathogens, improved transmission of data from health systems by Member States and improved reporting of epidemiological data by Member States and other data relevant to the management of cross-border threats as they become available.
The medical capacities of Member States to respond to the crisis (intensive care beds, medicine stocks, medicine production capacities) is also expected to be better assessed by the European Commission.
The future regulation will make it possible to set up and finance European reference laboratories.
It will also establish an advisory committee on the occurrence and recognition of emergencies at EU level. In addition, the Regulation will introduce provisions to clarify the recognition of emergency situations and the activation of the Union’s emergency mechanisms for health crisis management.
Véronique Trillet-Lenoir (Renew Europe, France), rapporteur of the text in the European Parliament, wanted to insist on the transparency of joint procurement, on the alignment of this regulation with the One Health approach, the horizontal integration of the health dimension in European policies.
The Parliament also wanted to emphasise the preventive dimension of the text, in particular for the EU preparedness plan or the increased attention to cross-border regions and their participation in the elaboration of prevention and preparedness plans.
The text will be reviewed for approval by the European Parliament’s Committee on the Environment and Public Health on 12-13 July and by the Member States’ ambassadors to the EU (Coreper). (Original version in French by Émilie Vanderhulst)