The EU Council Working Party on Pharmaceuticals and Medical devices discussed, on Tuesday 17 May, a first draft compromise on serious cross-border threats to health.
This draft, of which EUROPE obtained a copy, differs relatively little from the proposal for a regulation on the subject drawn up by the European Commission.
Of the few changes, however, some are intended to give Member States greater flexibility in relation to EU-imposed protocols, including protocols for assessing their preparedness and ability to respond to health threats.
The original proposal suggested, for example, that States should provide the European Commission with a report on this matter by the end of November 2021 and every two years thereafter. The draft compromise provides for these reports to be delivered by the end of November 2022, and then every three years.
It should be noted that the information received by the Commission will be compiled in a report submitted to a Health Security Committee.
The Commission suggested that the recommendations made in these reports be published on its website. The draft compromise recommends, instead, the publication only of an “overview of general recommendations”.
National audits. The same applies to the audits to be carried out by the European Centre for Disease Prevention and Control (ECDC) in the Member States in order to assess compliance with the instructions given at European level and the capacity of each Member State to react to potential threats.
The Commission suggested that these audits should take place every three years. The EU Council, on the other hand, requires a four-year interval between each. It would appear that it refuses to use the term ‘audit’, which was included in the initial proposal, preferring instead the term ‘review’.
It was further proposed that the Commission adopt delegated acts to determine the procedures, standards and criteria for such audits. On this point, the EU Council prefers the Commission to proceed by means of implementing acts - which will involve consultation of a committee in which the EU27 will be represented.
This draft regulation on serious cross-border threats to health was presented by the European Commission last November (see EUROPE 12600/24). It is one of three tools the EU intends to use to better prevent future health crises.
Furthermore, the Commission has also suggested revising the Regulation establishing the European Centre for Disease Prevention and Control (ECDC) and strengthening the role of the European Medicines Agency (EMA). EU Council draft compromises on both proposals are also under consideration at working group level (see EUROPE 12718/3). (Original version in French by Agathe Cherki)