Work continues in EU Council working groups on the draft regulation which, once adopted, should provide the Union with a more comprehensive legal framework for dealing with serious cross-border threats to health (see EUROPE 12600/24). After examining a first compromise proposal at the end of May (see EUROPE 12722/27), a second proposal, of which EUROPE has obtained a copy, was submitted to the national delegations on Tuesday 22 June.
The few changes that have been made are again mostly aimed at providing flexibility to Member States.
They include the joint procurement of medicines and medical devices. The draft regulation provides that this system—which has enabled the bundled purchase of Covid-19 vaccines—may in future be extended to the Member States of the European Free Trade Association and to the candidate countries for accession to the Union.
Non-exclusive procedure. The EU Council’s compromise proposal discussed last Tuesday suggests that, where such a joint procurement procedure would be implemented, it could be on an exclusive or non-exclusive basis.
In the case of an exclusive procedure, participants would not be able to procure the relevant medicinal product or device through other channels or to launch a parallel national negotiation procedure. They would, however, be allowed to do so in the case of a non-exclusive procedure.
The EU Council also envisages that the choice of procedure be left to the EU-27. “The assignment of each medical countermeasure to either an exclusive or a non-exclusive procurement procedure shall be decided jointly by Member States within the Health Security Committee”, the compromise proposal states.
The Health Security Committee is one of the new features that should be introduced once the Regulation is implemented. It will be responsible for coordinating the response of states to cross-border threats and their work with the Commission.
National reviews. Another point that has been amended is Article 8, which provides for reviews to be carried out by the European Centre for Disease Prevention and Control (ECDC) in the Member States to assess the capacity of each Member State to deal with cross-border threats and to ensure that all Member States are complying with the EU guidelines on this matter.
The new compromise proposal suggests that the ECDC should make recommendations to the Member States and the Commission following these reviews. It also provides that it will be possible to disregard these recommendations in the action plan to be presented by the Member States following the review, in order to remedy their shortcomings, provided that this choice is justified.
Finally, the Council of the EU is expected to call for enhanced cooperation between the ECDC and the World Health Organization, in particular “to avoid an overlap of reviewing activities with existing structures and mechanisms”. (Original version in French by Agathe Cherki)