The European Commission welcomes the Interinstitutional Agreement reached between the Council of the EU and the European Parliament on 24 June on the Regulation on serious cross-border health threats but has two criticisms.
In a document consulted by EUROPE, drafted in the context of the review by the Member States’ deputy ambassadors to the EU (Coreper I) of this agreement on the draft regulation (see EUROPE 12982/33), the Commission expressed reservations on two points.
On the one hand, the draft Regulation singles out an internal Commission service, whereas the legal act will be implemented by the Commission as a whole with other stakeholders. The European Health Emergency Preparedness and Response Authority (HERA), is in fact mentioned in the recitals of the draft Regulation. However, in the articles, reference is made to the Commission as a whole.
Furthermore, the Commission is critical that a revision clause in the draft Regulation provides for consideration of the establishment of HERA as a separate entity from the Commission. This type of assessment goes beyond the scope of the Regulation for the Commission and is redundant with another assessment (related to the Emergency Framework for Medical Countermeasures).
Bulgaria underlines its commitment to the principles of sovereignty and subsidiarity in this context. It is concerned about the legal nature of a future global pandemic preparedness instrument negotiated at the World Health Organization level and fears that references in the European legal order prejudge the outcome of the negotiations. The country is also concerned about the reporting and evaluation requirements of the future Regulation, which would strain its limited budgetary and administrative resources.
Hungary clarified that it interprets the term ‘gender’ as ‘sex’. Poland made similar comments.
Link to the note: https://aeur.eu/f/2kb
Link to the compromise: https://aeur.eu/f/2cu (Original version on French by Émilie Vanderhulst)