Negotiators between the Council and the European Parliament reached a common position today on a draft regulation on serious cross-border threats to health. This text strengthens EU and Member State preparedness, monitoring, risk assessment, and early warning and response to cross-border health threats.
New rules on cross – border health threats
The new legislation on cross-border health threats provides for a number of measures to strengthen the crisis preparedness framework, including the preparation of an EU plan to combat health crises and pandemics and the development of national plans by Member States. The Union plan will include provisions on information exchange at EU and national level, early warning and risk management. Member States’ plans will contain similar information and, when drawing up their national plans, Member States will contact each other and the Commission to ensure that their plan is consistent with the Union plan. A coherent and common framework for crisis preparedness and response will be established.
The text also allows the Commission to recognize a public health emergency at EU level, thus triggering mechanisms to monitor drug shortages or stepping up support for the European Center for Disease Prevention and Control (ECDC).
Health Security Committee
With regard to the Health Security Committee (HSC), the negotiators between the Council and the European Parliament agreed that the Health Security Committee should be involved in coordinating the actions of the Commission and the Member States to regulate cross-border health threats.
They also decided that the committee could adopt opinions and guidelines on response measures to prevent and control health threats. If the Health Security Committee is required to vote on the adoption of its instructions, the vote shall be taken by a two-thirds majority.
Stress tests, planning and joint procurement
The Council and the European Parliament also agreed that:
- The Commission will facilitate stress tests to ensure the functioning of the EU Preparedness and Response Plan and will update the plan if necessary;
- On the basis of the information provided by the Member States, the Commission will prepare reports on how they intend to respond to health crises. An overview of the recommendations made in the reports will be published;
- The Commission and the Member States will be able to engage in joint procurement of medical antidotes. The decision of the Member States to participate in such procurement will be taken on the basis of information provided in advance and in accordance with the conditions agreed with the Commission.
General information and next steps
This draft regulation is part of a wider package of proposals on the Health Union. This package, presented by the European Commission on 11 November 2020, consists of three legislative proposals: in addition to a regulation on cross-border health threats, it includes proposals for an enhanced mandate for the European Medicines Agency (EMA) and the Center for Disease Prevention and Control ( ECDC). The review of the mandates of both EMA and ECDC has already been completed. This package was complemented by the establishment in September 2021 of a new European Health Emergency Preparedness and Response Agency (HERA) to ensure the supply of medical antidotes before and during health crises.
The preliminary political agreement reached in the Council today will first be submitted to COREPER for approval. A formal adoption procedure will then be launched.