Provisional agreement on new EU law on serious cross-border threats to health

(Source: Council of the EU and European Council)

Negotiators from the Council and the European Parliament reached agreement today on a draft regulation on serious cross-border threats to health. The text reinforces preparedness, surveillance, risk assessment, early warning and responses at EU and member state level in the event of cross-border threats to health.

New rules on cross-border threats to health

The new legislation on cross-border threats to health provides for measures to strengthen the crisis-preparedness framework, including the establishment of an EU health crisis and pandemic plan, and national plans drawn up by the member states. The EU plan will include provisions on information exchange between the EU and the member states, early warning and risk management. Member states’ plans will contain similar information. When drawing up their national plans, member states will liaise with each other and with the Commission to ensure their plan is in line with the EU’s. This will enable a coherent and shared framework for crisis preparedness and response to be put in place.

The text also provides that the Commission can recognise a public health emergency at EU level, thereby triggering mechanisms to monitor shortages of medicines or activate the support of the European Centre for Disease Prevention and Control (ECDC).

Health Security Committee

The Council and European Parliament negotiators agreed that the Health Security Committee (HSC) should play a role in coordinating action taken by the Commission and member states in order to implement the regulation on cross-border threats to health.

They also decided that the HSC may adopt opinions and guidance on response measures for the prevention and control of a threat to health. If the HSC is to vote to adopt its guidance, the vote will be decided by a two-thirds majority.

Stress tests, planning and joint procurement

The Council and European Parliament also agreed that:

  • the Commission will facilitate stress tests to ensure the operation of the EU preparedness and response plan and update the plan as necessary
  • based on input from member states, the Commission will draft reports on their health crisis response planning; an overview of the report’s recommendations will be made public
  • the Commission and the member states will be able to jointly purchase medical countermeasures; member states will base their decision to take part in such purchases on information provided in advance and under conditions determined by mutual agreement with the Commission.

Background and next steps

This draft regulation is part of a package of proposals relating to the European Health Union. The package – put forward by the European Commission on 11 November 2020 – consists of three legislative proposals: in addition to the regulation on cross-border threats to health, it also includes a stronger mandate for the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC). The revision of the EMA and ECDC mandates has already been concluded. This package was complemented by the creation, in September 2021, of the new Health Emergency Preparedness and Response Authority (HERA), which is tasked with securing the supply of medical countermeasures before and during a health crisis.

Within the Council, the provisional political agreement reached today will first be submitted to the Permanent Representatives Committee for approval. A formal adoption procedure will then be launched.

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