European cooperation to be strengthened

The European Council and the European Parliament reached agreement in a trialogue on new EU legislation on serious cross-border health threats: the last remaining piece of legislation in the European Health Union legislative package is now close to adoption. After more than 39 technical meetings and five trialogues, the European Council and the European Parliament reached a provisional agreement on the proposed regulation on serious cross-border health threats on 23 June. The regulation aims to establish a legal framework that coordinates preparedness, monitoring, risk assessment and early warning measures at European level.

EU preparedness plan for health crises and pandemics

In future, the European Commission will draw up an EU plan for health crises and pandemics, which will contain provisions on the exchange of information on early warning and risk management between European and national authorities. This will be prepared together with Member States, EU authorities and in accordance with the WHO International Health Regulations. The respective pandemic plans of the EU Member States remain in place; however, they are to coordinate with the European Commission in creating a coherent framework. Stress tests and simulation exercises are to be used to check and, if necessary, adjust the preparedness and response plans.

Recognition of public health emergencies of European significance

It is also envisaged that the European Commission can declare a Union-wide public health emergency. This in turn leads to increased consensus between the EU and the Member States. The state of emergency is declared on the basis of risk assessments by the Advisory Committee on Public Health Emergencies. The European Parliament has worked to ensure that the One Health approach is reflected in the legislative text. Thus, in addition to infectious disease crises, the legal act also includes environmental, biological and food crises.

More opportunities for the European Parliament to participate

There was also an agreement on the transparency and participation opportunities of the European Parliament which had previously been criticised for being below par. In the negotiations, the members of parliament (MEPs) managed to secure a seat on the Health Security Committee (HSC). The Committee may adopt opinions and guidelines on precautionary and control measures in response to health threats. In the event of a vote on guidelines, the HSC shall decide by a two-thirds majority.

Stockpiling of medicinal products and medical devices

There is also a compromise on the joint procurement and stockpiling of medicinal products and medical devices. The European Parliament has succeeded in preventing Member States from conducting parallel procurement negotiations and buying the same products at EU level at the same time. Similarly, the European Commission will be required to give MEPs access to joint procurement contracts, but subject to the very vague restriction of "adequate protection of commercial confidentiality, commercial relations and the interests of the Union". New rules also stipulate that the European Commission will evaluate HERA, the new European Health Emergency Response Authority, by 2024. Thus, the European Commission should assess whether HERA should become a body independent of the European Commission, in contrast to the current situation.

The European Council and the European Parliament still have to formally confirm their agreement after the summer break. The Committee on Environment, Public Health and Food Safety (ENVI) already voted in favour of the agreement by a large majority on 12 July. The Regulation shall enter into force 20 days after its publication in the Official Journal of the European Union.