Regulation (EU) 2022/2371 on serious cross-border threats to health

Ce que fait l'acte

to strengthen the EU health security framework addressing cross-border health threats. PROPOSED ACT: Regulation of the European Parliament and of the Council. ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council. BACKGROUND: the current health security framework, established by Decision 1082/2013/EU on serious cross-border threats to health, provides a limited legal framework for EU level coordination, based essentially on a) an early warning system (EWRS) and the exchange of information and cooperation within the HSC. Early lessons learnt have shown that the current system has not allowed an optimal response at EU level to the COVID-19 pandemic. The European Parliament adopted by 594 votes to 85, with 16 abstentions, amendments to the proposal for a regulation of the European Parliament and of the Council on serious cross-border threats to health and repealing Decision No 1082/2013/EU. The matter was referred back to the committee responsible for interinstitutional negotiations. The main amendments adopted in plenary concern the following points: The proposal provides for a stronger and more comprehensive legal framework enabling the EU to react rapidly and to trigger preparedness and response measures to cross-border health threats throughout the EU. According to Members, the COVID-19 crisis has shown that more action is needed at EU level to support cooperation between Member States, in particular between border regions. The regulation should respect the 'One Health' and 'Health in All Policies' approaches and ensure that in future health emergencies, the detection of, health interventions and treatment of other serious diseases, are not halted. The regulation should apply to threats of biological origin including communicable diseases, including those of zoonotic origin, and to epidemiological surveillance of communicable diseases and monitoring of the impact of these diseases on major non-communicable diseases and health problems such as mental health. Members proposed that the EU call for the development of a WHO Framework Convention on Pandemic Preparedness and Response . This convention should facilitate the implementation of the International Health Regulations (2005) and address the shortcomings of these regulations identified during the COVID-19 crisis. Coordination of preparedness and response planning in the Health Security Committee (HSC) Representatives of relevant EU agencies, including the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA), should participate in HSC meetings as observers. The European Parliament should nominate representatives to participate in the HSC as observers. In liaison with the Commission and the relevant EU agencies, the HSC should coordinate Member States' prevention, preparedness and response planning. This plan should be drawn up by the Commission, in cooperation with the Member States and the relevant EU agencies and taking into account the WHO framework. It should include: - the mapping of the production capacities of medical products…