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EU Legislation in Progress BRIEFING EU Legislation in Progress Building up resilience to cross-border health threats Moving towards a European health union OVERVIEW On 11 November 2020, the European Commission put forward a proposal for a regulation on serious cross-border threats to health. In the light of lessons learned from the Covid-19 crisis, it aims to strengthen the EU's health security by revising Decision No 1082/2013/EU (the 'Cross-Border Health Threats Decision'). The proposal was presented in a package that also includes proposals to strengthen the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA), as first steps towards a European health union. Stakeholders widely welcome the proposal and the package. Some say it could be improved further, suggesting concrete elements, while others think it should go beyond crisis preparedness. Still others consider it a springboard to a bigger role for the European Union (EU) in health. Parliament has repeatedly called for stronger cooperation on health, for a new regulation to replace the Cross- Border Health Threats Decision, and for revised mandates of both the ECDC and the EMA. Parliament's Committee on the Environment, Public Health and Food Safety is responsible for the file and the rapporteur's draft report is expected to be presented in committee on 22 April 2021. In Council, work is ongoing in the working party on pharmaceuticals and medical devices. 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 Committee responsible: Environment, Public Health and Food COM(2020) 727 Safety (ENVI) 11.11.2020 Rapporteur: Véronique Trillet-Lenoir (Renew, France) 2020/0322 (COD) Shadow rapporteurs: Esther de Lange (EPP, Netherlands) Sara Cerdas (S&D, Portugal) Ordinary legislative Joëlle Mélin (ID, France) procedure (COD) Kateřina Konečná (The Left, Czechia) (Parliament and Council on equal footing – Next steps expected: Discussion of draft report formerly 'co-decision') EPRS | European Parliamentary Research Service Author: Nicole Scholz Members' Research Service PE 690.565 – April 2021 EN EPRS | European Parliamentary Research Service Introduction On 11 November 2020, the European Commission put forward a proposal for a regulation on serious cross-border threats to health. Building on lessons learned from the Covid-19 crisis, it aims to strengthen existing structures and mechanisms for better protection, prevention, preparedness and response against all health hazards at EU level, by revising and repealing Decision No 1082/2013/EU (the 'Cross-Border Health Threats Decision').1 The proposal was presented as part of a package of associated measures, namely: a communication setting out key lessons learned from the Covid-19 pandemic, and proposing a stronger and more comprehensive health security framework for the EU, and outlining the main elements of the future Health Emergency and Preparedness Response Authority (HERA); a proposal to strengthen the European Centre for Disease Prevention and Control (ECDC); and a proposal on a reinforced role for the European Medicines Agency (EMA) in crisis preparedness and management for medicinal products and medical devices. According to the Commission, the measures are first steps towards building the European health union announced by President Ursula von der Leyen in her 2020 State of the Union address. They would complement other provisions on crisis response and health, such as strategic stockpiling under the rescEU scheme; the emergency support instrument (ESI); the pharmaceutical strategy; and the new EU4Health programme. This briefing will focus on the cross-border health threats proposal. Context It is up to the EU Member States to define their own health policies and to manage public health crises, with the EU playing a supporting role. However, serious cross-border threats have, by their nature, a transnational dimension, and no country can tackle them on its own. So, as the Commission argues in the proposal's exploratory memorandum, individual countries' public health measures need to be consistent with each other and coordinated. The Commission noted in its 2021 work programme, adopted in October 2020, that the Covid-19 pandemic 'has exposed the need to strengthen the EU's crisis preparedness and management of cross-border health threats'. Drawing early lessons from the current crisis, this proposal is put forward in answer to that. The set of proposals was presented as the first building blocks of a more secure, better-prepared and more resilient EU in the area of health – a European health union – and are also referred to as the 'European health union proposals' or the 'European health union proposal package'. At the same time, some commentators have criticised the EU's (initial) response to the Covid-19 pandemic. They say that initiatives came too late or were implemented in fragments, and that, at the onset of the outbreak, the EU's reaction was defined by poorly coordinated national approaches. Some also argue that Covid-19 has exposed both the unpreparedness of European health systems to absorb a health crisis of this magnitude and the pre-existing structural weaknesses that rendered the systems even more vulnerable to the shock. The EU's lack of preparedness, among other shortcomings, has also been partly blamed for the slow Covid-19 vaccination rollout. A Court of Auditors December 2020 report also highlighted some of the challenges faced by the EU in its initial support to the Member States' public health response to Covid-19 (from January to the end of June 2020). These include setting an appropriate framework for cross-border health threats; facilitating provision of appropriate supplies in a crisis; and supporting the development of vaccines. According to the report, 'it was a challenge for the EU to rapidly complement the measures taken within its formal remit, by additional actions to support the public health response to the crisis. These experiences can provide lessons for any future reform of the EU's competences in this field'. 2 Building up resilience to cross-border health threats From a broader perspective, the Covid-19 crisis has thus amplified calls to increase the EU's competences in health. More than half of respondents (54 %) to a special Parliament survey conducted in October 2020 said that public health should be a spending priority for the EU budget, with public health the top spending priority for respondents in 18 countries. In the Special Eurobarometer 500 'Future of Europe', carried out in October/November 2020, respondents were asked to choose developments they wanted to see for Europe's future. A quarter of Europeans prioritised the development of a common health policy, and health-related risks were cited by 37 % as among the main global challenges affecting the EU in the future. The Conference on the future of Europe, officially launched on 24 March 2021, is expected by many to play a central role in shaping the future European health union. Existing situation The current European health security arrangements, as established by the 2013 Cross-Border Health Threats Decision, provide a – limited – legal framework for EU action on preparedness and response. The framework is based essentially on the early warning and response system (EWRS), and on information and cooperation exchange in the Health Security Committee, which coordinates preparedness and response planning, as well as the Member States' public health responses and crisis communication. However, as the Commission notes in the proposal's explanatory memorandum, early lessons learned from the Covid-19 pandemic have shown that the current system has failed to ensure an optimal EU-level response. While it laid the groundwork for information exchange and joint procurement for the purchase of medical countermeasures, such as personal protection gear and medical equipment, it did little to trigger a timely common EU level response, coordinate crucial aspects of risk communication, or ensure solidarity among Member States. It is therefore necessary to address the weaknesses exposed by setting out a comprehensive legislative framework for EU-level preparedness, surveillance, risk assessment, early warning and response, and to enhance the guidance offered by the EU for the adoption of common measures to face future health threats. As the proposed legal instrument will be about establishing procedures and structures for cooperation on joint, EU-level work, it was considered most suitable that it take the form of a regulation. Parliament's starting position Parliament has consistently promoted the establishment of a coherent EU public health policy. In its April 2020 resolution on EU coordinated action to combat the pandemic and its consequences, Parliament called for the competences, budget and staff of the ECDC and the EMA to be strengthened substantially, to enable them to coordinate medical responses in times of crisis. Parliament also called for the creation of a European health response mechanism, to improve preparation and respond in a common and coordinated way to any type of health or sanitary crisis that emerges at EU level. It argued that such a mechanism should function as both an information hub and an emergency response team 'able to deliver vital supplies, medical equipment and medical staff to regions experiencing a sudden surge in infections'. In its July 2020 resolution on the EU's public health strategy post-Covid-19, Parliament called for the European institutions and the Member States 'to draw the right lessons from the Covid-19 crisis and engage in far stronger cooperation in the area of health', calling for a number of measures to set up a European health union. More specifically, it called on the Commission to propose a new regulation on cross-border health treats to replace the Cross-Border Health Threats Decision, not least to make EU joint procurement faster and more effective in health crises, to guarantee the efficiency and transparency of the process, and to ensure equal and affordable access to new treatments.
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