4.C. Round table: The role of EU bodies and European Health Union policies, and implications for the Pandemic Treaty

Abstract As the CoViD-19 pandemic unfolded, policy- and decision-makers within and beyond European borders became acutely aware of the urgent need to revisit policies and cross-border collaboration to increase preparedness. CoViD-19 lessons, regional autonomy, the way EU bodies functioned at times of crisis but also at times of peace, and EU's role in global health were all considered. In 2022, a new EU body, the Health Emergency Preparedness and Response (HERA) Authority became operational “to prevent, detect, and rapidly respond to health emergencies, through intelligence gathering and building the necessary response capacities.” In March 2022, the Council of the EU adopted the decision to authorise the opening of negotiations for an international agreement on these topics, i.e., ‘The Pandemic Treaty’. Upon ratification, the treaty will become a legally binding instrument to determine coordination of public-private partnerships, towards discovery, and research and development (R&D) for vaccines, diagnostic and medicinal products. Negotiations started in the summer of 2022, with the Intergovernmental Negotiating Body (INB4) drafting the treaty in the WHO framework, the ‘Zero Draft’ presented in Nov 2022, progress to be reported to the World Health Assembly (WHA76) (May 2023), and a final draft agreement to be delivered in May 2024. In March 2023, HERA and the European Centre for Disease Prevention and Control (ECDC), and HERA and the European Medicines Agency (EMA) formalised agreements to clearly delineate working arrangements “to strengthen cooperation and to coordinate their work in support of health emergency preparedness and response in the area of medical countermeasures”. The increasing level of complexity, with rapid policy developments necessitates better understanding of the role of EU bodies and policies play, equipping public health professionals and of the tools to participate in these exchanges at national and cross-border levels, ultimately ensuring public health priorities and interests are served. This RT aims to provide an overview of recent developments for these bodies (HERA, EMA, ECDC), how they interact with WHO, and implications of the recently presented EU Global Health Strategy (EUGHS) (Nov 2022) and EU General Pharmaceutical Legislation (EUGPL) (Apr 2023). Panellists and Chairs include representatives to these bodies and legal experts to help elucidate key aspects. Brief interventions followed by discussion will explore: • The role of EU bodies in relation to the treaty • EU priorities, incl. regional autonomy, and related legislation, i.e., EUGPL and EUGHS • Key treaty articles and implications for European public health and global public health • The relevance of existing instruments, e.g., International Health Regulations, the Nagoya Protocol, the UN Biodiversity Convention • The guiding principles and rights in the Zero Draft Active audience interaction is envisioned via polls to prioritise topics and submit questions. Key messages • The global and European public health landscapes are rapidly being transformed. Comprehensive understanding of bodies and policies at interplay by public health professionals is key. • Current developments involve key deliberation and consultation steps at national, EU-wide and global levels. The public health community must be informed and engaged to safeguard public health. Speakers/Panelists Ricardo Mexia INSA - National Health Institute Doutor Ricardo Jorge, Lisbon, Portugal Debjani Muller HTAi, Edmonton, Canada Sujitha Subramanian UK Dimitra Lingri National Organization for Health Care Services Provision, Athens, Greece

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