Coalition for Epidemic Preparedness Innovations

EU Legislative Interests

• Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 • Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014 • Council Regulation (EU) 2021/2085 of 19 November 2021 establishing the Joint Undertakings under Horizon Europe and repealing Regulations (EC) No 219/2007, (EU) No 557/2014, (EU) No 558/2014, (EU) No 559/2014, (EU) No 560/2014, (EU) No 561/2014 and (EU) No 642/2014 • Proposal for a Regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 • Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC • Council Recommendation on strengthened cooperation against vaccine-preventable diseases (2018/C 466/01) • COM(2022)0675 EU Global Health Strategy - Better Health for All in a Changing World • 2025/2008(INI) Future of the EU biotechnology and biomanufacturing sector: leveraging research, boosting innovation and enhancing competitiveness • 2025/2568(RSP) Presentation of the proposal on Critical Medicines Act (CMA) • COM(2025)0030 A Competitiveness Compass for the EU • 2022/2076(INI) COVID-19 pandemic: lessons learned and recommendations for the future • COM (2022) 197: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Health Data Space Proposal for a Global Health Resilience Initiative (non-legislative initiative)

Communication Activities

The mission of the Coalition for Epidemic Preparedness Innovations (CEPI) is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. Since 2017, the joint partnership between CEPI and EC has generated many successes, especially reflected in the depth of collaboration of the CEPI- Health Emergency Preparedness and Response Authority of the European Commission (HERA) partnership from accelerating science to protect Europe and the world against the threats of rift valley fever, Covid and betacoronaviruses, filoviruses, chikungunya virus and funding scientific efforts to advance our understanding of infectious diseases via human challenge models, which CEPI is keen to build on into 2026 and beyond. CEPI is also engaging with multiple parts of the EC, including across Directorate-Generals, in order to promote synergies and to contribute to both European health security and global health security, develop aligned approaches to vaccine libraries and enabling networks, and promote global equitable access in a globally coordinated response. CEPI’s work involves influencing the formulation of policies, legislative proposals, decisions and recommendations, through direct engagement with EC, participation in EC consultation or in studies commissioned by the EC, and supporting the implementation of relevant policies and programmes including via grants under Horizon 2020 and Horizon Europe. Activities to date have been conducted in line with the Letter of Intent Regarding Cooperation between CEPI and HERA. This includes a mandate for: regular, senior-level meetings to identify and discuss topics of mutual interest and review the progress of the cooperation; sharing of technical data and analysis, strategic insights and views on work plans; and exchange of information on related research, development, manufacturing and other priorities relevant for medical countermeasures in order to ensure cooperation on the overall priorities. Where relevant, HERA coordinates with other Commission services, acting as a contact point. The Letter of Intent is publicly available and can be found here: https://health.ec.europa.eu/document/download/291392aa-b829-4a8e-8bbc-6b56f7acc0b9_en?filename=hera_cepi_loi_en.pdf

Interests Represented

Does not represent commercial interests

Member Of

Intermediary in the closed and current financial year Intermediary Name: Fourtold Associated annual cost: €50,000 - €99,999 EU legislative proposal: Global Health Resilience Initiative, MFF, FP10, European Competitiveness Fund, Biotech Act

Organisation Members

Built on the principles of speed, scale and equitable access, CEPI is supporting the research and development of a diverse portfolio of vaccine candidates based on a range of vaccine approaches. The overview of such partnerships can be found in this link: https://cepi.net/research_dev/our-portfolio/