Lobbying by Coalition for Epidemic Preparedness Innovations

Coalition for Epidemic Preparedness Innovations

CEPI

The Coalition for Epidemic Preparedness Innovations develops vaccines to stop future epidemic threats.

Focus Areas

2024-2025

2020-2024

Links

Website Transparency Register Profile

ID: 852523338633-03

Lobbying Activity

CEPI urges EU to adopt 100-day vaccine mission

27 Oct 2025

Topic — This consultation concerns a coordinated EU plan for health crises.

Message — Europe should commit to developing vaccines within 100 days. The EU should identify gaps in manufacturing and clinical trials. They suggest coordinating health readiness exercises with military actors.1 2 3

Why — Increased EU investment would bolster CEPI's global vaccine development partnerships.4

Impact — Proprietary manufacturers may face pressure to share manufacturing data and platforms.5

Read full response

Meeting with Maria Pilar Aguar Fernandez (Director Research and Innovation)

10 Oct 2025 · Introductory meeting with new RTD/D Director

Meeting with Olivér Várhelyi (Commissioner) and

2 Oct 2025 · Biotech Act and ECF

Meeting with Tiemo Wölken (Member of the European Parliament, Shadow rapporteur) and Deutsche Sozialversicherung Europavertretung

22 Jul 2025 · Critical Medicines Act

Meeting with Mohammed Chahim (Member of the European Parliament, Shadow rapporteur for opinion) and European Federation of Pharmaceutical Industries and Associations and

25 Jun 2025 · Roundtable Critical Medicines Act

Meeting with András Tivadar Kulja (Member of the European Parliament, Shadow rapporteur for opinion)

23 Jun 2025 · Critical medicines act

CEPI urges EU Biotech Act to prioritise pandemic preparedness funding

11 Jun 2025

Topic — The EU Biotech Act aims to accelerate laboratory-to-market transitions for biotechnology applications.

Message — CEPI requests a simplified, agile regulatory framework for clinical trials. They recommend allocating at least 20% of FP10 funding to health.1 2

Why — The proposal ensures stable funding and faster development timelines for vaccines.3

Impact — Developers might lose exclusive control through mandatory tech transfer and IP sharing.4

Read full response

Meeting with Florika Fink-Hooijer (Director-General Health Emergency Preparedness and Response Authority)

19 May 2025 · Introductory meeting with CEPI

Meeting with Florika Fink-Hooijer (Director-General Health Emergency Preparedness and Response Authority)

8 May 2025 · Pandemic preparedness under current and next MFF

Response to Communication on the EU Stockpiling Strategy

1 May 2025

Pandemic preparedness is crucial in an interconnected world. Emerging infectious diseases lead to loss of life, productivity, economic damage, social and political upheaval. The EU Stockpiling will play a pivotal role to strengthen access to vaccines, including raw materials, across the EU and globally in a crisis. This submission contains THREE recommendations that the Coalition for Epidemic Preparedness Innovations (CEPI) believes will help the Strategy deliver for the preparedness agenda. CEPI calls (1) to ensure investigational reserves of vaccines to be included in the stockpiling strategy, (2) to include a strong framework on agile manufacturing supply chain and include the essential role of interregional collaboration in use and donation of of medical countermeasure stockpiles. 1. investigational medical countermeasures Ready availability of vaccines and biologicals candidates is crucial as part of a public health and security response to outbreaks. Outbreaks of pandemic diseases are uncertain in occurrence and scale, making development of products complex and time sensitive. To protect populations and generate regulatory evidence such countermeasures must be stockpiled (using harmonised standards and reagents) before regulatory approval is achieved, so they can be immediate available once an outbreak is detected. No entity in the EU is clearly designated to stockpile investigational reserves: HERA should be directed to stockpile such investigational products. CEPI will support this and is (1) identifying approaches most appropriate for different pathogens and contexts and (2) assessing opportunities, trade-offs and risks of each approach, including preparatory actions needed to operationalise them. 2. Optimize stockpiling: agile manufacturing supply chains Stockpiling remains a major gap in the Critical Medicines Act. Key weakness is strong language to prevent (excessive, national) stockpiling negatively affecting access for smaller and poorer countries to critical products. Equally important is prioritising agile manufacturing supply chains and investing in the whole manufacturing ecosystem. The Strategy should clarify the need to invest in minimally required buffer stocks to secure and maintain access to critical medicines. Manufacturing capacity and innovation, along the whole supply chain of products, enabling agile adaptation to demand and scale needs to be prioritized for investment and by regulators. This needs to be linked with demand forecasting at regional and global levels, material supply agreements and mechanisms to off-set premiums needed to ensure accelerated supply chains during unplanned stock-outs, caused by disruptions or tariffs. This will reduce impact for business-as-usual manufacturing and reduce significant cost from stockpiles expiring and needing to be destroyed. The Strategy should also progress QR labelling to improve logistics and the optimal use of products across borders. 3. International collaboration and public-private partnerships CEPI is a key global partner for HERA and EU pandemic preparedness and ready to engage and ensure a successful Strategy. HERA should get a clear (continued) mandate to develop strategic buffer stocks of (investigational) medical countermeasures. Recent outbreaks, eg Mpox or Marburg, showed interregional public-private collaboration using stockpiles and investigational products function as insurance for EU health and economic security. Finally, cross-cutting themes to be addressed A. The Strategy must recognize public funded stockpiling should include equitable access and R&D provisions in contracts, allowing donations and R&D (head-to-head, dose sparing/reduction studies). B. EU funded innovation is essential to develop products needed for health security. The Strategy must propose funding for global health and pandemic diseases in FP10. It should ensure support for SMEs and public-private partnerships working on innovation of medical countermeasures.

Read full response

Response to EU Strategy on medical countermeasures

1 May 2025

preparedness is crucial in an interconnected world. Emerging infectious diseases lead to loss of life, productivity, economic damage, social and political upheaval. The Coalition for Epidemic Preparedness Innovations (CEPI), issued a 100-Day Mission research strategy (100DM, attached) outlining crucial scientific and technological innovations needed. Modelling shows that had safe effective COVID-19 vaccine been available in 100 days, 8.3 million deaths and $1.4 trillion productivity losses and $63 billion hospitalisation costs could have been averted. The 100DM, endorsed by G7, recognizes the need to "innovate innovation" to develop MCM products faster, at lower cost and with higher success rate. The Strategy to support medical countermeasures against public health threats plays a pivotal role to guide this work. CEPI sees opportunity to strengthen EU leadership in health innovation, promoting inclusive, sustainable development of medical countermeasures (MCM), and address biosecurity in Europe and beyond, including LMICs This submission contains THREE recommendations. CEPI calls (1) to include the 100 Day goal as an aspirational focus in the Strategy. The 100DM identifies areas for innovation, complemented by regulatory reform and biosecurity, that can form the basis for the MCM Strategy vaccines and biologics R&D chapter. Innovation should balance specific MCM development and innovation of innovation to be better prepared for novel pandemic threats; (2) for HERA to continue as the MCM stockpiling coordination body; and (3) to include the essential role of public-private partnerships, and inter-regional collaboration in R&D and use of (donated) stockpiles of medical countermeasures. 1. Vaccines and biologics R&D HERA should keep and strengthen its focus on MCM types (vaccines, biologics, diagnostics) and developing innovative technologies. The attached 100DM strategy details challenges and opportunities to strengthen and accelerate MCM development. The global nature of EID expertise and threat emergence requires collaborative global R&D funding. Partnership with international agencies, like CEPI, is essential. 2. Stockpiling CEPIs submission to the EU Stockpiling strategy (attached) recommends: HERA to continue coordinating MCM stockpiling; to support the development of agile manufacturing supply chains; and inclusion of investigational reserves of vaccines in stockpiled. The Strategy should include equitable access and R&D provisions in stockpiling contracts, eg allowing donations and R&D (head-to-head, dose sparing/reduction studies). 3. International collaboration and public-private partnerships CEPI is a key global partner to HERA and EU pandemic preparedness and ready to support the MCM Strategy. The EU focus and strategic autonomy are key, but international collaboration and partnerships remain essential for success. Recent outbreaks (eg Mpox or Marburg) showed interregional public-private collaboration in MCM development and stockpile use including investigational products functioned as insurance for European health and economic security. The following cross-cutting themes need to be addressed: A. HERA should use an end-to-end portfolio development approach - the Strategy requires dedicated funding for pandemic diseases in FP10 as essential to develop products & technologies for health security. It should support industry and public-private partnerships working in areas of market failure. B. Highlight a balance between product development with platform innovations, such as AI for vaccine prototype development, (non)animal models for safety and efficacy, manufacturing platform innovation, and regulatory science. This supports the 100DM and drives wider life sciences sector innovation and growth. C. The Strategy must recognize public funded research should include provisions for equitable access to research results and commit to inclusive governance, meaningful engagement of civil society and global partners.

Read full response

Response to EU Life sciences strategy

14 Apr 2025

Pandemic preparedness is crucial in an interconnected world. Emerging infectious diseases lead to loss of life, productivity, economic damage, social and political upheaval. Fragmented research hinders international collaboration, a coordinated and well-resourced approach ensure rapid and effective responses to health crises. The EU Life Science Strategy plays a pivotal role to guide this and CEPI sees the opportunity to strengthen the EU life science sector global leadership in health innovation, promoting inclusive, sustainable biotechnological development of medical countermeasures (MCM), and address biosecurity in Europe and beyond, including LMICs CEPI (Coalition for Epidemic Preparedness Innovations), issued a research strategy (100DM, attached) outlining crucial scientific and technological innovations. Research showed that safe effective COVID-19 vaccines available in 100 days, could have averted 8.3 million deaths, $1.4 trillion productivity losses and $63 billion hospitalisation costs. This 100DM strategy, supported by the G7, recognizes the need to "innovate innovation", improve faster, lower cost MCM development with higher success rate. we propose to include the 100DM and its 5 areas of innovation, complemented by regulatory reform and biosecurity, in the EU Life Science pandemic preparedness chapter (1) Creating a library of prototype vaccines (HERA/CEPI) (2) Ready clinical trials networks (RTD/EMA/CEPI). Linking EU and global clinical trial and lab networks is crucial (3) Speed up identification of immune response markers (RTD/EMA/CEPI) (4) Capacity to make top-quality, safe, and effective new vaccines quickly (HERA, CEPI, Critical Medicines Act). Innovating end-to-end manufacturing processes will be critical to respond to pandemic threats (5) Strengthening early-warning systems (ECDC/RTD/CEPI). Disease surveillance needs fast outbreak-alert triggers and rapid MCM development. Innovation in AI, data sharing and social sciences is essential (6) Regulatory innovation and simplification (EMA/CEPI). CEPI supports simplification and acceleration of EMA regulatory processes. The Strategy should build on the General Pharmaceutical Legislation and CEPI proposed provisions to be strengthened (attached) (7) The Strategy needs to promote Biosecurity (CEPI strategy attached) and emphasise preventing accidental and deliberate misuse of pathogens associated with research and address identified vulnerabilities: Strengthen biosafety risk identification, mitigation and oversight; Enhance biosecurity capability; Drive biosecurity in support of equity; Monitor and reduce risk across the life science portfolio; and accelerate biosecurity innovation The following cross-cutting themes also need addressed: A. ensure an end-to-end value-chain approach to EU funded innovation. The Strategy must propose dedicated funding streams for global health and pandemic diseases in FP10. It should ensure support for SMEs and public-private partnerships working on innovation in areas of market failures, such as medical countermeasures. Blended finance tools (e.g. EFSD+) can play a catalytic role in de-risking investments B. Highlight a balance between product development with platform innovations, such as AI for vaccine prototype development, (non)animal models for safety and efficacy, manufacturing platforms, and regulatory science. Each of these are important potential areas of economic activity and jointly will support the development and economic activity from life science products C. EU focus and strategic autonomy are key, but international collaboration and partnerships remain essential for success D. The Strategy must recognize public funded research should include provisions for equitable access of research results and commit to inclusive governance, meaningful engagement of civil society and global health actors CEPI is important in the EU pandemic R&I ecosystem and ready to engage and ensure a successful Life Science Strategy.

Read full response

Meeting with Felix Fernandez-Shaw (Director Directorate-General for International Partnerships) and

1 Apr 2025 · Plenary Feedback round on previously held GGIA Working Group sessions of 9 different thematical groups regarding Latin America and the Caribbean (LAC).

Meeting with Felice Zaccheo (Head of Unit Directorate-General for International Partnerships) and Valneva and

31 Mar 2025 · Exchange of views on bi-regional cooperation and private sector investment in strengthening LAC’s health sector self-sufficiency, regulatory harmonisation, regional tech transfers and manufacturing in Latin America.

Meeting with Ekaterina Zaharieva (Commissioner) and

27 Mar 2025 · Cooperation between CEPI and EU

Meeting with Tilly Metz (Member of the European Parliament)

6 Mar 2025 · Global health

Meeting with Elena Arveras (Cabinet of Commissioner Maria Luís Albuquerque)

27 Feb 2025 · Taxonomy

Meeting with Jana Dabbelt (Cabinet of Commissioner Olivér Várhelyi)

26 Feb 2025 · health policy

Meeting with Adam Jarubas (Member of the European Parliament, Committee chair)

24 Feb 2025 · accelerate the development of vaccines and vaccine-like technologies against emerging disease threats

Meeting with Kasia Jurczak (Head of Unit Research and Innovation)

27 Jan 2025 · CEPI is preparing new strategy 3.0 from 2027 and consults with key partners and funders

Meeting with Koen Doens (Director-General Directorate-General for International Partnerships)

25 Jun 2024 · Update on BioNTech partnerships following announcement at WHA

Meeting with Koen Doens (Director-General Directorate-General for International Partnerships)

26 Jan 2024 · End-to-end health security infrastructure in Rwanda

Meeting with Daphne Von Buxhoeveden (Cabinet of Commissioner Stella Kyriakides), Ines Prainsack (Cabinet of Commissioner Stella Kyriakides), Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)

10 May 2023 · Meeting on preparedness for future cross border health emergencies

Meeting with Signe Ratso (Acting Director-General Research and Innovation)

9 Jan 2023 · Meeting with CEO of the Coalition for Epidemic Preparedness Innovations (CEPI).

Meeting with Sandra Gallina (Director-General Health and Food Safety)

6 Dec 2022 · DG SANTE – CEPI bilateral meeting

Meeting with Maurits-Jan Prinz (Cabinet of Commissioner Thierry Breton)

10 Nov 2021 · Pandemic preparedness and the industrial dimension of HERA

Meeting with Sandra Gallina (Director-General Health and Food Safety) and Gates Foundation

10 Nov 2021 · Strengthening pandemic preparedness and response: a dialogue with CEPI CEO Richard Hatchett and Bill &Melinda Gates Foundation co-chair Melinda French Gates.