OpenLobby.EU
Explore

European Research Infrastructure for Translational Medicine

EATRIS

EATRIS is a non-profit organisation (European Research Infrastructure Consortium) that provides access to a vast array of expertise and facilities from over 150 top-tier academic centres across Europe.

Lobbying Activity

Response to EU cardiovascular health plan

12 Sept 2025

Input to the European Commissions initiative EU cardiovascular health plan The European research infrastructure for translational medicine (EATRIS) welcomes the EU Cardiovascular Health Plan and strongly supports a dedicated pillar on stroke, a leading cause of death, disability, and health-system costs in Europe. Building on evidence and operational experience from EU-funded initiatives such as UMBRELLA and TRUSTroke and in line with the consultations emphasis on the opportunities offered by emerging technologies including digital health tools, data-driven approaches, artificial intelligence, and virtual human twins as well as innovative, patient-centred and personalised solutions to prevent, detect early, and treat cardiovascular diseases, we propose a focused set of priorities to enable the safe, equitable, and scalable development and adoption of AI-enabled and data-driven stroke solutions across Member States. EATRIS recommendations Optimise data quality and interoperability. Ensure high-quality, FAIR, interoperable stroke datasets and common data models, with EHDS-ready, privacy-preserving federated learning to generate decision-grade RWE. Create clear and harmonised regulatory pathways. Align the AI Act with MDR/IVDR and GDPR, providing practical, predictable guidance for innovators within a unified framework. Build skills and AI competencies. Upskill physicians and clinical researchers in AI literacy, and applicable legal frameworks for effective and safe development and adoption of AI-based solutions. Engage patients and citizens. Embed meaningful involvement from early design through usability validation to build trust, acceptance, and equity. Facilitate publicprivate collaboration and investment. Support partnerships and clear reimbursement/value-based mechanisms, enabling resource pooling, risk-sharing, and sustainable scale-up. Promote pre-regulatory science and good practices. Foster early regulatory awareness and robust model-validation standards; embedding regulatory pathways from the outset will reduce downstream barriers, preserve scientific progress, and enhance Europes competitiveness. EATRIS is the European infrastructure for translational medicine, with 15 Member Countries. UMBRELLA is supported by the Innovative Health Initiative Joint Undertaking (IHI JU) under grant agreement No 101172825. TRUSTroke is a Horizon Europe project funded by the European Union under grant agreement No.101080564.
Read full response

Response to Gender Equality Strategy 2026-2030

29 Jul 2025

EATRIS welcomes the Commissions initiative and calls for stronger integration of sex and gender considerations throughout the biomedical research and innovation lifecycle. Our contribution highlights key priorities to improve womens health outcomes, including increased EU support for under-researched conditions, mandatory sex-disaggregated data in research, inclusive clinical trial design, and actions to eliminate gender bias in AI-driven tools. We also stress the need to support women in research careers and ensure the inclusion of diverse subgroups of women in studies. Full recommendations are provided in the attached annexed document: Gender Equality in Health and Biomedical Research: A Strategic Imperative. EATRIS is the European infrastructure for translational medicine, with 15 Member Countries.
Read full response

Response to Critical Medicines Act

16 Jun 2025

The draft regulation contains many commendable elements and serves as a strong foundation for a resilient pharmaceutical supply system. However, to fully realise its objectives, we recommend the inclusion of provisions supporting advanced personalised manufacturing, formulation innovation for vulnerable populations, and systematic drug repurposing pathways. EATRIS is pleased to see that many of the recommendations submitted in our response to the Commissions consultation (February 2025) are reflected in the current draft regulation: - Manufacturing resilience and strategic investments: The proposed framework to recognise and support Strategic Projects aimed at enhancing manufacturing capacity for critical medicines and key inputs in the EU is strongly aligned with our call for bolstering local and regional production. The regulations provisions for financial incentives, streamlined permitting, and prioritised regulatory support are critical enablers of resilient manufacturing ecosystems. - Sustainable production and procurement: We welcome the regulations emphasis on sustainable and socially responsible procurement practices through the mandatory application of MEAT (Most Economically Advantageous Tender) criteria. This offers important opportunities for environmental innovation and social value, consistent with EATRIS vision for green biomanufacturing and long-term sustainability. - Supply chain monitoring and vulnerability assessment: The inclusion of comprehensive mechanisms for supply chain vulnerability assessments, coordinated through the EMAs MSSG and supported by real-time data infrastructure is a significant step forward. While we commend the progress made, we urge the Commission and co-legislators to consider the following critical gaps to ensure the regulation fully reflects the needs of all stakeholders: - Smart on-site and Personalised Manufacturing Technologies: EATRIS encourages the explicit inclusion of advanced manufacturing innovations such as GMP-certified 3D printing for personalised medicine and smart fill-and-finish technologies. These innovations are essential for producing dose-adjusted therapies and ensuring access for patients with specialised needs, especially in rare diseases or decentralised healthcare settings. Acknowledging and supporting such technologies in the regulation will help future-proof Europes pharmaceutical infrastructure. - Reformulation for underserved populations: Despite the Acts strong focus on supply security, it lacks emphasis on ensuring appropriate formulations for paediatric, geriatric, and other underserved populations. Reformulation strategies, particularly for off-patent and essential medicines, are indispensable to improving treatment equity and access. EATRIS recommends the regulation include explicit incentives and regulatory facilitation for age-appropriate and alternative delivery formats of critical medicines. - Drug repurposing and on-label registration of essential medicines: The Act does not address the potential of drug repurposing as a cost-effective and timely strategy to expand treatment options for patients. We reiterate the importance of enabling multi-stakeholder repurposing initiatives with funding, regulatory clarity, and HTA alignment, to support drug repurposing from bench to bedside. We encourage continued dialogue between policymakers, academic stakeholders, industry, patient groups, and regulatory bodies to ensure the final regulation is inclusive, implementable, and aligned with public health needs. As a translational research infrastructure, EATRIS remains committed to supporting the implementation of the Critical Medicines Act through collaborative initiatives and by mobilising expertise across its pan-European network. About EATRIS: EATRIS is the European infrastructure for translational medicine, with 15 Member Countries.
Read full response

Response to Biotech Act

11 Jun 2025

EATRIS ERIC, the European Research Infrastructure for Translational Medicine, welcomes the European Commissions initiative to develop a European Biotech Act. For the Act to succeed in boosting EU competitiveness and resilience in the healthcare domain, it must directly tackle persistent systemic barriers across the innovation pipeline, 1. Bridge the translational gap with regulatory compliant, exploitable Research The Biotech Act should support rigorous goal-oriented, compliant-by-design applied research. Too much promising research halts before impact due to a lack of validation, reproducibility, and alignment with regulatory requirements. EU programmes must incentivise early integration of development expertise through access to trusted infrastructures, innovation management, regulatory science, and validation services to ensure data is not only publishable but translatable. 2. Create a coherent, inter-connected funding landscape that fills the gaps The lack of support for confirmatory studies remains one of the most critical weaknesses in Europe, while there are further phases where funding and incentives are weak, creating a stop-start innovation continuum with many gaps. EU funding instruments should be aligned and interlinked to support a coherent funding pipeline that also supports unsexy high risk areas. Particular attention should be paid to cutting edge areas such Advanced Therapies (ATMPs), biologics, drug repurposing, and AI-enabled clinical tools, as healthcare adoption of these therapies is hampered due to uncertainties in regulation, distribution and reimbursement. 3. Support Biomanufacturing Innovation with Infrastructure and Skills The Critical Medicines Act rightly recognised the strategic importance of advanced and sustainable biomanufacturing. The Biotech Act should expand this vision by supporting EU-wide biotech clusters and shared infrastructure to avoid duplication and build scale; Smart manufacturing platforms (e.g., 3D printing, fill-finish innovation) that enhance supply security while enabling personalization should be at the forefront. 4. Embed regulatory science and innovation frameworks EATRIS strongly supports efforts to streamline and accelerate market access, and these must go hand-in-hand with investments in regulatory science capacity. The Biotech Act should scale up training for researchers and SMEs in regulatory and HTA requirements, such as through the STARS curriculum and promote regulatory sandboxes and agile frameworks that support innovation without compromising safety. 5. Create a seamless, risk-sharing Investment Continuum with joint investment models (publicprivatephilanthropic) across the translational continuum where pooled funding mechanisms are encouraged and co-evaluation with expert infrastructures to better assess feasibility and readiness. By bringing funders together, Early stage companies can thrive through easier access to expertise in the research design phase, better evaluate the value of their research, and share risk. 6. Advance the single market through regulatory and reimbursement harmonisation Fragmentation in regulatory and reimbursement pathways remains a key obstacle to biotech innovation and scalability in Europe. Companies often face 27 different regulatory interpretations. The European Biotech Act should harmonise regulatory and reimbursement pathways, particularly for new and emerging biotech products including interoperability of national data and regulatory systems, aligned with the European Health Data Space. 7. Accelerate AI and Data Integration in Biotech EATRIS supports the emphasis on AI-readiness and secure data access. We recommend the support towards federated learning models and interoperable health data systems; ensuring curated, high-quality datasets are available for training trustworthy biotech AI models. About EATRIS: EATRIS is the European infrastructure for translational medicine, with 15 Member Countries.
Read full response

Response to A European Strategy for AI in science – paving the way for a European AI research council

5 Jun 2025

EATRIS-ERIC and EATRIS-CONNECT project partners welcome the development of the European Strategy for Artificial Intelligence in Science, recognising its potential to significantly enhance European healthcare innovation, patient outcomes, and system efficiency. AI technologies offer substantial opportunities for improving clinical decision-making, accelerating research translation, and delivering personalised patient care. To fully leverage AIs potential, several strategic considerations must be addressed at the EU level: Optimise Data Quality and Interoperability: Europes healthcare and research ecosystems require high-quality, diverse, interoperable datasets to support AI-driven innovations. Efforts should focus on adopting FAIR data principles, ensuring cross-disciplinary and crossborder usability. Incentivise early uptake of common data models, SOPs, and FAIR principles to facilitate regulatory readiness and scalability. Safeguard Privacy and Data Security: Public trust and responsible AI adoption rely on robust privacy and security. EU initiatives should strengthen privacy-enhancing technologies and expand federated learning approaches, aligning innovation with GDPR compliance. Create Clear and Harmonised Regulatory Pathways Complex regulatory environments, particularly for AI-enabled medical devices, hinder innovation. The AI Act should align with the MDR and IVDR, offering streamlined pathways for innovators and SMEs through clear guidelines and regulatory sandboxes. Ensure coherence with within the regulatory landscape for a unified operational framework for health-related AI. Strengthen Cybersecurity Measures Digitalisation heightens cybersecurity risks to healthcare and patients. Europe must bolster cybersecurity for AI health tech, with clear risk management guidelines throughout the lifecycle. Build Skills and Digital Competencies Widespread AI adoption demands investment in training and education (T&E). Embed digital literacy and AI skills into medical and healthcare T&E. Upskill researchers in Good Machine Learning Practices and AI standards, emphasising transparency, reproducibility, and ethical design. Engage Patients and Citizens Meaningfully Trust in, and acceptance of AI require public and patient engagement. Involve them meaningfully in AI development, leveraging existing platforms to ensure patient-centred, transparent, and ethically sound technologies. Foster co-creation from need definition to usability validation. Promote Environmental Sustainability AI development must reflect sustainability goals by addressing environmental impact through greener computing and energy-efficiency. EU policy should incentivise low-carbon AI aligned with the Green Deal. Facilitate Public-Private Collaboration and Investment Effective public-private partnerships and well-defined funding and reimbursement mechanisms are vital in scaling AI solutions. EU initiatives should encourage resource pooling, risk-sharing, and investment strategies, ensuring the rapid and sustainable adoption of innovations across healthcare systems. Promote Pre-Regulatory Knowledge and Good Practices A strong pre-regulatory phase accelerates safe, effective AI. Invest in early-stage regulatory education and model validation standards. Support the design of AI tools with regulatory pathways in mind from the outset, ensuring scientific rigour, reproducibility, transparency, and ethical compliance. This proactive approach will reduce downstream barriers, prevent loss of scientific progress during translation, and improve Europes competitiveness in health innovation. EATRIS is the European infrastructure for translational medicine, with 15 Member Countries. EATRIS-CONNECT is the current INFRA-DEV project using Digital Transformation to accelerate translational medicine. This project received funding from the EUs Horizon Europe research and innovation programme under grant agreement No. 101130349.
Read full response

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

23 May 2025 · Presentation of EATRIS and a discussion on their role as a clinical research infrastructure supporting multi-country clinical trials within the EU

Response to European strategy on research and technology infrastructures

20 May 2025

EATRIS ERIC, the European Research Infrastructure for Translational Medicine, welcomes the Commissions effort to develop a forward-looking Strategy for Research and Technology Infrastructures (RITI), and fully supports the recognition of their strategic role in enhancing European competitiveness, scientific excellence, and health resilience. To optimise the deployment of these key assets, we urge the Commission to address systemic barriers that continue to limit the full potential of Europes infrastructure landscape: 1. RIs and TIs as a continuum, not silos Research and Technology Infrastructures span the full R&D pipeline. Treating them in isolation causes duplication and inefficiencies. Many facilities perform both research and technology development in a fluid manner. Funding and collaboration models must support their interoperability and continuity, enabling seamless progression from science to innovation. 2. Reduce knowledge asymmetry across the R&D chain A major barrier is the lack of awareness in early development phases of the requirements further downstream. From the outset, data must be fit for regulatory and HTA reviewnot only for publication. All R&I actors, including funders, must encourage goal-oriented, compliant-by-design research. Trusted infrastructures can embed development expertise into early-stage projects, helping academic researchers know what they dont know. 3. Invest in validation, reproducibility, and standardisation The lack of funding for confirmatory studies and regulatory-aligned data generation is a critical weakness. EU support is essential, particularly in health and life sciences, where data quality determines translatability. Standardisation is also under-addressed, limiting our ability to build critical mass, ensure regulatory clarity, and incentivise investment. Too often, public research stops at proof-of-concept with no pathway to deployment or standard-setting. 4. Foster digitalisation and AI-readiness Trustworthy AI requires curated datasets, interoperable platforms, real-world testing, federated learning, and regulatory sandboxes. The RITI Strategy should support dedicated AI translation pipelines, especially for underserved diseases, and ensure research is backed by regulatory and innovation management expertise. 5. Support applied R&D with coordinated funding R&I funders must coordinate longitudinally (across development stages) and vertically (public-private-philanthropic). Infrastructures should act as evaluators, partners, and capacity buildersnot only recipientsto avoid a fund-and-forget model and enhance impact. 6. Infrastructure funding must cover operations and people Capital investment is not enough. Infrastructures need sustained funding for skilled personnelresearch managers, regulatory experts, business developers, trainers, and more. Operational continuity is essential to deliver professional, sustainable services across the R&I spectrum. 7. Promote regulatory science and innovation frameworks Support for early regulatory engagement, training in regulatory science, and EU-wide expert networks is needed. Fragmented national requirements should be streamlined into coherent, scalable frameworks aligned with the European Health Data Space, AI Act, and Medical Device Regulation. Conclusion To develop breakthrough solutions for patients, Europe must commit to goal-oriented, compliant-by-design research, supported by accessible, state-of-the-art infrastructures with regulatory literacy, operational continuity, and responsive funding mechanisms. EATRIS stands ready to contribute to RITI implementation. We believe Europe must shift from a fragmented, static infrastructure model to a connected, innovation-driven ecosystem that enables translation, valorisation, and resilience in the face of global challenges. About EATRIS: EATRIS is the European infrastructure for translational medicine, with currently 15 Member Countries.
Read full response

Response to EU Life sciences strategy

16 Apr 2025

EATRIS ERIC, the European Research Infrastructure for Translational Medicine, welcomes the European Life Sciences Strategy, which will provide a fillip to EU competitiveness. As recently concluded in the 2024 ERA scoreboard, Europe remains weak in knowledge valorisation relative to its immense scientific output. In life sciences in particular, the knowledge journey from science to society is long, risky and costly, with many actors along the value chain contributing to its further development. For success by leaving no good science behind, we must further de-silo the research and innovation continuum, connecting each phase with those preceding and succeeding it, and ensuring that each step is conducted with further exploitation in mind. Exploratory research is essential but must also be structured and supported to be able to advance into applied research if there is potential. In our view, the single greatest structural barrier that can be successfully tackled in the new strategy is that of knowledge asymmetry. This is manifested when there are knowledge gaps at any point in the R&D value chain namely knowledge of what will be required in later steps of the R&D process. Beyond the scientific case, there are many mission-critical expertise domains that even early-phase researchers and their funders must be fully aware of, such as future regulatory evidence standards required for entry into clinical development, health technology assessment requirements, scale-up and manufacturing needs, intellectual property and more. Funding research without assessment and monitoring of the fitness of these elements of the project is bound to fail as people do what you inspect, not what you expect. Europe can do this better by attending to another indicator that scored poorly in the 2024 ERA scoreboard, namely coordination of R&I investments. Research funders should work together both longitudinally (early, mid-stage and late-stage funders cooperating on programmes) and vertically, such as charities, public funders, philanthropy cooperating in a given phase of development. A crucial partner in this cooperative chain is the involvement of trusted third parties specialised national and European innovation infrastructures and initiatives - that can bring in applied R&D competences, so that the funders can better evaluate projects from a feasibility perspective and embed development expertise in the academic projects that they wish to fund. In so doing, we can move to an investment mindset and away from an arms-length fund-and-forget attitude that is no longer fit to task in this rapidly changing world. Finally, EU must further develop as a single market so that regulatory and reimbursement components of the commercialisation process are transparent and jointly conducted for a single process, not 27 different ones. In so doing we can also reduce inequalities across the bloc. Recommendations for a productive eco-system Ensure that scientific results are exploitable, not just publishable, by bringing funders together with infrastructures and other trusted third parties, to ensure feasibility and embed development expertise into projects Reduce information asymmetries by providing dedicated funding for access to services in validation, scale-up, and regulatory support, especially in early-phase academic translational research. Include reproducibility and early validation as mandatory elements of EU-funded research. Improve innovation capacity by upskilling public/academic institutions in regulatory science, e.g by rolling out the STARS curriculum Support harmonisation of reimbursement and uptake pathways to create a truly integrated European health innovation market. Continue investments in drug repurposing, ATMP (cell and gene therapies and tissue re-engineering), as well as artificial intelligence. Each of these represent areas of academic strength that can support cutting edge personalised medicine approaches.
Read full response

Response to EU Start-up and Scale-up Strategy

17 Mar 2025

Foundational research, which provides the scientific knowledge base upon which innovation can build, is dominated by the publication mandate. However, publishable data often does not equal exploitable data, lacking in the rigour and validatory steps required to form a solid dataset ready further investments. It is here that there is a translational gap - the early valley of death between the academic publication and uptake into the innovation process - that is owned by nobody, creating a break in the innovation continuum and reducing EU competitiveness significantly. The more good science that is rigorous and ready for investment, the more start-ups we can support. Non-profit/public funders try to address this but the research they fund too often remains academic and focused on papers, due to a lack of structural access to expertise and support in translational science, regulatory strategy, intellectual property etc. Funders often don't have the tools to monitor those aspects of projects, but "People do what you inspect, not what you expect." Thus funders and their grantees need easy access to these domains so that the seedbed of innovation can be richer, by ensuring that the research is designed with rigour and exploitability in mind, not just publication. This requires collaboration between funders to share resources and access to rare expertise, and with the research community to jointly invest in outcomes, not just publications. Hereby some practical suggestions: - Use EC funding as a lever to bring funders - public, philanthropy, charities and private capital - together around themes - Embed these funders together with trusted third parties that do not have the publication mandate, who can provide expertise and access to their facilities for design and execution of rigorous translational research. See the REMEDi4ALL project (https://remedi4all.org/) as an example of this. - Dedicate significant policy attention to upskilling researchers in rigour, reproducibility, and how to design and execute rigorous confirmatory research. They don't have to all be innovators, but all research needs to designed with rigour in mind. "Leave no good science behind." - dedicate attention to upskilling a small army of regulatory-aware individuals that can support increased engagement of academics with the regulatory agencies governing markets entry. Increasing regulatory accessibility needs to be matched by sufficient people that can act as a bridge between academic and regulatory language. - Encourage funders to engage not only like-minded funders, but also those that fund differnt stages and those with different risk profiles. This brings additional knowledge and risk-sharing and creates a seamless funding value chain that is the basis of a seamless innovation value chain. - Connect innovation regions to enable resource and best practice sharing and encourage joint long term investments in infrastructure. PRECISEU project is a good example. Also, not every institute/city/region needs their own technology X, sharing facilities allows higher efficiency deployment and better investments at the cutting edge.
Read full response

Response to Critical Medicines Act

27 Feb 2025

Ensuring the availability of critical medicines is essential for patient care, public health, and healthcare system resilience. Medicine shortages pose serious risks, particularly for essential and off-patent medicines with few or no alternatives. Shortages disproportionately affect underserved populations, leading to invisible harm when patients lack access to appropriate treatments, including pediatric, geriatric, and rare disease populations. A comprehensive EU-wide strategy should address supply chain vulnerabilities, enhance manufacturing resilience, and create incentives for sustainable pharmaceutical development. The following recommendations outline necessary actions to secure the supply of critical medicines while also supporting innovation in medicine production and regulatory frameworks. Enhancing Local and Regional Manufacturing Capabilities: a) Supporting regional manufacturing hubs, including production of active pharmaceutical ingredients (APIs) and essential medicines; b) Adopting innovative manufacturing platforms for affordable advanced therapy medicinal products (ATMPs), such as emerging gene and cell therapies; c) Providing financial incentives and regulatory flexibility to strengthen Europe's pharmaceutical manufacturing base. Smart On-Site Manufacturing and Fill-and-Finish Technologies: a) Promoting GMP-certified 3D printing technologies for small-scale, on-site production of personalized medicines; b) Encouraging smart fill-and-finish capabilities to allow real-time production of dose-adjusted therapies; c) Facilitating regulatory acceptance of advanced manufacturing technologies to optimize medicine production. Investing in Reformulation for Underserved Populations: a) Expanding EU support for reformulation initiatives to ensure age-appropriate formulations (e.g., liquid formulations for pediatric and geriatric patients); b) Incentivizing public and private investment in reformulation to improve accessibility and equitable distribution of essential medicines; c) Facilitating regulatory pathways for reformulated medicines to enable faster approvals and market entry. Sustainable and Green Biomanufacturing: a) Gradual adoption of green biomanufacturing technologies, prioritizing supply security alongside sustainability goals; b) Incentives for eco-friendly production methods, such as bio-based APIs and circular economy practices, where they do not disrupt medicine availability; c) Ensuring sustainable procurement criteria in public tenders for critical medicines. Strengthening Critical Medicines Supply Chain Resilience: a) Establishing a Critical Medicines Monitoring System to track availability, production capacity, and supply chain vulnerabilities across the EU; b) Enhancing real-time data sharing between EMA, national regulators, and industry to improve transparency and preparedness; c) Mandating risk assessments for critical medicines supply chains to preempt potential disruptions. Incentivizing Drug Repurposing and On-Label Registration of Essential Medicines: a) Public and private investment in repurposing initiatives, ensuring funding for translation, clinical trials, and regulatory approval; b) Incentivizing on-label registration of new uses for essential medicines, ensuring evidence-based repurposing reaches patients; c) Implementing clear regulatory and HTA pathways to facilitate faster approval, reimbursement, and uptake of repurposed drugs; d) Encouraging multi-stakeholder collaboration, including regulators, industry, researchers, payers, and patient organizations. To safeguard access to essential medicines, the Critical Medicines Act must take a holistic and proactive approachstrengthening supply chain resilience, supporting manufacturing innovation, and incentivizing drug repurposing for public health benefit. Addressing medicine shortages requires a combination of regulatory adaptation, investment in production, and strategic collaboration across sectors.
Read full response