Boosting the translation of biotech research into innovative health therapies

Topics under this destination are directed towards the Key Strategic Orientation 2 “The Digital Transition” and Key Strategic Orientation 3 “A More Resilient, Competitive, Inclusive, and Democratic Europe” of Horizon Europe’s strategic plan 2025-2027.

Research and Innovation supported under this destination should contribute to the following expected impact, set out in the strategic plan impact summary for the Health Cluster: “Health technologies, data, new tools, and digital solutions are applied effectively thanks to their inclusive, ethically sound, secure and sustainable delivery, integration and deployment in health policies and in health and care systems.”

The Health Cluster will continue work to develop and stimulate the uptake of new technologies and digital solutions to improve healthcare and health systems. This includes using technology to help people better understand and use health information, promote healthier lifestyles, improve pandemic/epidemic preparedness, prevent diseases, provide better diagnoses and more personalised treatments and care solutions, and improve access to health and care systems while making sure that even groups with limited access to good healthcare can benefit. The Cluster will help the EU ensure leadership in breakthrough health and medical technologies and achieve open strategic autonomy in essential medical supplies and digital innovations. By collecting and analysing health data across borders and creating human-centred health technologies, including the use of Artificial Intelligence (AI), research can improve and personalise medical care for different patients, increasing patient safety and leading to better health outcomes and wellbeing.

Support for Research and Innovation is needed on the large spectrum of tools and technologies for biomedical research, prevention, diagnosis, therapy and health monitoring. This includes enabling technologies not least innovative biotechnological approaches. The emergence of the European Health Data Space will create an additional boost to cross-border, data-driven approaches and innovation, e.g. for personalised medicine or patient safety. High-quality health data (incl. real world data) combined with digital technologies, modelling and AI tools, have a high potential for advancing biomedical Research and Innovation. Emerging and disruptive technologies using tools like new genomic techniques and AI tools, offer big opportunities for transforming healthcare, but also depend on the capacity to collect, integrate and interpret large amounts of data and on their compatibility with appropriate regulatory frameworks. Such technologies can provide better and more cost-efficient solutions with high societal impact, tailored to the specific healthcare needs of the individual. However, novel tools, technologies and digital approaches face specific barriers and hurdles in piloting, implementing and scaling-up before reaching the patient, encountering additional challenges such as public acceptance and trust. The development and uptake of new technologies for high-quality healthcare will need to draw on multiple disciplines and require cross-sectoral cooperation among all those concerned, including end-users (patients, healthcare providers and workforce, researchers, regulatory bodies, policymakers, and funders). These interactions will help address unmet needs via integrated tools, hybrid health technologies and digital solutions (including those with limited commercial interest). It will also support the design and development of health products and services tailored to the needs of specific population groups, thereby improving patient outcomes and reducing health inequalities.

This destination aims to promote the development of novel tools, technologies and digital solutions for prevention, diagnosis and therapy with the goal to improve health outcomes, while taking into consideration the rights of the individual, safety, effectiveness, appropriateness, accessibility, comparative value-added and fiscal sustainability as well as issues of ethical, legal and regulatory nature.

In this work programme part, Destination “Developing and using new tools, technologies and digital solutions for a healthy society” is driven by two key Commission policies, the “Biotechnology and Biomanufacturing Strategy^[1]” and the “Artificial Intelligence Strategy^[2]” and will focus on the development and use of innovative biotechnological tools for the improvement of the therapeutic arsenal of healthcare against diseases where there are currently no or only insufficient therapeutic strategies, on the development of Generative Artificial Intelligence models to help researchers in their activities to deliver new knowledge for advancing biomedical research and on the technology transfer of biotechnology-derived therapeutics from discovery to approved products. In particular, the topics under this destination will support activities aiming at: cellular and cell-free therapeutic approaches employing either genetic modifications or more classical techniques for improving the safety and therapeutic performance of these therapies, including their testing in clinical studies; development of generative AI models based on large-scale multi-modal health data for better understanding of diseases and their management thanks to the enhancement of biomedical discoveries and more personalised treatment solutions; bridging the gap between pre-clinical and clinical development stages of therapeutics developed through biotechnological methods and giving special emphasis on small and medium-sized enterprises (SMEs). In this context, specific attention is given to support the objectives of the Strategic Technologies for Europe Platform (STEP), adopted by the Commission in March 2024, which aims to boost investments in critical technologies in Europe (see introduction to this work programme part).

Under this destination, actions will support interdisciplinary Research and Innovation activities involving a broad spectrum of actors from different sectors, who will strive for the convergence of health technologies, combining medical technologies, pharmaceuticals, Advanced Therapy Medicinal Products (ATMPs) and digital health technologies, that will lead to integrated health solutions for the benefit of healthcare providers and patients.

In view of increasing the impact of EU investments under Horizon Europe, the European Commission welcomes and supports cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities such as the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. Opportunities for such activities and potential synergies exist between projects funded under the same topic but also between other projects funded under another topic, Cluster or pillar of Horizon Europe (but also with ongoing projects funded under Horizon 2020). In particular, this could involve projects related to European health research infrastructures (under pillar I of Horizon Europe), the EIC strategic challenges on health, the European Innovation Ecosystems (EIE) interregional networks on health and EIT-KIC Health (under pillar III of Horizon Europe) or in areas cutting across the health and other Clusters (under pillar II of Horizon Europe), like, for instance, with Cluster 4 “Digital, Industry and Space” on digitalisation of the health sector or key enabling technologies.

Expected Impacts:

Proposals for topics under this destination should set out a credible pathway towards the development and use of new tools, technologies and digital solutions for a healthy society, and more specifically to one or several of the following impacts:

• Europe’s scientific and technological expertise and know-how, its capabilities for innovation in new tools, technologies and digital solutions, and its ability to take-up, scale-up and integrate innovation in healthcare is world-class.
• Citizens benefit from targeted and faster research resulting in safer, more sustainable, efficient, cost-effective and affordable tools, technologies and digital solutions for improved (personalised) disease prevention, diagnosis, treatment and monitoring for better patient outcome and wellbeing, in particular through increasingly shared health resources (interoperable data, infrastructure, expertise, citizen/patient driven co-creation)^[3].
• The EU gains high visibility and leadership in terms of health technology development, including through international cooperation.
• The burden of diseases in the EU and worldwide is reduced through the development and integration of innovative diagnostic and therapeutic approaches, personalised medicine approaches, digital and other people-centred solutions for healthcare.
• Both the productivity of health Research and Innovation, and the quality and outcome of healthcare is improved thanks to the use of health data and innovative analytical tools, such as artificial intelligence (AI) supported decision-making, in a secure and ethical manner, respecting individual integrity and underpinned with public acceptance and trust.
• Citizens trust and support the opportunities offered by innovative technologies for healthcare, based on expected health outcomes and potential risks involved.

The protection of European communication networks has been identified as an important security interest of the Union and its Member States. Entities that are assessed as high-risk suppliers^[4] of mobile network communication equipment (and any entities they own or control) are not eligible to participate as beneficiaries, affiliated entities and associated partners to topics identified as “subject to restrictions for the protection of European communication networks”. Please refer to the Annex B of the General Annexes of this Work Programme for further details.

[1] Commission Communication on Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU; COM(2024) 137 final: https://research-and-innovation.ec.europa.eu/document/download/47554adc-dffc-411b-8cd6-b52417514cb3_en

[2] Commission Communication on Artificial Intelligence for Europe; COM(2018) 237 final: https://digital-strategy.ec.europa.eu/en/policies/european-approach-artificial-intelligence; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2018:237:FIN

[3] Commission Communication on the digital transformation of health and care; COM(2018) 233 final

[4] Entities assessed as “high-risk suppliers”, are currently set out in the second report on Member States’ progress in implementing the EU toolbox on 5G cybersecurity of 2023 (NIS Cooperation Group, Second report on Member States’ progress in implementing the EU Toolbox on 5G Cybersecurity, June 2023) and the related Communication on the implementation of the 5G cybersecurity toolbox of 2023 (Communication from the Commission: Implementation of the 5G cybersecurity Toolbox, Brussels, 15.6.2023 C(2023) 4049 final).

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