With its Communication of 2 July 2025, the European Commission presented a stand-alone and ambitious Life Sciences Strategy (COM(2025) 525 final), expressly aiming to “make Europe the most attractive location in the world for the life sciences by 2030”. The Strategy anchors the life sciences as an autonomous, systemically relevant field of policy and economic activity.
It is responding to increasingly intense global location and competitive pressure and is pursuing the objective of positioning the European Union, in the long term, as a leading hub for life science innovation. At the same time, it marks a regulatory-policy milestone for European research and innovation policy: for the first time, a highly dynamic technological field is not governed primarily through individual programmes or sector-specific legal acts, but through an integrated strategic approach that systematically brings together research funding, regulatory frameworks and innovation policy governance.
Life sciences made in Europe in figures: By 2022, approximately 29 million people were employed in the life-science sectors of the European Union; they generated value added of around EUR 1.5 trillion and thus accounted for 13.6% of total employment and 9.4% of the Union’s GDP. Over a ten-year period, these sectors also recorded continuous annual growth in value added of between four and seven per cent.
At the same time, the life sciences exemplify the structural tensions inherent in the European innovation model. Despite an exceptionally strong scientific base and highly developed research infrastructures, the European Union has so far been only partially successful in systematically translating scientific breakthroughs into scalable, market-ready innovations. This discrepancy is largely due to legal and institutional factors. Fragmented competences, complex and partly incoherent regulatory frameworks, and divergent national implementation practices generate legal uncertainty and hinder investment, particularly in capital-, data- and research-intensive phases of development.
Against this background, the present article takes the Strategy as an opportunity to present its core elements in a systematic manner and to assess them from a legal perspective.
1. Strengthening Research and Innovation in Europe – Legal and Institutional Course-Setting for the Life Sciences
Strengthening research and innovation constitutes the foundation of the European Life Sciences Strategy. Starting point is the fact that, although the European Union has an exceptionally strong research base in the life sciences, it continues to face structural difficulties in systematically translating scientific breakthroughs into clinical applications and marketable innovations. This so-called “translation gap” is understood as a reflection of a fragmented research and innovation ecosystem.
This deficit is closely linked to the distribution of competences between the Union and the Member States, as well as to complex regulatory and ethical frameworks. Despite a harmonised legal framework for clinical trials, significant differences persist in practical application across Member States, particularly in the interaction between authorising authorities, ethics committees and sponsors. This fragmentation leads to delays, increased administrative costs, and a decrease in Europe's attractiveness as a location for clinical research.
Against this background, the Commission attaches particular importance to accompanying coordination and support initiatives. Through the “Accelerating Clinical Trials in the European Union” (ACT EU) initiative, the Commission, the European Medicines Agency and the Heads of Medicines Agencies pursue the objective of making clinical trials more efficient by means of regulatory, technological and procedural innovation.
Complementing this, the MedEthicsEU initiative aims at improved coordination and alignment of the working methods of national ethics committees. It addresses a central bottleneck of clinical research that has so far often been underestimated, by contributing to the development of common guidelines, templates and best practices and thereby seeking to make the legal and ethical assessment of clinical trials more transparent and predictable. In doing so, it brings into focus an area that is regularly time-critical in practice and decisively influences the planning reliability of studies.
Finally, the COMBINE project responds to the increasing convergence of medicinal products and medical devices, particularly in the context of innovative and personalised therapies. By supporting sponsors in the parallel application of the different regulatory frameworks, it seeks to optimise the interface between pharmaceutical and medical device law and to reduce administrative burdens.
Indicative measures of the European Commission include, inter alia:
- development of an investment plan for clinical research to finance cross-border clinical trials;
- establishment of a network of European centres of excellence for advanced therapy medicinal products to pool and promote expertise, infrastructure and funding;
- pilot approach for phased funding of collaborative research under the 2026–2027 work programme of Horizon Europe;
- pilot project to strengthen cooperation among European biotech clusters, with the aim of increasing their international visibility, mobilising private capital and supporting the growth of start-ups and SMEs
2. The “One Health” Concept – Promoting a Holistic Approach to the Life Sciences
Promoting a holistic approach constitutes a core concept of the European Life Sciences Strategy. The holistic approach is based on the understanding that health risks and bioscientific innovations cannot be viewed in isolation. In particular, the One Health approach, which takes into account the interactions between human health, animal health, and the environment, serves as a conceptual reference framework. The aim is to systematically exploit cross-sectoral synergies through integrated management of research, regulation, and governance.
Indicative measures of the European Commission include, inter alia:
- promotion of the One Health approach in research and innovation through enhanced cooperation with Member States and relevant stakeholders;
- positioning Europe as a global leader in microbiome-based solutions within the framework of the One Health approach;
- development of guidelines for interdisciplinary and transdisciplinary research and innovation;
- implementation of a strategic research and innovation agenda on the interlinkages between health and environmental conditions;
- development of a strategic research and innovation agenda for food systems to promote competitive, sustainable and resilient solutions
3. Unlocking the Potential of Data and AI for Breakthrough Innovation – Navigating between Innovation, Ethics and Law
Unlocking the potential of data and artificial intelligence is a key lever of the European life sciences strategy for accelerating scientific breakthroughs and strengthening Europe's competitiveness. Data- and AI-driven methods enable new approaches to the analysis of complex biological systems, personalised medicine and the efficiency of R&D processes. Europe has extensive data resources and powerful research structures in this regard; however, their use remains constrained by legal fragmentation, limited interoperability and inconsistent access conditions.
In this context, the European Health Data Space (EHDS) plays a pivotal role. It establishes a Union-wide harmonised legal framework for secure, standardised and purpose-bound access to electronic health data for research and innovation.
Alongside this, the development and application of artificial intelligence is understood as an integral component of modern life science innovation pathways. Building on specialised AI infrastructures and strategic initiatives, the deployment of advanced AI models is to be systematically promoted. In addition, the development of an AI-based interactive instrument is envisaged to provide researchers and innovators with structured guidance through the complex European regulatory landscape, to facilitate access to relevant data resources and to support the early integration of regulatory requirements into project design.
Indicative measures of the European Commission include, inter alia:
- establishment of a European Life Sciences R&I Data Assembly to enable structured cooperation between competent Union and Member State authorities and relevant research and innovation institutions;
- development and provision of strategic biodata resources, including non-human biological data;
- targeted support for the integration of multimodal generative AI technologies into multidisciplinary biomedical research to accelerate data-driven discoveries and enable new scientific insights;
- strengthening of European genome data infrastructure in line with the European Health Data Space (EHDS)
4. Strengthening Skills and Career Opportunities for Competitive European Life Sciences
The availability of highly qualified professionals is highlighted in the Life Sciences Strategy as a central prerequisite for Europe’s competitiveness and innovative capacity. The life sciences are characterised by rapid scientific, technological and regulatory change, which continuously generates new competency profiles. At the same time, structural challenges persist, including limited and uncertain career prospects, restricted cross-sectoral mobility, and enduring imbalances, particularly with regard to gender equality.
The Strategy therefore does not view skills development and career advancement as an isolated education policy task, but as an integral component of a high-performing innovation ecosystem. The focus lies on strengthening permeable career paths between academia, industry and regulation, as well as on the targeted expansion of future-oriented skills—particularly in the fields of digitalisation, data and artificial intelligence. These efforts are accompanied by a reaffirmation of academic freedom, international cooperation, and diversity and inclusion.
Indicative measures of the European Commission include, inter alia:
- strengthening links between academia and industry to facilitate cross-sectoral career paths, promote knowledge transfer and structurally support the transition from research to application;
- expansion of mobility and exchange programmes to promote cross-border and cross-sectoral mobility of researchers, innovators and professionals in the life sciences;
- strengthening of measures to promote diversity, equality and inclusion;
- better utilisation of existing European instruments and networks, particularly in the fields of education, research and innovation.
5. Regulation in the Service of Innovation – Ensuring Smooth and Rapid Market Access
Efficient, predictable and innovation-friendly market access is identified in the Life Sciences Strategy as a decisive factor for the competitiveness of the European innovation ecosystem. Despite high scientific performance, Europe continues to face structural delays in the market introduction of life-science innovations. This is due in particular to the complexity, fragmentation and lack of coherence of regulatory frameworks along the innovation pathway.
The Strategy therefore intervenes at the interface between innovation support and regulation.
Its aim is to integrate regulatory procedures into innovation processes at an early stage, reduce legal uncertainty and better align transitions between legal regimes. The European Innovation Act is intended to provide a horizontal framework in this respect. Regulation is thus understood not as an ex post control mechanism, but as a structuring element of a functioning internal market. From this perspective, regulation is not a “brake” but—ideally—an enabling framework.
Given the multitude of horizontal and sector-specific legal acts—such as those in pharmaceutical, medical device, data and AI law—innovative actors are to receive early guidance to enable them to incorporate regulatory requirements into project design. In addition, the Strategy aims at a predictable and balanced framework for intellectual property that secures investment incentives while promoting knowledge transfer and competition. This is accompanied by announced reforms of key legal acts, in particular EU pharmaceutical law (the Pharma Package), the Regulation on Health Technology Assessment (HTA), the Medical Devices Regulations (MDR/IVDR), as well as the planned Biotech Act, which is intended to systematically accelerate biotechnological innovation.
Indicative measures of the European Commission include, inter alia:
- creation of an innovation-friendly and coherent regulatory framework through horizontal initiatives such as the European Innovation Act;
- further development of a predictable, balanced and innovation-supportive intellectual property framework to ensure investment security;
- reform of EU pharmaceutical law with the aim of making regulatory procedures more efficient and innovation-friendly;
- consistent implementation and further development of the Health Technology Assessment Regulation (HTA) to contribute to greater alignment of clinical assessments, avoid duplication of work and facilitate market access for innovative health solutions in the Member States;
- revision of the Regulations on medical devices and in vitro diagnostics (MDR/IVDR) to address identified bottlenecks, make regulatory procedures more proportionate and secure the availability of innovative products on the European market.
6. Promoting the Uptake and Use of Life-Science Innovations
Promoting the uptake and use of life-science innovations constitutes the final stage of the innovation pathway envisaged by the Life Sciences Strategy. It places particular emphasis on transparent communication, combating disinformation and the early involvement of users. The actual adoption of innovative solutions depends to a significant extent on whether they meet practical needs and can be integrated into existing structures. The promotion of uptake and use is therefore understood as an interface between innovation, society and governance.
Indicative measures of the European Commission include, inter alia:
- financial support from the 2026–2027 work programme of Horizon Europe to assist stakeholders and policymakers in the life sciences with public outreach activities
Ambition Meets Reality – An Outlook
The European Commission’s Life Sciences Strategy is characterised by a high degree of ambition and strategic foresight. It addresses key structural weaknesses in the European innovation system and sets out the goal of promoting life sciences innovation in a coherent manner along the entire value and innovation chain. From an industrial and health policy perspective, however, the question arises whether the Strategy, in its concrete design, is capable of actually overcoming the identified challenges.
In particular, pharmaceutical and medical device law continue to be marked by significant legal uncertainties that influence investment decisions. The reform of general EU pharmaceutical law, the revision of the Medical Devices and In Vitro Diagnostics Regulations, and the further development of the Health Technology Assessment Regulation must therefore not be viewed merely as isolated projects, but must be shaped as interrelated elements of an innovation-friendly regulatory framework.
The envisaged instruments and programmes provide important impetus, yet leave open whether the scale and orientation of the available resources are sufficient to close the gap between scientific excellence and industrial scaling. Especially for growth-intensive phases of start-ups and SMEs, as well as for industry-oriented research, additional and long-term predictable investment incentives are required in order to avoid tendencies towards relocation to other world regions.
Moreover, the Life Sciences Strategy does not operate in isolation, but in interaction with other key initiatives of the European Union. The planned Pharma Package, the European Innovation Act, the European Research Area Act, the announced Biotech Act, the revision of the MDR and IVDR, and the AI Act constitute the regulatory framework within which the Strategy must prove itself. Decisive will be whether these initiatives can be coherently interlinked and consistently aligned with the innovation principle. The European Innovation Act may function as a horizontal enabling framework, provided that it strengthens regulatory sandboxes and promotes innovation-friendly interpretations, while the Biotech Act has the potential to accelerate biotechnological innovation in a sector-specific manner. In parallel, a predictable and balanced framework for intellectual property is indispensable to ensure investment security and to effectively valorise research results.
In the field of data- and AI-driven innovation, there are two sets of expectations. On the one hand, the European Health Data Space is intended to enable secure and standardised access to data for research and innovation; on the other hand, clear and practicable rules for the use of artificial intelligence are required.
The Life Sciences Strategy sets out the correct diagnosis and an ambitious treatment plan. Whether it achieves its goal of establishing Europe as a leading location for bioscience innovation in the long term will ultimately be measured by its implementation. If regulatory coherence can be achieved, investment incentives strengthened, and the interests of innovation, competition and patient benefit balanced in an appropriate manner, the Strategy offers considerable transformative potential. Only then can it live up to its claim of positioning Europe not merely normatively, but also in factual terms, as a leading life sciences hub.
