EuropaBio, representing European biotechnology companies, welcomes the opportunity to contribute to the evaluation of the AI Strategy implementation.

EuropaBio emphasises the need to integrate artificial intelligence (AI) within strategic sectors to make Europe an ‘AI continent’. Biotechnology and AI are recognised as a strategic technology for the EU. Together, they are key enabling technologies for research, development, manufacturing, and regulatory functions. The application of AI across the biotech and pharmaceutical value chains is accelerating scientific discovery and improving the efficiency and quality of innovation processes, with the potential to deliver faster, safer, and more effective solutions to patients and society. Fostering strategic links between bioclusters and AI factories can accelerate innovation by combining cutting-edge biotechnology expertise with advanced data-driven capabilities, driving innovation breakthroughs.

AI is increasingly integrated in areas such as target identification, lead optimisation, in silico modelling, , nonclinical, diagnostics, trial design, biomanufacturing, and supply chain management. In this context, AI technologies are already transforming how biotech companies operate. However, the uptake and scale of AI in the sector depend on several factors that need to be addressed through an effective EU strategy: access to infrastructure and data quality, clarity of the regulatory environment, alignment with existing sectoral rules, and investment in specialised skills. These challenges are particularly acute for SMEs and mid-caps, which make up a significant share of the biotech ecosystem in Europe. The EU must create incentives to promote the integration and diffusion of trustworthy AI solutions across the entire biotech value chain.

The success of the strategy will depend on how well it reflects sector-specific needs. The life sciences sector operates within a robust and already heavily regulated framework, and the integration of AI must be enabled by fit-for-purpose, risk-based, and non-duplicative regulatory approaches. Within health biotech, this should be translated into enabling the use of AI throughout the medicine lifecycle and coherence across regulatory strategies and existing scientific practices. In a first step, the scope of the R&D exemption under the AI Act should be clarified to provide innovators with a predictable regulatory environment. It is also important that the Apply AI Strategy considers the ongoing work by the European Medicines Agency (EMA) and the European Medicines Regulatory Network (EMRN). EMA’s 2023 reflection paper and multi-annual AI workplan for 2023–2028 offer a sound basis for risk-based AI oversight in medicines development. These initiatives demonstrate how existing regulatory structures can evolve to accommodate AI without creating parallel or conflicting requirements. EuropaBio encourages the Commission to build on this approach and ensure that the Apply AI Strategy is coordinated with sectoral regulatory developments.

In parallel, the Commission should support the development of sector-specific guidance for the application of AI in biotechnology, to provide clarity to innovators, especially SMEs and mid-caps. Regulatory fragmentation and the absence of harmonised procedures across Member States continue to be a major obstacle for biotech developers of AI-enabled tools, including diagnostics and therapeutic platforms. Coordination between the AI Office and regulators such as EMA, as well as between Member States, will be essential to address this fragmentation and provide a predictable environment for AI innovation in life sciences.

Skills are a further limiting factor for the uptake of AI in biotech. The application of AI requires cross-disciplinary expertise in biology, bioinformatics, chemoinformatics, data science, IT, statistics, ethics, and regulation. Current education and training pathways do not yet meet the industry’s demand for such profiles. EuropaBio supports the Commission’s efforts to develop an AI Skills Academy designed in partnership with academia, industry, and regulators. At the same time, programmes should foster synergies between strategic technologies to accelerate integration and deployment of AI solutions.

Finally, EuropaBio highlights that there should be an assurance for coherence between the Apply AI Strategy and the new EU Biotech Act. The initiatives should be prepared in close collaboration to provide a cohesive policy framework to Europe's biotech sector. Biotech has to be among the strategic verticals adopted by the AI strategy, and enabling initiatives such as regulatory assistance, digital infrastructure, SME support, and skill development have to be fully aligned.

EuropaBio stands ready to contribute to the implementation of the Apply AI Strategy and to support the integration of AI in Europe’s biotechnology sector in a way that promotes innovation, safeguards patients and public trust, and strengthens EU leadership in life sciences.