EU's New Life Sciences Strategy: A "Choose Europe" Game Plan for Innovation
It is more than clear that the Draghi report had a clear impact and it was a true wake up call in EU as the EU is now really pushing for catching up in innovation. In a landmark move, the European Commission published its "Choose Europe for life sciences" strategy on July 2, 2025, unveiling an ambitious roadmap to establish the EU as the world's premier destination for life sciences by 2030. This comprehensive plan aims to do more than just bolster the economy; it seeks to drive innovation, fortify public health, champion clean technologies, and generate high-quality jobs across the continent.
A Vision for Global Leadership
The strategy's core ambition is to position the EU as the global leader in a sector that is pivotal for improving lives and protecting the planet. Life sciences, defined as the study of living systems using breakthrough technologies like biotech, digitalization, and AI, are recognized for their vast impact—from personalized medicine and sustainable agriculture to bio-based industries. With the sector already employing around 29 million people and adding €1.5 trillion in value in 2022, its economic significance is undeniable. The plan acknowledges Europe's existing strengths, such as top-tier research institutions and dynamic biotech clusters, but also confronts challenges like fierce global competition, fragmented R&I ecosystems, and complex regulations.
Supercharging the Research & Innovation (R&I) Ecosystem
A vibrant life sciences sector is built on a foundation of world-class research and innovation. The strategy directly targets the fragmentation that has historically held Europe back by promoting deeper cooperation between researchers, industry, and policymakers. Key focus areas include:
- Advanced Therapies (ATMPs): Significant investment in ATMP research is planned to solidify Europe's leadership in biomedical innovation for treating severe, chronic, or rare diseases.
- Clinical Trials: The plan aims to enhance the framework for clinical research by addressing regulatory hurdles and mobilizing more funding for multi-country trials, leveraging Europe's diverse population and high ethical standards.
- Data and AI: Recognizing the power of data, initiatives like the European Health Data Space (EHDS) Regulation and AI Factories are set to accelerate the use of AI in developing personalized healthcare solutions. An investment of €50 million is earmarked for 2025 to integrate generative AI into biomedical research.
- A 'One Health' Approach: The strategy champions the "One Health" concept, which acknowledges the deep interconnection between human, animal, and environmental health. This holistic view will guide R&I to tackle global challenges like antimicrobial resistance and the health impacts of climate change.
From Lab to Market: Streamlining Access and Driving Adoption
Innovation is only impactful if it reaches the people who need it. A central pillar of the strategy is to dismantle the regulatory and administrative barriers that delay market access for new life science products. The goal is to create more agile and proportionate regulatory procedures without ever compromising on safety. This will be supported by the "innovation principle," ensuring that all EU policies actively foster innovation. Furthermore, the plan intends to stimulate the adoption of these innovations through smarter public procurement and build public trust by transparently communicating the benefits of life science technologies.
Impact on Medical Device Manufacturers
For medical device manufacturers, this strategy signals a significant and welcome shift. The plan promises a "long-overdue shift from reactive compliance to innovation-responsive regulation". Key changes include:
- Regulatory Simplification: A targeted revision of the EU MDR and IVDR is on the horizon, aimed at simplification, speed, and smarter regulation while maintaining high safety standards.
- Faster Market Access: Efforts will be made to significantly shorten authorization times. The EU Health Technology Assessment (HTA) Regulation is expected to help manufacturers produce clinical evidence that satisfies both regulatory and HTA bodies from the outset.
- Modernized Evidence Generation: Investment in New Approach Methodologies (NAMs), such as non-animal testing and virtual human twins, will modernize preclinical evidence generation, potentially accelerating innovation and reducing costs.
- An AI-Powered Regulatory Tool: An interactive AI tool is being developed to help innovators navigate the complex EU regulatory landscape from the very beginning of the design process.
Impact on Pharmaceutical Manufacturers
The pharmaceutical industry also stands to benefit greatly from a more dynamic and supportive environment. The strategy outlines several key initiatives:
- Boosted R&I Ecosystem: A dedicated investment plan will facilitate multi-country clinical trials, while a new network of European Centres of Excellence for ATMPs will coordinate their development and cement Europe's leadership in cutting-edge treatments.
- Innovation-Responsive Regulation: The ongoing reform of EU pharmaceutical legislation will streamline the framework for innovative medicines, allowing for earlier interaction between regulators and companies and introducing future-proofing measures like regulatory sandboxes.
- Enhanced IP Framework: The promotion of the Unitary Patent system and reform of supplementary protection certificates (SPCs) will create a more predictable and attractive IP regime for investment.
- Unlocking Investment: Initiatives like the Savings and Investment Union and a dedicated matchmaking interface will help bridge the financing gap for life science startups and scaleups, connecting them with investors to fast-track their journey to market.
A Coordinated Push for a Competitive Future
This strategy does not exist in a vacuum. It is deeply interwoven with other major EU initiatives, including the forthcoming Biotech Act, the EU Health Data Space (EHDS), the AI Act, and reforms to pharmaceutical legislation. To ensure coherent implementation, a new Life Science Coordination Group will be established. With a clear timeline of actions beginning in 2025 and a final report due in 2028, the EU has laid down a clear marker of its intent to build a thriving, competitive, and innovative life sciences hub for the decades to come.
If you have the need to get up to speed and aligned with the latest EU push to speed up innovation in the EU, feel free to engage with our Excellence Consulting services:
- MedTech Regulatory Consulting
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- Operational Excellence Assessment
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