A new European strategy to foster life sciences innovation and market access

The Strategy comes at a critical time for Europe, where Europe’s future as leader in life sciences is questioned. The Strategy highlights the criticality of the life sciences sector for the European Union and indicates that while the European Union can count on several assets to attract life sciences investment, including strong research institutions and biotech clusters, high-value patenting and dynamism, it also faces challenges with fierce global competition, the struggle to scale up companies, a limited and delayed valorization of innovation, the underuse of data and AI and, importantly, complex and changing regulatory frameworks.

To enable the European Union to become a global life sciences leader by 2030, the Strategy sets forward three key pillars: (1) optimizing the ecosystem of research and innovation, (2) ensuring smooth and rapid market access for life sciences innovation, and (3) boosting the uptake and use of life sciences innovation.

Optimizing the ecosystem for research and innovation

To attract investment and development of ATMPs, facilitate multi-country clinical trials and leverage the strengths and capabilities of existing bioclusters, the Commission aims to:

• create European centers of excellence in ATMPs
• provide continued support, monitoring, and implementation of the Clinical Trials Regulation
• draft an investment plan for clinical trials to facilitate multi-country clinical trials.

In addition, to promote data and AI to ensure breakthrough innovation, the Strategy proposes amongst other things:

• the establishment of a European genomic reference database
• the creation of an EU Life Sciences R&D Data Assembly in 2026, composed of EU and national data authorities and EU research and innovation entities to ensure a consistent interpretation and harmonization of the legal framework and to strengthen cross-regulatory data collaboration.

Ensuring smooth and rapid market access for life sciences innovations

To promote smooth and rapid market access for life sciences innovation, the Strategy proposes actions aimed at facilitating navigation through the European regulatory landscape and promoting innovation-responsible regulation. Proposed actions relate to:

• the Biotech Act, planned for 2026, aiming to make EU regulatory environment more innovation-friendly, attractive to investors and innovators and facilitate uptake to market for scaleups and SMEs
• a proposal for a balanced legislation for the medical device sector from 2025
• an AI tool to navigate the European regulatory landscape in 2026.

The Strategy also emphasizes the role of intellectual property in supporting innovation to facilitate the access of new innovative medicines to the European market.

Boosting the uptake and use of life science innovation

Finally, the Strategy puts public procurement forward as an incentive for the uptake of innovation and the need to fight against disinformation through building trust. In particular, the Strategy relies on inclusive dialogues and proposes to establish a repository of tools and best practices in responsible research and innovation, risk, and communication and pilot public outreach measures.

Interestingly, the Strategy also proposes the establishment of a Life Sciences Coordination Group within the European Commission, which shall comprise stakeholders from the industry and aims to ensure innovation-friendly policies, funding as well as alignment with stakeholders’ priorities, resources, and international developments.

Conclusion

Representatives of the innovative pharmaceutical industry have praised the European Commission’s attempt to address the region’s competitiveness. There’s indeed much needed support for ATMPs, clinical trials, biotech clusters and AI/Data harmonization. The regulatory simplification and innovation tools are also welcomed and a life sciences coordination group and skills initiatives are considered beneficial.

However, the proposal remains relatively high-level and subject to concrete measures, and it remains to be seen to which extent there will be sufficient funding to implement the Strategy.

Whether or not this Strategy will help in making Europe the most attractive place for life sciences will also to a large extent depend on other pending European initiatives. For example, the envisaged reduction of regulatory incentives under the EU Pharma package does not seem to be entirely consistent with the aim of quicker market access for innovative medicines. It may in fact reduce the commercial motivation to invest in Europe’s life sciences scene.

The Strategy is available here, the press release here and the Q&A is available here.