EU Life Sciences Strategy drafted by the European Commission, outlining future plans for the sector

EU Life Sciences Strategy drafted by the European Commission, outlining future plans for the sector

European Commission Unveils Strategy to Make EU a Global Leader in Life Sciences by 2030

The European Commission has announced a comprehensive strategy aimed at positioning the EU as the world's most attractive destination for life sciences by 2030. This ambitious plan comes at a time when the UK government is setting out its strategic approach for the life sciences sector, aiming to become Europe's leading life sciences economy by 2030.

The strategy identifies significant challenges in the life sciences sector, including an "alarming failure" to translate innovation into products or services, a widening gap in venture capital (VC) funding, "worrying developments" in the number of clinical trials in the EU, and a high regulatory burden. To address these issues, the Commission has proposed the EU Biotech Act to make the EU's regulatory environment more conducive to biotech innovation, affecting pharmaceuticals, medical devices, and In Vitro Diagnostic Medical Devices (IVDs).

The strategy outlines three main pillars with specific proposals and initiatives:

1. Optimising the research and innovation ecosystem: The Commission plans to develop an EU investment plan to facilitate funding for multi-country clinical trials and strengthen European clinical research infrastructure. It also aims to promote a One Health approach to research and innovation and mobilise funding for microbiome-based solutions and cross-sectoral life sciences technologies.

2. Enabling rapid market access for life sciences innovations: The Commission proposes an EU Biotech Act to create a more innovation-friendly regulatory framework across biotech sectors, simplifying and accelerating market access. It also plans to launch a matchmaking interface to connect startups, industry players, and investors.

3. Boosting trust, uptake and use of innovation: The Commission plans to mobilise funding to stimulate procurement of innovations in key areas such as climate change adaptation, next-generation vaccines, and affordable cancer solutions. It also aims to establish a Life Science Coordination Group to align policies and funding across sectors and foster stakeholder engagement.

The strategy, backed by over €10 billion annually from the current EU budget, aims to accelerate innovation throughout the life sciences value chain, facilitate market access, and build public trust. It is designed to benefit health, the environment, and the economy while maintaining Europe’s global competitiveness in life sciences research and industry.

The life sciences sector in the EU employed around 29 million people and generated €1.5 trillion in 2022, accounting for nearly 10% of EU's GDP. Life sciences research and development (R&D) in the EU almost doubled between 2012 and 2022.

The Commission's strategy also acknowledges the intensifying scrutiny on EU health regulations and the need to find a balance between simplifying regulations and maintaining high standards for safety and public health. It discusses the new wave of legislative changes across health technologies, aiming to simplify existing regulations and uphold high standards for safety and public health.

The EU ranks second globally for patenting in the pharmaceutical and medical technologies (PMT) with an 18% share. However, the Commission notes the financial challenges faced by the EU life sciences industry, particularly the EU's relative weakness in Initial Public Offerings (IPOs) and venture capital (VC) funding. To address this, the Commission calls for EU and national budgets to prioritise investment in and deployment of advanced health technologies through public procurement.

The Commission also calls for more European bioclusters to breakdown interdisciplinary and national silos. It plans to invest over €10 billion annually from various funding programs to support the implementation of the strategy. The strategy also discusses the ongoing transformation of regulatory frameworks for pharmaceuticals and medical devices, including IVDs.

The EU Pharma Package is under negotiation at EU level, offering flexible tools such as regulatory sandboxes and early scientific advice to facilitate the approval of cutting-edge therapies. The Commission's strategy also aims to position the EU as the world's most attractive place for life sciences by 2030, but some proposals feel quite nebulous, and some financial measures seem limited given the scale of the challenge.

[1] European Commission. (2023). EU Life Sciences Strategy: Empowering the European Life Sciences Sector. Retrieved from https://ec.europa.eu/info/publications/eu-life-sciences-strategy-empowering-european-life-sciences-sector_en

[2] European Commission. (2023). Proposal for an EU Biotech Act. Retrieved from https://ec.europa.eu/info/publications/proposal-eu-biotech-act_en

[3] European Commission. (2023). Horizon Europe: Boosting Trust, Uptake and Use of Innovation. Retrieved from https://ec.europa.eu/programmes/horizon-europe/en/boosting-trust-uptake-and-use-innovation

[4] European Commission. (2023). One Health: A European Joint Action Plan. Retrieved from https://ec.europa.eu/info/publications/one-health-european-joint-action-plan_en

1. The EU aims to become the world's most attractive destination for life sciences, as revealed by the European Commission's strategy.
2. The UK is striving to be Europe's leading life sciences economy by 2030, according to its government's strategic approach.
3. The strategy highlights challenges in the life sciences sector, including the failure to translate innovation into products or services.
4. The Commission proposes the EU Biotech Act to improve the regulatory environment for biotech innovation.
5. The strategy identifies a gap in venture capital funding as a significant challenge.
6. The EU Biotech Act aims to create a more innovation-friendly regulatory framework across biotech sectors.
7. The Commission plans to develop an EU investment plan to facilitate multi-country clinical trials.
8. The strategy promotes a One Health approach to research and innovation.
9. Microbiome-based solutions and cross-sectoral life sciences technologies are areas the Commission aims to mobilise funding for.
10. The Commission plans to simplify and accelerate market access for life sciences innovations.
11. It also intends to launch a matchmaking interface to connect startups, industry players, and investors.
12. The strategy aims to stimulate procurement of innovations in key areas such as climate change adaptation.
13. The Commission plans to establish a Life Science Coordination Group to align policies and funding across sectors.
14. The strategy aims to benefit health, the environment, and the economy while maintaining Europe’s global competitiveness.
15. The life sciences sector in the EU generated nearly 10% of EU's GDP in 2022.
16. The EU ranks second globally for patenting in the pharmaceutical and medical technologies.
17. The Commission notes the financial challenges faced by the EU life sciences industry, particularly the EU's relative weakness in Initial Public Offerings (IPOs) and venture capital (VC) funding.
18. The Commission calls for EU and national budgets to prioritise investment in and deployment of advanced health technologies through public procurement.
19. The Commission also plans to invest over €10 billion annually from various funding programs to support the implementation of the strategy.
20. The Commission's strategy discusses the ongoing transformation of regulatory frameworks for pharmaceuticals and medical devices, including In Vitro Diagnostic Medical Devices (IVDs).
21. The EU Pharma Package, under negotiation at EU level, offers flexible tools such as regulatory sandboxes and early scientific advice to facilitate the approval of cutting-edge therapies.

Read also: