Our submission on the call for evidence on the new Strategy for European Life Sciences can be found here.

EFPIA welcomes the Commission initiative to develop a robust EU Life Sciences Strategy to strengthen Europe competitiveness and close the innovation gap with global peers. The strategy must address challenges across the full value chain, deepen public-private collaboration, and reinforce the link between a thriving industry, world-class research and manufacturing, and equitable access to medicines.

Amid geopolitical, societal, and climate challenges, a bold and coordinated EU approach is needed. Targeted policies supporting clinical research, SME funding, sustainable manufacturing, and a functioning internal market can help Europe regain its edge, enhance economic and health security, and deliver innovations to patients. Governance should be supported by an EU Office for Life Sciences, accountable for strategy implementation.

1. Translating innovation into impact
   Despite scientific excellence, Europe struggles to convert discoveries into transformative innovation. The strategy should:

• Strengthen globally competitive IP frameworks to attract R&D investment.
• Ensure robust funding for collaborative research in FP10, including public-private partnerships.
• Improve access to capital by:
  • Reforming pension fund rules to unlock private investment in high-risk ventures.
  • Reducing the cost of raising capital in EU stock markets.
  • Establishing guarantee mechanisms to de-risk innovation-focused investments.
• Invest in STEM education, upskilling and reskilling.

2. Restoring leadership in clinical research
   Europe has lost 60,000 clinical trial places to other regions, weakening its global role in drug development. The strategy should:

• Streamline approvals for multi-country clinical trials to reduce delays and maintain Europe’s attractiveness to conduct clinical trials.
• Ensure effective implementation of EHDS and AI Regulation to enable data-driven innovation, guard citizens’ privacy and, protect and promote industrial innovation.
• Reinforce European and global regulatory convergence.

A major barrier to competitiveness is the complexity of the EU regulatory framework. While the revision of the EU pharma legislation is an opportunity to deliver on a future-proof and streamlined regulatory system conducive to innovation, the strategy can:

• Accelerate digital transformation of regulatory systems.
• Enable predictable use of all evidence types, including real-world data.
• Ensure regulatory authorities are sustainably resourced and agile.

3. Strengthening the manufacturing base
   With the U.S., Singapore and China attracting increasing biopharma investment, Europe must:

• Align environmental, chemical and animal welfare policy with open strategic autonomy ensuring essential substances (e.g., PFAS, TiO2) are not unduly restricted, risking medicine supply.
• Fund next-generation manufacturing and workforce reskilling for sustainable production.

4. Timely & equitable access to innovation
   To remain globally competitive, Europe must ensure faster, fairer access to innovation:

• Implement a workable HTA framework with streamlined evidence requirements, early dialogue, and predictable processes to avoid duplication and delays.
• Develop value-based procurement guidelines that reward quality, sustainability, and supply security, not only price.
• Improve access through sustainable public pharmaceutical spending; short-term cost-containment undermines innovation.
• Enable Equity-Based Tiered Pricing (EBTP) reflecting ability to pay while rewarding innovation.
• Foster structured high-level dialogue between industry, policymakers and health stakeholders to address access barriers.

To restore Europe’s leadership in life sciences, the EU Life Sciences Strategy must be anchored in competitiveness, investment, and innovation. A forward-looking policy agenda will secure Europe’s role as a global hub for medical research, sustainable manufacturing, and equitable access to transformative treatments.