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The landscape of life sciences risk is evolving, and corresponding coverage may lag behind.

The Zurich report, Beyond 2030: The Future of Life Sciences, highlights significant shifts in the life sciences sector driven by advancements in AI and outcome-based models. Here are the key takeaways:

Accountability Challenges

  • Emerging Risks: As scientific discoveries accelerate, the systems for proving and delivering these innovations lag, creating liability issues not just in labs but also in real-world applications.
  • Insurance Coverage Gaps: Traditional life sciences policies may not adequately cover the complexities of AI and connected devices, posing risks at renewal times.

Regulatory Changes

  • EU’s Revised Product Liability Directive: Effective from 2026, this directive classifies software and AI systems as products with strict liability rules, impacting life sciences firms selling into EU markets.

Blurred Liability Lines

  • Multiple Parties Involved: In clinical settings, when failures occur, liability could span across manufacturers, software developers, cloud providers, and clinical teams, complicating accountability.
  • Insufficient Coverage: Many existing policies fail to explicitly cover bodily injury arising from technology products and services, highlighting urgent gaps.

Outcome-Based Models

  • Long-Term Obligations: New healthcare arrangements, like NHS England’s subscription model for antibiotics or outcome-based gene therapy contracts, introduce obligations that extend far beyond the initial treatments.

Single-Source Dependencies

  • Cyber Exposure: Reliance on single suppliers for essential services in life sciences raises underwriting risks, especially as cybersecurity threats grow, as demonstrated by a significant increase in ransomware attacks.

Conclusion

The report emphasizes that companies in the life sciences sector must adapt to navigate the complexities of regulatory, technological, and operational challenges to ensure that they can adequately manage liabilities and risks associated with their innovations.

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