Insurance Insights : Navigating Risk and Innovation in Life Science: A sector shaped by complexity, regulation, and opportunity

Life Science is a complex and evolving industry that touches all our lives and those of our loved ones – but it also comes with its own set of unique risks and opportunities

Mark Gupffert, Continental Europe Life Science Director at CNA Hardy

Since 2008, CNA Hardy has been a trusted partner in Life Science liability insurance across Europe, supporting companies from R&D through to commercialisation. Our insights into the evolving risk landscape help shape how we think about resilience and responsibility in the sector.

Life Science is more than an industry—it’s a mission that touches every life. From the development of breakthrough therapies to the delivery of precision diagnostics, the industry is rooted in improving patient outcomes and advancing global health. But with innovation comes complexity, and with complexity, a unique set of risks.

What does Life Science insurance cover?

Life Science liability insurance protects companies against claims arising from bodily injury or property damage caused by medical devices, pharmaceuticals and other healthcare products. 

Aside from bodily injury/property damage, we aim to meet the complex challenges that Life Science companies face, working in an industry that is highly regulated. Think of coverage for faulty packaging, product defects, contamination, spoilage, employee injury or third-party financial loss.

Our Clinical Trials product is tailored to the Life Science industry and conforms to the local standards in the countries where we offer this cover. Participants in clinical trials are covered for any bodily injury and/or property damage they suffer as result of their participation in the clinical trial.

Protecting every step of the journey

Whether it’s a single-use syringe or a multimillion-dollar MRI scanner, every tool used in patient care represents a critical link in the life science chain. Beyond devices, the life sciences ecosystem includes pharmaceuticals and clinical trials with human participants—all of which require robust risk management strategies.

Regulatory shifts

The Medical Devices Regulation (MDR) has redefined how innovation is brought to market. Under new legislation that became law in May 2021 and is applicable in all 27 EU Member States, European Economic Area (EEA) countries and Northern Ireland, even incremental improvements—such as a redesigned syringe—must undergo rigorous safety and tolerability testing. This shift ensures higher standards of patient safety but also introduces longer time to market and increased costs for manufacturers.

As a result, investment patterns have shifted. While the post-COVID era saw a surge in funding for vaccine development and biotech innovation, investor caution has returned amid regulatory complexity and supply chain constraints.

AI in Life Science: A new frontier for risk and insight

Artificial intelligence is transforming life science delivery. From analysing MRI scans to flagging anomalies in dental imaging, AI augments clinical decision-making with speed and precision. However, under Medical Devices Regulation (MDR), AI software used as a medical device is now classified as a product, bringing it under the scope of product liability insurance.

This regulatory reclassification has prompted closer collaboration between life sciences and technology teams, as insurers and developers work together to understand and mitigate emerging risks.

Expertise that matters

Because life science is a highly specialized field, only a few insurers offer specialist coverage and they bring deep technical expertise to every partnership. Our in-house experts have real-world industry experience and provide practical risk management to aid loss prevention, identify potential liability exposures, and reduce risk. They’re passionate and have an affinity for the sector.

We operate globally, supporting clients in over 200 countries and territories through local partnerships and tailored risk solutions.

Life Science insurance is a specialised field governed by its own standards and regulations. Our dedicated underwriters and claims experts understand the nuances of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and clinical trial protocols, ensuring that our clients are protected at every stage. We recruit talent and train them into Life Science specialists using our experience and thought leadership in the sector.

Claims that tell a story

In the Life Science sector, no two insurance claims are ever the same. The industry is characterised by a wide range of complex and often unexpected incidents. Claims can stem from product malfunctions that compromise patient safety, regulatory setbacks that delay or prevent product approvals, and even physical damage to facilities caused by corrosive substances. Additionally, there have been cases involving contamination of pharmaceuticals due to improper handling or lapses in quality control. Each scenario presents unique challenges, underscoring the need for specialised risk management and tailored insurance solutions.

Looking Ahead: Innovation and Opportunity

As medicine evolves, so do the risks—and the opportunities. From gene therapies to digital diagnostics, the future of life sciences will be shaped by personalised care, data-driven insights, and global collaboration.

Together with clients, brokers, regulators, and healthcare leaders, we’re building a safer, smarter ecosystem—one that’s focused on improving lives through science.

Insight from the Expert

Mark Gupffert has over 25 years’ experience in the insurance industry and has been with CNA Hardy since January 2016. He started as Senior Underwriter Life Science and worked his way up from Underwriting Manager Commercial Lines (including Life Science) to Life Science Director for Continental Europe.

Mark is responsible for the respective Underwriting teams, the wordings, recruitment, strategy, guidelines, distribution, and marketing of the Life Science product within CNA Hardy.

Before joining CNA Hardy, Mark held a range of positions including 12 years as a broker with Aon Risk Solutions in Amsterdam.

Anecdote:

Early in my Life Science career I insured a small Dutch company, developing a cure for a rare disease. I believed in their product and wanted to help them grow.

What started out as a small R&D company, grew into a Clinical stage Pharmaceutical with the need to insure Clinical Trials all over the world, with Clinical Trial policy wordings meeting all sorts of local requirements and legal needs. After successfully completing the Clinical stage, the company brought their first product to market bringing new insurance needs like Products Liability.

Throughout their development, the company was insured by us and still is, creating a relationship of mutual trust and belief in their product and in our expertise as specialists in the Life Science insurance market.

Looking to better understand this dynamic and diverse sector?

Discover our dossier: ‘A dynamic and diverse sector: Non-Life Insurance & Reinsurance in Luxembourg’. It features expert analyses, key figures, concrete examples, as well as testimonials and podcasts to explore the professions, products, and the role of Luxembourg as a European hub.

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