What does products liability insurance look like for a commercial cell or gene therapy?

Unlike a mass-market drug or device, a cell or gene therapy usually treats a small population, so the claim frequency is low. But each potential injury is severe, the intervention is often irreversible, and - for gene therapy - delayed adverse events can appear years later. The products program is therefore built for severity and duration, not volume: meaningful per-occurrence limits and a form that accounts for late-reported claims.

The most common gap is the seam between clinical trial liability (which covers subject injury during the study) and products liability (which covers injury from the marketed product). As a therapy approaches approval, the products and completed-operations coverage has to be in place and coordinated with the trial-liability program so that a claim arising around the transition is not caught between two policies with different triggers and retroactive dates. Planning this transition before launch is part of a clean CGT program.

Because the exposure is long-tailed, the choice of occurrence vs claims-made form and the maintenance of retroactive dates matter as much as they do for the trial-liability program. Limits are set to the severity of a single catastrophic outcome and to any contract, hospital, or treatment-center requirement, and they commonly sit well above a conventional specialty-pharma products tower.

Cell and gene therapies are novel products, so they are placed through the specialty life-sciences markets that understand the science and the regulatory path, not a generic products carrier that may exclude or mis-rate the exposure.

Products liability sits alongside the manufacturing-related property and cargo coverage, professional liability where a service is provided (for example patient-specific manufacturing or administration support), recall coverage, and the D&O program. For an autologous therapy, the chain-of-identity and batch-integrity exposures on the manufacturing side interact with the products exposure, so the two are scoped together.