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Cell & Gene Therapy FAQ

What is a retroactive date and why does it matter for gene therapy insurance?

A retroactive date is the point in time from which a claims-made policy will cover claims. A claims-made policy responds to a claim reported while the policy is in force, but only if the underlying act happened on or after the retroactive date. For gene therapy, where delayed injuries can surface many years after dosing, the retroactive date is one of the most important terms in the program.

If a company changes carriers or renews and the new policy is written with a later retroactive date, a claim tied to work done before that date can fall outside coverage - a gap in the claims-made chain. Over a 15-year long-term-follow-up horizon, an unpreserved retroactive date can quietly strand years of liability.

The fix is to preserve the original retroactive date across every renewal and carrier change, so the chain reaches back to cover all the work the company has done, and to pair that with a long extended reporting period (tail) at any close-out or exit. Retroactive-date continuity and the tail budget are the two mechanisms that keep the long-tail gene-therapy exposure funded.

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