Life Sciences
In Life Sciences value accumulates for years before a product exists, and much of it never appears on the balance sheet: a batch of biological material, a validated cleanroom, a trial dossier. Each phase has its own clock and the insurance market underwrites it on different criteria. Our specialists know how clinical trials, product liability and intellectual property are placed, and they accompany your company from protocol to market.
The covers that support a company in this sector
Each one is designed based on the company's real exposure. None are contracted the same in two companies in the same sector.
Lo que nos preguntan en life sciences
What insurance does the regulation require to promote a clinical trial?
Royal Decree 1090/2015 obliges the promoter of a clinical trial with medicines to have insurance or an equivalent financial guarantee that covers damage to the subject. Low-intervention trials are exempt from this specific requirement when potential damages are covered by the liability insurance of the centre or the participating professional, and checking this in writing before starting avoids discovering the gap with the study underway. In other cases, the regulation presumes that damages appearing during the trial and in the year following the end of the treatment are a consequence of it, so the cover must reach that period.
Once the trial is completed, must its policy be maintained?
Yes, at least during the year following the end of the treatment that Royal Decree 1090/2015 places within the presumption of causality, and afterwards as long as the subject's action remains active. This cover is not replaced by product cover, which starts when the medicine reaches the market and responds to something else. They coexist for a time, and the order between them is agreed upon before closing the study; when moving from trial to market, the retroactive date is what keeps the already completed study covered.
How is a batch of biological material insured?
By agreeing with the insurer on the valuation criteria before the claim, because the cost of reproducing it does not match any accounting value. Based on this, the machinery breakdown guarantee of the conservation equipment and the indemnity period are dimensioned, which must extend to the requalification of the room, following the repair of the equipment.
Our publications related to the Life Sciences sector
Product liability and recall expenses: two covers that are confused daily
One covers the damage caused by the product. The other pays for the operation of removing it from the market before it causes damage. They are not the same guarantee.
6 min readRegulatory updates
European AI Regulation: what changes for the liability of those who implement it
The regulation classifies systems by risk and imposes obligations on both the provider and the company that uses them. Insurance is still lagging behind.
6 min read