Emerging Life Science Risk of 2013: “No fault” Clinical Trials

Emerging Risks

The new drug and medical device discovery process necessarily requires human clinical trials.

Emerging Risks 2013
This post was part of What Risks Will Emerge in 2013?, published January 23, 2013. The special feature also covered emerging risks in these fields:

The insurance industry has traditionally provided insurance coverage for trial patients who are injured during a trial based on theories of negligence and tort liability.

An emerging risk for American drug and device companies is that many international regulators require patient compensation for trial subject injuries regardless of the sponsor’s or clinic’s negligence.

If insurance won’t respond, the sponsor and/or clinic will be required to pay for these injuries as an operating expense.

The insurance industry is struggling to keep pace with this emerging risk.

About David Shuey

David is an Executive Vice President & North America Practice Leader for Willis Life Sciences, based in Radnor,…
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