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International Clinical Trials

Liability Insurance: Protection in the Clinical Trial Setting

 

Product liability insurance, in its purest form, does not normally include the liability of an unproven, unregulated product in its testing stages. Usually, this is not a problem for manufacturers, since products are not distributed until the company and regulators feel the products are safe under normal use circumstances.

In the case of pharmaceuticals, medical devices or diagnostics, this is not the case. Testing is normally conducted in phases that can span years. Especially in the later phases of testing during clinical trials, there may be significant, uninsured liabilities incurred by the drug sponsor. These potential liabilities have created the need for clinical trials liability insurance. While sometimes referred to as ‘products liability’, their intent is to restrict coverage to the trial itself.


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Harry Wallace is the Practice Leader for RCM&D’s Life Science and High Technology Group where he oversees the delivery of risk management products and services to these industries. He has over 30 years of experience in the insurance industry. Prior to becoming a broker, he was employed by the Chubb Group of Insurance Companies for 21 years where he held several senior level and management positions. Harry is a graduate of Texas A&M University. He holds a Certified Insurance Counselor designation and is a member of the Professional Liability Underwriting Society. Harry was recently recognised as one of six ‘Power Brokers’ for 2009 by Risk and Insurance magazine in the area of pharmaceuticals.
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