In the United States we are accustomed to clinical trial liability policies that follow the concept of tort liability. For policy coverage to be triggered, the injured trial subject or his/her representative must make an expressed demand for damages or file a law suit.
I am noticing a trend in many foreign jurisdictions where regulators are requiring clinical trial participants to be compensated by the trial sponsor for injuries they sustain during participation in a trial.
In many cases, this patient compensation does not require a determination of fault. The stated reason for these regulations is to fulfill the government’s role to protect its citizens, but one could also surmise that this “no fault” requirement keeps patient injury treatment expenses out of the countries’ socialized medicine system.
As you can imagine, the regulations vary greatly by country and even within countries. New regulations are being proposed frequently, making it difficult for sponsors to stay current and assure compliance. All of this creates additional expense and administrative burden on the clinical trial sponsor.
|This post was part of the special feature about What Risks Will Emerge in 2012? published January 24, 2012. The feature also covered emerging risks in these other fields:|
Power & Utilities
Supply Chain Interruption