According to the current EU Clinical Trials Directive, sponsors must ensure that “provision has been made for the insurance or indemnity to cover the liability of the investigator and sponsor.” However, one of the proposed changes currently on the table would see an end to this blanket insurance in favour of a more risk-based approach supplemented by state-led schemes.
Critics of the current situation complain that overarching indemnity insurance is just too costly for some trials – especially those run by academic institutions – and just isn’t necessary in many cases.
On top of this, member states interpret the requirements in different ways leading to potential variations in protection between participants in the same international trial. This is not only questionable ethically; it can be extremely expensive and highly bureaucratic.
The proposal is to permit a risk-based approach with the intention of covering the majority of claims under existing insurance (albeit mainly for post-marketing products where the risks are more clearly defined). Alongside this, Member States would be obliged to set up their own procedures to cover compensation for clinical trials that go wrong.
“Low intervention” trials would not necessarily require any additional insurance, but how do you define low intervention? The draft legislation says that such trials should “not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice in any Member State concerned.”
This still seems rather vague. How many trials are honestly thought to pose high risk? Also, the comparison to “normal” clinical practice in the concerned state seems to suggest that risky trials may be OK in states with the poorest healthcare systems. But would states that cannot fund the best healthcare provision be able to afford the national insurance that the proposals demand?
This is over simplistic - of course there are many genuine ways to assess risk of trials, such as the severity of known adverse reactions, trial duration and the characteristics of the trial subject group. But even these involve a degree of guesswork – that’s inherent in the nature of trials.
Cutting red tape and unnecessary regulatory burden is a commendable aim but is this really the best way about it?
I can’t help thinking that if I were seeking compensation for damages resulting from a trial, I’d have more faith in the speed and accuracy of a commercial insurance firm than the vagaries of a government scheme. Maybe I’m being over cynical, but if others share my view, it could have a serious effect on patient recruitment.
I’d love to know what you think.
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