Proposed changes to EU regulation and clinical research risks are top concerns for clinical experts and insurers, Allianz has reported.
The risks of what happens when clinical trials go wrong all topped the bill of presentations by clinical experts to a broking audience, at Allianz Global Corporate & Specialty's one-day annual Clinical Trials Conference.
John Wadsworth, senior liability underwriter and clinical trials expert at Allianz, said at the event: "With clinical trials insurance consistently producing favourable combined operating ratios, it is a class of business that is increasingly attracting more insurers into the market.
"But still remains a class of business that needs to be significantly resourced with the right underwriting expertise in order to meet clients ever increasing demands for the very highest level of quality service."
Allianz has reported a consistent rise in the number of clinical trials annually since 2010, with a 30% uplift in the average number of patients taking part in the clinical trials on their books.
It added that while the increasing volume of trials was welcome the trend could add to underwriting challenges.
Allianz said Ethic Committees were continuously altering the requirements that needed to be met by insurer policies before endorsing clinical trials and a flexible approach was vital for insurers.
New EU regulations governing clinical trials have been drafted which aim tot ake effect in 2016.
Relaxing and streamlining the rules governing the clinical trial approval process to boost clinical research in Europe is a key aim.
Allianz stated: "The general accepted view is that legislation and Ethic Committee approval requirements outside of Europe are far more relaxed.
"This has negatively impacted upon the number of Clinical Trials taking place in Europe, in comparison to the rest of the world, over the past couple of years. The proposed EU regulations were the subject of much debate at the event."
Professor Alyn H Morice, speaking at the event, welcomed the move to simplify "overly bureaucratic" existing regulations.
Allianz said while the EU's proposed changes would likely impact the insurance industry if the number of trials taking place in Europe further increased, the expected impact was minimal for the short to medium term.
