Rising Number of Clinical Trials Challenges Insurers

The increasing volume of clinical trials and the demand to insure them is creating an underwriting challenge for the global insurance market. These are the latest finding of Allianz Global Corporate & Specialty (AGCS; London, United Kingdom), the Allianz (Munich, Germany) center for corporate and specialist risk.

AGCS reports a consistent rise in the number of clinical trials taking place annually since 2010, with a concomitant 30% uplift in the average number of patients taking part in the clinical trials on their books. This has driven ethic committees—governed by their own country's strict legislation and a keen interest to ensure that their citizens are adequately protected—to continuously alter the requirements that need to be met by the insurer's policies before they endorse any clinical trial to go ahead. One result of this shift is that insurer's need a flexible approach in order to anticipate and address the evolving requirements of individual countries and their ethic committees.

The report highlighted that with clinical trials insurance consistently producing favorable 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 proper underwriting expertise in order to meet the clients ever increasing demands for the very highest level of quality service. New European Union (EU) regulations governing clinical trials have recently been drafted which are targeted to take effect in 2016.

One of the clear aims of the new regulations is to relax and streamline the rules governing the clinical trial approval process aimed at boosting clinical research in Europe. The general accepted view is that legislation and ethic committee approval requirements outside of Europe are far more relaxed, and 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 report was presented at the AGCS annual one-day clinical trials conference, held during February 2013 in London (United Kingdom).

“Whilst the EU's proposed changes are likely to have an impact on the insurance industry, particularly if it achieves the desired affect and further increases the number of trials taking place in Europe, there is some way to go before 2016, so in the short to medium term the expected impact is minimal” concluded John Wadsworth, AGCS senior liability underwriter and clinical trials expert.

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