Allianz Global Corporate & Specialty (AGCS) recently held its annual one-day Clinical Trials Conference, addressing a number of vital issues and challenges that the Life Science Industry and Insurance Market currently face when conducting and insuring Clinical Trials around the globe. Proposed changes to EU regulation, the risks of carrying out Clinical Research and what happens when Clinical Trials go wrong all topped the bill of presentations by clinical experts to a broking audience.
AGCS Senior Liability Underwriter and Clinical Trials expert John Wadsworth opened proceedings with an updated overview of the clinical trials market from an Insurer’s perspective. It was highlighted that 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.
AGCS have seen a consistent rise in the number of clinical trials taking place annually since 2010. Simultaneously AGCS have seen a 30% uplift in the average number of patients taking part in the clinical trials on their books. Whilst the Insurance Market welcomes the increasing volume of trials and the demand to insure them, the trend can add to underwriting challenges. Ethic Committees, governed by their own country’s strict legislation and keen interest to ensure their citizens are adequately protected, continuously alter the requirements that need to be met by Insurer’s policies, before they will give their endorsement for any Clinical Trial to go ahead. It is therefore vital that Insurer’s have a flexible approach in order to anticipate and address the evolving requirements of individual countries and their Ethic Committees.
New EU regulations governing Clinical Trials have recently been drafted with the aim for these to take effect in 2016. One of the clear aims of the new regulation, is to relax and streamline the rules governing the Clinical Trial approval process to boost 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 proposed EU regulations were the subject of much debate at the event and Professor Alyn H Morice, who has conducted over 300 clinical trials, welcomed the move to simplify “overly bureaucratic” existing regulations.
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.
