New insurance template for Swiss clinical trials
The Swiss Ethics Committees on research involving humans has recently released a new certificate of insurance/policy template that insurers must follow. As part of this new format, the Committee now requires the insured risk be categorized as category A, B, or C as outlined by Ordinance on Clinical Trials in Human Research (Clinical Trials Ordinance; ClinO) of September 20, 2013 (Status as of January 1, 2014). Insurers do not have the descriptions for the classifications, and are prohibited from providing advice regarding categorization of a trial. Sponsors or their CROs must seek advice from the Swiss Ethics Committees on research involving humans to determine the appropriate classification for their trial. Categorization of the trial is required before the certificate of insurance meets the requirements of the Human Research Act (HRA) and the Ordinance on Clinical Trials in Human Research (ClinO) can be issued. Certificates cannot be issued without the categorization of the Insured risk.
The two biggest concerns when securing insurance requirements for international human clinical trials are time and cost. While obtaining coverage for human clinical trials in the U.S. is straightforward, the process can be complicated for those trials conducted outside of the U.S. If insurance requirements are not met, it could mean a delay in initiating the trial. To ensure timely submission to the Regulatory Authorities and manage budgets, it is imperative sponsors work with a brokerage partner who place coverage for international human clinical trials on a daily basis. Together with our international partner, we are able to advise on regulatory matters whether the trial be in Switzerland, Mexico or South Korea. We are also able to provide budget projections if provided with the countries where the sponsor plans on conducting trials. Having a partner experienced in the placement of human clinical trials is imperative to manage the four C’s – coverage, claims, (insurer) capacity, and cost.
About the Author
Amy Sinclair is an Area Executive Vice President and area co-leader of the Life Sciences Practice in Gallagher WGA’s Property and Casualty Group. She negotiates, implements and manages comprehensive insurance programs for a variety of clients, ranging from venture-backed start-up organizations up to publicly traded companies.