Globalisation is complicating the landscape for clinical trial insurance, warns risk management specialist Aon Corporation.

Issuing its 2009 Clinical Trials Risk Map, which provides an overview of clinical trial insurance across Western, Northern and Central and Eastern Europe (CEE), as well as Turkey, Egypt, Tunisia, Morocco and Israel, Aon notes that the shift in clinical trials from traditional markets such as the US and Western Europe to the emerging regions of CEE, Latin America and Asia has brought with it increased regulatory scrutiny and compliance requirements.

As such, the company warns, “a complex insurance regulatory environment is all but guaranteed across the industry”. An additional challenge, as highlighted by the 2009 Clinical Trials Risk Map, is the growing number of countries that now ask for admitted insurance – clinical trial coverage purchased from an insurance company licensed within the country where the trial is taking place.

In the past, observes James Walters, managing director of Aon’s Life Sciences practice, a certificate of insurance could be issued in the US, stating that the policies in place would address any liabilities associated with a clinical trial. Today, life sciences companies must often secure local country coverage, which means they need to understand the legal requirements in each jurisdiction.

The Clinical Trials Risk Map shows, for example, that there are now compulsory insurance requirements for clinical trials across Western, Northern and Central and Eastern Europe, with Romania the sole exception. In Western European and some CEE countries (e.g., Poland), these include extended reporting and life-of-trial requirements.

Most countries on the map are tagged as “admitted insurance laws may apply”. Broker-issued insurance certificates are normally accepted in some (e.g., Israel, France, Lithuania, Belgium). A high compulsory limit of liability applies in countries such as Germany, Switzerland, Slovakia, Italy, France, Slovenia and Belgium.