Sep 18 2009
Aon Corporation (NYSE: AOC), the leading global provider of risk management services, insurance and reinsurance brokerage, and human capital consulting, today issued the findings of its 2009 Clinical Trials Risk Map to address the constantly changing environment in which biotechnology, pharmaceutical and medical device companies conduct business around the world.
The likelihood that a clinical trial may be negatively impacted is on the rise in relation to the increasing scrutiny and compliance regulations associated with the shift in recent years toward moving clinical trials from the U.S. and Western Europe to emerging regions such as Eastern Europe, Latin America and Asia.
While the decision to conduct clinical trials abroad varies based upon each life sciences company's unique needs, a complex insurance regulatory environment is all but guaranteed across the industry. An additional challenge identified by the 2009 Clinical Trials Risk Map is the increasing number of countries that now require admitted insurance coverage, or coverage that is purchased from an insurance company licensed within the country where the trial is being conducted.
"In the past, a certificate of insurance could be issued in the U.S., stating that the policy in place would address any liabilities associated with a clinical trial," stated James Walters, managing director of Aon's Life Sciences practice and author of the 2009 Clinical Trials Risk Map. "Today, life sciences firms must often secure local country coverage, which requires the understanding of legal requirements in each jurisdiction. Without the proper counsel on the ground, the risk of error can be costly and ultimately result in a delayed or cancelled clinical trial."
Aon's 2009 Clinical Trials Risk Map assigns symbols to countries around the world to identify:
- Compulsory clinical trials insurance requirements - government-mandated
- Extended reporting or life-of-trial requirements - government-mandated
- Compulsory limit of liability - government-regulated
- High compulsory limit of liability - government-regulated
- Deductibles permitted by law
- Broker-issued insurance certificate permitted by regulatory authorities
- Admitted insurance requirements by local country
- Countries where Aon has a physical presence in one or multiple cities
Often fraught with intricacies related to local language regulations, levels of coverage and the specific contractual language required, clinical trials insurance demands the focused attention of a risk management partner intimately familiar with navigating each country's requirements to secure the proper admitted clinical trials insurance coverage.