The ACE Group of insurance and reinsurance companies today announced the
availability of an informational white paper focusing on insurance and
risk management issues faced by life sciences companies as they conduct
business in the U.S. and globally. The paper, “Managing the
Complex Challenges of a Global Insurance Program: Foreign Clinical
Trials Case Study,” appeared in the November issue of John Liner
Review, and is part of ACE
Progress ReportsSM, a collection of white papers,
articles and executive reports on current and emerging risk management
issues. Co-authored by Lee Farrow, Senior Vice President,
ACE Medical Risk and Robert Gaffney, ACE Global Client Executive, the
paper discusses how operating within the global market offers an
unprecedented growth opportunity for U.S.-based companies and
multinational corporations, while also creating the potential for
nontraditional exposures and governance issues.
“For a variety of reasons, U.S.-based life sciences companies now
conduct business and clinical trials all over the world, and their
dramatic global growth presents unique insurance and risk management
challenges. One of the largest is overseas clinical trials”
“For a variety of reasons, U.S.-based life sciences companies now
conduct business and clinical trials all over the world, and their
dramatic global growth presents unique insurance and risk management
challenges. One of the largest is overseas clinical trials,” said Mr.
Farrow. “Many challenges await the risk manager. For instance, to begin
a clinical trial, a life sciences company must have local insurance
policies (with the required coverages) in many different countries
around the world and provide the clinical trial insurance certificate in
the local language in a timely manner. In addition, ethics committees in
these countries may not permit the trial to proceed without an
appropriate certificate.”
Commenting on the need to keep track of insurance requirements around
the world, and the challenges faced when the regulations in a certain
country are not fully understood, Mr. Gaffney said, “Insurance
requirements for clinical trials vary by country. For example, studies
in Brazil typically need a local insurance broker, as the premium and
fees must be paid locally to the insurer. Other Latin American countries
require that the clinical trial sponsor have a local physical presence
in the country, and if not, a local representative is needed. In Europe,
many countries require significant limits, including France, The
Netherlands, and Belgium.”