An
underwriter reveals the must-do items he looks for when evaluating a
company for coverage.
By
Philip W. Fiscus
FEATURE ARTICLE
Confronting Risk Challenges to your business – both daily and long-term competitiveness – lurk in surprising places. BRUCE BELZAK explains how to protect your company.
ARTICLE EXTRAS
Case study: A medical device component manufacturer faces nervous senior executives
Case study: What happens when a fire strikes your production facility?
Five Things Not to Forget When Forecasting Forecast models can become complex, but the principles for gathering and vetting data for good predictions should remain basic.
Underwriter
scrutiny is like a dose of preventive
medicine: You may not like the taste of it, but it's good for
you. Life science companies that partner with an insurance carrier and
manage risk may qualify for higher limits of insurance at lower rates.
For those companies that do not take these steps, affordability of
insurance may be the least of their problems: They may not be able to
purchase insurance at any price and can expect to be a vulnerable
target in the event of litigation. Here are issues to consider when
evaluating your company's potential risk. Checking off each
one might not only lower your premiums, but also save your business.
1. Use "best
practices" rather than just following the letter of the law.
Commitment to safety and security should be so pervasive in the culture
of the organization that it's as apparent in the most senior
managers as it is to hourly maintenance personnel. For example, to help
ensure best practices for participants to understand a clinical trial,
companies could include readability testing of informed consent
documents, use information videos, and test participants on their
understanding of the document.
2. Protect your energy source. One biotech firm's cell culture, representing
an accumulated investment of $1.7 million over 22 months, spoiled after a power
outage cut electricity to the facility and the backup diesel generator failed.
The company lost both the critical cell line and the opportunity to earn a $1
million milestone payment from a sponsor. California is home to 25% of US biotech
firms, and the state's energy crisis in 2001 ruined experiments and damaged
costly equipment at the many organizations that lacked sufficient backup power.
This past summer's heat waves have again put pressure on the power grid; usage
was as much as five times greater than during the 2001 electricity crisis. Is
your company better equipped to weather brownouts or power interruptions today
as a result of risk management improvements since 2001?
3. Minimize physical threats to your R&D facility. Underwriters look for
safety measures that help protect not only the building and the expensive equipment
inside, but also research, documents, lab animals and other property that is
difficult to replace. A "good risk" will have effective duplication
procedures (for lab books, electronic data, samples, cell lines, and cultures)
and ensure that the duplicates are securely stored offsite. Underwriters also
look for a prudent facility-protection philosophy: proper storage and use of
flammable chemicals; controls to protect clean rooms from potential breaches;
alarms and a backup supply of electricity or refrigeration; systems that detect
both heat and smoke; and sprinkler systems designed to reduce the chance of
water contamination in a lab. Highly sensitive lab instruments are particularly
susceptible to smoke damage.
In
one example, a contract manufacturer sustained smoke damage from a
small oven fire. It took five weeks of round-the-clock work for
specialized cleaning contractors to get clean rooms back to the
required standard, and only then could regulatory authorities begin the
process of revalidating the rooms. In many such cases, a fire or other
damage will invalidate equipment warranties and service contracts,
making the cost of third-party warranties and service contracts a
factor in the claim adjustment. These types of exposures could be
elimi-nated (for example, by using infrared thermography cameras to
identify hot spots that could develop into fires); mitigated through
identifica-tion and segregation in a separate fire area; or alleviated
through the design of dedicated heating and air conditioning systems
with smoke dampers.
4. Protect against information theft. Start by conducting thorough background
checks on employees and contractors, requiring non-disclosure agreements, and
restricting access to facilities and sensitive information to those who need
such measures. Identity theft is also a concern, especially for companies that
conduct human clinical trials and need to collect personal information on a
large number of individuals. Safeguards should be in place to ensure that this
information is not accessible. For example, the information should not be stored
on discs or laptop computers that are taken home by employees, and access to
such information should be limited to those who need to see it.
Philip W. Fiscus is worldwide
product manager for Chubb & Son's life science
practice.