ACE Releases New White Paper Examining Insurance and Risk Management Considerations Related to Compassionate Drug Use During

  ACE Releases New White Paper Examining Insurance and Risk Management
  Considerations Related to Compassionate Drug Use During Clinical Trials

Business Wire

PHILADELPHIA -- December 18, 2012

ACE USA, the U.S.-based retail operations of the ACE Group, today announced
the release of a white paper exploring the insurance and risk management
issues that life sciences companies face when conducting clinical trials for
new drugs and medical devices – when they may be in demand for “compassionate
drug use.”

“Compassionate Use: Balancing Compassion and Risk in Clinical Trials,” was
authored by Justine Cuccia, Esq., Underwriter, ACE USA Medical Risk & Life
Sciences, and it discusses the issues that both life sciences companies and
patients face. According to Ms. Cuccia, “Life sciences companies can help
mitigate potential risks by managing patient expectations and make sure the
roles and responsibilities of all those involved in clinical trials are
clearly defined through documentation.”

“Compassionate use drug conflicts are on the rise,” said Tristan Gabriel,
Senior Vice President, ACE USA Life Sciences, “as more patients seek access to
clinical trial products as a last resort. For pharmaceutical and medical
device companies, the choice can be very hard. The human factor is clearly a
prime concern. However, everyone involved in the clinical trial process needs
to be aware of the increased overall risks of the demand for earlier access to
promising products and devices. To ensure proper protection, it is vital that
life sciences companies ensure a thorough risk management program for
protecting all the parties involved. By planning ahead, the risk of conflicts
resulting from patient requests can be effectively managed.”

Two recent court cases detailed in the report shed light on the difficult
choices that life science companies must make with regard to compassionate use
requests and underscore the importance of communication as well as clear
documentation by the drug or device company, their risk managers and counsel,
when agreeing to any type of compassionate drug use.

As part of a thorough risk management program, life science companies should
partner with an insurer who has significant experience in human clinical
trials and compassionate use situations, in addition to the following key

  *An understanding of the applicable regulations
  *A specialization in this type of coverage, to understand the risks
    involved regarding consent forms and clinical trial agreements
  *An ability to identify emerging risks from overall clinical trial
  *Financial strength and an excellent reputation
  *The ability to offer a broad range of products
  *For international companies, worldwide coverage offerings, with locally
    admitted policies

To access the report, please visit our website. The material presented in this
report is not intended to provide legal or other expert advice. It is
presented as informational only. Readers should consult legal counsel or other
experts, as applicable, with any specific questions they may have.

ACE Medical Risk & Life Sciences, a division of ACE USA, provides primary and
excess medical professional liability for hospitals, miscellaneous healthcare
facilities, and managed care errors and omissions coverage. In addition, ACE
offers products liability for clinical trials, biotechnology, and specialty
pharmaceutical companies, as well as a comprehensive package policy that
includes property, auto and crime coverages through its Life Sciences unit. To
learn more about ACE’s Medical Liability products and services, please visit
our website.

Insurance is provided by insurance companies within the ACE Group. All
products may not be available in all jurisdictions. The product information
above is a summary only. The insurance policy actually issued contains the
terms and limits of the contract.

ACE USA is the U.S.-based retail operating division of the ACE Group, headed
by ACE Limited, and is rated A+ (Superior) by A.M. Best Company and A+
(Strong) by Standard & Poor’s. ACE USA, through its underwriting companies,
provides insurance products and services throughout the U.S. Additional
information on ACE USA and its products and services can be found at The ACE Group is one of the world’s largest multiline
property and casualty insurers. With operations in 53 countries, ACE provides
commercial and personal property and casualty insurance, personal accident
supplemental health insurance, reinsurance, and life insurance to a diverse
group of clients. ACE Limited, the parent company of the ACE Group, is listed
on the New York Stock Exchange (NYSE: ACE) and is a component of the S&P 500
index. Additional information can be found at:


ACE North America Communications
Carla Ferrara, 215-640-4744
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