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 attributes:
- 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 experience
- 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
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. 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
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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.