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Institute of Medicine (US) Forum on Medical and Public Health Preparedness for Catastrophic Events. Dispensing Medical Countermeasures for Public Health Emergencies: Workshop Summary. Washington (DC): National Academies Press (US); 2008.

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Dispensing Medical Countermeasures for Public Health Emergencies: Workshop Summary.

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Liability Protection for Corporations and Nonprofit Partners

During public health emergencies, both corporations and nonprofit organizations are concerned about the extent of their liability protection if they participate in countermeasures dispensing. Fear of liability has been a major deterrent to expansion of public–private partnerships, including research and development, according to Margaret Binzer, a partner at McKenna Long & Aldridge, LLP. She explained that under current federal and state laws, individual volunteers (e.g., “Good Samaritans”) and government agencies (including their employees) have strong legal protections in dispensing during national emergencies, yet corporations and other entities lack immunity from liability in these circumstances. Recognition of the problem led to passage of new federal legislation, the Public Readiness and Emergency Preparedness Act of 2005 (Public Law 109-148), also known as the PREP Act.

At the time of passage, the PREP Act was hailed as a far-reaching piece of tort reform, giving liability protections to manufacturers willing to sell countermeasures during national emergencies. It protects manufacturers when selling pandemic products, security countermeasures, drugs, devices, and biological products. It also extends immunity to distributors and program planners, as well as to health care professionals who dispense medical countermeasures (Hoffman, 2008). The trigger for these liability protections is a declaration by the Health and Human Services Secretary that a public health emergency exists or is likely to exist. A Secretarial public health emergency declaration, if appropriately drafted, could provide additional liability protection to the private sector for assisting in the dispensing of medical countermeasures.

Although the PREP Act at the time of its passage seemed proactive to ensure coverage for future emergencies, it has only been used once. What was unforeseen was that the legal process to trigger a Secretarial declaration of a public health emergency has proved cumbersome and time consuming, Binzer said. Since passage of the Act, there has been only one declaration by the Secretary for sale and distribution of a vaccine against the avian flu H5N1, as well as supplements for H7 and H9 influenza vaccines. That so few declarations have been issued has been yet another signal to the private sector to remain deeply concerned about liability exposure, said Binzer and several other participants. A panelist mentioned that a large-scale anthrax attack would undoubtedly trigger a PREP declaration as well as a Presidential Disaster Declaration.

Another significant problem exists at the state level; few state statutes furnish immunity from liability to corporations and other entities when they act as Good Samaritans. In other words, private-sector entities such as hospitals, hotels, retail outlets, stadiums, and other organizations that donate time, space, supplies, and resources to emergency preparedness rarely enjoy liability protection (Hoffman, 2008). Iowa became the first state to extend its statutory Good Samaritan liability protection to corporations and nonprofit entities acting in good faith to provide emergency aid during a public health disaster. Georgia also recently passed similar innovative legislation—the Georgia Corporate Good Samaritan Act of 2008—to extend Good Samaritan protections to other entities besides individuals. Its basic features, which are described in Box 7, could serve as a model for other states. Liability protections are necessary to enlist support of the private sector in public–private partnerships, such as dispensing countermeasures to their employees (“closed PODs”). Similar efforts are under way in other states to explore ways to work within existing state laws to ensure that emergency volunteers and entities have broader immunity from liability during emergency response activities or to establish formal Good Samaritan entity liability protection for businesses.

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BOX 7

The Georgia Corporate Good Samaritan Act of 2008. The Georgia Corporate Good Samaritan Act of 2008 provides that: Any natural person, association, organization, or private entity (directors, employees, and agents of such organization); (more...)

Copyright © 2008, National Academy of Sciences.
Bookshelf ID: NBK4101
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