Biodefense and Vaccine Liability: Principles to Consider
Laws cannot be written to avoid all confusion and satisfy everyone affected by them. Inevitably, issues will arise that were not understood at the time of drafting. Moreover, laws set forth obligations and assign responsibility so individual interests will necessarily conflict. There is no easy balance among the competing goals of encouraging certain categories of individuals to get vaccinated while discouraging others, or providing adequate compensation to injured parties while limiting liability so manufacturers will produce desired vaccines and others in the private sector will administer them. However, the recent experience with the smallpox vaccine suggests several key principles related to liability that policymakers should consider when vaccines are used to defend against bioterrorism. As the smallpox vaccination program evolves and the liability and compensation schemes are tested, more lessons will be learned for future vaccination programs that involve potential agents of bioterrorism.
The government initially hoped to vaccinate approximately 439,000 civilian smallpox response team members in Phase I of the smallpox vaccination program, but as of April 18, 2003 (before compensation was offered), only 33,444 civilians had been vaccinated. This low participation was attributed, in part, to the widespread concern among healthcare providers that the Homeland Security Act did not provide them adequate liability protection or compensation.132,133 In fact, soon after the Homeland Security Act was enacted (November 25, 2002), government officials,134,135 associations, and individuals called for new law addressing the compensation issues. Fair, adequate, and prompt no-fault compensation and adequate liability protection must be provided to those expected to implement a pre-attack national vaccination program established in the name of national security, especially when the risk of attack with a particular biological agent is indeterminate or not imminent.
What is endorsed as fair and adequate liability protection and compensation will be achieved only with the input and partnership of those expected to implement the program. Responding to concerns raised about Section 304's liability protection and the lack of compensation, on April 24, 2003, Congress passed the Smallpox Emergency Personnel Protection Act, which President Bush signed on April 30, 2003. The amendments to Section 304 are clear improvements and address many of the criticisms that have been raised, demonstrating that the federal government can actively engage the stakeholders and quickly act to address their concerns. However, as of July 18, 2003 (nearly three months after the compensation provisions had been enacted), still only 37,971 civilians had been vaccinated. For practical purposes, the civilian smallpox vaccination program is almost at a standstill. The federal government should conduct or fund a study to determine the reasons behind the continued reluctance to participate in this vaccination program. Whether it is because the compensation now available is inadequate or for a reason unrelated to compensation and liability -- for example, has the failure to find biological weapons in Iraq engendered belief that the threat of a smallpox attack is too low to justify the risks of the vaccine? -- the answers should provide insight for this and future vaccination programs where national security issues are involved.
The Homeland Security Act was enacted on November 25, 2002, and became effective 60 days later on January 24, 2003, enabling vaccination to go forward on that date. The current Declaration, which lists the vaccines and treatments covered under the Act, specifies who can get vaccinated, and clarifies the Act itself, was also issued on January 24, 2003. Although the government had hoped for wide-scale vaccinations to begin on January 24, on that date only four healthcare workers were vaccinated in one state. More than half of the 62 jurisdictions with vaccination plans approved by the CDC had not even requested the vaccine, and most of those remaining had requested delivery of the vaccine after that date. Much confusion existed over the extent of liability protection under the Act at the time vaccination began, and compensation issues were still very much unresolved. A declaration should be issued sufficiently before the desired implementation date for the attorneys of providers, hospitals, and other participants to analyze the law and advise their clients accordingly.
The Homeland Security Act gives the Secretary explicit permission to shorten and extend the effective period of a declaration, and more than one declaration can be issued. This flexibility is essential because healthcare providers have liability protection for administering the smallpox vaccine and covered treatments only during this period. When the current deadline approaches (January 23, 2004), the Secretary will need to determine -- after consultation with hospital representatives and healthcare providers -- if the period should be extended to make sure that all treatments continued to be covered. In addition, the current Declaration lists only vaccinia vaccines, Cidofovir, and VIG as covered countermeasures. In the future, the Secretary may decide to add to the list additional treatments that can be used to treat the adverse reactions of these countermeasures. Because the course of an illness and the effects of treatments can have many unknowns, vaccine liability laws should have flexibility of this sort, but they must not be so flexible that liability protection is unclear or might be applied arbitrarily.
Now is the time to think about and provide for liability protection and compensation after a smallpox attack has occurred, because other factors come into play that the current laws do not adequately address. For example, in a post-attack scenario, getting proper informed consent from mass numbers of people prior to vaccination will present an entirely new set of management and organizational issues. In fact, some ethicists suggest that it might be "morally obligatory to dispense with the ordinary requirements of informed consent" post-attack, provided adequate no-fault compensation is provided. But except in limited circumstances, the current compensation scheme applies to a pre-attack scenario. Additionally, individuals with certain medical conditions who should not be vaccinated pre-attack might be recommended for vaccination post-attack, requiring extensive educational efforts. Post-attack vaccination also might require the use of investigational vaccines that do not have FDA approval, raising other liability concerns. Once an attack has occurred, the risk-benefit paradigm changes, and individuals and hospitals may be more willing to accept the risks associated with smallpox vaccination. The federal government, in part-nership with the other stakeholders -- including state and local governments, public health professionals, industry representatives, experts in the field of vaccine delivery, and potential vaccine recipients -- needs to work through these and other such issues before an attack occurs, and where necessary, enact new legislation to address a post-attack scenario.
We would like to thank Clifford J. Shoemaker, Tom Inglesby, Lew Radonovich, and the journal's reviewers for their thoughtful comments on the manuscript.Reprint Address
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Biosecur Bioterror. 2003;1(3) © 2003 Mary Ann Liebert, Inc.
Cite this: Vaccine Liability in the Era of Bioterrorism - Medscape - Oct 01, 2003.