U.S. politicians and regulators, many of whom ordinarily trend toward hyper-caution on new drug reviews and approvals, are rushing forward with policies aimed at speeding up development of Ebola vaccines and treatments. These measures include coordinated research among public health officials and drug makers, Food and Drug Administration (FDA) pledges of regulatory assistance, and congressional interest in legislation to qualify Ebola-targeted products for an FDA priority-review program. Such cooperation is encouraging, but government also needs to take action on another R&D disincentive which, if left unaddressed, could completely undermine current efforts on Ebola and frustrate future cooperative management of unforeseen pandemics. Ebola vaccine and treatment manufacturers need to have protection from tort liability exposure.
Any medical procedure, pharmaceutical product, or vaccine may have adverse health risks in some instances. Drug manufacturers must consider those risks when deciding whether to invest millions of dollars for product R&D, and the Food and Drug Administration (FDA) must weigh those risks against the benefits when approving a treatment. Such risks, along with the high regulatory barriers and low economic incentives attendant to investing in rare diseases, likely have been factors that explain the dearth of Ebola vaccines and treatments.
The United States government has the motivation and the means to minimize or eliminate such liability risks. Federal health agencies are already directly involved in vaccine development, and they will no doubt also be the major purchasers of the resulting drugs. Those federal entities could include a provision in the R&D agreements or purchasing contracts that would substitute the government as a defendant in any resulting lawsuits against private businesses, or indemnify companies from tort liability. The former option is certainly superior to indemnification, which could require the vaccine and treatment producers to litigate cases and then seek reimbursement for the losses or settlements. The companies would also have to negotiate with the government over whether the indemnification would cover litigation costs, such as attorneys’ fees.
The federal government indemnified manufacturers in contracts for a smallpox vaccine after the September 11, 2001 terrorist attacks. The companies argued that the proposed indemnification was insufficient, and in April 2003, Congress added expanded liability protections to the Homeland Security Act of 2002. For the one-year period of the national smallpox vaccination program (2003-2004), individuals allegedly harmed by a government-purchased smallpox vaccine could only sue the federal government under the Federal Tort Claims Act. Congress could consider the passage of a similar law for Ebola vaccines.
Congress could also legislatively alter the normal rules of liability in a manner beneficial to Ebola vaccine or treatment manufacturers. For instance, in the 2002 Homeland Security Act, Congress included the SAFETY Act. That law required persons allegedly harmed by “qualified anti-terrorism technology” (which could conceivably include vaccines) to file suit in federal court, and it prohibited them from pursuing exemplary damages. The law also limited the manufacturer’s damages to the amount of SAFETY Act-mandated liability insurance. Congress could also consider creating a specific liability compensation program for alleged victims of Ebola vaccines and/or treatments, or bring the nascent vaccines under the rubric of an existing no-fault regime for vaccines, namely the National Vaccine Injury Compensation Program.
One final option, which may be the most feasible and immediately beneficial, would be to apply the Public Readiness and Emergency Preparedness Act of 2005 (PREP Act) to Ebola vaccines and treatments. As explained in a 2006 Washington Legal Foundation Legal Opinion Letter, the act empowers the Secretary of Health and Human Services (HHS) to declare targeted liability protection for any vaccine or countermeasure in the event of a credible threat to public health or a public health emergency. Any person or entity can seek such a declaration, or the Secretary can make one sua sponte. The PREP Act applies only to tort liability claims, and the Secretary can limit the duration of the immunity and can apply other narrowing factors, such as geographical area and distribution method. Allegedly injured parties can only sue in federal court if the FDA or the Justice Department investigates and finds willful misconduct by the drug manufacturer. The act preempts all state laws that might limit distribution of the declared countermeasure, and it creates compensation funds for injured parties.
The HHS Secretary has previously declared PREP Act protection for six classes of drugs, most recently for the manufacture, distribution, and dispensing of avian influenza virus vaccine.
The passage of new laws, the expansion of current ones, or the use of the PREP Act to address liability arising from the testing, manufacture, and dispensing of Ebola vaccines and countermeasures should be high on Ebola “czar” Ronald Klain’s to-do list. America is fortunate that the feared deployment of smallpox as a bioterror weapon hasn’t materialized, and that the avian flu virus did not proliferate. But government policies to mitigate liability exposure and create programs that cut out avaricious plaintiffs’ lawyers from the injury compensation process successfully helped us to prepare. Similar measures are needed now as the deadly threat of Ebola stares us in the face, measures that may speed development of products that can stem the disease’s spread overseas as well.
Also published by Forbes.com at WLF’s contributor page