The Ebola Vaccine, Latrogenic Injuries, and Legal Liability

Thursday, December 3, 2015

Making vaccines is a risky, oftentimes unenviable business. Vaccines are administered to healthy people who tend to be unforgiving if an adverse side effect or injury subsequently develops. The risk of being sued, even when a vaccine supplier follows best practices, combined with growing anti-vaccination sentiment, creates a climate that is not conducive to vaccine innovation. The dissuasive effect of litigation risk and legal liability is heightened both for vaccines aimed at diseases of poor countries, for which the financial inducements are weak anyway [1,2], and vaccines for public health emergencies, which are developed in accelerated clinical trials that may lack the statistical power or detailed follow-up necessary to detect rare adverse effects. Yet, as the West African Ebola outbreak demonstrates, the world can ill afford not to have vaccines against diseases of poverty in emergency situations [1]. Several reasons exist for not having a vaccine available, relating to the biology of the virus and the epidemiological challenges pertaining to evaluating a vaccine for a rare disease. However, financial incentives and disincentives for vaccine manufactures to invest in vaccine trials for rare diseases in resource-poor countries also need to be considered. We argue that, as one part of a comprehensive plan to promote vaccine development, there needs to be a plan to lessen the risks of litigation and liability to remove disincentives for these vaccines to be developed and later deployed. As others point out, no satisfactory plan now exists [3].

In the past, worries about litigation and liability have delayed the availability of vaccines, even as other parts of the emergency response have been hastened. For example, during the 2009 H1N1 influenza pandemic, WHO reduced the process of prequalifying vaccines for safety and efficacy from the usual 12–24 months to as little as one day—but could not accelerate the legal issues similarly [4]. In Africa, the typical time taken from a country expressing interest to WHO about receiving donated vaccine, and signing the “letter of agreement” containing the liability arrangements, was about 100 days [5]. Progress was stalled by some countries lacking resources to interpret the liability issues that this vaccine raised. Liability holdups probably explain why some countries received vaccine after the pandemic’s peak had passed [4].

Post-H1N1, WHO recommended to “prepare in advance and maintain a framework…to expedite legal agreements during future pandemic events” [5]. That framework, however, never came into being, and so in this paper we review three options that have currency now, as the interim results of a clinical trial have demonstrated 100% protective efficacy for an Ebola vaccine [6]. The recognized options include the following: (1) the country experiencing the public health emergency can indemnify the vaccine supplier, or (2) the United Nations can use its immunity from lawsuit to shield the vaccine supplier. But we believe that both of these are surpassed by a third, superior option, in which (3) the international community can establish a no-fault compensation fund to fairly redress vaccine injuries. The three options are discussed more fully here.

Government Indemnity

In developed countries, it is often the case that governments advance the public goods of vaccination by assuming liability for vaccine injuries on a “no fault” basis (i.e. without a finding of wrongdoing) [7]. This requires a complex legislative scheme to resolve injury claims fairly outside of the courts. For example, in the United States, laws create an injury compensation fund and “vaccine court,” supported by a tax on vaccine sales, and shield vaccine manufacturers from lawsuits [8]. The system creates indemnity for select adult and childhood vaccines and for vaccines related to a declared public health emergency, except in the event of willful misconduct [9].

However, nearly all developing countries, and some developed ones (e.g., Canada), lack such national laws. Since authoring complex legislation during a pandemic is between difficult and infeasible, these governments can instead use interim, ad hoc arrangements in contract law to assume the risks faced by vaccine suppliers. These are commonly known as indemnity, or “hold harmless,” agreements.

Contractual agreements are by nature bilateral: there needs to be one for each manufacturer or supplier needing indemnification, although these could, if desired, conform to a template. The agreement can take the form of a stand-alone indemnity contract, or an indemnity clause can be included in the contract of sale. During the H1N1 pandemic, many countries that received vaccine donations relied on a WHO-drawn template, although some made independent arrangements. Regardless, the general formula is to provide the vaccine supplier a legally binding assurance that the government assumes all liability for vaccine-related injury, so long as the supplier complies with current good manufacturing practices and agreed-on specifications.

Source: PLOS (link opens in a new window)

Health Care
infectious diseases, vaccines