The Need for Vaccine Regulation Overhaul

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Legal scholar calls for reform of the National Childhood Vaccine Injury Act.

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The vast majority of health care providers in the United States fail to report vaccine injuries to the government as required by law, one study showed.

The source of the problem lies with an “outdated” National Childhood Vaccine Injury Act (NCVIA) which lacks sufficient punitive measures for noncompliance, according to an article published by Efthimios Parasidis, a law and public health professor at The Ohio State University. Parasidis emphasizes the need to reform how regulators take account of so-called vaccine adverse events—that is, any injury caused by vaccination.

Under current law, NCVIA mandates the U.S. Department of Health and Human Services (HHS) to monitor vaccine injuries reported by vaccine providers from across the United States. The failure to report adverse events masks the potentially life-threatening risks of vaccines from vaccine regulators, adds Parasidis. Moreover, when providers fail to report the potential risks of vaccination, HHS’s ability to orchestrate changes in how manufacturers design vaccines and providers administer vaccines decreases significantly.

To solve this reporting problem, Parasidis proposes that regulators penalize noncompliant providers by fining them or reducing the payments they get from health insurance companies for their vaccine services.

Parasidis further proposes that regulators directly require manufacturers to monitor adverse events after they put their vaccines to market. He argues manufacturers should be required to notify FDA immediately if product testing demonstrates an “imminent or substantial threat” to patients.

In addition to suggesting reforms to adverse event reporting requirements, Parasidis proposes that regulators make it easier for patients to receive compensation for vaccine injuries.

Currently, when patients experience vaccine injuries, they must submit a petition to the U.S. Court of Federal Claims to receive compensation through HHS’s National Vaccine Injury Compensation Program. A specialized team of government medical staff then evaluates the petition before making a preliminary recommendation on the petition’s merits. Finally, government officials use the medical staff’s recommendation to file an official report and legal analysis to the judge assigned to the petition.

Parasidis explains that under this unique legal process, the overwhelming majority of patients do not receive compensation for their injuries.

Indeed, to receive compensation, injured patients and their lawyers must put in a tremendous amount of work because of the NCVIA’s harsh evidentiary standards, according to Parasidis. Under the NCVIA’s current framework, injured patients bear the burden of showing that the vaccine they received caused the injury, which requires expert testimony, extensive medical evidence, and difficult legal analysis. And even if injured patients can provide convincing evidence, the government can still point to other factors that might have mitigated the causal relationship between the vaccine and the injury.

What Parasidis calls a “stringent legal bar” makes it almost impossible for petitions from injured patients to garner compensation, even if regulators intended the NCVIA to provide accessible remedies for vaccine injuries.

To make compensation more accessible, Parasidis proposes that policy-makers amend the NCVIA and put in place a new “burden-shifting paradigm.” This new approach would require petitioners to provide mere credible evidence to prove causation. If petitioners were to meet this lower standard, the government would then have the heavier burden to disprove the petitioner’s theory of causation.

According to Parasidis, this new approach would expand protections for vaccinated patients across the United States. Moreover, because the government’s liability exposure would increase, the government would have greater incentive to conduct more research on vaccine-related adverse events as such research could bolster their capacity to defend themselves in court.