Legal, BioPharma

Lawyers address what we can do and what we must do in vaccine rollout

Hospital counsel, state advisors, congregate care advocates and university leaders believe that public health ethics must drive the next steps in vaccine distribution and not the constraints of the law.

A host of legal experts advised their peers to be guided by ethics, not the constraints of the law, in this next wave of vaccine distribution, in a timely presentation titled “Legal Issues in Covid-19 Distribution” webcast to viewers across the country.

In a myth-busting and wide-ranging two-and-a-half hour discussion sponsored by the New York City Bar, health law experts from academia, government, health care institutions and nonprofit advocacy groups representing vulnerable populations explored the potential legal limits on an equitable vaccine rollout, concluding we need to remain creative and listen to the most impacted stakeholders as we fight this pandemic.

“We still don’t know what we don’t know about this virus,” said Linda Martin, chief compliance officer for CareOne. “We’re still at war with this invisible enemy and this is no time to lose our humility — information, in this war, may just be our most powerful weapon.”

Addressing informed consent, federalism, employment law, and protections under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), they concluded that structural inequality, broken trust and the limits of our imaginations hold far greater threats to a successful nationwide vaccine program than any law. Given the emergency nature of this pandemic, the government has a wide berth to act in the public interest — including sharing our data across agencies and entities, if it means winning this “war.”

However, a significant fault line erupted in the discussion on vaccine mandates, between what employers and the state can do under the law, and what some speakers feel they should do to achieve the desired end of herd immunity.

“Just because we can mandate, doesn’t mean we should,” said Karen Porter, Associate Dean and Executive Director of the Center for Health, Science and Public Policy at Brooklyn Law School.

What We Can Do, Under the Law
The panel began by addressing the question of whether the federal government might overstep its bounds by taking control of the currently state-led vaccine rollout, be it by establishing priority groups or deciding on procedures.

Professor Carl H. Coleman of Seton Hall University Law School and St. Peter’s Health Partners Vice President for Legal Services Robert N. Swidler addressed the legal limitations on Covid vaccine distribution at the federal and employer level, finding significant precedent to support both under both the Commerce Clause and Spending Clause of the Constitution.

While federalism would limit the U.S. government’s ability to govern state action on most things, Swidler argued that activities taken to protect the public health still fall under the Commerce Clause, even in the wake of 2012’s Supreme Court Decision in National Federation of Independent Business v. Sebelius. That decision challenged the constitutionality of the Affordable Care Act under the Commerce Clause and Spending Clause. There, Chief Justice Roberts said that “as expansive as this Court’s cases construing the scope of the commerce power have been, they uniformly describe the power as reaching ‘activity.’” Here, Swidler reasoned, the “activity” in question is distribution of vaccines, so the public is not being regulated for “doing nothing.”

Swidler also distinguished application of the Spending Clause to a federal oversight of vaccine distribution from the Affordable Care Act’s creation of a federal insurance marketplace. The Supreme Court in Sebelius reasoned that a state must knowingly and willingly accept the terms of federal grantmaking in advance of a shift in federal spending away from the states, which he said would be the case here.

Prof. Coleman discussed whether a vaccine could — or should — be mandated by the state, in the case that it is not willingly received. He shared that historically, the courts balance “an individual’s right to refuse treatment against the state’s interest in protecting third parties,” but that in the case of widespread public harm (such as a pandemic), they become significantly more deferential to the state. Coleman said there is no religious exemption to requiring vaccination, only one where delivering the vaccine would be medically contraindicated, in which case it would be “cruel and inhuman to the last degree,” according to the court in 1905’s Jacobson v. Massachusetts.

However, the FDA has clearly stated that individuals must be able to refuse administration of the vaccine while it is under an Emergency Use Authorization, stating: “For an unapproved product… and for an unapproved use of an approved product… the statute requires that FDA ensure that recipients are informed to the extent practicable given the applicable circumstances… that they have the option to accept or refuse the EUA product and of any consequences of refusing administration of the product.”

Given that limitation and the potential that broad mandates might backfire and increase mistrust in the vaccine distribution system, Coleman recommended looking at mandates as a last resort, in line with the “least restrictive alternative” principle of public health ethics.

Swidler made the case that whether the state took it upon itself to mandate, employers had the right, and in some cases the ethical duty, to require vaccination as a condition of employment. As legal executive of a hospital, he reasoned that such vaccination fell under OSHA’s obligation to provide a safe work environment and was further legally supported in a healthcare setting.

“Employers already can mandate vaccinations, subject to a couple of limitations (religious exemptions, Americans with Disabilities Act responsibilities, union collective bargaining agreements), and it’s likely to become more prevalent as a couple of things happen,” Swidler told listeners. “First, as the vaccine becomes more available, and second, as we collect more information about the vaccine, the safety and efficacy of it, the more likely employers are to mandate.”

What We Should Do, According to Public Health Ethics
Albany Law School Dean Alicia Ouellette recounted her experience serving on Governor Cuomo’s Covid-19 Vaccine Distribution and Implementation Task Force, where she brought her deep knowledge of bioethics to the development of the state’s vaccine prioritization scheme. Relying on an internet meme format for her comparison, Ouellette shared “how it started,” with the plan intending to target the hardest-hit seniors, front-line workers and communities of color.

However, the state’s execution of that plan used hospitals as hubs, relied too heavily on technology and failed to balance equity and efficiency, as Governor Cuomo opened up access to larger segments of the population despite no change in the state’s extremely limited vaccine supply.

Given those mistakes, she said that “how it’s going” has been anything but ethical, with hospital board members and wealthy, white, tech-savvy Americans getting shots intended for the state’s low-income, Black and Latino seniors.

Fixing this will require shifting our entire approach, Dean Porter said, and listening to the communities most harmed by this virus.

“They’re not interested in performative activities where lip service is paid to the fact of racial or other disparities or implementation delivery suggests a lack of recognition of the humanity of these groups and a true commitment to equitable access,” Porter said, “and that is how it is experienced when people are unable to get the access that they’ve been promised or feel they’ve been left behind.”

When the topic came to whether employees of nursing homes should be mandated to get inoculated, Dean Porter reminded listeners that the demographics of those workers skews heavily Black, female and low-access to information. She argued that a voluntary approach would be far more successful, given the trauma nursing home workers have experienced during this pandemic and the historical trauma of racism in healthcare.

She noted that building trust in communities would go much farther than any mandated vaccine programs in achieving the desired outcome of herd immunity, recommending we look to public health ethics, legal requirements and community concerns to retool the U.S. vaccine rollout, moving forward.

Dean Porter concluded that it would be unethical to place the burden to vaccinate on communities hardest-hit by Covid-19 without first addressing their fears and anxieties.

“They are tired of being villainized for vaccine hesitancy while the systems that created that hesitancy go unchanged,” Porter said.

Photo: LarisaBozhikova, Getty Images