close up photo of U.S. currency.

When “Pay-for-Delay” Becomes “Delay-Without-Pay”: Humira Antitrust Claims

By Laura Karas

In June 2020, the U.S. District Court for the Northern District of Illinois dismissed state and federal antitrust claims against AbbVie, maker of Humira (adalimumab), for accruing more than 130 patents on the top-selling drug and asserting allegedly unmeritorious patent infringement claims against makers of adalimumab biosimilars. AbbVie then settled the patent infringement litigation by entering into agreements with eight drug makers to allow adalimumab biosimilars to enter the U.S. market in 2023 and the European market in 2018.

In my last post, I discussed the district court’s memorandum opinion finding that “the vast majority” of AbbVie’s conduct was not “objectively baseless petitioning” and was therefore immunized under the Noerr-Pennington doctrine. In this post, I explore several problematic aspects of the court’s reasoning for rejecting the claims of pay-for-delay and market allocation.

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U.S. Capitol Building at Night

Advantages of Using the Congressional Review Act to Revoke Health Care Waivers

By Matthew B. Lawrence

The Trump Administration has granted health care waivers that the Biden Administration will surely look to end, including work requirement waivers that the Supreme Court is going to consider in Azar v. Gresham. How the Biden Administration approaches this task may set precedents that last far into the future, which is one argument in favor of considering the Congressional Review Act as a potential path forward.

Waivers are a huge part of health policy. They entail a state seeking approval from the federal government to make various changes to ACA or Medicaid programs. Waivers are normally approved for several years at a time, and routinely renewed. They foster experimentation, and are also (or especially) a tool the federal government uses to steer national health policy by pushing states to adopt some reforms and not others, as I explain in a forthcoming article.

Over at the Yale Journal of Regulation blog, I describe how the Congressional Review Act (CRA) could potentially be used to revoke health care waivers (like community engagement, aka work requirement, waivers).

In brief, the CRA is a way Congress can change the law to revoke agency actions without the votes necessary to override a filibuster. The CRA might be a cleaner alternative for revoking health care waivers than administrative revocation by the Biden Administration. One big policy advantage of this route is that it wouldn’t come back to haunt health policy. Revocations through the administrative process would set a precedent that could undermine the stability of all waivers, but revocations through the CRA would not.

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abortion protest outside supreme court.

The COVID-19 Pandemic Reveals the Stakes of the Campaign Against Abortion

By Mary Ziegler

Once again, we’re talking about whether abortion counts as health care. The COVID-19 pandemic has sparked new efforts to limit access, from the government’s unwillingness to lift in-person requirements for medication abortion to the introduction of stay-at-home orders blocking access altogether. The campaign to frame abortion as a moral, not medical, issue began decades ago. The pandemic has revealed the broader stakes of this campaign — and what it might mean for access to care well after the worst of the pandemic is behind us.

For antiabortion leaders, there are obvious strategic reasons to insist that abortion is not health care. The stigma surrounding abortion is real and durable. Notwithstanding recent increases, many obstetric programs do not provide comprehensive abortion training (if they provide any training at all). A 2020 study in Plos One found that a majority of patients believed that they would be looked down upon “at least a little” for having had an abortion. This perceived stigma affects those refused abortions — and causes longer-term adverse mental health outcomes. Stigma has long been an effective tool for the antiabortion movement. The pandemic has done nothing to change that.

But, put in historical context, today’s effort to treat reproductive services as unessential means much more. That campaign is part of a broader agenda to undermine the idea of an autonomy-rooted abortion rights — and lay the groundwork for overturning Roe v. Wade.

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image of the US Supreme Court

What the Supreme Court’s ACA Ruling Might Mean for Nonprofit Hospitals

By Jacob Madden

California v. Texas, a pending Supreme Court case that concerns the constitutionality of the Affordable Care Act (ACA)’s individual mandate, could have profound implications for the standards to which nonprofit hospitals are held.

The ACA’s individual mandate requires people to have health insurance or otherwise pay a penalty. While the Court previously upheld the individual mandate as being constitutional under Congress’ taxation power in the 2012 case National Federation of Independent Business v. Sebelius, it may not do so again. For one, the 2017 Trump tax cuts effectively eliminated the individual mandate’s penalty, raising the question of whether the individual mandate is still a valid exercise of Congress’ taxation power. And conservative Judge Amy Coney Barrett’s confirmation, filling the late Justice Ruth Bader Ginsburg’s seat, has significantly changed the composition of the court.

If the Court strikes down the individual mandate, the rest of the ACA could be in jeopardy, depending on the specifics of the ruling. The Court has several options: sever the individual mandate from the ACA and keep the ACA alive, strike down the ACA in part, or strike down the ACA entirely.

The immediate concern, should the Court strike down the ACA entirely, is that tens of millions of Americans likely would lose their health insurance and other protections afforded by the law. Another, albeit lesser known concern, is that we would lose § 501(r).

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abortion protest outside supreme court.

Reproductive Rights vs. Reproductive Justice: Why the Difference Matters in Bioethics

By Danielle M. Pacia

When conceptualizing the pursuit of reproductive freedom, we must acknowledge the ways that our systems and structures fail Black, Indigenous and people of color (BIPOC) populations.

2020 has been a year filled with anxiety and anger over the COVID-19 pandemic’s disproportionate negative effects on BIPOC populations. Black Lives Matter protests after the unjust deaths of Breonna Taylor, Mia Green, George Floyd, Rayshard Brooks, Riah Milton, and many others whose lives ended far too soon have prompted an overdue awakening. This has caused some to reexamine racism on a personal and institutional level. Like many disciplines in our country, the field of bioethics has begun to recognize how the field reinforces racism within its scholarship.

Part of this effort includes a critical examination of the frameworks we employ when analyzing bioethical subjects and events, and how they may exclude the historical contributions and narratives of BIPOC populations. Merely acknowledging racism is not enough.

Here, I will explain the differences in the terms reproductive justice and reproductive rights and advocate use of the reproductive justice framework instead of the reproductive rights framework. Within bioethics and health law policy, there is often a lack of clarity between the terms, which, in turn, leaves their important conceptual and historical differences ignored.

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U.S. Supreme Court building

The Artifices of Corporate Speech: Video Preview with Nathan Cortez

The Health Law Policy, Bioethics, and Biotechnology Workshop provides a forum for discussion of new scholarship in these fields from the world’s leading experts.

The workshop is led by Professor I. Glenn Cohen, and presenters come from a wide range of disciplines and departments.

In this video, Nathan Cortez gives a preview of his paper, “The Artifices of Corporate Speech,” which he will present at the Health Law Policy workshop on October 26, 2020. Watch the full video below:

abortion protest outside supreme court.

Abortion and the Law in America: Video Preview with Mary Ziegler

The Health Law Policy, Bioethics, and Biotechnology Workshop provides a forum for discussion of new scholarship in these fields from the world’s leading experts.

The workshop is led by Professor I. Glenn Cohen, and presenters come from a wide range of disciplines and departments.

In this video, Mary Ziegler gives a preview of her book, “Abortion and the Law in America: Roe v. Wade to the Present,” which she will present at the Health Law Policy workshop on October 19, 2020. Watch the full video below:

Washington DC.,USA, April 26, 1989. Supporters for and against legal abortion face off during a protest outside the United States Supreme Court Building during Webster V Health Services.

Event Video from “Reproductive Rights in 2020”

On July 16, 2020, the Petrie-Flom Center hosted a moderated discussion on recent developments for reproductive rights in the U.S.

2020 has been a notable year for reproductive rights, with the Supreme Court deciding June Medical Services v. Russo, and the COVID-19 pandemic affecting access to abortion, sexual health, and reproductive health services.

Watch panelists Mary Ziegler, Jamille Fields AllsbrookLouise P. King, and Julie Rikelman discuss these developments in a conversation moderated by Emily Bazelon.

London.UK.June 10th 2017.Anti DUP demonstration takes place in Parliament Square.

The Challenge of Implementing Abortion Law Reform in Northern Ireland During COVID-19

By Fiona Bloomer

As observed in the first two decades of the 21st century, abortion exceptionalism has carried through into 2020, remaining one of the most politicized issues globally.

In Northern Ireland (NI), this exceptionalism is evident in landmark developments to improve access, as well as in concerns over obstructions to services. Read More

globe.

June Medical Services and Access to Abortion: Comparative Lessons for the African Region

By Charles Ngwena

Drawing lessons from June Medical Services provides the African human rights system with an opportunity not to affirm what it has in common with the U.S., but rather to uphold its own approach and articulate the jurisprudence that sets it apart.

The U.S. regulates abortion primarily through its Supreme Court using jurisprudence which frames abortion as a right implied in the constitutional right to privacy.

On the other side of the comparison, the African human rights system frames abortion as a human right that transcends national borders in the African region. By “human rights system,” I am referring to the regional system founded under the African Charter on Human and Peoples’ Rights (the African Charter) and its supplementary treaties, especially the Protocol to the African Charter on Human and Peoples’ Rights on the Rights of Women in Africa (the Maputo Protocol).

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