blue brain hovers over bright blue circle.

Is OI the New AI? Questions Surrounding “Brainoware”

By Adithi Iyer

The idea of artificial intelligence is just seeping into our collective consciousness, but as we watch new developments in the space, the true “new kid on the block” may be a new type of infused human-technology intelligence — one derived from a blob of cells no larger than a grain of rice. These new units of computational prowess are brain organoids, grown in-lab and capable of producing very basic, but real-time, neurological activity. Brain organoids are a specific, and arguably the most interesting, subset of organoid models that are just beginning to enter legal debates.

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Culturing cells in tissue culture plates.

R&D Mini-Me? New Legal Questions for Organoids

By Adithi Iyer

I have written previously about the not-so-distant possibility and promise of regenerative medicine, an area concerned with therapies that encourage the body to repair or heal itself. Cell-mediated and tissue-based technologies hold promise in inducing self-repair from within the body, and they’re making their way to market in traditional medicine. Much has been made of recently discussed CAR-T cell therapies for cancer, which have been around since 2017, and in-human sickle cell treatment Casgevy. Such applications of regenerative medicine and tissue engineering are wide-spanning and range across the bench-to-bedside pathway.

One application of regenerative medicine gaining some ground in the R&D space is the organoid. Organoids are lab-grown masses of cells and tissue that assemble to form miniature organs or organ systems in vitro. They come, too, in different forms and types, and while some organoid applications are heavily modified for specific functions, many are meant to recreate and model the naturally occurring organ systems we would find in our own bodies.

Organoids may sound especially futuristic, but are currently used regularly in labs for different research and therapeutic applications. A functional “organ” model not attached to a human body could offer the opportunity to model diseases and test treatments in real time without the need for an animal model (like the mice used today), especially in preclinical and early clinical trials for new drugs. Organoids generate information and data, and a single organoid model can even be hooked up to a “system” with other organoids to model systems and interrelated processes at once. The production of these models occurs in-lab, often involving stem cells that can divide and organize into tissues and organs on their own.

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cell with pipette and needle.

Are Embryos Children? The Alabama Supreme Court Says Yes

By Joelle Boxer

This month, the Alabama Supreme Court held that the term “children” in a state statute includes embryos, or “extrauterine children.”

As fertility treatments like in vitro fertilization (IVF) involve the creation of multiple embryos, not all of which are implanted, the implications of this ruling could be far-reaching. Four million births each year in the U.S. are via IVF, an important pathway to parenthood for couples with infertility, LGBTQ couples, and single parents.

This article will examine the Alabama Supreme Court’s decision in LePage v. Mobile Infirmary Clinic and its consequences for Americans building their families through fertility services.

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Birmingham, Alabama - February 8, 2020: University of Alabama at Birmingham UAB Hospital title and logo on brick facade.

The Beginning of a Bad TRIP – Alabama’s Embryonic Personhood Decision and Targeted Restrictions on IVF Provision

By Katherine L. Kraschel

Last week, the Alabama Supreme Court called frozen embryos created via in vitro fertilization (IVF) “extrauterine children” and referred to the cryotanks where they are stored as  “cryogenic nurser(ies).” The Court sided with couples who claim the accidental destruction of frozen embryos created through IVF and cryopreserved ought to be treated equally to the death of a child. 

The case, LePage v. Center for Reproductive Medicine, involves plaintiffs seeking punitive damages from an Alabama fertility clinic for the “wrongful death” of their embryos that were destroyed when a patient in the hospital where they were stored removed them from the cryotank. While the lower Alabama Courts concluded that the cryopreserved embryos were not a person or child under the state’s law, the Alabama Supreme Court disagreed and held that the state’s Wrongful Death of a Minor Act “applies to all unborn children, regardless of their location,” and that the  plaintiff’s wrongful death claims could proceed. 

Thoughtful scholars have argued that existing state laws do not sufficiently redress mistakes and accidents that occur in the process of fertility care, pregnancy, and birth. However, the ends do not justify the means in this case; likening frozen embryos to children is not a legally sound mechanism to hold fertility clinics accountable for negligently storing embryos. It illustrates how sympathetic stories can be used to further the agendas of those who seek to equate embryos and fetuses  to “people” under the law and undercut the critical role modern fertility care plays in (re)defining the bonds that create families, and particularly, many LGBTQ+ and single parent families. 

Specifically, lawmaking in fertility care stands to fuel the movement to create fetal personhood rights and a federal abortion ban. It may also signify an inflection point in regulating assisted reproduction reminiscent of pre-Dobbs targeted restrictions on abortion provider (TRAP) laws that sought to limit abortion provision by imposing restrictions. TRAP laws’ new sibling – targeted restrictions on IVF Provision – or TRIP laws, as I call them, stand to rob patients of their ability to build their families by compelling physicians to provide less effective, more expensive care. TRIP laws will erect barriers and exacerbate long standing racial disparities in accessing fertility care, and they will disproportionately impact members of the LGBTQ+ community who wish to build families through fertility treatments.  The Alabama decision is severe, but it should serve as a warning to state legislators with a new responsibility to safeguard reproductive health care without the floor of Roe’s protections – proceed with extreme care and regard for “unintended” consequences of regulating fertility care.  Read More

see saw with earth as fulcrum and a pile of vaccines weighing down one side with nothing on the other side.

The Case for Procurement Transparency

By Tara Davis and Nicola Soekoe

In January 2021, the Director General of the World Health Organization (WHO) observed that the world was on the brink of a “catastrophic moral failure” if wealthier nations did not ensure the equitable distribution of COVID-19 vaccines. Global health activists and civil society organizations who worked transnationally to curtail what came to be referred to as “vaccine apartheid” faced a pharmaceutical industry that globally relied on secrecy, capital-friendly trade laws, and brute economic force to shirk considerations of human rights. In many ways, pharmaceutical companies and the states that protected them, including by failing to achieve consensus at the World Trade Organization (WTO) for a waiver of intellectual property rights with respect to vaccines, seemed impenetrable.

Unsurprisingly, given the extreme position of power from which pharmaceutical companies were negotiating contracts, there were widespread reports and allegations of inequitable contractual terms and a culture of bullying in the development of contracts. This was an issue of global concern for a long period during the pandemic. In South Africa, the Health Justice Initiative (HJI), a local advocacy organization, joined the global calls for greater procurement transparency.

However, when the South African Department of Health refused to disclose even the names of the entities with which it had entered into vaccine-related agreements, the HJI was forced to turn to the courts for relief.

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Close-up Of An Open Law Book On Wooden Desk In Courtroom.

Can Rights Make Any Difference for Access to Health? Insights from a Scoping Review on Constitutional Rights for the WHO Council on the Economics of Health for All

By Luciano Bottini Filho, Camila Gianella Malca, and Alicia Ely Yamin

The intersection of health financing and the right to health is a common concern in public health advocacy. However, it is challenging to isolate the mechanisms that connect individuals’ rights with increased public investment. As scholars, we grapple with the question of what happens once the right to health is constitutionalized and whether it has a transformative effect on the economy, government funding, and the material reality people face in struggling health care systems. In this article, we shed light on this significant gap between the adoption of the right to health through constitutions or legislation and actual changes in the economy and government funding for health. Our study was commissioned by the WHO Council on the Economics of Health for All, which received the mandate of formulating a new global economic model to achieve health for all.

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Strasbourg, France - April 13, 2018: the Hemicycle of the Parliamentary Assembly of the Council of Europe, PACE.

The Parliamentary Assembly of the Council of Europe: Responding to Public Health Emergencies by Upholding Human Rights, Democracy, and the Rule of Law

By Anita Gholami

The Parliamentary Assembly of the Council of Europe, which brings together parliamentarians from 46 member States, has been a vigilant guardian of respect for the European Convention on Human Rights and other international standards throughout the COVID-19 pandemic. The Assembly has adopted a number of resolutions and recommendations seeking to equip parliaments in our European member States and beyond with the relevant tools and expertise to uphold human rights, democracy and the rule of law. It has been an important forum for enabling States to address the fault lines in national public health systems, bridge gaps in global health security and policy, and strengthen collective efforts to build back better.

In June 2023, the Assembly adopted Resolution 2500 (2023) on “Public health emergency: the need for a holistic approach to multilateralism and health care.” The report supports the ongoing processes taking place at the international level to transform global health governance. It considers that States must build on the principles of equity and the protection of human rights and fundamental freedoms during public health emergencies, and thus makes specific and productive reference to the Principles and Guidelines on Human Rights and Public Health Emergencies (“the Principles”).

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hospital equipment

Scarcity Is Not an Excuse to Discriminate: Age and Disability in Health Care Rationing

By Silvia Serrano Guzmán

On July 4, 2023 the Constitutional Court of Colombia handed down a landmark decision on one of the most difficult dilemmas faced during the COVID-19 pandemic: the rationing of intensive care in situations of scarcity. Although the need for prioritization was a reality almost globally, many countries had no such regulation in place, which frequently led to the adoption of fragmented and discriminatory triage protocols.

The Colombian case reinforces that human rights and public health are not mutually exclusive. Importantly, this is reflected in the Principles and Guidelines on Human Rights & Public Health Emergencies (2023). Though the Principles did not exist during the litigation of the case, they will be of use in similar instances going forward, both for States working to develop human rights-compliant public health measures, as well as for courts reviewing such measures.

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Group of Diverse Kids Playing in a Field Together.

Securing a Place for Children’s Rights in Public Health Emergencies

By Sheila Varadan, Ton Liefaard, and Jaap Doek

The Principles and Guidelines on Human Rights and Public Health Emergencies (Principles) make a significant contribution towards clarifying the scope of States’ legal obligations under international human rights law during public health emergencies. What is missing, however, is a specific and detailed discussion on the rights obligations and principles owed to children during public health emergencies. This leaves open the question of how States will guarantee respect for and protection of children’s rights in future public health emergencies, and what measures, if any, will be taken to ensure children are actively listened to and engaged with in the prevention of, preparedness for, and response to public health emergencies (PPRR).

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Fertilized human egg cells dividing.

What the Law and Bioethics Tell Us About Synthetic Human Embryos

By Barbara Pfeffer Billauer

A synthetic embryo can now be constructed from very early pre-embryonic cells – without the need for an egg or sperm. These were initially created in mice. In April, researchers in China published about their creation of synthetic monkey embryos. In June, it was reported that the first synthetic human models were apparently created. This development throws a moral monkey-wrench into the current moratoria on embryonic research after 14 days. But there are more problems ahead.

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