red and green silhouette illustration of women having a conversation.

The Not-So-Sacred Human Genome: What South Africans Think About Heritable Human Genome Editing

By Donrich Thaldar

South Africans have issued a clarion call for research to move ahead on health-related applications of heritable human genome editing (HHGE), finds my research group’s new public engagement study — the first of its kind in Africa.

The study engaged a diverse group of 30 South Africans in three evenings of deliberations on the governance of HHGE. The methodology entailed (a) facilitated deliberation between the participants with the aim of finding consensus, although consensus was not forced; and (b) ensuring well-informed deliberations by providing participants with balanced, internationally peer-reviewed information about HHGE and the ethical arguments relating to it. The results of these deliberations are summarized briefly below.

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Genetic engineering and digital technology concept.

The ‘Res Nullius’ Construction of Human Genomic Data

By Donrich Thaldar

No one domain of the law holds exclusive sway over human genomic data. Instead, genomic data have a multidimensional legal nature, meaning that multiple legal domains — including property law, privacy law, contract law, and intellectual property law — are all applicable. This opens the door for different persons to have rights originating in different legal domains with respect to the same genomic data.

To determine who has rights with respect to a particular person’s genomic data, the rules of each relevant legal domain must be applied. The application of these rules to genomic data may be relatively straightforward in some domains, but in property law — which is relevant in determining ownership of genomic data — it is often more complicated. Only a handful of jurisdictions have specifically legislated on the ownership of genomic data. In the absence of such specific legislation that provides who owns genomic data, general property law rules must be applied. (In common law legal systems, and some mixed legal systems where legislation is absent, this would entail resorting to the jurisdiction’s common law.) However, given the novelty of applying property law rules to genomic data, it is not always obvious which of the general rules would apply. In this post, I will share some of my research group’s thinking in this regard. Although our thinking is based in South African law, many of the principles are shared with other legal systems.

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AI in Digital Health: Autonomy, Governance, and Privacy

The following post is adapted from the edited volume AI in eHealth: Human Autonomy, Data Governance and Privacy in Healthcare.

By Marcelo Corrales Compagnucci and Mark Fenwick

The emergence of digital platforms and related technologies are transforming healthcare and creating new opportunities and challenges for all stakeholders in the medical space. Many of these developments are predicated on data and AI algorithms to prevent, diagnose, treat, and monitor sources of epidemic diseases, such as the ongoing pandemic and other pathogenic outbreaks. However, these opportunities and challenges often have a complex character involving multiple dimensions, and any mapping of this emerging ecosystem requires a greater degree of inter-disciplinary dialogue and more nuanced appreciation of the normative and cognitive complexity of these issues.

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Book Review: ‘Drugs and the FDA: Safety, Efficacy, and the Public’s Trust’ by Mikkael A. Sekeres

By Matthew Chun

In Drugs and the FDA: Safety, Efficacy, and the Public’s Trust, oncologist Mikkael A. Sekeres tells a captivating story of how the U.S. Food and Drug Administration became the agency it is today and how it makes some of its toughest decisions regarding the regulation of potent drugs.

Sekeres centers his narrative on the controversial 2011 Avastin hearings, in which the FDA reconsidered and ultimately withdrew the breast cancer indication for Genentech’s Avastin drug. Having served on the Oncologic Drugs Advisory Committee (ODAC) tasked with making a recommendation to the FDA based on the hearings and clinical data, Sekeres provides a relatable personal account of the emotion-filled proceedings and the agonizing decision to withdraw approval of a beloved treatment option that never lived up to its promising initial results.

As he recounts his experience as an ODAC member, Sekeres skillfully weaves in historical references to various regulatory failures, including poisoned vaccines, opioid deaths, thalidomide-induced birth defects, and the woefully inadequate response to HIV/AIDS, which shaped the role of the FDA since its inception in 1930. Upon describing how the FDA developed its modern system of checks and balances to ensure drug safety, efficacy, and accessibility, Sekeres then illustrates how the Avastin hearings put all of these processes and values to the test. Among other things, Drugs and the FDA encourages readers to grapple with several important themes that pervade the agency’s decision-making process, including (1) the tension between drug safety and accessibility, (2) the relative weight of expert opinion versus patient autonomy, and (3) the role of democracy and transparency in drug regulation.

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Accessing COVID-19 mRNA Vaccines for Research: The Re-emergence of the Tragedy of the ‘Anticommons’

By Aparajita Lath

Some COVID-19 vaccine manufacturers in the US have refused to share vaccine samples for research purposes, creating an access issue with the potential to delay comparator studies, follow-on research, and new vaccine / drug development.

This issue may be the latest example of the tragedy of the “anticommons” in biomedical research.

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Blue biohazard sign in front of columns of binary code.

The International Weaponization of Health Data

By Matthew Chun

International collaboration through the sharing of health data is crucial for advancing human health. But it also comes with risks — risks that countries around the world seem increasingly unwilling to take.

On the one hand, the international sharing of health-related data sets has paved the way for important advances such as mapping the human genome, tracking global health outcomes, and fighting the rise of multidrug-resistant superbugs. On the other hand, it can pose serious risks for a nation’s citizens, including re-identification, exploitation of genetic vulnerabilities by foreign parties, and unauthorized data usage. As countries aim to strike a difficult balance between furthering research and protecting national interests, recent trends indicate a shift toward tighter controls that could chill international collaborations.

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Gamblers make bets at the roulette table in a casino.

We All Stand to Benefit from Biden’s $2 Billion Bet on the Bioeconomy

By Matthew Chun

Business is bustling for biotechnology and biomanufacturing. On September 12, 2022, President Biden signed an executive order, launching a “whole-of-government approach to advance biotechnology and biomanufacturing.” And two days later, he backed it up with a national summit and a $2 billion spending plan.

But who stands to benefit from this large commitment of federal money? We all do.

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Businessman crossing fingers behind his back.

Get Your Story Straight: Patent Office Cracks Down on Inconsistent Statements Made Before the FDA

By Matthew Chun

In an effort to “promote robust and reliable patents” and increase access to life-saving drugs, the United States Patent and Trademark Office (USPTO) recently issued a Federal Register Notice clarifying the responsibilities of individuals involved in the patent application process.

In the July 29, 2022 notice, the USPTO set forth its views on the “duty of disclosure” and “duty of reasonable inquiry,” emphasizing the importance of consistency between statements made to the USPTO, the FDA, and other governmental agencies. While the goals of the Federal Register Notice are certainly noble, its disruptive practical effects leave much to be desired.

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Bill of Health - Globe and vaccine, covid vaccine

Reclaiming Global Public Health

By Zain Rizvi

By December 2020, the world had astonishingly powerful tools against COVID-19. New mRNA vaccines, underpinned by decades of public investment, had been authorized by global regulators. Yet the promise of the vaccines was unevenly realized: deep fault lines emerged between those who were able to secure vaccines and those left behind, or what South Africa’s president Cyril Ramaphosa called “vaccine apartheid.”

Dose shortages elevated the role of pharmaceutical executives. Fielding calls from heads of state, they decided what vaccine deliveries to prioritize, shaping which countries could protect lives and livelihoods. The answer to one of the most important public health questions of our time — who gets access to vaccines? — was mostly determined neither by political representatives nor scientists, but by corporate executives.

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Cell culture.

A New Theory for Gene Ownership

By James Toomey

The story of Henrietta Lacks is surely among the most famous in the history of bioethics, and its facts are well-known. Ms. Lacks sought treatment for cervical cancer. After conducting a biopsy on her tumor, her doctors learned that her cancer cells reproduced uniquely effectively. Without her knowledge or consent, her doctors derived from the cells the HeLa cell line — the world’s first immortal human cell line, worth billions and a driver of the biotechnology revolution. Lacks died in poverty.

No doubt her doctors’ behavior was not consistent with today’s standards of informed consent. But another question has remained more persistently challenging — did the doctors steal something from Lacks? Did she own the cells of her tumor? Or, perhaps more precisely, because few argue that HeLa is really the same thing as Lacks’s tumor cells, did she own the genetic information contained in her tumor?

In a new paper, Property’s Boundaries (forthcoming in the Virginia Law Review, March 2023), I develop a theory of what can and cannot be owned to answer these kinds of questions — pervasive in bioethics, from debates about ownership of organs to embryos. My conclusion, in short, is that because the essence of the idea of ownership is a relationship of absolute control, anything that can be the subject of human control can, in principle, be owned. But that which we cannot control we cannot own. From this perspective, Henrietta Lacks owned the cells of her tumor, and the tumor itself. But the genetic information within them — facts about the universe subject to no human control — simply cannot be owned, by her or anyone else.

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