Single strand ribonucleic acid.

The Secret World of mRNA: HDT Bio Corp v. Emcure and Access to Next-Gen mRNA

By Aparajita Lath

The future of public health in an “RNA world” is on trial in a trade secrecy dispute worth $950 million currently being fought before the District Court of the Western District of Washington, Seattle between HDT Bio Corp. and Emcure Pharmaceuticals.

The trade secrets at issue concern an improvement over existing mRNA technology called “self-amplifying RNA” or “saRNA.” saRNA are effective at much smaller doses and lower costs. The saRNA technology is being used to develop vaccines for COVID, Zoster, Zika and Rabies.

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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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Person in protective yellow hazmat suit and mask holds pills in hands.

Book Review: ‘The Truth Pill: The Myth of Drug Regulation in India’

By Aparajita Lath

The Truth Pill, authored by Dinesh Thakur and Prashant Reddy, is a monumental work that convincingly shows that drug regulation is but a myth in India.

In their investigative style, the authors explain drug regulation in India through the lens of history, both Indian and global. The book’s combination of history and contemporary issues makes for an immersive and compelling read. It may, however, leave you feeling frightened, given the dysfunctional regulatory system in India and the impact this can have on patients around the world. However, the book not only highlights problems but also offers several well-thought-out and actionable paths to reform.

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Bill of Health - American currency (50, 100, 20) on a wooden table next to pills and spilling bottle of pharmaceuticals

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariAviva WangLiam Bendicksen, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of October. The selections feature topics ranging from newly enacted incentives for increasing diversity in clinical trials, to an analysis of how patients’ out of pocket costs changed after biosimilar versions of infliximab entered the US market, to an evaluation of how manufacturers have navigated postmarket requirements for drugs recently approved by the FDA. A full posting of abstracts/summaries of these articles may be found on our website.

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Woman with face mask getting vaccinated.

The Right Tool for the Job: Supporting Vaccination Rates with Universal Paid Sick Leave

By Alina Schnake-Mahl, Rebecca Finkel, and Jennifer Kolker

Policies like paid sick leave are key tools to prevent another “winter of death” and disruption, finds our recent study of U.S. cities’ sick leave and vaccination data. Further, universal paid sick leave policies are particularly effective at protecting the most vulnerable communities.

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Black and white photo of a woman with phone in hand; phone has color retouched image of her face on it.

The Filter Effect: What Does Comparing Our Bodies on Social Media Do to Our Health?

By Sarah Gabriele

Filters on social media apps such as Instagram and TikTok are great to take silly pictures alone and with friends, and they often give us a good laugh. However, as Dr. Christine Stabler from Penn Medicine writes, they also create an illusion, a perfection that we struggle to live up to every day. This is the case even if almost everyone is well aware that pictures are filtered and carefully selected, and that pictures do not always represent reality.

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UN United Nations general assembly building with world flags flying in front - First Avenue, New York City, NY, USA

The UN Must Take Steps To Be an Accountable Player in Public Health

By Bailey Kennedy

If a government commits a tort, it can be sued — but the United Nations cannot be. That’s because it is generally understood that the UN has absolute immunity, meaning that no national court has jurisdiction over the UN. This immunity is justified on the basis that the UN cannot effectively fulfill its role in the world if it is constantly at risk of being hauled into court around the globe. Moreover, at the time the UN was founded, it was understood to be an organization that would promote peace, security, and health across the globe — and why would such an organization need to be sued? 

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Medicine doctor and stethoscope in hand touching icon medical network connection with modern virtual screen interface, medical technology network concept

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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FDA approved concept. Rubber stamp with FDA and pills on craft paper. 3d illustration.

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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