Concept illustration of DNA and genes.

The Civil Rights Challenge to Gene Patenting

By Jorge L. Contreras

In 2009, the American Civil Liberties Union (ACLU) launched a unique lawsuit against Myriad Genetics, challenging fifteen claims of seven patents covering various aspects of the BRCA1/2 genes and their use in diagnosing risk for breast and ovarian cancer. In mounting this case, the ACLU assembled a coalition of lawyers, scientists, counselors, patients and advocates in an unprecedented challenge not only to one company’s patents, but the entire practice of gene patenting in America. And, against the odds, they won. In 2013, the U.S. Supreme Court ruled in Association for Molecular Pathology v. Myriad Genetics that naturally occurring DNA sequences are not patentable, a ruling that has had repercussions throughout the scientific community and the biotechnology industry.

In The Genome Defense: Inside the Epic Legal Battle to Determine Who Owns Your DNA (New York: Hachette/Algonquin, 2021), I describe the long road that led to this unlikely Supreme Court victory. It began in 2003 when the ACLU hired its first science advisor, a Berkeley-based cellist and non-profit organizer named Tania Simoncelli. At the ACLU, Simoncelli’s job was to identify science-related issues that the ACLU could do something about, from DNA fingerprinting to functional MRI brain imaging. A couple of years into the role, Simoncelli mentioned gene patenting to Chris Hansen, a veteran ACLU litigator who had been involved in cases covering mental health to school desegregation to online porn. At first, Hansen didn’t believe her. How could a company patent something inside the human body? But Simoncelli persisted, showing him articles and statistics demonstrating that, by 2005, more than 20% of the human genome was covered by patents. The realization led to Hansen’s oft-quoted exclamation, “Who can we sue?”

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Globe and vaccine.

Promoting Vaccine Equity

By Ana Santos Rutschman

The COVID-19 pandemic has brought into sharp relief longstanding equity problems surrounding the allocation of newly developed vaccines against emerging pathogens.

In my upcoming book, Vaccines as Technology: Innovation, Barriers, and the Public Health, I examine these problems and look into possible solutions to incrementally build more equitable frameworks of access to vaccines targeting emerging pathogens. These solutions focus on ensuring that vaccines are made available affordably to the populations that need them the most according to public health parameters.

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Doctor Holding Cell Phone. Cell phones and other kinds of mobile devices and communications technologies are of increasing importance in the delivery of health care. Photographer Daniel Sone.

Toward a Broader Telehealth Licensing Scheme

By Fazal Khan

Evidence generated during the first year the COVID-19 pandemic has called into question the need for many of the telehealth restrictions that were in effect prior to the pandemic.

The question many policymakers are asking now is: which of the telehealth regulatory waivers enacted during the pandemic should become permanent?

My forthcoming article proposes that the federal government use its spending power to incentivize states to adopt a de facto national telehealth licensing scheme through state-based mutual recognition of licensing and scope of practice reforms through a Medicaid program funding “bonus.”

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

Legal Capacity and Persons with Disabilities’ Struggle to Reclaim Control over Their Lives

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. Though the Workshop is typically open to the public, it is not currently, due to the COVID-19 pandemic. However, many of our presenters will contribute blog posts summarizing their work, which we are happy to share here on Bill of Health.

By Matthew S. Smith & Michael Ashley Stein

Persons with disabilities face an ongoing struggle to reclaim power and control over their lives.

The United Nations Convention on the Rights of Persons with Disabilities (CRPD) is an important tool in this struggle.

In mental health care settings, the CRPD has challenged states and practitioners to reject coercive forms of care orchestrated by substitute decision-makers — be they clinicians, family members, or court appointees — in favor of modalities that preserve and privilege individuals’ direct control over their care.

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abortion protest outside supreme court.

Pregnancy Loss, Abortion Rights, and a Holistic Reproductive Justice Movement

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. Though the Workshop is typically open to the public, it is not currently, due to the COVID-19 pandemic. However, many of our presenters will contribute blog posts summarizing their work, which we are happy to share here on Bill of Health.

By Greer Donley and Jill Wieber Lens

In the summer of 2020, celebrity Chrissy Teigen shared her son’s stillbirth with her tens of millions of followers on social media, including photos of her agony at her son’s simultaneous birth and death.

Teigen and her husband, John Legend, are noted supporters of abortion rights. After Jack’s death, Planned Parenthood tweeted its condolences: “We’re so sorry to hear that Chrissy Teigen and John Legend lost their son, and we admire them for sharing their story.”

Backlash was swift, accusing both Teigen and Planned Parenthood of hypocrisy, questioning how one could believe abortion involves only a “clump of cells,” yet grieve a pregnancy loss.

This anecdote perfectly highlights the perceived conflict between pregnancy loss and abortion rights — that any recognition of loss in the context of stillbirth or miscarriage could cause a slippery slope to fetal personhood.

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Petrie-Flom Center student fellows 2021-2022.

Petrie-Flom Welcomes 2021-2022 Student Fellows

(Clockwise from top left: Matt Bauer, Jack Becker, Bailey Kennedy, Cathy Zhang, Leah Pierson, Kaitlynn Milvert)

We are so excited to welcome a new group of Student Fellows to the Petrie-Flom Center family. These six students are a fantastic cohort of health law policy, biotechnology, and bioethics scholars who join us from across Harvard.

They each will undertake a year-long research project with mentorship from Center faculty and affiliates, and also will blog here at Bill of Health regularly. Keep an eye out for their bylines!

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Los Angeles, California, United States. June 23, 2021: #FreeBritney rally at LA Downtown Grand Park during a conservatorship hearing for Britney Spears.

There’s More to Decision-Making Capacity than Cognitive Function

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. Though the Workshop is typically open to the public, it is not currently, due to the COVID-19 pandemic. However, many of our presenters will contribute blog posts summarizing their work, which we are happy to share here on Bill of Health.

By James Toomey

The doctrine of capacity is a mess.

From Britney Spears’s high-profile struggles to establish her own capacity to the countless, quiet challenges of so many older adults, the doctrine of capacity, which requires people to have the cognitive functioning to understand the nature and consequences of a decision in order for it to be recognized in law, is vague, normatively and medically challenging, and inconsistently applied.

This is a big deal — at stake in every capacity case is whether, on the one hand, an individual may access the legal rights most of us take for granted, to enter into contracts, buy or transfer property, or get married or divorced; or, on the other, whether the legal system will ratify a decision the “real person” never would have made.

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Person filling syringe from vial.

Religious Exemptions to Vaccines and the Anti-Vax Movement

By Dorit Rubinstein Reiss

Two major problems with granting religious exemptions to vaccine mandates are that they are very hard to police, and that they are routinely gamed.

Religious freedom is a core value in the United States. This makes policing religious exemptions to vaccination hard – and rightly so. The government policing people’s religion raises a number of thorny issues.

The problem is that the same people who eagerly promote anti-vaccine misinformation are just as eager to misuse religion to avoid vaccinating, and have no hesitation or compunction about coaching others to do the same. And without policing, it is easy for those misled by anti-vaccine misinformation to use the religious exemption.

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Photograph of a stack of magazines on a chair

Impact of Journal of Law and the Biosciences Continues to Grow

The Journal of Law and Biosciences offers high-quality, open-access scholarship at the intersection of the biosciences and law. It is the first fully open-access, peer-reviewed legal journal to focus on these issues. The journal has international impact, with authors from across the globe vying for the opportunity to have their work published in the JLB.

Recently, the Journal of Law and the Biosciences received exciting news in the form of an updated impact factor score. The journal now has an impact factor of 3.583, a substantial increase from the year prior. It ranks #7 out of 151 law journals, an admirable position for the youngest journal included in the rankings. It is also second out of sixteen journals in the medical ethics category, as well as second out of seventeen journals in the legal medicine category.

In honor of this achievement, the Journal has compiled a list of the most impactful articles included in this calculation period.

The Journal continues to publish a wide variety of exciting new material. The most recent issue, which closed in June 2021, contains numerous articles from highly regarded scholars exploring hot-button issues in bioethics. The following excerpts offer a small preview of the wide breadth of analysis contained in the most recent edition.

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Traditional countryside scene in the Netherlands with windbreak lane of poplar trees in the wind under summer sky. Ens, Flevoland Province, the Netherlands.

Q&A with Mason Marks on New Psychedelics Law and Regulation Initiative

By Chloe Reichel

On June 30th, the Petrie-Flom Center announced the launch of a three-year research initiative, the Project on Psychedelics Law and Regulation (POPLAR), which is supported by a generous grant from the Saisei Foundation.

The Project on Psychedelics Law and Regulation at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School will advance evidence-based psychedelics law and policy.

In 2017, the FDA designated MDMA a breakthrough therapy for post-traumatic stress disorder, and in 2018 the agency recognized psilocybin as a breakthrough therapy for treatment-resistant depression. These designations indicate that psychedelics may represent substantial improvements over existing treatments for mental health conditions. Many other psychedelics, including ibogaine, ketamine, and dimethyltryptamine, are the focus of ongoing psychiatric research and commercialization efforts.

Despite the proliferation of clinical research centers and increasing private investment in psychedelic drug development, there is a relative lack of research on the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics.

In the following interview, which has been edited and condensed, Senior Fellow and POPLAR Project Lead Mason Marks explains how POPLAR will fill this gap, and previews some of the initiative’s topics of inquiry.

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