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Industry price guarantees for publicly funded medicines: learning from Project NextGen for pandemics and beyond J Law Biosci (IF 2.5) Pub Date : 2024-09-13 Holly Fernandez Lynch, Rena M Conti, Jorge L Contreras
The affordability of publicly funded medicines has been a longstanding concern. In 2023, the Biden administration took several steps on this front, including incorporation of a price constraint in an agreement between the US Biomedical Advanced Research and Development Authority (BARDA) and Regeneron Pharmaceuticals, Inc. to develop a new COVID-19 monoclonal antibody. The agreement included a ‘Most
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Considerations on expanding criminal offender DNA databases with Y-STR profiles J Law Biosci (IF 2.5) Pub Date : 2024-09-05 Arwin Ralf, Martin Zieger, Manfred Kayser
Although national criminal offender DNA databases (NCODDs) including autosomal short tandem repeats (STRs) have been a successful tool to identify criminals for decades in many countries, yet there are many criminal cases they cannot solve. In cases with mixed male–female samples, particularly sexual assault, expanding NCODDs with Y-chromosomal STR (Y-STR) profiles allows database matching in the absence
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Regulating embryo models in the UK. J Law Biosci (IF 2.5) Pub Date : 2024-07-18 Emily Jackson
One of this century's most dramatic scientific developments is the reprogramming of stem cells in order to create self-organizing embryo-like entities, known as stem cell based embryo models (SCBEMs). The science is moving very quickly, but if, as increasingly appears to be the case, scientists are capable of creating entities that are effectively indistinguishable from sperm and egg derived embryos
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Death and the artificial placenta J Law Biosci (IF 2.5) Pub Date : 2024-07-16 Anna Nelson, Elizabeth Chloe Romanis, Victoria Adkins, Christina Weis, Karolina Kuberska
Artificial Amnion and Placenta Technology (AAPT)—sometimes referred to as ‘Artificial Womb Technology’—could provide an extracorporeal alternative to bodily gestations, allowing a fetus delivered prematurely from the human uterus to continue development while maintaining fetal physiology. As AAPT moves nearer to being used in humans, important ethical and legal questions remain unanswered. In this
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Introducing biosimilar competition for cell and gene therapy products. J Law Biosci (IF 2.5) Pub Date : 2024-07-15 Brian Canter,Sabine Sussman,Stephen Colvill,Nitzan Arad,Elizabeth Staton,Arti Rai
This article provides an early analysis of the potential for creating future biosimilar competition for cell and gene therapies (CGTs) to lower prices and improve patient access, building on a unique set of interviews with relevant experts. Our discussion addressed regulatory, manufacturing, intellectual property, and market size challenges. Due to CGTs' complexity, meeting the regulatory requirement
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Bedside manufacturing as the next step in personalized medicine: medical progress and legal challenges J Law Biosci (IF 2.5) Pub Date : 2024-07-10 Tämer El Saadany, Claudia Seitz, Corina Bräm, Thomas Szucs
Bedside manufacturing is having a revival in healthcare, with a promise to revolutionize personalized medicine through on-site drug production. While this concept holds considerable promise, it also encounters a complex web of legal uncertainties. The current regulatory framework in Switzerland and the EU, which includes the Swiss Therapeutic Products Act and the EU directives, regulations, and guidelines
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The pressing need for FDA regulation of tattoo ink. J Law Biosci (IF 2.5) Pub Date : 2024-07-08 Lisa A Verity,Ana Santos Rutschman,Michael S Sinha
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Sorry you asked? Mayo, Myriad, and the battles over patent-eligibility. J Law Biosci (IF 2.5) Pub Date : 2024-06-04 Robert Cook-Deegan,Janis Geary,Kara Hapke,Zuzana Skvarkova,Marina Filipek,Jillian Leaver
Genetic testing for inherited cancer risk changed dramatically when the US Supreme Court handed down unanimous rulings in Mayo v. Prometheus (2012) and Myriad v. Association for Molecular Pathology (2013). Those decisions struck down claims to methods based on 'laws of nature' (Mayo) and DNA molecules corresponding to sequences found in nature (Myriad). Senators Thom Tillis (R-NC) and Christopher Coons
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Erratum to: U.S. public perceptions of the sensitivity of brain data. J Law Biosci (IF 2.5) Pub Date : 2024-06-01
[This corrects the article DOI: 10.1093/jlb/lsad032.].
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Implementing the human right to science in neuroscience J Law Biosci (IF 2.5) Pub Date : 2024-05-15 Henry T Greely
This article considers the implications of the international Human Right to Science for advances in neuroscience. First, it provides background information on both the Human Right to Science and on likely challenges arising from neuroscience in five categories: prediction, mind-reading, mind-control, mental enhancement, and “humanness.” Second, it examines the Human Right to Science, analyzing its
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COVID-19 pediatric vaccine authorization, FDA authority, and individual misperception of risk. J Law Biosci (IF 2.5) Pub Date : 2024-04-19 Joanna K Sax,Neal Doran
Vaccines are one component to the public health strategies to alleviate the COVID-19 pandemic. Hesitancy regarding COVID-19 vaccines in the United States has been problematic, which is not surprising given increasing overall vaccine hesitancy in recent decades. Most vaccines are administered during childhood years. Consequently, understanding hesitancy toward administration of vaccines in this age
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Illegal interlocks among life science company boards of directors. J Law Biosci (IF 2.5) Pub Date : 2024-04-13 Anoop Manjunath,Nathan Kahrobai,Mark A Lemley,Ishan Kumar
Competition between life science companies is critical to ensure innovative therapies are efficiently developed. Anticompetitive behavior may harm scientific progress and, ultimately, patients. One well-established category of anticompetitive behavior is the 'interlocking directorate'. It is illegal for companies' directors to 'interlock' by also serving on the boards of competitors. We evaluated overlaps
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How AI challenges the medical device regulation: patient safety, benefits, and intended uses J Law Biosci (IF 2.5) Pub Date : 2024-04-09 Daria Onitiu, Sandra Wachter, Brent Mittelstadt
This article examines whether the EU Medical Device Regulation (MDR) adequately addresses the novel risks of AI-based medical devices (AIaMDs), focusing on AI medical imaging tools. It examines two questions: first, does the MDR effectively deal with issues of adaptability, autonomy, bias, opacity, and the need of trustworthiness of AIaMD? Second, does the manufacturer’s translation of the MDR’s requirements
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Implementing the human right to science in the context of health-related data processing J Law Biosci (IF 2.5) Pub Date : 2024-03-16 Fruzsina Molnár-Gábor
This paper contributes to the exploration of the potential application of duties related to the diligent anticipation of the (imminent) harms and (potential) benefits to humans that scientific innovation engenders to health-related contexts. In particular, it addresses the intersection between the human right to science and health-related data processing, which plays a key role in the production, translation
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Certificates of confidentiality: privileging research data. J Law Biosci (IF 2.5) Pub Date : 2024-02-22 Leslie E Wolf,Natalie Ram,Jorge Contreras,Laura M Beskow
With the Supreme Court's decision in Dobbs, reproductive research now joins other sensitive research topics that present legal risks to research participants, underscoring the role of Certificates in protecting them. Yet, stakeholders question whether Certificates will hold up in court. In this article, we describe the essential arguments supporting Congress's regulation of biomedical research and
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Anticipation in the biosciences and the human right to science. J Law Biosci (IF 2.5) Pub Date : 2024-02-19 Andrea Boggio
Anticipation entails contemplating the beneficial and harmful impacts of scientific and technological progress. Anticipation has a long history in science, technology, and innovation policy partly due to future impacts of scientific progress being inescapable. The link between anticipation, an undertheorized concept, and human rights law is yet to be fully explored. This paper links anticipation to
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Purpose definition as a crucial step for determining the legal basis under the GDPR: implications for scientific research. J Law Biosci (IF 2.5) Pub Date : 2024-02-01 Regina Becker,Davit Chokoshvili,Adrian Thorogood,Edward S Dove,Fruzsina Molnár-Gábor,Alexandra Ziaka,Olga Tzortzatou-Nanopoulou,Giovanni Comandè
The General Data Protection Regulation (GDPR) of the European Union, which became applicable in 2018, contains a new accountability principle. Under this principle, controllers (ie parties determining the purposes and the means of the processing of personal data) are responsible for ensuring and demonstrating the overall compliance with the GDPR. However, interpretive uncertainties of the GDPR mean
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CRISPR-phage antibacterials to address the antibiotic resistance crisis: scientific, economic, and regulatory considerations. J Law Biosci (IF 2.5) Pub Date : 2024-01-26 Danielle M Pacia,Beatrice L Brown,Timo Minssen,Jonathan J Darrow
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U.S. public perceptions of the sensitivity of brain data J Law Biosci (IF 2.5) Pub Date : 2024-01-21 Shenyang Huang, Umika Paul, Shikhar Gupta, Karen Desai, Melinda Guo, Jennifer Jung, Beatrice Capestany, William D Krenzer, Dylan Stonecipher, Nita Farahany
As we approach an era of potentially widespread consumer neurotechnology, scholars and organizations worldwide have started to raise concerns about the data privacy issues these devices will present. Notably absent in these discussions is empirical evidence about how the public perceives that same information. This article presents the results of a nationwide survey on public perceptions of brain data
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The regulation of health data sharing in Africa: a comparative study J Law Biosci (IF 2.5) Pub Date : 2024-01-21 Annelize G Nienaber McKay, Dirk Brand, Marietjie Botes, Nezerith Cengiz, Marno Swart
The sharing of health data is an essential component in the provision of healthcare, in medical research, and disease surveillance. Health data sharing is subject to regulatory frameworks that vary across jurisdictions. In Africa, numerous factors complicate the regulation of health data sharing, including technological, motivational, economic, and political barriers, as well as ethical and legal challenges
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Defusing the legal and ethical minefield of epigenetic applications in the military, defense, and security context. J Law Biosci (IF 2.5) Pub Date : 2023-12-13 Gratien Dalpé,Katherine Huerne,Charles Dupras,Katherine Cheung,Nicole Palmour,Eva Winkler,Karla Alex,Maxwell Mehlman,John W Holloway,Eline Bunnik,Harald König,Isabelle M Mansuy,Marianne G Rots,Cheryl Erwin,Alexandre Erler,Emanuele Libertini,Yann Joly
Epigenetic research has brought several important technological achievements, including identifying epigenetic clocks and signatures, and developing epigenetic editing. The potential military applications of such technologies we discuss are stratifying soldiers' health, exposure to trauma using epigenetic testing, information about biological clocks, confirming child soldiers' minor status using epigenetic
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Leading with the trailing edge: facilitating patient choice for insulin products J Law Biosci (IF 2.5) Pub Date : 2023-12-13 Robin Feldman
Insulin prices have risen sharply, despite a century since its introduction. Against this backdrop, companies have discontinued dozens of insulin products. Discontinuation could relate to safety or effectiveness, or to the overwhelming benefits of newer products. On the other hand, discontinuation could suggest strategic behavior hampering competition and supporting prices. To test these theories,
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The AI cycle of health inequity and digital ageism: mitigating biases through the EU regulatory framework on medical devices. J Law Biosci (IF 2.5) Pub Date : 2023-12-07 Hannah van Kolfschooten
The use of Artificial Intelligence (AI) medical devices is rapidly growing. Although AI may benefit the quality and safety of healthcare for older adults, it simultaneously introduces new ethical and legal issues. Many AI medical devices exhibit age-related biases. The first part of this paper explains how 'digital ageism' is produced throughout the entire lifecycle of medical AI and may lead to health
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Cryopreservation and current legal problems: seeking and selling immortality J Law Biosci (IF 2.5) Pub Date : 2023-11-11 Alexandra Mullock, Elizabeth Chloe Romanis
Cryonics, the ‘freezing’ of the human body after death in the hope of reanimation in the future, remains a remote possibility, and yet it is becoming a more popular choice. There has been much academic discussion of the ethics of cryopreservation; however, the legal problems have received little attention. There are, however, several potential current conflicts that might arise, as was illustrated
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‘The law is very, very outdated and not keeping up with the technology’: novel forms of assisted gestation, legal challenges, and perspectives of reproductive rights advocates in England and Wales J Law Biosci (IF 2.5) Pub Date : 2023-11-07 Elizabeth Chloe Romanis
A growing body of literature examines the ethico-legal challenges resulting from novel forms of assisted gestation like uterus transplantation and artificial placentas (also known as ‘artificial wombs’). However, there has not yet been consideration of reproductive rights organizations/advocates’ understandings of novel forms of assisted gestation and their challenges. These perspectives provide critical
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Neuroethics guidance documents: principles, analysis, and implementation strategies. J Law Biosci (IF 2.5) Pub Date : 2023-10-26 Matthew R O'Shaughnessy,Walter G Johnson,Lucille Nalbach Tournas,Christopher J Rozell,Karen S Rommelfanger
Innovations in neurotechnologies have ignited conversations about ethics around the world, with implications for researchers, policymakers, and the private sector. The human rights impacts of neurotechnologies have drawn the attention of United Nations bodies; nearly 40 states are tasked with implementing the Organization for Economic Co-operation and Development's principles for responsible innovation
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Implementing the human right to science in the regulatory governance of artificial intelligence in healthcare J Law Biosci (IF 2.5) Pub Date : 2023-10-18 Calvin W L Ho
Artificial intelligence (AI) enables a medical device to optimize its performance through machine learning (ML), including the ability to learn from past experiences. In healthcare, ML is currently applied within controlled settings in devices to diagnose conditions like diabetic retinopathy without clinician input, for instance. In order to allow AI-based medical devices (AIMDs) to adapt actively
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The right to terminate pregnancy (abortion): reflections from Turkey. J Law Biosci (IF 2.5) Pub Date : 2023-09-03 Hatice Kübra Ercoşkun Şenol,Pelin Ercoşkun
In this article, the right to terminate pregnancy is discussed comparatively in terms of the situation in Turkey and the rest of the world. We have concluded that certain minimum conditions must be met to be able to talk about the full recognition of this right. Recognizing that pregnancy can be terminated voluntarily is the most important of these conditions. Just as the period in which this right
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Doctors' duty to provide abortion information. J Law Biosci (IF 2.5) Pub Date : 2023-09-01 Michelle Oberman,Lisa Soleymani Lehmann
With abortion remaining legal in over half of the country and a proliferation of websites offering information on how to access abortion medications, for those who know where to look, there are sound options for safely ending an unwanted early-stage pregnancy. But not all patients have equal access to reliable information. This Article addresses the urgent downstream harms caused by the lack of access
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Genetic data are not always personal-disaggregating the identifiability and sensitivity of genetic data. J Law Biosci (IF 2.5) Pub Date : 2023-07-24 Johanna Rahnasto
In both the EU and USA, genetic data are recognized as a special category of data that requires heightened privacy protection. Identifiability and sensitivity are central pillars of the regulatory framework in both jurisdictions: the privacy concerns stem from the assumption that genetic data are capable of identifying the individual and reveals sensitive information about them. But not all genetic
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Open science in play and in tension with patent protections J Law Biosci (IF 2.5) Pub Date : 2023-07-20 Anna Nuechterlein, Ari Rotenberg, Jeff LeDue, Paul Pavlidis, Judy Illes
The open science (OS) movement has garnered increasing support in academia alongside continued financial and reputational incentives to obtain intellectual property (IP) protections over research outputs. Here, we explore stakeholder perspectives about intersections between OS and IP to inform the development of institutional OS guidelines for the neurosciences in Canada. We held six focus groups and
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Patent term extension and test data protection obligations: identifying the gap in policy, research, and practice of implementing free trade agreements J Law Biosci (IF 2.5) Pub Date : 2023-07-19 Bryan Mercurio, Pratyush Nath Upreti
Much of the academic literature criticizes the inclusion of patent term extensions (PTE) and test data protection into the pharmaceutical provisions and/or intellectual property (IP) chapters of free trade agreements (FTAs), with many arguing that such provisions will increase the cost of pharmaceuticals for the implementing government. Such arguments are often backed by studies conducted prior to
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Terms and conditions apply: an ethical analysis of mobile health user agreements in research J Law Biosci (IF 2.5) Pub Date : 2023-07-14 Luke Gelinas, Walker Morrell, Barbara E Bierer
Mobile health (mHealth) technologies raise unique risks to user privacy and confidentiality that are often embedded in lengthy and complex Privacy Policies, Terms of Use, and End User License Agreements. We seek to improve the ethical review of these documents (‘user agreements’) and their risks in research using mHealth technologies by providing a framework for identifying when these risks are research
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Policy options to facilitate cancer genomic variant data sharing: outcomes of a modified policy Delphi J Law Biosci (IF 2.5) Pub Date : 2023-07-14 Jill O Robinson, Amira Daoud, Janis Geary, Vasiliki Rahimzadeh, Juli Bollinger, Christi J Guerrini, Robert Cook-Deegan, Amy L McGuire, Mary A Majumder
Sharing cancer gene variant and relevant clinical data could accelerate progress in cancer genomics. However, data sharing is currently impeded by issues related to financial sustainability, equity, incentives, privacy and security, and data quality. Evidence-based policy options to facilitate data sharing in these domains, and ultimately improve interpretation of cancer-associated genomic variants
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Payer reimbursement practices and incentives for improving interpretation of germline genetic testing J Law Biosci (IF 2.5) Pub Date : 2023-07-11 Patricia Deverka, Janis Geary, Charles Mathews, Matan Cohen, Gillian Hooker, Mary Majumder, Zuzana Skvarkova, Robert Cook-Deegan
Germline genetic testing for inherited cancer risk has shifted to multi-gene panel tests (MGPTs). While MGPTs detect more pathogenic variants, they also detect more variants of uncertain significance (VUSs) that increase the possibility of harms such as unnecessary surgery. Data sharing by laboratories is critical to addressing the VUS problem. However, barriers to sharing and an absence of incentives
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How penalizing substance use in pregnancy affects treatment and research: a qualitative examination of researchers’ perspectives J Law Biosci (IF 2.5) Pub Date : 2023-07-11 Seema K Shah, Leishla Perez-Cardona, Khrystyna Helner, Suena H Massey, Ashish Premkumar, Renee Edwards, Elizabeth S Norton, Cynthia E Rogers, Emily S Miller, Christopher D Smyser, Matthew M Davis, Lauren S Wakschlag
Introduction Laws regulating substance use in pregnancy are changing and may have unintended consequences on scientific efforts to address the opioid epidemic. Yet, how these laws affect care and research is poorly understood. Methods We conducted semi-structured qualitative interviews using purposive and snowball sampling of researchers who have engaged pregnant people experiencing substance use.
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Is benefit sharing with research participants lawful in South Africa? An unexplored question in the governance of genomics research J Law Biosci (IF 2.5) Pub Date : 2023-06-29 Donrich Thaldar, Bonginkosi Shozi
Despite advocacy in favour of benefit sharing with research participants in genomics research that is conducted in South Africa, there has been little critical legal engagement with this concept. That is what this article provides by posing the hitherto unexplored—but foundational—question: Is benefit sharing with research participants lawful in South Africa? The answer is clearly ‘no’. South African
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Should Canada adopt managed access agreements in Canada for expensive drugs? J Law Biosci (IF 2.5) Pub Date : 2023-06-16 Melanie McPhail, Tania Bubela
Drugs are increasingly authorized based on less mature evidence, leaving payors faced with significant clinical and cost-effectiveness uncertainties. As a result, payors must often choose between reimbursing a drug that may not turn out to be cost-effective (or may even be unsafe) or delaying the reimbursement of a drug that is cost-effective and offers clinical benefit to patients. Novel reimbursement
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Confidentiality, public interest, and the human right to science: when can confidential information be used for the benefit of the wider community? J Law Biosci (IF 2.5) Pub Date : 2023-06-14 Edward S Dove
This article explores whether the human right to science can support the public interest as a legal basis to use and disclose confidential information. The contextual focus is scientific research; the jurisdictional focus is England. The human right to science, as reflected in the Universal Declaration of Human Rights (Article 27) and the International Covenant on Economic, Social and Cultural Rights
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Ectogestation and the Good Samaritan Argument J Law Biosci (IF 2.5) Pub Date : 2023-06-08 Christopher Stratman
Philosophical discussions concerning ectogestation are trending. And given that the Supreme Court of the United States overturned Roe v. Wade (1973) and Casey v. Planned Parenthood (1992), questions regarding the moral and legal status of abortion in light of the advent of ectogestation will likely continue to be of central importance in the coming years. If ectogestation can intersect with or even
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Legal personhood and frozen embryos: implications for fertility patients and providers in post-Roe America J Law Biosci (IF 2.5) Pub Date : 2023-05-21 Gerard Letterie, Dov Fox
The demise of Roe v. Wade has prompted some state lawmakers to try to redefine legal personhood to begin before birth and even before pregnancy. The sweeping abortion bans passed and pending in the wake of Dobbs pose a threat to reproductive rights that extends beyond abortion. That threat spills over into in vitro fertilization (IVF) and other assisted reproductive technologies (ART). If legislatures
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The United Nations convention on the rights of persons with disabilities, neuroscience, and criminal legal capacity J Law Biosci (IF 2.5) Pub Date : 2023-05-19 Benjamin A Barsky, Michael Ashley Stein
The United Nations Convention on the Rights of Persons with Disabilities requires states parties to ‘recognize that persons with disabilities enjoy legal capacity on an equal basis with others in all aspects of life.’ This mandate has sparked debate about the interpretation of legal capacity, including within the criminal context as applied to the retrogressively named ‘insanity defense.’ Yet, under-examined
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Who would own the HeLa cell line if the Henrietta Lacks case happened in present-day South Africa? J Law Biosci (IF 2.5) Pub Date : 2023-05-19 Donrich W Thaldar
The HeLa cell line was created in 1951 without consent from Henrietta Lacks, the person whose tissue sample was used. In 2021, the descendants of Henrietta Lacks sued a well-known biotechnology company for the profits it made from the HeLa cell line. In this article, ownership of the cell lines is investigated from a South African legal perspective by considering three possible contemporary scenarios
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The various faces of vulnerability: offering neurointerventions to criminal offenders. J Law Biosci (IF 2.5) Pub Date : 2023-05-06 Sjors Ligthart,Emma Dore-Horgan,Gerben Meynen
In recent years, we have witnessed considerable progress in neurotechnologies that visualize or alter a person's brain and mental features. In the near future, some of these technologies could possibly be used to change neural parameters of high-risk behavior in criminal offenders, often referred to as neurointerventions. The idea of delivering neurointerventions to criminal justice populations has
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Lessons from Canada’s notice of compliance with conditions policy for the life-cycle regulation of drugs J Law Biosci (IF 2.5) Pub Date : 2023-04-13 Melanie McPhail, Howard Zhang, Zohra Bhimani, Tania Bubela
Innovative health technologies are not well regulated under current pathways, leading regulators to adopt contextual, life-cycle regulatory models, which authorize drugs based on earlier clinical evidence subject to the conduct of post-market trials that confirm clinical benefit and safety. In this paper, we evaluate all drugs authorized in Canada under the Notice of Compliance with conditions (NOC/c)
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The legal personhood of human brain organoids J Law Biosci (IF 2.5) Pub Date : 2023-04-03 Masanori Kataoka, Tsung-Ling Lee, Tsutomu Sawai
Research using three-dimensional neural tissues derived from human pluripotent stem cells—known as ‘human brain organoids’—has progressed rapidly in recent years. Although related ethical issues have been intensively discussed, legal issues have only been sparsely examined compared with the related ethical issues. In this paper, we explore a fundamental issue concerning the legal status of human brain
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Allocating organs through algorithms and equitable access to transplantation-a European human rights law approach. J Law Biosci (IF 2.5) Pub Date : 2023-03-31 Audrey Lebret
Digitization in transplantation is not a new phenomenon. Algorithms are being used, for example, to allocate organs based on medical compatibility and priority criteria. However, digitization is accelerating as computer scientists and physicians increasingly develop and use machine learning (ML) models to obtain better predictions on the chances of a successful transplant. The objective of the article
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FDA preemption of conflicting state drug regulation and the looming battle over abortion medications J Law Biosci (IF 2.5) Pub Date : 2023-03-15 Peter Grossi, Daphne O’Connor
Over the past 25 years, Congress and the FDA have determined the safest and most beneficial way to regulate the use of mifepristone (Mifeprex), the medication that accounts for the majority of abortions in the United States. The Dobbs decision has renewed the importance of those scientific determinations, especially FDA's decisions implementing the Risk Evaluation and Mitigation Strategy (REMS) provisions
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Governing nonconventional genetic experimentation J Law Biosci (IF 2.5) Pub Date : 2023-03-09 Maxwell J Mehlman, Ronald A Conlon, Alex Pearlman
A large and highly heterogeneous group of individuals conducts genetic and genomic research outside of traditional corporate and academic settings. They can be an important source of innovation, but their activities largely take place beyond the purview of existing regulatory systems for promoting safe and ethical practices. Historically the gene-targeting technology available for non-traditional genomic
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Pathogen dematerialization and the ABS loophole. J Law Biosci (IF 2.5) Pub Date : 2023-03-04 Abbie-Rose Hampton
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Rules for robots, and why medical AI breaks them J Law Biosci (IF 2.5) Pub Date : 2023-02-16 Barbara J Evans
This article critiques the quest to state general rules to protect human rights against AI/ML computational tools. The White House Blueprint for an AI Bill of Rights was a recent attempt that fails in ways this article explores. There are limits to how far ethicolegal analysis can go in abstracting AI/ML tools, as a category, from the specific contexts where AI tools are deployed. Health technology
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Vaccination of individuals lacking decision-making capacity during a public health emergency J Law Biosci (IF 2.5) Pub Date : 2023-01-16 G Owen Schaefer, Tess Johnson, Ryan Friets, Sumytra Menon, Julian Savulescu
This paper explores the ethical challenges in deciding whether to vaccinate individuals lacking the decision-making capacity needed to provide informed consent during a public health emergency like COVID-19. The best interests standard ordinarily governs such decisions, which under the law in jurisdictions like England, Wales and Singapore takes into account the individual’s past wishes and present
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Mifepristone, preemption, and public health federalism J Law Biosci (IF 2.5) Pub Date : 2022-12-22 Patricia J Zettler, Annamarie Beckmeyer, Beatrice L Brown, Ameet Sarpatwari
On June 24, 2022, the Supreme Court issued an opinion in which five justices voted to overturn Roe v Wade. Even before the final opinion issued, scholars and advocates had begun to consider legal strategies that might mitigate the decision’s anticipated harmful consequences. One such strategy involves challenging state restrictions on Food and Drug Administration (FDA)-approved pregnancy termination
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Deconstructing age(s): an analysis of the different conceptions of age as a legal criterion for access to assisted reproductive technologies. J Law Biosci (IF 2.5) Pub Date : 2022-12-15 Andrea Martani,Eva De Clercq,Christian De Geyter,Guido Pennings,Tenzin Wangmo,Bernice Simone Elger
Whether there should be restrictions for access to Assisted Reproductive Technologies (ART) is a matter of continuous medical, societal, and ethico-legal debate. One of the most controversial topics in this context is the use of parental age as a criterion to limit access to ART. Views are divided on whether there should be an upper age limit for one or both parents and on where such limits should
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Exploring access to genomic risk information and the contours of the HIPAA public health exception J Law Biosci (IF 2.5) Pub Date : 2022-12-10 Jennifer K Wagner, Juhi K Tanniru, Courtney A Chane, Michelle N Meyer
Considerable resources have been invested in research to identify pathogenic and likely pathogenic variants that cause morbidity and mortality and also in returning these results to patients. The public health impact and cost-effectiveness of these efforts are maximized when probands’ relatives are informed of their risk and offered testing. However, such ‘Traceback’ cascade testing programs face multiple
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Digital Sequence Information between Benefit-Sharing and Open Data J Law Biosci (IF 2.5) Pub Date : 2022-11-23 Irma Klünker, Heiko Richter
Currently, parties to the Convention on Biological Diversity (CBD) are negotiating a strategic plan to save biodiversity. One crucial element of an agreement is the question of whether and how digital sequence information (DSI) is subject to access and benefit-sharing from the utilization of genetic resources, one main instrument of the CBD. In the EU, the Open Data Directive (ODD) of 2019 and the
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The body of law: boundaries, extensions, and the human right to physical integrity in the biotechnical age. J Law Biosci (IF 2.5) Pub Date : 2022-10-31 Christoph Bublitz
The body is precondition of human existence and reference point of many legal norms. But the law only rarely asks what the body is more precisely. Answers might appear evident, but commonsensical conceptions of the body have been cast into doubt by feminists, artists, and disability theorists. Drawing on polyphonic arguments, they suggest social or post-human reconceptualizations with potential legal
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Prescribing unproven cancer drugs: physician perspectives on expanded access and right to try. J Law Biosci (IF 2.5) Pub Date : 2022-10-25 Haley Manley,Bryan A Sisk,Zubin Master,Christopher Thomas Scott
Background For gravely ill patients who have no treatment options and who are ineligible for clinical trials, the US Food and Drug Administration (FDA) established the Expanded Access Program (EAP). Motivated by efforts to weaken FDA regulation and sold as providing greater access to experimental drugs, the federal Right to Try Act (RTT) was passed in 2017. It reduces FDA oversight by not requiring
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Digital pills for the remote monitoring of medication intake: a stakeholder analysis and assessment of marketing approval and patent granting policies. J Law Biosci (IF 2.5) Pub Date : 2022-10-18 Katerina Sideri,Julian Cockbain,Wim Van Biesen,Marc De Hert,Johan Decruyenaere,Sigrid Sterckx
This article explores whether 'digital pills' that track medication intake should be used to enhance adherence. We concentrate on psychiatric conditions since these pose unique challenges. We analyze two public policies that potentially encourage the development of systems for remote monitoring of intake, namely the granting of patents and marketing authorization, and identify key stakeholders and
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Why uterine transplantation requires us to rethink the role of the pre-conception welfare principle J Law Biosci (IF 2.5) Pub Date : 2022-10-11 Laura O’Donovan
Uterine transplantation (UTx) is a programme of treatment aimed at providing a unique solution to absolute uterine factor infertility, enabling patients to have children as a result of their own pregnancies. As a transplant procedure performed for fertility purposes it may be thought obvious that the welfare of any children created should be assessed prior to treatment provision. However, major concerns