Journal of Law and the Biosciences最新文献

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 decision models and frameworks, such as managed access agreements (MAAs), may address this decision challenge. Here, we provide a comprehensive overview of the legal limitations, considerations, and implications for adopting MAAs in Canadian jurisdictions. We begin with an overview of current drug reimbursement processes in Canada, terminology and definitions of the different types of MAAs, and select international experiences with MAAs. We discuss the legal barriers to MAA governance frameworks, design and implementation considerations, and legal and policy implications of MAAs. Finally, we provide recommendations to guide policy development for implementing MAAs in Canada, based on existing literature, international experience, and our legal analysis. We conclude that legal and policy barriers likely prevent the adoption of a pan-Canadian MAA governance framework. More feasible is a quasi-federal or provincial approach, building on existing infrastructure.

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 designate embryos as legal persons, fertility clinics will be forced to change how they manage embryos, including current standard practices such as pre-implantation genetic testing, storage of unused embryos, and the disposal of those unlikely to have reproductive potential. This essay examines the many ways in which conferring the status of persons under private and public law is likely to impact patients pursuing IVF and clinics practicing ART.

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 offers a good example of this principle. The salient dilemma with AI/ML medical software is that privacy policy has the potential to undermine distributional justice, forcing a choice between two competing visions of privacy protection. The first, stressing individual consent, won favor among bioethicists, information privacy theorists, and policymakers after 1970 but displays an ominous potential to bias AI training data in ways that promote health care inequities. The alternative, an older duty-based approach from medical privacy law aligns with a broader critique of how late-20th-century American law and ethics endorsed atomistic autonomy as the highest moral good, neglecting principles of caring, social interdependency, justice, and equity. Disregarding the context of such choices can produce suboptimal policies when - as in medicine and many other contexts - the use of personal data has high social value.

In Box v Planned Parenthood, Justice Thomas wrote an impassioned concurrence describing abortions based on sex, disability or race as a form of 'modern-day eugenics'. He defended the challenged Indiana reason-based abortion (RBA) ban as a necessary antidote to these practices. Inspired by this concurrence, legislatures have increasingly enacted similar bills and statutes allegedly as a prophylactic to 'eugenics', its underlying discrimination, and the racial disparities eugenics caused. This article tests my hypothesis that this legislative focus on eugenics is largely performative, rather than evidence of true concern about the discrimination and disparities underlying eugenics. My research examined state laws in several areas that fall within narrow and broad understandings of eugenics to determine whether states with RBA bans have implemented policies to counteract eugenics more broadly. My analysis shows that they generally have not. Instead, the apparent motivation is to commandeer concerns about eugenics to restrict reproductive rights. This legislative mission is hypocritical, and it harms the very groups impacted by the eugenics movements-minorities, women, people with disabilities, the LGBTQ+ community, and immigrants. Ultimately, it has led us to Dobbs, which makes everyone vulnerable to the eugenics policies Thomas condemns by undercutting previous constitutional protections against eugenics.

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 is to shed light on the potential threats to equitable access to organs allocated through algorithms, whether these are the consequence of political choices made upstream of digitization or of the algorithmic design, or are produced by self-learning algorithms. The article shows that achieving equitable access requires an overall vision of the algorithmic development process and that European legal norms only partially contribute to preventing harm and addressing equality in access to organs.

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 bearing points of similarity to the Henrietta Lacks case. In the first scenario, informed consent is obtained to use a tissue sample for research and to commercialize the products of such research; in the second scenario, informed consent is materially deficient because of an honest mistake on the part of the research institution; and in the third scenario, informed consent is materially deficient due to willful disregard of the law on the part of the research institution. In the first two scenarios, ownership of the cell line created from the tissue sample would vest in the research institution, and the research participant would not have any legal action for financial compensation. However, in the third scenario, ownership of the cell line would vest in the research participant, who would be able to claim all profits made from trading the cell line. Whether the research institution acted in good faith is therefore a crucial determinant of the legal outcome.

Despite the non-recognition of same-sex relationships or marriage by the law, lesbian motherhood has become an emerging socio-legal issue in China. To fulfil their desires to reproduce and make a family, some Chinese lesbian couples adopt a `shared motherhood model' where one lesbian contributes an egg while her partner becomes pregnant through embryo transfer following artificial insemination with a donor's sperm. Because the shared motherhood model intentionally divides the roles of biological mother and gestational mother between lesbian couples, this has allowed legal controversies to emerge associated with the parenthood of the conceived child as well as custody, support of, and visitation of the child. There are two pending judicial cases involving a shared motherhood arrangement reported in the country. The courts have appeared reluctant to rule on them because Chinese law has not provided clear legal solutions to these controversial issues. They are highly cautious about delivering a decision not in line with the current legal position of non-recognition of same-sex marriage. Given little literature discussing Chinese legal responses to the shared motherhood model, this article aims to fill the gap by investigating the basis of parenthood under Chinese law and analysing the parentage issue concerning the different types of relationships between lesbians and children born of a shared motherhood arrangement.

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 recently adopted Data Governance Act (DGA) already cover research data and to some extent DSI. An analysis of the ODD and the DGA throws a spotlight on the legal uncertainty of utilizing DSI and reveals systemic tensions between open data principles and benefit-sharing restrictions on non-commercial use. It also suggests that a future benefit-sharing mechanism for DSI should avoid distinguishing between commercial and non-commercial use upstream, but should instead favor a solution, which imposes benefit-sharing obligations further downstream or outside of the DSI life cycle.

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 implications. Civil rights activists call for better protection of cyborg bodies; some legal scholars suggest redefining or even dismissing the right to bodily integrity because of its uncertain foundations. Of particular importance is the question of the boundaries of the body because the legal treatment of prostheses and assistive devices depends on whether they are part of it. This paper analyzes these boundaries with a focus on the right to bodily integrity, in light of the jurisprudence of the European Court of Human Rights and the foundational legal distinction between persons and things. It argues that bodies indeed have multiple boundaries, but none of them qualifies for legal purposes. The law must thus draw normative boundaries. Against the temper of times, it should resort to a naturalistic conception because it accommodates interests of stakeholders in the best way.