Journal of Law and the Biosciences最新文献

{"title":"FDA preemption of conflicting state drug regulation and the looming battle over abortion medications.","authors":"Peter Grossi, Daphne O'Connor","doi":"10.1093/jlb/lsad005","DOIUrl":"https://doi.org/10.1093/jlb/lsad005","url":null,"abstract":"<p><p>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 <i>Dobbs</i> decision has renewed the importance of those scientific determinations, especially FDA's decisions implementing the Risk Evaluation and Mitigation Strategy (REMS) provisions of the Federal Food Drug and Cosmetic Act (FDCA), that mifepristone may be taken by patients outside the presence of any healthcare provider (often through telemedicine prescription and shipment across state lines). Now that <i>Dobbs</i> has been decided, state officials have indicated that they will seek to enforce state statutes which conflict with FDA's regimen for the proper use of mifepristone, by banning its use entirely, prohibiting telemedicine prescription, or imposing other requirements which FDA has specifically considered and now rejected as contrary to the congressional mandate that FDA-approved drugs be as accessible as safety considerations allow. Litigation has already been filed to invalidate such statutes on the grounds that they are preempted by the doctrine that state law which conflicts with, or undermines the purposes of, FDA actions with respect to approved drugs are preempted under the Supremacy Clause of the Constitution. This article examines the Supreme Court caselaw and FDA actions which will dictate the outcome of that litigation. Part I details the statutory basis for FDA preemption of conflicting state law and the four decisions by the Supreme Court over the last 13 years (<i>Levine, Mensing, Bartlett</i> and <i>Albrecht</i>) which enunciate the governing legal standards for FDA preemption. We pay particular attention to the opinions of Justice Alito and the other conservative justices, which hold that such FDA preemption should be robust to ensure that there is one consistent, national policy for the distribution and regulation of drugs, under the science-based decisions of the FDA, rather than the 'parochialism' of differing state standards. Part II details FDA's comprehensive program for the balanced, though appropriately restricted, use of mifepristone, and the 22 years of FDA actions that brought that about. It then catalogs the state statutes limiting the use of the drug which, in material ways, conflict with those FDA determinations. Part III outlines the arguments made in one early lawsuit seeking preemption of the statutes of one state (Mississippi)-a law suit which previews the wider litigation to come. It then sets forth the strong arguments for FDA preemption of each type of state restriction and responses to the 'defenses' of those statutes that have been offered in an effort to avoid FDA preemption under the Supremacy Clause. That review shows that a straight-forward application of the FDCA and the Supreme Court caselaw should result in the preemption of the state restrictions that square","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 1","pages":"lsad005"},"PeriodicalIF":3.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10017072/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9146320","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Is benefit sharing with research participants lawful in South Africa? An unexplored question in the governance of genomics research.","authors":"Donrich Thaldar,&nbsp;Bonginkosi Shozi","doi":"10.1093/jlb/lsad018","DOIUrl":"https://doi.org/10.1093/jlb/lsad018","url":null,"abstract":"<p><p>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 law provides that it is unlawful to provide any financial or other reward to research participants for donating biospecimens-except for reimbursement of reasonable costs incurred. Accordingly, benefit sharing would be unlawful. The ramifications of this conclusion are far-reaching. Most pertinently, should any benefit-sharing agreements with research be put into practice, such agreements would be unenforceable and would expose all parties involved-including foreign collaborators-to criminal prosecution. The solution for proponents of benefit sharing in South Africa would be to lobby the South African government to revise the relevant law. However, as long as the law remains as it currently is, institutions and individuals all over the world who are involved in genomics research in South Africa would be well advised to comply with the law by not engaging in benefit sharing with research participants.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 1","pages":"lsad018"},"PeriodicalIF":3.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10307998/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9736472","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The United Nations convention on the rights of persons with disabilities, neuroscience, and criminal legal capacity.","authors":"Benjamin A Barsky,&nbsp;Michael Ashley Stein","doi":"10.1093/jlb/lsad010","DOIUrl":"https://doi.org/10.1093/jlb/lsad010","url":null,"abstract":"<p><p>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 are two questions: First, what defenses should defendants with psychosocial disabilities be able to invoke during criminal prosecutions? Second, what kind of evidence is consistent with, on the one hand, determining a defendant's decision-making capacity to establish culpability and, on the other hand, the right to equal recognition before the law? Developments in neuroscience offer a unique prism to grapple with these issues. We argue that neuroscientific evidence of impaired decision-making, insofar as it presents valid and interpretable diagnostic information, can be a useful tool for influencing judicial decision-making and outcomes in criminal court. In doing so, we oppose the argument espoused by significant members of the global disability rights community that bioscientific evidence of psychosocial disability should be inadmissible to negate criminal responsibility. Such a position risks more defendants being punished harshly, sentenced to death, and placed in solitary confinement.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 1","pages":"lsad010"},"PeriodicalIF":3.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10198698/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9496430","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The legal personhood of human brain organoids.","authors":"Masanori Kataoka,&nbsp;Tsung-Ling Lee,&nbsp;Tsutomu Sawai","doi":"10.1093/jlb/lsad007","DOIUrl":"https://doi.org/10.1093/jlb/lsad007","url":null,"abstract":"<p><p>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 organoids: whether they can be considered legal persons. We clearly distinguish between two types of legal personhood: 'natural person' as a human legal person and 'juridical person' as a nonhuman legal person. By examining natural and juridical personhood separately, we point out the bias and confusion in the remarks on the legal personhood of human brain organoids and provide a more comprehensive picture of the problem.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 1","pages":"lsad007"},"PeriodicalIF":3.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10070033/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9253258","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The various faces of vulnerability: offering neurointerventions to criminal offenders.","authors":"Sjors Ligthart,&nbsp;Emma Dore-Horgan,&nbsp;Gerben Meynen","doi":"10.1093/jlb/lsad009","DOIUrl":"https://doi.org/10.1093/jlb/lsad009","url":null,"abstract":"<p><p>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 raised fundamental normative concerns, but some authors have argued that <i>offering</i> neurointerventions to convicted offenders could be permissible. However, such offers raise normative concerns too. One prominent worry that is often emphasized in the literature, relates to the vulnerability of convicted offenders in prison and forensic patients in mental health facilities. In this paper, we aim to show that as far as vulnerability is considered relevant within the context of offering medical interventions to offenders, it could contribute to arguments against as well as in favor of these offers.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 1","pages":"lsad009"},"PeriodicalIF":3.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10165894/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9823483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ectogestation and the Good Samaritan Argument.","authors":"Christopher Stratman","doi":"10.1093/jlb/lsad012","DOIUrl":"https://doi.org/10.1093/jlb/lsad012","url":null,"abstract":"<p><p>Philosophical discussions concerning ectogestation are trending. And given that the Supreme Court of the United States overturned <i>Roe v. Wade</i> (1973) and <i>Casey v. Planned Parenthood</i> (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 determine abortion policy in the future, then a new philosophical analysis of the legal status of abortion is both warranted and urgently needed. I argue that, even if there is no 'moral' right to fetal destruction once ectogestation becomes a reality, societies ought not to implement legal prohibitions on a pregnant person's ability to safely obtain an abortion that results in fetal death because such laws are systemically misogynistic.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 1","pages":"lsad012"},"PeriodicalIF":3.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10247311/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9612969","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Confidentiality, public interest, and the human right to science: when can confidential information be used for the benefit of the wider community?","authors":"Edward S Dove","doi":"10.1093/jlb/lsad013","DOIUrl":"https://doi.org/10.1093/jlb/lsad013","url":null,"abstract":"<p><p>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 (Article 15), hitherto has not been invoked in support of a public interest basis for lawful disclosure, but the argument is made herein that there may be scope to develop this jurisprudentially. On grounds of both law and policy, and in line with the underlying rationale of recent UK Government deployment of 'COPI Notices' for lawful use of confidential patient information in the course of the COVID-19 pandemic, I contend that the human right to science may well serve as a valuable juridical buttress to an overriding public interest justification to lawfully share confidential information. However, this could occur only in restricted circumstances where the public interest is clearly manifest, namely studies researching serious, imminent health threats to the general population that rely on confidential information accessed outside of existing statutory gateways, and not more routine scientific endeavors.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 1","pages":"lsad013"},"PeriodicalIF":3.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10266933/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9646583","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Should Canada adopt managed access agreements in Canada for expensive drugs?","authors":"Melanie McPhail,&nbsp;Tania Bubela","doi":"10.1093/jlb/lsad014","DOIUrl":"https://doi.org/10.1093/jlb/lsad014","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 1","pages":"lsad014"},"PeriodicalIF":3.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10271214/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9662963","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rules for robots, and why medical AI breaks them.","authors":"Barbara J Evans","doi":"10.1093/jlb/lsad001","DOIUrl":"https://doi.org/10.1093/jlb/lsad001","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 1","pages":"lsad001"},"PeriodicalIF":3.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9934949/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10765202","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Legal personhood and frozen embryos: implications for fertility patients and providers in post-<i>Roe</i> America.","authors":"Gerard Letterie,&nbsp;Dov Fox","doi":"10.1093/jlb/lsad006","DOIUrl":"https://doi.org/10.1093/jlb/lsad006","url":null,"abstract":"<p><p>The demise of <i>Roe v. Wade</i> 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 <i>Dobbs</i> 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.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 1","pages":"lsad006"},"PeriodicalIF":3.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10200124/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9515265","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}