Journal of Law and the Biosciences最新文献

Universal forensic DNA databases are controversial privacy-wise given their omnibus scope of incorporating DNA profile data of the entire population into the system. Following the landmark decision of the European Court of Human Rights on the retention of DNA profiles in S. and Marper v. the United Kingdom, two differing opinions emerged on its application to universal databases: their acceptability and illegality. This paper makes use of the elements of the right to respect for private life (Article 8 ECHR), distilled from the Court's jurisprudence involving collection and retention of DNA profile data, in the form of tests-preliminary interference, legality, legitimate purpose, and proportionality-in assessing the feasibility of establishing population-wide DNA databases in Europe.

Recent technological advances in neuroscience offer a novel way for parents to nurture their children: altering brain activation to improve cognitive functions. Parental use and state regulation of cognitive enhancement will inevitably cause tensions between parent, child, and state. These tensions stem from three different but fundamentally related causes, namely minors' incompetency in making decisions about their own welfare, parental autonomy to make decisions about the upbringing of their minor children, and the state's interests in protecting minors' well-being. However, these tensions are not without precedents. The courts have frequently struggled to set the boundary of parental autonomy and to balance parents' rights, children's interests, and state's interests, and have accumulated extensive precedents in various contexts. This article reviews previous US court decisions in select contexts analogous to cognitive enhancement-medical intervention, education, and mandatory vaccination-and analyzes their implications for the use of cognitive enhancement on minors. This article will provide a useful guide for policy makers and researchers to identify and analyze issues regarding cognitive enhancement and to develop sound policies to ensure responsible use of this novel technology.

Standard contractual clauses (SCCs) have long been considered the most accessible method to transfer personal data legally across borders. In July 2020, the Court of Justice of the European Union (CJEU) in Data Protection Commissioner v Facebook Ireland Limited, Maximillian Schrems (Schrems II) placed heavy conditions on their use. The Schrems II Court found that SCCs were valid as 'appropriate safeguards' for data transfers from EU entities to others outside the EU/EEA as long as unspecified 'supplementary measures' were in place to compensate for the lack of data protection in the third country. Data protection officers are under intense pressure to explain these measures and allow routine transfers to continue. Some authorities interpret the decision as preventing the use of SCCs to transfer personal data outside of the EU because private contracts cannot comprehensively redress gaps in national law. This article argues that these authorities are mistaken and that notwithstanding Schrems II SCCs can still be useful instruments for cross-border transfers. This is especially true in highly regulated contexts such as medical research. This paper traces the history of SCCs under the General Data Protection Regulation (GDPR) and shows how the CJEU in Schrems II misunderstood the purpose of SCCs and other Article 46 GDPR 'appropriate safeguards'. The CJEU mistakenly approached Article 46 safeguards such as SCCs as being similar to country-specific adequacy rulings under Article 45 GDPR. But unlike Article 45 adequacy rulings, SCCs were not intended to provide a stand-alone mechanism for transfer reliant on the law of the importing country. Rather SCCs provide an alternative, multi-layered standard for data protection that encompasses law, technology and organizational commitments. Their purpose is to be used in situations where legislation alone is insufficient to protect data subject rights. The European Commission's new draft SCCs support this analysis.

The Biosecurity Law has laid down a regulatory framework on bioethics in China, from raising awareness through education, requiring researchers to conform to ethical principles and conduct ethical reviews on biomedical research, to giving special attention to human genetic resources. The law constructively leaves a wide range of discretion to medical institutions and professionals in ethical decision-making, adaptive to the biotechnology-ethics-regulation dynamics. This regulatory strategy poses crucial institutional challenges in its implementation, particularly on how to safeguard institutional review boards (IRB), a core mechanism in the governance, to effectively protect human subjects but not unnecessarily hinder the progress of biomedical research. Further measures need to clarify important issues on the IRB-based governance, including legal status of the IRB review decision, potential liabilities, and protections of the IRB members.

The implementation of social distancing measures through legal regulations to contain an epidemiologic outbreak has received little research attention. We reviewed and synthesized data on epidemiology, mobility trends and enforcement activities in the first 5 months of the COVID-19 epidemic in Hong Kong to examine the effectiveness of the newly enacted social distancing regulations. Data collected showed reduced patronage of retail and recreational activities during the epidemic. The regulations' enforcement could be inferred from the increase in the number of inspections, verbal warnings given to operators of scheduled premises and to people in public gatherings, but which rarely led to prosecutions. In parallel, the number of reported COVID-19 cases became stabilized. Our analyses suggested that public compliance with social distancing regulations could be maintained through promotional efforts without enforcement by prosecution. The adverse impacts of prolonged social distancing on the economy and citizens' social and psychological well-being were, however, of concern.

'Artificial womb' technology is highly anticipated for the benefits it might have as an alternative to neonatal intensive care and for pregnant people. In the bioethical literature, it has been suggested that such technology will force us to rethink the ethics of abortion. Some scholars have suggested that a pregnant person may be entitled to end a pregnancy but, with the advent of ectogestation, they may not be unilaterally entitled to opt for an abortion where the other genetic progenitor does not agree. Following two high-profile cases in England and Wales in the late 70s and 80s, English law is clear that genetic progenitors who do not gestate have no say in abortion decisions. It might be argued, however, that ectogestation casts doubt on the exclusion of all claims by genetic progenitors. In this article, I assess what a legal challenge to a decision to opt for abortion might look like with the advent of this technology, by examining whether genetic progenitors have the locus standi or grounds to seek an injunction to prevent abortion. I argue that such a challenge is unlikely to be successful.

Some of the most promising recent advances in health research offer opportunities to improve diagnosis and therapy for millions of patients. They also require access to massive collections of health data and specimens. This need has generated an aggressive and lucrative push toward amassing troves of human data and biospecimens within academia and private industry. But the differences between the strict regulations that govern federally funded researchers in academic medical centers (AMCs) versus those that apply to the collection of health data and specimens by industry can entrench disparities. This article will discuss the value of secondary research with data and specimens and analyze why AMCs have been put at a disadvantage as compared to industry in amassing the large datasets that enable this work. It will explore the limitations of this current governance structure and propose that, moving forward, AMCs should set their own standards for commercialization of the data and specimens they generate in-house, the ability of their researchers to use industry data for their own work, and baseline informed consent standards for their own patients in order to ensure future data accessibility.

This article explores the criminal regulation of misoprostol as a controlled drug in Brazil as a new form of abortion criminalization. A qualitative analysis of Brazilian case law shows how the courts use a public health rhetoric of unsafe abortion to criminalize the distribution of misoprostol in the informal sector. Rather than an invention of the local bench, this judicial rhetoric reflects global public health discourse and policy on unsafe abortion and the double life of misoprostol as both an essential medicine and a controlled drug. In contrast to previous studies, the article shows that abortion criminalization is not the cause, but rather the consequence of misoprostol's double life. In the last section, it draws on an outlier judgment of the case law to chart a regulatory future for misoprostol and its supply in the informal sector as a site of harm reduction and safe abortion in public health policy.

This manuscript examines how the Precautionary Principle has been applied to provide a mechanism for protection of the environment and health in response to the introduction of Genetically Modified Organisms (GMOs) in Europe. It discusses how the Court of Justice of the European Union (CJEU) handled national requests across four cases in which Member States had failed in their attempt to trigger the Precautionary Principle in order to uphold a ban or suspension of the cultivation or sale of GMOs in their territory. The analysis of these judgements suggests that the court has applied a narrow interpretation to the scientific evidence emerging from risk assessments, and has thereby limited the potential for precautionary measures by Member States to be upheld by the court. This outcome reflects a `weak' application of the Precautionary Principle by the court in contrast with the `moderate' formulation and `strong' interpretation of the principle offered by the European legal framework. Moreover, the analysis highlights that the CJEU's rulings are not keeping pace with the development of the European normative framework which considers the Precautionary Principle as a key tenet and, through the 2015 Directive, enables Member States to ban GMO cultivation without referring to scientific evidence.