Journal of Law and the Biosciences最新文献

In July 2023, the United States and the European Union introduced the Data Privacy Framework (DPF), introducing the third generation of cross-border data transfer agreements constituting adequacy with respect to personal data transfers under the General Data Protection Regulation (GDPR) between the European Union (EU) and the US. This framework may be used in cross-border healthcare and research relationships, which are highly desirable and increasingly essential to innovative health technology development and health services deployment. A reliable model meeting EU adequacy requirements could enhance the transfer of patient and research participant data. While the DPF might present a familiar terrain for US organizations, it also brings unique challenges. A notable concern is the ability of individual EU Member States to establish individual and additional requirements for health data that are more restrictive than GDPR requirements, which are not anticipated by the DPF. This article highlights the DPF's potential impact on the healthcare and research sectors, finding that the DPF may not provide the degree of lawful health data transfer desirable for healthcare entities. We examine the DPF against a background of existing Health Insurance Portability and Accountability Act obligations and other GDPR transfer tools to offer alternatives that can improve the likelihood of reliable, lawful health data transfer between the US and EU.

The regulation of neurotechnologies for non-medical purposes such as enhancement, gaming, or well-being is a topic of ongoing controversy. Without much attention, the European Union addressed it by two implementing regulations to the Medical Device Regulation (MDR) for non-invasive brain stimulation devices, passed in December 2022. This paper presents main aspect of these regulations and the conditions for placing non-medical neurodevices on the EU market, especially the risk threshold and the requirement for pre-market certification. It also provides a first critical comment on selected aspects and the unclear situation regarding research only devices which has alarmed the European neurotechnology sector.

Biologics are playing an increasingly important role in health care globally but are placing a substantial burden on payers. The development of biosimilars-drugs that are highly similar to and have no clinically meaningful differences from originator biologics-is critical to improving the affordability and accessibility of these medications. Medicines regulators, however, have had varied success with biosimilars to date. We examined agency guidance documents, peer-reviewed articles, and gray literature related to biosimilars in Australia, Canada, the European Union, the United Kingdom, and the United States to evaluate variations in the approaches to biosimilar approval taken by their respective medicines regulators. We found that the medicines regulators take similar approaches to biosimilar approvals, but that differences in their policies and their jurisdiction's laws regarding testing requirements, indication extrapolation, exclusivities, and substitution may contribute to the varied successes of biosimilars observed. Policies supportive of product-specific guidance, extrapolation, shorter exclusivity periods, and substitution were correlated with greater success in biosimilar approval and uptake. As medicines regulators work to promote biosimilars, understanding the impact of these laws and policies is crucial. Reforms consistent with these policies can create regulatory environments more supportive of biosimilar approvals, promoting access to affordable biologics for patients globally.

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 Favored Nation' (MFN) clause in which Regeneron agreed that the US commercial list price of certain products developed using BARDA funding would not exceed their retail price in comparable global markets. The Administration for Strategic Preparedness and Response (ASPR) included similar language in subsequent agreements, with a promise that this would become a new standard. Even beyond the preparedness context, government funders and purchasers might consider incorporating similar clauses in future contracts, especially given that the Regeneron agreement and its progeny have been praised as 'groundbreaking.' Yet a closer look reveals cause for skepticism. Regeneron's MFN clause includes several loopholes related to covered purchasers and reference countries, prices, and conditions. We describe agreement terms that can make the difference between legally meaningful price constraints and mere window dressing. Our critical analysis offers important lessons for future efforts to improve the affordability of medical technology developed with public funds.

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 of autosomal STR profiles. Although Y-STR matches are not individual-specific, this can be largely overcome with rapidly mutating Y-STRs (RM Y-STR) allowing separation of paternally related men. Expanding NCODDs with Y-STR profiles is also beneficial for law enforcement in cases without known suspects via familial searching. Expanding NCODDs with Y-STR profiles may raise concerns about genetic privacy and fundamental human rights. A legal analysis of the European Convention on Human Rights revealed that when primarily for reidentifying convicted sex offenders, it would be in line with the case law of the European Court of Human Rights, while a generalized approach primarily for familial searching and involving all types of offenders may not. This paper aims to stimulate a debate among various stakeholders regarding the benefits and risks of expanding NCODDs with Y-STR profiles that in some countries has already been practically implemented.

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, important legal questions arise. In countries like the UK, where a strict regulatory regime applies to research on embryos, should this be extended to SCBEM research, or would a different regulatory response be appropriate? Drawing on the 1984 Warnock Report, the Human Fertilisation and Embryology Act 1990 and the latest guidelines from the International Society for Stem Cell Research, this article considers principles for the regulation of the creation and use of SCBEMs.

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 paper, we explore how the death of the entity sustained by AAPT would be characterized in law. This question matters, as legal ambiguity in this area has the potential to compound uncertainty and the suffering of newly bereaved parent(s). We first identify the existing criteria used to delineate the legal characterization of death, which occurs before birth or during the immediate neonatal period in England and Wales. We then demonstrate that attempting to apply these in the context of AAPT gives rise to a number of challenges, which make it impossible to reach a definitive conclusion as to the nature of death in AAPT using the current legal framework. In doing so, we demonstrate that the current legal framework in England and Wales may be unable to adequately capture the situation of an entity being sustained by AAPT.

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 of 'high similarity with no clinically meaningful differences' will be difficult. Gene therapies are likely better candidates for biosimilar development than cell therapies. Biosimilarity should be met when gene therapy biosimilars contain the same genetic sequence as a reference product, and the variability in the vector meets the high similarity standard. Manufacturing challenges, including the lack of standardized platforms, high production costs, and complexity, pose significant obstacles. It may also be important to demonstrate biosimilarity within the manufacturing process. Intellectual property barriers, specifically patenting, trade secrecy, and regulatory exclusivity, could hinder biosimilars' ability to gain market share, although recent Supreme Court decisions limiting the breadth of patent claims could ease barriers to future CGT competition, including from biosimilars. Finally, inadequate market sizes might create hurdles, especially for curative treatments, as patient pools shrink following treatment by the reference CGT.

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, fails to adequately address its distinct challenges. Rising new technologies underscore the urgent need for regulatory reform. These technologies highlight the pressing demand for comprehensive legal frameworks that can reconcile the rapid pace of innovation with the imperatives of patient safety and product efficacy. Legal concerns extend beyond mere compliance; they encapsulate quality assurance, and liability in cases of human error. This study outlines the call for a recalibrated legal landscape that prioritizes patient-centered care while fostering the growth of bedside manufacturing. It is crucial for the legal system to evolve in tandem with these medical advancements, ensuring a secure, efficacious, and equitable integration of bedside manufacturing into healthcare.