Journal of Law and the Biosciences最新文献

Gene therapies represent a significant advancement in modern medicine, offering potential cures for untreatable genetic disorders. However, equitable access to these innovative therapies remains a critical ethical challenge within the European Union (EU). This paper examines the adequacy of the EU's centralized market authorization framework, supplemented by alternative pathways such as the Hospital Exemption and Compassionate Use Program, in addressing access disparities. While the centralized framework ensures high standards of safety, quality, and efficacy, its implementation reveals significant barriers related to affordability, geographical disparities, and fragmented national healthcare systems. High costs create financial obstacles for both healthcare systems and individuals, disproportionately affecting low-income countries and regions. Geographic disparities are further exacerbated by fragmented regulations and uneven healthcare infrastructures across member states, limiting patient access in rural areas. Alternative pathways, while designed to improve access, suffer from inconsistent national-level implementation. This paper argues that as the EU navigates the complexities of gene therapy regulation, it must focus on creating a more cohesive and inclusive framework. By doing so, it can ensure that the potential of gene therapies is realized in a manner that benefits all EU citizens, irrespective of their geographic or economic circumstances.

The human right to science, including the right to enjoy the benefits of scientific progress, is by far the least understood human right despite its central role in shaping scientific innovation. Research into innovative cancer therapies and biotechnologies has been pivotal in the realization of much of these advancements. Yet much of it is not accessible, affordable, or available to patients who need them most. This article examines the nature and scope of the right to science in cancer research in the context of General Comment No. 25 on Science and Economic, Social and Cultural Rights (E/C.12/GC/25) and Article 15 of the International Covenant on Economic, Social and Cultural Rights. The normative and ethical imperative of the right is annotated to provide a basis for its justiciability when redressing the pervasive issue of inequitable access to innovative cancer therapy. It argues that a constitutional dialogue that conceptualizes the right to science is warranted when rethinking ways ethical and human rights friendly research can be achieved. This renewed interest comes at a critical juncture when science in its contemporaneous situation needs to tackle cancer healthcare inequities amid turbulent geopolitical and epidemiologic challenges while addressing the rising cancer burden globally.

The situation of persons diagnosed with locked-in syndrome (LIS) raises a significant legal challenge. As a consequence of a brainstem stroke, they are quadriplegic and lack articulate speech but have normal visual perception, bodily sensations, consciousness, and cognitive functions. It is only with human and technological assistance that they can communicate, express their will, make responsible decisions, and exert their civil rights. Insofar as they can communicate, there seems in principle to be no reason for restricting their legal capacity. This, however, has not always been recognized. In the early 2000s in Spain, two men with LIS who had been declared 'incapable' and deprived of their civil rights reclaimed them in court. Rights were given back to the one who could use a computer. They were initially refused to the other, who communicated solely by blinking and depended on a human intermediary. Only the human-machine system was trusted to convey faithfully and reliably the subject's autonomous will. This article describes these two cases in their legal context and discusses how they can throw light on the exercise of legal capacity by persons with disabilities after the adoption in 2006 of the UN Convention on the Rights of Persons with Disabilities.

[This corrects the article DOI: 10.1093/jlb/lsae026.].

In February 2024, the United States Patent and Trademark Office (USPTO) issued a notice, Inventorship Guidance for AI-assisted Inventions ('Inventorship Guidance'), to clarify agency policy and the Office's interpretation of inventorship requirements for patents that describe inventions made with the assistance of artificial intelligence (AI). From the perspective of an AI-driven drug discovery (AIDD)-focused business, the Inventorship Guidance offers potential benefits that include increased clarity in patent eligibility, facilitated collaboration between AI experts and drug discovery scientists, and incentivization for continued development of AI tools. However, there remain concerns with the application of the framework outlined in the Inventorship Guidance, such as the complex assessment of substantial human contributions in the real world, challenges in applying the Inventorship Guidance to collaborations and partnerships in the drug discovery field, and challenges in determining inventorship for AI tools versus specific drug innovations. To address these challenges, I propose recommendations for modifying the Inventorship Guidance for the AIDD industry, suggest best practices for inventorship documentation and processes, and advocate for continued partnership between the USPTO and the AIDD sector. By refining the existing framework and fostering ongoing dialog, I aim to promote a balanced approach that encourages AI-driven innovation while recognizing essential human contributions in drug discovery.

Numerous cryopreserved surplus embryos are being stored in IVF units in Western countries. IVF patients are required to choose and consent to disposition options for their surplus embryos upon starting treatment. We focus on the option of embryo donation to others for reproductive purposes. The terminology used for this practice is inconsistent, as the term embryo 'donation' is used interchangeably with embryo 'adoption' in different jurisdictions, government programs, and by private initiatives. Our main argument is that the selected terminology bears conceptual and other consequences for public attitudes, in a way which affects the choice of such a surplus embryo-disposition-option. More specifically, we contend that the pairing of 'embryo-adoption' is misguided. We identify material, legal, and policy-related points of distinction between the practices of donation and adoption. Then, we discuss the importance of choosing the right terminology, given its power to influence the perception of embryo donation/adoption, and analyze conceptual differences between the two terms, finding only 'donation' to be fit for purpose. Next, relying on findings from an empirical study, we consider the effect of the non-personhood of the embryo on the appropriateness of each term. Subsequently, we distinguish donation from adoption and justify why the former is more appropriate.

Enacted primarily to encourage patents on federally funded inventions, an additional policy objective of the Bayh-Dole Act is to increase visibility around scientific discoveries made with US government support. The Bayh-Dole Act requires federal grantees to disclose subject inventions to funding agencies and declare government support in their patents. Prior research has shown, however, that hundreds of grantees have failed to declare federal funding in biomedical patents, and others have acknowledged government support several years late through certificates of corrections. Combining data from the National Institutes of Health and the Patent and Trademark Office, this study explores the extent to which grantees have declared government support late through certificates of corrections and likely reasons why this occurred. Over 3000 patents covering federally funded inventions have been corrected to acknowledge government support late, most in recent years. Many of these corrections appear to have been driven by high-profile controversies, changes in the Bayh-Dole regulations, and civil society advocacy. These findings call for policies to encourage timely compliance with invention reporting requirements and to increase the visibility of late acknowledgements of US government funding.

One way to ensure adequate legal protection against existing and emerging forms of mental interference is by specifying the human right to mental integrity. This paper considers three possible constructions of the scope of this right in human rights law. It argues that the Mental Control View and the Direct Harmful Interference View fall short of providing a persuasive definition of the right. Rather, it is proposed to construct the scope of the right along the lines of the Significant Mental Interference View. Meanwhile, the directness of a mental interference and the psychological harm it entails are plausibly relevant factors to the potential justification of rights infringements.

The capacity-building mechanism in the Biosafety Protocol aims to assist the parties, inter alia, in establishing and implementing national measures concerning genetically modified organisms (GMOs) that are aligned with the objectives of the Biosafety Protocol. Regulatory capacities of developing countries to address environmental risks caused by GMOs remain to be improved. The article takes China as an example to analyze how regulatory capacity-building activities organized under the Biosafety Protocol contributed to and will further influence China's establishment and implementation of GMO laws and regulations. A four-stage analytical framework is established to examine the interaction between capacity-building activities and the development of China's GMO regulation. China has gradually developed its GMO laws and regulations, with each stage having different regulatory needs and capacity-building efforts. External intervention and endogenous regulatory capacity-building activities mutually strengthened China's implementation of the Biosafety Protocol. Endogenous regulatory capacity-building activities are increasing in enhancing China's GMO regulation. The article concludes by proposing ways to enhance China's regulatory capacities regarding GMOs against the backdrop of adopting the Kunming-Montreal Global Biodiversity Framework and China's Biosecurity Law, involving making laws and regulations on GMOs consistent with the Biosecurity Law and reconsidering the regulatory modes on genome-editing techniques.