Journal of Law and the Biosciences最新文献

Much of the academic literature criticizes the inclusion of patent term extensions (PTE) and test data protection into the pharmaceutical provisions and/or intellectual property (IP) chapters of free trade agreements (FTAs), with many arguing that such provisions will increase the cost of pharmaceuticals for the implementing government. Such arguments are often backed by studies conducted prior to the conclusion of the relevant FTA. This is problematic for several reasons, most notably that the studies make assumptions that subsequently turn out not to be false and that the claims are not revisited and supported with empirical data following implementation. This article reviews the experience of two jurisdictions - Canada and Australia - in order to provide an analysis of legislative and judicial practices with a focus on implications and the cost of FTAs. The article examines how Canada and Australia have implemented their FTA obligations domestically and on the hereto ignored but important role of courts. One key finding is how courts in both countries are vigilant in narrowing the scope of obligations under FTAs to accommodate the need of the domestic market. The article ultimately concludes by calling on governments to conduct a detailed analysis of PTE and test data protection so as to better inform and prepare policymakers and, ultimately, improved FTA provisions and health outcomes.

In this article, the right to terminate pregnancy is discussed comparatively in terms of the situation in Turkey and the rest of the world. We have concluded that certain minimum conditions must be met to be able to talk about the full recognition of this right. Recognizing that pregnancy can be terminated voluntarily is the most important of these conditions. Just as the period in which this right can be exercised should not be kept short, it should also be accepted that it can only be used based on the will of a pregnant person who has the power of discernment. In addition, certain obligations must be avoided, such as receiving counseling services before the termination of pregnancy and then waiting for a certain period of time to pass. In cases where pregnancy can be terminated because of an anomaly, a disease, or a crime, it is important to make clear arrangements that will not make practitioners, especially physicians, hesitate to perform such a procedure. Finally, the State must never forget that it is obliged to organize services for the termination of pregnancies in a way that is easily accessible to everyone who may need this procedure.

Germline genetic testing for inherited cancer risk has shifted to multi-gene panel tests (MGPTs). While MGPTs detect more pathogenic variants, they also detect more variants of uncertain significance (VUSs) that increase the possibility of harms such as unnecessary surgery. Data sharing by laboratories is critical to addressing the VUS problem. However, barriers to sharing and an absence of incentives have limited laboratory contributions to the ClinVar database. Payers can play a crucial role in the expansion of knowledge and effectiveness of genetic testing. Current policies affecting MGPT reimbursement are complex and create perverse incentives. Trends in utilization and coverage for private payers and Medicare illustrate opportunities and challenges for data sharing to close knowledge gaps and improve clinical utility. Policy options include making data sharing (i) a condition of payment, and (ii) a metric of laboratory quality in payment contracts, yielding preferred coverage or enhanced reimbursement. Mandating data sharing sufficient to verify interpretations and resolve discordance among labs under Medicare and federal health programs is an option for the US Congress. Such policies can reduce the current waste of valuable data needed for precision oncology and improved patient outcomes, enabling a learning health system.

Sharing cancer gene variant and relevant clinical data could accelerate progress in cancer genomics. However, data sharing is currently impeded by issues related to financial sustainability, equity, incentives, privacy and security, and data quality. Evidence-based policy options to facilitate data sharing in these domains, and ultimately improve interpretation of cancer-associated genomic variants, are therefore needed. We conducted a modified policy Delphi with expert stakeholders that involved generating, evaluating, and ranking potential policy options to address these issues, with a focus on the US context. We found policy options in the financial sustainability domain were highly ranked, particularly stable funding for trusted entities. However, some Delphi panelists noted that the culture of public research funding has favored short-term grants. Panelists favored policy options focused on action by funders, which had the highest overall total scores that combined effectiveness and feasibility ratings and priority ranking within domains. Panelists also endorsed some policy options connected to actors such as journals, but they were more skeptical of policy options connected to legislative actors and data resources. These findings are critical inputs for policy makers as they consider policies to enable sharing of cancer gene variant data to improve health.

With abortion remaining legal in over half of the country and a proliferation of websites offering information on how to access abortion medications, for those who know where to look, there are sound options for safely ending an unwanted early-stage pregnancy. But not all patients have equal access to reliable information. This Article addresses the urgent downstream harms caused by the lack of access to abortion information, and argues that in view of these consequences, regardless of abortion's legal status, clinicians have a duty to provide their patients with abortion information. We begin by documenting clinicians' hesitation to share abortion information, drawing on our interviews with 25 doctors practicing medicine in a state where abortion is criminalized. Next, we explain why clinicians are duty-bound to provide all-options counseling. We then consider whether such duties shift where abortion is criminalized. After identifying the limited legal risks associated with supplying abortion information, and showing how, by requiring all-options counseling, professional societies might reduce risks to patients and clinicians, we conclude that, regardless of the legal status of abortion, clinicians have a professional responsibility to share basic abortion information - including treatment options and how to access those options.

Introduction: Laws regulating substance use in pregnancy are changing and may have unintended consequences on scientific efforts to address the opioid epidemic. Yet, how these laws affect care and research is poorly understood.

Methods: We conducted semi-structured qualitative interviews using purposive and snowball sampling of researchers who have engaged pregnant people experiencing substance use. We explored views on laws governing substance use in pregnancy and legal reform possibilities. Interviews were double coded. Data were examined using thematic analysis.

Results: We interviewed 22 researchers (response rate: 71 per cent) and identified four themes: (i) harms of punitive laws, (ii) negative legal impacts on research, (iii) proposals for legal reform, and (iv) activism over time.

Discussion: Researchers view laws penalizing substance use during pregnancy as failing to treat addiction as a disease and harming pregnant people and families. Respondents routinely made scientific compromises to protect participants. While some have successfully advocated for legal reform, ongoing advocacy is needed.

Conclusion: Adverse impacts from criminalizing substance use during pregnancy extend to research on this common and stigmatized problem. Rather than penalizing substance use in pregnancy, laws should approach addiction as a medical issue and support scientific efforts to improve outcomes for affected families.

Mobile health (mHealth) technologies raise unique risks to user privacy and confidentiality that are often embedded in lengthy and complex Privacy Policies, Terms of Use, and End User License Agreements. We seek to improve the ethical review of these documents ('user agreements') and their risks in research using mHealth technologies by providing a framework for identifying when these risks are research risks, categorizing the key information in these agreements under relevant ethical and regulatory categories, and proposing strategies to mitigate them. MHealth user agreements typically describe the nature of the data collected by mHealth technologies, why or for what purposes user data are collected and shared, who will have access to the different types of data collected, and may include exculpatory language. The risks raised by data collection and sharing typically increase with the sensitivity and identifiability of the data and vary by whether data are shared with researchers, the technology developer, and/or third-party entities. The most important risk mitigation strategy is disclosure of the key information found in user agreements to participants during the research consent process. In addition, researchers should prioritize mHealth technologies with favorable risk-benefit balances.

A large and highly heterogeneous group of individuals conducts genetic and genomic research outside of traditional corporate and academic settings. They can be an important source of innovation, but their activities largely take place beyond the purview of existing regulatory systems for promoting safe and ethical practices. Historically the gene-targeting technology available for non-traditional genomic research has been limited, and therefore these activities have attracted little regulatory attention. New technologies such as CRISPR/Cas9, however, give nonconventional experimenters more extensive gene editing abilities at an unprecedented level of accessibility. The affordability and accessibility of these powerful technologies are raising questions about whether the current largely laissez-faire governance approach is adequate. This article recommends steps to enhance self-governance, including establishing umbrella organizations to represent community interests, creating a community IRB modelled on the DIYBio Ask a Safety Expert Service, and adopting an ethical obligation to report rogue experiments.

Innovative health technologies are not well regulated under current pathways, leading regulators to adopt contextual, life-cycle regulatory models, which authorize drugs based on earlier clinical evidence subject to the conduct of post-market trials that confirm clinical benefit and safety. In this paper, we evaluate all drugs authorized in Canada under the Notice of Compliance with conditions (NOC/c) policy from 1998 to 2021 to analyze its function, identify challenges and areas for improvement, and make recommendations to inform Health Canada's regulatory reforms. We analyzed a sample of 148 drugs authorized between 1998 and 2021, including characteristics about the pre- and post-market clinical trials, finding that most NOC/c authorizations are based on one, single-arm clinical trial using a surrogate endpoint. Post-market trials are more likely to be randomized, Phase III trials but mostly use surrogate endpoints. Based on our findings, we recommend increasing decision-making transparency throughout the regulatory process, developing comprehensive eligibility criteria for selecting appropriate health technologies, modernizing pre-market evidence requirements, adopting a more active role in designing post-market trials, and utilizing automatic expiry, stronger penalties, and ongoing disclosure of the status of post-market trials to promote compliance.