This book examines how regulatory and liability mechanisms have impacted upon product safety decisions in the pharmaceutical and medical devices sectors in Europe, the USA and beyond since the 1950s. Thirty-five case studies illustrate the interplay between the regulatory regimes and litigation. Observations from medical practice have been the overwhelming means of identifying post-marketing safety issues. Drug and device safety decisions have increasingly been taken by public regulators and companies within the framework of the comprehensive (...) regulatory structure that has developed since the 1960s. In general product liability cases have not identified or defined safety issues, and function merely as compensation mechanisms. This is unsurprising as the thresholds for these two systems differ considerably; regulatory action can be triggered by the possibility a product is harmful, whereas establishing liability in litigation requires proving that the product was actually harmful.As litigation normally post-dates regulatory implementation, the 'private enforcement' of public law has generally not occurred in these sectors. This has profound implications for the design of sectoral regulatory and liability regimes, including associated features such as extended liability law, class actions and contingency fees. This book forms a major contribution to the academic debate on the comparative utility of regulatory and liability systems, on public versus private enforcement, and on mechanisms of behaviour control. (shrink)

Recent food emergencies throughout the world have raised some serious ethical and legal concerns for nations and health organizations. While the legal regulations addressing food risks and foodborne illnesses are considerably varied and variously effective, less is known about the ethical treatment of the subject. The purpose of this article is to discuss the roles, justifications, and limits of ethics of food safety as part of public health ethics and to argue for the development of this timely and emergent (...) field of ethics. The article is divided into three parts. After a short introduction on public health ethics, all levels of food safety processes are described and the role that ethics play in each of these levels is then analyzed. In the second part, different models describing the function of food law are examined. The relationship between these models and the role of ethics of food safety is assessed and discussed in the final part, leading to some relevant comments on the limits of the role and effect of ethics of food safety. (shrink)

Listening and responding to patients’ stories for over 20 years as an emergency physician has strengthened my appreciation for the many ways that the skills and principles drawn from writing fiction double as necessary clinical skills. The best medicine doesn’t work on the wrong story, and the stories patients tell sometimes feel like first drafts—vital and fragile works-in-progress. Increasingly complex health challenges compounded by social, financial, and psychological burdens make for stories that are difficult to articulate and comprehend. In this (...) essay, I argue that healthcare providers need to think like creative writers and the skills and sensitivities necessary to story construction deserve a vital space in medical education. A thorough understanding of story anatomy and the imaginative flexibility to work stories into open spaces serve as antidotes to the reductive nature of clinical decision making and have implications as patient safety and risk management strategies. The examples that I have selected demonstrate how thinking like a creative writer functions at the bedside, providing tools for clinical excellence and empathy. This approach asks that we re-imagine the importance of story in clinical care: from a vehicle to a diagnosis to its place as a critical destination. (shrink)

Despite recurring efforts, a gap exists across a variety of contexts between the protection of patients' safety in theory and in practice. This timely Research Handbook highlights these critical issues and suggests both legal and policy changes are necessary to better protect patients' safety. Multidisciplinary in nature, this Research Handbook features contributions from eminent academics, policy makers and medical practitioners from the Global North and South, discussing the essential facets concerning patient safety and the law. It (...) highlights how the role of legislation and case law has the potential to influence, both positively and negatively, medical practice and the quality of care. Chapters explore patient safety and the global health agenda; physiotherapy; 'non-therapeutic' clinical research with children; patient safety awareness in healthcare education; and the increasing use of robotics and artificial intelligence in healthcare. Outlining a wide range of international perspectives on patient safety and the law, this Research Handbook will appeal to academics and researchers specialising in health and medical law, human rights and healthcare regulation. It will also serve as a valuable resource for legal and medical practitioners alike, as well as clinicians and professionals working in healthcare governance. (shrink)

Systematically improving patient safety is of the utmost importance, but it is also an extremely complex and challenging task. This illuminating study evaluates the role of professionalism, regulation and law in seeking to improve safety, arguing that the 'medical dominance' model is ill-suited to this aim, which instead requires a patient-centred vision of professionalism. It brings together literatures on professions, regulation and trust, while examining the different legal mechanisms for responding to patient safety events. Oliver Quick (...) includes an examination in areas of law which have received little attention in this context, such as health and safety law, and coronial law, and contends in particular that the active involvement of patients in their own treatment is fundamental to ensuring their safety. (shrink)

The lack of economic sustainability of most healthcare systems and a higher demand for quality and safety has contributed to the development of regulation as a decisive factor for modernisation, innovation and competitiveness in the health sector. The aim of this paper is to determine the importance of the principle of public accountability in healthcare regulation, stressing the fact that sunshine regulation—as a direct and transparent control over health activities—is vital for an effective regulatory activity, for an appropriate supervision (...) of the different agents, to avoid quality shading problems and for healthy competition in this sector. Methodologically, the authors depart from Kieran Walshe’s regulatory theory that foresees healthcare regulation as an instrument of performance improvement and they articulate this theory with the different regulatory strategies. The authors conclude that sunshine regulation takes on a special relevance as, by promoting publicity of the performance indicators, it contributes directly and indirectly to an overall improvement of the healthcare services, namely in countries were citizens are more critical with regard to the overall performance of the system. Indeed, sunshine regulation contributes to the achievement of high levels of transparency, which are fundamental to overcoming some of the market failures that are inevitable in the transformation of a vertical and integrated public system into a decentralised network where entrepreneurialism appears to be the predominant culture. (shrink)

This article presents an analysis of contractual relations in sport from the standpoint of the Croatian legislative system. Due to the complexity of the subject matter, the author considers only a small fragment of it - the significance and the role of sport in Croatian society and the law of contracts „as a cornerstone on which „sports law“ has been built and which is of primary importance in most areas where there is an interface between sport and the law, irrespective (...) of whether the sport is being played at an elite level or at a more humble one“. Bearing in mind the limited extent of this article, the autor tries to provide some clarifications and some guidance on how to deal with the designation and the determination of the applicable law for contracts in the sporting context. Considering that there are different legal regimes which may come into play with regard to the designation of the law applicable to contracts in the sporting context, the author first presents the determination of the applicable law according to the Rome I Regulation and then according to the Croatian Arbitration Act, Swiss Private International Law Act and the CAS Code of Sports-related Arbitration, as the most common in sports practice. Then, the author deals with contracts concluded with minor athletes and the determination of the law applicable to some preliminary questions. Finally, the author presents her perception of the problems encountered and some suggestions for the improvement of the existing legal framework. (shrink)

This article presents a model for regulating cognitive enhancement devices. Recently, it has become very easy for individuals to purchase devices which directly modulate brain function. For example, transcranial direct current stimulators are increasingly being produced and marketed online as devices for cognitive enhancement. Despite posing risks in a similar way to medical devices, devices that do not make any therapeutic claims do not have to meet anything more than basic product safety standards. We present the case for (...) extending existing medical device legislation to cover CEDs. Medical devices and CEDs operate by the same or similar mechanisms and pose the same or similar risks. This fact coupled with the arbitrariness of the line between treatment and enhancement count in favour of regulating these devices in the same way. In arguing for this regulatory model, the paper highlights potential challenges to its implementation, and suggests solutions. (shrink)

This brief review of the efficacy, safety, and costs of IVF demonstrates that this procedure has become accepted medical practice without adequate scientific assessment. Its rapid proliferation especially in the market-oriented USA system, has preceded the type of outcomes research that is essential in order to protect both individual patients and the health care system. In addition, concern over the psychological costs borne by the vast majority of women who unsuccessfully pursue pregnancy through these techniques should warrant a (...) level of caution which to date has not been forthcoming. The demand for pregnancy, the organisation of medical specialties surrounding these procedures, the open-ended reimbursement and incentive structure, and powerful market forces make it unlikely that IVF and a whole range of medical technologies can be regulated without some semblance of a national health system. These findings clearly reinforce the themes raised by the Radical Statistics Health Group and illustrate some of the weaknesses of a market approach to medical care. (shrink)

Background Ethics committees and their system of research protocol peer-review are currently used worldwide. To ensure an international standard for research ethics and safety, however, data is needed on the quality and function of each nation's ethics committees. The purpose of this study was to describe the characteristics and developments of ethics committees established at medical schools and general hospitals in Japan. Methods This study consisted of four national surveys sent twice over a period of eight years to (...) two separate samples. The first target was the ethics committees of all 80 medical schools and the second target was all general hospitals with over 300 beds in Japan (n = 1457 in 1996 and n = 1491 in 2002). Instruments contained four sections: (1) committee structure, (2) frequency of annual meetings, (3) committee function, and (4) existence of a set of guidelines for the refusal of blood transfusion by Jehovah's Witnesses. Results Committee structure was overall interdisciplinary. Frequency of annual meetings increased significantly for both medical school and hospital ethics committees over the eight years. The primary activities for medical school and hospital ethics committees were research protocol reviews and policy making. Results also showed a significant increase in the use of ethical guidelines, particularly those related to the refusal of blood transfusion by Jehovah's Witnesses, among both medical school and hospital ethics committees. Conclusion Overall findings indicated a greater recognized degree of responsibilities and an increase in workload for Japanese ethics committees. (shrink)

In the past 50 years, an ethical-legal boundary has been drawn between treatment and research. It is based on the reasoning that the two activities pursue different purposes. Treatment is aimed at achieving optimal therapeutic benefits for the individual patient, whereas the goal of scientific research is to increase knowledge, in the public interest. From this viewpoint, the patient’s experience should be clearly distinguished from that of a participant in a clinical trial. On this premise, two parallel and mutually exclusive (...) regimes have been established. Yet in the case of deep brain stimulation (DBS), this presentation is a poor fit, for both the patient’s lived experience and medical practice and research. The frictions may be explained by the specificities of the treatment (including surgery and medical devices) and of the pathologies concerned (chronic and evolutive), and by the characteristics of the medical team implementing the treatment. These particularities challenge the dominant frame of reference in medical bioethics and cause difficulties for the current legal framework in fulfilling its dual role: to protect patients while supporting the development of innovative treatments. The dominant model is still the clinical trial for medication safety and legal requirements of drug market regulation. However, DBS forces us to reflect on a medical device that is permanently implanted in the brain by highly specialized multi-disciplinary neurosurgical teams, for the treatment of chronic evolutive diseases. These devices demand fine-tuning on a case-by-case basis and there is still a lot to discover about why DBS is effective (or not). As a result, the wall between treatment and research is osmotic: many discoveries are made incidentally, in the course of treatment. The following study begins with these observations, and suggests that we review legal provisions (especially in French and United States law) so that they are better adapted to the first-person needs and experience of the patient undergoing brain stimulation. (shrink)

Law and racism are intertwined, with legal tools bearing the potential to serve as instruments of oppression or equity. This Special Issue explores this dual nature of health law, with attention to policing in the context of mental health, schools, and substance use disorders; industry and the environment in the context of food advertising, tobacco regulation, worker safety, and environmental racism; health care and research in the context of infant mortality, bias in medical applications of AI, and (...) diverse inclusion in research; and anti-racist teaching and practice in the context of building an interprofessional curriculum and medical-legal partnerships. (shrink)

Background: Concern has been growing in the academic literature and popular media about the licensing, introduction and adoption of surgical devices before full effectiveness and safety evidence is available to inform clinical practice. Our research will seek empirical survey evidence about the roles, responsibilities, and information and policy needs of the key stakeholders in the introduction into clinical practice of new surgical devices for pelvic floor surgery, in terms of the underlying ethical principals involved in the economic decision-making process, (...) using the example of pelvic floor procedures.Methods/DesignOur study involves three linked case studies using, as examples, selected pelvic floor surgery devices representing Health Canada device safety risk classes: low, medium and high risk. Data collection will focus on stakeholder roles and responsibilities, information and policy needs, and perceptions of those of other key stakeholders, in seeking and using evidence about new surgical devices when licensing and adopting them into practice. For each class of device, interviews will be used to seek the opinions of stakeholders. The following stakeholders and ethical and economic principles provide the theoretical framework for the study:Stakeholders - federal regulatory body, device manufacturers, clinicians, patients, health care institutions, provincial health departments, and professional societies. Clinical settings in two centres (in different provinces) will be included.Ethics - beneficence, non-maleficence, autonomy, justice.Economics - scarcity of resources, choices, opportunity costs.For each class of device, responses will be analysed to compare and contrast between stakeholders. Applied ethics and economic theory, analysis and critical interpretation will be used to further illuminate the case study material.DiscussionThe significance of our research in this new area of ethics will lie in providing recommendations for regulatory bodies, device manufacturers, clinicians, health care institutions, policy makers and professional societies, to ensure surgical patients receive sufficient information before providing consent for pelvic floor surgery. In addition, we shall provide a wealth of information for future study in other areas of surgery and clinical management, and provide suggestions for changes to health policy. (shrink)

Laboratory safety regulations have been traditionally viewed by its learners and practitioners as a matter of law and policy, which simply requires compliance. A compliance mindset tends be passive and dissociates individuals (or even institutions) from the important reasons and principles underlying the safety rules and regulations, leading to disinterestedness and disdain. I posit that laboratory safety regulations would need to be crafted, presented and taught in a manner that is coupled to, or at least with an (...) emphasis on, research ethics. Learners and practitioners of laboratory safety must be led to fully grasp the ethical underpinnings of the rules and regulations, however perceivably cumbersome or inconvenient the latter may seem. In extended definitions beyond the classical fabrication, falsification and plagiarism, laboratory safety violation (LSV) should indeed be considered a form of research misconduct (RM). A full appreciation of the ethical principles underlying laboratory safety regulations would intuitively make LSVs morally impermissible, and as such defiance would be morally unacceptable. Importantly, LSVs framed as moral transgressions would be equally applied to all perpetrators in terms of culpability regardless of one’s endowment and power status. LSV perpetrators should thus also be punishable in accordance with the federal or institutional laws or bylaws of research ethics and integrity. Pedagogical and content modifications to laboratory safety education to adequately reflect a research ethics emphasis, as well as promotion of epistemic acuity in this regard, would be desirable. (shrink)

The research analyzes the process of formation of the ethics committee as a new institution in the system of regulation of genetic research. The external factors of this process are the increasing digitalization of medical and research practices, as well as the special situation that is developing in the field of genomic research and the use of genetic technologies, where issues of philosophy, jurisprudence and administration have generated many fundamentally new, and sometimes unexpected contexts. The author shows the similarity (...) and difference of approaches to the inclusion of the ethics committee in the national regulatory systems of different countries and determines the prospects for further integration of the new institution into normative and administrative-regulatory and law enforcement practices. The research applies all the main methods of system analysis and structural and functional analysis, as well as the comparative legal method. At the stage of generalization of empirical material, the author turns to the means and methods of philosophical phenomenology and phenomenological sociology. The study revealed that the ethics committee may have different institutional and regulatory functions in a variety of management and legal systems. Being hybrid in nature, the ethics committee performs various functions, and in various state legal systems and traditions it can combine elements of legislative, executive and judicial power. At times, the ethics committee may go beyond the scope of both a purely administrative and exclusively legal regulator. All this indicates that the integration of this institution into the legal system and into a variety of social practices is far from being completed. (shrink)

Many healthcare goods, such as surgical instruments, textiles and gloves, are manufactured in unregulated factories and sweatshops where, amongst other labour rights violations, workers are subject to considerable occupational health risks. In this paper we undertake an ethical analysis of the supply of sweatshop-produced surgical goods to healthcare providers, with a specific focus on the National Health Service of the United Kingdom. We contend that while labour abuses and occupational health deficiencies are morally unacceptable in the production of any (...) commodity, an additional wrong is incurred when the health of certain populations is secured in ways that endanger the health and well-being of people working and living elsewhere. While some measures have been taken to better regulate the supply chain to healthcare providers in the UK, further action is needed to ensure that surgical goods are sourced from suppliers who protect the labour and occupational health rights of their workers. (shrink)

This paper focuses on the contribution of meta-regulation in responding to the regulatory needs of a field beset by significant uncertainties concerning risks, benefits and development trajectories and characterised by fast development. Meta-regulation allows regulators to address problems when they lack the resources or information needed to develop sound “discretion-limiting rules”; meta-regulators exploit the information advantages of those actors to be regulated by leveraging them into the task of regulating itself. The contribution of meta-regulation to the governance of nanotechnologies is (...) assessed in terms of responsibilisation. Responsibilisation is regarded as a pre -requisite for regulatory actors to internalise social values (such as consumer safety and occupational health) and to ensure that these values are built into regulatory practice. In order to explore the potential of responsibilisation, the Code of Conduct for Responsible Nanosciences and Nanotechnologies Research launched by the European Commission in 2008 is evaluated. The Code is a good case of meta-regulation that aims to steer the self-regulation of nanotechnological business and research organisations. The paper concludes that, while efforts were made on the part of meta-regulators and self-regulators to contribute to responsibilisation, important opportunities for responsibilisation such as dissemination and promotion of the Code, trust-building activities, and failure to provide rewards, incentives and stakeholder guidance were not taken up. In order to foster responsibilisation within the meta-regulatory instrument of the EC Code, a number of crucial activities to be undertaken by meta-regulators are recommended. (shrink)

William Scoresby Jnr spent the first years of his working life as a whaler, and then became an ordained minister of the Church of England. His early writings on the environment of the Greenland Sea gained him a reputation as an Arctic scientist. In the later part of his life he turned to the investigation of magnetism as it concerned the ship's compass, trying to find the best form of needle, and how the compass was affected by the magnetism of (...) the ship itself.Though he lived in various parts of the country, Scoresby kept his attachment to Whitby and bequeathed his papers, books and apparatus to its Literary and Philosophical Society. In this catalogue the apparatus and material relics are related to published accounts of his work.In the text, [S] numbers refer to Scoresby's publications and [C] numbers to the catalogue. (shrink)

This article argues that current data for the safety and efficacy of fecal microbiota transplants as a treatment for any indication, including recurrent Clostridioides difficile infection, is low-quality. It develops a governance proposal that encourages production of high-quality evidence by incentivizing well-designed RCTs of stool and stoolderived microbial products. The proposal would require that FDA change its current enforcement approach, but it would not require any change in statutes or regulations.

This paper deals with the role of tort in the field of chemical air pollution regulation during the period 1863, when the first statutory intervention occurred, and 1881, when reforms to both the common law and statute were enacted. It compares the prominence of tort in this context with its significance in the field of injury to factory workers. The implications of tort's relevance in these contexts are then examined, having particular regard to those historiographies of Victorian government growth in (...) which the part played by tort is neglected. (shrink)

Transgenic animals—animals with genes added to their deoxyribonucleic acid —will no longer be limited by the gene pool of their parents. Such animals are slated to be created expressly to provide vital and novel benefits for human beings. These animals can have desirable characteristics or traits from virtually any gene pool and may also possess properties not present in nature or available through conventional breeding. They will be created for the production of new medical and pharmaceutical products and to (...) enhance meat, dairy, and fiber production efficiency. (shrink)

The complex history of pandemics has created a diversified array of anti-epidemic responses, which have allowed structures of authority to express their power in multiple ways. In this paper, by considering theories applicable to cases ranging from Europe to Asia, from the 11th to the 18th century, we conduct a comparative analysis capable of identifying common traits and radical differences, aiming to show how such deployment of power was not always commensurate with the medical theories of the age, and (...) with the gravity of the epidemiological situation. Specifically, we analyse how Western European States, in their process of formation, employed the concept of ‘public health’ to create the grounds for an unprecedented exercise of power over the private sphere. Furthermore, we compare this attitude with the discrimination of the minority known as burakumin in Japan, which was destined to undertake any ‘dirty’ or ‘impure’ occupation, to preserve the immunity of the community. In other words, we examine how structures of power have exploited states of exception to implement control measures beyond the needs of the situation through an increasingly hypertrophic apparatus of security; and ways in which political authorities have not aligned with medical or philosophical authorities of their times, for opportunistic reasons that benefited their own social, religious, or racial group. (shrink)

The Coronavirus disease 2019 pandemic is affecting many areas of life and has led to major changes in undergraduate medical education. Even before the COVID-19 pandemic, high mental burden of medical students has frequently been reported in the literature. Additional pandemic-specific stressors could exacerbate this situation. This study aimed to assess mental health outcomes among medical students during the first semester after the COVID-19 outbreak and perception of the students on how the learning environment has changed. In (...) May 2020, we conducted a cross-sectional survey among undergraduate medical students at a large medical school in Germany. The survey included validated mental health instruments and self-developed items to examine the perception of the study situation during the COVID-19 pandemic. Open-ended questions were analyzed by conventional content analyses. The response rate was 59.2%. Overall, 61.9% of the students reported distress levels above the cutoff. Year 1 students reported significantly higher levels of distress, anxiety and depression than students during their second to fourth year of studies. 48.3% of the students indicated a decrease in their study motivation since the beginning of the COVID-19 pandemic with significant differences between study years. The binary logistic regression model showed that male gender, being in study year 2, higher distress scores and higher symptoms of depression were significantly associated with a higher likelihood for experiencing serious worries. In the open-ended questions on current concerns related to the impact of the COVID-19 pandemic on their studies, students most frequently reported concerns about missing relevant practical learning experience, difficulties with self-regulated learning and self motivation as well as study-related worries. Year 4 students reported significantly more worries about the lack of practical training than students from study years 1 to 3. Analysis of gender differences showed that female students reported more frequently diverse worries. In contrast, female students shared more frequently helpful strategies in all the categories compared to male students. Our findings suggest that medical students experience significant levels of distress and mental burden during the COVID-19 pandemic and highlight the need for ongoing psychological and educational support for medical students during the COVID-19 pandemic and after. (shrink)

Background Traditional top-down national regulation of internationally mobile doctors and nurses is fast being rendered obsolete by the speed of globalisation and digitisation. Here we propose a bottom-up system in which responsibility for hiring and accrediting overseas staff begins to be shared by medical employers, managers, and insurers. Discussion In this model, professional Boards would retain authority for disciplinary proceedings in response to local complaints, but would lose their present power of veto over foreign practitioners recruited by employers who (...) have independently evaluated and approved such candidates' ability. Evaluations of this kind could be facilitated by globally accessible National Registers of professional work and conduct. A decentralised system of this kind could also dispense with time-consuming national oversight of continuing professional education and license revalidation, which tasks could be replaced over time by tighter institutional audit supported by stronger powers to terminate underperforming employees. Summary Market forces based on the reputation (and, hence, financial and political viability) of employers and institutions could continue to ensure patient safety in the future, while at the same time improving both national system efficiency and international professional mobility. (shrink)

The Truth and Reconciliation Commission of Canada made it clear that understanding the historical, social, cultural, and political landscape that shapes the relationships between Indigenous peoples and social institutions, including the health care system, is crucial to achieving social justice. How to translate this recognition into more equitable health policy and practice remains a challenge. In particular, there is limited understanding of ways to respond to situations in which conventional practices mandated by the state and regulated by its legal (...) class='Hi'>apparatus come into direct conflict with the values and autonomy of Indigenous individuals, communities, and nations. In this paper, we consider two cases of conflict between Indigenous and biomedical perspectives to clarify some of the competing values. We argue for the importance of person‐ and people‐centered approaches to health care. These value conflicts must be understood at multiple levels to clarify their personal, social, cultural, and political dimensions. Taking into account the divergence between epistemic cultures and communities allows us to understand the multiple narratives deployed in decision‐making processes in clinical, community, and juridical contexts. Recognizing the knowledge claims of Indigenous peoples in health care can help clinicians avoid reinforcing the divides created by the structural and institutional legacy of colonialism. This analysis also provides ways to adjudicate conflicts in health care decision‐making by disentangling cultural, political, medical, and pragmatic issues to allow for respectful dialogue. Insofar as the engagement with cultural pluralism in health care rights is conducted with reciprocal recognition, the medical community and Indigenous peoples can address together the difficult question of how to integrate different epistemic cultures in the health care system. (shrink)

The clinical introduction of medical devices often occurs with relatively little oversight, regulation and (long-term) follow-up. Some recent controversies underscore the weaknesses of the current regime, such as the complications surrounding the metal-on-metal hip implants and the scandal surrounding the global breast implant scare of silicone implants made by France's Poly Implant Prothese (PIP) Company. The absence of national registries hampered the collection of reliable information on the risks and harms of the PIP breast implants. To warrant long-term (...) class='Hi'>safety, a case can be made for mandatory post-marketing surveillance by means of the establishment of compulsory registries. In this edition of Public Health Ethics, Schofield calls for debate on how such a registry system should be initiated and maintained and how it would relate to the ethical requirement of consent. Here we use breast implant registries as a case to discuss whether and when a so-called ‘thick opt-out’ would be an appropriate method to include people in medical device registries. We conclude that a thick opt-out procedure for medical device registries is only justifiable in cases where inclusion does not involve burdens (or very low), when it does not involve a sensitive subject and when the data are stored anonymously (or at least not directly linked to the medical record). Otherwise, inclusion should be sought by means of an opt-in. (shrink)

We reviewed the current state of knowledge regarding visual function and its suitability as part of medical examinations for driving licenses. We focused only on Group 1 drivers. According to previous studies, visual acuity, which is the most common test, is weakly associated with a higher risk of road accidents, with a greater role of visual field. The inclusion of the visual field test in medical examinations is therefore important, but the actual limit value is still unclear and (...) further research in specific situations is needed. Color vision impairment was not found a threat to traffic safety. Contrast sensitivity decreases with age and is affected by abnormal eye conditions. Resulting glare can lead to an increased risk of traffic accidents during night driving in the elderly and others with conditions that impair contrast sensitivity. However, the universal cut-off limits have not been established either. The current European Union (EU) regulations therefore reflect minimum common denominator across the member states which may not entirely translate to optimal driving safety. Due to these open questions, standardized testing in simulators or on polygons that simulate real life conditions would be needed to better determine safe limits of visual function in different conditions. As there is a need to have better standardization across Europe regarding the requirements and rules regarding driving licenses in European countries, we first analyzed existing rules and compared them with each other, also in terms of deviations from the EU directive itself. We reviewed the literature in this field and prepared proposals for a more optimal regulation of the rules in the future. Particular attention is paid to the new method of examining the visual field that was created to respect the European directive. The paper can serve as a basis of information for research teams to design further protocols, as it gathers research findings to date on the importance and impact of various visual functions on driving safety, as well as a starting point for a debate on revising existing rules for obtaining and maintaining licenses, as it compares the current regulations in European countries and differences between them. (shrink)

This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Criteria assessment and expert elicitation are combined with existing literature, case law, and regulations in an integrative historical case studies approach. We then use our findings as a tool to explore possibilities for effective oversight and regulatory mechanisms for nanobiotechnology. Section (...) I describes oversight mechanisms for human drugs and medical devices and presents current nanotechnology products. Section II describes the results of expert elicitation research. Section III highlights key criteria and relates them to the literature and larger debate. We conclude with broad lessons for the oversight of nanobiotechnology informed by Sections I-III in order to provide useful analysis from multiple disciplines and perspectives to guide discussions regarding appropriate FDA oversight. (shrink)

Introduction No consent for health and medical research is appropriate when the criteria for a waiver of consent are met, yet some ethics committees and data custodians still require informed consent. Methods A single-blind parallel-group randomised controlled trial: 1129 families of children born at a South Australian hospital were sent information explaining data linkage of childhood immunisation and hospital records for vaccine safety surveillance with 4 weeks to opt in or opt out by reply form, telephone or email. (...) A subsequent telephone interview gauged the intent of 1026 parents (91%) in relation to their actions and the sociodemographic differences between participants and non-participants in each arm. Results The participation rate was 21% (n=120/564) in the opt-in arm and 96% (n=540/565) in the opt-out arm (χ2 (1 df) = 567.7, p<0.001). Participants in the opt-in arm were more likely than non-participants to be older, married/de facto, university educated and of higher socioeconomic status. Participants in the opt-out arm were similar to non-participants, except men were more likely to opt out. Substantial proportions did not receive, understand or properly consider study invitations, and opting in or opting out behaviour was often at odds with parents' stated underlying intentions. Conclusions The opt-in approach resulted in low participation and a biased sample that would render any subsequent data linkage unfeasible, while the opt-out approach achieved high participation and a representative sample. The waiver of consent afforded under current privacy regulations for data linkage studies meeting all appropriate criteria should be granted by ethics committees, and supported by data custodians. Trial registration number Australian New Zealand Clinical Trials Registry ACTRN12610000332022. (shrink)

The regulation of stem cell research is an issue that has drawn much comment, criticism and even judicial arbitration in recent years. An emerging issue, addressed in this article, is how the fruits of that research-stem cell medicine-are likely to be regulated en route from lab to market. Taking account of the ethical, legal, social and safety issues raised by stem cell medicine and the goals of governance, the article explains the relevant regulatory instruments (e.g. the draft UK (...) Stem Cell Bank Code, the EU Directive on Human Tissue, the EU Directives on medical products and devices, and the Human Tissue Act 2004) and critically examines the framework they provide. (shrink)

The genetic testing industry is in a period of potentially major structural change driven by several factors. These include weaker patent protections after Association for Molecular Pathology v. Myriad Genetics and Mayo Collaborative Services v. Prometheus Laboratories, Inc.; a continuing shift from single-gene tests to genome-scale sequencing; and a set of February 2014 amendments to the Clinical Laboratory Improvement Amendments of 1988 regulations and the Health Insurance Portability and Accountability Act Privacy Rule. This article explores the nature of these changes (...) and why they strain existing regulatory frameworks for protecting patients, research subjects, and other consumers who receive genetic testing.Oversight of genetic testing has, at least to date, had two major thrusts: privacy and ethical protections and traditional consumer health and safety regulations. Examples of the first are the Genetic Information Nondiscrimination Act and the HIPAA Privacy Rule, which after 2013 amendments expressly protects genetic privacy as well as other medical privacy. (shrink)

Existing regulation of end-of-life care is flawed. Problems include poorly-designed laws, policies, ethical codes, training, and funding programs, which often are neither effective nor helpful in guiding decision-making. This leads to adverse outcomes for patients, families, health professionals, and the health system as a whole. A key factor contributing to the harms of current regulation is a siloed approach to regulating end-of-life care. Existing approaches to regulation, and research into how that regulation could be improved, have tended to focus on (...) a single regulatory instrument (e.g., just law or just ethical codes). As a result, there has been a failure to capture holistically the various forces that guide end-of-life care. This article proposes a response to address this, identifying “regulatory space” theory as a candidate to provide the much-needed holistic insight into improving regulation of end-of-life care. The article concludes with practical implications of this approach for regulators and researchers. (shrink)

In the operating room, patient safety is of paramount importance. Medical students and junior trainees, despite their primary role as students, may play active roles in assessing patient safety and reporting suspected errors. Active consent is one layer of patient safety that is continuously assessed by several team members. This article examines an instance where patient consent may have been violated. Through the lens of trainee and senior perspectives, we discuss the ethical principles at stake and (...) provide recommendations for medical student and junior trainee involvement in patient care when an error is suspected. (shrink)

The article examines the issue of public health and medical services in Algeria and analyses the role of the public and private sectors in supporting and promoting public health. Our study is based on an analysis of legal texts that highlight Algeria’s health policies. Some significant aspects of the article are: the Algerian policy of opening health services up to private investment; the lack of contribution of private health institutions in the field of medical education; and issues surrounding (...) the organisation of blood donation. The article also notes the absence of foreign investment in Algerian hospitals. (shrink)

The new regulations on xenotransplantation pay insufficient attention to the broad ethical problems raised by this technique and that the abandonment of a national body with overall regulatory authority in this area is a mistake.Following reports from the Nuffield Council on Bioethics1 and, most importantly, the Advisory Group on the Ethics of Xenotransplantation2 , the UK Xenotransplantation Interim Regulatory Authority was established in 1997. The existence of a national body to govern xenotransplantation was deemed to be of critical importance by (...) the Kennedy report given the practical and ethical issues associated with xenotransplantation. Indeed, the Kennedy report recommended that ultimately UKXIRA should be placed on a statutory footing.2 The remit of UKXIRA was to advise the Secretary of State on particular applications, gather information on issues such as safety, and assess whether the preconditions identified by the Kennedy report had been met.3In December 2006, UKXIRA was quietly disbanded, and the Department of Health issued a statement of guidance, the terms of which now govern xenotransplantation in the UK. This document superseded procedures that had been in place since 1998, which had placed the overall regulation of applications to conduct xenotransplantation in the hands of UKXIRA and, ultimately, the Secretary of State.4 The revised guidance defines xenotransplantation as being: “… any procedure that involves the transplantation, implantation, or infusion into a human recipient of either live tissues or organs retrieved from animals, or, human body fluids, cells, tissue or organs that have undergone ex vivo contact with live non-human animal cells, tissues or organs.”5 . Given the range and nature of the procedures covered by the guidance, it is surprising, not to say a little worrying, that it is so …. (shrink)

The coronavirus disease imposes an unusual risk to the physical and mental health of healthcare workers and thereby to the functioning of healthcare systems during the crisis. This study investigates the clinical knowledge of healthcare workers about COVID-19, their ways of acquiring information, their emotional distress and risk perception, their adherence to preventive guidelines, their changed work situation due to the pandemic, and their perception of how the healthcare system has coped with the pandemic. It is based on a quantitative (...) cross-sectional survey of 185 Swiss healthcare workers directly attending to patients during the pandemic, with 22% of them being assigned to COVID-19-infected patients. The participants answered between 16th June and 15th July 2020, shortly after the first wave of COVID-19 had been overcome and the national government had relaxed its preventive regulations to a great extent. The questionnaire incorporated parts of the “Standard questionnaire on risk perception of an infectious disease outbreak”, which were adapted to the case of COVID-19. Clinical knowledge was lowest regarding the effectiveness of standard hygiene. Knowledge of infectiousness, incubation time, and life-threatening disease progression was higher, however still significantly lower than regarding asymptomatic cases and transmission without physical contact. 70% of the healthcare workers reported considerable emotional distress on at least one of the measured dimensions. They worried significantly more strongly about patients, elderly people, and family members, than about their own health. Adherence to preventive guidelines by the government displayed patterns such that not all guidelines were followed equally. Most of the participants were faced with a lack of protective materials, personnel, structures, processes, and contingency plans. An increase in stress level was the most prevalent among the diverse effects the pandemic had on their work situation. Better medical equipment, better protection for their own mental and physical health, more personnel, more comprehensive information about the symptoms of the disease, and a system of earlier warning were the primary lessons to be learned in view of upcoming waves of the pandemic. (shrink)

Law wrangles with setting and applying standards for the practice of medicine in many different arenas. One of the most prominent is medical malpractice litigation in which the trial process examines a physician's performance and measures it against the standard of care. The profession's prevailing custom, with some substantial tolerance for “respectable minority” views, has been the gold standard for scrutinizing physician practice and treatment decisions in the malpractice context. Using the profession's custom as the measure against which a (...) physician's performance is judged defers to the expertise of medicine. Deference to the medical profession is attractive as a tool for reining in law. Reliance on customary practice is criticized, however, for driving physicians to the relative safety of the middle of the herd. Creating such a strong incentive for compliance with customary practice can dampen medical innovation and the diffusion of new clinical knowledge. The safety of the herd can also deprive individual patients of the best care in their particular circumstances.Several current trends are strengthening claims that professional practice patterns are an inappropriate tool for distinguishing between high‐quality and substandard care. In particular, advocacy for evidence‐based medicine aggressively asserts that the traditional way of making medical treatment decisions is largely untethered from scientific method or data, rendering professional judgment, even in the aggregate, suspect. (shrink)

Patient safety has only recently been subjected to wide-spread systematic study. Healthcare differs from other high risk industries in being more diverse and multi-contextual, and less certain and regulated. Also many patient safety problems are low-frequency events associated with many, varied contributing factors. The subject of this paper is the epistemology of patient safety (the science of the method of finding out about patient safety). Patient safety research is considered here on the background of a (...) risk management framework which requires researchers to: • Understand the context - as a subset of healthcare quality, services and systems research, with technical and human behavioural (cultural) components and a range of external and internal organisational influences, a wide range of research disciplines is necessary • Identify the risks - identify the things that go wrong and the frequency and nature of different types of incidents from sources such as medical record review, observational studies, audit, incident and medico-legal reports • Analyse the risks - deconstruct the things that go wrong, identifying contributing factors and trying to detect trends and patterns in contributing factors, detection, mitigation factors, ameliorating factors and actions taken to reduce risk • Evaluate the risks - decide on priorities, identifying preventive and corrective strategies and judging the risk- and cost-benefit of potential corrective strategies such as standardisation or simplification of a process or device • Manage the risk - evaluate and scope preventive and/or corrective strategies and then implement these, or place the problem on a risk register pending solution, or accept that what is needed is unaffordable • Communicate and consult - use interactive sessions, audit, on-going feedback, reminders and patient mediated prompts • Monitor and review the state of the problem - get baseline trends and patterns so that changes can be tracked and properly attributed to an intervention A hierarchy of levels of evidence has been proposed for clinical research and we argue that insufficient weighting has been given to lower ranked levels of research and to qualitative research, although critical interpretive synthesis is now gaining acceptance in mainstream thinking (e.g. by the Cochrane Collaboration). Fundamental challenges remain including how to grasp the elusive concept of patient safety, how to quantify, characterise and cost the problems, how to judge the extent to which harm can be attributed to errors, violations or system failures, how to identify contributing factors and the extent to which they can be implicated, how to judge whether incidents or their precursors are preventable, how to generate strong evidence to make healthcare safer and how to translate research into practice. Future directions include addressing the mundane as well as rare, dramatic events, and developing further research in non-hospital settings and in developing countries. In summary, a mixture of qualitative and quantitative methods, using information from all available data sources and combining retrospective, real time and prospective study designs, is necessary to address some of the more difficult patient safety problems. (shrink)

Two decades of research on euthanasia in the Netherlands have resulted into clear insights in the frequency and characteristics of euthanasia and other medical end-of-life decisions in the Netherlands. These empirical studies have contributed to the quality of the public debate, and to the regulating and public control of euthanasia and physician-assisted suicide. No slippery slope seems to have occurred. Physicians seem to adhere to the criteria for due care in the large majority of cases. Further, it has been (...) shown that the majority of physicians think that the euthanasia Act has improved their legal certainty and contributes to the carefulness of life-terminating acts. In 2005, eighty percent of the euthanasia cases were reported to the review committees. Thus, the transparency envisaged by the Act still does not extend to all cases. Unreported cases almost all involve the use of opioids, and are not considered to be euthanasia by physicians. More education and debate is needed to disentangle in these situations which acts should be regarded as euthanasia and which should not. Medical end-of-life decision-making is a crucial part of end-of-life care. It should therefore be given continuous attention in health care policy and medical training. Systematic periodic research is crucial for enhancing our understanding of end-of-life care in modern medicine, in which the pursuit of a good quality of dying is nowadays widely recognized as an important goal, in addition to the traditional goals such as curing diseases and prolonging life. (shrink)

People have a love/hate relationship with rapidly changing healthcare technology. While consumer demand for medical apps continues to grow as rapidly as does supply, healthcare professionals and safety experts worry about the impact of these apps on the health consumer. In response to the rapidly growing mobile healthcare sector, the Food and Drug Administration has put forth guidelines to regulate ‘mobile medical apps’, those health-related apps that are designated as medical devices. In this article, I argue (...) that this decision, to only regulate apps that bill themselves as medical devices, will create a market for ‘off-label’ app use. Further, I will talk about the oft used analogy between off-label apps and off-label pharmaceuticals, showing that off-labeling apps will provide patients none of the benefits that come with a physician prescribing a drug off-label, while exposing the mobile healthcare consumer to significant risks that go significantly beyond those that we know of from prescription drugs. Recognizing that the Food and Drug Administration is not going to be able to significantly change its policies on oversight, I will suggest specific actions to at least mitigate some of the risks associated with off-label app use. (shrink)

The case of Dr. Nancy Olivieri, the Hospital for Sick Children, the University of Toronto, and Apotex Inc. vividly illustrates many of the issues central to contemporary health research and the safety of research participants. First, it exemplifies the financial and health stakes in such research. Second, it shows deficits in the ways in which research is governed. Finally, it was and remains relevant not only in Toronto but in communities across Canada and well beyond its borders because, absent (...) appropriate policies, what happened in Toronto could have happened (and could well still happen) elsewhere. In Part One of this paper, we review the facts of the Olivieri case relevant to the issues we wish to highlight: first, the right of participants in a clinical trial to be informed of a risk that an investigator had identified during the course of the trial and the obligation of the investigator to inform participants (both her own and those of other investigators); and second, the obligation of institutions to protect and promote the well-being of research participants as well as academic freedom and research integrity, the obligations of research sponsors to inform participants, research regulators, and others about unforeseen risks, and the obligations of research regulators to ensure that participants are informed of unforeseen risks and to otherwise protect and promote research integrity. In Part Two, we relate these facts and issues to New Zealand and Australia. We also make detailed recommendations for changes to the various instruments used for the governance of research involving humans in Australasia. (shrink)

Written by one of Ireland's leading medical law academics, this practical book comprehensively covers case law and regulations regarding the healthcare system, the law relating to human reproduction, and the key issues of consent and treatment. Designed to be used by lawyers and healthcare professionals, Medicine, Ethics and the Law in Ireland provides an invaluable reference tool for anybody who requires accurate information and guidance on this area of Irish law. This new edition includes: Medical research and clinical (...) trials; Organ donation and transportation; Patient safety and QA; and Biobanking. (shrink)

This article examines how scientists and regulators distribute the benefit of the doubt about drug safety under conditions of scientific uncertainty. The focus of the empirical research is the regulatory controversy over the hepatorenal toxicity of benoxaprofen in the United Kingdom and the United States. By scrutinizing the technical coherence of the arguments put forward by industrial and government scientists, it is concluded that these scientists are willing to award the commercial interests of the pharmaceutical industry an enormous benefit (...) of the sccentific doubt, which is not consistent with the best interests of patients. Interpretative flexibility, the burden of proof falling on regulators and their trust in, and dependence on, industrial scientists facilitates that distribution of the benefit of the scientific doubt. However, regulatory authorities' need for viability and the rationality common to opposing scientific views suggest that it is possible, in principle, to alter this dominant trend. To achieve adequate patient protection, drug regulation in the United Kingdom and the United States requires extensive reform. Some preliminary policy changes are sketched. (shrink)

What role do science and scientists play in the transition between food regimes? Scientific communities are integral to understanding political struggle during food regime transitions in part due to the broader scientization of politics since the late 1800s. While social movements contest the rules of the game in explicitly value-laden terms, scientific communities make claims to the truth based on boundary work, or efforts to mark some science and scientists as legitimate while marking others as illegitimate. In doing so, scientific (...) communities attempt to establish and maintain the privileged position of science in contests over policy. In this paper, we situate scientific boundary work within its world historical context in order to ask two key questions: (1) how does scientific boundary work vary across food regimes; and, in turn, (2) what role does scientific boundary work play in the political contestation that drives transitions between food regimes? We explore these questions through the case of one scientific community—the AOAC (Association of Official Analytical Communities)—involved in food safety regulation across the British, US, and corporate food regimes. We argue that scientific boundary work is shaped by historically specific patterns of social conflict within food regimes and, in particular, the double-movement dynamics that Polanyi (The great transformation: the political and economic origins of our times. Boston: Beacon, 1957[1944]) theorizes. Moreover, as scientific communities reconstruct their internal rules, norms, and procedures to claim their own legitimacy in relation to prevailing forms of social conflict, they also reshape who sets scientific agendas and thus the knowledge available for making new rules within periods of food regime transition. To elaborate this argument in theoretical terms, we build on recent efforts to integrate a neo-Polanyian perspective into food regime analysis and link this to research on scientific boundary work by scholars in science and technology studies. (shrink)

This article probes the advisability of regulating U.S. food and drug safety according to the precautionary principle. To do so, a precautionary regulatory regime is formulated on the basis of the beliefs that motivate most proponents of this initiative. That hypothetical regime is critically analyzed on the basis of an actual instantiation of a similarly stylized initiative. It will be argued that the precautionary principle entails regulatory constraints that are apt to violate basis tenets of political legitimacy. The modifications (...) that would change this finding would also change precautionary regulation to the point that it would be indistinguishable from orthodox safety protocols. It is concluded on the basis of its impoverished content that the precautionary principle should not be taken seriously as a formal approach to the regulation of U.S. food and drug safety. (shrink)