Routledge Handbook of Medical Law and Ethics

Yann Joly, Bartha Maria Knoppers

• Publisher: Routledge
• Year: 2014
• ISBN:
  9781134448722
• Edition: 1
• Topic: Law
• Subtopic: Medical Law
• Index: Law

This book explores the scope, application and role of medical law, regulatory norms and ethics, and addresses key challenges introduced by contemporary advances in biomedical research and healthcare. While mindful of national developments, the handbook supports a global perspective in its approach to medical law.

Contributors include leading scholars in both medical law and ethics, who have developed specially commissioned pieces in order to present a critical overview and analysis of the current state of medical law and ethics. Each chapter offers comprehensive coverage of longstanding and traditional topics in medical law and ethics, and provides dynamic insights into contemporary and emerging issues in this heavily debated field. Topics covered include:

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• Bioethics, health and human rights

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• Medical liability

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• Law and emerging health technologies

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• Public health law

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• Personalized medicine

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• The law and ethics of access to medicines in developing countries

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• Medical research in the genome era

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• Emerging legal and ethical issues in reproductive technologies

This advanced level reference work will prove invaluable to legal practitioners, scholars, students and researchers in the disciplines of law, medicine, genetics, dentistry, theology, and medical ethics.

1

Introduction

Vasiliki Rahimzadeh, Yann Joly, and Bartha Maria Knoppers

The domains of medical law and ethics are distinct, yet inextricably connected. Whereas the law delimits the scope of activities permitted in a liberal society, ethics forms the basis whereby these activities subscribe to the values and moral principles society constructs. Social norms find their expression in ethics and often subsequently in the law (Posner 2000). Understanding the ways in which both shape the structure and function of the medical enterprise is the cornerstone of good professional practice, not to mention central to the humanitarian care of patients.

The societal and individual moral applications manifested in the law and ethics respectively, have together guided the practice of medicine since ancient times.¹ It would be naive to assume, however, that their relationship has always been a symbiotic one (Beauchamp 2004). Capron (1979) argues that law and ethics give rise to different forms of rights that can be used to make apparent a distinction between the two. He asserts that from the study of ethics in a medical context there emerge moral rights attributed to users of healthcare systems, which can be defended using philosophical paradigms such as Aristotelian virtue ethics, utilitarianism and Kantianism, to name a few, whereas from the law emerges legal rights, which assign enforceable duties and responsibilities ‘among the competing, and often conflicting, interests of its citizens’ within a legal system (Hodge and Gostin 2001).

Eras of rapidly evolving innovation within medicine – and within other scientific and technology disciplines to be sure – continue to underscore the immediacy of iterative reevaluation, reconceptualization and reform in the law in order to keep apace with medical progress. In this way, ethics provide a theoretical and conceptual framework for clarifying – but also problematizing – emergent laws that are both jurisdiction-specific and international in outlook in the wake of contemporary controversies. Such laws, therefore, become useful elements of scholarship and offer a methodology for contextualizing medical advancement in conversation with its ethical implications (DeGrazia 1999). This book enters into these discussions by exploring the application, scope and role of medical law and its regulatory norms in laying the groundwork for ethical policy and practice in healthcare. It attempts to find cohesion between medical law and ethics, debating new practical approaches to theoretical problems. Though the study of medical ethics is multidisciplinary by nature, this book unifies the otherwise incredibly diverse perspectives of interlocutors in the field under the auspices of medical law. It sets out to bring the complexities of this intersection to the fore of novel modalities and systems of care made possible by, inter alia, the genomic revolution and data-intensive sciences. Engaging with such themes is, we suggest, critical to navigating an increasingly data-driven healthcare system (Ozdemir et al. 2011), while preserving the ethos of rights-based medicine and optimizing health outcomes for populations globally. The Handbook, therefore, offers rich discussions of classical and novel ethical issues in medical jurisprudence from authors with a variety of theoretical perspectives, approaches and expertise. This diversity intentionally seeks to represent the key emerging domains of the field of medical law, and the breadth of ethical approaches purposefully addresses the many challenges of these new domains.

The authors of each chapter present the fundamental ethical and legal aspects, as well as discuss key international and national documents governing the activities in their field. Many offer an overview of the legal history and evolution of legal thinking, verifying their influence on the current legislative climate in which these issues are being examined. The chapters offer relevant case analyses, illustrating the practical applications of theoretical and normative ethics within a range of national and supra-national jurisdictions. The emergence of case law and precedence – as well as the formation of public opinion in response – alert us to the significance of legal processes in redefining socioethical norms and standards. Finally, each chapter carves a space for forward thinking and reflection. Authors provide critical commentary on some of the newest developments in their respective fields, elucidating the ways in which medical law governs advances in healthcare and clinical practice. It is called a Handbook not to put forth protocols or procedural guidance in deploying the law to resolve ethical conflicts. Rather it serves as a detailed compendium of legal instruments and ideas, both current and historical, in responding to matters of pressing ethical import in healthcare.

The Handbook takes up a number of these compelling issues and arranges them in four categories. Rights of Persons comprises chapters that interrogate the protections and freedoms of patients in their interaction with the healthcare system, including the traditionally more vulnerable categories of persons such as children (Chapter 5) and the mentally disabled (Chapter 7). It touches upon long-standing principles of bioethics, including consent (Chapter 3) and confidentiality (Chapter 4) and brings to light the contemporary challenges of preserving these traditional fixtures in the doctor–patient relationship. To this point, an entire category of the Handbook is dedicated to the Professional Relationship. Ries investigates the organizational infrastructures and healthcare mandates that guarantee adherence to, and maintenance of, professional standards of practice (Chapter 10). Moreover, the chapters in this section make clear that protecting patient safety is the focal point of professional standards. Khoury (Chapter 11), for example, puts into sharp relief the serious ethical and legal consequences when healthcare professionals fail to meet such standards in preventing nosocomial infections, and contextualizes the emergence of patient safety legislation in the aftermath of the tort frenzies that followed.

As its name suggests, Medical Interventions and Emerging Technologies highlights some of the frontiers of medical science, and the ways in which researchers and policymakers alike are attempting to chart their sociotechnical futures. From creating online clinical interfaces through telemedicine (Chapter 15), to developing high-precision techniques in assisted reproduction (Chapter 13), novel technologies and machines are transforming the landscape of healthcare delivery (Kahvejian et al. 2008). In turn, the law and regulatory mechanisms are challenged to evolve in parallel with the technological sophistication witnessed in recent years. As life expectancies and quality of life are projected to increase with greater adoption of technology – though almost exclusively in countries able to invest in costly research and development – the need for international dialogue on access and policy harmonization has never been more immediate.

Likewise, multidisciplinary collaboration is required to translate research discoveries into routine medical practice. Our ethicolegal engagement with the increasingly genome-oriented objectives in research and care is reflected in From Bench to Bedside. In Chapter 17, Chalmers argues that the regulatory and legislative governance of medical research must adapt ethical frameworks better suited to preserve scientific freedom, and minimize risks unique to research participation in the ‘genome era.’ He underscores the fact that little more than a decade after completion of the Human Genome Project, diagnostics and treatment strategies are chiefly centering on a patient’s genomic profile, most notably in rare genetic diseases (Ng et al. 2010; Bamshad et al. 2011) and cancer (Lander et al. 2001; Roychowdhury et al. 2011; Curtis et al. 2012). Sequencing techniques and an explosion in computational power have blossomed into entirely new research and clinical subfields, such as pharmacogenomics (Chapter 11), nutrigenetics (Fenech 2014; Mutch et al. 2005) and bioinformatics (Ouzounis 2012).

Where legal apparati purported to regulate new technologies often face issues of classification and applicability, the role of the law in safeguarding public health can raise questions of scope and competing notions of rights. ‘The crux of public health,’ Gostin maintains, ‘is a public or governmental entity that harbors the power and responsibility to assure community well-being … perhaps the single most important feature of public health is that it strives to improve the functioning and longevity of populations’ (2008). In Public Health and International Health Systems, authors provide an international take on models of public health law, and its purpose and permanence in augmenting a human right to health. Through a rights-based lens, Munyi canvasses the issue of access to essential medicines in the developing world (Chapter 22), where international instruments expand such access. Because public health practice is concerned with optimizing the health of populations, it is fitting that good public health policy recognizes the different sociocultural and regional constructions of health and wellbeing across the world. Kaan (Chapter 23) explores this complicated relationship by analyzing the protective capability of public health law between predominant medical traditions in the Global North and South.

Notwithstanding the plethora of legal structures and interpretations represented in this Handbook, a number of common motifs weave throughout the chapters. When examined together, they isolate the points of theoretical convergence that allow medical law and ethics discourse to complement each other toward the provision of effective and ethically sound healthcare.

1.1 Human rights and professional accountabilities in the law

Many contributors to this Handbook employ rights-based rhetoric to defend the vehicle of accountability espoused by medical law. December 10, 2013 marked the 65th anniversary of the 1948 Universal Declaration on Human Rights. An undoubtedly poignant moment in history, it was an opportunity to restore faith in humanity through collective agreement and codification of the inviolability of human life. For some, reference to human rights doctrines is implicit in the framing, formulation and protection the law offers its respective constituents. For others, these principles act as the starting point from which to assign legal accountability in facing ethical uncertainty. As was true at the time of its ratification, political will is necessary to actualize the Declaration’s principles in national laws governing medicine and healthcare.

Annas (Chapter 2) describes this translational process in the context of leveraging the triad of bioethics, law and medicine to devise effective healthcare legislation. He argues that not to acknowledge how the three in fact coexist and inform each other is to create irresponsible law at best. Nowhere is this potential incongruity between the principles of human rights and the law starker than in drafting antidiscrimination legislation for communities of people with disabilities. Indeed, Hendriks (Chapter 6) affirms the frequent violations of human rights within this population, where patients are largely devalued and disregarded by the healthcare system.

Health professionals personify the actualization of rights through practice, and mediate the triangulated relationships Annas identifies. The role of the health professional, therefore, as both a specific technology user and care deliverer, is a centerpiece in ethics discourse on professionalism. Rothstein explores this theme in Chapter 4. He examines the unique transformations in the uptake and dissemination of health information through online networks and social media platforms such as Facebook and Twitter, and how the connectivity they allow are in fact reshaping standards of patient interaction. Moreover, with greater online presence comes enhanced privacy risks and the need to develop advanced information storage platforms. Others share this view, identifying the added ethical implications for healthcare professionals whose online presences have, more than ever, broadened their visibility and ready accessibility to patients (DeCamp et al. 2013).

Freckelton and Bennett’s discussion of the migration of healthcare professionals and patients across national borders (Chapter 9) raises new questions in the way of redefining a professional ethic of care. They chronicle recent trends in the regulation of medical practice, charting a move from professional self-regulation through to contemporary (read external) models of oversight and accountability.

Similar transitions dare us to consider quis custodiet ipsos custodes? or, ‘who will guard the guardians?’² Do our professional codes of ethics – like the law, purported to be reflections of the values and virtues society deems essential to the realm of professional practice – indeed protect healthcare users from abuses of the system or clarify legal accountability where ethical ambiguity dominates?

The authors in this Handbook do not resolve these pending questions per se. Perhaps more ambitiously, what resonates from their analyses is a demand for reconsidering the basic notions of professionalism and revisiting the fundamental purpose(s) of medicine. In doing so, the authors offer grounded perspectives on the extent to which the law ought to build on these foundational concepts so as to draw legal theory and clinical practice into healthier confines.

1.2 Reevaluating foundations

Implied above is how the law serves as a practical instrument to ground bioethical and human rights principles in the realities of healthcare delivery. It is from this practical standpoint that the conception of professionalism and a professional ethic of care emerge. In a healthcare context, there are three spheres of ethical priority setting that (ideally) converge on patients’ best interests: that of the patient, the professional and the institution. Gastmans and Nys confirm this in Chapter 8. Through exploring the ethical tensions of end-of-life care in neonates, they validate the true challenges in determining the moral permissibility of withdrawing care, at what point, and to what end. The authors contend that medical prognosis – and the courses of action it inspires – is but consideration as part of the ethical analysis that determines the child’s best interest. Tensions arise when healthcare professionals find they must allow assessments on quality of life to become the province of, in the case of neonates, parental expertise. Oftentimes, these views can denounce Western medicine’s obsession with curative rigor and rigid definitions of futile treatment.

That sophistication of medical technology, namely in genetics/genomics, can convert modalities of care and professional norms is key to Thorogood and Knoppers’ thesis in Chapter 18. They argue how the notion of best interests can be problematic for healthcare professionals hoping to offer preventative care through genetic surveillance to pediatric patients and their families. Until recently, searching for particular biomarkers known to predispose...

Table of contents

• Cover Page
• Half-Title Page
• Title Page
• Copyright Page
• Table of Contents
• Contributors
• Acknowledgements
• PART I Rights of persons
• PART II Professional relationships
• PART III Medical interventions and emerging technologies
• PART IV From bench to bedside
• PART V Public health and international health trends
• Index