Editors’ Introduction to The Oxford Handbook of Comparative Health Law

This introductory chapter provides an overview of The Oxford Handbook of Comparative Health Law. Why compare health laws? Situated at the interfaces between human rights, dignity, autonomy, and solidarity, and between multinational business activity, state regulation, and the most private of individual decision-making, health law is perhaps unique in its capacity to provoke a range of responses to how law should constrain and facilitate human activity. Scholars, legislators, and judges grappling with critical questions—such as how to finance healthcare, how to regulate the pharmaceutical industry, and how to protect against threats to public health that can quickly cross national borders—can learn from the successes and failures of the different approaches taken in different countries. The chapter then outlines the scope of the Handbook, which brings together the existing and emerging body of research in health law, with a key focus on the United States–European comparative perspective.

Research with Human Participants in the European Union

This chapter examines research with human participants in the European Union. In the EU, the driving force for legislation is the creation of the single market. Research with human participants is both a response to the urgent demand to advance the health of EU citizens through the efficiencies of the single market, and to the commitment of the EU to act in accordance with the shared social and cultural values of the Member States. One might expect, therefore, that EU legislation on research with human participants would be clear, creating a harmonized framework within the single market both for internal consistency and to enhance external competitiveness. However, each of the 27 Member States of the EU operates with a large amount of independence in relation to the governance of research with human participants. The chapter then describes the EU legislation on clinical trials and considers the protection of privacy through the General Data Protection Regulation.

Organ Transplantation

This chapter examines the process of organ transplantation, which is different from other therapies in a very important way—there is a persistent and large gap between the need for transplants and the availability of organs. Many more patients need a transplant than can receive one. The shortage of organs is compounded by enormous variability in the donation and transplant activity of different countries. These disparities in access reflect factors that are highly complex and sensitive, including legal, organizational, and cultural. Still, as indicated, the shortage of organs is a global problem that affects all countries, both those that have implemented effective donation and transplant systems and those that still lack them. Accordingly, in the regulation of organ transplantation, considerable attention is paid to strategies for increasing the organ supply and policies for allocating the organs that are available.

Introduction to Research with Human Participants

Research with human participants is conducted for a variety of reasons, including developing drugs, medical devices, or other medical interventions; understanding human cognition and behavior; and evaluating the impact of public policy interventions. It can provide enormous social benefits, but it also raises significant ethical dilemmas. These dilemmas stem from a tension that is inherent in the nature of the activity: the goal is to generate knowledge for the potential benefit of persons in the future, but achieving this goal often requires exposing individuals in the present to the possibility of harm. This tension is particularly pronounced in clinical trials involving investigational drugs, devices, or other medical interventions, where the risks of participation may be particularly significant. The chapter presents a brief sketch of the legal framework surrounding research with human participants in two important centers of research: the United States and the European Union.

Paradigms of Healthcare Systems, Law, and Regulation

This chapter assesses how the law creates and sustains healthcare systems. It considers six paradigm concepts which are important in the structures of healthcare systems and how the law seeks to support and encourage the effective provision of healthcare to relevant populations. These concepts are quality/accessibility; health citizenship and a “right to health”; individual liberty; market competition; economic productivity; and “health justice” and integrated social services. The chapter then discusses five structures for health system regulation, starting with the simplest: public provision of health services, publicly funded but privately supplied health services, self-regulating health professions, public–private partnerships, and nonprofit and charitable organizations. Finally, it compares European and American approaches to the geographical dimensions of health system law and regulation, discussing paradigms of federalism and localism.

Medical Liability

This chapter presents a comparison of liability/compensation systems across countries, which can be challenging because of substantial differences in tort doctrine, judicial systems, and administrative compensation mechanisms. It approaches the problem of patient injury in a healthcare system from the dual (and dueling) perspectives of system responsibility and provider culpability. The basic question that the chapter asks is this: Who should bear the economic costs of medical adverse events? The US system remains solidly anchored in the tort liability system, with its emphasis on negligence-based culpability in medical malpractice cases—but with timid moves toward enterprise liability and statutory communication and resolution programs. By contrast, the Scandinavian systems have publicly funded patient compensation funds.

Introduction to Incomplete Commodification and Its Creeping Counterpart

This chapter provides an overview of incomplete commodification and its creeping counterpart. The course of commodification of human tissues—including blood, sperm, and eggs—is both the same and opposite for the United States and Europe. The law on the ground in each system may be quite different, but the lived experiences of individuals providing these body products are becoming increasingly similar. Within both systems, compensation for human transplantable organs—and at least some tissues—is proscribed by law. Even where the law does not formally proscribe remuneration for body product providers, many continue to donate without payment. But monetary exchange also appears in both systems to some degree. In Europe, even though voluntary unpaid donation remains the norm, most systems allow forms of compensation. Moreover, the US prohibition on profit-seeking in body products is only partial. These similarities in policy and practices might appear commonsensical, yet they also reflect a remarkable convergence in international norms despite substantially different background assumptions and legal frameworks.

Research with Human Participants in the United States

This chapter discusses research with human participants in the United States, most of which has been subject to federal regulations requiring prospective ethical oversight by entities known as institutional review boards (IRBs) since the 1970s. Research that is subject to the federal regulations may not begin until IRB approval has been obtained. The chapter begins by examining key aspects of the federal regulations governing IRB review of research with human participants, including the type of activities that fall under the IRB’s jurisdiction, how IRBs are organized, and some of the key substantive standards that IRBs apply. It then looks at additional regulatory standards that apply to studies involving particular populations, including pregnant women and fetuses, prisoners, and children. Finally, the chapter examines several other bodies of law related to research with human participants, including policies governing the inclusion of women and racial minorities in clinical trials; legal principles governing compensation for injuries to research participants; and requirements for registering clinical trials, reporting trial results, and disclosing research-related conflicts of interest.

Decisions at the End of Life

This chapter examines the similarities and differences between US and European legal thinking and jurisprudence regarding end-of-life medical care. In recent decades, courts and legislatures have increasingly respected the right to self-determination of patients or their families in deciding about the way people want to die. In most jurisdictions, patients may have unwanted medical treatment withheld or withdrawn, even when the treatment would be or is life-sustaining. Hospice and other palliative care are important alternatives, although in many cases, suffering may still persist. In a small but growing number of jurisdictions, patients may receive a lethal dose of medication to bring about death. Less recognized, but very important too, are cases in which patients request life-sustaining care that their health care providers consider “futile.” As with other rights, the right to make medical decisions is subject to limits. In deciding the extent of rights to make end-of-life decisions, the law has recognized that while seriously ill patients have the greatest stake in their medical care, family members, healthcare providers, and the state also have important interests. Accordingly, health law has had to balance a number of competing interests in determining when it is permissible to discontinue medical care or take other actions that will shorten life, and the scope of the right to decide has been much debated.

Genetics and the Law

This chapter examines state and federal laws in the United States that govern legal and ethical issues concerning genetic and genomic analysis for diagnostic purposes; regulation of genetic testing, genetic discrimination, and privacy; and clinical applications of genomics. At the state level, legislatures have enacted laws in various areas, including newborn screening and nondiscrimination and privacy protections. In addition, state courts have addressed some issues concerning genetics, such as the duty to warn. At the federal level, the US Congress has enacted a specific statute, the Genetic Information and Nondiscrimination Act, which protects genetic information. Other federal statutes, which do not address genetics or genomics in particular, also have relevance in the genetics context, including laws that protect against certain forms of discrimination or that regulate laboratories. Federal agencies also play a role, for example, in protecting genetic privacy or regulating genetic tests. Finally, the US Constitution is relevant to genomics, especially concerning reproductive rights, which are pertinent to reproductive genetic testing.