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This chapter outlines the aims and objectives of the book and its focus on regulatory reform of the General Medical Council and how it investigates complaints against a doctor’s fitness to practise alongside the introduction of medical revalidation to periodically test professional competence. To set the scene to this analysis in subsequent chapters, the emergence of risk-based approaches to professional regulation are outlined as well as how these have transformed traditional ‘doctors only’ approaches to medical governance.

The chapter provides a historical policy account of the introduction of medical revalidation in the UK and outlines the limiting structural and cultural factors at play and how these might well hinder its ability to identify poorly performing doctors.

This chapter articulates conversion arguments for and against the regulatory regimes overseen by the Occupational Health and Safety Administration, the Food and Drug Administration, the Consumer Product Safety Commission, and the regulatory regimes that administer occupational licensure in the various states, with special attention to the licensing of physicians.

In light of previous chapters, the final chapter outlines how recent developments in the regulation of doctors are a result of the fluctuating social conditions associated with the emergence of the risk society. It discusses the possible future of risk-based forms of medical regulation and sets out a conceptual and policy-focused research agenda for ascertaining the impact of regulatory reform on both the public and the medical profession.

This chapter analyses a range of country-specific pathways of re-regulation in relation to markets in healthcare, with a focus on the differences between broadly similar models of re-regulation. It analyses sector-specific institutional contexts from a cross-country comparative perspective based on five countries — Britain, Denmark, Germany, Italy and Norway. Medical governance is closely related to redistributive policies, where the influence of country-specific institutions tends to be pertinent. Medical governance provides a good basis for studying both the dynamics of governance and the difference institutions make.

This chapter applies the requirements of Chapter 11 to selected items on the modern liberal regulatory agenda, specifically the prohibition on race and sex discrimination, occupational health Yeand safety regulation as embodied in OSHA, and medical products regulation as overseen by the Food and Drug Administration. It concludes that with the exception of one form of race discrimination, the imposition of these elements of the modern liberal regulatory agenda has not been morally legitimate, since one or more of the requirements articulated in Chapter 11 has been violated. Those elements could have been legitimately imposed, but they were not—and this is because of the way it was done (e.g., by judicial or bureaucratic fiat, after arguing for it in bad faith).

Medical research, and specifically clinical trial research on human subjects, is necessary to make advances in medicine. Such research depends on high levels of trust between the subjects and the physician scientists conducting the trials. This chapter addresses the erosion of public trust in health research, its causes and consequences, and some solutions. Abuses of the past have left a broad legacy of mistrust. Government regulation attempted to impose better procedures to ensure good medical ethics. Institutional Review Boards were formed to monitor federally funded research. However, patient mistrust and conflicts of interest by researchers remain concerns in the field. The chapter recommends moving from a culture of compliance to a culture of conscience, in which people act responsibly because it is the right thing to do. In addition, it discusses the importance of providing incentives for good performance.

This chapter explores the medical licensure and specialty certification environment in United States and examines the persistent difficulties with ensuring that all physicians keep up with the changing demands and advances in medicine. Government agencies (state and federal legislatures, departments and courts), multiple medical organisations, and market bodies (consumers and insurance companies) are intertwined in complex and conflict-prone interactions. This chapter critically explores if the United States can continue to leave it to medical professionals or local state legislatures to oversee maintaining competency and licensure. States currently vary as to the strategy they adopt, the preferred method reflecting local traditions and physician practices, leaving gaps in standards. Anti-regulation sentiments have been on the rise, with the result that efforts by some medical organisations to nudge others toward greater oversight have been stymied by others which launch legal and political challenges against regulatory changes. The diversity of institutions with a stake in the regulatory process complicates the matter. The chapter concludes that what tends to get lost in this state of affairs is the ‘public interest’.

The interface of law with medical education brings to the fore a range of topics starting from establishing educational institutions to securing admission, from setting standards of medical education not merely of students passing out of colleges established in India but also to appraising persons who have graduated from foreign universities before being granted the license to practice in India. The IMC regulations provide the course content and admission norms but the preoccupation has been essentially in garnering the limited number of seats in colleges by application of rules of reservation without compromising on issues of merit. Private enterprise in establishing colleges has raised the costs of medical education and unconscionable levy of capitation fees. State control that began as attempts to abolish the practice have been tempered with over a time through judicial pronouncements that have not been consistent. Minority-run institutions have pressed home to enjoy immunities from state control in matters of admission and levy of hefty tuition fees. Flights of students to hitherto unknown foreign universities for acquisition of degrees have become common place.

The history of biomedical product regulation is a history of hard-won progress. Often, only after tragedy, has regulatory statute caught up to drugs with horrid side effects or medical devices that offer no benefit but may do harm. Harmful or questionable products slip through cracks in regulatory statutes and are brought to market quickly and prolifically, while regulators play catch up and must demonstrate harms before being enabled to police or regulate them. A notable present-day example is e-cigarettes, a multi-billion-dollar industry with clearly questionable marketing practices, which arrived and grew quickly without any form of premarket regulatory obligation. Similarly, digital health tools are proliferating, and most are yet to be subject to premarket regulation. This chapter provides a brief history of biomedical-products regulation with a focus on benefit-risk determination and its impacts on regulatory policy.

This chapter describes the sanitary conditions of the seventeenth-century Caribbean, the diversity of ideas about illnesses, spaces for healing and diseasing, and the multitude of practitioners who operated in this context. It introduces a Caribbean geography of health and disease, the contours of which appear familiar, but upon closer scrutiny morph into unsettling spaces. Rather than being mere reproductions of Old World hierarchies and dynamics, the chapter shows, Caribbean landscapes of healing were created anew through the multiple encounters that occurred between mostly black historical actors in the highly competitive cultural economy based on the experiential that developed in the region. These were arenas in which a variety of actors deployed multiple visions of the natural, cultural, and social world of the early modern Atlantic. The multiplicity of origins of practitioners of African descent implies that analysis of their historical circumstances cannot be contained in simple dialectic terms of continuities, ruptures, or coarsely defined hybridities. By unmasking muddying labels and maps of social and physical landscapes conceived through Old World imaginaries, we begin to perceive the countless ways in which black Atlantic actors usurped canonical and mundane spaces in which to enact their own corporeal encounters.