Chapter 7 examines how international patient movements, inspired by organizations in the USA and Western Europe, have come to see ‘de-regulation’ as a way to accelerate the translation of science into marketable medical products. But in research abroad and an international meeting hosted in the UK, conversations with international patient organisation (health organisation) representatives for Muscular Dystrophy (MD) and Spinal Cord Injury (SCI) and patients from Asia, Europe and the USA shed different light on this. Discussions show that, in a world characterized by regulatory capitalism and inequality among countries, ‘de-regulation’ cannot ‘save’ patients through increased access to experimental medicine in the same way. For, the performance of regulation in a country is contingent upon the material and organisational resources available to health organisations and the population in general in a juridical mandate. The politics of redemptive regulation in international health movements risks reconfiguring healthcare developments by a misrecognition of actual patient needs and local practices. This chapter further raises questions about the potential benefits and costs of regenerative medicine to various patient groups in societies with different standards of wealth, welfare and political governance.

This chapter analyses the international science collaboration between scientists in Chulalongkorn University (CU) in Bangkok and scientists and managers from Kawasaki Heavy Industry (KHI), Japan. The Chapter argues, first, that the integrity of national regulations is violated through international science collaborations, including by the governments whose regulations are violated. As there is no credible regulatory mandate on a global level, such violations receive little attention. Second, in contrast with notions of science collaboration that view collaboration as a bond between two or more partners to attain a shared goal by pooling resources, the chapter’s examination of the collaborative project shows that its goals are shared in different, often incompatible ways. And, third, observing how regulation in international science collaboration is treated as a form of ‘regulatory capital’, the chapter argues that international collaboration and competition form part of the same process. This study of regulatory capital explains why the examination of science collaborations does not just pertain to exchanges of scientific know-how and technological expertise; it also requires the investigation of the ways in which socio-economic, political and regulatory conditions enable available resources to be used to satisfy a range of goals, many of which are mutually incompatible.

Chapter 4 examines how countries with different scientific institutional histories and income levels have dealt with scientific uncertainty and the ethics of ‘experimental’ interventions using so-called mesenchymal ‘stem’ cells, that is cells of uncertain therapeutic character. Observing regulatory practices for clinical research and commercial interventions in the context of global competition, the chapter describes the complex intertwinement of catering for patient needs and demands, the protection of high quality scientific research, the affordability of testing methods, and the prospect of economic growth through investment into regenerative medicine in China and in higher-income countries (HICs). HICs that traditionally have had the power to define standards and conditions set by regulation, even when that power is on the wane, still enjoy considerable ‘regulatory immunity’: their reputation allows HICs to tolerate regulatory violations. In HICs, a scientific boundary is commonly asserted between established stem cell scientists and clinical providers that violate official guidelines. Scapegoating, here, is used as means to defend the reputation of the regulated collective against unauthorized, but tolerated clinical cell-applications. Examples show that the USA and the EU have used regulatory immunization to protect the reputation of stem cell communities alongside violators.

Final Chapter 9 explains why ‘free’ market competition under regulatory capitalism underlies widespread unrecognized regulatory violence and argues that the cultivation of competitive desire (cf. Girard 2000) succeeds at the expense of what have become ‘sacrificeable’ patients. After a discussion of suggestions of altering the social contract between science and publics, and the observation of the prevalence of competitive desire in the context of political debate in the UK, I explain how, instead of regulatory capitalism based on competitive desire, a vision of caring solidarity applying the generative principle of creative desire (Adams 2000) would be more conducive to policies aimed at medical and public-health targets. I argue that guidelines rooted in ‘caring solidarity’ can largely prevent the violence of regulatory competition that has become endemic to regulatory capitalism. By avoiding high-risk strategies that are oriented on one-size-fit-all solutions expected to generate high-profit margins, the proposed vision of caring solidarity is more conducive to sustainable health. The rudiments of such a model, I suggest, would use the generative principle of creative desire, building on local notions of wisdom incorporating virtue ethics of prudence and justice.

Chapter 8 asks how various forms of regulatory brokerage (informal; with state-support; deregulation; international; and, global) are interrelated, and how they have emerged across time in the field of regenerative medicine. A distinction between opportunistic (profiting from discrepancies between jurisdictions to forge collaborations) and active forms of regulatory brokerage (involving activities directed at the creation of regulations) helps to show how awareness of regulation as capital has spread. Extending from individual science-entrepreneurs to larger organisations, including universities, companies, state institutions and international organisations, regulatory brokerage has become part of the entrepreneurial culture of science management. To remain competitive, countries strategically follow the regulatory reforms of competitors, culminating in a cascade of regulatory adjustments and accompanied by the proliferation of regulatory violence. National discussions on regulatory trends in regenerative medicine, suggest that, though differently expressed, competitive desire tends to be an important driver of regulatory reform. But, at the same time, in some countries trends emerge that do not centre on competitive desire but on solidarity and concern for care.

Introductory and regulatory capitalism, and it outlines the methodology and the chapters. On the basis of a discussion of the notion of ‘regulatory violence’ in the context of various relevant legal, political, philosophical and criminological literatures on regulation and violence, I propose to define regulatory violence as the forseeable and possibly preventable violence that obtains when regulation is created and applied for reasons that are illegitimate. In the field of regenerative medicine, this means that when research regulation is developed for reasons other than patient safety and scientific development, it is likely to cause foreseeable harm to patients, the development of science and the public at large. Although in a world dominated by regulatory capitalism, regulatory competition is a main driver of regulatory adjustments, regulatory violence is not unavoidable: some countries manage to change regulation by prioritising patient needs and high-quality science. The Chapter also discusses the challenges involved in regulating the safety and scientific quality of clinical research and the marketing of new regenerative therapies and the main arguments for moving from ‘competitive desire’ to ‘caring solidarity’.

Chapter 6 pertains to the politics of regulatory redemption. Success in iPS research led to Japan’s regulatory reforms in 2013, which transformed the image of Japan’s regulation of regenerative medicine: from a cautious means of protecting patients and scientific quality, Japan’s regulation metamorphosed into a saviour of public health, an enabler of scientific achievements and clinical firsts, and a booster of the national economy. Exploring the performance of the regulatory reforms through the so-called All Japan System (the policy that symbolizes and champions these redemptive ideals), the Chapter illustrates how the political aims and ideas embodied in the new regulation support certain industries and sanctify particular clinical targets to gain a global competitive edge, as well as pursuing scientific, economic and public health goals. Prompted by competitive desire, these regulatory policies were designed to strengthen financial budgets, national economic growth and international competition, misrecognizing the structural alterations of Japan’s science community and the role of patients and their families who would have to co-finance it and play a role as experimental subjects.

Chapter 2 provides an overview of the international regulatory landscape and explores the international dynamics of regulatory competition in regenerative medicine over a turbulent period of six years (2008-2014). The overview indicates that wealth conditions and country size in jurisdictions are associated with particular preferences for clinical research regulation. At the same time, international movements of patients and research to some extent change with regulatory politics. One dimension of this, I describe in terms of regulatory boundary-work, that is, the international politics of regulatory reputation. As a heuristic tool, ‘regulatory boundary-work’ calls for attention to how countries formulate stem cell policies through locally available political and regulatory mechanisms to articulate circumstances ‘at home’ with global regulatory trends. I argue that regulatory capitalism creates conditions that are affected by other countries, where perceived competitors benefit from what they regard as beneficial regulation. The regulation in competitor countries is seen as ‘captured’ or influenced by industry, scientists and other players. Exploring international drivers and the dynamics of regulatory competition, we see that regulatory capture takes place next to and entwined with ambitions to gain international competitive advantage as well as the interests of industry, hospitals, patients and science at home.