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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.
International case-studies on regulation and science collaboration show how competition and economic pressures on the national regulators of biomedicine condition the development of jurisdictive regulations. But regulation that fails to guarantee a jurisdiction's optimal protection of patients and scientific research in favour of other interests commits foreseeable and avoidable “regulatory violence”. Even when well-intended, regulation gets caught up in the intense international competition to support public health and generate national wealth, with real-world implications. Evidence from Asia, Europe and the USA challenges the belief that regulation improves ethical practices in regenerative medicine, connects practitioners with good science, and protects patient safety. This book explains why this is so, and points to ways in which science could help us address healthcare issues in greater solidarity. This title is also available as Open Access on Cambridge Core.
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