Under the global dynamics of regulatory capitalism, lower-and-middle income countries have been under pressure to engage with alien models for regulating regenerative medicine. Nevertheless, Chapter 3 argues that notions of Western hegemonic power are becoming outdated as a main analytical tool for understanding global regulation: changing global reconfigurations of power and scientific institutions in the global life-sciences have created structural spaces for both enterprises and regulators to negotiate new regulation. Chapter 3 introduces the notion of regulatory capacity building to illustrate the changing global reconfigurations of power and scientific institutions in the global life-sciences through the structural spaces in which individual enterprises and regulators alike ‘broker’ regulation. The chapter argues that building regulatory capacity is not a matter of the wholesale import of internationally accepted regulation, but of the nation-state, in negotiation with local developments and interest groups, shaping regulatory boundaries at provincial, national and global levels of organisation. Case studies on regulatory development in China and in India illustrate how the adaption of ‘foreign’ regulation requires complex political efforts to forge compromises between ‘the ideal’ models used by the laboratories of the global elites and feasible standards aimed for and set ‘at home’.

Clinical innovation is ubiquitous in medical practice and is generally viewed as both necessary and desirable. While innovation has been the source of considerable benefit, many clinical innovations have failed to demonstrate evidence of clinical benefit and/or caused harm. Given uncertainly regarding the consequences of innovation, it is broadly accepted that it needs some form of oversight. But there is also pushback against what is perceived to be obstruction of access to innovative interventions. In this chapter, we argue that this pushback is misguided and dangerous – particularly because of the myriad competing and conflicting interests that drive and shape clinical innovation.