CONICET | Buscador de Institutos y Recursos Humanos

The international landscape of medicine regulation has in recent years been subject to rapid changes. What can be observed is an ongoing process of regulatory diversification. A comparative analysis of regulatory developments in regenerative stem cell medicine in Argentina, China, the European Union, India, Japan and the USA shows that the evidence-based medicine paradigm, with the use of multi-phase randomized controlled trials at the centre, is increasingly contested and replaced by new models of clinical validation. Four patterns of regulatory diversification are identified. Existing studies in STS have used a limited set of factors to explain these changes, such as growing pressure form health consumers and patient organizations; the role of pharmaceutical companies to lobby for fast, affordable drug development; the influence of neoliberal ideas and libertarian advocacy of deregulation; and the agency of national governments to enable domestic innovation opportunities in the context of global competition and inequalities. Whilst these studies provide important pieces of a puzzle, they fail to account for the increasing variation in medicine regulation both at national and global levels. This article integrates elements ofexisting explanations into a framework that works with four pairs of conflictingregulatory choices, which play a central role in the formation of medicine regulation.Use of this framework has foregrounded both, the different aspirations and conflicts of interests that drive regulatory diversification in different global settings, and the tensions and consequences that result from these changes. Key regulatory concepts such as evidence, risk, safety, efficacy, responsibility and accountability acquire different meanings, and reshape medicine innovation in far-reaching and often contradictory ways. As medicine regulation diversifies, the boundaries between medical research and health care provision, commerce and humanitarian service, as well as state control and medical self-regulation are re-defined, with implications that are only just coming into view.

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