RESUMEN
Cell and tissue-based products, such as autologous adult stem cells, are being prescribed by physicians across the world for diseases and illnesses that they have neither been approved for or been demonstrated as safe and effective in formal clinical trials. These doctors often form part of informal transnational networks that exploit differences and similarities in the regulatory systems across geographical contexts. In this paper, we examine the regulatory infrastructure of five geographically diverse but socio-economically comparable countries with the aim of identifying similarities and differences in how these products are regulated and governed within clinical contexts. We find that while there are many subtle technical differences in how these regulations are implemented, they are sufficiently similar that it is difficult to explain why these practices appear more prevalent in some countries and not in others. We conclude with suggestions for how international governance frameworks might be improved to discourage the exploitation of vulnerable patient populations while enabling innovation in the clinical application of cellular therapies.
Asunto(s)
Células Madre Adultas/trasplante , Ética Médica , Regulación Gubernamental , Cooperación Internacional , Trasplante de Células Madre , Trasplante Autólogo , Australia , Comparación Transcultural , Humanos , Japón , Principios Morales , Singapur , Trasplante de Células Madre/ética , Trasplante de Células Madre/legislación & jurisprudencia , Trasplante Autólogo/ética , Trasplante Autólogo/legislación & jurisprudencia , Reino Unido , Estados Unidos , Poblaciones VulnerablesRESUMEN
This article is an analysis of Derek Morgan's manuscript-'Coming Back to Life: The Normal Chaos of Medical Law', which remained unpublished at his death in 2011. Morgan made two claims in the manuscript: (1) medical practitioners and patients approach health from the different perspectives of 'reason' and 'emotion' respectively, while medical law treads the line between these ultimately resulting in 'normal chaos'. (2) In this respect, medical law ought to be coaxed 'back to life' so that it can address broader principles and values in respect to practical resolution; however, it has, in the face of this chaos, become dull in its ambitions. In this article, I first analyse these two claims in detail, before, second, illustrating the 'normal chaos' of medical law using the debate over ownership of human cells and tissues. I draw my own conclusions as to whether Morgan's final thesis was successful.
Asunto(s)
Células , Legislación Médica , Propiedad/legislación & jurisprudencia , Derechos Humanos , HumanosRESUMEN
Autologous adult stem cells (ASCs) are being administered by physicians for indications that have not been demonstrated as safe and effective in formal clinical trials. Examination of regulatory frameworks across five countries suggests that balancing the demands of research with clinical freedom has created structural weaknesses that are being exploited.
