Between the Local and the Global: Evaluating European regulation of stem cell regenerative medicine

This is the author accepted manuscript. The final version is available from Johns Hopkins University Press via the DOI in this record.Current European regulations hinder the compilation of the evidence that would be required to bring safe and effective autologous stem cell–based interventions (SCBIs) into standard clinical care. European agencies have expanded their regulations to cover all new SCBIs and research. They establish demanding conditions for cell retrieval, processing, and application. Drawing on empirical sociological findings from observing the implementation of the first phase III stem cell clinical trial in 2 Europe, this article teases out some ethical problems effected by that policy. They include that because of the costs of bringing treatments to market, new autologous SCBs may remain untested and that this plays in favour of the growing direct-to-consumer market. Furthermore, that the research pathways in regenerative medicine and the role of clinician-scientists in developing new treatments is restricted, because the regulations are biased to enable specific SCBI’s that are of interest to industry. This present situation contradicts the moral and social concerns in favour of new treatments and patient interests, which the regulations supposedly safeguard. To align aims and effects of policy better, European regulatory authorities should reconfigure their regulations to advance a fair and effective governance regime that allows pursuit of all promising SCBIs.This research was funded through the European Union’s Seventh Framework Programme for research, technological development, and demonstration under grant agreement No. 27896