Between the Local and the Global: Evaluating European regulation of stem cell regenerative medicine
Hauskeller, C
Date: 9 November 2018
Journal
Perspectives in Biology and Medicine
Publisher
Johns Hopkins University Press
Publisher DOI
Abstract
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 ...
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
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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.
Social and Political Sciences, Philosophy, and Anthropology
Faculty of Humanities, Arts and Social Sciences
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