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Emerging Regulatory Issues for Human Stem Cell Medicine1


The regulation of stem cell research is an issue that has drawn much comment, criticism and even judicial arbitration in recent years. An emerging issue, addressed in this article, is how the fruits of that research-stem cell medicine-are likely to be regulated en route from lab to market. Taking account of the ethical, legal, social and safety issues raised by stem cell medicine and the goals of governance, the article explains the relevant regulatory instruments (e.g. the draft UK Stem Cell Bank Code, the EU Directive on Human Tissue, the EU Directives on medical products and devices, and the Human Tissue Act 2004) and critically examines the framework they provide.


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Open Access This is an open access article distributed under the terms of the Creative Commons Attribution Noncommercial License ( ), which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.

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Liddell, K., Wallace, S. Emerging Regulatory Issues for Human Stem Cell Medicine1. Life Sci Soc Policy 1, 54 (2005).

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