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Risk Governance of Stem Cells as Therapeutic Products and Broader Implications for Innovation

Mittra, J

PEALS Spring Symposium (The Identification, Regulation and Implications of Risk Within Stem Cell Research)

Durham Castle

Invited speaker |

April 10 – 11 2008

Advances in stem cell science have led to changes in national and international regulation to deal with emerging issues around risk, uncertainty and appropriate governance. While risk issues around safety, quality and efficacy are high on the regulatory agenda, little emphasis has been placed on the broader implications of regulation and risk-governance for different sectors in the innovation community. This paper will consider the risks associated with different types of stem cell therapy; outline what are the current requirements for moving towards safe clinical trials and market authorisation; and assess how new regulations, particularly Europe’s Advanced Therapies Regulation, might impact on the innovation potential of different types of research organisations. It will be argued that regulation built on the existing drug model will favour the conventional and highly dominant big pharma sector, but a radically new system of regulation and governance could enable smaller firms to exploit the commercial development of stem cell therapies. Nevertheless, a number of known and potential risks associated with all cell therapies need to be resolved before the promise of stem cell-based therapeutic intervention becomes a realistic option.