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Policy Interoperability in Stem Cell Research: Demystifying Harmonization

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Abstract

Scientific developments in the field of stem cell research continue to emerge at incredible speed and so too has the contentious debate surrounding their broad implications. Though economic, socio-ethical and legal concerns remain, at both national and international forums; we are witnessing a departure from an “embryo-centric” approach, to one that is focused on the globalization of research and to the ensuing need for policy interoperability. The common response to the challenges associated with the meaning, scope, and ethical significance of variance in national policies, is a call for the creation of uniform legal and ethical standards. However, this call towards policy convergence on the fundamental ethical and governance principles underpinning policies choices has led to confusion and to the mystification of the notion of harmonization. In this article we aim demystify the notion of policy harmonization in the context of stem cell research. We will do so by surveying the diverse elements to be harmonized. We will then present the problems of policy interoperability in the context of the globalization of SC research, in order to propose that the goal of harmonization in this field lies in the identification of prospective strategies to foster seamless cross-jurisdictional collaboration. Finally, policy interoperability will be analyzed through the lens of a range of policy approaches addressing the cross-jurisdictional transfer of hESC lines with the aim of demonstrating that the apparent ethical-political-legal divide in some contexts largely vanishes once we grasp the notion of harmonization and identify points of convergence.

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Notes

  1. Given the conceptual differences between the notion of harmonization and standardization, in this paper we will reserve the use of the term “standard” to refer to those requirements or regulations surrounding the characterization, validation, storage and distribution of stem cell lines, or in a nutshell, to strictly technical and scientific aspects. We follow the approach taken by the International Conference on Harmonisation which defines standardization as the process towards scientific guidance in the adoption of uniform scientific and technical requirements and common guidelines. (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, www.ich.org).

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Acknowledgements

The author would like to thank the Canadian Stem Cell Network, the International Regulome Consortium and the International Stem Cell Forum for their funding support. The author would also thanks Professors Bartha M. Knoppers and Timothy Caulfield for their comments and thoughtful suggestions on an earlier version of the present article. The opinions are those of the author alone.

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  1. CRDP, Université de Montréal, Montréal, Canada

    Rosario M. Isasi

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  1. Rosario M. Isasi
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Correspondence to Rosario M. Isasi.

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Isasi, R.M. Policy Interoperability in Stem Cell Research: Demystifying Harmonization. Stem Cell Rev and Rep 5, 108–115 (2009). https://doi.org/10.1007/s12015-009-9067-z

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  • DOI: https://doi.org/10.1007/s12015-009-9067-z

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