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  • Regulating Induced Pluripotent Stem Cells Ethically in the Bio-Economy: A Preliminary Enquiry1
  • Benjamin Capps (bio)

1. Introduction

Human induced pluripotent stem cells (IPSCs) first caught the headlines in 2007.2 They are thought to have comparable characteristics as embryonic stem cells—that is, able to be cultured indefinitely and coaxed into differentiating into any of the cells that make up the body. Their discovery suggested some appealing clinical applications: deriving IPSCs from a patient’s own cells seems in principle to be reasonably straightforward to do; involving a simple biopsy followed by “inducement” to a pluripotent state. The resulting cell lines would be compatible with the patient’s immune system, making them ideal for autologous regenerative therapies. They would also be a neat way to study human development (avoiding the controversies of embryo research), and could be engineered to model and study diseases—a stem cell line from a patient with a degenerative condition would also prospectively have the relevant faults in vitro. This article is a preliminary enquiry into the issues that IPSCs prospectively raise if they meet this potential. It is a forward-looking analysis, considering the future of regenerative medicine within existing ethical and legal frameworks, and a reflection on the challenges created by these new technologies. In many ways, IPSCs do not raise any distinctive ethical issues: they fall into existing markets and the rules and ethics that govern them. However, IPSCs, and the ways that they become interwoven with legal frameworks and social conventions, will magnify anomalies and challenges to existing issues in health tourism, property in human derived materials, and reproductive and regenerative medicine. [End Page 208]

My enquiry begins by concisely defining the Bio-Economy: the social and legal framework in which IPSCs will be expected to have a leading role. The Bio-Economy broadly refers to “economic activities relating to the invention, development, production and use of biological products and processes”.3 Yet, as I will later elucidate, this economy prospectively defines how we think about ourselves, our interpersonal relationships, and about society in general in relation to technologies; as such, it raises some regulatory puzzles and, depending on how we choose to approach them, intriguing opportunities and challenges to socio-legal convention. There is still a lot to do to identify realistic prospects and to scope the margins for legitimate technologies; hopefully, this is done meticulously to avoid repercussions creeping up in unexpected ways. To meet these challenges, societies must consider the ethical legitimacy, as well as the currency of regulatory frameworks.

First, then, I will describe the features of the Bio-Economy relevant to IPSCs. Next, I look in detail at some of the regulatory issues important to potential IPSCs markets. To start with, I ask whether IPSCs are at all exceptional in raising ethical and legal issues. Perhaps the most important aspect of this is the idea that they will bypass the ethical controversies of embryonic, cloning and foetal research, thus impacting on the future governance of stem cell technologies. In the final part, I look in detail at some particular aspects of a potential Bio-Economy—complicity in the research agenda; and the emergence of stem cell markets in two areas: health tourism; and trading in human body parts. If there is one take-home message, it is that, in these three examples, existing regulatory conventions seem somewhat inadequate to deal with the technological and social implications of these emergent technologies.

1.1 “The Bio-Economy”

The Bio-Economy describes an epoch in which technologies that use or benefit living systems contribute to a significant share of economic output.4 It is characterised by sophisticated gene manipulation techniques and novel ways of harnessing complex cell processes, and their integration with advanced material and mechanical technologies. It involves assimilation of technologies across all sectors: health, trade, industry and public service; and interconnects diverse groups and communities across the globe. It has therefore become a common feature of political rhetoric about future investment policies and the key to progress. The Bio-Economy is already well underway, with already a great deal of investment spent on strategic biotechnological initiatives; yet there is much to be said about the extent...

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