Stem cell research, scientific freedom and the commodification concern

For more than a decade, stem cell research has been the topic of often-polarized debates about the nature and scope of scientific freedom (Caulfield, 2004; Downie et al, 2005; Foley, 2000; Hsu, 1999; Keane, 2006; Taylor, 2003). Some have suggested that attempts to regulate the field have yielded an unprecedented degree of political interference in the arena of scientific inquiry (Cattaneo & Corbellini, 2011). For instance, many countries, including Canada, have passed legislation that takes the relatively rare step of criminalizing specific research activities, such as creating human embryos for research (Canada, 2004). Most recently, the Court of Justice of the European Union in Luxembourg, in a landmark decision with wide-ranging implications for stem cell research and its commercial development in Europe, ruled that methods to manipulate stem cells, such as differentiating them into other cell types, cannot be patented.

Regulatory policy and research ethics rules have long placed limits on what research can be done and how it can be undertaken. Such limits have generally been based on issues of human health and safety—such as the regulation of clinical trials or hazardous materials—or the protection of well-established and identifiable individual rights, for instance, respecting the autonomy of research participants. By contrast, many of the justifications for the strict regulation of and the resulting constraints on research involving human embryonic stem cells have been amorphous and contested. There is accordingly little agreement on whether these regulations address traditional or well-established research ethics concerns and norms (Caulfield & Brownsword, 2006).The highly contested claim that some forms of stem cell research undermine human dignity, a common justification for recommending bans on establishing stem cell lines from human embryos and on research cloning (somatic cell nuclear transfer), is an excellent example of this phenomenon (President's Council on Bioethics, 2002). This claim persists even though there is little agreement in either the academic or policy-making communities about how research cloning undermines human dignity or, indeed, about the meaning, scope and demands of the principle of human dignity (Brownsword, 2003; Hayry, 2004; Macklin, 2003; Ogbogu & Caulfield, 2009; Pinker, 2008). In fact, it has been suggested that human dignity is used merely as a slogan, or as a vague placeholder for a variety of imprecise fears about socially controversial science (Macklin, 2003; Ogbogu & Caulfield, 2009; Pinker, 2008). At the very least, all parties seem to agree that dignity is an ambiguous concept that demands a more precise definition when used in policy-making (Harmon, 2009).

Regulatory policy and research ethics rules have long placed limits on what research can be done and how it can be undertaken

Another vague term frequently heard in stem cell policy debates is 'commodification'. The term seems to have emerged in the bioethics and biopolicy lexicon around the late 1990s. An early reference appears in a report issued by the Canadian House of Commons' Standing Committee on Health that recommended a ban on somatic cell nuclear transfer because “it is unsafe and commodifies the embryo” (Standing Committee on Health, 2001). Ever since, commodification has been frequently deployed in legislation, case law, policy debates and in white papers commissioned by government and private sector institutions. Also, ideas associated with the term turned up in the European Court of Justice's recent decision on stem cell patents.

However, our review of the uses of the term commodification and our analysis of the contexts in which it is used shows that, much like human dignity, the term is rarely defined, and its applications in stem cell policy debates are both varied and imprecise (Table 1). Also, like human dignity, commodification seems to be an attractive justification for science policy precisely because it can mean different things to different people, and because it has an intuitive appeal that is difficult to counter in public debate.

...commodification seems to be an attractive justification for science policy [...] because it is has an intuitive appeal that is difficult to counter in public debate

Table 1. Example uses of 'commodification' in regulatory and ethics policy documents.

Source	Reference
Tri-Council Policy Statement (Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, 2010)	“Significant ethical issues [associated with research involving materials related to human reproduction] include consent to research involving materials related to human reproduction, privacy concerns, the risk of harm to those who provide reproductive materials, an embryo or fetus, and potential commodification of reproductive capabilities and materials related to reproduction.”
President's Council on Bioethics (2002)	“[I]t seems difficult to claim—even in theory but especially in practice—the presence of reverence once...we treat the animals we kill...simply as resources or commodities. In a similar way, we find it difficult to imagine that biotechnology companies or scientists who routinely engaged in cloning-for-biomedical-research would evince solemn respect for human life each time a cloned embryo was used and destroyed... It seems scarcely possible to preserve a spirit of humility and solemnity while engaging in routinized (and in many cases corporately competitive) research that creates, uses, and destroys them.”
Chief Justice Beverley McLachlin (Supreme Court of Canada, 2010)	“Transgenic science has been associated with other harmful techniques of assisted reproduction, such as human cloning and the commodification of reproductive materials...These risks support the use of the criminal law to control transgenic research.”
Nuffield Council on Bioethics (2011)	“The fact that ES [embryonic stem] cells potentially have valuable applications in a wide range of diseases raises the question of whether increased demand might lead to the creation of embryos specifically for research which has the purpose of obtaining ES cells and creating immortalised cell lines. Such a development might be seen as a step towards commodification of the embryo and one that denies the embryo the respect it should be accorded.”
Standing Committee on Health (2001)	“'[T]herapeutic cloning' should be banned as it is unsafe and commodifies the embryo.”
Canadian Institutes of Health Research Ad Hoc Working Group on Stem Cell Research (2002)	“While the moral status of an embryo does not depend on the circumstances of its creation, this distinction [between supernumerary IVF embryos and embryos created specifically for research] may be useful as a measure to preclude or minimize the commodification of human life.”

In this brief essay, we outline examples of how commodification is used in regulatory and ethics policy documents on stem cell research. We aim to show that there is vexing uncertainty surrounding the uses of the term that undermines the salience of the underlying concerns that its use aims to express. Furthermore, we suggest that there are reasons to question whether the term can stand as a sound justification for the curtailment of scientific freedom.

What, exactly, is commodification? As we will see, one of the central issues in the context of stem cell research policy is that there is a lack of clarity about both the definition and the nature of the social harms with which it is associated. Scholarly discussion of the term—most notably in the fields of law and economics and cultural studies—centre around the idea, which has roots in Marxist theory, that commodification entails treating something that is untainted by commerce as a commodity, thus rendering it subject to commercial valuation, exchange and exploitation (Ertman & Williams, 2005; Marx & Engels, 1848; Radin, 1987, 1996; Sandel, 2000).

In this vein, Margaret Radin and Madhavi Sunder (2005) define the term as the “reduction of the person (subject) to a thing (object)”, thus highlighting the negative, disruptive and corruptive influence that a commodifier—that is, market relations—can have on something considered inalienable and non-reducible, such as social relations. Similarly, Ertman & Williams (2005) view the term as reflecting a tension between liberty interests—the freedom to contract and to exchange goods and services in the marketplace—and socially constructed views about what should or should not be exchanged in that marketplace. From this viewpoint, the world is bifurcated into two hostile halves, one an “economic arena dominated by rational self-interest and self-interest alone ('the market'), and a sharply different arena of intimacy and altruism that must be protected from the kind of instrumental behaviour that is appropriate in market contexts” (Ertman & Williams, 2005).

In simpler terms, therefore, commodification denotes three main propositions. First, some things are alienable whereas others are not (Calabresi & Melamed, 1972). Second, transforming that which is considered inalienable into a commodity devalues it. Third, views about what should or should not be inalienable are more or less socially constructed and mutable. Beyond these propositions, the more challenging questions are why something should be considered inalienable, and what values are compromised when that thing becomes a commodity.

In the context of humans and human body parts, it is claimed that commodification amounts to the objectification of humans and, in turn, the infringement or corruption of concepts such as human dignity, personhood, integrity and moral worth (Ertman & Williams, 2005; Holland, 2001; Levine, 2010; Resnik, 2003; Sandel, 2000; Scheper-Hughes, 2002). Resnik asserts, for example, that patents on human genes, tissues and other body parts “would threaten [...] human dignity, because they would treat human beings as incomplete commodities, not as complete commodities” and that “the threat to human dignity posed by the commodification of human body parts arises because incomplete commodification of a thing can lead to complete commodification” (Resnik, 2003). Evelyne Shuster notes similarly that “the basic dignity problem with cloning is the commodification problem, because cloning commodifies humans and the commodification of humans is dehumanising and degrading [...] an insult to human dignity because it undermines individual autonomy, uniqueness, identity, and rights” (Shuster, 2003). Yet another commentator asserts that tissues, gametes and embryos “have an intimate connection to personhood” and as such, their commodification should be subject to government regulation because it “contributes to a diminishing sense of human personhood on an individual level, even as it erodes commitments to human flourishing at the societal level” (Holland, 2001). Such assertions, frequently deployed in bioethics literature and in stem cell policy debates without elaboration or robust analysis, either rely on contested concepts such as human dignity or lack what Ruth Macklin describes as a “principled moral argument” that supports the claims and prescriptions they advance (Macklin, 1999). Moreover, empirical evidence of actual harm is rarely, if ever, presented. In general, the argument is rarely more nuanced than the following: commodification is bad because it leads to commodification.

In general, the argument is rarely more nuanced than the following: commodification is bad because it leads to commodification

In the stem cell policy context, the term commodification abounds in white papers issued by governments and bioethics bodies, but it has also been used in research ethics instruments and judicial decisions to justify placing limits on research. The Canadian Tri-Council Policy Statement, which governs ethical review of publicly funded research, stipulates, for example, that research involving human reproductive materials, which includes stem cell research, poses significant ethical questions, including “potential commodification of reproductive capabilities and materials related to reproduction” (Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, 2010). A judicial reference to the term can be found in a recent Canadian Supreme Court opinion, in which the Chief Justice, in a minority decision, urged the criminalization of transgenics research on the grounds that it “has been associated with other harmful techniques of assisted reproduction, such as human cloning and the commodification of reproductive materials” (Supreme Court of Canada, 2010). A peculiar feature of these high-profile mentions of the term is that they are neither accompanied by any explicit definition nor supported with a precise statement of associated harms, but rather, are merely asserted in a manner that assumes the legitimacy or credibility of the alleged harm.

In addition to explicit mentions, ideas associated with commodification abound in legislation and policy documents, as well as in judicial decisions. This is evident in the wide-ranging decision of the Court of Justice of the European Union in Oliver Brüstle v Greenpeace e.V. The court was called upon to consider whether a patent on a method to develop human embryonic stem cells into neuronal cells contravened European Union (EU) law, which prohibits the patenting of uses of human embryos for industrial or commercial application. The Court ruled against the patent, noting that “the grant of a patent implies, in principle, its industrial or commercial application” (Court of Justice of the European Union, 2011). Greenpeace Germany, challengers of the patent in this case, have cited concerns over the “commercialization of the human body”—a common theme in anti-commodification arguments—as the primary motive for their challenge (Naik, 2011). EU law also bars the patenting of an invention where its commercial exploitation is deemed contrary to ordre public (public policy) or morality, thus providing another possible basis for invoking commodification-type arguments against the patenting of human embryonic stem cell inventions.

...where the term is employed without definition or context, as is often the case, it is difficult to grasp the exact harm that is being expressed

What exactly is problematic about the uses and applications of the term commodification? First, where the term is used without definition or context, as is often the case, it is difficult to grasp the exact harm that is being expressed. The resulting vagueness impedes and frustrates ethical reflection, an issue that is especially troubling when the reference is accompanied by calls for a ban on particular scientific research.

Second, even when the term is used with a degree of context, its rhetorical weight and persuasive force—who, after all, could be against stopping the commodification of humans?—often masks the evidentiary uncertainty about the suggested harms. Take, for example, the claim that providing financial compensation for donating gametes to research amounts to commodification because it leads to the exploitation of donors. Studies that probe women's views on financial compensation for oocyte donation to stem cell research suggest that most women neither accept the view that reproductive materials are inalienable, nor agree that financial imperatives render them incapable of making ethical choices (Haimes et al, 2011); the majority of women in one study opted for financial compensation over altruistic donation, but would prefer to donate for reproductive rather than research purposes (Klitzman & Sauer, 2009). Our point here is not that exploitation is not a potential problem in this context, but that it is not necessarily a clear-cut outcome, as is often implied by the reference to commodification. Note also that we are not suggesting that policy action cannot proceed without empirical evidence, but rather, at a minimum, that it is desirable to consider such evidence where available. Indeed, notable bioethics bodies have increasingly sought and applied empirical evidence in investigating biomedical research issues (Nuffield Council on Bioethics, 2011).

Finally, appeals to commodification-based harms, especially when accompanied by proposals for regulation or prohibition of research activities, often fail to assess whether existing ethical and legal mechanisms would be sufficient to address alleged harms. Rather, the mere assertion of harm or mention of the term is deemed sufficiently weighty, in and of itself, to trigger legal sanctions. In the Supreme Court of Canada decision referred to above, the Chief Justice relied on concerns about commodification to support the existing regulatory framework, which includes criminal prohibition of a range of scientific techniques. Another example relates to the concern that human cloning will lead to the commodification of human beings by providing the means for their manufacture and sale. Putting aside the speculative nature of this claim, existing research policies almost universally condemn and prohibit human cloning for reproductive purposes.

While the legal status of the notion of scientific freedom is far from certain, it is, at least, a concept that is highly valued within the academic community (Ferguson, 1979). It has also been linked with fundamental liberal democratic constitutional and human rights norms, such as freedom of speech, thought and expression, and substantive due process; that is, the freedom to acquire useful knowledge (Delgado & Millen, 1977; Ferguson, 1979, 1981; Irwin, 2005; Keane, 2006). As such, one would expect that attempts to curtail scientific freedom should be based on well-formulated, clear and defensible reasons that advance and preserve these underlying norms. Science policy that is based on catchphrases or vague assertions of ethical harm do not only constitute a threat to scientific freedom and its supporting values, but render such policies unintelligible and, thus, incapable of providing sound ethical or legal guidance.

We should note that some uses of the term commodification are associated with concerns that deserve further scrutiny and research, such as the degree to which financial compensation incentivizes exploitative practices in the context of donating human biological material to medicine and research (Dickenson, 2002; Nuffield Council on Bioethics, 2011). However, when associated with commodification, such concerns become obscured by its definitional baggage and imprecise content or scope. Some commentators have noted, for example, that the term is applied to mischaracterize reality when used to assert certain claims in the assisted reproduction context, such as the claim that paid surrogacy commodifies children; opponents of this view contend that surrogacy compensates the surrogate mother for the considerable effort expended in providing reproductive services (Hnatiuk, 2007). Also, concerns that are valid in one context, say, in relation to reproductive technologies, might be inapplicable or irrelevant to others, such as research activities, a point that is often glossed over when the term commodification is invoked in policy discourse.

How then can the term be rescued, if at all, from the current conceptual chaos? Given the uncertainty surrounding its definition, content and scope, we are sceptical about whether the term can ever legitimately guide ethical analysis or, on its own, provide a sound justification for limiting scientific freedom. However, the term is also unlikely to disappear from usage, especially considering the fact that it has already worked its way into policy documents, case law and research ethics policy. We therefore urge that proponents should be given the task of clarifying the harm that their usage of the term implies or is meant to convey, support their claims with arguments devoid of tautological assertions and, where necessary and possible, with empirical evidence. Sound ethical and regulatory scrutiny is fundamental both to the development of regulatory policy with enduring relevance and to the safeguarding of societal interests implicated by scientific inquiry. As such, it is a task that we ought not to surrender to slogans, assertions or impoverished speculation.

Timothy Caulfield

Ubaka Ogbogu