Hum. Reprod. Advance Access originally published online on March 29, 2006
Human Reproduction 2006 21(7):1662-1667; doi:10.1093/humrep/del087
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OPINIONS |
Embryo research: is disclosing commercial intent enough?
Research Centre for Reproductive Health and Repromed, Department of Obstetrics & Gynaecology, University of Adelaide, South Australia, Australia
1 To whom correspondence should be addressed at: Research Centre for Reproductive Health, University of Adelaide, The Queen Elizabeth Hospital, Woodville Road, Woodville, Adelaide, South Australia 5011. E-mail: sheryl.delacey{at}adelaide.edu.au
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Abstract |
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This article critically reviews legislative and ethical frameworks that regulate embryo research. Australian legislation for embryo research is currently being reviewed. It is a legal mandate that scientists disclose to embryo donors any intent to pursue commercial gain from altruistic donation. But scientists are also required to inform donors that, as donors, they too must not benefit financially. In the same political context, public subsidy for IVF treatment is under review. There is contradiction in values and indication of inequity in the Australian social context. IVF is undervalued, yet products derived from IVF embryos are imbued with public hope. Rather than regulate to balance this inequity, assumptions of altruism and attention to autonomy in legislative framework give it further scope. This article proposes that justice be addressed by acknowledging reproductive effort, and thereby embryo research be considered in terms of reciprocity. It further proposes regulation of commercial profit and the imposition of a redirected tax levy.
Key words: commercialization/commodification/donation/embryo/research
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Introduction |
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Controversy surrounds the issue of embryo research and commercialization of products so that ethical guidelines for the management of human embryos in commercialized research must account for opposing views. In the wake of legislation that allows human embryos to be used in research, products derived from embryonic material (such as stem cell lines) can be the subject of patents and the production and bio-banking of them the object of venture capital. Although this constitutes good sense for scientists, companies and potential investors in terms of intellectual property and its trade, for some members of the community such commodification of human embryos is morally repugnant. In particular, for some, the commercialization of human embryos in research resonates with historic and morally condemned practices (Lysaught, 2002
).
In Australia (see Table 1 for a summary of the political process), the legislative framework was accompanied by a public process that highlighted polarized views about the moral meaning and status of human embryos. Because of its contentious nature, the Bill was put to a conscience vote that reportedly hinged upon hope that embryo research will lead to improved public health and greater good (Community Affairs Legislation Committee, 2002; Stott-Despoja, 2003). Following enactment, the Licensing body developed guidelines for the conduct of embryo research that drew upon clauses already published in ethical guidelines for assisted reproductive technology (ART) (Australian Health Ethics Committee, 2004) and research involving humans (National Health and Medical Research Council, 1999).
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An unusual feature of the Licensing guidelines is that they mandate a scientist’s blatant disclosure that they may profit commercially from an altruistic donation and that infertile donors will not benefit financially themselves from their donation of embryos. But in the light of recent threats to Government subsidy of IVF in Australia, the issue of financial inequity warrants reconsideration. There are broader principles at stake in the regulation of commercial science. We must also consider the nature and limits of altruism, and whether we are prepared to achieve greater good at the expense of infertile patients who are an already marginalized group. As Dickenson (2001)
has argued: ‘a compulsory one-way gift relationship is not a gift, but exploitation’. The risk in ignoring equity issues is that over time confidence in science may be eroded and mistrust of capitalism fuelled. This article critically explores the issue of research and commercialization of human embryonic tissue and the mandate for scientists to disclose but not share capital gain. Further, it proposes that commercialization of embryo research be reconsidered and regulated within an ethical framework of social rather than economic capital and that financial reimbursement for embryo donors be introduced and regulated. |
Science and commerce |
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In Australia, as in other western societies, commercial development of science is encouraged and achieved through the practice of obtaining legally enforceable patents. A legal patent establishes the scientist’s property right to commercially exploit the invention for 8–20 years (IP Australia, 2006
). Moreover, commercial success relies on the formation of a company and attracting venture capital to support and sustain economic and innovative development. Several such companies already exist in Australia and other countries. Property rights are meant to be lucrative, and the primary aim of a company is to make profit. Thus, embryo research is commonly considered in a framework of commerce or economic capital.
But a human embryo is not inanimate and cannot be considered to be like objects or even other biological tissue. Human embryos are persons or at least have symbolic significance and are owed respect (ESHRE Taskforce on Ethics and Law, 2001; Legislation Review Committee, 2005). Aside from their moral value as potential persons, they have unique genealogical meaning to their infertile donors (de Lacey, 2005). But in Australian legislative frameworks at least, the moral value ascribed an embryo is typically associated with its biological potential. There are public interests at play in the defined value of an embryo, because, globally, the public have invested hope in stem cell research for the cure of debilitating disease and disability (ESHRE Taskforce on Ethics and Law, 2002; Stott-Despoja, 2003; Legislation Review Committee, 2005). There is also utility in regarding human embryos as property, because it is believed that the development of products for cure will be enhanced through commercial enterprise (Gold, 1996; Legislation Review Committee, 2005).
Such a view is surprising, because it presumes firstly that scientists will only conduct research for profit, and secondly that the public will have equal access to derivative technologies. A problem is that in an economic framework, the purpose of commercialization and patenting is not primarily aimed at benefit for the greater good. Rather, individual or institutional ownership of intellectual property is emphasized. Consider another view that commercialization of science restricts rather than facilitates the free flow of scientific information and access to products (Knowles, 1999). Indeed, it is recognized that the potential benefits to the community of stem cell research may be hampered by an emphasis on property rights and distribution control rather than on the swift distribution of new knowledge or technologies (ESHRE Taskforce on Ethics and Law, 2002).
In the commerce of embryo research, the issue of reimbursement for embryo donors has been avoided most likely because as a group infertile patients have not overtly demanded it. But there is also evidence that monitory exchange around biological donation is taboo because of assumptions about its power to coerce patients and to corrupt ethical consent processes (Radcliffe Richards, 1996). Also relevant is the legal difficulty and potential for dispute in proportioning property rights for biological material if commercial profits were shared (Gold, 1996). There is already evidence of exploitation in commercial research involving human tissue, and as a result, property interests in human biological tissue have already been subject to competing claims of ownership. The case of Moore versus Regents of the University of California (see summary at Table 2) is notable to this critical analysis because judicial opinion reveals different understandings of the application of property law to biological tissue (LSU Law Center’s Medical and Public Health Law Site; Gold, 1996). In Moore versus Regents of the University of California, judicial opinion rejected Moore’s claim to a proprietary interest in the products of research. It was held that allowing donors property rights in their biological tissue would result in a ‘litigation lottery’ that would discourage manufacturing and marketing companies. Nevertheless, judicial opinion condemned concealment of commercial intent by scientists and awarded Moore financial compensation (Gold, 1996).
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There are therefore competing views about the benefit of commercial science and a legal precedent to disallowing entitlement for tissue donors to property rights. However, there is scope for consideration of reimbursement of effort and compensation for breaches of fiduciary duty. Also present are competing public interests in access to manufactured products. In this matrix of competing public schema, the interests of infertile embryo donors may be obscured or silent. It is already evident that the disabled and chronically ill in the community rather than the infertile are at the forefront of public concern (Dayton, 2005
). |
The interests of infertile embryo donors |
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It is widely accepted that protection of an individual’s autonomy and avoidance of coercion, inducement or influence that would impair their freedom (to consent or refuse to participate) constitute ethical research practice (National Health and Medical Research Council, 1999
). Historically, the ‘voluntariness’ of subjects has been assumed protection by an absence of financial incentive. Altruism is prized and monetary exchange is believed to preclude it in the donation of biological material (Radcliffe Richards, 1996). Australia, in particular, has a long history of criticizing and condemning commercial gain from donation of gametes or reproductive services such as surrogacy (Anleu, 1992).
In the presence of these beliefs, it follows that the notion of donors receiving a share of profit from embryo research would seem ethically unacceptable. But in the wake of Moore versus Regents of the University of California, it is apparently also unacceptable to omit disclosing profit from the consent process. Therefore, guidelines stipulate that researchers must make it clear that stem cells may be used for commercial purposes (ESHRE Taskforce on Ethics and Law, 2002) and that the researcher may gain financial benefits (Licensing Committee, 2005). But at the same moment the Australian guidelines acknowledge civil rights, they mandate altruistic donation. Scientists are advised that they should inform embryo donors that they will not receive financial or other benefits from commercial development (Licensing Committee, 2005). The guidelines for consent to donate embryos to research appear to enhance the moral conduct of research and protect the autonomy of embryo donors. There is clearly a belief that information of this sort may matter in the expression of autonomy for some individuals who might wish to advance scientific discovery but recoil at the thought of advancing corporate wealth (Knowles, 1999). Briefly, their purpose appears to be the protection of altruism and voluntariness; however, their effect is to further scientific and economic interests and trivialize the contribution of infertile embryo donors.
Moreover, they are no longer ethically robust. The issue of property rights aside, another view is this: money has important symbolisms for practices of appreciation (de Castro, 2005). Monetary valuing reflects valuing in general and rather than embryo donors being paid for their embryos, their gift and the effort it took to create them is being acknowledged and appreciated. Conventional views that financial inducement interferes with voluntary decision-making have been roundly challenged (Grady, 2001). Money alone does not make the situation coercive (Moreno, 2001), and inducements in any case are recognized as coming in several forms, many of which may be non-monetary (Grady, 2001). Payment to research participants in a range of studies is no longer considered to be inappropriate even when altruism underpins voluntariness. Nor is it considered to be a direct payment for tissue, blood or, in this case, embryos. Instead, it is argued to be a reimbursement for a participant’s effort (Reame, 2002). Moreover, it is recognized that even when motives to participate are altruistic, compensation for inconvenience, discomfort and labour is morally appropriate (Dickenson, 2002; Resnik, 2002).
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The missing factor: reproductive effort |
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 TopAbstractIntroductionScience and commerceThe interests of infertile... The missing factor: reproductive... Addressing equity in embryo...Implementing a system of...Conclusion Acknowledgements References |
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IVF is a controversial and publicly scrutinized technology. As such, it is the subject of extensive media attention (Hughes and Giacomini, 2001
). The public may be relatively familiar with the ethical issues arising from ART but what women (and their partners) do, endure (both physically and emotionally) and pay in the process of creating embryos is poorly understood (Dickenson, 2002). Lack of recognition of reproductive labour is as pervasive in the debate of embryo research as it is in the debate of surrogacy (Anleu, 1992).
Running parallel to the process of licensing embryo research and legislative review in Australia is a seemingly disparate public debate about the cost-effectiveness of infertility treatment (Chambers et al., 2005). Before the National budget in 2005, the Australian Government announced its intention to cut IVF funding. This is but one of a series of threats to the Government subsidy of IVF. It was claimed that A$7 million could be saved and that IVF ‘is an elective, non-essential procedure’ (Wroe, 2005). In a concentrated campaign that quickly followed, IVF clinics and IVF patients asserted that ‘infertility is a disease like other disease and deserves to be treated equally’ (Kennedy, 2005). Finally, faced with a backlash within his own party, the prime minister intervened by announcing an independent review (Wroe, 2005). The report of this committee was expected in February 2006 (Maley, 2005).
Australia is reported to be the only country in the world with unlimited government reimbursement for infertility treatment (Hughes and Giacomini, 2001). Therefore, in economic terms, the burden of creating embryos is much less for Australians than for those in other countries. For instance, it is calculated that in the UK one IVF treatment is equivalent to 10% of annual household expenditure and in Canada approximately 16% of household expenditure (Collins, 2002). But despite a generous Government subsidy of approximately half the cost of each IVF treatment, Australian patients are reported to pay as much as A$10 000 for out-of-pocket expenses (ABC Newsonline, 2005).
The economic burden of IVF is important to this exploration because financial pressure is acknowledged as an indirect force in patients’ decisions (Brzyski et al., 2000; ESHRE Task Force on Ethics and Law, 2003). However, my argument is not that patients should be paid directly for treatments that result in residual embryos donated to research. This would complicate laboratory procedures and in any case may sap research sector funding rather than more appropriately, lucrative commercial profit. My purpose is to point out an inequity of valuing that exists in relation to IVF. The purpose of an IVF procedure is to create embryos and donated IVF embryos are the only source of embryonic material for stem cells. It is apparent that although on the one hand the public trivializes the reproductive effort of creating embryos (Hughes and Giacomini, 2001), it simultaneously welcomes the donation of residual embryos for stem cell research. A striking contradiction in public values about embryo research then is this: apparently we find it morally distasteful for infertile donors to experience financial reimbursement or even profit from the donation of human embryos but felicitous for scientists and companies to profit both financially and professionally from the use of donated embryos. We are apparently willing to turn a blind eye to inequity so that ultimately the public can benefit. The pivotal factor in our moral ‘blindness’ is a belief that donation arises from altruism and that altruism is selfless. But altruism has been identified as holding elements of generosity and self-interest (Titmuss, 1971).
There is a question then of who profits and who loses in commercialized embryo research for, as I have argued above, the framework of consumer altruism gives scope only to commercial science. When this question is considered in the light of the economic burden of infertility treatment for embryo donors, the mandate to disclose commercial gain seems at best a principle that values autonomy in consent processes and at worst that sanctions inequity and misuse (Dickenson, 2001). It has been argued that regulation of embryo research that excludes patients from the financial outcome of their donation while allowing companies to stake lucrative property claims on the gift they have made is ‘manipulating the endless inventiveness of capitalism’ (Knowles, 1999).
Over time, the current legislative framework may undermine altruism and diminish social capital. Embryo donors may baulk when it is evident that scientists are profiting in broad terms through regulation of patents and tissue ‘bio-banks’ while their funding is restricted and out of pocket costs for IVF treatment are escalating. Equitable regulation of commerce in embryo research requires acknowledgement of reproductive effort as a valuable form of labour and recognition of the genealogical value of human embryos to infertile donors. Such acknowledgement suggests embedding guidelines about commercialization in a social rather than economic framework.
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Addressing equity in embryo research: collaboration and reciprocity |
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According to social theorists, a society’s capital consists of economic, cultural and social transactions (Winter, 2000
). Whereas the framework of economic capital is competition, profit and control, the framework of social capital is building trust through reciprocity to facilitate actions of mutual benefit (For example see Pennings, 2005). In particular, it suggests a system of equity and collaboration between scientists and embryo donors. The position currently held that trade will be enhanced through property rights of biological tissue granted to researchers and companies does not exclude the possibility of recognition of reproductive effort for embryo donors. The ethical framework of social capital acknowledges reproductive effort and personal valuing of embryos as well as economic growth and greater good.
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Implementing a system of compensation for embryo donors |
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It has been argued that to protect the vulnerable from exploitation, we should regulate biological trade (Radcliffe Richards, 1998
). If in regulating embryo research, property interests were differentiated from the issue of compensation for reproductive effort, how might reimbursement of embryo donors take place? Clearly, in a laboratory situation in which stem cell lines are derived, individual reimbursement according to the value of a particular embryo derivative would be both morally inappropriate (de Castro, 2005) and practically impossible. In relation to the altruistic donation of organs, a tissue tax has been proposed (Bovenberg, 2005), and it would seem appropriate to also consider this system of reimbursement in embryo donation. Taxation is an effective, if indirect, mechanism for benefit sharing (Bovenberg, 2005). It is manageable and enforceable in most countries, and in general terms, the levy and its distribution are subject to democratic control (Bovenberg, 2005). It is more likely to result in fair distribution (Radcliffe Richards, 1998). But it has other perceived advantages. It does not exert undue influence on would-be embryo donors, but at the same time, it acknowledges effort and values the gift especially if embryo donors were to receive an acknowledgement regarding receipt of the levy. It preserves existing scientific incentives and does not require radical change to existing systems of commercialization for it is only applied when actual profit has been made. A set levy avoids endless negotiation and court-mediated claims of under-compensation in relation to profit (Bovenberg, 2005). Tax is both familiar and morally acceptable and may be a less distasteful form of compensation. A tax could take the form of subsidy for infertility treatments through a suitable Government body or healthcare insurance scheme. In Australia, redirected taxes such as this exist already. For instance, in Australia, petrol is subject to road maintenance tax, tobacco is subject to tax that is directed to ‘quit’ campaigns and gambling profits (such as poker machines in hotels and casinos) are taxed for support of relevant welfare charities. The indirect nature of a tissue tax means that embryo donors are unlikely to experience direct financial compensation. There is indication that infertile donors wish to help other infertile couples (McMahon et al., 2000, 2003; de Lacey, 2005); however further research is necessary to determine whether they would feel sufficiently rewarded by this indirect means of benefitting other infertile couples. |
Conclusion |
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The mandated exclusion of donors from reimbursement for reproductive labour intersects with ambivalent community attitudes to IVF and its subsidy in a way that undermines rather than arbitrates fair and reasonable management of embryo donation and research.
Current ethical guidelines represent and promote the interests of science in absence of the full consideration of other stakeholders—namely, infertile donors. In legislative frameworks, the matter of research involving human embryos is separated from therapeutic infertility procedures and treated as if it were a disparate area with isolated issues and considerations. The dominant focus on stem cell derivation as the outcome of embryo research and as having benefits for the community and not for infertility per se has obscured the need for collaboration and reciprocity. A problem with this is that the two frameworks of embryo research and infertility treatment are mutually dependent. If infertile patients cease to donate their residual embryos to research in the current legislative context where somatic nuclear cell transfer is prohibited, embryonic stem cell research will flounder and hope for increased public health will be extinguished.
Rather than continuing to avoid the issue of compensation, this subject needs to be opened for discussion. This article has offered suggestions for a levy applied to commercial profit and redirected to subsidy of the clinical treatments from which donated IVF embryos are drawn.
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Acknowledgements |
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The work this article draws on is supported by an NHMRC Clinical Research Fellowship. I acknowledge the thoughts and insight of colleagues with whom an earlier version of this article was discussed within the Health Ethics Group of the Ethics Centre of South Australia. I also acknowledge appreciation for the support of Professor Rob Norman in commentary on this article. Finally, I thank the anonymous reviewers of this article who offered important insights to its revision.
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Submitted on October 5, 2005; resubmitted on February 27, 2006; accepted on March 1, 2006.
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