Lecturer in Law, Sheffield Institute of Biotechnological Law and Ethics, University of Sheffield
S.Pattinson@shef.ac.uk


Copyright © Shaun D. Pattinson 2003
First Published in Web Journal of Current Legal Issues

*The author would like to thank those who commented on this article, including the anonymous referee.

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Should we allow commercial dealings in human organs? Negative answers are given by the regulatory frameworks of at least 24 countries; albeit it negative answers that otherwise display as many differences as common features. This article challenges these regulatory positions by questioning the defensibility of prohibiting living persons from selling their organs. It is argued that existing blanket prohibitions threaten the autonomy and self-determination interests of potential organ providers, and the interests of potential organ recipients. Thus, it is argued, rights-based (and other autonomy-focused) moral theories must be prima facie supportive of regulated organ dealings.

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• Introduction
• Part One: Legal Background
• Table 1: Regulatory prohibitions of commercial dealings in human organs*
• Material covered
• Types of incentive or reimbursement allowed
• Types of sanction for violation
• Summary
• Part Two: Moral Evaluation
• Overview of moral frameworks
• Free market, heavily regulated market, or prohibition of organ dealings?
• Conclusion

Bibliography

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Scarcity of human organs is causing otherwise preventable death and suffering. Every year thousands of human bodies are buried or cremated when their organs could save lives. Every year thousands suffer or die on waiting lists when there are potential living organ providers willing to sell their organs. Around the world legislatures have deliberately restrained or prohibited access to these organs in the interests of morality and public policy. In this paper, I wish to challenge what will be shown to be the regulatory consensus across twenty-four countries, namely, prohibition of persons selling their organs. It will be suggested that the justification for globalised restraint on commercial dealings in human organs is being illegitimately held out as a justification for globalised prohibition.

I have not exaggerated the problem of scarcity. In the UK alone, although around 2,700 solid organs transplants are performed each year, around 6,800 people are on waiting lists.⁽¹⁾ What is more, waiting lists do not reveal the whole picture, because the chronic shortage of human organs means that some transplant clinicians are extremely selective about which patients they put on the waiting list (see Council of Europe 1999). In the US, for example, there are over 250,000 patients with end-stage renal disease, many of whom would benefit from transplantation, but there are only about 44,000 on the waiting list (see Lysaght and Mason 2000, 253).

Although the success rate for transplantation operations is improving, the demand for organs is increasing. The population is ageing and transplanted organs often do not last the lifespan of the patient. The situation is not entirely bleak. The lifespan of transplanted organs is increasing. In the UK, for example, official statistics report that 95% of kidneys from living donors and 86% of kidneys from cadaver donors are still “functioning well” after a year (see UK Transplant website). Nonetheless, even in the developed world, only 70% of solid organ transplants last over 5 years (see Council of Europe 1999),⁽²⁾ with a 9–10 year average for kidneys (Garwood-Gowers and Summan 2001, 13).

Possible mechanisms for addressing this shortfall are controversial, impracticable, or inadequate. One obvious response would be to increase availability and use of cadaver organs by weakening or removing the ability of the deceased (prior to death) or surviving relatives to veto transplantation. In theory, there are many different permutations of regulatory responses to both the deceased’s views and the views of loved ones and surviving relatives. The deceased’s views can be relied on or ignored, the deceased could have been required to express an official view before death or left to decide whether to express a view, and the law might even operate a rebuttable presumption as to what the deceased’s views were. Similarly, the views of surviving relatives and loved ones can be treated as persuasive, determinate, or irrelevant. To complicate matters further, the law might allow for a different approach to that operated in practice. Section 1(1) of the British Human Tissue Act 1961, for example, allows the removal of organs if the deceased had consented to such removal irrespective of the views of relatives, but, in practice, organs are not removed where relatives object. Similarly, the unnecessary authorisation of relatives is acquired in Belgium and France (see Kurnit 1994, esp. 423; Jefferies 1998, esp. 637–638).

Even universal adoption of a strict system of presumed consent, whereby the deceased is presumed to have consented in the absence of a written declaration to the contrary, would be unlikely to eliminate organ shortages (see Jefferies 1998, 639; Cooper et al. 2002, 134; New et al. 1994) Moreover, alternatives to use of human organs—xenotransplantation, tissue engineering, and artificial organs—are infeasible or inadequate. Xenotransplantation, the use of animal organs, is still very much in its infancy (see Cooper et al. 2002, esp. 135–136) and raises practical and ethical problems.⁽³⁾ Tissue engineering, growing organs in laboratories, is far from being a reality although some progress has been made, as skin tissue and even bladders have been grown in laboratories (see Harding et al 2002, 162; Tanne 1999). Most artificial organs have not reached the stage where they can be anything other than temporary “bridges” or holding devices until human organs become available (see Rettig 1991). The most successful is the artificial kidney, which is now used everywhere for dialysis, but is not a permanent solution and compromises the quality of the life of the patient (see Rettig 1991, esp. 523; Anderson 1995, 253, fn 20; 281). (Left ventricular assist devices are another, more recent, success: see Cooper et al. 2002, 134.)

This paper will explore one the most controversial ways of increasing the availability of suitable human organs: allowing persons to sell their organs. This paper is divided into two parts. Part one demonstrates the popularity of prohibitive regulatory responses to commercial dealings in human tissue by exploring the ambit of various national and international instruments. Although particular attention will be paid to the British regulatory position, 24 countries have been studied, encompassing jurisdictions in Europe (the 15 EU countries, Slovakia, and Turkey), North American (Canada and the US), Australia, and Asia (Hong Kong, India, Japan, and Singapore). These countries were simply the ones on which reliable information was available, often in the form of an authoritative translation of the relevant legislation. Part two explores the claim that commercial dealings in human organs ought to be prohibited, focusing on the selling of organs by living organ providers. After presenting a brief overview of potential moral frameworks, the major arguments against legal organ trading will be addressed. It will be argued that many of the arguments against commercial dealings are inadequate or overstated, particularly those arguments grounded in the interests of the organ provider.

For ease of expression, I will refer to the person from whom an organ is removed as the “organ provider”, reserving the term “organ donor” for organ providers who receive no financial incentive.

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Legislation directly addressing organ transplantation is surprisingly ubiquitous (see table 1 below). There is also a surprising level of regulatory convergence on the issue of commercial dealings with human organs. In fact, all 24 countries studied prohibit commercial dealings with human organs and in all but one this prohibition has legislative force. On the face of it, this appears to be a rare area of regulatory consensus. Below the surface, however, there are many regulatory differences and points of divergence.

The degree of international convergence is displayed by various international instruments and the pronouncements of international organisations. The Council of Europe, for example, has expressed disapproval of commercial dealings in human organs in a number of instruments. Article 21 of European Convention on Human Rights and Biomedicine asserts that “[t]he human body and its parts shall not, as such, give rise to financial gain”. This is bolstered by the Additional Protocol on Transplantation of Organs and Tissues of Human Origin, which opened for signature in January 2002. Article 21 of this Protocol seeks to prohibit “financial gain or comparable advantage” from the human body and its parts “as such” and from advertising the need for or availability of such. This protocol goes on to prohibit organ and tissue trafficking (Article 22) and require parties to it to provide “appropriate sanctions” for infringement of its provisions (Article 26). Similarly prohibitive recommendations have been adopted by the World Medical Association (WMA) and the World Health Organisation (WHO). The 52nd General Assembly of the WMA adopted a statement in October 2000 declaring that offering financial incentives to live donors for the provision of their organs “can be coercive and should be prohibited” (WMA 2000, para. 26). WHO has set down nine guiding principles on human organ transplantation, principles five to eight of which seek to prohibit payment for organs, associated advertising, and the engagement of health professionals in such activities (see IDHL 1991a).

These international instruments and recommendations do not, however, prohibit all dealings with, or even all commercialisation of, human tissue. They are concerned with individuals or organisations gaining or offering certain types of incentive or compensation for supplying or obtaining certain types of human tissue. According to the explanatory report to the Convention on Human Rights and Biomedicine, for example, the prohibition in Article 21 does not prohibit the payment of compensation to donors to cover their expenses and lost income nor does it apply to commonly discarded tissues such as hair and nails (see paras. 132 and 133, respectively). Similarly, although all 24 countries studied prohibit certain commercial dealings with human organs (see Table 1, below), they are not concerned with all commercialisation of all human tissue.

*English translations or summaries cited to the International Digest of Health Legislation (IDHL) where indicated .

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The material encompassed by these prohibitions on commercial dealings is often specifically defined and delineated. At one extreme, some countries adopt all-encompassing definitions of material covered by the prohibition. The French legislation, for example, prohibits payment to a person who submits to the removal of “elements from his body or the collection of products thereof” (Art. 665-13), which appears to encompass all human tissue. This approach implies that the justification for prohibition applies to all human tissue, apparently placing hair and kidneys in the same category. At the other extreme, some countries adopt very narrow definitions of material covered by the prohibition on commercial dealings. The prohibition in the US federal legislation, for example, covers only a small number of organs, but allows for future additions, by defining the encompassed material as

the human (including fetal) kidney, liver, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other human organ...specified by the Secretary of Health and Human Services by regulation.

The Japanese legislation adopts the same approach and defines an “organ” as the heart, lungs, liver, kidneys, eyeballs, or other organs specified by order of the Minister of Health and Social Welfare (s.5). Here the material covered is precisely defined, but these definitions appear arbitrary. They do not, for example, cover all non-regenerative material capable of being removed from living persons. How does payment for small bowel segments differ from payment for lung lobes?

Most countries fall somewhere between these two extremes. Many prohibitions have been drafted with a wide ambit, subject to specified exceptions for certain types of (typically regenerative) tissue. The Swedish legislation, for example, prohibits intentional gain-taking from delivering, receiving, or procuring “biological material” but then goes on to exclude blood, hair, breast milk, and teeth from this prohibition (s.15). Similarly, the relevant Turkish legislation explicitly excludes hair, skin, and blood from its ambit (s.2).

A small number of countries adopt rather idiosyncratic definitions of encompassed material. The British Human Organ Transplants Act 1989 is a well-recognised example. This prohibits specified commercial dealings with human organs (from both living and dead organ providers) and bolsters this prohibition by requiring the agreement of a regulatory body for transplants between living persons who are not “genetically related”.⁽⁵⁾ but only applies to “human organs” defined in s.7(2) as,

It is not clear whether the removal of part of an organ is covered by this definition where that part (but not the organ as whole) is capable of regeneration, ie, capable of being “replicated by the body”. It has become possible to transplant a liver segment from a living donor, which will then regenerate. If the phrase “wholly removed” refers to the part that is removed, then liver segments are not covered. If, as when read more naturally, “wholly removed” refers to the organ as a whole, then liver segments are covered. In practice, it is assumed that liver segments are covered, but this is inconsistent with the treatment of skin as falling outside of the legislation—logically either both skin and liver segments are included or neither is included (see Kennedy and Grubb 2000, 1764). Since the courts will interpret this definition to give best effect to the policy of the legislation (R (On the Application of Quintavalle) v Secretary of State for Health [2003] UKHL 13) and the legislation was clearly intended to exclude non-regenerative material (see ibid.; Price and Mackay 1991, 1273), it would appear that both skin and liver segments are excluded from the prohibition. Interestingly, this issue is not restricted to the British legislation, as the same definition is adopted by the legislation of Hong Kong (s.2) and India (s.2(k)), despite being passed a number of years after liver segments transplants became a reality in the late 1980s (see Raia 1989).

Many of these difficulties stem from attempts to exclude some or all types of regenerative material from legislative prohibitions. The phrase “structured arrangement of tissue” in the British legislation is, indeed, successful in excluding regenerative tissues such as bone marrow, blood, and gametes (being unicellular) from its ambit. Regenerative tissues typically excluded from prohibitions on commercial dealings include blood, gametes, embryos, and reproductive organs. Blood is explicitly stated to be excluded from the prohibition in the organ transplantation legislation of (most of) the Canadian provinces, Finland (s.1), Germany (s.1(2)), Spain (s.2 of the Additional Provisions), Sweden (s.15), and Turkey (s.2). It is also implicitly excluded by the legislative prohibitions of many other countries. Since the US federal legislation does not cover blood (see above), in the US persons are sometimes paid for providing blood—in contrast to Britain where no blood donors are paid and Sweden where, according to Price (2000, 381), all blood providers are paid.

Provisions excluding some forms of reproductive material (such as gametes, embryos, and gamete producing organs) exist in the transplantation legislation of Belgium (s.1(2)), Britain (s.7(2)), Finland (s.1), Germany (s.1(2)), Japan (s.5), the Netherlands (s.1), Portugal (s.1(2), Sweden (s.2), and the US (s.274e). Such material is usually excluded by provisions asserting that it will be covered by specific legislation or, in the case of Japan and the US, by the adoption of an exclusive definition not including such materials. Where no other legislation exists, such exclusions can mean that reproductive material is subject to less stringent regulation. Section 1(1) of the Belgian Legislation, for example, states that the Act does not apply to transplantations of testicles and ovaries, or the use of gametes—despite the absence of any legislation governing the excluded material (see Pattinson 2002, esp. 171). Alternatively, such donations might be regulated by other legislation or regulatory bodies. In Britain, for example, gamete donation is regulated by the Human Fertilisation and Embryology Authority,⁽⁶⁾ which limits payment to “a maximum of £15 [around $25] for each donation plus their reasonable expenses” (HFEA 2000, 2). In contrast, in the US, some women have been paid up to $50,000 [about £30,500] to donate their eggs (see Karsjens 2002, 65).

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Incentives or compensation can take a number of forms. In theory, a variety of incentive or compensatory payments could be made to suppliers, procurers, or advertisers of human tissue. A person supplying an organ could, for example, be permitted to receive directly attributable costs (such as travel expenses and loss of earnings) or monetary payment (either regulated or unregulated), could be protected from incurring directly attributable costs (by, for example, social security and sick pay provision), or could be prohibited from receiving any incentive, compensation, or financial protection. None of the countries studied allow payment (whether regulated or not), but many allow directly attributable costs to be reimbursed or seek to protect donors from incurring such costs.

Countries whose legislation explicitly allows organ providers to recover directly attributable costs such as expenses and loss of earnings include Belgium (s.4(2)), Britain (s.1(3)), France (Art. L. 665-13), Germany (s.17(1)(1)), Hong Kong (s.2), India (s.2(k)), Japan (s.11(6)), Luxembourg (s.16), the Netherlands (s.2), and the US.⁽⁷⁾ The legislation of some other countries implicitly allows recovery of such costs. For example, the Swedish legislation prohibits “gain-taking” (s.15), which implies that it is permissible to recover expenses (and this is explicitly stated in the official commentary: Ministry of Health and Social Affairs 1997, 17–18). Australia displays both approaches, as the permissibility of payment for the organ donor’s out-of-pocket expenses is explicit in the legislation of New South Wales, South Australia, Tasmania, Western Australia, Capital Territory, and Northern Territory, but only implicit in the legislation of Victoria and Queensland.

The Portuguese legislation is unusually restrictive as s.5(2) states that it is “illegal to reimburse the costs incurred or to compensate for damages that are the immediate results of, or have as their cause” donation procedures. Thus, it appears that even reimbursement of expenses and loss of earnings is prohibited in Portugal. The intention must have been to prevent payment under the guise of reimbursement, but it also means that it will actually cost a person to donate an organ. The Portuguese legislation does provide for compulsory insurance to be taken out by transplant centres (s.9(2)) and grants the donor the right to medical care until fully recovered and compensation for any injury “irrespective of whether there has been misconduct” (s.9(1)). (Similarly, the Slovakian legislation requires health establishments to take out “a special insurance policy against liability in damages that may be caused to a living donor during organ removal”: s.46(3).) Thus, donors are at least protected from medical costs or losses attributable to an injury.

In contrast to this restrictive approach to costs and expenses, a small number of countries actually require donors to be compensated for their out of pocket expenses. Section 4(2) of the Belgian legislation, for example, requires the state to provide for the compensation of living donors at public expense (or by a state-designated social security agency) to cover the costs and loss of income directly resulting from the provision of an organ. The French legislation requires the health care establishment carrying out the removal to reimburse the donor for the costs of transportation and accommodation and, where appropriate, lost remuneration (Decree No. 2000-409 of 11 May 2000 (see IDHL 2000) and Article 665-13). Similarly, the Spanish legislation states that resources shall be made available to ensure no hardship is caused to the living donor or the family of a deceased person (s.2 and Crown Degree No. 426 of 22 February 1980, s.5). The Finnish legislation, is slightly less generous but nonetheless provides that an organ donor who loses income for a whole day and does not get receive compensation is entitled to a daily allowance under the Sickness Insurance Act (364/1963) (s.18).

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Legislative sanctions also vary. Variations include a fine (eg, Austria, Denmark, and Finland), a fine or a term of imprisonment (eg, Britain, Germany, Singapore, Sweden, and the US), and a fine and a term of imprisonment (eg, India, Italy, Singapore, Turkey, and the US). Singapore and the US appear in two categories because the relevant legislation imposes a criminal sanction of a fine and/or imprisonment. For example, S.274(e)b) of the US Federal legislation imposes a sanction of a fine and/or imprisonment of up to 5 years on persons who “knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce”.

There are also variations within individual jurisdictions, as some legislative provisions distinguish different types of commercial activity involving human organs or tissue. In theory, criminal sanctions could be imposed on those who sell their own organ/tissue, purchase an organ, supply an organ purchased from another, participate in activities involving a purchased organ, or advertise services connected with the purchase of an organ. Different sanctions can be attached to different activities or persons.

The British legislation, for example, imposes two levels of sanction (s.1(5)). A fine or a term of imprisonment of up to three months is imposed on those who make or receive payment for an organ intended for transplant, seek a person willing to supply such for payment, offer to supply an organ for payment, or participate in the negotiation of any such arrangement. Whereas a fine or a term of imprisonment of up to five years is imposed on those who cause the publication or distribution of an advertisement inviting persons to supply organs for payment, offering to supply organs for payment, or indicate a willingness to initiate or negotiate any such arrangement. It is no coincidence that activities associated with organ trafficking are sanctioned so harshly; the legislation was hurriedly enacted to calm public anxiety following the discovery that Turkish people had been travelling to Britain to sell their organs in the late 1980s.

The legislation of some countries even applies to prohibited activities taking place abroad. The German legislation, for example, does not limit the prohibitions against trading to German territory. The consequence is that these prohibitions apply to patients returning to Germany who have had transplants implanted abroad in contravention of s.17⁽⁸⁾ (although the courts have a discretion court to forego or reduce the punishment of the organ recipient: s.18(4)). Similarly, the British legislation renders organ trading illegal if conducted in Britain even if the transplant itself takes place, or is due to take place, outside of Britain (s.1(a)). Although many other legislative enactments remain silent on activities taking place abroad, this does not imply that these legislatures have no truck with commercial dealings outside their borders. Legislative silence could equally stem from a general legal presumption that legislation applies outside its borders or limitations on the jurisdictional competence of the relevant legislature.

The legislative position is, however, only part of the picture. In Ireland, for example, although there is no legislation prohibiting payment for organs, the Irish Medical Council would take such payment very seriously (see IDHL 1991a, 407). Indeed, para. 23.4 of the Medical Council’s ethical guidelines declare that “[p]ayment of any sort, apart from incidental expenses, should not be a factor in the ultimate decision made about organ donation” (Medical Council 1998, 38). Violation of these ethical guidelines can constitute professional misconduct, whereby the Council will revoke the licence to practice of any medical practitioner who performs a prohibited activity. Similarly, in Britain, although there is legislation imposing criminal sanctions, the General Medical Council (GMC) will take disciplinary action against medical practitioners partaking in such activities. Guidelines issued in 1992 clearly state that “[i]n no circumstances may doctors participate in or encourage in any way the trade in human organs from live donors” (see GMC 1992). The GMC has twice taken such action against doctors who had allegedly taken part in and encouraged the sale of human organs from live donors, first in the late 1980s and, more recently, at the end of 2002 (see Mason et al. 2002, 435; Allison 2002; respectively). On both occasions the doctors were found guilty of profession misconduct. Thus, British doctors involved in commercial dealings can be criminally convicted, fined, imprisoned, and lose their livelihood. Such harsh sanctions—similar to those imposed under the Italian legislation—need the support of a powerful justification.

The effectiveness of legislative prohibitions backed up by criminal sanctions is not consistent across all the countries studied. The Indian legislation—which criminalises the same activities as the British legislation but imposes a fine and a term of imprisonment of between two and seven years for all these activities (s.19)—is widely reported to be ineffective (see Goyal et al. 2002, esp. 1590; Jefferies 1998, esp. 622; Kumar 2003). There is also some anecdotal evidence that commercial dealings in kidneys occur in other countries whose regulatory positions I have not studied, such as China, Chine, South Africa, South America, the Middle East, and Pakistan (see Goyal et al. 2002, 1590; Jefferies 1998, 622; Karsjens 2002, 68; Friedlaender 2002, 971). In the countries such as Britain and the US, however, legislative prohibitions have clearly inhibited commercial dealings.

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All 24 countries studied (some encompassing numerous jurisdictions) prohibit organ dealings with the major organs. Few, however, go as far as Article 21 of the Convention on Human Rights and Biomedicine, which prohibits trading in all human tissue (the only implicit exception being tissues that are commonly discharged such as hair and nails). Instead, there are differences in the type of material covered by these prohibitions and the differences in regulatory responses towards recovery of the costs and loss of earnings directly incurred by organ donors.

Current prohibitions are likely to remain. In Britain, for example, although a recent consultation document asks whether the current prohibition should remain (DOH 2002, 184), this prohibition still has the support of key medical groups. The GMC, for example, has recently disciplined doctors for conduct relating to prohibited activities and the British Medical Association (BMA) has recently announced that it is “against any moves to legalise the sale of donor organs” (BMA website: http://www.bma.org.uk). Thus, there appears to be little realistic prospect that the British prohibition will be removed.

Only small cracks in the international consensus can be found. Recently Israel’s health ministry presented draft legislation that seeks to legalise reimbursement of organ providers “for their time, inconvenience, discomfort, and recovery” (Siegel-Itzkovich 2003). This would introduce a form of regulated payment; the first of its kind in the world. Even this proposal, however, displays reluctance to compensate the organ provider for the organ itself. In Australia, various State and Provincial legislation explicitly allow for future exceptions to the prohibitions. To cite a representative example, the Human Tissue Act 1982 of Victoria states,

Where he considers it desirable by reason of special circumstances so to do, the Minister may, by a permit in writing, authorize a person, subject to such conditions and restrictions as may be specified in the permit, to buy tissue (other than spermatozoa or ova) or the right to take tissue (other than spermatozoa or ova) from the body of another person. (s.33(2))

In general, however, the force of prohibitive approaches remains strong.

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This section will explore the major moral frameworks and their consequences for the selling and purchase of human organs. One moral framework, a rights-based moral framework, will be held out as supporting some types of regulated organ dealings.

Although organs could be sold by an organ provider for removal before or after death, the latter is often asserted to be easier to defend. Lysaght and Mason, for example, assert that the argument against sale of organs is “admittedly stronger” when directed at living donors than cadaveric donors (2000, 255). Similarly, Erin and Harris claim that “[a]rguing for commerce in the context of organs obtained from cadavers is less morally problematic than in the case of the living” (1994, 135). This conclusion is common (see also Blumstein 1993, 24; Cohen 1989, 2). By considering only payment to living donors this paper will, therefore, be focusing on the most controversial organ sales.

Two points about the comparison between living and cadaver donation should, however, be borne in mind. First, it is much easier to support a positive obligation to donate one’s organs posthumously than to support a positive obligation to donate one’s organs while still alive—because the burdens of providing a cadaver organ are lower.⁽⁹⁾ Thus, if financial incentives can be justified, an organ provider has a prima facie greater claim to a financial incentive when providing the organ pre-mortem than when prospectively providing a post-mortem organ. Second, from a medical point of view, it is well established that live unrelated graft and patient survival rates are better than cadaveric unrelated transplants, and are comparable to living related donor transplantations (see Sever et al. 2001, 1481; Cecka 1999; Josephson et al. 1998).

There is a vast number of potential criteria for distinguishing the morally permissible from the morally impermissible. A number of prominent camps or positions are typically invoked when addressing the permissibility of commercial dealings in organs provided by live organ providers. I will briefly explore five such positions: utilitarianism, virtue ethics, rights-based theories, duty-based theories, and compromise positions. All five positions are collections of moral theories, the precise implications of which will depend on the specific instantiation in play. Nonetheless, a number of general points can be made about each. These are no more than broad brushstroke generalisations.

Utilitarianism is a collection of moral theories holding that we are morally required to seek the best possible balance of utility over disutility. Classical or hedonistic utilitarianism seeks to maximise pleasure over pain, whereas the most popular contemporary version, preference utilitarianism, in its most popular instantiation seeks to maximise the subjective preferences of persons. All forms invoke a calculus in which the relevant interests of all individuals count equally. The permissibility of any particular action (for act-utilitarians) or rule (for rule-utilitarians) is dependent on its consequences for the utility balance, so the likely effects of any commercial dealings in human organs are crucial. The high utility of obtaining an organ (especially where the organ saves the recipient’s life), the generally high utility of facilitating autonomy, and the likelihood that some form of commercial market in organs from live organ providers will increase the number of available organs should render utilitarians prima face predisposed towards allowing some types of commercial organ dealings. Some utilitarians might, however, take a different view because this general position contains differing theories of value and can lead to different assessments of probable outcomes.

Virtue ethics rejects all action-based moralities—including utilitarian, rights-based, and duty-based theories—in favour of character-based values. For virtue ethics, all moral obligations are linked to human flourishing, assessed according to some “objective” criterion. Since such theories are prima facie inclined towards the development of altruistic over purely self-interested motives, it might be thought that virtue ethics is inherently opposed to the commercialism of human organs. According to Pellegrino, for example, the commercialisation of consent to organ donations is to be rejected because altruism “is a fundamental virtue of good societies and good persons” (1991, 1305).

However, not all commercial organ provision displays an absence of altruism (and not all organ donations display predominantly other-regarding motives). To take a popular example: a father who sells his kidney to obtain the money for his daughter’s medical treatment is acting no less altruistically than one who donates his kidney to treat his daughter’s kidney failure (see Radcliffe Richards 1991, 190–191; Bernat 1995, 187; Radcliffe Richards et al. 1998, 1951). It is also not difficult to imagine circumstances where the purchaser of an organ acts entirely altruistically, such as (modifying the above example slightly) where a father purchases an organ to save his daughter’s life. Indeed, the focus of virtue ethics on character and motive is such that very few categories of action can be regarded as immoral per se. It must not be forgotten that commercialisation does not remove a person’s ability to act altruistically—a person who donates without payment in a system in which payment is available has taken the opportunity to act even more altruistically than would otherwise have been possible. Alternatively, an altruistic person acting within such a system could donate any payment to charity or use the money for altruistic purposes. Moreover, virtue ethicists do not generally reject the existence of commercial transactions for other life-saving or life-providing goods such as food and shelter.

If, however, it is the case that altruism begets altruism—so that the existence of a system prohibiting organ providers from selling their organs itself increases the altruistic tendencies of society or at least the willingness to donate altruistically—a virtue ethicist might be prima facie in favour of prohibiting organ sales. A virtue ethicist is not, therefore, straightforwardly committed to prohibiting or permitting commercial dealings in organs as much will depend on the particular criterion of human flourishing in play and the predicted consequences of allowing persons to sell their organs.

Rights-based and duty-based theories, as I define them, are action-based moralities and strictly deontological. It follows that, in contrast to virtue ethics, for these theories a virtuous character is simply one predisposing towards actions consistent with one’s moral obligations. It also follows that, unlike utilitarianism, they do not allow the aggregation or averaging of individual interests. What matters is the weight of the relevant right or duty, not the number of persons involved. The difference between rights-based and duty-based theories stems from the waivability of the benefit of any moral obligation. Rights-based theories hold that all moral obligations reduce to moral rights, understood as justifiable claims, the benefits of which are waivable by the rights-holder. On the other hand, duty-based theories are more paternalistic and do not automatically entitle the recipient of the duty to waive its benefit. For some this distinction is one within rights-theories—a distinction between the will (or choice) conception of rights and the benefit (or interest) conception. This is simply a matter of terminology carrying no substantive import.

The implications of rights and duty-based theories for commercial dealings with organs differ with the different sub-variants. Rights-based theory is, however, committed to a particular stance on persons selling their organs. Since this position holds that all moral duties derive from rights the benefits of which are waivable, it follows that it is meaningless for a rights-holder to have direct duties to him or herself. For rights-based theories, protecting the organ provider’s interests (rights) cannot justify preventing the organ provider from freely choosing to sell his or her organs. Thus, where the organ provider is acting voluntarily, rights-based theorists are committed to allowing organ dealings, subject only to such regulatory control as is necessary to ensure this voluntariness and to protect the rights of others.

The fifth moral camp, compromise positions, is a collection of eclectic moral positions drawing elements from the other four. These positions are rarely foundationalist and adhere more closely to the ethical reasoning of the layperson. A classical example is Beauchamp and Childress’ principalism, which advocates four principles of biomedical ethics:

Their position explicitly seeks a compromise between overarching deep moral theory and practical ethics by adopting elements of utilitarianism, rights and duty-based theories, and virtue ethics. Although Beauchamp and Childress’ position lacks foundationalist grounding, “very few critics argue that any one of the four principles is incompatible with his or her preferred theory or approach to biomedical ethics” (Gillon 1995, 324).

The broad nature of this camp makes specific generalisations with regard to the payment of organ providers difficult. Beauchamp and Childress, for example, do not directly address this issue, except to say that it is “appropriate to consider potential donors’ motives, at least to the extent of investigating whether financial gain is the motivating factor” (2001, 50). Commercial dealings highlight tensions among these four principles, particularly between autonomy and beneficence, the resolution of which must either revert to deep theory or rely on the idiosyncratic, contingent intuitions of the decision-maker.

In sum, rights-based theories aside, at this level of abstraction the major approaches to bioethics provide little guidance on the permissibility of allowing persons to sell their organs. To advance further we must either adopt one specific moral position and draw out its precise implications or argue from premises capable of attracting the support of all (or most of) these camps. In other contexts I have often adopted the former approach and I argued for and from a particular rights-based moral theory (see, eg, Pattinson 2002).⁽¹⁰⁾ Indeed, some arguments in favour of prohibiting organ dealings can only be addressed at the level moral epistemology. There are, however, many arguments that rely on premises that are relevant to just about all of the camps outlined above.

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Commercial use of one’s body is not new. Modern society is littered with employment opportunities involving the marketing of one’s physical self (eg, modelling and professional sports), the hiring of one’s body (eg, prostitution, surrogacy, and modelling), the selling of human body parts and derivatives (eg, human hair for wigs and drugs made from placental tissue), and risks to life and limb (eg, being a soldier, fire fighter, or boxer). Although most of these are legal and some are highly valued, there is widespread uneasiness with the commercial exploitation of one’s bodily integrity and human tissue in particular (see, eg, Wilkinson and Garrard 1996, esp. 338). Indeed, the diversity of possible views ensures that no system designed to provide organs for those in need will ever satisfy every possible moral position. It will, however, be shown that the major arguments against legal trade in human organs are not nearly as conclusive as the current regulatory consensus would suggest.

One concern evoked by commercial dealings is simply cost. Allowing payment would surely increase the cost of organ transplantation, because of the additional cost of purchasing an organ (see Evans 1993). However, even for those for which it is highly important, this fear fails to take account of the fact that organ transplantation is often cheaper than long-term treatment alternatives for protracted kidney, heart, or liver failure. One analysis of renal transplantation, for example, estimated that “although short-term costs are higher, transplantation saves nearly $42,000 [around £27,000] per patient over a 10-year period” (Beasley et al. 1997, 549). According to Williams (1994, 361), nearly ten years ago it cost “$32,000 [£20,000] per year for dialysis for one patient, as compared to $56,000 [£35,000] for the first year of a kidney transplant, and $6,000 [£3,700] per year thereafter.” In addition, organ transplantation also tends to produce a better quality of life than the alternatives and, even if payment did increase costs, any increase in organs will save lives.

Some might wish to question whether allowing payment will increase the availability of organs. There are suggestions—albeit usually advanced in the context of cadaver organs (or blood provision)—that allowing commercial dealings will be detrimental to the overall organ supply, by reducing the willingness to donate organs (see Hansmann 1993, 67–68). It is plausible that if organs are available to purchase, related living donors will be more reluctant to come forward (see Abouna et al. 1991, 167; Broyer 1991, 199). However, this objection is not fatal. Firstly, a reduction in the number of living donors stemming from the availability of purchasable organs does not imply a reduction in the number of organs, which is unlikely. Secondly, if relatives were more reluctant to donate where purchasable organs are available, this is most likely to be because of reduced emotional and social pressure to donate. Emotional and other pressures on relatives can be considerable (see Kallich and Merz 1995, esp. 145–148).⁽¹¹⁾ Thirdly, prohibiting payment is not the only method of encouraging relatives to donate. Where, for example, there are reasons for preferring a related donor to a paid organ provider (such as increased compatibility of the organ or decreased likelihood of disease from the organ) these could be divulged to the relatives to encourage donation. Also, since a market in live organs is unlikely completely to satisfy demand, a related donor could not rely on the market to provide an organ if those in need of organs were prevented from purchasing them directly.

The major line of arguments against commercial dealings in organs centres on the fear of exploitation. It is widely feared that allowing legal trade in organs from living organ providers will lead to the exploitation of the vulnerable, particularly the poor as potential organ providers. For example, it has been claimed that countries that that have banned commercial sales

The destitute are the most likely to consider selling an organ. A financial incentive will, self-evidentially, be proportionately more enticing to those who are poor. It is, however, plausible that if properly regulated even the not so desperate might be encouraged to sell their organs, such as (say) a middle-aged, relatively well-off man who simply wishes to obtain enough money to retire early or a young person who wants the money for an expensive holiday. Moreover, depriving the desperate of what they consider to be their best option only restricts their options further. Banning organ sales is a misguided way of addressing the conditions that make a potential organ provider vulnerable in the first place. In the words of one commentator, it is “like ending the miseries of slum dwelling by bulldozing slums, or solving the problems of ingrowing toenails by chopping off feet” (Radcliffe Richards 1996, 391).

The mere existence of a financial incentive to motivate someone to do something that they would not otherwise have done is not itself exploitative (cf. Sells 1992, 2198). If it were then many essential activities would be exploitative. There are many menial, dangerous, and, indeed, everyday jobs that few would perform without a financial incentive. What is more, the organ provider appears to be the only one in the transplantation process expected to go without payment—others, from the transplant surgeon to the provider of immunosuppressant drugs, are routinely paid quite handsomely.⁽¹²⁾ The purportedly exploitative nature of organ dealings must, therefore, stem from something in addition to the existence of a financial incentive. A number of candidates have been suggested, including the small sums of money typically given to organ providers, the inability of some organ providers to manage even small sums, the risks to organ providers, and the consequential pressures on the poor to sell their organs against their will. These concerns are elements of current, unregulated commercial dealings in organs.

The sums typically paid to organ providers are, as one commentator put it, “paltry” (Williams 1994, 322). Many studies report average payments to organ providers of $1000—around £600 (see Sever et al. 1994, 351; Goyal et al. 2002, 1591). Some report much lower amounts (see Kumar 2003, who cites average figures of $523, around £300), typically in situations where a much greater amount had been promised (see Goyal et al. 2002, 1591). Not surprisingly, the money paid to organ providers is often not enough to enable the poor to overcome their poverty (see Sever et al. 2001, 1482; Abouna et al. 1991, 166). There is also some evidence that, even where the sums are higher, many have difficulty managing such sums (see Nisselle 2002, 74). It is but a small step to claim that organ providers are being exploited as existing commercial practices take advantage of them (see Zohar 1993, 555).

These issues are not restricted to commercial organ dealings. Many labour markets, especially in the developing world, pay workers paltry sums of money and, even the comparatively well off can have difficulty managing money, whether it is everyday debt or a large windfall such as a lottery win. It is difficult to see why if these concerns justify prohibiting organ dealings, rather than the need for regulation and supportive structures, they do not justify the prohibition of any activity paying low wages and generating large sums of money. More strikingly, organ provision for low or insufficient payment can be no worse than donation for no payment. In practice, low wages for what are highly valued goods, human organs, are likely to be the result of bargaining inequalities or the extraction of value by middlemen. Regulation can be more precisely target at such issues.

The risks of organ transplants for the organ provider are another major source of exploitative concern. In addition to the inevitable pain and scarring, having an organ removed carries risks of mortality, morbidity, psychological harm, and long-term complications. In terms of morality the risks are small, but “a small number, particularly those donating partial livers, have died as a consequence” (Cooper 2002, 134). The mortality rate for kidney donation was estimated at about 0.03% by a survey of members of the American Society of Transplant Surgeons in 1992 (see Najarian 1992, esp. 807).⁽¹³⁾ One study of 871 kidney donors at a US hospital, reported no mortalities and relatively few complications—including two major complications and minor complications in only 8% of donors, resulting in an overall complication rate of 8.2% (see Johnson 1997, esp. 1125). Similarly, although no one has yet died from donating a lung lobe in Britain or the US, since

Similar risks are reported for living transplants of pancreas segments (see Margreiter 1991, esp. 105) and small bowel segments (see Deltz 1991).

However, prohibition is not justified by the mere existence of risk. Many activities carry unavoidable risks to life including certain jobs (notably being a solider, lifeguard, fire fighter, or boxer) and activities (such as smoking, skydiving, rock climbing, or driving). The risks of organ provision must be put into perspective; it has been argued that the increased risk of death to a healthy 35-year-old from giving up a single kidney is equivalent to driving sixteen miles a day to and from work (see Hansmann 1993, 72). If this risk is unacceptable for paid organ providers why is it accepted for unpaid organ donors?

The evidence suggests that these risks would be much higher if a free, unregulated market in human organs were allowed. Where transplantation takes place in developing countries, often in back-street clinics, the death, complication, infection, and graft rejection rate appears to be much higher (see Kher 2002, 357). This is borne out by studies in a Turkish hospital following a commercial kidney transplant elsewhere (see Sever et al. 1994; Sever et al. 2001) and a similar study in Saudi Arabia of patients transplanted in other countries (see Al-Wakeel 2000). Moreover, there is also some evidence of negative psychological effects on commercial organ providers from developing countries (see Taghavi 2001, esp. 2636; Zargooshi 2001, esp. 387). However, this evidence also suggests that these increased risks are a consequence of the black market, unsatisfactory operating facilities, inexperienced surgeons, and poor pre- and post-operative procedures (including the lack of basic information and counselling facilities). These are all aspects of wider, systemic problems in developing countries. These increased risks, generated by the activities of the unregulated market in developing countries, should not be assumed to apply to every possible form of regulated market capable of being implemented in the developed world.

It is often forgotten that those in need of organs are also vulnerable, sometimes more vulnerable than potential organ providers. Transplantation is the only hope for many with failing hearts and livers. Kidney transplantation is also the only hope for those in countries such as India where there is no effective cadaver transplant or long-term haemodialysis programme (see Reddy 1993, 137). The desperation of some is somewhat anecdotally highlighted by the attempt of a man from Florida to auction a kidney on eBay—the price got up to $5.7 million before eBay stepped in and cancelled the auction (see Nisselle 2002, 74). This vulnerability is only made worse by restricting the available organs. It has also been claimed that many are driven to the unregulated (largely illegal) market, which tends to create increased organ rejections, infections, and diseases (see Skene 2002, 72).

The very vulnerability of potential organ recipients has been cited as a reason for prohibiting payment for organs, on the basis that altruistic donors provide better quality organs. Analogies have been drawn between payment for organs and payment for blood (see, eg, Pellegrino 1991, 1306). Titmuss, in his study of the commercialisation of blood donations, presents evidence that “commercial markets are much more likely to distribute contaminated blood; the risks for the patient of disease and death are substantially greater” (1970, 246), because payment encourages sellers to conceal information and attracts “as donors drug addicts, alcoholics, and carriers of hepatitis, malaria and other diseases” (ibid., 76). Even if these claims are conceded (see Price 2000, 400 for some counter evidence on paid blood provision), the import of this should not be overstated. What are the alternatives for a person in need of an organ? In the absence of a suitable organ, many patients face certain death. Ignorance of the provider’s complete history does not prevent the use of cadaver organs from unrelated persons nor should it be regarded as a suitable reason for prohibiting all organ dealings. Payment does not prevent pre-operative assessment of the organ, the organ recipient being informed about the risks, or those in need of an organ obtaining one from a willing donor.

If a free market in human organs operated, however, those in need of an organ would not be equally vulnerable. Free market systems are easily dominated by the rich and powerful (see Sells 1992, 2198). In such a system the (medically preferable) organs obtained from living providers would be allocated to those best able to satisfy the demands of the market. This is not, however, an argument against organ providers selling their organs, it is an argument against those in need of the organs directly purchasing them. Here the feared abuse is at the level of acquisition and allocation of the available supply of organs. It is, therefore, best addressed by at the level of allocation by, for example, seeking to prevent allocation according to ability to pay.

The most poignant argument stemming from the exploitation of the vulnerable is that commercial dealings in organs will place pressures on persons to sell their organs against their will. The argument advanced is that potential organ providers will be coerced, possibly by family members or by moneylenders. There are reports that, where organs have been sold by poor persons,

and

The evidence is only anecdotal but these scenarios are very plausible. They should not, however, be taken out of context, this anecdotal evidence derives from countries characterised by widespread problems of exploitation and human right abuses. Moreover, the vulnerability of some persons to coercion does not straightforwardly justify prohibiting all persons from engaging in such practices. A person whose mother will die without a kidney is vulnerable to emotional pressure including pressure from family members, so should all such persons be prohibited from donating an organ? In some societies or families individuals are likely to be bullied into an unwelcome marriage. Does that justify the prohibition of all marriage? Prohibition must be the most defensible way of addressing potential coercion, all things considered. In the context of organ dealings relevant considerations include the effectiveness of feasible alternative regulatory responses, the interests of those who voluntarily wish to sell their organs, and the interests of potential recipients.

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Many of the arguments against a market for human tissue are not arguments against commercialisation but about who should gain financially, and this paper has defended the payment of live organ providers. Although the literature defending commercial dealings in human organs is now prolific, little of it is specifically directed towards live organ providers. (A notable exception is work of Radcliffe Richards (1991; 1996; 1998).) I have argued in favour of regulated commercial dealings in organs from live organ providers. This is not presented as a solution to the vast organ shortage—cadavers represent the most fruitful source of organs. Nonetheless, I have argued that the autonomy and self-determination interests of potential organ providers, and the interests of potential organ recipients are undermined by the existing blanket prohibitions on commercial organ dealings. This conclusion has particular force for rights-based moral theories, which reject the idea that organ providers can owe direct duties to themselves.⁽¹⁴⁾

To give effect to this conclusion many countries would need not only to remove their prohibition on commercial dealings, but also to relax limitations on the required relationship between organ providers and recipients. Several jurisdictions restrict live organ donation to specified relatives and (in some cases) spouses—including France (Art. L. 671-13), Hong Kong (s.5), India (s.9(1)), and Portugal (s.6(2)). In the case of Germany the required relationship is extended to those with an “intimate personal relationship” (s.8(1)), the Swedish legislation generally requires a “very close” relationship except in “special cases” (s.7), the Finnish legislation restricts adult donation of non-regenerative tissue to “a near relative or other person close to them” (s.4), and the British legislation allows donation between persons who are not “genetically related” only with the permission of the Unrelated Live Transplant Regulatory Authority (ULTRA) (s.2).

Relaxing the need for an intimate relationship between the organ provider and organ recipient is, however, only one step. The major step will require an answer to a question not addressed in this article: if a regulated system of organ dealings is to be allowed what type of system should that be?

The suggestions provided in the literature are skewed towards systems of dealings with cadaver organs (see, eg, Cohen 1989; Schwindt and Vining 1998; Spurr 1993; Blumstein 1993). A popular proposal for cadaver organ sales, for example, involves establishing a “futures market” in organs whereby the right to remove an organ upon death would be purchased from the person while alive (see, eg, Schwindt and Vining 1986 and 1998; Hansmann 1993; Cohen 1989; Crespi 1994; Love 1997). The defensibility of such systems is not my concern here; this article makes no claim with regard to the defensibility of commercial dealings with cadaveric organs.

The literature does, however, suggest many regulatory safeguards that are capable of applying to living organ providers, including the imposition of compulsory waiting periods between agreeing to sell and organ removal, a minimum age for the seller, a minimum price mechanism, preoperative assessment panels (including, say, physicians and social workers), the imposition of mandatory financial disclosure and counselling requirements, restrictions on those able to buy organs, the separation of buying and allocation bodies, and the restriction of the commercial market to particular jurisdictions. I have cited some of these approaches as examples of alternatives to prohibition when responding to some of the arguments above. The choice of system is inextricably bound up with the particular moral theory used to justify the system (eg, not all moral theories accept positive duties to assist) and practical considerations, such as effectiveness and the political situation. In practice, any new regulatory system would need to be phased in gradually and would need to be designed to prevent abuse.

The restriction of organ purchases to a single buyer has particular appeal as a means to preventing coercion. Even this suggestion, however, has multiple possible variants. Jefferies (1998, esp. 625) suggests a system of licensed organ “warehouses” to “prevent the exploitation of the poor”. Erin and Harris, suggest a “monopsony” (ie, a single purchaser for the products of several sellers), which would “be required to take responsibility for ensuring equitable distribution of all organs and tissues purchased...[to] prevent the rich people using their purchasing power to exploit the market at the expense of the poor (1994, 141). In a similar vein, Mason et al. (2002, 435) suggest that Britain could extend the role of ULTRA, so that it becomes a purchasing and regulatory body ensuring the voluntariness of the decisions of all organ providers. The creation or modification of an appropriate regulatory body also has the advantage of its being able to react quickly to unanticipated events.

The defence of any particular regulatory system will, however, have to be left to another paper. The purpose of this paper has been to highlight the need to focus our concerns on alternatives to prohibition. Although few countries are currently prepared to consider allowing regulated payment for organ providers, it has to be hoped that position does not last. Now is the time to act. Opportunities for change are presented by the current review of the organ transplantation legislation in Britain and the current discussion on a framework decision to prevent and control trafficking in human organs and tissues initiated by the presidency of the EU.

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