1 - University of Manchester
Tissue Providers for Stem Cell Research: The Dispossessed
Abstract: Stem cell researchers cannot hope to realise their aims of the development of treatments and cures for serious diseases unless human tissues are made available for their work. It is currently prohibited to pay the providers of tissue for this contribution. This article will explore the meaning of property in human tissues leading to the conclusion that, in giving control to tissue providers to determine whether their tissues should be made available for research purposes, UK law bestows property powers in such providers over their tissues. The article goes on to suggest how tissue providers should be recompensed in this context.
Keywords: Stem Cell Research; Human Tissues; Property; Recompense
Author:
Sarah Devaney
Lecturer
*Institute of Science, Ethics and Innovation
Centre for Social Ethics and Policy
School of Law
University of Manchester
The author wishes to acknowledge the stimulus and support of the Institute for Science, Ethics and Innovation Wellcome Programme "The Human Body: Its Scope, Limits and Future". The author would like to thank Margaret Brazier, Simona Giordano and Chris Thorne for their comments.
Wordcount: 12,302 (15323 including footnotes)
Tissue Providers for Stem Cell Research: The Dispossessed
‘We are witnessing nothing less than a new kind of gold rush, and the territory is the body’.[1]
The global business of biotechnology is thriving. Stem cell (SC) research is no exception, with significant investments being made in those private companies, university laboratories and clinical departments which hope to realise its potential to provide therapies for serious diseases.[2] The corollary to such investment (and its impetus) is the potential financial reward for those researchers (and their financial sponsors) who succeed in these endeavours. SC science is part of the growing trend of emerging technologies which depend for their success on the physical contributions of human raw materials, i.e. tissues such as ova and embryos, by willing providers. These vital contributors, without whom many SC research projects would simply fail to be undertaken, are however currently excluded by UK law from sharing in the potential commercial successes which will accompany therapeutic advances[3] or from any appropriate recognition of the value of their contribution to the science. Tissue providers (TPs) are the dispossessed of the research arena, a matter which should be rectified through the provision of appropriate recompense to them so that the applicable law can convincingly claim to be consistent and legitimate on this point.
In addition to the commercial stimulus to carry out SC research, the hope that effective SC therapies will be developed for the benefit of patients, the ‘social utility aim’ of this research, drives its pursuit. Commercial considerations play a role even in relation to this goal, as without substantial financial investment in the field, therapeutic benefits have no hope of coming to light. To include TPs within the categories of those who are entitled to benefit financially from their contribution to SC research is an effective and fair way to enhance the chances of achieving its aims. This article will therefore argue for the acknowledgement of property rights for providers of human tissues (of any kind) for SC research, submitting that there is no convincing legal or philosophical objection to a property-based regime in this area.
In supporting this position, the nature of property itself will be examined, leading to the conclusion that human tissues attain its characteristics from the moment they are removed from the body. Until the recent past, the law in England and Wales has viewed tissues as property only after they have been removed from the body, their progenitor has consented to their use by others and those others have changed the tissues in some way through the application of skill. However, in Yearworth and Others v North Bristol NHS Trust[4] the Court of Appeal overruled this stance in relation to stored sperm samples. It will be argued here that until the implications of their judgment are applied in full and TPs for research are acknowledged as one of the categories of individuals who have property rights in their tissue, the ability of others to use it for financial gain is unjust. It will be concluded that as a pre-requisite for adequate regulation of SC research, certain types of property rights over their tissues should be granted to them within a regulated arena. Having made these arguments, suggestions will be made about the approach which might be deployed to assess the value of that property and the contribution made by TPs to SC research.
Concepts of Property in Human Tissues
‘Any general notion of property is notoriously elusive’.[5]
Many alternative accounts of the nature of property are available to analysts of this complex concept.[6] Two main forms of property provide a focus for analysis of the use and allocation of property in human tissues in this piece.[7] The first describes the object which constitutes property (for example, a house, a car, a vase), while the second describes the relationship between the object and one or more individuals (for example, if I rent a house from Bob but have furnished it with my own belongings, I have different property relationships and therefore rights in relation to both the house and its furnishings than does Bob). Within the second of these two main categories, different levels of property entitlements may exist in relation to numerous individuals. ‘The concept of ownership is no more than a convenient global description of different collections of rights held by persons over physical and other things’.[8] Different relationships between a person and a thing can be enjoyed by one or more people at a time, including user entitlements (what I may do with the property), trespassory control (what I may prevent others from doing with it) and powers of transfer (to whom and on what basis I may bestow elements of control over the property).[9]
The formulation of property which will be applied in exploring individuals’ property relationships with objects in the form of human tissue, is that constituted by a bundle of rights, duties and responsibilities of a liberal system of ownership defined by Honoré.[10] Honoré set out eleven rights which can jointly and severally indicate ownership:
‘the right to possess, the right to use, the right to manage, the right to the income of the thing, the right to the capital, the right to security, the rights or incidents of transmissibility and absence of term, the duty to prevent harm, liability to execution, and the incident of residuarity’.[11]
There are a number of ways in which this approach is helpful in the regulation of SC research. First, it is a concept of property which can comfortably encompass the challenging issues which arise when considering who has rights to the commercial benefits arising out of the use of excised tissues in therapeutic research. Its usefulness lies in its accommodation of the varying degrees of property rights over a given object which different individuals or categories of individuals can possess. It can easily allow, for example, for the Human Fertilisation and Embryology Authority (HFEA) to grant licences limiting researchers’ uses of gametes and embryos; for the Human Tissue Authority to oversee the transplantation of tissues into other humans; for commercial organisations to exchange tissues on financial terms; and for TPs to exercise control over the uses to which their excised tissues are put. It also enables appropriate limits to be placed on the nature and extent of the property rights available to those in control of excised tissue at any point. In considering the most appropriate regulatory framework for SC research, it provides the opportunity to redress imbalances between such parties, and to allow detailed examination of the most appropriate form of property rights which TPs should be afforded.
The Language of Property and the Body
In identifying property as both a social and legal institution, Harris observes that ‘the open-ended nature of many proprietary principles entails that, even when embodied in law, their official interpretation and implementation often interacts with current social understandings of them’.[12] This is no better illustrated than in our use of language in both lay and legal parlance to indicate how we view objects and our connections to them.
The language we use to describe our relationship to our bodies and their parts, or to our tangible property such as cars or furniture, has significant overlaps. Both ‘my house’ and ‘my leg’ can properly be described as ‘mine’ indicating that I am in a position to assert a strong degree of control over each. Equally however, I may assume that it is understood that the rights I have over each, and the things that others may be permitted to do, or be prevented from doing, to or with them, are different in relation to each entity. So, despite the fact that lay language may deploy property-type vocabulary,
‘the fact that people deploy possessive pronouns in relation to their bodies is, in itself, no indication of ownership assumptions. ‘My’, ‘yours’, ‘his’, or ‘hers’ may signify a host of relationships which have nothing to do with owning’.[13]
This overlap in vocabulary also emerges with regard to those with whom I have relationships, such as relatives, friends and colleagues. However, when I refer to ‘my daughters’ I do not mean to indicate that they are entities which I could sell for profit on the open market, as I might my car. When used in this context of interpersonal relationships, the possessive pronoun is not indicative of elements of control, but rather a signal of our connectedness in one form or another. Given the difficulties in defining concepts of property and ownership, and the pervasiveness of the concept of property in popular consciousness,[14] an analysis of the language used to describe our overall relationship with our bodies and its parts is therefore not helpful in determining whether or not property exists there.
It is when we come to the issue of a subset of that relationship, the ability to transfer control over our excised tissues, that an analysis of the language used to describe such transfers becomes more enlightening, suggesting at the very least a broad acceptance that excised tissues are a type of property. The language of property pervades both lay and legal discussions about the status of excised human tissues on transfer. It provides useful indications of popular understandings of TPs’ entitlements to make such transfers. In addition, the lengths which are gone to in legal and policy documents to ensure that limits are placed on the commercial benefits which may accrue to TPs, such limits couched within property terminology, are telling. Their imposition suggests that the law recognises that entitlements do exist, but must, for some reason, be constrained.
By way of example, in its 1995 report, Human Tissue: Ethical and Legal Issues,[15] the Nuffield Council on Bioethics concluded that property law should not be used to regulate human tissues due to concerns that this would plunge society into lengthy discussions with progenitors on the nature and extent of their consent to tissue provision, to bargaining about its value, and to the springing up of agencies whose purpose was to negotiate on the terms of exchange, all of which would serve to impede research.[16] The Council therefore recommended that any tissue removed from the patient during the course of consensual treatment should be regarded as abandoned[17] and that voluntarily ‘donated’ tissue removed other than for treatment purposes should be regarded as a ‘gift’.[18] It is evident that, in making its recommendations, the Council, whether deliberately or otherwise, deployed the language of property and ownership to suggest ways in which TPs could be excluded from the property sphere. This use of language, mirrored in a variety of other documents dealing with tissues and their transfer[19] suggests a policy position that there is property in these tissues, but that ethical considerations mean that it would be better for us not to acknowledge the property value until it has moved beyond the control of TPs.[20] If this is the law’s position, it reflects a misrepresentation of the true role and entitlements of TPs within the sphere of biotechnology,[21] belying any claims that the law is clear and unambiguous, both of which are vital attributes for a regulatory framework governing this area.
This general acceptance of property in tissues becomes more overt once control over those tissues has transferred from the progenitor to other individuals.[22] The contribution made by TPs to science is typically described in terms of ‘donation’,[23] terminology which, while indicating that the transfer of the entity is not undertaken on a commercial basis, nevertheless indicates that the tissue is property of a sort. After all, I cannot donate those objects which I do not own. Rather than denying that TPs have property in their excised tissues, the language of ‘donation’ simply serves to indicate that under our present system, the extent of those property rights is limited to the ability to transfer control over those tissues for no financial gain, and foregoing any further interest in the future use of those tissues beyond the terms of their consent to such transfer. It seems therefore that only a limited number of strands of the property bundle are legally available to TPs in relation to their excised tissues, that is to transfer ownership and, to a limited extent, to control their use through deciding whether to consent to certain future applications.[24]
‘Donation’ terminology will not be used in this article when referring to the actions of TPs as it immediately undermines the argument that they should be recognised as having broader and more extensive property entitlements over their excised tissues than the legal system currently acknowledges. This lies in the implicit assumption that a ‘donation’ is an act which has an inherent value on the basis of its incorporation of the moral good of altruism which can enhance social cohesion and provide a sense of reciprocal responsibility. The phrase ‘tissue provider’ (TP) will instead continue to be used to describe an individual who makes their excised tissues (of whatever kind) available to SC research. This description is more accurate in reflecting the active contribution they make to this endeavour while still allowing for an acknowledgement of the social and moral value this action affords to society, even where recompense is made for it. Its neutrality in relation to commercial aspects avoids the danger of the assumption to which the language of donation gives rise, that is that TPs are not entitled to financial recompense for this activity. Its use therefore allows for a thorough exploration, unfettered by the language of property, of the question of whether or not commercial activity should be permitted in transactions occurring at the first stage of tissue provision to research.
Are Tissues Property? The Yearworth Common Law Revolution
Having asserted that a commercial value can be placed on excised tissues without undermining the respect with which they must be treated, the common law’s position on whether excised tissues constitute property must be considered. A significant case on this point is that of R v Kelly[25] in which the Criminal Division of the Court of Appeal upheld convictions for theft in relation to preserved anatomical specimens removed from the Royal College of Surgeons without permission.[26] In this case, the judge at first instance held that the specimens were property, being an exception to the common law rule that there is no property in the body.[27] The basis of that exception was a decision of the High Court of Australia in R v Doodeward and Spence[28] in which it was ruled that ‘a human body, or a portion of a human body, is capable by law of becoming the subject of property’.[29] The trigger for such a transformation to the status of property was, according to the court, when ‘a person has by the lawful exercise of work or skill so dealt with a human body or part of a human body in his lawful possession that it has acquired some attributes differentiating it from a mere corpse awaiting burial’.[30] This action entitles that person to ‘a right to retain possession of it’ subject to the right of those entitled to possession of the body for lawful burial or any other law forbidding such retention.[31] As a result, where tissues ‘have acquired different attributes by virtue of the application of skill, such as dissection or preservation techniques, for exhibition or teaching purposes’ they are capable of constituting property within section 4 of the Theft Act 1968.[32]
Rose LJ anticipated that it may be that in future ‘the courts will hold that human body parts are capable of being property … even without the acquisition of different attributes, if they have a use or significance beyond their mere existence’[33] and this supposition has been confirmed in the case of Yearworth and Others v North Bristol NHS Trust.[34] The latter case involved the appeal by five men and the executor of the estate of a sixth against a first instance finding that they neither suffered personal injury nor injury to their property when sperm which they had stored for future reproductive use was damaged in an admitted breach of a duty of care on the part of the fertility clinic storing it. The Court of Appeal observed that ‘the law ... has remained noticeably silent about parts or products of a living human body, probably because, until recently, medical science did not endow them with any value or other significance’.[35] Advances in medical science however meant that ‘a re-analysis of the common law’s treatment of and approach to the issue of ownership of parts or products of a living human body’ was required[36] and in the context of this case led to a finding that the appellants had ownership of the sperm which had been stored for their personal use.[37]
The Court of Appeal in Yearworth regarded the 1993 decision of the Californian Court of Appeal in Hecht v Superior Court for Los Angeles County[38] as being of ‘considerable interest’ in making a significant step towards ‘recognition of ownership of parts and products of a living body’.[39] In this case, William Kane had before his suicide ejaculated and caused to have cryopreserved fifteen vials of his own sperm. In his will he had bequeathed these to his partner of five years, Deborah Hecht, with the intention and hope that she would use them to conceive and bear their child. Kane’s adult children from a previous relationship challenged Hecht’s right to receive and use the sperm in this way. The Court of Appeal held that Kane had had ‘sufficient decision-making authority in relation to the use of his sperm for it to amount to “property” for the purpose of the state’s Probate Code’.[40]
The Hecht case was bitter and protracted, involving numerous appearances before a variety of courts. The Court of Appeal judgment in Yearworth does not make reference to a subsequent decision of the Los Angeles Court of Appeal in which that court was asked to settle ‘the conflict between decedent’s clear intent to donate his sperm to petitioner for purposes of procreation and a property settlement purporting to distribute all residual “assets” of decedent’s estate’ between Hecht and the children.[41] This judgment is of interest in the context of this thesis, as gives rise to a question also left unanswered in Yearworth[42] about whether tissue can constitute property where it is intended for use by people other than its progenitor.
In Hecht, Kane’s children had disputed the entire contents of his will and eventually reached a global settlement that Hecht was entitled to 20 per cent of the estate. As a result, in April 1994 a probate judge ordered that she was only entitled to use three of the vials of stored sperm. Even after this finding, Hecht had to petition the court again for release of these three vials. The matter then came before the appeal court again when Hecht requested access to the remaining twelve vials. The Los Angeles Court of Appeal granted Hecht access to the remaining stored sperm noting that it was a ‘unique form of “property”’ which was ‘not subject to the terms of a property settlement between claimants under the will’.[43] They noted that this form of property in this case ‘can only be used by and thus only has value to one person, the petitioner’ and ‘the intent of the sperm donor – and no-one else’s – controls the disposition and use of the sperm ... the sole issue becomes that of intent’.[44] The principle underlying the respect which that intent must be accorded was Kane’s ‘fundamental right’ to reproduce with whom he chooses, to ‘choose the genetic inheritance he leaves on this earth’.[45] Even Hecht herself may not ‘sell or contract away the decedent’s “fundamental right” to other persons’.[46]
In the realm of tissues provided for SC research we have reached the point where body parts or products have the sort of use or significance anticipated by Rose LJ in Kelly.[47] SCs are an example of the sorts of cells which naturally possess such significance, given their ability in certain circumstances to replicate themselves indefinitely and to differentiate into any cell type of the body. The formal acknowledgement of this category of property will depend to a certain extent on the ability of scientists to harness and control the abilities of SCs. Thus the law may be required to adapt and respond to scientific progress, a role which will be considered in further detail later in this thesis. The fact that SCs’ significance may be realised through their use by individuals other than their provider does not detract from this, and it will not be an unreasonable extension of the judgment in Yearworth for the courts so to hold. The Courts of Appeal in both Hecht and Yearworth justified their findings that sperm can be property on the basis that the intentions of its provider bestowed that status upon it. Below, arguments which support the extension of property rights in excised tissue from those who wish to use it themselves to those who permit its use for others will be examined. First however, alternative justifications for the argument that tissues should be classified as property will be explored.
Arguments Opponents of the Property Position Might Make
1 Why not just pay for the service element?
One way of avoiding the thorny issue of whether human tissues are property is to identify any service being provided by TPs and making just recompense for that aspect of their role. The benefit of such an approach might arise where fundamental objections are made, for example, to the selling of human embryos or reproductive tissues, where this ‘bodily-use freedom principle’, would avoid allegations of ‘baby selling’ with an assertion that the service in making these tissues available (rather than the tissue itself) is the commodity for which payment is justifiably being made.[48] However, the provision of such a service is inherently bound to another element, without which it is valueless in the research context - the tissue itself.[49] The issue of whether TPs are providing a service cannot be removed in its entirety from the question of whether the product which is made available through that service is property. For example, ova providers for SC research supply ‘a product of exchangeable value’, with the woman’s work being required to make the ova available for the use of researchers. [50] In relation to tissues provided for research, ‘it is not practicable to realise [their] potential unless someone is accorded ownership privileges and powers over [them] – that is, no enumeration of all beneficial uses can be attained, so it is necessary to invoke the familiar organizing idea provided by a property institution’.[51] The question of whether tissues constitute property as part of such an institution will be explored now.
Others may counter the ‘service’ position on the basis that, in many circumstances, the tissue will have become available as a ‘by-product’ of another aim which the TPs were attempting to achieve to benefit themselves. For example, it might be argued that providers of embryos for research undertook all of the medical interventions necessary to get to the stage of having their embryos stored in a laboratory (which could be classed as labour) because they were trying to conceive a child, rather than because they wished to contribute to endeavours to develop new SC therapies. Equally it might be argued that there is little justification to provide payment to women who are undergoing ova retrieval for their own IVF treatment in any event.
However, it is not important why TPs went through the physical interventions necessary to make their tissues available. The relevant fact is that they are now making the fruits of those actions available for therapeutic research. We do not expect workers in other employment markets to deny the fact that they come to work in order to benefit themselves before we are prepared to pay them for providing benefits to others in the form of the application of their skills. Neither do we require them to establish that the reason that they undertake their workplace duties is in order that others, rather then they themselves, will benefit from their labours. For many workers, benefits to their customers or clients will be a by-product of their own endeavours to make a living, and there is no reason why we should require more of an impetus to provide recompense for their work than that. In short, merely because individuals will undergo the interventions required to obtain their tissues to meet their own purposes for no financial reward, but may later make them available for others’ purposes, should not mean that they are not entitled to financial recompense for that service. ‘One does not lose a legitimate right to compensation by virtue of a willingness to act without compensation’[52].
2 The argument that commercialising them doesn’t negate their other forms of value
Arguments might be made that human tissues have a special status which means that no price can be placed on them – to do so would be to deny their other forms of significance such as their fundamental (including genetic) connection to their provider, or their potential therapeutic value. As has been noted, ‘there is a range of values which can be applied to the body and its parts, extending from the emotional on the one hand, to the scientific on the other’.[53] This applied equally to human tissue, for example some holding that it is inherently bound to human dignity, others recognising that it may have a role to play in the market. Such objects have been labelled ‘contested commodities’,[54] meaning that they can be treated as property without denying that they have more than ‘extrinsic value’.[55] Excised tissue possesses the sorts of traits we associate with objects we acknowledge as property. ‘It is definable, defensible, and divestible. Property rights in human tissue include rights to use, alienate, exclude, or in any way control materials’.[56] It is acknowledged that classifying an object as property in this way involves a form of commodification, ‘a social process in which people treat things (i.e. objects, structures, processes) as property and apply market rhetoric to those things’.[57]
To allow commerciality to play a role in the exchange of such items is not to devalue them by denying their other forms of worth. Numerous objects which can be traded on the market also have other forms of value which we are still able to recognise – my home or an antique family heirloom for example will be valuable to me in a variety of ways. Allowing commerciality to appear at the stage of transfer of tissues from progenitor to other users does not mean that society or the law regard that tissue as a commercial object to the exclusion of all other ways of thinking about it.[58] It merely serves to invite regulation to provide appropriate mechanisms to ensure that other values in tissues are protected and acknowledged where appropriate.[59]
‘One may plausibly say of external things, or, at any rate, of external things in their initial state, of raw land and natural resources (out of which all unraw external things are, be it noted, made), that no person has, at least to begin with, a greater right in them than any other does; whereas the same thought is less compelling when it is applied to human parts and powers’.[60]
3 First Possession
In this section, the argument that excised tissue becomes the property of their progenitor on excision will be more fully explored. A first step in this process must be to raise and dismiss a potential justification for acknowledging property rights only after tissue is removed from a TP: the case of ‘“first possession”. Examples of this in law are slain wild animals or plucked wild flowers, ‘the “first possessor” acquires the rights over them where previously there had been none’.[61] On this basis, it might be argued, TPs for research would be denied rights in the property sphere because tissues do not become property until they are taken into possession by another individual. However, the first possession argument has been disputed on the basis that it is an unnecessary duplication of the exclusion from the property sphere which results from the ‘work or skill’ requirement under current law.[62] In addition this position is illogical. Currently, after the initial transfer of tissue from the progenitor in what appears to be a property vacuum, ‘property will frequently re-emerge further down the line, to be held by those who produce fruits of labour involving human material’.[63] However, it is not clear why the property or just recompense chain should begin one step removed from TPs rather than vesting in them as their source after excision. Where tissues with such significance in their raw state are provided to research, it would seem that the only logical person able to be possessed of property rights in them would be their provider. To fail to do so would leave an inexplicable gap in the ownership chain. If tissues become property on excision, why should they be without an owner until transfer beyond the control of their source? Harris writes that ‘it is a controversial question whether there are any natural conditions of title, that is, facts about the world from which it follows, in justice, that an individual or group ought to be accorded some conception of ownership and the protection of trespassory rules’.[64] However, if there is any entity about which this can be most instinctively said, surely that is the right of TPs to control (to a certain extent) the transfer and use of their own excised tissue. Two arguments will be made here to support the contention that property in tissues should vest in TPs for research on excision. NB THIS ALSO CONFLICTS WITH YEARWORTH
4 The Application of Work or Skill
In Kelly the court was willing to acknowledge that tissues can constitute property where the application of work or skill has transformed those tissues in some way. This position finds its origins in Locke’s formulation on work and skill.[65] However, in the context of tissues intended for use in SC research, the work or skill requirement is vague, inapplicable and of insufficient weight to justify according property rights to TPs, having been overtaken by the relevance of the special status of these tissues.
The common law has not provided clarity on the extent of the skill which must be applied to bestow property status in tissues. Vague requirements of an application of human skill to detached biological specimens[66] are not of assistance in clarifying this point. Dissection and preservation techniques were provided as examples of such skill in Kelly and confirmed as being such in AB v Leeds Teaching Hospital NHS Trust.[67] The courts have not however been forthcoming on what level of ‘work’ would be required to fulfil the criterion.[68] It therefore remains a moot point that in providing consent and undergoing the procedure involved in extracting tissues from their bodies, some TPs such as ova providers are carrying out a form of work, recognised within the property sphere, which allows the tissues to become separate from their body, and thus property.[69] However, basing the existence of property rights on the level of intervention required to extract the relevant tissue seems arbitrary and inequitable.[70]
Further, it might be argued that providers of human tissue have not actively done anything to add value to their excised tissues; their bodies simply and by chance contain tissues which, once removed, may be able to be used for commercial gain or to achieve therapeutic advances by another person fortunate enough to be possessed of appropriate skills and knowledge to be able to add such value. What then entitles TPs to be accorded property rights in the same way as such researchers or physicians?[71] A failure to apply skill to add value is also insufficient justification to deprive TPs entirely of rights to property in their excised tissue. We do not require that owners of other types of property demonstrate that they have added value to an object in order that we recognise their full ownership entitlements. Should my Great Aunt Nelly bequeath her delightful country cottage to me, I will not be required to deploy my extensive DIY skills to install a new kitchen and bathroom before I can legally take possession of it. A convincing argument is needed to justify according TPs lesser (or no) property entitlements in their excised tissues. That argument might be the special status of human tissues, the commercial trading in which requires additional legal oversight. Such oversight can however be implemented through alternative regulatory mechanisms to the unnecessary and unjustified prohibition on TP ownership.
In Yearworth[72] (in which storage of sperm in liquid nitrogen was held to constitute requisite work and skill) the Court of Appeal cast doubt on the credibility of the work and skill requirement, and was ‘not content to see the common law in this area founded upon the principle in Doodeward,[73] which was devised as an exception to a principle, itself of exceptional character, relating to the ownership of a human corpse’, concluding that ‘a distinction between the capacity to own body parts or products which have, and which have not, been subject to the exercise of work or skill is not entirely logical’.[74] Instead, it was the element of control which TPs can exert over their tissues post-extraction which was held to be fundamental in classifying them as property.
In law, after tissues have been extracted, a TP must then make a decision about the exclusion, access or use rights of others in relation to those tissues, and the terms on which those rights are granted.[75] The combination of consenting, first to excision and then to the resulting tissues’ use in SC research, is an exercise of intrinsic property rights. This was one of the aspects that convinced the Court of Appeal that sperm was property as ‘by its provisions for consent, the [1990] Act assiduously preserves the ability of the men to direct that the sperm be not used in a certain way: their negative control over its use remains absolute’.[76] Opponents of this view have argued that the property rights involved in deciding whether to transfer tissue involve ‘an open-ended set of use privileges and control-powers’ which do not extend as far as constituting ownership rights.[77] However, this argument does not adequately demonstrate how such privileges differ from equivalent strands of the property bundle and it is difficult to see how their expression can be anything other than an assertion of ownership with all that that entails, including an entitlement to commercial benefits or other benefits.
The Court of Appeal’s pronouncement that,
‘developments in medical science now require a re-analysis of the common law’s treatment of and approach to the issue of ownership of parts or products of a living human body, whether for present purposes (viz an action in negligence) or otherwise’
is apposite in this context. The therapeutic potential of SCs in their raw state, and even the ability of other cells of the body to be reprogrammed to such a state in the form of iPSCs, support the argument that such cells fulfil Rose LJ’s exception.[78] On this basis the requirement of work or skill becomes obsolete. The fundamental factor here is that the decision of TPs to make their tissues available to SC research is vital to the chances of developing new therapies. Their contribution should not be undervalued in any way, including commercially. While it is true that the full commercial value of the tissues cannot be realised without the application of scientific skill and knowledge,[79] neither can it be realised if tissues with therapeutic significance in their very existence are not supplied in the first place. Each is a necessary and vital step in the chain of therapeutic development. If the Government wishes to implement regulation to facilitate SC research then consideration to rectifying this anomaly must be given.
5 Contribution to Scientific Endeavour
In addition to recognising property in tissue on the basis of the control which TPs are able to exert over it after extraction, there is a second, perhaps more pragmatic justification which can be given for according this recognition. The importance of the contribution made by TPs to progress in SC research should not be under-valued. Without their consent to the excision and use of their tissue, ‘no such things would have been added to the store of valuable resources’ and as such their involvement has ‘the greater causal significance’.[80] Such a ‘property-specific justice’ argument[81] supports the contention that the social utility aim of SC research cannot be achieved without a property institution to incentivise TPs to contribute in this way. Arguments have also been made that allowing recompense to TPs would increase the available supply of tissues.[82] Without payment for tissues, researchers will not be able to achieve their goals, or to do so in a timely fashion. Affording property rights to TPs is by no means the only model which could achieve this aim[83] but it is the approach which would lead to more cohesion within the current legal system. Empirical evidence shows that TPs for research consider that they are taking part in a communal effort to do good which engenders feelings of solidarity with others involved in the same cause.[84] An amendment to the law to allow property in tissues would reflect this more than reasonable position and encourage more people to behave in this way. The value of the property concept in the SC arena is thus to encourage participation in potentially beneficial research, and to instil confidence in the scientific profession.[85]
In considering how the law might respond to this argument, the case of Moore v Regents of University of California[86] is of interest, being a useful source of legal analysis of the impact which according ownership to TPs might have on the biotechnology industry. This case involved the development of a commercially valuable cell line from Moore’s tissues by his clinician, who obtained them without Moore’s knowledge of, or consent to, their use in research. Moore asserted that he was entitled to a proportion of any profits derived from the use of the cell line. The California Supreme Court found however that while he had no ownership rights over his tissue, he did have a claim in relation to a breach of fiduciary duty and the failure of his doctor to obtain consent for his actions., holding that the doctor should have provided information about his research activities and their potential commercial applications as part of obtaining consent based on all relevant information.
The grounds for this were that Moore’s original cells and the cell line produced through the efforts of the researchers were distinctly different entities,[87] and that to grant Moore’s claim to property in these cells would significantly impede the development of the biotechnology industry.[88] It was important that biotechnology companies were incentivised by their entitlement to commercial control over the cells in order that they would carry out beneficial research, incentives which would be reduced if they had to be shared with TPs.[89] Further, researchers might be inhibited from undertaking research if TPs were granted property rights in their tissues, on the basis that they would be afraid of being exposed to civil liability where a provider disputed that they had provided a valid consent.[90] On this latter point, potential future uncertainty or disputes between TPs and researchers could be avoided by them ‘clearly specifying the terms of their transaction and the future compensation, if any, due to the donor’.[91]
It is not expected that any other individuals working within the SC arena be excluded from their entitlement to payment on the basis that payment to them increases the costs of research – their role is rightly acknowledged as one for which financial recompense should be made.[92] There is no convincing argument to support making a distinction between TP and researcher in this regard. ‘It is hard to argue that there is something fundamentally wrong with participating in the market by selling one's own tissue … but not with market participation that includes buying tissue derived from others’.[93] To do so gives a false impression of the real financial costs of carrying out SC research. The Court made a concerted effort to exclude Moore from the tissue property realm on the basis of unsound reasoning. In holding that ‘in effect, what Mr Moore is asking us to do is to impose a tort duty on scientists to investigate the consensual pedigree of each human cell used in research’,[94] the majority of the court were perpetuating a stance which remains stubbornly oblivious to the fact that the biotechnology industry reaps profits, both as a result of restricting access to its intellectual property through the use of patents,[95] and as a result of being provided with its raw materials at no cost. A requirement that TPs are not paid on the basis of prohibitive costs in the biotechnology sphere could be used against all other parties working in the research field. However, companies are less likely to invest in and undertake research in SC therapies without the prospect of being able to make money out of them, protected in the form of patents or licences.[96] Further, there is no reason to suppose that research could not actually be furthered by encouraging those who would be reluctant to provide in the absence of property rights.[97] In other areas which provide benefits to society, organisations would be expected to make certain investments in manpower or money in order to obtain raw materials to use in the pursuit of financial reward. If, for example, a river runs through the land on which my cottage sits, which river could be diverted to provide a source of energy and water for the local community, it would naturally be assumed that financial investments would have to be made to pay me as the owner of that land for it to be accessed or diverted for such use, despite the fact that I have done nothing to add to its potential value in this endeavour. Investment must be made so that the social utility aim is achieved without unfairness to those who play a fundamental role in its realisation.
In considering whether providing recompense to TPs will increase the resulting costs of the therapies and so disincentivise the carrying out of this work, an example of the potential costs which might be incurred in recompensing ova providers can be given. In the US, a research team had enquiries from 391 women to adverts requesting donations of eggs to SC research. After screening these women for suitability, 28 began hormone injections and 23 completed the donation process. Eight of them donated twice while 3 donated 3 times. A total of 274 oocytes were obtained at an average cost of $3673 per egg. Taking into account the costs of screening and evaluating the women, the cost per woman of each completed cycle was $27,200. The women were reimbursed for time, travel and child care expenses, receiving between $560 and $4004.[98] It is arguable therefore that, depending on the system of recompense deployed, additional costs could be added to the carrying out of this work. However, these costs need not be prohibitive[99] and in any event must be balanced against the importance of attempting to achieve the social utility aim. Even if payment for the raw materials for SC research did lead to an increase in costs of this work, it does not automatically follow that as a result TPs should not receive some form of recompense. Instead, the regulatory system should consider how the burdens of such costs should be shared amongst participants and society as a whole.[100]
The denial of property rights in excised tissues for TPs has led to the position that ‘the one person always to be excluded from the body/property equation is the very person who is the source of the property itself’.[101] This ‘reveals an ambiguousness about the true status of body parts and betrays underlying conflicting notions about the nature of any claims that we might have to ourselves’.[102] In contrast, the benefits of a transfer at no financial cost for the donee are considerable, as they tend to be without conditions which ‘leaves considerable scope for the future use or disposal of the gift, free from unwarranted restraint’.[103] Thus the progenitor of tissues for use by another in research is denied acknowledgment of ownership of their tissue, with a resultant dearth of remedies available to them for misuse of it.[104] TPs’ fundamental contribution to the ability of the SC industry to flourish is almost entirely overlooked, an unjustified situation which must be resolved through regulation.
The Second Form of Property – a Relationship of Control
‘The added value of a property model lies in its ability to empower individuals and communities and to provide the crucial continuing control over samples or information through which moral and legal influence may be exerted’[105].
In the previous section, justifications were provided for recognising excised tissues as property. In Yearworth, the issue of whether they remain so where they are intended to be used by others was explicitly left open.[106] Here, attempts will be made to deal with that subject, leading to the conclusion that such tissues retain their property status whether they are intended for personal use or for the use of others.
It has been argued thus far that property exists in excised human tissue generally. Tissue also possesses those characteristics which instil within it the second of the fundamental elements of property, which is that an individual (in this case its provider) can exert control over it, dictating the extent to which others can access and use it, such control being described by Harris as ‘trespassory rules’.[107] TPs for research are entitled to impose trespassory rules over future possessors of their tissues through the nature and extent of the consent they provide in transferring control, just as, further along the chain of uses of the tissues, ‘it is regularly used, possessed, bought, and sold by researchers, laboratories, and corporations’.[108]
Such control is a means by which the autonomous wishes of TPs can be recognised in realising the additional, tangible, value which tissues can have outside of the body. Personal autonomy is, ‘at a minimum, self-rule that is free from both controlling interference by others and from limitations, such as inadequate understanding, that prevent meaningful choice’.[109] The role of consent is to ensure that the autonomous decision of an individual, made after having been provided with all relevant information required to reach that position, is respected.[110] In a medical and research setting this will assist in protecting autonomy and bodily integrity. Opponents of allowing TPs to benefit financially from providing their tissues for scientific research may assert that autonomy can be respected without society having to demonstrate this through commercial means. Money does not have to change hands in order for me to respect your wish not to be hit about the head with my newspaper. After all, ‘the bodily-use freedom principle has whatever normative force it has without benefit of self-ownership notions’.[111] However once ownership, with all of the control elements that entails, has been established, there exists no convincing reason why TPs should be denied access to recompense for making their property available to others.
The law goes to great lengths to ensure that autonomy is respected in relation to the removal of human tissue from the body. Legislation governing the obtaining of tissues for research and transplantation in the UK contains central provisions relating to the consent of the person from whom those tissues are removed. For example, under the provisions of the 1990 Act (as amended) and of the Human Tissue Act 2004 (2004 Act) (which deals with ‘relevant material’ intended for transplant (excluding gametes and embryos which fall under the 1990 Act)),[112] SC researchers cannot excise or use certain tissues in their research unless the progenitor has provided a legally valid consent for them to do so.[113] The statutory model governing tissues for transplant has been arrived at in part as a result of the coming to light of past routine practices in hospitals in the UK of removing, storing and using tissues without the knowledge of their progenitors or their families. It is worth briefly considering the 2004 Act’s response to these scandals. The Bristol Inquiry,[114] which undertook investigations into paediatric heart surgery, produced an interim report in May 2000.[115] It was here that the long-term practice at the Bristol Royal Infirmary of storing and using tissue removed at post mortem of children who had died post-operatively, without the knowledge or consent of their parents, was exposed. The report’s authors observed, ‘the law regulating the removal, retention, use and disposal of human material is obscure, uncertain and arcane’.[116] Vaguely phrased consent forms for hospital post-mortems and the retention of organs beyond determining the cause of death in coroner’s post mortems (for which no parental consent is required) were considered to be ‘practices of dubious legality (to put it at its most favourable)’.[117] The report revealed ‘cogent evidence of the gulf between families’ expectations and medical practice’.[118] Similar practices came to light in The Royal Liverpool Children’s Inquiry Report.[119] The loss of trust in the medical and scientific professions which arose as a consequence of these practices continues to lend additional weight to the argument that TPs should be consulted about the potential uses to which their tissues will be put, and legally valid consent obtained for those uses.
The fact that TPs have decision-making power about whether to make tissues available means that they have the relationship of control over those tissues which constitutes the second form of property, albeit to a limited extent.[120] These elements of information-provision and decision-making are indicative of a property relationship with the removed tissue. The law holds that to take tissue without the consent of its source (where that source is a competent adult or mature minor) would be unlawful.[121] The justification for allowing TPs to restrict what others may do with their tissues is an extension of their ability to do so when they were still connected to the body, rather than a newly created ability to control them.[122]
The applicable legislation however persists in the law’s refusal to acknowledge overtly that excised tissues can constitute property. It has been argued that the failure, for example, within the 2004 Act to make reference to removed tissues or organs as property indicates that no individual property rights exist in such materials.[123] The only legislative reference to tissue as property is contained in the in section 32(9)(c) where the application of the skill exception to a prohibition on commercial dealings in tissue is set out. No explanation of the requirements to fulfil the ‘application of human skill’ is given. A similar failure to clarify the property position of tissues is evident in the 1990 Act (as amended). Both this lack of clarity and the absence of overt reference to the property status of such materials generally belies the law’s true position on this question. It permits and prohibits dealings with such tissues as though they are property, with the effect of according them such status. The detailed consent requirements in Schedule 3 which must be adhered to when obtaining tissues from their progenitors indicate a tacit recognition that TPs do possess proprietary rights of certain forms in those tissues. This approach should be made explicit within a legal regime governing the area. Further, the requirement to respect the autonomous wishes of TPs about future uses of those tissues lends weight to the call for the law now to openly acknowledge their property entitlements.
The Yearworth judgment goes some way to doing this. The finding that the men’s sperm was property was justified on the basis that the sperm came from their bodies alone.[124] The fact that the 1990 Act limits the ways in which they may use the sperm in the future did not impair their ownership claims as the law places a variety of restrictions on uses of other forms of property without affecting their status and, as we have seen, the law preserves their absolute negative control over its use.[125] While the licensed clinic ‘has duties which may conflict with the wishes of the men ... no person, whether human or corporate, other than each man has any rights in relation to the sperm which he has produced’.[126] Further, the fact that the men could require destruction of the sperm at any time is a fundamental feature of ownership.[127]
Three issues remain to be clarified in arguing that excised tissue is property, whatever its intended use. The first is whether this contention is affected by the fact that TPs require the intervention of others in order that their tissues be used in research. Some tissues such as ova will require the assistance of others in order to remove them from the TP’s body. This is irrelevant if they have consented to such intervention – the existence of ownership is not affected by the fact that medical assistance is required in relation to its use, and there is no meaningful distinction between use and extraction which would impede property status being recongnised.
The second issue is whether the Court is saying that a harm must have occurred for property to be recognised. It said that in deciding whether sperm could be owned ‘part of our enquiry must be into the existence or otherwise of a nexus between the incidence of ownership most strongly demonstrated by the facts of the case’ and ‘the nature of the damage consequent upon the breach of the duty of care (here their inability to use it notwithstanding that this was the specific purpose for which it was generated)’.[128] It appears that in fact the Court was highlighting the fact that the men were harmed in their ability to use their tissues in the way of their choosing within the parameters of what is permitted in law.[129] The corollary in the research context would be a prevention of their ability to ‘use’ it by directing its use for research purposes and prevention of the ability to obtain just recompense for it.
Finally, it is irrelevant whether the tissue will be used for the TPs own purposes, either for research or reproductive objectives, or for the purposes of others in such contexts. The primary aspect in recognising property in the tissues is the element of control the TP has in directing its future use, what has been identified as one of the twin pillars of the Act.[130] The 1990 Act permits the direction by TPs for the use of their tissues by others and their rights to do so can be equally impaired whether they are intended for their own use or not. To create a distinction on the basis of who it was intended would use the tissue in future would, in the words of the Court of Appeal, ‘generate paradoxes, and yield ramifications, productive of substantial uncertainty, expensive debate and nice distinctions in an area of law which should be simple, and the principles clear’.[131]
The failure to afford individuals property rights over their excised tissue infringes respect for autonomy in so far as being able to exert control over one’s body and its parts is concerned. Why should we have so much say over whether or not our tissues are removed and whether or not they are used in research projects, but no commercial control over parts of it which have become separated from us, even though such commercial control vests in the person who next uses it? Affording corresponding property rights, including the right to transfer for commercial gain, to TPs for research would provide appropriate acknowledgement that their tissues originated from their bodies, strengthening their ability to control what happens to those tissues, akin to some categories of the property ‘bundle’, and doing away with the current manifest injustice in this area of research which leave the rights of tissue progenitors ‘inevitably less than complete’.[132] It would also reassure researchers and society in general that samples are being dealt with within an equitable legal system[133] which conforms to good regulatory practices.
Having established that excised tissues are the property of TPs from the moment of removal, and where the TPs consent to their transfer and certain forms of use of those tissues, we can justify according them their rightful place amongst those who stand to benefit financially from SC research. The question then arises as to the appropriate level and form which such financial benefit should assume.
Ownership Strands and Mechanisms of Recompense
A regulatory system which attempts to ensure equality of recognition and entitlement to recompense to all contributors to SC research must incorporate practical mechanisms to achieve this aim.[134] It will be argued here that an appropriate system of recompense would combine modest payments to tissue providers at the time their tissues are made available, as well as preferential access to resulting therapies in the future.
The analysis undertaken in this chapter leads to the conclusion that the law already acknowledges that TPs ‘own’ their tissues in relation to certain strands of Honoré’s property bundle.[135] First, they are entitled to the right to posses, defined as having ‘exclusive physical control of the thing, or to have such control as the nature of the thing admits’.[136] As noted by the Court of Appeal in Yearworth,[137] this control is manifested and protected by the requirement that consent be given before tissues may be used, with legal remedies available where such consent is breached.[138] Secondly, TPs enjoy a limited right to manage their tissues, that is, ‘the right to decide how and by whom the thing should be used’.[139] This right is currently restricted in that TPs may only provide consent for their tissues to be used in ways that are permitted by the current parameters of the law. So for example, while the providers of sperm may consent to this being used to create human admixed embryos[140] and to certain uses of that human admixed embryo,[141] they may not consent to such embryos being inserted into the body of a woman as this is expressly prohibited by the 1990 Act (as amended).[142]
In addition to the two property strands which the law already acknowledges, it has been argued here that a strand which exists but is not appropriately recognised by the law is the ability to make a transfer of control of tissue for financial gain. If this is to be recognised in law,[143] the regulatory system must determine at what stage and in what form payments should be made.[144]
1 Right to the Income
Acknowledging TPs’ ‘right to the income’ might involve a system where a TP shares in profits resulting from therapies developed through the use of their tissues if a successful, marketable therapy arises out of their use.[145] However, this would mean that most providers would never receive any form of payment, but the lucky ones would receive an enormous and disproportionate benefit. Tissue samples would have to be coded upon collection and tracked through to marketing of the product[146] and TPs would have to be prepared for anonymisation of their tissue to be reversed at the point where it was required to contact them in relation to their potential profits.[147] If the tissue provider was not contactable, their share might be paid into a charitable fund (possibly linked to the biotechnology or health field).[148] Many tissues used for medical research will not however lead to the development of commercial therapeutic products,[149] thus the chances of the TP obtaining any benefit under this system are low. In addition, a profits-related payment system fails to acknowledge the contribution which all TPs make to the social utility aim of SC research, that is the attempt to develop treatments for serious diseases, whether that attempt succeeds or not. On this basis of these objections, such as scheme is rejected in this thesis.
2 Right to the Capital
The ‘right to the capital’ is the power to alienate the property and transfer title to another by way of sale.[150] Payment for the type of tissue itself could be made under a tariff system established by the relevant regulator after public consultation on the issue of how the levels of compensation are set.[151] The regulator’s role in this regard would serve to avoid muddying the relationship between provider and researcher through the interference of financial issues.
The vexing question is how to assess the value of the tissues provided. In the Yearworth case, despite extensive investigations into whether the sperm was property, no financial value was placed on the sperm in order that the claimants could be compensated for its loss. Representatives of the claimants ‘conceded that sperm had only a nominal value in itself’[152] and instead the value of the loss to each individual was assessed in relation to its effect on them in terms of whether it represented the loss of the ability to reproduce with their own genetic material where their fertility had been lost through their cancer treatment, and the psychiatric distress to them as a result of the destruction of their sperm. As a result, to date, settlement awards have ranged from £1500 to £48,500 and ‘where the Claimants regained fertility but suffered 2 years of distress before establishing this was the case damages have been in the region of £5,000.’[153]
Financial values are placed on parts of the body in the context of awards of damages for personal injuries, in which sphere broad categories of injury are identified,[154] with final awards being determined from there by reference to precedent awards. Although the Court of Appeal in Yearworth rejected any suggestion that the destruction of the sperm represented a personal injury[155] nevertheless, it is instructive to look at the ways in which parts of the body are valued in this context. It has been suggested that it is open to debate that in addition to tissues provided for SC research being property, some TPs provide a service in making these available to researchers. While it would be illogical to base the existence or otherwise of property in the body on the level of physical burden required to obtain these tissues, nevertheless it is beyond dispute that the provision, for example of ova, is more arduous than that of sperm, and this should be reflected by any system of recompense. Payment for the service element could also be incorporated into the tariff with its level being established through an assessment of the time, inconvenience, physical burden and risk inherent in retrieval of the relevant tissue.
Let us take the example of ova provision which involves exposure to hormones through injection and then an invasive procedure to extract the eggs. How might this be valued by way of reference to these guidelines? Negligently caused sterility or infertility without additional psychiatric harm will result in awards of around £4250 (for men) and up to £8000 for women,[156] but it is to be hoped that in the normal course of things the provision of ova will not result in infertility and so on the basis of this comparison TPs might be over-recompensed. An alternative comparison might be illness resulting from non-traumatic injury such as food poisoning[157] ‘causing significant discomfort, stomach cramps, alteration of bowel function and fatigue[, h]ospital admission for some days with symptoms lasting for a few weeks but complete recovery within a year or two’ is valued at £2500 to £6150[158] while the less unpleasant experience of ‘various degrees of disabling pain, cramps and diarrhoea continuing for some days or weeks’ would lead to an award of £600 to £2500.[159] A reasonable payment for the discomfort in undergoing ova extraction could therefore be said to be around £2500. A nominal amount, perhaps in the region of £100 would be payable for sperm or tissues retrieved during other operations, with payments to the providers of embryos being based not on the embryo itself but on the basis of the gametes provided to create that embryo. Such modest sums would not be prohibitive for research groups undertaking this work, and would still allow us to recognise the full spectrum of values inherent in such human tissues. Section 12(e) of the 1990 Act provides that ‘no money or other benefit shall be given or received in respect of any supply of gametes, embryos or human admixed embryos unless authorised by directions’. This provision should be taken advantage of to implement directions to allow for payment to TPs. In addition, TPs should continue to be entitled to reimbursement for reasonably incurred expenses.[160]
3 Payment in Kind
Direct forms of payment may not accord with the aims of the TP in contributing to SC research, that is to contribute to the development of effective treatments for the condition from which they or a family member is suffering so that they can then access such treatments. A system in which TPs have priority access to SC therapies in recognition of their contribution[161] would overcome this, and avoid situations where individuals who had contributed their tissues to the development of therapies were denied access to them at a later stage due to prohibitive cost. An example of this occurring was the case of Greenberg v Miami Children’s Hospital Research Institute[162] in which tissue samples were provided from the families of children with Canavan disease and which were then used to patent the gene and tests for the condition so that licence fees had to be paid by sufferers to access these tests. The court concluded that the researchers and the hospital to which they were affiliated had the right to be granted such patents.
It is therefore recommended that a hybrid system be implemented. This would combine direct tariff-based payments taking into account the value of both the tissue and the physical burden (a form of service provided by some TPs) experienced at the time of tissue provision, and access to benefits in kind in the form of SC therapies where available. Before such a system could be implemented, sufficient evidence would have to be obtained that its implementation would achieve the objective of increasing the amounts of tissue available for SC research,[163] so that its financial and administrative burdens could be justified. Tissue providers would have to be warned that there would be no guarantees that such therapies would become available. Appropriate oversight by the HFEA would be required to ensure that the system of payment was properly implemented and run. As argued above in light of the Moore case,[164] the level of recompense available to TPs must be made explicit to them in advance, an opportune time to discuss this being during the counselling and consent process undergone before tissue provision.
Conclusion
It has been demonstrated in this chapter that excised human tissue provided for research use can validly be categorised as property, with all that entails in terms of the basis on which it is exchanged and the entitlements of its owners to do certain things with it. The common law has left the door open for recognition of the intrinsic value of tissue for a variety of scientific purposes. The special nature of such tissue within the realm of SC research leads us to the conclusion that the law should fully acknowledge its property status and the entitlements to recompense which this accords its providers.
Commercial involvement is needed in biotechnology so that the potential of SC therapies can be explored in the hope that effective treatments will in due course be made available to the public.[165] It is doubtful that commercial enterprise could be removed from the arena entirely, as ‘there is no effective mechanism, analogous to the price system, capable of solving "the information and coordination problems confronting a legion of altruistic citizens looking to engage in collectively beneficial activities”’.[166] This is not to say that the current system is the most appropriate.[167] However, if recompense is to be available to any of those who contribute to the process (whether through labour or raw materials), it should be available to all. Given the thriving trade in tissues which exists once tissues move beyond the control of TPs, the law appears to have carried out a remarkable sleight of hand in denying property to them. Rather than perpetuating an unjust exclusion from the commercial sphere, the legal system should instead focus on the extent to which property rights can be acknowledged at each stage in the development process. The current unjustifiable imbalance which provides that SC researchers may possess property rights over excised tissues but which denies outright such entitlements to TPs for research, must be corrected in order for the law to retain its legitimacy.
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[1] Suzanne Holland, ‘Contested Commodities at Both Ends of Life: Buying and Selling Gametes, Embryos, and Body Tissues’ (2001) 11(3) Kennedy Institute of Ethics Journal 266.
[2] David B Resnik, ‘The Commercialization of Human Stem Cells: Ethical and Policy Issues’, 10(2) (2002) Health Care Analysis 127.
[3] For example, s 12(1)(e) of the Human Fertilisation and Embryology Act 1990 (the 1990 Act) (as amended) provides that ‘no money or other benefit shall be given or received in respect of any supply of gametes, embryos or human admixed embryos unless authorised by directions’.
[4] [2009] EWCA Civ 37.
[5] James W Harris, ‘Who Owns My Body?’ 16(1) (1996) Oxford Journal of Legal Studies 55-84, 57.
[6] For an exposition of just some of these see for example Crawford B Macpherson (Ed) Property: Mainstream and Critical Positions (Blackwell: Oxford 1978).
[7] Andrew Grubb, ‘“I, Me Mine”: Bodies, Parts and Property’, (1998) 3 Medical Law International 299-317.
[8] Yearworth, (n4) [28].
[9] Grubb (n7).
[10] Tony Honoré, Making Law Bind: Essays Legal and Philosophical, (Clarendon Press, Oxford 1987).
[11] Ibid, 165.
[12] Harris (n5) 57.
[13] Ibid, 65.
[14] For a discussion of bodily ownership ‘rhetoric’ see Harris (n5), 62-65.
[15] Nuffield Council on Bioethics, Human Tissue: Ethical and Legal Issues (1 April 1995). Note that this issue is being explored again by the Nuffield Council on Bioethics in its consultation document, Give and Take? Human Bodies in Medicine and Research (April 2010),
(accessed 9 July 2010).
[16] Nuffield Council on Bioethics (1995) ibid [9.13].
[17] Ibid [9.14].
[18] J Kenyon Mason and Graeme T Laurie, ‘Consent or Property? Dealing with the Body and its Parts in the Shadow of Bristol and Alder Hey’ 64 (2001) Modern Law Review 725.
[19] For example, Medical Research Council, Human Tissue and Biological Samples for Use in Research - Operational and Ethical Guidelines (2001) which describes tissue provision for research as being part of a ‘gift’ relationship; Human Fertilisation and Embryology Authority Code of Practice (8th Edition) in its provisions on ‘donation’.
[20] Mason and Laurie (n18) 725.
[21] Something which the Nuffield Council on Bioethics is going some way to acknowledging in its latest consultation on this topic, (2010), (n15).
[22] Holland (n 1) 272.
[23] Ibid, 272.
[24] See Yearworth (n4) at [45(f)(ii)] for confirmation that the law bestows a limited ‘right to use’ their sperm on men who have stored it in licensed fertility clinic premises for future reproductive use.
[25] (1998) 3 All ER 741 (CA Crim).
[26] The position adopted in this thesis is that, for the purposes of determining whether or not excised tissue can be property, it matters not whether they are removed from the body of the living or the dead. The tissues themselves have the same potential commercial applications in both cases. For a debate on the issues of importance to the families of the deceased from whom tissues have been removed, see John Harris, ‘Law and Regulation of Retained Organs: The Ethical Issues’ 22(4) (2002) Legal Studies 527 and, in response, Margaret Brazier ‘Retained Organs: Ethics and Humanity’, Legal Studies 22(4) (2002) 550-569.
[27] Note a number of exceptions to this general tenet in the case of bodily substances, e.g. blood specimens (R v Rothery [1976] RTR 550 (CA) 552-53); urine samples (R v Welsh [1974] RTR 478 (CA) 479); and hair (R v Herbert [1961] JPLGR 12, 13.
[28] 1908 6 CLR 406.
[29] Ibid at 414.
[30] Ibid at 414.
[31] Ibid at 414.
[32] R v Kelly (n40) at 749-750 referring again to Doodeward and Spence, ibid, and see Dobson v North Tyneside Health Authority [1997] 1 WLR 596 (CA) at 601, where this proposition appears to have been accepted.
[33] R v Kelly, ibid at 750 using the examples of an organ transplant operation, or the extraction of DNA or as a trial exhibit.
[34] (n4).
[35] Ibid at [29].
[36] Ibid at [45(a)].
[37] Ibid at [45(f)].
[38] 20 Cal Rptr 2d 275.
[39] Yearworth (n4) at [40].
[40] Ibid.
[41] Hecht v Superior Court of the County of Los Angeles (1996) 50 Cal.App.4th 1289.
[42] (n4). The Court of Appeal noted at [45(b)] that they had not been invited to consider whether a significant difference existed between cases where the tissue was intended for use by its progenitor and those where it was not.
[43] Ibid.
[44] Ibid.
[45] Ibid.
[46] Ibid.
[47] For example ova or embryos used in SCNT or cells reprogrammed to their pluripotent state.
[48] Ibid 76.
[49] Julia D Mahoney, ‘The Market for Human Tissue’ 86(2) (2000) Virginia Law Review, 163-223, 182.
[50] Donna Dickensen, Property in the Body: Feminist Perspectives, (Cambridge University Press, Cambridge 2007) 74.
[51] Harris (n5) 77.
[52] Françoise Baylis and Carolyn McLeod, ‘The Stem Cell Debate Continues: the Buying and Selling of Eggs for Research’ 33 (2007) Journal of Medical Ethics 728.
[53] Mason and Laurie (n18) 713.
[54] Radin, M, Contested Commodities (Harvard University Press, Cambridge, MA 1996).
[55] Resnik (n2) 140.
[56] Mahoney (n28) 201.
[57] Resnik (n2) 140.
[58] Mahoney (n28) 208.
[59] Holland (n1) 279-80.
[60] Gerald A Cohen, Self-Ownership, Freedom and Equality, (Cambridge University Press, Cambridge 1995) 71.
[61] Grubb (n7) 311. But note that if wild flowers grow in a garden they belong to the garden’s owner.
[62] Rohan Hardcastle, Law and the Human Body: Property Rights, Ownership and Control (Hart Publishing, Oxford and Portland, Oregon 2007) 130.
[63] Mason and Laurie, (n18) 726.
[64] Harris (n5) 60.
[65] John Locke, The Second Treatise of Government, Edited by Gough JW, (Basil Blackwell, Oxford 1976) at Chapter 5 [27] ‘Whatsoever, then, he removes out of the state that nature hath provided and left it in, he hath mixed his labour with, and joined to it something that is his own, and thereby makes it his property’.
[66] In for example Dobson v North Tyneside Health Authority [1997] 1 WLR 596 (CA) – note however that preservation of the brain in paraffin in this case was not sufficient to constitute work or skill.
[67] [2004] EWHC 644 (QB); [2005] QB 506.
[68] Hardcastle (n69) 39.
[69] Although it is acknowledged that the level of work is significantly more onerous for a TP making ova available than for one who provides sperm or skin cells.
[70] Although it may have relevance in relation to the level of recompense awarded – see section 9 below.
[71] This issue has been considered in relation to genetic material by Kadri Simm, ‘Benefit-Sharing: An Inquiry Regarding the Meaning and Limits of the Concept in Human Genetic Research’, (2005) 1(2) Genomics, Society and Policy, 34.
[72] (N4).
[73] (N47).
[74] (N4) at [45(d)].
[75] In paragraph 2(1) of Schedule 3 of the 1990 Act, consent to use a stored embryo may specify conditions as to its use (including research uses) while paragraph 2(2) allows consent to storage of gametes, embryos or human admixed embryos to include conditions. Under Schedule 3 paragraph 4, consent may apply to any embryo created through the provisions of gametes. The Human Fertilisation and Embryology Authority’s Code of Practice (8th Edition) also provides that individuals providing gametes (or embryos made from them) for research or other purposes may specify conditions as to their use – see section 5.5.
[76] Yearworth (n4) at [45(f)(ii)].
[77] Harris (n5) 82.
[78] (N40).
[79] Charles A Erin, ‘Who Owns Mo? Using Historical Entitlement Theory to Decide the Ownership of Human Derived Cell Lines’, in Anthony Dyson and John Harris (eds) Ethics and Biotechnology (Routledge, London and New York 1994) 167.
[80] Harris (n5) 81-82.
[81] Ibid, 66.
[82] Mary Dixon-Woods et al, ‘Tissue Samples as ‘Gifts’ for Research: A Qualitative Study of Families and Professionals’ (2008) 9(2) Medical Law International 131-150; Janet Radcliffe Richards et al ‘The Case for Allowing Kidney Sales’ (1998) 351 Lancet 1950-1952.
[83] For example, a distributional argument could be used to suggest that profits from SC therapies can be made as long as this does not mean that beneficial treatments are unavailable to those who cannot afford them –see Harris (n5) 66 for discussion of this form of argument.
[84] Dixon-Woods (n89). The study’s authors note that some of these feelings may have been engendered as a result of the context of the tissue provision: paediatric oncology research.
[85] See Lionel Bently and Brad Sherman, ‘The Ethics of Patenting: Towards a Transgenic Patent System’ (1995) 3 Modern Law Review 275-291 noting mistrust in scientific communities and Rhydian Hapgood, Chris McCabe and Darren Schickle, ‘Public Preferences for Participation in a Large DNA Cohort Study: A Discrete Choice Experiment’ (2004) Discussion Paper 04/5, acc. 18 May 2010 where the prospect of profits or patents for biotechnology companies as a result of public participation in their projects undermined confidence.
[86] (1990) 793 P 2d 479 (Cal Sup Ct).
[87] At 492.
[88] At 494.
[89] At 494.
[90] [1990] 271 Cal Rptr 146, 154-5, 160-3.
[91] Russell B Korobkin, ‘Buying and Selling Human Tissues for Stem Cell Research’, Arizona Law Review, 49, (2007) 61. See also section 8.
[92] Ibid, 63.
[93] Mahoney (n28) 211.
[94] 793 P 2d 479 Cal SC.
[95] Lori P Knowles, ‘Human Primordial Stem Cells: Property, Progeny and Patents’ (1999) 29(2) The Hastings Center Report 39.
[96] Resnik (n2) 138.
[97] Mason and Laurie (n18) 727.
[98] Gretchen Vogel, ‘Ethical Oocytes: Available for a Price’ (2006) 313 Science 155.
[99] For a discussion of the types of systems of recompense which might be applied, see section 2.9 below.
[100] Mahoney (n28) 215.
[101] Mason and Laurie (n18) 725.
[102] Ibid, 726.
[103] Ibid, 725.
[104] Where the tissues are intended for the TP’s own use, damages are available in bailment (in which a duty to take reasonable care of a chattel transferred into their possession falls onto a bailee – see Yearworth (n4) at [48].
[105] Graeme Laurie, Genetic Privacy: A Challenge to Medico-Legal Norms (Cambridge University Press, Cambridge 2002) 316.
[106] Yearworth (n4) at [45(b)].
[107] Harris (n5) 59.
[108] Knowles (n104) 39.
[109] Tom L Beauchamp and James F Childress, Principles of Biomedical Ethics, (5th Edn Oxford University Press, Oxford 2001) 58.
[110] Ibid, 77.
[111] Harris (n5) 65.
[112] Note the comparative provisions on ‘authorisation’ in the Human Tissue (Scotland) Act 2006.
[113] Schedule 3 of the 1990 Act (as amended).
[114] See Ian Kennedy, The Report of the Public Inquiry into Children’s Heart Surgery at the Bristol Royal Infirmary 1984-1985: Learning from Bristol (July 2001 CM 5207(1)).
[115] Ian Kennedy, Removal and Retention of Human Materials, Interim Report of the Inquiry into the Management of Care of Children Receiving Complex Heart Surgery at the Bristol Royal Infirmary, (May 2000).
[116] Ibid, 1.
[117] Brazier (n41) 552. See Medical Research Council Public Perceptions of the Collection of Human Biological Samples (London 2000) for evidence that the consent system was not viewed as adequate by the general public.
[118] Brazier (n41) 554.
[119] (London: The Stationary Office, 2001). This report resulted from an inquiry into the circumstances leading to the removal, retention and disposal of human tissue, including organs and body parts, from children at the Royal Liverpool Children's NHS Trust (and its predecessor NHS organisations) who had undergone post mortems.
[120] Mahoney (n28) 181-2.
[121] Airedale NHS Trust v Bland [1993] AC 789 (HL); Re MB (Adult: Medical Treatment) (1997) 38 BMLR 175 (CA); St George’s Healthcare NHS Trust v S [1998] 3 All ER 673 (CA); Gillick v West Norfolk and Wisbech Area Health Authority [1985] 3 All ER 402.
[122] Harris (n5) 82.
[123] Hardcastle (n69) 79.
[124] (N4) at [45(f)(i)].
[125] Ibid at [45(f)(ii)].
[126] Ibid at [45(f)(iv)].
[127] Ibid at [45(f)(iii)].
[128] Ibid at [28].
[129] See their repetition of this point at [45(f)(v)].
[130] Evans v Amicus Healthcare Ltd (Secretary of State for Health Intervening) [2005] Fam 1 para 23 (the other pillar identified in the same paragraph as being the focus on the welfare of any child born as a result of actions taken under the 1990 Act).
[131] Yearworth (n4) at [23].
[132] Dickensen (n29) 28 and see Mason and Laurie (n18) 719.
[133] Jean McHale, ‘Waste, Ownership and Bodily Products’ (2000) 8(2) Health Care Analysis 126.
[134] The use of appropriately regulated mechanisms would obviate the need for gimmicks such as the raffling of ova which occurred in the UK in March 2010. This was undertaken to provide an ovum for reproductive purposes in the US. See Aislinn Laing, ‘Fertility Clinic to Raffle Human Egg in London to Promote IVF Service’ The Telegraph (London 14 March 2010).
[135] Honoré (n10).
[136] Ibid, 166.
[137] (N4).
[138] For example, compensation in bailment as awarded under Yearworth.
[139] Honoré (n10) 168
[140] Human Fertilisation and Embryology Act 1990 Schedule 3 Paragraph 12(1).
[141] Human Fertilisation and Embryology Act 1990 Schedule 3 Paragraphs 2(1A) and (4) and 12(2) and (3).
[142] Section 4A(1)(a).
[143] It is acknowledged that the arguments made in this section may have implications for other spheres such as organ donation or reproductive technologies but these are beyond the remit of this thesis. For a consideration of the issues involved on a wider scale see Nuffield Council on Bioethics (April 2010) (n15).
[144] For an argument that in relation to blood and blood products, a system of voluntary, unpaid donation should be maintained for ethical, safety and economic reasons, see Richard M Titmuss, The Gift Relationship: From Human Blood to Social Policy, (London: George Allen and Unwin, 1970). The ability of such a system to ensure the safety of these tissues is disputed in Anne-Maree Farrell, ‘Is the Gift Still Good? Examining the Politics and Regulation of Blood Safety in the European Union’, (2006) 14(2) Medical Law Review 155-179.
[145] Such a system has been considered in Charlotte H Harrison, ‘Neither Moore Nor the Market: Alternative Models for Compensating Contributors of Human Tissue’ (2002) 28 American Journal of Law and Medicine 77-105.
[146] Ibid, 98. This is not an impossible task – similar requirements are made under Council Directive 2004/23/EC (Tissue Directive) enshrined in UK law through the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (SI 2007/1522) which ensures that stem cell lines for human application be traceable between provider and recipient. Further, s12(3)(a) 1990 Act holds that all stem cell research licenses should require ‘such information as is necessary to facilitate the traceability of gametes and embryos’ be recorded and supplied to the HFEA on request.
[147] Such systems are provided for in example in the Human Tissue Authority Code of Practice on Consent (2009) [119].
[148] Harrison (n154) 98. The 1990 Act provides that cells from those lacking capacity (either as children or adults) or where the donor can no longer be identified or has died can be used and stored – resulting financial benefits should go into the person’s estate or a charitable scientific fund.
[149] Dixon-Woods (n89) 131-150.
[150] Honoré (n10) 170. Note that such transfer can take place for no financial gain if that is the wish of the TP, the position which the law currently provides for.
[151] Harrison (n154) 96. This is a form of exercise currently being undertaken by the Nuffield Council on Bioethics (2010) (n15). See also a similar system introduced by the Empire State Stem Cell Board in New York in June 2009, ‘Statement of the Empire State Stem Cell Board
on the Compensation of Oocyte Donors’,
accessed 28 June 2010.
[152] Statement by Chris Thorne, Partner, Foot Anstey Solicitors, (Solicitors for the Claimants in Yearworth) (Personal email correspondence 27 April 2010).
[153] Statement by Chris Thorne, Partner, Foot Anstey Solicitors, (Solicitors for the Claimants in Yearworth) (Personal email correspondence 20 April 2010).
[154] The starting point is usually by way of reference to the categories of injury identified in Judicial Studies Board, Guidelines for the Assessment of General Damages in Personal Injury Cases (9th edn, Oxford: Oxford University Press, 2008).
[155] Yearworth (n4) [23].
[156] Judicial Studies Board (n163) Chapter 5 Injuries to Internal Organs sections E(e) and F(c).
[157] Ibid, Chapter 5.
[158] Ibid, Chapter 5 Injuries to Internal Organs section G(b)(iii).
[159] Ibid, Chapter 5 Injuries to Internal Organs section G(b)(iv).
[160] Gamete and embryo donors can claim any expenses which relate to the provision of these tissues subject to a daily limit of £61.28 and an overall cap of £250. See Human Fertilisation and Embryology Authority, Directions: Gamete and Embryo Donation, Ref 0001, Version 2 (April 2010) accessed 18 May 2010.
[161] Considered in Harrison (n154).
[162] 264 F Supp 2d 1064 (US DC Florida 2003).
[163] For example by undertaking the sorts of surveys which led to the organ donation law in Israel which grants priority allocation of donated organs to those who have been registered as an organ donor for three years or more. See Jacob Lavee et al, ‘A New Law for Allocation of Donor Organs in Israel’ 375 (2010) The Lancet 1131-33.
[164] (N93).
[165] Stephen Wilkinson S, ‘Biomedical Research and the Commercial Exploitation of Human Tissue’, (2005) 1(1) Genomics Society and Policy 27-40, 32.
[166] Mahoney JD (n28), 197 citing Avner Ben-Ner and Louis G Putterman, ‘Values and Institutions in Economic Analysis’ in Avner Ben-Ner and Louis G Putterman (eds) Economics, Values and Organizations (Cambridge: Cambridge University Press, 1998).
[167] For references on patents and morality see Deryck Beyleveld and Roger Brownsword, Mice, Morality and Patents (London: Common Law Institute of Intellectual Property, 1993); AmandaWarren-Jones ‘Morally Regulating Innovation: What is Commercial Exploitation?’ Intellectual Property Quarterly, (2008) 193-212 and Amanda Odell-West, ‘The Absence of Informed Consent to Commercial Exploitation for Inventions Developed from Human Biological Material: A Bar to Patentability?’ (2009) 3 Intellectual Property Quarterly 373-390.
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