Utilising parts of the dead: Organ donation and posthumous reproduction
Organ donation and posthumous reproduction
Today our thoughts regarding the disposition of our bodies [are] not limited to the wake, the shroud, the casket and the funeral.1
Corpses are not simply inanimate beings destined for speedy disposal; they play a vital role in medical research and teaching, as well as educational exhibits and museum displays,2 and in scientific experiments to give a few examples.3 While the subject-matter is dead material (either the intact corpse or specific bodily components), living material supplied by dead donors can also be put to various uses – setting surviving relatives on a collision course before thoughts have even turned to the funeral. Two of the most common scenarios involve organs used for transplant purposes, and reproductive material to facilitate post-mortem genetic parenting.
Both technologies entered the medical scene in the latter half of the twentieth century, and raise a host of legal and ethical issues. In analysing the law’s response to cadaveric organ transplants and posthumous reproduction, this chapter focuses on the respective legal frameworks, and who has decision-making authority under each. It also examines potential conflicts between the wishes of the dead and those of the living or within the deceased’s family itself (recurring themes in any discourse involving the dead), and questions the legal status of excised human material.
Major medical strides have been made since the first successful kidney transplant in the 1950s, with several thousand organ transplants carried out annually in the UK.4 While these include living and dead donors, the latter account for the majority of transplant procedures, offering the hope of life-saving (or life-prolonging) treatment to growing numbers of people.
Pattison describes the regulation and practice of cadaveric transplantation as an “ethical minefield”5 – hardly surprising given the complex issues at play.6 Individual legal systems must strike a delicate balance between the rights of the donor, the interests of their family and the public need for organs,7 while recognising deep-rooted social, religious and cultural views on the inviolability of the human corpse that shape contemporary attitudes to donation.8 Meanwhile, the success of cadaveric organ transplants has also forced certain changes in the law. Since most major organs have to be removed within a short time of death and only remain transplantable for a few hours, one of the most important has been the introduction of the brain-stem death standard alongside the traditional concept of cardiopulmonary death.9 And while the preoccupation with being able to tell whether or not someone is ‘really dead’ is not a novel one,10 it has added resonance here. As Mims explains:
At one time the main worry was that people might be buried before they had actually died.… For organ transplantation, however, time is of the essence, and fear of premature burial has been replaced by fear of premature organ removal. The concept of ‘brain death’ was introduced to assuage this anxiety.11
By defining and applying strict diagnostic standards for brain-stem death,12 the law reassures private citizens that they cannot simply be pronounced dead by overly-zealous transplant surgeons, loitering by the deathbed to harvest organs for needy recipients. However, altering the definition of death is only one aspect of the law’s response to transplantation; legislators also had to introduce a specific legal mechanism for donating organs at the point of death. English law favours an ‘opt-in’ system, whereby organs can only be removed if the deceased consented to this while alive, or (failing that) surviving relatives sanction their retrieval.13 This particular regulatory framework has been criticised, since the need to consciously opt in does little to address the acute shortfall in organs when thousands remain on waiting lists for transplants every year.14 The perennial issue of demand outstripping supply is a global one, with other jurisdictions adopting an ‘opt-out’ or ‘presumed consent’ system (here, everyone is deemed to be a donor, unless they have registered their objection15) as a deliberate organ procurement strat egy.16 Wales is currently implementing this scheme,17 though debates about similar legislative changes are ongoing throughout the rest of the UK.18
1. The legal framework: The Human Tissue Act 2004
The current legislation is the Human Tissue Act 2004, passed in response to high-profile organ retention scandals at Alder Hey Hospital and others19 throughout the UK in the late 1990s.20 Its remit is an extensive one; as well as covering the storage and use of human tissue from living donors, the 2004 Act regulates the removal, storage and use of “relevant material” from the dead21 – including human organs for transplant.22
The Act is underpinned by the principle of “appropriate consent”.23 Organ donation, however, contemplates three distinct levels of consent starting with the deceased’s prior approval (or refusal) as a living, competent adult in accordance with s 3.24 Where the deceased has not made their wishes known, decision-making authority passes to a nominated representative, or (failing that) to a person who stood in a “qualifying relationship” with the deceased.25 An innovative feature of the 2004 Act, nominated representatives effectively act as surrogate decision-makers – important, for example, where the deceased does not want to burden (or, perhaps, does not trust) specific relatives with organ donation choices.26 However, where family members are approached, the 2004 Act is more reflective of modern kinship structures than other laws concerning the fate of the dead.27 Section 27(4) of the 2004 Act ranks qualifying relationships, in descending order, as follows: (a) spouse or partner, (b) parent or child, (c) sibling, (d) grandparent or grandchild, (e) niece or nephew, (f) stepmother or stepfather, (g) half-sibling and (h) a friend of long standing.28 The fact that partners have the same rights as spouses is a significant development,29 as is the inclusion of step-parents and a long-term friend where all other relational categories have been exhausted.30 Such an expansive listing allows the consent-seeking net to be cast widely if this tertiary layer is invoked. However, the 2004 Act allows an individual’s relationship to be omitted if he/she declines to deal with the issue, is unable to give consent,31 or cannot be located in time to consider a request for organ donation.32 Here, decision-making powers pass to the next person in the hierarchy (or within the same class).
Securing appropriate consent makes the relevant activity lawful under the 2004 Act.33 However, the legislation also imposes criminal law sanctions for breach of this requirement, and for the unauthorised use of donated corpses and bodily material.34 For example, under s 5(1) a person commits an offence if they fail to obtain appropriate consent when needed, unless that person “reasonably believes” that they are carrying out the relevant activity (such as obtaining organs for transplantation) with the requisite consent. Section 32 also prohibits commercial dealings in human material for transplantation.35
2. The wishes of the dead versus the preferences of the living
Harvesting organs is often the first flash-point over the fate of the deceased’s remains, as surviving relatives register their objections. Commonly cited reasons include bodily integrity, religious or cultural sensitivities, fears of ‘harming’ the dead, and an innate aversion towards organ donation; in brain-stem death scenarios, the patient’s life-like appearance and concerns that death is being hastened for organ retrieval are also powerful influences.36
Any organ donation law “requires balancing the interests of multiple stakeholders”.37 Under the 2004 Act, appropriate consent can only be given by someone in a qualifying relationship with the deceased, if the latter’s wishes are unknown (and there is no nominated representative). When confronted with a difference of opinion within the deceased’s family, the law reverts to type and looks to the highest ranking individual in the statutory hierarchy;38 their decision is final, and medical staff cannot traverse the pecking order to solicit permission from someone lower down the list.39 Specific provisions also apply where there is a conflict between individuals who are ranked together – for example, if a partner’s willingness to donate the deceased’s organs is contested by an estranged spouse, or only one of the deceased’s children is prepared to consent.40 In keeping with the broad utilitarian objectives of transplantation (and the time-sensitive nature of organ retrieval), one person’s consent will suffice here;41 the procedure is lawful and can go ahead.
More complex issues arise, however, where the deceased has explicitly stated that they want to be an organ donor, but family members object.42 Under the 2004 Act, the legal position is clear: the deceased’s ante-mortem preferences are the first indicator of appropriate consent and should be prioritised accordingly. However, the operational realities are very different. In both this country and elsewhere, standard medical practice is to negotiate organ retrieval with the next-of-kin regardless of the deceased’s prior consent; if they object, organs will not be harvested, giving family members an effective right of veto over the deceased’s opt-in.43 While accepting that the emotional well-being of grieving relatives is a legitimate concern, Cantor has criticised this culture of deference because:
… nonadherence to decedents’ wishes … deprives decedents of their legal right to donate their organs or tissue for transplant. The decedent’s prospective autonomy prerogative then remains a theoretical legal right without a remedy if neither the health facility nor another family member chooses to contest survivors’ objections to implementing the decedents’ wishes.44
Respect for autonomy, as a core value of most legal systems, dictates that an individual has the final say on the fate of their remains.45 If the substantive requirements of the 2004 Act are met, the deceased’s conscious choice to be an organ donor should not be discounted just because of family opposition. Besides, the right to self-determination is only part of the picture here; increasing the supply of organs has clear utilitarian objectives, which strengthen the case for the deceased’s donative preferences being paramount.46
These basic ideas are reflected in the Codes of Practice accompanying the 2004 Act, which suggest that family members should be “encouraged to recognise the wishes of the deceased” and reminded, “if necessary, that they do not have the legal right to veto or overrule their [loved one’s] wishes”.47
There is – unsurprisingly – no English case law on whether a family can override valid donor consent based on either conscientious objections, or other grounds of disapproval. Unlike funeral instructions where the deceased’s wishes are not legally enforceable, the 2004 Act provides a statutory mechanism for post-mortem donation which theoretically supersedes any entitlements that the deceased’s next-of-kin (or executor) have by virtue of their common law right to possession of the remains.48 While medical facilities could simply ignore family objections and harvest organs based on the deceased’s explicit consent, this is unlikely to happen; ethical issues aside, inflicting emotional distress on grieving relatives would attract negative publicity, and doctors might fear the prospect of legal action if they proceed.49 Until the relevant legislation (and procurement protocols) make it clear that valid donor consent is legally binding and should be followed where retrieval is medically viable,50 organ donation is an area where the wishes of the dead will often yield to the sensitivities of the living.
3. The legal status of transplant material
Removal of bodily material from a human source raises inevitable questions around its legal status. What if an excised organ is damaged before it can be placed in a potential recipient; or lost or misappropriated while being transported between medical facilities? The 2004 Act imposes criminal law sanctions for breach of its consent provisions,51 but is silent on the question of civil redress in the scenarios identified here.52 Private law remedies are an obvious solution, but raise complex questions53 – not just around the applicable cause of action, but what rights living and dead donors (or family members representing the deceased) have in removed organs, and what legal entitlement (if any) the intended recipient has where that person has been identified when the damage or loss occurred.54
The fact that organ donations are handled exclusively by the NHS in England and Wales (and the rest of the UK) precludes recovery in contract because there is no such arrangement with the relevant hospital.55 A cause of action in negligence is also unlikely. For example, negligent infliction of psychiatric illness (what used to be termed ‘nervous shock’) would be extremely difficult to establish,56 while damage to property as a result of negligence would depend on courts recognising a sufficient proprietary interest in the damaged or lost organ to found such a claim – something which would also be required in an action in bailment.57 The decision in Yearworth v North Bristol NHS Trust58 at least opens up the possibility of an individual having proprietary interests in his/her donated material, and vociferous arguments have been made elsewhere that donated organs should be treated as a species of property to facilitate certain causes of action and recovery for damage or loss sustained in the period between removal and transplantation.59 Whether surviving relatives could seek redress on behalf of a dead donor is questionable;60 if asserting their own distinct, legal entitlement, would the right to possession of the body for disposal purposes extend to excised organs, given that these have been removed with appropriate consent and proprietary claims almost certainly relinquished at this stage?61 A property-based analysis is more apposite with living donors, and in directed donation scenarios generally when the rights of the intended recipient also come into play.62
Children coming into existence after the death of a parent is not a new phenomenon, though the ways in which this can occur have altered dramatically. Historically, the only example was where a child already in its mother’s womb (‘en ventre sa mere’, to use the common law’s descriptive term) was born after the death of its father.63 However, modern science facilitates postmortem reproduction (and even conception) where one of the biological parents is dead.64 For example, frozen embryos65 created as part of an earlier IVF cycle can be defrosted and implanted in the biological mother66 (or a willing surrogate, if the former has died and her husband or partner wants to continue the couple’s quest for parenthood). Frozen sperm samples – often deposited as precautionary measure where a man’s fertility might be compromised67 – can be used to inseminate his wife or partner in the event of the donor’s death.68 Moving a step further, sperm can be retrieved from a recently deceased male, or one who is in a coma, or a persistent vegetative state (‘PVS’) or has been pronounced brain-dead; this is then used to create the donor’s biological child.69
Enabling the dead to procreate using artificial methods raises complex legal, medical, social and ethical issues, which all shade into each other at various points.70 From the law’s perspective, however, the most significant are entitlements to access and use reproductive material, and the legal status of frozen embryos and sperm.
1. The legal framework: Contracts, consent and statute
Both IVF and assisted reproduction are regulated by statute throughout the UK, under the combined provisions of Human Fertilisation and Embryology Act 1990 and the Human Fertilisation and Embryology Act 2008. The 1990 Act also established the Human Fertilisation and Embryology Authority (‘HFEA’);71 as an independent regulatory body,72 the HFEA licenses fertility clinics and centres carrying out IVF and other assisted conception procedures in this country, and issues ethical guidelines in the form of a Code of Practice, which is revised every few years.73 HFEA-issued licences are required for the creation of embryos outside the body, and for their subsequent freezing or use; the same applies to the freezing or use of donated gametes such as sperm.74 From a treatment perspective, however, the key requirement is “effective consent” as detailed in Sch 3 of the 1990 Act.75 In short, written and signed consent is required from each of the parties being treated for infertility by a licensed clinic or centre;76 this consent includes the use of any embryo in providing treatment services,77 as well as the storage of gametes or embryos.78
While some other countries determine the use of frozen embryos or gametes through private law litigation,79 the regulatory framework outlined above plays a major role in this jurisdiction. If a bereaved spouse or partner wants to access surplus embryos from an earlier IVF cycle, his/her ability to do so will depend on the deceased’s express consent to their use in another treatment cycle – derived from the standard consent forms that the parties originally signed with the clinic, and mirroring the legal requirements of the 1990 Act.80 Accessing preserved sperm in an attempt to conceive the deceased’s biological child also depends on the deceased having consented to their use in this specific manner, and naming the surviving spouse or partner as the person to use his gametes in any treatment.81 Once again, the regulatory framework upholds the core ideal of reproductive autonomy, as reflected in the deceased’s ante-mortem choices.82
Much more complex legal (and ethical) issues arise where conceiving a biological child involves retrieving sperm from a sudden death or a comatose, PVS or brain-stem-dead male – usually at the request of the man’s spouse, girlfriend or partner.83 While posthumous reproduction should be predicated on the deceased’s express consent, the sudden and unexpected course of events means that the deceased will not have explicitly agreed to the retrieval of his sperm or its subsequent use. In these circumstances, the law looks for evidence of implied consent, based on things like the couple having mentioned having (more) children to family and friends, or having sought advice on fertility treatment at some stage in the past. The inherent dangers are obvious: it is easy to lose sight of the legal requirements when faced with the desperate pleas of a grieving spouse or partner,84 and decision-makers may struggle with how much weight to give self-serving statements about the deceased’s apparent willingness to conceive a child posthumously where he died without any explicit indication.85 What constitutes implied consent is open to debate;86 merely being in a committed relationship does not, in itself, prove that the deceased and their surviving partner were agreed on having children – let alone that the same partner should conceive, carry and raise the individual’s child after his death. Cantor, for example, emphasises that the deceased’s prospective autonomy interest can be damaged if there is no compelling evidence that he wanted to become a post-mortem parent.87
The legal position is also unclear, and was first explored in this country by R v Human Fertilisation and Embryology Authority, ex parte Blood88 where Diane Blood wanted to use sperm extracted from her comatose husband shortly before he died, in order to conceive the couple’s biological child.89 Since the storage of gametes and their use in any subsequent fertility treatment in the UK is dependent on effective consent in accordance with the 1990 Act,90 and no such consent had been obtained from the deceased here, the Court of Appeal decided that the sperm was being stored and preserved unlawfully. The HFEA was asked to reconsider its decision to refuse an export licence for the sperm,91 and the gametes were eventually transferred to a clinic in Belgium.92 A decade later, similar issues arose in L v Human Fertilisation and Embryology Authority (‘HFEA’)93 where the deceased’s wife wanted to use her husband’s sperm (obtained after his sudden death following an appendectomy),94 with questions once again being posed over the lawfulness of storing gametes in this country without the written consent of the gamete provider.95 However, the court also addressed the more fundamental issue of authorising sperm retrieval from a dead or irretrievably unconscious male. In Blood, the Court of Appeal sidestepped the issue, pointing out that the lawfulness (or otherwise) of the initial extraction was not regulated by the 1990 Act96 but governed by “common law principles relating to the patient’s consent … which have not been argued before us”.97 However, Charles J in L v HFEA