The law relating to organ transplantation
Organ transplants can vastly improve patients’ quality of life and benefit their families and society in general by restoring an ill and dependent individual to health. On cost benefit analysis transplants prove ultimately cheaper than long-term dialysis by £191,000 per patient on average. However, there are fewer donors than there are needy patients although this should not be the case, because the percentage of willing donors lie in the 70s. Nonetheless, actual donations languish in the 20s. I argue that this is due to the misdirected and incoherent legal structure in place. I suggest that to increase the number of organs for transplantation a presumed consent system should be implemented to close the gap between willing and actual donations. In conjunction with improved coordination this will ameliorate the severe shortage. Such a system is ethically and morally justified. I consider other options under cadaveric donation such as increased investment in coordination without a change in the default position of deference to relatives (in the footsteps of Spain), as well as alternatives to cadaveric donation, such as live donations and xenotransplantation. They are however problematic both ethically and practically, such that even if the law formally and effectively ensures that all who need organs get them, it would be normatively wrong.
1 The law relating to organ transplantation
The terms of the relevant law must be subject to critique, because ultimately healthcare workers must work within the existing common law and legislation, even as they seek to save patients from an avoidable early death.
The definition of death is problematic. Today the concept of brain death has been adopted by most Western countries. Others suggest however that when the capacity for sentience is irrevocably absent, the minimum criteria for personhood no longer exists, despite the presence of a functioning brain stem. Perhaps it is best to admit that it is impossible to define the moment of death with any certainty or precision, and that the important task therefore is to determine at what point in the process of dying organ retrieval becomes legitimate.
In the UK, s1(4) of the HTA61 specifies that the doctor be satisfied that life is extinct before organ retrieval may take place but there is no statutory definition of death, leaving that to a matter of clinical judgement. Standard practice is for two independent doctors to perform two sets of tests to determine brain stem death.
The HTA61 outdated and prevents the facilitation of a successful programme. The current system tries to allow for all possible scenarios. S1(1) approximates an opt-in system, but there is no definition of who the person ‘lawfully in possession of the body’ is, and a verbal intention is only legally valid when it is made in the course of the last illness. Further, according to HSC 1998/035, 8.2, if a patient is a recorded willing donor, there is no legal requirement to establish a lack of objection on the part of relatives, but in practice it is good practice for any objectives raised by relatives to take priority over donors’ wishes.
S1(2) approximates a weak ‘opt-out’ scheme applying where the deceased has left no recorded expression of his or her wishes. The person lawfully in possession of the body is authorised to remove organs for transplantation if reasonable enquiry shows that the deceased did not object to organ removal or that the surviving spouse or any surviving relative has no objection to the use of the organs. Although it is fairly evident why spouses should be invited to express their views, this does not reflect the reality of the situation in which many adults now live – cohabitees or long term partners now fulfil this role.
The system is on aggregate incoherent and piecemeal, and when an organ is taken, no one knows for sure why – is it because the medical team has requested, or is it because the medical team has procured it under s1(2) of the HTA61? McLean opines that the current legislation is more of a hindrance than an assistance to an effective transplantation programme. So, to increase the number of organs for transplantation a presumed consent system should be implemented in conjunction with improved coordination to ameliorate the severe shortage. Such a system is ethically and morally justified.
2 Dead Donors
Historically doctors were thought reluctant to ask families of the deceased about the possibility of donating their relative’s organs. However, Gentleman et al. found that in fact request rates were reasonably high such that the belief that a failure to request is the cause for organs shortage is no longer sustainable. Rather, the problem with the opt-in system is its inability to enforce deceased individuals’ preferences because the family vetoes it, in part because they were never made known. For a grieving and bereft family, a request for organ donation is difficult to agree to because they can only guess at the wishes of the deceased and if there were any doubt at all, would not the natural answer be a rejection? If relatives had severe objections, they should be taken into account for to do otherwise raises the spectre of the swastika, but the point remains that by changing the default position of organ donation it is a veto clearly against the deceased’s wishes, which would be rather more unlikely to take place than the current veto due to a simple lack of information. It is not that the PC system is ethically unsound.
This is a preview of the whole essay
I argue that presumed consent is superior to the opt-in system because it truly ensures autonomy by giving effect to choices each person makes. It gives legal effect to individual autonomy and it ensures truly informed consent when accompanied by public education and information, instead of intuitive responses to organ donation.
Nonetheless, some problems with presumed consent have been pointed out.
Patient autonomy lies at the very heart of modern medicine and medical research . This is partly a reaction against medical paternalism and an increasing awareness of the integrity of the individual. It may be argued that a presumed consent (PC) system is paternalistic – but it concomitantly reinforces individual autonomy and preserves the dignity and integrity of the individual especially in comparison to, for example, an organs market.
McLean points out that underpinning the UK system of organ donation is the fundamental view that organ transplantation should be a gift relationship. So Sir Morris doubts that proposals to change legislation to allow presumed consent to be introduced are likely to be publicly accepted. However, why is presumed consent any less a gift? It does not mean widespread harvesting of cadaveric organs. It means greater public awareness and individual choice that is made concrete.
More practical considerations also exist. First, the need for sophisticated infrastructure to maintain an opting-out register. But this is a problem of the past century. Today, only Internet access and a computer is necessary. It is no more difficult than maintaining a register for opting-in patients. If the number of donors truly reflects the number that are willing at 70% then it is in fact more efficient to keep a shorter list of those who do not wish to donate, which would constitute only 30% of the population. Secondly, there is a fear of adverse publicity if organs are taken in the face of relatives’ objections – but as argued above, these could be taken into account, and public education – moral suasion – could persuade the public of the logic of a need for such a system, to cause a change in social values. For example, when the presumed consent system was implemented in Singapore, statistics showed that more people came forward as donors under a separate legal scheme as a result of heightened public awareness of great need. Even the family was more likely to agree to organ harvesting – the Muslim cadaver belongs to her family, so despite the exemption of Muslims from the presumed consent system, Muslim donations rose as well. Due to the widespread awareness of the merits of organ donation with public education and the support of religious leaders with clear moral grounds for the scheme, social values developed to embrace this medical system. Third, one might ask if resources could be better employed than on the maintenance of such a system – but if it solves the problem of organ shortage and alleviates medical conditions at the knife-edge between life and death, it is a small price to pay in terms of opportunity cost.
Alternatives to Presumed Consent
Required request of families bypasses individual autonomy. It is precisely the problem with the current system.
Financial and medical priority incentives – a survey of the systems currently in place reveals that compensation is illegal. Blumstein says that in the US, families are offended when financial incentives are offered when they consent to their deceased relative’s organs being donated. Nonetheless, the American Medical Association (AMA) has voted to encourage studies to determine whether financial incentives could increase the pool of cadaveric organ donors. Among strategies considered are small payments to deflect the funeral cost of a relative and preferential consideration for organ donation when a member of someone’s family has donated an organ. This prioritisation is manifestly unethical – it may be pragmatic but why should donation work on this basis? Should it not work on a basis of response to medical need, instead of allowing queue jumping by people who volunteer someone else’s organs? Financial incentives could increase the pool of cadaveric organs, but there are other methods to consider – namely my proposal of presumed consent – which are far more egalitarian and prima facie altruistic so far as cadeveric donations are concerned.
Relaxed restrictions amounts to mere tweaking of the existing system which does not address ethical problems with the current system, such as the undermining of individual autonomy. If the list of criteria for the exclusion of donors is made less stringent, to allow a greater pool of potential donors, the final filtrate of donors will still be paltry in comparison with a comprehensive overhaul of the current system.
Improved coordination – take for example Spain’s system based on familial consent. The lessons learnt are that a decentralised system appears most effective, comprising 1) local organisations that focus mainly on organ procurement and promotion of donation and 2) large structures that focus on promoting organ sharing and co-operation. This simply means more investment is needed. The real issue remains this: if the main reason forwarded for not having the opt-out system – diminished personal freedom – is the same reason for why the Spanish coordination system works, should we not be wary, even if the numbers crunch delectably? Coupled with the PC system however this would greatly increase the effectiveness of the organ transplantation system and protect autonomy too.
Elective Ventilation of deep coma patients close to death with no possibility of recovery for a few hours to preserve their organs long enough to prepare for their removal after death. A trial held in Exeter in 1988 led to a 50% increase in the number of organs suitable for transplantation, but was halted in 1994 when the Department of Health declared in unlawful, because it was not in the patients’ best interests – but whilst of no direct benefit to the patient, it is not contrary to the patient’s interests and has the potential to benefit others. Nonetheless, this would still be subject to relatives’ vetoes without a systemic revamp.
3 Live Donors
Full, free and informed consent necessary because it is not in best interests of the live donor. It is not fully compatible with the traditional Hippocratic oath and its fundamental principle “Primum Non Nocere”. To prevent organ sales on pretext of altruistic donation, HOTA89 s2(1)(b) allows only genetically related organ transfers. But why should altruism be limited to the dead? Then again, why should altruism be necessary if there is no problem in the first place? Live donors are indeed an alternative resource to cadaveric donors – but with what incentives? HOTA89 s1 prohibits payment.
There are six reasons forwarded against a market in organs. First, many believe there is something intrinsically wrong with commodifying the human body, and that it would be either impossible or degrading to put a value on human body parts. Indeed, human dignity trumps autonomy – if the human body is uniquely valuable and cannot be owned by others or ourselves, it cannot be bought or sold. Second, commercialisation undermines the principle that organ donation should be altruistic. Third, this trade would exploit the poor, and the fact that such markets flourish in developing countries is taken to be evidence that only the poor and marginalized would agree to donate their organs for money – only those who see no other way but sell parts of their body, or would rather sell parts of their body than work. Fourth, financial incentives may overbear a person’s will and thus cast doubt upon the voluntariness of their consent. Fifth, some are troubled by the prospect of people assuming some risk to health in return for financial reward. Finally, a free market in organs would mean that only the rich would be able to afford to buy them, thus disrupting the principle that scarce health care resources should be distributed according to need rather than ability to pay.
With regard to the first, Jackson argues that it is not strictly true that it would be impossible to put a value on a human organ, nor that doing so is inevitably degrading – tort law routinely quantifies the loss of various body parts without any assumption that such damages undermine the intrinsic value of the human body. However, to put a finer point on it, the issue is the valuation of the body with the intention of commodification. Few people set up elaborate schemes to hurt themselves and then procure damages. Indeed such schemes if found out would be illegal. The whole point of the law is to compensate individuals for loss, not to reward them for a commercial exchange.
If a free market safeguards against wrongful exploitation and concern is shown for vulnerable people, as well as accounting for considerations of justice and equity – if this can be done then a market in human body products will be shown to be, at the very least, not prima facie unethical. It has been recommended that the single buyer would take on the responsibility for ensuring equitable distribution of all organs and tissues purchased. This would prevent the rich from using their purchasing power to exploit the market at the expense of the poor. The monopsonist would also have other obligations, such as ensuring correct tissue typing to maximise histocompatibility and so minimise graft rejection, and screening for diseased or otherwise hazardous organs and tissues. Pricing would also be at low levels because it is bound to be – and as it is the only buyer it is also the price setter of what it purchases. Furthermore, since there is no direct purchasing, rich people cannot prey upon poor people – all stand an equal chance of benefiting.
However, the objection is that a donation of a kidney by a living donor is one of the most extraordinary acts of altruism that can be imagined, and this should not be tarnished by making it a commercial transaction. The ethical cornerstone of transplantation is based on the gift of an organ to the recipient whether the donor is alive or dead. To this, cynics such as Erin and Harris argue that there is much hypocrisy about the ethics of buying and selling organs and indeed other body products and services. This means everyone is paid but the unfortunate and heroic donor, who is supposed to put up with the insult of no reward, to add to the injury of the operation. But who is to put a value on altruism? Certainly Erin and Harris make themselves out to be incapable of it.
That aside, the point remains that if a presumed consent system were in place, which ensures autonomy, is backed by religious and moral principles and being effective it would preclude a need for this organs market, whether effective and monopsonistic or otherwise.
Instead of constraining choice, a presumed consent system would enforce autonomy, which is the same reason why the organs market is suggested – it provides choice while solving the problem of scarcity, but as I have shown, so does the presumed consent system. It is superior for the following reasons. A presumed consent system for cadaveric transplants would meets the needs of long waiting lists without commodification and commercialisation thus ensuring greater human dignity, so it would more ethically sound than a market in organs. The procedure would be non-maleficent to the dead donor, and of beneficence to the donee. Distributive justice would be more abided by – the organ would presumably go to the patient in need, rather than the most able to pay. There is greater welfare on aggregate – instead of just one kidney being transplanted from a live donor requiring a period for recuperation on top of 15% who complain of lasting weakness after the operation, on average 3.5 organs can be harvested from a cadaveric donor. Rule utilitarianism would also be satisfied – above all do no harm – as no harm is done to the cadaver, whereas harm would be done to the living donor. Further, according to virtue ethics organ donation is the most virtuous thing to do – this would save lives, and what use are organs in a cadaver if they are destined to rot, or burn? Major religions back organ transplantations – Judeo-Christian and Islamic emphasise charity, whilst Catholic, Buddhist and Hindu emphasise doing good to gain metaphysical favour. So what remains the objection to a presumed consent system?
If xenotransplantation were successful in humans it would solve all our problems of organ shortage. However, many practical barriers would have to be overcome, not least of which is the occurrence of natural antibodies in humans against all species except the higher order primates. Thus, without modification of this pre-existing immune response, transplantation of, say, a pig organ into a human would lead to hyperacute rejection of the organ. This could one day be prevented, but numerous other immunological responses to a xenograft have yet to be solved. In addition there is great concern about the possible transfer of infection from the organ donor and in particular transmission of porcine endogenous retroviruses (PERVs). Given the proven risks and the reality of disease transmission from animals to humans from BSE and CJD in particular, and concern about HIV and Aids in relation to animal-to-human contact, there is an acute awareness of the risk of transplanting animal organs into humans. Indeed until there is some confidence that such retroviruses cannot be transmitted from pig tissues into the human xenotransplantation remains on hold – consider the moratorium imposed by the Council of Europe which has yet to be lifted.
So far, no one has survived beyond 2 months, so no one knows how the cells interact. Furthermore, there are ethical issues related to the production, use, care and disposal of animals. These have direct bearing on ethics and humanity, not just at the level of specific moral concerns but also at the ethical and philosophical levels of our understanding of the nature of human beings over and against the nature of animals, and the particular issue of human and animal rights.
The response to this moral objection of ‘playing God’ which bedevils all transplantation is threefold. First, we already share a great deal of genetic material and DNA with animals. The extra amount is not really significant and will not turn animals into human beings. In response however, we are more concerned that xenotransplantation has effects we have yet to understand or are able to control – consider the diseases which cause human lives to be less than complete because of mutated genes leading to hereditary disorders. The fear is not that animals will turn into human beings, but that the results would be monstrous. Secondly, faced with such human suffering and the possibility of relief and even cure, to refuse to use helpful medical techniques is not just wasteful but immoral. However, if we had the presumed consent system in place instead, would not the problem be solved, and the issue of great need be irrelevant? Finally, the main argument is that in reality we are constantly interfering with natural functions. The whole of medical practice while it operating in a complementary way to nature does in fact resist the natural processes of disease and dysfunction. Medicine tries to restore what has broken down and to maximise the amount of health and well-being possible for humanity. To this we could just as well respond, as Fox and McHale have – do we really believe that human life should be extended by all means and at all costs? Are the boundaries of health, or indeed life itself destined for inevitable extension or have we reached appoint where it is time to say that enough is really enough, and that for ethical reasons, including resource allocation, our energies would be better devoted to other health care issues? Indeed, that move from active treatment to the provision of care and comfort for someone about to die is not always easy or clear, but there is a limit where death cannot be resisted and the attempt itself is degrading and creates more pain and distress for all concerned than benefit. Part of good medical practice is knowing when to stop treatment and let people die with dignity.
Xenotransplantation offers a real, though currently distant, hope of providing a source of organs for those who urgently require a transplant. Before that hope can become a reality, good medical and scientific progress and also careful, publicly acknowledged safeguards and regulation must be in place. The good news is that the various national authorities and the Council of Europe have established such stringent regulations. This is an excellent example of being proactive rather than simply reactive to new scientific advances. This will prevent the horse from bolting rather than trying to close the stable door after the horse has gone.
Catholics and Protestants advocate prudence, not only because of the ill-defined nature of this new medical adventure but also because of the risks of contamination it may entail. The question of the identity of humankind generally and of particular individuals is on the table and is especially crucial. The question of xenographs in fact pushes to their utmost limits all the ethical problems posed by transplants – powers and limitations of human beings, identity, sense of solidarity and justice. Buddhists are not in favour of xenografts and xenotransplantation but regard them as acceptable in certain circumstances – no commercialism, decent living conditions and treatment for the animal, and the procedure should be regarded as a transitional phase, which should be as short as possible.
Judaism takes a pragmatic stance, saying that given the importance attached to life, xenotransplants do not pose any religious problem. It is permissible to save a human life by transplanting animal organs, tissue or cells, especially as there is currently a drastic shortage of human donors – on condition that no unnecessary suffering is caused to the animal. Consideration of physical and psychological impact on recipients of animal organs necessary, but also necessary are further developments in the research field before the full physical impact might be known. Humankind is permitted and even duty-bound to change and improve the world in any way deemed beneficial for humanity.