Abstract
The demand for donor organs for transplantation in the UK far exceeds the supply. A number of improvements in the infrastructure surrounding organ donation, as well as attempts to increase public awareness, have been made over recent years, but there remains a massive shortfall. It has been proposed that a system of presumed consent for organ donation, in which all individuals are considered to be potential organ donors after death unless they have previously opted out, may serve to increase the supply of organs. Recently the Welsh Assembly passed a Bill introducing presumed consent by 2015, but the debates regarding legislative changes are still on-going in England, Scotland and Northern Ireland. The ethical implications of presumed consent legislation are at the centre of these discussions. When examined by a principlist approach, presumed consent may be deemed to be an ethically beneficial measure to increase organ donation rates. It is argued here that the system of presumed consent may actually be more respectful of the principle of autonomy than a system of explicit consent, on the basis that it goes against the wishes of the fewest number of people, and it has clear benefits in terms of beneficence and justice whilst also being compatible with the principle of nonmaleficence. Although there is some debate about the precise impact that presumed consent would have on donation rates, there is evidence to suggest that it would result in an increase in the donor organ supply, when combined with improvements in education and infrastructure.
Consent for organ donation
The first successful human organ transplantation was performed in 1954, and since then many thousands of lives have been saved and many thousands more vastly improved in quality by the donation of organs for transplantation. 1 However, as a result of changes in disease patterns, improvements in surgical skills, technological advancements and the development of improved anti-rejection therapies, the need for organs has increased greatly, to the point where demand now far exceeds supply. Over 4000 transplants were performed in the UK in the year 2012 to 2013, but there are currently just over 7000 patients on the transplant waiting list, and up to 1000 people die each year whilst waiting for an organ. 1 The gap between the supply and demand for organs is slowly decreasing: in the 12-year period between 2001 and 2013, the number of patients on the transplant waiting list in the UK increased by 7%, whilst the number of deceased donors increased by 56%.1 However, there is still a huge difference between the number of patients requiring donor organs and the number that are available. The donor rate in the UK in 2011 was 17.0 per million of population, which is comparable to the European Union average, but lower than in the USA. 2
In an attempt to redress this balance, the UK Transplant Authority was established in 2000, with the UK Organ Donor Taskforce following in 2006. These bodies have made a number of recommendations aimed at increasing public awareness of organ donation and improving the infrastructure surrounding it. As an adjunct to these measures the Chief Medical Officer, in his annual report published in 2007, advised that the creation of an opt-out system for organ donation could also produce an increase in transplant rates. 3 The current organ donation system in the UK is one of explicit consent, whereby individuals must express their wish, or ‘opt-in’, to become an organ donor after their death; this is done by joining the NHS Organ Donor Register, either by telephone or via the internet, or when registering with a General Practice or applying for a driving licence. 1 At the time of death, the individual’s relatives are consulted, to ensure that there are no strong objections to donation; in this situation approximately 90% of families agree for donation to go ahead. 4 If an individual has not opted in prior to death then a nominated representative or family member can give consent to organ donation; however, in these circumstances only around 60% of relatives give consent. 4 There are currently around 19.5 million people on the NHS Organ Donor Register, representing around 31% of the UK population. 1 This is despite the fact that surveys have reported that up to 90% of the population support organ donation.4,5 Clearly, not everyone who supports organ donation goes as far as registering his or her wish to become an organ donor. This may reflect the natural reluctance of healthy people to contemplate their own deaths, or may represent a deficiency in providing the necessary information to would-be donors on how to go about registering their wishes.
With a system of presumed consent, all individuals are considered to be potential organ donors after their death, unless they have previously registered their wish not to be a donor, or ‘opted-out’. There are different variations on this system: the so-called ‘hard’ system of presumed consent considers all individuals who have not opted out as potential donors, irrespective of the relatives' wishes, whereas ‘soft’ presumed consent involves all individuals who have not opted out automatically being considered as potential organ donors after death unless their family reports that they were against donation, or if donating the organs would cause severe distress to the family. It is this ‘soft’ system that has been proposed for introduction in the UK.
In 2008, the Organ Donation Taskforce rejected the implementation of the proposal on presumed consent for organ donation, on the basis that they found no convincing evidence that it would significantly increase the supply of donor organs. 4 It was argued that such a system may undermine the concept of donation as a gift, erode trust in NHS professionals and the government, and may have a negative impact on donor numbers. There was also concern it would deflect attention away from other important issues, including infrastructure improvements and increasing public awareness and understanding. The Taskforce did, however, make 14 specific recommendations for improvements that should be made to the infrastructure surrounding organ donation, including donor identification and referral, donor coordination and organ retrieval. 6 In the five years since this report there has been a 50% increase in the number of deceased donors and a 30% increase in the number of transplants performed, but there is still a massive shortfall in the supply of organs for transplantation. 7 In 2013, a new UK strategy entitled ‘Taking Organ Transplantation to 2020’, developed by NHS Blood and Transplant and the four UK Health Departments, was published, aimed at increasing the number of potential donors, improving donor conversion rates, making the most of donor organs, improving the survival of transplant patients, and improving systems to support organ donation and transplantation. 7 The single most important objective of the strategy was to increase consent for organ donation. However, this strategy was criticised for not going far enough, and a number of groups, including the British Medical Association, again appealed for the policy of presumed consent to be introduced.
In July 2013, the Welsh Assembly passed the Human Transplantation (Wales) Bill, bringing a system of presumed consent for organ donation into law by 2015, and during a recent consultation in Northern Ireland, 82% of respondents said they would support an opt-out system. Across England, Scotland and Northern Ireland the pressure is mounting for further discussions on the role of presumed consent legislation, with the ethical arguments surrounding this issue at the centre of the debate.
Principlism
The issue of presumed consent in organ donation lends itself to examination by moral reasoning, whereby specific ethical principles are applied to a given situation in order to arrive at a rational and considered conclusion which is ethically defensible. The four moral principles described by Beauchamp and Childress of respect for autonomy, beneficence, nonmaleficence and justice are considered to be key within healthcare ethics and can be used in the current context to examine the impact of presumed consent on both individuals and on society as a whole 8 ; the ethical approach that is based on these four principles is termed ‘principlism’. Autonomy is the right of an individual to decide for themselves what happens to them and what care they receive, without interference from others and with adequate understanding, and is the basis for the practice of informed consent; beneficence is the principle of doing good, which describes a moral obligation to act in a way which will benefit other people, including the prevention and removal of harm, doing good deeds and balancing the likelihood of benefit and harm of a particular decision; nonmaleficence is the principle of doing no harm, whereby one ought not to inflict mental or physical injury on another person either by actions or lack of actions, and justice is the principle of fairness, with equal rights and opportunities for all, within a system which allocates resources equitably.8,9
Principlism is being used as the preferred method of moral reasoning to examine the issue of presumed consent for organ donation because it provides a comprehensive and unified moral approach, compatible with a wide range of cultural and religious beliefs, and is based on principles that are universally recognisable. 10 It has long been used as an approach to ethical decision-making in medicine, and although more often used for case analysis it encompasses ethical values which are appropriate and applicable to this policy issue. There are drawbacks to this approach, including the criticism that the principles do not encompass all of the universally held moral values 11 ; however, it includes arguably the most important principles relating to the issue of consent for organ donation, and provides a sufficient basis for an ethically justifiable conclusion to be reached. The four principles have no set hierarchy, and in order to arrive at an ethical decision regarding a policy of presumed consent for organ donation, all four principles should be considered relevant.
The ethics of presumed consent
Autonomy
Those who oppose the system of presumed consent argue that it is not compatible with the principle of autonomy, because it potentially threatens an individual’s power to decide what happens to their body after death. There may be individuals who do not wish to donate their organs, but who haven’t registered their wish to opt out of the system, due to disorganisation, apathy or a lack of awareness or understanding of the system. There is, therefore, also the potential to discriminate against ethnic minorities and people who do not have access to such information, such as the homeless. The Human Tissue Act of 2004 gave guidance that consent is a positive, not passive, process which by its nature aims to ensure that individuals and their families have control over the use of their tissues for research or other purposes 12 ; there have been concerns that presumed consent may jeopardise this. Furthermore, it has been suggested that by being seen to oppose the principle of autonomy, introducing a system of presumed consent may actually provoke a negative reaction towards organ donation and have a detrimental effect on donor numbers. This has been evidenced in Brazil, where the system of presumed consent which was introduced in 1997 had to be withdrawn because of mistrust in the healthcare system and accusations of body-snatching. 4 However, the situation in Brazil is not directly comparable to that in the UK; there is more variation in terms of access to, and quality of, healthcare in Brazil, and the presumed consent legislation was brought in at a time when there was a general mistrust of the medical profession.
Conversely, the case has also been made that the system of presumed consent actually preserves autonomy. 13 If individuals have not discussed their wishes regarding organ donation with their relatives prior to death, and are not on the organ donor register, then under the current system their wishes may not be fulfilled. Around 70% of the UK population are not on the organ donor register and around 40% of families refuse organ donation following a relative’s death, so based on the reports that 90% of the population support organ donation, this means that up to 30% of individuals who would have wished to donate their organs do not have their wishes granted. Furthermore, there is also potential for the 10% who are against organ donation not to have their wishes met, if their families unknowingly consent to donation. Under a system of presumed consent, even if all of those who are against organ donation fail to opt-out, it would go against the wishes of 10% of the population at the most. Of course, these figures rely on the 90% support for organ donation quoted from the UK Transplant survey being accurate and correlating to the number who would, in reality, donate their own organs. It must be considered that this figure may be falsely high, as people may feel obliged to respond to such surveys in a way that they feel would be considered morally correct, even if this does not reflect their true opinions.
The application of the principle of autonomy after death is a controversial issue. It is argued that individuals cannot be deemed to have the same entitlement to autonomy after death as they have in life, and therefore the needs of an individual requiring an organ transplant could be seen to override the wishes of an individual not to have their organs removed for donation after death. 14 At the extreme of this, there are those who believe that no individual should be able to control what happens to their body after death, and that it is in fact immoral to give people the right to refuse to donate their organs after death when at cost are the lives of other human beings.15,16 In contrast, it has also been argued that the mistaken removal of organs against a person’s wishes is morally much worse than the mistaken non-removal of organs, on the basis that the mistaken removal of organs violates the principle of respect for autonomy by removing the individual’s power of bodily control. 13 However, in both situations the individual’s autonomy is being dishonoured, and to argue that one decision is more worthy of respect than another is contentious. 13 Indeed, it seems more likely that not removing organs from someone who wished to be a donor causes more harm than removing them from someone who didn’t wish to be a donor, as the potential recipient of the organ also suffers and the opportunity for beneficence is wasted.13,17
These issues may be better understood by considering the two different models of respect for autonomy described by Gill 13 ; he differentiates between the non-interference model of autonomy, whereby it is wrong to interfere with a person’s body without their explicit permission, and the respect-for-wishes model, which states that a person’s body should be treated in the way that they wished for it to be treated. When considering the treatment of a deceased individual, it is argued that the interference model cannot be applied, because literal non-interference, i.e. doing nothing with a person’s body after death, is not practical, and therefore we should act under the respect-for-wishes model. Using this model it is clear that both the mistaken removal and the mistaken non-removal of organs are of equal ethical significance, as both are going against the individual’s wishes. It follows that the most ethical consent system for organ donation is that which goes against the wishes of the fewest number of people, which, as argued above, is the system of presumed consent.
A system of presumed consent may serve to stimulate discussion of the issue of organ donation amongst families, and may have the additional benefit of relieving the burden on families to make the difficult decision regarding organ donation, if the deceased’s views are not known.18,19 Although this does not on its own justify the introduction of presumed consent, it is another advantage of the system for society as a whole.
Those members of society who are unable to make autonomous decisions, including children, and adults who lack the capacity required to consent, must be adequately protected by any consent system. The British Medical Association advises that children under 16 years of age, and adults who lack capacity, should be excluded from an opt-out system, with responsibility for giving consent to donation after death remaining with the individual's parents or relatives. 20 Some children younger than 16 years will be able to understand and weigh up the information surrounding this issue, and therefore should still be given the opportunity to opt in to organ donation themselves. Adults who lack capacity are not able to make an independent decision to opt-out, and it is therefore right to exclude these individuals from a change in legislation, in order to protect them from potential exploitation. There has been a concern that this approach may run the risk of propagating the unintended impression that the organs of such individuals are inferior in value 21 ; however, it would be simple for any legislation to clearly explain that incorporating this approach into a system of presumed consent just ensures that vulnerable adults are adequately safeguarded.
Beneficence
In the debate about presumed consent, the principle of beneficence may be applied to the potential organ donor, the potential recipient, the relatives of both sides, and society as a whole. However, the challenge is achieving beneficence for all of these groups within a single system.
The fundamental basis for the proposal to introduce a system of presumed consent is to increase the number of organ donors, thereby providing the opportunity for improved quality of life for thousands of patients with end-stage organ failure and saving the lives of some of the thousand patients who die each year awaiting a transplant. There would be few who disagree that increasing the supply of organs is a good thing for society and the individuals within it, all of whom may potentially require an organ transplant at some point during their lives. It is widely assumed that an increase in the number of donor organs would indeed be the consequence of such a change in legislation; however, careful examination of the evidence surrounding this assumption reveals some uncertainties.
Data from countries who already use a system of presumed consent can be studied in an attempt to predict the impact that such a system would have in the UK. Spain passed presumed consent legislation in 1979, and now has the highest recorded donor rate in the world. However, it is debatable how much of this increase can be attributed solely to the introduction of presumed consent; it is notable that donor rates did not start to increase until 1989, which coincided with the founding of the National Transplant Organisation. 4 It is therefore likely that it was the introduction of the new infrastructure measures and education systems that accompanied the National Transplant Organisation that had the greatest impact on donor numbers. Some transplant centres in Belgium introduced a system of presumed consent in 1986, and the country saw a rise in donation rates by 55% in five years. 18 In Austria, where presumed consent was introduced in 1982, organ donation rates quadrupled in the 8 years that followed. Conversely, Sweden introduced a system of presumed consent in 1996 but still has one of the lowest rates of organ donation in Europe. 4 A regression analysis comparing organ donation rates in 22 countries over 10 years, reported that countries operating a system of presumed consent had donation rates 25% to 30% higher than countries operating a system of informed consent, after taking other determinants of donation rates into account such as health expenditure, religious beliefs and legislative systems. 22 However, a systematic review of the relevant literature commissioned by the Organ Donation Taskforce concluded that it could not be inferred from the available evidence that the introduction of presumed consent would lead to an increase in the number of organ donors 23 ; although presumed consent legislation was consistently followed by an increase in organ donation rates in all five of the studies included in the review, the relative contribution of this change compared with other changes that took place in education and infrastructure at the same time was not clear.
Clearly there is some difficulty in separating the impact of presumed consent legislation on organ donation rates from the impact of other changes to the organ donation infrastructure. However, the regression analysis discussed above would lead us to believe that at least some increase in donation rates would occur purely as a result of a system of presumed consent, making it compatible with the principle of beneficence. As well as being a key component of principlism, beneficence is also at the heart of the utilitarian view of ethics, which holds that the moral course of action is that which provides the best outcome for the most number of people. Any system that benefits the majority, by increasing the supply of organs for transplantation, is therefore also supported by utilitarianism, with any potential compromise to individual autonomy being considered to be an acceptable cost.
Nonmaleficence
The principle of nonmaleficence should likewise be applied to potential donors and their relatives, potential organ recipients and their relatives, and to the healthcare system itself. Taking organs from individuals who were opposed to organ donation but who had not registered their objections could be considered to be doing harm to them. However, it can be argued that harm cannot be done to someone after they are dead. Furthermore, with the ‘soft’ system of presumed consent, the risk of doing harm is minimised, by allowing patients to opt-out if they don’t agree with organ donation and by retaining the safeguard of involvement of the patient’s family. 18 It can be argued that the failure to utilise viable organs which could potentially be put to life-saving use, does immense harm to the thousands of people who need, and die for the lack of, an organ transplantation. Indeed, it has been claimed that it would be unethical to continue with a system that does not allow the supply of organs to be increased in line with demand.18,19
Both healthcare professionals and the public have expressed concern that introducing the system of presumed consent would have a negative impact on the relationships between doctors, their patients and their patient’s families, which strongly rely on trust. Some patient groups have reported fears that doctors may not make all efforts possible to save a patient’s life, if they are seen as a potential organ donor. 4 Reassurance that doctors looking after such patients would continue to make every possible effort to save their lives, and clarification that there are two different teams involved in these situations, the intensive care team looking after the patient and the transplant team who will remove and transplant the organs, may help to alleviate these particular concerns.
Justice
The shortage of donors means that not all patients who require an organ transplantation have an equal opportunity to receive a donor organ; inevitably, decisions have to be made about the allocation of limited resources, which means that some patients miss out. Any measure that is likely to increase the supply of organs is therefore congruent with the principle of justice, which requires equal opportunities for all. However, it must be ensured that all of those who object to organ donation have the opportunity to register their wishes under a system of presumed consent. Those who do not understand or are not aware of a change to a system of presumed consent, such as individuals who aren’t fluent in the English language, and hard-to-reach groups such as the homeless, may potentially be disadvantaged by this system. 4 This is not an insurmountable problem, and recognising these challenges serves to emphasise the importance of having a clear, easily accessible and widely publicised route for opting out of organ donation.
Another consideration is the wider impact a change in legislation would have on the provision of other healthcare services within the NHS. Allocating more resources to organ donation and transplantation may mean that resources for other areas of healthcare are limited or even reduced. However, it has been reported that in patients with end-stage renal failure, kidney transplantation actually results in overall financial savings because there is no longer a requirement for the more costly haemodialysis sessions. 6 Clearly further health services research and policy expertise is required in order to fully appreciate the financial impact that changes in the consent legislation would have in the UK.
Conclusions
Throughout the examination of the issues surrounding presumed consent one fact remains constant: the demand for donor organs far exceeds the supply. Therefore, any measures that may redress this balance should be considered and debated openly. There are some interventions which appear to be universally acceptable, including the improvement of the infrastructure associated with organ donation, encouraging healthcare professionals to engage in open discussions about donation, and educating the public in order to increase awareness. The provision of specialist donor co-ordinators and trained personnel to guide donor families through the donation process, as well as educating healthcare professionals about the importance of early involvement of these co-ordinators, are important components of the infrastructure. Ensuring that there are the necessary teams to remove, transport and implant donor organs quickly and efficiently will also have a positive impact on transplant rates. If the donation pathway is fragmented, complex, and difficult to access for donors, their families and healthcare professionals, then donation rates will inevitably be low. Following the report from the Organ Donation Taskforce in 2008, a number of measures were introduced to try and increase donor rates, including improvements in donor identification and referral, donor coordination and organ retrieval. 4 Although there has been a 50% increase in the number of deceased donors in the five years since this report, 6 there is still a massive shortfall in the supply of organs for transplantation. The system of presumed consent has been proposed in an attempt to increase the rate of organ donation further.
By examining the issue of presumed consent more closely and subjecting it to ethical scrutiny by the process of moral reasoning using a principlist approach, it appears there are many advantages and moral arguments in support of the introduction of presumed consent. Despite some concerns that a system of presumed consent would threaten individual autonomy, it has been argued here that as an opt-out system would reflect the wishes of the majority of the population, it is actually more respectful of the principle of autonomy than the current consent system. Individuals who object to organ donation are provided with a means to register their wish not to become a donor, which they currently do not have. Furthermore, by providing the opportunity for life-saving and life-improving organ transplantation to many more patients with end-stage organ failure, without causing harm, the system of presumed consent is also consistent with the principles of beneficence, justice and nonmalificence. Thus, presumed consent has been shown to be an ethically beneficial policy when examined by a principlist approach.
Although the evidence on the effect of presumed consent on donation rates in other countries is disputed, because of the difficulty in separating the contribution it has made to increases in donor numbers from that of other changes in infrastructure and education, it appears that it would be reasonable to expect some degree of increase in organ donation as a result of a change in legislation. Indeed, it would seem logical that a combination of improved infrastructure and the introduction of presumed consent would be the best way to maximise donor numbers in the face of an ever expanding supply deficit.
There are, however, issues which must be addressed before a system of presumed consent can be introduced, in order to maximise its chance of succeeding. The need for a clear, simple and easy-to-access mechanism for opting out is absolute, and of course other means of increasing donor numbers should continue to be investigated and implemented alongside a change in legislation, where appropriate. A more widespread public debate is vital to the success of presumed consent, and should be encouraged prior to any change in legislation, in order to gauge public opinion and reduce the risk of any negative impact on organ donation as a whole. Finally, the implications for vulnerable and socially isolated groups must be considered, and such individuals protected, before any change in the system of consent can be implemented.
The conclusions reached from the principlist analysis of presumed consent that has been presented here indicate that there are powerful moral arguments in favour of a change in the UK legislation regarding consent for organ donation, and indeed the recent Bill passed by the Welsh Assembly bringing presumed consent into law by 2015 suggests that these arguments are starting to be heeded in the context of a pressing need for more donor organs for transplantation. There are of course other factors which impact on such policy decisions, and which must be taken into account by the governments of England, Scotland and Northern Ireland, including the financial considerations, logistical challenges and the objections which have already been expressed by such influential groups as the campaign group Patient Concern and the Christian Medical Fellowship. Despite these considerations, a unified approach to the consent system within the UK must be encouraged, as the current fracturing of the organ donation system will have implications for the whole transplantation infrastructure and result in inequalities in terms of access to donor organs; it will also raise more difficult questions, such as should donor organs from one country that has a system of presumed consent go to recipients in another country which has a system of explicit consent? Groups including the British Medical Association continue to press the governments of the UK on the issue of presumed consent for organ donation, and further debates should focus on the moral arguments in favour of a change in legislation.
Footnotes
Acknowledgments
The author would like to thank Liz Smith for her guidance and advice during the writing of this article.
Declaration of conflicting interests
None declared.
Funding
This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
Author note
All views expressed in this paper are the authors own.