Nicola J Williams, Laura O’Donovan, Stephen Wilkinson, Presumed Dissent? Opt-out Organ Donation and the Exclusion of Organs and Tissues, Medical Law Review, Volume 30, Issue 2, Spring 2022, Pages 268–298, https://doi.org/10.1093/medlaw/fwac001
Navbar Search Filter Mobile Enter search term Search Navbar Search Filter Enter search term SearchIt is often claimed that a legitimate approach to organ donation is an opt-out system, also known as ‘presumed consent’, ‘deemed consent’, or ‘deemed authorisation’, whereby individuals are presumed or deemed willing to donate at least some of their organs and tissues after death unless they have explicitly refused permission. While sharing a default in favour of donation, such systems differ in several key respects, such as the role and importance assigned to the family members of prospective donors and their preferences, and exclusions and safeguards which often specify the demographic groups, purposes, or organs and tissues that will remain outside the scope of the opt-out system. Using the recent shift to opt-out in England, Scotland, and Northern Ireland as case studies, and by reference to the key goals motivating this shift across the UK, this article asks whether and, if so, why, and how, opt-out systems for post-mortem organ donation should restrict the types of organs and tissues for which consent is deemed. In other words, ought opt-out systems for PMOD presume dissent regarding the donation of certain organs and tissues?
Within the philosophical and policy literature on organ donation, it is commonly claimed that a legitimate alternative to requiring explicit consent for organ retrieval from the deceased is an opt-out system, also known as ‘presumed consent’, ‘deemed consent’, or ‘deemed authorisation’. 1 In such systems, the state presumes (or deems) 2 that in the absence of explicit refusal of permission, individuals are willing to ‘donate’ 3 their organs and tissues post-mortem. Using evidence from psychology and the social sciences regarding ‘default effects’ 4 and procrastination and inertia among willing but unregistered organ donors, 5 opt-out’s proponents claim that shifting the default in this manner is liable (in many nations) to both (i) increase the number of organs and tissues available for transplant, moving some way towards closing the transplant gap, and (ii) result in organ retrieval practices that better reflect the organ donation preferences of the majority. 6 As a result of such claims—and despite objections from those who question the legitimacy of opt-out policies and/or their ability to provide the benefits their proponents promise—many countries have implemented opt-out legislation over the last 30 years, 7 with England, 8 Scotland, 9 and the Netherlands 10 joining this list in the last few years and Northern Ireland likely to follow later in 2022. 11
While opt-out systems for post-mortem organ donation (PMOD) share a default in favour of organ donation, they differ in several key respects. One key example is the role and weight assigned to the views of the families of the deceased. Approaches to this range from those that afford family members of registered donors absolutely no power to influence PMOD outcomes (so-called ‘hard’ opt-out policies), 12 to ‘softer’ ones that provide family members or nominated representatives with significant (sometimes overriding) power to shape donation outcomes. 13 While the role and weight assigned to family views are important issues, 14 this article considers a different and underexplored matter—the various exclusions built into opt-out systems. These normally specify groups for whom explicit consent is still required, with many countries excluding populations such as children, incapacitated adults, foreign visitors, and new residents. 15 Such exclusions may also, and most importantly for the purposes of this article, be applied to specific types of organs and tissues. In this type of system, the kinds of organs and tissues for which consent is presumed are restricted, so that explicit consent is required from donors prior to death or, more likely, their relatives or nominated representative/s, post-mortem. In other words, dissent to particular organs and tissues falling within the scope of opt-out schemes is presumed. Examples of this can be found in the jurisdictions within the UK where a significant number of organs and tissues are excluded from the new (in Northern Ireland, proposed) opt-out arrangements on grounds of their being used for ‘experimental’ or ‘novel’ transplants. 16
While such exclusions are commonplace, there has to date been little discussion of how they might be justified in either the philosophical or policy literatures on organ donation—a gap that this article seeks to address. By analysing the policy goals underpinning shifts to opt-out systems for PMOD in England, Scotland, Wales, and Northern Ireland, we aim to ascertain whether and, if so, when, why, and how opt-out systems for PMOD should restrict (and in the future revise) the types of organs and tissues for which consent can be deemed. In Section II, we begin by articulating the policy goals and arguments that motivated recent shifts to opt-out systems in England, Scotland, and Wales and the proposed shift in Northern Ireland. Section III then considers the relevance of those goals to questions about the scope of opt-out systems for organ donation, with a focus on restrictions placed on the kinds of organs and tissues included within such policies. Sections IV and V then examine and critique the policy development processes in England, Scotland, Wales, and Northern Ireland and make recommendations for improvement.
In philosophical, behavioural economics, and social psychology literatures surrounding organ donation, opt-out defaults are often proposed as a means of increasing the supply of organs and tissues for transplant (thereby reducing the so-called ‘transplant gap’) in nations with opt-in policy defaults for organ and tissue donation. While ‘default effects’ are not fully understood, opt-out defaults in organ donation are thought to increase supply for a number of reasons. Foremost among these is that opt-out defaults are thought to reduce the effects of procrastination and inertia in willing organ donors who ‘fail to get around’ to registering a positive preference to donate on an organ donor register (ODR). 17 They are also thought to increase levels of donation willingness in the population more generally, by harnessing the effects of cognitive biases such as status quo bias, loss aversion, and implicit endorsement. These push the choices of prospective donors in the direction of the policy default (donation in the case of opt-out policies). 18
While it may be reasonable to infer from the scientific and economic literatures surrounding choice architecture and defaults that opt-out systems are liable to increase donation rates when compared to opt-in systems, empirical evidence proving their efficacy in this respect is difficult to assess. Comparative data exploring donation rates across opt-in and opt-out nations, 19 and within opt-out nations pre- and post-transition, 20 do generally support claims regarding increased donation rates under opt-out policies. However, the utility of these is limited due to a range of confounding factors. Across nations, for example, mortality rates from road traffic accidents, overall health expenditure, religion, education, and transplant infrastructure significantly influence organ donation rates. 21 Within nations, where increases have been observed after shifts to opt-out policies, ‘many other changes were introduced … such as better infrastructure or increased funding for transplant programmes’. 22
Despite uncertainty regarding the effectiveness of opt-out PMOD systems in this respect, a key stated goal of shifts to such systems, has, in many nations, nevertheless been to increase the supply of organs and tissues available for transplantation. 23 This has been the case in the UK, with policy and consultation documents in all four jurisdictions clearly articulating this goal. The Welsh 2011 Consultation and 2017 Impact Evaluation Report, for example, state that the aim of the shift to an opt-out system was to ‘increase the number of organ and tissue donors in Wales, allowing more lives to be saved’ 24 and to ‘increase the number of organs and tissues available for transplant’. 25 English policy documents regarding the 2019 Organ Donation (Deemed Consent) Act explain that reforms were ‘intended to … increase the annual number and quality of organs transplanted so that everyone requiring a transplant stands the best chance of receiving one’, 26 noting an ambition to see ‘700 extra transplants a year, transforming 700 lives’ as a result. 27
Similarly, in Scotland, policy and consultation documents surrounding the Human Tissue (Authorisation) (Scotland) Act 2019 note both a core aim of ‘increasing the number of organ and tissue donors’ 28 and an ‘aspiration that transplantation waiting lists will decrease and the demand for transplants will be met’, 29 to meet the government’s long-term goal to ‘reduce the numbers of people in Scotland waiting for transplants or dying waiting’. 30 Further rationales underpinning goals of increasing the supply of organs and tissues for transplantation can be seen in the policy memorandum accompanying the 2019 Act. These include expressions of hope that the new system for organ/tissue donation will ‘support a Healthier Scotland’, 31 by ‘increasing healthy life expectancy’, 32 allow ‘individuals to return to work who are otherwise unable to do so because of serious illness’, 33 and increase quality-of-life by ‘relieving the stress, anxiety, and the financial burden’ 34 experienced by those with long-term illnesses and their families. In Northern Ireland too, goals to increase organ and tissue supply are confirmed in a 2020 public consultation document surrounding the 2021 Organ and Tissue Donation (Deemed Consent) Bill. 35 As in Scotland, where financial and social benefits are anticipated as a result of increased donation and transplantation rates, the Department of Health in Northern Ireland expresses similar hopes that the health service will benefit not only from ‘the reduced cost of treating patients whose health has been improved’, 36 but also by ‘releasing resources to provide treatments for patients suffering from other ill-health conditions’. 37
Another key benefit claimed of opt-out systems is their potential to generate organ retrieval practices that better reflect individual preferences surrounding PMOD in countries where donor registration rates remain low despite high levels of public support for organ donation. Notable examples of such countries include the USA, where 90% of the population support donation but only 60% are registered donors; 38 Australia, where despite majority support (circa 76%) 39 for donation, only 34% 40 are registered donors; and England, where (prior to recent legislative changes) despite high levels of public support for PMOD (around 80%), 41 and 65% of citizens expressing a willingness to donate post-mortem, only 39% of citizens had signed the ODR. 42 This discrepancy between reported PMOD willingness and donor registration is generally attributed to procrastination and inertia in prospective organ donors who fail to register their (positive) donation preferences. 43 Thus, in countries where there is a mismatch between public sentiment and donor registration rates, it is often claimed that shifting the default position from 'no' to 'yes' will result in an organ donation system that better reflects individual preferences. 44
Appeals to positive preferences regarding organ donation have been used to both motivate and justify shifts to opt-out legislation across the UK. All four jurisdictions refer to opt-out’s potential to result in retrieval practices that better reflect the organ donation preferences of the majority. In Wales, for example, a 2011 consultation paper followed a statement of fact regarding registrations to the ODR (31%), with an appeal to research suggesting that ‘many more people would like to join the register but have not yet done so’. 45 It was thus implied, but not explicitly stated, that an opt-out system could remedy this. In England, more explicit claims regarding the potential of opt-out in this respect have been made. These have included claims that opt-out ‘will better reflect what we know already, that the vast majority of the public in England support making their organs available to help others in need’, 46 and that because ‘the vast majority of people support organ donation … it is right that we change the law to better reflect this’. 47
In Scotland too, opt-out has been positioned as a means to ‘ensure individuals who would want to donate are able to do so’, 48 and to solve problems ‘of people not getting round to making their [donation] wishes known’. 49 Finally, in Northern Ireland, in policy documents it was lamented that given that 80% of the Northern Irish population supports organ donation, but only 48% have recorded a decision to donate, ‘the ODR is not yet truly representative of the Northern Ireland population’s willingness to donate their organs and tissue after their death’. 50 Opt-out has, therefore, been presented as a potential solution to this problem, ‘as a means of … better reflecting the levels of public support for organ donation’. 51
Across the UK, opt-out systems for PMOD have been implemented and/or proposed in service of the two key goals outlined above: increasing the supply of organs and tissues available for transplantation, and better reflecting individual preferences surrounding PMOD. However, it is not enough simply to decide to implement an opt-out policy; it is also necessary to specify the key characteristics of the system beyond the default choice it imposes. Numerous and potentially difficult decisions must thus be made regarding the details of such systems, and any exemptions and safeguards. These include decisions regarding the role that should be afforded to the families of would-be organ donors when these conflict with the avowed or deemed preferences of the donor; whether certain demographic groups such as children, overseas visitors, new residents, and adults lacking capacity to make decisions about organ donation should be exempt from the scope of opt-out provisions such that explicit consent to donation from the donor or, more likely, a legally appropriate proxy is still required; and whether the new opt-out arrangements should apply straightforwardly to all potentially transplantable organs and tissues, or whether certain organs and tissues be excluded from its scope and so still require explicit consent.
How should such matters be decided? Absent compelling reasons to the contrary, such details should be driven by the rationale for the prior choice to implement an opt-out system with the aim of maximising the coherence and effectiveness of the overall policy framework within which it sits. Thus, policymakers designing the details of opt-out systems across the UK (and other nations with similar policy goals), should do so with two questions at the forefront of their minds. First, which version of opt-out is most likely to meaningfully increase the supply of organs and tissues for transplantation? Secondly, which version is most likely to align PMOD outcomes with individual preferences surrounding PMOD?
While the role and weight assigned to family views is an important issue, 52 and so too are questions surrounding excluded demographic groups, the focus of this article is the under-explored matter of scope exclusions applying at the level of organs and tissues (e.g. organs and tissues for which dissent, rather than consent, is presumed or deemed). Thus, in this section, we focus on whether, why, and if so, how, the exclusion of specific organs and tissues from the scope of opt-out across the UK is likely to better align posthumous donation outcomes with individual preferences surrounding PMOD, than opt-out systems that are not restricted in this manner. We also consider how, through reflecting preferences, opt-out systems that exclude certain organs and tissues from the scope of opt-out may also better serve the goal of meaningfully increasing the supply of organs and tissues available for transplantation. This will then inform work undertaken in Sections IV and V, where the approach taken to determining organ and tissue exclusions across the UK are examined.
Across the UK, appeals to high levels of public support for organ donation have been used to motivate shifts to opt-out systems, with policymakers readily pairing claims regarding public sentiment (for example, ‘8 out of 10 people say they would want to donate their organs and tissue after their death’), with claims that a shift to opt-out will better reflect these sentiments (for example, opt-out ‘better reflects the position of the majority of people who would be happy to donate their organs and tissue when they die’). 53 Despite this, evidence from national ODRs, national and regional surveys tracking PMOD willingness, and large and small scale studies in the humanities and social sciences, have demonstrated that individual preferences surrounding PMOD are more complicated than can be garnered by reference to general levels of donation willingness alone. Instead, just as general preferences regarding organ donation differ from person to person, individual donation preferences differ from tissue to tissue, with high levels of variation demonstrated dependent on the organs and tissues in question.
In the UK, for example, evidence from the NHS Blood and Transplant service (NHSBT) shows that although 85% of registered donors are willing to donate kidneys, pancreases, hearts, lungs, livers, and corneas post-mortem, 15% selectively refuse to donate at least one of these, with 10.1% refusing to donate their corneas. 54 Evidence from a 2018 survey of knowledge, attitudes, and behaviour of 4,001 members of the German population regarding organ donation shows similar levels of variation, finding that 13% of willing donors would refuse to donate certain organs and tissues with corneas, hearts, and skin the most likely to be refused. 55 Small and large scale studies of donation preferences in the social sciences also provide evidence of this variation, with a study of 445 US adolescents’ attitudes surrounding PMOD finding that among respondents who expressed willingness to donate their organs and tissues post-mortem (49.2% of total respondents), a significant proportion would selectively refuse to donate their eyes (32%), pancreas (13.8%), lungs (12.8%), or heart (9.9%). 56
The above data explore variations in PMOD preferences surrounding commonly transplanted organs and tissues, such as hearts, lungs, and corneas, and show that only a minority (albeit sometimes a sizeable one) of donors are likely to refuse their donation. A number of studies also explore variation in preferences surrounding the donation of less commonly transplanted, novel, or experimental organs and tissues, such as hands, feet, skin, faces, and uteri. These data, while relatively sparse, suggest that significantly lower levels of donation willingness may be observed for such organs and tissues than for more commonly transplanted organs and tissues. 57 For example, the results of a 2016 German survey of 755 medicine and economics students’ PMOD preferences showed that while more than 70% respondents were willing to donate their kidneys and livers, only around 30% were willing to donate a hand or a foot or a ‘large area of skin’. 58 Similarly, a 2014 study looking to preferences and rationales for organ donation among 1,027 individuals in New Jersey showed that respondents were less willing to donate uteri, hands, and faces than hearts, lungs, kidneys, and corneas. 59 A 2019 Gallup poll in the USA also points to variation in donation willingness regarding novel transplants. For, while 90.4% of respondents to the poll supported or strongly supported PMOD, only 64% and 46.9% of respondents were willing to donate their hands and faces for transplantation post-mortem. 60
Furthermore, research exploring selective refusals from donor families (and other proxies) to donate specific organs and tissues also provides evidence of significant variation in PMOD willingness dependent on the organs and tissues in question. In the UK, for example, data collected from consent forms signed by the families or nominated representatives of the 1,580 deceased organ donors in 2019–20 show that consent is more often provided for ‘major transplantable organs’ than for tissues. Refusal rates per organ and tissue among ‘consented’ donors were as follows: kidneys (0.25%), liver (0.38%), pancreas (1.08%), lungs (2.6%), heart (3.38%), bowel (5.71%), 61 blood vessels (5.96%), heart valves (14.66%), skin (40.34%), bone (42.99%), tendons (49.21%), corneas (51.09), and meniscus (56.8). 62 Similar data are available from Australia and New Zealand, 63 and Brazil. 64 Studies or reports of familial preferences with smaller sample sizes and/or a focus on particular organs and tissues also provide evidence of this variation. A study of 10,681 patient charts over a four year period in the USA, for example, shows significant differences between familial consent to PMOD generally (46.5%), tissue donation (34.5%), and corneal donation (23.5%), 65 and a 2016 report from the UK’s ocular advisory group showed eye donation rates of only 40% among organ donors with family and donor refusals providing the reason for non-donation in 61.3% of cases. 66
The studies and reports described here provide mixed evidence regarding the prevalence and content of selective PMOD preferences, where individuals exhibit willingness to donate certain organs and tissues post-mortem but not others. Unfortunately, little to no comparative research bringing together, comparing and/or exploring general trends arising from the data is currently available. However, what is clear is that while a shift to opt-out systems is likely to reflect public sentiment regarding the PMOD of certain organs and tissues, policymakers should not assume that this will be the case for all transplantable organs and tissues. Individual donation preferences can differ significantly from tissue to tissue, and the available evidence suggests that prospective donors are likely to be more willing to donate what might be thought of as commonly transplanted or life-saving organs and tissues, than those which may be used in experimental, novel, visible, uncommon, or non-life saving transplants, like skin, limbs, faces, bones, uteri.
Given this, where opt-out PMOD systems truly seek to reflect the preferences of prospective donors, concerted effort should be directed to uncovering donation preferences at the level of specific organ and tissue types prior to the implementation of the system, and to excluding organs and tissues for which levels of donation willingness are low. One cannot, after-all, in good conscience, appeal to positive public sentiments surrounding PMOD generally as justifying a shift to opt-out with respect to uterus, face, skin, or limb donation, when such sentiments are unlikely to apply to those organs and tissues.
Furthermore, public awareness of the ability to transplant some organs and tissues (for example, uteri, faces, or limbs) may be lower than for others, such as hearts, lungs, corneas, or kidneys. Given this, policymakers should be aware that in addition to lower levels of donation willingness with respect to such organs and tissues, a significant number of prospective donors may never have considered the possibility of their donation at all. Consequently, many prospective donors may well lack donation preferences altogether with respect to the donation for ‘novel’ or ‘experimental’ purposes, even in cases where they have signed an ODR and expressed a willingness to donate ‘any part’ of their body after death. 67 In such instances, questions about the appropriateness of ‘deeming’ or ‘presuming’ consent to donation arise. These mirror concerns which may be raised regarding the appropriateness of including certain demographic groups within the scope of opt-out systems (such as children and adults who lack capacity, overseas visitors, and new residents). It would, after-all, be inappropriate to ‘presume’ or ‘deem’ consent to organ donation in those who lack the capacity to consent for themselves, and based on the inaction of those whom we cannot reasonably expect to be familiar with the mechanisms by which consent or refusal to organ donation is provided. Given this, it may also be argued that it would be unreasonable to ‘presume’ or ‘deem’ consent to the donation of organs and tissues for transplantation purposes so novel that very few individuals can be expected to have considered (and thus formulated donation preferences regarding) them. 68
Given the evidence regarding selective organ donation preferences explored above, and the lack of public awareness of organ transplantation, opt-out systems for PMOD which exclude organs and tissues on this basis are liable to result in donation outcomes which better reflect the population’s preferences (a core goal underpinning shifts to opt-out systems). Reducing the scope of opt-out could also help achieve the second core goal underpinning shifts to opt-out systems: meaningfully increasing the supply of organs and tissues for transplant. For, as explored below, excluding organs and tissues from the scope of deemed consent (presuming dissent or unwillingness) based on evidence about levels of donation willingness may ameliorate concerns that could otherwise lead previously willing donors to opt-out altogether.
While one of the major claimed advantages of opt-out systems is their potential to increase donation rates, critics of such systems also note their potential (given strongly held objections to opt-out policies for organ donation) to negatively affect public sentiment and erode trust in organ donation. This could result in significant numbers of potential donors (including some who would have signed the ODR under an opt-in system) opting out from PMOD. 69 Notable objections to opt-out systems include beliefs that such systems fail adequately to respect the concept of organ donation ‘as a gift’, and associated worries that they increase the likelihood that organs will be retrieved from unwilling ‘donors’. 70 Worries have also been expressed that opt-out systems pay insufficient attention to the preferences of family members of prospective organ donors, push the limits of legitimate state interference, bordering on or constituting ‘organ conscription’, 71 or even increase the likelihood of ‘organ donation murder’ or the sub-par medical care of potential donors. 72 Finally, it may also be argued that opt-out policy defaults are unjustifiably manipulative given their reliance on the effects of unconscious cognitive processes to increase donation rates. As explained in Section II, a key mechanism by which policy defaults are considered to increase donation rates is through harnessing the effects of unconscious cognitive biases such as status quo bias, loss aversion, and implicit endorsement to ‘nudge’ choices in a particular direction (towards the default). MacKay and Robinson, however, argue that this is ‘disrespectful of people's autonomy’ 73 as it takes ‘deliberate advantage of their cognitive biases … bypassing, not engaging their rational capacities’. 74
Such concerns may or may not be well founded, but they could nonetheless have negative effects on donation rates, in some jurisdictions at least. In England, 15% (2,509 of 16,730) of respondents to the Department of Health and Social Care (DHSC)’s 2017 consultation on ‘Introducing “opt-out” consent for organ and tissue donation in England’ answered the question: ‘If the law changes would this affect your decision about organ donation’ with ‘yes, I will opt-out’. 75 Should 15% of previously willing organ donors register their refusal to donate under an opt-out policy, this would significantly limit any gains in organ donation rates in England associated with opt-out. Another pertinent example is Brazil, where opt-out PMOD legislation was repealed a year after its implementation in 1998. The Lancet reported that ‘popular imagination’ played a key part in this:
Part of the population feared that their organs would be removed even before they were clinically dead. Many rushed to public offices to register themselves as non-donors, to avoid such a risk. 76
As well as some people’s general concerns, specific incidents attracting adverse publicity could also suppress donation rates. A key example of this is the so-called Amiens Affair which occurred in France in the early 1990s. In this case, a legal complaint was filed by the parents of Christophe Tesniere, after the legally permitted but not explicitly parentally sanctioned removal of their son’s eyes during a PMOD procedure. 77 This captured the public imagination, leading to significant reductions in public trust surrounding organ donation in France, 78 and a fall in corneal donation rates (by 38% from 3,774 in 1991 to 2,383 in 1993) after the incident. 79 Donation rates then took over four years to return to levels observed in 1991. 80
The purpose of raising these concerns here is not to advance an objection to opt-out per se. Rather, the point is that even if a move to opt-out would be generally positive in terms of donation rates, there are some disadvantages (notably those linked to public trust) that could reduce any potential gains. Thus, in order to make opt-out systems as effective as possible, assuaging people’s concerns and so reducing the extent of those disadvantages is desirable. There are several ways of doing that. Clear and consistent messaging about precisely how opt-out works is one. Another way, more relevant for our purposes, is limiting the scope of opt-out so that types of transplantation liable to arouse discomfort or mistrust are left outside the scope of the opt-out system.
One relatively straightforward example of how this approach might work in practice is the choice between ‘hard’ and ‘soft’ opt-out systems, the latter being ones in which the deceased person’s relatives or other living third parties have a formal role in posthumous donation decision-making. On the face of it, ‘hard’ opt-out systems would seem best in terms of organ supply as they do not allow relatives to stand in the way of donation. However, such policies may 'backfire' by encouraging more people to opt-out during their lifetimes, fearful of a scenario where organs are taken against the wishes of their loved ones. Thus, an argument could be made that ‘soft’ opt-out is better, not only because of the respect it affords to relatives but also because it is more likely to maximise supply in the long term. The same kind of argument can be made in relation to the scope of opt-out systems, with respect to either tissue types or purposes. If rare, novel or experimental transplants were within scope of the opt-out, people who were worried that their bodies may be used in ways that they either fear or do not understand may be inclined to opt out completely. However, if opt-out arrangements only applied to familiar lifesaving transplants (such as kidneys, hearts, or livers) and decisions regarding organ and tissues excluded from the scope of opt-out were based on evidence regarding public preferences regarding PMOD, this could provide comfort to those with such worries. Those individuals may then feel less motivated to completely exit the donation system, provided that the limited scope of the opt-out system was clearly communicated.
Limiting the scope of opt-out polices, then, may well have advantages for the overall organ supply. It could also go some way towards addressing concerns about legitimate state interference in organ donation from those who believe that pushing, or nudging, as Thaler and Sunstein would have us call it, 81 at such limits can be justified in certain ‘high stakes’ cases and contexts. This would include saving lives or in cases of organ shortage, but not others situations, such as cosmetic, experimental, or reproductive purposes, or where there is no shortage.
Previous sections have outlined the more general rationales underpinning shifts to opt-out systems across the UK, and explored the potential for policy exclusions applied at the level of organs and tissues to support the goals of meaningfully increasing the supply of organs and tissues available for transplantation and better reflecting the preferences of potential organ donors. In this section, after setting out some foundational information regarding how opt-out legislation operates across the UK and the policy timeline, we examine the rationales underpinning organ and tissue exclusion policies across the UK. This is done with the aim of providing necessary context for the critical work following in Section V.
The legal basis underpinning organ donation in the UK is ‘appropriate consent’ in England, Wales, and Northern Ireland, 82 and ‘express authorisation’ in Scotland. 83 These types of consent are considered in place where an individual provides written consent to donation prior to their death, they are registered as donors on the national ODR, and/or where their nearest family members (that is, those in a ‘qualifying relationship’ to them) 84 or nominated representative, 85 authorise PMOD. Given that appropriate consent/express authorisation forms the cornerstone of the regulatory apparatus governing organ donation, for the shift to an opt-out system to become operational in England, Scotland, and Wales, legislative amendment of donation and transplantation laws was required to accommodate ‘deemed consent’ in England and Wales 86 and ‘deemed authorisation’ in Scotland, 87 and to specify the groups of persons to whom these apply. 88 Alongside this, secondary legislation was required to specify the organs and tissues excluded from the opt-out systems, meaning that explicit consent or express authorisation to their donation will continue to be required—from the deceased, their nearest relative(s), or nominated representative (in England and Wales). 89
The chronology of the UK’s legislative shift to opt-out began in Wales with the passing of the Human Transplantation (Wales) Act 2013. 90 The new ‘deemed consent’ system did not become operational until December 2015 following the enactment of the Human Transplantation (Excluded Relevant Material) (Wales) Regulations 2015, 91 which specified the meaning of ‘excluded relevant material’—material to which the 2013 Act does not apply. 92 Almost four years later, in 2019, legislation setting out a statutory framework for opt-out was passed in England and Scotland. By virtue of section 1(4) of the Organ Donation (Deemed Consent) Act 2019, ‘deemed consent’ in England applies only to ‘permitted material’—material other than a type specified in regulations. 93 In May 2020, the English opt-out system went live with the coming into force of the Human Tissue (Permitted Material: Exceptions) (England) Regulations 2020, 94 which specify types of ‘relevant material that is not permitted material’. 95 In Scotland, the Human Tissue (Authorisation) Scotland Act 2019 provides that ‘deemed authorisation’ does not apply in relation to an excepted body part, 96 and following the passing of the Human Tissue (Excepted Body Parts) (Scotland) Regulations 2020, 97 which set out relevant groups of excepted organs and tissues, the new system became operational in March 2021.
The role of the deceased’s family in opt-out systems should be noted. To determine whether consent to donation can be deemed, qualifying relatives of the deceased will be asked whether they have information that would lead a reasonable person to conclude that the potential donor would not have consented. 98 If information to this effect is provided, then donation will not proceed. Nor will it proceed if no family is available to provide information about the deceased’s last known wishes. This is because the Human Tissue Authority considers that ‘the risks to public confidence of [donation] proceeding in these circumstances would outweigh the benefits’. 99
In all three countries, consultation exercises preceded both the creation of legislation governing deemed consent/authorisation, 100 and the introduction of regulations specifying the excluded organs and tissues. 101 Understanding how the approach of each country built on the experience of another not only serves to explain how and why England, Scotland, and Wales have arrived at particular sets of exclusions, but also illustrates the weaknesses inherent in the policy processes that led to their enactment. For a complete overview of the policy timeline see Fig. 1.