Since it first became possible to replace defective organs with healthy organs from other persons, including from the recently deceased, it has become possible to think in terms of a certain need for organs for transplantation. Where this need outstrips the numbers of organs available it has become possible to speak of an organ shortage. The extent of the organ shortage can be illustrated through the numbers of patients registered on the transplant waiting list.¹ Currently there are 118,184 people on the US waiting list,² 15,500 people registered on the Eurotransplant waiting list,³ 7,636 patients on the UK waiting list,⁴ around 300 of whom are Welsh⁵ residents (Griffiths 2012, para. 5). The seriousness of the organ shortage problem is shown by the fact that every year people who are registered on the waiting lists die for want of a transplant.

Organs can be supplied inter vivos (which is increasingly popular in the UK: see Jackson (2010, p. 595)), but this carries risks for the donor, which means that it is largely seen as an act of extraordinary generosity. As such, this mode of donation cannot be relied upon as the sole or primary source of organs. By contrast, cadaveric donation is generally seen as a less ethically problematic form of donation, because there are no ongoing clinical risks for the donor and it retains the same potential benefits for those in need of organ transplantation. However, there do remain ethical concerns relating to the proper and dignified treatment of corpses (see Feinberg 1985, pp. 72–77) and this is reflected by the current law in England and Wales ⁶ which protects the body of the deceased by inter alia prohibiting the removal of organs for transplantation without prior patient consent, without the consent of an appointed proxy (on the rare occasions when a proxy is appointed: see NAWHSCC (2013, para. 180) (Dr Alan Clamp)), or the consent of someone in a “qualifying relationship” (s 54(9) Human Tissue Act 2004 (HT Act)). As express consent is required in these cases, cadaveric donation is still seen as a genuine form of donation, but one which is less onerous for the giver than living donation . Hence it is the promotion of cadaveric donation that is considered the most appropriate strategy for increasing the overall rate of donation ahead of some of the more contentious options.⁷

The very ability to transplant organs from the recently deceased and thereby save lives generates a tremendous normative pull towards increasing cadaveric donation. And, as the state has an interest in promoting the health of its population (Foucault 2004, p. 242), the state must be concerned with increasing donation rates. But, in liberal societies, there is also a demand on government to minimise its interventions in order to maximise freedoms (Rose 1993, pp.  290–292). Thus there is a compromise to be made between the extreme of the compulsory confiscation of organs and making absolutely no intervention on organ donation. In the UK, that compromise has been arrived at by maintaining express and informed consent as the cornerstone of the donor system, but by simultaneously maintaining a place for people to record their wishes to become a donor (i.e. the Organ Donor Register (ODR)), promoting donation through advertisements, and allowing a fairly high level of persuasion (i.e. anything which does not ‘overbear the will’: U v Centre for Reproductive Medicine [2002] EWCA Civ 565) to encourage donation. Indeed, governments within the European Union are required to actively promote organ donation (Directive 2010/45/EU). Additionally, a blind eye is turned to the low possibility of making a meaningful capacity assessment at the point of registration on the ODR, as consent can be granted by ticking a box on a form without being in the presence of another (See Rithalia et al. 2009, p. 3). Notwithstanding these measures, the Welsh government believed that the normative case for increasing organ donation provided adequate justification for going still further, by legislating for an opt out system of consent.

The question of moving to an opt out system (i.e. one in which people will be presumed to have consented unless they give an explicit refusal) was considered in 2008 in the light of the UK’s comparatively poor rate of organ donation at the time (ODT 2008b, p. 1.5).⁸ Such a move would have brought the UK in line with countries with higher donation rates (see ODT 2008a, p. 10). The theory behind such a move is consistent with the popular policy strategy of ‘nudging’ people through the normative manipulation, in order to routinise cadaveric donation (Thaler and Sunstein 2008, pp. 175–182). However, the Organ Donation Taskforce (ODT), established by the UK government, rejected this option. It did so mainly on the grounds that opt out systems may violate the European Convention on Human Rights (ECHR) (ODT 2008a, p. 12), that the potential for an adverse public reaction may even cause a reduction in the rates of donation as happened in Brazil (see ODT 2008a, p. 23), that the public support for opt out systems found in opinion polls might not offer a genuine reflection of public opinion and that, fundamentally, whatever the problems with the ethical safeguards of the present system, inferring an active consent from a failure to object is logically and ethically dubious (ODT 2008a, p. 15).

Notwithstanding the conclusions of the ODT, the Welsh government viewed the opt in system as an impediment to organ donation, as it believed that changing the law to an opt out (or deemed consent) system, as it has, would result in an increase in available organs. Some commentators, such as John Harris (1975), have suggested taking a more radical approach and dispensing with any consent requirements (see Price 2010, p. 44). However, such a move would be highly controversial given the considerable importance afforded to the doctrine of informed consent in the UK. In recognition of this, the National Assembly for Wales (NAW) have sought to arrive at a position which balances the competing deontological interests pertaining to autonomy with the utilitarian, community interest reducing the organ shortage.

Even so, serious concerns were raised that such a system would change the nature of organ donation from an act of altruism , into an act made under obligation. Under opt in systems (i.e. those which require express consent), those who do not donate might simply be regarded as being less generous than others, but under an opt out system, those people might be viewed as being selfish or antisocial. Potentially those who choose not to become donors may experience a degree of shame, even if there is no requirement to make their decision public. It is questionable whether it is legitimate to expose people, who may have a strong conscientious or religious objection to donating their organs,⁹ to this kind of shame (even indirectly) in these circumstances.

John Fabre has also argued that moving to a system of deemed consent would “degrade the ethical framework of our society” (Devlin 2008) as it goes against the central post-war medical norm of express and informed consent as the basis for medical intervention.¹⁰ On this point, it would be unfair to suggest that presumed consent precludes the possibility of informed consent, as it is possible for the absence of a decision to opt out to be well-considered and informed. It would also be misleading to pretend that all instances of express consent are meaningfully well-considered and informed (see O’Neill 2002, pp. 42–44). However, under an opt in system, steps can be taken to ensure that sufficient information is made available prior to the decision to consent. Under an opt out system, by contrast, there is no guarantee that those who fail to opt out are doing so having had a real opportunity to become so informed. Furthermore, under an opt out system, there is no way of knowing that the donor directed their mind to the question of donation, whereas this is at least minimally indicated in opt in systems through the expression of consent itself.

Some of these concerns may be assuaged if it were clear that the change would increase donation rates. The NAW relied on research from Abadie and Gay, which suggests that opt out systems are associated with a 25–30 % increase in the rate of organ donation (Griffiths 2012, para. 103). If this is realised it will provide 15 extra organ donors in Wales and with an average donation of three organs per donor, there would be an additional 45 organs made available for transplantation. The NAW use this estimate to project this increase in donors to result in a net saving of £ 148 m over ten years (see Griffiths 2012, para. 124) based on the Quality Adjusted Life Years (QALYs) gained and the reduction in the need for costly chronic treatments, such as dialysis .

However, not all studies project an increase of this magnitude and although opt out systems may be correlative with higher rates of donation (Boyarski et al. 2012), a clear causal link between opt out systems and increases in rates of donation has not been established (Rithalia et al. 2009, p. 20; Rudge and Buggins 2011). Establishing this causal link would require the examination and control of a much larger number of variables than the system of consent alone. In particular, the differences in the systems and infrastructure which surround organ donation are also considered to be highly important (see e.g. Hitchen 2008; see Fabre et al. 2010). This is a point which ought to resonate strongly in the UK which has “the lowest number of critical care beds in Europe” and is thereby limited in the number of transplants that can be performed (NAWHSCC 2013, paras. 100–101) (Dr Peter Matthews). Moreover, in Wales, the only transplant operations which can be performed are kidney and pancreas transplants and therefore Wales is reliant on the services and infrastructure in England for all other transplant operations (Griffiths 2012, para. 54). Thus, there are plainly alternative ways of improving the rate of donation without resorting to modifying the associated consent requirements.

However, in the event that the Human Transplantation (Wales) Act 2013 (HTWA) does precipitate an increase in organ donation once it comes into force (in December 2015), the rest of the UK beyond Wales will also benefit. This is because, only around 30 % of organs donated by people in Wales are currently provided to people in Wales (Griffiths 2012, para. 129). If this trend were to continue, the positive effect of the legal change will be diluted for Welsh citizens.

Adding to the doubts over the likely efficacy of the legislation, the director of the Organización Nacional de Trasplantes in Spain (the system to which Wales implicitly aspires in its new legislation) is even reported to have said that concentrating on the legal framework and overestimating its power to bring about changes in practice would be ‘dangerous’ (See also Devlin 2008). Indeed Spain itself provides a good example of the importance of addressing factors beyond consent. It moved to an opt out system of consent in 1979, but it was only when the specialist training , infrastructure and the systems for coordinating donation processes were developed in the 1990s that a significant increase in the number of donations and transplantations was achieved (Fabre et al. 2010 and see also NHSBT (2008)). Furthermore, in practice, it is reported that Spain does not strictly enforce its presumed consent law (Rithalia et al. 2009, p. 11) and therefore it is rather disingenuous to present it as an exemplar for presumed consent, per se, boosting rates of donation.

Still more troubling than underestimating the potential increase, is the possibility that there could be a decrease in the rate of donation if public trust in the system is lost. There is precedent for this scenario in Brazil, where, after the system of consent was changed to an opt out system, opponents decided to opt out en masse and ultimately forced the system to be reversed (Csillag 1998). Indeed, suspicions of a public backlash have already been raised following the release of statistics which indicate a 22 % year-on-year decline in the number of organ donations taking place in Wales since commencement of the legislative process for the HTWA¹¹ NHSBT 2013). The NAW minister responsible for the Bill was quick to downplay any link between the decrease and the passage of the legislation,¹² but the figures must be a matter of concern considering that the other four nations of the UK experienced increases in their rates of donation over the same period (see NHSBT 2013).

Such concerns chime with some recent experiences in which public confidence in the medical system has been shaken. For example, in the aftermath of Andrew Wakefield’s discredited report suggesting a link between the Measles Mumps and Rubella (MMR) vaccine and autism there has been a marked reduction in the rate of vaccination among children (who were therefore exposed to the risk of serious illness).¹³ The scandals in the UK at Bristol (see Kennedy 2001) and Alder Hey (see Redfern 2001) damaged public confidence in the medical profession and led to a strengthening in the informed consent requirements when dealing with human tissue and organs which the HT Act emphasises. More recently, Germany suffered an 18 % reduction in the rate of organ donation¹⁴ following a scandal concerning the allocation of donated organs.¹⁵ Such is the importance of public confidence in the medical profession and the corrosive consequences of its loss.

Notably some patient groups expressed concern during the passage of the the Human Transplantation (Wales) Act 2013 (HTWA) through the Welsh legislature. The Patients Association argued that consent is fundamental to modern medical practice and that “[p]resumed consent is no consent” (2011). This point was echoed by 92 % of respondents to the consultation on the Bill¹⁶ questioned whether it was possible to speak of deemed consent, without undermining consent as a concept (Welsh Government Consultation 2012, p. 5). Another group, Patient Concern, argued along similar lines and drew attention to the fact that a system of presumed consent had been considered a number of times previously and had been rejected and branded the proposed opt out system as “dishonest, disrespectful and unethical” (2011, p. 1). And although the British Medical Association (BMA)¹⁷ currently supports a move to an opt out system (BMA 2012), it is at least possible that there will be medical professionals who might have a conscionable objection to an involvement in the transplantation of organs under a system of presumed consent, if they consider such a system to lack ethical legitimacy.

In spite of these concerns, there was a popular mandate for the change in Wales, as the Welsh Labour Party made a manifesto pledge to introduce an opt out system in Wales in the 2011 NAW elections (2001, p. 53) and since being elected to government have made good on that pledge by through legislation. Furthermore there have been surveys that suggest a high level of support for the principle of opt out legislation (i.e. 63 % of those questioned: BBC/ICM 2012). However, reliance on this poll is somewhat questionable, as the respondents were asked their opinion on organ donation (Q4), whereas the HTWA speaks of the donation of relevant material meaning: “material, other than gametes, which consists of or includes human cells” (s 18(1)).

The distinction is significant, because it is likely that some people who would like to consent to their kidneys or liver being explanted after their death, but who might not be willing for their hands, face or uterus¹⁸ to be removed and transplanted. This is possible to request under the current opt in system,¹⁹ but both the HTWA its explanatory note and the explanatory memorandum which accompanied the Bill are silent on the question of whether a person may refuse to donate certain organs but not others. As a matter of legal logic, this should be possible, but whether this would take place in practice would depend on instituting a system that could deal with such wishes. But, before anyone could render such a refusal to donate certain organs, they would need to know which organs would be the subject of deemed consent; a point which is currently unclear because while there are plans to introduce regulations (under s 7(2) HTWA) about what kinds of tissue could be explanted under the deemed consent provisions, excluding novel forms of transplantation (Griffiths 2012, para. 20), precisely what will be excluded remains a further point of obscurity until specific Regulations are created.²⁰

Much of the HTWA replicates, or approximates to, the current law governing both England and Wales through the HT Act, particularly as regards consent to living organ donation (HTWA s 4(3)) and the establishment of certain criminal offences for acting without valid consent (ss 10–11). While this has the advantage of keeping much of the relevant law on organ donation within the same legislative document, it has made the Act more complex and laboured than was necessary to effect the changes sought. One example is where HTWA refers to those cases in which the donor is both adult and alive. The HTWA states that on such occasions express consent is required.²¹ Unhelpfully, express consent is defined simply as: “The person’s consent” (s 4(3)). The major point of divergence is the mode by which consent to cadaveric donation is established.

The HTWA makes clear that in respect of adults, regard must be had to any express wishes of the deceased during their lifetime, whether for or against becoming a donor (ss 4(2)–(3)). If no such wishes are in evidence, and if that person has not appointed another to act as a proxy to give consent on their behalf (which rarely happens under the HT Act (NAWHSCC 2013, para. 180)(Dr Alan Clamp)on the matter, consent can be deemed subject to limited grounds of objection from persons in a qualifying relationship to the deceased (ss 4(4) and 19(3) HTWA).²² Voluntariness is therefore respected through the fact that those who do not wish to have their organs removed will be able to prevent this by registering their refusal²³ and, in addition, those in a qualifying relationship to the deceased (i.e. relatives and long-standing friends) may also prevent the removal of organs by claiming that the deceased would have objected (s 4(4)(b) HTWA).