Presumed Consent for Organ Donation - Written Evidence from Professor John Saunders
Strategies for procurement of organs for transplantation: mandated choice.
A. Background
1. Organ transplantation has been supported and promoted for over 30 years. All reasonable people are committed to ethical attempts to encourage the transplantation of organs to save life and improve its quality. Organ shortages are a longstanding issue. In 1972, for example, it was noted in a joint report that the short supply of cadaveric kidneys was a "major problem that limits the further expansion of transplantation”. Rather more optimistically, the report continued, "it is a problem that should prove soluble”. It was thought at that time that negative attitudes were the major limiting factor in expansion of the service and that there were more than enough potential donors available (1). A further report appeared in 1987 report (2), chaired by Sir Raymond Hoffenberg.
2. The gap between supply and need is widening. As transplantation has expanded to involve other organs and a wider range of patients, so too has the organ shortage. Currently between 7-8000 patients await transplant and the numbers are rising by 8% per year. Almost a quarter of the population (24%) are now on the transplant register to donate organs in the event of their deaths making this possible.
3. The rising numbers of those awaiting transplantation have led to a number of public initiatives and discussion:
The 2006 report of the Chief Medical Officer for England (published 17/7/07) discussed this issue and stated that the CMO favoured proposals to amend legislation to create an opt out system.
A communication from the EU Commission to the European Parliament and Commission discussed policy at EU level.
The House of Lords Select Committee on the European Union conducted an inquiry in 2007, including a public consultation.
The British Medical Association (BMA) has adopted a policy of advocating so-called "soft presumed consent”.
The Government set up the Organ Donation Taskforce which reported in January 2008 (3).
Following the Taskforce report, an independent Donation Ethics Group has been established.
4. The Organ Donation Taskforce report noted ethical difficulties that included:
The quality of consent with the current donor card. "Amongst clinicians there is a certain amount of concern that the carrying of a donor card, or even registration with the donor register, falls short of what would usually be defined a consent in a medical setting. Furthermore…. the passage of time between registration and death is seen by some to weaken the ethical force of the action. These concerns cannot be ignored…” (para 4.8)
Secondly, (4.11), "having made a decision to withdraw treatment from a patient who is known to be a potential donor, one faces the ethical question of whether it is morally acceptable to manage the process of treatment withdrawal and the death of the patient in the interests of ensuring the best possible retrieval of the organ”. The report continues (4.12), "if we are unclear about the value of the consent, or where no wishes have been stated, we would have to concede that some of the actions taken to facilitate donation may not necessarily be in the interests of the donor”. It would be treating one patient not as an end in themselves, but as an object to promote another’s ends. It was a policy of this sort in Exeter (4) some years ago that was declared illegal when patients with stroke were identified and treated as potential donors.
Thirdly, the Task Force report avoids any detailed discussion of policy on obtaining consent to organ retrieval. However it notes that whereas nationally the relatives of 40% of potential donors refuse consent to donation, this is 75% in the case of those from a Black & Minority Ethnic background. The CMO’s report had noted that 2% of renal donors are from BME backgrounds, compared to 18% or recipients. There are also significant differences in different geographical areas of the UK.
5. Many of the recommendations of the Task Force Report are relatively free of controversy. They include consideration of widening the donor pool e.g. consideration of use of "marginal” donors (e.g. older, diabetic, CJD risk, hepatitis B & C positive in certain groups etc).
B. Determining the best policy
6. The independent Donation Ethics Group, set up after the Task Force Report, has been established to take matters forward. Similarly in Wales, the Health, Wellbeing & Local Government Committee is considering this matter.
7. It is extremely important that the Donation Ethics Group (& its Welsh equivalent) should consider all possibilities. Current public discourse has concentrated almost entirely on 'presumed consent’ - perhaps more accurately termed 'presumed lack of objection’ (PLO). In this submission, it is suggested that other proposals should be the subject of serious scrutiny. In particular, and in the light of the Report of the Council on Ethical and Judicial Affairs of the American Medical Association (5), it is suggested that a policy of mandated choice is worthy of assessment.
8. The seriousness of the problem and the proposal for changes in the law make it strongly desirable that all options are assessed.
9. Such assessment could involve opinion polls or focus groups, for example, as well as expert opinion.
10. In the remainder of this submission, the focus is on the arguments in favour of a policy of Mandated Choice (MC) over one of presumed lack of objection/presumed consent (PLO). In doing so, it is hoped that the Donation Ethics Group etc will be persuaded that this option should be considered alongside PLO or, indeed, alongside an enhancement of current policies. Many believe that there are ethical advantages in MC that make a compelling case for its consideration.
C. Problems with presumed lack of objection ('presumed consent’)
11. The Human Tissue Act 2004 established that consent is the fundamental principle underpinning the use of organs from the bodies of deceased persons. It is lawful to use the organs of dead people only if there is what is called in the English legislation "appropriate consent" and what is called in the Scottish version "authorisation by an appropriate person" (The Human Tissue (Scotland) Act 2006). Although the law is different in its wording in Scotland and England, the expectation is that the same actions will be legal in both countries. The HT Act also necessitated the approval of the Human Tissue Authority in all living transplant procedures.
12. I have noted above the varying donor rates in other countries and the multiple factors that contribute to them. Isolating one factor is difficult. For example, Sweden has a system of 'presumed consent’ but a lower transplant rate than the UK, whereas Austria, also with 'presumed consent’ has a higher rate. However, one frequently quoted review has concluded that a shift to 'presumed consent’ might increase the donor rate by 25-30% (6). Nevertheless, expert opinion is divided and many believe that the policy of PLO may not be the key factor in the high transplant rates found, for example, in Spain (indeed in Spain, PLO is almost certainly not the main reason for the success of its high organ retrieval rates). It could, of course, still be a contributory one.
13. 'Presumed consent’ is not consent. The Redfern Inquiry that followed events at Alder Hey Hospital pointed out that the Human Tissue Act 1961 "was drawn up against a backdrop of advice from the Minister for medical practitioners to obtain the 'consent' of relatives, where available, in relation to the removal of eyes for cornea grafting. (9.1) ...There was no suggestion that the doctor had to enquire as a matter of routine beyond the next of kin if they did not object” (9.2) The terms of the Act were that "having made such reasonable enquiry as may be practicable”, there would be "no reason to believe that any surviving relative of the deceased objects to the body being used in particular for medical education and research purposes". (24.1) As the government’s consultation document, Human Bodies, Human Choices
emphasized in 2002, specific consent was not required by the Act (3.5). The unsatisfactory nature of this led to Human Tissue Act 2004. It seems curious that lack of objection that was so unacceptable then should become acceptable now.
14. Some commentators describe presumed consent as " a fiction” (7). Erin and Harris argue that however well intended the outcome, the language of consent attempts to disguise what we are actually doing, which is appealing to a principle of respect for individual autonomy. In reality, by presuming we are acting against that principle, being disrespectful of autonomy. However we present it, we are actually articulating a particular society’s view of what it is morally supportable to do with a dead body. Presuming consent is an affront to the moral principle that is the foundation of consent itself. McClachlan has expressed this more strongly (8): "To say that it can reasonably be presumed that we consent to donate our organs if we do not specifically say that we do not consent is absurd. It is a deceitful piece of sophistry. There might be a good utilitarian case for having an opt-out rather than an opt-in system of organ donation. However, this would mean that there is a case for using our organs even in the absence of our consent. If consent matters in this area, then only the explicit consent of the people concerned can justify the using of their organs after their deaths. If consent does not matter and the use of their organs can be justified without it, then consent does not matter. We should not appeal to the bogus notion of presumed consent”.
15. The widely varying donor rates among ethnic groups has already been noted. In the Potential Donor Audit (1/4/03 to 31/3/06), the refusal rate was 35% (95% confidence limits 33-37) among white and 70% (64-74) among non-white potential donors. This means that presuming consent in the non-white 'donor’ is more likely to be wrong than right, if relatives’ wishes currently relate even loosely to donors’ wishes.
16. The 'soft’ system of 'presumed consent’ advocated by the BMA appears to represent little benefit over current good practice. For it is the customary approach to the grieving family to inquire if the patient had any objections to organ removal, rather than whether they had expressed a wish to donate. Given that the 'soft presumed consent’ proposed continues to give the family a veto over organ removal, it seems possible that introducing such a scheme would fail to significantly improve organ retrieval rates, or even, through the public debate that might ensue, lead to a fall.
17. Any policy of 'presumed consent’ requires repeated publicity and public education to ensure that those who wish to opt out at least know how to do so. It seems all too likely that such publicity and public education would lapse after a period and the minority that do not wish to donate would not be informed of how to register their choice.
18. Opting out is a viable system only for those patients who understand how the system works and how to express their objections to donation. When individuals or their families are not told that they can object or how to object to organ donation, 'presumed consent’ becomes in effect a strategy for avoiding 'consent’ entirely (5).
19. The proposal for 'presumed consent’ entirely fails to address the ethical issues identified by the Task Force of patient care before death or the quality of the consent on the current donor card, as noted above. Only advanced choice can address the former concern, voluntary or mandated.
D. Why consider Mandated Choice?
20. Mandated Choice (MC) is a legally mandated decision. Under MC, all adults would be mandated by law to indicate their wishes regarding use of their organs after death.
21. This could be done through the electoral roll, given that all adults are represented on the roll (in contrast to driving licences, tax returns etc) or be mandatory on registering with a general practice or some other mechanism that a working group would need to explore. (In the case of general practice registration, it could be supported by payment through the QOF). There would be no influence on the decision itself, of course.
22. Among detail that a working group would need to decide would be whether the choices should be limited only to consent (all or some organs) or refusal; or whether choices could be extended to 'ask my family’ or a 'don’t know’ or a 'don’t want to choose’ (i.e. a choice not to choose). The details are likely to be crucial both to the acceptability of MC and its success.
23. MC would improve advance consent even if associated with no penalties, although a working group would need to examine this: a (threatened) fine, status on the electoral roll, non-registration in a general practice, for example, would all constitute penalties. Acceptability might well depend on such detail which would need to be explored.
24. In advocating consideration of Mandated Choice, the possibility of a pilot period in one of the devolved jurisdictions (e.g. Scotland or Wales) might inform a UK decision and policy.
25. MC replaces the implied consent under 'presumed consent’ with real consent.
26. By standardising the approach to potential donors over the present mixture of routes, the provision of information could be improved and standardised. This would address concerns of the Task Force around the understanding of consent.
27. MC would also address the Task Force’s legitimate concern around the support to the patient before death in optimising the condition of transplanted organs. For if consent is known in advance it can be reasonably argued that in promoting the optimal condition of potential transplantable organs, one is also promoting the patient’s interests. This cannot be argued under 'presumed consent’ of course. This is potentially a huge advantage, for the Exeter experience (4) has demonstrated that there is the potential for increasing the donor supply if advance consent is accessible. The experience of so called 'elective ventilation’ in Exeter provides evidence, as opposed to speculation, that advance consent could identify a potential donor pool that is not currently accessed, with increased retrieval rates.
28. Under MC, family members will know that a genuine choice has been made. This has the potential to relieve distress. If relatives wish to refuse organ retrieval, then MC would relieve the uncomfortable action of refusal itself. Instead with MC, they are comforted in knowing that wishes have been honoured.
29. It would also relieve the accusation that patient wishes are being thwarted. Opinion polls have apparently suggested that at least 10% do not wish to donate organs. Under 'presumed consent’ these organs could be retrieved, especially if there were no available next of kin. These numbers are not trivial (and they are proportionately even greater in black and ethnic minority groups). Under MC, family members would not have to live with the anxiety that what was done was not wanted.
30. In a survey of young adults in the USA, an overwhelming 90% indicated that they would support MC, while only 60% approved of 'presumed consent’ (9). I am not aware of any similar surveys in the UK that would compare the acceptability of these two approaches.
31. Having choice increases the probability of satisfying our wants. It allays fears in medical treatment of mistreatment of the dead and dying (10). Because we control what happens to our bodies it enhances autonomy, by preventing relatives from over-ruling the deceased’s wishes. (Relatives tend to be negative if not sure, based on opinion poll evidence). No other strategy can claim to enhance autonomy.
32. There is an irony in enhancing autonomy by coercing choice. But without that advance choice, autonomy for organ use is indeed frustrated. The acceptability of MC has never been assessed and there is no precedent in healthcare. However, MC is used in Australia to mandate voting in elections. It is accepted and it works.
33. It is surely irresponsible to fail to decide about organ donation when the lives of other may depend on this decision and where the act of choosing is minimally demanding. Of course, not all morally desirable actions should be legally enforceable: we are not morally obligated to be Good Samaritans, only to be what Thompson calls a minimally decent Samaritan (11). However, the minimal curtailment of liberty involved in MC should be balanced against the lives that it could save.
34. Some compulsion is a necessary end to a more or less decent society. Freedom is not licence and we cannot do as we please. Where the benefits to others are great and obvious, we compel: most obviously in taxation. There is no opt out from tax, no matter how much we would like to pay less or none. Voluntarism would be incapable of delivering the benefits - rather less so than the voluntarism of current organ donation policy. So it can be argued that the objection of compulsion is not itself compelling.
35 "I am not obliged to do small good to society at the expense of a great harm to myself”, wrote David Hume (12,13). All our obligations to do good to society seem to imply something reciprocal. I receive the benefits of society and ought to promote its interests.
36. Both Thomas Aquinas and John Stuart Mill famously argued that liberty may be restricted when harm to others may accrue from an individual’s choice. Government interference with a citizen’s behaviour (by mandating choice) is necessary to prevent harm to others - in this case the harm of dying without an organ - when the burden of rescue is so small.
37. A recent 'personal view’ described the experience of deciding on organ donation in the state of confusion, exhaustion and bereavement that follows a death, when the author was 'in no state to make a decision about anything’ (12). MC avoids all this. The decision has already been made.
38. The American Council on Ethical and Judicial Affairs in its stated preference for MC comments that it avoids the widespread reluctance to consider one’s own death and the prospect of body mutilation that organ harvesting might entail by ensuring that it is confronted. (5) It is the reluctance to face our mortality that leads to the too limited success of current policy based on voluntary advance choice.
39. In the same US report, it is commented that 'presumed consent’ may achieve some success because of a failure by the decedent to have overcome inertia and confront the decision squarely, not because the decedent’s failure to opt out actually indicated a willingness to opt in (5).
40. The current opt in system might need to continue for the donation of organs from children (depending on the detail of any proposal) and the choices of those with learning difficulties would require detailed consideration by a working group.
41. Obviously any proposed change will require public education before its introduction. Presumed consent did not have public support when first proposed (7) and MC would require advocacy.
42. It can therefore be suggested that mandated choice is inherently ethically the superior strategy for it breaks the link between numbers of organs retrieved and the expression of autonomy. Even if the number of organs retrieved were to be the same, it offers the possibility of realising the wishes of the donor - who really would be a donor, one who gives, and not just the supplier of organs.
Hence the policy of mandated choice, (-which has not featured prominently in recent discussion in the UK-), should be explored in depth. It is acknowledged that public policy requires consideration of costs and that any exploration of 'mandated choice’ should include some assessment of its costs in relation to its ethical benefits. Mandated choice could be a superior strategy to 'presumed consent’ and deserves more active consideration than it has been given to date.
References
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Organs for Transplant. A report from the organ donation taskforce. Department of Health, London 2008.
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