Elective ventilation as a transplantation policy

The term ‘elective ventilation’ may be understood in various ways. In public and academic debates, it is most widely taken to denote the initiation of invasive measures to ventilate an irreversibly unconscious patient in order to optimise the chances of successful posthumous organ donation, following a decision that continued treatment can provide no benefit to the patient's own health or clinical prospects. It is common to find plain assertions in academic papers and public documents stating that elective ventilation is outright unlawful.

Things are not, however, so straightforward. For a start, it should be noted that elective ventilation is not itself a term of legal art in English law; the law does not in terms ‘say’ anything about a practice of this name. Furthermore, any exploration of the legality of potential policies now must account for the significant changes in principle since the mid-1990s. We should treat with caution arguments made at that time concerning the unlawfulness of the Exeter Protocol. The law governing treatment of adult patients who lack decision-making capacity continues to apply a best interests test (save in instances where an advance directive applies or if there is a formally appointed proxy decision-maker, in accordance with the Mental Capacity Act 2005). However, as explained below, best interests now enjoys a much richer and more nuanced understanding than it did in the 1990s,10 at which point it was largely reducible to so-called ‘medical interests’. Acknowledging the very broad scope of best interests in English law it is hard for anyone to claim with certainty that elective ventilation as described at the start of this section would always and in every case be unlawful.

Given the developments in principle, and also the span of practical discussions on organ policy and elective ventilation, I do not limit the scope of this paper just to the institution of ventilation. While some ethical and professional perspectives differ on this, at law there is no automatic distinction to be drawn between a practice of continuing ventilation and starting ventilation; in either case, a decision simply has to be made in accordance with a patient's best interests. So if the law does debar a particular instance of elective ventilation, this is not due to a universal principle on instituting ventilation in and of itself; exposure to a heightened risk of harm in initiation rather than continuation may make the difference, but this would in principle be a question assessed on a case by case basis, rather than as an abstract and general matter. It is more instructive, therefore, to widen the net, even if some readers do not consider what follows to be solely about what they would term elective ventilation. Probably the most contested medical-ethical questions in what follows concern instituting, as opposed to continuing, invasive measures, and handling uncertainty concerning the substantive content of a patient's best interests. These matters receive attention, but to cover all of the relevant ground it is most useful to enumerate four situations, all of which repay specific legal and ethical analysis in the current debate. My aim in describing them as I do is to facilitate analysis by separating some of the different ethical concerns that arise. They all apply to patients who lack decision-making capacity, and who have no specific advance-directive or decision-making proxy appointed to consent on their behalves. Thus, there can be no role for consent. With each potential practice, there is, at least on the face of things, increasing ethical complexity. I label them respectively: ‘basic elective ventilation’, ‘epistemically complex elective ventilation’, ‘practically complex elective ventilation’, and ‘epistemically and practically complex elective ventilation’: Basic elective ventilation: Here we have a dying, critically ill patient in the intensive care unit (ICU). It is decided that continued, life-sustaining ventilation is no longer clinically beneficial to the patient. However, it is recognised that the patient would be a suitable organ donor after he dies, and it is known that this decision is commensurate with what the patient would have wanted to happen. A further decision is therefore made to continue ventilation, which causes no harm to the patient even as it confers no therapeutic benefit. During this continuation, a surgical retrieval team has time to make necessary preparations to perform a transplant. The modest intervention of continued ventilation, withdrawn slightly later with a result of a slightly delayed cardiac death, followed by better co-ordinated transplantation, optimises the chances of a successful posthumous donation. Epistemically complex elective ventilation: Here the process differs from basic elective ventilation because it is not known whether the dying patient wanted to become a posthumous donor. Given such uncertainty, the patient's life is prolonged following the judgment of therapeutic futility not because it is inferred that he would want that in order to optimise chances of successful donation. Rather, it is prolonged so that his (probable) wishes can be established, in case it transpires that still further prolongation of ventilation is indicated in order to optimise the chances of successful posthumous donation. Thus, an intervention that is judged to be clinically futile is continued because it is thought to be in the best interests of the patient to assure that more facts about his best interests and the question of posthumous donation are established before he is allowed to die. Practically complex elective ventilation: Here the process differs from basic elective ventilation because the dying, critically ill patient is not in ICU. It is expected that the withdrawal of treatment from the patient will cause cardiac death, and clinically this is the indicated course of action. Although continued treatment is considered to be clinically futile, however, it is known that the patient would want to become a posthumous organ donor. He is thus moved to ICU where his condition is stabilised, and withdrawal—and consequent cardiac death—occur after the transplantation team is prepared. Epistemically and practically complex elective ventilation: Here the process combines complicating elements of the previous two. It is not known whether the dying, critically ill patient, who is not in ICU, would wish to become a posthumous donor. Following the decision that continued treatment confers no therapeutic benefit, the patient is moved to ICU and is ventilated first to allow time to make an informed best interests assessment of whether further continued stabilisation and ventilation for posthumous transplantation is indicated, and second to provide such continuation should that finding be affirmative.

Legal analysis

Although decisions about elective ventilation are made with a view to posthumous donation, the decision-making necessarily relates to would-be donors before death; the patient at the centre of the decision may be dying, but he is legally alive. Accordingly, decisions must be made on the basis of his best interests as this standard is formulated at law. Given the focus of our discussion, it is important to stress again that analysis must be made according to contemporary legal standards. While the legal literature and policy statements on organ donation span decades, principle now is markedly distinct to that even 15 years ago, and thus only limited reliance can be placed on conclusions expressed in older arguments. This point presents itself most starkly if we contrast the findings in two papers by David Price, the first published in 1996,2 the second in 2011.6 The practical conclusions of each are importantly different. Price's 2011 paper provides the most notable contemporary statement and analysis of end-of-life law as it relates to organ donation, and its contrast with his 1996 argument demonstrates clearly the substantial changes in principle, and their implications for practice and policy developments now.

Public ethics, policy and practices: beyond the law

If the desired—and realisable—numbers of organ transplantations are to be achieved, a diversity of continued developments in practice is needed.3 ,7 Policy-makers need to consider what may (and may not) be done to increase transplants both from living and dead donors. Full deliberation includes tackling questions of what is ethically viable, practically possible, politically realistic, and professionally and socially acceptable. Consideration must be given to legal frameworks, healthcare infrastructures, and healthcare practices. Beyond the widespread academic debates, there have in recent years been a range of high-profile public reports and guidance documents on these matters in the UK.3 ,7–9 Although there are some marked differences in these reports, in substance there seems to be more agreement than disagreement. Optimism can be drawn from a wide public-ethical and political accord on many issues. Perhaps most notably, there seems to be a broad consensus on the following: that financial incentives to living donors should not be permitted; that the right ‘philosophy’ underpinning posthumous donation is that it should be the norm; and that nevertheless the system is one of respectful pluralism that permits those with objections against donation not to have their organs ‘harvested’ against their will. Although there are philosophical disagreements about the wisdom and coherence of each of these propositions, from a policy perspective a broad consensus that will lead to better outcomes is clearly preferable to stubborn and sub-optimal stasis given dogged intellectual disagreement that results in avoidable death and suffering.19

Building on this consensus, continued efforts are needed in many areas of strategy and policy-development. Readers of journals such as this are all too familiar with the idea that knowing what the law ‘says’ does not speak to what is ethically permissible or mandatory (familiar to the extent that sometimes the law can be too quickly ignored when it provides at the very least an important fact about the world that requires consideration in a practical, action-guiding ethical argument!). Equally, it is widely recognised that there are all too many questions in healthcare law to which the rather unhelpful answer is ‘The law on this is not entirely clear.’; or ‘It depends…’.

A further, related point that demands acknowledgment is that policies and practices are only sensibly implemented if we allow for more than legality and morality. There is increasing recognition in contemporary bioethical debates of the importance of public ethics.20–25 This can be understood not simply as moral agents having to be able to account for their morality and its implications; to give reasons. Far beyond an exercise in pure morality, it is a political study, examining the force, limits, and implications of different sorts of normative and other argument in the practical situations we find (including in healthcare).26

In this paper, I have explained how English law is able to accommodate various practices that fall within the ambit of ‘elective ventilation’. I have not here made the moral arguments, but would simply assert (and in another place have to defend the position) that the moral case can also be made in its favour. Of significance in my concluding comments, however, is that legal and moral legitimacy are not all that we need before we can accept the unrolling of a policy. The debates on public ethics remind us how important it is to look to the acceptability of new policies, both to professionals who will be required to work under them, and to the wider public. Organ donation policy is controversial, and leads to heated argument and potentially deep suspicion both of the healthcare profession and of the State. Before implementing a policy in this area, it is essential that due attention be given to its acceptability (its actual, not its ‘in principle’, acceptability) and probable effects. Past experience—for example concerning the Exeter Protocol, or the organ retention scandals27 ,28—tells us that politically these different policies and strategies are not entirely separable. If it is to become practice, it is crucial to know that an elective ventilation policy would be lawful. But it is fundamental also to assure it will not lead to any political or professional backlash. This is not just because of defending the policy itself, but also to protect wider advances in the overall progress to an ethically better, more respectful, and less wasteful organ donation system.