Con Rebuttal: Presumed Consent Won’t Increase Organ Donations

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Presumed consent doesn’t save lives, other factors at play

Rebecca Brown, September 25, 2017, Organ Donation: Presumed Consent and Focusing on What Matters,

It makes intuitive sense that presumed consent systems would increase organ donation rates, and those who fail to support their introduction often come under criticism. Such criticism tends to assume that failure to support presumed consent is due to a failure to properly recognise the importance of organ donation or a sentimental or squeamish attitude towards bodies as well as oversensitivity towards those who are hesitant about organ donation. Yet, even if one is very concerned with increasing organ donation rates, there are grounds for scepticism about the helpfulness of presumed consent systems as a means of achieving this. First, it is worth recognising that presumed consent systems may, essentially, be no different from opt-out schemes. An excellent article by John Fabre and colleagues, published in the BMJ in 2010, describes in detail the Spanish system for organ donation, which is often held up as an example of a presumed consent system which results in very high rates of donation. The authors describe how, although Spain is often said to have a presumed consent system, in practice, the requirement to make sure people haven’t (at some point) expressed a desire to opt-out means that the deceased’s family is always asked for consent, and if they refuse then this is always respected. In fact, almost all countries with presumed consent systems adopt a similar (sometimes called ‘soft opt-out’) system whereby family members are always approached to confirm that the deceased would not object to their organs being donated. This creates the opportunity for ‘family overrule,’ even where an individual has expressly signed up to be an organ donor. Rarely do countries adopt a system where the family has no right to overrule the presumed or declared wishes of a donor (Austria is one such exception). Fabre et al point to a number of other factors that could be important contributors to Spain’s high donation rates relative to the UK: for various reasons, Spain has more potential donors than the UK (including number of road traffic accidents and provision of intensive care); infrastructural systems to promote openness and trust in the donation system; and the introduction of transplant coordinators who play an important role in all aspects of donation, including approaching family members at an early stage in order to begin discussions about the potential for donation. It is difficult to tease out what is important and what isn’t in determining how to improve organ donation rates. Presumed consent systems may have virtues, such as signally a national commitment to increasing organ donation and helping to shift social norms towards donation and away from refusal. However, they may ultimately have little impact, and there is a risk they could reduce donation rates. I was at a talk by a transplant surgeon who was urging the audience to sign up to the organ donor register. He described how, when approaching family members after the death of a loved one to discuss donation, the information that someone had expressed a wish to donate their organs could be very helpful in supporting families to make a decision to donate: “It’s something concrete we can take in to the room and say “here: this is what they wanted””, the surgeon said. The same surgeon was also enthusiastic about the move to a presumed consent system. Yet, it seems to me, where presumed consent is adopted, the imperative for people to actively agree to donate their organs is lost (or significantly weakened). The fact that someone is on the register doesn’t express their wishes to donate in the same way if there is no opt-in: it just means they never opted-out. One worry, then, is that medical teams will be less likely to have this information about someone’s wish to donate. Practical ethics encourages us to use reason to inform decisions about how we set up our social institutions. Sometimes the most useful thing philosophers can do is to identify unimportant and misleading lines of argument that distract from more important debates. Engaging with empirical evidence is often essential to such efforts. There is currently particular interest in organ donation and the impact the change in Wales’s policy is having on donation rates. It is vital that science-literate ethicists and philosophers attend carefully to the data emerging from Wales, questioning whether the explanations given for changes in behaviour are justified.So far, newspaper reporting has been enthusiastic, claiming that “dozens” of lives have been saved as a result of the new system. Yet, as pointed out in an article by Margaret McCartney, and a series of responses in the BMJ, the data from Wales actually shows a small reduction in deceased donors when compared with donation rates during the same period the previous year, although caution is required interpreting these data: Wales is a small country, organ transplantation is relatively rare, and presumed consent has been in place for less than two years. Still, this has not held back excitable editors and campaigners presenting evidence from Wales in a way that indicates presumed consent is an effective way of promoting donation. This may be having an effect: the Scottish Government Minister for Public Health has announced plans to introduce presumed consent in Scotland, and there is increasing pressure for its introduction in the remainder of the UK. If presumed consent really is an efficient way of promoting organ donation, this may be an excellent move. But it will be a shame if intuitive reasoning and political expedience prevent proper collection and scrutiny of evidence vital to understanding how to increase organ donation and, ultimately, save lives.

Turn — Presumed consent undermines physician-patient relations

Simon Bramhall, 2011, Ann R Coll Surg Engl. 2011 May; 93(4): 270–272.

There is a belief among some members of the medical profession that the introduction of presumed consent might damage the relationship of trust between clinicians caring for patients at the end of life and their families (survey of Intensive Care Society members, 2008). There is a possibility that some clinicians could opt out of donation programmes at a time when their support is required to improve rates of organ donation. In addition, evidence from recipients of organs suggests that many need to know that organs had been donated without coercion by the organ donor and his or her family. The families of organ donors usually find great comfort in being an active part of the decision to donate.

Turn — Presumed consent would undermine support for donations

Simon Bramhall, 2011, Ann R Coll Surg Engl. 2011 May; 93(4): 270–272.

Despite support among the UK population for organ donation an attempt to introduce a system of presumed consent might provoke anti-donation feelings and even active anti-donation campaigning among some vocal groups. This view has been supported by some faith leaders who under the current system support organ donation.5 A hard system of presumed consent would almost certainly lead to an increase in rates of donation but its introduction would be open to challenge. The current opt-in system of either registration on the organ donor register or obtaining consent from the next of kin is actually little different to a system of soft presumed consent. In both cases the families of the deceased are approached to obtain family consent; the only difference is the emphasis of any conversation. While such a system could be introduced the cost would run into many tens of millions of pounds6 and would run the risk of alienating members of the medical and nursing professions whose support is required to run a donation programme. In addition, there would be a real risk of a backlash from members of the public who currently support organ donation, which could have a negative impact on donation rates.

Paul Hsieh, August 29, 2017, Should The Government Require Your Consent To Be An Organ Donor?,

However, critics of “opt out” note that changing the default runs counter to standard Western views of individual autonomy over one’s own body. For the state to presume the authority to harvest my organs (or to allow others to do so) without my explicit consent strikes me as deep violation of my freedom and autonomy. My body and my organs are mine — not mere means to others’ ends.

All physicians swear to uphold and protect patients’ individual bodily autonomy. Although my heart goes out to patients on the waiting lists in urgent need of a transplant, they’re not entitled to anyone else’s organs. I’ve volunteered to be an organ donor ever since I got my driver’s license. I would be delighted if my organs could help others after my own death. But all I require is that I be asked first. This affirmative decision is my call, and the default should respect that. Moreover, other organ donors under the current system have told me that if the US changed to an “opt out” system, they would immediately opt out — and they would aggressively encourage others to do the same. Depending on how widespread this attitude was, an “opt out” system in the US could backfire badly…. Regarding the negative American reactions to “opt out,” UNOS spokesperson Anne Paschke noted, “Our attitudes here are very different. Individual rights are very important in this country more so than in other countries. Opt-out hasn’t been very popular because of the way that people here view government making decisions for them.” I fully agree with Paschke’s point. And I’m glad the issue of individual rights is crucial for so many Americans. The “opt in” system protects those rights, whereas the “opt out” system systematically violates them. I hope future organ donors such as myself never lose

No gain from presumed consent

Donate Life California, no date,

Presumed Consent is an Attractive

Concept with Unattractive Results

The waiting list for organ transplants has exceeded 117,000[i] and is growing roughly 10% a year, despite more than 28,000[ii] transplants being performed annually, and with the diseases of aging and obesity that damage organs, this trend is expected to worsen.[iii] While prevention and medical innovation can over the next half a century reduce or even end the need for organ transplants, they can do nothing to save the lives of those suffering from organ failure today; clearly, we must make more organs available.

It is this clear-cut need that prompts well-meaning legislators, wait-listed potential transplant patients, and community-minded citizens to conclude that our forty-year-old Opt-In, Explicit Consent (EC) organ donation system is broken and needs to be fixed by implementing Opt-Out Presumed Consent (PC). After all, if we could be compelled to donate organs upon our deaths, as a country we could meet our need for organ transplants; wouldn’t we?

The Facts Suggest Otherwise:

First, 72% of Californians and 75% of Americans who can become organ donors actually donate and save lives at the time of their deaths.

Second,  California’s actual donation rate of 32.3 nDPM (normalized Donors per Million population[iv])  leads the US ‘s 26.1 nDPM and every country in the world except for Spain’s 33.5 nDPM[1] Meanwhile all other countries trail donation in California and the US; whether they have Presumed Consent or Explicit Consent laws.

A review of the accompanying chart indicates the wide disparity within European Presumed Consent countries donation rates, from a high of Spain’s 33.5 to a low of Greece’s 5.7, with a simple average of 12.5 nDPM, which is insignificantly different from the Explicit Consent average of 12.1 nDPM. This finding reconfirms a British Medical Journal article that studied inter-country European donation data and found that Presumed Consent and Explicit Consent donation rate variances were not statistically definitive[v]. This insignificant difference in DPM suggests that social, cultural, and operational factors, rather than legal structures are at play. For example, of the European countries with more than 70%, Roman Catholic populations nDPM averages 16.3 while the countries with populations that are less than 70% Roman Catholic donation rates were only 9.1 nDPM; with a mix of PC and EC in each group of countries. Thus, it is very likely that religion plays a far more dominant and successful role in increasing organ donation in Europe than Presumed Consent.

Most significant in this assessment of PC vs EC is the fact that the European countries that developed and maintain presumed Consent in their laws do not rely on it to actually recover organs.  A 2012 survey of practices reports[vi] that donation professionals in all of these countries require family consent prior to recovery of organs. The fact that all countries that have PC laws do not actually rely on the right of the state to take organs speaks to the public trust and autonomy issues that arise when countries seek to claim any type of property, and makes it clear that the variance in donation rates is a function of cultural and operational aspects rather than legal characteristics of their donation programs. While these data are convincing that Presumed Consent does not improve organ donation, there are those who still suggest that California is somehow different and implementing a PC system would further improve our already impressive donation rates.  However, we have some measures of our own population’s initial perception of donation that should give us pause. The significant variance between the 31%[vii] of Californians who register to be donors while applying for driver licenses and the 72% who actually donate at the time of death suggests a concern:  when people are applying for a driver license a significant majority either feel under-informed, are misinformed, oppose donation, or simply do not choose to register at that time. Yet, when confronting the unavoidable end of life and the need to make final decisions, individuals and families seek and are receptive to information that prompts them to choose to donate. Unfortunately, under a Presumed Consent system, the “Opt-Out” provision would capture people’s premature, under-informed, and unplanned decisions to NOT donate, while individuals are in the immediate process of focusing on the process of getting a driver license. And, once recorded as a “No” there is little opportunity to address misinformation and inspire individuals and families to donate; the work we in the four California OPOs help to do today that moves us from the 35% who register as donors to the 72% who actually donate. The significance of misinformation is not merely theoretical; as reported in the 2010 Donate Life America/Astellas independent[viii] poll a shocking 52 percent of people incorrectly believe that doctors may not try as hard to save their lives if they know they wish to be organ or tissue donors, that 48 percent believe a black market exists in the U.S. for organs and tissue, and a remarkably high 61 percent mistakenly believe it may be possible for a brain dead person to recover from his or her injuries.  With these serious misconceptions out there, it is very realistic to conclude that an Opt-Out, Presumed Consent decision, made early in life, without access to accurate information would lead to millions of ill-informed decisions and no chance to address these misconceptions when the opportunity to donate occurred.

Fear of litigation means presumed consent won’t actually increase organ donation

Sheldon Zink, PhD, Rachel Zeehandelaar, and Stacey Wertlieb, MBe, September 2005, AMA Journal of Ethics, Presumed vs Expressed Consent in the US and Internationally,

It seems unlikely that the United States will make the transition to a system of presumed consent for organ procurement in the near future. State bills proposing presumed consent were defeated in Maryland and Pennsylvania [8], and fear of litigation would put a serious damper on its feasibility.

Family members end up objecting and both systems fail – families undermine soft consent systems and public backlash undermines had consent systems

Sebastian Agredo, 2014—5, Bioethics,, Should the United States Sign Off on Presumed Consent?

Although Gill’s conclusion would certainly appease those fighting for the implementation of presumed consent, his notion is meant for a country with a stronger communitarian ethic; one in which the tenets of utilitarian moralism outweigh those of individual autonomy. Such a policy, however, goes “against the grain of American individualism.”13 As Orentlicher  states, the United States has actually tried presumed consent on a limited basis for the past forty years, and it failed because it went either too far or not far enough. In allowing family members to overrule the presumption that the decedent would have preferred donation, presumed consent did not go far enough. This deference to the family in regard to organ donation never allowed presumed consent to surpass the real reason why decedents do not become organ donors, namely the refusal of family members to give consent.13 This is akin to the kind of “soft” presumed consent found in Spain. Spain places great importance upon the fact that death is not an isolated event involving the deceased, but instead engages the whole family. Spain realizes that any organ procurement system relies on the trust that exists between the patient’s family and the physicians or transplant coordinators. Undermining that trust would completely damage the entire organ donation process. This serves to highlight Spain’s accomplishment in keeping the refusal rate so low at 15 percent; which is achieved mainly through its extensive training of transplant coordinators, lack of donor registry , and enhanced capacity to identify potential donors.4 In essence, the Spanish model succeeds without much need for presumed consent.

According to Orentlicher, presumed consent in the United States went too far in regard to the fact that public officials attempted to bypass family members in an effort to avoid the possibility of family refusal. Such attempts only exacerbated concerns and fears that physicians would harvest organs from those who would not have wished for their removal. Starting in the late 1960s, state legislatures passed measures that authorized the removal of corneas, pituitary glands, and sometimes even hearts, lungs, kidneys, and livers if the decedent’s body came under the custody of a medical examiner or coroner. The lawmakers’ reasoning was rather simple – since the body of these individuals would already be subjected to a major intrusion in the form of an autopsy, then removal of an organ for the benefit of living persons was acceptable. This practice was supported and reinforced by the 1987 Uniform Anatomical Gift Act, but has since been discarded since the document’s 2006 revision and adoption by a vast majority of states.13 Therefore, the largest hurdle for presumed consent to conquer is that of public perception and attitudes against it. Because the registration process varies from state to state, many state legislatures have tried to bring up the issue of presumed consent, proposing opt-out systems. These have never gotten very far due to concerns about individual rights—another testament to the importance of autonomy, which is present in American minds. For example, Colorado tried to pass an opt-out law in 2011, but the lawmaker who introduced the bill was forced to pull it due to negative reactions from the public.10

There has been abundant skepticism about the possibility of presumed consent as a solution to close the organ gap that exists in the United States.11,[20] Researchers have concluded that despite the substantive differences in the laws themselves, presumed consent, in countries like Spain, does not differ dramatically from the application of explicit consent in the United States. In both the United States and Spain, primacy is given to respecting the wishes of the individual and the family. If anything, the experience in Spain has shown that what can truly improve the donation rate is diligent attention to the infrastructure of the organ transplantation system, using it to quickly and efficiently identify patients in the intensive care unit who are potential donors and taking the necessary steps to ensure that the organs are procured ethically and respectfully once death occurs. With respect to the procurement system currently in place in the United States, legislation was introduced by the Surgeon General that legally requires all hospitals to identify and refer potential donors to an organ donor organization.3 Potential donors are identified using clinical markers that are present in patients likely to be diagnosed as brain dead, and organ donor organizations are well-staffed with an extensive network of trained organ coordinators.

Spain does not actually have an informed consent system and its donation rates are high

John Fabre, professor emeritus, 2014, Presumed consent for organ donation: a clinically unnecessary and corrupting influence in medicine and politics, Clin Med (Lond). 2014 Dec; 14(6): 567–571.,


Spain has consistently had the world’s best donation rate, about 32–35 pmp, for more than 10 years, and its family acceptance rate is an outstanding 85%.5 However, Spain does not operate a presumed consent systemAs a result of its pre-eminent international position, advocates of presumed consent very frequently misrepresent Spain, out of either ignorance or wishful thinking. Spain passed presumed consent legislation in 1979. However, the legislation did not have a positive influence on donation, and so, in 1989, crucial organisational changes were instituted at a national level. These changes created an organisational infrastructure for transplantation, now internationally known as ‘the Spanish system’, and it is this system that the UK has emulated so successfully in recent years. It is from 1989 that Spain’s donation rate began to rise to the pre-eminent position that it currently occupiesMany observers have wrongly attributed Spain’s success to its 1979 presumed consent legislation. To correct this misconception, the Director of the Spanish Organ Donation Organisation, Dr Rafael Matesanz, was co-author of a paper published in the British Medical Journal (BMJ) in 2010, which clearly stated that the presumed consent law in Spain is dormant.6 This paper emphasised that Spain does not have an opt-out register for those who do not wish to become organ donors, and that Spain makes no effort to make its citizens aware of the 1979 legislation. How can there be an operational presumed consent system when citizens have no mechanism to opt out, and when the state does not inform citizens of the existence of the presumed consent law If there is any lingering doubt, it is worth noting that in Spain the consent of the donor (even the explicit consent of carrying a donor card) is not sufficient to permit donation to proceed. The written consent of the family is required.7 In these circumstances, it is difficult to imagine how anyone can sensibly or honestly persist in the contention that Spain operates a presumed consent system.

It is sometimes argued that the mere presence of the presumed consent legislation in Spain has had a positive cultural influence, even if the legislation has been dormant. It is impossible to argue definitively one way or the other on this point, other than perhaps to note that the positive influence was not seen for the first 10 years after Spain’s legislation. In any case, a positive cultural influence of dormant legislation is certainly not what is being contemplated in the UK or what is coming into effect in Wales. Improving cultural attitudes is the key to improving consent rates, but there are less divisive, more effective and, almost certainly, less expensive ways of achieving cultural change than legislating for the consent of donors (see later).

Spain is doesn’t actually have informed consent and its donations are high for cultural reasons

Ryan M. Marquardt, Cedarville University, October 2017, Presumed Consent for Organ Donation:. Principlism Opts Out, Bioethics in Faith and Practice,

While the data indicate that implementing presumed consent may possibly increase donor rates, several mitigating factors not yet mentioned warrant consideration. First, one author argues that Spain, the country with the world’s highest donor rates and counted as a presumed consent country in the studies above, does not truly operate on a presumed consent system.25 Further scrutiny shows that Spain’s introduction of presumed consent legislation, approved by parliament in 197926, did not produce a significant effect, so major organizational and infrastructure changes were made ten years later. At that point, Spain’s donor rates began to increase to what they are today. In fact, the Director of the Spanish Organ Donation Organisation co-authored a paper in 2010 that asserts the presumed consent legislation in Spain is not enforced, and further investigation reveals that written consent of the family is actually required before organ removal can proceed.27 Since donor rates did not increase until organizational changes led to better awareness and societal acceptance of organ donation, the true explanation of Spain’s high donor rates seems to be their cultural acceptance and 85% family acceptance rate. 28 Another reason that data from other countries might not apply well to the U.S. is based on current policy and enforcement. Since first person authorization law technically overrides the desires of the family if a donor is registered, and it is still not evenly enforced by OPOs, switching to a soft presumed consent system where families always have the right to veto donation could end up resulting in the loss of the ability to overrule a family who disagrees with the donor’s prior decision to donate. The solution to this could be to instead use a hard presumed consent rule where the family cannot opt a person out, but this seems likely to provoke public backlash.

Presumed consent won’t lead to a large increases and families will object

Timothy Caulfield holds the Canada Research Chair in Health Law and Policy at the University of Alberta, April 11, 2019, COMMENTARY || We need more organ donors, but presumed consent is not a magical fix,–we-need-more-organ-donors-but-presumed-consent-is-not-a-magical-fix.html

Intuitively, the legislation feels like it should go a long way to fixing the intention/action gap and, as a result, lead to a significant increase in available organs. In fact, the evidence regarding the potential impact of this new law is far from clear. While studies have found that countries with an opt-out policy generally have higher organ-donation rates, this is not uniformly the case. Luxembourg, Sweden and Bulgaria, for example, have presumed-consent laws but have donation rates that are even lower than Canada’s. A 2018 review by the Scottish government of the relevant science on this issue concluded there is “little firm evidence that opt-out legislation in isolation causes increases in organ donation and transplantation.” Organ donation takes place within the context of a complex system. It requires many actors working in a co-ordinated manner in order to optimize both donation rates and successful transplantations. The implementation of an opt-out scheme addresses just one aspect of the system: consent to donate. And even here, the adoption of an opt-out approach may not bring the desired clarity. In countries with similar opt-out laws, transplant physicians often still err on the side of obtaining family consent. If the family vetoes the donation, the organ retrieval will not go forward. “Checking in with the patient’s loved ones” has already been suggested as being part of the Nova Scotia system.

All opt-out countries do not have high donation rates

Pradeep Kumar Prabhu, 2019, J Intensive Care Soc. 2019 May; 20(2): 92–97., Is presumed consent an ethically acceptable way of obtaining organs for transplant?,

The BMA’s Medical Ethics Committee endorsed presumed consent for organ donation in the UK calling for a consolidated approach to organ donation for the 21st century.7,17 This resulted in a report by the Organ Donation Taskforce (2008), which suggested that while presumed consent was ethically acceptable, an improved opt-in system or a system of mandated choice may be a better way of ensuring that the wishes of the donor were honoured.18 The review of existing studies commissioned by the taskforce concluded that while most jurisdictions did clearly have higher donor numbers per million population (pmp) after introduction of opt-out legislation, this could by no means be conclusively attributed to the opt-out legislation in isolation.19 Opt-out countries such as Spain, Austria and Belgium have among the highest donation rates, but some such as Bulgaria and Luxemburg have among the lowest.

Education, not presumed consent, key to higher donation rates

Tanya Bridgen, November 22, 2017,, Should we presume consent for organs?

However, changes in legislation in countries where presumed consent has been successfully employed take place in the context of better infrastructure, increased funding for transplant programs and public awareness campaigns, making it difficult to assess the exact contribution of presumed consent legislation alone. As Spain will attest, organisational change, not legislation, has been the key to their success. Sweden, Greece and Bulgaria all have lower donation rates than the UK, despite operating under the presumed consent model. Indeed, the most recent available figures from Wales’ adoption of the system in December 2015, shows a small decrease in deceased donors since the same period the previous year. Although variability is to be expected, they don’t show the obvious increase in donations that were hoped for.

Presumed consent has no  impact organ donation rates in many countries

Simon Bramhall, 2011, Ann R Coll Surg Engl. 2011 May; 93(4): 270–272.

A number of countries have a system of presumed consent, including Spain, but very few use the system in practice. In Spain presumed consent had been part of statute for 10 years prior to the organisational changes without any effect on rates of donation.3 The US does not have presumed consent legislation. Both have impressive rates of organ donation and both have seen a rapid increase in a relatively short period of time. Sweden switched to a presumed consent system in 1996 but continues to have very poor rates of organ donation (10 PMP) and attempts to introduce presumed consent legislation in Brazil and France led to a backlash against organ donation.