(Pro) Contention: Presumed Consent Saves Lives

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Definition of presumed consent, presumed consent increases organ donation. This saves lives.

Dr. Stephen D. Beed, Intensivist and anesthesiologist in Halifax, June 25, 2019, Should there be ‘presumed consent’ for organ donations?, https://www.thestar.com/opinion/contributors/thebigdebate/2019/06/25/should-there-be-presumed-consent-for-organ-donations.html

By 2020, every Nova Scotian will be presumed to have given consent to donate their organs unless they have opted out. Dr. Stephen D. Beed argues yes — this is a good idea that will save lives — while ethicist Jed Gross argues no — formidable challenges to make the opt-out model equitable still remain. Nova Scotia recently unanimously passed a law that, once it takes effect in mid- to late-2020, gives every Nova Scotian the opportunity to be an organ and tissue donor unless they opt out. This approach, a first in North America, is referred to as presumed consent. Countries that enhance their donation systems and adopt this approach usually, but not universally, have seen donation rates increase. An increasing number of Canadians have end-stage organ failure optimally treated with transplantation. This lengthens life and increases quality of life for recipients, and yields dramatic cost savings for the health-care system (particularly in kidney failure), but number of donors limits access. Thousands of our neighbours suffer, hundreds will die, and costs increase while patients wait for an organ.

22 people die a day in the US waiting for organs

Paul Hsieh, August 29, 2017, Should The Government Require Your Consent To Be An Organ Donor?, https://www.forbes.com/sites/paulhsieh/2017/08/29/should-the-government-need-your-consent-to-be-an-organ-donor/?sh=1f9a41b1a0e8

In the US, there’s a significant shortage of donated organs relative to those who need them. According to the United Network for Organ Sharing (UNOS), the non-profit organization that manages the US organ transplant system, there are 117,000 waiting list candidates who need a life-saving organ transplant. Roughly 22 people a day die while waiting for a transplant. This shortfall frustrates many physicians and organ donation advocates. UNOS notes that 95% of adult Americans support organ donation in theory — but only 54% have actually signed up to be donors.

7500 die per year

University of Michigan Health Lab, 2019, How Opt-Out Donation Could Affect U.S. Waiting Lists, https://labblog.uofmhealth.org/industry-dx/how-opt-out-donation-could-affect-us-waiting-lists

Every year in the United States, about 7,500 people die while waiting for an organ transplant, and that number is expected to increase in coming years as demographics shift. A new study from the University of Michigan suggests that a policy shift from the current system in which you opt in to be an organ donor to one of “presumed consent”—unless you opt out—could improve the situation. But it’s not a silver bullet. “Thousands of patients are dying yearly while awaiting transplantation and one reason for that is simply lack of organs,” says study author Neehar Parikh, M.D., a liver transplant specialist at Michigan Medicine. “Based on the experience of other countries that have instituted presumed consent policies, a similar system in the U.S. could alleviate some of this burden.”

Up to 11,000 life years will be gained

Luke J. DeRoos, MS1; Wesley J. Marrero, MS1; Elliot B. Tapper, MD2, 2019, Journal of the American Medical Association, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2752089 Estimated Association Between Organ Availability and Presumed Consent in Solid Organ Transplant

Results  This study considered 524 359 unique candidates (aged ≥18 years; 320 908 [61.2%] male) for a solid organ transplant from January 1, 2004, to December 31, 2014. With a base case scenario of a 5% presumed consent–associated increase in donors, the removals (owing to death or illness) from the waiting list for all organs would have an associated 3.2% to 10.4% mean reduction, depending on the random or ideal allocation of new organs to patients on the waiting list. Sensitivity analyses showed that waiting list removals could be decreased up to 52%; however, this reduction was not enough to completely eliminate waiting list removals during the study period. The biggest estimated increases in annual life-years gained associated with a presumed consent policy were in kidney transplant candidates (95% CIs by deceased donor increase: 5% increase, 3440-3466 years; 15% increase, 10 321-10 399 years; 25% increase, 17 201-17 332 years) and liver transplant candidates (95% CIs by deceased donor increase: 5% increase, 898-905 years; 15% increase, 2693-2714 years; 25% increase, 4448-4523 years). Adoption of a presumed consent policy could result in a 4295-year (95% CI, 4277-4313 years) to 11 387-year (95% CI, 11 339-11 435 years) increase in life-years, accounting for the survival advantages associated with a transplant.

a 5% increase in presumed consent-associated deceased donors, there would be a 3.2% reduction in removals from the waiting list due to death or illness

Healio, October 11, 2019, https://www.healio.com/news/nephrology/20191011/presumed-consent-policy-may-help-improve-organ-donation-in-the-us

Based on published changes from a presumed consent policy in several countries (including Austria, Singapore and Spain), the number of organs available for donation and life-years gained were determined considering an increase in deceased donors of 5%, 15% or 25%.

Even a small increase in donations will save thousands of lives

University of Michigan, October 2, 2019, How opt-out organ donation could affect US waiting lists, https://www.sciencedaily.com/releases/2019/10/191002165224.htm                      

A new study from the University of Michigan suggests that a policy shift from the current system in which you opt in to be an organ donor to one of “presumed consent” — unless you opt out — could improve the situation. But it’s not a silver bullet. Thousands of patients are dying yearly while awaiting transplantation and one reason for that is simply lack of organs,” said Neehar Parikh, a transplant hepatologist at Michigan Medicine and an author of the study. “Based on the experience of other countries that have instituted presumed consent policies, a similar system in the U.S. could alleviate some of this burden.” But the researchers were surprised to find that even with their most optimistic estimates, presumed consent would only reduce the waiting list by a marginal amount.”It speaks to the magnitude of the deficit we have for organ transplantation in the U.S.,” Parikh said. “At the same time, we did find that such a policy could potentially translate to large gains in life years for the thousands of patients awaiting organ transplantation in the U.S.” Simulating opt-out impacts on 2004-2014 wait lists Using data from the Organ Procurement and Transplantation Network Standard Transplant Analysis and Research files, the researchers built a computer model to simulate how such a policy shift would affect patients on the waiting list for a heart, kidney, liver, lung or pancreas between 2004 and 2014. The study is published today in JAMA Network Open. They found that opt-out, or presumed consent, would have added between 4,300 and 11,400 life years for the more than a half million patients on the list during the study period. Under the most conservative estimate, it would have reduced the number of people taken off the list due to illness or death by between 3% and 10%. And under ideal circumstances, it might have decreased waitlist removals by 52% — but not enough to completely provide organs to everyone who needs one in time.

Presumed consent increased organ donation in the UK

Denis Cambell, October 5, 2017, https://www.theguardian.com/society/2017/oct/05/doctors-praise-plan-for-organ-donor-presumed-consent-in-england, Doctors praise plan for organ donor presumed consent in England

Transplant doctors and health charities have praised Theresa May’s decision to change how organ donation works in England in an attempt to provide more hearts, kidneys and livers for patients in need. The prime minister announced plans to move to a system of presumed consent – meaning everyone is presumed to agree to the removal and reuse of body parts after their death unless they opt out – in her speech to the Conservative party conference in Manchester on Wednesday. She said change was needed because 500 people died last year while waiting in vain for a replacement heart, lungs, kidney or liver. With 6,500 patients on the organ transplant waiting list, “our ability to help people who need transplants is limited by the number of organ donors that come forward,” May said. Families call for UN to launch inquiry into police killings of Black Americans

Roberto Cacciola, a kidney transplant specialist at Barts Health NHS trust in London, said: “As a transplant surgeon I’m delighted with and excited by this initiative because there’s a chronic need for more organs and therefore for more donors to come forward. “We’ve been waiting a long time for this to happen. I have 400 patients on my waiting list for a kidney, of which I manage to transplant 120 a year. I would do more if more kidneys were available. I hope that in future I will be able to do more.” According to NHS Blood and Transplant, the agency responsible for boosting donation rates, there are more than 50,000 people alive today in the UK who would have died if they had not undergone an organ transplant. Of those, 36,300 received a kidney, 9,800 a liver, 3,900 either a heart, lungs or both, and 1,900 a replacement pancreas. Last year 4,753 people – the highest number ever – received an organ. The number of recipients has risen by 20% over the past five years. The number of people who have signed the NHS organ donor register, signalling their willingness to have their organs harvested after their death, has risen by 4.9 million over the same period and now stands at 23.6 million, also a record high. Fiona Loud, policy director at the charity Kidney Care UK, said: “The government has done the right thing and made a vital step towards increasing donations and transplantation, which is fantastic news for the thousands of people currently waiting for a kidney transplant.” The proposed switch to presumed consent, which will be subject to a public consultation, could prove “truly transformational”, Loud said. “With one person dying every day in the UK whilst waiting for a kidney transplant, this change cannot come soon enough.” Wales introduced presumed consent in December 2015 and has seen organ retrieval rates rise as a result. Scotland and Northern Ireland have both expressed interest in following suit.

Even when alternative factors are considered, presumed consent increases donation rates

Zúñiga-Fajuri, University of Valparaíso, 2014, Increasing organ donation by presumed consent and allocation priority: Chile, https://www.who.int/bulletin/volumes/93/3/14-139535/en/

The best way to predict the results of implementing presumed consent would seemingly be to look at countries that have implemented it, compare the number of donors in that country before and after the change, and compare the numbers in that country to other countries that use explicit consent. One such study utilizes a panel of 13 presumed consent and 9 explicit consent countries to make a comparison.22 While the straight comparison does not yield significant results, other factors must be noted. For example, commonly held religious beliefs in a certain region would likely impact donation rates, whether in a positive or negative way. Additionally, the rates of death by motor vehicle accident and cerebro-vascular diseases also vary by region and greatly impact the number of potential donors available. Controlling for these and other factors results in the statistically significant conclusion that cadaveric donation rates are 25–30% higher on average in presumed consent countries. 23 A more recent meta-analysis focuses on five studies comparing donation rates before and after the introduction of presumed consent and four studies comparing donation rates in countries with presumed consent versus explicit consent. 24 All of the before and after studies showed an increase in the number of donors; however, the authors note that these studies do not account well for other factors such as simultaneous infrastructure changes and increased publicity. Similarly, all of the comparison studies showed correlation between presumed consent and higher organ donation rates, three of which exhibited statistical significance. Again, the authors of the meta-analysis note that significant correlations also exist between higher donation rates and factors such as higher healthcare expenditure, high rates of Catholicism, and common law rather than civil law. The authors ultimately conclude that presumed consent is associated with higher donor rates, but it cannot be inferred that a change would lead to increased rates for every country.

Organ shortage now, the US model doesn’t make enough organs available, presumed consent solves

Sheldon Zink, PhD, Rachel Zeehandelaar, and Stacey Wertlieb, MBe, September 2005, AMA Journal of Ethics, Presumed vs Expressed Consent in the US and Internationally, https://journalofethics.ama-assn.org/article/presumed-vs-expressed-consent-us-and-internationally/2005-09

The shortage of organs available for transplant has been a serious and unchanging worldwide problem since such surgeries were first made feasible and safe several decades ago. Nations around the world have relied on different strategies to try to alleviate this problem with varying levels of success. The United States’ system for organ procurement operates under a model of expressed consent. This means that an individual will not be an organ donor unless he or she explicitly states otherwise. The desire to be a donor is typically noted on a driver’s license, in an advance directive, or by a surrogate with decision-making responsibility. While maintaining the autonomy of potential donors, the expressed-consent model has not been shown to be effective in increasing the supply of organs to a level anywhere near that of the demand.

Other countries prove presumed consent increases 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, https://journalofethics.ama-assn.org/article/presumed-vs-expressed-consent-us-and-internationally/2005-09

With 33.5 out of every 1 million residents having organs that are in a condition that allows them to be transplanted after death, Spain has the world’s highest rate of actual donation [2]. Spain’s presumed-consent law was passed in 1979 and requires the prospective donor to be declared dead on neurological criteria (“brain dead”) by 3 physicians [3]. Once death has been declared, any individual who has not formally registered an opposition is considered a potential donor. This system, combined with a societal respect for organ donors, has contributed to Spain’s successful organ procurement program [4]. Moreover, the presumed-consent policy in Spain is cost-effective, saving the National Health Service more than 200 000 euros in medical costs for each kidney transplant preformed on a patient on dialysis [2]. A similar presumed-consent law was passed in Belgium in 1986 and implemented in 1987 [3,5]. If an individual does not want to donate, he or she is required to register the objection with the Central Health Authority. Prospective donors can change their decision at any time [6]. While physicians in Belgium are under no obligation to ask the prospective donor’s family for permission to recover the organs, or even to inform them of their intention to do so, if a family member explicitly opposes organ recovery, the physician cannot proceed [6]. Consent is presumed not only for Belgian citizens, but for anyone who has lived in the country for 6 months or more [6]. After widespread educational efforts and almost 20 years’ experience since the policy was implemented, less than 2 percent of the Belgian population has registered an objection to organ donation [5]. Other countries with presumed-consent policies include Austria, France, Columbia, Norway, Italy, and Singapore. In Austria, the rate of donation quadrupled within 8 years of a presumed-consent policy’s being introduced [3,6]. Under Austrian legislation, organs can be recovered irrespective of relatives’ objections [7]. Today, the procurement rate in Austria is twice as high as those in the United States and most of Europe, with the number of kidney transplants performed nearly equal to the number of people awaiting donor kidneys [4].

Switching from presumed consent to explicit consent reduces donations

Maya Gunnerson, 2020, Maya Gunnarsson is the Executive Online Editor of the McGill Journal of Law and Health and a second-year B.C.L./ J.D. student at McGill University’s Faculty of Law. Maya holds an M.A. in Canadian Studies and Indigenous Studies from Trent University where she focused her research on the role of the media in the ongoing crisis of violence against Indigenous women and girls. Maya has worked as a researcher at the Higher Education Quality Council of Ontario and interned at the Office of the UN High Commissioner for Human Rights, Presumed Consent in Organ Donation: a Silver Bullet for Nova Scotia? https://mjlh.mcgill.ca/2020/04/07/presumed-consent-in-organ-donation-a-silver-bullet-for-nova-scotia/

Other policies for organ donation include the Caillavet Law of France passed in December 1976, which allows a third party to state whether the potential donor had objections, even if the donor himself had not registered them [4]. A Columbian law states: “There shall be a legal presumption of donation if a person during his lifetime has refrained from exercising his right to object to the removal from his body of anatomical organs or parts during his death” [8]. In Norway, organs may be removed after the relatives have been informed of the intention to remove them, and only the immediate next-of-kin can halt procurement by withholding consent [7]. Contrastingly, in Italy, despite presumed-consent laws, organs may only be removed once it has been determined that the donor’s relatives do not object [7]. Lastly, in Singapore a presumed-consent law has been in effect since 1987 [9]. All residents receive a letter when they reach the age of 18 that states they are presumed to consent to organ donation unless they explicitly object to it. The only exceptions to this policy are Muslims, who are automatically considered objectors unless they opt in [9]. Countries with presumed consent have generally seen higher rates of organ donation than countries with expressed consent such as the United States. In fact, when Denmark switched from presumed to expressed consent in 1986, donation rates fell by 50 percent [3]. A study from UCLA in 2018 aimed to measure the impact of presumed consent laws on liver and kidney donation rates by comparing donor rates in six countries (Argentina, Chile, Finland, Poland, Slovakia and Uruguay) before and after their adoption of presumed consent laws. All 6 countries saw an increase in liver donation rates, with a mean increase of 100%. Four of the six countries saw an increase in kidney donation rates, with a mean increase of almost 50%. The authors believe that the change in consent laws had a greater impact on liver donation rates than kidney donation rates, because a greater proportion of kidney donations come from living donors and would thus be unaffected by a change in consent policies for deceased donors. This conclusion implies that the donation rate for other organs that can only be donated by the deceased may increase significantly as well with the shift to a presumed consent system.

Since people go with what exists, more people will donate under opt-out

Jessica Li and Till Nikolka, 2016, https://www.econstor.eu/bitstream/10419/167291/1/ifo-dice-report-v14-y2016-i4-p90-94.pdf, The Effect of Presumed Consent Defaults

on Organ Donation, CESifo DICE Report, ISSN 1613-6373, ifo Institut – Leibniz-Institut für Wirtschaftsforschung an der Universität München, München, Vol. 14, Iss. 4, pp. 90-94, The Effect of Presumed Consent Defaults on Organ


In the behavioral economics literature, changing to a presumed consent regime is expected to increase the number of registered donors by influencing attitude and behavior. First, “opt-out consent systems are likely to bridge the gap between people’s intentions and their behavior by removing the need to undertake an actions in order to become an organ donor” (Shepherd, O’Carroll and Ferguson 2014). Results from a US 1993 Gallup survey support the theory that the need for deliberate, physical effort is a barrier between people’s preferences and registration: although 85 percent of Americans favor organ donation and 69 percent would like to donate their organs after death, in practice only 28 percent actually become donors in registries (Gallup 1993). Second, individuals take the default as a suggestion by policymakers and are more likely to act according to what they view as the recommendation (Johnson and Goldstein 2003; McKenzie, Liersch and Finkelstein 2006). Finally, according to the concept of loss aversion, people gravitate toward the status quo because the losses weigh more heavily psychologically than the equivalent gains in a change; thus people in opt-out countries are less likely to deviate from the default. In essence, presumed consent laws could increase deceased donation rates because opt-out systems influence people’s  attitudes, decision-making behavior, and consent decisions in favor of deceased organ donation. Basic descriptive statistics for a sample of OECD countries suggest that countries with opt-out policies do indeed tend to have more deceased donors per million of the population (pmp) than countries with opt-in policies. Table 1 shows donation and transplantation rates for the OECD countries in 2014, excluding countries with populations smaller than two million.2 The mean number of actual deceased donors pmp in 2014 was 19.46 in opt-out countries versus 13.59 in opt-in countries, or approximately six percentage points more. Likewise, the average number of deceased organ transplantations pmp and the average share of deceased organ transplantations out of both living and deceased transplantations were comparatively higher in countries with presumed consent laws. Germany and Austria – which have different consent default systems, but are otherwise very similar with respect to cultural, social and institutional characteristics – provide an interesting comparison. While Germany, an opt-in country, had 10.45 actual deceased donors pmp in 2014, Austria, an opt-out country, had more than double at 24.94 deceased donors pmp. Finland and Denmark can be compared in a similar manner: as an opt-in country Denmark had 14.29 actual deceased donors pmp in comparison to Finland, which had 22.41 deceased donors pmp.