Chapter 7: Organ Donation

 

INTRODUCTION

Thousands of Canadians are waiting for the phone call that will let them know they may have a chance to live longer with a new liver, to live better with a new kidney, or just to live— to live beyond the next weeks or months upon receiving a donated heart. Organ donation has changed the lives of millions and has pushed the limits of medical treatment; limits that transcend the death of one person and extend to the life of another. In this space between the realms of altered life and cheated death ethical considerations, not surprisingly, arise, and these are the substance of this chapter.

The discussion will start with a brief look at the Canadian scene, the numbers that make up the landscape of the organ failure and organ donation picture in Canada. It will then turn to a snapshot of the oversight and policy that exists in this realm. The description of the numbers and the governance quickly betray the location of the ethical issues that attach to this topic, and those will be examined in the rest of the chapter.

The issues quite simply and quite often come down to just how to reconcile the growing wait lists with a finite number of organs, how to justly and equitably distribute this finite resource, and what methods can and cannot be employed in placing a greater number of organs into an ever growing number of people. As with many things that pit competing needs against each other, economic solutions are often sought as remedies. The first ethical issue to be tackled will be a consideration of the sale of organs: getting clear on Canadian law and policy, but also an examination of “transplant tourism” and Canada’s place in the global arena on this front. Further discussion will be made as to the legitimate, even the necessary, organ payment concerns that can improve organ procurement.

Next will be an examination of the changing landscape of organ donation. The expanding domain of both the donors and recipients will be considered, especially with a view toward how this has changed the ethics of organ donation in Canada. It will be seen that there are people vying to get onto both transplant and donor lists with equal rights being demanded on both sides.

Consent issues are multifaceted in the topic of organ donation. Discussion will turn to how Canadians feel about consenting to organ donation… and then to how they actually act on these opinions. The disparity between feeling positive about donation and actually taking the steps to donate has generated speculation about whether and how to revamp the consent structure in Canada. The current law and policy will be discussed, and some predictions for the future will be made.

Canada is a large and multicultural society. Acceptance and pluralism have made religious and cultural issues small factors in the ethics of organ donation in Canada and this will be briefly discussed before turning to weightier issues of organ allocation. While there is beauty in the vastness and diversity in Canada, there are ethical issues and organ allocation barriers that form along geopolitical lines. Canadian health care is, largely, a provincial affair. For the most part, it is something Canadians are content with, but this has created problems in the cooperation necessary on a national level to ensure increased transplant rates and the standardisation of transplant programs. An examination will be made of the problems, and some of the future solutions, that seem possible.

Finally, an in depth analysis of a controversial and expanding area of transplant medicine and transplant ethics: Donation after Cardiac Death. Canada, like most of the industrialized world, has benefited from rapidly evolving medical capabilities, and has seen the pendulum swing on the issue of defining death. An analysis will be made of this definition and a look at how it squares with the concept of transplanting organs from donors who do not meet traditional criteria of death. Furthermore, there will be a discussion on how these programs have been implemented and where Canada sits in relation to other nations such as the US. Where some would equate the issues surrounding DCD to those surrounding the use of anencephalic infants as organ donors, this discourse will point out the differences. A discussion of Canada’s stand on anencephalic infants as donors will be made in relation to issues that arose in a Canadian case of that nature.

CANADIAN STATISTICS

The first organ transplants were done in the 1950’s in the US, but these techniques were quickly adopted in Canada. The first renal transplant in the Commonwealth was performed in 1958 by Dr. John Dossetor in Montreal between two identical twin girls.1 In a sense, Canada has never looked back, in this highly technology oriented area of medicine Canada has thrived and transplant capabilities have risen drastically. The flip side to this situation is that while more people are enjoying longer life from receiving transplanted organs, the technological capability has markedly outpaced the availability of organs; the waiting lists grow ever longer. In the US the waiting list for recipients stands at over 100,000 2 and despite the fact that transplant rates have been as high as 28,000 (23,288 in 2008)3, there remains a perpetual, and growing, shortfall. This problem is being realized worldwide and as more nations develop transplant capacity, the problem will inevitably grow larger.

Canada enjoys no immunity from the growing disparity between the number of organs needed, and the number that are, or will become, available. There were 2085 transplants of solid organs (kidney, liver, lung, heart, pancreas) in 2007 and although this number is growing, the number of transplants needed is outpacing the number performed.  The Canadian Institute for Health Information (CIHI) maintains the Canadian Organ Replacement Register (CORR) which carefully monitors statistics in end stage organ disease and transplantation, and compiles yearly reviews. In the ten years between 1998 and 2008 there were notable trends in organ transplantation in Canada. End stage renal failure increased (1998-2008) owing to the aging population and increased accommodation of renal failure patients on dialysis—there were 35,000 Canadians living with end stage renal disease, up 70% from a decade earlier. As new technologies replace older treatment modalities a disproportionate increase in the waiting lists is realized. Liver transplantation has undergone such innovation that it is now the “gold-standard” treatment for liver failure. Not surprisingly, this has meant an increase of 122% (286 to 635 people)for those awaiting transplant but only a 42% increase in the number (480 in 2007) of completed transplants from 1998-2007. Heart transplantation has remained relatively stable over the decade with 163 performed in 2007, but still there were 115 people waiting in 2007—19 of whom died while waiting. Lung transplantation has seen a disproportionate rise in waiting list times as the technology is refined. This trend is also played out in new transplant modalities such as pancreas transplants (which began in the US in 1996) and bowel transplants.4 As transplant technology improves, more people that would have previously had to live with their chronic disease, or indeed may have died, will live—but more of them will live waiting on waiting lists.

Canada has, at best, mixed results with respect to its transplant rates compared to other countries. The most commonly employed statistic in characterizing organ donation is donations per-million-population (PMP). Recent statistics show that donation rates vary drastically from 39 PMP in Spain to 0.6 PMP in Japan, with many countries not registering statistics (including many Asian and Middle Easter countries). The US showed a rate of 26.8 in 2007.5 Canada has always had a poor showing in the global statistics consistently showing donor rates of 13 to 15 PMP.5-7 But these numbers fail to tell the entire story. Comparing donor rates is heavily dependent on statistical manoeuvring. Canada “counts” its donations differently than many other countries inasmuch as donations are only recorded if a recipient receives an organ; Spanish and American statistics record also the identification of a donor organ of a recently deceased person even if the identified organs do not find their place in a recipient.8 Interestingly Canada has a very high rate of live donor transplants, up to 15 PMP, compared with less than 1 PMP in Spain.5, 8 In 2001 the rate of live donor donations exceeded those of cadaveric donations in both the US and Canada.8, 9 Comparisons are also difficult for reasons that go beyond an examination of the transplant numbers, the outcome measures of transplant programs must also accommodate an analysis of morbidity and mortality, and here too it is very difficult to compare countries. One analysis, for example showed that Canadians fare better in the year after renal transplant—a 4% mortality rate versus 6% in the US.10 It is difficult to draw firm conclusions about any of this data in terms of how to rank Canada in the quality or efficiency of its transplant capacity.

Canadian opinions on transplantation issues are well documented. The vast majority (96%) approve of organ donation in general, and 80% see the need for increased donation.11 Canadians, in general, want and intend to donate. In 2004 a survey found that 73% of Canadians intended to donate their organs, but despite this good intent, only 34% signed donor cards.12 Similarly, a survey conducted in 2005 found only 54% of Canadians had signed donor cards and only 17% had registered with a provincial registry (although 35% of those surveyed knew about provincial registries).11 Regarding Donation after Cardiac Death (DCD), only 13% of Canadians had a working understanding of this in 2005, but 74% agreed with such donation in principle—however far fewer found the notion of administering medications or other preparatory procedures before death (in order to enhance transplant success) to be acceptable.11 A survey done on health professionals found a near unanimous recognition of the importance and increased need for organ donation. Regarding measures to enhance procurement, professionals were asked about options to improve procurement of organs through more robust or expanded patient consent practices (discussed below), and 80% of respondents felt that decedents’ wishes regarding transplant should be observed, even in the face of opposition from family members. Similarly regarding enhancing procurement, 72% of health care professionals were familiar with DCD, and 84% agreed with this practice.13 Ultimately, knowledge of transplant issues among lay persons and professionals is good, and capacity in the health care system exists to provide better transplant services, so these factors are not responsible for the discrepancy between the waiting lists and the potential donor lists, the gaps seem to exist in part on the basis of attitudes and ethical pitfalls that will be discussed below.

OVERSIGHT

Oversight of transplant services in Canada is a complicated affair. Canada has an extensive network of transplant programs and registries. It had 60 active programs across all provinces in 2004.6 Canada does not have a central registry for organ donation—neither a registry of persons awaiting an organ, nor a registry of potential donors.8 The Canadian organ donation enterprise has been criticized on this count, as discussed below. Because health care is largely managed at the provincial level, each province had its own organ donation and transplant system (ODTS). Each individual ODTS sets its own policies for organ allocation, and these allocation protocols are then implemented by organ procurement organizations (OPOs). There are sometimes more than one OPO in a province (such as Alberta) and there is sometimes more than one province served by an OPO (such as the Atlantic Provinces). Currently matching donors and recipients is often done regionally or provincially through these local registries. Where possible, organs are procured and transplanted locally and only infrequently sent across provinces and large distances. This is a product of the vast Canadian geography, but is also a product of the fragmented system as is discussed below.

In 2001 the Canadian Council for Donation and Transplantation (CCDT) was struck to fulfill the role of overseeing and advising on a national strategy to improve organ donation. While the council made headway in developing standards and clinical practice guidelines, its other roles of strategizing and coordinating efforts across Canada to improve transplant services, increase information transfer, and monitor Canada’s place in the global scene, all fell by the wayside.8 In 2008, Canadian Blood Services (CBS) merged with the CCDT and took over this mandate as it expanded its role to include more than just blood products. This arrangement has attracted speculation that the Canadian system could become more centralized (like that of the US) and enable greater efficiency.

In 2010 CBS finalized the first steps in organizing a national registry of sorts for living kidney donation. While it only addresses kidney donation and is not a registry for other organs, it is a significant step in remedying the national registry issue. The program, the “Living Donor Paired Exchange” (LDPE) facilitates living donor exchanges between incompatible donor-recipient pairs with other donor-recipient pairs or with “non-directed donors” (those simply willing to donate a kidney to any compatible recipient). This facilitation occurs through a national registry and the matching program is run every three months.14

The oversight by CBS is supplemented by several public and non-profit ancillary organizations. The Canadian Society of Transplantation (CST) is a professional organization of physicians and other transplant professionals that serves in the advancement of research and the science of transplantation. There is a not-for-profit organization, The Canadian Association of Transplantation (CAT), which has as its mission, the facilitation of the transplant process through education of both lay and professional communities. It enhances awareness through its own campaigns and educational activities, and through collaborative work with CST in putting on national conferences dealing with transplantation issues. Another non-profit agency, the Organ Donation & Transplant Association of Canada (ODTAC) is a registered charity that, through solicitation efforts and programs, enhances transplant issue awareness and provides funds for transplant services. Finally there is the Canadian Transplant Association (not to be confused with the CAT) which is a non-profit charitable organization that improves awareness and support of transplant issues for the broader public. It is a patient/organ recipient focused group with most of its board members being organ recipients.

Aside from the organ donation and transplantation system and the organ procurement shortcomings, actual organ transplantation is carefully regulated in Canada. All the practical aspects of transfer and procurement of organs (as well as cells and tissues) falls under the auspices of Health Canada, and specifically the Health Products and Food Branch, which sets out very specific guidelines as to the handling of cells tissues and organs for transplantation. The document was updated in 2009 under the title Guidance Document for Cell, Tissue and Organ Establishments – Safety of Human Cells, Tissues and Organs for Transplantation.15 The transplantation process is also overseen in each province and territory by its own Human Tissue Gift Act (with only a few exceptions it is known by this name in each province), except Quebec which has no specific legislation. While these acts are consistent with one another, the lack of oversight through federal legislation (like the lack of a national organ procurement organization noted above) is seen as a serious shortcoming in Canadian transplant integration and oversight.

THE ISSUES

When viewed through the bioethics lens, the topic of organ donation has mostly to do with how to confront and manage the fact that the need will likely continue to outweigh the supply. Bioethical issues in organ donation is a topic that can be unpacked in many different ways, the attention here will be skewed toward Canadian concerns. Simply put, the issues come down to the ways and means of ethically and legally putting more organs into those that need them. The discussion above outlined the Canadian situation with respect to the numbers and the oversight, a closer look at the existing situation sheds light on the fact that there are fundamental ethical issues based simply on the system as it exists today. Living donors are usually kidney donors, but other live organ donations are possible; it is possible to donate lung tissue or part of a liver. While the concept of live donation is straightforward, ethical issues arise in contemplation of some of the ways to enhance live donation. And the first of these issues to consider is the buying and selling of organs. Procuring more organs can also be had by accepting poorer quality organs, and this will bridge the gap between living-donor issues and cadaveric-donor issues. The procurement of cadaveric donor organs has a wealth of issues such as changing consent laws, donation after cardiac death etc.; these too will be discussed below with a Canadian focus and an explication of Canadian resolutions and answers.

A)     ALLOCATION—THE WAITING LIST

Even a cursory look at the statistics and information presented above quickly lends to an understanding of one of the most significant issues in donation: the ever growing waiting lists. The navigation of the organ donation waiting list has its own set of ethical considerations. These are made even more difficult in Canada because of the lack of a national registry and transplant services that are fragmented into provincial organizations. A thorough discussion of allocation systems is beyond the scope of this discourse if for no other reason than it is largely a concern of empirical science and not one of ethics.  To be sure, there are robust evidence based consensus guidelines in Canada on how to waitlist and stratify persons with failing organs—for example establishing eligibility for renal transplant.16 But in 2005, 275 people (on a list of some 4000 people) died while waiting for an organ (140 while waiting for a liver, 67 waiting for a kidney, and the rest waiting for other organs) compared with 225 in 2004.17 In 2007 things had not much improved, 4167 awaiting transplant, 146 did not survive to be put on the list for 2008.18 Canada is often cited as having one of the worst donation rates in the developed world (even putting aside the statistical gymnastics noted above). And this is precisely where this issue becomes less about hard science and more about ethics. Some of these ethical issues with organ allocation will now be discussed.

Notwithstanding the Canadian Organ Replacement Register (CORR), which tabulates retrospective statistics, there is no national register for those in need of organs or for willing donors. Furthermore, stakeholders in the transplant enterprise, both the potential recipients and the health care providers, have been critical of the lack of a national allocation mechanism in Canada. This situation stands in stark contrast to the US where the United Network for Organ Sharing (UNOS) maintains a registry and matches donors and recipients effectively by managing the singular organ procurement network (the Organ Procurement and Transplantation Network (OPTN)). As noted above, as health care is regulated at the provincial level, each province has its own organ donation and transplant system (ODTS), and each province has its own organ procurement organization (OPO). Sometimes OPOs are duplicated in a province and sometimes one OPO serves more than one province. The lack of a national organisation only complicates matters further.

There is a striking difference in the donation rates between provinces. Deceased donations range from 5.1 PMP in Manitoba to 17.9 in Quebec; while living donations stood at 7.0 in Quebec and 19.9 in Alberta in 2005.19 Alberta residents were 3 times more likely than Ontarians to receive a kidney in any given year on a waiting list and the average Albertan waited 3 years compared to 8 years in Ontario.20 Even if some of these differences could be accounted for by the differing values and cultural make-up of the various provinces, some of those suffering as a result of the disparity could be aided by enhanced cooperation between provinces. Kidney transplant patients wait much longer in Canada than in the US—6.1 years versus 4.26 years between 1996-2000— and this could in part be due to the effect of the national registry in the US (in fact it is even difficult to derive such statistics owing to the lack of a national registry in Canada).18

Currently matching donors and recipients is done regionally and through local registries. Organs are often procured and transplanted regionally or provincially and only rarely are organs conveyed out of province (or country). The fractured system outlined above has been criticized as being detrimental both to the procurement of organs within and between provinces because the provinces do not necessarily facilitate each other’s needs effectively.18 In fact critics from within the system have noted significant intergovernmental and jurisdictional “wrangling.”21

In one respect, it is likely that this scenario will not be entirely resolved, if for no other reason than that geography and logistics play a limiting role in a country as large as Canada. When the window of opportunity permits scarce few hours, logistically negotiating huge distances is impossible.8 Nonetheless, as the waiting lists grow, Canadian government agencies continue to monitor the problem for ethically astute solutions that can be realized through better governance. It seems Canada has reached an important threshold on that front.

As noted above, in 2008 Canadian Blood Services took over the national leadership of transplant services in Canada. It secured funding at all levels of government to fulfill a broad mandate including the creation of a national registry and a national donation allocation system.22 In addition to this there have been other positive moves aimed at better interprovincial cooperation. One initiative has been the 2009 creation and the 2010 rollout of the Living Donor Paired Exchange Registry discussed above. As Canada has consistently high levels of live donor (usually kidney) transplants this registry is an appropriate innovation. As noted above, it enables the swap of organs from those willing to donate, and yet who are not a match for the family members they wish to donate to. If another donor-recipient pair can be found in a similar predicament, and the donor matches the recipient in the first pair, a two way donation is made. CBS has also consolidated a national stem cell and bone marrow network (the OneMatch Stem Cell and Marrow Network). There have been centres of excellence in donation in Canada in regional pockets, CBS does hope to exploit the knowledge and expertise, and transform local excellence into nationally distributed benefits.

B)     PAYING DONORS

When contemplating issues in organ donation the issue that perhaps captures more attention, and springs immediately to the mind of most, is the issue of trafficking human organs. This issue is introduced here, early on in the enumeration of the issues, because it exposes and confronts more frankly the issue of the gap between the supply and the demand for organs. And it does so in a manner that is accessible to most people; it confronts the issue in economic terms. The issue of organ trafficking lays bare some of the fundamentals of organ donation ethics. Ethicists have weighed in on both sides of the debate, and a complete account of that debate is well beyond the scope of this text and will not be aired here. According to R. R. Kishore, the President of the Indian Society for Health Laws and Ethics: “The basic ethical principle involved in organ transplantation is whether a person has a right to enjoy life on the basis of organs belonging to others. Once we choose to answer this question in the affirmative we concede that we are prepared to inflict harm on others in order to improve our health or to prolong our life.23 Aptly and succinctly put, this is the foundation of the ethical problem; where opinions diverge is the place where people begin to define how much harm to others is acceptable, and what measures can, and should, be taken to mitigate the harm done in this exchange.

The relationship between living donor and recipient is a very unique relationship, and the economics of this relationship between donor and recipient are complicated and steeped in ethical theory that goes beyond the scope of this discourse. The considerations extend to all the stakeholders: the recipient wants to continue to enjoy life and is willing to pay a price including the infliction of harm on a loved one (or stranger) for the privilege of obtaining a new organ, or even to pay a monetary price for the new organ. The donor also figures into the equation inasmuch as she or he is giving something up—an organ—and receiving something in return—the prolonged life of a loved one, the moral fulfillment (even religious fulfillment) that comes from an altruistic act, etc. There is give and take on both sides of the equation, but at bottom, this can be viewed as a relationship that can be understood in economic terms—albeit an economy that does not necessarily involve cash transactions. What then becomes the issue is whether this relationship is morally acceptable. In Canada the answer to this is that yes, the arrangement of organ donation is morally acceptable—but the devil of the ethics is in the details.

While it is considered acceptable to balance the needs and requests of patients with failing organs with the willingness of donors to provide, the economics of it are in intangible forms. The pain of an operation is balanced with mental and moral satisfaction, or the prolonged retention of a loved one. As soon as tangible goods (such as money) enter the picture the lens shifts and the spectre of moral impropriety enters the room. One description of this is to be had in viewing the selling of organs as a move from non-marketable to marketable transactions—turning organs into commodities that can be bought or sold. The commoditisation process is repugnant to many on the grounds that it involves a move away from altruism, a normative shift from “other-regarding” mores to “self-regarding” mores.24 But there are some that view the sale of organs in a market driven manner as being ethically situated much closer to the sale of water to the thirsty, than to exploitative arrangement between the powerful and the disempowered and unwilling. Proponents of the selling of organs point out that medicine is always need-based, and yet, economics is not viewed as repugnant when other medical services are paid for. Furthermore, proponents appeal to the basic human right to relieve suffering as something that should not be infringed upon by persons or powers (government or policy makers) external to the needs and interests of the parties themselves.23 For the recipient this translates into the right to prolonged life and an end to physical hardship inflicted on them by their failing organ; and for the donor this translates into the right to end suffering through better economic circumstances.

In sharp contrast, and in response to the arguments for the sale of organs, is the argument put forward by those who have studied the effects of the trade; those such as American anthropologist Nancy Scheper-Hughes. In her oft cited opinion, theoretical and rational arguments are out of touch with the medical and socio-political realities of the world. The pro arguments work fine along North American or Northern European ideals, but the favelas of Rio, and the impoverished village in Sub-Saharan Africa, have a different set of social realities that impose new ethical considerations. In these settings the equal relationship between donor and recipient, is not established, and the notion of buying and selling in a fair market system does not exist. The governance in countries brokering donation is sorely lacking, the medical systems underfunded and unregulated. The sale of organs has expanded to include poorer parts of Brazil, Moldova, Turkey, Romania, Iraq and Iran. Generally, the trend is from East to West, South to North, poorer to richer, black and brown bodies to Caucasian bodies. The risks to the donors are understated. Their health suffers (some die), they can be forced to endure chronic pain, and they may develop the need for organ in the future, compounding an already bad problem. And there is psychological hardship (disillusionment, anger with the recipient and the surgeon), and social hardship (decreased productivity, and inability to work after the operation) to contend with as well. 25

Another stark reality is the non-monetary cost to the recipients and their country. A Canadian analysis noted that transplant tourists have significantly poorer outcomes than domestically procured kidneys (increased rejection rate, higher infection rate etc.)26 and these costs to the patient are also felt by the health care system that provides the after care for less than optimum procedures.

So, while free market arguments do look good in theory, the realities of the differences between wealthy and less wealthy nations is such that the market place is inherently unequal, and this fact will have to be reconciled before the global acceptance of organ selling ever becomes a reality.

The solution to this debate is not herein contained and the only reason for an explication as prolonged as this has been, is to point out the alignment of Canadian values with the latter arguments than with the former. The Canadian legal position on these matters is clear; there is universal condemnation of the sale of organs in Canada. The Human Tissue Gift Acts, in the various provinces and territories, each contain sections forbidding the sale of human organs. There is no specific mention of selling organs in the Criminal Code, so presumably no means to prosecute these activities if they were to occur in Canada under the Criminal Code.  While it would be naïve to suggest that Canadians do not take part in the illegal procurement of organs,26 attaching numbers to these presumptions is very difficult.27

Canadian law does not make it strictly illegal to travel abroad to receive an organ,28 even though Canada has joined most of the world in the condemnation of the sale of organs and transplant tourism. The World Health Organization condemns any activities relating to the sale of organs.29 Similarly, in 2008 several countries that were areas of transplant tourist activities, as well as other concerned nations, united in condemnation of such activities, and this is reflected in the multinational statement, The Istanbul Declaration.30, 31 The declaration calls for more rigid oversight of the problem in each country, the creation of programs that would require countries to care for victims of transplant tourism, and requests that countries’ legislative instruments, and other instruments within professional societies, prohibit members from being complicit in allowing these activities.30 Canada, as a participant at the conference, if it is to take these declarations to heart, may need to modify its existing legislation.

In consideration of paying donors, and when viewing this issue in its most complete form, one must also consider other payment issues. The state of Pennsylvania provides money for funeral expenses of deceased donors, and in 2006 UNOS was considering other financial incentives for deceased donors.19 While these types of incentives are rare in the world and not being contemplated in Canada, there are other payments that are much less optional and considered by many to be requisite. While paying a Moldovan in relative penury for his kidney (extracted and transplanted in a clandestine foreign hospital) is clearly on the wrong side of the Canadian law, and is furthermore roundly chastised by national transplant bodies and agencies, there are other more domestic pecuniary concerns that legitimately enter into the mix. Transplant awareness advocates have long asked government to spare a thought (and a few dollars) for the hardship brought upon the living donors. As was noted above, since 2001 the rate of living donation outstrips the rate of cadaveric donation, and this rate continues to climb.  These law abiding, taxpaying, voting citizens have been donating their kidneys and other organs to loved ones with scarce compensation for the pain, the recuperation, and the ongoing hardship of living with a less than complete set of organs. Donors, furthermore, generate significant cost savings for the government every time someone is taken off the transplant list and off a dialysis machine.32 The costs to donors are much more than mental and physical anguish; living donors incur significant costs in the form of lost wages while recuperating, and through ongoing decreased productivity.32, 33 The universal health care system pays the direct medical costs, and employer insurance (if the person is fortunate enough to work in a job that supplies this) helps defray the costs, but this is arguably not enough. In 2008 Ontario and Manitoba joined British Columbia in instituting financial compensation schemes that aid living donors for their hardships.34

And so we end once more with the notion of actual payment for organs. While payment of compensation for organ donors squares well with the Canadian social and political sentiments, paying for an organ from an external source does not. Once more the devil of making sense of this is in the details, and in this case, the palatability of paying compensation to donors leans heavily on the fairness of the exchange and the proximity of the donor to the recipient. In Canada, a living donor is a fully informed donor, receiving world class, above board medical care. He or she is, presumably, not under economic or political duress, and is donating for reasons that are not purely financial. An examination of the whole landscape of this issue has led some to speculate that it is possible to bring payment for donation to a more ethically acceptable level if the inequalities were addressed. Some advocate that payment that was federally regulated, and organ donation that was properly compensated and performed in proper facilities with proper post-operative care, could alleviate the covert black market trade and be beneficial to donors recipients and government. The notion of regulating this process, in order to curb the problems inherent in “transplant tourism,” has Canadian and international advocates.35, 36 Again, this is not the forum to debate this argument, but it is important to note that the argument for such a regulated scheme of paying for organs is still a long way off in Canada.

C)     EXPANDING LANDSCAPE OF DONORS AND RECIPIENTS

As technology improves there are expansions in both the numbers of donors and recipients. More recipients are being considered for donation; older patients, frailer patients, and even patients with chronic diseases like Hepatitis C and HIV who would not have been considered for transplant in the past, are now receiving livers, kidneys and other organs.16, 37 Many of these patients are doing surprisingly well despite concurrent chronic infections such as Hepatitis C.38 The donor pool has been expanding as well but has not kept pace with the recipient list. In all areas of transplantation, donor criteria are being revisited and modified to enlarge the donor criteria envelope.39 Ethical issues surrounding where to draw lines and how to set limits, are being tackled by evidence based medicine and contained by technical limitations.

An example of this is seen in renal transplants. The list of renal patients awaiting transplant continues to outpace the growth of the donor list. There are also many more patients being kept alive longer with renal dialysis and new medical innovation, and this increases the disparity. One solution has been in the institution of Expanded Criteria Donor Kidneys being permitted for donation. These are kidneys from older patients or from patients with kidneys that are functioning less than optimally. While these transplants do not improve longevity as much as Standard Criteria Donor kidneys, this is seen as a reasonable trade-off for someone who faces death waiting for a standard kidney. This shift represents a significant trend in the donation of kidneys in the last decade and has been a positive influence on the waiting-list/donor-list disparity.40

But, have the criteria expanded enough? Health Canada has very rigid guidelines surrounding transplant protocol. While Health Canada (and various transplant registries) is quick to point out that every organ can be “considered” for transplant, there is a very broad list of circumstances that place an organ donor (and his or her organs) in a high risk category.41 Exclusory criteria include persons that die of unknown causes, of prion diseases (Creutzfeldt-Jacob Disease), of encephalitis and so on. These exclusory criteria also, however, include not only HIV and Hepatitis C but those persons at risk of contracting such viral infections including men who have sex with men, intravenous drug users, persons who have been in prison, and persons who have had recent tattooing or body piercing.8, 15 While Health Canada has received criticism for these criteria, especially from gay rights activists amongst others, it is quick to defend these criteria as being developed along international guidelines and in keeping with strategies derived in the US and internationally.41 Furthermore, there is in the latest cell, tissue, and organ transplant guidelines, a very detailed section (Guidance Document For Cell, Tissue And Organ Establishments: Safety Of Human Cells, Tissues And Organs For Transplantation Section 40-42) which explicitly permits the exceptional distribution of organs of persons from these high risk groups, provided the recipient acknowledges the risks and signs informed consent documents.15 This is in keeping with practices in the US, such as the transplantation of Hepatitis C positive donor organs into Hepatitis C positive recipients. While the empirical evidence on the success of these ventures is far from complete,42, 43 there is optimism that this may expand the donor pool significantly.44 The message from Health Canada in its guidelines, ultimately, is that, despite the list of circumstances that make an organ of dubious quality, every organ should at least be considered for transplant, and this squares with the message from transplant advocacy groups that every person should endeavour to register as a donor.

So on one end of the spectrum of the expanding organ donation domain is donor pool expansion; but on the other end are some issues which are classic conundrums in transplant ethics, such as the transplant of organs into those that have organ damage from poor lifestyle choices and unhealthy habits. These include, for example, whether alcoholics should be placed higher or lower in priority for liver transplants or whether smokers deserve lung transplants, or whether patients should be considered differently if they acquired their Hepatitis C infection from IV drug use (versus from a tainted blood transfusion). The analysis of these ethical conundrums cannot be made here, but it should be noted that the Canadian answer to these issues is a practical one that leaves most moral considerations out of the equation. Practically speaking, allocation criteria are established by transplant experts and are reflected in the transplant guidelines noted above. The eligibility criteria are decided upon by the need of the recipient, the availability of an organ, and the state of health of the recipient. The latter concern, in some respects, accommodates such things as smoking, alcoholism and drug use inasmuch as the ongoing participation in these lifestyle choices excludes people from transplant lists on the basis of their physical health and prospects of success, rather than their moral health. This, it should be noted, is commensurate with some of the fundamentals of the Canadian health care system: a system based on equity, a system that places need above ability to pay, but also a system that places need above the requirement to pay for past moral opprobrium.

Some of ethical issues relating to expanding donor pools may soon be decided in the courts. Despite changes in 2009 to its exclusion criteria,45 Canadian Blood Services (which oversees transfusion and blood product procurement as well as organ donation as noted above) has come under attack for restricting blood donation. The criteria are similar to those enumerated above and the exclusion of men who have sex with men has met with fierce opposition in gay rights groups. In September of 2009 court proceedings were begun in the case of a man who is suing CBS, alleging discrimination in not allowing him to donate blood because of his sexual orientation. This case involved a complex action on behalf of CBS who was suing Ontario resident, Kyle Freeman, for lying on the consent questionnaire, and Mr. Freeman countersuing for infringement on his Charter rights in having his sexual orientation scrutinized in that questionnaire.46 A decision was rendered in September of 2010 finding for CBS and fining Mr. Freeman $10,000 in damages for the danger imposed on blood recipients from his actions.47 For its part the CBS cites a paucity of research on the safety of blood donation from gay men as a reason to maintain its ban on blood donation.48 It is questions, and cases, like these that will propel the debates over expanding criteria for organs in new directions as Canadians continue to face the challenge of reconciling supply and demand.

The consent process has been cited as a significant stumbling block to improved organ procurement. “Express consent” is the norm in Canada; potential donors have to sign an organ donation card (these are often distributed with driver’s licenses but are readily available through organ donation charities and associations etc.) and/or register with a regional organ donation society. This means potential donors have to contemplate their own death, and consider their thoughts about the disposition of their body (including the removal of their organs), and then they must express a written consent, but also (see below) make their wishes known explicitly to their family on an ongoing basis.49 A survey done by Leger Marketing in 2004 found that 73% of Canadians intend to donate their organs, but only 34% of Canadians have taken the necessary measures to do so. It is important to note that the survey also found that 17% of Canadians would actually refuse to donate their organs when they die.12 This method of consent, even at the outset, represents significant barriers to enhanced organ procurement.49, 50 As discussed above, there are several things which influence the quality of organs (such as pre-existing diseases) and keep people off transplant lists (such as a history of IV drug use). In spite of this, transplant advocates, and transplant researchers, are very keen to overcome the barriers and get every Canadian to register as a donor. This is based on an assumption that organ donation is the right thing to do, and that when given with the opportunity, people would save a life if they could.51

Complications accumulate even after a donor card is signed, insofar as there is no way for physicians to know if the person has not rescinded this consent in the interim between signing and death; and a physician has a statutory liability if she or he proceeds in the face of doubt about the consent. It is therefore common practice to ask the next of kin for consent to go forward with the organ donation, and the next of kin can, and sometimes does, refuse to allow the harvesting of organs. While the physician can attract legal action for procuring organs under dubious consent, the family member that fraudulently misrepresents the wishes of a decedent, and refuses to permit organ procurement, is not legally liable for such an act.49 At present, in all provinces except Manitoba and Quebec a valid donor consent is legally binding consent; family members have no legal authority to override this consent.52 And yet, confusion over the law on behalf of donors’ families, and on behalf of physicians contemplating proceeding to organ harvesting, has led to donors’ wishes being countermanded by well-wishing but uncertain families. So even if a well-intentioned Canadian takes the necessary steps to donate, his or her wishes may ultimately be thwarted.

This state of affairs has led to strong calls for law reform and rewriting of laws to make clear that donor’s wishes are to be observed despite any apprehensions that the family may have. Some provinces, such as BC, are becoming more proactive and rigid in enforcing donor consents.52 Furthermore, while enhancing donor numbers by enacting different consent laws is currently not an option, legislative change that makes it mandatory to notify local organ procurement organizations of all brain deaths, cardiac deaths or imminent deaths, does fall within the realm of palatable policy and law. This is being done in BC, Ontario, and Manitoba.53 Such policy would enable an approach to more family members (or even to make it obligatory to approach family members) and request consent for donation for persons who have not expressed a specific choice to donate or not donate. As noted below, this does not have to compromise good end of life care for the donor, nor should it compromise good and compassionate care and support for the family and loved ones.

Difficulties with consent have also spurred the contemplation of other consent structures to enable more donations to take place. The express consent process used in Canada is one means of consent. It employs an “opt-in” mechanism and maximizes autonomy over organ donation. At the other end of the spectrum is mandatory donation, or “conscription” whereby every person’s organs would be considered for transplant upon their death—clearly this minimal autonomy approach would not square well with the Canadian Charter of Rights and Freedoms. So, other softer mechanisms exist. One is to institute “presumed consent” legislation whereby persons would be presumed to consent to organ transplantation unless wishes were expressed to the contrary. This mechanism has two sub-types, the first of which is the “mandated choice,” whereby every person must make and record a choice, and the second is the “opt-out” method, whereby every person is a presumed donor and must make efforts and take steps to opt-out, presumably by registering such a decision on a donor card or with a donor registry. While presumptive methods are viewed as ethically acceptable51, they have not been well received by government or legal community in Canada.49 Analysis of presumed consent methods in other countries (Belgium, Austria, Singapore, Netherlands and Germany to name a few) has revealed that increasing donor rates in countries where it has been successful has depended on several factors other than just legislation (social programs, professional collaboration etc.), and enacting legislation has, furthermore, not been sufficient to ensure success.8, 49 Changes to the consent laws, is at best, some way off in Canada, and for now and the foreseeable future, express consent will remain the norm.

In a similar vein to expanding consent criteria is the notion of expanding the approach to donors and families. More rigidity in adherence to registered donors’ wishes does not have to be at the cost of respect and sympathy to the family, strong leadership in ethically challenging areas can still be accomplished while respecting, sympathising and caring for family members. Evidence points to a certain symbiosis between support and consent. Families that are facing decisions about donation of the organs of their loved one need both information and education, and support; if these are given there may be greater success in gaining consent for organ donation.54

Practices such as donor awareness programs and media drives are common in Canada, but more can be done to improve awareness. Laws which expand consent mechanisms must also be followed up with public education; both the pre-emptive education of families through education campaigns about transplant and donation awareness, and physician education about the nature and power of donor consent. Improving physician training and knowledge is certainly possible, as is broader endorsement and encouragement from professional colleges and associations. Professional education in precisely how to manage these difficult times with empathy and tact, is lacking. It is possible to implement training programs which improve communication with, and support of, family and loved ones of potential donors.55 Certainly anything which enhances education, and which could improve the yield of donated organs within the current consent structure in Canada could only be to the good.

E)      RELIGIOUS AND CULTURAL ISSUES

On the topic of religious issues, this may more properly be filed under “non-issues”. Canada is a multicultural society that embraces all cultures and acknowledges the legitimacy of all religious affiliations; it is a pluralistic society. As such, where organ donation and religion intersect, conflicts arise only insofar as religious pronouncements against organ donation exist. And this is, fortunately, minimal. Most major world’s religions endorse organ transplantation or permit their members discretion in participating in donating or receiving.56 Notable exceptions are the Shinto religion and the Roma (Gypsy) culture both of which generally condemn organ donation. Canadian religious tolerance dictates that the state stay free of any religious choices individuals may make in this regard.

Permitting organ donation required a robust definition of death. (Much of this was discussed in Chapter 3 which examined the concept of defining death, and this topic will be taken up again below in the discussion on Donation after Cardiac Death.) While the US and Canada and most Western and European countries have accepted a definition of brain death, other countries have been slow to do so, and this has impinged on numbers of organ donations. Owing to cultural beliefs about the integrity of the body after death, many Middle Eastern and Asian countries have been reluctant to accept the brainstem death criteria, even though most nations have legislation permitting this definition and even have organ donation programs in place to accommodate willing participants. Canada, as a multicultural country with a substantial immigrant population (see Chapter 1), has imported many of these problems. A disturbing trend in the consideration of cultural differences in organ donation, is that these differences are particularly acute in multicultural societies.57 Canada is a prime example of this, its Aboriginal and Asian populations are in higher need of transplant organs, but in fact availability is much less than the national average—higher need is met with reduced access either through reduced donorship in these populations or reduced access to health care or both. As the world shifts its opinions on transplantation, and many initially sceptical cultures shift their views, it is likely that Canadians that trace their origins to these cultures will shift as well.

F)      DONATION AFTER CARDIAC DEATH

One manner of increasing numbers of cadaveric donor organs is to expand the criteria for defining precisely what a dead donor is. Donation After Cardiac Death (DCD) refers to the donation of vital organs after the death of a donor that is defined as a cardiocirculatory death, and not a brain death.58 These donors are sometimes called “non-heart beating” donors. Using strict guidelines of neurological determination of death was arguably responsible for restricting the number of potential organ donations. Waiting for strict neurological criteria to be met saw many organs go unused, and this was often contrary to the wishes of potential donors and their families, to the medical professionals that now possessed the technology to harvest these organs, and, of course, to the potential recipients that missed opportunities for a better life. This was debated in the literature for some time before the US took bold steps to allow for the donation of organs after the withdrawal of treatment of terminally ill patients that then subsequently “died” of cardiocirculatory arrest. Canada is in the evolving process of developing DCD programs across the country.

There are several very controversial areas to consider in the acceptance and implementation of a DCD program. The first of these is the manner in which the concept of DCD is to be reconciled with the concept of death. An in-depth examination of defining death in Canada was conveyed in Chapter 3 amidst a broader discourse on end of life issues. It was here that the evolution of this concept was discussed from a Canadian perspective, and this will not be revisited in its entirety, except to point out that this is an evolving concept and has seen significant change over the years. Picking up where this story left off in Chapter 3, these concepts have direct application to a better understanding of DCD.

While all persons have an indisputable notion that there is, conceptually, such a thing as death (the cessation of life) there remains great difficulty in capturing this concept in a useful, meaningful, and consistent way.59 The ad hoc committee at the Harvard School of Medicine which was struck in 1968 to grapple with these issues, is commonly recognized as the first significant attempt to refine this definition.60 The deliberations of the committee represented not the first time (and certainly not the last time) that these concepts would be wrestled with. But 1968 represented an important occasion inasmuch as the definition of death had now become a fluid concept and one open to debate. (See Chapter 3 for a richer discussion of this topic.)

Different countries have defined death using different criteria. Despite the fact that Canada has benefitted from, and inherited much of, the rich bioethical thought and policy developed in the US, it has not, as the US has, formed national legislation on the definition of death. The US is guided by the Uniform Determination of Death Act (UDDA) which suggests two acceptable criteria for the determination of death: either the irreversible cessation of cardiocirculatory or respiratory functions, or the irreversible cessation of the whole brain.61 In Canada there is no legislation with national jurisdiction, nor are there strictly congruent provincial definitions.62 In 2007 a forum was convened to formulate a more robust nationally recognized definition to ensure reliability and consistency between the provinces and regions.63 While the forum has chosen a new term, “Brain Arrest”, as the name for this concept, it relies on internationally accepted criteria for the determination of brain death that is, for the most part, a “whole brain” definition. It would seem that the best concrete definition of death in Canada, even in the absence of a legal definition, is still very much one of brain death.

The first ethical controversy in DCD is navigating this shifting definition of death. It is acknowledged, by and large, in Canada that, except for live organ donors, ethically speaking, donors must be dead—and this is the genesis of the commonly used term “the dead donor rule”. There are many that see the definition of death along irreversible cardiorespiratory cessation as a true and robust definition of death. There are some critics, however, who strongly criticize this definition as being unacceptable due to the uncertainty of the irreversibility of death along cardiorespiratory criteria. That is, that cardiorespiratory collapse may be amenable to successful resuscitation and hence a person who is presumed dead by the criteria of pulselessness and absence of breathing, may not necessarily be truly dead because they could be resuscitated by CPR (or experience an auto-resuscitation whereby their own circulatory system “kicks” back in). This presumption of death, this evidence of death, does not necessarily make a person dead. The description does not create or define the entity of death; similarly a person can have significant evidence indicating that they are guilty of a crime and yet be innocent (or guilty) irrespective of this evidence, or to take another example, that something that looks like a duck and quacks like a duck (such as a child in a duck costume) does not transform that entity into water fowl. And so, critics argue, criteria of death (evidence that lends to a presumption of death) does not strictly mean that death has truly occurred, nor that the dead donor rule has been adhered to.64

There are two ways forward through this conundrum, either dispensing with the “dead donor rule” (and accept that organ retrieval can be commenced on dying—but not yet dead—patients), or to more firmly establish exactly what “irreversibility” means with respect to “irreversible cardiorespiratory cessation,” and call persons in that predicament truly dead.  This is not the forum to air or resolve this debate, but it is necessary to be clear that Canada has acknowledged these pitfalls and addressed the meeting of the “dead donor rule” by revising certain death criteria specific to DCD. In Canada, the “dead donor rule” is still in effect. Donors are considered truly dead when they meet the criteria set out, and hence they are not merely dying and, in fact, killed by the removal of their organs (for under Canadian law this would be murder at worst, or euthanasia at best). Furthermore, to facilitate this situation, an enhanced understanding of irreversibility has been established such that: when one is in an irreversible situation, one is for all intents and purposes, dead.

Absent from the “Brain Arrest” definition discussed above, is the cardio-respiratory determination of death necessary for going forward with DCD. It was left to a forum convened by the Canadian Council for Donation and Transplantation (CCDT), which met in 2005, to establish some workable criteria on this front. A report, which both endorsed DCD and also suggested guidelines for implementing programs across Canada, was published in the Canadian Medical Association Journal in 2006.62 It was here that some consensus was reached on defining cardiorespiratory death as irreversible cardiorespiratory function of at least 5 minutes. This definition of death is not a legal definition, and its use (as per the guidelines), is for the determination of death in a DCD scenario. This definition leans heavily on the concept of the “accepted medical practice” of assessment of death and then defines this to include: 5 minutes of absence of cardiorespiratory signs and concurrence in the assessment by two independent physicians who are duly qualified to make such assessments. The panel chose 5 minutes based on the best medical evidence, and as much consensus as could be mustered in the medical community world-wide. The majority of countries reviewed by the panel use 5 minutes as their criteria, however some areas of the US use 2 minutes. These numbers have attracted criticism as being somewhat arbitrary and not immune to the possibility that a person could show a spontaneous return of circulation and hence “life.”64, 65 In addition, owing to the difference in resilience in children when compared with adults, there are different accepted criteria for neurological determination of death in adults and children (different criteria for “Brain Arrest”) according to the Canadian forum,63 and it is, perhaps, for this reason that DCD after the 5 minute rule is not palatable to a majority of Canadian paediatricians.66

With respect to the issue of irreversibility, the guidelines suggest that DCD should only occur after the option of resuscitation measures is clearly dealt with, either that the resuscitation will not be done in the name of futility (on medical grounds), or that the decision has been made by the surrogate decision maker (these patients are almost universally unable to make their own contemporaneous decision in this matter because they are usually unconscious) to withdraw life-preserving treatment. This seems to answer the question of reversibility by avoiding the issue of whether resuscitation could bring the person back to “life,” and instead relies on the fact that the patient would not be resuscitated in any event. There must be full disclosure and transparency with the family of the dying loved one and the best care extended not only to the patient, but also the family. Furthermore, the decision to withdraw treatment has to be along established evidence based medical protocol and the decisions must be made prior to any discussion of organ donation.

In making the last recommendation, the panel tried to evade another ethical pitfall, that of conflict of interest. But on that note, the guidelines go much further than this: there is to be no association between the physicians determining death and withdrawing treatment, and the patient who may be an organ recipient. Furthermore, the physicians that are involved in the withdrawal of treatment may not be involved in the transplant proceedings. This seems to address an inherent and obvious conflict of interest between doctors who want to provide the best care for very ill patients near their death, and yet also want the best for patients awaiting organs. However, even within the panel not all of these issues of conflict of interest were completely resolved to all panel members’ satisfaction.65

One final ethical issue in the discussion of DCD is the permissibility of antemortem administration of medications to enhance DCD success. In short, is it acceptable to administer medications that do not have bearing on the comfort care of the dying patient (or might even interfere with the comfort care of the dying patient) in order to facilitate organ procurement? The panel guidelines make strict recommendations in this area in prohibiting any medications that may in any way adversely affect the proper care of the dying patient, and any administration of medications must still be in adherence to proper comfort care protocols.62 While there is an established set of guidelines, this issue remains a lightning rod of strong ethical opinion on either side of the debate.67-69 Canada finds itself near the centre within this spectrum between European nations that do not often use antemortem medications, and the US where it is standard practice.67 A vexing issue in this realm is in securing consent for antemortem medications to be delivered. It seems the provincial legislation is ill equipped to deal with properly gaining this consent as the patient is almost invariably incompetent, and it is the substitute decision maker that must give consent. Neither the various provincial tissue gift acts, nor the consent acts, nor the advance directive acts consistently or sufficiently address this problem in the provinces and territories.53 The concern is that the substitute decision maker has the right to make decisions for the patient and his or her health at the end of life, but antemortem medication to enhance organ donation steps out of the concerns of the dying patient and moves beyond, to the realm of improving the lives of others. As Canada moves forward in its development of DCD programs these and other medico-legal wrinkles will need to be ironed out.

Much of the foregoing discussion pertains to DCD in a controlled environment. The guidelines, and the accepted norm in Canada, are for DCD events to occur in a critical care setting with a principled decision to withdraw treatment in a person at the end of life. If all goes according to the protocols and suggestions set out above, this would represent a controlled DCD, and the panel set out recommendations for the implementation of such procedures in hospitals across Canada that calls upon the input and expertise of all stakeholders (ICU staff, Emergency Room personnel, transplant coordinators and experts, ethics committees etc.).62, 70 The panel recognized the possible need for, and the implementation of, “uncontrolled” DCD once controlled sites were well established. Uncontrolled DCD is that which would occur in the event of an unforeseen or sudden cardiac death, and where a step by step protocol for controlled DCD is not possible. These uncontrolled DCD protocols and procedures are not currently established in Canada, and, as a result, uncontrolled DCD does not occur in Canada.

Despite the ethical pitfalls discussed above, DCD is being implemented in Canada with programs in Ontario, Quebec and British Columbia. The first DCD procedure in Canada was performed in June 2006 in Ottawa.65, 71 The first DCD transplants were kidneys but soon after lungs were also transplanted.71 The pace of progress is very slow and programs are only in their infancy and proceeding with the utmost caution—a situation that some Canadian transplant experts find abhorrent.18 The slow progress is seen to be, in part, a result of the very fractured system of oversight that was outlined above. This situation is in sharp contrast with the US where the spirit of this concept has taken hold, and the US, can boast an improvement in its organ procurement because of the work that came out of such endeavours as the National Congress for Donation After Cardiac Death which convened in 2005 and was instrumental in asserting the propriety of DCD and setting up guidelines for its adoption.72 A study done in 2008 found that 72% of American paediatric hospitals had a DCD program in place, and 19% of the others were developing policies.73 There are, however, definite signs of a quickening pace of DCD transplants in Canada, as the London Health Sciences Centre indicated that the institution had performed 100 organ donations by 2010 and has led the province and the country in this initiative.74

G)     ORGANS FROM ANENCEPHALIC INFANTS

Widespread acceptance and adoption of DCD has prompted the re-visitation of an old ethical problem—the use of anencephalic infants as the source of organs for transplant. Anencephalic babies are born, to greater or lesser extents, with very little neural tissue above the brainstem, that is, they are born without the capacity for any cognitive function. They do not experience consciousness and hence do not feel pain. They are often stillborn, but if they are live at birth, they usually die after a few days or weeks, except in the most exceptional of circumstances with maximal life support measures. This tragic situation often prompts heart-broken parents to ask if the organs can be transplanted to other infants—to somehow offset the tragic loss by giving life to another infant. Physicians and ethicists are not unreceptive to their pleas, but the situation is much more complicated than it first appears. A detailed analysis of this issue intersects with many very interesting areas of philosophy and ethics— defining personhood, consciousness, and autonomy (and surrogate decision making) to name just a few—and discussion of these will be left to other ethics and philosophy texts. But there are several aspects of Canadian bioethics that are of practical concern, and many of these can best be demonstrated by an actual case.

This issue became a lightning rod of ethical debate in 1987 when a Canadian anencephalic infant, Baby Gabrielle, was born on October 12th, placed on a ventilator to prolong her life, and was flown to Loma Linda California to have her organs harvested four days later, and transplanted into Paul Holc, a young baby boy who was delivered early by Caesarean section in order to take advantage of the Gabrielle’s heart which could replace his malformed heart.75 This story is important to Canadian bioethics for more than just the fact that Gabrielle was born in Canada: it highlights several of the issues surrounding babies with anencephaly being used as organ donors.

First, with respect to the timing, it was in defining death that these issues came to be issues. The Baby Gabrielle case came at an important time, a time when the topic was being considered in the public and among academics, and it touched off further speculation that has ended in concrete position statements and guidelines. Historically, anencephalic hearts had been transplanted with varying degrees of success in the 1960’s76 but this soon became untenable in the evolving debates in defining death. It was in 1968 that death became defined along neurological criteria. This was never as easily established in the paediatric literature, and was something both the American and Canadian paediatric societies grappled with and continue to grapple with. The Baby Gabrielle case came at a time when the world was considering the legal status of death and the “dead donor rule”. The Loma Linda institute shut down further transplantation from anencephalics in 1988 to study the matter, and the program was never restarted. In 1992 the American Academy of Pediatrics released it guidelines prohibiting the use of organs from anencephalics outside the usual transplant guidelines, and it has continued to reaffirm these guidelines up until and including its latest position statement in 2007.77 Following these trends and timelines, the Canadian Paediatric Society (CPS) has rejected anencephalics as a source of organs since 1990.  The current CPS guidelines on this matter date to 2005, with reaffirmation of the guideline in 2009.78

The difficulty with anencephalics being used as organ donors has to do with their peculiar position on the grid of life and death. A full exposition of this topic is not possible here. Anencephalics have enough brainstem function to control primitive reflexes and control breathing and heart function. Death criteria are, at best, subtly but significantly different in infants and children than they are with adults owing to innate resiliency of younger tissues and organs; and this situation is complicated even further by biological grey zone cases such as anencephalic babies. Neurological determinants have been the criteria for defining and diagnosing death for the last few decades in Canada.63, 78 But irreversible cessation of circulation and respiratory function have also been established as a reasonable criterion as set out by the Uniform Determination of Death Act, as discussed above. Anencephalics meet neither criteria and are very difficult to define as dead either legally, biologically, or ethically (and philosophically). Their hearts beat, and their brainstems function, but they function poorly leading to a decline in their health until they do ultimately experience cardio-respiratory arrest and truly die from both a neurological and cardiorespiratory standpoint. Until that point they are technically alive, and at the point of their death their organs have suffered irreversible damage and cannot, typically, be used for transplantation.

Though unusual, there are exceptions. These are not legal or moral exceptions but statistical exceptions. It should be stressed that despite the statements by both Canadian and American paediatric societies that anencephalics cannot be used for donation before they meet the criteria for death, they certainly can be used for organ donation once they have met the criteria of death, it is just simply the case that most of these infants, once they have crossed that threshold, will have unusable organs. That is, of course, unless other interventions enhance their vital functions.

Baby Gabrielle was put on a ventilator to allow her to sustain her organs until transplantation. This is not permissible by current Canadian guidelines but is allowed under certain circumstances in the US.78 Throughout the last several years the debate in the US has, in part, been on whether there should be some kind of an explicit exception to the UDDA to allow for anencephalics as organ donors.79 As yet, this has not occurred, but the question has been asked in Canada as well, and often at the request of well-intentioned parents who only want something good to come of the tragedy of watching an otherwise healthy infant die. And there may be some inkling of change afoot. In 2008 the International Federation of Obstetrics and Gynecology released a very brief statement that seems to allow for donation of organs from anencephalics at the strong urging of the parents, in fact, it suggests that it is suitable to maintain these infants on a ventilator until a donation opportunity arises.80 Although interventions such as medications and ventilator support are, or may become, acceptable in other countries, at present this practice is discouraged by the CPS.

Contemplating the ethics of Donation after Cardiac Death has invited comparison with the use of anencephalics as organ donors. In light of the “buzz” surrounding “non-heart beating” donors being used for organs, there are those that feel that, perhaps, some other exceptions can be made surrounding anencephalics on appealing to the same type of ethical principles. But a fine grained analysis will reveal these comparisons to be specious. Considerable debate was had (as discussed above) as to just how to accept DCD and yet observe the “dead donor rule”. To recap: the Canadian donor is dead along lines defined by the irreversibility of his or her ceased cardiorespiratory function, even if not thoroughly brain dead—the dead donor rule is observed. For anencephalics, they are not strictly brain dead, and by the time their organs deteriorate enough to cause cardiorespiratory collapse, the tissues will be useless in transplant. Barring some exception to the rule that the donor must meet the rigid criteria for death, anencephalics will continue to not be used in Canada for organ donation.

Many are quick to point out that modern society does continue to inch toward some resolutions in this ethically rich and emotionally charged issue. Because of increased antenatal screening and imaging, most anencephalics will be detected early, and pregnancy termination can be performed if the patients request it. Furthermore, due to enhanced dietary practices (increased folate intake for instance) and more insight into the nature of anencephaly, these tragic cases are becoming rarer. It should also be noted that movement in this positive direction is obviating concern over another rather wildly speculative and perverse slippery slope notion, that anencephalics, if they were to be used for organ transplantation, could be then intentionally cultivated for that purpose. Moving in a trajectory of increasingly limiting this devastating disease seems to be all to the good.

As a final consideration, examining the predicament of anencephalic infants begs for a comparison with those persons in a similar state. The Persistent Vegetative State (PVS) is a condition of severe neurological injury and compromise whereby a patient has lost all ability to interact in any meaningful way with his or her surroundings; while they have lost all higher brain function they often retain some residual brainstem function. These unfortunate people have lost that essential capacity that defines personhood. This is not the forum for a discussion on defining personhood, but to point out that there are similarities in anencephaly and PVS that would invite comparison, and that comparison would extend to questions about organ donation. Persons in a PVS are not brain dead, and they do often have preserved capacity of their vital organs. Persons in a PVS are not, strictly speaking, dead.81 And so, persons in a PVS are not eligible for transplantation until they have met these criteria and are “dead donors”. This is a conclusion that was also reinforced by The President’s Council on Bioethics in deliberations on re-examining the definitions of death and criteria for organ donation.82 The PVS and other neurological peculiarities, as well as exceptional medical disorders in other body systems, will continue to pose challenges for defining death and hence for defining eligibility and limits for organ donation in Canada.

SUMMARY

Canada has undergone significant changes in the realm of organ donation. It has seen increases of technological innovation and, like the rest of the world, has been witness to an ever increasing gap between the number of people on waiting lists and the number of organs made available for donation as technical ability has outpaced donor registration and organ procurement. Canada has a poor record of cadaveric donations in comparison with much of the developed world, but has an impressive number of live donor transplants. All this is in spite of the fact that the majority of Canadians are knowledgeable about the need for organs and are in favour of donation. The disconnect between these two facts seems to be evident in witnessing the relatively low percentage of persons that go through the procedure of actually registering as donors. This chapter began with an examination of some of these numbers and trends and went on to describe the oversight of the organ transplant enterprise which can best be described as fragmented owing to the provincial nature of health care administration in Canada. Despite largely consistent organ donation acts and legislation in the individual provinces, and despite the institution new national guidance in organ donation under the direction of Canadian Blood Services, hundreds still die every year waiting for organs, and Canadians wait longer than their US neighbours for kidneys and other organs. This may connect directly to the lack of a national registry for organ donors and recipients, and the lack of a national organ procurement program—things that the US has and Canada does not.

Moving beyond issues with waiting lists, the discussion turned to issues relating to means by which the waiting lists could be shortened. The first issue tackled was an examination of paying for donor organs. There are arguments on either side of the debate but Canada falls squarely within the camp which condemns paying for organs, and Canada has joined much of the international community in restricting the illegal trade of organs and to curb “transplant tourism.” Nonetheless, while Canadian law prohibits the sale of organs, many Canadians feel that more must be done to financially aid and compensate living donors within Canada.

Medical advances and the relentless march of progress have improved transplant capabilities, but have also been responsible for maintaining the health of chronically ill people such that more end up on transplant waiting lists. People with advanced age and disease, and even those with chronic infections (such as Hepatitis C), are now technically able to benefit from organ transplantation, but rigid criteria around which organs are acceptable mean an ever increasing disparity between those waiting lists and organ donation registrants. Canada has done much to enhance the technological capability of transplanting less than optimum organs into persons in need, and the results are promising. But while these so called “Expanded Criteria” organs are more readily being accepted, Canadian Blood Services, and the guidance criteria for organ acceptability set out by Health Canada, have been criticized as being too restrictive and rigid in turning away some potential donors, such as men who engage in same-sex sexual practices. In addition Canadian transplant organizations and legal scholars have criticized the fundamental way in which organ donation consent is derived in the first place. Many feel that changing consent tactics to one in which consent to organ donation is presumed for all citizens (rather than the existing situation in which people have to go through some trouble in actually registering as a donor) will enhance donation rates in Canada. Just shy of changing the donation consent laws, is the need to clarify the existing consent laws such that once a donor card is signed or a donor registered, the decision cannot be arbitrarily vetoed by confused or apprehensive family members.  Furthermore, there is a push to increase the means by which organ procurement can be enhanced by identifying potential donors in ICU’s and Emergency Rooms, by more assertively and effectively procuring organs from those who have signed donor cards, and by improving dialogue with family members of potential donors etc.

Donation after Cardiac Death is an emerging phenomenon in Canada, but it is one that has forced the health care system to confront ethical issues surrounding the definition of death. Canada has adopted neurological criteria (“Brain Arrest”) to define death. That it may be acceptable to harvest organs from persons who do not meet these strict criteria, is something that has been addressed in other nations, most notably the US. With a broader set of criteria for establishing that patients are indeed dead, these countries are able to satisfy the “dead donor rule” whereby the donor is dead before organ retrieval, and not as a result of organ retrieval. While Canada has not broadened its criteria per se, it has established that persons who have suffered irreversible cardiocirculatory arrest are eligible for organ donation. “Irreversible” in this sense is based on the fact that it has been decided by the patient, or the patient’s rightful decision makers, that resuscitation will be withheld, and furthermore, organ harvesting can only occur after a certain period of time (5 minutes is the norm in Canada) has elapsed after the heart has stopped beating. Strict DCD guidelines have been established in Canada that ensure that the best end of life care be extended to a patient that is a potential donor in this situation. There are strict criteria to ensure that there is no conflict of interest between the care providers for donors and recipients. DCD has been occurring in Canada since 2006 and there are DCD programs in Ontario, Quebec, and BC.

With the advent of DCD, an older ethical debate has re-emerged, the question of whether it is acceptable to use organs of anencephalic infants. A careful analysis reveals that babies with anencephaly do not meet the criteria for either brain death or cardiocirculatory death. It is mostly this fact that stands in the way of opening the door to organ donation, even though many parents of these infants would welcome the opportunity to recover some redeeming good from an otherwise hopeless and tragic situation. The Canadian Paediatric Society has joined many other nations in prohibiting donation of organs from anencephalics until they meet the same criteria as any other donors—sadly this often occurs after the organs are unusable. In a similar vein, organs are not harvested from those in a Persistent Vegetative State.

Moving forward, as technology enhances the longevity of many persons with chronic disease, the organ donation crisis will continue. Canada, along with the rest of the world, faces ever growing disparity between the numbers of patients waiting for organs and the number of persons registered or eligible to donate. Ethical issues continue to arise in the means by which Canada attempts to reconcile these lists, address these facts, and approach solutions in an acceptable, principled manner.

 

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