Organ Scarcity in Kidney Transplantation
Ethical challenges in Priority Setting
Faisal Omar
Department of Medical and Health Sciences Linköping University, Sweden
Linköping 2011 Faisal Omar, 2011
Cover picture/illustration:
Published article has been reprinted with the permission of the copyright holder.
Printed in Sweden by LiU-Tryck, Linköping, Sweden, 2011
ISBN XX-XXXX-XXX-X ISSN XXXX-XXXX “We cannot solve our problems by using the same kind of thinking we used when we created them.” Albert Einstein NOTE:
This Kappa is a work in progress. I am aware that the parts which I have written need to be cleaned up and tidied. Also the references are not complete, some will either be missing from the bibliography, or I have not had the chance to include others in the text. I have tried to concentrate on giving the overall structure of the kappa, so that I can benefit from the seminar as much as possible. I particularly look forward to feedback regarding:
1. If there are themes that you believe are missing from the background, concepts, or theory sections
2. Ideas regarding discussion points
3. Feedback regarding the structure of the Kappa, if there are particular rearrangements you believe would be beneficial
4. And finally other kinds of feedback not related to the above is also most welcome
Thank you! Table of Contents
LIST OF PAPERS...... 2
ABBREVIATIONS...... 4
INTRODUCTION...... 5
AIMS...... 8
METHODS...... 9
BACKGROUND...... 16
CONCEPTS AND THEORIES...... 23
MAIN FINDINGS...... 31 PAPER I...... 32 PAPER II...... 35 PAPER III...... 38 PAPER IV...... 40
DICUSSSION...... 42
POLICY IMPLICATIONS AND CONCLUSIONS...... 46
REFEENCES...... 49
ABSTRACT
1 LIST OF PAPERS
I. Faisal Omar, Per Carlsson, Marie Omnelle-Persson, and Stellan Welin. Priority Setting in Kidney Transplantation in Sweden. BMC Health Services research. (submitted)
II. Faisal Omar, Linda Wright. Priority setting in The Assessment for Kidney Transplantation Candidacy: A Canadian Case Study (manuscript)
III. Faisal Omar, Gunnar Tufveson, and Stellan Welin. Compensated living kidney donation: a plea for pragmatism. Health Care Analysis. 2010 Mar; 18(1):85-101.
IV. Faisal Omar, Gustav Tinghög, and Stellan Welin: Incentivizing deceased organ donation: A Swedish priority-setting perspective. Scandinavian Journal of Public Health. 2011 (39), 2, 156-163.
2 3 ABBREVIATIONS
A4R Accountability for Reasonableness
CEA Cost effectiveness analysis
ESRD End Stage Renal Disease
DD Deceased Donation
FEO Fair equality of opportunity
LD Living Donation
NDD Non- Directed Donation
QALY Quality Added Life Years
TGH Toronto General Hospital
UHN University Health Network
4 INTRODUCTION
Susana, a 39 year old mother of three active young girls; she is passionate about nature and enjoys spending summers camping and hiking with her children in the Swedish country side. Pelle, 59, is a successful businessman, and a highly regarded leader in the community with a long and distinguished history of philanthropy; he relishes traveling with his recently retired wife to European capitals on business trips. Johannes, 22, has just begun university studies for his dream occupation as an aviation engineer; he builds and races model airplanes with friends in his spare time. While this cast of characters are decidedly different in many respects they share a common affliction. They are on the kidney transplant waiting list; their health’s are deteriorating, and desperately desire kidney transplantation. Consider now that you have been given the assignment of choosing only one person among them to whom will be allocated a kidney, allowing him/her to avoid a premature death, regain their health, return to their normal life, and pursue their passions. They are all equally fit to receive the kidney, and are equally vying for it.
How will you choose amongst these competing claims for the kidney at your discretion? Will you be swayed by the powerful image of Susan’s young daughters growing up without their mother? Possibly you will be influenced by Pelle’s leadership status and his philanthropic contribution to society as an input when making your choice. Finally will you take into account that Johannes is the youngest of the three and has yet to live as many years of the good life as the others? Each of these concerns above which you may consider rests on sound moral reasoning, but none can independently capture our complex moral values; hence we can anticipate reasonable disagreement. Each position can be counter argued as being punitive to the others for reasons beyond their control. For instance if you consider Susana’s three young children will you be punishing Johannes for simply being too young to have had the chance to build a family of his own. To avoid making these complex value judgments, you might opt for other strategies. Perhaps you will decide depending on who became sick first and allot the kidney on those bases. Some of you may prefer a completely random approach; flipping a coin or pulling straws as a way of giving each a random and equal chance at the transplant.
5 If you succeed at navigating the labyrinth of moral dilemmas, raised by the scenario, and settle on one person as your chosen recipient how do you feel after? You may find that once the anxiety of making this difficult choice has subsided you are left with a lingering sense of frustration and dissatisfaction; no matter whom you chose, no matter how much you laboured to do the right thing, there is the unfortunate reality that two individual’s pressing health needs remain unmet. You may (like myself) wish there is some way to secure two additional kidneys so all three would have a transplant, and you relived of being arbiter between their legitimate claims.
With any luck you will never be faced with making such a decision in your life time. The reality, however, is that transplant programs where I conducted my fieldwork, and others around the word routinely deal with the challenges the above scenario raises as consequences of the unremitting kidney scarcity. People like Susana, Pelle, and Johannes, who have a real chance of survival, deteriorate and die while waiting for transplantation; leaving behind their families, future plans and passions. The above example serves to illustrate the vexing nature of the moral dilemmas posed by the scarcity of organs in the field of kidney transplantation. Further, it introduces two parallel themes which this thesis attempts to address. The first concerns fairness in the allocation of kidney transplantation as a scarce medical resource. The second concerns increasing the supply of kidneys required for transplantation. Together these themes represent two of the most pressing challenges raised by kidney scarcity. They are essentially both challenges of priority setting. Fair allocation is at the clinical level and is an immediate reaction to the kidney scarcity, to ensure that the resources at our disposal are distributed in the fairest way possible. Increasing kidney supply is a long term policy concern; this requires a system level strategic approach to find a solution to the root issue of scarcity. Although these priority setting levels admittedly overlap to some extent it is helpful to separate them; doing so better allows for dealing with the unique types of ethical challenges they raise.
Fairness in the allocation kidney transplantation as a scarce resource belongs to the broader arena distributive justice, a rich and complex normative concept. A common distinction made is between outcome focused distributive justice and a procedurally based distributive justice, focusing on fair process. I will, in the first two papers of this thesis investigate the fairness of the priority setting process underpinning access to kidney transplantation at the clinical level. To do this I will employ the notion of fairness as justice
6 advanced by Daniels and Sabin in the Accountability for reasonableness ethical (A4R) framework. This is a procedural framework whose goal is to shift the attention of priority setting from decision outcomes to fair process since we may reasonably disagree on what outcomes are desirable depending on the philosophical and moral beliefs. Recognizing the plurality of values governing priority setting, it is more suitable to evaluate fairness from a procedural approach rather than focusing on outcomes; with the hope that if we agree on the fairness of the process, we are more likely to agree on decision outcomes also.
No matter how fairly we distribute kidney transplantation there remains the obstacle of kidney scarcity. There have been numerous attempts to address the scarcity, varying in degrees of success and the level of ethical challenges they raise. My goal in the second two papers of the thesis is to focus on an approach that not only poses interesting ethical questions, but is also a reasonable and sustainable solution for addressing the scarcity in kidneys. Previous and current efforts have had piecemeal impact on the kidney supply, and a bold policy level approach is now required. I will present incentive based donation as a macro level policy solution to the organ scarcity. This is presented from a position that is clearly in favour of incentive based models.
7 Aims
The general aim of this thesis is to highlight clinical and policy level priority setting ethical challenges arising from organ scarcity in the area of kidney transplantation. To achieve this, two particular themes will be explored. I) procedural fairness in access to kidney transplantation II) Incentive based donation as policy approach to addressing the organ scarcity. Each of these themes corresponds to two papers which will be presented in this thesis.
Paper I evaluates procedural fairness, in reference to A4R, in the priority setting process underpinning Swedish kidney transplantation. This includes both the assessment for transplant candidacy and the allocation of deceased donor kidneys.
Paper II evaluates procedural fairness, in reference to the A4R, in the assessment for kidney transplant candidacy within Canada’s largest transplant program at the Toronto General Hospital.
Paper III proposes incentive based living kidney donation as a policy level solution to the kidney scarcity, and discusses potential ethical challenges raised by this proposal.
Paper IV proposes incentive based deceased organ donation as a policy level solution to the organ scarcity; and examines its compatibility with the ethical values of the Swedish health care system.
8 Methods
Addressing both clinical and policy based priority setting requires an interdisciplinary approach as reflected by the methods used in the papers included in this thesis. I have two goals in this section. First is to give an overview of the methods used in the papers on which this thesis is based, and within this overview to share the rationale behind the choices. I will not go into too much detail about aspects such as study sites, and subjects, since these are sufficiently covered in the papers. The second goal is to provide a characterisation of the thesis as a cohesive work and situate it within the arena of ethics where I believe this work belongs.
Papers I & II: Accountability for reasonableness The A4R has gained increased prominence over the past number of years as an ethical framework for priority setting, becoming a leading paradigm in health policy. Using it allows my research to be timely and relevant to those involved in this field. Furthermore the framework was particularly attractive due to its practical nature. It avoids abstract ethical discussions and provides a practical lens through which priority setting process can be examined, analysed, and commented on. I believe it is should be a goal for studies in applied ethics of the nature that papers I and II are that they are relevant to the community which the research is based on. The A4R has in a number of studies been shown to be well accepted by decision makers in the medical profession as reflecting the key indicators of fairness in priority setting. This increases the relevance of the findings, and discussion, within the transplant communities the studies are based on.
The A4R offers four conditions which contribute to the fairness and legitimacy of priority setting processes: Relevance, Publicity, Appeals (Revisions), and Enforcement.
I) Relevance: Rationales for limit-setting must rest on reasons and principles that fair minded persons agree are relevant in meeting the diverse needs of the population, in the context of reasonable resource constraints. Fair minded persons seek mutually justifiable grounds for cooperation.
9 II) Publicity conditions: Limit-setting decisions and their rationales must be publicly accessible.
III) Appeals (Revisions): There is a mechanism for challenging and disputing decisions of limit setting, as well as the opportunity to revisit decisions in the light of further evidence.
IV) Enforcement: There is voluntary or public regulation to ensure that the first three conditions are met.
The framework has over the past decade been employed widely across different health care systems including Canada, the UK, Uganda, to mention a few. It has also been applied across different levels of priority setting including clinical, institutional, and policy levels. Proponents who have applied the framework to clinical level priority setting report a number of reasons why it is more suited for this task than traditions methods. First, philosophical approaches such as utilitarianism and egalitarianism can be abstract and take as their starting point different “values and lead to different decision outcomes, none of which are clearly correct” . Secondly, solely economical approaches such Cost effective analysis (CEA) are unable to wholly capture the humanistic aspect of health care decision making.
Alongside the wide use of the framework, or perhaps because of it, it has attracted some criticism in recent years. It has been criticized on the grounds of the diminished role it assigns to substantive values that underlie priority setting processes, even if there is no unanimous agreement on such values . It is argued that being explicit about the substantive principles fosters legitimacy for the decisions reached. It has also been criticized for limiting the range of stakeholders included into the priority setting process .
Despite the criticism, there remain valuable contributions regarding procedural fairness that the application of the A4R can make. The approach taken in thesis will be to use the framework’s strengths as a tool for examining issues related to procedural fairness while also heeding what I find to the most significant critique, by highlighting the substantive values which underlie the priority setting processes.
Data collection and analysis
10 When I decided to investigate clinical priority setting two options which I considered were either conducting a survey study or a qualitative interview based study. There were clear advantages to both. The survey study would be less time intensive; it would also eliminate logistical issues of arranging interviews across the country with busy professionals.
On the other hand there is a limit to how much one can learn about a practical medical practice from reading texts, and carrying out surveys. Visiting the environments where decision making occurs, and meeting the decision makers in person for in-depth interviews would provide me with more nuanced understanding of the context in which priorities are set, helping to generate a richer data set. It would allow probing topics which arise during the interviews that may not have been considered in the survey. Qualitative methods are more suitable to understanding the underlying factors contributing to priority setting decisions. It acknowledges the importance of the social worlds that the events take place which can be lost when conducting purely quantitative research . Fairness is not easily quantified since it is a rich and complex concept. In order to deal with it adequately it was necessary to carry out in-depth interviews. This was made clear in two quantitative studies which I conducted at the beginning of my PhD studies. They were both survey studies one investigating attitudes regarding priority setting and the other compensated donation ( Omar, Tinghög et al 2010). These papers contributed to the insight that a normative subject such as fairness is best dealt with using a qualitative approach. For the above reasons interviews were chosen as the primary source of data.
The method chosen for analyzing the interviews was thematic analysis. While grounded theory as a possible option was considered it was ruled out for two reasons. Primarily because the object of the studies was not theory generation, in which case grounded theory would have been appropriate. Secondly the central role of the A4R in the studies required a method with the flexibility to allow bringing in an external framework which would have been difficult with grounded theory. Thematic analysis allowed identifying extracting emerging patterns, and themes which were significant to the research questions and aims. The evaluative nature of the studies ruled out grounded theory and made thematic analysis more suitable .
In the Canadian study there was an additional dimension to data collection and analysis. I had been given permission by the Toronto General Hospital
11 (TGH) to sit in on weekly listing meetings where the actual decisions regarding admission to the transplant waiting list occurred over a 4 month period. This was an indispensible component of Paper II. In conjunction with the interviews observing these meetings helped to me to gain a fuller appreciation for the difficult nature of decisions regarding admission to the transplant waiting list and the context in which they take place
The reason why a Canadian case study was included, I think needs to be briefly explained, since it may at first glance look somewhat out of place. However international comparison of health expenditure, clinical guidelines, and priority setting are not uncommon The Canadian and Swedish health care systems are similar in many respects with regards to the financing, administration, and access to universal health care. Investigating a case study of how priorities are set within the same medical specialty in a similar health care system helps to draw out best practices, and areas of improvements in relation to one another. While this has not been done within the papers since they deal with each case separately, some apace will be allotted in this thesis to discuss the two studies in relations to one another and what lessons emerged.
Ethical approvals The necessary ethical approvals were granted in both studies. In Sweden the study was approved by the Linköping Regional Ethics Board. In Toronto it was granted by the University Health Network (UHN) Review Ethics Board (REB). Interviewees read and signed a consent form before the interview; it stated that confidentiality regarding the identity of all participants would be upheld throughout the study and its publication.
Papers III & IV These two papers are conceptual papers; written as policy proposals and do not involve original empirical research. However the papers base the arguments they raise on relevant empirical research from literature across a
12 wide range of fields, which strengthens the arguments within. The papers make a clear moral judgement that is in favour of incentive based donation. I will below remark on common philosophical approaches used to reach judgement on normative issues such as those treated in these papers.
Moral Judgment: intuition and reason Proposals of incentives involving human organ have a tendency to trigger strong moral feelings, this is whether one ultimately agrees or disagrees with incentive based donation. These moral feelings or intuitions are common to many circumstances that involve normative questions. Moral intuitions are judgements or assessments of actual or hypothetical scenarios which occur quickly and carry strong feelings of authority; it does not require one to undergo a process of conscious reasoning to arrive at the judgements (Woodward 2007). Such immediate Intuitions are often tied to the notion of repugnance, which may be invoked in normative discussions to argue for or against a particular position. Kass (1997) describes repugnance in the following way:
“ Emotional expression of deep wisdom beyond reason’s power fully to articulate it. Can anyone really give an argument fully adequate to the horror which is father-daughter incest (even with consent), or having sex with animals, or mutilating a corpse, or eating human flesh….would anyone’s failure to give full rational justification for his or her revulsion at these practices make that revulsion ethically suspect? Not at all”
This type of reliance on intuitive repugnance as a replacement for reasoned argument has been criticized for disallowing a meaningful discussion on a given moral issue. Furthermore strong moral intuitions can be fallible, take for example a religious extremists moral disgust (in some parts of the world) regarding a woman working outside her home. It is not difficult to see how faulty, and in need of denunciation, these moral intuitions are no matter how strong they maybe. Moral intuition can be biased, or a reflection of a social group’s dispositions to certain subjects. For instance while many of us find the practice of eating dog meat, or polygamy repugnant, in other cultures it is perfectly accepted. Hence what we find morally repugnant can vary across cultures and across persons.
13 Peter singer strongly argues that moral judgment should be rationally rather than emotionally based. This is in line with his earlier work in which he finds intuitions suspect, believing their roots can be traced to:
“discarded religious systems, from warped views of sex and bodily functions, or from customs necessary for the survival of the group in social and economic circumstances that now lie in the distant past” (singer 1974: 516)
Singer’s views on the unreliability of intuitions however is not the dominant view, since it is common in philosophical discussion to either begin the process of reasoning from an intuition regarding a normative issue, or to argue against a moral position based on the fact its conclusions run counter to moral intuitions (Malmqvist 2008). However in light of the above discussion we need to be cautious regarding how much weight to place on moral intuitions. The fact that incentives for organ donation trigger strong moral intuition is not sufficient on its own to be a veto against incentive based donation. In the same way that letting people die on the transplant waiting list triggers strong moral intuitions is not sufficient to allow incentive based donation. These moral intuitions are important starting points; however they are not robust enough for reaching adequate moral judgments on their own. They must be balanced against moral reasoning, which in contrast to intuitions involves an attempt to support the moral judgment with consistent and logical reasoning. How should such a balance be reached?
John Rawls “reflective equilibrium” is an approach which allows a place for moral intuition within a more comprehensive and deliberative process of reaching moral judgement . The process involves going back and forth between ones intuitions, in particular those which we’ve given thought to (considered moral judgement), regarding a given case and their ethical principles, evaluating and revising them as necessary to reach coherence between them. At the conclusion of this deliberative process where coherence is achieved a person reaches a state of “reflective equilibrium”. Alternatively we can describe the approach used to reach the state of coherence as the “method of reflective equilibrium”. (Daniels 2011). While this may sound somewhat complicated, it is something we do routinely when we scrutinize our moral judgements. We shuffle back and forth between those judgments, our judgements on similar cases, and wider facts and moral issues to generate a rationale for our judgements that is consist with the rest of our beliefs.
14 A final note on intuition; for a successful proposal of incentive based donation moral intuitions is important for two critical reasons. Firstly a proposal that runs counter to the majority’s moral intuitions has little chance of being adopted. Secondly the moral intuitions against incentives have a very practical and beneficial purpose. It alerts us to the nuances and potential pitfalls that need to be addressed if we are to make a strong morally reasoned case for incentive based donation. This is a tall order, but I believe can be accomplished by setting clear conditions, for how, when and why incentives for donation are morally appropriate.
Overall thesis characterization In light of the above discussion and the topics which are covered by the papers how might this thesis a whole be characterized? It uses empirical data, it applies procedural approaches to evaluate fairness in the allocation of scarce resources, and uses moral reasoning to propose incentive based donation. The underlying connection of the works presented here is that they fall within the scope of normative ethics. Normative ethics is concerned with moral questions, particularly questions of what is right or wrong. What are fair or unfair criteria in the allocation kidney transplantation? Is an incentive based organ donation model ethically appropriate? These questions which I deal with are based on concrete medical practices and concrete moral issues, some involving original empirical research; which means this thesis can be further sub characterised as belonging to the branch of applied normative ethics.
15 BACKGROUND End stage renal disease (ESRD), is a condition in which kidney function decreases significantly and permanently requiring renal replacement therapy. This can be in the form of dialysis or Kidney transplantation. Almost all ESRD patients will, however, undergo dialysis at some point. For some as a maintenance testament until they receive transplantation, while for others it becomes the long term treatment. Very elderly and frail patients may in rare circumstances choose not to undergo any treatment at all. ESRD patients in Sweden, are treated in one of 65 dialysis centers the majority (90%) of which are hospital based. These centers are responsible for referring patients to transplant centers to be considered for kidney transplantation. This general structure is shared by most health care systems. Depending on the area of residence Swedish patients are referred to one of four centers which in the order of patient populations served are Sahlgrenska University Hospital in Göteborg, Huddinge University Hospital in Stockholm, Skåne University Hospital in Malmö, and Uppsala University Hospital. If a patient is deemed eligible for transplantation, they are placed on the waiting list, unless they have a living donor. Figure 1 illustrates the stages for the treatment of ESRD. Figure 1. Treatment stages
16 Dialysis There are two broad categories of dialysis. Hemodialysis the most widely used involves the removal of blood from the patient and into a dialyzer to filter out toxins. This treatment is mainly carried out in a hospital or outpatient clinic at least three times a week, each session lasting four to five hours. Peritoneal dialysis exploits the filtering capabilities of the peritoneum membrane (lining of abdominal cavity) to mimic kidney function. The treatment is carried out at home eliminating the need for hospital visits. Nonetheless the procedure must be carried out four times daily each taking 30 and 45 minutes . Patients can utilize this form of dialysis for a maximum of 4–6 years due to the risk of peritoneum failure, and other potentially dangerous anatomic changes in the tissue . Common side effects of dialysis include: low blood pressure, muscle cramps, infection and clotting of dialysis access points, hernias, malnutrition, and sexual dysfunction .
Transplantation Kidney transplantation, once regarded as an experimental treatment, has become the treatment of choice for ESRD. This is a result of improvements in surgical methods, clinical management of postoperative complications, and developments in immunosuppression. Transplantation has proven advantages including improved survival rates, and a higher quality of life compared with dialysis . From a societal and health care perspective transplantation is significantly more cost effective . I will next present the source of organs currently used for transplantation.
Deceased donation Deceased donation (DD) is a long established practice and is the corner stone of organ transplantation; DDs simultaneously provide multiple organs meeting needs in different disease categories . The typical deceased donor is someone who is “brain dead” — maintained on a mechanical ventilator but declared dead on neurological criteria, often after sever trauma. Since the deceased no longer needs the organs there is no risk of causing harm. Furthermore it is accepted by the major religions. Organ donations from the deceased are, in most parts of the world non-directed. Neither the deceased nor the relatives can choose to whom the organs should be allocated. The donation must not be contrary to the expressed wish of the deceased. Most countries operate under a system of explicit consent, usually given by the donor (when alive); if their will is unknown, by close relatives. Sweden has a system of legally presumed consent, where if the will of the deceased is
17 unknown consent is assumed. However, prior to all DD close relatives are routinely contacted and may veto donation .
Directed living donation Most humans are able to live healthy and fulfilling lives with only one kidney. While historically living donation (LD) was restricted to very close relatives (between siblings and parent to child) this has changed over the last few decades. This is in part due to decreases in the risk to donors with better surgical and post-operative care, and the advantages of LD allografts compared to DD. The rate of LD has increased over the past number of decades; accounting for nearly 40% of kidney transplants in Sweden. Individuals with access to a living donor will receive a transplant much quicker than patients waiting for a DD kidney. Some patients may be transplanted pre-emptively (without any dialysis) a practice which is associated with increased survival. LD is often an agreement reached within the family, or between friends. It is without monetary reward, there is presumably an emotional reward, however . Directed donation may also be solicited; some individuals publish an appeal on the internet for instance in the hopes of soliciting donors; transplant programs often go to great lengths to verify that no monetary exchange is involved.
Non-Directed living donation Non-directed donation (NDD) is relatively new phenomenon. This is where a person approaches a transplant center and offers a kidney to be allocated to whomever the center deems appropriate. Anonymity is often strongly encouraged, or absolutely required as is the case in Sweden.The evaluation process for NDD is lengthy, and designed to allow every possibility of withdrawing from the process. There has been trepidation surrounding these donors at first, as it is rare for a person to be willing to donate a kidney to a complete stranger. Many transplant programs went to great length to insure that donation decisions were no due to underlying psychological complications. In Sweden the guidelines follow the principles set in the US national conference report on non-directed donation. There is no active recruitment for non-directed donors following an initial telephone interview; the prospective donor receives an information package. After reading the information, the donor must actively re-initiate contact. All prospective donors are carefully evaluated by a multidisciplinary team consisting of: transplant surgeon, coordinator, nephrologists, social worker; and psychiatrist. Pending a
18 final approval the donor is given a three month cooling off period to reconsider .
Unregulated Organ Trade In Sweden, similar to the vast majority of countries, the sale of or trade in organs is illegal under law SFS 1995:831. The legislation prohibits ‘‘intentional gain-taking from delivering, receiving, or procuring biological material’’; violation of the law can carry a fine or a term of imprisonment .Despite this legislation and others like it in many developed countries there are booming organ black markets in some developing countries often using kidneys from poor vendor. Individuals who travel to the developing world to purchase a kidney for transplantation are not held to account, and return to their home country to receive post-operative care.
Kidney Scarcity Transplantation’s marked advantage and concurrent rise in the incidence of ESRD, has increased demand for kidney transplantation while rates of organ donation remain relatively stable . The prevalence of ends-stage renal disease in Europe is nearly 1,000 per million populations (PMP) . Of these patients only between 20 and 30 percent are accepted on to transplant waiting lists; consequently many others that could benefit are unable to undergo the lifesaving treatment. The council of the European Union has indicated that in order to decrease ‘‘both renal waiting patients and waiting times’’ an estimated 60 kidney transplantations PMP are needed. This is a number that many jurisdictions fall short of reaching. For example in 2007, the overall number of kidney transplantations PMP in Sweden was 41.34, Denmark 31.26 and Finland 32.78 .
The unremitting scarcity of kidneys has resulted in the implementation of various measures to narrow the gap between supply and demand. These include the use of marginal (lower quality) deceased donor kidneys; domino transplants (bringing together pairs of incompatible donor/recipient to find matches),the creation of organ procurement initiatives, lifting restrictions on living donation.
Despite the various sources of kidneys presented above and the innovative efforts made to bridge the gap between supply and demand the scarcity
19 persists, which means limits must be set regarding who can receive kidney transplantation as a scarce resource.
Resource Scarcity and Priority setting In the face of resource constraints, healthcare systems must set limits regarding the health interventions they provide. This is often referred to as health care rationing; where a beneficial treatment to a patient or group of patients is withheld or delayed as consequence of resource scarcity . Other terms which are often used synonymously are resources allocation, and limit setting. Priority setting is an umbrella concept used to refer both to rationing decisions as well as general decisions regarding the allocation and management of health resources that do not necessarily involve withholding resources. I will use priority setting in this wider context, referring to rationing as described above as well as in the general sense of heath resource management. Priority setting process and decisions exist at various two important levels: the clinical (micro) and policy (macro) levels.
Clinical level, also referred to as micro level, priority setting or bedside rationing occurs as its name indicates in the clinical setting. A distinction of clinical level priority setting is that it affects individual and identifiable patients, while policy level decisions effect patient groups (Tinghög, 2011). Clinical level priority setting can include things such as not ordering a particular screening test, or placing patients on the kidney transplant list.
Policy level, also referred to as macro level or system level, priority setting, takes place outside of the clinical setting (will however have an impact on clinical practice) and is often made by policy makers. Decisions can involve population groups (e.g. the elderly), patient groups (e.g. cancer patients) or disease categories. Macro level priorities could be informed by public opinion through mechanisms such citizens juries, . An example of macro level priority setting is whether a new cancer drug will be included in the national drug formulary. Decisions of how many bird flu inoculations will be purchased by the regional authority and defining vulnerable groups for priority to receive them is another example. Macro level priority setting often involve long-term strategic planning for managing health resources, a widely publicized example was the 2003 explicit limit setting efforts which took place in Östergötland county (Bäckman, Karlsson et al. 2006)
20 Approaches to priority setting With the advance of expensive medical technologies and the aging of the population a realization for the need to set limits in health care began to percolate in the late 80s. Since priority-setting decisions are linked to the need for providing health care within a finite set of resources, it involves difficult and potentially controversial decisions. When the discussion on priority setting appeared in the international arena in the late 80s and into the mid-90s there was no consensus on how these difficult decisions should be made in a fair and legitimate way. This in turn paved the way for a variety of international priority-setting initiatives . It is generally regarded that international priority setting efforts have thus far gone through two distinct phases since their inception.
The first phase is characterized by an appeal to sets of simple rules or principles which were trusted can easily lead to the appropriate priority setting outcomes. An often discussed example of this approach was the experience in the state of Oregon in the USA. Legislators explicitly prioritized interventions on a list based solely on cost effectiveness analysis (CEA). This list was then used to determine which interventions were included and excluded from Medicare coverage. The resultant list had some deficiencies; one often sighted example is that tooth capping was ranked with higher priority than appendectomy which is a lifesaving intervention. This naturally ran counter to rational intuition causing a great public outcry. In response to the outcry medical experts were called in and consultation were held with the public to rearrange items on the rankings list based on the patient populations effected, and other societal values . During this first phase other countries opted for different, yet still simplistic, solutions. Norway for example created a priority setting system based mostly on severity of conditions. Sweden on the other hand formulated a set of principles which were at the time envisaged as simple rules on which priority setting decisions could easily be determined. In Sweden this was the priority setting platform which contained three lexically ordered ethical principles
The principles which together make up the Swedish ethical platform for priority setting are presented below:
i) Human dignity: All individuals have equal value and rights irrespective of personal characteristics and position in society.
21 ii) Need and solidarity. Resources should be used in domains (or patients) where needs are considered to be greatest.
iii) Cost-effectiveness. Resources should be used in the most effective way without neglecting fundamental tasks concerning improving health and quality of life.
These principles represent the core values of the Swedish health care system, furthermore they are intended to guide decision making at all levels of the health care system.
Over the next few years there emerged a growing dissatisfaction with the simple rule approach stemming from a realization that priority setting decisions are inherently complex. Simple approaches such as using CEA, severity criterion, or wide ethical principles were not capable of capturing this complexity. Attention slowly shifted towards the process in which priority setting decisions are made. In Sweden for example while the ethical platform continues to play a central role, there is a growing recognition of the need to establish an explicit and open priority-setting process as a way of lending legitimacy to decision making1, i.e. Legitimacy both internally, among different healthcare and political decision makers as well as externally with the public (Garpenby 2004). It is during the second phase of international priority setting with increasing attention on the process, in which priorities are set, that the accountability for reasonableness procedural framework emerged as leading paradigm in priority setting discourse. The framework has been widely received to the point that it is touted as the priority setting paradigm for the National Institute for Health and Clinical Excellence in England, further highlighting the growing emphasis on priority setting processes.
Concepts and Theories
The concepts and theories which will be presented in this section are complex, and often have numerous variations and intricacies which are outside of the scope of thesis. The goal here is not to give an exhaustive description of each, since they can each by the subject of an independent thesis. My aim is to introduce the aspects of these concepts and theories which are relevant for contextualizing the findings and discussion which will follow. The concepts and theories presented either have a direct relationship to the way decisions 22 are made in priority setting, or they often arise within discussion on incentive based donation; in some cases they are relevant for both.
Concepts
Dignity Human dignity is a broad concept lending itself to diverse applications both in health care and beyond as often found in the political discourse of the EU and other international bodies. The notion which will be presented here is the formulation put forth by Nordenfelt which usefully and clearly explicates various varieties of dignity . Nordenfelt distinguishes between four varieties of human dignity. These are the dignities of merit, moral stature, identity, and finally a universal type of human dignity (MenschenwÜrde). The dignity of merit is attached to an individual’s social rank or position, for example that which is derived from one’s occupation. The dignity of moral stature is tied to an individual’s moral doings or thoughts. The dignity of identity is tied to our image of ourselves as autonomous persons with a history, future, and relationships with other persons. These first three varieties exist in different degrees and are not evenly distributed amongst individuals in society, and they are subject to change over time depending on shifts in one’s social position or actions. The final variety of human dignity as presented by Nordenfelt, MenschenwÜrde referring to a common and equal dignity based on human value and rights, is the conception of dignity which is most relevant within healthcare discourse. A basic dignity independent of personal characteristics and is the basis for equitable health care. Under this conception of dignity all individuals should have equal opportunity in getting their health needs meet i.e. patients should not be discriminated based on non-medical factors such as income, gender (), race and so on.
Autonomy There are at least two conceptions of autonomy that deserve mention here. The first conception holds that autonomy is:
“ The capacity to reflectively control and identify with one’s basic (first- order) desires or preferences though higher level (second order) desires or preferences”
This conception has been criticized as being too idealistic. The difficulty in distinguishing between first order and second order preferences makes it of 23 little practical use for the average person; for whom we need a workable conception of autonomy. A different conception is one which concentrates on the moral requirements necessary to facilitate “respect for autonomy”. In this conception autonomous choice is assessed on whether they are made 1) intentionally II) with understanding III) without controlling influences. While the first condition is not a matter of degrees, the second two conditions are. This makes the concept far more practical since requiring complete autonomy would render the majority of our choices invalid; since our choices are seldom free from outside influences, or made with complete understanding of every intricacy. The key is that one should achieve a substantial level of autonomy with intentionality, and sufficient degrees of: understanding and freedom from controlling influences; and not demand complete levels.
Coercion Coercion is a concept that is often discussed in conjunction with autonomy ( in the context of incentives and donation). It is with regards to the third condition of respect for autonomy above “without controlling influences” where coercion is invoked in the incentive debate. The argument being that incentives are so strong of a controlling influence to the degree that they infringe on freedom, rendering the decision of participating in an incentive based donation model non autonomous. It is thus important to take up the concept of coercion, and understand what is meant by it. Opinions differ regarding what constitutes coercion. The prevailing position within the contemporary accounts of coercion (Nozick1 969) holds that coercion must involve an external threat. This conception has however been challenged by the likes of Zimmerman (1981) and others who argue that offers can also be coercive. Offers are generally considered coercive if the person proposing the offer is also actively engaged in activities that hinder the coercee from reaching “a better state of bargaining” (Anderson 2006). There are also some who hold that an offer maybe coercive even if the coercer is not responsible for creating the undesirable (coercive) conditions. However this conception is better identified as exploitation as opposed to coercion. Here the argument is closely related to the disparity in power between the bargaining parties. The stronger party (with the offer) will take advantage of the pre-existing undesirable condition the weaker party is in (Anderson 2006).
Commodification In economic theory commodity is often defined as something which is produced and which can be sold, exchanged or given freely (Tinghög et al.
24 2011). Since the discussion regarding commodity concerns the human body, or parts of it, it is not something which is produced. However the remaining characteristics still hold. Organs are sold in many part of the world, they are routinely exchanged for love or friendship and they may be given away for free. If these characteristics already exist in organs in their present state there should be little concern that they will be considered a commodity. However the invocation of the commodification concept is often not for the commodification per se, it is often entangled with considerations of dignity. We will return to this relationship in the discussion.
Theories
When dealing with normative question of the nature that this thesis is concerned with there are two broad categories of moral theories which are of particular relevance: Consequentialist and deontological ethics. I will briefly explicate the meaning of each in this section and the relationship between the two.
The Consequentialist view holds that the morality of an action can only be assessed on the consequences (effects) it produces. Hence an action is morally good if produces a good outcome. While all consequentialists will prescribe to this general definition, differences do exist between them on how the “good” is defined. Some will define the good from the individual’s perspective as pleasure or happiness. Others view the Good form a pluralist perspective, and hold that how the good is distributed amongst members of the society is itself
25 part of the “good” (Sinnott-Armstrong 2008). There is also a distinction between act and rule consequentialism. Act consequentialism always judges the morality of an action purely on the consequences it produces in that particular circumstance. On the other had rule consequentialism holds that the moral action follows particular rules; which are selected in terms of the consequences they will bring about; these rules are not expendable in different circumstances even if it will lead to lower levels of the ‘good’ in a particular context.
The Deontological view holds that the morality of an action often can be assessed irrespective of its consequences. The assessment is based on duties or rights which take presence over the good (consequences). In this approach duties or rights should not be violated even if it brings about better consequences. (Alexander and Moore 2008) The most famous of the duty based theories is Kant’s theory of categorical imperative.
An often used thought experiment to illustrate the difference between the consequentialist and deontological positions is the trolley problem which goes something along the following line:
A runaway trolley is hurtling at full speed towards 5 people working on the train tracks. You happen to be working in a nearby watch tower, where there is switch you can press to change the direction of the train to an adjacent track where there is a lone worker on the track. You have the choice of sacrificing the one worker to save the 5 or simply do nothing and let the 5 die. What is the moral course of action in the scenario? The Utilitarian will hold that pressing the switch is the moral action as judged by the consequences in which more people’s lives will be saved. The deontological perspective will hold that the moral action is not to do so, since you must abide by the law of not taking a person’s life. Now consider a similar scenario, where there is no switch but in order to stop the train from killing the 5 you must obstruct the trains path with a heavy object; and you happen to be standing next to a large person whose weight is sufficient to stop the train if you push him over (you are too light so sacrificing yourself will not stop the train).
The majority of people often take a consequentialist approach in the first case, and will press the switch. In the second case the majority will not push the person over, this is while the consequences are exactly the same. The reason
26 why this difference exists is arguable (singer 2005). Whatever the underlying reason, the fact is that the majority take a deontological position in the second scenario (not use a person as a means to an end no matter how good the consequence). The strict consequentialist does not make a distinction between causing and letting things happen since the end result is the same. However even a consequentialist will find it troubling to push a person over, and may argue that acting by the rule of not causing harm precludes him from pushing the person over. The distinction of causing or letting happen is of clear relevance from a deontological perspective. This is why arguments such as the doctrine of double effect are invoked to work around difficult cases like pressing the switch; it may be argued that pressing the switch is done with the intention to save the 5 people and the 1 person dying is a secondary effect.
What is important to take from the moral dilemmas above is that both positions (consequentialist or deontological) if followed in the strict sense run counter to some significant intuitions in the different contexts. Not surprisingly we find that these two general approaches are often combined in real life practices. This is the case in health care, where combinations of theories are used to make decisions. It is often the case that policy level priority setting is dominated by consequentialist values; while deontological values have a stronger presence at the clinical level.
Theories of distributive fairness in health care
Maximization The maximization approach is concerned with maximizing the aggregated outcome in the domain of interest. In Health care, health is the domain of interest which should be maximized. Utilitarianism is one of the principal examples of the maximization view, in which the distribution of resources is fair if it contributes to maximizing the overall utility. While the utilitarian view is concerned with the aggregate maximization of utility it is possible within this conception to justify special consideration to those worst off. The reasoning being that the worst off will derive more utility from a particular resource than someone who is better off, in turn contributing to greater overall utility. Economic approaches such as cost effectiveness analysis (CEA) and quality added life years (QALY) are methods of formal analysis which play an increasing role in health care policy and decision making today. They are by
27 nature maximization based approaches in that the goals are the maximization of benefit.
Egalitarian Egalitarian theories generally hold that fair distribution is that which equalizes outcome in the domain of interest. With regards to health this will imply giving special attention to those who have lowest levels of health. The strict egalitarian view is concerned with how people will fare in relation to one another. The idea that everyone should receive an equal share of resources has been criticized on the grounds of what is known as the leveling down- objection; it is argued that equality resulting in an overall decrease in health is undesirable. (Temkin 1993 Nozik 1974). There are variations with the egalitarian theories. (some more examples)
Prioritrianism The Prioritrianism approach to fair distribution as its name suggests places a higher priority in allocating resources those worst off. The prioritarian view takes into consideration the potential for an individual to benefit from the resource being distributed. The understanding being that a person who is much worse off will benefit more from the same set of resources than a person who is better off. While this may seem similar to the special consideration utilitarians give to the worst off, the difference is that Prioritrianism places an inherent value on giving priority to the worst off regardless of the measured utility.
Communitarian Communitarian theories hold that fair distribution depends on the “community- derived standards”. These theories emphasize responsibilities, either those the community has to the individual or the individual’s responsibility to the community. The notion of solidarity is sometimes used in communitarian theories in place of justice. European societies espouse the language of solidarity in health care as demonstrated by priority setting experiences of Denmark, The Netherlands, and significantly Sweden.
A procedural alternative The above approaches have divergent moral and philosophical points of departure, with the potential of leading to disagreement on what constitutes fair distribution; as a result procedural approaches have been presented in recent years as an alternative. The basis being that disagreement in resource
28 distribution maybe resolved though fair process rather than relying on substantive principles alone. Procedures are argued to be important for three reasons: they promote better outcomes, have an inherent value in themselves, and finally they contribute to other important values such as legitimacy of the process or of the decision makers. (Dolan et al, 2007). The paradigm example for procedural approach in health care today is Daniels and Sabin, the accountability for reasonableness: the underlying rational for their procedural approach is captured by the authors as follows:
“In pluralist societies we are likely to find reasonable disagreement about principles that should govern priority setting. For example, some will want to give more priority to the worst off, some less; some will be willing to aggregate benefits in ways that others are not. In the absence of consensus on principles, a fair process allows us to agree on what is legitimate and fair.” (Daniels and Sabin)
The A4R has its roots in Rawlsian ideas of justice. It extends Rawls theory of justice as fairness to include health care as a primary good (alongside e.g. food, shelter, and basic political liberties) which should be distributed fairly. The principle of faire equality of opportunity (FEO) plays a central role in the A4R framework. Rawls (1971) original formulation of the (FEO) in his theory of justice was concerned with designing institutions (e.g. public schools) in order to correct for factors (e.g. gender, or, race) which lessen ones range of opportunities. The A4R extends this idea one step further and applies it to health care:
“We must think of disease and disability as creating additional obstacles that we have obligations to eliminate in order for us to have fair opportunities” (Daniels and Sabin)
The framework stipulates four conditions which contribute to fairness in priority setting processes: relevance publicity, appeals/revisions, and enforcement. While the last three conditions are rather self-explanatory, the relevance condition requires some further clarification. The relevance condition places “constraints on the types of criteria which can justify limit setting decisions in a fair process”. The type of constraints could best be understood through the central role of Rawls’ FEO principle within the
29 framework. Looked at in relation to the FEO, the relevance condition can be considered a ‘‘threshold test of justice’’. For example basing a patients access admission to the transplant list on their ethnicity, does not satisfy the FEO, and is in turn an irrelevant decision making factor. Amongst the constrained range of options which satisfy the FEO, conditions II-IV then ensure that there is a fair procedure to choose amongst them.
30 Main findings
Procedural Fairness in Priority Setting: Paper I & II
31 Paper I: Priority Setting in Kidney Transplantation in Sweden
Swedish transplant programs operate in an environment of chronic resource constraints in terms of kidneys required for transplantation. They in turn employ various methods to prioritize among potential recipients as a means of rationing the limited resources. This prioritization occurs by two means. One is by setting limits regarding who is permitted placement on the transplant waiting list. The second means of rationing is by creating criteria on how patient will be prioritized for receiving a kidney. Paper I investigated these two stages with significant impact on access to kidney transplantation: (1) assessment for transplant candidacy, and (2) allocation of deceased donor kidneys. Considering the decentralized nature of Swedish healthcare and in the absence of national guidelines either for assessing eligibility for transplantation or the allocation of kidneys, important questions arise regarding the fairness of the priority setting process determining access to transplantation. Fairness was investigated in reference to the A4R framework. To gather data interviews were carried out with 15 professionals from the transplant community: 7 transplant surgeons, 6 nephrologists, and 2 transplant coordinators. At least on surgeon from each of the transplant centers, and one nephrologist from each transplant region was included for representativeness.
Generally speaking each of the transplant centers are autonomous with regards to one another. They are responsible for the nephrology units within their region, providing them with the required information before patients are referred. The final decision lies with the transplant center. The centers differ regarding how decisions are made at both the assessment and allocation stages. Two centers make decisions regarding admission to the list in a gatekeeper meeting where decisions were made jointly. In the remaining centers the final decision was on the most part made by the surgeon responsible for the patient. However the decision was communicated with the rest of the department during daily rounds.
All centers allocate kidneys which become available in house. Unless there is a special match with a highly sensitized patient on the Scandiatransplant list, in which case the kidney would be sent away. The surgeon on duty, often in coordination with an immunologist makes the allocation decision. One center had a systemic approach to allocation on two levels. First by providing reasons why a kidney was allocated to one patient over another; secondly all allocation
32 decision were gather in a data base to track patterns to be used for assessing allocation procedures.
Decisions at both stages are based factors which belong to one of three levels: Patient, Professional, and institutional. For any given decision a cluster of factors across the levels are considered. The majority of factors are at the patient level. This is because whether transplantation as a treatment is indicated depends on multiple patient specific factors which can be clinical, life style, or quality of life based. Furthermore in the allocation stage the available organs are matched on multiple levels to an individual patient to bring about the best post-operative results. (The full list of factors can be found in table 1).
The decision making factors were further identified as appealing to one of three general values: maximizing benefit, priority to the worst off, equal treatment. Maximizing benefit is found in both stages (malignancies, age, HLA, age-matching), however it plays a greater role at the allocation stage. An example of giving priority to the worst off is illustrated by the consideration given to negative experiences with dialysis, where well-being is taken as a value input at the assessment stage. The clearest example of equal treatment is prioritization by waiting time (first come first served) as a an objective measure of deservedness.
The factors and the values in this paper on the most part satisfied the relevance condition of the A4R framework. However two particular factors with a potential to create unequal treatment were identified: clinical judgment and center specific policies. The well-established appeals mechanism in Sweden acted as an equalizer between divergent decision makers and differences between centers. However with no guarantee that a patient will seek a second opinion these sources of unequal treatment are problematic. The publicity of the range of factors and the values on which they rest is an area that needs improvement. The information available on hospital websites do not reflect the full range of factors identifies in this paper. Finally there were some examples of best practices in the area of enforcement. These were the gatekeeper meetings, and the system for rationalizing and reporting allocation decisions. These were however limited to some centers; enforcement on the national level is lacking.
33 Table 1. Overview of factors and values impacting on priority setting decisions in Swedish kidney transplantation
Patient level factors Cardiovascular status
Malignancies
Obesity
Overall fitness
Technical issues due to patient physiology
Age ( biological age in assessment, age matching in allocation)
Compliance-related issues (continued alcohol abuse, functioning social network)
Risk benefit ratio (well-being on dialysis and patient motivation)
Availability of living donor
Other medical indications (reason for kidney disease, co-morbidities, urological complications, , immunological status, virological.)
Blood group
HLA compatibility
Waiting time
Special priority for young patients
Need (rare situations)
Professional Level factors Clinical judgment
Risk aversion
Resource utilization (constraints)
Institutional level factors Institutional policies (marginal donor program)
Scandiatransplant kidney exchange obligation
Values Maximizing benefit
Priority to the worst off
Equal treatment
34 PAPER II: Priority Setting in the Assessment for Kidney Transplant Candidacy: A Canadian Case study
Resource scarcity is a challenge shared by transplant programs globally; this creates an opportunity for priority setting lessons by examining how other systems operate. Paper II investigated the priority setting process in the assessment for transplant candidacy at one of Canada largest transplant programs at the Toronto General Hospital (TGH) situated within The University Hospital Network. The aim was to evaluate the process in reference to the A4 R framework. Only the assessment for candidacy was evaluated because kidney allocation in Ontario, the province where the city of Toronto is situated, is done centrally by an independent body that manages a provincial transplant waiting list.
The study relied on three sources for data collection: semi structured interviews, process observation of weekly listing meetings, and review of relevant documents. Interviews were conducted with key members in the Kidney Transplant program: 4 nephrologist, 2 surgeons, and 1 transplant coordinator.
Priority setting decisions at the TGH are made in a group setting comprising twelve professionals. The group has a wide variety of ages and professional experiences ranging from a few years to over three decades of experience. A number of professions are represented including nephrologists, surgeons, nurses, socials workers, and immunologists; who are involved in clinical, academic, and research activities. Group census is sought for all decisions. If a consensus cannot be reached during a particular meeting the case is put aside and revisited when more information is available. This consensus building was viewed positively by all participants. It invites diverse perspectives into the decision making process bringing to light issues that one decision maker may miss on their own. This system allows the team to share the burden of decision making, which was particularly important for difficult cases. For these reasons the listing meeting contributes to the efficacy of the priority setting process and should be considered a best practice.
35 Listing decisions were based on cluster of factors. These factors as observed both during listing meetings, and elaborated on by decision makers reflected the factors in the Canadian consensus guidelines for the assessment for kidney transplantation, developed by the Canadian Society of Transplantation in 2005. The criteria outlined in the consensus guidelines have been agreed to be the relevant issues in the assessment for transplant candidacy across the nation. The guidelines cover a number of different areas each of which underwent a rigorous literature review by members of a guidelines committee to create treatment recommendations. The recommendations are rated according to the level of evidence. The experience with the guidelines was positive. They were reported to contribute to transparency of the factors on which decisions are based, as well as increase accountability.
The Canadian consensus guidelines for the assessment for transplant candidacy emerged as a best practice contributing to the fairness of the priority setting process, in reference to the A4R, on multiple levels. They ensure that factors which have been agreed as relevant are those which are used in decision making. Furthermore the ease of accessibility of these guidelines to both professionals and the general public helps to meet the publicity condition of the framework. Finally, the guidelines explicitly state the right to second opinions (appeals) to patients who have been denied admission to the list. In short the guidelines enforce all conditions of the framework. The practices at the TGH kidney transplant program met all conditions of the accountability for reasonableness framework.
36 Incentive based donation
Papers III & IV
37 Paper III: Compensated living kidney donation: a plea for pragmatism
The unremitting kidney scarcity has generated much discussion regarding financial incentives for organ donation. These discussions often concentrate on one of a number of aspects: medical, economic, ethical, or attitudes towards compensated donation. Paper III reconciles these interrelated topics which are often discussed separately, and provides a comprehensive discussion of compensated donation. The paper proposes the introduction of compensated living kidney donation a as policy to address the kidney shortage.
The details of the proposal are as follows:
I) Proposal is intended for countries with a national health care system, and an adequate welfare system which meets the basic needs of its citizens
II) National health agency will offer compensation to healthy volunteers to donate.
III) Compensation is non-negotiable: a set price to be calculated by the health care system
IV) Donations for full compensation are non-directed
V) Exhaustive medical, social and psychiatric evaluation
VI) Cooling off period before the donation takes place, to allow time to withdraw
After presenting the details of the proposal, the paper next examines the benefits which can be expected from a system of compensated donation; beginning with decreasing the black market trade. Creating a well regulated compensated system will help create organ self-sufficiency in developed countries curtailing their contribution to unregulated trade. Furthermore a compensated system can be expected to equalize opportunities for transplantation for two certain groups. First are people without the social 38 networks necessary for accessing potential living donors; also those who are unable to articulate their need well enough to find a living donor.
One of the primary advantages the paper raises is the decreasing dependence on dialysis. This has two particular benefits: cost savings, and increases in quality of life. The costs savings from transplantation is well documented. Matas and Schnitzler calculate the break even and cost effective (including QALY) payments for kidney donors which is indicator for the savings. These payments are 95,000 and 25,000 dollars respectively. It is also quite clear from the medical literature that transplantation offers a higher quality of life than dialysis. Evidence indicates that kidney transplantation increases survival compared with dialysis. Finally, living kidney transplants and pre-emptive transplants are correlated with improved graft life.
Can the proposal stand the ethics test? To answer this question the paper approaches four of the most frequently invoked objections to compensated donation: coercion, exploitation, commodification, and dignity. It is argued that in welfare state, where basic needs are guaranteed non one will be forced to donate to secure basic necessities which would indeed be coercive. Regarding exploitation, its argues that it is exploitive to demand that all donations be only based on pure altruism when we readily compensate other pro social behaviour in areas such as foster care. On the issue of commodification, it is clarified that he proposal does not allow people to buy or sell kidneys at varying rates, which would render kidneys into a commodity. This is a regulated system with a fixed compensation, and single purchaser. Finally since non compensated donation does not impede on dignity, there is little reason to believe that introducing compensation will make it undignified; however care must be taken to maintain the discourse on donation, whether compensated or not as a beneficent act.
In the final part, the paper refers to data from the US and The Netherlands to show that 25% and 28%, of adults in those countries respectively are in favour of compensation; drawing the conclusions that public support for such a program would be adequate enough that we can realistically eliminate the transplant waiting list if compensation is introduced.
39 Paper IV: Incentivising deceased organ donation: a Swedish Priority Setting Perspective
It is often reiterated during international transplantation and organ donation conferences that countries should strive to reach organ self-sufficiency; most recently expressed in the 2008 Istanbul declaration on organ trafficking and transplant tourism. It is also acknowledged that ‘‘Individual countries will need to study alternative, locally relevant models, considered ethical in their societies”. However papers which discuss organ donation from the perspective of the values of a particular health care system are scant. The aim of this paper was twofold; firstly to develop a proposal for compensated deceased organ donation based on a nuanced incentive scheme that could potentially bridge the gap in transplantation needs; Secondly to examine the compatibility of this proposal with the values of the Swedish healthcare system.
To achieve the first aim it was necessary to construct a proposal that would entice a significant proportion of the population. To do this, the literature on rational behaviour and incentive theory was consulted identifying three major sources of motivation for people to act pro socially: Extrinsic, Intrinsic, and signalling motivations. Extrinsic motivation is external to the individual, monetary rewards fall under this category. Intrinsic motivation is tied to the pleasure one derives from the activity itself, pure altruism fall under this category. Finally signalling motivation is tied to an individual’s concern with how they are regarded by others; an example here is the increase in donation to charity when such donations are publicised. Combining these sources of motivation a proposal was constructed that would have the widest appeal possible. The details of the proposal are as follows:
I) € 5,000 contribution to the estate or family of the deceased towards funeral expenses. II) Deceased (advanced directive) or family could decline the contribution in full. III) All or part of the €5,000 contribution could be directed as a publicized donation to a reputable charity of the deceased (if the will is known) or family’s choice. IV) In all circumstances the right to self-determination of the deceased must be respected; and the decision of the family cannot be in contradiction to the will of the deceased if it is explicitly stated. 40 Having constructed a workable proposal, the paper next evaluates its compatibility with the values of the Swedish health care system. This was done in reference to the lexically ordered principles of the Swedish priority setting ethical platform: Human dignity, needs and solidarity, and cost effectiveness. These principles represent the core values of Swedish health care, are intended to guide decision making at all level of the health care system. Any such policy must satisfy these principles to be considered seriously.
Through the discussion it is argued that successful incentive based organ donation model which results in an increase of deceased donor organs is more able to effectively meet the goal of the human dignity principle by equalizing opportunities for transplantation; it will remove non-medically relevant criteria, such as social capital as determinants to access to transplantation. Offering payment or incentives for donated organs does not defy the principle of needs and solidarity. Firstly, incentives can increase the amount of shared resources (a necessary element for practising solidarity). Secondly, it allows us to better distribute these resources according to needs, thus meeting the principle of need and solidarity With regards to the final principle of cost effectiveness the literature uniformly indicates that efforts to increase organ donation are highly desirable even at a high cost per additional donor. It has been indicated that an investment of roughly $1.3 million for each additional deceased donor would be considered cost effective making the modest contribution of €5000 readily satisfy the cost-effectiveness principle.
The paper draws attention to some possible concerns and objection which may arise which are related to coercion, commodification and loss of trust in the health care system. However these concerns can be controlled for with careful planning: Furthermore they are not strong enough to allow people, who can otherwise be saved, to die. In conclusion the proposal merits serious consideration.
41 DISCUSSION
Fair priority setting: principles and procedures
Talk about the factors and values and their relevance
Talk about fairness and how well it was achieved. Talk about differences between Swedish centers and impact on fairness
Talk about what can be learned from the comparison with Canada
Talk about the role of the guidelines and centralized allocation
Talk about experience of working with the A4R strengths and weaknesses…
A rather interesting comment made by one retired surgeon who had experience at a number of the centers was the idea of reducing the number of transplant programs form the current 4 to 2. The rational being that it would decrease variation, and concentrate expertise within two units. (difficult to dismantle programs, however talk about implications)
42 Incentive based donation: living and deceased donation
“Distress at making difficult choices through explicit decisions sometime leads society to modify its macro allocation policies….to increase the supply of a particular resource” (Beauchamp and Childress 2008)
The above quote captures the sentiment of advocates for incentive based donation. It is time for a new policy approach. Old way is no longer working.
The above is what happened with dialysis in the 60s. Many countries stopped rationing it and made it universally available for everyone. It was much simpler with dialysis… since it only involved increasing the budgets…. With transplantation it would cost less however introducing the macro level policy regarding incentives requires a bigger leap
Discuss coercion, commodification, and dignity in relation to incentives
Highlight the role of repugnance-
“ When we or our integral body parts are sold, our dignity as human beings is denied. ... Indeed, we feel so strongly that organs integral to human functioning have a certain dignity that we are reluctant to sell them even after we have died and no longer need them” 291-292
An important part of the discussion is that kidneys are a special case… different from other organs…
“ An international trade exists in cadaveric body parts for medical education and research and pharmaceutical companies purchase large quantities of tissue for commercial purposes. Other companies openly purchase and sell tissue” (Bellagio task force 1997)
This commercialization exists in all countries regarding deceased bodies… why is everyone making money off the donors’ bodies while they get nothing
43 The deceased donation paper is a unique contribution to the literature. It addresses a call which has been made repetitively by international bodies to investigate the local relevance of policies….. we did it with the ethical platform
Health promoting activities, perhaps vacations….. Many living donors are hesitant…. We could have small incentives
“ We give monetary rewards to outstanding citizens for noteworthy accomplishments. We offer monetary incentives to those who can contribute information leading to the arrest of criminals. We give monetary rewards to outstanding and dedicated teachers. We also give special monetary benefits to family members left behind by soldiers killed in battle. It does not usually cross our minds that the giving or acceptance of the reward may commodity the recipient or diminish the value of his or her contribution to society”
Preference to go with incentive based deceased donation to measure impact before considering living donation
Methodological discussion
44 There are some methodological issues that need to be addressed and discussed. In Paper I Interviews and literature were the primary sources of data. It would have been beneficial to carry out participant observation within the centers to create a richer data set. The reason this was not done is because I as the primary researcher did not have sufficient knowledge of the Swedish language, precluding me from carrying out observation. In retrospect, it would have been worthwhile to include someone in the study who would have been able to carry out such observation. However one of the authors of the paper is a veteran transplant personnel who has been in the field for almost two decades who has also carried out research related to the topic. She was able to validate that the data and analysis of the process did reflect practices within the field. The shortcoming was addressed in the Toronto study, where I did observe actual decision making over a number of months.
Furthermore both papers I and II evaluated the process using data gathered form professionals in the field. It should be highlighted that the ESRD population as the primary stakeholders have an important perspective. Within a thesis project there is a limit to the amount of perspectives you can include, and the perspective I chose is the professional perspective. Future research should however investigate perceptions of fairness amongst the ESRD population, both patient which have been accepted and other who have been denied transplantation. With regards to generalizability of the results: The studies reflect only two particular contexts (Sweden) and a Canadian case study. Transplant programs are organized differently in different countries and differently even within the same country (as illustrated by the Swedish study). However the results clearly indicated that similar issues are considered across centers even if they are in different countries. Hence the papers should have relevance to a wide range of transplant programs, and even other fields which face the challenge of allocating scarce health resources.
Finally with regards to papers III and IV. The success of the proposals presented in the papers depends in large part on public, professional, and political acceptance. This is a perspective that has not been pursued which would help to further shape the discussion. Once again there are limits to how many studies can be carries out with on thesis. Having said that, information regarding attitudes towards incentive based donation amongst the general public, medical professionals, and the political strata in Sweden would be a fruitful direction for suture research.
45 POLICY IMPLICATIONS AND CONCLUSIONS
American politics have (ironically) in recent years popularized the role of the Czar (spelled Tsar in Europe). For example George Bush had 34 Czars, while President Obama has appointed 37 who are responsible for areas as wide as, education, drug enforcement, and energy. It has also been common to appoint Czars for particular public health problems, for example there are Czars for health reform, bird flu, and Aids. The mission of the Czar is to take a leading role by synthesizing information and formulating a way forward regarding complex problems.
In the spirit of the Czar’s newly (re)gained powers I will write the policy implication of this thesis from the perspective of a (self-appointed) kidney transplantation Czar; who’s role is to take a comprehensive look at the state of kidney transplantation as a field and address the clinical and policy levels challenges it is facing. This overall perspective mirrors the approach to this thesis which has examined short term issues regarding fair allocation and long terms issues regarding increasing the kidney supply.
The following are policy implication and conclusions which might be derived from thesis in reference to the challenges in kidney transplantation
Begin a dialogue within transplant community in Sweden regarding national consensus guidelines…
Further study benefits of centralized allocation of kidneys… weighing the trade-off between flexibility on the one hand and fairness on the other
Initiate procedures which facilitate knowledge transfer regarding best practices between centres in Sweden
Study perception of fairness in kidney transplantation from other stakeholder perspectives; patient organizations, as well as actual patients
46 Carry out public attitude surveys on incentive based deceased donation
Study the possibility of launching a 5 year pilot study for incentives based deceased organ donation. During this 5 year period a special task force will be responsible for collecting comprehensive sets of data; tracking import issues such as which alternatives are most widely chosen by the public. Conduct follow- up interviews with the family of the deceased to elucidate their experiences and how they feel 6 months and 1 year post their loved ones donation.
47 ACKNOWLEDGEMENTS
I have been fortunate to be affiliated with two departments which support and embody the ethos of interdisciplinary research. I have for the duration of my research befitted immensely from the research environments at the division of health and society and the National centre for priority setting in health care.
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48 References
REFERENCES
Zimmerman, David (1981). “Coercive Wage Offers.” Philosophy and Public Affairs 10: 121-145.
Feinberg, Joel (1986). Harm to Self. (New York: Oxford University Press): especially chs. 23-24.
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