Ethical and Legal Aspects of Kidney Donation





Acknowledgments


The authors wish to thank Leonie Lopp, Gert van Dijk, Medard Hilhorst, and the ELPAT Working Group on Living Organ Donation (led by Annette Lennerling and Frank Dor) for allowing us to use and refer to their materials.




Definitions





  • Altruism : A moral act intended to promote the happiness of others



  • Biomedicine Convention : Legally binding treaty, drafted by the Council of Europe for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine



  • Black market of organs : Illegal market that coexists to meet the demand that altruistic systems fail to fulfill



  • Conditional donation : When a donor organ is offered to a specific class of recipient



  • Hippocratic oath : Requires doctors to do what they consider beneficial for their patients and to “abstain from whatever is deleterious and mischievous”



  • Home-based education programs : Patient and family education on transplantation and donation in the patient’s own environment



  • Informed consent : Medical doctors provide a patient with all relevant information about a proposed procedure or treatment before obtaining the consent of the patient to carry out the procedure. This ensures that the autonomy of the individual is respected



  • Justice : Requires a fair opportunity for everyone in need of an organ transplant



  • Monopsonistic market : A regulated market of organ sales confined to a self-governing geopolitical area such as a nation state or the European Union



  • Organ trafficking : The recruitment, transport, transfer, harboring, or receipt of living or deceased persons or their organs by means of the threat or use of force or other forms of coercion, of abduction, of fraud, of deception, of the abuse of power or of a position of vulnerability, or of the giving to, or the receiving by, a third party of payments or benefits to achieve the transfer of control over the potential donor, for the purpose of exploitation by the removal of organs for transplantation



  • Paternalism : Neglecting a competent person’s will or even acting against it



  • Preemptive transplantation : Transplantation that takes place before commencement of dialysis



  • Principle of nonmaleficence : This principle stems from the Latin phrase primum non nocere, which means “first (or above all) do no harm”



  • Specified direct donation : When a person donates directly to his or her intended recipient



  • Specified indirect donation : When a person donates indirectly to his or her intended recipient or donates to a specified recipient through an exchange program



  • Subsidiarity : Removal of organs or tissue from a living person may be carried out where there is no suitable organ or tissue available from a deceased person



  • Transplant commercialism : A policy or practice in which an organ is treated as a commodity, including by being bought or sold or used for material gain



  • Transplant tourism : Travel for transplantation that involves organ trafficking and/or transplant commercialism or if the resources (organs, professionals, and transplant centers) devoted to providing transplants to patients from outside a country undermine the country’s ability to provide transplant services for its own population



  • Travel for transplantation : The movement of organs, donors, recipients or transplant professionals across jurisdictional borders for transplantation purposes



  • Unspecified donation : Donation to an anonymous and unspecified recipient such as donation to the waitlist or to the recipient of an exchange couple in the case of domino-paired exchange



  • Utility : Each organ should be transplanted into a recipient in whom it will survive the longest



  • Volenti non fit iniuria : When the person concerned consents, no injury is done



  • World Health Organization (WHO) : The United Nations specialized agency that coordinates international public health





Introduction


In organ transplantation an increasing amount of emphasis is given to ethical and legal aspects. The main reason for this is, of course, the increasing organ scarcity. The range of ethical and legal considerations in relation to organ donation that is focused on in scholarly literature is considerable. This chapter aims to provide a snapshot of important ethical and legal principles that arise in contemporary, everyday medical practice concerning both deceased and living organ donation (LOD) and transplantation. The focus will primarily be on kidneys. This chapter presents ethical and legal considerations that arise in: (1) deceased donor organ allocation, (2) the expansion and encouragement of living kidney donation (LKD), and (3) commercialization of organs.




Deceased Donor Organ Allocation


In general, three key principles govern the allocation of deceased donor organs :



  • 1.

    Impartial equitable allocation according to the principles of justice and equity


  • 2.

    The requirement of informed consent


  • 3.

    The absence of conditionality



Each principle is addressed in the following sections.


Justice Versus Utility


Perhaps the greatest challenge faced by transplant professionals is how, and according to what criteria, organs should be allocated. A range of options exists when considering the distribution of scarce resources. These include distribution on the basis of social worth or merit, according to the ability to pay, by queue (first come, first served), by lottery (chance), and by maximum benefit (greatest good to the greatest number). The last method is considered most appropriate by the international transplant community.


However, maximizing the benefit of this scarce resource raises ethical issues about the utility of transplantation versus equitable access. The utilitarian argument proclaims that each organ should be transplanted into a recipient in whom it will survive the longest (optimal benefit from each organ). The principle of equity or justice requires a fair opportunity for everyone in need of an organ transplant.


Which of the two is the better way to allocate organs? According to Courtney and Maxwell, transplant doctors must always find a compromise between both potentially conflicting ethical principles. Veatch argues that the conflict between both principles is inevitable. To resolve the conflict, one must be aware of the problems caused by each principle.


Problems Caused by Utility


Organ allocation networks were, for a long time, driven by utilitarian considerations. The US United Network for Organ Sharing, for instance, used to allocate livers in a way it believed would produce the most benefit. That meant giving livers to healthier and local patients first. Giving organs to those who were sickest was not favored, because it meant decreased survival rates. It was believed that local allocation would encourage more people to donate. Local priority also meant shorter cold ischemia times and better graft and patient survival rates.


The same considerations were applied to kidney allocation. In the 1980s transplant doctors gave priority to recipients who had the best human leukocyte antigen (HLA) antigen match. The problem was that allocating on the basis of HLA-matching criteria might have favored more healthy patients at the expense of sicker patients. Allocating organs on the basis of utility only excludes patients that have an older age, are diabetic or obese, or carry other comorbidities. Maximizing medical utility also requires relying on social data to identify groups that do better statistically, regarding, for instance, race, income, and gender. Defenders of the principle of justice or equity thus began to claim that allocating on the basis of utility was unfair.


Problems Caused by Justice or Equity


In the 21st century more allocation policies arose that were based on justice. Justice is considered synonymous with the concept of equity and is associated with the idea of equal treatment or nondiscrimination.


The problem with justice as a criterion, however, is that it is not exactly clear what is meant by justice . One interpretation is to allocate organs to those on the waitlist who are the “worst off.” But what is meant by saying that justice requires giving priority to the worst-off patients? Similarly to those who endorse utility, a group could be selected who are socially worst off, but may not have a serious medical disease. And even if we do focus on those who are medically worst off, it still remains unclear which candidates on the waitlist should be labeled worst off. The Model for End-Stage Liver Disease formula, to allocate liver grafts, implies that the worst off are those in most urgent need and who will die the soonest. However, one could also argue that the organs should go to the person with the most severe complaints, even if he or she is not predicted to die very soon.


Who Decides Between Justice and Utility?


Who decides what the morally acceptable method of allocation is?


Most countries have no explicit legal provisions governing the manner of organ allocation. Most laws state or imply that the allocation criteria should be medical only, thus leaving the question open on what ethical criterion the allocation should be based.


The Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (1996) (Biomedicine Convention) states that “Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality” (Article 3). This is proclaimed in accordance with the purpose of the Convention (Article 1) that states that the treatment of persons shall be “without discrimination.”


The Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin states that “Parties shall guarantee that a system exists to provide equitable access to transplantation services for patients … organs and, where appropriate, tissues shall be allocated only among patients on an official waiting list, in conformity with transparent, objective and duly justified rules according to medical criteria.” The World Health Organization (WHO) states that “in the light of the principles of distributive justice and equity, donated organs should be made available to patients on the basis of medical need and not on the basis of financial or other considerations.”


The aforementioned provisions illustrate the legal intention that access and allocation cannot rely on nonmedical factors. But these laws do not answer the question of who is allowed to “pick and choose” between utility and justice.


Transplant professionals, driven by the Hippocratic oath to do as much good as possible for the patient, commonly tend to lean toward the efficiency side of the calculus (local allocation). The general public, philosophers, and lawyers lean toward justice (national or regional allocation). During a debate about the issue between doctors and nondoctors in 1992, a political compromise was made wherein justice and utility were considered to count equally in organ allocation.


David Price has stated that these principles are not necessarily in conflict. Both are possible criteria for allocating organs. Veatch says that balancing the competing claims is a process for public debate “by the entire moral community.”


Allocation of Marginal Donors


Extended Donor Criteria


Because of the increasing organ scarcity, an increasing number of organs are now donated that would have been considered unsuitable for transplantation 20 years ago. This includes, for example, organs from donors older than age 70 years, from nonheart-beating donors, from donors with hypertension or diabetes, and organs that suffered a long cold ischemia time. The clinical outcome of a proportion of these transplants is poorer than that of donor organs of better quality.


Informed Consent


Based on the informed consent doctrine, potential recipients need to be informed of a possible poorer outcome. However, they should also be made aware of what might happen if they are not transplanted. Informed consent means that “medical doctors provide a patient with all relevant information about a proposed procedure or treatment prior to obtaining the consent of the patient to carry out the procedure.”


This doctrine aims to promote individual autonomy, respect human dignity, and avoid deceit and coercion. Although legal standards of disclosure differ between countries, these principles apply to all Western legal systems.


Allocation of marginal donor organs raises questions of justice and utility: Who should receive them? From a utilitarian perspective, patients who are not expected to be appropriate recipients will likely be disadvantaged. Consistent application of this principle would violate the principle of equal respect and the principle that the person in greatest need has special claims to be helped. This applies, for instance, to the concept of age. Age is taken as evidence that the duration of the benefit of the intervention will be shorter. To place older donor kidneys in older patients is common practice in the US. In Europe this practice has been implemented in the Eurotransplant Senior Program.


Absence of Conditionality


The third principle that governs the allocation of deceased donor organs is the absence of conditionality. For instance, the UK Department of Health states that “it is a fundamental principle of the UK donation program, that organs are freely and unconditionally given. It is therefore not acceptable, to attach any conditions to the donation of organs, other than by specifying the organ/s for which consent/authorisation has been given.”


Thus although an individual is the only person who is entitled to consent to donation of his or her organs, the moment they are donated and enter the stage of allocation, principles of fairness and equity govern distribution and not the authority of the individual donor.


Conditional donation challenges these principles. Conditional donation is when a donor organ is offered to a specific class of recipient. Directed donation (further discussed later), when a donor organ is directed toward a specific person, also challenges the principles of fairness and equity. Both forms of donation are considered unacceptable based on current allocation regimes.


Yet one can think of scenarios that may render directed donation acceptable. Take the example of a planned living donation procedure that is underway in accordance with legal and medical requirements. Before the procedure, the potential living donor suddenly dies and becomes a deceased organ donor. At a workshop held during the Ethical, Legal, and Psychosocial Aspects of Organ Transplantation (ELPAT) conference, the majority of participants claimed that such deceased directed donation should be allowed. However, most agreed that others in urgent clinical need should not be harmed by the request for the organ by the designated recipient.




Expansion and Encouragement of Living Kidney Donation


New Donor–Recipient Relationships


Because of the shortage of deceased donor kidneys, LKD has become the most important alternative to fulfill the need of the increasing amount of patients with end-stage renal disease in need of transplantation.


World Health Organization


In 1991 the WHO, which is the United Nations’ (UN) specialized agency that coordinates international public health, drew up guiding principles on human organ transplantation. The aim of the guiding principles was to provide “an orderly, ethical and acceptable framework for regulation of the acquisition and transplantation of human organs.” Principle 3 stated that organs for transplantation “should be removed preferably from the bodies of deceased persons.” Adult living persons “may donate organs, but in general should be genetically related to the recipient.” Thus for many years living donation was commonly restricted to genetically related adults.


Expansion of the Donor Pool


However, because of the organ scarcity, strong advancements in transplant technology, and excellent results in LKD, the donor pool has expanded over the past 3 decades from genetically related donors to spouses, friends, acquaintances, and even anonymous donors. The need to expand the living donor pool has been recognized by transplant professionals and international organizations worldwide. By 2010, genetically unrelated donors accounted for 2990/6277 (48%) of LKD in the United States, 574/1262 (45%) in the Eurotransplant area, and 246/473 (52%) in the Netherlands. In 2008 the WHO updated its guiding principles. Principle 3 now states, “living donors should be genetically, legally or emotionally related to their recipients.”


Spouses, friends, acquaintances, and other nongenetically related donors are often referred to as “unrelated” donors, to distinguish them from genetically related donors. Yet many of these genetically unrelated donors have an emotional relationship with their recipient. The use of the term “unrelated” thus seems inappropriate. The introduction of new schemes, such as paired exchange programs, have contributed to the complexity of donor–recipient relationships.


Ethical, Legal, and Psychosocial Aspects of Organ Transplantation


For this reason, a working group of the European platform on ELPAT developed a new classification for LOD. The group distinguishes between specified and unspecified donation. Specified donation, in turn, can consist of direct and indirect donation through an exchange program. This classification is presented in Table 41.1 .



Table 41.1

New Ethical, Legal, and Psychosocial Aspects of Organ Transplantation (ELPAT) Classification for Living Organ Donation

From Dor F, Massey E, Frunza M, et al. New classification of ELPAT for living organ donation. Transplantation 2011;91:935–8.



























Specified Donation
Direct Donation
When a person donates directly to his or her intended recipient
Donation to genetically and emotionally related recipient (e.g., to one’s child, parent, or sibling)
Donation to genetically unrelated but emotionally related recipient (e.g., to one’s spouse, friend, or acquaintance)
Donation to genetically related but emotionally unrelated recipient (e.g., to an estranged child, parent, or sibling)
Donation to genetically and emotionally unrelated recipient, but the recipient (or the group to which he/she should belong) is specified (e.g., to persons younger than 18 years or a specific person in need of a transplantation who was interviewed by the media)
Indirect Donation
When a person donates indirectly to his or her intended recipient
Donation to a specified recipient through an exchange program
Unspecified Donation
Donation to an anonymous and unspecified recipient (e.g., donation to the waiting list or to the recipient of an exchange couple in the case of domino-paired exchange)


Alternative Living Donation Programs


Examples of successful alternative living donation programs are national kidney-exchange programs, ABO-incompatible programs, desensitization in HLA-incompatible recipients, and domino-paired anonymous donation. National kidney exchange enables incompatible couples to donate and receive a kidney indirectly through exchange with another incompatible couple. This is also referred to as indirect specified donation (see Table 41.1 ). ABO-incompatible programs make it possible to transplant patients despite ABO incompatibility when, after adequate immunoabsorbent and immunomodulating treatment, an adequate decrease in anti-ABO titer can be realized. Desensitization involves the use of preconditioning, either with high-dose intravenous immune globulin or with plasmapheresis plus low-dose intravenous immune globulin to enable transplantation across HLA barriers. In a domino-paired anonymous donation, the anonymous donor donates to the recipient of an incompatible couple, and the potential donor of this couple donates to a patient on the waitlist (domino donor). This is referred to as unspecified donation (see Table 41.1 ).


The contribution of exchange programs to the overall number of LKDs has been significant. In the Netherlands, for example, by 2010 almost 30% of LKDs were performed through alternative living donation programs.


The Welfare and Protection of The Live Donor


The Principle of Nonmaleficence


The expansion of specified and unspecified LKD raises ethical and legal considerations. One of the most frequently mentioned considerations is that LOD violates the principle of nonmaleficence. This principle stems from the Latin phrase, primum non nocere, which means “first (or above all) do no harm.” The origins of this phrase are unknown. It is not a literal translation of any part of the Hippocratic oath, which requires doctors to do what they consider beneficial for their patients and to “abstain from whatever is deleterious and mischievous.” The oath does not mention anything about “first (or above all) do no harm.”


The Hippocratic oath, although a prominent principle in medical practice, is not absolute. It is a prima facie obligation—one that can be overridden if there are compelling counterobligations. Indeed, many medical procedures cause harm even as they benefit the patient.


Risks Versus Benefits


In LOD, the health of one individual is put at risk to benefit another. The justification for LOD, especially LKD, thus lies in the expectance that the benefits outweigh the harms. Thus if the benefits to the donor (psychological and moral) outweigh the risks to the donor (physical and possibly psychological), then LOD is morally permissible. Therefore arguments given against LOD on the claim that it violates the physician’s responsibility to do no harm are not convincing.


Donor Risks in Living Kidney Donation


The foregoing implies a need to understand the physical and psychological risks for the donor. The protection of live donors from these possible harms is emphasized in various national and international (legal) rules and regulations. The EU Directive on standards of quality and safety of human organs intended for transplantation states that “the highest possible protection of living donors should be ensured.” The WHO underpins that “live donations are acceptable when the donor’s informed and voluntary consent is obtained, when professional care of donors is ensured and follow-up is well organized.”


Even though LKD transplantation has acquired an outstanding record worldwide, LKD involves risks, including morbidity and mortality, for the live donor. Nevertheless, these risks are very low. The risk of death is cited as 1 in 3000 (0.03%), and the risk of postoperative morbidity is 2% to 4%. It is conceivable that the more widespread use of laparoscopic nephrectomy techniques will decrease morbidity in the coming years.


Psychological harms of the donor may involve coercion. Arguably, there is always coercion in LKD, especially when the person suffering is a loved one. Pressure may be put on people to donate, leading those who are reluctant to do so to feel coerced.


Elliott has argued that, to minimize the likelihood of coercion or other psychological harms of the live donor, LKD should be restricted to relatives. This belief is shared by Glannon, who also states that the risk in nephrectomy is justified because of shared emotions among family members, but that these factors are lacking when the donor is not a relative. The argument here is that the suffering of another person is perceived to be felt more intensely if the person concerned is a relative. If, for example, a mother offers to donate her organ to her daughter, her explanation that her donation occurs for the sake of her child will be deemed sufficient. In contrast, if an altruistic or Samaritan donor offers to donate his or her organ to a stranger, the motivation is often not well understood. Furthermore, these donors do not have the opportunity to witness and enjoy the benefits from the donation. Hence, it is perceived to be more acceptable to benefit from the donor’s selflessness when he or she is a relative rather than a stranger.


Coercion also may arise as a result of the expansion of alternative living donation programs. With the increased reliance on exchange programs, for example, comes the increased number of potential suitable organ donors. In the past, when a person became reluctant to donate, transplant doctors were willing to identify a plausible medical excuse, so that the person could “bow out gracefully.” In alternative LKD programs the possibility of a medical excuse for unwilling donors no longer exists. In a study performed by Kranenburg et al. among 48 donors and recipients, the question was asked whether they felt additional pressure or coercion into donating within the exchange donation program. All but two responded that this was not the case.


Legal Restrictions in Europe


The possible physical and psychological risks underlie the justifications given for restrictions in law regarding donor–recipient relationships. In Estonia, for instance, LOD is allowed only for the benefit of the donor’s descendant, spouse, cohabitee, parent, or grandparent. In the Czech Republic, Finland, Germany, Hungary, Italy, Poland, and Sweden, in addition to the listed relationships, additional donor–recipient relationships are possible because of an open clause. Denmark, the Netherlands, and Switzerland, by contrast, do not have any regulations addressing whether donor and recipient have to be related, or whether any specific procedure must be followed.


National kidney exchange problems are legal in the countries that do not require a defined donor–recipient relationship (Belgium, Denmark, Latvia, the Netherlands, Portugal, Scotland, Spain, Switzerland, and the United Kingdom). In contrast, in Germany, Bulgaria, Estonia, Finland, Hungary, and Lithuania, cross-over LOD is illegal.


Indeed, the differences in these national legal regulations are reflected in the wide disparity in numbers of LKD across Europe.


Equal Donor Risks in Direct, Indirect, and Unspecified Living Organ Donation


Lopp, Hilhorst et al., and others argue that none of the arguments used to justify restrictions in donor–recipient relationships (based on possible harm inflicted on the donor) are convincing.


First of all they point out that the donor’s risks are equally high in direct, indirect, and unspecified LOD. Practice and research show that there is no important difference between specified and unspecified LKD in terms of motivations and outcomes. Motivations and reasons to donate to strangers, for instance, are found to be equally understandable as donations to relatives. Medical evaluations of unspecified donors have shown these donors to be truly generous and selfless.


In fact, when comparing the donation to benefit a stranger with the donation to benefit a relative, the unspecified donation could be regarded as the highest expression of altruism. Indeed, altruism may “receive its highest expression in the absence of personal relationships.” The special relationship between a donor and recipient, according to Hilhorst et al., is “not the morally relevant key feature that provides a justification for LKD.” Both specified and unspecified donation, Lopp argues, should be treated equally.


Donor Autonomy


The same authors claim that these restrictions violate the donor’s right to autonomy. When donors voluntarily decide to take part in the surgery, they exercise their right of autonomy and thus cannot be considered to be harmed. This argument is also referred to as the volenti non fit iniuria principle. This principle means that, when the person concerned consents, no injury is done.


The concept of informed consent is closely related to the right of autonomy. Informed consent ensures that the autonomy of the individual is respected. Deception and coercion are mitigated by consent procedures, which is why such procedures have become standard requirements in most countries. Reasons to refuse the donation that refer to the donor’s best interests can be called paternalistic, that is, “neglecting a competent person’s will or even acting against it.”


The principle of autonomy is applicable to all donors, be they specified or unspecified. From this perspective it has been argued that, if a competent adult wants to act altruistically and offers to donate his or her organ to a stranger unconditionally, and the adult understands the risks and benefits of the procedure, and gives informed consent to the procurement, then his or her wishes should be respected.


Besides moral arguments to support organ donation by indirect or unspecified donors, there is also a pragmatic reason. Indeed, as illustrated previously, there is increasing support for unspecified and indirect donation to relieve the ever-increasing demand for organs.


Subsidiarity


Considering the excellent results in LKD, some transplant professionals have raised the question whether “health care professionals should encourage LKD.” This question touches on the question whether LKD should be “subsidiary” to deceased donation.


The Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin (Article 9) declares that “Removal of organs or tissue from a living person may be carried out … where there is no suitable organ or tissue available from a deceased person.” Many countries, such as Austria, the Czech Republic, Estonia, Finland, Germany, Hungary, Lithuania, Moldova, Portugal, and Slovakia, follow this proclamation and prohibit the performance of LOD when an organ from a deceased person is available.


Other countries, such as Italy, Latvia, the Netherlands, Norway, Poland, Scotland, Slovenia, Spain, Sweden, Switzerland, and the United Kingdom, do not regulate the relationship between LOD and postmortem donation. In these countries both deceased and living donation are considered equal.


Encouraging Live Kidney Donation


Hilhorst et al. write that good medical and ethical reasons exist to promote the many options of LKD. The advantages of LKD over cadaveric donation are manifold: LKD helps patients circumvent the waitlist and relieves them of the burden of dialysis. Furthermore, the kidney survival rates for living kidneys are significantly better (50% still functioning after 20 years; for postmortem organs this is only 10 years). Many patients prefer living to cadaveric donation. Transplant care professionals may therefore feel an obligation to bring these facts to the attention of patients and their relatives.


Cronin argues that, given the low risks for the donor, it is not unethical for doctors to encourage healthy adults to donate their kidneys, even to strangers. Demonstrating that such encouragement is unethical requires a powerful argument against it.


Home-Based Education Programs


There are a number of approaches to patient and family education on living donation. One is the “Norwegian approach,” where the doctor discusses potential living donors with the patient and then personally contacts these individuals and invites them for evaluation. Another approach (done in the United States) is home-based, where a psychologist gives transplant education to the (pre)dialysis patient and family and friends in the patient’s home. This program has proved successful in increasing knowledge and willingness to communicate about living donation and in decreasing living donor transplant concerns.


The home-based program by Massey et al. (the Netherlands) is similar to the US “house call” but offers the educational meeting earlier in the clinical course to include the option of preemptive transplantation. Preemptive transplantation, that takes place before commencement of dialysis, offers optimal graft and patient survival compared with transplantation after dialysis. Massey et al. state that the “interference in people’s lives” is justified if a number of criteria are fulfilled. The criteria that they propose include that the patient decides whom to invite, the invitees have the right to withdraw at any point, and confidentiality should be maintained at all times.


In the foregoing section, we addressed the ethical and legal issues that arise in expanding LKD. The following section focuses on the various considerations that arise in the debate on the commercialization of organs.

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Dec 26, 2019 | Posted by in NEPHROLOGY | Comments Off on Ethical and Legal Aspects of Kidney Donation

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