American Journal of Law & Medicine

Legal & ethical safeguards: protection of society's most vulnerable participants in a commercialized organ transplantation system.

INTRODUCTION

Legal and ethical questions regarding existing organ transplant procurement policies and practices are numerous and unsettling. They arise because transplantable organs are scarce. The scarcity of such organs has been the hue and cry of several medical and legal scholars.(1) For example, the scarcity creates competition among those who wait, necessitating equitable organ allocation procedures and guidelines.(2) Medical obstacles surround the determination of when, how, and on whom such procedures can be performed successfully. Other obstacles range from finding a suitable donor for proper "matching" with the intended donee, to the time constraints involved in preserving excised organs until transplantation, to the donee's ability to fight off rejection of transplanted organs.(3) There is also the obstacle of locating available organs. As medical technology continues to advance, the number of possible organ sources increases. Currently, these sources have included live human donors, cadavers, mechanical devices, animals, fetuses, anencephalic infants, and "brain-dead" donors.

Each of these organ donor sources generates legal and ethical issues. One of the most controversial is whether medical personnel improperly subject brain-dead donors to a prolonged death-like existence until potential donees can be located.(4) Additionally, with respect to euthanasia and the "right to die," some fear that the value of life of the brain-dead may diminish so as to create prey for organ-hungry opportunists should society eventually reach the bottom of the slippery slope.(5)

The scarcity of human organs for transplant purposes leads the debate in the organ transplant industry. Some argue that the current voluntary system has failed and have proposed several alternate systems. The proposals include the enactment of a presumed consent or compulsory organ donation system,(6) and the partial or full commercialization of human organs and body parts for transplantation purposes.(7)

This Article will discuss ethical implications which must be addressed if a commercial organ transplant system becomes legal. Safeguards must be developed to protect society's most vulnerable individuals who participate as transferors in a legalized commercial organ market.

Part I of this Article provides an overview of medical advancements in the organ transplant field that have created current legal and ethical controversies. It also forecasts the impact that such current controversies might have on a legalized commercial organ system. Part II focuses on regulating the organ transplant industry. This includes an overview of the proposed compulsory and commercial organ transplant systems and the existing organ donation system. Part III provides a more detailed discussion of the three major commercial systems which have been proposed to replace the current system. Finally, Part IV proposes legal safeguards for vulnerable transferors who participate in a legalized commercial market in human organs.

I. THE ORGAN TRANSPLANT INDUSTRY

Scientists who have fought to successfully transplant human tissue have faced three major threshold obstacles. The first is the medical technology required to perform the basic operation.(8) The second is preserving extracted organs long enough to allow a successful transplant.(9) The third is warding off threatening infections in the donee caused by the presence of foreign tissue.(10)

Medical advancements in these three areas have continued to provide options in the field of organ transplants. Scientists, however, remain challenged to overcome the ever-present problem inherent in all three of these obstacles--the problem of identifying readily available organ donors.(11) Although certain scientific medical developments have increased the supply of available organs for human transplants, they have also created legal and ethical issues.

The human body has approximately thirty transplantable parts.(12) Scientific developments have made it medically possible to replace both structural and cellular human body parts.(13) And with cellular human body parts, there is a major physiological distinction between regenerative and nonregenerative cells.(14) The problem of identifying available donors has been present in both regenerative and nonregenerative human organ and tissue transplants due to the various medical obstacles identified above.(15) Regenerative tissue is more readily transplanted from living donors, whereas nonregenerative organs generally come from cadavers or animals.(16)

The primary legal distinction between regenerative and nonregenerative human organs and tissue is the manner of transaction permitted under law in the transfer of such organs or tissue between the donor and donee. Current national and state laws permit both the donation and sale of regenerative tissue such as blood, sperm, ovum, cells, hair, and other such body products.(17) On the other hand, nonregenerative solid body organs such as the heart, lungs, liver, pancreas and kidneys, can only be transferred by participation in the existing volunteer organ donation system.(18) The sale of such nonregenerative organs is strictly prohibited in the United States as well as in many other countries.(19)

A. REGENERATIVE HUMAN TISSUE

A look at two major types of regenerative human tissue--human blood and sexual reproductive tissue (sperm and ovum), provides substantial insight into probable ethical and legal issues which may also be present if the sale of nonregenerative human organs ever becomes legal.

1. Blood Transfusions

The process now commonly known as a "blood transfusion" was not always a legal and safe medical procedure. The first attempts in the early 1800s resulted in risks of criminal liability against scientists when fatalities were involved.(20) The widespread legal use of the blood transfusion process was due to significant medical developments throughout the 1900s(21) and during periods of great demand such as the American Civil War and World Wars I and II.(22)

Once the transfusion process was deemed safe, scientists were faced with the problem of increasing the supply of readily available human blood. The development of blood component therapy in the 1960s insured a greater storage capacity of human blood which was eventually extracted from blood donors and stored for future use in blood banks.(23) Initially, nonprofit community based organizations such as the American Red Cross (now quasi-governmental) served as the intermediary between blood donor and blood recipient.(24) Now, commercial blood centers routinely pay blood donors for providing blood.(25)

Human blood continues to replenish itself in the blood donor, generally leaving the donor in no worse condition than before the extraction of his or her blood. However, controversy has arisen regarding the liability of hospitals, physicians, blood banks, and blood producers for negligent transfusions that have resulted in some type of injury to transfusion participants and their families.(26)

The transfusion of contaminated blood led to controversy over appropriate standards of informed consent from donees. The first blood contaminant scare was the spread of Hepatitis B.(27) The 1980s brought significant cases involving blood contaminated by the HIV virus causing AIDS (Acquired Immune Deficiency Syndrome).(28) Both of these epidemic-like blood contaminants created a widespread fear of participating in the blood transfusion process. This fear forced the industry to develop improved blood testing and patient screening techniques.(29) The current organ donation system also faces issues related to donor and organ screening. Health care providers in the organ transplant industry have found themselves facing civil liability for the negligent transmission of infectious diseases.(30) The fear of possible transmission of the HIV virus causing AIDS has led federal health officials to consider the creation of a nationwide organ donor tracking system. This system is proposed to track organs from the donor to the potential recipient.(31)

The determination of whether blood was a "good" under the Uniform Commercial Code's warranty and strict liability provisions, or whether it was the provision of a service which fell outside the protection of such warranty provisions was central to determining the liability of blood providers.(32) The landmark case in this area is the 1954 case of Perlmutter v. Beth David Hospital.(33) In Perlmutter, a patient diagnosed with hepatitis brought an unsuccessful suit against the hospital for administering a blood transfusion with hepatitis-infected blood. The court set a long-standing precedent, which has now been codified by most states,(34) that the provision of blood was a service and not a sale. As such, the court held that the hospital could not be sued under the state's sales act pursuant to claims of breach of implied warranty or merchantability. The court reasoned that "[c]oncepts of purchase and sale cannot separately be attached to the healing materials--such as medicines, drugs or, indeed, blood--supplied by the hospital for a price as part of the medical services it offers."(35) The court further recognized the rule that, "when service predominates, and transfer of personal property is but an incidental feature of the transaction, the transaction is not deemed a sale within the Sales Act."(36)

Ethical arguments have been made against the commercialization of the blood industry. The objections are similar to those currently raised by opponents of the commercialization of human organs.(37) One early account summarizes the ethical arguments of Richard M. Titmuss against the commercial blood market:

... it represses the expression of altruism; it erodes the sense of community; it sanctions the making of profits in hospitals and clinical laboratories; it legalizes hostility between doctor and patient; it subjects critical areas of medicine to the laws of the marketplace; it places social costs upon those least able to bear them--the poor, the sick and the inept; it increases the danger of unethical behavior in various sectors of medical science and practice; and it results in situations in which proportionately more and more blood is supplied by the poor, the unskilled, the unemployed, Negroes and other low income groups and categories of exploited human population of high blood yielders so that blood is redistributed from the poor to the rich.(38)

The blood transfusion industry has successfully overcome these ethical and moral objections to the point where the commercial blood market is now an acceptable blood supplier.(39) From its early prohibition to its eventual legalization and commercialization, the blood transfusion industry has been affected significantly by continued medical developments and the legal and ethical issues which determine whether the demand for human blood for transfusion purposes will be met.

2. Human Sexual Reproductive Cells

The other significant regenerative human tissue or cells are sperm(40) and ovum.(41) These sexual reproductive cells have been widely used to allow infertile couples to bear children through new reproductive medical techniques. Procedures such as artificial insemination,(42) artificial inovulation(43) and embryo transplantation(44) are reproductive techniques that have involved the use of donated or purchased reproductive cells.(45)

The sale of sperm is permitted pursuant to local statutes which also provide that the sale of sperm is the provision of a service and not the sale of a good.(46) Third parties have also been paid for providing the fertilized or unfertilized eggs or for the use of their bodies as gestational hosts who carry children to full term for the custodial parents.(47) The gestational host may also be paid for her services when the process of artificial insemination impregnates her with the sperm of the custodial father. This transaction is governed generally by what is known as a "surrogacy contract."(48)

The legal and ethical controversies inherent in these types of sexual reproductive processes are twofold. First, it must be decided whether the use of human sperm and eggs procured by donation or sale constitutes a transfer of "human life" akin to "baby selling" prohibited by existing law and public policy. Second, should the process be declared legal, it must be decided who will be entitled to parental rights such as custody and visitation, or charged with parental obligations such as child support.(49)

The determination of whether constitutionally protected human life results from these processes was addressed in two controversial cases involving the inheritance rights to frozen sperm(50) and parental rights to frozen embryos.(51) In Davis v. Davis,(52) a Tennessee court struggled to determine the status of frozen embryos in a divorce proceeding. The court ultimately refused to confer the status of property upon the embryos, but instead concentrated on the "decisional authority" the providers had over the disposition of the embryos.(53) The court found that both spouses had decisional authority akin to a special ownership interest over the frozen embryos.(54) The decisional authority included the provider's right to destroy, donate or use the frozen embryos.

The Hecht v. Superior Ct. of California(55) court, relying heavily on the Davis opinion, addressed the issue of whether cryopreserved sperm constituted a property interest which could be disposed of by will under probate jurisdiction. The court avoided the issue of whether human sperm constituted a traditional property interest. Instead, it limited its decision to the narrow determination that the decedent's frozen sperm properly fell under the jurisdiction of the probate court as probate property, due to its special interim category as potential life.(56) The court concluded that sperm was "unlike other human tissue because it is 'gametic material' ... that can be used for reproduction,"(57) and thus held that at the decedent's death his ownership interest over the sperm entitled him to exercise his decision making authority to determine the reproductive use of the sperm. The court did acknowledge that human sperm, as reproductive material, was a "unique type of 'property'."(58)

Both Hecht and Davis refused to base their decisions upon the theory that sperm and embryos were persons and thus entitled to a full level of constitutional protection. Instead, the courts decided to simply acknowledge that these human sexual by-products represented "potential life" which should, at most, be accorded special respect. In doing so, they indirectly answered in the negative the query of whether the use of such reproductive processes, which may involve the commercial transfer of the human sperm and embryo, violated existing laws which prohibit the sale of human life.(59)

This line of reasoning may also provide the basis to legalize the sale of human organs. These judicial decisions provide significant insight into the determination of when fully protected human life begins. The courts' determination that the human sperm and embryo were not persons allowed them to avoid any public policy objections against the transfer and destruction of human flesh. As such, the sperm and embryo providers were afforded a greater degree of control over the disposition of human material that was only "potential life." Market proponents emphatically argue that the sale of human organs would not violate any public policy or laws prohibiting the sale of human flesh. Instead, they contend that organ providers should be accorded a greater level of control over the disposition of their organs--which should also include the right to transfer them for monetary consideration.(60) By decreasing the human significance and symbolism often attached to organs, greater emphasis would shift towards the organ providers' personal autonomy, liberty interest or decisional authority over their own bodies. Once legal authorities overcome the hurdle of determining whether the sale of human organs is akin to selling human life, the legalization of such transfers is likely to follow.(61)

In cases involving the use of reproductive techniques, such as artificial insemination, courts have also concentrated on determining the parental rights or obligations of each participant. In The Matter of "Baby M,"(62) a major case in the late 1980s, involved a New Jersey court's determination of whether a surrogacy contract could be enforced so as to terminate parental rights of the gestational host(63) and affirm the parental rights of the adopting custodial mother. This case specifically addressed the issue of whether such contracts amounted to a legal adoption agreement or an attempt to sell a baby.(64) The Baby M court determined that the surrogacy contract was unenforceable under existing law because the consideration provided to the gestational host by the natural father was a payment for his wife's right to adopt the baby.(65) Thus, the court found that this was tantamount to a contract to sell a baby.

Opponents of a commercialized organ market also fear that its legalization would be equivalent to selling a "human life" or bartering for "human organs."(66) They ardently support the current organ donation system as far superior to the proposed commercial market in human organs.(67) The Baby M decision may support such arguments. Although the court held that surrogacy contracts based on consideration were illegal, it was prepared to accept gratuitous surrogacy arrangements which provided the host or gestational mother with a period after the birth of the child to change her mind.(68)

B. NONREGENERATIVE HUMAN TISSUE OR ORGANS

Nonregenerative human tissue can be divided into two groups--vital and nonvital. Vital nonregenerative tissue consists primarily of organs that are irreplaceable and are essential in preserving the life of the donor. These include such life-sustaining organs as the heart, lungs, liver, pancreas, stomach and both kidneys. Nonvital, nonregenerative organs and tissue are those which can be removed from the donor without causing death due to their absence. These include one of two properly functioning kidneys(69) and a dissected portion of a functioning liver.(70) The difference between vital and nonvital organs is most apparent when dealing with the obstacle of identifying readily available transplantable organs. Live donors are only allowed to donate nonvital organs, whereas cadavers are used to provide vital as well as nonvital organs.(71)

1. Identifying Donors

From March 1964 through March 1965, approximately 273 kidney transplants were performed throughout the world(72) compared to 9,569 in the United States alone during 1990,(73) and 7,507 in 1993.(74) Over 100,000 kidney transplants had been performed worldwide by 1984. The steady increase of organ transplants over the last thirty years has caused the shortage of available human organs for transplantation purposes continues. As of March 31, 1994, almost 35,000 people were registered for kidney, liver, pancreas, lung, intestine, heart, and multiple organ transplants on national organ waiting lists of the United Network for Organ Sharing ("UNOS").(75) Of that number at least 25,000 persons were registered to receive kidneys.(76) Many who are listed die before an available organ is located.(77)

There are currently three sources that supply organs for transplantation purposes--human beings, animals, and mechanical or artificial devices. The medical community has made vast progress in the transplantation of animal organs into humans during the last twenty years.(78) The most recent attempts have failed to establish animal donors as effective and safe providers of organs for human organ transplantation purposes.(79) The use of mechanical devices that perform the function of failed vital human organs have proven far more successful and valuable to the organ donation industry than animal organs.(80) These devices have played a significant role in maintaining the required bodily functions of clinical or brain dead individuals in cases where their organs are to be transplanted.(81) Furthermore, the lives of many waiting organ recipients are temporarily sustained by mechanical organ devices until an available transplantable human organ is identified. Scientists have yet to extend the use of such devices beyond these short term functions in a manner which would decrease the shortage of transplantable human organs.(82) The primary providers of successful, long-term transplantable organs are living human beings and cadavers. Proposals for a commercialized transplantation system have focused on human organs as the commodity.(83)

Organ transplants between humans, or the same species, are referred to as a "homograft" or "homo-allo transplant."(84) Homo-kidney transplants were first performed as early as 1954.(85) Kidney and cornea transplants(86) have been by far the most common and successful human organ transplants.(87)

The early 1960s brought about first successful liver transplants, followed by heart(88) and lung transplants and pancreas transplants.(89) For the most part, pancreatic transplants were considered experimental as late as 1991.(90) The transplantation of the human lungs are considered difficult due to the delicate nature of lung tissue. Often, lung transplantations are done in conjunction with a heart transplant.(91) Multiple organ transplants such as kidney-pancreas, kidney-heart, and the heart-lung are becoming more common due to continued medical developments. As of April 1, 1994, UNOS reported that over 3,000 multiple organ transplants had been performed in the United States alone in 1993.(92)

There are two categories of possible human organ donors--live donors and cadavers or "nearly dead" donors.

a. Live Human Donors

Typically, the living donor voluntarily agrees to donate a nonvital organ or tissue to a donee who is most often a blood relative.(93) Continued medical developments in immunosuppressive drugs have made it possible to expand the availability of nonvital live human organ donors to include unrelated third parties, who have a high degree of consanguinity or histocompatibility with the intended donee.(94)

The most common controversy involving competent, live human organ donors centers on whether the donor's consent to donate is voluntary and informed. Organ transplants from live donors are considered voluntary where full, informed consent has been obtained from a competent donor.(95) The requirement of informed consent comes from the long-standing common law principle of self-determination which recognizes, in part, that every individual has the right to refuse unwanted medical treatment.(96) Most would agree that "ideas of self-preservation, self-determination, and self-fulfillment are jeopardized when consent to a medical procedure is either uninformed, involuntary, or absent."(97)

The doctrine of informed consent requires that the physician and donor discuss the risks associated with the removal of the donor's organ.(98) For instance, in a kidney donation, this would include information on the risks and medical treatment available should there be a future renal failure of a donor's remaining kidney.(99) The absence of such information would destroy the voluntary nature of such transplants.

Transplantations involving living human organ donors have not always been viewed as purely voluntary. One scholar noted that the "[p]rocurement of tissues from living donors can raise issues concerning human dignity, undue influences, family pressure upon a member to donate, the morality of depleting a person's body, and the morality of removing tissues from children or others who lack capacity or whose consent is not free."(100) In a system laden with such ethical concerns, courts have been asked to address such quasi-involuntary organ transplants between living family members. In one case,(101) a Pennsylvania court refused to force a cousin to submit to an involuntary bone marrow transplant, even though the cousin was the only identified "match" and the transplant was required to save the life of his cousin.(102) The court recognized the cousin's constitutional right to privacy which necessarily included the right to refuse medical treatment and to maintain his bodily integrity.(103) Other instances of involuntary organ transplants involved live kidney donors who were mentally incompetent due to age or mental disability.(104)

Unlike cadavers, which provide both vital and nonvital organs for transplants, living kidney organ donors are at a greater medical risk because they are left with only one remaining kidney upon which they must rely to perform all of the body's blood purification functions.(105) These potential medical risks, along with psychological and religious barriers, have contributed to the shortage in compatible and willing live organ donors.(106) Even so, most agree that a commercialized market in human organs should prohibit the commercial transfer of organs by live human donors,(107) whether competent or incompetent. If permitted, however, safeguards must be present to ensure that such transfers are voluntary, and performed with the fully informed consent of the organ provider.

b. Cadaver or "Nearly Dead" Donors

Cadavers are the primary source for both vital and nonvital nonregenerative organs for transplant purposes.(108) Controversy over the use of cadavers for organ transplant purposes is usually found in the context of patient and family consent issues resulting in tort claims for negligent disposition of the body and emotional distress claims.(109) These issues evoke the ever-present question of whether a property interest exists in dead bodies, and if so, to what extent does such interests extend to the decased, the family or the guardian.(110) This question must be answered if individuals' right to dispose of their bodies by sale in a commercialized market in human organs is to be recognized.(111)

Although cadavers often provide the main source of readily available organs, there are medical and legal complications that threaten the use of such organs. The primary complication is locating cadavers that have fresh organs which can be used by the intended donee. Cadaver organs must be removed from the body within a relatively short time after pronouncement of death--before the tissues begin to deteriorate.(112) In many instances, the cadaver donor is a permanently unconscious or terminally ill person who has been declared "brain-dead."(113) Ethical and legal controversies have arisen regarding the use of "brain-dead" or "nearly dead" persons as organ donors.

In one particularly devastating case,(114) a husband brought a claim against his deceased wife's attending physician for the physician's removal of her kidneys for transplantation after a premature determination of her death.(115) The husband was informed of his wife's death only to later find that she was kept alive by life-sustaining equipment in order to preserve her body for a transplant that he had consented to after learning of her supposed death.(116) Upon learning that his wife was still alive, the husband frantically hurried to revoke his consent; however, the kidney transplant was underway and his wife had been declared "officially dead."(117) The court in this case did not address whether the physician or hospital might be liable for the woman's death. It did determine, however, that when considering the civil and criminal immunity provisions of the state's Uniform Anatomical Gift Act ("UAGA"), "the ... complaint, growing out of the circumstances of the transplant, is subject to the defense, if proved, of the defendants-respondents' good faith."(118)

Medical personnel continue to be sued for the unauthorized removal of human organs or tissue.(119) These alleged nonconsensual transplant procedures on "living persons" clearly fall outside of the purview and immunity provisions of the UAGA.(120) The medical personnel's liability in such cases has been based upon whether a relative's or the decedent's consent was obtained and whether vital organs were removed from the decedent while still alive. The consent issue is rooted in the common law and constitutionally protected "right to privacy" which requires that a patient give fully informed consent prior to any operation or medical treatment performed upon him.(121) This informed consent also protects nearly dead patients from any unauthorized invasion or intrusion upon their bodily integrity.(122)

The use of terminally ill, permanently unconscious, incompetent patients as organ donors may become less complicated due to "living will" and "medical health care directive" legislation which has now been passed by all states.(123) Such legislation provides competent adults with the right to predesignate in writing their desire regarding the use, continuance or withdrawal of life-sustaining equipment should they ever become terminally ill or in a permanently unconscious condition.(124) Some fear that such legislation places physicians in the awkward position of making the medical determination required to enforce a patient's living will, while another patient eagerly awaits the dying patient's potentially transplantable organs.(125) Inherent conflicts of interest may exist where the physician who makes the determination of the donor's death also participates in the organ transplantation procedure. Health care providers should not be given the opportunity to balance the quality of the dying or near death patient's life against the life expectancy the donated organ will provide for the organ recipient.(126) The potential for abuse in such cases may also exist in a commercial organ system where there is some added direct, or indirect, financial incentive provided to physicians. It would seem unlikely, however, that financial incentives would be great enough to motivate physicians to act in such abusive behavior.(127)

The greater potential for abuse of the nearly-dead or dying in a commercial system exists where the decision to terminate the patient's life support has not been expressed in a living will. In the absence of a living will, the incompetent patient's life, death, and treatment decisions rest, initially at least, with family members.(128) Life support termination decisions become complex where relatives seek to use the incompetent's organs for transplantation into some third party.(129) The decision of whether such incompetent persons will be used as organ donors involves a decision of whether the person meets the legal definition of death.(130)

A state court in Florida decided this issue in a case involving a 9-day-old anencephalic infant. The anencephalic infant, (an infant born alive but with only a portion of the lower brain or brain stem) has been suggested as a source of "nearly dead" organ donors by legal scholars.(131) In 1992, a Florida couple sought to donate the vital organs of their anencephalic daughter, Theresa Ann Campbell Pearson, before her impending death. The couple petitioned a Florida court to allow them to donate their daughter's organs prior to the legal determination of her death under Florida's version of the Uniform Determination of Death Act ("UDDA")(132) solely because of her congenital deformity. Florida defined death as the cessation of the whole brain. The court refused to expand the Florida definition to the cessation of the upper brain in order to make the infant legally dead for purposes of removing her organs.(133)

In this case, the parent's motives to donate their daughter's organs were altruistic. Even so, the court rightfully protected the incompetent child's liberty interest in life, regardless of its quality.(134) Courts should continue to preserve the lives of dying incompetents even where some third party may benefit from the patient's death.(135)

The potential for depriving incompetents of such fundamental rights in premature determination of death cases intensifies in a commercialized organ industry.(136) Financial incentives may motivate family members to prematurely hasten the death of incompetent relatives.(137) A major safeguard against such abuse is to ensure that the determination of death conforms with existing legal standards.(138) Where this standard is violated, perpetrators should be punished and prohibited from receiving financial benefit from any sale of the deceased's organ.(139) An absolute prohibition of the sale of organs from incompetent persons would provide the greatest degree of protection.(140)

2. Identifying Donees

The existing transplant system operates by a nationwide network of organizations that link potential donees to the organs.(141) The system places prospective donees on a nationwide organ resource list categorized by the required organ and other geographical and medical criteria.(142)

In some cases, "social worth" allocation criteria have also been used to determine a patient's potential to be a productive citizen after the transplant. Criteria such as "the person's relationship to authority figures, past irresponsible behavior, and intelligence .... [t]he patient's marital status, number of dependents, income, educational background and employment record were all evaluated to determine the patient's potential to return to a 'productive life'."(143) Other, more equitable random allocation systems have been suggested such as a lottery system or "first-come, first-serve" basis, where the recipient's ability to pay, medical status and discriminatory social worth criteria are not considered.(144) Opponents argue that such random organ allocation systems will only benefit those educated persons who have greater access to such services.(145) One state's organ donation Task Force stated, when concluding that a patient's medical criteria should be the sole basis for organ allocation decisions, that "[c]riteria to select transplant recipients must be uniform, public and fair. They must be applied in a process that ensures that like cases are treated alike and precludes the operation of bias based on race, social class, sex or other invidious criteria."(146)

The existing allocation system would be substantially affected by a commercialized organ industry because allocation decisions would theoretically be based upon the potential donee's ability to pay for the purchased organ. An allocation system which is predicated solely upon a person's financial status may preclude lower class and some middle class donees from receiving organs.(147) Furthermore, it is possible that poor people will become a commodity of transplantable organs for rich organ recipients.(148)

Safeguards are necessary to ensure that indigent persons will not be discriminated against in a commercial organ industry based upon their social class. The first level of protection would be the legalization of a commercial system which will best accommodate all social classes of organ donees. Among the proposed systems, some type of hybrid commercial/donation system might best address these concerns.(149) Governmental organ subsidy and voucher programs and price and quality controls may also provide further protection for the poor.(150)

The shortage in human organs for transplantation purposes continues to challenge the medical and legal community to create new ways to meet the growing demand for organs. Standards should be also developed to insure that potential participants who are vulnerable because of their age, incompetency (mental and/or physical), physical state of living or dying, or economic status are treated fairly. From the provision of blood to other nonregenerative body organs and tissues, the protection of these transplant participants must be secured in the event the sale of organs is ever legalized. In order to properly develop such safeguards, it is important to understand the legal and regulatory controls existing in the organ donation industry.

II. REGULATION OF THE ORGAN TRANSPLANT INDUSTRY

A. THE ORGAN DONATION SYSTEM

The current organ donation system in America is premised upon an "encouraged volunteerism" basis, which recognizes that organ donation is legally permissible where the organ donor has freely (without coercion or undue influence) agreed to donate an organ for transplantation or other medical research purposes.(151) The extent of one's right to donate one's body or body parts and organs for such purposes is regulated primarily by state law.(152) The common law right to donate human organs evolved from the common law recognition of a family's right to control or determine the disposition of the cadaver of a deceased relative for burial purposes.(153) In early cases, relatives often sought to expand their limited right to dispose of a deceased relative's body so as to exercise some other traditional right associated with the ownership of property.(154) Although in recent cases, courts have also been asked to view this early common law as a recognition of some type of property interest in dead bodies, they have repeatedly refused to do so.(155) Instead, the courts have determined that the right of such relatives is limited to burial purposes without any significant property interest attached.(156) State courts have confirmed that the existing right to donate one's body is not based upon a person's fundamental property interest in his or her own body.(157)

The determination of whether a property interest exists in the human body is also crucial in legalizing a market in human organs.(158) The legal classification of the human body as property would permit individuals to exercise traditional disposition rights associated with the ownership of property.(159) Those who oppose a market in human organs argue, however, that the human body deserves much greater respect than to be classified as property to be sold on the open market.(160) The determination of the status of the human body, as property or life, is a major hurdle which may need to be resolved before a market in human organs is legalized.(161)

The postmortem donation of human organs was initially regulated by statues in about thirty-eight states.(162) These statutes were viewed as ineffective and massively inconsistent. In 1968, in an effort to reconcile these inconsistencies and inefficiencies, the National Conference of Commissioners on Uniform State Laws and the American Bar Association adopted a uniform organ donation law to serve as model legislation for the states. By 1973, every state had enacted, in part or whole, some version of the Uniform Anatomical Gift Act ("UAGA").(163) The UAGA permits individuals who are of sound mind and at least eighteen years old to donate all or part of their bodies, upon death, for medical research, therapy or transplantation purposes.(164) State-enacted versions of the UAGA generally restrict such gifts from being made by minors and the mentally infirm. All states recognize, at some level, the limited capacity of minors and mentally disabled individuals to make such decisions, perhaps in consideration of the potential for abuse in such situations(165) as well as the inability of such persons to give the legal consent required to donate one's organs. …

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