Legal Aspects of Transplantation of Organs

The individual person is subjected to rights and duties derived from the human nature. The need to protect the human being against abuses towards his dignity is worring society, as long as social and political transformations have even allowed human personality desintegration. The threaten to phisical and moral individuality clearly appears everytime a person is assassinated or everytime one has his dignity, honor and freedom attacked. In this sense, human rights must be protected. It is needed to protect life, body and freedom within a proper subject. This subject is the "personal rights", known by german specialists as "individualrechte" or "personalitätsrechte.

a) they are absolute concerning their own nature and imposing the general duty of refraining from doing;

b) they are inalienable, a right that cannot be transferred or surrendered (inherent right);

c) they are not commodities and in this sense, they cannot be object of attachment and they are not submitted to prescription;

d) they are necessary and for life in the sense that they always exist and they are needed; for the whole life they exist and have legal protection.

Among these three groups the first one is the one which brings us up to the debate. The second group is related to copyrights and the third one concerns general civil rights.

The right to physical integrity is a private right and it is considered by doctrine as a fundamental right, as far as it is related to life. People have the right to life and, in this sense, they have the right to a physical integrity. Therefore, we must concern that the body is composed by corpus and soul, which comprehends life in its essence. Life is the sacred gift to be protected and without life it is not possible to speak about life. The right to physical integrity is also divided into three groups:

The objective of this presentation is to demonstrate that the right to be submitted to a transplantation surgery is a personal right. People have the right to phisical integrity, as far as the human body is intangible. In this context we may argue that people have a right to any kind of surgery, which can be conducted without consent for therapeutical purposes. A transplantation surgery is an exception, because physician's conduct depends on donations or upon a conduct to be assumed by another person. The human body is the main object of medical sciences and it is also the main attraction to law, concerning the right of disposition.

The transplantation of tissues and organs from animals, in ancient time, was a thesis advocated by Catholicism's great thirteenth-century philosopher-saint, Thomas Aquinas, in his wonderful paper "Summa Teologica". Aquinas was convicted that a full human soul, which is essentially intellectual, cannot be the form of a creature that has never had the material shape necessary for even the most rudimentary stage of thought of sentience. He defined the term "person" as the most perfect thing in universe: Persona significat id quod est perfectissimum in tota natura, scilicet subsistens in natura rationali. There is no other alive being as perfect as the human being in universe.

Actually, people face science progress and related, the deep problem of the taken of organs and tissues from the dead body. Two main questions arise from this debate: i) the definition of human body and consent, related to commerce; ii) the definition of death.

The definition of human body alive and dead It is neither accidental nor gratuitous that from its inception, human organ transplantation has been based on the belief that the human body and the extraordinary generosity inherent in donating organs are altogether too precious to be commodified. There is no doubt that human body is something extra commercium. As a consequence, there will only be gratuitous donations. Therefore it is associated to values as altruism and solidarity that also belongs to human society. The limitations that people suffer to his own body is also related to the limitation other people must respect. Nevertheless, this right is not that absolute. The right on his own body cannot limit the right to life nor the right of getting sick and refusing treatment. Moreover, freedom of choice is not an "absolut" right that can justify the sale of organs. It is in accepted legal and moral imperative that societies have a duty to maintain a community sense of values that prevents sgregious exploitation of individuals. We cannot allow people to kill nor to sell themselves. As example, we forbid suicide and prostitution^[1]. These prohibitions are ultimately based on a traditional sense of the respect owed to the human person. In fact, this traditional sense of the respect owed to the human person is an important argument for the prohibition of sale of organs. In fact, a person does not owe his or her body; a person is his or her own body^[2]. The dogma of human body intangibility does not constitute legal protection only to living people. This dogma persues death, as far as human body has a transcendental value which goes beyond life and death. Therefore, law must also protect the corpse. If a living person cannot be an object of commodity, a dead body is also a good out of commerce or extra commercium. Nevertheless, to affirm that a person is dead and his or her body is a corpse, it is necessary to develop another complex concept: the concept of death. Redefining Death As the international controversy surrounding the marketing of organs heats up, the demand for these scarce and valuable medical commodities has contributed to a historic and arming shift in the legal meaning of death. In ancient time death was thought to occur when the soul left the body. In early time the ability to breathe is given as the esse of life. Cessation of breathing was the major criterion of death. The definition of death changed from a primarily spiritual concept to a biological one only after Harvey's discovery of circulation in the seventeenth century, and the ability to monitor the heart in the eighteenth century. The heartbeat and spontaneous breathing criteria of death had become a constant by the twentieth century. But in the late 1960s, technology would push a new picture of death. Patients who seemed to have lost brain functions could be kept alive by life-support equipments that artificially maintained respiration and circulation. These could ensure that organs would still be in good condition to be removed. This fact brought the conclusion that a definition of death based on the cessation of breathing and of heartbeat would not fit anymore, because in order to have viable organs, physicians needed to remove organs while circulation and respiration were still ongoing. Faced with this dilemma, a 1968 Harvard Medical School committee recommended a criteria to determine death based on brain activity. This brain death criteria means that the brain and brain stem have irreversibly and totally ceased to function, and that this will inevitably lead to the permanent cessation of respiration and heart function. Even though the brain death concept has important advantages, such as the diagnosis of irreversible loss of all brain function is practical and reliable and patients in this situation are an excellent source of organs, however, it has not been an unquestioned success and it still continues to cause perplexity. But this perplexity has not stopped the debate about a new definition of death. Over the last few years, there has been a growing effort to further widen the legal definition of brain death. Current proposals go considerably beyond whole brain death to include among the legally dead those who have lost their "higher" brain functions. This is often referred to as cerebral death or as neocortical death. A neocortical death standard could significantly increase availability and access to transplants because patients declared dead under a neocortical definition could be biologically maintained for years as opposed to a few hours or days, as in the case of whole brain death. Moreover, because they breathe on their own and do not require artificial respiration as current "brain dead" patients do, they can be used as neomorts far more easily. One may say that this new definition must be rejected, as long as thousands of breathing neomorts in hospitals would be used as living "banks" of organs for donation and experimentation. That is not all. Treating people in a permanent state as cadavers creates a range of ethical dilemmas: a) what should be done with the corpse? Should burial or cremation take place while respiration continues? b) Would it be homicide if a family member suffocated a relative who had been vegetative for months? c) Should someone take responsability for suffocating the corpse first? d) The main question: is a neomort really a corpse? Besides this moral and ethical questions^[3], we must include a scientific difficulty. If one starts equating the loss of higher functions with death, then, which higher functions? Damage to one hemisphere of both? If to one hemisphere, to he verbalizing dominant one, or to the "attentive" non-dominant one?^[4]. Concerning these dilemmas - moral and scientific - this criteria must be rejected. A proposed standard to define death has to accurately reflect the social meaning of death and not constitute a mere legal fiction. By using this general criteria, we may conclude that it is more appropriate to keep the actual definition of death - whole brain death - but not to encompass neocortical death^[5].

This discussion indicates a serious tension inherent in legal and moral traditions. While moral traditions reject every conduct that would become the direct cause of death, law would not do it, if a broader definition of death was accepted. By considering a neomort a corpse moral tradition would be revised. This tension would lead us to another complex premise: to draw a distinction between human beings and persons. Furthermore, this distinction pushes to the outlining of the theory of personhood and to the most complex question in this debate: what properties must a being possess in order for it to have a right to life?".

It is necessary to show some concepts of Brazilian Law and how physicians and legal expertises are dealing with these main problems about transplantation: a) definition of death; b) donations and the implication for commerce.

Brazilian ruling law is Federal Law n. 9.434, enacted on 02-05-1997. It rules about removal of organs, tissues and parts of the human body for purposes of transplantation and treatment.

Article 3 of Federal Law n. 9.434, enacted on 02.05.1997, is concerned to the definition of death. The concept of brain death has been adopted by Brazilian ruling law. It provides that the diagnosis must be elaborated and registered by two physicians who are not members of the removal and transplantation group. The criterions for brain death must be the ones edited by the Federal Council of Medicine. The ruling Resolution is the n. 1480, enacted on 08-08-1997. Current diagnosis of brain death rely on testing for synaptic activity of brain tissue for a few hours. A 10-minute apnea testing usually follows clinical examination demonstrating absence of brain stem reflexes in a deeply comatose patient --Glasgow Coma Scale (GCS) score of 3. A flat electroencephalogram (EEG) may ultimately confirm brain death for procurement of transplantable organs. Therefore, the overall absence of neurologic function for usually 6 hours has been regarded as a consequence of irreversible whole brain or brain stem damage^[6].

According to the scientific progress and due to the need of giving a definition for death, a law aimed to allow transplantations from the corpse (from dead people) must be constantly atualized. The question is not only whether a person a dead. The question is related to the criteria we must assume to say that a person is dead. For transplantation purposes, since Harvard Ad Hoc Commission, death has been defined as brain death. Accepted this concept, the question is whether the criteria and the diagnosis of brain death are valid.

The ruling law about transplantations in Brazil, based on presumed consent for organ donation, has raised discussions concerning the reliability of diagnosis of brain death.

Professor Cicero Galli Coimbra, M.D. and Professor at the Experimental Neurology Branch of the Department of Neurology and Neurosurgery, from the Federal Medical School of São Paulo State, has published an important paper which is intended to advance such controversy to the international level, by discussing the implications of ischemic penumbra to the diagnosis of irreversible brain damage and intracranial circulatory arrest. He argues that patients declared brain-dead may actually sustain global or regional (brain-stem) ischemic penumbra and respond to moderate hypothermia and/or thrombolysis. Time-consuming procedures currently in use may induce rather than diagnose irreversible brain damage. He claims that the 30-year old guidelines for diagnosis of brain death are to be urgently reconsidered^[7].

Brazilian academies of medical science and of law science are facing a complex dilemma. The question is that the actual approach for establishing diagnostic criteria clearly manifests misconceptions. The criteria - and not the definition of death - is being argued to be modified. The legal implication of this conclusion remarks that we may not have a legal criteria divorced from scientific progress, otherwise a dying person will be defined as a dead person. As from the point of view of ethics organ removal is to be linked to absolute intolerance to false positives, death cannot be defined as unlikely a legal fiction.

Although there is no doubt that Brazilian Law is updated to the international definition of death, which has adopted the concept of brain death, the diagnosis of brain death cannot lack scientific validation and technical feasibility. A clear and strict criteria ought to be accepted taking into account all the therapeutic techniques known by science in order to avoid a fundamental error: killing a dying person for harvesting organ transplant.

Article 1 establishes that law allows gratuitous disposal of tissues, organs and parts of the human body in vitam or post mortem. It excludes blood, sperm and eggs. These tissues are not considered goods extra commercium. Under this statute, the human body or parts of it are not a commodity and commerce is forbidden. An important issue has been deeply discussed by Article 4 of the Federal Law n. 9.434, acted on 02-05-1997. It establishes the presumed donation. It means that, except by an express and contrary disposition, the donation of tissues, organs and parts of the human body, for purposes of transplantations and therapeutic conducts post mortem are presumed.

This concept of presumed or tacit consent has been divided into two groups: the strong or wide and the weak. Countries such as Austria, Denmark, Polony, Switzerland and France are included in the first group. Within the second group are Brazil, Finland, Greece, Italy, Norway, Spain and Sweden. The presumed and strong consent allows physicians to remove organs from every corpse, without any objection or consent of donor or his family. It advocates the doctrine of the "socialization of corpses". The presumed and weak consent, on the contrary, needs express objection to that medical proceeding. In the absence of this express opposition, declared on the I.D. Card on the Driver's License, everyone is a potential donor.

This doctrine has been objected by Brazilian lawyers. The main argument focus on the barely knowledge that Brazilian people have about the law. Considering that people have not been told about the effects and the extension of this law, also concerning that Brazilian people, in a great majority, does not have access to it, people may be considered donors without knowing it.

The right to life is a fundamental right and it is granted and protected by Brazilian Federal Constitution. It is absolute and intangible. Therefore, it needs an express consent and not a presumed one. If a country has strong tradition of property and individual rights, the consent has to be expressed, in order to have the State protecting and granting people's rights and will. The presumed consent, as established by Brazilian law, protects collective rights rather than individual rights. The justification to adopt this doctrine - presumed consent - was the low number of donations. Therefore, after three years, the number of donations has not increased.

A reconsideration of the presumed consent doctrine in Brazilian law must be replaced by the doctrine which advocates the express consent, because there is no other way to donate a good. According to Brazilian Civil Code donations must be clearly expressed. There is no reason to give a different treatment to organs donations, specially concerning that the right to life is a fundamental right, protected by Constitution.

Transplantation is a complex issue because it is realized only with human beings contribution. The main problem is to find a balance in order to build a general regulation. In fact, sometimes it might be more interesting to proceed a strict regulation, concerning adjudication of bodies in order to support people who are almost to die. However, we cannot forget that the right to life is related to the right to die; the right to physical integrity goes beyond the living body, it achieves the dead body; man's domain is not only over living body, man's domain over his body follows the corpse. In this sense, the doctrine of presumed consent does not consider the right to dispose about one's own corpse and it advocates the idea of an implicit adjudication of bodies by the State. This doctrine must be rejected, because it violates a fundamental right. Even though it protects the right of opposition to donations, it opens the doors to potential donors who do not know that they are donors. In other sense, as far as the right to physical integrity is a fundamental right, granted by the Constitution, the consent to donation of organs, tissues and parts of the human body must be express and not presumed.

Finally, due to the controversy over the sale or organs, our view of the human body is key to decisions on how to define death. Questions of what is life, what is death, who is a proper donor of organs and who is not, come down to our understanding of what constitutes personhood. All this issues are related to fundamental and personal rights: right to life, right to die, right to health, right to physical integrity, right to one's own body. Despite the different views among the medical community, definitions of death cannot be separated from moral and ethical judgments. In this sense, we may affirm that those who are "higher" brain dead and see in this definition of death an efficient source of organs and as potential tools in biomedical research, do not view these individuals as human beings ALIVE. Concerning that laws considers an individual as a person with the breathing, the so-called permanent vegetative state or the neomorts, still have personhood, as reflected in their living bodies. Therefore, these patients cannot be treated as a body shop commodity, no matter how altruistic the result is.

In this sense, as noted in the Brazilian debate, the criteria to diagnose the whole brain death must be clear and technical reliable, otherwise the number of neomorts will increase and dying people will be considered dead people for transplantation purposes. In fact, in a situation like this, if death is reversible, the personhood, as reflected in the living body, is still functioning. Furthermore, this conception of death - brain death - must be taken into account only for transplantation purposes. Legislations about transplantation must be clear and must link this broad definition only to transplantation.

In conclusion, we may say that just as transplantation has caused profound confusion about the definition of death, it is also becoming part of the ongoing explosive debate on the definition of life. We are facing an era of extremes in the scientific world: the edges between life and death. The aim to define death has discovered life.

ANDORNO, Roberto, La Bioéthique et la Dignité de la Personne, Médicine et Société, PUF - Presses Universitaries de France (France: 1997).

COIMBRA, Cícero Galli, "Implications of Ischemic Penumbra for the Diagnosis of Brain Death", Brazilian Journal of Medical and Biological Research, vol. 32 (12), december 1999 (Brazil: 1999).

FRIEDMAN, A . Jay, "Taking the Camel by the Nose: The Anencephalic as a Source for Pediatric Organ Transplants", Columbia Law Review, vol. 90 (USA: 1990).

KIMBRELL, Andrew, The Human Body Shop: The Engineering and Marketing of Life, HarperSan Francisco (USA: 1993).

VALDÉS, Ernesto Garzón, "Algunas Consideraciones Éticas Sobre el Trasplante de Órganos", Bioética y derecho: Fundamentos y problemas actuales, Rodolfo Vásquez (compilador), Istituto Tecnológico Autónomo de México, Fondo de Cultura Económica (México: 1999).

[1] Two important arguments are posed by Ernesto Garzón Valdés in order to reject the merchandising of organs. As he says: "el argumento de la degradación moral, y b) el argumento de la explotación". He explains: "a) El argumento de la degradación moral. Tenemos la obligación moral de defender nuestra propia dignidad. Kant establecía una clara distinción en el reino de los fines: todas las cosas tienem allí un precio o una dignidad. ... La venta de partes del propio cuerpo equivaldría a poner precio a elementos integrantes de la "naturaleza animal" de la persona, es decir, contradiría el principio de dignidad humana. ... b) El argumento de la explotación. El comercio de órganos es una de las formas más perversas de explotación ya que quiem vende partes de su cuerpo se convierte en medio para la obtención de recursos accesibles mediante el pago de una determinada suma de dinero. Se viola así la autonomia del vendedor, es decir, se le impide actuar como sujeto moral". Algunas Consideraciones Éticas Sobre El Trasplante de Órganos. In: Bioética y derecho: Fundamentos y problemas actuales. Rodolfo Vázquez (compilador). Instituto Tecnológico Autónomo de México. Fondo de Cultura Económica: México, 1999, p. 225.

[2] In accordance with Roberto Andorno, "C'est pourquoi l'idée d'un droit sur le propre corps (ius in se ipsum) est normalement refusée par les juristes, car elle est contradictoire: le droit implique par définition une relation d'altérité. Là où il ný a qu'une seule personne, il n'y pas de lien juridique. Ainsi, la notion de propriété sur le corps est contraire à la nature même de l'homme, qui est une unitè. L'être humain ne peut se diviser à l'intérieur de soi-même entre un "sujet du droit" et un "objet du droit" sans que son unité la plus radicale soit brisée", in La Bioéthique et la Dignité de la Personne, Médecine et Société, PUF: Presses Universitaires de France, 1997, p. 35.

[3] The higher brain death concept also represents a philosophical view of death fundamentally different from that embodied in either the whole brain or cardiopulmonary formulations. The former equates personhood with consciousness and the cognitive functions, arguing that since these abilities arewhat set humanity apart from other species, their loss can be equated with death. For those who advocate the whole brain view, it represents merely an updated set of criteria to diagnose death.

[4] As noted by Krauthammer and others, cited by Andrew Kimbrell in The Human Body Shop: the Engineering and Marketing of Life, HarperSan Francisco, 1993, p. 42.

[5] One important reason for rejecting the neocortical view as the prerequisite that any standard adopted reflect "scientific knowledge and clinical reality". The criteria for whole brain death are highly reliable. Although reports do surface of brain-dead patients "returning to life", experts agree that such instances, which occur most frequently when organ donation is contemplated, can be attributed to a lack of proficiency or care in correctly applying the criteria. The corresponding situation with regard to neocortical death is far less clear. Neuroscientists agree that functions such as cognition and consciousness result from complex interconnections between the brainstem and the cerebral cortex. Therefore, because it is impossible to be certain that with the shutdown of specific areas of the brain a complete loss of cognitive functions occurs, "the 'higher brain' may well exist only as a metaphorical concept, not in reality". The difficulty of formulating reliable diagnosis criteria is thus a principal obstacle that has prevented the adoption of neocortical death as a standard. See Jay A . Friedman, Taking the Camel by the Nose: The Anencephalic as a Source for Pediatric Organ Transplants, Columbia Law Review, vol. 90, p. 960.

[6] Irreversible damage of brain stem or whole brain is assumed when synapse-dependent phenomena (consciousness, cephalic reflexes, respiratory control, electrographic activity) remain absent for usually 6 hours.

[7] He proposes: "1) the lack of any set of clinically detectable brain functions does not provide a safe diagnosis of brain or brain stem death; 2) apnea testing may induce irreversible brain damage and may induce irreversible brain damage and should be abandoned; 3) moderate hypothermia, antipyresis, prevention of arterial hypotension, and occasionally intra-arterial thrombolysis may contribute to good recovery of a possibly large subset of cases of brain injury currently regarded as irreversible; 4) confirmatory testes for brain death should not replace or delay the administration of potentially effective therapeutic measures; 5) in order to validate comfirmatory tests, further research is needed to relate their results to specific levels of blood supply to the brain". And concludes: "The current criteria for the diagnosis of brain death should be revised". Implications of ischemic penumbra for the diagnosis of brain death. Brazilian Journal of Medical and Biological Research, December 1999, vol. 32 (12), 1479-1487.