The Law Relating to Organ Donation - Assignment Example

Medical Law Question One Shazia had been suffering from renal failure. Her doctors wanted her to accept a kidney transplant, despite her wishes to undergo holistic medicine. The doctors identified her father, who had been in a vegetative state and her twin sister, as potential kidney donors. However, her twin sister was disinterested in donating her kidney. In order to advice the Hightown Foundation Trust, for effecting a kidney transplant, the following issues have to be considered. The Human Tissue Act 2004 introduces a legal framework that regulates the issues pertaining to whole body donation.1 It also addresses the issues arising from the procurement, storage and use of human organs and tissue. The basic principle underlying the legal storage and use of human bodies, body parts, organs and tissue is that of appropriate content. This principle also regulates the extraction of material from cadavers. 2 The draft Human Tissue Act Code of Practice has furnished a beneficial flowchart for assisting consent decisions. However, this flowchart presumes adequate knowledge and understanding of the statutory hierarchy and consent framework. As a consequence, it becomes important to promote staff briefings and training, with respect to the codes and the Act. Moreover, the staff should develop the assurance that the pertinent consent has been procured, prior to their extracting, storing or using the relevant matter.3 This Act identifies several criminal offences. However, these do not apply to those who reasonably assume that the necessary consent has been obtained. Moreover, these offences do not apply when the individuals concerned reasonably believer that such consent is unnecessary under the given circumstances.4 The European Union Organ Donation Directive has established certain minimum norms. These standards have to be satisfied by all its Member States.5 The National Health Service Blood and Transplantation (NHSBT) has undertaken the commendable task of implementing a consistent and harmonised regulatory framework. This initiative has been taken in conjunction with the Human Tissue Authority and organisations involved with transplantation and organ donation.6 Under the Human Organ Transplants Act 1989, and the Human Organ Transplants (Unrelated Persons) Regulations 1989, a rider had been placed upon kidney transplants from live donors. Specifically, such transplants were permitted only between the emotionally or genetically related. The advent of new types of permitted transplants, namely the altruistic and paired donations, could expedite the procurement of an organ from a dead donor.7 In some of the European nations, donation of organs by children who are living is prohibited. In the places where such organ donation is permitted, it is restricted to siblings. This is one of the requirement under the Oviedo Convention that has been issued by the Council of Europe. This restriction is founded on the contention that children are not mature enough to take decisions of an altruistic nature, with respect to organ donation.8 Nevertheless, it is possible to regard such instances of organ donation as being in the interest of the child making the donation, to furnish health or even life to a loved sibling. Five requirements have been stipulated by the Oviedo Convention. These are, first, there should be no other organ donor available. Second, the organ donation should be made only to a sibling. Third, such organ donation should have the potential to prove life saving for the recipient. Fourth, the organ donation should be accompanied by authorisation from the parents. Lastly, there should be no objection from the donor regarding the organ donation.9 In the case of Re E (A Minor), the court ruled that the 15 year old boy involved, was not competent. This was on the basis of the perception that the boy’s will had been influenced and altered by his faith. In this case, the judge was unable to determine, whether the boy was acting of his own free will. Moreover, the judge harboured the doubt that this boy could subsequently change his religious convictions.10 A consequence of this decision is that a judge, upon disagreeing with the religious convictions of the minor, can ignore the refusal of treatment by the latter. However, the judge should not manipulate the Gillick test or the doctrine of undue influence to ignore refusal of treatment by a minor.11 Similarly in our case Shazia was interested in holistic medicine instead of kidney transplantation. Her wishes for holistic medicines can be ignored by the doctors as per the decision in Re E (A Minor), who can then undertake a kidney transplantation in the best interests of Shazia. In addition, consent permits actions that would otherwise be precluded. However, there are limits to such authorisation. For instance, consent fails to make available substantive justification and does nothing more than provide procedural justification. The term substantive justification describes a class of underlying norms or specific permitted acts.12 On the other hand, procedural justification can be understood as an act or decision that has an authorising effect. The Gewirth’s Principle of Generic Consistency states that every agent should act in a manner that does not violate the generic and fundamental rights. In this regard, the emphasis is to a greater extent upon the liberty rights and the right to some of the standards of wellbeing.13 The welfare of the child has been provided with the utmost importance by the court. This has been in accordance with the provisions of the Children Act 1989.14 One of the tests applied by the courts that pertains to the care of adults declared to be mentally incompetent, is the best interests test. This test tends to be complicated and its strict application prevents any manner of medical intervention that is not therapeutic.15 This test is based upon the reasoning that it cannot be stated that the interests of an incompetent person are safeguarded when that person is made an organ donor. A wider interpretation of the best interests test includes the danger of manipulation so as to attain the desired results. The welfare test could be abused, so as to endanger the health of those who should be protected.16 The doctrine of necessity was established by the court in the case of Re A (Children) (Conjoined Twins: Surgical Separation). This principle states that an act that would otherwise be a crime can be condoned, under certain circumstances. Specifically, the accused, in such instances, has to demonstrate that the act was done solely with the intention of avoiding certain outcomes.17 Moreover, such outcomes should not admit of being avoided, other than by the commission of the said act. In addition, these consequences should be such that they would have caused inevitable and irreparable harm to the accused or to the persons whom the accused was constrained to protect.18 Furthermore, the accused should have done just what was reasonably necessary for that purpose. Another requirement is that the damage caused by the act of the accused should not be incommensurate to the evil circumvented.19 In Re Y,20 the court ruled that an adult female with a severe mental handicap was to donate her bone marrow to her sister who was suffering with leukæmia. This person had a young daughter, whose care would have fallen upon their mother, in the event of her demise. The judge felt that the welfare of the mother and the young daughter justified the bone marrow transplant.21 The significance of the ruling in Re Y is that it recognises the importance of not only the physical but also the psychological interests. Such a view has also been persistent in the US courts, where a number of incompetent individuals were allowed to act as donors. For instance, in Hart v Brown, the court approved of the provision of consent by the parents. This was with regard to the donation of a kidney by their minor daughter to her identical twin sister. The court, while granting its approval, recognised the strong identification between these twin sisters.22 Similarly, in Strunk v Strunk, the court permitted a kidney transplant from an adult suffering with a mental handicap to his brother.23 This line of reasoning was abandoned in Curran v Bosze. In this case, a mother of three year old twins refused to submit them to testing as potential bone marrow donors. The court found an absence of a close family relationship between the potential donors and the recipient. Hence, it upheld the refusal of the twins’ mother .24 With regard to the welfare of the child or incompetent adult, several unknown factors tend to persist. This is despite the different ways in which the best interests test is interpreted. The courts, by and large, have concentrated upon the interests of all the concerned parties in the event of an outcome that proves to be satisfactory. However, the courts have not given much thought to situations, in which the transplant proves to be a failure.25 Re F dealt with the issue of the sterilisation of the mentally handicapped individuals. In this case, their Lordships examined this problem and concluded that it was to be subjected to judicial scrutiny. During the hearing of this case, some of the judges were of the opinion that this manner of thinking was to be extended to organ donation.26 Moreover, the decision Re Y has resulted in bone marrow donations being included in the category requiring judicial scrutiny. This category of cases relates to donors who are mentally incompetent. Such inclusion has been widely acclaimed as a sensible precaution. This is due to the fact that there is no legal system for surrogate decision making on behalf of adults who are mentally incompetent, as no adult may provide consent on behalf of another adult.27 Similarly in our case, if the doctors want to proceed with the kidney transplantation, involving the minor twin sister, they have to seek the permission of the court. The doctors can also check the possibility of considering Shazia’s father as a donor, by complying with the tests and procedures prescribed by the legislation in this regard. Question Two The law relating to organ donation mandates the application of certain tests and procedures by the healthcare professionals. These have to be undertaken, prior to taking a decision regarding organ donation by incapacitated persons. The following discussion elaborates upon this requirement. Consent regarding organ donation is established by the views made known to a family member or by membership of the Organ Donor Register. In the event of the death of an individual who has not stated his wish, in this context, to relatives; the healthcare professional will discuss organ donation with that individual’s family members.28 A tenth of the families of potential donors, on the list of the Organ Donor Register have refused to assent to donation. The extant practice is to honour the wishes of the family, with regard to organ donation, even in the presence of valid legal consent for the same.29 The improvements in anæsthesia and surgical procedures have reduced the risk of danger to live donors. Nevertheless, donors who are dead or on the verge of death remain the donors of choice. The various transplant programmes tend to rely upon consented donations from the irreversibly apnœic coma patients undergoing treatment in the intensive care units. However, the number of such patients has shown a steady decline.30 The law stipulates that donors should be of the consented and comatose variety. In addition, such donors should not satisfy the neurological criteria for diagnosis of death. Moreover, this diagnosis of death should not be such that it has to be subjected to a period of cardiac stand still and whole body ischæmia, which is not the same in all the jurisdictions.31 Such subjection is with regard to the cardiac criteria for returning a diagnosis of death, prior to the removal of organs. With regard to instances, wherein the donor is not in a state of coma there is considerable legal ambiguity regarding the controlled stoppage of treatment for removing the organs. This also holds good with respect to individuals with critical cerebral injuries.32 In ‘Who Decides? Making decisions on behalf of mentally incapacitated adults’, a Government Green Paper, the government had made a very important observation. It stated that it recognised the common law position and the principle that a court ruling was essential for any treatment or procedure pertaining to the donation of bone marrow or non – regenerative tissue from a mentally incompetent adult. 33 In Re A (Children) (Conjoined Twins: Surgical Separation), the court had to take a momentous decision.34 The attending physicians were of the view that the conjoined twins were to be separated, thereby providing the stronger of the twins with an opportunity to live. This was opposed by the parents who were deeply religious. These parents believed that any decision regarding the continuance of the life of their children fell under the purview of the Divine Will. It was their firm belief that no individual was to intentionally cause the death of another.35 The welfare principle had empowered the courts of the UK to override the decision of parents, if this was in the best interests of their children. Thus, the Family Division Court, came to the conclusion that it was in the best interests of the conjoined twins to surgically separate them.36 The ruling of this court was that the separation was not aimed at killing one of the conjoined twins. It was purely an instance of passive euthanasia, as food and hydration to the weaker of the conjoined twins, who was drawing sustenance from the stronger twin, would be discontinued. 37 This decision was appealed against by the parents of the conjoined twins. At the British Appeals Court, Justice Ward conceded that the parents were entitled to consent to or reject medical treatment, as proxies for their minor children. However, any such decision had to be in the best interests of the children. At the same time, the attending doctors were entitled to request the court to reject the decision of the parents and permit the operation.38 After a protracted examination of the various issues involved, the Court of Appeal dismissed the appeal of the parents of the conjoined twins. Six weeks after this decision, the operation was performed and the conjoined twins were separated. The weaker of the twins breathed her last during the surgery.39 The outcome of obtaining the consent of an incapacitated person results in legal proceedings, as such consent is invalid. Capacity assessment has to be performed, whenever a patient refuses a procedure, treatment, placement or food. It is also required, if the patient wishes to leave the hospital or clinic, against medical advice. In addition, evaluation of capacity is necessary with regard to the donation of organs by that person.40 Physicians dreading legal consequences, devoid of the skills to evaluate capacity, enjoying a poor rapport with the patient, and harbouring other such deficiencies should consult a psychiatrist. It is the duty of the physician to promote the interests of the patients. In addition, physicians should adopt the measures necessary for safeguarding them. They should also promote the autonomy of the patient.41 In instances, wherein the cognitive competencies of the patient are in doubt, such measures can prove to be daunting to adopt. To a certain extent, collateral information provided by the family members of the patients and other allied health care personnel can assist in differentiating facts from the statements of these patients.42 With respect to individuals who lack the capacity to make specific decisions on their own, the necessary legal framework for taking decisions and acting on their behalf, is provided by the Mental Capacity Act 2005.43 It is imperative for every individual caring for or working with an adult who could be devoid of capacity to take specific decisions, to act in compliance with this Act. This is with regard to taking decisions or acting on behalf of persons who may lack such capacity. These rules apply in all the cases, regardless of whether such decisions relate to commonplace matters or life altering events.44 Healthcare professionals are under a duty to care towards their patients. This duty requires the former to take all reasonable measures to prolong the life of their patients. It is indisputable that there is a strong presumption that favours the provision of life sustaining treatment. However, there are circumstances, under which the continuance of life sustaining treatment fails to bestow any benefit upon the patient.45 Moreover, such medical intervention could also be contraindicated from the clinical perspective. It is a well – established principle that healthcare professionals have to invariably act in a manner that promotes the best interests of their patients. Evaluation of capacity and best interests assumes considerable importance, due to the seriousness of decisions related to life prolonging treatment.46 The provisions of the Mental Capacity Act 2005 have to be applied by healthcare professionals, in situations where the concerned adults are devoid of the capacity to decide for themselves. Such capacity can be affected by the very dying process. Any decision regarding life prolonging treatment, with respect to patients who do not possess the capacity to decide for themselves, should promote their best interests.47 In addition, such decisions should be in accordance with their wishes, provided the latter have been made known. Prior to withholding or withdrawing life sustaining treatment, the concerned healthcare professional has to examine the various treatment options available and then decide as to what would be best suited to the specific requirements of the patient.48 It is imperative for the healthcare professional to consider all the factors enumerated in the Code of Practice and the Mental Capacity Act 2005. Specifically, the healthcare professional should take into account the statements made by the patients regarding their opinion and wishes, with respect to life sustaining treatment.49 The healthcare professional should also consider any advance instructions provided by the patients, when they had possessed the requisite mental capacity. Furthermore, healthcare professionals should take the relevant professional guidance at the time of taking decisions relating to life sustaining treatment. The capacity of the patient has to be assessed by the healthcare professional and the same is to be recorded in detail.50 With regard to children, it can be safely presumed that parents have the same degree of care towards them. Consequently, it can be assumed that parents will not harm one child, in order to benefit another. However, with regard to handicapped adults, the parents may no longer be alive. In addition, the family unity and cohesiveness that can normally be assumed, may no longer be present. This is all the more pertinent with regard to a prospective donor who does not reside with the rest of the family. 51 For instance, in Re B, the Law Lords ruled that cases involving any case involving minors had to be referred for judicial consideration, to the High Court. With this decision, the question of involuntary sterilisation of children was made subject to judicial scrutiny.52 In Burke v GMC, the plaintiff who was suffering from a progressive degenerative ailment sought a declaration from the court. His disease was expected to culminate in the loss of movement and speech. Moreover, artificial nutrition would have to be provided to him. Burke feared that when such an eventuality would arise, treatment would be discontinued. This would lead to death by starvation, which he would experience.53 Burke cited the provisions of Articles 2 and 3 of the European Convention on Human Rights (ECHR), which respectively dealt with the right to life and the prohibition of degrading and inhumane treatment. The court held that the duty of care imposed upon healthcare professionals would compel them to provide treatment that prolonged life.54 In Glass v United Kingdom, David Glass had been undergoing a serious neurological disability, since his birth. He was admitted in a hospital, due to respiratory distress and put on a ventilator. However, the attending physicians removed the ventilator stating that David was on the verge of death. His mother insisted that the ventilator be continued. A dispute developed over the treatment to be accorded to David, and his mother attempted to remove him from the hospital. She was threatened with arrest by the police.55 The European Court of Human Rights held that ignoring the wishes of the mother of a critically ill child breached Article 8 of the ECHR According to the above discussion and decided case law, regarding organ transplantation by incapacitated persons, the courts have mandated several tests and procedures to be followed, before taking a decision. The health care professionals should consider all the circumstances and take decisions that are in the best interests of the vegetative or dying patient. Taking decisions without complying with the legal procedures will make them criminally liable. Bibliography — — ‘Improving consent in organ donation’ [2012] 28(3) Medical Ethics Advisor 32 — — ‘In Re A (Minors) (Conjoined Twins: Medical Treatment); aka In re A (Children) (Conjoined Twins: Surgical Separation); CA 22-Sep-2000’ (swarb.co.uk, 2 November 2012) < http://swarb.co.uk/in-re-a-minors-conjoined-twins-medical-treatment-aka-in-re-a-children-conjoined-twins-surgical-separation-ca-22-sep-2000/> accessed 23 November 2013 — — ‘Legislation’ (organ donation) accessed 23 November 2013 — — ‘Mental Capacity Act 2005 Code of Practice’ (Department of Constitutional Affairs, 23 April 2007) accessed 24 November 2013 Burke v GMC [2005] EWCA Civ 1003 Children Act 1989 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine [1997] Council Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation [2010] OJ L 207/2010 Curran v Bosze [1990] 566 NE 2d 1319 Davies J L, ‘The Implications of the Human Tissue Act 2004’ [2006] 12(3) Clinical Risk 92 Engström I, ‘Ethical reflections on organ donation from children’ [2011] 100(9) Acta Pædiatrica 1172 Glass v United Kingdom App no 61827/00 (ECtHR, 9 March 2004) Hart v Brown [1972] 289 A 2d 386 Human Organ Transplants Act 1989 Human Organ Transplants (Unrelated Persons) Regulations 1989 Human Tissues Act 2004 Johnson G and Wilson A, ‘Human Tissue Act 2004: The age of consent arrives in the UK’ [2005] 12(1) Journal of Commercial Biotechnology 40 Lynch J, Consent to Treatment (Radcliffe Publishing 2011) Manson N C, ‘Review of Consent in the Law By Deryck Beyleveld & Roger Brownsword’ [2010] 27(2) Journal of Applied Philosophy 215 Mental Capacity Act 2005 Meraj A and Poje A, ‘Capacity assessment: a fundamental skill’ [2011] 10(9) Current Psychiatry 72 Mumford SE, ‘Donation without Consent? 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