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Organ donation

Without organ donation countless lives each year cannot be saved. This article begins with a brief discussion of whether we own our body parts before moving onto the scandals at the Bristol Royal Infirmary and the Alder Hey Children's Hospital where organ retention without consent led to the introduction of the Human Tissue Act 2004. With consent still in mind, the article also discusses organ donation and the current system of opt-in for organ donors in England and Wales before concluding by exploring "deemed" or "presumed" consent which comes into effect in Wales on 1 December 2015. Thereafter, other methods of encouraging organ donation are explored.

Is our body our own?

1. Historically, a person's body was not considered to be property and therefore could not be stolen unless there was some "work and skill" involved (Doodeward and Spence 1908 6 C.L.R. 406). In R. v Kelly (Anthony Noel) [1999] Q.B. 621 the court suggested that organ retrieved for organ transplantation could amount to property for the purposes of s.4 of the Theft Act 1968. Although Dobson v North Tyneside HA [1997] 1 W.L.R. 596 held there was no ownership in a corpse and the next of kin could not recover his brain when it had been removed for autopsy, treated and stored, the case of Yearworth v North Bristol NHS Trust [2009] EWCA Civ 37; [2010] Q.B. 1 rejected the approach in Doodeward and Spence and held the claimants sperm belonged to the patients and the hospital were liable in negligence for the negligent storage.

Background to the Human Tissue Act 2004

2. The Kennedy Inquiry 1998 investigated the deaths of a number of babies who had died undergoing heart surgery at the Bristol Royal Infirmary Hospital and the Alder Hey Children's Hospital during the late 1980's and 1990's. Whilst the inquiry was wide ranging, it transpired that children's organs had been retained without the parents' consent. The pathologists did not seek consent to save the families from further distress and simply wished to retain the organs for the purposes of research or education. The case of A v Leeds Teaching Hospitals NHS Trust [2004] EWHC 644 (QB); [2005] Q.B. 506 concerned the parents claim for psychiatric injury as a result of their deceased's children's organ retention. Although one claim succeeded, removal of organs fell within the remit of the Human Tissue Act 1961 and there was no subsequent right of possession of the organs.

The Human Tissue Act 2004

3. The Human Tissue Act 2004 was set up as a direct response to the scandal over retained organs at the Alder Hey Hospital and the Bristol Royal Infirmary. The Act's objective was "to provide a consistent legislative framework relating to the whole body donation and the taking, storage and use of human organs and tissue" with consent for removal of organs being the underlying principle. Section 1 states that, where "appropriate consent" is obtained from the deceased or the living person before removal, storage and use of relevant material can be permitted. "Relevant material" is defined in s.53 as tissue and material which includes cells but gametes and embryos are excluded. It is now a criminal offence to removal organs without the person's consent (s.5(1)).

4. The Act's stated objective belies its real value. Whilst it was not intended to promote or encourage organ transplantation, the introduction of legislation helped to renew the public's faith in organ retrieval. The Act is extensive in its provisions requiring consent and considerable attention is paid to who is able to provide consent and how consent is dealt with where the person lacks capacity. Moreover, the provisions relating to the illegality of commercialization of organ donation ensured the public would have confidence that it was increasingly difficult for there to be a trade in human organs. The Act introduced extensive Codes of Practice and perhaps more importantly, the Human Tissue Authority to assist regulation of the Act and to issue licences to retain and use material where appropriate. The Human Tissue Act 2004 has achieved a considerable amount in restoring public confidence in organ retrieval and donation and is at the forefront of consent issues in this crucial area of medical law.

The definition of death

5. For the purposes of organ transplantation, it is important to be able to precisely determine when a patient dies. Although the accepted definition of death in the UK is brain stem death, historically, death had been defined as cardio pulmonary failure (when the heart and lungs had ceased to function). However, with the advent of assisted ventilation, the body could be maintained artificially and the definition of death ceased to have any clear meaning. By 1954, the first kidney transplant was successfully performed in Boston, USA and only 13 years later the first heart transplant was carried out in South Africa. In 1995, (although earlier in the USA), brain stem death was defined and accepted as the "irreversible loss of the capacity for consciousness, combined with irreversible loss of the capacity to breathe". The judiciary has accepted the definition of death set down by the medical profession (see Lord Lane CJ in R. v Malcherek (Richard Tadeusz) [1981] 1 W.L.R. 690 at 426) and in Airedale NHS Trust v Bland [1993] A.C. 789 Lord Keith noted that in "the eyes of the medical world and of the law, a person is not clinically dead so long as the brain stem retains its function".

Organ donation in the UK

6. Without organ donation there cannot be organ transplantation. However, it is a question of supply and demand; there are insufficient available organs to meet the demand of those patients waiting for organ transplantations. The majority of organs derive from deceased patients and in 2013/14 there was a record 1,320 deceased organ donors. Living kidney organ donors increased to 1,146. However, there were still 7,026 patients waiting for organs for transplantations and 456 patients died waiting for a transplant or were removed from the list as their condition deteriorated to the extent that were unable to have a transplant. (Source: NHSBT Summary of Donor and Transplant Activity Report 2013/14)

Live organ donations

7. Live organ donations are now governed by statute.s.1 of the Human Tissue Act 2004 set out the framework for the storage and use of material from a human body. Section 1(1)(d) requires appropriate consent for the storage or use of relevant material which can include transplantation (Sch.1 Pt 1). An incompetent adult cannot consent to organ donation but may still donate an organ if the court considers it to be in their best interests. In Y (Mental Patient: Bone Marrow Donation), Re [1997] Fam. 110 although Y lacked capacity to consent to donating bone marrow to her sister, her "best interests" were widely defined. Whilst it was not in Y's best interests to undergo an invasive procedure, best interests included both emotional and psychological factors and the courts permitted the donation. Although bone marrow is regenerative, difficult ethical issues would arise in the case of a non-regenerative organ such as a kidney from a patient that lacked capacity to consent. In Strunk v Strunk 1969 445 SW 2d 145, an American case, the court permitted a kidney transplant from an incompetent patient to his brother relying on a wide definition of best interests.

The child donor

8. The Human Tissue Authority Code of Practice A 2013 states that organ donations from children would only be permitted in "extremely rare circumstances" and prior approval of the court would be required. In these circumstances, it would be the potential donor's interests which would be the paramount consideration, rather than the potential recipient. However, the best interests of the donor child "is not limited to medical interests, and should take account of potential emotional, psychological and social benefits and risks".

The sale of live organs -the law and ethics

9. The Human Tissue Act 2004 prohibits the sale of live organs. Section 32 states that a person commits a criminal offence if he a) "gives or receives a reward for the supply of, or for an offer to supply, any controlled material" or is involved in the commercialisation of the supply of live organs.

10. Although the sale of live organs is unlawful, a black market in the trade of organs thrives and a number of cash-for-organs scandals have been exposed. China has not denied retrieving organs from prisoners after execution despite the obvious unethical implications of such a practice. The black trade market is worldwide and thousands of organs (including over 7,000 kidneys) are illegally bought and sold each year often in brutal and coercive circumstances. (World Health Organisation Bulletin). However, there are more puzzling instances, take for example, Daniel Tuck, then aged 26, who was convicted when he agreed to sell his organ for £24,000 in order to pay off his gambling debts, or consider the more recent example of an Irish lady who wanted to sell her kidney, in order to purchase a new house.

11. In reality, the rich pay large sums of money to obtain a compatible organ without lengthy periods of time spent on the Organ Donor waiting list or their health deteriorating further. It is the poor who sell their organs, and often see it as their only option to be achieving some financial gain. The brokers make a healthy profit and in doing so exploit the poor. Although by and large it is the poor who sells their kidneys for financial benefit, there are also examples where kidneys have been sold to pay off gambling debts and even to raise money to buy a home. Distribution of available organs should be based upon clinical need and not on wealth.

12. Is it ethically acceptable for a person to sell their kidney to another? From a utilitarian perspective, the sale of kidneys will increase the number of available organs thereby improving the recipient's life therefore should a person wish to sell their kidney and the donee is willing to buy it, it can be seen as a positive step satisfying utilitarian values of creating more pleasure than pain (see Jeremy Bentham's The Principles of Morals and Legislation 1789; the felicific calculus). The pleasure is caused to the donee as he receives the organ that will save and/or improve the quality of his life and the donor who sells her organs also experiences pleasure because her quality of life is improved by receiving the money for the kidney she has sold. In contrast, one may argue it treats the donor as a commodity and is contrary to deontological principles (see Immanuel Kant's Groundwork of the Metaphysics of Morals 1785, the Categorical Imperative) where one should never "act in such a way that you treat humanity, whether in your own person or in the person of any other, never merely as a means to an end, but always at the same time as an end". The donor is being exploited and from this perspective the sale of organs is unethical.

13. However, one must remember that it is the donor's autonomous decision whether or not to sell her organ and her wish should be respected but can a person really provide true and informed consent when her only access to money is by selling her organ?

14. The black market trade is perpetuated by its illegality and there are thousands who suffer each year as a direct result. Given that it is impossible to remove the worldwide black market, Harris J and Erin C "An ethically defensible market in organs" BMJ 2002; 325: 114-115 advocate that an ethically sustainable market in human body parts could be established. This, they argue, could take the form of a monopsony where a fair price is fixed in order to protect the exploited poor, which would avoid the overly inflated prices paid by the highest bidder. Although at first glance this seems disturbing unethical, arguably there is mileage in the argument that dealing with the existence of a black market creatively is considerably preferable to ignoring its existence or policing it ineffectively, allowing it to continue and flourish.

Opt in or express consent

15. Currently, should a person wish to become an organ donor they must register their intention by signing the Organ Donor Register either on line or in traditional paper form. Other ways of indicating a willingness to donate organs on death include ticking appropriate boxes on the new style UK driving licence or by way of schemes such as the Boots Advantage Card (a loyalty card). This is referred to as opt-in or express consent since it one takes a positive step to donate organs on death by expressly indicating an intention to do so.

The role of relatives

16. If a person has not expressed a wish to donate his organs on his death, it is permissible for a relative to consent to organ donation on the deceased's behalf. If the deceased consented to donation of his organs during his lifetime, the Human Tissue Authority's Code of Practice, March 2013 (clause 99) states that the matter should be discussed sensitively with the relatives of the deceased but the relatives can no overrule the deceased's wishes to donate organs. The Code of Practice explains that despite the fact there is no family veto, each case should be considered on its merits.

17. If on death, a person has not expressed any wishes during his lifetime to donate his organs the Human Tissue Authority allows a relative to indicate that person may have wanted to donate organs even if he had not expressly "opted in". Where the deceased consented to donation of his organs, the Human Tissue Authority's Code of Practice, March 2013 (clause 99) states that the relatives cannot overrule the deceased's wishes to donate organs but the subject should be discussed sensitively. The Code of Practice explains that despite the fact there is no family veto, each case should be considered on its merits.

18. In "Taking Organ Transplantation to 2020", an NHSBT strategic document dated July 2013, one of the stated objectives is to improve donor conversion rates as the UK faces one of the highest family refusal rates for organ donation in the West. In fact, some 40% of families refuse donation once their loved one has died, which is one of the primary reasons why transplant teams miss out on potentially viable organs from the deceased. In 2012/13 115 families (13%) refused to support their loved ones wish to donate their organs upon death compared with 799 families who supported their relatives express wish.

19. In 2015, the Human Transplantation (Wales) Act 2013 becomes effective and will introduce a form of "soft opt-out" or where the relatives' role will be to confirm whether the deceased had any unregistered objection, making it easier for families simply to confirm the deceased's wishes rather than make decisions on their behalf. Being less able to overrule or veto a deceased's wishes regarding organ donation, the deceased's autonomy would be respected. There is also an advantage for the medical professional who is now relieved of the responsibility of asking intensely difficult questions regarding organ donation at a very personal time and distressing time.

20. Opt-out or presumed consent: There are no current proposals to introduce presumed consent in England. However, the Human Transplantation (Wales) Act 2013, which will become effective from December 2015 provides that a competent adult over the age of 18 and living in Wales for the preceding 12 months, will be "deemed" or presumed to have consented to donate their organs on death.

21. The Act's intention is to increase organ donors in Wales by 25% and although organs will be available to those in need throughout the UK, lives may well be saved in Wales as a result of introducing opt out. In 2012/13, 36 patients died in Wales whilst waiting for an organ transplant but only 32% of people living in Wales had signed the Organ Donor Register.

22. The Act applies to those who are "ordinarily resident" in Wales and may apply to students in Wales and those in the armed forces and their families who are stationed in Wales. Where the deceased lacked capacity during his or her lifetime, consent cannot be deemed. However, a person in a qualifying relationship or an appointed representative will be asked to make a decision about organ donation on their behalf.

23. Presumed consent assumes that a person consents to organ donation on their death and should they not wish to, they must opt out. The reasoning for introducing presumed consent is that there could be a significant increase in the amount of available organs as surveys indicate that far more people are actually willing to donate organs than are registered. Presumed consent assumes a person's registration.

24. Introducing presumed consent is costly as there would have to be a significant and education with a high level of public awareness in order for presumed consent and all that it entails to be fully understood. However, more organ donors means more organ transplantations freeing kidney patients from time consuming and costly dialysis and allowing them to return home, to lead healthier lives, returning to work and contributing to family life. The cost in promoting organ donation could well result in a significantly lower burden on the NHS caring for patients on the Organ Donor waiting list.

25. People are reluctant to consider their own death and to discuss options with their families. Even with adequate education about an opt out system; there may be those who do not opt out either through apathy or failure to understand the system. Campaigns of awareness must ensure that everyone who does not opt out positively consents to organ donation rather than be a victim of either ignorance or indifference. Consent should be informed consent failing which, consent is not real. There will be those who are less educated and less likely to truly appreciate the importance of opting out, whose organs will be removed on death probably against their true wishes. In turn, arguably, this would amount to treating the deceased as a public resource.

26. Does presumed consent increase the numbers of organ donors? Statistics supplied by the Council of Europe, National Transplant Organisation suggest that countries which exercise presumed consent (an "opt out" system) also have the highest number of donors; for example, Spain has an opt out system and, in 2003, 33.8 organ donors per million population. These statistics have remained consistently high, even rising to 34.4 per million inhabitants before dropping to 32 per million in 2010. However, the reason why Spain's donor statistics remain so high is largely connected not only to their opt out system but also to their organ transplantation infrastructure. Other countries which have adopted presumed consent, such as Austria, Belgium, Finland and at least five other European countries also have noticeably high organ donor rates.

27. Nevertheless, Sweden which adopted presumed consent in 1996 also has one of the lowest rates of organ donation in Europe and Brazil adopted presumed consent in 1997 but due to government mistrust and concerns about body-snatching, the policy was reversed the following year. In 1992 in France a young man died in a road traffic accident, at which point his corneas were removed. However, his parents had only consented to limited organ donation and the subsequent negative press publicity damaged the image and trust of presumed consent.

28. Incentives for organ donation: Organ donation is considered to be an altruistic act, a charitable act of great kindness and therefore arguably, it would not be ethically acceptable to financially reward the donor for his act of compassion and kindness.

29. To this end, the report from the Nuffield Council on Bioethics (Human Bodies: Donation for Medicine and Research 2011) recommended a pilot scheme to ascertain whether payment of funeral expenses would increase organ donation rates. This is not intended to be a financial incentive as such and the payment would only be made once a person has already indicated their willingness to donate their organs on death. Therefore the payment is seen as a form of gratitude, does not amount to payment and is not open to accusations of being contrary to deontological principles by treating people solely as a means to an end. However, it is arguable that a balance can be achieved between paying someone for donating an organ on their death (financially rewarding them) and creating a financial incentive to donate.

30. Other incentives could include tax breaks or giving those who indicate their willingness to donate a higher priority on the organ transplant waiting list. This latter concept has already been introduced in countries such as Singapore and Israel. In Israel only 4% of the population carries Organ Donor cards according to the Israeli National Center for Transplantation. In 2008 the Israeli Organ Transplant Law 2008 was passed and came into force in 2012. The Act offers privileges to those who donate over those who do not. Once a person has agreed to become a donor, both they and their first-degree relatives are given priority over those who have not agreed to become organ donors. The scheme which has already seen increasing numbers of organ donors has been criticized for encouraging 'gaming': that is, donor cards will be signed to gain priority without any real intention to donate. Another difficulty relates to one of the attractions: if signing up to become a donor is attractive because it provides both the donor and his first-degree relatives with a potentially higher priority, this becomes a disadvantage if a potential donor comes from a smaller family who would then find the incentive scheme less attractive.

31. In 2013 the National Health Service Blood and Transplant Authority in the UK published a strategic document entitled "Taking Organ Transplantation to 2020". One of the most radical considerations was whether to explore options relating to whether those on the Organ Donor Register should receive higher priority should they need an organ to those who are not registered. Whether there is appetite amongst public policy makers to start these discussions remains to be seen.

Mandated choice:

32. Another less popular method of attracting organ donors is by introducing mandated choice which would require every person to decide what will happen to their organs on their death. This could be done either through tax returns or through the state benefit system.

Compulsory removal of organs from the deceased

33. A more extreme measure, but one that would ensure a plentiful supply of organs would be if organs were automatically removed from the deceased. As (Law and regulation of retained organs: the ethical issues L.S. 2002, 22(4), 527-549) we have no interests in our organs after our death and removal of our organs would not harm us, they should be removed even without our express consent. Whilst there may be considerable advantage in terms of available organs for donation, it would fail to respect religious or cultural views and the deceased's express wishes.

Education and campaigns

34. One method of creating greater awareness of organ donation could be to introduce the issue as a compulsory subject into Personal, Health and Social Education as part of the National Curriculum in schools. This would be an effective way of introducing the subject to young adults and a way of allowing the subject into family life where it appears to be the permanent white elephant in the room. Campaigns are an alternative and effective method of increasing awareness of the need for organ donors. A campaign by the ITV network "From the Heart" aired in February 2013 which followed the story of heart recipient Will Pope, motivated 48,000 people in a single day to pledge their organs to help others on their death and changed apathy into activism.

Xenotransplantation

35. Xenotransplantation is where the organ and or tissue of an animal are transplanted into a human body. In 2006 the Department of Health defined xenotransplantation as:
  "any procedure that involves the transplantation, implantation, or infusion into a human recipient of either live tissues or organs retrieved from animals, or, human body fluids, cells, tissue or organs that have undergone ex vivo contact with live non-human animal cells tissues or organs."

36. If legal, ethically acceptable and medically successful, xenotransplantation could instantly eliminate the shortage of organs available for transplantation by using pig organs. There has been no xenotransplantation in the UK to date but in 1984 a baboon's heart was transferred to "Baby Fae" in the USA who survived 20 days post transplantation. The 1990's has seen further development and problems concerning immune suppressants have improved. If xenotransplantation could evolve further it could resolve the shortage of donor organs. Nevertheless, there may also be thought to be ethical considerations including the risk of transmitting animal viruses to humans, the rights of the animal and religious objections.

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