Presumed Consent?

1. Presumed Consent? An examination of the bioethics involved in ‘opt out’ methods of human organ procurement and the impact such systems may have on the future role of xenotransplantation. Stephen J Doyle

2. Introduction Some of the most important initiatives in medicine in the last 50 years have been in the field of organ transplantation. Since the first transplants were carried out in the 1950s and 60s, there has been an imbalance between the amount of donated organs available at any one time, and the number of hopeful recipients. Organ donation was originally viewed as a purely altruistic choice for an individual but many models have since been used to try to address the issue of organ availability. One method used by various countries has been to change the responsibility of a person to opt in to a system of donation and to instead actively opt out if they do not want to donate their organs after death. This so called presumed consent system has many ethical considerations that will be addressed in this presentation. Another approach to the problem of insufficient organ supply is to grow the organs in animals. Xenotransplantation. We will look at his briefly later in the presentation and ask the question of how presumed consent systems, if implemented on a wide scale, may affect it.

3. Current System At the moment in the UK we can only harvest from people who have joined the donor register, carry a donor card or have made their wishes clear to their nearest and dearest. This policy is known as expressed consent and ethically relies on the assumption that express or explicit consent is always prospective informed consent. Current legislation is provided by the Human Tissue Act 2004(1)and the Human Tissue (Scotland) Act 2006(2). Last year in the UK, there were 7300 people on the waiting list for a life saving transplant. However, only 3235 transplants were carried out using the organs from just 1665 donors, moreover, 851 of these were living donors. 400 people die each year in this country due to this shortage of organs. Although there are nearly 16 million people registered on the UK national transplant database, statistical analysis indicates that closer to 40 million would be willing to donate but just haven’t signed the register. Up to 40% of possible donations are not carried out because of opposition from the relatives of the deceased even though they have no legal right of veto. (all statistics taken from the UK national database on 20th October 2008)(3)

4. Alternatives • Increased promotion/ education. • Paid or compensated donor schemes. • Priority for transplants given to those that have agreed to donate. • Mechanical engineered organs. • Biologically engineered organs. • Living donors. • Paired/pooled schemes. • Required referral. • Aggressive consent pursuit. • Forced donation. • Donation after cardiac death donation (DCD). • Xenotransplantation. • Presumed consent.

5. Presumed consent Presumed consent takes the onus away from the individual to register in order to become an organ donor. Instead, the individual must sign a register in order to make his views known that he does not want to donate. Therefore everyone is treated as a donor unless they implicitly opt out. This removes the anomaly that (in the UK), 25% of people are registered on the national transplant database whilst up to 80% of individuals are willing to donate their organs after death but have never got around to signing the database(3). There are two methodologies applied to the presumed consent approach. The soft (lenient) system as carried out in Spain which still takes into account the views of relatives and the hard (stringent) system as instigated in Austria (the only country to use this system), where no consultation with family is legislated for(4). 22 nations have so far implemented presumed consent laws and evidence points to them doing slightly better than informed consent countries(4), however, their performance in many cases improved long after the laws were implemented and seem to be due in part to other effectors(5). Interestingly, in most countries using presumed consent, there is only a 2% rate of individuals opting out of donation, which may indicate a procrastination on behalf of people who may well not want to donate(6).

6. Presumed consent The success of the system is difficult to assess. In Sweden, an advocate of the system, donation rates are lower then in the UK. Whereas in Spain, donation rates are three times what they are here(7). What clouds the issue is that in Spain, there are transplant coordinators in all major hospitals, more intensive care beds, and a higher rate of fatal road traffic collisions which all lead to higher take up rates of organ donation(8) The consensus however, seems to indicate that although presumed consent is not the panacea of organ procurement strategies, it does seem to increase donation levels. In 2003 countries implementing opt-out systems had donation rates of over 20 people per million compared with the UK levels of 12.3(4). Furthermore, in 2006, Abadie and Gay published a detailed regression study taking into account other determinants that may effect donor rates and concluded that presumed consent systems still increased rates of donation by 25-30%.(9). Some studies however, indicate no higher donation rates despite implementation of opt-out systems(10). Moreover, some authors as illustrated below, tend to compare effective consent rates rather than actual procurement rates which exaggerate the success of countries using presumed consent. Table 1 from http://www.iq.harvard.edu/blog/sss/archives/2008/04/do_defaults_sav.shtml Table 2 from http://www.kieranhealy.org/blog/archives/2008/04/09/psychology-vs-organizations-in-organ-procurement/

7. Graphical illustration of effective consent rates and donor procurement rates in European countries. .

8. Ethical arguments for presumed consent • It is considered obscene by many people that huge numbers of perfectly good hearts, livers, kidneys and lungs are destroyed each day by cremation or burial while people are dying for want of these organs. • Possible donors may have just not got around to registering. Surveys have shown up to 80% of people are willing to donate organs after they die, but only a quarter register. Most people do not consider it likely that they may die prematurely and it is therefore difficult to persuade them to consider donation in advance. • Levels of organ availability are greatly reduced by relatives refusing donation. The stringent system of presumed consent could be justified from a utilitarian viewpoint in that it should result in more donors. However, even in countries using the lenient system, donation veto by relatives is reduced.(9) • As between 60-80% of people would be willing to donate according to surveys, changing the default position would better reflect public opinion. • A shift to presumed consent may instigate more discussion within families about organ donation. • Presumed consent laws may lead to a culture change meaning that people would view organ donation as the norm rather than the exception.

9. Ethical arguments against presumed consent • It could be very easy to regard very ill patients as just a source of multiple organs that could help many recipients. In today's climate, distrust of some fields of medicine and certainly those concerned with organ retention e.g. the Bristol enquiry(11), could lead to paranoia amongst patients and their relatives. • Surely organ donation should be an altruistic choice rather than coerced. Indeed many patients who have received an organ say that it was more easily accepted because it was freely given as a gift. Some recipients may therefore feel some degree of guilt in receiving an organ that was maybe not 100% freely given. • The non signing of a register cannot automatically be taken as a willingness to donate, many people will just not get around to signing it. It is difficult for people to envisage a future that may entail an early demise for them. • There are concerns that the rules for the definition of donor death may need tightening up. For decades, organs would only be removed when a patient was declared brain dead. However, a procedure called donation after cardiac death is being used more and more, often as a way to make organs more plentiful, leading to some controversy.(12) Last year in the UK, there was a 36% increase in organ retrieval from non heart beating donors(3). • Further concerns are evident in the mental aptitude of a large proportion of the population to make an informed decision on opting out. Not signing the register may indicate a lack of understanding rather than a willingness to donate. The burden of ensuring respect for their wishes will be shifted from the state to themselves.

10. Ethical arguments against presumed consent • The age of consent may be another minefield of unsure legislation. Should presumed consent only apply to those aged above sixteen? eighteen? This age of autonomy once decided upon could lead to questioning of Gillick competency(13). A Gillick competent child although below the age of autonomy is considered mature enough to be treated as an adult. • The responsibility for maintaining and securing an up to date and accessible database is not something the government has a very good record with. It is unsure and improbable that 100% safeguards can be given. Situations will occur where information is erroneously recorded, not found, or have issues with concurrency. • Maintaining that 60-80% of people could be willing to donate, by looking at systems in Europe which may have only a 2% opt out could mean that 20-40% of individuals may be caught in the trap of donating against their will. • The state should not presume ownership of an individuals body after death. It is akin to nationalisation. • Various religions may not only have theological objections to organ donation, but also have concerns on how a body is treated after death. Not to mention concerns with the legal definition of death as mentioned previously with non beating heart donation. The state is therefore imposing a secular viewpoint and in states such as Singapore, exemptions have had to be made for Muslims on religious grounds(14).

11. Ethical arguments against presumed consent • There is evidence that, certainly in the UK, people on the donor register now will leave it in protest at state intervention although this may be seen by some as political manoeuvring(15). Could presumed consent reduce donation rates in countries where autonomy is highly prized? It had to be withdrawn in Brazil because of mistrust in the health system(16). • Could the system, taken to extreme, result in total removal of all organs? At the moment, many individuals cherry pick which organs they’d like to donate and for instance would not donate corneas thinking they may need them in ‘the next life'. Once this legislation is introduced, doctors may consider the presumption of consent allows major harvests of all parts of the body leaving an empty shell.

12. Xenotransplantation • Xenotransplantation is the transplantation of tissues or organs or tissues from one species to another. Many issues stand in the way of allowing it to be used clinically. • Originally, it was proposed that primates may be the most useful donor animals, however, problems were encountered including small organ sizes, long gestation periods, ethical concerns in using one of man’s close relatives and risk of disease transmission because of their close phylogenetic distance to humans. • Current uses involve porcine pancreatic tissue for diabetes control, heart valve replacements, and porcine livers as temporary ‘bedside’ replacements pre human liver transplants. • Many barriers are still to be overcome in regards to immune rejection. The response is generally stronger than in allotransplants because of antigenic dissimilarity. Much scientific research is being carried out in immunosuppressive techniques in order to overcome the various acute and chronic rejection problems. Transgenic (genetically engineered) animals are seen as possible solution to this. • Inter species disease transmission,(xenosis) is another hurdle that must be overcome. Porcine viruses include circovirus, parvovirus and rotavirus and the animals must be carefully screened in order to eliminate these risks, especially with potential organ recipients likely to be immunocompromised(17).

13. Xenotransplantation • A major cause for concern are endogenous retroviruses. These are fragments of old viral infections integrated into the DNA of most species. About 50 Porcine retroviruses (PERVS) are harboured by pigs and although not disease causing in the host, may become infectious in another species. • Other concerns are evident. Pigs live for about 15 years and their organs age at different rates to humans throwing into confusion the estimates of donation viability. Their organs are smaller, work at different temperatures, different fluidic pressures and there could be problems with some proteins and hormones being incompatible. • Amongst many other organ procurement initiatives, xenotransplantation also has quite complicated ethical issues attached. Is it right to use animals purely as hosts to grow organs for humans? How will religious beliefs reconcile with the use of pigs as a donor source? Is it right (in the case of transgenic animals) to permanently alter the genetic code of a species? How do we maintain informed consent of potential recipients with such an experimental procedure? • However, there has been no ‘magic bullet’ for the problem of organ shortages and any solution is likely to involve a multi faceted approach. For this reason, xenotransplantation would appear to still remain a viable technology even after the adoption of other procurement techniques such as presumed consent legislation.

14. Conclusions A policy of presumed consent although potentially beneficial is highly problematic. Evidence may suggest an increase in donor rates where countries have implemented such systems, however such increases are neither guaranteed nor obviously due to the opt out system alone.Indeed many countries that have more donors per million of population also have stronger systems of transfusion coordination and a more pro active system of pursuing family approval. It is therefore important to attempt to identify the variables that together may increase organ donation and try to implement the less ethically debatable options including improved education before we go down the route of presumed consent. One possible solution would be to adopt a system of required referral or mandated choice and protect these choices from familial veto. Although the system has been adopted elsewhere, it is by no means accepted that it would increase donation rates in the UK. We are a rebellious people by nature and any coercive solution I think could be opposed. Even in countries lauded as ideal proponents of presumed consent, waiting lists have not been eliminated and this is likely to worsen due to increased prevalence of diseases like hepatitis C, and so it seems likely that no single strategy is likely to solve it. Therefore, even if the opt out system is adopted widely, other strategies such as research into Xenotransplantation are unlikely to be disregarded for the foreseeable future.

15. References http://www.opsi.gov.uk/ACTS/acts2004/ukpga_20040030_en_1 http://www.opsi.gov.uk/legislation/scotland/acts2006/asp_20060004_en_1 http://www.uktransplant.org.uk/ukt/statistics/statistics.jsp Gimbel RW,Stosberg MA, Lehrman SE, Gefenas E, Taft F-Presumed consent and other predictors of cadervaric organ donation in Europe. Progress in transplantation 2003;13(1):17-23 www.kieranhealy.org/files/papers/presumed-consent.pdf Ashraf H. Doctor and patient groups vote for presumed consent. Lancet 1999; 354: 230. Council of Europe. Deceased organ donors. Transplant Newsletter 2006;11(1):4. Miranda B, Vilardell J, Grinyo JM. Optimizing cadaveric organ procurement: the Catalan and Spanish experience. Am J Transplant 2003;3:1189-96 Abadie, Alberto and Gay, Sebastien,The Impact of Presumed Consent Legislation on Cadaveric Organ Donation: A Cross Country Study(June 2004). KSG Working Paper No. RWP04-024. Coppen R, Friele RD, Marquet RL, Gevers SKM. Opting-out systems: no guarantee for higher donation rates. Transpl Int 2005;18:1275-9 Bristol Royal Infirmary Inquiry. The inquiry into the management of care of children receiving complex heart surgery at the Bristol Royal Infirmary. (Interim report): Removal and retention of human material. Bristol: Bristol Royal Infirmary Inquiry; 2000. http://apnews.myway.com/article/20080814/D92I8TC00.html Gillick v West Norfolk and Wisbech Area Health Authority [1985] UKHL 7, [1986] 1 FLR 229, [1986] AC 112. Singapore Ministry of Health. Human Organ Transplant Act. .www.moh.gov.sg/mohcorp/legislations.aspx?id=1672 http://conservativehome.blogs.com/torydiary/2008/01/lansley-it-is-s.html Institute of Medicine. Organ donation: opportunities for action. Washington, DC: National Academies Press, 2006 Michler, R. 1996. Xenotransplantation: Risks, Clinical Potential, and Future Prospects. Emerging infectious diseases volume 2 number 1. Jan-Mar 1996 Kennedy I, Sells RA, Daar AS, Guttmann RD, Hoffenberg R, Lock M, et al. The case for "presumed consent" in organ donation. International Forum for Transplant Ethics. Lancet 1998;351:1650.