Future doctors perspectives on the implications of opt-out legislation for organ donation

Transcription

1 Future doctors perspectives on the implications of opt-out legislation for organ donation Amy Barber, Simon Patterson, Maria Ward and Lois Murray, 2 nd Year Medical Students, Queen s University Belfast Address for Correspondence: School of Medicine, Dentistry and Biomedical Sciences, Queen s University Belfast, University Road, Belfast BT7 1NN. abarber02@qub.ac.uk The UK has an opt-in organ donation policy, whereby a person must actively join a register in order to give consent to donate their organs. Given the clear shortage of organ donors (currently over 7,000 people are awaiting an organ transplant and last year but only 3,087 transplants were performed. [2] ), we can conclude that something needs to be done in order to reduce, if not eliminate this deficit. Upon considering an opt-out policy, whereby consent to donate organs is presumed unless action is taken against such a presumption, we have evidence that the shortage may be reduced: for example, there are 35.1 donors per million population (pmp) in Spain compared with 12.8pmp in Britain. [5] Such an approach may be welcome in the UK so long as it begins as a soft approach, whereby the family s wishes will still be considered when considering donation, as we do not wish to have the same outcome as Brazil, whereby the hard approach, which doesn t require the consideration of family wishes, was unsuccessful and subsequently revoked. [13] It is essential that, if an opt-out policy is to be introduced, public cooperation is key and clear cut guidelines surrounding every aspect of the policy are essential, in order to prevent public confusion over a presumed consent system, to protect ethnic minorities and so as not to undermine the need for informed consent that has been highlighted in the likes of the Royal Children s Inquiry. [15] J NI Ethics Forum 2008, 5:

2 Introduction and rationale Existing United Kingdom (U.K) organ donation policy requires donors to opt-in, or express explicit consent to allow their organs to be used for transplantation. This is implemented by UK Transplant. [1] Currently over 7,000 people are awaiting an organ transplant and last year, 3,087 transplants were performed whilst 459 patients awaiting a transplant died. [2] The UK s opt-in system requires an individual to actively take measures to join the transplant register, and such measures include signing on via the internet, by mail, on the telephone, or when applying for a driving license. [1] If the individual hasn t joined the register, the family have the opportunity to make the decision on their behalf in the case of unexpected death. [3] In contrast, Spain operates an opt-out system, where everyone is presumed to consent unless they express against it or if major distress would be caused to the family. [4] This system resulted in 35.1 donors per million population (pmp) compared with 12.8pmp in Britain. [5] Such legislation has a range of positive and negative implications and this paper seeks to examine the merits, drawbacks and consequences of adopting an opt-out policy, as well as our recommendations as to how such a policy should be implemented if it came into effect in the UK. We will discuss some of the ethical, religious and practical issues surrounding a change in policy as well as comparing hard opt-out versus soft opt-out, thus concluding what we feel would be best for the UK. Perceived benefits of the presumed consent approach A presumed consent policy may increase the supply of donor organs. Current studies indicate that 90% of the population are in favour of organ donation. [5] Evidence would suggest that 67% of these have not registered their wishes and therefore the final decision is left to relatives at the time of death, and 40% of these relatives will subsequently refuse donation, being unsure of the donor s wishes. [5] This may provide an 26

3 explanation for the UK s low donation rate of 12.2 people per million of the population. [6] Research indicates that donation rates are 25-30% greater in countries when an opt-out system is implemented. [7] To evaluate the variation in success of opt-out systems a useful example is the comparison of two Belgian Centres with two different donation systems. Antwerp retains opt-in legislation and Leuven has adopted the opt-out scheme. Over a 3 year period there was no change in donation rates in Antwerp whereas rates in Leuven rose from 15 to 40 donors per year. [8] The beneficial effects of presumed consent are not only confined to quantity of organs but also, because organs can be removed without delay before physiological deterioration, the quality of organs for transplantation improves, thus increasing the likelihood of transplant success. [9] Moustarah argues that an opt-out policy will have positive implications for patient autonomy, stating that, since the majority of the population support organ donation, presumed consent is the morally correct way to proceed, acknowledging the unexpressed but autonomous will of the majority of society. [9] English argues that the presumption stated above can only be made on the basis that the population is fully informed about the transplantation process and aware of their individual right to object. [3] Another positive implication would be provision of an official mechanism by which objections could be registered, [3] meaning that families will be more aware of their deceased relative s wishes, and may not be so reluctant to allow donation to proceed. [5] In practice there are two types of opt-out system: hard and soft. The soft option is most likely to be adopted by the UK. With this, doctors don t have to proceed with donation if it causes extreme distress to the family. [10] A cross-sectional study shows that, allowing for confounders, 27

4 countries with soft opt out systems still have 25-30% higher donation rates than opt-in countries. [6] This may be due to the fact that four in ten families currently choose the default option. [10] Possible disadvantages of an opt-out system Scepticism continues to enshroud claims of higher donation rates being associated with opt-out legislation. A report by Abadie and Gay found that countries employing opt-out legislation had a higher average of donors per million per year, compared to with informed consent. [7] This distinction however, was statistically insignificant when tested due to many confounding factors such as mortality rates for road traffic collisions (RTCs), suggesting a positive link between availability of viable organs and a higher incidence of RTCs. [11] For example Spain, heralded as the opt-out success story, has higher rates of RTCs. [11] France has a similar donation system yet lower donation rates of 22.2 pmp versus 30.1 pmp. [12] In adopting an opt-out policy, there may be increased potential for ethical conflicts. Csillag s article stresses that medical professionals are not legal experts, and struggle to decide whether it is right to procure the deceased s organs simply based on a document stating that consent has been presumed. [13] This was illustrated in Brazil where doctors refused to remove organs without familial consent, despite having legal justification, resulting in the subsequent abolishment of the legislation. [13] Another ethical consideration is that by presuming consent, the government is assuming legal ownership of the cadaver. This carries a risk of error, such as computer errors or loss of documents, resulting in bodies which have opted out being mistakenly procured against consent. [14] Should this occur, it wouldn t comply with the Human Tissue Bill. [15] Ignorance of this bill has already been highlighted in the Royal Liverpool Children s inquiry where organs were retained without 28

5 consent. [15] The report emphasizes the need for explicit consent and aims to restore public confidence. It is feared these outcomes would be undermined by opt-out legislation. The Human Tissue Authority maintains that presumed consent could detract from stipulations requiring consent for non-mandatory autopsies and body donation for research. [16] Such regression towards the practice of routine salvaging [9] epitomizes paternalistic medicine. English argues that the validity of presumed consent can only be achieved on the basis that the population is fully informed about the transplantation process and their individual right to object and he argues that an opt-out donation policy is doomed due to the greater uncertainty regarding informed consent. [3] Such a policy may also result in negative societal attitudes towards organ donation. Without sufficient public support donors may lose faith in such a system and choose to opt-out because they have no autonomy over the decision-making process. [17] Surveys have identified that fewer than 10% of people agree with the principle of presumed consent as it appears to contradict autonomy. [18] Winterton states that donation must maintain gift status. [19] It is possible to draw a comparison with the gift-relationship of blood donation, which states that no such gift can be utterly detached, disinterested or impersonal. [20] Altering the gift-relationship can have psychological impacts for recipients as well as donors. Recipients may not wish to receive an organ unless it has been given freely and for this reason, organisations such as the British Organ Donor Society disapprove of opt-out legislation. [21] Developing a reliable infrastructure to support the legislation has significant financial implications. Successful organ donation requires intensive care beds which constitute only 0.5% of total available beds in the NHS. [18] An increase in organ donation may place strain on limited resources. Availability of skilled transplant surgeons and support facilities 29

6 are other limiting factors that must be considered. Wright attributes the successful rates of donation in Spain of 35.1 per million (2005), to the high level of financial input and staff support provided. [17] Concluding comments In conclusion it is evident that change in the donation system is required to increase donation rates in the UK. Statistics show that a system of presumed consent is likely to increase organ availability, however there remains variation in the success of opt out legislation, as seen between Spain and Brazil. In order for opt-out success, the NHS should proceed cautiously and cooperate fully with the public. Clear guidelines are essential to prevent public confusion over a presumed consent system. A consensus of public support must be obtained prior to implementing such a change and this may require substantial investment in campaigns to ensure public awareness. Premature implementation could result in alienation of certain groups in society and lack of trust in the health care system. Significant investment in the improvement of transplant infrastructure would also be required to meet the increased availability of organs. The opt-out system benefits the individual by implementing the wishes of the majority [10] although the effect on donor autonomy remains a subject for debate. Inclusion of discretion with the soft option acts in the best interests of relatives and ameliorates relations between families and health professionals. Amy, Simon, Maria and Lois obtained the highest marks in their year group for their individual essays on this topic, submitted in fulfilment of coursework requirements for the module Science, Society and Medicine ; this module, co-ordinated by Dr Margaret Cupples, formed part of the core first year medical curriculum at QUB. These four students subsequently gave a joint communication at the Forum s Annual Conference 2008 and co-authored this paper. 30

7 References [1] UK Transplant. Welcome to UK Transplant [Online] [cited 2007 Dec 4]; Available from: URL: [2] Statistics and Audit Directorate. Transplant Activity in the UK. Transplant UK, August 2007 [3] English V, Sommerville A. Presumed consent for transplantation: a dead issue after Alder Hey? J Med Ethics, June 2003; 29: [4] Matesanz R. Factors influencing the adaptation of the Spanish Model of organ donation. Transplant International. October 2003; 16: [5] English V. Is presumed consent the answer to organ shortages? Yes. BMJ May 2007; 334: 1088 [6] Barber K, Falvey S, Hamilton C, Collett D, Rudge C. Potential for organ donation in the United Kingdom: audit of intensive care records. BMJ 2006 May 13; 332: [7] Abadie A, Gay S. The impact of presumed consent legislation on cadaveric organ donation: a cross-country study. J Health Econ 2006;25: [8] Institute of Medicine. Organ donation: opportunities for action. Washington, DC: National Academies Press, [9] Moustarah F. Organ procurement: let s presume consent. Can Med Assoc J 1998 Jan 27; 158(2): [10] British Medical Association. Organ donation in the 21 st century. Time for a consolidated approach. London; BMA, 2000 [11] Fabre J. Organ donation and presumed consent. Lancet 1998 Jul 11;352(9122):150. [12] IPSOS MORI. Human Tissue Authority stakeholder evaluation. General Public Qualitative and Quantitative Research. June 2007 [13] Csillag C. Brazil abolishes presumed consent in organ donation. Lancet 2005 Apr; 352(9137):

8 [14] Johnson E, Goldstein D. Do defaults save lives? Science 2003 Nov 21;302(5649): [15] Redfern M. The Royal Liverpool Children s Inquiry Report. London: The stationery office; 2001 [16] Human Tissue Authority. Statement on Chief Medical Officer's announcement. [online] Jul 24 [cited 2007 Dec 3];[2 screens]. Available from: URL: =customwidgets.content_view_1&cit_id=358 [17] Wright L. Is presumed consent the answer to organ shortages? No. Br Med J 2007 May 26; 334:1089 [18] McMister P. Paying respect to organs. Lancet 1999 Aug 21; 354(9179): [19] Department of Health. Government rules out presumed consent Jan 14 [cited 2007 Dec 1];[3 screens]. Available from: URL: s/dh_ [20] Titmuss R. The gift relationship: from human blood to social policy. London: Allen and Unwin; [21] Parliamentary Office of Science and Technology. Organ Transplants. [online] Oct [cited 2007 dec 1];[4 screens]. Available from: URL: 32