Proposed Legislative Competence Orders relating to Organ Donation and Cycle Paths - Welsh Affairs Committee Contents


Written evidence submitted by Christian Action Research and Education (CARE)

INTRODUCTION

1.  The Welsh Assembly Government is seeking to introduce a soft opt out system[33] for organ donation for those living and dying in Wales, in addition to continuing to participate in the existing UK-wide opt-in system. The LCO consultation paper recommends the introduction of presumed consent for organ donation. Their recommendations appear to be based primarily on the supply and demand for organs, on public opinion polling and on the views of the BMA. CARE is supportive of voluntary organ donation, however we have strong reservations about the introduction of presumed consent, for the reasons detailed following.

EVIDENCE USED FOR PROPOSED ORDER

2.  The explanatory memorandum for the proposed LCO is highly selective in its use of evidence and fails to fully engage with many significant ethical and practical issues raised by the proposal to introduce presumed consent and neither does it consider some of the potential negative effects from introducing presumed consent.

3.  One of the most striking omissions is the failure to cite the range of views, recommendations and thinking behind the Organ Donation Task Force (ODTF) 2008. This was only undertaken three years ago so cannot be considered to be outdated yet. Moreover, the ODTF looked in far greater detail at a broad range of issues raised by presumed consent than the LCO memorandum, including consideration of the ethical issues, and it did not limit itself to concerns about the supply and demand for organs. It concluded—we believe correctly—that presumed consent is neither necessary, nor right, to introduce. Indeed it: "found considerable evidence highlighting the potential downside of such a move." (para 1.8). The failure of LCO to properly consider such evidence indicates a lack of balance and objectivity.

4.  The conclusions of the ODTF should be heeded as it has been the most rigorous review of this issue that has been undertaken in the UK. It comprised working groups, literature reviews, interviews, public events etc and it carried out a thoughtful, comprehensive, detailed and rigorous investigation of presumed consent, which was only completed three years ago.

5.  In contrast, we note that the LCO primarily draws on the statement by the BMA on presumed consent to back up its recommendations for introduction. However, the ODTF notes that: "the BMA policy may not directly reflect the views of its professional membership (especially critical care professionals), since it was determined at an Annual Representative Meeting by locally elected representatives, rather than by a poll of all its members. The group advises that the BMA's position on presumed consent should be regarded as that of a well developed policy that has been produced by an experienced and respected ethics group rather than one that is representative of the body of medical opinion in the UK."

COMMENTS ON ASPECTS OF THE PROPOSED ORDER

6.  The LCO asks for comments on the following aspects of the proposed order:

To what extent is there a demand for legislation on the matter(s) in question?

7.  The LCO document fails to make any comment on the UK surveys that the ODTF reviewed. Yet these are equally relevant to those cited by the LCO. The ODTF reports that: "Among the eight UK surveys reviewed, there was considerable variation in the level of support for presumed consent, ranging from 30% to over 60%." (para 12.1) This by no means suggests a clear majority of the population are definitely in favour of presumed consent, unlike the suggestion by the LCO. Again, we are concerned about the selective nature of the evidence used by the LCO to justify its conclusion.

8.  Even if the majority of the population were in agreement with presumed consent this does not automatically imply that individuals themselves would want to donate. The ODTF in Annex E, 10.2 comments that although there appears to be strong support within the public domain that donation is considered a "gift", there is limited knowledge about the process of donation. Three case studies were presented which identified reasons why families who were generally supportive of donation nevertheless declined themselves. The main reason why these families who supported donation but struggled with consent, appeared to be due to circumstances that came together at the time of death. The most important of these emerged as:

  • (a)  The perception of a need to protect the body and keep it "whole".
  • (b)  The adverse influence of a poorly timed or constructed approach to the family.
  • (c)  A lack of information, or an inability to process it.
  • (d)  A desire not to prolong the perceived "suffering" of the deceased.
  • (e)  The need to witness the observable end of life.

9.  Clearly therefore, it cannot be assumed that there is a correlation between a general support for donation in principle and the personal willingness to donate organs oneself. Moreover the concerns listed would be better overcome through better education and advertising on organ donation, not presumed consent.

10.  Not only is the demand argument weak, there are other reasons why introducing presumed consent is unnecessary. For example, it may actually make little difference to donor rates: "…a literature review commissioned by the ODTF showed that the evidence for a causal relationship between 'opt out' consent systems and increased donor rates was inconclusive, because of the competing factors that might affect donation rates."

11.  Moreover, the LCO itself notes the success in increasing donation rates after implementing the ODTF recommendations. "Evidence was presented from Ms Fiona Murphy, the head a team of bereavement nurses in the Royal Bolton Hospitals NHS Trust, who has recently demonstrated impressive increases in organ donation through the incorporation of donation into standardised care pathways for patients dying on intensive care units… this work indicates how substantial increases in donor numbers can be achieved within current legislative frameworks." (ODTF para Annex E, 9.1).

12.  Thirdly, introducing informed consent may actually have an adverse effect on donation. "The experience in France, where various public scandals relating to organ donation (including an incident involving the taking of corneas when the donor's parents had not agreed to this, even though their consent was not required by law) had an adverse effect on donation rates. We therefore urge the Taskforce to consider the potential for a negative as well as a positive impact on donation rates of introducing an opt out system in the UK."

13.  The Committee asks: Does the LCO have the potential to increase the regulatory burden on the private or public sector?

14.  We believe that the LCO does indeed have the potential to increase the regulatory burden on the public sector, as well as an increased financial burden.

15.  The introduction of presumed consent would require a large-scale publicity campaign to reach all societal groups, irrespective of their culture or first language. A key message in the campaign would have to be about how people can exercise their right to opt out and who this applies to.

16.  In order to gain a high level of confidence and trust in the presumed consent system and for organ donation (and to keep donor numbers sufficiently high to justify the costs) it would require a vast, sustained and highly effective public education campaign and genuinely accessible facilities for registering an opt out decision. Also, rigorous record and regulation would be necessary.

17.  As the ODTF itself concluded, having costed this carefully: "It became increasingly clear that it would be both complex in practical terms and also costly to put in place an opt out system that could command the trust of professionals and members of the public…real concerns were expressed about the security of information on an opt out register; this issue would need to be addressed by using a robust and secure iT system." (para 1.11)

18.  The Committee asks: Does the LCO have the potential to cause confusion regarding legal jurisdiction and the individuals to whom any Measure would apply to?

19.  Clearly, operating two different systems in the UK and Wales would have obvious potential to cause complexity, confusion, extra regulation and extra advertising for individuals across the two jurisdictions. People across the whole of the UK would need to be aware of the differences between Wales and the rest of the UK as many family members, (involved in decision-making for the soft opt-out presumed consent option), will come from both jurisdictions.

20.  Families prefer to be fully engaged in the decision-making process to ensure that decisions are made that are right for each individual case. There is a risk of a loss of trust in the system if families were to feel in any way pressured or coerced or, importantly, confused and unprepared.

ETHICAL ISSUES

21.  The LCO fails to address some important ethical issues with presumed consent and organ donation in general which, we believe, indicates a lack of effective engagement with the issue. These following issues should have been taken into consideration before reaching any conclusions about presumed consent.

22.  One of the primary problems with organ donation is the ascertaining and timing of a diagnosis of death—the blurring of distinctions between life and death is aggravated by organ donation. Pope John Paul II noted this is "…one of the most debated issues in contemporary bioethics." (2000: 2). Truog even suggests that: "the medical profession has been gerrymandering the definition of death to carefully conform with conditions that are most favorable for transplantation." (2008). Should "death" reference the brain or other organs? How long must the heart have stopped beating before a patient is unambiguously, irreversibly, dead? It is difficult to put a specific time on something that is, in essence, a process.

23.  Secondly, there is no consideration of the concern that treatment before death could be influenced in some way by the preservation of organs after death. There is need to discuss whether there is potential for compromising the care of living patients in favour of potential procurement of organs after death. Is there danger (as has been claimed with the Pittsburgh protocol) that the events surrounding the "high tech" death could be manipulated to accommodate organ retrieval? Even with "official" safeguards, it seems likely that death may be hastened, or at least care compromised, if a hospital set up is to optimise the retrieval of viable organs. As the ODTF also notes: "Some intensive care staff in particular fear that a move to an opt out system would make critical care more difficult." (para 1.9).

24.  As noted briefly above (para 8), some individuals express concerns about keeping the body "whole". There are important questions with donation about the value of bodily integrity, and what is sacred about bodily death. Is the donation of vital organs good in principle or not? In what sense is there a shortage of organs that must be overcome? (Meilaender 2006). Donation of organs is not therapeutic for donors; they are given for utilitarian reasons for someone else's benefit. Is it right to "aim at my own harm in order to do good to my neighbour?" (Meilaender 1996: 93)[34] or should it be regarded as an unreciprocal gift?

25.  There is a very real danger that presumed consent could undermine donation as a gift and erode trust in professionals. The President's Council on Bioethics states that "the central ethical challenge for any transplantation protocol is to give the gift of life to one human being without taking life away from another." (2008: 119).

26.  The ODTF reports that representatives from the Donor Family Network also highlight the importance of the gift relationship. They were concerned that a system of presumed consent, however weak, would promote conflict between families and clinical staff, conflict that would rapidly degrade the trust that was vital to decision making.

27.  Recipients and their families themselves are concerned that donation should always be a genuine gift: "The working group considering clinical implications heard powerful evidence from recipients of organs who stressed their need to know that organs had been freely given by donors and their families, and from donor families who often find great comfort in being an active part of the decision to donate." (Para 1.10).

CONCLUSION

28.  The emphasis of the LCO appears to be primarily directed to the needs of the recipients and we believe is unbalanced in its use of the evidence for and against presumed consent. There must be equal care for the prospective donor as well as recipient, whilst maintaining the intrinsic value of vulnerable human life, the gift element of donation and awareness of the danger in re-defining death. There is too little consideration in the LCO for the prospective donors, for the ethics of organ donation, for maintaining the gift element of donation and for any of the possible negative outcomes of presumed consent.

29.  Whilst we are not against voluntary organ donation, CARE cannot support the LCO proposal to introduce presumed consent and we would instead encourage the Welsh assembly to consider how to further implement the recommendations of the ODTF to increase donor rates through public education and information, as it has successfully done thus far. This would of course be a less complex, less expensive and less controversial option.

February 2011

REFERENCES

Organ Donation Taskforce. 2008. The Potential Impact Of An Opt Out System For Organ Donation In The UK: An Independent Report From The Organ Donation Taskforce.

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_090312

Meilaender, G, 2006. Organ Procurement: What are the Questions? Paper presented to the US President's Council on Bioethics.

http://www.bioethics.gov/background/meilaender_organs.html#edn17 (accessed 04/01/09).

Meilaender, G, 1996. Bioethics: A Primer for Christians. Carlisle: Paternoster Press.

Pope John Paul II. 2000. Address to the 18th International Congress of the Transplantation Society. Catholic Information Network.

http://www.cin.org/pope/organ-transplant-cloning.html (accessed 04/02/09).

The President's Council on Bioethics. 2008. Controversies in the Determination of Death. A White Paper of the President's Council on Bioethics. Washington DC. www.bioethics.gov. (accessed 03/02/09).

Truog, R & Miller, F, 2008. "The Dead Donor Rule and Organ Transplantation". The New England Journal of Medicine. Vol.359 (7), pp. 674-675.

http://content.nejm.org/cgi/content/full/359/7/674?query=TOC (accessed 30/12/08).



33   A "soft" opt out system, is one in which, as a safeguard, family members would be consulted about donation. Back

34   As opposed to aiming at my neighbour's good, knowing that in doing so I may be harmed (Meilaender 2006: 93). Back


 
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Prepared 4 April 2011