House of Lords - European Union - Minutes of Evidence

Select Committee on European Union Minutes of Evidence

Memorandum by Dr Magi Sque and Dr Tracy Long

1. INTRODUCTION

1.1 We favour the Third Level Option of European Union (EU) intervention that promotes active coordination between Member States (MS) on organ quality, safety and availability as well as minimum harmonisation on quality and safety, plus initiative on organ trafficking.

1.2 We have responded to issues on the following:

— illegal trafficking in organs;

— EU-wide shortage of organs available for transplantation;

— The presumed consent approach for identifying organ donors,

— The arrangements for taking into account the views of relatives about removing organs from a deceased donor (both under the present system of "opting in" or under the "presumed consent" system for identifying donors).

— raising public awareness about organ donation;

— use of organ donor cards, including the idea of a European organ donor card.

— Organisation of organ donor and transplantation systems.

1.3 European Union (EU) intervention to address the issues that concern organ donation and transplantation is welcome; particularly in addressing the shortage of organs, developing a rigorous and orchestrated response to organ trafficking and in strengthening the harmonisation of quality issues. We would support the development of a Coordinating or Regulatory body that would facilitate donation and transplant activities among Member States (MS). It would be necessary for this body to also consider EU appropriate donation and transplantation Research and Development. Many of the ideas highlighted in EU Council document 9843/07 were issues of discussion at the recent conference in Rotterdam, 1-4 April 2007, which launched The European Platform on Ethical, Legal and Psychosocial Aspects of Organ Transplantation (ELPAT) http://www.elpat.eu/platform.html.[1] ELPAT is attempting to provide a structure through which the complex issues that concern organ transplantation can be discussed by drawing on European expertise in the legal, ethical and psychosocial aspects of organ transplantation. ELPAT aims to map and resolve complex differences between MS by formulating European guidelines reflecting the ethical, legal and psychosocial aspects of organ transplantation. ELPAT's goal is to be a link between the European Union, the Council of Europe and European Society of Organ Transplantation thereby benefiting all the individuals within MS in need of a transplant operation.

2. ILLEGAL TRAFFICKING IN ORGANS

2.1 The ELPAT conference in April 2007 ended with delegates asked to vote on a number of resolutions; among them a resolution regarding organ trafficking. Organ trafficking appears to be impinging on EU borders, notably in the Eastern European countries of Moldova and the Ukraine, which should be of concern to MS. Evidence for this is drawn from Council of Europe Parliamentary Assembly Doc. 9822, 3 June 2003, "Trafficking in organs in Europe", Report Social, Health and Family Affairs Committee, Rapporteur: Mrs Ruth-Gaby Vermot-Mangold http://assembly.coe.int/documents/workingdocs/doc03/edoc9822.htm

Point 12 and 13 from the document, Trafficking in organs in Europe states that:

12. "While prohibition of organ trafficking is legally established in member states, most countries still have legislative loopholes in this domain. Criminal responsibility in organ trade is rarely clearly specified in national Criminal Codes. Criminal responsibility should include brokers, intermediaries, hospital/nursing staff and medical laboratory technicians involved in the illegal transplant procedure. Medical staff who encourage and provide information on "transplant tourism" should also be liable. The medical staff involved in follow-up care of patients who have purchased organs should be accountable if they fail to alert the health authorities."

13. "Member states have a common responsibility to deal openly with this problem nationally, but also through multilateral co-operation at the European level—bringing together Ministries of Health, Interior and Justice."

The resolutions agreed at the ELPAT conference supported these initiatives and stated that: "This congress condemns without reservation any practice that subverts or violates a potential donor's human rights or that involves coercion or deception."

(a) The transplantation of organs and tissues from executed prisoners should be universally banned by law.

(b) The practice of organ and tissue trafficking should be universally banned.

(d) Health care professionals should be banned by law from facilitating organ and tissue trafficking (ie referring a patient to a foreign transplant service known to be involved in trafficking).

(e) Governments should be encouraged to carry out the necessary surveys to quantify organ and tissue trafficking.

Collective action across the EU could help stop exploitation of individuals for the purpose of illegal organ trafficking.

3. EU-WIDE SHORTAGE OF ORGANS AVAILABLE FOR TRANSPLANTATION

3.1 As pointed out in EU Council document 4 June 2007 9834/07 ADD1 (9834/07) organ shortage is the dominant problem in the field of transplantation. Organ and tissue donation require the participation of society for their full development and could not exist (under present ethical and legal standards) without the support of the public. This support is fragile because deceased organ donation is an emotive issue and depends to a large extent on public trust in the professionals who are making decisions about the life or death of a critically injured family member. With regard to donation from the deceased it appears that no matter which legislative system is in place in MS ie "presumed consent" or "opt-in" the potential for donation is discussed with the bereaved family and their consent or lack of an objection sought before organ donation can take place. So theoretically whilst "presumed consent" allows organs of the deceased to be donated, if that is what the deceased in life had wished and documented, in practice the principle that prevails is that of family agreement or consent. One of the greatest barriers to donation is the refusal of bereaved families to give consent for donation to take place.

3.2 It must be noted that there is no "evidenced" link between an indicated support for organ donation and an agreement to donate when faced with the sudden death of a family member (Sque et al 2006). The suddenness of death and their status as newly bereaved may well impact decision-making by relatives about organ donation. Also due to the low numbers of people who die in circumstances that facilitate donation potential donor families are unlikely to have any role models for their behaviour. Families of potential organ donors are first, bereaved families, and need to be supported by staff educated to work with bereaved people.

3.3 Whilst there may be an assumption that the public is familiar with the process of donation Sque et al (2003, 2006, 2007) have shown that donation was declined because bereaved family members did not possess sufficient information about donation nor were their needs recognised at the time of the request (eg they did not know what the process of donation involved; did not understand how autopsy and donation worked together; did not understand how death was certified by brain stem criteria; thought only a tiny minority of bereaved relatives did not donate). There remains enormous scope for public education.

3.4 Sque et al (2006) in a UK-based study recently challenged the notion that the most important reason for relatives agreeing or declining donation is knowledge of the deceased person's wishes, as most families reported a wish to protect the integrity of the deceased person's body even if it meant the deceased's wish to be an organ donor was not fulfilled. This decision made by participants to decline organ or tissue donation appeared to be made in the context of deeply distressing concerns related to the "cutting up" of the body. Concerns about dissection may have some value in explaining why, in populations where there is broad awareness of the benefits of organ transplantation, refusal rates remain high as reflected in the figures gained when EU participants were asked about donating a family member's organs, 23% would not (9834/07 p23). Unfortunately the research does not give the reasons why EU participants would not donate.

3.5 Research suggests, that many donations are denied because families will not give consent, even if they knew in life the potential donor wished to be an actual donor (Dodd-McCue et al 2006, Sque et al 2006). Adjusting practice to support donor's rights moves health professionals' communication mission from requesting donation to one of informing or supporting a choice previously made by the potential donor. Dodd-McCue et al's research provides evidence that indicates that families are not negatively affected by strict enforcement of "donor designation". Within its limits the research upholds that donor designation can lead to positive results for families as well as organ recipients. Even with laws however, ie "presumed consent" in place, in a number of MS, to support the choice of the deceased, disparity exists in practice. The challenge for health professionals in MS is to how to help families reconcile their repugnance for dissection (Richardson 2007) with the benefit of donation to the waiting recipient.

4. RAISING PUBLIC AWARENESS ABOUT ORGAN DONATION

4.1 Donor relatives have an important contribution to make in sustaining donation rates both in the educational role they play within their own communities and the formal roles they sometimes adopt, to help educate health care professionals, and bereavement support groups. Magi Sque was advised (verbal communication) that, in the USA, for every donor, approximately 1,000 people will receive informal donation education. Families for instance appear motivated by what their deceased family member achieved through donation, illustrated by the heroic status which is attributed to them due to their ability to save life or give life and to have that achievement appreciated, valued and not forgotten (Sque and Payne 1996, Sque 2007). Thought therefore needs to be given to the way organ donation is promoted so that the contribution of the donor and their family is celebrated and the donor's achievement is appreciated, valued and not forgotten. Furthermore continuing to articulate organ donation within a "gift of life" discourse does not reflect the depth and complexity of the process more aligned to "sacrifice", and is therefore not an adequate framework for understanding what is important for families faced with a donation decision (Sque et al 2006, in press 2007). Meeting their needs may be an effective way of improving donating rates across the EU.

4.2 Information regarding the possibility of organ donation should be fundamental to all areas of EU health care systems and not left until individuals are at the death bed. The function of public education therefore should be to enhance awareness of organ donation to the extent that when the question of organ donation is raised the idea is neither foreign nor intimidating to the grieving family but simply reminds them that other lives hang in the balance of their response.

4.3 Sque (1996), Sque et al (2003) has shown it is helpful to families of the deceased to have concrete evidence of the wishes of the deceased with regard to organ donation. It may be feasible for some MS to maintain organ registries. For other MS unable to maintain a registry the use of a donor card may be appropriate; in light of this there should be widely available to the public. The issue is that many people who carry a donor card or are on an organ donor registry often do not know what is involved in the donation process (Sque et al 2006). Organ registries may be more amiable as they require less "work" and one only has to register once. It should be possible with the right technology for MS to access each other's registries.

5. ORGANISATION OF ORGAN DONOR AND TRANSPLANTATION SYSTEMS

5.1 Staff development—Any successful organ donation and transplant system must begin with an effective workforce that is knowledgeable about all aspects of the donation process and the benefits of transplantation. Nurses and doctors are the people charged with the crucial responsibility of identifying and caring for potential donors, a key area to increasing donation rates. Collaboration between MS in sharing best practice could enhance all areas of practice. Models and systems of care need to be assessed and best practice elicited and implemented.

5.1.1 Organ donation needs to be considered as part of good end of life or bereavement care, coordinated with other health initiatives, such as the End of Life Strategy (UK) and public initiatives. Across the EU the police, rescue services, funeral directors need to be integrated with the health system as their practice has the capacity to impact donation rates.

5.1.2 There is also work to be done with health professionals examining their own feelings about donation. Research has shown that nurses who are often the main supporters of families are no more informed about organ donation and transplantation practices than the general public (Sque et al 2000). Few nurses have attended a donation operation and many have concerns about the care and treatment of the organ donor. Positive role models are needed in clinical practice. An educated EU workforce could lead discussions in the field: be it during potential donation encounters or while carrying out their roles as health educators in the public arena and who can separate grief reactions and donation reactions. This depends on the integration of bereavement theory into health professionals' education related to sudden death and organ donation. These subjects need to be mandatory in all pre-qualifying programmes for doctors and nurses.

5.2 Harmonising systems—Organ donation system needs to be adequately resourced across the EU. Harmonising of practices across MS such as non-heartbeating donation, paired and altruistic donations, and expanded criteria donors, would provide a greater pool of organs for MS. This needs to involve expansion and commitment to the non-heartbeating donor programmes in Accident and Emergency Departments, general wards as well as ICUs. An expansion and commitment to the non-heartbeating programme may help families to donate who wish to be with the deceased and witness the observable ending of life, represented by the cessation of the heartbeat, which is important to some (Sque et al 2006). Greater EU collaboration could provide a greater pool of data for unusual events than would be as possible within individual MS and for resources for "organovigilance".

5.2.2 The focus on public education and agreement, education and support of health professionals must be balanced by a rigorous audit of the number of potential donors in each MS, and stringent reviews of the number of donated organs, which are not retrieved for transplant operations. Personal communication has indicated that a large number of hearts were not retrieved within the UK for the years 2003-06, contributing to a fall in the number of heart transplant operations. If the public in MS is to be confident that their agreement to donate is important this must be reflected in the efforts made to retrieve organs. All aspects of the health care system that presents obstacles to increasing organ donation (eg intensive care bed provision and admission policy (Briggs et al (1997)), and shortage of transplant staff (Statham 2006) must be addressed.

5.2.3 The EU must also look to reduce the type of lifestyle illnesses for which organ transplantation is the only effective therapy. Organ donation and transplantation should be placed within a wider arena of a holistic health awareness that includes lifestyle choices in relation to diet, risk related health behaviours and exercise.

References

Briggs JD, Crombie A, Fabre J, Thorogood J and Veitch PS, (1997) Organ donation in the UK: a survey by the British Transplantation Society Working Party. Nephrology Dialysis Transplantation, 12: 2251-2257.

Dodd-McCue D, Cowherd R, Iveson A and Myer K. (2006) Family responses to donor designation in donation cases: a longitudinal study. Progress in Transplantation, 16: 2, 150-154.

Richardson R, (2007) Human dissection and organ transplantation in historical context. In Sque M and Payne S, Organ and tissue donation: an evidence base for practice. Maidenhead: Open University, 4-20.

Sque M and Payne S, (1996) Dissonant Loss: the experiences of donor relatives. Social Science and Medicine, 43: 9, 1359-1370.

Sque M, A dissonant loss: the bereavement of donor families. (2007) In Sque M. and Payne S. Organ and tissue donation: an evidence base for practice. Maidenhead: Open University, 59-81.

Sque, M, Long T and Payne S, (in press) Why relatives do not donate organs for transplant operations: is "sacrifice" a more appropriate family care model than the "gift of life"? Journal of Advanced Nursing.

Sque M, Long T and Payne S, (2003) Organ and tissue donation: exploring the needs of families. Final report of a three-year study sponsored by the British Organ Donor Society, funded by the Community Fund, February.

Sque, M, Long T and Payne S, (2005) Organ donation: Key factors influencing families' decision-making. Transplantation Proceedings, 37: 2, 543-546.

Sque M, Long T and Payne S, and Allardyce D, (2006) Exploring the end of life decision-making and hospital experiences of families who did not donate organs or tissues for transplant operations. Final report of a study funded by UK Transplant, February.

Sque M, Payne S and Macleod Clark J, (2006) Gift of life or sacrifice?: Key discourses to understanding organ donor families' decision-making. Mortality, 11: 2, 117-132.

Sque M, Payne S and Vlachonikolis I, (2000) Cadaveric donotransplantation: nurses' attitudes, knowledge and behaviour. Social Science & Medicine, 50: 4, 541-552.

Statham TF, (2006) A transplant summit: Patients grab transplant attention. British Journal of Transplantation,1: 1, 15-18.

25 September 2007

1 ELPAT is funded by a grant from the European Union. ELPAT is based at Erasmus MC University in Rotterdam, Jan J.V. Busschbach and Willem Weimar, Erasmus University Medical Centre, Rotterdam; Bernadette Haase-Kromwijk, Dutch Transplant Foundation, and Michael Bos, Health Council of The Netherlands, are funding members; Leonieke Kranenburg, Marian van Noord are ELPAT secretariat. ELPAT working group members will be experts in the field in Europe. The membership is currently being invited. Back

2 Statements a-f above resulted from Workshop 1, Commercialisation and Trafficking. Back