Select Committee on European Union Minutes of Evidence


Memorandum by Dr Muireann Quigley and Professor Margaret Brazier

  Please accept this submission on the Inquiry into the EU Commission's Communication on organ donation and transplantation: policy actions at EU level. This is being submitted on behalf of core participants in the ESRC-sponsored Seminar Series: Transplantation and Organ Deficit in the UK: Pragmatic Solutions to Ethical Controversy.

  This submission has been prepared by Dr Muireann Quigley and Professor Margaret Brazier, CSEP, School of Law, University of Manchester. It draws on discussions to date between core participants, as well as findings, from the seminar series. For further information concerning core participants in the seminar series, please refer to the website created for the series:

  http://www.law.manchester.ac.uk/aboutus/news/seminars/transplant-seminars/index.html

  Members of the Centre for Social Ethics and Policy (CSEP), School of Law, University of Manchester, were awarded funding by the Economic and Social Research Council (ESRC) to conduct a five part seminar series examining key issues relating to organ shortage in the United Kingdom (UK). The series runs from November 2006 until March 2008. The core participants come from a range of backgrounds, including bioethicists, lawyers, health care professionals and patient advocates. Details of the seminar series can be found at:

http://www.law.manchester.ac.uk/aboutus/news/seminars/transplant-seminars/index.html.

  This group recently made a submission to the Organ Donation Taskforce (copy available on request). This submission draws on discussions and findings from the seminar series to date and responds on the following issues:

    1.  General comments

    2.  Harmonisation of systems

    3.  Presumed consent

    4.  European donor card

    5.  Living organ donation

    6.  Organ trafficking

GENERAL COMMENTS

  1.  We regard it as immensely important that national governments unequivocally endorse the importance of transplant medicine and that the Department of Health should be expressly subject to a duty to seek to promote an adequate supply of organs for transplant as is provided for in the Human Tissue (Scotland) Act 2006. We appreciate that there is no easy, "quick-fix" solution to the problem of the chronic shortage of organs available for transplantation in the UK and Europe. Finding solutions to address such shortage is imperative, however, given current waiting lists and the likelihood that they will increase in the future. One of the key aims of the seminar series is to identify a pragmatic way to address organ shortage which is principled in approach, but shifts the focus away from the longstanding ethical, religious and cultural controversy over organ donation, which has inhibited productive debate and resolution of differences. Priority should be accorded to measures that can be effected swiftly and without significant changes to national laws (See comments below on presumed consent).

  2.  The collection of robust empirical evidence is key in informing policy-making and regulation, therefore, the Commission should set aside money to conduct much needed research into (i) the social, psychological, institutional and economic aspects of organ donation, (ii) evaluation of the empirical data on annual organ donation rates for individual European countries and/or for individual transplantation units with a view to identifying any disparities in practice and the reasons for such disparities, and (iii) an assessment of the existence and extent of organ trafficking.

  3.  Organ and tissue donation require the participation of society for their full development and depend on public support. This support is fragile because organ donation is an emotive issue and deceased donation depends to a large extent on public trust in the professionals making decisions about the life or death of a critically injured relative. We believe that transparency is vital to improving and maintaining public faith in the organ donation system, especially amongst minority groups. At present, there is a lack of accessibility to and knowledge of the allocation rules, which should be simplified and conveyed much more overtly to the public. Likewise, clear rules relating to the definition of death and the procedures and tests used to determine death. This information would help to allay concerns about fairness and would emphasise the consistency of practices in this sphere.

HARMONISATION OF SYSTEM

  4.  We favour the third level option: active coordination through the Open Method of Coordination (OMC), backed up by a legal instrument such as a framework Directive on quality and safety standards with regard to organ donation and transplantation.

  5.  A European dimension could potentially assist in effecting increased donation and distribution of organs and tissues for transplantation. This may be achieved in the sphere of living as well as deceased donors, as kidney "exchange" and "pool" schemes become established. The critical mass necessary for such programmes to work optimally lends itself to an EU wide scheme for kidneys, provided transport and organ deterioration issues are addressed.

  6.  The adoption of a framework Directive on organ donation and transplantation would follow the legislative model previously adopted in both the Blood Directive (2002/98/EC) and Tissues and Cells Directives (EUTDC—2004/23/EC). These Directives set minimum standards of quality and safety pursuant to the narrow legal competence granted under Article 152(4)(a) EC. This minimum harmonisation approach has proved particularly useful in ensuring that Member States (MS) have appropriate standards in place.

  7.  Given that donors can donate both organs and tissues, there is a need to ensure uniformity in standard-setting between both the Tissues/Cells Directive and any proposed Directive on Organ Donation/Transplantation (see p. 43, Impact Assessment).

PRESUMED CONSENT

  8.  Any attempt to focus exclusively on the need for presumed consent regimes as providing the answer to organ shortage fails to address the fact that this is a complex issue which requires a multi-pronged approach. In our view, a multi-pronged approach at EU level requires at a minimum a focus on (1) donor education; and (2) ensuring appropriate institutional and staffing arrangements are in place for the promotion of organ donation/transplantation. A presumed consent regime is only going to work well if (1) and (2) are in place, as the preference for professional staff is still to ask for families' agreement where deceased donation is involved.

  9.  Proponents of presumed consent often cite Spain as incontrovertible evidence that it is presumed consent which results in better rates of organ donation. Spain has the highest rate of deceased donor transplantation in the world, 33.8 pmp,[1] but we do not consider their presumed consent legislation to be the key to their success.

  10.  In Spain deceased donation rates did not start to rise for 10 years after the change in the law. It was the introduction of an organisation to coordinate all aspects of donation activity, the Organizaçion Naçional de Transplantes, which made the difference. Donation activity is coordinated at national, regional, and local levels, with highly trained and qualified physicians taking on the role of transplant co-ordinators and being responsible for, inter alia, donor detection and approaches to families. Hospitals which provide donors receive suitable re-imbursement, recognising donation as part of a hospital's core role. In practice, Spanish transplant co-ordinators always consult relatives and never take organs against the objections of the family. Accordingly the UK could adopt most of the model implemented in Spain without introducing presumed consent.

  11.  As the Spanish Model indicates, whatever legal rules regarding organ donation may be in place, Europe and national governments need to commit significant financial resources to the process of organ procurement. If an effective system is in place this is likely to achieve an increase in donation rates more swiftly than a mere change in the law which might take up to five years to come into force.

  12.  We think EU "best practice" guidance on consent requirements with regard to organ donation/transplantation would be useful, however, we would be against any legally-mandated requirements in this regard being included in the Directive. In any case, there is likely to be too much political opposition to any attempt at setting "one size fits all" consent requirements across the EU.

EUROPEAN DONOR CARD

  13.  The evidence does not suggest the benefit of an EU donor card as effort is required to obtain/retain/maintain a donor card (Please see related abstract in Appendix 1). Some people who carry donor cards do not know what is involved in the donation process (Sque et al 2006). Organ registries may be more effective as they require less "work".

LIVING ORGAN DONATION

  14.  We are in favour of the promotion of donation from living donors where possible, although there needs to be greater public awareness and/or evidence of favourable outcomes through this method of donation. Greater transparency (through national standard setting) is needed in relation to determining criteria for living organ donation.

  15.  While criteria are in place for living organ donation (see Human Tissue Authority Code of Practice No. 2), there may be practical obstacles placed in the way of living organ donors (particularly if they are non-related altruistic donors). Such obstacles include loss of earnings while the donor is in hospital and during their recovery from the operation, pejorative views of professional staff, and the overriding fear that this type of donor is seeking "financial reward".

  16.  We support the reimbursement to living donors of costs incurred and losses attributable to the transplant donation process. Policy makers must give careful thought and due consideration to the possible ways in which costs incurred and losses attributable may arise in this context. Donors should be assured of free and adequate medical and psychological follow-up for the rest of their lives under their national health care systems.

  17.  There needs to be greater clarity about which organisation is responsible and/or willing to pay for reimbursement of expenses. It is our view that such reimbursement should be the responsibility of the health services and any system set up to provide such reimbursement should have appropriate safeguards in place that effectively exclude the possibility of exploitation of donors or profit to intermediaries.

  18.  The commitment to voluntary, unrewarded "altruistic" donation is stated in almost mantra-like fashion in EU policy-making and regulation in relation to human body parts/substances. It is stated to be an "ethical issue" (see Impact Assessment, page 24) that is explicitly and/or implicitly linked into "quality and safety". Our view (whether or not individual participants are opposed to payments) is that this has not been substantiated on the available evidence. We would like to see policy-makers being more open to giving at least some consideration to the promotion of alternative methods of organ donation (preferably through state-controlled or state-sponsored initiatives both in the regulatory domain and outside of it).

ORGAN TRAFFICKING

  19.  An illegal market in human body parts for transplantation exists. There is evidence that this illegal market results in the exploitation of (often) vulnerable persons and allows intermediaries to profit financially. Collective action across the EU could help stop exploitation of (often vulnerable) individuals from organ trafficking.

  20.  This said, however, it is not clear from the evidence presented to date by either the European Parliament or the Council of Europe that it is a significant problem in the EU context. Their published reports seem to rely largely on anecdotal evidence and we would want to see more robust evidence/empirical research on the issue.

  21.  If there is a particular concern that organ trafficking is becoming a significant issue, all MS should agree to the adoption of legislation setting out criminal penalties for trafficking.

REFERENCESSque M. Long T. 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. University of Southampton, Southampton.

5 October 2007



1   Data for 2006 available on the website of Organizacio«n Nacional de Trasplantes (ONT) http://www.ont.es/Estadistica?accion=1&idnodo=19&id_estadistica=48Perfil=.Accessed 12/09/07Back


 
previous page contents next page

House of Lords home page Parliament home page House of Commons home page search page enquiries index

© Parliamentary copyright 2008