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:
2. Harmonisation of systems
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
12/09/07. Back
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