Supplementary evidence by Professor Margaret
Brazier, Centre for Ethics and Social Policy, University of Manchester
LEGISLATION RELATING
TO ORGAN
DONATION
Q. What lessons have you learned from your
work with the Retained Organs Commission which are of direct relevance
for consideration of the legislation and which you feel should
be in place to regulate organ donation?
The evidence that we received from families
and the many hundreds of relatives whom we met demonstrated very
graphically to me that reverence for the bodies of the dead and
the freedom to ensure that a dead loved one was treated with respect
was of great importance to many people. They saw such reverence
as the last service that they could undertake for that person—an
exercise in love. How that service should be rendered varied.
While there are a number of people for whom burial or cremation
entire is of supreme importance many families would have donated
organs for transplant and indeed donated organs for research or
education had they been asked. It was treating their relatives
as mere objects that inflamed such anger and provoked such grief.
I think it is important too to avoid stereotyping.
Religious observance was a major factor in a number of cases.
And beliefs about the body are of immense significance to many
families but it is not simply families from certain faith or ethnic
groups who have deep seated objections to tampering with the body.
It was not only organ retention from children that provoked such
distress. And that distress was absolutely genuine and not part
of a media frenzy or driven by a desire for compensation.
So I think we must not forget those lessons
and how important it is for families to be part of decisions about
what happens after death. Any death where transplantation is an
option is likely to be traumatic and deciding what becomes of
the remains of the loved person is a crucial factor in how a family
comes to terms with the death.
I worry that changing the law again now might
result in a level of distrust that even if any change was said
to be solely relevant to removal of organs for transplant there
would be suspicions that all the undertakings made re organ removal.
Q. What is your view of the need for an EU
directive covering organ quality and safety? What pitfalls do
you think should be avoided in framing such a Directive, and what
areas, if any, do you think it should cover beyond those envisaged
so far by the Commission?
It at first sight sensible and logical to act
at EU level in relation to quality and safety. There is an obvious
model in the Blood and Tissue directive. As EU citizens become
more mobile across the EU and if we are to have more pooling of
organs there is a need to be reassured that wherever you receive
treatment the process is as safe as it can be. I suspect that
agreeing and enforcing such standards may not be easy I think
it is important to remain within the safety and quality brief
and be cautious about attempting to impose greater uniformity
under the cloak of quality eg a common consent regime And I think
we must ask whether the time is yet right for a Directive even
one limited to quality and safety.
As the Commission states in the Communication,
the "main challenge" that needs to be addressed at both
national and EU levels is the shortage of organs available for
transplantation.
The Commission has identified a number of areas
which it will focus in the short to medium term in this policy
area which are (1) improving quality and safety; (2) increasing
organ availability; and (3) making transplantation systems more
efficient and accessible. In terms of an action plan for addressing
these issues, the Commission will promote greater cooperation
between Member States through the use of the Open Method of Coordination
which will include the reporting and exchange of information on
best practices, as well as the setting of benchmarks based on
qualitative and quantitative indicators.
It is clear from the Commission's research (as
set out in the Impact Assessment accompanying the Communication)
that there is significant variability amongst Member States across
a range of issues involved in the organ transplantation process.
It is also clear that some Member States have systems in place
that result in significantly higher rates of (cadaveric) organ
donation (eg, Spain). So, we welcome any structured process through
which best practice in the organ transplantation process can be
developed and disseminated on a uniform basis throughout the EU.
In the Communication, the Commission is clearly
aware that any action it takes in this field including the development
of a legislative proposal for a framework Directive needs to take
account of the "main challenge" of organ shortage. It
acknowledges that this challenge significantly alters the risk-benefit
ratio, and that any Directive setting out standards of quality
and safety would need to take this into account. The problem that
the Commission faces is that the terms of its formal legal competence
to act in this field is fairly circumscribed under Articles 152(4)(a)
and (5) EC, and is essentially limited to the adoption of minimum
harmonisations measures which involves standard setting with respect
to quality and safety. While this may have been appropriate in
relation to earlier regulatory initiatives under this Article,
such as the Blood Directive (2002/98/EC) and the Tissues/Cells
Directive (2004/33/EC) [and even that was stretching it in light
of interinstitutional conflict over the ethics of human embryonic
stem cell use], it is too narrow a competence to deal with the
complex questions raised by organ donation and transplantation—in
particular organ shortage, as well as the altered risk-benefit
ratio created by this issue.
The question that needs to be asked is whether
the focus on quality and safety in any Directive in the field
will sufficiently address the issue organ shortage OR will it
divert attention and resources unnecessarily from this issue?
Nobody would deny that quality and safety are
important factors in organ donation and transplantation, but they
are just two factors among many that need to be addressed in the
field. Indeed, in some of the newer accession States, setting
standards in relation to quality and safety may be particularly
useful as they develop systems for organ donation and procurement.
For most Member States, however, the main challenge in the short
to medium term is how to address organ shortage.
It is clear from the success enjoyed in Spain
that how organ donation and procurement is organised at an institutional
level has been crucial. The Council of Europe has published a
consensus document on how this organisational model can be adapted
and implemented at national level and this clearly needs to be
the focus in the short to medium term. To ensure appropriate organisation
in organ donation and procurement requires time, effort and significant
financial and personnel resources. While countries such as the
UK may draw on the experience of the Spanish model, there is a
need to evaluate how best that can be adapted in the national
context and particularly in the context of the organisation of
the national health system.
The danger in adopting a Directive at this point
which has as its focus standard setting in quality and safety
in organ donation and transplantation runs the risk of creating
additional layers of (unnecessary) bureaucracy, particularly as
a Directive is likely to mandate the implementation of standards
with respect to authorising establishments to engage in organ
donation and procurement, setting up inspection and control measures,
and setting standards in relation to the storage, preservation
and transport of organs. While implementing such standards may
be useful in the long term, it is likely to divert valuable (and
in many Member States scarce) personnel and financial resources
away from a necessary focus on organ shortage in the short to
medium term.
In short, we consider that any move towards
the publication of a legislative proposal for a Directive would
be premature in the short to medium term. The focus instead should
be on strengthening cooperation through OMC along the lines noted
above. The adoption of a Directive should be viewed as an option
for the long term.
Perhaps it would be best if EU institutions
gave consideration to expanding the treaty competence to act in
relation to organ donation and transplantation so as to allow
the issue of organ shortage to be addressed more directly as the
main focus in any regulatory initiative that may be brought forward
in the field.
WIDER ROLE
OF THE
EU IN RELATION
TO ORGAN
DONATION
Q. In your discussions, as a medical lawyer,
with academic and clinical colleagues from around Europe, what
have you identified as successful European collaboration in relation
to organ donation, and where do you feel the Commission could
or should encourage further work?
What we have heard suggests that around Europe
there is a wealth of evidence about what works and what does not.
The EU is best placed to conduct the research that will allow
the preparation of guidance on best practice including on how
consent regimes may work and how they are received in MS. It is
obvious that there is much to be learned from Spain but we need
to understand more about how far the Spanish model is exportable
to MS with different health service organisation, different population
make up, and perhaps a different perspective on ethical debates.
Specifically a mechanism needs to be put in place to bring together
and analyse the results of research already available on what
works and what does not. Additionally more research may be needed
to try and identify these factors within the varying donation
systems across the EU.
Greater understanding of why we see such different
patterns of donation within the EU is also important. We need
to identify the limits of harmonisation. In some MS geography
means that there will always be a greater emphasis on living donors.
Cultures differ and imposition of EU "Rules" can sometimes
be counterproductive.
Support for the promotion of donation and education
would be good. Let people learn about Spain and get Spanish donor
families to share their experiences. However, we would guard against
a one size fits all approach to education in this area. The differing
practice and culture of donation amongst the member states may
necessitate differing approaches. A mechanism by which member
states can draw on research in this area would be useful.
A recent European collaboration is the ELPAT
platform which aims to establish continuity in European communication
on "Ethical, Legal and Psychosocial aspects of Organ Transplantation".
ELPAT functions as an independent entity within the European Society
for Organ Transplantation (ESOT). This or a similar EU-led organisation
would serve as an effective mechanism for both the collection
and analysis of relevant research that is already available, and
for conducting further research (funded by either the EU or individual
member states).
HUMAN TRAFFICKING
IN RELATION
TO ORGAN
DONATION
Q. To your knowledge, how significant a problem
is human trafficking in relation to organ donation? To what extent
do you judge that the legal structures already in place to deal
with this issue are adequate? Please could you expand on what
you had in mind in your written evidence to us about the potential
for the introduction of EU legislation which sets out criminal
penalties for trafficking
Our concern is just that such robust empirical
evidence is not to our knowledge available. We have heard many
anecdotes some of them very disturbing. We recognise that often
the problem lies outside the EU with recipients travelling to
countries where donors may be at risk and/or be exploited and
where recipients own health care may be sub optimal. But a common
approach within the EU would be valuable first step to limiting
trafficking. However I suspect that laws will have only a marginal
effect while desperate people judge that they will not be bale
to have timely access to organs within the legal and ethical framework
of their own EU state. The best answer to trafficking is to make
it unnecessary.
It is clear that the issue of organ trafficking
was identified as an issue of concern during the Greek and Italian
Presidencies in 2003. This has been followed through by a request
for Europol to provide a report on the extent of the problem in
the EU context. At this stage, no further data has been forthcoming
from the Commission on the issue so it is difficult to know the
extent of the problem and therefore how to address it in a systematic
way in terms of policy or regulatory processes at either national
or EU levels. It is interesting to note that the Commission in
its Communication acknowledges organ trafficking as an issue which
it will monitor in terms of any developments (see p.8), and a
survey has been commissioned to ascertain what legislation exists
at Member State level in the area, as well as to identify problems
and solutions (see IA, p. 8). The Commission makes clear in the
Communication, however, that further work in the area is not seen
as a priority in its proposed action plan.
We also need to be clear whether if EU states
retain a ban on markets in organs whether certain kinds of incentive/reward
are nonetheless permissible such as meeting funeral expenses (a
recent report on this has been carried out in the Netherlands—van
Dijk, G, Hilhorst, M.T., Financial Incentives for Organ Donation:
An Investigation of the Ethical Issues, available via www.ceg.nl
or www.rvz.net).
ORGAN DONATION
TASKFORCE PROPOSAL
TO SET
UP A
UK-WIDE DONATION
ETHICS GROUP
Q. What do you see as the most difficult ethical
issues surrounding organ donation and transplantation? What advantages
do envisage there would be in establishing an independent UK-wide
Donation Ethics Group? To what extent do you think there could
be benefits in extending the discussion of such ethical issues
across other EU Member States?
I suspect that the difficult ethical issues
are little different from 20 years ago, should payments be allowed
for any kinds of donation, should explicit consent to cadaver
donation be required. I do think an effective forum to debate
these issues would be useful but care needs to be taken not to
duplicate work done elsewhere and in particular to work out here
the HTA would sit in such a framework. Given the benefit of an
EU approach to how we organise transplantation yes I think an
EU dimension to the ethical review of such issues is valuable
and offers an opportunity to exchange experiences of different
consent regimes and how the ethical debate has developed in MS.
My worry would be practical how could an EU wide group function
efficiently and not be a mere expensive talking shop.
To answer the first part of the question our
experience has been that the focus on grand ethical debates has
diverted attention from what can practically be done. What laws
say or how states vies ethical issues seems much less important
than good systems to co-ordinate transplantation. Our group has
very different views in many of the grand ethical questions. What
we agree on is that there are so many practical questions that
could be addressed without any change in legislation that would
improve current donation rates.
Identifying donors and asking for consent and
asking well is so important that how to seek consent must be a
priority for future work.
March 2008
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