Memorandum by UK Transplant (on behalf
of NHS Blood and Transplant)
The House of Lords EU Select Committee
has called for evidence in the light of the intention by the European
Commission to develop an EU Directive on Organs for transplantation.
The following 17 bullet points summarise the issues on which the
Select Committee seeks evidence, and each bullet point is followed
by the proposed response.
1. EU-WIDE SHORTAGE
OF ORGANS
AVAILABLE FOR
TRANSPLANTATION
It is clear that there is a severe shortage
of organs in every EU state (with the possible exception of Spain).
Spain has 35 deceased donors per million population (pmp), whilst
most other EU states have donor rates in the range 12 to 23 pmp.
The figure for the UK is 12.8 pmp. There are currently over 8000
patients in need of a transplant in the UK. The transplant list
rose by 8% last year, with approximately 1000 of those patients
accepted for the transplant list dying each year before a suitable
organ becomes available. Thousands more patients who would benefit
from a transplant are not placed on the transplant list as a result
of the shortage of organs and it is difficult to define the true
need for organs for transplantation. The pool of heart beating
donors is likely to reduce further as changes in the management
of severely brain-injured patients (e.g. decompressive surgery)
result in fewer patients who progress to brain stem death. Some
of these patients will fail to recover and, at some point, treatment
is likely to be withdrawn. Such patients may be potential non-heartbeating
organ donors (NHBOD) and NHBOD programmes should be expanded to
capture this potential.
2. ORGANISATION
OF ORGAN
DONOR AND
TRANSPLANTATION SYSTEMS
The Spanish success is clearly the result of
an integrated and systematic approach to organ donation which
has been replicated in northern Italy and several South American
countries. Whilst few have achieved the Spanish donation rate,
all have seen a major increase in donation. It is of absolute
importance for states to have a national organisation with responsibility
for the donation system. The key components of a successful donation
system are:
— A clear legal framework for the diagnosis
of death by neurological tests (brain death) and a legal and ethical
framework for donation after cardiac death;
— Commitment from all hospitals with
critical care facilities to ensure that all potential organ donors
are identified and notified to the donor co-ordinator network.
Donation must be seen as an integral part of end-of-life care
for all suitable patients;
— A well-structured national donor
co-ordinator network, including an individual with responsibility
for organ donation in every hospital with critical care facilities;
— Support from the general public for
donation. In Spain, the families of 83% of potential donors agree
to donation as compared to only 60% in the UK;
— Efficient and fully-resourced organ
retrieval teams;
— Accurate data to monitor all steps
of the process and robust performance management;
— High level political commitment.
3. RAISING PUBLIC
AWARENESS OF
ORGAN DONATION
The public has a key role to play in the promotion
of organ donation. Whilst it is encouraging that research shows
that 90% of people in the UK express their support for organ donation,
the reality is that four out of every ten hearts, livers, kidneys
and other organs that could be donated and transplanted are lost
because the donor's family refuse permission (see above). This
is not a consequence simply of the law (see below). Even in the
UK, following the introduction in September 2006 of the Human
Tissue Act 2004 and the Human Tissue (Scotland) Act 2006 which
both give absolute primacy in law to the wishes of the individual
(if known), it is acknowledged by the Human Tissue Authority Codes
of Practice that organ donation may not be appropriate if the
family is implacably opposed. Much has been done in recent years
to promote organ donation in the UK, in particular introducing
the NHS Organ Donor Register (ODR) which currently has almost
14.7 million people who have registered their wish to donate their
organs after death. This figure is rising by approximately 1 million
per year, but still represents less than 25% of the population.
Much more work is required to identify the most effective way
to promote public awareness, and even more importantly public
acceptance of organ donation. This in turn needs to be supported
by adequate funding of a high-profile, national campaign. This
might go some way towards addressing the discrepancy between the
large numbers of individuals who claim to be supportive of organ
donation and the actual number who register as donors. The variation
in relative refusal rate across member states is also an area
for action informed by the outcome of studies in this area (e.g.
the collaborative requesting study in the UK).
4. USE OF
ORGAN DONOR
CARDS, INCLUDING
THE IDEA
OF A
EUROPEAN ORGAN
DONOR CARD
The NHS Organ Donor Register (and its predecessor,
the donor card) have proved to be very useful vehicles for the
promotion of organ donation to the public. However, there is little
direct evidence that donor cards or registers have an effect on
actual donation. There are those who question whether any card
or register can provide enough information to people who want
to register their wishes to ensure that their consent to donation
is informed and valid (in the general rather than the legal sense).
These concerns could be magnified by the introduction of a European
donor card. It is not clear whether any such card could sit easily
alongside national systems (particularly those states with presumed
consent legislation) or would be expected to replace them—a
sure recipe for confusion and muddle. The key question relates
to the status in law of a European card or a register. It may
be more effective as a simple record of the wishes of the individual.
As proof of legally valid consent, however, it could raise major
anxieties about its use, not least amongst the public, with the
possibility of negative impact on the level of willingness to
sign up for donation.
5. USE OF
VOLUNTEER LIVING
DONORS
Living donor kidney transplantation has been
established in the UK for many years, as is the case in most EU
states. The number of such transplants has more than doubled in
the UK in the past five to six years to approximately 700 per
year. The process is well regulated by the Human Tissue Authority.
Living donor liver transplantation is relatively new to the UK,
and the numbers are very small, but is more common in other EU
states (particularly Germany). There are clear national and international
professional guidelines on living donor transplantation and the
care of the living donor.
One area where EU co-operation may be of interest
is in so called paired donation whereby one live donor-recipient
pair who are not matched exchange a kidney with another pair.
These patients are more likely to find a suitable exchange when
there is a large number of pairs in the pool. The system came
into operation only recently in the UK and more experience is
needed, but there could be additional benefits from international
co-operation in the future.
6. ENSURING THE
QUALITY AND
SAFETY OF
CROSS-BORDER
ORGAN DONATION
WITHIN THE
EU
The various Organ Exchange Organisations within
Europe (not all of which are within the EU) have met annually
in a semi-formal way for many years and there are proposals to
establish future meetings in a more formal way. Few organs are
exchanged across national boundaries (with the exception of the
seven countries that take part in the Eurotransplant Foundation).
There would be considerable merit in a more structured approach
to ensure that appropriate information is always available to
make an informed judgement about the risk-benefit analysis inherent
in organ exchange between EU states and to harmonise the documentation,
transport and traceability requirements. Additionally, consideration
should be given to standardisation of the diagnosis of death by
neurological and cardiovascular criteria across the EU. This would
prevent national differences in diagnosis impeding cross EU co-operation
in organ donation.
7. ETHICAL ISSUES
RELATING TO
ORGAN DONATION
AND TRANSPLANTATION
Donation and transplantation raise profound
ethical issues that are the subject of much debate at an international
level. The (international) Transplantation Society and the World
Health Organisation are both very active in this field. However,
the translation of ethical principles into a legal framework is
equally important and this could be an area of potential interest
to the EU states. There is, currently, considerable anxiety in
the UK about the legality of some parts of the donation pathway,
most specifically relating to non-heartbeating donors. To some
extent these anxieties stem from unintended consequences of the
Mental Capacity Act 2005 which places absolute priority on "the
best interests" of the patient without defining that term—specifically,
it is important to establish that organ donation is in "the
best interests" if the patient and their family wish this.
These difficulties must be resolved. It is equally important that
due care is given to any potential harmonisation of the legal
and ethical framework for donation across the EU to avoid any
further unintended or unanticipated difficulties.
8. HEALTH AND
SOCIAL WELFARE
BENEFITS OF
ORGAN TRANSPLANTATION
There is overwhelming evidence that, for appropriate
patients, life expectancy is considerably longer after a kidney
transplant as compared to the alternative treatment—dialysis.
There is also clear evidence that quality of life is improved.
For most other forms of organ failure, the only alternative to
a transplant is early death. For all organ transplants, 85-95%
of patients will be alive and well one year after the transplant,
with survival at ten years in the range 50-80%, depending on the
type of transplant. Moreover, regardless of the nature of the
healthcare system and the funding mechanism, it is considerably
cheaper to provide long-term care for a patient with a functioning
kidney transplant than to provide dialysis. Increasing kidney
transplantation has the possibility to save millions of pounds
in the UK and the EU-wide savings could be very significant indeed.
9. MEDICAL RISKS
OF ORGAN
TRANSPLANTATION
These relate very largely to the need for lifelong
immunosuppressive drugs to prevent rejection of the transplant.
There is much active research into possible means of minimising
or even avoiding entirely the need for such drugs and there could
be considerable benefits if the EU were to play a role in funding
and co-ordinating such research on an international basis.
10. ILLEGAL TRAFFICKING
IN ORGANS
There is almost universal acceptance of the
principle that to buy or sell organs from living donors is not
acceptable. Many EU states (and other countries) have incorporated
this principle into national law—in the UK, through the
Human Tissue Acts. Whilst there is little or no good evidence
of organ trafficking within EU states, there is concern about
past or present activity within several of the newer eastern European
states and to an even greater extent about recent practice in
India, Pakistan, China, the Philippines and South Africa. Most
of these countries are now seeking to prohibit organ trafficking.
A small number of UK residents continue to travel abroad each
year to have a kidney transplant from a paid donor, who then return
to the UK for long-term follow-up and treatment. The EU clearly
has a role in maintaining vigilance to ensure that organ trafficking
cannot and does not occur within member states.
OTHER ISSUES
OF RELEVANCE
TO THE
COMMISSION DOCUMENT:
11. ORGAN DONATION
AND TRANSPLANTATION
FROM A
FAITH-BASED
POINT OF
VIEW
National leaders of the six major faiths in
the UK—Christianity, Judaism, Islam, Hinduism, Buddhism
and Sikhism—have all explicitly endorsed organ donation
and transplantation. However, differences of opinion exist amongst
local faith leaders across the country, a situation exacerbated
by a blurred distinction between faith, culture and ethnicity.
There is a clear and urgent need for local leaders to use their
considerable influence to promote support for organ donation in
their communities, particularly given that opinion at grassroots
does not always reflect the official view of the faith.
12. ORGAN DONATION
AND TRANSPLANTATION
FROM THE
POINT OF
VIEW OF
POPULATION SUB-GROUPS
WITHIN THE
UK
There are considerable problems relating to
organ donation and transplantation stemming from the culturally
and ethnically diverse population of the UK. Patients of Asian
or African-Caribbean origin are three to four more times more
likely to develop kidney failure and need a transplant than their
white counterparts. Moreover, the frequency of certain blood groups
and tissue types differs between people of different ethnic origin,
making it difficult to find a well-matched kidney for black and
minority ethnic (BME) groups. Unfortunately, for a number of reasons,
organ donation from the BME population is lower than from the
white population. This is due, in large part, to the lower rate
of consent for donation (60% if the potential donor is white,
25% if the donor is of any other ethnic origin). As a result,
whilst 23% of patients waiting for a transplant are of BME origin,
they comprise only 8% of the general population. There is also
a marked variation between different areas of the UK, related
to the ethnic make-up of the population in different areas.
13. THE "PRESUMED
CONSENT" APPROACH
FOR IDENTIFYING
ORGAN DONORS
Of all aspects of organ donation, presumed consent
(or opting-out) generates probably more debate and controversy
than any other. However, there is virtually no evidence to confirm
that presumed consent legislation is associated with an increased
donor rate, and there is some evidence to demonstrate that the
legislative framework has little or no impact on the donation
rate in different countries. The architect of the uniquely successful
Spanish model, Dr Rafael Matesanz, is firmly of the view that
the key factor in this success is the systematic approach to donation
in Spain, rather than the legislation. The debate often centres
only on the potential to increase organ donor numbers. The impact
of presumed consent is, of course, wider and the possible effects
on the relationship between critical care clinicians and their
patients/relatives should not be underestimated. The primary role
of these clinicians is to provide support to patients with the
expectation of survival and organ donation is only considered
when further treatment options are unavailable or inappropriate.
The public currently understands and accepts this situation and
has faith that their physicians always act in their best interests
(rather than those of a potential organ recipient). Ensuring that
this faith is maintained is critical. Any debate on changes to
the legislation should carefully consider this issue.
14. ARRANGEMENTS
FOR TAKING
INTO ACCOUNT
THE VIEWS
OF RELATIVES
ABOUT REMOVING
ORGANS FOR
TRANSPLANTATION FROM
A DECEASED
DONOR
The relatives of potential organ donor must
always be involved in the donation process, and this involvement
is almost identical whether there is presumed consent or opting-in
legislation (as in the UK). In order to ensure the quality and
safety of donated organs, it is necessary to obtain not only a
full medical history of the donor, but also his/her social history,
the use of intravenous recreational drugs and sexual activity.
In practice, these requirements can only be met through a detailed
discussion with the donor's relatives. This is best achieved by
fully-trained donor transplant co-ordinators and it is essential
that there is a robust national network of co-ordinators with
the time and expertise to obtain this information in a sensitive
manner. It should also be noted that the relatives have a de facto
veto over donation so that if they are unwilling to provide the
necessary information to ensure quality and safety, donation cannot
proceed. These discussions take place in exactly the same way
in Spain (which has opting-out legislation) as in the UK (which
has opting-in legislation) and this reinforces the view that the
legislative framework is peripheral to the need for a national
organisation to ensure a systematic approach to organ donation.
THE NEED
FOR AN
EU ROLE IN
THIS FIELD—THE
COMMISSION'S
ARGUMENT IS
THAT IT
IS NEEDED
FOR THREE
MAIN REASONS:
15. TO PROMOTE
CO-OPERATION
BETWEEN MEMBER
STATES IN
ORDER TO
SHARE EXPERTISE
AND TO
EXPAND THE
SIZE OF
THE POTENTIAL
DONOR POOL
IN EACH
MEMBER STATE
Most EU states face broadly similar challenges,
but have approached the need to promote organ donation in a variety
of ways. There would clearly be advantages to greater co-operation
in the sharing of experience and the more general introduction
of best practice. The scientific and clinical communities internationally
share knowledge and expertise regularly and constructively. Such
co-operation between EU member states on organ donation and transplantation
has been developing through projects such as Alliance-O, but there
would be clear benefits to extending this collaboration. Good
information, in a standardised format, on the identification and
referral of potential donors and the consent rate for donation
is one of the many areas where accurate and comparable data are
essential. It would also be of value to ensure a more standardised
training programme for donor transplant co-ordinators, with training
being recognised and transferable between EU states.
16. TO PROVIDE
A CROSS-BORDER
FRAMEWORK FOR
THE ORGANISATION
OF ORGAN
DONATION AND
TRANSPLANTATION, WITH
HARMONISED RULES
THAT WOULD
PROVIDE EU CITIZENS
WITH HIGHER
STANDARDS FOR
ORGAN SAFETY
AND QUALITY
THAN CAN
BE ASSURED
BY THE
NATIONAL LEGISLATIONS
OF MEMBER
STATES ACTING
SEPARATELY
The EU has, in recent years, introduced directives
covering blood, tissues and cells to provide assurance on quality
and safety standards. Organ donation and transplantation also
require considerations of quality and safety, but there is one
fundamentally important difference. The supply of blood, tissues
and cells can be maintained whilst applying the highest levels
of quality and safety, whereas the supply of organs does not currently
meet the demand and across Europe thousands of patients die each
year because an organ is not available. For some patients—particularly
those with sudden fulminant liver failure—death will be
inevitable within hours if a liver is not available for transplantation.
The risk-benefit analysis of a suitable donated organ is therefore
completely different from the risk-benefit analysis associated
with blood, tissue and cell donation, and will itself vary with
the clinical needs of the individual recipient. In other words,
the risks associated with a given organ may be deemed unacceptable
for one recipient (who can wait for a so-called better organ),
but entirely acceptable for a second recipient for whom the almost
inevitable alternative, if the organ is declined, is death. In
the UK, there is clear guidance on the risks that may be associated
with donated organs, but a recognition that the final decision
as to whether to transplant a particular organ must rest with
the clinician, the patient and the patient's family. Whilst it
would be helpful to have an EU-wide common data set of information
about the donor and the organ, in order to allow informed decision-making,
it would be essential to guard against excessive priority being
given to safety and quality that could reduce further the number
of organs that can be transplanted.
A further area of concern is the impact of the
European Working Time Directive (EWTD). By its very nature, organ
donation is totally unpredictable and donor co-ordinators and
surgical retrieval teams must be available at all times. Most
organ retrieval procedures take place outside working hours and
the transplant operations need to take place within hours of retrieval
to ensure that the organs are viable. The surgical staffing of
retrieval and transplant teams (which frequently involve the same
team of surgeons) is under serious threat from full implementation
of the EWTD. Whilst this is most pronounced in the case of heart
and lung transplantation, other organ transplant programmes are
also affected.
17. TO ENABLE
MORE EFFECTIVE
ACTION ACROSS
THE EU TO
FIGHT ILLEGAL
ORGAN TRAFFICKING
While illegal organ trafficking is not perceived
to be a significant problem within EU states at present, it is
essential that vigilance is maintained. This is most effectively
achieved through the appropriate legal and regulatory framework
within each state—as currently exists within the UK. Increased
co-operation between the regulatory authorities would ensure that
the position does not deteriorate in the future.
October 2007
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