Memorandum by Mr John L R Forsythe, Clinical
Director and Consultant Surgeon
Many thanks for the invitation to submit evidence
regarding the Inquiry into the EU Commission's Communication on
Organ Donation and Transplantation: policy actions at EU level.
Please find enclosed written evidence. I have also enclosed a
list of my interests but stress that these comments are made on
a personal basis although the comments have also been submitted
to a number of the different organisations (Scottish Transplant
Group, British Transplantation Society, Board of NHSBT).
LIST OF
RELEVANT INTERESTS
Immediate Past-President, British Transplantation
Society.
Chairman, Scottish Transplant Group (Advisory
Group to Scottish Minister of Health).
Non-executive Board Member, NHS Blood &
Transplant.
Specialty Advisor to Chief Medical Officer (Scottish
Executive).
Regional Advisor to Royal College of Surgeons
of Edinburgh.
ISSUES RAISED
IN THE
COMMISSION'S
COMMUNICATION
EU-wide shortage of organs available for transplantation
There have been dramatic advances in the field
of transplantation over the last 20 years. In patients with terminal
heart, liver or lung failure, transplantation offers the only
current option for survival and renal transplantation is established
as the optimum treatment for irreversible kidney failure. Transplantation
is also successful in the long-term, a number of transplant patients
have survived well over 25 years and five year survival rates
for most organ transplant recipients are over 70%.
The shortage of cadaveric organ donors imposes
a severe limit on the number of patients who can benefit from
transplantation while there is an ever increasing demand for cadaveric
solid organs in most countries.
The situation in Europe is very heterogeneous
from very low levels in Eastern European countries to over 30
donors per million population in Spain and some regions in Italy,
France and Austria. The reasons for this variability are multiple
although it is clear that it cannot be attributed to differences
in the public willingness to donate organs but rather to differences
in health structure, hospital facilities and especially the organisation
of the organ donation system.
It is clear that all European countries share
an ever increasing gap between the number of available organs
and the number of patients waiting on the transplant list.
Spain
In the early 1990s, under the leadership of
Rafael Matesanz, Spain began an original, integrated approach
designed to improve cadaveric organ donation. This programme was
accomplished by a combination of:
(i) A proactive donor detection programme
run by well trained transplant co-ordinators.
(ii) Systematic death audits in hospital.
(iii) Positive public attitudes enhanced
by education and publicity through mass media.
(iv) Adequate reimbursement for hospitals
for donor expenses.
The result was a massive increase in the donor
rate up to 35 donors per million population in 2005. This compares
with 2005 rates in other European countries as follows.
UK 12.8, Ireland 17.6, France 22.2, Germany
14.8, Italy 21, Portugal 19 donors pmp (figures from September
2006, Newsletter Transplant, EU document).
At first many explained these figures as a "Spanish
phenomenon"; some even commented that the Spanish road traffic
accident death rate was very high to explain the comparative difference
between their own member state and Spain. Since that time, the
programme in Spain has been "transplanted" to the Northern
region of Italy with similar increase in the organ donor numbers.
The principles of the Spanish system were also used in a region
of Australia, again with similar effectiveness.
Rafael Matesanz summarises the recommendations
which have been at the centre of the Spanish programme as shown
below. It is of note that these recommendations touch on many
of the issues on which responses have been invited in relation
to the Commission's Communication. These include:
(i) Organisation of organ donor and transplantation
systems.
(ii) Raising public awareness of organ donation.
(iii) Ensuring the quality and safety of
cross-border organ donation within the EU.
(iv) Medical risks of organ transplantation.
RECOMMENDATIONS
TO MEET
THE ORGAN
SHORTAGE
1. The transplant process is long and complex
and cannot be left to chance. Protocols should be developed for
each step. A key person should be made responsible in each area/hospital
for managing and monitoring the process with the power to determine
where efforts and resources should be directed.
2. Published national or regional figures
cannot be extrapolated to provide local rates of potential versus
effective donors (although marked differences from published rates
for potential donors should be considered as suggestive of underdetection).
A donor detection gap should be established for each hospital/area
and systems for monitoring the rates established.
3. A means should be developed to evaluate
the size and characteristics of the potential donor pool to measure
and monitor potential donor detection rates. To ensure reliability,
data should be collected prospectively and analysed retrospectively
as recommended in the "Donor Action Programme".
4. Proactive donor detection programmes
should be instituted in every acute hospital using specially trained
professionals (key donation persons) working to agreed protocols
and ethical rules.
5. A "key donation person", independent
from transplant teams, should be appointed in every acute hospital,
with a clearly defined role and responsibility for establishing,
managing and auditing systems for donor identification and identifying
potential areas for improvement.
6. Protocols should be developed setting
out the criteria for screening potential donors and their organs
for the risk of disease transmission of infectious and neoplastic
diseases.
7. The incidence of irreversible cardiac
arrest, sepsis and other contraindications to organ donation relating
to management of potential donors should be monitored and audited
to detect and correct any problems identified. Involvement of
ICU staff in research and/or educational programmes on donor management
should help raise standards.
8. An appropriate legal framework for donation
and transplantation is required, which adequately defines:
— the type of consent authorisation
required for retrieval (see below); and
— the means of organ retrieval
that ensures traceability but maintains confidentiality and bans
organ trafficking.
9. Law professionals should be fully aware
of the transplant process, and the cooperation of those most closely
involved, ie judges and coroners, should be sought to reduce legal
refusals to a minimum.
10. It is advisable to ascertain the opinion
of the public and health professionals about presumed or informed
consent for organ donation before considering legal changes that
might be potentially detrimental. The key donation person appointed
in each centre/area must be aware of all local legal criteria
and should be responsible for meeting these requirements. There
should be a system for the safe custody of all certificates and
test results required by the law.
11. Because both positive and negative messages
can affect the public's willingness to donate organs, there is
a need for a professional attitude to communications, which may
require support from experts. They should help to minimise the
impact of "bad news", and maximise the communication
of "good news" about transplantation to health professionals,
the media and the public. Special attention should be paid to
both content of the message and the best means of dealing with
the most controversial topics. The preparation of specific briefing
materials should be considered.
12. The most cost-effective means of increasing
the public's willingness to donate seems to be improving the knowledge
of health professionals (not directly involved in transplantation)
and the media about transplantation issues. Continuing education
should form an essential element of any communication strategy.
A transplant "hotline" manned by appropriately trained
professionals should be considered.
13. People should be encouraged to speak
about organ donation and transplantation and to communicate their
wishes to their relatives. As a donor's wishes will not always
be known, staff in a position to make requested for agreement
to organ donation to relatives should be properly trained for
the purpose. If such requests are well handled the rate of donation
refusals can be reduced.
14. Organ retrieval procedures should be
well planned to minimise delay and disruption to the donor hospital.
Retrieval teams should be led by experienced surgeons trained,
where appropriate, in multiorgan retrieval. Organ damage during
retrieval should be reported and monitored and further training
provided as necessary to minimise damage during retrieval or transportation.
15. An organ sharing/allocation organisation
is essential but its roles and responsibilities must be clearly
defined, particularly if it is to have a role in organ donation
and procurement (see below).
16. Attention should be paid to ensuring
that hospitals are properly resourced and, if necessary, reimbursed
for maximising organ procurement.
17. In order to optimise organ donation
there is need for a supra-hospital transplant organisation, appropriate
in size and structure to the local situation with specific responsibilities
for the whole process of organ procurement.
18. The most effective organisational approach
is one that balances the requirements for effective organ procurement
(small, local) with those for organ allocation (large, national/multinational)
(see below). The aim should be to optimise organ procurement whilst
ensuring the most clinically effective allocation of organs and
tissues.
19. Health administrations are responsible
for ensuring that there is proper organisational support for organ
donation and distribution and should guarantee the fairness, transparency
and safety of the whole system.
20. International cooperation on the promotion
of organ donation is desirable to help maximise organ donation
and equalise access to transplantation between countries. Governments
should actively promote such cooperation.
21. Priority should be given to international
cooperation that improves standards of training, exchange of experience,
and helps guarantee the safety of organs and the ethical standards
by which they are retrieved and transplanted.
There is no doubting the success of the Spanish
system and the fact that it is possible to translate principles
from one national context to another. However there are other
issues which play in this area. Within Spain, the population is
relatively homogeneous but in large cities where there is more
heterogeneity (increased black and ethnic minority groups) the
organ donation rate is not as great as the rest of Spain. Therefore
cultural differences and inter-faith differences continue to be
important (see relevant section below).
Use of organ donor cards including the idea of
a European Organ Donor Card
The concept of an organ donor card has become
very familiar in everyday language and usage. When there has been
critical appraisal of its success in raising awareness of organ
donation, there has been no definite confirmation of the prime
importance of such a card. Rather the use of cards (or registers)
act as a focus for public education and awareness and programmes
to increase awareness of the organ donor shortage. With recent
legislative change in the UK, inclusion on the organ donor register
acts as a "living will" and if a European organ donor
card is to be used, the ethical dilemma of whether a signature
on a card acts as such a form of consent should be considered.
Undoubtedly the production of a European organ donor card would
serve as a focus for organ donation awareness across the whole
of the EU but perhaps the money might be spent on mass media programmes
more effectively. If a European card was produced would all European
members be asked to sign it? What would be the status of the organ
donor card held (and signed) by individuals within each member
state?
Ethical issues relating to organ donation and
transplantation
It has been said that transplantation is medical
ethics in action. Examples include:
— Consent for organ donation:
Should consent be an "opt-in" or "opt-out"
system? Should minors be considered for organ donation purposes
in the event of tragic death? What if a child of 15 has clearly
stated a wish to donate but their parents do not wish donation
to take place? Should registration on an organ donor register
act as a living will? What if the relatives say that the potential
organ donor changed their mind and forgot to remove their name
from the register?
Should organs go to the most needy (with the
least chance of long-term survival) or the slightly fitter patient?
How should the time on waiting list affect the organ allocation
process? If the organ allocation policy is (unwittingly) allocating
less organs to the ethnic minority populations, should this be
rectified or is this a natural result of less organs being donated
by those populations?
Should paired donation be accepted? (Now accepted
in the UK but not across all EU states). Should volunteer living
donors be accepted without question? If there is a higher risk
than usual for a particular donor to give to a relative, at what
level of risk should that donor be told that the procedure cannot
go ahead?
Clearly it is relatively easy to set principles
of ethics such as the right to justice and promotion of fairness,
respect of autonomy and beneficence; however strict detailed regulations
in this general area would be very difficult to enforce and make
future proof.
Use of volunteer living donors
Living donation for the purposes of kidney transplantation
has increased markedly across the world in the last few years.
40 to 50% of kidney transplants in Norway and the United States
now occur from a live donor. The figures have also increased in
the United Kingdom so that many units are performing 30% of total
transplants as live donor operations. This has happened for a
number of different reasons which could be listed as follows:
(i) Realisation of the severe organ donor
shortage with the individual impact which that brings for patients
on dialysis waiting for transplantation for a long time.
(ii) Recent figures which have shown a significant
survival benefit of transplantation over dialysis and live donor
transplant over transplant from a dead donor.
(iii) Laparoscopic surgery (keyhole surgery)
as a successful technique for many cases of live donor transplantation
enabling a faster recovery for the donor.
(iv) Modern immunosuppression means that
more patients can benefit from live donor transplantation; spouse
to spouse, partner to partner, friend to friend, paired donation
transplants are all now possible when they were not a few years
ago.
It would be the view in the UK that this increase
in live donation has been very successful and has allowed many
patients to escape dialysis. Live donation rates vary quite considerably
across the EU and these benefits of live donation could therefore
be spread to other European countries.
ALTRUISTIC DONATION
(NON-DIRECTED
DONATION)
A relatively controversial form of live donor
transplantation is altruistic donation (or since all live donation
is altruistic this is sometimes called non-directed donation).
Here an individual decides to give a kidney into the general pool
simply for the purposes of "doing good". Clearly it
is important that any individual who puts their name up for such
a procedure is both physically and psychologically robust. This
minimises the potential negative effect of any donation. However
there are a small number of individuals who have gone through
the whole process of medical and psychiatric work-up successfully
in a few centres in the world. It is the view in the UK that this
procedure should be allowed, provided donor work-up is comprehensive
and uniformly satisfactory. It is unlikely that the small number
of donors per country will significantly reduce the organ donor
shortage but in circumstances where genuine individuals wish to
take this course, it is the view in the UK that they should not
be prevented.
HEALTH AND
SOCIAL WELFARE
BENEFITS OF
ORGAN TRANSPLANTATION
The Commission's Communication cites evidence
of the benefit of organ transplantation. These include direct
health benefits, quality of life improvement and economic benefits.
Direct health benefits
Clearly in those patients where organ failure
will lead to death without a transplant, there is an obvious direct
health benefit. But in the last few years it has become clear
that even when there is an alternative such as dialysis, the direct
health benefit of transplantation over dialysis is considerable.
Patients not only have a better quality of life but they have
a better quantity of life. This has been proven by US and British
data (Wolfe et al, Oniscu et al).
Quality of life
Again for those where there is no alternative
other than transplantation, quality of life must be better. However
those who require transplantation for renal failure also have
better quality of life even though the drugs for avoidance of
rejection have many side effects. Patients cite return to almost
normal activity including return to work with the consequent economic
benefits for the society.
Economic
There have been multiple assessments of the
economic benefits of transplantation. All these show that transplantation
is more expensive than dialysis in the first year after the transplant
procedure but thereafter is much less expensive. The economic
benefit is addressed in a number of sections of the Commission's
Communication.
ENSURING THE
QUALITY AND
SAFETY OF
CROSS-BORDER
ORGAN DONATION
WITHIN THE
EU AND MEDICAL
RISKS OF
ORGAN TRANSPLANTATION
The EU has been very successful in harmonising
quality standards for blood donation and administration as well
as tissue donation and transplantation. It is commonly accepted
that this harmonisation has improved the situation across Europe
and made the administration of these bio-substances much safer.
It is quite natural and logical to extend the same wish for quality
assessment into the field of organ transplantation. However the
risk/benefit analysis of any particular organ transplant is very
different from the same analysis carried out for the recipient
of a tissue donation.
Transplants have many benefits, whether live-saving
(such as heart or bone marrow transplants) or aimed at improving
the quality of life (such as bone grafts). The risk of infection
from a particular donor may be an absolute contra indication to
accepting a bone donation but a relatively minor contra indication
for liver donation where the potential recipient would otherwise
die from liver failure. Therefore it is very important that a
zeal to harmonise quality standards across the EU does not remove
the clinical ability to make a high risk decision for a patient
who would otherwise die from organ failure. An example would be
the acceptance of a liver from a donor with a higher risk of tumour
transmission than average, for a patient who has taken a paracetamol
overdose with 24 to 48 hours to live. The important factor here
would be that in all cases, where unusual or extra risks of infection
are identified, these should be discussed in detail with the person
who would receive the organs or their family. At times within
the Commission's Communication, the desire to harmonise quality
initiatives seems to be paramount to the desire to improve the
organ donor shortage. It is important that the priorities are
set correctly.
ILLEGAL TRAFFICKING
IN ORGANS
There is little evidence (other than urban myth)
of significant involvement in organ trafficking by criminal groups
within the UK. However there is a large number of patients, particularly
those from Asian origin, who have travelled to other countries
in the world to receive organs which have been bought. There is
also evidence of patients travelling to China to receive organs
from executed prisoners prior to this practice being made illegal
by the Chinese authorities. Most UK clinicians have direct experience
of patients who ask about travelling to other countries (outside
the EU) to receive organs which are retrieved from individuals
who have presumably been paid for this donation. Patients are
discouraged from doing this because of the illegality and also
because of the risk to their health since the quality of donor
organ and the risk of transmission of infection or malignancy
is much higher. Nevertheless there is evidence that the practice
is continuing and patients return to the UK requesting continued
care. In general terms clinicians feel duty-bound to care for
these patients even though they have acted against previous medical
advice.
There is also anecdotal evidence of illegal
organ trafficking particularly at the geographical fringes of
the EU. This is illegal and the UK community would support all
measures to make any such practice more difficult for any criminal
individuals involved.
SITUATION IN
THE UK
Leading individuals in the UK were pioneers
in the field of transplantation and therefore transplant services
have a relatively long history compared with other countries in
the world. These services are therefore well developed and the
results of solid organ transplantation are as good as or better
than most in the world.
The organ donor shortage is, however, very severe.
The organ donor numbers are lower than most other EU countries.
There is good organisation of transplant services
in the UK with a multidisciplinary professional organisation,
the British Transplantation Society, which has led the way in
the production of guidelines, standards and protocols for many
aspects of transplantation (http://www.bts.org.uk/).
United Kingdom Transplant which is now an operating
division of NHS Blood and Transplant, has duties to keep records
of patients on the waiting list, organ donors, patients in follow-up
after transplantation and information about transplant units in
the UK. In the last years, UKT has been involved in a number of
initiatives to increase the number of transplants performed. Although
there has been a very small increase in the total number of transplants
carried out in the last year, the difference between the organ
donor rate in the UK and that in other European countries, especially
Spain, remains a significant gap.
Patient groups within the UK are also relatively
powerful and the National Kidney Federation is an example of this.
It is a patient charity that led a 2006 transplant summit hosted
by the All Party Parliamentary Kidney Group. At this summit it
was agreed that the organ donor shortage was very severe and with
an aging population and a higher incidence of renal disease, this
problem was likely to get worse.
In 2006, with the support of patient groups,
transplant professionals and NHSBT, a Donor Task Force was set-up
to report directly to the Minister of Health and this group also
had representation from all the devolved administrations. The
task force is made up of patients, public, media experts, NHSBT
staff and transplant professionals. The group has considered evidence
from a wide variety of sources including experts in the United
States and Spain. Recommendations are in last draft form and are
wide ranging. These are to be produced in September 2007. There
is a real feeling that these recommendations, if fully enacted,
will make a major difference to the organ donor rate within the
UK.
Quality and safety
All aspects of organ donation come under close
scrutiny, from the assessment prior to donation of a potential
donor through to transplant follow-up. There are many important
protocols enacted by transplant co-ordinators and transplant surgeons.
Not least is the guidance on the Microbiological Safety of Human
Organs, Tissues and Cells produced in August 2000. A re-write
of this document is presently in preparation, organised by the
Department of Health.
QUESTIONS WHICH
MAY ARISE
IN RELATION
TO ORGAN
DONATION AND
TRANSPLANTATION FROM
A FAITH-BASED
POINT OF
VIEW
All of the major religions of the world support
the concept of organ donation for the purposes of transplantation.
Cultural differences remain which are complex and are to do with
the physical treatment of the body after death and belief about
the spirit of the individual. This means that in countries where
the religious leaders have backed organ donation, cultural and
social mores have resulted in poor organ donor rates. In the UK
there has been much effort to promote organ donation within black
and minority ethnic groups. It is clear that this is a long-term
programme which requires much education and support from religious
leaders, which has been readily given. Nevertheless further work
is required.
PRESUMED CONSENT
Recently the Chief Medical Officer of England
and the British Medical Association have confirmed their support
for a system of opting out in the legislation for organ donation.
It is clear that there is a level of public support for such an
initiative even allowing for the fact that the relevant legislation
changed only in 2006 (Human Tissue Act 2006). It is also clear
that there are also individuals in the community who disagree
with a system of opting out given the reaction in the print media.
The severity of the organ donor shortage allows
some people to argue that opting out is required since those countries
that have an opt out approach have, in general, a higher rate
of organ donation than those with an opt in approach. It is also
felt that the discussion with relatives at the time of tragedy,
is much easier if one can approach the loved ones of the deceased
saying that organ donation is "what usually happens"
and so this may ease the decision for the relatives at a difficult
time.
Those that oppose opt out are generally pro
organ donation but feel that to assume (or presume) any particular
action for a donor after their death is fraught with danger particularly
in a country which experienced the Alder Hey scandal. It is felt
that the potential negative effects of a single case which goes
wrong could be wide-ranging. The Human Tissue Act (2006) has enabled
transplant co-ordinators to make a much more sensitive approach
to relatives and therefore the system acts much more like the
soft opt out approach in most European countries. It is of interest
that Rafael Matesanz from Spain says that the way our legislation
is enacted is exactly the same as the way opt out policy is used
in Spain. He does not feel that legislation, in and by itself,
will be the answer to organ donor problems. Rather a raft of measures
is required to make a difference.
Lastly, the hard opt out approach (where relatives
have no say at all over the potential for organ donation) is used
in a full way in only one country in the EU (Austria) and this
is a country where post mortems have been mandatory for many years.
PARTICULAR ISSUES
RAISED IN
THE COMMISSION'S
COMMUNICATION
The need for an EU role in this field
The impact document which accompanies the Commission's
Communication describes three levels of options which are available.
These are as follows:
(i) Use of existing programmes only.
(ii) Active co-ordination between member
states on organ quality, safety and availability.
(iii) Second level plus harmonisation of
quality and safety with an initiative on organ trafficking.
After consideration, there is a role for the
EU in this area. It is clear that some EU countries have put in
place initiatives which are successful for the population of that
member state and these best practices could be spread to other
countries as long as the national and cultural context is sensitively
managed. Examples are as follows.
A number of countries, but Spain in particular,
have achieved donor rates which are almost double their neighbouring
countries and many times more than the least developed EU countries.
Those involved in a Spanish programme have translated their ideas
to other European countries most successfully. This would indicate
that a similar approach would be of considerable benefit across
Europe. It is likely that the same level of success will not be
achieved because of cultural differences but it is also likely
that a substantial increase in organ donor numbers could be brought
about.
There are differing views on living donation
across the EU and indeed there are also different legislative
programmes in place across different countries. The benefits of
living donation are clear and new techniques such as laparoscopic
nephrectomy will enhance these programmes further. Again these
best practices could be spread from those countries in which high
live donor rates exist across to others where dialysis patients,
patients with liver failure and even patients with lung failure
could benefit from live donor transplantation.
(iii) Quality and safety.
It is important that this third option is seen
as lesser in priority to the two above. It may be easier to establish
rules in quality and safety and these are important especially
because some organs are transported across borders. It should
be expected that organ transplantation should be equally safe
across the EU and some harmonisation of quality is required. However
just because this is an easier task does not mean that it should
take priority over attempts to increase organ availability which
would benefit many more European citizens.
The way in which the EU can help
The resources and skills which are available
to the EU could allow programmes to be developed which may enhance
the process of organ donation and transplantation across Europe.
Programmes could include the following:
(i) Public awareness campaigns.
(ii) Mass media campaigns.
(iii) Public education and school education
programmes.
(iv) Spreading of best practice by the organisation
of focused conferences and meetings between individuals involved
in the organisation of donor and transplant services.
(v) Initiation of partnerships between transplant
units in different countries.
(vi) Continued funding of research programmes
in organ donation and transplant programmes.
References
International Figures on Organ, Tissue and Transplantation
Activities (Newsletter Transplant 2006). Editors Rafael Matesanz,
Blanca Mirander.
More Transplants, Saving More Lives, a report
of the findings of the 2006 Transplant Summit, published by the
NKF 2006.
Guidance of the Microbiological Safety of Human
Organs, Tissues and Cells used in Transplantation, published by
Department of Health, London August 2000.
Rafael Matesanz, C J Rudge . The Acute Shortage
of Donors: a UK and European perspective in A Companion to Specialist
Surgical Practice (Transplantation) . Editor J L R Forsythe, published
Elsevier 2005.
Roberts et al. The Effect of Changing
HLA on Organ Allocation and Ethnic Minorities, N Engl J Med 2004;
350(6): 545.
Wolfe et al. Comparison of Mortality
in Dialysis and Transplant Patients. N Engl J Med 1999; 341 (23):
1725.
Oniscu G, Forsythe JLR. How old is old for renal
transplantation? American Journal of Transplantation. Vol 4, No.
12: 1931-2140.
23 August 2007
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