Memorandum by the Patient Liaison Group
RCSEng
The Patient Liaison Group RCSEng is particularly
interested in the issues raised by "Presumed Consent"
and how to make the public better informed about organ transplantation.
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Comments are below:
EU-WIDE SHORTAGE
OF ORGANS
Supply side
Greater awareness, understanding and trust in
the system drawn up among members of the public, may well encourage
more donors to come forward.
If the system were an "opted in" one,
this would have a dramatic effect on the potential supply of donated
organs.
There is a need for an overarching "Eurotransplant"
with representation from EU countries that will investigate organ
donation, looking at best practices and create a EU-wide legal
framework. In the UK particularly, the shortage of ITU beds must
be addressed urgently.
The issuing of drivers licence and other essential
documents could contain a legally binding clause to fill in the
section as to whether there is agreement to transplantation or
not. Currently this often comes as a separate optional form, which
is inevitably never returned.
Demand side
Presumably alongside transplantation work, there
is currently funded research going on into alternative therapies
to transplantation?
Where particular shortages are identified among
ethnic/religious groups then a more concerted campaign should
be organised e.g. dialogue with leaders/priests and the need to
target this group in a campaign, which highlights the benefit
to their particular community. Earlier identification of renal/liver/heart
failure through improved medical training, screening/funds for
testing—injection of EU funds to those areas. This could
diminish the numbers at "end stage" organ failure. Better
management of diabetes and early identification.
ORGANISATION OF
ORGAN DONOR
AND TRANSPLANTATION
SYSTEMS
In order to increase public trust it is crucial
that QA and procedural differences between the approaches adopted
by individual Member States towards organ donation are reduced
by establishing legally binding regulations and effective Quality
Assurance.
On this basis, Option 3, as outlined in the
Impact Assessment document would be the ideal option.
This can be done through EU Legislation, standards
of compliance and regulations over procedures when a patient is
in ICU and due to die, and in setting up a structured system of
waiting list for donors. Medical training is also the key to incentivising
clinicians. EU funds and facilities should promote the exchange
of expertise and best practices.
Whilst an increase in NHBDs may be a short-term
solution, the aim should be to increase the pool of brain stem
dead heart beating donors. It would be ideal if there was a uniform
system of organisation of organ donation and transplantation across
the EU.
In the UK there is a need for Clinical Champions
in every hospital, which has an ITU. It would be best if this
person was independent of the transplant team and also independent
of ITU and UKTS but maintaining relationships with all three.
RAISING PUBLIC
AWARENESS OF
ORGAN DONATION
Trust in the reliability/safety of the system
is crucial. Without this the public will not engage with it. It
is vital to communicate with the public. If consent is presumed
because people are automatically opted in, then if that consent
is to be "informed" consent, it must be mandatory for
the NHS to inform every member of the public.
Health professionals could visit schools and
higher education institutes to explain what is meant by presumed
consent and something of the procedure.
Primary care could be the source of far more
information about transplantation and donor procedures, when routine
checkups etc are done information could be given to patients.
Posters and leaflets could be posted in all A&E depts and
hospital waiting rooms. Health professionals could be trained
to explain the procedures to patients. National Blood Transfusion
service for example, could provide leaflets and information.
Case studies of patients who have benefited
from transplantation should be made more accessible to the public.
TV could be used to make appeals.
This must not be "one-off" advertising
but a concerted long-term drive. Danger of bad publicity via TV
programmes. Public are easily influenced by the media.
USE OF
ORGAN DONOR
CARDS, INCLUDING
THE IDEA
OF A
EUROPEAN ORGAN
DONOR CARD
This is a useful idea, as it would result in
a reliable register of donors. Again the biggest hurdle remains
inertia by people to sign up if the system is involves having
to opt in.
Information held must be accurate and easily
accessed—time is of the essence. National register seems
a good idea for the public and clinicians when in urgent need
of a donor. A register would be needed if there were an automatic
"opted in" system, so that the NHS could record those
who had "opted out". This register could be used like
an electoral roll, with those listed asked at regular intervals
if their details are still correct. This in turn would inform
people of the donor system and provide an opportunity for them
to opt out if they so wished.
USE OF
VOLUNTEER LIVING
DONORS
This is problematic in countries where success
rates of transplantation are not good. Living donor transplantation
should only be used where the rates of success justify this and
thus standards of expertise will need to be raised Europe-wide
before rules on this are formulated.
Altruistic organ donation should be clearly
explained. If there were enough deceased donors, altruistic non-directed
organ donation would be superfluous. If procedures to increase
the number of deceased donors progresses, then the need for living
donors should decrease.
ENSURING THE
QUALITY AND
SAFETY OF
CROSS-BORDER
ORGAN DONATION
WITHIN THE
EU
This is vital and procedures agreed should be
made legally binding.
ETHICAL ISSUES
RELATING TO
ORGAN DONATION
AND TRANSPLANTATION
These must be taken into account, especially
in a system, which plans to use the "presumed consent"
approach. There must be no risk of the public seeing themselves
as becoming the means of providing "spare parts" for
clinicians keen to save another life. There may be a fear that
given a dying patient in intensive care and a patient in urgent
need of an organ, the survival chances of the former could be
compromised if organ donation took priority. Separating out the
responsibilities very clearly of those who provide declaration
of death of the patient (and care for them in their last days)
from those who evaluate the patient for donation is essential
and would reduce this fear.
The "heart beating donors" issue is
a difficult one and the public will need reassurance on the ethics
of it as well as greater clarification about how it is defined.
Issues related to the diagnosis of brain stem death must be transparent,
with clear guidelines and nothing left to clinical judgement.
Public education on understanding of brain stem death as opposed
to cardiac death is important.
HEALTH AND
SOCIAL WELFARE
BENEFITS OF
ORGAN TRANSPLANTATION
Information should be far more freely available
to the public on these issues, so that decisions as to whether
to become a donor and not opt out are informed decisions.
MEDICAL RISKS
OF ORGAN
TRANSPLANTATION
Prevention of spread of diseases via transplantation
and screening are very important and standards must be set that
are common to all countries.
It is very important to establish the consistent
reporting of adverse reactions in an organ donor/recipient. Must
at all costs avoid loss of public trust.
ILLEGAL TRAFFICKING
IN ORGANS
More public awareness of the issues will raise
the number of donors coming forward, which would in turn reduce
the levels of trafficking.
Greater availability of organs should go some
way to helping solve this. Nothing can be done about those who
go outside the EU for trafficking in the LDCs.
Also essential to tighten up controls on those
obtaining organs from patients illegally.
QUESTIONS, WHICH
MAY ARISE
IN RELATION
TO ORGAN
DONATION AND
TRANSPLANTATION FROM
A FAITH-BASED
POINT OF
VIEW
There are cultural and religious considerations
which will need to be explored, reflected upon and an action plan
drawn up to tailor-make the awareness campaign and promote the
desire to donate in the different cultural areas of the EU.
There is a need for a Department of Health sponsored
major symposium, bringing together representatives of all religions
and faiths within the transplant and ITU community. This would
be extremely beneficial and allow the various faiths to put forward
their point of view on brain stem death and organ transplantation
and for the transplant community and ITU community to dispel any
myths.
THE "PRESUMED
CONSENT" APPROACH
FOR IDENTIFYING
ORGAN DONORS
(UNDER WHICH
A WILLINGNESS
TO DONATE
ORGANS BECOMES
THE DEFAULT
POSITION AND
PEOPLE WISHING
TO OPT
OUT FROM
THIS NEED
TO MAKE
THIS KNOWN
How does the suggestion of presumed consent
square with the recent Human Tissue Act, where consent of the
individual is given primacy?
How will the consent of the individual be safeguarded?
The patient must be aware that he/she is automatically
"opted in", otherwise it is not "informed"
consent. If the patient did not know that they are automatically
opted in, then they have not consented to it. It is therefore
mandatory for the NHS to have informed every member of the public
of this opted in situation.
At what point in their life is it proposed that
an individual is automatically "opted in" to this system?
How would the crucial understanding of an automatically
opted in system be assured for people with low IQ, or those with
a poor understanding of English?
If presumed consent is to be adopted, then opting
out must have a transparent procedure for implementation and be
thoroughly understood as an individual right.
If a patient is to be part of a presumed consent,
then they must know exactly what they are consenting to. It is
therefore important that adequate literature is provided as far
as presumed consent is concerned. It must not be made difficult
for people to opt out. Ideally, the electoral roll could be used.
Regular checks of the electoral roll are made as far as local
elections are concerned and there could be space on the forms,
which are returned to indicate that you wish to opt out.
Those countries with legally automatic "opting
in" approaches will presumably have potentially greater availability
of donors—the supply across the Member States could become
unbalanced. This would encourage "donor tourism".
Not sure whether in an automatically opted in
system, that patients would necessarily agree to their organs
being used outside the UK. Would the system allow for this? Would
donors feel that they could specify where and to whom their organ
should go?
These are all issues that the Patient Liaison
Group is particularly concerned about.
THE ARRANGEMENTS
FOR TAKING
INTO ACCOUNT
THE VIEWS
OF RELATIVES
ABOUT REMOVING
ORGANS FOR
TRANSPLANTATION FROM
A DECEASED
DONOR (BOTH
UNDER THE
PRESENT SYSTEM
OF "OPTING
IN" OR
UNDER THE
"PRESUMED CONSENT"
SYSTEM FOR
IDENTIFYING DONORS)
If presumed consent applies, does that mean
that no family confirmation is needed?
In an "opted in" system will the family
have no say? What about confrontation between family and clinician
at the deathbed? There surely must be some allowance made for
this?
If relatives have the final veto, a presumed
consent system could become unworkable.
VIEWS ON
THE NEED
FOR A
EU ROLE
To promote cooperation between Member States
and particularly for funding and facilitating exchange of expertise.
TO PROVIDE
A CROSS-BORDER
FRAMEWORK FOR
ORGANISATION OF
ORGAN DONATION
AND TRANSPLANTATION
This is necessary in order to make sure that
the QA, screening and clinical procedures are of the highest possible
standard throughout the EU.
5 October 2007
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