Clinical judgement
116. A number of witnesses, including clinicians
working within the transplant field, were particularly keen to
stress that clinical judgement and the ability of the patient
to make an informed choice should not be inhibited by the introduction
of an over elaborate directive. Individual clinicians and patients
should be allowed to make the final decision regarding the suitability
for donation of a particular organ in a particular case.
117. Mr John Forsythe, an experienced surgeon,
wrote, "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" (pp 216-223). Dr Vivienne Nathanson,
BMA, acknowledged the value of some EU directives but warned,
"The danger is that you could end up with so much bureaucracy,
that you hamstring the doctors' ability to say 'In this patient's
case a non-standard answer is the only proper answer'" (Q 386).
118. Dr Nathanson's concerns were echoed
by Ms Lesley Bentley, Lay Chair of the Patient Liaison Group of
the Royal College of Surgeons, who, while emphasising that it
was important for patients to be able to assume acceptable levels
of safety and quality (Q 152), suggested that, if a patient
has a lot of difficulty in finding an organ, an organ of less
than the highest quality might be considered (Q 154). She
emphasised that the patient should have the opportunity to talk
through this type of issue with the doctor (Q 157).
119. The DH Minister, Mrs Ann Keen MP,
recognised clearly the concern that, in the context of applying
a directive relating to quality and safety, it would be important
to maintain the flexibility for clinicians to exercise their medical
judgement. She told us, "I think it is important that we
say straight away that UK transplant clinicians already work to
high quality standards in organ procurement and transplantation.
It is almost a gold-plated service. What problems could we have
if we were to work to a real directive? I think clinicians must
ultimately make that judgement for themselves and not necessarily
follow the directive" (Q 469).
120. Dr Adamou MEP was able to confirm that
these concerns were shared by his European Parliament colleagues.
He explained the position in the following terms. "There
are countries today which have very good organisational systems
and if we change that we might help some countries which have
low or medium standards, but what about the others that already
have high standards? How are we going to do this? Are they going
to diminish their standards to come to a common level? I do not
think this is the issue here; we are trying to help, we do not
want to add bureaucracy for the Member States. This is very clear
and it is made very clear to the Commission that the Member States
will not accept such a burden" (Q 439).
Conclusions
121. We are persuaded that the introduction of
a European directive, on the quality and safety of organ donation
and transplantation, would be a valuable measure for helping potential
organ recipients to feel confident in the basic quality of an
organ and the safety of procedures wherever in the EU an organ
had been donated and wherever transplantation was to take place.
Given the relatively low levels of cross border donation, for
most recipients this would translate into confidence in their
national systems, but for hard-to-match recipients or patients
living in countries other than their own, it would mean that they
should feel confident to accept any organ offered by an EU Member
State. (paras 92-101)
122. We share and underline the concerns of several
of our witnesses, however, that a directive should not introduce
stringent or overly-bureaucratic requirements beyond those which
are clinically justified. There needs to be sufficient flexibility
in a directive to allow scope for clinical judgment and informed
patient choice to be applied, particularly where existing systems
are working well. (paras 102-115)
123. In particular, we were convinced by the
case made to us that clinicians and patients together must have
the freedom to make informed decisions about the balance between
the acceptable quality of organs to be transplanted and the medical
needs of the patient. An organ deemed of insufficient quality
for a patient who can afford to wait longer for a transplant may
be judged suitable for transplant to a patient who, without it,
would have a high risk of imminent death. (paras 116-120)
Recommendations
124. We recommend that the Government should
support the introduction of an EU directive on the quality and
safety of organ donation and transplantation in a form which provides
minimum standards across the EU, but is not overly bureaucratic
and which does not impose requirements beyond those which are
clinically justified.
125. We recommend further that the Government
should seek to ensure that the directive allows sufficient flexibility
for decisions, about the quality of organs to be used for transplantation,
to be informed by soundly based clinical judgement of the medical
urgency of need of the patient and informed patient choice.
23 op.cit Back
24
The periods during which donated organs are deprived of an oxygen
supply during their transportation to the transplant recipients Back
