Written evidence submitted by Patient
Concern
EXECUTIVE SUMMARY
1. This application for a Legislative Competence
Order (LCO) to allow presumed consent to organ donation in Wales
should be rejected as perverse, arrogant and untimely because
it:
- goes well beyond the scope of the current devolution
position for Wales;
- is being brought forward a matter of weeks before
a referendum on full devolution for Wales is to be held;
- may well impinge on the rights granted in articles
8 and 9 of the Human Rights Act;
- rejects the conclusions of three investigating
bodies (Organ Donation Taskforce, House of Lords EU committee
and the Welsh Assembly's own health committee) against introducing
such a system at this time;
- any demand for legislation has been whipped up
by a determined and long-running campaign;
- will allow the Welsh Health Minister to continue
focusing attention and finance on this supposed "quick fix"
for the organ shortage, rather than concentrating on improving
infrastructure to enable the transplantation programme to flourish;
and
- ignores our UK history of organ removal without
informed consent and the reason for our Human Tissue Act.
Introducing such a system would:
- undermine the core principle of healthcare—active
informed consent;
- pretend agreement to donation when no such agreement
has been obtained, which is dishonest, disrespectful and unethical;
- replace the ethos of organ donation as an altruistic
gift with one of state requisition of our bodies;
- risk undermining trust and confidence in the
healthcare profession, particularly if families feel that they
are under obligation to agree to organs being taken from loved
ones; and
- risk a backlash which would adversely affect
the whole transplant programme.
INTRODUCTION
2. Patient Concern is an independent voluntary
organisation set up eleven years ago to give patients a voice
and our core principle has always been active informed consent,
which must be given for any procedure affecting our bodies. It
took several medical scandals in the late '90s for this principle
to become firmly established.
3. We realise that the Committee is particularly
seeking views on the legality of the LCO. We are not lawyers so
some of the listed questions are beyond our competence but there
are issues of our fundamental rights which we are sure the Committee
will wish to bear in mind.
MAIN COMMENTARY
4. This LCO appears to go far beyond what was
intended by the devolution settlement of 2006. Normally LCOs concern
far more parochial matters on which it is legitimate for Wales
to proceed with its own regulations. This is a far more fundamental
question which goes directly against current UK law and should
not be passed through in this way.
- (a) The timing of this LCO is suspect. In
March a referendum is due on full devolution for Wales. If this
is passed, Wales will be free to pass its own primary legislation,
so the rush to push through such an important change at this juncture
seems premature.
- (b) On 12 January 2011, Health Minister Edwina
Hart admitted, on receipt of a query from the Attorney General,
that the LCO would usually only be submitted on confirmation that
the UK Government was content with it. But, she said, she would
press ahead because of the "tight timetable". Presumably
there are political motives, connected with the May elections
in Wales.
5. Article 8 of the Human Rights Act guarantees
bodily integrity; our right to control what happens to our bodies.
Article 9 guarantees freedom of thought and conscience.
- (a) Supporters of presumed consent argue
that because we would be able to register an opt-out, our rights
are preserved. However, there is no way of ensuring that every
citizen will know about a change in the law or understand that
assumptions will now be made about their wishes unless they take
action.
- (b) We have the recent example of electronic
summary care records being uploaded on the basis of presumed consent.
There was strenuous publicity in pilot areas, including a letter
sent to every patient. We were assured that everyone would know
and understand the new system. However, a subsequent report from
University College London showed that the majority of patients
had no idea that it had happened.
- (c) Our daily contact with patients indicates
that the concept of presumed consent is poorly understood. The
idea of opting out is unfamiliar. The articulate middle classes
are well placed to assert their preference but we cannot claim
that the elderly, those with learning difficulties, or members
of ethnic minority communities speaking little or no English,
would appreciate that choice needs to be made. The so-called "hard
to reach" groups are given that name for a reason.
- (d) Opting out forces people into the position
of conscientious objectors and this may well raise fears of discrimination.
Patients may fear that they may suffer discrimination in health
care if they are seen as "awkward". Though that fear
may be unjustified, worries about having to face harassment and
aggressive criticism if it becomes known that they have opted
out are not. Whenever Patient Concern speaks out against presumed
consent we experience abuse and insulting name-calling from those
who seem unable to distinguish between an anti-donor and a pro-consent
stance. We note that several members of the public who opposed
presumed consent in submissions to the 10 day consultation launched
by the Assembly's Legislative Committee chose to do so anonymously,
perhaps fearing the same negative response.
- (e) Both the articles 8 and 9 are, of course,
qualified rights and therefore can be limited by law, but particular
problems are raised by bringing in a law limiting these rights
in one part of a country.
6. Over the past couple of years, three expert
bodies have considered the issue of presumed consent, collecting
and evaluating all the evidence. The House of Lords EU committee,
the Organ Donation Taskforce and the Welsh Assembly's own Health
and Wellbeing Committee all came to the conclusion that the law
should not be changed at this time. The English Government read
the facts and took the advice.
- (a) Welsh Health Minister Edwina Hart immediately
rejected the Assembly's report and announced that she would press
ahead with obtaining powers for presumed consent in Wales.
- (b) She launched a public debate. Of those
who voted, 22% voted for a soft opt-out system and 27% for a mandated
choice system. The resulting report said that "participants
on the whole felt that any resources available should be directed
towards improving education and public awareness about organ donation
rather than spent on changing the consent system".
- (c) Ms Hart, undeterred, then launched a
consultation. In the consultation paper mandated choice (which
would be acceptable to Patient Concern as the least worst option
in changing the law) was not offered as an option for a change
in the system, though it had been more popular than presumed consent
in the debate. This time a majority of consultees chose the option
of looking at legislative options to change to an opt-out system.
- (d) This course would allow Ms Hart to continue
focusing attention and money on this imagined "silver bullet"
to solve the organ shortage, rather than concentrating on improving
the infrastructure.
- (e) The success of some other European countries,
particularly Spain, in the numbers of transplants was frequently
quoted in the consultations as proof that their presumed consent
laws are the key to this success. This is a fallacy. The Taskforce
decided that there was no evidence of a causal link.
- (f) Spain has the highest rate of organ donation
in the world: 34-5 per million population, as opposed to the UK
rate of approx 15 per million. In Wales it is 13-14 per million.
Presumed consent was introduced in Spain in 1979. Ten years later
the organ donation rate was unaltered and was roughly the same
as ours. It only rose when an effective transplant coordination
network was put in place. Raphael Matesanz who, as head of transplantation,
was largely responsible for the scheme, has said many times (most
recently BMJ 18 October 2010) that the presumed consent law is
inactive in Spain and that the quest for "opt-out" laws
is a distraction, diverting resources to imaginary solutions.
- (g) Following the recommendations of the
Taskforce, some areas of England have reached organ donation levels
comparable with the levels achieved in the most successful European
countries eg 28.1 in Cambridge, 25.2 in Plymouth. We have seen
no evidence that such levels are being reached in any area of
Wales.
7. The gathering and use of organs is currently
governed by the Human Tissue Act and we should never forget how
that came into being. It followed the enormous outcry that resulted
from the discovery that organs were routinely being removed from
bodies and stored for possible future research, without relatives
being consulted. It centred on Alder Hey but was a widespread
practice, with Welsh hospitals among those involved. The Isaacs
Report showed that tens of thousands of brains had been removed
without consent.
- (a) The Code of Practice for the Human Tissue
Act says that "giving of consent is a positive act".
No positive act is involved in not registering an objection to
donating an organ.
- (b) Presumably if Wales opted for presumed
consent, the Human Tissue Act would have to be re-written or at
least amended to exclude Wales. This would rob the Welsh people
of the many safeguards of the Act.
- (c) Active informed consent is now firmly
established as the cornerstone of healthcare: the right of patients
to decide what happens to their bodies in life and death.
- (d) It is enshrined in the Human Tissue Act,
the Mental Capacity Act 2005, which makes it clear that no assumptions
should be made about an individual's wishes, and the General Medical
Council's latest guidance to doctors, Good Medical Practice, published
on 13 November, 2006. This position has been hard-won and has
only come about through the anguish of large numbers of people.
- (e) If consent is to mean anything, it must
be actively sought and positively given. If consent is presumed,
it is not even the result of a positive decision and it cannot
possibly be informed. Therefore it is no consent at all: it is
a disrespectful pretence. This would be a seriously retrograde
step, undermining all the progress we have made.
8. The concept of an altruistic gift has always
been a very important aspect of donation. It is no longer justified
to talk about "donation" in the face of a presumed consent
law, which assumes that the state has some right to our bodies
after death:
- (a) Donation is, by definition, something
gifted willingly. If it is taken by default it is something quite
different. People have contacted us to say that if presumed consent
was accepted, they would tear up the donor cards they have carried
for years because they would feel that their gift had been de-valued.
The choice over offering the gift of an organ should not simply
be to offer or refuse to offer. It should extend to not choosing
one way or another at any particular time.
- (b) All major religions support organ donation
because the wish to save a life supersedes the need to keep the
body inviolate, but they stress the importance of the individual
decision; the altruism of a free gift. Families often regard donation
as a sacrifice but one that is well worth making.
9. Doctors are committed to acting in the best
interests of their patients, yet when steps have to be taken to
preserve organs in the best possible condition this is obviously
not in the best interests of the donor. If we wish to act in an
ethical manner, this surely underlines the necessity to ensure
a considered choice on the part of those wishing to donate.
- (a) If we took away the necessity for such
a choice, we would risk giving the message to vulnerable people
that they are more valuable as donors than as very sick patients.
- (b) A poll carried out for the Intensive
Care Society in September 2008 showed that 50% of intensivists
were worried that a change to presumed consent might damage the
trust between patients, their families and doctors.
10. The memorandum to the LCO states that "while
relatives would still be consulted they would be relieved of the
burden of making the decision in the absence of any indication
of the deceased person's wishes". This is arrogant in the
extreme.
- (a) The BMA has said that a major change
after presumed consent would be a change in the conversation with
relatives: they would no longer be asked for permission. They
would be "informed" that the individual had not registered
an objection while alive so that donation would become the default
position. Currently one of the great obstacles to donation is
that 40% of families refuse at the bedside, 75% in the case of
ethnic minorities. The only way that presumed consent could make
a marked difference is if families were "leaned on"
to make the "right decision". This is coercion by stealth,
at a time when people are most vulnerable and it is unacceptable.
- (b) It is interesting to note that under
the Spanish system, the family is always asked for consent and
their decision is final.
11. All objections to presumed consent are met
by the argument "if you feel strongly enough, you can opt-out".
However it is obvious that inertia, lack of knowledge and reluctance
to think about death would militate against "opting out",
just as they currently militate against "opting in".
It seems to us unethical to turn the law around in order to exploit
these factors to get the desired result.
- (a) It would only take one or two mistakes,
where it could be shown after a transplant that the donor had
in fact been unwilling, to raise the spectre of Alder Hey and
cause a media storm and national outcry. Recent mistakes on the
organ donor register leading to the preferences of donors being
mis-recorded demonstrates how easily mistakes could be made. Following
Alder Hey organ transplantation dropped by 10%. A further scandal
could cause a backlash that would cause damage to the transplantation
programme from which it might never recover.
- (b) The memorandum attached to the LCO states
that the new system would not apply to those who die in Wales
but do not live there, or to under 18s and adults lacking capacity.
This introduces potential for confusion and makes it all the more
likely that mistakes would be made.
STATEMENT BY
THE PARLIAMENTARY
UNDER-SECRETARY
OF STATE,
DEPARTMENT OF
HEALTH (EARL
HOWE)—HOUSE
OF LORDS,
1 FEBRUARY 2011
12. "I can offer your Lordships absolute
reassurance that our plans do not represent any threat to patients
safety, nor to the safeguards held within the legislative framework
of provisions within the Human Fertilisation and Embryology Act
and Human Tissue Act."
13. "I stress again that, despite what some
commentators have said, there is no intention to revisit the ethical
provisions and safeguards in the HFE Act , the principles set
out in the Warnock Report, or the principles of consent underpinning
the Human Tissue Act."
February 2011
|
