Transcript Slide 1

Law and Donation Masterclass
“Best Interest is Best Practice”
Professor David Price
Dr Chris Danbury
2 February 2009
“Improving organ donation within
your hospital”
Professional Development Programme for Organ Donation
What does the taskforce say about organs for transplants
ethical, legal and professional issues?
Recommendation 3 of the Organ Taskforce states:
‘Urgent attention is required to resolve outstanding legal, ethical and professional issues in
order to ensure that all clinicians are supported and able to work within a clear and
unambiguous framework of good practice. Additionally, an independent UK-wide Donation
Ethics Group should be established.’
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What are the objectives of this Masterclass?
• To deliver an adequate understanding of the legal frameworks that support deceased
organ donation in the UK
• To ensure that the option of organ donation is not denied to a patient or their family
through lack of knowledge or misunderstanding of these legal frameworks
• To develop the skills that will be required to introduce and expand local organ donation
programmes that are based upon the evolving and broadening interpretation of ‘best
interests’ in the UK
• To appreciate how an expanded definition of best interests may permit donation in
other circumstances where a patient is dying but not yet dead
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Agenda
1
Aspects of the law relevant to organ and tissue donation
10 minutes
2
The law governing end-of-life care
30 minutes
3
Application of governmental guidelines on Non-Heart Beating
Donation into clinical practice
30 minutes
4
Case studies and Q&A
35 minutes
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Issues to be covered
1
Clarification of the laws governing deceased organ and tissue
donation
2
Clarification of the laws governing end-of-life care
3
Understanding the impact of the law on potential organ donation
and end-of-life care
4
Understanding the concept of best interest and how it can be
applied
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Aspects of Law relevant to
Organ and Tissue Donation
Professor David Price
6
What are the legal authorities governing Organ
Donation?
There are 5 core legal authorities which govern organ donation:
•
Statutes
•
Statutory Instruments
•
EU Directives
•
Human Rights Act 1998 (European Convention on Human Rights)
•
Judge-made (Common) Law
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What are the statutory jurisdictions?
The statutory jurisdictions governing organ donation differ across countries in the UK
England & Wales
• Human Tissue Act 2004
• Mental Capacity Act 2005
Northern Ireland
• Human Tissue Act 2004
Scotland
• Human Tissue (Scotland) Act 2006
• Adults with Incapacity (Scotland) Act 2000
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What areas of Organ Donation are dealt with through the
Law?
Laws which govern Organ Donation primarily focus on removal of tissue from cadavers
and end of life care.
1) Removal of organs and tissue:
Organ Donation Process
Addressed by which law
Removal of tissue and organ from a cadaver
Governed by statute law (Human Tissue Acts)
2) End of life care:
Organ Donation Process
Addressed by which law
Law relating to consent to medical treatment
Common Law: UK generally
Test for decision-making capacity and best
interests
Mental Capacity Act 2005: England & Wales
Adults with Incapacity Act 2000: Scotland
Common law: Northern Ireland
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Laws governing removal of
organs and tissue
Human Tissue Act 2004
Human Tissue (Scotland) Act 2006
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What is the relevant law in England, Wales and Northern
Ireland?
Human Tissue Act (2004) addresses the removal of organ and tissue from cadavers
“Governs the removal, storage and use of
organs and tissues from deceased persons for
the purposes of transplantation. No licence is
required from the Human Tissue Authority for
storage where it is an organ or part of an organ
or where it is stored for less than 48 hours”
Human Tissue Act
(2004) specifically
uses the term
‘consent’, even
when this is given
by families.
Human Tissue Act, 2004
[ Reg 3, SI 2006 No. 1260]
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Who can give consent for donation?
Introductory line...
For adults
For minors
• If a decision of a deceased person to
consent to the activity, or a decision of
his not to consent to it, was in force
immediately before he had died, his
consent
• The consent of the (competent) minor
• Where such a decision is not in force,
consent is required from a nominated
representative or a person in a
qualifying relationship (such as next of
kin)
• If there is no person with parental
responsibility it is the consent of a
‘qualifying relative’
• Where no decision was made prior to
death or the minor was not competent
to deal with the issue it is the consent of
a person with parental responsibility
• No particular form for consent is
specified
As applied in NI, Wales and England
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If no decision is made, how can consent be given?
Introductory line...
Nominated Representatives: (high-level description
required)
Qualifying Relatives: (high-level description required)
• One or more persons
• Spouse or partner
• Made orally in the presence of two witnesses or in
• Parent or child
writing either:
 Signed in the presence of at least one witness
 At his direction and in his presence and in the presence
• Brother or sister
• Grandparent or grandchild
• Niece or nephew
of at least one witness
 Made in a will
• Stepfather or stepmother
• Half brother or sister
• Friend of long-standing
As applied in NI, Wales and England
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What is the relevant law in Scotland?
Human Tissue (Scotland) Act addresses the removal of organ and tissue from cadavers
• Uses the concept of ‘authorisation’ rather than ‘consent’
• General donation framework similar to rest of UK
• Different provisions relating to 16 year olds and 12-16 year
olds
Key message from slide –
eg. The Human Tissue Act in
Scotland applies a different
principle to that which is used
in the rest of the UK
As applied in Scotland
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What does ‘authorisation’ mean in Scotland?
Authorisation is xxx
• Authorisation may be given by the adult person or, where no such authorisation has
been given, by the adult’s nearest relative
• The nearest relative may not give authorisation if he or she has actual knowledge that
the person was unwilling that the body (or the relevant part) be used for transplantation
• Authorisation may be in writing or expressed verbally (and signed in the case of a
nearest relative)
Key message from slide –
eg. xxx
As applied in Scotland
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If no decision is made, how can authorisation be given in
Scotland?
The table below highlights the qualifying relatives for adults in Scotland
Qualifying Relatives for Adults in Scotland
1. Spouse or civil partner
6. Grandparent
2. Living with the adult as husband or
wife or in a relationship which had
the characteristics of the relationship
between civil partners and had been
so living for not less than 6 months;
7. Grandchild
3. Child
11. A friend of longstanding of the
adult
4. Parent
8. Uncle or aunt
9. Cousin
10. Niece or nephew
5. Brother or sister
As applied in Scotland
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The Law Governing End-of-life
Care
Decision Making Powers
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Who has decision making powers in end-of-life care?
Decision making powers in end-of-life care vary across countries in the UK
The chart below shows the decision making process for end-of-life care
Patient competent (Y/N)?
YES
NO
Patient has decision making
power
Legal authorities have
decision making power
England &
Wales
Scotland
Northern
Ireland
Lasting Power of
Attorney
Welfare
Attorney
Court
Court Appointed
by Deputy
Guardian
Clinician
Court of
Protection
Clinician or Carer
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Intervener
Court of
Session
Clinician
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How does the Law in England and Wales define
competence?
Introductory sentence – eg. The Mental Capacity Act 2005 ...
• A person is assumed to possess capacity unless it is established otherwise
• All practicable steps should be taken to facilitate decision-making capacity
• All acts done, or decisions made, for a person lacking capacity must be done
or made in the person’s best interests
As applied in Wales and England
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How does the Law in Scotland define competence?
Introductory sentence – eg The issue of capacity in Scotland is defined in relation to
incapacity
Adults with Incapacity (Scotland) Act 2000
“[T]he medical practitioner primarily responsible for the medical treatment of
the adult shall have, during the period specified in the certificate, authority to
do what is reasonable in the circumstances, in relation to the medical
treatment, to safeguard or promote the physical or mental health of the adult”
Section 47(2)
“There shall be no intervention in the affairs of an adult unless the person
responsible for authorising or effecting the intervention is satisfied that the
intervention will benefit the adult and that such benefit cannot reasonably be
achieved without the intervention”
Key message from
slide – xxxThe
issue of capacity in
Scotland is defined
in relation to
incapacity
Section 1(2)
‘In determining if an intervention is to be made, account must be taken of,
amongst other things,the present and past wishes and feelings of the adult so
far as they can be ascertained by any means of communication, whether
human or by mechanical aid (whether of an interpretative nature or otherwise)
appropriate to the adult’
Section 1(4)
As applied in Scotland
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Best Interests
Assessing Best Interests
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What is ‘best interests’?
When a person no longer has decision making capacity, decisions must be made
in their best interests
David, can you review sub-title
sentence
Best interest can be defined as:
• It is the patient’s interests only that count
• The decision will be a function of all the circumstances of the individual case
• Best interests includes reference to all factors affecting the person’s interests
and in particular the person’s past and present wishes
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How is the term best interest defined?
Introductory sentence – eg Common law has further determined that a person’s best
interests must account for the range of interests which a person has
“best interests encompasses medical,
emotional and all other welfare issues”
Dame Butler-Sloss in In re A (Medical Treatment: Male
Sterilisation) [2000]
What ‘other interests’ are there?
Emotional
Spiritual
Psychological
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Altruistic
Welfare
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How is the principle of ‘best interests’ safeguarded?
Introductory sentence, eg. The Mental Capacity Act 2005...
• Must consider, as far as is reasonably ascertainable…
 The person’s past and present wishes and feelings (and in particular any relevant
written statement made when he had capacity)
 The beliefs and values that would be likely to influence his decision if he had
capacity
 The other factors that he would be likely to consider if he were able to do so
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What potential harm does this prevent?
Introductory sentence...
• Worsening of the patient’s medical condition
• Shortening of the patient’s life
• Pain from an invasive procedure
• Distress to family and friends
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The Law in Practice
Applying the principles to specific scenarios
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How has the principle of best interest been supported by
the law?
Case law has established that a life support system can not lawfully be
administered if it is not in the best interests of the patient
Airedale NHS Trust v Bland [1993]
General Note
Are there any key points to highlight
as background to the case?
‘[I]f there comes a stage where the responsible doctor comes to the reasonable
conclusion (which accords with the views of a responsible body of medical
opinion) that further continuance of an intrusive life support system is not in the
best interests of the patient, he can no longer lawfully continue that life support
system: to do so would constitute the crime of battery and the tort of trespass to
the person’
[Lord Browne-Wilkinson]
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In which instance has the broad definition of best interest
been applied?
Introductory sentence – xxx
Ahsan v UHL NHS Trust [2007]
• Patient was in a persistent vegetative state
• Clinicians believed patient was better cared for in hospital
• Court allowed patient to be taken home as this was more consistent with her
spiritual beliefs
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What are the specific scenarios impacted by Organ
Donation Law (1/2)?
There are 4 key specific scenarios impacted by organ donation law:
• Initiation of ‘futile’ life-supporting ventilation
• Allegedly not in the patient’s best interests
• Only best medical interests considered
Elective
Ventilation
• No account taken of the person’s wishes regarding organ donation
• Different approach today where the person wished to be an Organ Donor
Introduction of new therapies e.g.
• Inotropic or cardio-respiratory support
• Venous cannulae
Life-Prolonging
Treatments
Adjustments to existing treatments e.g.
•
•
•
•
Increases in oxygen concentration
Alterations to rates of fluids or drugs or
Ventilation settings, etc
The individual’s best interest
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What are the specific scenarios impacted by Organ
Donation Law (2/2)?
There are 4 key specific scenarios impacted by organ donation law:
• Removing blood from a patient who lacks capacity must be in their best
interests
• Stored whole blood or serum may be tested for the purposes of
transplantation where this is in the patient’s best interests
Blood Sampling
• The person’s desire to be an organ donor would be a relevant factor in
determining if either of the above was in the individual’s best
• No procedure which will hasten the patient’s death may be administered in
the interests of organ donation
More Invasive
Interventions
• Procedures that place the individual at risk of serious harm (e.g. systematic
heparinisation; resuscitation; femoral cannulation) are unlikely ever to be in
a patient’s best interests
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Application of governmental
guidelines on Non-Heart
Beating Donation into clinical
practice
Dr Chris Danbury
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What are the duties of a doctor when it comes to life and
death?
Life is sacred
Biophysicists have been able to comment on the nature and
qualities of life forms:
• Life forms function on negative entropy
• They are able to decrease their internal entropy at the expense of
substances or free energy taken in from the environment and
subsequently rejected in a degraded form
As doctors it is our role to preserve life:
Hippocratic Oath:
Duties of a doctor:
I will prescribe regimens for the
good of my patients according
to my ability and my judgment
and never do harm to anyone.
I will not give a lethal drug to
anyone if I am asked, nor will I
advise such a plan
Patients must be able to trust
doctors with their lives and
health. To justify that trust you
must show respect for human
life and you must:
Make the care of your patient
your first concern
Professional Development Programme for Organ Donation
Death is inevitable
• As doctors we will all at some
point in our careers will be faced
with death
• It is our role to make the best
possible decisions to save lives
• It is our role to make the best
possible decisions when it
comes to withdrawing care
Life's a laugh and
death's a joke, it's true.
You'll see it's all a show,
Keep 'em laughing as
you go.
Just remember that the
last laugh is on you.
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How have we typically justified end of life decisions and
is this the right way?
Traditionally decisions to withdraw care have been made on the grounds of futility, from a
physiological, probability and economic perspective
Physiology
Body is no longer responding to drugs or any other form of
palliative care. Continued treatment would therefore be futile
Probability
Conjecture that the patient will not survive even if treatment is
administered. Treatment therefore is futile
Economic
Continued care will be too costly with a small chance of
success where treatment is continued. Treatment is therefore
futile
Airedale NHS Trust v Bland [1993] A.C. 789
‘In certain circumstances medical treatment
can properly be categorised as futile, that is, if
it cannot cure or palliate the disease from
which the patient is suffering’
The concept of futility is nebulous and therefore
does not help us, as doctors, to make the most
effective, legal and best decisions when it comes
to withdrawal of patient care
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Why is best interest now best practice when it comes to
end-of-life decision making?
We need to move away from justifying withdrawal of care on the grounds of futility and now
make decisions based on what is in the patient’s best interest
• Best interest is now best practice when it comes to end-oflife care decision making
Recent Case Law to support Best
Interest:
• This form of diagnosis has been supported by recent case
law: Bland and re A
Bland
Moreover, a doctor's decision
whether invasive care is in the
best interests of the patient falls to
be assessed by reference to the
test laid down in
• In the context or organ donation, the concept of best interest
allow us to consider the following:
 Organ donation where the patient is registered on the
Organ Donation Register
 xxx
Bolam v. Friern Hospital Management
Committee
1957] 1 W.L.R. 582 [1993] A.C. 789
In re A
In my judgment best interests
encompasses medical, emotional
and all other welfare issues
[2000] 1 FCR 193, at 200
<Key message to link to next slide to be inserted
here?
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How can we ensure that we make the right decision when
it comes to withdrawal of care?
The GMC Fitness to Practice Panel Hearing provides a strong message that best interest
is now a critical factor when making end-of-life care decisions
• In November 2005, the defendant in the GMC Fitness to Practice Panel Hearing was found to have
made a decision to withdraw patient care, given Patient S’s condition at the time, that was:
i. clinically unjustified,
ii. inappropriate,
iii.premature,
iv.not in the patient’s best interests
• In 2010...
(Can we add a couple of bullets here about how to ensure making right decision i.e.
- Need to properly document decision (perhaps using a policy doc like the LCP?
- How can doctors overcome challenges to decisions and be confident they are making the
right one)
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Summary
1. End of life decisions are an integral part of good medicine
2. There needs to be a clear, patient centred, documented reason
3. This reason may be subject to challenge
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Case Studies and Q&A
37
Agenda for case study break-out session
1.
Attendees to follow one patient case throughout the case study which is to be split into 2 sections
over a 40 minute period
2.
First half of the case study is to focus on patient who is haemodynamically unstable who might be
brainstem dead (15mins)
3.
Second half of the case study is to focus on patient who has progressed to a state with a nonsurvivable brain injury in the Department of Emergency Medicine (15mins)
4.
Group feedback on their discussions is to be included to share views and ideas (10mins)
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Case Study Part A
Context:
A motorcyclist trauma case has arrived at the doors of the Emergency Medicine
department. The patient is intubated and ventilated. Upon speaking to the paramedics it
turns out that the patient fell of his bike and hit his head. The patient is rushed to the
neurological department who perform a CAT scan that shows a catastrophic head injury
with suspected lack of brainstem function and that the patient would therefore be unlikely
to respond to any treatment. The patient is taken back to the Emergency Medicine
department where the patient’s family are now waiting for news.
Questions to discuss:
1. What steps do you take as the clinician in charge to proceed with this patient case?
2. What might you use to help you document your patient’s situation to support your
decision making?
3. Who may you need to contact at this point to support you now and later on in the
process?
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Case Study Part B
Context:
Whilst you are speaking to the family your bleeper goes off informing you that the patient’s
condition has worsened. The patient is no longer breathing for themselves, their pupils are
fixed & dilated and their heart has stopped beating. A nurse has informed you that they
found an ODR card in the patient’s wallet whilst looking for the patient’s identity.
Questions to discuss:
1. What conditions to you suspect and how will you confirm these?
2. What are the options open to you and how will you relate these to the family?
3. What next steps do you need to take once your decision has been made, documented
and agreed by the family?
4. Who may you need to contact at this point to support you and what role would they
play?
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