LEGAL ISSUES IN ORGAN DONATION FOR TRANSPLANTATION FOLLOWING CIRCULATORY DEATH (DCD): THE ENGLISH EXPERIENCE

Penney Lewis, Centre of Medical Law & Ethics, Dickson Poon School of Law, King’s College London

Plan: legal frameworks

¨  post-mortem ¤  consent for organ donation under the Human Tissue Act

2004 ¨  pre-mortem

¤  end of life decision-making under the Mental Capacity Act 2005

¤  interventions prior to death n  current best interests approach n  advance consent (requiring legal change)

¨  diagnosis and confirmation of death ¨  conflicts of interest

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1.  consent to donation under the Human Tissue

Act 2004 (HTAct) before or after death)

2.  end of life decision-making under the Mental Capacity Act 2005 (MCA) if patient lacks capacity

Legal frameworks 3

1. Consent under HTAct

¨  organ donation can only proceed if consent to that donation is available under the HTAct from either donor or third party: 1.  consent to donation after death is available from

donor in advance usually via Organ Donor Register (ODR), or

2.  consent to donation after death will be provided by: n  someone nominated by donor (a ‘nominated

representative’ (NR)) n or more likely, by the family (someone in a ‘qualifying

relationship’ (QR) to the donor)

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Consent from donor

¨  both categories will include a spectrum of possibilities

¨  ‘consent from donor’ category will include: (i) donors who have both consented to donation and

agreed to undergo any procedures which would increase the probability of a successful transplant;

(ii) donors who have simply consented to donation by joining the ODR or signing a donor card; and

(iii) donors who have consented to donation without performing one of the formalities in (ii)

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Consent from third party

¨  within ‘consent from third party’ category, most consent providers will be influenced by donor’s wishes, although not required by HTAct

¨  cases in this category could therefore encompass: (iii) donors who have consented to donation, but endorsement is

nonetheless sought from a NR or person in a QR to the donor; (iv) donors for whom consent is provided on the basis of their wishes

and feelings; (v) donors for whom consent is provided on the basis of the beliefs

and values that would be likely to influence their decision; and (vi) donors for whom consent is provided although there is little or no

evidence of their wishes and feelings on donation, or that donation would be consistent with their beliefs and values

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Post-mortem interventions 7

¨  HTA s.43 allows the body of the deceased to be retained and steps to be taken to preserve the body while it is established whether consent to donation has or will be given

2. Mental Capacity Act 2005 (MCA)

¨  governs health, welfare and financial decisions made on behalf of patients (Ps) ≥ 16 in England and Wales

¨  also must consider: ¤  judicial interpretations of the ‘best interests’ test (pre-

and post-MCA) ¤ MCA Code of Practice

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MCA Capacity test 9

s.1(2) A person must be assumed to have capacity unless it is established that he lacks capacity

s.2(1) A person lacks capacity in relation to a matter if at the material time he is unable to make a decision for himself in relation to the matter because of an impairment of, or a disturbance in the functioning of, the mind or brain

s.3(1) a person is unable to make a decision for himself if he is unable

a)  to understand the information relevant to the decision, b)  to retain that information, c)  to use or weigh that information as part of the process of

making the decision, or d)  to communicate his decision (whether by talking, using sign

language or any other means)

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MCA Capacity test

s.1(3) A person is not to be treated as unable to make a decision unless all practicable steps to help him to do so have been taken without success

s.1(4) A person is not to be treated as unable to make a decision merely because he makes an unwise decision

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MCA Capacity principles

Person who lacks capacity: P

¨  best interests (BI) is legal standard for action: MCA, s.1(5)

¨  factors (from MCA s.4(6)): ¤ P’s past and present wishes and feelings (including any

relevant written statement made by him 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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Best interests

¨  cannot be established merely by reference to age, appearance or condition

¨  must consider likelihood of future capacity ¨  must permit and encourage P’s participation as fully

as possible in any act or decision ¨  for life-sustaining treatment: decision must not be

motivated by a desire to bring about P’s death (s.4(5))

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Best interests: consultation

¨  if consultation practicable and appropriate, must take into account views of: ¤  person named by P as consultee ¤  carer(s) or person(s) interested in P’s welfare ¤  P-appointed donee of lasting power of attorney ¤  court-appointed deputy

¨  possible need for Independent Mental Capacity Advocate (IMCA) if no-one unpaid available to consult ¤  only for ‘serious medical treatment’ including when there is a

likelihood of serious consequences for P eg withdrawal of life-sustaining treatment

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“All reasonable steps which are in the person’s best interests should be taken to prolong their life. There will be a limited number of cases where treatment is futile, overly burdensome to the patient or where there is no prospect of recovery. In circumstances such as these, it may be that an assessment of best interests leads to the conclusion that it would be in the best interests of the patient to withdraw or withhold life-sustaining treatment, even if this may result in the person’s death.”

MCA Code of Practice [5.31] 15

Scope of ‘best interests’

Re Y [1996] 2 FLR 787 (HC): best interests include ‘emotional, psychological and social benefit’

Re MB [1997] 2 FCR 541 (CA): ‘Best interests are not limited to best medical interests.’

Re A [2000] 1 FCR 193 (CA): ‘best interests encompasses medical, emotional and all other welfare issues.’

Aintree v James [2013] UKSC 67: ‘in considering the best interests of this particular patient at this particular time, decision-makers must look at his welfare in the widest sense, not just medical but social and psychological’

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MCA Code of Practice [5.48]

‘The Act allows actions that benefit other people, as long as they are in the best interests of [P]. For example, having considered all the circumstances of the particular case, a decision might be made to take a blood sample from [P], to check for a genetic link to cancer within the family, because this might benefit someone else in the family. But it might still be in the best interests of [P]. ‘Best interests’ goes beyond the person’s medical interests. ...

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MCA Code of Practice [5.48]

... For example, courts have previously ruled that possible wider benefits to [P], such as providing or gaining emotional support from close relationships, are important factors in working out [P’s] own best interests [citing Re Y & Re A]. If it is likely that [P] would have considered these factors themselves, they can be seen as part of [P’s] best interests.’

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Re A: balance sheet needed

‘the ... judge ... should draw up a balance sheet. The first entry should be of any factor or factors of actual benefit. ... Then on the other sheet the judge should write any counterbalancing dis-benefits to [P]. ... Then the judge should enter on each sheet the potential gains and losses in each instance making some estimate of the extent of the possibility that the gain or loss might accrue. At the end of that exercise the judge should be better placed to strike a balance between the sum of the certain and possible gains against the sum of the certain and possible losses. Obviously only if the account is in relatively significant credit will the judge conclude that the application is likely to advance the best interests of [P].’

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MCA Code of Practice [5.62]

‘Some cases will be straightforward. Others will require decision-makers to balance the pros and cons of all relevant factors.’ [citing Re A]

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UKDEC DCD Guidance 2011

Guiding principles: 1.  offer of donation

should be routine part of planning end of life care (EoLC)

2.  once agreed that donation is in P’s BI, ethical imperative to enable most successful outcome

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is continuation of life-sustaining treatment

in P’s BI?

yes: continue treatment

no: would organ donation be in P’s BI?

no: plan end of life care without donation

yes: consider interventions when

planning end of life care to include

donation

3 decision-making stages

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Stage 1: UKDEC DCD guidance

UKDEC Recommendation: Two senior doctors, who should both have been registered for at least five years, and at least one of whom should be a consultant, should verify that further active treatment is [no longer in P’s BI]. It would be preferable for this to be the case for all patients, not only for those where organ donation is a possibility (although the UKDEC remit extends only to organ donation).

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Stages 2 & 3: donation as part of EoLC (1)

¨  once a decision has been made by the treating team that continuing life-sustaining treatment is no longer in P’s BI, EoLC plan, & decisions on EoLC may be taken in light of P’s views on organ donation, if known ¤ unlike decision to donate taken after P’s death, which

may not reflect P’s wishes or (necessarily) be in accordance with P’s interests (category vi above), decisions about P’s EoLC must be taken in P’s BI

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BI vs substituted judgment

¨  Re G(TJ) [2010] EWHC 3005 ¤  ‘the matters which the court must consider under these

paragraphs of [MCA s.]4(6) involve the court in drawing up the balance sheet of factors which P would be likely to draw up if he were able to do so’ n  ‘the balance sheet of factors which P would draw up, if he

had capacity to make the decision, is a relevant factor for the court’s decision’

¤  ‘However, it is absolutely clear that the ultimate test for the court is the test of best interests and not the test of substituted judgment.’

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... to optimise donor organ quality and improve transplant outcomes

Interventions prior to death ... 27

“The Department of Health’s view of the legal position in relation to the action that can be lawfully taken prior to death to support non-heartbeating donation. The intention is that those working in this area will be able to use it to draw up more detailed guidance to support clinical practice. This guidance is only applicable in England and Wales.” 20 November 2009

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DH guidance 2009

“Once it has been established that a person wanted to donate, either through direct knowledge of their wishes or as a result of discussions about what the person would have wanted, successful donation may be seen to be in the person’s wider best interests in a number of ways:

a) by maximising the chance of fulfilling the donor’s wishes about what happens to them after death;

b) by enhancing the donor’s chances of performing an altruistic act of donation; and

c) by promoting the prospects of positive memories of the donor after death.”

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Donation as part of EoLC (2)

¨  facilitating DCD may involve continuing or adjusting or commencing treatments, instituting procedures, changing the place of care or other decisions which may have no direct medical benefit to P

¨  every decision taken must nonetheless be in P’s BI ¤  the stronger the evidence of P’s consent (or wish) to donate,

the more likely it is that care that facilitates successful donation is compatible with their BI n  however, additional evidence of P’s relevant wishes, feelings,

beliefs and values must also be considered, eg on EoLC n  type of decision being made and its risks and burdens (if any) to

the patient and/or their loved ones will also need to be considered in each individualised BI assessment

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DH position

¨  procedure to facilitate donation may be in P’s BI if: ¤  does not cause P harm or distress, or place P at material/

significant risk of experiencing harm or distress (also mentions risk of distress to P’s family) n  anything that places P at risk of serious harm or distress is unlikely

ever to be in P’s BI n  systemic heparinisation cited as example of procedure which

places P at risk of serious harm n  resuscitation cited as example of procedure which places P at risk

of serious distress DH [6.14]: “A clinician would need strong and compelling reasons to

consider these types of actions and would be recommended to seek a declaration from the Court of Protection in relation to the person’s best interests before doing so.”

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UKDEC proposed interventions guidance ¨  review prompted primarily by debate over heparin ¨  also discussion about (eg):

¤ integral to withdrawal of life-sustaining treatment (WLST) n extubation

n  varied practice especially children vs adults n symptom alleviation

¤ independent of WLST n femoral cannulation

¤ providing treatment to facilitate donation n elective ventilation

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Draft guidance

¨  two working groups: clinical; ethical/legal ¨  workshop with stakeholders 1/3/2013

¤  intensive care specialists – clinicians, nurses, professional body ¤  transplant specialists – surgeons, nurses, British Transplant Society,

retrieval teams, SN-ODs ¤  ethical and legal experts ¤  lay/patient/family perspective – donor family network, recipients ¤  Coroners’ representative

¨  revision on basis of workshop feedback currently under way ¨  submission to DH summer 2013?

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potential (risk of) harm

potential benefits

knowing wishes will be facilitated

legacy

indirect benefit via family/friends

pain or discomfort

shortening life or worsening condition

distress

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Potential benefits

¨  prospective benefit of knowing their wishes will be facilitated (DH)

¨  future benefit attaching to their legacy ¨  indirect benefit if donation helps family and friends

come to terms with their loss and promotes prospects of positive memories of P after death (DH) ¤  in most cases P will have an interest in well-being of

their family and friends

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Potential harms

¨  pain (DH) ¨  discomfort ¨  shortening P’s life (DH)

¨  worsening P’s medical condition (DH)

¨  distress caused to P’s family (DH)

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Potential distress

¨  suffocation, choking or gasping ¨  panic ¨  weakness ¨  isolation or loneliness ¨  invasion of privacy

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Factors affecting balancing

1.  potential of intervention to optimise donor organ quality and improve transplant outcomes

2.  strength of P’s decision or wish to donate 3.  possibility of alleviation of symptoms or

avoidance of distress for P and/or P’s family & friends

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1: intervention potential

¨  clear justification for intervention in terms of its potential to optimise donor organ quality and improve transplant outcomes from P’s donation(s) should be identified

¨  absolute minimum level of intervention should be used consistent with facilitating success of transplant

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2. strength of P’s decision/wish

¨  stronger evidence of P’s desire to become donor, greater weight this should be given in assessing whether a particular intervention would be in P’s BI ¤  further information from P’s family and friends about

their wishes, feelings, beliefs and values about organ donation and (if available) any procedures designed to optimise donor organ quality and improve transplant outcomes may also be valuable in building up a picture of P’s wishes

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2. strength of P’s decision/wish

… If, for example, the patient has provided consent to a particular intervention in advance of the loss of capacity, this should be regarded as compelling evidence that the intervention would be in P’s BI unless it would cause the patient harm or distress (or a significant risk of harm or distress).

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3. alleviation/avoidance

¨  Account should be taken of the extent to which symptoms of pain, discomfort or distress which might be so caused could be alleviated.

¨  Ways of minimising [distress caused to P’s family and friends] should be explored through careful explanation of both the need for particular interventions in order to facilitate the patient’s wish to be a donor and what is involved in those interventions.

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3. alleviation/avoidance

¨  Those caring for the patient must also ensure that interventions are carried out in a way which is as respectful as possible of the patient and their family and friends.

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Balancing potential benefits and harms

¨  For each patient and each proposed intervention, the clinical team will need to assess whether the potential benefits of the intervention outweigh any potential harms which cannot be prevented or alleviated.

¨  If so, the proposed intervention would be in P’s BI ¨  A wide range of relatively minor interventions are likely

to meet this threshold for all patients who wanted to become organ donors. A few interventions carry such serious risks of harm that very strong evidence of potential benefits would be needed in order for them to be in P’s BI.

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Revisiting evidence

The evidence relating to the risks of harm or distress associated with particular interventions and their potential to optimise donor organ quality and improve transplant outcomes is likely to change over time. It should be regularly revisited by UKDEC or another suitable body in order to ensure that clinicians are able to make evidence-based assessments of those risks and benefits.

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Possible legal change: Advance consents (1) ¨  at present, English law explicitly allows only for

advance refusals of medical treatment, including an advance refusal of treatment when that treatment is in P’s best interests (BI): Re T, Bland, Re C, Re AK, Mental Capacity Act 2005 ss.24-26

¨  advance consents to procedures which are in P’s BI are common eg surgical consents

¨  no case involving advance authorisation of a medical procedure that is against the medical interests of an incompetent patient has come before the English courts

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Advance consents (2)

¨  two-fold argument can be made in support of the legality of such advance consents relying on law’s acceptance of primacy of individual’s autonomy interests over judicial determinations of her BI, both ¤ when treatment is refused in advance, & ¤ when contemporaneous decisions are made

n  as egs of the latter, competent adult Ps can contemporaneously consent to procedures that are against their medical interests, such as organ donation & participation in non-therapeutic research – the argument runs therefore, that in order to fully respect their autonomy, they should be allowed to consent in advance to such procedures, provided the requirements for a valid consent are met

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Advance consents (3)

¨  while legal change may be desirable, current legal position does not permit advance consent to procedures to facilitate DCD DH: “While registration on the ODR provides consent for

donation after death for the purposes of the HTA, the Department of Health does not consider that registration can be viewed as advance consent to steps to facilitate NHBD [DCD]”

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Children 49

Children and the HTAct

¨  organ donation can only proceed if consent to that donation is available under the HTAct ¤ consent can be provided either by the child donor or by

a third party; either: 1.  consent to donation after death is available from the

(competent) child donor 2.  consent to donation after the child donor’s death will be

provided by: n  person with parental responsibility, or n  if no one had parental responsibility, someone in a ‘qualifying

relationship’ to the donor

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End of life decision-making for children

¨  decision-maker ¤ child, if competent ¤ person with parental responsibility ¤ court

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Standard for decision-making

¨  legal test is best interests ¨  intolerability only a ‘valuable guide’ to BI ¨  balance sheet approach Portsmouth Hospitals NHS Trust v Wyatt [2005] EWCA

Civ 1181 ¨  DH has not issued guidance specific to children on

procedures to facilitate DCD

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Diagnosis and confirmation of death 53

Definition of death

¨  UK ¤ no statutory definition of death ¤  regarded as a matter of clinical judgement

¨  medical criteria ¤ Working group Royal College of Physicians 1995

n  ‘brain-stem death’

¤  Irreversible loss of capacity n  for consciousness, combined with n  to breathe

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AoMRC Code of Practice

¨  issued in 2008 ¨  authoring group

chaired by Sir Peter Simpson, first Chair of UKDEC

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Diagnosis of death 56

Applying the AoMRC Code of Practice

¨  death is the irreversible loss of the capacity for consciousness combined with the irreversible loss of the capacity to breathe, both of which are functions of the brain-stem and are lost rapidly after cardiac arrest

¨  diagnosis should be independent of any consideration of organ donation

¨  brain death diagnosis by neurological criteria using the AoMRC Code of Practice is the accepted standard in the UK

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Diagnosis of death using cardio-respiratory criteria

¨  cardio-respiratory diagnosis as normally practised does not need to be made quickly

¨  cardio-respiratory criteria are valid since they infer that the integrative and consciousness aspects of brain function will inevitably be lost over time

¨  cardio-respiratory diagnosis linked to organ donation introduces a critical time issue

¨  time critical for organ viability and to minimise warm ischaemia time

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5 minute rule

¨  in DBD, brain death criteria use specific tests to confirm that the integrative and consciousness aspects of brain function have been lost

¨  in DCD, cardio-respiratory criteria are valid since can infer that the integrative and consciousness aspects of brain function will inevitably be lost provided that certain pre-requisites are fulfilled ¤  in DCD, 5 minute rule refers to the period beyond which

auto-resuscitation will not occur ¤  in the UK, death can be confirmed after 5 minutes of

complete and continuous absence of cardio-respiratory function

¤  other jurisdictions use different time intervals

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Diagnosis of death and organ retrieval: requirements

¨  clear intention not to perform cardio-

pulmonary resuscitation

¨  confidence that the possibility of spontaneous return of cardiac function

has passed (auto-resuscitation)

¨  absolute prohibition on any intervention

that might restore cerebral oxygenation

¤  restoration of myocardial contractility

¤  extracorporeal oxygenation: restrict to relevant organs

The brain remains responsive to restoration of oxygenation for some

minutes

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Death and individual organ function

¨  death as diagnosed by cardio-respiratory criteria means that integrated bodily function in terms of consciousness or the capacity to breathe has ceased, rather than that individual organs have died

¨  thus filtration activity of the kidney or metabolic activity of the liver can be restored by the provision of a supply of oxygenated blood

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Cardiac donation

¨  in the case of circulatory death, heart stops because its inherent pumping action is inhibited by build up of acid metabolites, secondary to hypoxia, following cessation of respiration

¨  in this situation, heart itself has not actually died and reperfusion of the heart, in a variety of ways, with oxygenated blood will restore its pumping action

¨  thus cardiac function is preserved in a brain dead patient who is still being artificially ventilated

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Organ re-perfusion

¨  any in vivo procedure which restores blood flow to the whole body rather than an isolated organ contravenes the provisions under which the 5 minute rule is valid

UKDEC Recommendation: When reperfusion of organs with oxygenated blood is performed as part of the retrieval process, it should, as far as it practical, be restricted to the relevant organs.

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Isolating the cerebral circulation

¨  any procedure that risks restoring circulation throughout the whole body has the potential merely to prolong the final stages of the dying process, and is therefore unethical and not of overall benefit to the patient (in P’s BI)

¨  AoMRC Code of Practice clearly states “it is obviously inappropriate to initiate any intervention that has the potential to restore cerebral perfusion after death has been confirmed”

¨  recent evidence suggests that cerebral re-perfusion may also have a detrimental effect on the organs to be donated

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Conflicts of interest 65

UKDEC DCD Guidance (1)

UKDEC Recommendation: Any clinician involved in the care of the donor should not have a duty of care to the recipient at that time. In particular, members of the retrieval team and the recipient’s clinical team should not be involved in the care of the potential donor prior to death being confirmed. There should, however, be effective liaison and communication between the retrieval team and those caring for the potential donor in order to ensure that the interests of the patient as a potential donor are maintained at all times.

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UKDEC DCD Guidance (2)

UKDEC Recommendation: After death, the potential conflict of interest between saving the life of the patient and respecting their interest to be an organ donor disappears. Once the decision to accept the organs has been taken, it is for the overall benefit of both the deceased patient and the recipient for procedures such as re-intubation to facilitate lung retrieval, to be carried out by suitably trained individual. Thus, although this professional may have been a member of the donor’s clinical team prior to death, this no longer represents a conflict of interest.

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Management before WLST

UKDEC Recommendation: If organ donation has been identified as part of the end of life care pathway for a patient, then caring for that patient during the dying process in such a way as to maintain the organs in the best possible condition for donation does not represent a conflict of interest on the part of the treating clinician. ...

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5  min  obs  

pa+ent  dying  

Timelines  and  responsibili+es  Before  death  confirmed   A:er  death  confirmed  

WLST  

Death  diagnosed  

Note:  Any  resump8on  of  cardiac  ac8vity    should  prompt  recall  of  the  donor  clinical    team  and  the  diagnosis  and  confirma8on    of  death  protocol  should  be  repeated  .  

Consent    to  donate   WLST  Timeline  

Donor  

SN-­‐OD  

Donor  team  

Retrieval    team  

Con

firm

atio

n of

Dea

th

Retrieval  commences  

pa+ent  maintained  

Organs  removed  

Organs  transported  

Liaison  role  between  family  and  donor    and  recipient  teams.  Does  not  provide    medical  care  to  the  donor  

Liaison  role  con+nues  even  if  dona+on  does  not  proceed.    May  now  provide  medical  care  to  the  donor  Performs  final  act  of  care  

Responsible  for  care  of  poten+al  donor    and  undertake  all  interven+ons.      Diagnosis  and  confirma+on  of  death    

Hand  over  to  retrieval  team.    May  re-­‐intubate  for  lung  retrieval.      

Responsible  for  care  of  donor  

Carry  out  retrieval  surgery      

Set  up  for  retrieval.      Take  no  part  in  caring  for  the  poten+al    Donor,  but  liaise  with  donor  team.        

Note:  Donor  team  undertake  all  interven8ons,    including  any  intended  specifically  to    maintain  organs  .  

Surgery    complete  

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