Lecture 14-17 Transplantation PDF

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Lecture 14 Outline (Transplantation Part 1)Dr Marianna IliadouOutline: Scarcity of human organs  Artificial organs or animal organs?  Life-saving or non-vital transplants too?  Deceased donors v Living donorsScarcity of human organs nearly 5,000 solid organs transplants are performed each year y...

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Lecture 14 Outline (Transplantation Part 1) Dr Marianna Iliadou Outline:    

Scarcity of human organs Artificial organs or animal organs? Life-saving or non-vital transplants too? Deceased donors v Living donors

Scarcity of human organs • •

nearly 5,000 solid organs transplants are performed each year yet around 10,000 remain on waiting lists

NHS Blood & Transplant, Activity Report 2019/2020

Allocation: For example, for kidney allocation from brain-stem dead donors: – A. complete matches for hard-to-match child patients – B. complete matches for other children – C. complete matches for hard-to-match adults – D. complete matches for other adults & well-matched children – E. all other eligible patients (adults & children) Increasing need for organs • Population ageing • Improved road safety • Organs often do not last the patient’s lifespan BAME community concern: NHS Blood and Transplant (2020) Organ Donation and Transplantation data for Black, Asian and Minority Ethnic (BAME) communities: Aileen Editha, ‘Why England’s new opt-out won’t help BAME communities’ BMJ Alternatives to human organs • Artificial organs/medical devices (Paolo Macchiarini, the Downfall of a Supersurgeon) • Tissue engineering & regenerative medicine • Animal organs (xenotransplantation) Unfortunately, alternatives to human organ donation, like artificial organs, regenerative medicine and xenotransplantation are unfeasible or inadequate. 1

Deceased donors There is no statutory definition of death.  Circulatory Death  Brain-stem Death ‘The definition of death should be regarded as the irreversible loss of the capacity for consciousness, combined with irreversible loss of the capacity to breathe’ Code of Practice for the Diagnosis and Confirmation of Death, Academy of Medical Royal Colleges, 2008

See Manchester University NHS FT v Midrar Namiq (a minor) and others [2020] EWHC 6 (Fam).

Brain-stem Death ≠ PVS or MCS (alive): advance decision or best interests

For the purposes of transplantation, diagnosis of brain-stem death is to be made by at least two experienced doctors who are not members of the transplant team. (2008 Code of Practice by the Academy of Medical Royal Colleges 2008, para 6.3)

2019-2020: • 1,580 deceased donors of solid organs: – 634 after cardiac death – 946 after brain-stem death • Cf 1,001 living solid organ donors Some find problematic the idea of brain-stem death: The lower the moral status of the potential organ provider, the easier it is to justify removing their organs for the benefit of another.

Deceased donors: Life-prolonging/saving organs and tissues (examples): • • • • • •

Kidney Liver Lung Pancreas Heart Cornea, bone, heart valves, etc.

Deceased donors: Non-vital organs & tissue (examples):  

Hand transplants Face transplants 2

   

Penile transplants Leg transplants Larynx Womb transplant

Living donors: • • • • • •

Blood Bone marrow Kidneys Liver segment Lung segment Others: heart (domino transplant), womb, etc.

Womb/uterine transplantation: combination of transplantation and IVF. (Comparison with surrogacy, access issues, public funding, etc.) Amel Alghrani, ‘Uterus transplantation in and beyond cisgender women: revisiting procreative liberty in light of emerging reproductive technologies’ (2018) 5 Journal of Law and the Biosciences 301–328. Legal overview: LJ Black: ‘families are formed in different ways these days and the law must attempt to keep up and to respond to developments’ Re G (Children) [2014] EWCA Civ 336. Similarly for transplantation.

Human Tissue Act 2004 Supplemented by:  Secondary legislation  Human Tissue Authority Codes of Practice  The common law (& the Mental Capacity Act 2005) The 2004 Act regulates four things:  We have a consent-based system governing the  removal, storage & use of “relevant material” from deceased persons for transplantation (s.1)  storage & use of “relevant material” from living persons for transplantation (s.1)  Restrictions are imposed on  removal or use of “transplantable material” from living persons for transplant purposes (s.33)  commercial dealings in “controlled material” for transplantation (s.32) 3

Materials covered:  “relevant material”: s.53 2004 Act (& s.54(7))  “transplantable material”: s.33  “controlled material”: s.32  “bodily material”  “excepted material”  “permitted material”: s.3(9) – s.3(6)(ab) Human Tissue Authority - Codes of Practice: Code A: Guiding Principles and the fundamental principle of consent Code F: Donation of solid organs and tissue for transplantation [new draft] Code G: Donation of Allogenic bone marrow and peripheral blood stem cells for transplantation. Acquisition of material from deceased donors: Opt-in: consent system

narrow v wide

Opt-out: objection

narrow v wide formal v informal

Conscription: no choice

Even in best case scenario of all eligible donors, none can completely solve the problem.

Opt-out in the UK:   

Wales: The Human Transplantation (Wales) Act 2013 England: Organ Donation (Deemed Consent) Act 2019 Scotland: Human Tissue (Authorisation) (Scotland) Act 2019

Parsons and Moorlock, ‘A global pandemic is not a good time to introduce ‘opt-out’ for organ donation’ (2020) 20 Medical Law International 155-166. Lecture 15 Outline (Transplantation Part 2) Dr Marianna Iliadou Outline: Deceased Donors:  Adults  Children  Opt-out system

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Human Tissue Act 2004: • “appropriate consent” is required for the removal, storage & use of “relevant material” from a deceased person for transplantation s.1(1)(a)/(b)/(c) & Sch. 1, part 1 •

removal, storage & use (deceased donors)

(Living donors: s.1 only for storage and use) Deceased: relevant material ‘relevant material’(both living and deceased donors): s.53 — material that ‘consists of or includes human cells’ — except: (a) gametes & embryos (s.53(1)/(2)(a)) (b) hair & nail from a living person (s.53(2)(b)) & (c) material created outside of the human body (s.54(7)) Preservation of body for deceased donors: s.43(1)-(3): where a body is lying in a hospital, nursing home or other institution, it is lawful for the person having control & management to retain the body & take minimum steps to preserve for transplantation. Code F, paras 209-218

“Appropriate consent”: deceased adults (s.3) – hierarchy: s.3(6): Where the person concerned has died …"appropriate consent" means (a) if a decision to consent to the activity, or a decision not to consent to it, was in force immediately before they died, their consent; (b) If (i) paragraph (a) does not apply, and (ii) they have appointed a person or persons under section 4 to deal after their death with the issue of consent in relation to the activity, consent given under the appointment; (ba) if neither paragraph (a) nor paragraph (b) applies and the activity is one to which subsection (6A) applies, the deemed consent of the person concerned (c) if neither paragraph (a) nor paragraph (b) applies and the activity is not one to which subsection (6A) applies, the consent of a person who stood in a qualifying relationship to them immediately before they died. Simplified version: (a) the deceased’s consent (b) the consent of a nominated representative (ba) deemed consent (c) the consent of qualifying relative (a) Deceased’s consent • “The concept of valid consent is established in common law and mental capacity legislation”: Code A, [19] 5

• •

“references to consent should be taken to mean appropriate and valid consent”: Code A, [20] Capacity, information, voluntariness

(b) Adults: nominated representative (s.4) s.4(3): Appointment may be made orally or in writing s.4(4): An oral appointment must be made before 2 witnesses present at the same time s.4(5): A written appointment must be signed by (or at the direction of) the person making it, in the presence of at least one witness, or contained in a valid will s.4(6): if more than one, only one needs to give consent, unless the terms of the appointment specify otherwise (ba) “Appropriate consent”: adults (s.3) s.3(6)(ba) if neither (a) nor (b) applies and the activity is one to which s.3(6A) applies, the deemed consent of the person concerned “Deemed consent” under s.3(6)(ba) s.3(6A) This subsection applies to the removal, storage and use of “permitted material” from a deceased body for transplantation, unless the body is that of an “excepted adult” s.3(9)) An “excepted adult” means”: (a) an adult who has died and who had not been ordinarily resident in England for a period of at least 12 months immediately before dying, or (b) an adult who has died and who for a significant period before dying lacked capacity to understand the effect of s.3(6)(ba). s.3(10) A significant period means a sufficiently long period as to lead a reasonable person to conclude that it would be inappropriate for consent to be deemed to be given. Code F, [187] – 12 months

“Permitted material” means relevant material unless excluded by regulations The Human Tissue (Permitted Material: Exceptions) (England) Regulations 2020 s.3(6B) Consent is to be deemed “unless a person who stood in a qualifying relationship to the person concerned immediately before death provides information that would lead a reasonable person to conclude that the person concerned would not have consented”. Code F, [189-198]

Summary: Consent is to be deemed for • transplantation activities in connected with “permitted material” 6

• •

where removed from an adult who was (a) ordinarily resident in England & (b) did not lack capacity for a significant period unless a qualifying relative provides information that reasonably shows deceased would not have consented

(c) Adults: qualifying relationship (s.27(4)) Ranked in the following order: (a) spouse, civil partner, or partner (b) parent or child (c) brother or sister (d) grandparent or grandchild (e) child of a person falling within para. (c) (i.e. niece or nephew) (f) stepfather or stepmother (g) half-brother or half-sister (h) friend of longstanding s.27(5) (equal ranking in same para.) & s.27(7) (one will suffice) NB. Code A, [30]–[39] What if a family member or loved one objects? No legal right to overrule an appropriate consent, but should be discussed “sensitively” with those close to donor: Code A, [36-37]

“Appropriate consent”: children (s.2) s.2(7): Where the child concerned has died … "appropriate consent" means(a) if a decision to consent to the activity, or a decision not to consent to it, was in force immediately before they died, their consent; (b) if para. (a) does not apply (i) the consent of a person who had parental responsibility for them immediately before they died, or (ii) where no person had parental responsibility for them immediately before they died, the consent of a person who stood in a qualifying relationship to them at that time

Simplified version:

(a) deceased child’s consent (b) parental responsibility (c) consent of qualifying relative

Children: The deceased’s consent 7

s.8 FLRA 1969 does not apply (surgical, medical or dental treatment) Test applied: Gillick (sufficient intelligence and understanding). Code A, [88] ‘In any case where a child has consented to the use of their body or tissue, it is essential to discuss this with the child's relatives’ Code A, [91]

Deceased donors (both adults and children): If no appropriate consent:  

Criminal offence: s.5(1) (‘reasonably believe’) penalty: s.5(7) Lecture 16 Outline (Transplantation Part 3) Dr Marianna Iliadou

Lecture Outline: • Allocation (Deceased Donors) • Living Donors: Removal of Organs/Tissues • Living Donors: Storage & Use of Organs/Tissues Allocation of material from deceased donors National allocation system run by NHS Blood & Transplant Example: Kidneys from brain-stem dead donors  A. complete matches for hard-to-match child patients  B. complete matches for other children  C. complete matches for hard-to-match adults  D. complete matches for other adults & well-matched children  E. all other eligible patients (adults & children) Conditional & directed donation from deceased donors • Conditional donation: Can donors make donation “conditional” upon the recipient being in (or not being in) a specified group? “[T]o attach any condition to a donation is unacceptable, because it offends against the fundamental principle that organs are donated altruistically and should go to patients in the greatest need”. (An Investigation into Conditional Organ Donation, 2000) • Directed donation: Does this rule out donation being “directed” to a specified individual? Rachel Leake & her daughter Laura Ashworth 2010 Guidance issued by the Department of Health • Directed donation rejected, but requested allocation supported Allocating to a specified individual is permitted where: 1. consent has been given unconditionally 2. the preferred recipient is a relative or friend of long standing 3. the preferred recipient has a recognised clinical need for the organ 8

4. there is no one in more urgent clinical need (i.e. priority is to be given to those on the NHSBT Urgent Heart/Liver/Lung Scheme) Recipients • Don’t forget that a lawful justification is required to transplant tissue or an organ into a patient • You need consent or another justification (i.e. s.5 MCA 2005 or necessity under Gillick)

Living donors: overview 3 hurdles: (1) Lawful Removal: Common law & Mental Capacity Act 2005. Otherwise, battery/criminal assault (2) Lawful Storage & Use: s.1, 2004 Act (appropriate consent for storage & use). Otherwise, offence s.5, 2004 Act. (3) For both removal & use: Offence s.33, 2004 Act (restrictions on transplantation from living donors)

(1) Lawful Removal - Living donors: Common Law (Adult) Living Donor’s consent: Capacity, voluntariness, information  Adults with capacity can consent to non-therapeutic operations if not against public policy (e.g. R v Brown [1994])  Exception: tissues/organs essential to maintain living donor’s life Incapacitated adults as living donors Re Y (Mental Incapacity: Bone Marrow Transplant) [1996] (pre-MCA) Connell J: Best Interests  ‘I should perhaps emphasise that this is a rather unusual case and…a particularly close family…  It is doubtful that this case would act as a useful precedent in cases where the surgery involved is more intrusive than in this case, where the evidence shows that the bone marrow harvested is speedily regenerated and that a healthy individual can donate as much as two pints with no long term consequences at all…  if on any future occasion there was a need or a wish to perform a bone marrow harvesting procedure on an adult incompetent, it was appropriate for the matter first to be ventilated in court before the procedures took place’ 9

A NHS Foundation Trust v MC [2020] EWCOP 33 Cohen J:  Best interests (s.4 MCA 2005)  Close family relationship - emotional, social and psychological benefits  ‘MC's case has come before the court because she is in law an adult in circumstances where there is no Lasting Power of Attorney or a Court Appointed Deputy who can give consent, hence the decision is to be taken by me’ More intrusive surgeries for donation?  Strunk v Strunk (1969) (US Case) kidney donation authorised  European Convention on Human Rights and Biomedicine (UK not signed or ratified) Art.20 prohibits donation for non-regenerative tissues/organs Children as donors s.8(1), FLRA 1969 only applies to “treatment”, i.e. not to organ donation Test applied: Gillick (sufficient intelligence and understanding) Obiter (Lord Donaldson): Re W [1992] • • • •

•

Consent must be obtained from a proxy or a Gillick competent child It is “highly improbable” that any particular child would be Gillick competent It is “inconceivable” that a doctor would proceed without the parents’ and child’s consent The common law right of a Gillick competent child to consent to treatment “which again cannot be overridden by those with parental responsibility…extends to the donation of blood or organs” Doctors are advised to apply for guidance!

(2) Lawful Storage & Use - Living Donors: HTA 2004 ‘Appropriate consent’ is required for the storage & use of “relevant material” from living persons for transplantation (s.1(1)(d)/(f) & Sch.1, part 1)  ‘Relevant material’ (both living and deceased donors): s.53 — Material that ‘consists of or includes human cells’ — except: (a) gametes & embryos (s.53(1)/(2)(a)) (b) hair & nail from a living person (s.53(2)(b)) & (c) material created outside of the human body (s.54(7)) 

Appropriate consent: from whom? Adults: the donor’s consent (s.3(2), 2004 Act) ‘The concept of valid consent is established in common law and mental capacity legislation’: Code A, [19] ‘references to consent should be taken to mean appropriate and valid consent’: Code A, [20]

What if the adult lacks capacity? 10



s.6: where there is no valid decision for the storage or use of material for a schedule purpose from a living adult who lacks capacity, regulations may deem appropriate consent to have been given

HTA 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006/1659 • Reg. 3(2)(a): where the person is acting in what he reasonably believes to be the donor’s best interests Usually: Justification for removal of organ/tissue

[Common law & MCA 2005]

Same justification for its storage and use

[Human Tissue Act]

e.g. consent or best interests consideration Exception: differently when removal not for donation purposes

(2) Lawful Storage & Use: Appropriate consent: from whom? Child (someone under 18: s.54(1)): 

the donor child’s consent (s.2(2)); or



if the child has not made a valid decision & either is not competent to make a decision or fails to do so, then the consent of a person with parental responsibility (s.2(3))

‘The HT Act is silent on how to assess a child's competence. The responsibility for assessing competence rests with the person seeking consent. The Gillick test…is considered to be the appropriate benchmark for assessing a child’s competence.’ [Code A, 131] ‘Where there is any dispute between people with parental responsibility or any doubt as to the child's best interests, the matter should be referred to court for approval.’ [Code A, 132] ‘Where a child has capacity to consent, and agrees to the sharing of their information, it is good practice to consult the person (or people) who have parental responsibility for the child and to involve them in the process of the child making the decision. However, it should be emphasised that, if the child has capacity to consent, the decision to consent and to share their information must be the child’s. It is also essential to make sure that a child has consented voluntarily and has not been unduly influenced by anyone else.’ [Code A, 133]

Lecture 17 Outline (Transplantation Part 4) 11

Dr Marianna Iliadou Lecture Outline:  Living Donors: s.33 offence  Commercial Dealings  Summary of law on transplants

Living donors: overview (1) Lawful Removal: Common law & Mental Capacity Act 2005. Otherwise, battery/criminal assault (2) Lawful Storage & Use: s.1, 2004 Act (appropriate consent for storage & use). Otherwise, offence s.5, 2004 Act. (3) For both removal & use: Offence s.33, 2004 Act (restrictions on transplantation from living donors) Section 33 restriction on transplants involving a live donor s.33(1)/(2): it is an offence to remove or use ‘transplantable material’ from a living person for the purposes of transplantation s.33(3): this may be permitted by regulations, where: (a) the Human Tissue Authority is satisfie...