#3536 - Organ Donation - Medical Law

HTA 2004

• Coverage

• Part I – applies to storage & use of material for particular purposes only

• doesn’t apply to removal of human material, sperm, eggs, embryos, coroner’s duties etc

• Things lawfully done to certain human material

1. Storage & use of whole body

2. Removal, storage, use of human material from deceased

3. Storage, use of human material from the living

• Need consent + act done for a Schedule 1 Purpose

• Consent

• To storage or use for a particular purpose only (unless for research – consenting once is sufficient)

• Must be positive

• Who can consent

1. Competent adults (s3)

2. Incompetent adults – consent can be deemed

1. in best interests (schedule 1 purpose only)

2. clinical trials

3. research

3. Deceased adults

1. own views pre-death

2. appointed rep

3. person in closest qualifying relationship

4. Children (s2)

• No definition of “appropriate consent”

• Schedule I purposes (2 parts = 12 purposes)

• Criminal offences

1. Failure to obtain appropriate consent for storage/use of whole body or bodily material or removal, storage, use of human material (s5 HTA)

• Max sentence – 3 years

• Defence – reasonably believed he had appropriate consent or that consent not required

2. False representation of consent

3. Failure to obtain death certificate

4. Using/storing donation material for improper purposes

• Defence: reasonably believed he wasn’t dealing w/donated material

5. Analysis of DNA w/out consent

• Unless results are for excepted purpose (conduct of prosecutions, nat. security etc)

• NB:

1. Consent isn’t defined in the Act

2. Broad definition of uman material

3. Questionable distinction b/w bodies of living & dead

4. Compromise b/w rights based and utilitarian approaches?

• Should deceased’s views carry any weight?

• Harris – although person might have some interests in what happens to his body after death, it should carry little weight b/c after death he can’t be harmed. We regularly dispose of body parts and tissue through menstrual bleeding, bowel movement etc. so should be no more concerned about bits of it being taken by docs. The only interests are that body be disposed of in a way posing no health risks, respecting public decency & attaching weight to legitimate interests of deceased

• Brazier – Harris’ views are driven by cold rationality. Easy to overstate the claims of research. At Alder Hey, vast majority of organs were simply stored. People’s/relatives’ views highest respect b/c just like families live differently, they also grieve differently. Just as we allow people to decide what should be done w/their property through will, should allow them to decide re their bodies. We live in knowledge of death’s inevitability & how we’ll be treated after death affects our welfare in life

• Harris

1. No role for consent in organ retention – even where deceased has made a competent prior direction as to disposal of tissue and organs, respect for consent in this context is no more than extension of courtesy. Posthumous interests, if any, aren’t of the type to be protected by consent.

2. There are no posthumous interests warranting protection of consent on either of 2 theories

1. Choice – rights securing protection & promotion of liberty/autonomy

2. Protection – rights serving to further individual’s welfare/well being

By not respecting wishes of someone at a point when they are no longer autonomous, we don’t violate their autonomy. Knowing what deceased wanted is a “powerful steer”, nothing more.

3. There’s an absurd, if understandable, preoccupation w/reverence & respect post Alder Hey – we don’t feel such emotions towards our organs whilst alive, so why give it such reverence when dead? Inconsistency of views shouldn’t for the basis of legal distinctions

4. Illusions are fine but state & courts shouldn’t give judicial or official support to them – particularly where it might deprive others of possibility of life saving therapies

• McGuiness & Brazier: respect for the living = respect for the dead

1. Law should acknowledge that some of the same considerations requiring respect for integrity of the living demand respect for their wishes about what should happen to their corpse

2. Values held by deceased in life (esp. religious & conscientious) can’t be simply discarded nor can values of bereaved families

3. Bodily integrity has high value under the law (Art 8 ECHR, battery etc) and even where no strict harm per se is caused, it’s violated

4. Balancing exercise of weighing respect for human organism against the good bodily material can do to others isn’t the right way to approach this

5. Harris’ statements re illusions ignore much of history & culture

6. Those who argue the dead have no interests fail to appreciate the transition period – it’s not like some switch is pressed and person ceases to matter

7. Although often attacked as irrational, those beliefs have normative value & compel us to act in certain way

Living Donors

• Distinguish

1. Donation of regenerative tissue (bone marrow, blood)

2. Donation of non regenerative tissue

• 3 legal principles

1. Can’t consent to procedure causing death

2. Must fully understand the process involved

3. Must be permissible under HTA 2004

• Children Donation

• No case law/specific guidance

• Code of Practice – donations very rare, need approval by the Panel + court order (though where child’s Gillick competent, weight must be given in favour of the order) – consider if in child’s best interests (emotional, psychological, physical etc)

• Can donation ever be in child’s best interests?

1. Yes – if sibling would otherwise die, welfare of child promoted by donation + emotional benefits

2. No – World Health Organ suggested a blanket ban

3. Yes (qualified) – only where it’s a necessity (the only feasible option for preserving life/well being of the recipient who’s a key component in donor’s well being) + BMA: truly exceptional circumstances

• Incompetent donors

• S6 HTA – if adult lacks capacity to consent:

1. Consent can be deemed under MCA 2005

1. Advance directive (only refusing treatment)

2. Power of attorney (authorise treatment in P’s best interests only)

3. P’s best interests (s1(5) MCA)

• ReY – held it’s in P’s best interests to donate bone marrow to sibling on the basis that she would otherwise die, impacting negatively the level of support & care which mother could provide to the donor.

2. Court approval

3. HTA Panel’s approval (min 3 members)

Dead Donors

• S1 HTA – removal, storage, use of organs for transplantation is lawful only if there’s appropriate consent

• Consider:

1. Has he made a decision whether to consent in force immediately b/f his death? (must be respected)

2. Has he nominated a rep for deciding? (s4)

3. Person in closest qualifying relationship immediately b/f his death can decide (s27(4) ranks relationship)

• Surgeon who performs operation w/out consent = up to 3 years in prison

• Unless can show that reasonably believed consent had been given

Ethics

• Limits

1. Law should allow donation where it results in serious injury or death b/c risk may in fact be very small + great psychological benefits could be due

• But that would infringe the principle that docs can do no harm

2. Compulsory donation

• Harris’ survival lottery – where 2 or more people need donation, computer should randomly select one b/c killing one is better than killing two. A person who’s responsible for own failure of organs; e.g. drinking problem; wouldn’t be eligible under the scheme.

• D. Ho – moral resp. shouldn’t be used as criterion for allocation of human resources b/c it undermines the functioning of medicine, presents practical difficulties & is contrary to autonomy.

• But the basis of autonomy & resp. are mutually entailing, so that freedom to make choices & act on them entails capacity to take resp. for the consequences

• Harris’ argument is utilitarian, so could reply in the same terms – i.e. impact on society would be such as to outweigh the benefits

• Harris: fanciful – more people are killed in car crashes yet they don’t seem constantly worried about it

3. Conditional donation – permitting donor to attach conditions on who is going to receive his donation

• Not legal, unless donation is live

• Criticisms:

1. Where P fitting the description is at the top of the queue, shouldn’t object unrealistic!

2. Means organs go to waste

• Cronin & Douglas: should allow conditional donation for both living and dead b/c the principle of unconditional donation amounts to nothing more than operation policy and isn’t a legally binding principle. HT authority can reject conditional donations but can’t vary/discard them w/out incurring possible crim. liability

• Main Issues

1. Beating heart donation

• NB: unlawful to keep person ventilated to preserve the organs (elective ventilation)

2. 4 systems

1. Opt in (current) + do more to increase registration (public education, incentives, make it easier to register etc)

2. Mandated – require citizens to indicate either way by e.g. ticking a box in tax returns, driving licence apps etc. + devising a punishment for those who don’t

3. Mandatory – on death, organs are donated, regardless of deceased’s wishes

• Harris: we already override deceased’s wishes in context of post mortems, justifying it as necessary for community. If public interest is sufficient there, why not in organ donation?

• Because equates to profound violation of autonomy, esp. where views are based on religious beliefs

4. Opt out – presumes person wishes to donate, unless provided otherwise (much support, incl. BMA)

• Issues

1. Consent should be presumed b/c it’s morally correct to consent

• But law doesn’t normally compel people to act in a...