#1727 - Organ Transplant - Medical Law

Organ Transplant

Live Organ Donation

Types of Tissue involved

• Regenerative tissue

  • If a living donor wishes to donate regenerative tissue (e.g. blood or bone marrow) there are few legal and ethical issues

    • We need only be concerned whether consent was fully informed

• Non-regenerative tissue

  • Where P wants to donate something like a kidney, which will not naturally regenerate, the issue becomes more complex. There are three basic principles:

    • It is not permissible to consent to a procedure which causes death or serious injury

      • Therefore, a parent cannot donate a heart to a child, as the parent will die in doing so.

      • Donation of a single kidney, segment of liver or lobe of a lung may be permissible if the donor is in good health

    • There must be consent to the procedure

      • So the donor must fully understanding the processes involved

      • And an incompetent person cannot donate unless it is in their best interests – and it is unlikely that it will ever be

        • However, the court in Y managed to get there by contorted backward reasoning

        • Although the HOTA 1989 means that if a donation is to someone not genetically related to the donor, it is extremely unlikely that it would be lawful for an incompetent person to donate.

    • The procedure must be permissible under HTAct 2004 s.33

      • Subsections (1) and (2) respectively attach criminal proceedings to (a)

        • anyone who removes transplantable material for transplant into another,

        • or uses the transplantable material respectively

          • if (b) he knows or is reasonably expected to know the “donor” is alive

      • This is subject to subsection (3), which states that the Sec of State may by regulations that (1) or (2) should not apply in a case where

        • (a) the Authority is satisfied

          • (i) that no reward has been or is given for a contravention of ss.32 [commercial dealing]

          • (ii) and such other conditions as are specified in the regulations are satisfied

        • AND (b) such other requirements as specified in the regulations are complied with

      • Herring: The Human Tissue Authority has extensive regulations concerning live donors

        • It has to be discussed with the donor the implications on their health and that there is no guarantee the organ will help the donee.

          • Where the donor is genetically or emotionally related to the recipient and they have met with a clinician and independent assessor, the donation can go ahead

          • However, if there is no genetic/emotional relationship, the parties need approval from a HTA panel.

Who should be able to donate organs?

• Children?

  • HTA has a Code of Practice:

    • There it is said that donations from children will be extremely rare

    • Any donation from a child must also be approved by the Panel of the HTA

  • Where organs are donated, in whole or in part, a court order is required:

    • HTA Code: As with cases involving lack of capacity, this is because on the face of it, the procedure is not therapeutic

      • and not obviously in the best interests of the prospective donor child

      • The court will have to determine this, looking beyond medical interests into potential emotional, psychological and social benefits and risks.

    • Herring: so even were kid is Gillick competent, the consent of the court is required

      • Could the donation be in the best interests of the child?

        • Welfare of child would be promoted if donate organ to someone with whom they had a close bond (e.g. sister) who might otherwise die

          • Might run into trouble with more distant relationship, or donation to recently born sibling – future benefits can be taken into accounts?

        • The emotional and social benefits must also be taken into account, not just medical ones

  • Hashimi – HOL approved “savour sibling” – genetic screening in order to find bone marrow match in potential child for cure genetic problems.

• Incompetent donors?

  • There are three main ways by which the removal or transplantation or an organ can be authorized by an incompetent person

    • Advance Directive – s.28 MCA 2005

      • However, the advance directive only refers to a refusal of treatment

    • An enduring power of attorney

      • The incompetent person might have signed an enduring power of attorney which has authorized someone to make decisions concerning his or her welfare

        • However, as with advance directions, the legislation only permits the donee of the power of attorney to authorise treatment –

          • and it’s questionable whether donation of bodily material is treatment

    • The best interests of the patient – MCA s.1(5)

      • Can it ever be in a person’s best interests to donate material?

        • Re Y

          • Permitted b/c otherwise Y’s mother might die and this would impact Y’s welfare

            • So Y, as match of bone marrow, should donate to Y’s sisters

        • Problem =

          • Backward reasoning

          • Connell J doubtful that would apply to non-regenerative material or more invasive surgery

Living Donors – the Ethical issues

• The stark statistics

  • Choudbry et al: The UK has the lowest level of donations in Europe

    • People are dying b/c of our reluctance to accept live donors

    • Even though transplants tend to be more successful from live donors

• Should there be limits to the donation of organs?

  • Are we permitted to allow donation of an organ if they are liable to suffer serious injury or death?

    • Risk of injury from live transplants is quite low

      • Death rates = 0.03-0.06%

      • Rate of complications for nephrectomy is 2% and wound pain 3.2%

      • People who successfully complete evaluation for living kidney transplant have an above average life expectancy (although this is likely before they have donated a kidney!)

    • There are great psychological benefits

      • Garwood-Gowers (1999): survey of 84 live donors, only 3 said would not go through it if had time again

    • Serious injuries come from a noble objective

      • Might be the potential for serious injury and law should perhaps discourage this

        • But we don’t discourage bungee jumping b/c of potential risks, and saving a life is arguably a more noble and worthier objective for risking harm.

  • The problem comes where there will definitely be serious harm – such as where F has already donated one kidney to save a son

    • And then offers to donate his other to another son in need, arguing that it is better for him and the older person to remain on dialysis for the shorter remainder of his life than his son.

      • Gardoowd Gowers:

        • The justification for the law stepping in as not to prevent people voluntarily assuming risk

          • But to prevent others from using the fact that a person has consented as a basis for mutilating them.

• Should a genetic relationship be necessary?

  • A clear distinction is drawn between live donors who are genetically linked to the recipient and those who are not

    • All cases of “altruistic non directed donation” must be referred to the HTA for approval

      • The assumption is that those who are not genetically related to the recipient are more likely to be improperly motivated

        • Possibly by money

          • So great caution is required before accepting it.

      • For those with a genetic link, we assume that it is motivated by altruism and therefore subject to less scrutiny

    • Schaunberg (2001): Perfectly possible for a stranger to be willing to donate out of genuine spirit of altruism ~(e.g. “Jesus Christians”)

      • And people under emotional pressure to donate – i.e. relatives – might have their consent impacted far more than offers of money.

Organ Transplant from the Dead

The Law

• Appropriate consent is required under HTA 2004 s.1 before organs can be removed, stored or transplanted

  • First port of call: has the deceased made a decision which was in force before their death?

    • If they have, this consent can be shown orally or in writing

    • If the deceased has made a decision, this must be respected

      • So if D makes it clear he wants his organs donated, his family cannot override this

      • Similarly, if D has made it clear he does not want his organs used, his/her family cannot override these wishes

  • If the deceased has left no views...

    • Has the deceased nominated a representative to make decisions under s.4?

      • This can also be made orally or in writing

        • If orally, made in the presence of two or more witnesses

        • If in writing, signed and witnessed

      • S.4(10) The representative must be an adult, and can renounce their appointment if they wish (s.4(9))

      • S,4(6) if more than one representative is appointed, the consent of one of them is all that is required unless the terms of the appointment show they must act jointly.

    • If not, is there anyone in a qualifying relationship immediately before death who can make a choice?

      • S.3(6) covers this, ranking down from

        • Spouse/partner to parent/child to brother/sister to grandparents

        • To child of brother/sister, to stepfather/stepmother to half brother/sister and finally a “friend of longstanding”

      • So if the spouse and parents of the deceased disagree, spouse wins

        • And if relationship of those nearby is same (e.g. brother and sister both present), then consent of one is all that is required

• Assessment of the law

  • Will virtually always be someone with potential consent via qualifying relationship

  • Step children aren’t included in the list

  • The requirement of “immediately before death” means that a former spouse cannot make a decision

  • May be difficulties as surgeon criminally liable if gets consent from wrong person

    • How is surgeon meant to know which relative is which, and whether the person claiming to be D’s representative is actually one in law?

      • Add to this the mix of transplant decisions needing to be made quickly, and it’s a pretty harsh sanction to have in place

      • Luckily there...