Medical Law Presentation Donor Organ Donations

The object of this presentation is to show the differences in law between a living and deceased organ donor and how their relative position effects their instructions and wishes. To consider the position of the current law, how the law is and could be interpreted within this area.

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The human Tissue Act 2004 [1] came into effect on the 1st of September 2008. The Act consolidated the law on organ donation and repealed earlier legislation [2] . Under the Human Tissue Act 1961, the Autonomy Act 1984 and the Human Organ Transplant Act1989.

The 2004 Act, significantly altered the law. Organ donation now became unlawful, except under defined circumstances. The main relevant new rules are as follows:

(1)     The 2004 Act permits authorised activities for certain scheduled purposes to be carried out. The 2004 Act covers seven scheduled purposes requiring general consent, one of which is transplantation.

   (2)   Authorised activities are only lawful if done with 'appropriate consent'

(3)     Unauthorised dealings are now criminal offences, carrying penalties.

(4)     A regulatory body, the HTA, has been set up to oversee and control the working of the Act.

(5)     Codes of practice establish guidelines for practice, especially as regards the meaning and extent of 'appropriate consent'. It is thus essential to know the precise meaning of 'appropriate consent' since otherwise criminal liability may be incurred.

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It is important to establish the meaning of consent under this 2004 act;

Section 3 ss (6) Where the person concerned has died and the activity is not one to which subsection (4) applies, “appropriate consent" means—

If a decision of his to consent to the activity, or a decision of his not to consent to it, was in force immediately before he died, this section does not stipulate consent in writing.

Slide 5

The Act established a new Regulatory body the “Human Tissue Authority “(HTA) [3] whose remit is to regulate amongst other things the removal, use and storage of human organs.

The HTA works in conjunction with the NHS Blood and Transplant Organ Donation and Transplant Directorate (NHSBT ODT) who since 2009 is responsible for the allocation of deceased donor organs within the United Kingdom. [4] 

Slide 6

These bodies follow long established policies with regard to undirected or unconditional deceased organ donation [5] .

The central principle within deceased organ donation is that the organ goes to the recipient most in need.

A report by the Department of health in 2000 into Conditional Organ Donation concluded that Donors cannot impose conditions as to whom or where the organ goes nor can they choose to direct the organ toward a specific recipient [6] . Beecham outlined that ` Donors and relatives must place no restrictions on organ use` [7] 

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A conditional donation is where the organ is offered to or withheld from a specific recipient or class of recipient [8] .

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A Directed donation is where the organ is directed to a specific person or where a nominated recipient is given priority. An ethical discussion in respect of this area is presented in a paper by Volk and Ubel [9] .

Slide9

Impartial justice is the bedrock of deceased organ donation. The Department of Health and Human Services task force on organ transplantation have remarked that organs are public resources to be distributed by relevant agencies on behalf of the state this will support the beliefs of many that this procedure will have the greatest benefit for the greatest number of people. This also supports the position that deceased organs are public goods and would therefore allow automatic transplantation without the need for further consent from the donor.

Emson, in his article, ‘It is immoral to require consent for cadaver organ donations` [10] justifies this position by stating that ` the human body as opposed to the human spirit is on an extended loan from the biomass to the individual with which it forms a part`. Whilst Harris a leading protagonist in his article `Dead interests, living needs` [11] sees organ donation as` no more than an example of a small but significant class of public goods, participation in which should be mandatory` Harris also believes that people would get used to the idea. [12] Current investigations into reforms within this area are being considered as of 2008 in respect of an opting out system as opposed to an opting in system.

Traditionally the human body has been deemed not to be property and it was established in the case of DR Handyside in 1749 [13] and later in Williams versus Williams 1852 [14] that there is no property in a corpse. This area has come under scrutiny after the Alder hey hospital retained body tissue and body parts [15] and in the case of the Crown versus Kelly [16] the Criminal Appeals Court held that body parts could acquire the attributes of property for the purposes of section 4 of the Theft act 1968, if skilled work has been performed on them, thus any unlawful appropriation retention or usage would amount to an offence.

Slide 10

In complete contrast to this, the underpinning values of the living donor organ donation is` the respect for an individual’s autonomy and wishes`, here Individuals are entitled to donate organs where they have a familial or intimate personal relationship, kluge in the article `designated Organ Donation: Private Choice in Social Context` [17] argues that these types of donations sustain intimate relations and should provide for exceptions to the rules of impartial allocation [18] .

Living directed donations between close family is lawful provided there is no element of financial remuneration or undue pressure. This is regulated by section 33 of the 2004 act. This type of donation in respect of kidney transplants now accounts for over one third of kidney transplants in the UK [19] .

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It appears that there are then two principles governing the donation and allocation of organs the impartial justice principle in respect of deceased donations and a partial autonomy based principle in respect of living donation.

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The deceased donor allocation system is challenged by directed and conditional donations which allow, whilst living that a donation may be directed to family or close personal relationship with appropriate consent [20] . It is by virtue of s 3 of the 2004 act an individual can consent or refuse organ donation. As Both living and deceased donations are covered under the 2004 act how can it be that deceased donors cannot place conditions or restriction up on their donation prior to their death.

It appears that although we have the right to decide for ourselves that we wish to after death become donors, we seem not to have the right to attach any conditions to that donation. Even if that person was of close intimate tie as with living donations. Slide 13

This however is not as straight forward as it seems altruistic (selflessness) anonymous donations are permitted by strangers under 2004 act at present these donations cannot be directed and again the organ is allocated to the most needy on the transplant list.

However;

Pooled and Paired donations are permitted from living donors where the potential donor 1 is not a match for the family recipient A, but is a match for a second recipient B and in turn their potential family donor 2 is a match for the first recipient A [21] . In effect they swap donations with each other which fly in the face of Anonymous donation directives above.

Slide 14

Organ trafficking has been banned in the United Kingdom since 1989; In 1990 Dr Raymond Crockett was struck off the BMA register for buying donor kidneys from Turkey and placing them with British patients [22] . The emergence of organ trafficking has placed further restrictions on living donations requiring prior authorisation by the HTA. Section 3 of the 2004 Act provides that in relation to deceased donation prior consent is required prior to harvesting of the organ for transplantation. Effectively now both living, and deceased donations are overseen by a statutory body. On the positive side this facilitates and ensures uniform donation throughout the country however on the negative side these authorities have the ability, when unchallenged to misinterpret the law and apply their own principles, policies and decisions which again UN challenged may reduce ones personal autonomy in respect of personal decisions and choices.

Slide 15

It could be said that the principle surrounding the unconditional deceased organ donation system is neither legal nor binding and that it is merely a principle that has remained unchallenged in the courts thus far.

Should that be so, the current position of disallowing or overruling directed or conditional deceased organ donation would interfere with an individual’s right of choice, and by attempting to place any condition on a donation may go against the appropriate consent principle which is fundamental to the 2004 act. And thus may conflict in law.

Slide 16

The argument so far appears to be between an individual’s choice and authorisation and the public benefit of the impartial justice system. This was brought to the fore front in The Ashworth affair in 2008 [23] which caused controversy within this area.

Laura Ashworth wished to donate part of her liver to her mother however at the time of her death Laura had not began the formal paperwork to become a living donor so upon her un expected death her organ could not be directed to her mother as deceased donor donations do not allow directed conditions.

This area in question has been subject of American Courts as far back as 1994 where a daughter carrying a donor card was who was killed in a car accident was permitted to give her heart to her father Chester Szuber. The court used a discretionary power within federal regulations to allow the directed donation.

Slide 17

TM Wilkinson in the article ` What’s not wrong with Conditional Organ donation` [24] argues on the inflexibility of the HTA policy, it is reflected in Laura`s case that had she completed the process of becoming a living donor and had still been alive the HTA would have approved the donation to her mother.

In view of the Szuber should Parliament and the relevant agencies consider and adopt the discretionary powers enabling donation in these circumstances?

The Ashworth matter was referred to the HTA who on the 14 of April 2008 stated that the central principle is," that when a person dies neither that person nor their family can choose who their organs go to". The HTA did however concede that there may be exceptional circumstances where the rules may be reconsidered however in this case they stated that the organ would be provided to the neediest candidate.

Slide18

The HTA statement appears to make some assumptions of the 2004 act with regard to deceased donations in that

All deceased donations must be unconditional,

Any restrictions attaching to donations may be lawfully set aside and the donations treated as unconditional.

All deceased donations in the UK must be allocated through UK Transplant, now NHSBT ODT, the national allocation body, in accordance with the central principle of the HTA.

Slide 19

It appears however that the 2004 Act does not prevent directed or conditional deceased donations but actually caters for them within its statutory codes. It could possibly be established that the HTA`s power is limited to guidance only and that they have no powers to vary the words contained within the act.

Supporters of the present system argue that section 3 of the 2004 act must be read and interpreted with parliament’s true intention in mind (which is also that of the HTA and NHSBT ODT), that it should be illegal to have any restrictions placed on deceased donations.

However if you look at the principles of statutory interpretation and the case of Pickstone v Freeman [25] Lord Oliver stated that the basic principle of statutory interpretation is that the intention of parliament has to be ascertained from the words which it has used and those words are to be construed according to their plain and ordinary meaning.

The 2004 act is silent on conditional and directed deceased donations to that end the act should not be twisted as to provide for them.

The revised code of practice1, consent 2009, issued by the HTA stresses that for consent to be valid that it must be informed consent. How there for does that sit with consent at common law where consent will be uninformed consent where a person’s conditions amounting to the consent given will not be provided for. [26] In Chatterton [27] Justice Bristow held consent was invalidated and destroyed when the requests to be provided for were only in form and not in reality.

Slide 21

So could it be said that where organs are donated with attached conditions any usage outside those conditions by the HTA in line with their own policies could amount to dealing with the organs without consent thus illegally.

An offence under section 5 of the 2004 act provides for such unauthorised usage, to take it a step further in the Crown versus Kelly Lord Justice Rose stated that ` the law does not stand still the courts on some occasion should the question arise may hold that body parts are capable of being property under section 4 of the Theft Act 1968. There for should an organ be donated and later stole the perpetrator would be open to a prosecution for theft.

Taking this in context with organ donations this may suggest that where an organ is donated with attached conditions should the regulating bodies appropriate the organ in line with their own policies that it is argued are not backed up or catered for within the HTA 2004 then any usage against the conditions of the donor would amount to an appropriation and there for a theft.

Cronin in the article `Directed and Conditional Deceased Donor Organ Donations: Laws and Misconceptions [28] suggests that it is only in the absence of a legal challenge to the unconditional donation principle that has prevented the court from drawing this conclusion already.

CONCLUSION SLIDE

This author`s view supports the position that the 2004 act does not cater for the principles and guidelines of the HTA, that the individual living or dead should have the choice as to where their organs go and that the public may be more supportive of donating if they had a choice which in turn would increase the availability of organs and save more lives.