Medical Law with Tort

Research Module

Medical Law With Tort : Question 8

Q1. Does the law enforce a person’s inalienable right to self autonomy including the disposal and exploitation of their own body ?

Outline Answer: The law does not enforce a person to act against his appropriate consent. The Human Tissue Act 2004 (HTA) deals with the removal, storage and use of human material. The HTA regulates all aspects of human transplantation ,whether organs (Tissue ) removed from the living or dead: Brazier & Cave

S1 HTA 2004 deals with the lawfully removal, storing, using human material from the deceased person ; store or use a whole body ;

Store or use human material form a living person ;

provided there is a necessary consent and the act was done for the schedule 1 purposes.

What Is Human Material ?

S 53 HTA 2004 defines relevant (human) material as: tissue, cells, organs of human beings, excluding gametes, embryos outside the body, hair , nails from a living person. Cell lines & any human material created outside the human body are also excluded acc to s 54 (7) HTA 2004.

What Is Appropriate Consent ?

Consent must be given to store or use for a particular purpose except for research purposes acc to McHale 2006a;

Lord Warner 2004 argues that if the person is willing for their material to be used in research then it is not necessary to obtain consent for every individual research project;

Positive consent is required;

Failure to object is insufficient HT Authority 2007 : para 17 ;

To give consent a person must understand the nature and purpose of what is being proposed & Must be able to make a balanced judgement, must be told any material or significant risks inherent, how the tissue will be used & any possible implication of its use e.g, genetic tests. (The code of practice is governed by the general law on consent )

Who Can Give Consent ?

1. Adults: s 3 HTA 2004 defines competent adults appropriate consent can be provided by the individuals themselves ; consent must be given voluntarily by an appropriately informed person who has capacity (HT Authority : para31)

2. Deceased Adults : three sources ;

A. The Deceased (himself) : if deceased made clear about his views then use of human tissue which involves storage for purposes of public displays or anatomical examinations, the consent must be in writing s 2(5)HTA; for all other activities in the act there is no need of written consent. The decision must have been in force immediately before death. Consent is not effective , if there is a change of mind before death.

B. Appointed Representative : s 4 HTA deals with appointment of a representative , orally or in writing. If death occurs without expression of decision about use of bodily material then his/her appointed representative can make a decision on his/her behalf.

C. Qualifying Relationship : s 27 (4)HTA 2004

If death occurs without expression of decision and appointment of a representative then a person in the closest qualifying relationship can make a decision.

Qualifying relationships in descending order: spouse or partner, parent or child, brother or sister, grandparent or grandchild, child within para (c) ,stepfather or stepmother , half brother or half sister, friends of longstanding ; If two persons of same rank, consent from one of them is enough (HM Government 2007a)

3. Children : (Children Are People Under 18 Of Age)

s2 HTA 2004 A competent child (competence is not defined , although presumably the Gillick competence test will be used) if expressed advance consent ,such decision must be respected ;If not competent a child then a person by ‘parental responsibility’ will be able to consent for child

(HT Authority 2007: para 43). If the child dies without anyone having parental responsibility then someone in ‘qualifying relationship’ can consent to removal , storage & use s 2 (7) HTA 2004.

4. Incapacitated Adults :

consent deemed in certain circumstances under HTA 2004 for persons lacking capacity to consent , Regulations 2006

HTA code of practice:

• storage and use of relevant material for scheduled purposes by a person acting in best interests of incapacitated adult. Scheduled purposes defined under the regulations are scientific & medical information about living or deceased person and transplantation.
• storage and use of relevant material for clinical trial from an incapacitated person.
• consistent with s 30 – s 34 MCA 2005 , allowing for storage & use of relevant material from persons lacking capacity for research purposes (HT Authority 2007d : para 40)

What Is The Schedule Purpose?

A person’s act is made lawful by HTA , s1 if she/he is acting for the purpose of schedule 1.

Part 1:

1. anatomical examination ,

2. determining the cause of death ,

3. establishing the efficacy of any drug,

4. obtaining scientific & medical information about living or dead,

5. public display,

6. research – disorders or functioning of human body

7. transplantation

Part 2 :

8. clinical audit,

9. education or training, relating to human health,

10. performance assessment,

11. public health monitoring ,

12. quality assurance

Appropriate consent required for any of the 12 purposes:

1. storage of the body of a deceased person (excluding anatomical examination)
2. removal of any relevant material from the body of a deceased person

Appropriate consent required for a purpose in part 1 of schedule 1 :

storage or use of any relevant material came form a human body

Consent not required for a purpose in part 2 of schedule 2 :

storage or use of any relevant material came from the body of a deceased person

s 1( 2) & (3) HTA 2004 notifies the special provisions dealing with the storage of bodies for anatomical examinations.

The HTA 2004 does not apply where bodily material is being used for a purpose other than approved in schedule 1.

Storage & Usage Of Relevant Material : Without Consent

1. Schedule 1, part 2 purpose : ( e.g, education, training and audit )

No consent is required for part 2 of schedule 1 purposes excluding research ;

Use of material is essential for the proper conduct of patient’s treatment or health of nation DoH 2004f : para 13

2. HT Authority may deem consent if :

No trace is available from where the material originates s7 HTA 2004;

Tissue of a relative used for genetic testing purposes to help diagnosis or treatment of patient;

material has come from the body of a living person;

it is in the interests of another person to obtain scientific or medical information ;

if the person is not dead or has not consented to use of his/her material

3. High court order :

A HC can order Appropriate consent is required for research purposes in connection with disorders or functions of human body acc to s 7 (4) HTA which cover storage of body of living or a deceased person and the removal & use of relevant material. This HC order should be in public interest and Price 2005 a: 801 argues that government states that this power is to be used in most exceptional cases.

3. Storage for research purposes :

If relevant material form living bodies is stored for research purposes for disorders or functioning of human body then no consent is required if:

a. research has been ethically approved by SoS acc to regulations

b. Material has been anonomized so that identity of person is undisclosed from which the material originates s 1 (7) & (9) HTA 2004.

Important provision as It permits the use of human body for research even if patient positively objects. This does not justify the removal of material without patients consent therefore it covers removed material with consent.

4. Surplus material :

If material is removed during treatment, diagnostic tests or research purposes,

That material is characterised as waste and no consent is required before disposal acc to s 44 HTA 2004.

5. Imported material :

No is consent required for imported body or bodily materials

7. Existing Holdings :

No consent is required if material is stored by the hospital or surgeon before the enactment of HTA 2004 acc to s 9(4)HTA ;

HT Authority issues code of practice for storage, use & disposal of existing holdings.

8. Coroner’s activities :

Functions of coroner are not covered by the HTA 2004 ;

Coroner may authorize the retention of organs without compliance to HTA 2004.

Human Tissue Authority:

HTA 2004 part 2 sets up HT Authority for removal, storage , use & disposal of human material HT Authority 2007a ;

HTA sets up Licensing scheme : licence required for activities connected with human tissue;

Offence to conduct activities without licence HT Authority 2007a ;

Code of practice for dealings with human tissue ;

HTA have No power for criminal justice purposes, such as coroner’s post mortem (s39 HTA).

HT Authority remit includes :

• Storage & use of human bodies & tissue , removal of tissue for scheduled purposes
• Import / export of human bodies & tissue for schedule purposes
• Disposal of human tissue , including imported tissue following its use

Blood & its derivatives are dealt with by National Blood Service not by HT Authority.

Comments On HTA 2004:

The Meaning Of Consent:

Consent is not defined in HTA (Nuffield council2004)

The law is not enough regarding the amount of information that must be provided before the consent is effective (no requirement of informed consent) ;

HT Authority produce guidance on level of information for the consent to be effective;

Definition of consent does not appear on the face of the act (Parry, Zimmerman, Hall and Lidell 2004:5)

Exceptions to the consent principle :

No material can be taken away from the body without the consent, unless it is permitted under the HTA ;

A person’s material can be used without their consent for audit, training or teaching ; The justification of exception ( i.e, essential for proper conduct of patient’s treatment or public health of the nation ) will not convince everyone ( DoH 2004 : para13) ;

Why is research not regarded necessary for public health of the nation ? (Zimmeran, Hall & Liddell 2004) ;

Is there a clear distinction b/w education and research ? (Parry et al 2004) ;

the distinction is made more complex by the fact that under s1(7) – (9) , use of material for research purposes without consent is permitted if factors ( importantly anonomization of any sample and approval by a Research ethics committee Zimmeran , Hall & Liddell 2004) are met.

Why it is lawful to use material form living bodies for teaching purposes(without explicit consent ) but unlawful to do the same with material from cadaver ?

Is there any logical distinction b/w living and the dead?

Rights Or Utility :

Utilitarian reasoning : Done for the greatest good to remove the tissue and not to tell parents what has happened.

Rights based approach : Recognizing the rights of the individuals to have control over their bodies (Morrison)

HTA is a compromise b/w utilitarian & rights based approach. firstly statute appears to grant clear rights not to use or store materials without consent, many exceptions justified in the name of public good, indicate utilitarian reasoning.

Balancing b/w rights of individuals and public good for research is necessary (Morrison)

Rights analysis requires the rights of the community balanced against the interest of the general community: ECHR, At 8

Is The Act Practical:

There can be a feeling that HTA fails to realise the sensitivities of the family members of deceased. To approach the family members for post mortem examinations or removal of organ for transplant should not be callous or insensitive.

Suggestion that HTA should emphasise on authorisation rather consent ( Brazier 2003a ) as it is not comfortable to consent to invasion or retention of body parts, however authorization simply permit to go ahead with the procedure.

The consent requirements should not hamper medical research ( Nuffield Council 2004) and the presence of relating criminal offences envisages excessive caution (parry et al 2004)

The role of parents:

Parents have a deep concern about the bodies of their deceased children, but how to balance b/w sentiments and science advancement.

Brazier’s Suggestions:

• The child is theirs, he/she belong to them, his/ her body belongs to them, they are still the parents although bereaved parents.
• Parents are guardians of family values, whether religious, cultural, or personal convictions.
• For parents child loss is difficult to bear, they need some means of regaining control.
• Parents’ own mental & emotional state is at risk.
• A child is still alive in their imagination which haunt their memories (Brazier, 2003:3a)

Law has to rise above emotions, parents wishes might hinder research in childhood illness thus trumping public interest which could have save lives of many children. post mortem is more in public interest than research into childhood illness (Harris : 2002)

The leading scientists claim that the bill fails to strike a balance b/w needs and rights of individuals and those of the community. Changes have to be made to balance b/w the requirements of individual patients, individual citizens and those of public health and public interest ( Pary et al 2004)

Criminal Offences:

Failure to obtain appropriate consent:

S5 states a person commits an offence if he does an activity without an appropriate consent or he reasonably believes that he does an activity to which this subsection does not apply. This section covers storage, use of whole body or bodily material; Removal , storage , or use of human material form a deceased person. It means that it constitutes a criminal offence to retain a child’s organ without consent: the alder hay case is an example which caused uproar.max sentence is 3 years.

The defence of reasonable belief means that a doctor convinced about the document stating the consent of a patient to use his/ her body but in fact the document is forged, the doctor could not be prosecuted in this case.

A false representation of consent:

False representation of an appropriate consent or an activity does not require any consent s 5(2) HTA2004.

Failure to obtain a death certificate :

Storage or use of a body for an anatomical examination without a death certificate s 8 (2) HTA 2004. Defence for reasonable belief or not an activity covered by HT Authority.

Using or storing donated material for an improper purpose:

Usage or storage of donated material does not constitute a defence unless;

• Schedule 1 purposes
• Medical diagnosis or treatment
• Decent disposal
• Regulations made by SoS contain purposes S 8 HTA 2004

Defence for a reasonable belief not to deal with donated material, s 8 (2) HTA 2004

Analysis of DNA without consent ;

Analysis of DNA without qualifying consent is an offence unless the results are for excepted purposes s 45 HTA 2004 , Which are;

• Medical diagnosis or treatment
• Coroner functions or purposes
• Prevention or detection of crime
• Conduct of prosecution
• National security purposes
• Court order or direction , including outside UK
• High court order for medical research
• Existing holding purposes
• DNA taken from a living being can be used without consent for ;

Research

Clinic audits

Education

Performance assessment

Under Human tissue authority directions

For other person’s benefit

Trafficking human tissue for transplantation:

Selling or trafficking human tissue for transplantation constitutes an offence, s 32 HTA 2004

Unlicensed activities:

Carrying out licensable activities without a license for HTA is an offence, s 16 HTA 2004

Failing to produce records or obstructing HTA also an offence, s 16 HTA2004.

Miscellaneous provisions:

S 43 HTA 2004 makes the preservation of organs of deceased persons lawful while appropriate consent is sought.

S 44 HTA 2004 envisages disposal of waste human material

S 47 HTA 2004 gives power to national museums to transfer human remains out of their collection.

Q. Organ Selling

Selling organs:

It has been a criminal offence to be involved in selling of organs and doctors found in organ selling have been struck off the medical register (Dyer 1990)

The criminal offences :

S 32 HTA 2004 contains offences of commercial dealing of organs for transplantation; 1.a person commits an offence if he:

• a. Gives , receives a reward for the supply of or for an offer to supply any controlled material.
• b. Seeks a person willing to supply for reward any controlled material
• c. Offers to supply any controlled material for reward
• d. Initiates or negotiates a reward for the supply of or for an offer to supply any controlled material
• e. The initiation or negotiation of arrangements like the management or the control of body of persons corporated or unincorporated.

Reward includes a financial or other material advantage.

Offence dealing with advertising and soliciting commercial dealings with human materials :

2. a person commits an offence if he causes to be published or distributed or knowingly publishes or distributes an advertisement;

• a. inviting persons to supply or offering to supply any controlled material for reward.
• b. indicating that the advertiser is willing to initiates or negotiates any such arrangement

In s 32 (7) HTA 2004 , reward does not apply to expenses incurred during removing, storing , or transporting the organ also it does not include loss of earnings of a person donating organ. payments can be made by a ‘proper authority’ e.g, NHS trust and not by recipients’ relatives ( HT Authority 2006:

Para 64)

The offences relate to the controlled material consists of human cells intended to be used in transplantation. it excludes gametes, embryos, or material which is subject of property because of an application of human skill s 32 (9) HTA 2004.an organ removed and preserved for later transplant may be the subject of property although arguable.

HT Authority under s 32 (3) can designate a person to lawfully engage in trade in human material e.g, National Blood Service is permitted to purchase blood from abroad.

Professional Guidance:

Sale of organs also involves a breach of professional guidance.

GMC guidance; the doctors must not participate or encourage the trade in human organs from live donors. they must not advertise nor make financial arrangements for people to buy or sell organs.

Doctor must satisfy himself of appropriate consent including the offer of a financial or material benefit. A doctor or any qualified professional must assess the donors’ motivation .

The Ethical Issues:

Autonomy is the starting point for the people advocating sale of organs. (Stacey Talyor 2005). If anyone wants to sell their organs without harm they should be permitted to do so ( Fabre 2006)

If the rich are free to involve in dangerous sports or jobs , why the poor are thought to be misguided and cannot sell kidney for greater rewards , savings relatives’ lives or extricating from poverty & debt ( Radcliff Richards et al 1998)

The Organ Selling Should Be Only Allowed For A Good Reason.

Arguments Against Permitting Organ Selling:

1. Gains for the rich :

wealthy will be able to purchase organs on the basis of wealth whereas poor will be on the disadvantage because of not having sufficient funds despite dire need. Harris and Erin 2002 suggested to allow NHS to purchase organs and distribute them on the basis of need. If the rich have access to quicker and higher quality medicine , then why they cannot buy organs ? an argument presented contrary to above discussion that NHS may not be effective to discourage black market in organs.

2. Vendors are coerced or do not validly consent to the sale of their organs

Opponents of organ trade argue that people stricken by abject poverty or debts are forced to sell their organs and thus their consent under desperation should be considered as invalid.

Supporters of organ trade that by making the market lawful , the market can be regulated by ensuring a genuine consent to donate , and whether people driven by poverty to organ selling can be described as coercion.

People are influenced by monetary benefits and do things which they might not do without money e.g, they work because of fear of poverty, re they acting with free will or coerced ?. Wilkinson 2003:118 refers to a survey in which 65 percent people questioned said that they would sleep with a complete stranger for one million pounds. Herring 2002:53 states that the courts will focus on the legitimacy of pressure to determine whether a person entered into a contract freely or under duress.

Another question arises is that allowing organ sale is to infringe individuals right of autonomy? Strange claim ; allowing organ selling is to increase options available to someone, thus some philosophers argue that an extra choice can inhibit autonomy. Hughes 1998 states that the choice is self defeating where it restricts their lifestyle choices. Boyle 1999 states that organ selling should be regarded as a phenomena which disrespects ones’ body or a way to gain financial position while also saving lives.

3. Exploitation

To allow the most impoverished people to sell their organs to combat financial situation is not a disaster ? Is it not an analogy b/w organ selling and slavery ?

Thomas Goerge states that the evolution of human civilisation witnessed many periods of gross human exploitation. today the sale of organs for financial considerations make human beings less valuable than others, this value system which permits sale of kidneys needs to be changed( George : 2005;1)

3. Bodily invasion :

To remove an organ is prima facie wrong as an invasion of bodily integrity. Wilkinson 2003b sees no countervailing good in the commercial sale of organs. Mason and laurie 2006 : 434 states that an act can be altruistic if a person sell his organs to obtain money for another persons’ benefit e.g, a child’s medical treatment. It must be rare to sale kidney to increase own happiness.

5. Public opinion:

The public opinion should match the strong opposition to the idea of organ selling. Guttmann and Guttmann 1993 conducted a survey which showed 40 – 50 percent people thought to be permissible to pay for organs. Feelings of disgust to deny treatment to the dying is the question of debate.

6. Commercialization Of The Body :

Bjorkmann 2007 argues that by allowing body parts to be bought or sold reduces our bodies to the status of cars or televisions. It resulted in devaluation of body and of human life. Cherry 1999 : 9 argues that the body is now considered as a collection of parts to be disposed at will. Wilkinsson 2003:107 sees a wrong in society where an advert for kidney sale appeared on e bay and was removed by the managers when the bidding reached 5.7 million dollars. But de castro 2003b argues the commercialization of the body is a hopelessly vague notion.

7. Harm To Altruism :

System of organ donation supports altruism. Keown 1997b believes that there is a danger this virtuous act of organ donation be replaced by a organ selling. Stephen Wilkinson does not believe that if there is payment so there is no altruism. People buy raffle tickets to support charity as well as of winning some amount. Herring (2005: 55) argues that the government provides tax benefits to donors and it does not undermine their altruism.

Arguments In Favour Of Permitting Organ Selling

1. Freedom :

Stacey Taylor 2005 argues that organ selling does no harm and it should be

permitted as it is a part of their autonomy. People sell hair, take part in

high risk sports, receive money for certain immoral or improper purposes so

why not organ selling be allowed.

2. It Increases The Number Of Organs Available For Transplant

Erin & Harris 2003 claims that by permitting organ selling , larger number of organs available and many lives can be saved. There are suggestions that people who donated organs in the past out of altruism may not like commercial transplantation. Radcliff Richards et al 1998 claims that by allowing a market will increase the number of organs available for transplant.

3. Avoids exploitation :

Permitted organ selling will avoid exploitation. donors in spite of being valuable source receive no payment. Larijani ,zahedi and ghafouri – fard (2004 : 2540) argues that the professionals involve will all receive payment but the organ provider will not. Hughes argues that organ selling supports dependency relations.

4. Avoids the black market :

Larijani argues that organ selling being illegal , there is underground organ market which is rampant. It work against the interest of vulnerable donors who do not complain about bad treatment for being prosecuted for an offence. De Castro 2003b argues that an organ market will ensure a fair price and protected health needs of donors.

A Middle View

although organ sales should be not be allowed but expenses of donors should be taken care of. Garwood – gower made the following suggestions:

• Right to fair compensation for the loss of material reasonably worth to the donor & for the pain , intrinsic & non intrinsic stemming form donation.
• Right to free medical care & regular check ups
• Right to fair compensation of time involved in donation
• Right to defrayment / reimbursement of reasonable costs of donation
• Right to compensation for discrimination stemming from having donated

The Living Body As Property

The Law :

Hardcastle 2007, herring and chau 2007 , dworkin and kennedy 1993, Mathews 1995 all academics discussed that whether our bodies can be said our property ?

Gage J accepted that English law was uncertain and unclear ( AB V Leeds teacing hospital NHS Trust 2004). There are certain aspects where the body can be treated as a property whereas in other respects cannot, there is no coherent picture.

Traditionally there is no property in human body according to common law (Doodgewood v Spence 1908 , confirmed recently in AB v Leeds TH NHS trust 2004), although the no property rule is largely obiter dicta : Magnusson 1998.

DoH 2002e supports the no property rule.

The find it difficult to find separated body parts or products as property. Hair acc to Director of public prosecutions v Smith 2006; R v Herbert , Blood acc to R v Rothery 1976 , Urine acc to R v welsh 1974 all are found to be property for the purposes of the theft act 1968.

Rv Kelly 1998 :

A technician at the royal college of surgeons removed body parts from the college and gave to an artist who used them as moulds for sculptures. The technician and artist were charged with theft but they argued not to be guilty on the basis that corpses and parts of corpses could not be property. The CA held that parts of corpse are capable of being property if they acquire different attributes by virtue of the application of skill, such as dissection or preservation techniques , for exhibition or teaching purposes. The body parts are preserved and used as specimens, therefore becomes property and the defendant committed theft. The CA went further and suggested that if parts attracted a use or significance beyond their mere existence, they could become property.

Dobson V Northern Tyneside Health Authority 1996 :

The relatives of a woman died of brain tumour sought to bring a negligence claim against the health authority for failing to diagnose the deceased condition. They found out that brain sample had been removed and disposed of, when they want a brain sample to establish their claim. The relatives brought a further claim in the tort of conversion claiming that they had no right of unauthorized disposal. The CA held that the relatives had no right of possession or ownership of brain or the corpse. An executor or administrator of a deceased person had a limited right to a corpse with a views to its burial or disposal. The next of kin did not have even that right.

The CA held that property rights could arise in respect of body parts where some work or skill differentiated it from its natural state.

Reliance was placed on the case ; Doodeward v Spence 1908 : where Grifith CJ held that where a person by lawful exercise of work or skill so dealt with a human body or a part of a human body in his lawful possession that It has acquired some attributes differentiating it from being a mere corpse awaiting burial, he acquires the right to retain its possession , at least as against any person not entitled to have it delivered to him for the purposes of burial.

The exercise of skill remains undecided in these cases as which skills made corpse a property. The exercise of skill in dissection or preservation may well be sufficient.

In AB v Leeds TH NHS trust , the parents could claim no kind of property rights attached to their children during post mortem. Skene 2002 argues that the executors of a hospital can claim lawful possession of a corpse, even though it can not be owned.

Margret brazier 2003a:563 states that the deceased did not own their body and could not bequeath it t