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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 to their estate. The estate could claim the body for decent disposal although may not acc to deceased’s wishes. Parts are taken from the body with either deceased’s or family’s approval. By the of medicine on body parts , they become property owned by persons unknown and for unseen purposes. this is not a good law acc to brazier.

Commercialization & Body : Ethical Issues

Moore v regents of the university of Californian 1990 :

John Moore suffering from hairy cell leukaemia , had his spleen removed by Dr Golde who developed a cell line from it and eventually sold it for $ 15 million and the products developed resultantly worth billion of dollars. His research was carried out with Moore’s consent or knowledge.

Moore brought a claim based on conversion; breach of fiduciary duty and informed consent. The California supreme rejected the conversion claim declaring that there is no precedent to recognise property rights in human bodies and is inappropriate to recognise now as it might hinder medical research by restricting access to raw materials and lead to a litigation lottery. they accepted Moore’s claim of breach of fiduciary duty.

Justice Mosk gave a dissenting opinion that the law at least recognise Moore’s right to do it with his own tissue whatever the defendants(including doctor & the university) did with it i.e, he could have contracted to develop & exploit the vast commercial potential of his tissue & its products.

Summarized Views:

1.We own our bodies. individuals have control over their bodies even when they are remove. It is possible to sell, bail, or loan body parts. A person can seek the return of wrongfully taken part. The profit made made from a body part without consent can be

compensated.

2. Munzar 1994 argues to regard the body as property is demeaning to the body. Some things are too precious to be owned. Brazier 2003a: 479 states that principles that govern bodies are consent , dignity and respect. Brownsword 2003c discussed the need to focus on the rights of autonomy or the rights of dignified treatment rather than property rights.

3. To constitute property an item should have certain characteristics and be subject to certain kinds of treatment. As bodies are neither divisible nor transferable, they can be treated as property. Harris 1996 : 59 states although we feel that we own our bodies but they cannot be regarded as property as the term understood in property law.

Q3. Intellectual Property

The Law :

If a person makes an invention he can seek a patent to protect his discovery. The patent will prevent anyone else marketing a product using that invention for up to 20 years without patent holders’ permission but the invention must have novelty.

Patenting body parts or genetic materials : the EU law on this is governed by the EC directive on the legal protection of Biotechnical Inventions 98 / 44 / EC and the European patent convention 2000.

Article 5 of the directive states:

1. The human body ,at various stages of its formation and development , and the simple discovery of its elements , including the sequence or partial sequence of a gene , cannot constitute patentable inventions.
2. An element isolated from the human body or otherwise produced by means of a technical process , including the sequence or partial sequence of a gene , may constitute a patentable invention , even if the structure of that element is identical to that of a natural element.
3. The industrial application of a sequence or partial sequence of a gene must be disclosed in the patent application.

The EU patent convention (EPO)1973 which governs a patent in Europe can refuse a patent , if publication or exploitation of the invention would be contrary to morality.

Harvard / ONC mouse 1990, sought to patent a mouse which was genetically engineered with a human cancer gene means that the mouse would inevitably develop cancer. It was argued that EU patent should not be granted because of the suffering of the animal which was rejected as the potential cure of cancer was good enough to outweigh the harm to the mouse. It was also argued that EPO did not permit patents in respect of plant and animal varieties , and mouse was argued not to be an animal variety and thus not caught by this prohibition. Mason and laurie 2006 : 465 argued that the decisions were influenced more by the policy concerns of making Europe an attractive place to do research than a proper consideration of moral issues. The EPO states that the patent would not have been granted , had the mouse been developed to establish a cure for hair loss.

Howard Florey / Relaxim 1995 : H2 Relaxin is a protein produced naturally by women during childbirth. A company artificially produced this protein and sought to patent it which was subsequently granted. Arguments to support exploitation and an offence to human dignity were rejected on the basis that only women who consented were required to supply the material. Argument that DNA is life and therefore could not be patented , the reply was that DNA is not life but a chemical substance which contains genetic information. The patent was allowed as no woman was affected in any way by the present patent.

Directive of EU parliament and of The Council on the Legal Protection of Biotechnological Inventions no 98/ 44/ EC (July 6, 1998) covers biotechnical patents. it is in general terms. It was challenged as being so vague to infringe principle of legal certainty, the claim was rejected in Netherlands v European parliament 2002. Even if the product has moral questionability is permitted if there is substantial medical benefit to humanity or animals.

In English law patenting of human material is permissible if :

1. There is sufficient novelty and inventive step
2. The patent is not objectionable on moral grounds

Are Patents Necessary To Encourage Research And Development ?

In 2000 £ 70 billion was made from biotechnological industry worldwide and in UK alone £ 9 billon was made according to DTI 1999 : 2.1. The law of patents is meant to ensure a person or a company which puts in time, energy, research and money to discover a new drug to reaps the reward for the discovery against stealing or copying by some other person or company. The company can enjoy monopoly for the discovery for about 20 years.

Nuffield Council on Bioethics 2002 argues that by giving monopoly over production there is no control over prices and an extortionate sum can be charged or even a company may decide not to produce the drug at all. BBC Newsonline 2004 reported that HIV / AIDS medication is available to only 440,000 in Africa of the 6 million people.

The charity Medicines Sans Frontiers reported on patents and medicines and suggest that patents for 18 essential medicines are providing barriers to those who need medicine in the developing world.

Inhibition Of Future Research :

Heller and Eisenberg 1998 showed concerns that a patent over a crucial technique can restrict access to it. In biotechnological area, many advances in medicines have used combination of previously well known medicines or the application of well known medicines in a new way. The patent system acts to prevent companies trying new companies of established drugs or using them in new ways.

The BMA 2001b:1 states that :

To gain maximum benefit for society , some patenting of genetic research may be appropriate and desirable. By setting the threshold too low would result in too much being protected but setting it too high would be equally damaging by failing to protect some key inventions.

Immorality Of Patenting Life :

In area of patenting and biotechnology , ethical considerations should be considered. The Canadian biotechnology advisory committee on patenting of higher life forms suggested :

1. Patent law should be concerned with economic considerations. Ethical or social concerns were better dealt with by regulation or the criminal law acc to Laurie 1997.
2. Patent system largely concerned with economic forces , although it has limited ability to address some ethical issues.
3. Ethical and social matters should be given equal consideration when considering patents. Overall social good should be the prime objective of the patent system.
4. There should be absolute bar on patents over higher life forms or other sensitive biotech areas even if economic factors come into play.

Q: Organ Transplant

Organ Transplant :

1. Live organ donation : an organ taken from the a live person and given to another.
2. Cadaver organ donation : an organ taken form person shortly after death and transplanted to another.
3. Xenotransplantation : an organ taken from another animal and used in a human.
4. Genetically created organs : an organ created in a laboratory from a person’s own genetic material, used to be placed in a person.
5. Artificial organ : some work is being done to create robotic / mechanical organs for transplant , with some success acc to BBC Newsonline 2005.

Medical problems regarding organ transplant :

1. Rejection of the transplanted organ by the host : it is a natural reaction of a body to reject tissue which is not genetically belong to the host which might be controlled by medicine to some extent. Xenotransplantation causes particular problems in this regard.
2. The donated organs must be healthy: it is desirable to remove organ from the donor as soon as possible after death to ensure they are usable. UK Transplant 2007 reported 41% of relatives refuse to consent to transplantation when approached shortly after the death of a person.
3. The organs must be preserved b/w the time of removal and the time of being placed into the recipient.

Living Donors : The law

If a living donor wishes to donate regenerative tissue ( e.g, blood or bone marrow) there are few legal or ethical objections to this. There has been increase in the number of live kidney donors and these now represent a quarter of all kidney donation ( UK Transplant 2007). The main legal issue is about the genuine consent to the donation.

(kidney , liver, heart etc : non regenerative tissue )

Main Legal Principles :

1. It is not permissible to consent to a procedure which causes death or injury acc to Law commission consultation paper 139 (1995 : para 8.32)
2. There must be consent to the procedure. The donor must understand fully the process involved. In case of an incompetent patient the donation will be permitted only if it is in the donor’s interests.
3. The procedure must be permissible under the Human Tissue Act 2004. HT Authority 2006b provides an accessible summary of the law.

S 33 HTA 2004 states:

1. Subject to subsections 3 & 5 , a person commits an offence if

1. He removes any transplantable material from the body of a living person intending for transplantation
2. When he removes the material , he knows or might reasonably be expected to know that the removed material from the person is alive.

2. Subject to ss 3 & 5

1. Use of any transplantable material which has come from the body of a living person
2. He knows or reasonably expected to know that the transplantable material has come from the body of a living person.

3. The SoS may by regulation provide that ss 1 & 2 shall not apply in a case where :

1. The authority is satisfied that no reward has been or is to be given in contravention of s 32 or that such conditions specified in regulations are satisfied.
2. Such other conditions as specified in the regulations are complied with.

The Removal And Use Of Organs Can Be Lawful If :

1. There are no payments
2. The regulations required by HT Authority have been satisfied.

There are two further requirements :

1. The organ must not subject to commercial dealing of the kind prohibited by s 32 HTA 2004.
2. The HT Authority will issue regulations concerning live donations. The code of practice provides a list of issues to be discussed with the proposed donor including the risks involved in the donation that there is no guarantee that the recipient will benefit from the organ. Where the donor is genetically or emotionally related to the recipient ,must be given necessary information , met with clinician and independent assessor, the donation can go ahead without specific approval of the HTA , where the donor is not emotionally or genetically attached , approval from HTA panel is required HT Authority 2006b. The code suggests a psychiatrist must meet with the donor and ensure a genuine consent.

Organ Transplant From The Dead :

S1 HTA 2004 permits the removal , storage and use of organs for transplantation from a deceased person as long as there is appropriate consent.

S3 HTA 2004 defines appropriate consent

The following questions are important to consider :

1. Has the deceased made a decision whether or not to consent to the transplant which was in force immediately before her / his death ?

The decision can be oral or in writing (there are no formal requirements ; no need to consent in writing)

The deceased’s decision must be respected and his family cannot override those wishes acc to HT Authority 2006d : para 47

2. If the deceased has not left any views : has the deceased nominated a representative to make decisions ?

S 4 HTA 2004 sets out circumstances in which nomination can be made whether orally or in writing. Oral consent must be made in presence of two or more witnesses and if in writing it must be signed and witnessed.

According to s 4 (10) HTA an adult representative can make the decision regarding transplant.

Acc to s 4 (9) HTA 2004 the nominated representative can renounce his/her appointment.

Acc to s 4(6) HTA 2004 the consent of only one nominated representative is necessary if two or more people are nominated unless the terms of the agreement suggest that they have to act jointly.

3. If the deceased has not made a decision and not nominated a representative or the representative is not able to give consent then the person in closest qualifying relationship to the deceased immediately before her/his death can make the decision acc to s 3 (6) HTA 2004.

S 27 (4) HTA2004 ranks the qualifying relationship in the following order:

1. Spouse or partner
2. Parent or child
3. Brother or sister
4. Grandparent or grandchild
5. Child of a person within para ( c)
6. Stepfather or stepmother
7. Half-brother or half-sister
8. Friend of longstanding

The person who is the highest up the list immediately before the death of the deceased can make a decision

Acc to s 9 (4)HTA 2004 it is sufficient to obtain consent of any one of two or more persons concerning the deceased who accorded equal ranking.

S5 (1) & (7) HTA 2004 defines the criminal offence attracting a maximum prison of 3 years if a surgeon performs an organ transplant from a deceased person without the necessary consent.

S5 (1)(b) HTA 2004 provides a defence if the person concerned reasonably believed that the appropriate consent had been given.

Refrences:

Medicine Patients And The Law : Margret Brazier & Emma Cave

Medical law : John Herring

Human Tissue Act 2004