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A Guide to the Human Tissue Act 2004

Dr Jane Kaye

1. When is it in force?

The Human Tissue Act was passed by Parliament on 15th November 2004. The Act repeals the following Acts in England and Wales:

(a) Human Tissue Act 1961,

(b) Anatomy Act 1984,

(c) Corneal Tissue Act 1986,

(d) Human Organ Transplants Act 1989.

The Secretary of State must make an order by statutory instrument stating when the various sections of the Act come into effect. This has not been done yet and full implementation is not expected to be before April 2006.

2. What does the act cover?

The Act covers the removal, storage, and use of ‘relevant material’ from deceased persons and also human organs for transplant. However when it comes to living persons the Act only regulates the storage and use of ‘relevant material’. The removal of tissue from living persons will still be covered by common law principles, which makes it an offence to interfere with a person’s body without consent. The Act makes it unlawful to use bodies or human material once donated for purposes other than those set out in the Act and establishes penalties for non-compliance.

3. What is ‘relevant material’?

The Act only applies to ‘relevant material’ that is defined as ‘material other than gametes, which consists of or includes human cells.’ [1] Excluded from this definition are embryos outside the human body, or hair or nail from the body of a living person. [2] This definition means that a blood or tissue sample is regulated by the Act because it ‘consists of or includes human cells’. However once DNA is isolated and extracted from the blood or tissue, the DNA would not fall under this definition as it does not ‘consist of or include human cells’. The Act has a number of provisions that relate specifically to the analysis of DNA (see in particular s. 45). The Act also does not apply to ‘relevant material’ that is used or stored in connected with a device to which the Directive 98/79/EC on in vitro diagnostic medical devices applies. Genetic testing devices will fall within this Directive and so the ‘relevant material’ that they tested on, are not regulated by the Act.

4. What activities are lawful?

The Act stipulates the activities that can be undertaken with regard to human material and bodies. These activities can only be undertaken for specific purposes (e.g. research) which are listed in Schedule 1 of the Act. Not all activities can be carried out for all purposes and there are essentially four different groupings. ‘Appropriate consent’ is needed for all activities unless an exemption applies (see below).

a) Activities allowed for all lawful purposes specified under all Parts of Schedule 1

The following activities will be lawful as long as there is ‘appropriate consent’ under section.1 of the Act:

a) the storage of the body of a deceased person (excluding anatomical examination) [3]

b) the removal from the body of a deceased person of any ‘relevant material’ of which the body consists or which it contains. [4]

These activities may only be carried out for the following purposes:

1. Anatomical examination.

2. Determining the cause of death.

3. Establishing after a person’s death the efficacy of any drug or other treatment administered to him.

4. Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person).

5. Public display.

6. Research in connection with disorders, or the functioning, of the human body.

7. Transplantation.

8. Clinical Audit.

9. Education or training relating to human health.

10. Performance Assessment.

11. Public health monitoring.

12. Quality Assurance.

b) Activities allowed only for the purposes specified in Part 1 of Schedule 1

The following activities will be lawful as long as there is ‘appropriate consent’ under s.1 of the Act (unless an exemption applies):

a) the storage for use of any ‘relevant material’ which has come from a human body. [5]

b) the use of any ‘relevant material’ which has come from a human body. [6]

These activities can only be carried out for the following purposes which are listed under Schedule 1, Part 1 of the Act:-

1. Anatomical examination.

2. Determining the cause of death.

3. Establishing after a person’s death the efficacy of any drug or other treatment administered to him.

4. Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person).

5. Public display.

6. Research in connection with disorders, or the functioning, of the human body.

7. Transplantation.

c) Activities allowed only for the purposes specified in Part 2 of Schedule 1

The following activities will be lawful as long as there is ‘appropriate consent’ under s.1 of the Act (unless an exemption applies):

a) the storage for use of any ‘relevant material’ which has come from the body of a deceased person. [7]

b) the use of any ‘relevant material’ which has come from the body of a deceased person. [8]

These activities can only be carried out for the following purposes which are listed under Schedule 1, Part 2 of the Act:-

8. Clinical Audit.

9. Education or training relating to human health.

10. Performance Assessment.

11. Public health monitoring.

12. Quality Assurance.

d) Activities that are specified in the Act

d) the use of the body of a deceased person for a purpose so specified, other than anatomical examination. [9]

5. What is ‘appropriate consent’?

The Act requires that all removal and use of tissue should be carried out with ‘appropriate consent’. However there are subtle variations as to what constitutes ‘appropriate consent’ depending whether the person is an adult, child, incapacitated, living or deceased. The requirements for consent (in terms of the type of information needed to be given to individuals for example) is not defined in the Act but will be determined in the Codes of Practice to be issued by the Human Tissue Authority when it is established. [10] ‘Qualifying consent’ applies to the analysis of DNA (see Schedule 4 of the Act). The provisions for ‘appropriate consent’ are as follows:-

a) Adults

i) Living Adults

For adults that are alive, where the activity involves the body or material from the body, ‘appropriate consent’ is consent that comes from him/her [11]. An adult can also appoint one or more persons to represent him and to give consent on his behalf after his death either under an oral or written appointment. [12]

ii) Deceased Adults

For deceased adults, where human tissue involves storage for use or use for the purposes of public display or anatomical examination there must be consent in writing. [13] For anatomical examination there must also be registration of the death or the signing of a death certificate. [14] However for all other activities the Act merely requires that there must be ‘a decision of his to consent to the activity, or a decision of his not to consent to it’, [15] which must have been in force immediately before he died. Note: this is a decision to consent to the activity rather than a formal consent. Where the person concerned has died and he has not made a decision, a representative can make the decision as long as this appointment of the representative has been made according to the requirements of s.4 of the Act. This appointment can be made orally or in writing with appropriate witnesses or under a will. [16] If the person has not appointed a representative then the person who stood in a qualifying relationship to him immediately before he died can give consent (see below). Section.27 (4) establishes who will be considered to be in a qualifying relationship). [17]

e) Children

i). Living children

When a child is alive ‘appropriate consent’ means his consent. [18] This will be defined by the Human Tissue Authority. The Act also allows a person who has parental responsibility to make a decision on behalf of a child in cases where the child has not made a decision to consent to the activity, because the child is not competent to make a decision, or even though competent, the child has not made a decision. [19]

ii). Deceased children

Where the child has died (and the material and body will not be used or stored for public display or anatomical examination), then a decision of the child (rather than a formal consent) not to consent to the activity or to consent to the activity, will constitute ‘appropriate consent’. [20] A parent or someone in a qualifying relationship can consent on behalf of the child if the child has not made a decision when he/she was alive. [21] If the ‘relevant material’ and/or the body will be used and stored for public display and anatomical examination then the child’s consent is required in writing. [22]

f) Incapacitated Persons

If an incapacitated adult has not made a decision to consent, or not to consent, to the use or storage of ‘relevant material’, there will be deemed consent if it is done in circumstances that have been specified in regulations made by the Secretary of State. [23] These regulations will dovetail with the requirements of the Mental Capacity Act 2004.

g) Qualifying Relationships

Under the Act the following relationships will be considered ‘qualifying relationships’. They are ranked according to where they are on the following list:-

(a) spouse or partner;

(b) parent or child;

(c) brother or sister;

(d) grandparent or grandchild;

(e) child of a person falling within paragraph (c);

(f) stepfather or stepmother;

(g) half-brother or half-sister;

(h) friend of longstanding. [24]

6. Exemptions from consent

There are eight situations detailed in the Act where it is lawful that there is an exemption from consent requirements for the storage and use of ‘relevant material’ and bodies. In these situations consent would not need to have been obtained from the individual or their representatives.

a) Human Tissue Authorities power to dispense with consent

There are two situations when the Human Tissue Authority can dispense with consent. The first is when it is not possible to trace the donor of the material and the second is when someone has not made a decision.

i). Untraceable Donor

If it is not reasonably possible to trace the donor of the material the Human Tissue Authority may direct that there is consent for the use of the material. However this only applies if the Human Tissue Authority is satisfied that:

  • The ‘relevant material’ has come from the body of a living person.
  • That it is not reasonably possible to trace the person from whose body the material has come (“the donor”).
  • It is in the interests of another person to obtain scientific or medical information about the donor and
  • There is no reason to believe that the donor has died; or that the donor has made a decision not to consent to the use of that material for that purpose; or that the donor lacks capacity to consent to the use of material for that purpose. [25]

ii). Undecided Donor

If ‘reasonable efforts have been made to get the donor to decide whether to consent to the use of material for that purpose’ the Human Tissue Authority may direct that there is consent for the use of the material. However this only applies if the Human Tissue Authority is satisfied that:

  • The ‘relevant material’ has come from the body of a living person.
  • That reasonable efforts have been made to get the donor to decide whether to consent to the use of the material for that purpose.
  • It is in the interests of another person to obtain scientific or medical information about the donor.
  • There is no reason to believe that the donor has died; or that the donor has made a decision not to consent to the use of that material for that purpose; or that the donor lacks capacity to consent to the use of material for that purpose and
  • The donor has been given notice that the Human Tissue Authority has been asked to give such a direction [26]

b) High Court Order

The Secretary of State can make regulations that would enable the High Court to make an order deeming that there is ‘appropriate consent’ for ‘research purposes in connection with disorders, or the functioning of the human body’. [27] Such orders could cover:

  • The storage of a deceased person.
  • The use of the body of a deceased person and the removal of ‘relevant material’ from the body of a deceased person.
  • The use and storage for use of any ‘relevant material’ from a human body. [28]

c) Storage for Research Purposes

Consent is not required under s.1 (7) for the storage of ‘relevant material’ for use for the purpose of research in connection with disorders, or the functioning, of the human body if:-

  • the material comes from the body of a living person. [29]
  • the research has been ethically approved in accordance with regulations made by the Secretary of State [30] and
  • the person from whom the material comes cannot be identified. [31]

d) Activities where consent not required

‘Appropriate consent’ is not required for the storage [32] or use of material [33] that is for clinical audit, education and training relating to human health, performance assessment, public health monitoring, or quality assurance. [34] According to the Explanatory Notes of the Act this would include ‘evaluations of in-vitro diagnostic devices’. Note: ‘in-vitro diagnostic devices’ are covered by Directive 98/79/EC and would include genetic tests. and therefore…….

e) Surplus Tissue

It is lawful for material that has come from a person’s body in the course of receiving medical treatment, undergoing diagnostic testing or participating in research to be dealt with as waste. [35] This applies to any ‘relevant material’ that has come from a human body and ceases to be used or stored for use for a purpose specified in Schedule 1 [36]. And the implications…

f) Importation

As long as the activities are lawful under the Act, then consent is not required for a body that has been imported, [37] or ‘relevant material’ that has been imported [38] (whether it comes from a living or dead person) or if ‘relevant material’ has come from a body that has been imported. [39] These exemptions from consent also apply to material or bodies where the person was dead before the Act comes into force or in cases where 100 years have lapsed since the person’s death. [40] However the Act does not allow material or bodies to be exported then imported to take advantage of this provision and this is expressly prohibited under s.1 (13).

g) Existing Holdings

‘Existing holdings’ are defined as the body of a deceased person or ‘relevant material’ which has come from a human body that was held immediately before s.1 (1) of the Act comes into force, for a use specified in Schedule 1 of the Act. [41] ‘Appropriate consent’ is not necessary for the use or storage of existing holdings as long as they are used for the purposes specified under Schedule 1 of the Act [42] and as long as they are not anatomical specimens. [43] The Code of Practice to be issued by the Human Tissue Authority will deal with the storage, use and disposal of existing holdings. [44]

h) Coroners Activities

The functions of the Coroner under exempt from the requirements of this Act.

7. Offences

The Act provides 5 situations where the use or storage of relevant material will constitute an offence if it is carried out without consent. The most detailed provisions are for the offence of analysing DNA without consent, however, there are a number of exceptions. Under the Act the following actions will constitute an offence under the Act and a person found guilty will be liable to either a fine, imprisonment or both. [45]

a) Failure to obtain ‘appropriate consent’

If an activity specified under the Act is carried out without ‘appropriate consent’, it will be an offence unless ‘the person reasonably believes that he does the activity with ‘appropriate consent’, or that what he does is not an activity to which the subsection applies’. [46] For example this may apply to laboratory scientists who are sent DNA samples to test but have no contact with the patient and so may ‘reasonably’ believe that the appropriate consent has been given by the patient.…

b) False representation

It will be an offence if an individual falsely represents that there is ‘appropriate consent’ or that the activity is a ‘lawful activity’ to a person who is going to, or may do, an activity. [47] The person making the statement must know that the representation is false or does not believe it to be true.

c) Failure to obtain a death certificate

It is an offence to store or use a body for anatomical examination without a signed certificate as to the cause of death, [48] unless the person believes that there is a death certificate, [49] or what he does is not an activity covered by the Act.[50]

d) Donated material

A person who uses or stores donated material (the body of a deceased person or material that has come from a human body and is donated), for purposes other than those specified under the Act, can be liable for an offence, unless the person reasonably believes that it was not donated material. [51] The specified purposes that lawful are:

  • the purposes detailed in Schedule 1;
  • medical diagnosis or treatment;
  • decent disposal;
  • for purposes specified in regulations made by the Secretary of State.[52]

e) Analysis of DNA without consent

A person commits an offence if:

  • he has any ‘bodily material’ (material that has come from a human body, and consists of or includes human cells [53] ) intending that any human DNA in the material be analysed without ‘qualifying consent’ and
  • that the results of the analysis be used otherwise than for an ‘excepted purpose’.

Therefore in order to be prosecuted for this offence there must be an intent that the DNA be analysed without ‘qualifying consent’ and that the results must be used for purposes other than those listed as an ‘excepted purpose’ as stated in the Act. A person guilty of an offence under this section is liable for a fine, or imprisonment or both. [54] For the purposes of this offence ‘qualifying consent’ and ‘excepted purpose’ are defined as follows:-

i). ‘Qualifying Consent’

Adults

In the case of adults ’qualifying consent’ means his consent, unless the person is deceased. In the case of a person who has died an adult, a decision (rather than a formal consent) either not to consent or to consent will constitute ‘qualifying consent’. [55] If there was no decision made by the deceased then ‘qualifying consent’ can be given by someone who is in a qualifying relationship (see above) with the deceased. [56]

Children

In the case of a living child, a person who has parental responsibility can consent on behalf of the child. This is if the child has not made a decision to consent or not to consent to the activity, because the child is not competent to make a decision, or even though competent, the child has failed to make a decision. [57] In the case of a deceased child a decision of the child (rather than a formal consent) not to consent to the activity or to consent to the activity, will constitute ‘appropriate consent’. [58] Someone with parental responsibility or in a qualifying relationship can consent on behalf of the child if the child has not made a decision when they were alive.

ii). ‘Excepted purpose’

Under the Act there are 5 activities which come under the ‘excepted purposes’ exemption, allowing DNA to be analysed without consent and for this not to be an offence.

a) General applications

The results of an analysis of DNA can be used for the following excepted purposes:-

(a) the medical diagnosis or treatment of the person whose body manufactured the DNA;

(b) purposes of functions of a coroner;

(c) purposes of functions of a procurator fiscal in connection with the investigation of deaths;

(d) the prevention or detection of a crime;

(e) the conduct of a prosecution;

(f) purposes of national security;

(g) implementing an order or direction of a court or tribunal, including one outside the United Kingdom. [59]

b) Research in connection with disorders, or functioning, of the human body

Under s.6(1) of Schedule 4 the Secretary of State may by regulations specify circumstances in which the High Court may order that research in connection with disorders, or the functioning of the human body can apply to bodily material.

c) Purposes relating to existing holdings

The results of an analysis of DNA can be used for the following ‘excepted purposes’ if the bodily material concerned is an existing holding, (which is the body of a deceased person or ‘relevant material’ which has come from a human body that was held immediately before s.1(1) of the Act comes into force [60]):-

(a) clinical audit;

(b) determining the cause of death;

(c) education or training relating to human health;

(d) establishing after a person’s death the efficacy of any drug or other treatment administered to him;

(e) obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person);

(f) performance assessment;

(g) public health monitoring;

(h) quality assurance;

(i) research in connection with disorders, or the functioning, of the human body;

(j) transplantation.

Note that epidemiology is not included in this list.

d) Purposes relating to material from body of a living person

Under this section there are 5 situations when ‘bodily material’ from a living person and the DNA derived from it can be used without consent and will not constitute an offence. These are for general purposes; under a direction of the Human Tissue Authority for the benefit of another person; for research purposes; for a purpose authorised under s1 (1) of the Act; for purposes relating to an adult who does not have the capacity to consent.

i) General purposes

If bodily material is from the body of a living person and DNA is analysed from it, then use of the results of an analysis of DNA for any of the following purposes is use for an ‘excepted purpose’ -

(a) clinical audit;

(b) education or training relating to human health;

(c) performance assessment;

(d) public health monitoring;

(e) quality assurance. [61]

ii) Direction or Order

These provisions mirror the provisions that apply to ‘bodily material’ under s.7 of the Act. A direction can be obtained from the Human Tissue Authority (or in Scotland an order from the Court of Sessions) to analyse the DNA in the ‘bodily material’ for the purpose of obtaining scientific or medical information about the person whose body manufactured the DNA. This will be considered use for an ‘excepted purpose’ and therefore consent is not required in the following situations:-

a) If someone cannot be traced

If the Human Tissue Authority gives a direction that DNA in the ‘bodily material’ be used for the purpose of obtaining scientific or medical information about the person, whose body manufactured the DNA, be used for the benefit of someone else, then this will be an ‘excepted purpose’ under the Act. However this can only be done if the Authority is satisfied-

(a) that bodily material has come from the body of a living person,

(b) that it is not reasonably possible to trace the person from whose body the material has come (“the donor”),

(c) that it is desirable in the interests of another person (including a future person) that DNA in the material be analysed for the purpose of obtaining scientific or medical information about the donor, and

(d) that there is no reason to believe-

(i) that the donor has died,

(ii) that a decision of the donor to refuse consent to the use of the material for that purpose is in force, or

(iii) that the donor lacks capacity to consent to the use of the material for that purpose. [62]

b) If the donor has not made a decision

If the Human Tissue Authority gives a direction that the DNA in the ‘bodily material’ be used for the purpose of obtaining scientific or medical information about the person, whose body manufactured the DNA, be used for the benefit of someone else, then this will be an ‘excepted purpose’ under the Act. However this can only be done if the Authority is satisfied-

(a) that bodily material has come from the body of a living person,

(b) that it is desirable in the interests of another person (including a future person) that DNA in the material be analysed for the purpose of obtaining scientific or medical information about the person from whose body the material has come (“the donor”),

(c) that reasonable efforts have been made to get the donor to decide whether to consent to the use of the material for that purpose,

(d) that there is no reason to believe-

(i) that the donor has died,

(ii) that a decision of the donor to refuse to consent to the use of the material for that purpose is in force, or

(iii) that the donor lacks capacity to consent to the use of the material for that purpose, and

(e) that the donor has been given notice of the application for the exercise of the power conferred by this sub-paragraph. [63]


iii) Research Exemption

Use of the results of an analysis of DNA for the purpose of research in connection with disorders, or the functioning, of the human body is use for an excepted purpose if-

(a) the bodily material concerned is from the body of a living person,

(b) the research is ethically approved in accordance with regulations made by the Secretary of State, and

(c) the analysis is to be carried out in circumstances such that the person carrying it out is not in possession, and not likely to come into possession, of information from which the individual from whose body the material has come can be identified. 64


iv) Purpose authorised under section 1

Use of the results of an analysis of DNA for a purpose specified in paragraph 7 is use for an ‘excepted purpose’ if the use in England and Wales, or Northern Ireland, for that purpose of the bodily material concerned is authorised by section 1(1) or (10)(c) (anatomical examination). [65]

v) Purposes relating to DNA of adults who lack capacity to consent

The Secretary of State can specify in regulations the purposes for which DNA may be analysed for adults that lack the capacity to consent. Use of the results of an analysis of DNA for a purpose specified under the regulations is use for an excepted purpose if-

(a) the DNA has been manufactured by the body of a person who-

(i) has attained the age of 18 years and, under the law of England and Wales or Northern Ireland, lacks capacity to consent to analysis of the DNA, or

(ii) under the law of Scotland, is an adult with incapacity within the meaning of the Adults with Incapacity (Scotland) Act 2000 (asp 4), and

(b) neither a decision of his to consent to analysis of the DNA for that purpose, nor a decision of his not to consent to analysis of it for that purpose, is in force. [66]

d) Power to amend paragraphs 5, 7 and 8

The Secretary of State may by order amend, vary or add to the paragraphs in this Schedule that relate to the purposes of general application (para.5); purposes relating to existing holdings (para. 7) or the purposes detailed in para.8.

8. Regulation of Activities

a) The Human Tissue Authority

The Human Tissue Authority will be established to oversee the removal, use, storage, import and export and disposal of ‘relevant material’ and bodies. [67] The Human Tissue Authority must provide Codes of Practice and guidance; ensure compliance with the Act; monitor developments and advise the Secretary of State [68]. However if a Code of Practice is not followed this shall not of itself render the person liable to any proceedings [69]. The Human Tissue Authority has the power to issue, revoke, review and suspend licenses as well as stipulate the conditions that apply to individual licences. The Human Tissue Authority has powers of inspection, entry, search and seizure, which are detailed in Schedule 5 of the Act.

b) Licences

The Human Tissue Authority has the authority to issue licences for lawful activities under the Act. A licence is not required for the body of a person who died before the day on which this section comes into force, or to material which has come from the body over a person who died over a hundred years ago. This excludes many museum collections from the licence requirements. Storage for transplantation is also excluded for the licence provisions. The current situation is that it is prohibited to carry out the following activities unless the Human Tissue Authority has issued a licence:-

(a) the carrying-out of an anatomical examination;

(b) the making of a post-mortem examination;

(c) the removal from the body of a deceased person (otherwise than in the course of an activity mentioned in paragraph (a) or (b)) of ‘relevant material’ of which the body consists or which it contains, for use for a scheduled purpose other than transplantation;

(d) the storage of an anatomical specimen;

(e) the storage of the body of a deceased person, or ‘relevant material’ which has come from a human body,

(f) the use, for the purpose of public display, of the body of a deceased person, or ‘relevant material’ which has come from the body of a deceased person. [70]

Therefore a licence would be required for storage of ‘relevant material’ from a living person but not for the use of ‘relevant material’ derived from a living person. The Secretary of State may also make regulations to exempt the storage of ‘relevant material’ by a person who intends to use it for a scheduled purpose from the need to obtain a licence [71]. These regulations have not been made as yet, but the Act can authorise the Secretary of State to do so in the future.

This Guide to the Human Tissue Act 2004 is provided for information purposes only and does not constitute legal advice. Professional legal advice should be obtained before taking or refraining from any action as a result of the contents of this document.

Dr Jane Kaye
Oxford Genetics Knowledge Park
Ethox Centre
University of Oxford
Old Road Campus
Headington
Oxford OX3 7LF

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References

  • 1. s.53 (1)
  • 2. s.53 (2)
  • 3. s.1(1)(a)
  • 4. s.1(1)(c)
  • 5. s.1(1)(d)
  • 6. s.1(1)(f)
  • 7. s.1(1)(e)
  • 8. s.1(1)(g)
  • 9. s.1(1)(b)
  • 10. s.26(3)
  • 11. s.3 (2)
  • 12. See s.4.
  • 13. s.3 (3)
  • 14. See s.1 (2) and (3)
  • 15. s.3 (6)
  • 16. s.4
  • 17. s.3(6)b)
  • 18. s.2 (2)
  • 19. s.2 (3)
  • 20. s.2(7)(a)
  • 21. s.2(7)(b)
  • 22. s.2(5) and (6)
  • 23. s.6
  • 24. s.27(4)
  • 25. s.7(1)
  • 26. s.7(2)
  • 27. s.7(4)
  • 28. s.7(4)
  • 29. s.1(8) (a)
  • 30. s.1(9) (a)
  • 31. s.1(9) (b)
  • 32. s.1 (10)(a)
  • 33. s.1 (10)(b)
  • 34. s.1 (10)
  • 35. s.44(1) and (2)
  • 36. s.44(3)
  • 37. s.1 (5)(a)v
  • 38. s.1 (6)(a)
  • 39. s.1 (6)(b)
  • 40. s.1 (5)(b) and s.1(6)(c)
  • 41. s.9(4)
  • 42. s.9(1)
  • 43. s.9(2)
  • 44. s.26
  • 45. s.5(7)
  • 46. s.5(1)
  • 47. s.5(2)
  • 48. s.5(3)
  • 49. s.5(5)
  • 50. s.5
  • 51. s.8(2)
  • 52. s.8(4)
  • 53. s.45(5) Note: Bodily material is excepted if -
    (a) it is material which has come from the body of a person who died before the day on which this section comes into force and at least one hundred years have elapsed since the date of the person’s death,
    (b) it is an existing holding (bodily material held immediately before the day on which this section comes into force) and the person who has it is not in possession, and not likely to come into possession, of information from which the individual from whose body the material has come can be identified, or
    (c) it is an embryo outside the human body.
  • 54. s.45(3)v
  • 55. Schedule 4 para.2(3)(a)
  • 56. Schedule 4 para.2(3)(b)
  • 57. Schedule 4
  • 58. Schedule 4 para.2(4)
  • 59. Schedule 4 para.5(1)
  • 60. Schedule 4 para.7(4)
  • 61. Schedule 4 para.8
  • 62. Schedule 4 para. 9(2)
  • 63. Schedule 4 para. 9(3)
  • 64. Schedule 4 para.10
  • 65. Schedule 4 para.11
  • 66. Schedule 4 para.12
  • 67. s.14
  • 68. see s.15
  • 69. s.28
  • 70. s.16(2)
  • 71. s.16(3)