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Human Tissue Act 2004

Commentary on Sections

Part 1 - Removal, Storage and Use of Human Organs and Other Tissue for Scheduled Purposes

Section 1: Authorisation of activities for scheduled purposes

10.Section 1 is the foundation of the Act. It establishes that consent from an appropriate person ('appropriate consent' as defined in sections 2 and 3) is required before certain activities can be undertaken for particular purposes. These activities are storage and use of whole bodies, removal, storage and use of relevant material from the body of a deceased person, and storage and use of relevant material from a living person. The purposes to be regulated are listed in Schedule 1 and are referred to in these notes as 'scheduled purposes'. Relevant material from a human body is defined at section 53 as any material consisting of, or including, human cells, with the exception of gametes, embryos outside the body (as defined in, and separately regulated by, the Human Fertilisation and Embryology Act 1990), and hair and nail from a living person. Cell lines are also excluded by virtue of section 54(7), as is any other human material created outside the human body.

11.Subsections (2) & (3) deal with the special requirements for the lawful storage and use of a body for anatomical examination. These provisions are carried over from the Anatomy Act 1984.

12.Subsections (4) to (9) allow activities of the kind mentioned in subsections (1) to (3) to be done in certain cases without meeting the conditions for which those subsections provide. The exceptions relate to imported bodies and material and to bodies, and material from bodies, of persons who died before the coming into force of the new regime where there is a gap of more than 100 years between the date of death and the activity concerned. This will allow continued import of tissue for research and will exclude archaeological specimens from the consent provisions. There is also an exception for health-related research on material from living people where the material is not linked to an identifiable individual and the research has been ethically approved in accordance with regulations. It is anticipated that this ethical approval will be given by existing Research Ethics Committees.

13.Subsection (10) makes it lawful for relevant material, which has been obtained from a living person, to be stored and used for the limited purposes set out in Schedule 1 Part 2, without any consent. These purposes are ones considered intrinsic to the proper conduct of a patient’s treatment (clinical audit, quality assurance and performance assessment - which could include evaluations of in-vitro diagnostic devices) or necessary for the public health of the nation (public health monitoring and health-related education and training).

14.Subsection (11) provides that the Secretary of State may vary, omit or add to the purposes set out in Schedule 1, by means of a statutory instrument, subject to affirmative resolution in both Houses. Subsection (12) excludes from the consent requirements of section 1 the storage and use of relevant material in in-vitro diagnostic medical device testing where this is already regulated by Directive 98/79/EC. Subsection (13) is aimed at ensuring that bodies and relevant material are not exported and re-imported simply to get around the consent requirements.

Section 2: “Appropriate consent”: children

15.Section 2 sets out the meaning of 'appropriate consent' in relation to activities regarding the body of a deceased child, or relevant material from living or deceased children. For the purposes of this section, children are people under the age of 18.

16.Living children who are competent to do so may give their own consent. If they are not competent or choose not to decide, appropriate consent will be that of a person with parental responsibility for them. Competence is not defined in the Act, but will be established according to common law principles (the 'Gillick test').

17.Where a child has died, if he or she was competent and made an advance decision (to give or refuse consent), that will apply. Subsections (4) to (6) provide that consent of a competent child to have his or her body used for anatomical examination or public display must be in writing and witnessed. No-one other than a competent child may give consent to the use of his or her own body for purposes of anatomical examination or public display. Anatomical examination is defined in section 54. Subsection (5) of this section provides that prior written, witnessed consent to anatomical examination is only necessary in relation to material which is not excepted material (as defined in section 12), that is, in relation to a whole body, or material which has come from a whole body during an anatomical examination. For other scheduled purposes, such as the carrying out of a post mortem examination or the use of organs for transplantation, the consent of someone with parental responsibility will be appropriate consent, but only if the child did not deal with the issue of consent. Subsection (7) provides that if a child has died and there is no-one with parental responsibility, someone in a 'qualifying relationship' may give consent to removal, storage or use of the child’s body or material from the body. (The group of next of kin etc who qualify for these purposes is given at section 54(9) and dealt with further at section 27(4)).

Section 3: “Appropriate consent”: adults

18.Section 3 sets out the meaning of 'appropriate consent', in relation to activities concerning the body of a deceased adult or relevant material from a person who is (at the time of the activity) a living or deceased adult. If the adult is alive his own consent is required. Subsections (3) to (5) provide that after death, the adult’s consent, given in advance in writing and witnessed, is required for purposes of anatomical examination or public display. As explained in the previous paragraph, anatomical examination is relevant only in relation to a whole body or material which has come from a whole body during an anatomical examination. For other scheduled purposes, if the adult made no prior decision, a person nominated by him in accordance with section 4 to make decisions after his death or, failing that, someone in a 'qualifying relationship' (as listed in section 54(9) and dealt with further at section 27(4)) may give consent.

Section 4: Nominated Representatives

19.This section sets out how an adult aged 18 or over can make a valid appointment of one or more 'nominated representative(s)', who may give consent after the adult’s death to storage or use of his or her body, or removal, storage and use of relevant material from his or her body for scheduled purposes. Subsection (6) says that where two or more people are appointed as nominated representative, they will be assumed to be able to act alone unless the appointment says they must act jointly. Unless they have been appointed to act jointly, the consent of one of several nominated representatives is sufficient to make the activity lawful, even if the others object.

Section 5: Prohibition of activities without consent

20.Subsection (1) penalises the carrying-out of any of the activities to which section 1(1), (2) or (3) applies if done without appropriate consent. This means that where there is consent to use material for one purpose, it may not be used for another.  However, a person does not commit an offence if he reasonably believed that the appropriate consent was in place, or that the activity was not one in relation to which consent was required.

21.Subsection (2) penalises a person who knowingly makes a false representation to another person that appropriate consent has been given or is not needed.  Subsections (3) to (6) relate to offences and penalties in connection with anatomical examination which have been transferred from the Anatomy Act 1984.

Section 6: Activities involving material from adults who lack capacity

22.This section enables the Secretary of State to specify in regulations the circumstances in which there is to be deemed to be consent to activities regulated by the Act in relation to adults who lack capacity to consent for themselves, where a decision of theirs about such matters is not already in force. It is envisaged that the regulations will provide for consent to be deemed to be in place where the activity would be in the adult's best interests - for example, it could be in their best interests to donate tissue to a close relative for transplantation.  The regulations will also be able to provide that where consent has been given by a proxy in accordance with Schedule 1 to the Medicines For Human Use (Clinical Trials) Regulations 2004/1031, storage and use of material from the adult lacking capacity as part of the trial should be treated as done with consent.  The regulations will also be able to take account of the Mental Capacity Bill, introduced in the House of Commons on 17 June 2004, in particular in relation to research involving those who lack capacity to consent, which will be regulated by that Bill.

Section 7: Powers of court to dispense with the need for consent

23.Subsections (1) to (3) of this section allow the Human Tissue Authority to give a direction deeming consent to be in place in relation to relevant material from a living person who is either untraceable, or who has not responded to requests for consent to use of his material, but where the material could be used to provide information which may be relevant to another person. These are expected to be rarely-used powers, but they may be important where valuable information could be obtained about the treatment and diagnosis of the applicant for the direction.

24.Subsection (4) enables the Secretary of State to make regulations which would provide a similar power for a court to deem consent to be in place where relevant material or a body could be used for health-related research.  It is envisaged that this power would be exercised only in rare and unusual cases where the research would be in the overwhelming public interest, for example, where a person has died of an unknown virus which has the potential to spread among the general population.

Section 8: Restriction of activities in relation to donated material

25.This section provides that, where the body of a deceased person or relevant material from a human body is the subject of any consent under section 1, it may not be used, or stored for use, for purposes other than the following: (a) a purpose listed in Schedule 1, (b) medical diagnosis or treatment, (c) disposal or (d) another purpose excepted by regulations. It will be an offence to use such material for any other purpose. The offence will not apply where a person believes on reasonable grounds that the body or material is not relevant material which is the subject of appropriate consent. The regulation-making power is intended to be used to ensure that legitimate uses of tissue which may come to light in future will not be criminalised.

Section 9: Existing Holdings

26.This section deals with 'existing holdings', namely, a body, or relevant material, which is already held for use for a scheduled purpose when the new regime comes into force. In such a case, the effect of the section is that use, or storage for use, for a scheduled purpose is authorised under section 1(1) without the need for appropriate consent. However, this does not apply to storage and use of bodies or material in relation to which there is an authority under the Anatomy Act 1984 and where the anatomical examination is not concluded before the Act comes into force. Such bodies and material are dealt with in section 10. The code of practice to be issued by the HTA under section 26 will deal with the storage, use and disposal of existing holdings.

Section 10: Existing Anatomical Specimens

27.This section provides for what should be done, once the consent provisions of the Act take effect, about bodies and parts of bodies already donated for dissection under the Anatomy Act 1984, but where the anatomical examination of them has not been concluded. The Anatomy Act provides that bodies might be kept for up to three years with the donor’s or his next of kin’s authority and body parts might be kept for longer. This section provides that the terms of the authority given under the Anatomy Act 1984 are to be treated as 'appropriate consent' to anatomical examination. In addition, if the existing authority allowed parts of the body to be held after conclusion of the examination and the examination was not in fact concluded before the consent provisions in the Act came into force, the authority is to be treated as “appropriate consent” to storage for the purposes of education and research.

28.Subsection (6) is intended to ensure that, where authority under the Anatomy Act has been given on terms, the authority under the Act which is based on that authority is also subject to those terms.

Section 11: Coroners

29.In order to maintain the current legal position regarding coroners, this section exempts from the requirements of Part 1 of the Act anything done for the functions of a coroner or under his authority. This includes both his statutory functions and his common law authority. Subsection (2) provides that if a body or material from it may be needed for the purposes of the coroner, the authority conferred by section 1 to act in relation to the body or material does not apply.

Section 12: Interpretation of Part 1

30.This section defines 'excepted material' which is relevant to the references in sections 2 and 3 to anatomical examination.

Part 2 - Regulation of Activities Involving Human Tissue

The Human Tissue Authority

Section 13: The Human Tissue Authority

31.This section establishes the HTA as a body corporate and gives effect to Schedule 2 (which includes provision about the membership of the Authority, its organisation and financial matters).

Section 14: Remit

32.Subsection (1) lists the activities within the HTA’s remit. The activities include disposal of bodies and relevant material stored or used for scheduled purposes.  Subsection (3) excludes from the remit of the HTA activities done in relation to material from bodies, or bodies, where the person died before the Act comes into force and has been dead for at least 100 years.  Subsection (4) provides that the Secretary of State may by order add to the activities within the remit of the HTA. Subsection (5) defines 'relevant material' in this section as excluding blood or anything derived from blood for the purpose of transplantation.   Blood and blood products for transfusion will be regulated upon implementation of Directive 2002/98/EC setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components.

Licensing

Section 16: Licence Requirements

33.Subsection (1) prohibits the carrying on of activities to which the section applies without a licence.  Subsection (2) sets out the activities to which the licence requirement applies.  Subsection (3) provides that the Secretary of State may by regulations specify circumstances in which storage of relevant material by a person who intends to use it for a scheduled purpose is excepted from the licence requirement.  This will allow distinction to be made between tissue banks, for example, and individuals using tissue in research projects, who will not then require to be licensed.  Subsection (4) excludes from the licensing requirement activities done in relation to material from bodies, or bodies, where the person died before the Act comes into force and has been dead for at least 100 years.  Subsection (5) provides that the Secretary of State may by regulations add, remove or alter the description of an activity listed in the section.Subsection (7) excludes from the licence requirement storage incidental to transportation.  It also excludes use of blood or blood products for transplantation, and storage of blood or blood products for use for that purpose.  Schedule 3 contains the detailed procedures for granting, varying, revoking and suspending licences.  Licensing functions under the Schedule are conferred on the HTA.

Section 17: Persons to whom licence applies

34.This section defines who is permitted to act under the authority conferred by a licence: the individual designated in the licence as the person under whose supervision the licensed activity is authorised to be carried on (the 'designated individual'), any other person notified to the HTA by the designated individual as a person to whom the licence applies, and any person acting under the direction of either of the first two.

Section 18: Duty of the designated individual

35.This section provides that the individual designated in the licence is responsible for securing that the other persons to whom the licence applies are suitable to participate in the licensed activity, that suitable practices are used and that all licence conditions are complied with.

Section 19: Right to reconsideration of licensing decisions

36.This section provides that an applicant may require the HTA to reconsider licensing decisions in respect of a refusal of an application to grant, revoke or vary a licence, or a licence holder or designated person may require the HTA to reconsider a decision to revoke or vary a licence. Subsection (3) provides that notice of exercise of the right to reconsideration must be given to the HTA by the appellant within 28 days of the HTA giving notice of the decision.

Section 20: Appeals Committee

37.This section requires the HTA to maintain one or more appeals committees composed of not less than 5 (with a quorum of 3) members of the HTA. The appeals committee will be responsible for dealing with requests for reconsideration of HTA decisions under section 19.

Section 21: Procedure on reconsideration

38.This section sets out the procedure for reconsideration of licensing decisions, which will be by way of fresh decision. Subsection (5) provides that the HTA may by regulations make other provision in relation to the procedure on reconsideration as it thinks fit.

Section 23: Conduct of licensed activities

39.This section provides that directions issued by the HTA may impose particular requirements relating to the conduct of activities authorised by a licence. Subsection (2) says directions may be general, applicable to particular kinds of licence or to an individual licence. Subsection (3) makes it a statutory requirement that they are complied with by those to whom they apply.

Section 24: Changes of licence circumstance

40.Subsections (1) to (3) provide that directions may be made for the purpose of dealing with a situation in consequence of the variation of a licence or the ceasing of a licence to have effect, and identify the persons on whom requirements may be imposed.  Subsection (5) provides that in the event of the death or dissolution of a licence holder, anything done before directions are given will be treated as authorised, provided it would have been authorised by the licence holder’s licence (were it still in force).

Section 25: Breach of licence requirement

41.This section establishes the offence of carrying on a licensed activity otherwise than under the authority of a licence granted under section 16(1), unless the person carrying on the activity reasonably believes the activity is not licensable or that he acts under the authority of a licence. Subsection (2) sets out penalties for the offence.

Codes of Practice

Section 26: Preparation of codes

42.Subsection (1) provides that the HTA may prepare and issue codes of practice giving guidance and setting standards in relation to activities within its remit. Subsections (2) and (3) list the matters which must be dealt with in the codes of practice prepared by the HTA.

Section 27: Provision with respect to consent

43.Subsection (1) provides that in a code of practice dealing with consent the HTA must lay down standards relating to obtaining consent from a person in a qualifying relationship. Subsection (3) provides that the HTA may lay down different standards for obtaining consent in exceptional cases, for example, a blood relative lower down the hierarchy than a partner or spouse may have a greater interest in obtaining information about their deceased relative’s health where this may be relevant to their own health.  Subsection (4) sets out the hierarchy of people close to a deceased person who are eligible to give 'appropriate consent' to the activities listed in section 1(1) to (3) (other than for the purposes of anatomical examinations or public display).  If there is more than one person in an eligible class who is competent to give consent, the consent of any one of them would suffice.  Subsection (9) provides that the Secretary of State may amend the hierarchy by order.

Section 28: Effect of codes

44.This section provides that, while failure to observe a provision of a code of practice will not itself make a person liable to any proceedings, the HTA may take account of observance or failure to observe a provision of a code of practice dealing with a matter that is subject to a licence requirement when carrying out its licensing functions.

Section 29: Approval of codes

45.This section provides that draft codes of practice dealing with matters that are subject to a licence requirement must be approved by the Secretary of State and laid before Parliament by him. The code may not be issued by the HTA until it has been before Parliament for 40 days with no resolution not to approve it having been made by either House.

Anatomy

Section 30: Possession of anatomical specimens away from licensed premises

46.This section and the following one transpose provisions of the Anatomy Act 1984 relating to control of possession of anatomical specimens. This section makes it an offence to keep anatomical specimens away from licensed premises. Exceptions are provided for possession authorised by a designated individual for authorised purposes, for persons in lawful possession of bodies immediately after death and for possession for the purpose of transport to licensed premises or premises where the specimen is to be used for the purpose of education, training or research. These exceptions are intended, for example, to allow an anatomy teacher to take a specimen away from a dissecting room to a lecture theatre for teaching purposes, and to allow undertakers to deliver bodies to the medical school. An exception is also provided where the person has possession for the purposes of functions of or under the authority of a coroner.

Section 31: Possession of former anatomical specimens away from licensed premises

47.This section makes it an offence for a person to have a former anatomical specimen in his possession away from licensed storage premises. As under the preceding section, exceptions are provided for possession authorised by a designated individual for authorised purposes, for possession for the purposes of transport to licensed premises or premises where the former specimen is to be used for the purpose of education, training or research. There are also exceptions where the person has possession for the purposes of decent disposal or where he has possession for the purposes of functions of, or under, the authority of a coroner.

Trafficking

Section 32: Prohibition of commercial dealings in human material for transplantation

48.This section transposes the existing prohibition on buying or selling organs from the Human Organ Transplants Act 1989, and extends the prohibition to cover all human material (subject to certain exceptions) intended to be used for transplantation. Advertising for suppliers of material for reward is also prohibited. Subsection (3) allows the HTA to designate a person who may lawfully engage in trade in human material (for example, the National Blood Service will continue to be allowed to purchase blood from abroad). Subsection (7) provides that reimbursement for expenses connected with transporting, removing, preparing, preserving or storing the body of a deceased person or relevant human material is not prohibited. Subsection (6) allows for the possibility of commercial tissue banks by allowing licence-holders to receive more than just expenses in relation to these activities. Subsection (7) also provides that it is not an offence to provide expenses or recompense for loss of earnings given to an individual supplying human material, and allows for costs incurred by others to be passed along a chain of suppliers. Subsection (9) makes clear that the material covered by the prohibition excludes gametes and embryos (as defined in, and regulated by, the Human Fertilisation and Embryology Act 1990), and material which has become property by reason of the application of human skill. Cell lines are excluded from the section by virtue of section 54(7).

Transplants

Section 33: Restriction on transplants involving a live donorSection 34: Information about transplant operations

49.These sections are transposed from the Human Organ Transplants Act 1989. Section 33 sets out the offence and penalties related to the removal and transplantation of organs and other material from living donors in circumstances other than those provided for in regulations made under this section. These include circumstances where the HTA is satisfied that no reward has been given in relation to the transplant. Section 34 replicates the existing requirement for information about organ transplants to be supplied to the specified authority (UK Transplant). Failure to supply information, or the supply of false information, is an offence under this section.

General

Section 35: Agency arrangements and provision of services

50.This section enables the HTA to make arrangements with other public bodies for the carrying out of any of the HTA’s functions by the other body or its staff or for the other body to provide administrative, professional or technical services to the HTA.

Section 36: Annual Report

51.This section requires the HTA to prepare an annual report to be submitted to the Secretary of State, the National Assembly for Wales and the relevant Northern Ireland department, and for the Secretary of State and the relevant Northern Ireland Department to lay a copy before each House of Parliament and before the Northern Ireland Assembly respectively.

Section 37: Directions

52.This section makes provision with respect to the giving of directions by the HTA under Part 2, which must be in writing.

Section 38: Duties in relation to carrying out functions

53.This section sets out how the HTA must carry out its functions and the matters to which it must have regard in doing so.

Exceptions

Section 39: Criminal Justice purposes

54.This section deals with excluding activities done for criminal justice purposes from the relevant provisions of Part 2 of the Act. The intention is for all coroners' post mortem examinations carried out in premises to be subject to regulation, so even where these are carried out also for criminal justice purposes, they will not be excluded from Part 2 of the Act. Subsection (2) of the section achieves this. Subsection (1) excludes from the regulatory regime of Part 2 of the Act other activities done for criminal justice purposes. Examples of activities excluded from regulation by this section might be post mortem examinations authorised by a coroner in a criminal case to take place at the place where the police first attend a body (which would not need a licence) and disposal of material which has been removed from a body during a post mortem examination in a criminal case (which would not be within the HTA's remit and not subject to any code of practice on this subject).

Section 40: Religious relics

55.This section excludes the public display of religious relics and storage of such relics for the purpose of public display, from the remit of the HTA, from the requirement for a licence and from the remit of the Inspectorate of Anatomy & Pathology. It applies to relics displayed in places of public religious worship or associated places.

Part 3 - Miscellaneous and General

Miscellaneous

Section 43: Preservation for transplantation

56.This section makes it lawful to retain the body of a dead person and preserve organs in the body which may be suitable for transplantation, while consent to use the organs is sought, provided the preservation involves the minimum steps necessary and the least invasive procedures.

Section 44: Surplus tissue

57.This section allows any human material which comes from a body during medical treatment, diagnostic testing or research, or 'relevant material' (as defined in section 53) which is no longer required for scheduled purposes, to be disposed of. Subsection (4) makes it clear that the reference to lawful disposals in the section is not intended to affect the lawfulness or otherwise of other disposals of human material.

Section 45: Non-consensual analysis of DNA

58.It is an offence under section 45(1) to have any bodily material (that is, any material which has come from a human body and which consists of or contains human cells) intending to analyse the DNA in it without qualifying consent, subject to certain exceptions. This offence applies to the whole of the UK. The offence does not apply if the results of the analysis are to be used for excepted purposes and these are listed in Part 2 of Schedule 4. These include general purposes such as medical treatment and criminal justice purposes, as well as more specific matters which largely reflect what may be done without consent under Part 1 of the Act, with modifications for Scotland where necessary. Paragraph 11 of Schedule 4 also has the effect that, if consent to use material has been obtained under section 1(1) of the Act, it is not necessary to obtain a separate consent where that use involves DNA analysis.

59.What constitutes qualifying consent is set out in Part 1 of Schedule 4. It may be given to analysis of DNA for any purpose. It can be given by the person from whose body the material came or someone with parental responsibility if the person is a child. Once the person has died, consent may be given by anyone who stood in a qualifying relationship (as listed in section 54(9)) with the deceased immediately before he died. The hierarchy referred to in section 27(4) does not apply to this list.

60.Certain material is outside the scope of the offence altogether and this includes material from a person who died more than 100 years ago and embryos outside the body (as these are subject to separate regulation by the Human Fertilisation & Embryology Act 1990).  Also outside the scope of the offence are existing holdings of material where the identity of the person from whom it came is not known, and is not likely to become known.  There is also an exemption if the person reasonably believes the material they have to be excepted.

General

Section 47: Power to give effect to Community obligations

61.This section contains a power to amend the Act at a later date by regulations subject to the affirmative procedure in order to implement Community obligations in relation to human material. This section has in view Directive 2004/23/EC of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, which is due to be implemented by 7 April 2006. The power in this section will allow any necessary amendments to be made to the Act by regulations.

Section 47: Power to de-accession human remains

62.This section confers a power upon the bodies listed in subsection (1) ('listed institutions') to de-accession human remains.

63.Subsection (2) enables listed institutions to transfer human remains from their collections if it appears to them appropriate to do so for any reason whether or not it relates to their other functions. The power only applies to human remains which are reasonably believed to be of a person who died less that 1,000 years before this section comes into force.

64.Subsection (3) provides that if it appears to a listed institution that human remains are mixed or bound up with non-human material and it is undesirable or impracticable to separate them, the power to de-accession the human remains extends also to the associated non-human material.  This has the effect of enabling artefacts such as mummies (where non-human material is integral to the human remains) to be de-accessioned intact.  The provision does not extend to grave chattels that are buried with but are separate from human remains found in a grave.

65.Subsection (4) provides that the power contained in subsection (2) does not affect any trust or condition subject to which a listed institution may hold human remains.

Section 48: Powers of inspection, entry, search and seizure

66.This section gives effect to Schedule 5, which provides a power for persons authorised by the HTA to inspect certain records, enter, search and inspect premises and seize things on the premises in connection with the HTA’s regulatory functions.

Section 50: Prosecutions

67.This section specifies that proceedings regarding offences relating to appropriate consent, commercial dealing in tissue and payment for transplants will be instituted only with the consent of the Director of Public Prosecutions.

Section 58: Transition

68.This section provides for the fact that the maximum penalties in the Act reflect the provisions of the Criminal Justice Act 2003. Until such time as the relevant provisions of the 2003 Act are in force, the maximum penalties are to be read as those which apply under the law currently in force.

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