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 donor

Section 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.

COMMENCEMENT DATE

69.     The substantive provisions of the Act will come into force on days appointed by the Secretary of State by order. Full implementation is not expected to be before April 2006.

HANSARD REFERENCES

The following table sets out the dates and Hansard references for each stage of this Act's passage through Parliament.

Royal Assent -- 15 November 2004     House of Lords Hansard Vol. 666, Col. 1185

                         House of Commons Hansard Vol. 426, Col. 1009