Clause 20: Appeals Committee

37.     This clause 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 clause 19.

Clause 21: Procedure on reconsideration

38.     This clause 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.

Clause 23: Conduct of licensed activities

39.     This clause 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.

Clause 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).

Clause 25: Breach of licence requirement

41.     This clause establishes the offence of carrying on a licensed activity otherwise than under the authority of a licence granted under clause 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

Clause 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.

Clause 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 clause 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.

Clause 28: Effect of codes

44.     This clause 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.

Clause 29: Approval of codes

45.     This clause 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

Clause 30: Possession of anatomical specimens away from licensed premises

46.     This clause and the following one transpose provisions of the Anatomy Act 1984 relating to control of possession of anatomical specimens. This clause 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.

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

47.     This clause 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 clause, 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

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

48.     This clause 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 clause by virtue of clause 59(7).

Transplants

Clause 33: Restriction on transplants involving a live donor

Clause 34: Information about transplant operations

49.     These clauses are transposed from the Human Organ Transplants Act 1989. Clause 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 clause. These include circumstances where the HTA is satisfied that no reward has been given in relation to the transplant. Clause 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 clause.

Inspectorates

Clause 35: Inspectorate of Anatomy and Pathology

Clause 36: Remit of Inspectorate of Anatomy and Pathology

50.     These clauses establish and set out the constitution and remit of the Inspectorate of Anatomy and Pathology. The Inspectorate will be responsible for carrying out such of the functions of the HTA as are within its remit.

Clause 37: Inspectorate of Organs and Tissue for Human Use

Clause 38: Remit of Inspectorate of Organs and Tissue for Human Use

51.     These clauses establish and set out the constitution and remit of the Inspectorate of Organs and Tissue for Human Use. The Inspectorate will be responsible for carrying out such of the functions of the HTA as are within its remit.

Clause 39: Duties in relation to discharge of functions of Inspectorates

52.     This clause provides that the inspectorates must have regard to the principles set out by the HTA, and that the HTA will in turn monitor the functioning of the inspectorates.

General

Clause 40: Agency arrangements and provision of services

53.     This clause 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.

Clause 41: Annual Report

54.     This clause 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.

Clause 42: Directions

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

Clause 43: Duties in relation to carrying out functions

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

Exceptions

Clause 44: Criminal Justice purposes

57.     This clause deals with excluding activities done for criminal justice purposes from the relevant provisions of Part 2 of the Bill. 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 Bill. Subsection (2) of the clause achieves this. Subsection (1) excludes from the regulatory regime of Part 2 of the Bill other activities done for criminal justice purposes. Examples of activities excluded from regulation by this clause might be post mortem examinations authorised by a coroner in a criminal case to take place at the site of discovery of 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).

Clause 45: Religious relics

58.     This clause 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

Clause 48: Preservation for transplantation

59.     This clause 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.

Clause 49: Surplus tissue

60.     This clause allows any human material which comes from a body during medical treatment, diagnostic testing or research, or "relevant material" (as defined in clause 58) 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 clause is not intended to affect the lawfulness or otherwise of other disposals of human material.

Clause 50: Non-consensual analysis of DNA

61.     It is an offence under clause 50(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 5. 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 Bill, with modifications for Scotland where necessary. Paragraph 11 of Schedule 5 also has the effect that, if consent to use material has been obtained under clause 1(1) of the Bill, it is not necessary to obtain a separate consent where that use involves DNA analysis.

62.     What constitutes qualifying consent is set out in Part 1 of Schedule 5. 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 clause 59(9)) with the deceased immediately before he died. The hierarchy referred to in clause 27(4) does not apply to this list.

63.     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

Clause 51: Power to give effect to Community obligations

64.     This clause contains a power to amend the Bill at a later date by regulations subject to the affirmative procedure in order to implement Community obligations in relation to human material. This clause has in view Directive 2004/23/EC of 31st 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 7th April 2006. The power in this clause will allow any necessary amendments to be made to the Bill by regulations.

Clause 52: Power to de-accession human remains

65.     This clause confers a power upon the bodies listed in subsection (1) ("listed institutions") to de-accession human remains.

66.     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.

67.     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.

68.     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.

Clause 53: Powers of inspection, entry, search and seizure

69.     This clause gives effect to Schedule 6, 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.

Clause 55: Prosecutions

70.     This clause 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.

Clause 63: Transition

71.     This clause provides for the fact that the maximum penalties in the Bill 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.

EUROPEAN CONVENTION ON HUMAN RIGHTS

72.     Convention issues arise in relation to several provisions in the Bill. The Department is satisfied that the regime established by Part 1 of the Bill for consent for use of human bodies and material protects the rights of people under Article 8 of the Convention to respect for private and family life, which includes the right to bodily integrity, autonomy and self-determination.

73.     Article 6(1) of the Convention requires that, in any determination of civil rights and obligations, everyone is entitled to a fair and public hearing within a reasonable time by an independent and impartial. This will be relevant for some licensing decisions taken by the HTA. The Department considers that the provisions of Part 2 of the Bill which relate to the reconsideration of licensing decisions comply with the requirements of Article 6 of the Convention.

74.     Licensing decisions under Part 2 might also engage rights under Article 10 of the Convention (freedom of expression) and Article 1 of the First Protocol to the Convention (protection of property) in individual cases. The Department is satisfied that any interference with an individual's rights under Article 10 of the Convention is justified if it is proportionate to the ends of the prevention of crime, for the protection of health or morals and the protection of the rights of others. The Department is also satisfied that the powers are compatible with Article 1 of the First Protocol to the Convention as any interference strikes a fair balance between the protection of an individual's right to property and the public interest as a whole.

75.     The provisions of Schedule 6 give various powers to persons duly authorised by the HTA to require production of records and to inspect and take copies of records produced and to enter and inspect licensed premises. They may be authorised by warrant to enter and inspect premises in connection with a suspected offence. They also have powers to seize things found on premises that have been entered and inspected. The exercise of these powers may constitute an interference with rights under Article 8 of the Convention and Article 1 of the First Protocol to the Convention. The Department's view is that the safeguards in the Schedule are sufficient to guard against abuse and will ensure that any interference with an individual's rights under Article 8 of the Convention is proportionate to the ends of the prevention of crime, for the protection of health or morals and the protection of the rights and freedoms of others. The Department also takes the view that the powers are compatible with Article 1 of the First Protocol to the Convention as any interference strikes a fair balance between the protection of an individual's right to property and the public interest as a whole.

76.     Section 19 of the Human Rights Act 1998 requires the Minister in charge of a Bill in either House of Parliament to make a statement about the compatibility of the provisions of the Bill with the Convention rights (as defined in section 1 of that Act). The statement has to be made before second reading. On 28th June 2004, the Lord Warner made the following statement:

"In my view the provisions of the Human Tissue Bill are compatible with the Convention rights."

ESTIMATE OF PUBLIC SECTOR FINANCIAL COST AND PUBLIC SECTOR MANPOWER EFFECTS

Training and implementation regarding consent

77.     The main impact of implementation of the legislation will be felt across the Health Service. Staff involved with bereavement, post mortem examinations, and other tissue retention activities will need to ensure that their work is in line with the requirements of the new legislation. In support of this, £2.7 m per annum has been included in the NHS baseline for the development of bereavement services in England from 2003/04. This enables English trusts to develop services that will be compliant with the new consent requirements of the Bill. Post mortem examination consent forms, and guidance on their use, have already been issued so that Trusts will already be moving towards procedures that enable them to work in accordance with the standards set out under the Bill.

78.     This work is supported by central training initiatives. £300,000 per annum for three years, commencing in 2003/04, has been identified and provided for English central training initiatives to support the development of new procedures for consent around post mortem examinations and communication with families and next of kin at the time of bereavement.

79.     As the provision of Health Services in Wales and Northern Ireland is a devolved issue, there will be similar resource implications for Wales and Northern Ireland to support this legislation.

80.     The other area in which there may be an impact in terms of training following implementation, is in relation to Coroners and Coroners' Officers. In England and Wales, coroner law falls within the responsibility of the Home Office, while the costs of the service are met by relevant local authorities. In Northern Ireland, the service is the responsibility of the Northern Ireland Courts Service.

81.     The Home Office is currently undertaking a major review of coroners' services. An initial report on this review was published in June 2003, and this will be taken forward in a co-ordinated fashion alongside the reports from the Shipman Inquiry. Legislation is anticipated as a consequence of the review of coroners' services, and this will clearly take account of those provisions of the Human Tissue Bill that may affect coroners. The Home Office will work with the Department of Health to facilitate relevant training, development and implementation requirements at that time. Meanwhile, the funding available through the Department of Health for training and development initiatives around post mortem examinations and bereavement services is available to coroners' officers in England as they have been invited to participate in those training initiatives. Again, there will be separate resource implications for Wales and Northern Ireland.

82.     In the case of living patients, practice guidance for the NHS in England and Wales has been issued by the Department of Health in "Good Practice in Consent" (Nov 2001) and the "Interim statement on the use of human tissue and organs" (April 2003). These make it clear that consent should be obtained to using tissue for purposes unrelated to the patient's treatment. Similar guidance on consent regarding living patients has been issued in Northern Ireland. NHS pathology services should therefore be meeting these standards or be in the process of complying.

The Human Tissue Authority (HTA)

83.     The Retained Organs Commission was funded by the Department of Health at a cost of £1m per year. Her Majesty's Inspector of Anatomy and the Unrelated Live Transplants Regulatory Authority are also funded by the Department of Health. It is expected that this funding, totalling around £1.15m, will be available to the new body as it takes on the same or extended functions. The HTA will also generate income from licences and inspection fees. It will be a non-departmental public body and is expected to have a staff of up to 25.

Anatomy Schools

84.     The HTA will charge fees for licences and inspections. Transferring regulation of anatomy schools (about 30 in number) which are largely in the academic sector, from Her Majesty's Inspector of Anatomy (HMIA) to the HTA, will transfer the cost of licensing and inspection from the Department of Health to the anatomy schools. The fees would likely be about £2,000 for the first year and £1,000 per year thereafter, with biennial inspections.

Pathology Laboratories, Tissue Banks, Medical Teaching Collections, Public Mortuaries and Museums

85.     NHS pathology laboratories where post mortem examinations are undertaken, or human tissue is stored for research or education will need to be licensed and inspected by the HTA. It is estimated that there are about 300 of these. The likely cost of licences would be £2,000 initially, with a charge of £1,000 per year, with biennial inspections.

86.     Tissue banks storing material for education and research purposes, tissue collections for medical education, and public mortuaries undertaking coroners' post mortem examinations, will need to be licensed and inspected on the same basis. Most existing tissue banks are funded by the NHS or a mix of NHS/academic institutions/MRC and the Wellcome Foundation. Public mortuaries are declining in number but about 20 remain which will need to be licensed. Public mortuaries are run by local authorities and charge fees to coroners, who in turn are paid by local authorities. Where public mortuaries do not also store human material, the scope of inspections and licence fees is likely to be reduced.

87.     Public institutions/museums holding or displaying human remains which are from a person who died less than 100 years ago will also need to be licensed and inspected. Few museums hold such material in their permanent collections. The cost to those institutions will reflect the cost of licensing and inspection, and is likely to be proportionate to the volume of material they keep or display.

88.     Tissue banks which process, store and distribute tissue for human use (transplantation), of which there are about 345 in the public sector, will be subject to a more extensive licensing and inspection regime, including safety and quality issues. The Department of Health has underwritten the costs of setting up and running a voluntary scheme to regulate these for the UK since 1999. The MHRA currently charges fees directly for regulating pharmaceutical manufacturers and wholesalers by a regime of licensing and inspection for compliance with Good Manufacturing Practice and Good Distribution Practice. Charges, based on this regime, to individual tissue banks undertaking sterile processing, would currently be approximately £5,000 in the first year to cover the costs of initial application and inspection, with subsequent annual recurring costs, including biennial re-inspection, of approximately £1,500. The costs for banks undertaking storage and distribution only would be less; approximately £2,000 in the first year, with annual recurring costs of approximately £700. These costs will be transferred to the tissue banks which are likely to pass them to the NHS. (These costs anticipate what will become obligatory for regulation under an EU Directive on Tissues and Cells which must be implemented by April 2006.)