House of Commons - Explanatory Note
Human Tissue Bill - continued          House of Commons

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Clause 25: Effect of codes

40.     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 26: Approval of codes

41.     This clause provides that codes of practice dealing with matters that are subject to a licence requirement must be approved by the Secretary of State and that he shall only approve a code relating to Wales after consulting the Welsh Assembly, and that he shall only approve a code relating to Northern Ireland after consulting the relevant Northern Ireland department. If the Secretary of State approves a draft code of practice, he must lay it before each House of Parliament. If the code relates to Wales he must send a copy to the National Assembly for Wales, and if it relates to Northern Ireland he must send a copy to the relevant Northern Ireland Department. The code will take effect on a day appointed in directions. If the Secretary of State does not approve a code he must give reasons to the HTA.

Anatomy

Clause 27: Possession of anatomical specimens away from licensed premises

42.     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 28: Possession of former anatomical specimens away from licensed premises

43.     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 clause 27, 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 29: Prohibition of commercial dealings in human material

44.     This clause transposes the existing prohibition on buying or selling organs from the Human Organ Transplants Act 1989, and extends the prohibition to cover whole bodies and all human material (subject to certain exceptions). Advertising for suppliers of material for reward is also prohibited. Subsection (3) excludes from the offence activities in connection with acquisitions for the purposes of certain museums (clause 42 explains which museums). It also 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). Subsections (6) and (7) provide 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, nor is providing expenses or recompense for loss of earnings given to an individual supplying human material. Subsections (8) and (9) make clear that human material in this context excludes hair and nail from living persons, 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 56(7).

Transplants

Clause 30: Restriction on transplants involving a live donor

Clause 31: Information about transplant operations

45.     These clauses are transposed from the Human Organ Transplants Act 1989. Clause 30 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 31 replicates the requirement for information about organ transplants to be supplied to the specified authority. This has previously been UK Transplant and is expected to continue to be UK Transplant in the future. Failure to supply information, or the supply of false information, is an offence under clause 31.

Inspectorates

Clause 32: Inspectorate of Anatomy and Pathology

Clause 33: Remit of Inspectorate of Anatomy and Pathology

46.     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 34: Inspectorate of Organs and Tissue for Human Use

Clause 35: Remit of Inspectorate of Organs and Tissue for Human Use

47.     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 36: Duties in relation to discharge of functions of Inspectorates

48.     Clause 36 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 37: Agency arrangements and provision of services

49.     Clause 37 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 38: Annual Report

50.     Clause 38 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 39: Directions

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

Exceptions

Clause 40: Criminal Justice purposes

52.     This clause exempts from the remit of the HTA, the requirement for a licence and the remit of the Inspectorate of Anatomy & Pathology, anything done for the purposes of the criminal justice system, as described in the clause. Coroners' post-mortem examinations are not exempted, however, unless they consist of removal of material from a body at the place where it is found.

Clause 41: Religious relics

53.     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.

Supplementary

Clause 42: "Qualifying museum"

54.     This clause explains what a "qualifying museum" is for the purposes of Part 2 of the Bill. Basically, it is a museum with a permanent collection that is open to the public and which is a non-profit making institution. However, some museums, for example, those maintained by the Royal College of Surgeons, are not separate institutions. So the definition is extended to include museums which are maintained by a non-profit making institution. Subsection (3) explains when an institution is non-profit making for this purpose (i.e. when it is an "eligible institution").

PART 3 - MISCELLANEOUS AND GENERAL

Miscellaneous

Clause 44: Preservation for transplantation

55.     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 45: Surplus tissue

56.     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 55) 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 46: Offences relating to non-consensual analysis of DNA

57.     This clause makes it an offence to have any bodily material with a view to the DNA being analysed without qualifying consent and for a purpose other than one specified in clause 47. Under Schedule 5 what counts as "qualifying consent" for this purpose differs according to the nature of the material and the purpose for which the results of the analysis are to be used. Where the material is "relevant material" (as defined by clause 55) and the results of the analysis are to be used for a scheduled purpose, authority under Part 1 to use the material for a scheduled purpose constitutes "qualifying consent" to analysis for that purpose. Where the material is not "relevant material" or the results are not to be used for a scheduled purpose, "qualifying consent" basically means the consent of the person from whose body the material comes. Further rules apply where that person is a child or has died. The offence is subject to certain exceptions. Subsection 1(c) provides that the offence is not committed where the person reasonably believes the material to fall within one of the exceptions under subsection (2). Subsection (2) excepts from the offence material from the body of a person who died before the Bill comes into force and where 100 years have elapsed since their death, and also embryos outside the human body. Subsection (5) defines bodily material as material which has come from a human body and which consists of or includes human cells. This would include hair, nail and gametes (hair and nail from a living person, and gametes within the meaning of the Human Fertilisation and Embryology Act 1990, are conversely, excluded for the purposes of the consent provisions in clause 1 of the Bill).

Clause 47: Purposes for which DNA may be analysed without consent

58.     This clause lists the purposes for which material may be held for DNA analysis without consent. These include for the person's own medical treatment, for the purposes of a coroner or procurator fiscal, for preventing or detecting crime, for conducting a prosecution, for national security purposes or for implementing the order of a court. Subsection (2) provides that (if the person was living when the material was taken) DNA testing may also take place without consent where it is for various public health purposes or for practical training and education purposes. Subsections (3), (4) and (5) detail what constitutes a crime and prosecution for the purposes of subsection (2). Subsection (7) provides a power for the Secretary of State to amend the excepted purposes listed in subsection (1) and (2) by order.

General

Clause 48: Power to give effect to Community obligations

59.     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 the draft directive on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, which is currently being negotiated. If the directive is adopted, the power in this clause will allow any necessary amendments to be made to the Bill by regulations.

Clause 49: Power to de-accession human remains

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

61.     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.

62.     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.

63.     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 50: Powers of inspection, entry, search and seizure

64.     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 52: Prosecutions

65.     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 60: Transition

66.     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

67.     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.

68.     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.

69.     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.

70.     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.

71.     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 13 November 2003, John Reid, Secretary of State for Health, 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

72.     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.

73.     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.

74.     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.

75.     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.

76.     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.

77.     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)

78.     The Retained Organs Commission is 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

79.     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 and Public Mortuaries

80.     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.

81.     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. There are about 5 tissue banks for research in England and Wales, and 3 more are planned. Most are funded by the NHS or a mix of NHS/academic institutions/MRC and Wellcome. Public mortuaries are declining in numbers 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.

82.     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 is currently in negotiation.)

Inspection staff

83.     The HTA will have the power to commission other bodies to carry out inspections on its behalf, such as new CHAI and the MHRA, since these will already be carrying out inspections in this field. In this way the burden of inspection on those to be inspected should be minimised, as well as the demands on the pool of appropriately qualified and trained staff to carry out the work.

 
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Prepared: 4 December 2003