2004 Chapter 30

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These notes refer to the Human Tissue Act 2004(c. 30) which received Royal Assent on 15 November 2004

HUMAN TISSUE ACT 2004

EXPLANATORY NOTES

INTRODUCTION

1.     These explanatory notes relate to the Human Tissue Act 2004 which received Royal Assent on 15 November 2004. They have been prepared by the Department of Health, in consultation with the National Assembly for Wales and the Northern Ireland Office, in order to assist the reader in their understanding of the Act. They do not form part of the Act and have not been endorsed by Parliament.

2.     The explanatory notes need to be read in conjunction with the Act and are not meant to be a comprehensive description of the Act. So where a section or part of a section of the Act does not seem to require any explanation or comment, none is given.

3.     The Act will extend to England, Wales and Northern Ireland, except for section 45 and Schedule 4 (non-consensual DNA-analysis), which will apply throughout the UK. Section 47 (power of museums to 'de-accession' human remains) will also extend, as a matter of law, to the whole of the UK, but will only apply to named museums in England.

SUMMARY AND BACKGROUND

4.     The purpose of the Act is to provide a consistent legislative framework for issues relating to whole body donation and the taking, storage and use of human organs and tissue. It will make consent the fundamental principle underpinning the lawful storage and use of human bodies, body parts, organs and tissue and the removal of material from the bodies of deceased persons. It will set up an over-arching authority which is intended to rationalise existing regulation of activities like transplantation and anatomical examination, and will introduce regulation of other activities like post mortem examinations, and the storage of human material for education, training and research. It is intended to achieve a balance between the rights and expectations of individuals and families, and broader considerations, such as the importance of research, education, training, pathology and public health surveillance to the population as a whole.

5.     The Act arose from concern raised by events at Bristol Royal Infirmary and the Royal Liverpool Children's Hospital (Alder Hey) 1999 - 2000. The Kennedy and Redfern inquiries at these hospitals established that organs and tissue from children who had died had often been removed, stored and used without proper consent. A subsequent census by the Chief Medical Officer for England (2000) and the Isaacs Report (2003) showed that storage and use of organs and tissue from both adults and children without proper consent has been widespread in the past. It also became clear that the current law in this area was not comprehensive, nor as clear and consistent as it might be for professionals or for the families involved. In Northern Ireland the Report of the Human Organs Inquiry (June 2002) had reached a similar conclusion.

6.     In advice to the Government, The Removal, Retention and Use of Human Organs and Tissue from Post Mortem Examination published in 2001, the Chief Medical Officer for England recommended that there should be a fundamental and broad revision of the law on human organs and tissues taken from adults or children, either during surgery or after death. A consultation document, Human Bodies, Human Choices was launched in July 2002, setting out proposals to review the current law in England and Wales. The broad approach to changing the law outlined in the consultation document drew a large degree of consensus and formed the basis of the proposals for the Act. In May 2001, the Department of Culture Media and Sport set up a Working Group on Human Remains which reported in November 2003, recommending that the laws preventing repatriation of human remains by certain national museums should be relaxed.

TERRITORIAL APPLICATION: WALES

7.     The Act has been drafted in liaison and agreement with the Welsh Assembly. Except for section 47, it deals with reserved matters and will apply equally in Wales. However, as it may impact on the National Health Service and other issues in Wales responsibility for which is transferred to the National Assembly for Wales, the Act includes powers for the Assembly to appoint a member to the Human Tissue Authority. The Secretary of State will also be required to consult the Assembly on a range of issues, including statutory codes of practice. Section 47 deals with museums. Responsibility for museums in Wales is transferred to the Assembly. So although the section extends to England and Wales, the bodies to which this section applies do not include museums in Wales.

THE ACT

8.     The Act will repeal and replace the Human Tissue Act 1961, the Anatomy Act 1984 and the Human Organ Transplants Act 1989 as they relate to England and Wales. It will also repeal and replace the Human Tissue Act (Northern Ireland) 1962, the Human Organ Transplants (Northern Ireland) Order 1989 and the Anatomy (Northern Ireland) Order 1992.

9.     The Act is in three parts and has seven schedules:

Part 1 is about consent. It sets out the requirement to obtain appropriate consent to carry out activities regulated under the Act: storage and use of whole bodies, removal, storage and use of human material (organs, tissues and cells) from the bodies of deceased persons, and storage and use of material from living people, for purposes set out in Schedule 1. It defines appropriate consent by reference to who may give it, and provides for a 'nominated representative' who may make decisions about regulated activities after a person's death. Part 1 makes it an offence to carry out regulated activities without appropriate consent, makes it unlawful to use bodies or human material, once donated, for purposes other than those set out in Schedule 1 and establishes penalties. Part 1 also sets out what should happen to 'existing holdings' of human material obtained before the consent provisions take effect. This Part also exempts coroners from the requirements of Part 1 of the Act, and allows storage and use of human material, obtained from living persons, for specified purposes without consent.

Part 1 does not apply to the removal (as opposed to the storage and use) of human material from living persons. The current law will continue to apply to that. Nor does Part 1 affect the existing law on storage and use of human material for purposes other than those mentioned in Part 1.

Part 2 is about the regulatory system to be established to make sure that regulated activities are carried out in a proper manner. It sets up the Human Tissue Authority (HTA) with a remit covering removal, storage, use and disposal of human material. It also sets out the range of activities for which a licence from the HTA is required. It prohibits the conduct of those activities without a licence and establishes penalties for so doing. This Part also sets out who will be responsible for a licence, their duties under a licence and related procedures. It provides for the HTA to issue codes of practice concerning the proper conduct of activities within its remit, to issue directions and make reports. Part 2 brings the regulation of transplants between living persons under the HTA and prohibits commercial dealing in human material.

Part 3 deals with various important supplementary issues and general provisions. Section 43 makes it clear that it is lawful for hospital authorities to take the minimum steps to preserve the organs of deceased persons whilst appropriate consent to transplantation is sought. Section 44 provides for disposal of human material which is no longer to be kept. Section 45 makes it an offence, with specified exceptions, for a person to have human material with a view to analysing its DNA without consent. Section 47 creates a power for certain national museums to transfer human remains out of their collections if they think it appropriate to do so. This Part also contains general provisions including powers of inspection, entry, search and seizure, the power to make regulations and orders by way of statutory instruments, interpretation and consequential changes to existing statutes.

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.