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| Human Tissue Bill |
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These notes refer to the Human Tissue Bill HUMAN TISSUE BILLEXPLANATORY NOTESINTRODUCTION 1. These explanatory notes 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 of the Bill and to help inform debate upon it. They do not form part of the Bill. 2. The explanatory notes are to be read in conjunction with the Bill and are not meant to be a comprehensive description of the Bill. So where a clause or part of a clause of the Bill does not seem to require any explanation or comment, none is given. 3. The Bill will extend to England, Wales and Northern Ireland, except for clauses 46 and 47 (non-consensual DNA-analysis), which will apply throughout the UK. Clause 49 (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 Human Tissue Bill 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. [Bill 9—EN] 53/3 5. This Bill arises 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 forms the basis of the proposals in the Bill. 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 Bill, except clause 49, 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 Bill includes powers for the Assembly to appoint a member to the Human Tissue Authority and to consent to the bringing of activities involving human tissue which are carried on by museums in Wales under the auspices of the Authority. The Secretary of State will also be required to consult the Assembly on a range of issues, including statutory codes of practice. Clause 49 deals with museums. Responsibility for museums in Wales is transferred to the Assembly. So although the clause extends to England and Wales, the bodies to which this clause applies do not include museums in Wales. The Bill has been drafted in liaison and agreement with the Assembly. THE BILL 8. The Bill 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 Bill is in three parts and has eight schedules: Part 1 is about consent. It sets out the requirement to obtain appropriate consent to carry out activities regulated under the Bill: 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 and 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 Bill, and allows storage and use of human material, obtained from living persons, for limited 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 all human organ transplants between living persons under the HTA and prohibits commercial dealing in human material. Part 2 also sets up, under the HTA, the Inspectorate of Anatomy & Pathology and the Inspectorate for Organs and Tissues for Human Use and sets out their functions. Part 3 deals with various important supplementary issues and general provisions. Clause 44 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. Clause 45 provides for disposal of human material which is no longer to be kept. Clause 46 makes it an offence, with specified exceptions, for a person to have human material with a view to analysing its DNA without consent. Clause 49 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 CLAUSES PART 1 - REMOVAL, STORAGE AND USE OF HUMAN ORGANS AND OTHER TISSUE FOR SCHEDULED PURPOSES Clause 1: Authorisation of activities for scheduled purposes 10. Clause 1 is the foundation of the Bill. It establishes that consent from an appropriate person ("appropriate consent" as defined in clauses 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 clause 55 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 clause 56(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), (5) and (6) 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. 13. Subsection (7) 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 or necessary for the public health of the nation. 14. Subsection (8) 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 (9) is aimed at ensuring that bodies and relevant material are not exported and re-imported simply to get around the consent requirements. Clause 2: "Appropriate consent": children 15. Clause 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 the Bill, 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 Bill, 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) and (5) 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. 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 (6) 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 clause 56(9) and dealt with further at clause 24(4)). Clause 3: "Appropriate consent": adults 18. Clause 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) and (4) 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. For other scheduled purposes, if the adult made no prior decision, a person nominated by him in accordance with clause 4 to make decisions after his death or, failing that, someone in a "qualifying relationship" (as listed in clause 56(9) and dealt with further at clause 24(4)) may give consent. Clause 4: Nominated Representatives 19. This clause 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. Clause 5: Prohibition of activities without consent 20. This clause sets out the offences committed where appropriate consent is not obtained to the activities listed in clause 1, and provides that the offences will not apply where a person believes on reasonable grounds that appropriate consent has been given, or that it is not required. 21. Subsection (1) penalises the carrying-out of any of the activities to which clause 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. Subsections (2) to (6) relate to offences and penalties in connection with anatomical examination which have been transferred from the Anatomy Act 1984. Clause 6: Restriction of activities in relation to donated material 22. This clause provides that, where the body of a deceased person or relevant material from a human body is the subject of any consent under clause 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 exclude from the offence the use of tissue in, for example, performance evaluation of in vitro diagnostic testing kits, where consent to use the tissue for such evaluation is already required under the In Vitro Diagnostic Medical Devices Regulations (SI 2000/1315). Clause 7: Existing Holdings 23. This clause 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 clause is that use, or storage for use, for a scheduled purpose is authorised under clause 1(1) without the need for appropriate consent. However, this does not apply to use for the purpose of anatomical examination. Existing anatomical specimens are the subject of clause 8. The code of practice to be issued by the HTA under clause 23 will deal with the storage, use and disposal of existing holdings. Clause 8: Existing Anatomical Specimens 24. This clause provides for what should be done, once the consent provisions of the Bill 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 clause 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 Bill came into force, the authority is to be treated as "appropriate consent" to storage for the purposes of education and research. 25. Subsection (6) is intended to ensure that, where authority under the Anatomy Act has been given on terms, the authority under the Bill which is based on that authority is also subject to those terms. Clause 9: Coroners 26. In order to maintain the current legal position regarding coroners, this clause exempts from the requirements of Part 1 of the Bill anything done for the functions of a coroner or under his 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 clause 1 to act in relation to the body or material does not apply. PART 2 - REGULATION OF ACTIVITIES INVOLVING HUMAN TISSUE The Human Tissue Authority Clause 10: The Human Tissue Authority 27. This clause 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). Clause 11: Remit 28. 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 the activities of certain museums from the remit of the HTA (clause 42 explains which museums for these purposes). 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 Clause 13: Licence Requirements 29. Subsection (1) prohibits the carrying on of activities to which the clause 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 museums from the licensing requirement if they satisfy the requirements of clause 42 (broadly, they must be open to the public and not-for-profit). Subsection (5) provides that the Secretary of State may by regulations add, remove or alter the description of an activity listed in the clause. 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. Clause 14: Persons to whom licence applies 30. This clause 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. Clause 15: Duty of the designated individual 31. This clause 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. Clause 16: Right to reconsideration of licensing decisions 32. This clause 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. Clause 17: Appeals Committee 33. 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 16. Clause 18: Procedure on reconsideration 34. 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 20: Conduct of licensed activities 35. 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 21: Changes of licence circumstance 36. Subsections (1) -(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 22: Breach of licence requirement 37. This clause establishes the offence of carrying on a licensed activity otherwise than under the authority of a licence granted under clause 13(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 23: Preparation of codes 38. Subsection (1) provides that the HTA may prepare codes of practice giving guidance and setting standards in relation to activities within its remit. Subsection (2) lists the matters which must be dealt with in the codes of practice prepared by the HTA. Subsection (4) requires the HTA to consult the National Assembly for Wales and relevant department in Northern Ireland before preparing codes of practice which relate to Wales and Northern Ireland. Subsection (5) requires the HTA to publish the codes in a way likely to bring them to the attention of those interested. Subsection (6) provides that codes may make different provision for England, Wales and Northern Ireland. Clause 24: Provision with respect to consent 39. Subsection (1) provides that in codes of practice dealing with the matters mentioned the HTA must lay down standards relating to obtaining consent. Subsection (2) requires that the standards laid down must include provision to the effect set out in subsections (4) to (8). 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. |
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