http://www.legislation.gov.uk/ukpga/2004/30/contentsHuman Tissue Act 2004An Act to make provision with respect to activities involving human tissue; to make provision about the transfer of human remains from certain museum collections; and for connected purposes.texttext/xmlenStatute Law Database2011-05-272004-11-15 s. 14(1)(h)reg. 30(2)Human Tissue Act 2004The Human Tissue (Quality and Safety for Human Application) Regulations 2007s. 14(2A)reg. 30(3)Human Tissue Act 2004The Human Tissue (Quality and Safety for Human Application) Regulations 2007s. 15(a)(b)reg. 9Human Tissue Act 2004The Human Tissue (Quality and Safety for Human Application) Regulations 2007s. 15(c)(ii)reg. 9Human Tissue Act 2004The Human Tissue (Quality and Safety for Human Application) Regulations 2007s. 15(d)(e)(f)reg. 9Human Tissue Act 2004The Human Tissue (Quality and Safety for Human Application) Regulations 2007s. 16(2A)(2B)reg. 31(2)Human Tissue Act 2004The Human Tissue (Quality and Safety for Human Application) Regulations 2007s. 17reg. 8(2)(a)Human Tissue Act 2004The Human Tissue (Quality and Safety for Human Application) Regulations 2007s. 19(1)(2)reg. 8(2)(b)Human Tissue Act 2004The Human Tissue (Quality and Safety for Human Application) Regulations 2007s. 19(5)(7)reg. 8(2)(b)Human Tissue Act 2004The Human Tissue (Quality and Safety for Human Application) Regulations 2007s. 20-24reg. 8(2)(c)(4)Human Tissue Act 2004The Human Tissue (Quality and Safety for Human Application) Regulations 2007s. 26(1)reg. 9Human Tissue Act 2004The Human Tissue (Quality and Safety for Human Application) Regulations 2007s. 26(4)-(8)reg. 9Human Tissue Act 2004The Human Tissue (Quality and Safety for Human Application) Regulations 2007s. 37(1)-(5)reg. 8(2)(d)(5)Human Tissue Act 2004The Human Tissue (Quality and Safety for Human Application) Regulations 2007s. 41reg. 32Human Tissue Act 2004The Human Tissue (Quality and Safety for Human Application) Regulations 2007Sch. 3 para. 2(4)(c)-(f)reg. 8(2)(e)(6)(7)Human Tissue Act 2004The Human Tissue (Quality and Safety for Human Application) Regulations 2007Sch. 3 para. 2(5)reg. 8(2)(e)(6)(7)Human Tissue Act 2004The Human Tissue (Quality and Safety for Human Application) Regulations 2007Sch. 3 para. 5reg. 8(2)(e)(6)(7)Human Tissue Act 2004The Human Tissue (Quality and Safety for Human Application) Regulations 2007Sch. 3 para. 7-11reg. 8(2)(e)(6)(7)Human Tissue Act 2004The Human Tissue (Quality and Safety for Human Application) Regulations 2007Sch. 3 para. 13reg. 8(2)(e)(6)(7)Human Tissue Act 2004The Human Tissue (Quality and Safety for Human Application) Regulations 2007Sch. 3 para. 13(1)reg. 33Human Tissue Act 2004The Human Tissue (Quality and Safety for Human Application) Regulations 2007s. 1(2)Sch. 21 para. 48Human Tissue Act 2004Coroners and Justice Act 2009s. 5(3)Sch. 21 para. 49(2)Human Tissue Act 2004Coroners and Justice Act 2009s. 5(4)(a)(i)Sch. 21 para. 49(3)Human Tissue Act 2004Coroners and Justice Act 2009s. 39(6)(c)Sch. 1 para. 55Human Tissue Act 2004The Armed Forces Act 2006 (Transitional Provisions etc) Order 2009s. 43(5A)Sch. 21 para. 50Human Tissue Act 2004Coroners and Justice Act 2009Sch. 2 para. 9A-9CSch. 3 para. 7Human Tissue Act 2004Health Act 2009Sch. 4 para. 5(4)(c)Sch. 1 para. 55Human Tissue Act 2004The Armed Forces Act 2006 (Transitional Provisions etc) Order 2009Sch. 6 para. 3Sch. 23 Pt. 1Human Tissue Act 2004Coroners and Justice Act 2009specified amended provision(s)art. 3commencement order for 2006 c. 52Human Tissue Act 2004The Armed Forces Act 2006 (Commencement No. 4) Order 2009specified amended provision(s)OrderHuman Tissue Act 2004The Armed Forces Act 2006 (Transitional Provisions etc) Order 2009specified amended provision(s)art. 3 4commencement order for 2006 c. 52Human Tissue Act 2004The Armed Forces Act 2006 (Commencement No. 5) Order 2009specified amended provision(s)art. 2commencement order for 2008 c. 22Human Tissue Act 2004The Human Fertilisation and Embryology Act 2008 (Commencement No.2 and Transitional Provision) and (Commencement No.1 Amendment) Order 2009s. 33(1)(2)reg. 11Human Tissue Act 2004The Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006s. 33(1)(2)art. 7Human Tissue Act 2004The Human Tissue Act 2004 (Commencement No. 5 and Transitional Provisions) Order 2006s. 33(1)(2)art. 2(3)Human Tissue Act 2004The Human Tissue Act 2004 (Commencement No.5 and Transitional Provisions) (Amendment) Order 2006s. 39(6)(c)Sch. 16 para. 241Human Tissue Act 2004Armed Forces Act 2006Sch. 4 para. 5(4)(c)Sch. 16 para. 242Human Tissue Act 2004Armed Forces Act 2006specified amended provision(s)art. 2-7 Sch.commencement order for 2005 c. 15Human Tissue Act 2004The Serious Organised Crime and Police Act 2005 (Commencement No. 5 and Transitional and Transitory Provisions and Savings) Order 2006specified provision(s)art. 2 4commencement order for 2004 c. 30Human Tissue Act 2004The Human Tissue Act 2004 (Commencement No. 4 and Transitional Provisions) Order 2006specified provision(s)art. 2commencement order for 2004 c. 30Human Tissue Act 2004The Human Tissue Act 2004 (Commencement No.5 and Transitional Provisions) (Amendment) Order 2006specified provision(s) and purposesart. 2-4commencement order for 2004 c. 30Human Tissue Act 2004The Human Tissue Act 2004 (Commencement No. 4 and Transitional Provisions) Order 2006specified provision(s) and purposesart. 2 3commencement order for 2004 c. 30. This SI is amended by SI 2006/2169Human Tissue Act 2004The Human Tissue Act 2004 (Commencement No. 5 and Transitional Provisions) Order 2006s. 1(9A)Sch. 7 para. 22(a)Human Tissue Act 2004Human Fertilisation and Embryology Act 2008s. 1(10A)Sch. 7 para. 22(b)Human Tissue Act 2004Human Fertilisation and Embryology Act 2008s. 14(2ZA)Sch. 7 para. 23Human Tissue Act 2004Human Fertilisation and Embryology Act 2008s. 54(6)Sch. 7 para. 24Human Tissue Act 2004Human Fertilisation and Embryology Act 2008s. 27(4)(a)Sch. 4 para. 12(2)Human Tissue Act 2004The Civil Partnership Act 2004 (Overseas Relationships and Consequential, etc. Amendments) Order 2005s. 54(9)Sch. 4 para. 12(3)Human Tissue Act 2004The Civil Partnership Act 2004 (Overseas Relationships and Consequential, etc. Amendments) Order 2005specified provision(s)art. 3 Sch.commencement order for 2004 c. 30Human Tissue Act 2004The Human Tissue Act 2004 (Commencement No.1) Order 2005specified provision(s) and purposesart. 2commencement order for 2004 c. 30Human Tissue Act 2004The Human Tissue Act 2004 (Commencement No.3 and Transitional Provisions) Order 2005specified amended provision(s)art. 2-4commencement order for 2009 c. 21Human Tissue Act 2004The Health Act 2009 (Commencement No. 1) Order 2010Blanket amendmentart. 3 6Human Tissue Act 2004The Treaty of Lisbon (Changes in Terminology) Order 2011 Human Tissue Act 2004Part 1Removal, storage and use of human organs and other tissue for scheduled purposes1Authorisation of activities for scheduled purposes2“Appropriate consent”: children3“Appropriate consent”: adults4Nominated representatives5Prohibition of activities without consent etc.6Activities involving material from adults who lack capacity to consent7Powers to dispense with need for consent8Restriction of activities in relation to donated material9Existing holdings10Existing anatomical specimens11Coroners12Interpretation of Part 1Part 2Regulation of activities involving human tissueThe Human Tissue Authority13The Human Tissue Authority14Remit15General functionsLicensing16Licence requirement17Persons to whom licence applies18Duty of the designated individual19Right to reconsideration of licensing decisions20Appeals committees21Procedure on reconsideration22Appeal on point of law23Conduct of licensed activities24Changes of licence circumstance25Breach of licence requirementCodes of practice26Preparation of codes27Provision with respect to consent28Effect of codes29Approval of codesAnatomy30Possession of anatomical specimens away from licensed premises31Possession of former anatomical specimens away from licensed premisesTrafficking32Prohibition of commercial dealings in human material for transplantationTransplants33Restriction on transplants involving a live donor34Information about transplant operationsGeneral35Agency arrangements and provision of services36Annual report37Directions38Duties in relation to carrying out functionsExceptions39Criminal justice purposes40Religious relicsSupplementary41Interpretation of Part 2Part 3Miscellaneous and generalMiscellaneous42Power of Human Tissue Authority to assist other public authorities43Preservation for transplantation44Surplus tissue45Non-consensual analysis of DNA46Power to give effect to Community obligations47Power to de-accession human remainsGeneral48Powers of inspection, entry, search and seizure49Offences by bodies corporate50Prosecutions51Offences: Northern Ireland52Orders and regulations53“Relevant material”54General interpretation55Financial provisions56Consequential amendments57Repeals and revocations58Transition59Extent60Commencement61Short titleSCHEDULESSCHEDULE 1Scheduled purposesPart 1Purposes requiring consent: general1Anatomical examination. 2Determining the cause of death. 3Establishing after a person’s death the efficacy of any drug...4Obtaining scientific or medical information about a living or deceased...5Public display. 6Research in connection with disorders, or the functioning, of the...7Transplantation. Part 2Purposes requiring consent: deceased persons8Clinical audit. 9Education or training relating to human health. 10Performance assessment. 11Public health monitoring. 12Quality assurance. SCHEDULE 2The human tissue authorityMembership1(1) The Authority shall consist of— (a) a chairman appointed...Disqualification2A person is disqualified for being appointed as chairman of...3(1) A person is disqualified for being appointed as chairman...Tenure of office4Subject to the following provisions of this Schedule, the chairman...5(1) The terms of appointment of the chairman and other...6Previous service as chairman or other member of the Authority...7A person holding office as chairman or other member of...8A person holding office as chairman or other member of...9A person may be removed from office as chairman or...Remuneration and pensions of members10(1) The Authority may pay to the chairman or any...Staff11The Authority may appoint such staff as it considers appropriate,...Proceedings12Subject to any provision of this Act, the Authority may...13The validity of any proceedings of the Authority shall not...Members' interests14(1) The Authority shall establish and maintain a system for...Finance15The Secretary of State may out of money provided by...Accounts and audit16(1) The Authority shall keep proper accounts and proper records...Instruments17The application of the seal of the Authority shall be...18A document purporting— (a) to be duly executed under the...Status19(1) The Authority is not to be regarded as the...Supplementary powers20The Authority may do anything which is calculated to facilitate,...21The Authority may delegate any of its functions (to such...Application of Statutory Instruments Act 194622The Statutory Instruments Act 1946 (c. 36) shall apply to...Public records23In Schedule 1 to the Public Records Act 1958 (c....Investigation by Parliamentary Commissioner24In Schedule 2 to the Parliamentary Commissioner Act 1967 (c....House of Commons Disqualification25In Part 2 of Schedule 1 to the House of...Northern Ireland Assembly Disqualification26In Part 2 of Schedule 1 to the Northern Ireland...Freedom of information27In Part 6 of Schedule 1 to the Freedom of...SCHEDULE 3Licences for the purposes of section 16Power to grant licence1The Authority may on application grant a licence for the...Characteristics of licence2(1) A licence shall not authorise the carrying-on of more...3(1) This paragraph applies to a licence authorising the storage...4(1) This paragraph applies to a licence authorising the activity...Power to impose conditions5The Authority may grant a licence subject to such further...Pre-conditions to grant of licence6(1) The Authority may not grant a licence in pursuance...Power to revoke licence7(1) The Authority may revoke a licence on application by—...Power to vary licence8(1) The Authority may on application by the holder of...Power to suspend licence9(1) Where the Authority— (a) has reasonable grounds to suspect...Procedure in relation to licensing decisions10(1) Before making a decision— (a) to refuse an application...Notification of licensing decisions11(1) In the case of a decision to grant a...Permission for the purposes of the licence condition required by paragraph 3(2)12(1) This paragraph applies to a licence authorising the storage...Applications under this Schedule13(1) The Authority may by regulations make provision about applications...SCHEDULE 4Section 45: supplementaryPart 1Qualifying consentIntroductory1This Part of this Schedule makes provision for the interpretation...Qualifying consent2(1) In relation to analysis of DNA manufactured by the...Application to Scotland3(1) In its application to Scotland, paragraph 2 has effect...Part 2Use for an excepted purposeIntroductory4This Part of this Schedule makes provision for the interpretation...Purposes of general application5(1) Use of the results of an analysis of DNA...Purpose of research in connection with disorders, or functioning, of the human body6(1) Use of the results of an analysis of DNA...Purposes relating to existing holdings7Use of the results of an analysis of DNA for...Purposes relating to material from body of a living person8Use of the results of an analysis of DNA for...9(1) Use of the results of an analysis of DNA...10Use of the results of an analysis of DNA for...Purpose authorised under section 111Use of the results of an analysis of DNA for...Purposes relating to DNA of adults who lack capacity to consent12(1) Use of the results of an analysis of DNA...Power to amend paragraphs 5, 7 and 813The Secretary of State may by order amend paragraph 5,...SCHEDULE 5Powers of inspection, entry, search and seizureInspection of statutory records1(1) A duly authorised person may require a person to...Entry and inspection of licensed premises2(1) A duly authorised person may at any reasonable time...Entry and search in connection with suspected offence3(1) If a justice of the peace is satisfied on...Execution of warrants4(1) Entry and search under a warrant under paragraph 3...Seizure in the course of inspection or search5(1) A duly authorised person entering and inspecting premises under...Powers: supplementary6(1) Power under this Schedule to enter and inspect or...7(1) A person’s right to exercise a power under this...Enforcement8(1) A person commits an offence if— Interpretation9In this Schedule, “duly authorised person”, in the context of...SCHEDULE 6Consequential amendmentsWills Act 1837 (c. 26)1In section 1 of the Wills Act 1837, in the...Anatomy Act 1984 (c. 14)2In section 4 of the Anatomy Act 1984 (lawful examinations),...Coroners Act 1988 (c. 13)3(1) The Coroners Act 1988 is amended as follows. Human Organ Transplants Act 1989 (c. 31)4In section 1(1)(a) of the Human Organ Transplants Act 1989,...Criminal Justice and Police Act 2001 (c. 16)5(1) Part 2 of the Criminal Justice and Police Act...Enterprise Act 2002 (c. 40)6(1) Paragraph 3(1)(b), (2) and (3) of Schedule 2 shall...Asylum and Immigration (Treatment of Claimants, etc.) Act 20047In section 4 of the Asylum and Immigration (Treatment of...SCHEDULE 7Repeals and revocationsPart 1RepealsPart 2Revocations2004 c. 30An Act to make provision with respect to activities involving human tissue; to make provision about the transfer of human remains from certain museum collections; and for connected purposes.[15th November 2004]Be it enacted by the Queen’s most Excellent Majesty, by and with the advice and consent of the Lords Spiritual and Temporal, and Commons, in this present Parliament assembled, and by the authority of the same, as follows:—