Human Tissue Act 2004

1. Introductory Text

2. Part 1 Removal, storage and use of human organs and other tissue for scheduled purposes

   1. 1. Authorisation of activities for scheduled purposes

   2. 2. “Appropriate consent”: children

   3. 3. “Appropriate consent”: adults

   4. 4. Nominated representatives

   5. 5. Prohibition of activities without consent etc.

   6. 6. Activities involving material from adults who lack capacity to consent

   7. 7. Powers to dispense with need for consent

   8. 8. Restriction of activities in relation to donated material

   9. 9. Existing holdings

   10. 10. Existing anatomical specimens

   11. 11. Coroners

   12. 12. Interpretation of Part 1

3. Part 2 Regulation of activities involving human tissue

   1. The Human Tissue Authority

      1. 13. The Human Tissue Authority

      2. 14. Remit

      3. 15. General functions

   2. Licensing

      1. 16. Licence requirement

      2. 17. Persons to whom licence applies

      3. 18. Duty of the designated individual

      4. 19. Right to reconsideration of licensing decisions

      5. 20. Appeals committees

      6. 21. Procedure on reconsideration

      7. 22. Appeal on point of law

      8. 23. Conduct of licensed activities

      9. 24. Changes of licence circumstance

      10. 25. Breach of licence requirement

   3. Codes of practice

      1. 26. Preparation of codes

      2. 27. Provision with respect to consent

      3. 28. Effect of codes

      4. 29. Approval of codes

   4. Anatomy

      1. 30. Possession of anatomical specimens away from licensed premises

      2. 31. Possession of former anatomical specimens away from licensed premises

   5. Trafficking

      1. 32. Prohibition of commercial dealings in human material for transplantation

   6. Transplants

      1. 33. Restriction on transplants involving a live donor

      2. 34. Information about transplant operations

   7. General

      1. 35. Agency arrangements and provision of services

      2. 36. Annual report

      3. 37. Directions

      4. 38. Duties in relation to carrying out functions

   8. Exceptions

      1. 39. Criminal justice purposes

      2. 40. Religious relics

   9. Supplementary

      1. 41. Interpretation of Part 2

4. Part 3 Miscellaneous and general

   1. Miscellaneous

      1. 42. Power of Human Tissue Authority to assist other public authorities

      2. 43. Preservation for transplantation

      3. 44. Surplus tissue

      4. 45. Non-consensual analysis of DNA

      5. 46. Power to give effect to Community obligations

      6. 47. Power to de-accession human remains

   2. General

      1. 48. Powers of inspection, entry, search and seizure

      2. 49. Offences by bodies corporate

      3. 50. Prosecutions

      4. 51. Offences: Northern Ireland

      5. 52. Orders and regulations

      6. 53. “Relevant material”

      7. 54. General interpretation

      8. 55. Financial provisions

      9. 56. Consequential amendments

      10. 57. Repeals and revocations

      11. 58. Transition

      12. 59. Extent

      13. 60. Commencement

      14. 61. Short title

5. SCHEDULES

   1. SCHEDULE 1

      Scheduled purposes

      1. Part 1 Purposes requiring consent: general

         1. 1. Anatomical examination.

         2. 2. Determining the cause of death.

         3. 3. Establishing after a person’s death the efficacy of any drug...

         4. 4. Obtaining scientific or medical information about a living or deceased...

         5. 5. Public display.

         6. 6. Research in connection with disorders, or the functioning, of the...

         7. 7. Transplantation.

      2. Part 2 Purposes requiring consent: deceased persons

         1. 8. Clinical audit.

         2. 9. Education or training relating to human health.

         3. 10. Performance assessment.

         4. 11. Public health monitoring.

         5. 12. Quality assurance.

   2. SCHEDULE 2

      The human tissue authority

      1. Membership

         1. 1. (1) The Authority shall consist of— (a) a chairman appointed...

      2. Disqualification

         1. 2. A person is disqualified for being appointed as chairman of...

         2. 3. (1) A person is disqualified for being appointed as chairman...

      3. Tenure of office

         1. 4. Subject to the following provisions of this Schedule, the chairman...

         2. 5. (1) The terms of appointment of the chairman and other...

         3. 6. Previous service as chairman or other member of the Authority...

         4. 7. A person holding office as chairman or other member of...

         5. 8. A person holding office as chairman or other member of...

         6. 9. A person may be removed from office as chairman or...

      4. Remuneration and pensions of members

         1. 10. (1) The Authority may pay to the chairman or any...

      5. Staff

         1. 11. The Authority may appoint such staff as it considers appropriate,...

      6. Proceedings

         1. 12. Subject to any provision of this Act, the Authority may...

         2. 13. The validity of any proceedings of the Authority shall not...

      7. Members' interests

         1. 14. (1) The Authority shall establish and maintain a system for...

      8. Finance

         1. 15. The Secretary of State may out of money provided by...

      9. Accounts and audit

         1. 16. (1) The Authority shall keep proper accounts and proper records...

      10. Instruments

          1. 17. The application of the seal of the Authority shall be...

          2. 18. A document purporting— (a) to be duly executed under the...

      11. Status

          1. 19. (1) The Authority is not to be regarded as the...

      12. Supplementary powers

          1. 20. The Authority may do anything which is calculated to facilitate,...

          2. 21. The Authority may delegate any of its functions (to such...

      13. Application of Statutory Instruments Act 1946

          1. 22. The Statutory Instruments Act 1946 (c. 36) shall apply to...

      14. Public records

          1. 23. In Schedule 1 to the Public Records Act 1958 (c....

      15. Investigation by Parliamentary Commissioner

          1. 24. In Schedule 2 to the Parliamentary Commissioner Act 1967 (c....

      16. House of Commons Disqualification

          1. 25. In Part 2 of Schedule 1 to the House of...

      17. Northern Ireland Assembly Disqualification

          1. 26. In Part 2 of Schedule 1 to the Northern Ireland...

      18. Freedom of information

          1. 27. In Part 6 of Schedule 1 to the Freedom of...

   3. SCHEDULE 3

      Licences for the purposes of section 16

      1. Power to grant licence

         1. 1. The Authority may on application grant a licence for the...

      2. Characteristics of licence

         1. 2. (1) A licence shall not authorise the carrying-on of more...

         2. 3. (1) This paragraph applies to a licence authorising the storage...

         3. 4. (1) This paragraph applies to a licence authorising the activity...

      3. Power to impose conditions

         1. 5. The Authority may grant a licence subject to such further...

      4. Pre-conditions to grant of licence

         1. 6. (1) The Authority may not grant a licence in pursuance...

      5. Power to revoke licence

         1. 7. (1) The Authority may revoke a licence on application by—...

      6. Power to vary licence

         1. 8. (1) The Authority may on application by the holder of...

      7. Power to suspend licence

         1. 9. (1) Where the Authority— (a) has reasonable grounds to suspect...

      8. Procedure in relation to licensing decisions

         1. 10. (1) Before making a decision— (a) to refuse an application...

      9. Notification of licensing decisions

         1. 11. (1) In the case of a decision to grant a...

      10. Permission for the purposes of the licence condition required by paragraph 3(2)

          1. 12. (1) This paragraph applies to a licence authorising the storage...

      11. Applications under this Schedule

          1. 13. (1) The Authority may by regulations make provision about applications...

   4. SCHEDULE 4

      Section 45: supplementary

      1. Part 1 Qualifying consent

         1. Introductory

            1. 1. This Part of this Schedule makes provision for the interpretation...

         2. Qualifying consent

            1. 2. (1) In relation to analysis of DNA manufactured by the...

         3. Application to Scotland

            1. 3. (1) In its application to Scotland, paragraph 2 has effect...

      2. Part 2 Use for an excepted purpose

         1. Introductory

            1. 4. This Part of this Schedule makes provision for the interpretation...

         2. Purposes of general application

            1. 5. (1) Use of the results of an analysis of DNA...

         3. Purpose of research in connection with disorders, or functioning, of the human body

            1. 6. (1) Use of the results of an analysis of DNA...

         4. Purposes relating to existing holdings

            1. 7. Use of the results of an analysis of DNA for...

         5. Purposes relating to material from body of a living person

            1. 8. Use of the results of an analysis of DNA for...

            2. 9. (1) Use of the results of an analysis of DNA...

            3. 10. Use of the results of an analysis of DNA for...

         6. Purpose authorised under section 1

            1. 11. Use of the results of an analysis of DNA for...

         7. Purposes relating to DNA of adults who lack capacity to consent

            1. 12. (1) Use of the results of an analysis of DNA...

         8. Power to amend paragraphs 5, 7 and 8

            1. 13. The Secretary of State may by order amend paragraph 5,...

   5. SCHEDULE 5

      Powers of inspection, entry, search and seizure

      1. Inspection of statutory records

         1. 1. (1) A duly authorised person may require a person to...

      2. Entry and inspection of licensed premises

         1. 2. (1) A duly authorised person may at any reasonable time...

      3. Entry and search in connection with suspected offence

         1. 3. (1) If a justice of the peace is satisfied on...

      4. Execution of warrants

         1. 4. (1) Entry and search under a warrant under paragraph 3...

      5. Seizure in the course of inspection or search

         1. 5. (1) A duly authorised person entering and inspecting premises under...

      6. Powers: supplementary

         1. 6. (1) Power under this Schedule to enter and inspect or...

         2. 7. (1) A person’s right to exercise a power under this...

      7. Enforcement

         1. 8. (1) A person commits an offence if—

      8. Interpretation

         1. 9. In this Schedule, “duly authorised person”, in the context of...

   6. SCHEDULE 6

      Consequential amendments

      1. Wills Act 1837 (c. 26)

         1. 1. In section 1 of the Wills Act 1837, in the...

      2. Anatomy Act 1984 (c. 14)

         1. 2. In section 4 of the Anatomy Act 1984 (lawful examinations),...

      3. Coroners Act 1988 (c. 13)

         1. 3. (1) The Coroners Act 1988 is amended as follows.

      4. Human Organ Transplants Act 1989 (c. 31)

         1. 4. In section 1(1)(a) of the Human Organ Transplants Act 1989,...

      5. Criminal Justice and Police Act 2001 (c. 16)

         1. 5. (1) Part 2 of the Criminal Justice and Police Act...

      6. Enterprise Act 2002 (c. 40)

         1. 6. (1) Paragraph 3(1)(b), (2) and (3) of Schedule 2 shall...

      7. Asylum and Immigration (Treatment of Claimants, etc.) Act 2004

         1. 7. In section 4 of the Asylum and Immigration (Treatment of...

   7. SCHEDULE 7

      Repeals and revocations

      1. Part 1 Repeals

      2. Part 2 Revocations