Human Tissue Act 2005. SUMMARY OF THE ACT 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.
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.
1. Professor Michael Banner (Director, ESRC Genomics Forum) 2. Dr David Davies (Licensed Anatomist, reader and lecturer in neuroscience ) 3. Mrs Shirley Harrison (Company Director) 4. Professor James Ironside (Professor of Clinical Neuropathology, University of Edinburgh) 5. Jane Jeffs (Retired Chief Officer of Community Health Councils – Member appointed by the National Assembly for Wales ) 6. Professor El-Nasir Lalani (Professor of Molecular and Cellular Pathology and Honorary Consultant Histopathologist) 7. Ms Sharmila Nebhrajani (Chief Operating Officer and Finance Director, BBC New Media & Technology ) 8. Dr Andrew Reid (HM Coroner, Inner North London) 9. Mr Keith Rigg (Consultant General & Transplant Surgeon, Nottingham City Hospital NHS Trust.) 10. Dr Katherine Robson-Brown (Archaeologist, University of Bristol) 11. Ms Helen Shaw (Co-Director of INQUEST charity working with bereaved people attending inquests ) 12. Professor Sir James Underwood (Professor of Pathology, University of Sheffield. President, Royal College of Pathologists) 13. Mrs Michaela Willis (Chief Executive of the National Bereavement Partnership)
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.
Who? – Industry lobbying was led by Laura Gilbert, Head of Public Affairs for the BioIndustry Association (BIA)
With BIVDA and ABPI participating
Interested industry representatives including Corinne Pluchino,
Consulted with other parties:
BMA, MRC, Wellcome Foundation and Royal College of Pathology
Recognised that each organisation would have its own interests but consolidation would be most successful approach
In House of Commons:
Introduction 3 December 2003
Second Reading 15 January 2004 Committee 27 & 29 January 2004 3 & 5 February 2004
Report & Third Reading 28 June 2004
Commons Consideration of Lords
Amendments 10 November 2004
In House of Lords:
First Reading 29 June 2004
Second Reading 22 July 2004
Grand Committee 15 September 2004 16 September 2004 11 October 2004
Report 25 October
Third Reading 3 November 2004
Royal Assent -- 15 November 2004