The Human Tissue Act 2004
| Published date | 01 September 2005 |
| Author | David Price |
| Date | 01 September 2005 |
| DOI | http://doi.org/10.1111/j.1468-2230.2005.00561.x |
LEGISLATION
The HumanTissue Act 2004
David Price
n
INTRODUCTION
The HumanTissue Bill, described in Parliament as a ‘landmark Bill’,
1
was int ro-
duced into the House of Commons on 3 December 2003 by Secretary of State
John Reid, was brought to the House of Lords on 29 June 2004, completed its
progress through the Upper Hou se on 10 November 2004, and received the Royal
Assent on 15 November 2004. It is due to come into force, for the most part, on
days to be speci¢ed in commencement orders. Full implementation is not antici-
pated until at least April 2006, although transitional arrangements will be put in
place.The Act will repeal in their entirety the HumanTissue Act1961, the Anat-
omyAct1984 and the Human OrganTransplants Act1989 (except with regard to
Scotland), and the Human Tissue Act (Northern Ireland) 1962, as well as making
various other smaller and consequential amendments.
The Act is principally a response to the furore generated by revelations about
practices relating to the retention and use of human tissue in the Bristol Royal
In¢rmary
2
(Kennedy) and Alder Hey Children’s Hospital in Liverpool
3
(Redfern)
Inquiry Reports, and more latterly the Isaacs Report,
4
in particular.
5
These
Reports catalogued local practices resulting in relatives, principally parents of
dead children, lacking appreciation of subsequent tissue retention and use for
research following (generally coroners’)
6
post-mortem examinations, often
resulting inthe burial or cremation of loved ones without therealisation that they
were not‘complete’, and somefurther burials or cremations of body parts.
7
It tran-
n
Professor of Medical Law, De Montfort University, Leicester.
1 Dr Ian Gibson MP, HC Debvol 416col 1012 15 Jan20 04.
2Bristol Inquiry Interim Report: Removal and Retention of Human Material, 2000 http://www.bristol-
inquiry.org.uk/interim_report/report.htm
3The Royal Liverpool Children’s Inquiry Report (The Stationery O⁄ce 2001) H.C. [Session 2000^1];
112-II, see http://www.rlcinquiry.org.uk/download/index/htm
4 HM Inspector of Anatomy,The Investigation of eventsthat followedthe death of Cyril MarkIsaacs,May
2003 http://www.doh.gov.uk/cmo/isaacsreport/
5 The Inquiries related to England and Wales, but similar revelations occurred in Scotland and
Northern Ireland (see the Reportof the Independent Review Group on Retentionof Organs at
Post-Mortem (the McLean Report) and the Report of the Human Organs Inquiry at http://
www.hoi-ni.org).
6 90% of the hearts retained at Bristol werefrom coroners’post-mortems.
7 In some instances individuals and/or relatives’wis hes were simply ignored (as in the case of Mr
and Mrs Isaacs), in others there was confusion generated by ambiguity as to the scope of terms
such as ‘tissue’ used in ‘consent’forms and other information provided, and sometimes only cur-
sory information was given or approaches made to relatives, ostensibly out of a lack of knowledge
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spired that such practices were widespread rather than merely local.
8
ACensus
conducted by the Chief Medical O⁄cer found that as of the end of1999, 54,300
organs, body parts, stillborn children and foetuses were retained byTrusts in Eng-
land following post-mortems.
9
The Parliamentary Under-Secretary for Health,
Dr Stephen Ladyman, did not mince his words in the House of Commons, stat-
ing that ‘The background to this Bill is scandal’.
10
These practices occurred against the backdrop of the law contained in the
HumanTissue Act 1961, which permitted the person lawfully in possession of the
body (in practice the hospital wherein the person died) to authorise the removal
and use of human material for the purposes of therapy, education and research
where s/he had no reason to believe, having made such reasonable enquiries as
werepracticable, thateither the deceased orany survivingspouse or relative objected
to it. It was a common theme of the Inquiry Reports that the law should be
reformed so that ‘informed consent’ rather than an ‘absence of objection’ should
become the central guiding legal principle justifying removal, retention and use
of cadaveric material for various permissible purposes, in addition to a need for
sanctions for breach of the statute; a quite remarkable lacuna under the 1961 Act.
11
Gage J statedi nthe High Court in AB and OthersvLeedsTeaching Hospital NHS Trust
and Another that ‘There may be little conceptual di¡erence between consent and
non-objection, but the l atter in my view implies a more passive approach than a
requirement for conse nt’.
12
TheGovernmentacceptedthesekeyreforms
13
but
stalled them pending a broader review of the law initiated principally through
the Consultation report Human Bodies, Human Choices published in 2002.
14
The passage of the Bill was remarkable for a high level of consensus and all
party support. A lack of pre-legislative scrutiny however contributed to initial
drafting problems, a hiatus of four and half months between Committee and
Report stages in the House of Commons, and steady revisions up until the very
culmination of parliamentary deliberations.
15
The original version of the Bill
or a paternalistic desire tospare relatives further su¡ering.The law even needed to be amended to
permit cremation of body parts, see Cremation (Amendment) Regulations 2000 (SI 2000/58)
amending the Cremation Regulations 1930 S.R.& O.1930/1016.
8 Although retention was s eemingly more ‘systematic’dur ing the van Velzen years at Alder Hey
with very manyorgans never being used for research at all.
9 Chief Medical O⁄cer, Reportof a Census of Organs andTissues Retained by PathologyServices in Eng-
land, January 2001 http://www.doh.gov.uk/organcensus/index.htm
10 HC Deb vol 416 col 104115 Jan 20 04.
11 See generally D. Price,‘From Cosmos and Damien tovan Velzen: the Human Tissue Saga Con-
tinues’ (2003)11(1) Med LR 1for a discussion of the background to the Bill.
12 AB and OthersvLeedsTeachingHospitalNHSTrust and Another[2004] EWHC 644: (2004) 77 BMLR
145,177 QB. Although the Redfern Report rightly observed that under the 1961Act there could
only be‘no reason to believe in the absence of objections’where some attempt was made to contact
and inform relatives in the ¢rst place, see n 3 above at 364.
13 The Government further endorsed all 17 Recommendations contained in a Report by the C hief
Medical O⁄cer on the Removal, Retention and Use of Human Organs and Tissue from Post-Mortem
Examination, published in January 2001.
14 http://www.doh.gov.uk/tissue/human bodieschoices.pdf
15 Dr Ladyman conceded during second reading that a draft Bill would have been published had
drafting resources then been available, see HC Deb vol 416 col 1043 15 Jan 2004. 46 groups of
amendments weretabled in Standing Committee and 99 new clauses and amendments proposed
at Reportstage.
David Price
799rThe Modern LawReview Limited 2005
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