(1) Background and Overview
Sociological context
The Human Tissue Act 2004 (HTA 2004) was introduced to address serious concerns raised in the course of the 1998 Kennedy Inquiry.[1] The primary Inquiry mandate was to investigate numerous and suspicious Bristol Royal Infirmary Hospital and the Alder Hey Children’s Hospital infant deaths. These late 1980s and early 1990s events had occurred whilst these babies were undergoing heart surgery. The Inquiry found that in many cases, the Hospitals had retained the deceased infants’ organs without parental knowledge or consent. The Hospital pathologists did not seek consent, as they had honest concerns that such discussions would heighten parental stress. The organs were retained solely for research purposes.
The subsequent A v Leeds Teaching Hospitals decision underscores the dimensions of the public concerns expressed regarding this organ retention practice.[2] In assessing three claims for psychiatric injury advanced against numerous hospitals arising from non-consensual infant organ retention, the Court held that doctors conceivably owe a duty of care to parents after their infant’s death during an operation.[3] This duty might extend to include doctors being required to provide parents with an explanation concerning: (i) post-mortem purposes; (ii) what a post-mortem investigation entails; (iii) alerting parents to the possibility their child’s organs might be retained for further research study.[4] The Court specifically notes that other public inquiry reports (including Kennedy) refer to the distress caused to large numbers of parents when they learnt for the first time that their children’s bodies had been buried or cremated without one or more of their major organs.[5]
Legal context
The HTA 2004 provisions were designed to address two inter-related legal issues: (i) who owns a human body or its constituent parts (organs, bones, blood or other bodily fluids) after death; (ii) when consent to retain post-mortem body parts must be obtained from next-of-kin.[6] The stated Act objectives reinforce the need to provide a consistent ‘whole body donation’ legislative framework, with its guiding principle being consensual human organ and tissue taking, storage and use must be secured by consent.[7]
The unstated legal premise driving the HTA 2004 philosophy is equally important. The Act establishes the basis by which organ donation transplantation can be more effectively promoted. The UK has experienced an ongoing organ shortage for many years, particularly kidneys required to permit patients to avoid expensive dialysis treatments.[8] Through the detailed HTA 2004 consent provisions, it is apparent that UK public confidence in organ retrieval has been increased as compared to levels observed after the Kennedy Inquiry report publication.[9]
Main changes and key HTA 2004 provisions
The Act specifies how requisite consent for the storage or use of relevant material must be obtained (including intended transplantation organs or tissues).[10]In this important respect, HTA 2004 also establishes the Human Tissue Authority,[11] the UK regulator with oversight concerning any activities involving the removal any relevant material from a human body, for uses permitted by the Act.[12]
To counter possible ‘black market’ organ sales and related organ transplant waiting list ‘queue jumping’, HTA 2004 also criminalises any organ removal undertaken without the person’s consent.[13] Persons may not correspondingly offer or provide a reward for the supply of any bodily materials defined in HTA 2004.[14] Where the prospective organ donor lacks mental capacity to consent to organ removal,[15] the procedure will only be permitted where this person’s best interests favour removal (such interests include emotional and psychological factors, as discussed in the pre-HTA 2004 decision, Y (Mental Patient: Bone Marrow Donation).[16]
Similarly, child organ donations are only permitted in ‘extremely rare circumstances’, and only then with prior judicial approval.[17] The removal must meet this standard: (i) it advances the potential donor’s interests (paramount consideration); but (ii), donor child best interests are not limited to medical interests, and these may include ‘potential emotional, psychological and social benefits and risks’.[18] These child donor provisions are an example of how various HTA 2004 Codes of Practice give further dimensions to the permitted organ removal circumstances.[19] Together with the Act licensing regime, whereby persons such as medical researchers retain and use removed material under appropriate conditions, The HTA 2004 represents a significant step forward from the poorly defined legal framework considered by the Kennedy Inquiry.
A final important HTA 2004 feature remains controversial. The Act has inspired the NHS Organ Donor Register, where anyone can register online to provide their consent for organ removal in the event of death.[20] The Act contemplates an ‘opt-in’, express consent system. Other EU nations have adopted an ‘opt-out’, presumed donor consent system, where the subject must expressly decline organ removal permission.[21] Opt-in systems have been endorsed as contributing to better survival rates amongst persons needing a transplant. These approaches have also been strongly criticised as impermissibly restricting fundamental human rights of control over one’s body.[22]
2026 update
The Human Tissue Act 2004 remains a central statute governing the removal, storage and use of human tissue, and it continues to regulate consent-based activities and the work of the Human Tissue Authority. However, this summary is no longer fully up to date on organ donation. In particular, the original opt-in model for deceased organ and tissue donation in England was amended by the Organ Donation (Deemed Consent) Act 2019, which introduced a system of deemed consent from 2020 for eligible adults unless they have opted out or fall within an excluded group. Related developments have also occurred elsewhere in the UK, including deemed-consent legislation in Wales and deemed-authorisation legislation in Scotland. The Human Tissue Act 2004 therefore remains highly important, but the discussion above of organ donation should now be read in light of these later reforms.
Bibliography
1.Cases
A v Leeds Teaching Hospitals NHS Trust [2004] EWHC 644 (QB); [2005] Q.B. 506 (QB)
Bourne, R v [1939] 1 K.B. 687 (CA (Crim))
Dobson v North Tyneside HA [1997] 1 W.L.R. 596 (CA (Civ))
Doogan v Greater Glasgow and Clyde Health Board [2014] UKSC 68; [2015] A.C. 640 (SC)
K (a minor), Northern Health and Social Services Board v F and G (1991) 2 Med LR 371
Y (Mental Patient: Bone Marrow Donation), [1997] Fam. 110 (Fam)
2.Legislation
Abortion Act 1967
Human Tissue Act 1961
Human Tissue Act 2004
Human Tissue Authority Code of Practice A 2013
Human Tissue (Quality and Safety for Human Application) Regulations 2007/1523
Offences Against the Person Act 1861
3.Secondary sources
(1)Texts and journals
Binchey, W ‘Human dignity and the unborn child – a comment’ (2014) 20(2) M.L.J.I. 82
Goold, I and Herring, J Great Debates in Medical Law and Ethics (Palgrave, 2014)
McGuinness, S and Thomson, M ‘Medicine and abortion law: complicating the reforming profession’ (2015) 23(2) Med. L. Rev. 177
Miola, J ‘Making decisions about decision-making: conscience, regulation, and the law’ (2015) 23(2) Med. L. Rev. 263
Pattinson, S ‘Directed donation and ownership of human organs’ (2011) 31(3) L.S. 392
Puppinck, G ‘Abortion and the European Convention on Human Rights’ (2013) 3(2) I.J.L.S. 142
Russell, P ‘An archive of the women’s liberation movement: a document of social and legislative change’ (2015) 15(1) L.I.M 31
Samuels, A ‘Organ removal and retention’ (2005) 73(2) Med. Leg. J. 73
Shaw, N ‘The damage done by dichotomies’ (2008) 14 UCL Juris. Rev. 285
(2)Other sources
Emsley C, Hitchcock T, and Shoemaker S, ‘Historical Background – Gender in the Proceedings’, Old Bailey Proceedings Online [Online] Available: <www.oldbaileyonline.org, version=”” 7.0=””> [17 February 2016]</www.oldbaileyonline.org,>
Hamilton Practice ‘Organ Donation’ (2016) [Online] Available: [17 February 2016]
Kennedy, I Learning from Bristol: the report of the public inquiry into children’s heart surgery at the Bristol Royal Infirmary 1984 -1995 (2001) [Online] Available: [17 February 2016]
NHS Blood & Transplant, ‘Summary of Donor and Transplant Activity Report 2013/14’ (2014) [Online] Available: [17 February 2016]
NHS Organ Donor Register (2016) [Online] Available: [17 February 2016]
Footnotes
[1]Ian Kennedy, Learning from Bristol: the report of the public inquiry into children’s heart surgery at the Bristol Royal Infirmary 1984 -1995 (2001) [Online] Available: [17 February 2016].
[2]A v Leeds Teaching Hospitals NHS Trust [2004] EWHC 644 (QB); [2005] Q.B. 506 (QB).
[3]Ibid, [117], [118].
[4] Ibid, [126], citing Human Tissue Act 1961, s. 1.
[5] Ibid, [114]; see also Alec Samuels, ‘Organ removal and retention’ (2005) 73(2) Med. Leg. J. 73, 74.
[6]Human Tissue Act 2004 (HTA 2004), see also Dobson v North Tyneside HA [1997] 1 W.L.R. 596 (CA (Civ)), re no ownership rights in a corpse.
[7]HTA 2004 s. 1 (consent) and s. 53 (organ and tissue definition that includes sperm).
[8] NHS Blood & Transplant, ‘Summary of Donor and Transplant Activity Report 2013/14’ (2014) [Online] Available: [17 February 2016].
[9]The Hamilton Practice ‘Organ Donation’ (2016) [Online] Available: [17 February 2016].
[10]HTA 2004 s. 1(1)(d), and Schedule 1, Part 1.
[11]Ibid, s. 13
[12]Ibid, s. 14(1), and as further defined by regulation; see e.g. Human Tissue (Quality and Safety for Human Application) Regulations 2007/1523 Pt 6 reg.30(2).
[13]HTA 2004, s. 5(1).
[14]Ibid, s. 32.
[15]Ibid, ss. 6, 7.
[16]Re Y (Mental Patient: Bone Marrow Donation), [1997] Fam. 110 (Fam).
[17] Human Tissue Authority Code of Practice A 2013.
[18]Ibid.
[19]HTA 2004, ss. 26-29.
[20]NHS Organ Donor Register (2016) [Online] Available: [17 February 2016].
[21] Jose Miola, ‘Making decisions about decision-making: conscience, regulation, and the law’ (2015) 23(2) Med. L. Rev. 263.
[22] Shaun Pattinson, ‘Directed donation and ownership of human organs’ (2011) 31(3) L.S. 392.
