medical law Acts

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Human Tissue Act 2004

(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]

1. Abortion Act 1967

(1) Background and Overview

Sociological context

The Abortion Act 1967 provisions remain controversial almost 50 years after their enactment. At its essence, the Act seeks to address two extremely challenging and largely antithetical human rights considerations. The first is that all human life is sacred, where ‘life’ is defined as commencing with conception, and extending until death.[23] By definition, abortion is any spontaneous or induced pregnancy termination prior to the foetus reaching a viable age (where it can live outside the mother’s womb).[24] For its opponents, abortion thus constitutes an unlawful killing of the foetus. In contrast, abortion proponents argue that a woman’s right to control her reproductive system is absolute.[25] Just as modern day medical ethics do not sanction forced medical treatment, the State may not dictate how, or under what circumstances women will choose to bear children.[26]

Illegal abortions had long been a UK societal feature.[27] Unmarried women who became pregnant either through accident, or by rape often died at the hands of amateur abortionists.[28] The post-WW II social climate was changing rapidly, with more women eager to pursue careers beyond conventional domestic duties and primary family childcare obligations.[29] In other instances, where the mother had already given birth to several children, abortion represented a way to potentially improve overall family financial prospects, whilst contributing to an individual woman’s greater wellbeing.[30]

Legal context

The pre-1967 Act UK social landscape revealed many conflicting abortion access perspectives. Abortion was a crime;[31] the sole permitted defence was where the abortion was administered to preserve the mother’s life.[32] The seeds for the current law as discussed below are revealed in the 1939 R v Bourne reasons. The Court of Appeal determined that the phrase ‘preserving the life of the mother’ must be reasonably construed, in that such circumstances could extend beyond the mother’s risk of death, to include cases where the continued pregnancy would likely cause significant physical or mental health damage.

Main changes and key Abortion Act 1967 provisions

Whilst abortion remains a criminal offence under 1967 Act auspices,[33] its main provisions seek to balance the conflicting sociological factors noted above.[34] Act s. 1(1) provides that no offence is committed where the abortion is performed by a registered medical practitioner (most often a licensed doctor), under these circumstances.[35] The pregnancy must be terminated by a registered medical practitioner, if two registered medical practitioners have formed the good faith opinion that: (i) the pregnancy has not exceeded its twenty-fourth week (second trimester), where its continuance would involve greater likely risk to the mother than if it were terminated; or (ii) abortion will necessarily prevent the woman’s grave permanent physical or mental health injury; or (iii), pregnancy continuation poses risks exceeding those on termination; or (iv), a substantial risk exists the child will be born with seriously debilitating physical or mental abnormalities.[36]

Act s. 1(1) conditions are further qualified by the permitted ‘proper account’ taken of the pregnant woman's actual or reasonably foreseeable environment.[37]The Act provisions must be strictly followed by anyone performing an authorised abortion.[38]It is noted the Act s. 1(1) language defines abortion as an exception to the criminal offence rule, as opposed to expressly endorsing such pregnancy termination procedures as lawful.[39] It is also important to appreciate the 1967 Act limitations. It does not apply to Northern Ireland, where all abortion (unless falling with the Bourne exception described above) remains a criminal offence.[40] The Act also provides this straightforward ‘law relating to abortion’ definition as meaning the above-noted Offences against the Person Act 1861 provisions, and ‘any rule of law [including the common law] relating to the procurement of abortion’.[41]

The Act also defines circumstances where a doctor or other healthcare professional person may exercise their right of conscientious objection to participating in an abortion procedure.[42] This right is qualified by s. 4(2), where persons otherwise legitimately claiming conscientious objector status remain bound by "any duty to participate in treatment necessary to save the life or to prevent grave permanent injury” to a pregnant woman’s physical or mental health.[43]

This right was more recently given a clear Supreme Court interpretation in Doogan v Greater Glasgow.[44]The Court found that Act s. 4(1) conscientious objector rights’ only pertained to persons actually taking part in the medical procedure. Such rights do not extend to person carrying out ancillary, administrative or managerial tasks associated with the various activities necessary to provide abortion services. The Doogan claimants (two midwives working as maternity ward coordinators could not rely on Act s.4(1) language to conscientiously object to their roles, ones that involved supervising and supporting staff providing care to abortion patients.[45]

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]

Hamilton Practice ‘Organ Donation’ (2016) [Online] Available: <http://www.hamiltonpractice.nhs.uk/health-information/organ-donation-register/> [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: <http://webarchive.nationalarchives.gov.uk/20090811143745/http:/www.bristol-inquiry.org.uk/final_report/report/index.htm> [17 February 2016]

NHS Blood & Transplant, ‘Summary of Donor and Transplant Activity Report 2013/14’ (2014) [Online] Available: <http://www.odt.nhs.uk> [17 February 2016]

NHS Organ Donor Register (2016) [Online] Available:< https://www.organdonation.nhs.uk/register-to-donate/?campaignCode=-1> [17 February 2016]


[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: <http://webarchive.nationalarchives.gov.uk/20090811143745/http:/www.bristol-inquiry.org.uk/final_report/report/index.htm> [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: <http://www.odt.nhs.uk> [17 February 2016].

[9] The Hamilton Practice ‘Organ Donation’ (2016) [Online] Available: < http://www.hamiltonpractice.nhs.uk/health-information/organ-donation-register/> [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:<https://www.organdonation.nhs.uk/register-to-donate/?campaignCode=-1> [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.

[23] William Binchey, ‘Human dignity and the unborn child - a comment’ (2014) 20(2) M.L.J.I. 82, 85.

[24] Ibid.

[25]As discussed in Gregor Puppinck, ‘Abortion and the European Convention on Human Rights’ (2013) 3(2) I.J.L.S. 142.

[26] Imogene Goold and Jonathan Herring, Great Debates in Medical Law and Ethics (Palgrave, 2014), 138, 140.

[27] As confirmed by the London ‘Old Bailey’ records to 1914; see Clive Emsley, Tim Hitchcock and Robert Shoemaker, ‘Historical Background - Gender in the Proceedings’, Old Bailey Proceedings Online [Online] Available: <www.oldbaileyonline.org, version 7.0> [17 January 2016].

[28] Ibid.

[29] Sheelagh McGuinness and Michael Thomson, ‘Medicine and abortion law: complicating the reforming profession’ (2015) 23(2) Med. L. Rev. 177, 180-183.

[30] Ibid.

[31] Offences Against the Person Act 1861, s. 58.

[32] R v Bourne [1939] 1 K.B. 687 (CA (Crim)).

[33] Preserving the Offences Against the Person Act 1861 offence, see (n 31).

[34] Polly Russell, ‘An archive of the women's liberation movement: a document of social and legislative change’ (2015) 15(1) L.I.M 31, 35.

[35] Abortion Act 1967, s.1(1).

[36] Ibid, ss. 1(1) (a) – (d).

[37] Ibid, s. 1(2).

[38] Ibid, s. 5 (2).

[39] A point taken from Natalie Shaw, ‘The damage done by dichotomies’ (2008) 14 UCL Juris. Rev. 285, 291 (Paternalism versus feminism).

[40] Abortion Act 1967, s. 7(3); see Re K (a minor), Northern Health and Social Services Board v F and G (1991) 2 Med LR 371.

[41] Ibid, s. 6.

[42] Abortion Act 1967, s. 4(1).

[43] Ibid, s. 4(2).

[44] Doogan v Greater Glasgow and Clyde Health Board [2014] UKSC 68; [2015] A.C. 640 (SC).

[45] Ibid, [33], [35].