#1758 - The Human Tissue Act 2004 - Medical Law

The Human Tissue Act 2004

The background to the Act

• Doctors and Body Parts

  • Doctors tend, when they do an operation on someone, either throw bits away

    • or if the organ or bit of organ was particularly unusual, they might store it for educational purposes or research

  • The old law was very vague on whether this was permitted

    • It talked about needing lawful permission for retaining organs, but didn’t say what it meant

• Alder Hey scandal

  • This concerned a hospital where it was found that many surgeons were retaining organs from operations many of which were from children’s bodies –

    • but often they were being taken without permission of the parents,

      • or taking a whole liver or heart when saying that they were taking “tissue” (which parents thought meant small samples)

  • Many parents were shocked and distressed as they thought they had buried their children’s bodies whole but had found out they had not

    • Felt that they had been disrupted in that last parental task of properly disposing of their children’s’ bodies.

      • Many doctors were flabbergasted by the parents’ reaction to it – they were throwing away bits of organs all of the time.

Lawfully storing or using bodily material

Lawful Activities with relevant material

• What is relevant material?

  • HTA 2004 s.53:

    • Relevant material is tissue, cells and organs of human beings

      • Excluding gametes, embryos outside the body, hair and nails from a living person

    • S.54(7) Cells lines are also excluded

• What Activities are Lawful?

  • HTA 2004 s.1

    • (1)The following activities shall be lawful ...

      • (a) + (b) [the storage or use of a whole body]

      • (c) + (e) + (g) [Remove, store or use human material from a deceased person]

      • (d) + (f) [the storage/use of human material from living people]

    • [Providing that]

      • (1)...[there is] appropriate consent

      • The act was done for a Schedule 1 purpose

What is appropriate consent?

• Qualifying relationships s.27(4)

  • [If there is call for consent from a qualifying relationship, the relationships are ranked in this order, with the higher (if in existence and present) having the final say]

    • (a) spouse or partner

    • (b) parent or child

    • (c)brother of sister

    • (d) grandparent or grandchild

    • (e) child of a person falling within para (c) [niece or nephew]

    • (f) stepfather or stepmother

    • (g) half brother or half sister

    • (h) friend of longstanding

• Children – s.2

  • S.3(a)Where the child is alive

    • [and](b)neither a decision of his to consent to the activity, nor a decision of his not to consent to it, is in force, and

    • (c)either he is not competent to consent or has not dealt with the decision

      • “appropriate consent” means the consent of a person who has parental responsibility for him

  • (7)Where the child concerned has died and ...subsection (5) [does not apply]

    • “appropriate consent” means —

      • (a) ...a decision of his consent/non-consent was in force immediately before he died

      • OR (b)if paragraph (a) does not apply—

        • (i)the consent of a person who had parental responsibility for him immediately before he died, or

        • (ii)where [there is]no person ...the consent of a person who stood in a qualifying relationship to him at that time.

  • (4)Where the child concerned has died and ... subsection (5) applies,

    • “appropriate consent” means his consent in writing.

      • (5)This subsection applies to an activity involving storage for use, or use, for the purpose of—

        • (a)public display, or

        • (b)where the subject-matter of the activity is not excepted material, anatomical examination

      • (6)Consent in writing for the purposes of subsection (4) is only valid if—

        • (a)it is signed by the child concerned in the presence of at least one witness who attests the signature, or

        • (b)it is signed at the direction of the child concerned, in his presence and in the presence of at least one witness who attests the signature.

• Adults with capacity s.3:

  • (2)Where the person concerned is alive

    • “appropriate consent” means his consent.

  • (3)Where the person concerned has died ... subsection (4) applies,

    • “appropriate consent” means his consent in writing.

    • (4)This subsection applies to an activity involving storage for use, or use, for the purpose of—

      • (a)public display, or

      • (b)where the subject-matter of the activity is not excepted material, anatomical examination.

    • (5)Consent in writing for the purposes of subsection (3) is only valid if—

      • (a)it is signed by the person concerned in the presence of at least one witness who attests the signature,

      • (b)it is signed at the direction of the person concerned, in his presence and in the presence of at least one witness who attests the signature, or

      • (c)it is contained in a will of the person concerned made in accordance with the requirements of [Testamentary formalities]

  • (6)Where the person concerned has died ... subsection (4)[does not] apply,

    • “appropriate consent” means—

      • (a)[a decision to consent/not consent was in force]; his consent

      • (b)if

        • (i) para (a) does not apply and

        • (ii)he has appointed a person or persons under section 4 to deal after his death with the issue of consent in relation to the activity,

          • consent given under the appointment;

      • (c)if neither paragraph (a) nor paragraph (b) applies,

        • the consent of a person who stood in a qualifying relationship to him immediately before he died.

• Adults without capacity s.6

  • (1) Where—

    • (a)an activity of a kind mentioned in section 1(1)(d) or (f) involves material from the body of a person who—

      • (i)is an adult, and

      • (ii)lacks capacity to consent to the activity, and

    • (b)neither a decision of his to consent to the activity, nor a decision of his not to consent to it, is in force,

      • there shall ... be deemed to be consent ... if it is done in circumstances of a kind specified by regulations made by the Secretary of State.

  • HTA 2004 (Persons who lack capacity) Regulations 2006

    • Scheduled Purposes

      • Storage of relevant material for a scheduled purpose by a person acting in what they reasonably believe is the best interests of the person lacking capacity

        • This includes obtaining scientific or medical information about a person

          • which may be relevant to another (possibly future) person and transplantation

      • Storage and use of material for the purpose of an authorised clinical trial

      • Allowing for the storage of relevant material for research consistent w/ s.30-34 MCA 2005

What is a Schedule 1 purpose?

• The Purposes

  • Activities under Part 1

    • 1. Anatomical Examination

    • 2. Determining the Cause of Death

    • 3. Establishing after a person’s death the efficacy of any... treatments administered

    • 4. Obtaining scientific or medical information about a living or deceased person which may be relevant to a future person

    • 5. Public Display

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

    • 7. Transplantation

  • Activities under Part 2

    • 8. Clinical Audit

    • 9. Education or training related to human health

    • 10. Performance Assessment

    • 11. Public health monitoring

    • 12. Quality Assurance

• What can be done for those purposes

  • Storage/use of bodies with consent for any of the 12 purposes

  • Storage/use of any materials with consent for any Part 1 purposes

  • Storage/use of any materials even without consent for Part 2 purposes

When can human material be stored or used without consent?

• For a Schedule 1 Part II purpose, as above

• Where the Human Tissue Authority deems consent

  • S.7: The HTA has power to deem consent where it is not possible to trace the individual from whom the material originated

  • Herring:

    • Only likely to use this power where tissue relating to a relative or a patient could be used for genetic testing purposes to assist the diagnosis of a patient

    • Also has power to deem consent where it is satisfied that

      • The material has come from a living person

      • It is in the interests of another person to obtain scientific or medical information about the individual

      • And there is no reason to believe the individual has died or made a decision not to consent to the use of the material

• A High Court order

• Storage for Research Purposes

  • If relevant material is taken from living bodies for the purpose of research into disorders,

    • S.1(7)-(9)Then consent is not required if

      • (i) the research has been ethically approved

      • (ii) the material has been anonymized so it is not possible to identify the person from which is was removed

    • Herring: This allows doctors to take material even if a person has objected.

• Surplus material (s.44)

  • If material has been removed in the course of treatment, diagnostic tests or research then that material can be dealt with as waste

    • E.g. consent for an operation to remove a tumour means consent for its disposal as well, w/o need for this to be explicit

• Imported material from abroad and existing holdings of organs before Act came into force

• Coroner’s Activities

Criminal Offences

• S.5 offences

  • Failure to obtain appropriate consent

    • S.5(1)A person commits an offence if, without appropriate consent,

      • he does an activity to which subsection (1), (2) or (3) of section 1 applies, unless he reasonably believes—

        • (a)that he does the activity with appropriate consent, or

        • (b)that what he does is not an activity to which the subsection applies.

  • A false representation of consent

    • S.5(2)A person commits an offence if—

      • (a)he falsely represents to a person whom he knows or believes is going to, or may, do an activity to which subsection (1), (2) or (3) of section 1 applies—

        • (i)that there is appropriate consent to the doing of the activity, or

        • (ii)that the activity is not one to which the...