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The Human Tissue Act 2004 Notes

Updated The Human Tissue Act 2004 Notes

Medical Law Notes

Medical Law

Approximately 1067 pages

Medical Law notes fully updated for recent exams at Oxford and Cambridge. These notes cover all the LLB medical law cases and so are perfect for anyone doing an LLB in the UK or a great supplement for those doing LLBs abroad, whether that be in Ireland, Hong Kong or Malaysia (University of London).

These were the best Medical Law notes the director of Oxbridge Notes (an Oxford law graduate) could find after combing through forty-eight LLB samples from outstanding law students with the highest...

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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...

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