Human Tissue Bill

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Human Tissue Bill

Human Tissue Bill
Part 1 — Removal, storage and use of human organs and other tissue for scheduled purposes
1

A
Bill
To
Make provision with respect to activities involving human tissue; to make
provision about the transfer of human remains from certain museum
collections; and for connected purposes.
Be it enacted by the Queen’s most Excellent Majesty, by and with the advice and
consent of the Lords Spiritual and Temporal, and Commons, in this present
Parliament assembled, and by the authority of the same, as follows:—
Part 1
Removal, storage and use of human organs and other tissue for scheduled
purposes
1
Authorisation of activities for scheduled purposes
(1)
The following activities shall be lawful if done with appropriate consent—
5
(a)
the storage of the body of a deceased person for use for a purpose
specified in Schedule 1, other than anatomical examination;
(b)
the use of the body of a deceased person for a purpose so specified,
other than anatomical examination;
(c)
the removal from the body of a deceased person, for use for a purpose
10
specified in Schedule 1, of any relevant material of which the body
consists or which it contains;
(d)
the storage for use for a purpose specified in Part 1 of Schedule 1 of any
relevant material which has come from a human body;
(e)
the storage for use for a purpose specified in Part 2 of Schedule 1 of any
15
relevant material which has come from the body of a deceased person;
(f)
the use for a purpose specified in Part 1 of Schedule 1 of any relevant
material which has come from a human body;
(g)
the use for a purpose specified in Part 2 of Schedule 1 of any relevant
material which has come from the body of a deceased person.
20
(2)
The storage of the body of a deceased person for use for the purpose of
anatomical examination shall be lawful if done—
(a)
with appropriate consent, and

HL Bill 94 53/3

Human Tissue Bill
Part 1 — Removal, storage and use of human organs and other tissue for scheduled purposes
2

(b)
after the signing of a certificate—
(i)
under section 22(1) of the Births and Deaths Registration Act
1953 (c. 20), or
(ii)
under Article 25(2) of the Births and Deaths Registration
(Northern Ireland) Order 1976 (S.I. 1976/1041 (N.I. 14)),
5

of the cause of death of the person.
(3)
The use of the body of a deceased person for the purpose of anatomical
examination shall be lawful if done—
(a)
with appropriate consent, and
(b)
after the death of the person has been registered—
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(i)
under section 15 of the Births and Deaths Registration Act 1953,
or
(ii)
under Article 21 of the Births and Deaths Registration
(Northern Ireland) Order 1976.
(4)
Subsections (1) to (3) do not apply to an activity of a kind mentioned there if it
15
is done in relation to—
(a)
a body to which subsection (5) applies, or
(b)
relevant material to which subsection (6) applies.
(5)
This subsection applies to a body if—
(a)
it has been imported, or
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(b)
it is the body of a person who died before the day on which this section
comes into force and at least one hundred years have elapsed since the
date of the person’s death.
(6)
This subsection applies to relevant material if—
(a)
it has been imported,
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(b)
it has come from a body which has been imported, or
(c)
it is material which has come from the body of a person who died
before the day on which this section comes into force and at least one
hundred years have elapsed since the date of the person’s death.
(7)
Subsection (1)(d) does not apply to the storage of relevant material for use for
30
the purpose of research in connection with disorders, or the functioning, of the
human body if—
(a)
the material has come from the body of a living person, and
(b)
the research falls within subsection (9).
(8)
Subsection (1)(f) does not apply to the use of relevant material for the purpose
35
of research in connection with disorders, or the functioning, of the human body
if—
(a)
the material has come from the body of a living person, and
(b)
the research falls within subsection (9).
(9)
Research falls within this subsection if—
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(a)
it is ethically approved in accordance with regulations made by the
Secretary of State, and
(b)
it is to be, or is, carried out in circumstances such that the person
carrying it out is not in possession, and not likely to come into
possession, of information from which the person from whose body the
45
material has come can be identified.

Human Tissue Bill
Part 1 — Removal, storage and use of human organs and other tissue for scheduled purposes
3

(10)
The following activities shall be lawful—
(a)
the storage for use for a purpose specified in Part 2 of Schedule 1 of any
relevant material which has come from the body of a living person;
(b)
the use for such a purpose of any relevant material which has come
from the body of a living person;
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(c)
an activity in relation to which subsection (4), (7) or (8) has effect.
(11)
The Secretary of State may by order—
(a)
vary or omit any of the purposes specified in Part 1 or 2 of Schedule 1,
or
(b)
add to the purposes specified in Part 1 or 2 of that Schedule.
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(12)
Nothing in this section applies to—
(a)
the use of relevant material in connection with a device to which
Directive 98/79/EC of the European Parliament and of the Council on
in vitro diagnostic medical devices applies, where the use falls within
the Directive, or
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(b)
the storage of relevant material for use falling within paragraph (a).
(13)
In this section, the references to a body or material which has been imported
do not include a body or material which has been imported after having been
exported with a view to its subsequently being re-imported.
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“Appropriate consent”: children
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(1)
This section makes provision for the interpretation of “appropriate consent” in
section 1 in relation to an activity involving the body, or material from the
body, of a person who is a child or has died a child (“the child concerned”).
(2)
Subject to subsection (3), where the child concerned is alive, “appropriate
consent” means his consent.
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(3)
Where—
(a)
the child concerned is alive,
(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 deal with the issue of consent in relation
30
to the activity or, though he is competent to deal with that issue, he fails
to do so,

“appropriate consent” means the consent of a person who has parental
responsibility for him.
(4)
Where the child concerned has died and the activity is one to which subsection
35
(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,
40
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

Human Tissue Bill
Part 1 — Removal, storage and use of human organs and other tissue for scheduled purposes
4

(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.
(7)
Where the child concerned has died and the activity is not one to which
subsection (5) applies, “appropriate consent” means —
(a)
if a decision of his to consent to the activity, or a decision of his not to
5
consent to it, was in force immediately before he died, his consent;
(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 no person had parental responsibility for him
10
immediately before he died, the consent of a person who stood
in a qualifying relationship to him at that time.
3
“Appropriate consent”: adults
(1)
This section makes provision for the interpretation of “appropriate consent” in
section 1 in relation to an activity involving the body, or material from the
15
body, of a person who is an adult or has died an adult (“the person
concerned”).
(2)
Where the person concerned is alive, “appropriate consent” means his consent.
(3)
Where the person concerned has died and the activity is one to which
subsection (4) applies, “appropriate consent” means his consent in writing.
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(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.
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(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
30
(c)
it is contained in a will of the person concerned made in accordance
with the requirements of—
(i)
section 9 of the Wills Act 1837 (c. 26), or
(ii)
Article 5 of the Wills and Administration Proceedings
(Northern Ireland) Order 1994 (S.I. 1994/1899 (N.I. 13)).
35
(6)
Where the person concerned has died and the activity is not one to which
subsection (4) applies, “appropriate consent” means—
(a)
if a decision of his to consent to the activity, or a decision of his not to
consent to it, was in force immediately before he died, his consent;
(b)
if—
40
(i)
paragraph (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;
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Human Tissue Bill
Part 1 — Removal, storage and use of human organs and other tissue for scheduled purposes
5

(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.
(7)
Where the person concerned has appointed a person or persons under section
4 to deal after his death with the issue of consent in relation to the activity, the
5
appointment shall be disregarded for the purposes of subsection (6) if no one
is able to give consent under it.
(8)
If it is not reasonably practicable to communicate with a person appointed
under section 4 within the time available if consent in relation to the activity is
to be acted on, he shall be treated for the purposes of subsection (7) as not able
10
to give consent under the appointment in relation to it.
4
Nominated representatives
(1)
An adult may appoint one or more persons to represent him after his death in
relation to consent for the purposes of section 1.
(2)
An appointment under this section may be general or limited to consent in
15
relation to such one or more activities as may be specified in the appointment.
(3)
An appointment under this section may be made orally or in writing.
(4)
An oral appointment under this section is only valid if made in the presence of
at least two witnesses present at the same time.
(5)
A written appointment under this section is only valid if—
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(a)
it is signed by the person making it in the presence of at least one
witness who attests the signature,
(b)
it is signed at the direction of the person making it, 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 making it, being a will which is
25
made in accordance with the requirements of—
(i)
section 9 of the Wills Act 1837 (c. 26), or
(ii)
Article 5 of the Wills and Administration Proceedings
(Northern Ireland) Order 1994 (S.I. 1994/1899 (N.I. 13)).
(6)
Where a person appoints two or more persons under this section in relation to
30
the same activity, they shall be regarded as appointed to act jointly and
severally unless the appointment provides that they are appointed to act
jointly.
(7)
An appointment under this section may be revoked at any time.
(8)
Subsections (3) to (5) apply to the revocation of an appointment under this
35
section as they apply to the making of such an appointment.
(9)
A person appointed under this section may at any time renounce his
appointment.
(10)
A person may not act under an appointment under this section if—
(a)
he is not an adult, or
40
(b)
he is of a description prescribed for the purposes of this provision by
regulations made by the Secretary of State.