Human Tissue Act 2004 (Amendment) Bill

House of Commons

Session 2004 - 05
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Human Tissue Act 2004 (Amendment) Bill

Human Tissue Act 2004 (Amendment) Bill
1

A
Bill
To
amend the Human Tissue Act 2004 in relation to the removal of organs for the
purpose of transplantation from adults who have died.
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 relevant authority of the same, as follows:—
1
Amendment of Part 1 of the Human Tissue Act 2004
(1)
Part 1 of the Human Tissue Act 2004 (c. 30) is amended as follows.
(2)
After section 3(4) insert—
“(4A)
Where the person concerned has died and the activity is one to which
subsection (4B) applies, ‘appropriate consent’ means consent
5
determined in accordance with the provisions of section 3A.
(4B)
This subsection applies to an activity involving the removal, storage for
use, or use, of an organ for the purpose of transplantation where each
of the conditions specified in section 3A(2) is met.”
(3)
In section 3(6) (meaning of “appropriate consent” where adult has died), after
10
the words “subsection (4)”, insert the words “or (4B)”.
(4)
After section 3 insert—
“3A
Determination of consent for purpose of transplantation where certain
conditions are met
(1)
Where part of the body of a deceased adult (“person A”) lying in a
15
hospital or other institution is or may be suitable for use for
transplantation, it shall be the duty of the person having the control and
management of the institution to ensure that, before any organ is
removed from the body of person A for the purpose of transplantation
under the provisions of this section, each of the conditions specified in
20
subsection (2) is met.
(2)
Those conditions are—

Bill 32 53/4

Human Tissue Act 2004 (Amendment) Bill
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(a)
that person A was, immediately before he died, ordinarily
resident in England, Wales or Northern Ireland;
(b)
that person A did not, at any time during the relevant period,
lack the capacity to decide to make his organs, or the relevant
organ, unavailable for removal for the purpose of
5
transplantation;
(c)
that, where the person to whom the duty under subsection (1)
applies knows, or has reason to believe, that—
(i)
the body of person A, or
(ii)
relevant material which has come from the body of
10
person A,

is, or may be, required for purposes of functions of a coroner,
the consent of the coroner for the removal of the organ has been
obtained;
(d)
that it has been duly ascertained that person A—
15
(i)
had decided to make his organs, or the relevant organ,
available for removal for the purpose of transplantation
and had had that decision duly recorded in the register,
or
(ii)
had not had a decision to make his organs, or the
20
relevant organ, unavailable for removal for the purpose
of transplantation duly recorded in that register; and
(e)
that no person with a right to signify an objection under the
provisions of section 34C has done so.
(3)
Where each condition in subsection (2) is met, ‘appropriate consent’
25
shall have been determined for—
(a)
the removal of organs, or the relevant organ, from the body of
person A for the purpose of transplantation,
(b)
the storage for use for the purpose of transplantation of those
organs or that organ, and
30
(c)
the use for the purpose of transplantation of those organs or that
organ.
(4)
Where a body is transferred to another institution prior to the removal
of any organ for the purpose of transplantation, the duty under
subsection (1) shall also be transferred to the person having the control
35
and management of the institution to which the body has been
transferred.
(5)
The person to whom the duty under subsection (1) applies may
designate another person to perform activities in relation to that duty.
(6)
It shall be the duty of the person to whom the duty under subsection (1)
40
applies to secure that any person designated under subsection (5) to
perform activities is a suitable person to participate in the carrying on
of those activities.
3B
Interpretation of section 3A, etc.
(1)
Nothing in section 3A prevents the carrying on of an activity involving
45
the removal, storage for use, or use, of an organ for the purpose of
transplantation where that activity is one to which section 3(6) applies.

Human Tissue Act 2004 (Amendment) Bill
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(2)
For the purposes of section 3A, this section and sections 34A and 34C,
the death of person A shall be determined in accordance with the terms
of the code of practice issued under section 26(1) that deals with the
matters specified in subsection (2)(d) and (da) of that section.
(3)
During the period that ends three years after the coming into force of
5
section 34A, ‘the relevant period’ for the purposes of section 3A(2)(b)
means the period that—
(a)
begins with the date on which section 34A comes into force, and
(b)
ends with the date determined in accordance with the
provisions of subsections (5) and (6).
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(4)
During the period that starts three years after the coming into force of
section 34A, ‘the relevant period’ for the purposes of section 3A(2)(b)
means the period that—
(a)
begins on the date that falls three years before the date
determined in accordance with the provisions of subsections (5)
15
and (6), and
(b)
ends with the date determined in accordance with the
provisions of subsections (5) and (6).
(5)
In any case where the death of person A is caused by the occurrence of
an accident or event that impairs or disturbs the functioning of the
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mind or brain of person A, the date on which the relevant period ends
is the date of the occurrence of that accident or event.
(6)
In any case where subsection (5) does not apply, the date on which the
relevant period ends is the date of the death of person A.
(7)
For the purposes of section 3A(2)(b), the term ‘lack the capacity’ shall
25
be construed in accordance with the provisions of Part 1 of the Mental
Capacity Act 2005.”
(5)
In section 4(1) (circumstances where nominated representative may be
appointed), at end, insert the words “except where consent stands to be
determined in accordance with the provisions of section 3A”.
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2
Amendment of Part 2 of the Human Tissue Act 2004
(1)
Part 2 of the Human Tissue Act 2004 (c. 30) is amended as follows.
(2)
In section 26(2) (matters with which codes of practice shall deal), for paragraph
(d) substitute—
“(d)
the definitions of death for the purposes of this Act, including a
35
definition of death confirmed by brain stem tests for the
purpose of sections 3A and 3B;
(da)
the procedures to be followed in relation to brain stem tests for
the purpose of confirming death;”.
(3)
After section 26(3), insert—
40
“(3A)
In dealing under subsection (1) with the matters mentioned in
subsection (2)(g), (h) and (i), the Authority shall, in particular, lay down
the standards expected in relation to the performance of duties under
sections 3A and 34C.”

Human Tissue Act 2004 (Amendment) Bill
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(4)
After section 34 insert—
“34A
Register of personal decisions about availability of organs for purpose
of transplantation
(1)
It shall be the duty of the relevant authority to establish and maintain a
register of information provided to the relevant authority in accordance
5
with the provisions of this section.
(2)
Any person who decides to make his organs generally, or specified
organs—
(a)
available, or
(b)
unavailable,
10

for removal for the purpose of transplantation may inform the relevant
authority of that decision in a prescribed manner.
(3)
Any person who—
(a)
has informed the relevant authority of his decision under
subsection (2), and
15
(b)
then makes a subsequent decision about the matter,

may inform the relevant authority of that subsequent decision in a
prescribed manner.
(4)
Any person informing the relevant authority of a decision under
subsection (2) or (3) may also provide the relevant authority in a
20
prescribed manner with the name and contact details of a person to be
contacted in the event of his death.
(5)
As soon as practicable after the receipt of information from a person in
accordance with subsection (2), (3) or (4), the relevant authority shall—
(a)
confirm to that person in writing that the information has been
25
received,
(b)
make available to that person an organ donor card summarising
the information contained, or to be contained, in the entry in the
register in respect of that person, and
(c)
ensure that—
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(i)
an entry in respect of that person is made in the register,
or
(ii)
the entry in respect of that person is amended.
(6)
The prescribed manner in which an adult may provide information to
the relevant authority for the purposes of this section shall include
35
opportunities to provide such information when a person is—
(a)
receiving primary medical services,
(b)
applying for a United Kingdom driving licence, or
(c)
applying for a United Kingdom passport (within the meaning
of the Immigration Act 1971).
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(7)
For the purposes of subsection (6)—
‘primary medical services’—
(a)
in relation to England and Wales, has the same meaning
as in section 128(1) of the National Health Service Act
1977 (interpretation), and
45
(b)
in relation to Northern Ireland, means any service under
any enactment which extends to Northern Ireland and

Human Tissue Act 2004 (Amendment) Bill
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which corresponds to services within the meaning of the
term ‘primary medical services’ in section 128(1) of the
National Health Service Act 1977,
and ‘receiving primary medical services’ includes registering
for the receipt of primary medical services;
5
‘a United Kingdom driving licence’ means—
(a)
a licence to drive a motor vehicle granted under Part 3 of
the Road Traffic Act 1988, or
(b)
a licence to drive a motor vehicle granted under Part 2 of
the Road Traffic (Northern Ireland) Order 1981
10
(S.I. 1981/154 (N.I. 1)).
(8)
The relevant authority shall take such steps as it considers appropriate
to promote public awareness of the register and of the means by which
a person may make or amend an entry in the register.
(9)
Where the relevant authority is satisfied that—
15
(a)
a person in relation to whom information is held on the register
has died, and
(b)
a period of one month has elapsed since his death,

the relevant authority may remove the entry in respect of that person
from the register.
20
(10)
Information held by the relevant authority in accordance with the
provisions of this section may only be made available to—
(a)
the person in respect of whom the information is held (“person
R”),
(b)
persons holding an office or employment the duties of which
25
relate, in whole or in part, to the establishment or maintenance
of the register, or
(c)
(when either condition in subsection (11) is met), the persons
specified in or under subsection (12).
(11)
The conditions in this subsection are—
30
(a)
that person R has died, or
(b)
that, in the opinion of the person to whom the duty under
section 3A(1) would apply in relation to person R if person R
were to die—
(i)
part of the body of person R is or may be suitable for use
35
for transplantation, and
(ii)
the death of person R is imminent.
(12)
Those persons specified in this subsection are—
(a)
a person who stands in a qualifying relationship to person R,
(b)
the person to whom the duty under section 3A(1) applies in
40
relation to person R or would apply in relation to person R if
person R were to die,
(c)
a person who is designated under section 3A(5) to perform
activities in relation to person R,
(d)
persons of such classes as may be prescribed by regulations.
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(13)
In this section and sections 34B and 34C, ‘the relevant authority’ has the
prescribed meaning.

Human Tissue Act 2004 (Amendment) Bill
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(14)
In this section and section 34B, ‘prescribed’ means prescribed by
regulations made by the Secretary of State.
34B
Unauthorised disclosure of information and offences relating to
entries in the register
(1)
A person is guilty of an offence if, without lawful authority—
5
(a)
he provides any person with information that he is required to
keep confidential;
(b)
he otherwise makes a disclosure of any such information; or
(c)
he wilfully does anything which causes an entry in the
register—
10
(i)
not to be made after the relevant authority has been
informed in a prescribed manner,
(ii)
to be removed without due authorisation, or
(iii)
to be false or incomplete.
(2)
For the purposes of this section a person is required to keep information
15
confidential if it is information that is or has become available to him by
reason of his holding an office or employment the duties of which
relate, in whole or in part, to the establishment or maintenance of the
register.
(3)
For the purposes of this section information is provided or otherwise
20
disclosed with lawful authority if, and only if—
(a)
it is authorised by or under this Act or another enactment; or
(b)
it is made for the purpose of performing the duties of an office
or employment of the sort mentioned in subsection (2).
(4)
It is a defence for a person charged with an offence under this section
25
to show that, at the time of the alleged offence, he believed, on
reasonable grounds, that he had lawful authority to—
(a)
provide the information or to make the other disclosure in
question, or
(b)
to alter, remove or not make the entry in question.
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(5)
A person guilty of an offence under this section shall be liable to—
(a)
imprisonment for a term not exceeding 12 months, or
(b)
a fine not exceeding the statutory maximum, or
(c)
both.
34C
Duties to persons who stood in a qualifying relationship in relation to
35
transplantation
(1)
It shall be the duty of the person to whom the duty under section 3A(1)
applies in relation to person A, as soon as practicable after the death of
person A, to—
(a)
inform the person or persons who stood in a qualifying
40
relationship to person A immediately before the death of person
A of the rights of that person or those persons under this
section, and
(b)
to provide him or them with an opportunity to exercise those
rights.
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(2)
Those rights are—

Human Tissue Act 2004 (Amendment) Bill
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(a)
to be informed about the operation of the relevant provisions of
this Act, and
(b)
to signify an objection to the removal of a relevant organ from
person A for a reason specified in subsection (4), (5) or (6).
(3)
For the purposes of subsection (2)(a), ‘the relevant provisions of this
5
Act’ are—
(a)
section 3A,
(b)
section 3B,
(c)
section 26(3A),
(d)
section 34A,
10
(e)
this section, and
(f)
section 43.
(4)
The reason specified in this subsection is that person A had made
known his decision to make his organs generally, or a relevant organ,
unavailable for removal for the purpose of transplantation, but had not
15
informed the relevant authority for the purpose of securing the making
or amending of the entry in the register in respect of person A.
(5)
The reason specified in this subsection is that—
(a)
person A had made known his decision to make his organs
generally, or a relevant organ, unavailable for removal for the
20
purpose of transplantation, and
(b)
person A had informed the relevant authority accordingly, but
either—
(i)
an entry in respect of person A was not made in the
register, or
25
(ii)
the entry in respect of person A in the register was not
amended accordingly.
(6)
The reason specified in this subsection is that the removal of a relevant
organ from person A for the purpose of transplantation would cause
significant distress to any person who stood in a qualifying relationship
30
to person A immediately before the death of person A.
(7)
The person to whom the duty under subsection (1) applies may
designate another person to perform activities in relation to that duty.
(8)
It shall be the duty of the person to whom the duty under subsection (1)
applies to secure that any person designated under subsection (7) to
35
perform activities is a suitable person to participate in the carrying on
of those activities.
(9)
The qualifying relationships for the purposes of this section are—
(a)
spouse or partner;
(b)
parent or child;
40
(c)
brother or sister.
(10)
The qualifying relationships shall be ranked in the order given in
subsection (9) for the purposes of subsection (1).
(11)
Relationships in the same paragraph of subsection (9) shall be accorded
equal ranking for those purposes.
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