Human Tissue Bill

House of Commons

Session 2003 - 04
Internet Publications
Other Bills before Parliament

Human Tissue Bill

Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
21

(5)
Where under subsection (3) an exception from subsection (1) or (2) is in force,
a person does not commit an offence under that subsection if he reasonably
believes that the exception applies.
(6)
A person guilty of an offence under this section is liable on summary
conviction—
5
(a)
to imprisonment for a term not exceeding 51 weeks, or
(b)
to a fine not exceeding level 5 on the standard scale, or
(c)
to both.
(7)
In this section—

“reward” has the same meaning as in section 29;
10

“transplantable material” means material of a description specified by
order made by the Authority.
31
Information about transplant operations
(1)
The Secretary of State may make regulations requiring such persons as may be
specified in the regulations to supply to such authority as may be so specified
15
such information as may be so specified with respect to transplants that have
been or are proposed to be carried out using transplantable material removed
from a human body.
(2)
Any such authority shall keep a record of information supplied to it in
pursuance of regulations under this section.
20
(3)
A person commits an offence if—
(a)
he fails without reasonable excuse to comply with regulations under
this section, or
(b)
in purported compliance with such regulations, he knowingly or
recklessly supplies information which is false or misleading in a
25
material respect.
(4)
A person guilty of an offence under subsection (3)(a) is liable on summary
conviction to a fine not exceeding level 3 on the standard scale.
(5)
A person guilty of an offence under subsection (3)(b) is liable on summary
conviction to a fine not exceeding level 5 on the standard scale.
30
(6)
In this section, “transplantable material” has the same meaning as in section 30.
Inspectorates
32
Inspectorate of Anatomy and Pathology
(1)
There shall be an Inspectorate of Anatomy and Pathology consisting of—
(a)
a board,
35
(b)
a chief executive officer appointed by the Authority, and
(c)
such other staff of the Authority as may be assigned by the Authority
to assist the board.
(2)
The chief executive officer and the other staff assigned to assist the board of the
Inspectorate of Anatomy and Pathology shall be under the direction of the
40
board.

Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
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(3)
The board of the Inspectorate of Anatomy and Pathology shall carry out on
behalf of the Authority such of the Authority’s functions in relation to activities
within the remit of the Inspectorate as the Secretary of State may by order
provide.
(4)
The Authority may delegate to the board of the Inspectorate of Anatomy and
5
Pathology (to such extent as it may determine) any function in relation to an
activity within the remit of the Inspectorate.
(5)
Schedule 4 has effect in relation to the board of the Inspectorate of Anatomy
and Pathology.
33
Remit of Inspectorate of Anatomy and Pathology
10
(1)
The following are the activities within the remit of the Inspectorate of Anatomy
and Pathology—
(a)
the removal from a human body, for use for a scheduled purpose other
than transplantation, of relevant material of which the body consists or
which it contains;
15
(b)
the use of—
(i)
the body of a deceased person, or
(ii)
relevant material which has come from a human body,

for a scheduled purpose other than transplantation;
(c)
the storage of an anatomical specimen or former anatomical specimen;
20
(d)
the storage (in any case not falling within paragraph (c)) of—
(i)
the body of a deceased person, or
(ii)
relevant material which has come from a human body,

for use for a scheduled purpose other than transplantation;
(e)
the import or export of—
25
(i)
the body of a deceased person, or
(ii)
relevant material which has come from a human body,

for use for a scheduled purpose other than transplantation;
(f)
the disposal of the body of a deceased person which has been—
(i)
imported for use,
30
(ii)
stored for use, or
(iii)
used,

for a scheduled purpose;
(g)
the disposal of relevant material which—
(i)
has been removed from a person’s body for the purposes of his
35
medical treatment,
(ii)
has been removed from the body of a deceased person for the
purposes of an anatomical, or post-mortem, examination,
(iii)
has been removed from a human body (otherwise than as
mentioned in sub-paragraph (ii)) for use for a scheduled
40
purpose other than transplantation,
(iv)
has come from a human body and been imported for use for a
scheduled purpose other than transplantation, or
(v)
has come from the body of a deceased person which has been
imported for use for a scheduled purpose.
45

Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
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(2)
Without prejudice to the generality of subsection (1)(a) and (b), the activities
within the remit of the Inspectorate of Anatomy and Pathology include, in
particular—
(a)
the carrying-out of an anatomical examination, and
(b)
the making of a post-mortem examination.
5
(3)
An activity is excluded from the remit of the Inspectorate of Anatomy and
Pathology if it is done for purposes of a qualifying museum.
(4)
The Secretary of State may by order amend this section for the purpose of
adding to the activities within the remit of the Inspectorate of Anatomy and
Pathology an activity within the remit of the Authority.
10
34
Inspectorate of Organ and Tissue for Human Use
(1)
There shall be an Inspectorate of Organ and Tissue for Human Use consisting
of—
(a)
a board,
(b)
a chief executive officer appointed by the Authority, and
15
(c)
such other staff of the Authority as may be assigned by the Authority
to assist the board.
(2)
The chief executive officer and the other staff assigned to assist the board of the
Inspectorate of Organ and Tissue for Human Use shall be under the direction
of the board.
20
(3)
The board of the Inspectorate of Organ and Tissue for Human Use shall carry
out on behalf of the Authority such of the Authority’s functions in relation to
activities within the remit of the Inspectorate as the Secretary of State may by
order provide.
(4)
The Authority may delegate to the board of the Inspectorate of Organ and
25
Tissue for Human Use (to such extent as it may determine) any function in
relation to an activity within the remit of the Inspectorate.
(5)
Schedule 4 has effect in relation to the board of the Inspectorate of Organ and
Tissue for Human Use.
35
Remit of Inspectorate of Organ and Tissue for Human Use
30
(1)
The following are the activities within the remit of the Inspectorate of Organ
and Tissue for Human Use—
(a)
the removal from a human body, for use for the purpose of
transplantation, of relevant material of which the body consists or
which it contains;
35
(b)
the use, for the purpose of transplantation, of relevant material which
has come from a human body;
(c)
the storage, for use for the purpose of transplantation, of relevant
material which has come from a human body;
(d)
the import or export, for use for the purpose of transplantation, of
40
relevant material which has come from a human body;
(e)
the disposal of relevant material which—
(i)
has been removed from a human body for use for the purpose
of transplantation, or

Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
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(ii)
has come from a human body and been imported for use for the
purpose of transplantation.
(2)
The Secretary of State may by order amend this section for the purpose of
adding to the activities within the remit of the Inspectorate of Organ and Tissue
for Human Use an activity within the remit of the Authority.
5
(3)
In this section, “relevant material” does not include blood or anything derived
from blood.
36
Duties in relation to discharge of functions by Inspectorates
(1)
In carrying out functions of the Authority, each of the Inspectorates shall have
regard to the general principles which the Authority has for the time being
10
stated for the purposes of section 12(a)(ii).
(2)
The Authority shall monitor the carrying-out of functions by each of the
Inspectorates.
(3)
The Authority shall establish a procedure for dealing with complaints in
relation to the carrying-out of functions by each of the Inspectorates.
15
General
37
Agency arrangements and provision of services
(1)
Arrangements may be made between the Authority and a government
department, a public authority or the holder of a public office (“the other
authority”) for—
20
(a)
any functions of the Authority to be carried out by, or by members of
staff of, the other authority, or
(b)
the provision by the other authority of administrative, professional or
technical services to the Authority.
(2)
Arrangements under subsection (1)(a) shall not affect responsibility for the
25
carrying-out of the Authority’s functions.
(3)
Subsection (1)(a) shall not apply to functions of making subordinate legislation
(within the meaning of the Interpretation Act 1978 (c. 30)).
38
Annual report
(1)
The Authority shall prepare—
30
(a)
a report for the first twelve months of its existence, and
(b)
a report for each succeeding period of twelve months.
(2)
A report under this section shall deal with the activities of the Authority and
the Inspectorates in the period to which the report relates.
(3)
The Authority shall send each report under this section—
35
(a)
to the Secretary of State,
(b)
to the National Assembly for Wales, and
(c)
to the relevant Northern Ireland department,

as soon as practicable after the end of the period to which the report relates.

Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
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(4)
The Secretary of State shall lay a copy of each report received by him under this
section before each House of Parliament.
(5)
The relevant Northern Ireland department shall lay a copy of each report
received by it under this section before the Northern Ireland Assembly.
39
Directions
5
(1)
The Authority may give directions for any purpose for which directions may
be given under this Part.
(2)
Any power under this Part to give directions includes power to vary or revoke
directions given in previous exercise of the power.
(3)
Any power under this Part to give directions is exercisable by instrument in
10
writing.
(4)
Directions under this Part to a particular person shall be given by serving
notice of the directions on the person.
(5)
Directions under this Part in respect of any licence (including one which has
ceased to have effect) may be given—
15
(a)
by serving notice of the directions on the person who is (or was
immediately before the cessation) the designated individual or holder
of the licence, or
(b)
if it appears to the Authority that it is not practicable to give notice in
that way, by publishing the directions in such way as, in its opinion, is
20
likely to bring them to the attention of the persons to whom they are
applicable.
(6)
Directions under this Part which appear to the Authority to be general
directions may be given by publishing them as mentioned in subsection (5)(b).
(7)
This section does not apply to directions under Schedule 2.
25
Exceptions
40
Criminal justice purposes
(1)
Subject to subsection (2), nothing in section 11(1), 13(2) or 33(1) applies to
anything done for purposes related to—
(a)
the prevention or detection of crime, or
30
(b)
the conduct of a prosecution.
(2)
Subsection (1) does not except from section 11(1), 13(2) or 33(1) the carrying-
out of a post-mortem examination for purposes of functions of a coroner.
(3)
The reference in subsection (2) to the carrying-out of a post-mortem
examination does not include the removal of relevant material from the body
35
of a deceased person, or from a part of the body of a deceased person, at the
place where the body or part is first found by a constable.
(4)
For the purposes of subsection (1)(a), detecting crime shall be taken to
include—
(a)
establishing by whom, for what purpose, by what means and generally
40
in what circumstances any crime was committed, and
(b)
the apprehension of the person by whom any crime was committed;

Human Tissue Bill
Part 2 — Regulation of activities involving human tissue
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and the reference in subsection (1)(a) to the detection of crime includes any
detection outside the United Kingdom of any crime or suspected crime.
(5)
In subsection (1)(b), the reference to a prosecution includes a prosecution
brought in respect of any crime in a country or territory outside the United
Kingdom.
5
(6)
In this section, references to crime include a reference to any conduct which—
(a)
constitutes one or more criminal offences (whether under the law of a
part of the United Kingdom or of a country or territory outside the
United Kingdom),
(b)
is, or corresponds to, any conduct which, if it all took place in any one
10
part of the United Kingdom, would constitute one or more criminal
offences, or
(c)
constitutes one or more offences of a kind triable by court-martial
under the Army Act 1955 (3 & 4 Eliz. 2 c. 18), the Air Force Act 1955
(3 & 4 Eliz. 2 c. 19) or the Naval Discipline Act 1957 (c. 53).
15
41
Religious relics
(1)
This section applies—
(a)
to the use of—
(i)
the body of a deceased person, or
(ii)
relevant material which has come from a human body,
20

for the purpose of public display at a place of public religious worship
or at a place associated with such a place, and
(b)
to the storage of—
(i)
the body of a deceased person, or
(ii)
relevant material which has come from a human body,
25

for use for the purpose mentioned in paragraph (a).
(2)
An activity to which this section applies is excluded from sections 11(1), 13(2)
and 33(1) if there is a connection between—
(a)
the body or material to which the activity relates, and
(b)
the religious worship which takes place at the place of public religious
30
worship concerned.
(3)
For the purposes of this section, a place is associated with a place of public
religious worship if it is used for purposes associated with the religious
worship which takes place there.
Supplementary
35
42
“Qualifying museum”
(1)
For the purposes of this Part, a museum is a “qualifying museum” if—
(a)
it has a permanent collection that is open to the public, and
(b)
it is, or is maintained by, an eligible institution.
(2)
In this Part, references to purposes of a qualifying museum, where the
40
qualifying museum is maintained by an eligible institution, are to purposes of
the institution which maintains the museum, so far as relating to the museum.
(3)
In this section, “eligible institution” means an institution which—

Human Tissue Bill
Part 3 — Miscellaneous and general
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(a)
does not make profits,
(b)
is precluded from distributing any profits it makes, or
(c)
may distribute any profits it makes only to eligible institutions.
43
Interpretation of Part 2
(1)
In this Part—
5

“anatomical specimen” means—
(a)
the body of a deceased person to be used for the purpose of
anatomical examination, or
(b)
the body of a deceased person in the course of being used for the
purpose of anatomical examination (including separated parts
10
of such a body);

“appeals committee” has the meaning given by section 17(2);

“designated individual”, in relation to a licence, means the individual
designated in the licence as the person under whose supervision the
licensed activity is authorised to be carried on;
15

“export” means export from England, Wales or Northern Ireland to a
place outside England, Wales and Northern Ireland;

“import” means import into England, Wales or Northern Ireland from a
place outside England, Wales and Northern Ireland;

“the Inspectorates” means the Inspectorate of Anatomy and Pathology
20
and the Inspectorate of Organ and Tissue for Human Use;

“scheduled purpose” means a purpose specified in Schedule 1.
(2)
In this Part, references to a person to whom a licence applies are to a person to
whom the authority conferred by the licence extends (as provided by section
14).
25
Part 3
Miscellaneous and general
Miscellaneous
44
Preservation for transplantation
(1)
Where part of a body lying in a hospital, nursing home or other institution is
30
or may be suitable for use for transplantation, it shall be lawful for the person
having the control and management of the institution—
(a)
to take steps for the purpose of preserving the part for use for
transplantation, and
(b)
to retain the body for that purpose.
35
(2)
Authority under subsection (1)(a) shall only extend—
(a)
to the taking of the minimum steps necessary for the purpose
mentioned in that provision, and
(b)
to the use of the least invasive procedure.
(3)
Authority under subsection (1) ceases to apply once it has been established that
40
consent making removal of the part for transplantation lawful has not been,
and will not be, given.